medicine

Montana Supreme Court Brushes Aside ‘Citizens United’

by Mike Sacks on January 4, 2012

Huffington Post…

WASHINGTON — The Montana Supreme Court has put itself on a collision course with the U.S. Supreme Court by upholding a century-old state law that bans corporate spending in state and local political campaigns. The law, which was passed by Montana voters in 1912 to combat Gilded Age corporate control over much of Montana’s government, states that a “corporation may not make … an expenditure in connection with a candidate or a political party that supports or opposes a candidate or a political party.” In 2010, the U.S. Supreme Court, in its landmark Citizens United v. Federal Election Commission decision , struck down a similar federal statute, holding that independent electoral spending by corporations “do not give rise to corruption or the appearance of corruption” that such laws were enacted to combat. That reasoning — described by the Citizens United dissenters as a ” crabbed view of corruption ” — compelled 23 of the 24 states with independent spending bans to stop enforcing their restrictions, according to Edwin Bender, executive director of the Helena, Mont.-based National Institute on Money in State Politics . Montana, however, stood by its 1912 law, which led several corporations to challenge it as unconstitutional. By a 5-2 vote this past Friday, the Montana Supreme Court declined to recognize the common understanding that Citizens United bars all laws limiting independent electoral spending. Instead, Chief Justice Mike McGrath, writing on behalf of the majority, called on the history surrounding the state law to show that corporate money, even if not directly contributed to a campaign, can give rise to corruption. McGrath’s opinion in Western Tradition Partnership v. Attorney General harkens back to the turn of the 20th century, when Montana’s ” Copper Kings ” — the natural resource-rich state’s version of the robber barons — competed “for political and economic domination” so effectively that by the time the Montana voters banned corporate spending in a voter initiative, “the State of Montana and its government were operating under a mere shell of legal authority.” One such Copper King, wrote Mark Twain in a quotation cited by McGrath, was “said to have bought legislatures and judges as other men buy food and raiment.” Paul S. Ryan, associate legal counsel at the Campaign Legal Center , characterized the Montana Supreme Court’s reliance on factual findings culled from a century of state history, plus the trial testimony from contemporary politicians of both parties, as “an antidote to the crabbed view of corruption” adopted in Citizens United . Nevertheless, most observers, including Ryan, do not anticipate the U.S. Supreme Court accepting that antidote. The ruling in Citizens United that independent spending does not give rise to corruption introduced a categorical rule that no factual reality can overcome as long as the decision’s five-justice majority remains on the Court. To make this point, dissenting state Justice Beth Baker wrote that Montana “made no more compelling a case than that painstakingly presented in the 90-page dissenting opinion of Justice [John Paul] Stevens and emphatically rejected by the majority in Citizens United .” And state Justice James Nelson, also dissenting, put the point more bluntly. Even while lambasting Citizens United ‘s reasoning as “utter nonsense” and “smoke and mirrors,” among other insults, he found himself duty-bound to defer to the decision of the highest court in the land. “The Supreme Court in Citizens United rejected several asserted governmental interests,” wrote Nelson, “and this Court has now come along, retrieved those interests from the garbage can, dusted them off, slapped a ‘Made in Montana’ sticker on them, and held them up as grounds for sustaining a patently unconstitutional state statute.” Nelson wrote that it “would not surprise me in the least” if the U.S. Supreme Court reversed his court’s decision without even asking for briefs or oral argument from the opposing parties. To reverse the Montana Supreme Court, however, the justices would have to extract themselves from a quandary of their own making, noted professor Rick Hasen of the University of California-Irvine Law School on his popular Election Law Blog. “If the Court were being honest in Citizens United ,” Hasen wrote, “it would have said something like: We don’t care whether or not independent spending can or cannot corrupt; the First Amendment trumps this risk of corruption.” But by “dress[ing] up its value judgment … as a factual statement,” continued Hasen, the U.S. Supreme Court must now explain why the Montana Supreme Court was not correct to consider the factual record when it came to justifying corporate spending limits in campaign finance laws. How the Citizens United majority will deny the force of Montana’s factual record or, for that matter, Mark Twain’s observations — and whether the Citizens United dissenters will express their schadenfreude at their colleagues’ efforts — remains hypothetical for now. Donald Ferguson, executive director of lead plaintiff American Tradition Partnership (formerly known as Western Tradition Partnership), wrote in an email to HuffPost that his organization has “not yet made a decision on future actions regarding the suit.”

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Montana Supreme Court Brushes Aside ‘Citizens United’

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Obama Threatens To Veto GOP Bill Aimed At Weakening Controversial New Agency

by AP on July 20, 2011

Huffington Post…

WASHINGTON — The White House on Wednesday threatened to veto a House Republican bill that would curb the powers of the new Consumer Financial Protection Bureau, reviving last year’s pitched partisan battle over President Barack Obama’s overhaul of the rules governing financial markets. The veto threat came a day before the House was to vote on the GOP legislation – a debate to be held on the very day that the bureau officially opens. The agency was created by the financial overhaul measure, which Obama signed into law a year ago Thursday as a response to the 2008 financial crisis. While the legislation is expected to clear the Republican-run House, it has little chance of even being considered by the Democratic-led Senate, making both the bill and the veto threat symbolic gestures. The bureau is supposed to protect consumers from abuses involving mortgages, credit cards and other financial instruments. It’s been embraced by Democrats but opposed by many Republicans who say it threatens to stifle financial companies. The GOP bill being debated this week would replace the bureau’s director with a five-member bipartisan commission. It would delay the planned transfer of powers to the bureau from other agencies until a Senate-confirmed chair of the commission was in place, and make it easier for other federal financial regulators to block the bureau from issuing regulations. The Republican measure “simply promotes greater accountability and transparency” at the bureau, House Financial Services Committee Chairman Spencer Bachus, R-Ala., said in a written statement. “The American people want accountability at every massive government bureaucracy.” In its written statement on the GOP legislation, the White House said the bill “would expose American consumers and the nation’s economy to the same risks that led to the 2008 financial crisis.” The statement said that Obama’s senior advisers would recommend that he veto the legislation and any other that poses similar threats. All 47 Republican senators have promised to block confirmation of anyone to head the bureau unless Obama agrees to change it, including replacing the director with a bipartisan commission. That would leave Senate Democrats seven votes short of the 60 votes they would need to confirm a director. Presidential adviser Elizabeth Warren, a Harvard law professor and longtime consumer activist, has led the administration’s start-up of the agency. Facing sharp GOP opposition to her becoming its director, Obama this week nominated Richard Cordray, the former Ohio attorney general who has been the bureau’s enforcement chief, to become director.

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Obama Threatens To Veto GOP Bill Aimed At Weakening Controversial New Agency

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Anti-Tax Billionaire Steve Schwarzman: Even Rich Americans Need To ‘Give Something Up’ To Help Narrow Deficit

April 26, 2011

The billionaire who last year compared Obama’s attempts to raise taxes on private equity firms with Hitler’s invasion of Poland, on Monday said even rich Americans will have to “give something up” to help narrow the deficit. In response to a question about raising taxes on the richest 2 percent of Americans, Stephen Schwarzman, the billionaire founder of private equity giant, the Blackstone Group, said the deficit was serious enough that almost everybody in society would have to “give something up.” (Scroll down for video.) “And no one’s going to like it,” Schwarzman told Bloomberg. “It’s like medicine in the old days that tasted really bad, but if you didn’t take your medicine, you weren’t going to get healthy,” he said of the attempts to effectively end the Bush-era tax cuts. “I think this is a widespread issue where everyone is going to be giving something up, and if you don’t, you’re not going to be able to solve the problems we have.” If Americans didn’t make sacrifices, he said, people’s livelihoods would be under threat — and everybody but the poorest Americans, who need protection, he said — would have to chip in, he reiterated. The comments appear to mark a reversal for the billionaire, who last year, compared an Obama administration push to increase taxes on private equity firms — so they would pay the same tax rate as the rest of America — to a “war… like when Hitler invaded Poland in 1939.” In Monday’s Bloomberg interview, Schwarzman noted that the rhetoric from politicians has been more sympathetic towards business since the mid-term elections in November. Earlier in 2010 Schwarzman also controvertially said that Wall Street-bashing would make banks “insecure” and tighten up lending. The remarks come as a battle rages over how to make up the budget shortfall. The Obama administration and Congress must come up with an aggressive long-term plan to reduce the currently $1.5 trillion budget deficit , roughly equivalent to 9.8 percent of U.S. economic output. Earlier this month, the Obama administration proposed a plan that would cut $4 trillion from the budget deficit over the next 12 years, mostly through spending cuts and tax hikes on the rich. Just before, the Republican-controlled House of Representatives approved a different deal to reduce deficits by $4 trillion over the next 10 years while also extending President George W. Bush’s tax cuts at all income levels and repealing Obama’s health care law. The two factions must strike a deal before the country reaches its $14.3 trillion debt ceiling — the maximum amount it can borrow under law. Treasury Secretary Tim Geithner has warned Congress that the debt limit will be hit by May 16, but that he can take “extraordinary measures” to make sure the nation’s debts are paid until roughly July 8, at which point the government would default on some of its debts.

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Mark W. Kline, M.D.: Fighting Sickle Cell Disease in Angola: Building Partnerships to Match the Challenge

March 22, 2011

Angola has one of the world’s highest rates of sickle cell disease, but lacked a formal, organized effort to fight it — until now. A history-making agreement was signed today in the capital of Luanda, initiating the West African nation’s first program to address a disease that likely affects some 6,000 babies born in Angola each year. Even though a fifth of Angola’s roughly 17 million people have the sickle cell trait, information on the number of children affected is sketchy, as only a fraction are diagnosed. Serious complications of the disease — including bacterial infections and stroke — mean that only about half of Angola’s affected children reach age 2. The disease is a major contributor to Angola’s child mortality rate, among the world’s highest. A staggering one in four Angolan children will die before they reach their fifth birthday. The good news is that we now have the tools to change this bleak outlook for African children born with sickle cell disease — in exactly the same way we now expect American children with the disease to live long and full lives. The key is early diagnosis and treatment. That’s the focus of a new public-private partnership of the Republic of Angola, the Baylor International Pediatrics AIDS Initiative (BIPAI) — a joint program of Baylor College of Medicine and Texas Children’s Hospital — and Chevron. Based on experience in the United States — which accounts for less than one percent of the estimated 300,000 to 500,000 global cases of sickle cell disease each year and where newborn screening is universal — the program’s pilot will begin with newborn screening and subsequent treatment at two large maternity hospitals in Luanda. The project, designed by leading global sickle cell disease expert Dr. Russell Ware in close coordination with BIPAI and medical experts in Angola, is comprehensive. Following the pilot, the goal will be to expand subsequent phases to Angola’s 18 provinces, simultaneously building Angola’s capacity to address the disease through public health policies, health training and the dissemination of clinical research. Why is Angola’s need so acute? Although rich in natural resources such as diamonds and oil – Angola is the second-largest oil producer in sub-Saharan Africa and the 7th largest supplier to the U.S. — Angola is only eight years removed from a 27-year civil war that devastated its infrastructure, including its healthcare system, and severely impacted its socio-economic development. Why this particular partnership? To help its children, the Angolan government reached out to Chevron. Not only has Chevron operated in Angola for more than 50 years, it also has been a driver of the successful Angola Partnership Initiative, a multipartner, multiyear effort to rebuild Angola’s agricultural sector and promote small business [outside the oil industry]. Chevron, in turn, reached out to experts — in this disease, in pediatric medicine and, as in the case of Baylor College of Medicine and Texas Children’s Hospital, to organizations with a proven track record establishing medical capacity building programs. To make headway against such a disease, especially in a time of limited resources, the engagement of corporate partners is critical. Success depends on building smart partnerships — that include the core strengths of leading global companies — that match the size of the challenge. But why do Angola’s health issues concern business? Only with a healthy local workforce and a healthy local economy can a business, global or local, operate successfully over the long term. It’s in the interests of business to help address unmet basic human needs — health, education and economic development — that pose risks to any community. Chevron has learned that success depends on committed partners, with unique and complementary resources, who collaborate — the same ingredients at work in other partnerships Chevron engages in around the globe. Partners with strategically aligned strengths are even more effective vehicles for bringing focused action to diseases such HIV/AIDS, tuberculosis and malaria. As with its other partnerships, Chevron’s $4 million investment in this new alliance comes with a hands-on commitment to achieve lasting results: the involvement of its employees and business partners. The agreement signed today is only the beginning of giving more of Angola’s children a greater chance at life .. and moving Angola one step closer to harnessing its vast national potential. We all have a stake in helping write history like that.

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Joseph J. Thorndike: Will Business Kill Tax Reform?

January 26, 2011

Corporations like to complain about their taxes. In testimony, statements, and speeches, executives rehearse the same old litany of woe. Rates are too high! We pay too much! We can’t compete with foreign companies! There’s a kernel of truth in these complaints. U.S. corporate tax rates are among the highest in the world. And some U.S. companies are paying a lot of taxes. Corporate tax reform, as President Obama declared in his State of the Union speech, is certainly long overdue. But what sort of reform? Some corporations are paying too much, but others aren’t paying enough. We talk about the “business community” like it really exists, but when it comes to tax reform, it’s riven by fault lines. Business support for tax reform depends on papering over these divisions in the hopes of procuring a pain-free package of goodies from Congress. Level playing field? My colleague at Tax Analysts, Marty Sullivan, has underscored the disparities plaguing the corporate income tax. “The essence of an efficient and competitive tax system is a level playing field,” he told the House Ways and Means Committee last week. “Government should not attempt to outguess the market and pick winners and losers. Unfortunately, there is a wide disparity in the tax treatment of businesses under current law.” Wide disparities, indeed. In recent years, General Electric paid taxes at an effective rate of just 3.6 percent, while Home Depot paid 35.4 percent. Merck paid 12.5 percent, while Disney paid 36.5 percent. Pfizer paid 17.1 percent while CVS paid 38.8 percent. Why do some companies pay so little while others pay so much? Low rates are common, according to Sullivan, in industries where operations and technology can be readily moved offshore to low-tax jurisdictions. By contrast, companies that find their markets here in the United States aren’t so lucky. It’s hard to ship your customers overseas along with your factories. Tax disparities within the business sector mean that policy reforms helping one company will end up hurting another. And that makes genuine reform a long shot, since business support for reform is likely to evaporate once talk moves from the general to the specific. Hands off my loophole! Multinational companies are doing pretty well under the current tax system, thank you very much. And while they’re happy to see statutory rates fall, they aren’t so wild about additional reforms that might be used to pay for lower rates. Closing loopholes always seems like a good idea until it’s your loophole that’s getting closed. Among multinational corporations with low effective rates (thanks to provisions allowing them to shift profits to overseas subsidiaries), any effort to shore up the tax base is likely to run headlong into a buzz saw of opposition. In his speech, Obama attributed tax law disparities to the “parade of lobbyists” who have advanced the interests of their clients even as they undermined the tax system as a whole. And he’s certainly right. But many of the benefits showered on multinational corporations have been deliberate, designed to encourage the competitiveness of U.S. corporations and protect U.S. jobs. That’s not crazy, but it’s not right, either. As Marty Sullivan told Congress: Yes, U.S. multinationals create jobs. But so do purely domestic corporations. So do small businesses. And so also do foreign-headquartered companies that invest in the United States. Multinational companies have their own needs and desires, often quite distinct from those of real, live American workers. The tax system doesn’t need to penalize multinationals, but it shouldn’t favor them either. Tax favors aren’t just unfair, they’re also unwise. As the Center on Budget and Policy Priorities has observed, tax disparities distort decision-making , encouraging companies to make investments based on tax consequences, not business fundamentals. Leveling the playing field among corporate taxpayers would help eliminate such distortions, boosting efficiency across the economy. Goodies for everyone But if you’re hoping for that sort of tax reform, get ready for disappointment. Tax reform is currently all the rage, as evidenced by Obama’s endorsement. But the popularity of the idea – especially within the “business community” — is premised on the unspoken condition that reform means rate cuts without loophole closing. That sort of “reform” neatly avoids creating winners and losers by simply making everyone a winner. At least over the short term. Over the long-term, however, that sort of reform would be a disaster. It costs about $8 billion for each percentage-point reduction in the corporate tax rate, according to a report from Bloomberg. Unless offset by base broadening, that sort of giveaway is simply unaffordable in our current fiscal climate. Indeed, corporate tax reform should really be used to raise money, not lose it. Sadly, though, revenue-losing tax reform is still a distinct possibility, despite its patent absurdity. As New York University law professor Daniel Shaviro has observed , “You don’t need to rely on broader intellectual consensus if you are simply handing out goodies, rather than mixing them with sour medicine.” Business leaders, like Proctor & Gamble CEO Robert McDonald, have been urging precisely that sort of pain-free tax reform. Obama has made clear that corporate tax reform shouldn’t lose money. And maybe he’ll stick to his guns, demanding a broader tax base in exchange for lower rates. But as last December’s tax deal made clear, there’s plenty of congressional interest in further tax reduction, especially among Republicans. Let’s hope Obama will stand up to them. And stand up for real reform.

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Video: J&J Recalls Tylenol Cold Drugs Over Alcohol Labeling

November 24, 2010

Nov. 24 (Bloomberg) — Bloomberg’s Shannon Pettypiece talks about Johnson & Johnson’s recall of Tylenol cold treatments. The world’s largest health-products company recalled 9.3 million bottles of the medicine because they don’t disclose the medicine’s alcohol content on the front label. Pettypiece speaks with Lisa Murphy on Bloomberg Television’s “Fast Forward.” (Source: Bloomberg)

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Health Enhancement Products Appoints Dr. John D. Crissman to Its Board of Directors

October 19, 2010

Former Dean of Wayne State University School of Medicine to Join HEPI BOD

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Health Enhancement Products Appoints Dr. John D. Crissman to Its Board of Directors

October 19, 2010

Former Dean of Wayne State University School of Medicine to Join HEPI BOD

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Richard Zombeck: Bankers New Tactic: Blame the Victim

October 18, 2010

Once again, as another harebrained scheme unravels, the swinging dicks of Wall Street manage to appear impervious to reality and completely immune to the truth. Nearly every Attorney General in the country is now investigating what was not just simply serial fraud but a no-holds-barred crime spree affecting millions of mortgages across the country. If you want to see an excellent explanation of the foreclosure fraud, check out the in-depth post, ” Foreclosure Fraud For Dummies ” by Michael Konczal’s, a fellow at the Roosevelt Institute. The Wall Street frat boys, in a propaganda blitz that would make Tokyo Rose and Joseph Goebbels envious, have come out in droves to blame the victims. In a piece from the New York Observer , one guy who was most likely too gutless to be identified by name is described only as a man wearing a bespoke blue-striped shirt, a Hermés tie patterned with elephants and Ferragamo loafers said, “You had people putting zero down to get massive houses they couldn’t afford to be in, but now they want to stay. And the government wants to let them stay, because they’re voters.” One example of these massive houses is the house in Maine that started the robo-signer investigations. Nicolle Bradbury bought her house seven years ago for a whopping $75,000. “A major step up from the trailer she had been living in with her family”, the New York Times reported . Propaganda isn’t new to the Masters of the Universe. It started with the dream of homeownership and cheap loans. Alan Greenspan perpetuated the attitude by suggesting that people use their homes as ATM machines and praised the use of Adjustable Rate Mortgages (ARM). Wall Street ran with that and pushed ARMs at an alarming rate. At the height of the boom, during the four to five year period before the financial meltdown it was virtually impossible to get a conventional 30 year mortgage. When the financial crisis hit, banks quickly went into action and blamed the entire fiasco on subprime borrowers. “If it weren’t for the banks pushing these risky mortgages on brokers and agents with massive incentives, no one would have bought them. But when it’s the only thing you can buy and you’re looking at skyrocketing home values being artificially inflated, what choice do you have,” said Steve Dibert a loan fraud investigator at MFI-Miami . Bankers, of course, see it the other way around and prefer to blame homeowners — who had nothing to do with creating, what bankers refer to as “complex financial instruments” when asked to explain credit default swaps, securitized loans, and derivatives as if the rest of us are too stupid to understand. Citi chairman Richard D. Parsons told the Observer this summer in an interview, “The loans wouldn’t have been there in the first place if American home buyers, driven by what The Weekly Standard calls immediate gratification without personal responsibility, hadn’t overstepped their bounds.” Stories like Bradbury’s are the majority. As opposed to the occasional ridiculous story of the cab driver with eight homes and the 14-year-old who bought a McMansion with paper route money, which the banks would like us to believe are the cause of the meltdown. The majority are hardworking, honest people who simply want to stop being screwed at every turn. One homeowner who contacted me through ShameTheBanks.org had this to say: For the past three years, my life has been on hold. All of my income goes right back to fix my mistakes. I don’t have enough to eat but don’t qualify for food stamps because I make too much money. I don’t get free legal assistance to fight foreclosure because I make too much money. No help paying for my medicine because I have health insurance and make too much money. I work two jobs and burn the candle at both ends. I sold almost everything I have, which is fine; probably shouldn’t have it in the first place. Now I have two things left – my art house/foreign film movie collection and my childhood Lego sets that I wanted to give to my children someday. I shouldn’t have to be making that choice. Not this close to the finish line. Follow the money. I pay taxes. TARP gives that tax money to the banks. Some of it comes back to me to get me over the hump. I continue to pay taxes and my creditors. Everyone wins. Try to explain that to an editor for the Wall Street Journal , also for some reason anonymous in the New York Observer article who joked, “The problem is they don’t deserve to be in that place. They probably deserve to be there less than they used to,” referring to incomes lower now than they’d been when the loans were made in the first place. “You do need to foreclose, and you need to go back to people living in houses that are consistent with their income levels.” That’s right, let the serfs go back to their hovels. Cake anyone? Anton Schutz, president of Mendon Capital Advisers said, “Your mortgage didn’t get to a robo-signer by accident, it’s because you’re not paying.” “We’re not evicting people who deserve to stay in their house,” Jamie Dimon, JPMorgan Chase chief executive, said on a conference call with analysts on the company’s third-quarter earnings last week. John Carney, Senior Editor, CNBC.com, wrote , “It’s actually a bit sickening to hear defaulted borrowers describing the misdeeds of banks as ‘mortgage fraud.’ What some banks have done might well be fraud–but the fact of that fraud doesn’t erase the other fact that the borrower agreed to make payments or face the penalty of losing her home.” What Mr. Carney along with the rest of the foreclosure proponents, doesn’t seem to understand, or has conveniently forgotten, is that millions of homeowners were convinced by the banks and servicers that defaulting on their loans would help save the very homes he seems to think they deserve to lose. In many cases banks and servicers pushed people into default with false promises of modifying their loans. Banks were offered programs like Making Home Affordable and HAMP in an effort to negotiate interest and principal reduction with homeowners. The same banks and servicers told struggling and desperate homeowners that in order to qualify for the program they had to be in default. Once homeowners were behind on their mortgage, some were offered trial modifications that according to the program guidelines, were to last three months and then made permanent if the new payments were made on time. Over one million trial modifications were started, some lasting up to nine months. Inevitably, at some point in the trial process homeowners were denied a permanent modification – in most cases no reason was given for the denial. The banks and servicers took this opportunity to hold homeowners accountable for the difference in the payments, added fees and fines for default, legal fees, and a slew of other junk fees servicers have become notorious for, pushing them even further into default. By managing to keep people paying for a little longer, tacking on fees, and stalling the foreclosures, loan servicers were able to suck out an estimated $4 billion from struggling homeowners – all by playing them for suckers. In addition they were also over charging investors extra fees for managing the loans. Chandra Anand, 59, a telecommunications consultant from Germantown, told The Washington Post that he called his lender in the fall of 2008, before he missed any payments, to warn the company that his wife’s open-heart surgery might cause the family financial difficulty. He was told that in order to qualify for a loan modification he needed to miss payments. So he did and applied for a modification. He never heard back from his lender until he got a foreclosure notice in January 2009. Every time he calls his lender to resolve his situation an official tells him “to be patient, that it could take 60 more days to review things,” Anand said. “It’s now been a year and a half.” There are hundreds of stories like this, submitted by homeowners, at ShameTheBanks.org . In response to attorneys general and lawyers questioning the paperwork around foreclosures a few of the banks have postponed foreclosures in an attempt to rectify the situation. To hear the banks tell it, it will be a quick fix. According to a Wall Street Journal article , a bank spokesman for Chase said that its cancellations only cover foreclosure sales scheduled between Oct. 9 and Oct. 31 because it doesn’t expect the review to take longer. Jamie Dimon, Chase’s CEO made a similar statement. These are the same bankers who told Congress nearly 2 years ago that it could take years to ramp up their infrastructure to handle loan modifications in order to help homeowners. Maybe they’re planning on another hiring spree like the one they had when they needed to foreclose on millions of homes. To keep up with the rash of foreclosures, document processors and mortgage service firms rushed to hire anyone they could — hair stylists, Wal-Mart clerks, assembly-line workers who made blinds — and gave them jobs in their foreclosure departments without formal training, according to court papers. Several of these employees have testified that they did not really know what a mortgage was, couldn’t define “affidavit,” and knew they were lying when they signed documents related to foreclosures, according to depositions of 150 employees for mortgage companies taken by a law firm in Florida. Martin Andelman of MandelmanMatters interviewed a former Chase employee who told him, “A perfect foreclosure  was supposed to take 120 days and the closer you came to that benchmark, the better your numbers looked and higher your bonus would be.” The point is, foreclosure makes more money than modifications. It even makes more money than high interest rates. As Moe Tkacik, of Washington City Paper writes: Banks do not just walk away from a cash cow like “mortgage servicing” without a good reason. Mortgage servicing is a $200 billion a year business and that is not because of the flat 0.25% fee mortgage servicers receive to process the timely payments of responsible homeowners. In the boom years, mortgage servicers raked in fees every time they convinced a homeowner to refinance–the more “adjustable” the better!–and in the bust years, late fees and foreclosures  are the cash cows. Like all things banks do, it is truly recession-proof! The catch is that because foreclosures sort of necessarily involve, you know, “laws” governing “property rights” and “trespassing” and whatever, they require someone acting on behalf of the theoretical new “owner” of the property (whoever that is) to sign an affidavit saying something along the lines of, “yes, I’ve thought about it and reviewed the documents and whoever the local sheriff is should know that definitely these people deserve to have their locks abruptly changed and all their shit ransacked by some contract team of meatheads, and whoever shows up on this property after that they should feel free to harass, arrest, and what the hell waterboard. Andrea Bopp Stark, a lawyer with the Molleur Law Office in Biddeford, Maine, told The Washington Post , “that a number of her clients should be eligible for loan modifications through a Treasury Department program but that servicers are in such a state of disarray that they often can’t give homeowners basic answers about the state of their loan modification request. Then a few weeks or months later, the same servicers evict homeowners as if those applications were never filed.” “Their whole bureaucratic procedure,” Stark said, “is working against helping homeowners.” “There are several class actions pending for homeowners who allege that they are being foreclosed despite being eligible for HAMP modifications,” said Alan White, a professor at the Valparaiso University Law School. “In a case where a homeowner should be approved for HAMP modification, but the servicer has lost the paperwork or just hasn’t responded yet, the robo-signer will send the foreclosure documents to the court without checking to see whether in fact there is an alternative to foreclosure in the works.” “We waited and waited and waited for wide-scale loan modifications,” said Sheila C. Bair, the chairwoman of the Federal Deposit Insurance Corporation , one of the first government officials to call on the industry to take action. “They never owned up to all the problems leading to the mortgage crisis. They have always downplayed it.” The latest development, uncovered by Huffington Post Investigative Fund, is about banks now collecting taxes . According to the article: In many cases, the banks and hedge funds created new companies to do their bidding. They gave the companies obscure, even whimsical names and used post office boxes as their addresses, masking Wall Street’s dominant new role as a surrogate tax collector. In exchange for paying overdue real estate taxes, the investors gain legal powers from local governments to collect the debt and levy fees. At first, property owners may owe little more than a few hundred dollars, only to find their bills soaring into the thousands. In some jurisdictions, the new Wall Street tax collectors also chase debtors over other small bills, such as for water, sewer and sidewalk repair. Pretty convenient arrangement considering they also collect those taxes in the form of escrow payments from borrowers. I have heard and read hundreds of stories from homeowners who have paid their taxes and insurance through escrow payments with their mortgage only to find that the servicer didn’t actually pass those payments along to tax offices and insurance companies. Now the homeowner is behind on their taxes and the insurance has been canceled for non-payment. So, one department collects the escrow payments that should be going towards taxes, but doesn’t pay it, then another department takes over the collection of taxes and fines the homeowner – who has been paying all along. In many cases the the servicer don’t apply these payments to anything. They simply pocket the money, much in the same way they pocket trial modification payments. By blaming homeowners, bankers are trying to harness the anger of ordinary people — who are angered by the economic disaster that Wall Street itself created — and give ordinary people a reason to turn on each other. In a pervasive culture of greed, like the one that exists on Wall Street, the lack of ethics and compassion has permeated every corner of the industry. It has become more important for banks to simply make money at any cost than it has to take part and play a role in a flourishing and successful economy, as they are designed and expected to do. That being said, it almost makes sense that they would vilify the very people who they bilked, conned, and stole from, now that the jig is up. In her book” Bird by Bird”, Anne Lamott tells the story of a conversation with her pastor. In it she questions why she doesn’t have an abundance of money. The pastor says to her, “If you really want to see what God thinks about money, just look at who he gives it to.”

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Stephen Herrington: Open Wide, Minimum Wage Is Good For You

October 7, 2010

There comes a time, every few years actually, when government has to be the mommy of all the little greedy business boys and girls and make them take their medicine. Among the medications that business most dislikes the taste of is the Minimum Wage. Because business dislikes it, the GOP dislikes it, joined at the hip as they are to business. Joe Miller, the crackpot Tea Party loon that won the GOP nomination for Senate from Alaska recently said, in public, that he thought the minimum wage to be unconstitutional. Bear in mind that the entire GOP hates the minimum wage. They stalled increases in it for the entire Bush Administration. Even more mainstream GOP candidates like Dino Rossi, Senate candidate in Washington State, have argued to lower it, although on less obviously irrational grounds than its constitutionality. Both Joe Miller and Dino are irretrievably wrong. Rossi argues that Minimum wage is bad for business, raises costs and so raises prices. Rossi, apparently, flunked ECON 101. The cornerstone of economics is that productivity increases create wealth. Where that wealth ends up is critical to an economy. If productivity increases are shared between labor and business, the economy grows. If not, the economy is damaged by either of inflation or deflation. Trickle down economics is, by its nature, deflationary. Wages that are too high relative to value added are inflationary. Ideally these forces balance in the free market. But as libertarians are fond of pointing out, there is not such thing as a free market, never has been. Business is the main offender in preventing a free labor market. Unions arose because of the inherent advantage that business has in setting wage scales. Unions and management can balance each other out over time and a certain amount of head knocking. But labor and management are more often than not in imbalance, wages growing more slowly with reference to productivity gains. Minimum wage is a measure by government to redress imbalance and so reduce the head knocking outcomes. That is its purpose, a sane government making sane choices about ameliorating the conflict between two natural enemies so that the conflict doesn’t spill out into the streets with torches and pitchforks. When politicians are invested in having one or the other of the sides win, the intent of minimum wages as law is corrupted. It is not intended to create winners and losers, it is intended to maintain order. So while Dino Rossi is intent on corrupting a system that has worked for 75 years to mediate the inherent conflict of labor and industry, the neophyte politician Joe Miller, and others of the current crazy crop of Tea Party candidates, is decrying it as unconstitutional. Miller is among the Tenth Amendment idiots, no clearer in vision and no more honest in intent than were the idiots who forced the Tenth’s inclusion in the Bill of Rights in the first place. The Tenth is meaningless. The Tenth Amendment endeavors, in club blunt words, to limit the power of the federal government to what was written in 1791 including the Tenth itself, seemingly negating all the effort of enacting the additional amendments. Government, both federal and state, should have saved their time if a pustule in the stream of competence such as is the Tea Party can succeed in convincing the public that all law post to the Tenth is illegal and unconstitutional. The Tenth Amendment is a joke and was seen so when adopted solely to mollify the South that feared emancipation even then. The Southern States sought to freeze the argument over slavery with the Tenth. They might have succeeded had it not been for the simple logic that the venerable document that formed the nation was left unfinished for sake of the expediency of placating the slavers. The Tenthers then seem to be arguing that a Constitution that denies the personhood of tens of percents of the population is just fine with them, even though the prime tenant of the Declaration is that all men are created equal, self evidently. Not so self evident to the King or to the Tea Party it seems. The Tenth states, “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” It does not say that laws derived under and consistent with the Articles of the Constitution cannot be enacted over and above the original writing or that States, and certainly not individual citizens, obtain a power from it to overrule federal law or amendments duly adopted by two thirds of the states. The authority for making law over and above the words in the original Constitution is based in implied powers and is among the earliest arguments in Constitutional law. Implied powers are derived from the general welfare and necessary and proper clauses of the Preamble. Under the Tea Party interpretation that the Tenth limits the federal government in imposition of post ratification law, the Tenth is, logically, self nullifying. There can be no power to amend the Constitution that is asserted by a denial of its power to amend itself. It could just as easily be amended to say “we were just kidding with the Tenth”. What defines law is a recognition of what best serves all or at least most of us, it is that we all agree on the enlightened and progressive thought that is the Preamble on which the Constitution and all law that follows is based. Anything that does not meet this measure is simply not sustainable as law. No court in the land that has more than a trained ape in the seat of justice will uphold a challenge to Minimum Wage as it passes the test of promoting the general welfare. You would have to believe in Trickle Down economics to believe that it would not, and no one any longer believes in Trickle Down, if they ever did. Joe Miller is out on a Constitutional limb that won’t support a down feather, and is an attorney. All you can conclude is that he is the most intellectually dishonest cracker to run for the Senate since “Tail Gunner” Joe McCarthy. In 1968 the Minimum Wage was $1.80 per hour. On that hourly wage, in 40 hours a week, you could support a family of four with a stay at home mom in most of the country. The CPI has drifted around and the politic climate has change since then, and now the minimum wage will support about two thirds of one person. You have double up in housing and transportation to get by on it now. Don’t add children or you will need food stamps and Medicaid, things invented to fight wage deflation. The reason Minimum Wage won’t support a person is that Republicans have been winning their war on Minimum Wage and Democrats have been tepid to chilly in defending it. The moderate Democrats seem to have bought into the idea that a growing economy and a free markets obviate the need for it. In this they are wrong, but not as wrong as are Republicans. The drift away from support for Minimum Wage has been ill advised on several levels. There is no free market for wages without government support. Business and corporations exert incessant pressure to lower wages and benefits with massive advantages. Against that pressure the only recourse without government involvement is labor unions. The National Labor Relations Board was created to balance the playing field. Unions have been eviscerated starting with Reagan’s appointments to the NLRB of anti-union hard liners. Union busting became its own industry and wages have been in decline ever since. The fair market for labor, created by the New Deal Wagner Act, was destroyed by Republican governments. Minimum Wage, as an act of Congress, is now the main tool in balancing the benefits of economic growth, and without it, the economy is hostage to the willful misapprehensions of wage and economy dynamics of business and the Republicans. Now, attacks on the minimum wage are the final resort of business to maintain profitability in markets put into decline by their own anti-labor agenda. Should they succeed in eliminating the minimum wage, there is no bottom for wages in America short of parity with the $2 a day scales of the third world. Business still fails to comprehend that a world filled with subsistence consumers will not power profits of any kind, not even with slaves as laborers. It is an insanity of the gravest kind that business does not recognize the fate to which their aspirations lead. A world of impoverished people will not produce rich people. The already rich don’t care. But those that follow, their own children and the working class of the world, should care, for they inherit the consequences of their parents and their parents employer’s insatiable greed. Assault on the minimum wage is not only an assault on the working class, it’s an assault on the economy of the Untied States of America and all but an arrogant few who’s futures do not depend on that economy. In the parlance of total warfare, it’s the ultimate act of war. So, it’s more than medicine for the greedy business boys and girls, it’s really badly needed life saving medicine that they are marshaling armies of lobbyists and Tea Party zombies to resist. It’s manifestly stupid to support them for not wanting to take the medicine.

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Video: Hamburg Says Avandia Restricted to `Limited Condtions’: Video

September 23, 2010

Sept. 23 (Bloomberg) — Margaret Hamburg, commissioner of the Food and Drug Administration, talks with Bloomberg’s Melissa Long and Michael Waldholz about the FDA’s decision to restrict the use of GlaxoSmithKline Plc’s Avandia. Avandia, once the world’s best-selling diabetes drug, will be withdrawn in Europe and restricted in the U.S. after a three-year review of the medicine’s heart risks. (Source: Bloomberg)

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Heather Donahue: The New Marijuana Middle Class

August 30, 2010

Marijuana brings an estimated $14 billion a year to California. That number is enough to inspire awe, drool even, when thinking of the slice that could be devoured by the state’s hungry coffers. Add to that number the money saved on enforcing prohibition. In this context, Prop 19, California’s initiative to tax and regulate marijuana for recreational use, sounds like a no-brainer. However, if it passes, the RAND Drug Policy Research Center projects an 80% price drop. In that case, projected tax revenues will be pipe dreams, and only those who produce mass quantities will be able to stay in business. Most of the cannabis small business owners I talked to at the recent Hemp Con in San Jose are just that, small business owners of the sort who are supposed to be rebuilding our economy. Kelly Shaeffer wears a gleaming white hoodie embroidered with nugs; if not for that, you might mistake her for a soccer mom. She and her brother own Plant Providers Plus, a delivery service based in San Jose. “I had a business in landscape design for ten years which fell out with the economy, so I turned his hobby into a business and we’re doing very well. We’re helping a lot of people, a lot of patients. It’s very rewarding.” When asked what she thinks about Prop 19, she says, “The drop in prices–that would affect my business greatly. Letting the big guys come in, the pharmaceutical companies. They would take over our industry.” California’s unemployment rate has been in the double digits since January of 2009. The Cannabusiness is one of the only segments of the world’s eighth largest economy to see explosive growth. This has been cause for alarm in places like Los Angeles, where over 400 dispensaries were recently shut down. It’s also been seen as an opportunity for government price gouging, as in the case of Oakland’s recent ruling to charge $211,000 for a permit to cultivate in an industrial setting. David Holmes, founder of a website called Cannagen, says of Prop 19, “If Oakland’s the model, then I’m against it.” It’s not by accident that marijuana has become a socio-economic superstar. Underground cultivators have been altering genetics and adapting technologies to turn Mary Jane into the powerhouse she is today. It’s not unreasonable to think of a large ag, pharma, or tobacco company attempting to patent a version of Train Wreck or Purple Urkel, strains that have been developed not just for money, but for love. I ask a gent wearing a shirt printed with buds and leaves, “Have you ever worn an aspirin shirt?” He looks bewildered. “Aspirin shirt?” “Or like an Excedrin shirt?” “No.” “What is it about this medicine that makes you feel like not only taking it, but also…” “…Celebrating it? This is actually a hemp shirt, not necessarily cannabis medicine. I’m a glaucoma patient so I appreciate the 25% reduction in eye pressure. It’s helped me sleep, it’s relived my asthma. It makes Twinkies taste like creme brulee. I like–” He corrects himself: “I love the herb.” Pot educator Jason Browne says, “Cannabis is pure Americana, in the deepest sense. The founders of the country, who were rebels, all grew it or used it or supported it and understood its benefits to society and a free country.” He adds, “Is cannabis the key to unlocking America’s true subconscious? Is cannabis the key to reminding us what our roots are? And that it’s okay to step away from some of this crap that we’ve been investing in for so long, and to rethink everything? Maybe the answer is yes.” No matter what happens with Prop 19 this November, pot is here to stay. Humans and cannabis have been coevolving for thousands of years, and not even the war on drugs could convince weed to throw up the white flag. In fact, with adversity, it’s grown stronger–in both potency and number of users. The question now, it seems to me, is will the marijuana middle class continue to grow? Or will cannabis become another corporate commodity; an industry with impenetrable barriers to entry? Is there a middle path?

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Micromet’s Search-and-Destroy Cancer Missiles Lure Boehringer, Sanofi

June 14, 2010

By Ellen Gibson June 14 (Bloomberg) — Micromet Inc. , a 17-year-old biotechnology company with no medicines on the market, is attracting attention from product-hungry drugmakers. The lure: a technology for fighting cancer without using toxic chemicals. What Micromet has developed is a way to activate T-cells , the elite troops of the immune system, to attack malignancies, including a rare leukemia that strikes children. It has signed partnerships with five of Europe’s largest drug companies: Bayer AG , Sanofi-Aventis SA , AstraZeneca Plc , Merck KGaA and Boehringer Ingelheim GmbH . For years, companies like Micromet have struggled to perfect so-called immunotherapies that mobilize the body’s natural defenses against cancer. At the European Hematology Association ’s meeting in Barcelona on Saturday, Micromet announced that its leukemia treatment led to remission in almost four-fifths of patients in a trial. “With Micromet’s technology, you can give any T-cell the ability to recognize and kill the tumor,” said Michael Morse, an associate professor of medicine and tumor immunology specialist at Duke University School of Medicine in Durham, North Carolina. Although the technology is not fully tested, “there’s every reason to believe that this could work.” The company’s most-advanced drug, blinatumomab, is derived from a common immune-system protein called an antibody that its scientists refashioned to carry out an unnatural task. One end of the protein attracts T cells; the other is engineered to latch onto specific types of cancer cells. Replenishing Armies When batches of these proteins, called BiTEs, for bispecific T-cell engager, are released into the bloodstream, they not only summon the immune cells to attack the cancer, they also stimulate the body to produce more of the cells, thus replenishing its armies. “We’re leveraging the most potent arm of the patient’s immune system and directing it onto the tumor,” said Micromet chief executive officer Christian Itin in an interview. Immunotherapies got a boost on April 29 when the U.S. Food and Drug Administration approved Dendreon Corp. ’s first-of-its- kind cancer vaccine for prostate tumors. The day of its approval, Dendreon’s stock soared as much as 38 percent, and the Nasdaq Biotech Index had its biggest one-day rise in six months. It was a “landmark approval” that gave “positive momentum to the whole biotech space,” said Joseph Pantginis , an analyst at Roth Capital Partners LLC in Newport Beach, CA. Changing Mindset Like Micromet’s drug, Provenge primes the patient’s natural immune system. To make the vaccine, doctors extract white blood cells from a prostate-cancer patient, mix them with vaccine components and inject the combination back into the bloodstream. Provenge “opens a door and changes people’s mindset” about the immunotherapy approach, said Jeffrey Crawford , chief of medical oncology at Duke. The disease blinatumomab is designed to treat, acute lymphocytic leukemia or ALL, isn’t common, but it is a high priority for some doctors. One reason is that two-thirds of the 5,400 new cases in the U.S. each year are children, many of whom only survive with painful chemotherapy that continues for years. In adults the disease is harder to treat than in children; only 30 percent to 40 percent are cured with conventional chemotherapy. At the Barcelona hematology meeting, Micromet showed that blinatumomab can induce complete remission in patients who still had residual leukemia cells after multiple rounds of chemotherapy. About 80 percent of patients who stayed in the study were relapse-free at a median follow-up of 11 months. Killing Leukemia “With older patients, it’s very difficult to rout out the last bit of leukemia,” said Peter Marks , director of leukemia services at Yale-New Haven Hospital. Immunologic methods such as Micromet’s “can be very powerful,” he said. “A treatment that could specifically kill leukemia without causing toxicity would certainly be in demand,” he said. Micromet will begin the last phase of testing required for European approval of blinatumomab this June. Edward Tenthoff , an analyst with Piper Jaffray & Co. in New York, said it could be cleared for use in the U.S. by 2012, and within five years could see $1 billion in annual sales. “There have been no improvements in ALL treatment in three decades,” said Mark Reisenauer , Micromet’s chief commercial officer. “The only comparably underserved disease is melanoma.” Riddled With Cancer Libby Johns is the kind of patient who inspires cancer researchers to try harder. She was diagnosed with ALL in June 2009, a month after her second birthday. When her parents noticed bruising all over her legs, they brought her to the hospital, where doctors found that 90 percent of her bone marrow was riddled with cancer cells. Now three years old, Libby has had blood transfusions and continuous chemotherapy at the Hospital for Sick Children in Toronto, said her mother, Megan. The girl takes pills every day, has intravenous treatments once a month, and shots in the spine once every three months. This cycle, known as the “ maintenance ” phase of treatment, lasts 20 months. Libby must continue the regimen until August of next year. In the course of treatment, Libby’s hair has fallen out three times, and Megan says it’s a struggle to keep the girl’s weight up. Fevers and low blood sugar have put her in and out of the hospital, and when she’s home, the drugs can leave her lethargic. “Some days she doesn’t have the energy to do much,” her mother said. “We just stay home, watch movies, have picnics in the house. I try to let her lead as normal a life as possible.” Few Options While Libby is responding well to treatment, few options are available to children who are not cured with chemotherapy. For adults, who have a high relapse rate, an ineffective procedure called stem cell transplant is the only other line of defense, according to Yale’s Marks. Proven drugs are “very much needed,” he said. Each of Micromet’s partnerships with large drugmakers is aimed at a different, hard-to-treat cancer. The collaboration with Boehringer, announced May 5, will take aim at multiple myeloma , a deadly disease that starts in the bone marrow and often fails to respond to chemotherapy. Pantginis said drugmakers’ interest in the startup goes beyond a desire to license the small company’s drugs. They’re eyeing Micromet’s platform as a way to boost the effectiveness of cancer drugs they already sell, and also to extend the patent protection on those products, he said. If the companies can retool their older drugs using BiTE technology, they can stave off competition from generics in the future. Lab-Grown Proteins The concept of immunotherapy took a long time to bear fruit. In the early 1970s scientists started developing lab- grown proteins called monoclonal antibodies , designed either to block tumor growth or make tumors visible to other immune-system cells. They do this by homing in on specific molecules or “targets” on the surface of cancer cells. The first commercial success came in 1997, when Genentech Inc. and Biogen Idec Inc. launched Rituxan, a drug for non- Hodgkin’s lymphoma. This was followed by best-selling drugs led by Roche Holding AG ’s colon cancer drug Avastin, with almost $6 billion in global sales last year. While these drugs are a big business for companies, most have shortcomings as medicines, said Steven Rosenberg , chief of surgery at the National Cancer Institute in Bethesda, Maryland. “We need to do better than prolonging survival by months,” Rosenberg said. Most of these drugs target just one of multiple drivers of tumor growth. In just a matter of months, tumors in many patients grow resistant to the drugs. Second Generation Scientists at Micromet and other biotech companies said that second-generation antibodies of the sort they are testing will be more effective. Companies like Bothell, Washington-based Seattle Genetics Inc. and Waltham, Massachusetts-based Immunogen Inc. employ what’s known as the “payload” technique. The idea is to link a targeted antibody to a toxic drug that is unleashed once the medicine enters the tumor. One of these experimental drugs, T-DM1 for breast cancer, joins Roche’s best-selling Herceptin to a cancer-killing toxin using Immunogen’s technology and could be approved next year. “The industry understands the limitations of traditional antibodies,” said Micromet CEO Itin. “We’re starting to see very interesting clinical candidates to enhance the activity of antibodies. We’re seeing an evolution.” To contact the reporters on this story: Ellen Gibson in New York at egibson9@bloomberg.net ;

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Food Regulation Needs Single U.S. Agency for Greater Safety, Report Says

June 8, 2010

By David Olmos June 8 (Bloomberg) — Food safety in the U.S. would improve if a single agency were responsible for oversight of produce, poultry and meat, a report ordered by Congress said. The Food and Drug Administration, which monitors 80 percent of the U.S. food supply, should create a single food-safety agency and establish a formal system for evaluating which issues pose the biggest risk to public health, the Institute of Medicine, an independent group that is part of the National Academy of Sciences , said today in its report . FDA Commissioner Margaret Hamburg has made the curtailment of food-related illnesses a focus of agency efforts after a White House task force called for more inspections of processing plants and better surveillance. The agency has been criticized for failing to adequately monitor food suppliers and distributors and not doing enough in advance to prevent outbreaks, according to the IOM report. Last month, the FDA announced recalls of shredded lettuce linked to at least 26 E. coli-related illnesses in five states and alfalfa sprouts now linked to 35 cases of salmonella in 11 states. The FDA “lacks a comprehensive, systematic vision for a risk-based food safety system,” according to the institute report. The agency has made “limited progress” in developing a method for measuring how well it is doing at improving food safety, the report said. The FDA shares responsibility for food safety with the U.S. Department of Agriculture , which oversees meat and poultry. Unify Efforts The U.S. should “move toward the establishment of a single food safety agency to unify the efforts of all agencies and departments with major responsibility for the safety of the U.S. food supply,” the report said. About 5,000 Americans die from food-borne illness each year and more than 300,000 are hospitalized, according to the Atlanta-based Centers for Disease Control and Prevention. The Government Accountability Office, the investigative arm of Congress, last month said the FDA’s effort to protect the country’s food has been hampered by gaps in scientific research at the agency. Legislation approved last year by the U.S. House of Representatives would among its provisions give the FDA enhanced authority over imported food. A Senate version of the bill is awaiting a vote. The National Academy of Sciences serves as an advisory group to the U.S. government on scientific and technological issues involving policy decisions. To contact the reporter on this story: David Olmos in San Francisco at dolmos@bloomberg.net

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Novartis MS Pill’s Risks May Outweigh Benefits as FDA Advisers Review Drug

June 8, 2010

By Elizabeth Lopatto and Molly Peterson June 8 (Bloomberg) — Novartis AG ’s drug Gilenia has risks that may outweigh its benefit in treating multiple sclerosis, according to U.S. regulators reviewing whether to approve the first pill to slow progression of the disease. Gilenia, while effective, causes a gradual decline in lung function and is linked to certain cancers, Food and Drug Administration staff said in a review today. Outside advisers to the FDA will meet June 10 to recommend whether the drug, also called fingolimod , should be approved for sale. Novartis, of Basel, Switzerland, is racing German drugmaker Merck KGaA to sell the first pill to stall MS, competing with injected remedies led by Biogen Idec Inc.’s Avonex. The FDA has said it will complete its review by September. Gilenia may go on sale in 2010 and reap $1 billion a year, Novartis has said. “The pivotal efficacy studies provide robust evidence of the efficacy of fingolimod to reduce the frequency of clinical exacerbations in patients with relapsing remitting MS,” FDA staff said in the report. “The clinical development program also uncovered a number of safety issues, which will be the primary focus for the advisory committee meeting.” Skin cancer and heart risks will probably fuel a “vigorous debate” at the panel meeting, Yaron Werber , an analyst for Citibank in New York, said June 4 in a research note. Those risks were linked to the treatment in a study published in January in the New England Journal of Medicine, and also identified as adverse events in the FDA review today. Novartis fell 35 centimes, or 0.7 percent, to 52.05 Swiss francs at 2:35 p.m. local time in Zurich trading. More Information The FDA may ask for more information on Gilenia in September instead of clearing it, a move that would delay approval until the end of 2011, Werber said. “A positive recommendation is far from certain and, even if the panel does give a positive vote, the FDA’s recent track record has become somewhat less predictable,” Werber said. Global sales of Gilenia may reach $780 million in 2014, he said. The FDA rejected Merck’s application for rival pill cladribine in November, saying it was incomplete. Merck, based in Darmstadt, Germany, said today it resubmitted the drug for U.S. approval. Multiple sclerosis affects about 2.5 million people, according to the National Multiple Sclerosis Society in the U.S., causing the body to attack itself through the immune system. Immune System Gilenia and cladribine both blunt the immune system’s attack on nerve cells. Cladribine was approved more than a decade ago to fight leukemia; both it and Gilenia target certain white blood cells that are part of multiple sclerosis’s attack on the protective coating of nerve cells. Acorda Therapeutics Inc. ’s pill to improve walking in multiple sclerosis patients was approved by U.S. regulators in January, the first therapy of its kind cleared for sale. The pill, which is co-promoted with Biogen, doesn’t treat the underlying disease. Doctors also often prescribe oral corticosteroids to damp the immune system’s effects during acute attacks; they don’t affect the underlying disease either. Novartis and Mitsubishi Tanabe Pharma Corp. will develop and sell fingolimod together in Japan, said Takayuki Ikeda, a spokesman for the Osaka-based drugmaker. Novartis bought overseas rights in September 1997 to the medicine, discovered in research involving Mitsubishi Tanabe’s predecessor company, Ikeda said. To contact the reporter on this story: Elizabeth Lopatto in New York at elopatto@bloomberg.net ; Molly Peterson in Washington at mpeterson9@bloomberg.net

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Lilly’s Erbitux Fails in Study to Stop Colon Cancer Before It Has Spread

June 6, 2010

By Tom Randall June 6 (Bloomberg) — Eli Lilly & Co. and Merck KGaA’s Erbitux, approved for advanced colon cancer, failed to slow tumors in a study designed to expand the medicine’s use to patients whose disease is in an earlier stage. Erbitux, used to treat aggressive colorectal tumors that have reached other areas of the body, didn’t help stop the spread when added to chemotherapy, according to a study reported today at the American Society of Clinical Oncology meeting in Chicago. Erbitux added to the side effects of chemotherapy. The finding is the latest of at least three studies that have narrowed the scope of a drug that was the first of its kind for colon cancer when approved in 2004. Last year, Erbitux’s prescribing information was changed to say that patients whose tumors have a mutation to a gene called KRAS –found in about 40 percent of colon cancer cases — aren’t helped by the treatment. “Unfortunately with cancer, things that are hoped to work don’t always end up working,” said Herbert Hurwitz , associate professor of medicine at Duke University Medical Center in Durham, North Carolina, who wasn’t involved in the study. “This was a well-run study that asked a good clean question and got a good clean answer.” Erbitux had sales of about $1.4 billion last year, according to IMS Health, a drug research company. It continues to be a useful drug for patients with tumors that have spread, said Hurwitz, who spoke in a telephone interview. In those patients, Erbitux competes with Roche Holding AG’s Avastin, which has shown similarly poor performance in studies for mid- stage colon cancer that hasn’t spread. Expected to Work “From a market-share perspective, this would have been a big group of new patients and would have distinguished it from” Avastin, Hurwitz said. “Most people would probably have expected this drug to work as well or better” in earlier stages as later stages, he said in a phone interview. The trial involved about 1,800 participants. About half were given Erbitux along with a chemotherapy called Folfox, while 858 patients were given Folfox alone. After a follow-up of 16 months, both groups had a similar number of patients who didn’t show signs of their cancer returning. Patients taking Erbitux were actually slightly less likely to survive, with 82 percent still alive at follow-up compared with 87 percent taking chemotherapy alone. About 147,000 Americans are diagnosed with colon cancer every year, making it one of the most common forms of tumors, according to the National Cancer Institute . Cancer That’s Spread About 25 percent of patients are first identified with so- called metastatic cancer, which means the disease has already spread to multiple areas of the body, said Steven Alberts , lead researcher on today’s study and professor of oncology at the Mayo Clinic College of Medicine in Rochester, Minnesota. Another third of colon cancer patients are diagnosed with stage 3 tumors, meaning the cancer has begun to reach nearby lymph nodes but haven’t yet established themselves in new regions of the body, Alberts said. The Erbitux study was aimed at stage 3 colon cancer patients. “Maybe it didn’t live up to some of the initial hopes or expectations, but at the end of the day it still is an important drug that clearly is benefiting a proportion of patients,” Alberts said in an interview at the conference. “It is a meaningful drug in the metastatic setting; just not in the earlier setting. “The hard part is to figure out why it happened. That’s the focus of our research now,” Alberts said. KRAS Mutation Erbitux is a man-made antibody, a substance naturally produced by the immune system in response to infection. The drug works by latching onto cancerous cells and blocking replication. The flaw in the KRAS gene, which holds the blueprint for part of a messaging system inside the cell, is thought to render Erbitux ineffective. As many as 40 percent of patients with colorectal cancer have the mutation, according to previous research . Among those without the gene mutation, only about a third to half of patients respond to treatment, Alberts said. In September, a study known as the COIN study found that Erbitux failed to improve the outcomes even for its target group of metastatic colon-cancer patients with normal KRAS genes. Researchers are still examining results from that study to determine why they contradicted other studies. Part of the difference may be due to a different type of chemotherapy and lower doses of treatment used in the COIN study, Alberts said. Lilly, based in Indianapolis, and New York-based Bristol Myers market Erbitux in the U.S., while Merck KGaA, of Darmstadt, Germany, sells it elsewhere. It’s approved for use in colorectal as well as head and neck tumors. The European Union in July rejected the drug as a treatment for a form of lung cancer. To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net .

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Lilly’s Erbitux Cancer Drug Fails to Stop Colon Tumors From Spreading

June 6, 2010

By Tom Randall June 6 (Bloomberg) — Eli Lilly & Co. and Merck KGaA’s Erbitux, approved for advanced colon cancer, failed to slow tumors in a study designed to expand the medicine’s use to patients whose disease is in an earlier stage. Erbitux, used to treat aggressive colorectal tumors that have reached other areas of the body, didn’t help stop the spread when added to chemotherapy, according to a study reported today at the American Society of Clinical Oncology meeting in Chicago. Erbitux added to the side effects of chemotherapy. The finding is the latest of at least three studies that have narrowed the scope of a drug that was the first of its kind for colon cancer when approved in 2004. Last year, Erbitux’s prescribing information was changed to say that patients whose tumors have a mutation to a gene called KRAS –found in about 40 percent of colon cancer cases — aren’t helped by the treatment. “Unfortunately with cancer, things that are hoped to work don’t always end up working,” said Herbert Hurwitz , associate professor of medicine at Duke University Medical Center in Durham, North Carolina, who wasn’t involved in the study. “This was a well-run study that asked a good clean question and got a good clean answer.” Erbitux had sales of about $1.4 billion last year, according to IMS Health, a drug research company. It continues to be a useful drug for patients with tumors that have spread, said Hurwitz, who spoke in a telephone interview. In those patients, Erbitux competes with Roche Holding AG’s Avastin, which has shown similarly poor performance in studies for mid- stage colon cancer that hasn’t spread. Expected to Work “From a market-share perspective, this would have been a big group of new patients and would have distinguished it from” Avastin, Hurwitz said. “Most people would probably have expected this drug to work as well or better” in earlier stages as later stages, he said in a phone interview. The trial involved about 1,800 participants. About half were given Erbitux along with a chemotherapy called Folfox, while 858 patients were given Folfox alone. After a follow-up of 16 months, both groups had a similar number of patients who didn’t show signs of their cancer returning. Patients taking Erbitux were actually slightly less likely to survive, with 82 percent still alive at follow-up compared with 87 percent taking chemotherapy alone. About 147,000 Americans are diagnosed with colon cancer every year, making it one of the most common forms of tumors, according to the National Cancer Institute . Cancer That’s Spread About 25 percent of patients are first identified with so- called metastatic cancer, which means the disease has already spread to multiple areas of the body, said Steven Alberts , lead researcher on today’s study and professor of oncology at the Mayo Clinic College of Medicine in Rochester, Minnesota. Another third of colon cancer patients are diagnosed with stage 3 tumors, meaning the cancer has begun to reach nearby lymph nodes but haven’t yet established themselves in new regions of the body, Alberts said. The Erbitux study was aimed at stage 3 colon cancer patients. “Maybe it didn’t live up to some of the initial hopes or expectations, but at the end of the day it still is an important drug that clearly is benefiting a proportion of patients,” Alberts said in an interview at the conference. “It is a meaningful drug in the metastatic setting; just not in the earlier setting. “The hard part is to figure out why it happened. That’s the focus of our research now,” Alberts said. KRAS Mutation Erbitux is a man-made antibody, a substance naturally produced by the immune system in response to infection. The drug works by latching onto cancerous cells and blocking replication. The flaw in the KRAS gene, which holds the blueprint for part of a messaging system inside the cell, is thought to render Erbitux ineffective. As many as 40 percent of patients with colorectal cancer have the mutation, according to previous research . Among those without the gene mutation, only about a third to half of patients respond to treatment, Alberts said. In September, a study known as the COIN study found that Erbitux failed to improve the outcomes even for its target group of metastatic colon-cancer patients with normal KRAS genes. Researchers are still examining results from that study to determine why they contradicted other studies. Part of the difference may be due to a different type of chemotherapy and lower doses of treatment used in the COIN study, Alberts said. Lilly, based in Indianapolis, and New York-based Bristol Myers market Erbitux in the U.S., while Merck KGaA, of Darmstadt, Germany, sells it elsewhere. It’s approved for use in colorectal as well as head and neck tumors. The European Union in July rejected the drug as a treatment for a form of lung cancer. To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net .

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Bristol-Myers Sprycel Drug Beats Gleevec in Leukemia Patients, Study Says

June 5, 2010

By Shannon Pettypiece June 5 (Bloomberg) — Bristol-Myers Squibb Co. ’s cancer pill Sprycel worked better and faster at eliminating leukemia cells than Novartis AG’s Gleevec, the standard treatment for the blood malignancy, a study of newly diagnosed patients found. Bristol-Myers said it plans to use the finding to seek expanded U.S. approval for Sprycel as an initial treatment for the form of blood cancer called chronic myelogenous leukemia or CML. Sprycel is already approved as a second-line option for patients who fail to benefit from Gleevec. The expanded use could more than double sales of Sprycel by 2015 to $900 million, said Tony Butler , an analyst with Barclays. Novartis is also racing to get a next generation leukemia drug, Tasigna, approved as a first-line therapy. Gleevec, Novartis’s second best-selling drug with 2009 sales of $3.9 billion, revolutionized the treatment of CML nine years ago, turning it from a fatal to chronic disease for many patients. Now, the arrival of two new drugs could cut Gleevec’s market share 25 percent in the next five years, Butler said in a report. “Sprycel could become the next frontline drug for CML and could replace Gleevec,” said Hagop Kantarjian , a leukemia specialist at the University of Texas MD Anderson Cancer Center in Houston, who studied the drug. “For anyone who has a new diagnosis, they should consider this new kind of inhibitor as a viable option that could be better.” Results from the Sprycel study were released today at the American Society of Clinical Oncology annual meeting in Chicago. Tasigna cut levels of a protein linked to chronic myeloid leukemia in three times as many patients as those taking Gleevec after 18 months, Basel, Novartis reported yesterday in a statement. Regulatory Decision Due U.S. regulators are due to make a decision this year on whether to clear Tasigna for newly diagnosed patients, Basel, Switzerland-based Novartis said in April. Like Sprycel, Tasigna already is approved for patients who don’t benefit from Gleevec. New York-based Bristol-Myers plans to seek U.S. regulatory approval this year for Sprycel, the company said in March. The study released today focused on Sprycel’s ability to attack cells with a defective chromosome in the bone marrow called the Philadelphia chromosome, named after the city where it was discovered. In CML, which affects about 5,000 people a year in the U.S., the Philadelphia chromosome produces a gene called Bcr-AbL, which leads to the overproduction of white blood cells. Gleevec, Sprycel and Tasigna stop this chain of events. Cell Signal Target Gleevec was the first drug approved that is designed to suppress a cell signal known to cause cancer rather than poison the tumor cells, as with chemotherapy. Before Gleevec became available, CML patients lived an average of three to five years, according to the American Society of Hematology. With new treatments that have become available over the past decade, 95 percent of CML patients live at least five years. “Gleevec is a great drug, you will never hear me say anything negative about Gleevec, but in this trial Sprycel did even better,” said Renzo Canetta , Bristol-Myers’s vice president of oncology clinical research. “We think Sprycel can offer something more.” In the study, 77 percent of patients taking Sprycel had a confirmed complete cytogenetic response, meaning no cells with the Philadelphia chromosome could be found, compared with 66 percent taking Gleevec. An absence of tumor cells is an indicator of longer survival, said Canetta in a telephone interview. The study followed 519 newly diagnosed patients for at least 12 months. Side Effects Patients given Sprycel were more likely to have a loss of platelets and fluid build-up in the lungs while patients taking Gleevec were more likely to have fluid retention under the skin. Patients taking Gleevec were also more likely to have nausea, rash and muscle pain. Doctors will probably need longer-term data on the benefit of Sprycel and Tasigna over Gleevec for 24 to 36 months before they routinely prescribe the newer treatments as a first-line therapy, said Seamus Fernandez , an analyst with Leerink Swann & Co. in a research report. Price may also keep doctors and patients on Gleevec, said Kantarjian. When generic copies of Gleevec enter the market in 2015 it will cause the price to fall from its average wholesale price of $4,340 for a month’s supply. That price difference could sway some patients to try Gleevec first instead of Sprycel, Kantarjian said. The wholesale price of Sprycel is $6,950 at the 100-milligram dose, Bristol-Myers said. Gleevec Still ‘Reassuring’ “I don’t think this is going to be the end of Gleevec,” Kantarjian said in a telephone interview. “The long-term follow up with Gleevec is very reassuring. Gleevec will also become generic in four to five years so the price difference could become significant.” Bristol-Myers also reported data today that showed its experimental skin cancer drug ipilimumab almost doubled the number of patients alive after two years compared with another experimental treatment called gp100, developed by the National Cancer Institute. Bristol-Myers said it hopes to start selling the medicine by the end of 2012. If approved, ipilimumab could generate more than $1 billion in annual sales, analysts said. To contact the reporter responsible for this story: Shannon Pettypiece at spettypiece@bloomberg.net .

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Amgen’s Bone Drug Cleared by FDA for Osteoporosis in Older Women

June 2, 2010

By Rob Waters June 1 (Bloomberg) — Amgen Inc.’s bone-strengthening drug denosumab, the focus of the largest development program in the company’s history, was cleared by U.S. regulators for use in postmenopausal women with osteoporosis. The U.S. Food and Drug Administration announced the approval of the drug, to be marketed as Prolia, today in a statement. The action follows the May 28 approval by European regulators. Amgen, the world’s largest biotechnology company, is looking to denosumab to boost growth amid slowing sales of its core products , anemia drugs Aranesp and Epogen. The medicine may have sales of $942 million next year, according to the average estimate of eight analysts surveyed by Bloomberg. It will take time for primary care doctors to learn about the medicine and become comfortable prescribing it, said Eric Schmidt , an analyst for Cowen & Co. in New York. “This will have a somewhat gradual rollout,” Schmidt said today in a telephone interview. “Doctors are going to be conservative in adopting a therapy that doesn’t yet have a long- term track record. There are very good drugs for osteoporosis with established track records and they’re cheap.” One of every two U.S. women older than age 50 will break a bone in their lifetime because of osteoporosis, the FDA said. More than 10 million people, mostly women, have the disease and another 34 million have low bone mass, according to estimates from the National Osteoporosis Foundation . Public Health “Due to its prevalence, osteoporosis is a serious concern to public health,” said Julie Beitz , director of the FDA’s Office of Drug Evaluation III, in the agency’s statement. The osteoporosis market was worth $8.4 billion in 2008, according to IMS Health Inc. , a research company in Norwalk, Connecticut. Currently marketed drugs include Fosamax, made by Whitehouse Station, New Jersey-based Merck & Co. , and Actonel, sold by Warner Chilcott Plc of County Louth, Ireland. “This is the first biotech product introduced into a general practice environment,” Roger Perlmutter , executive vice president for research and development for Thousand Oaks, California-based Amgen, said today in a telephone interview. “Physicians will want to understand it well.” The research and development effort devoted to denosumab was the most extensive and expensive in the company’s history, Perlmutter said. Injection Twice Yearly Amgen will start selling Prolia to doctors within two weeks at a wholesale price of $825 for a single 60-milligram injection, Perlmutter said. Patients get a shot once every six months. GlaxoSmithKline Plc , based in London, will co-market the drug in Europe. The treatment was approved based on studies of more than 7,800 women with osteoporosis and was shown to reduce fractures by 20 percent to 68 percent, depending on the bone location. Among patients treated with Prolia, 4 percent suffered serious skin infections, compared with 3.3 percent of those who took placebos, Perlmutter said. Amgen will follow more than 4,500 women who started taking denosumab in clinical trials for up to 10 years and will create a monitoring program to solicit reports and compile records about any adverse events in women taking the drug, the company said in a statement. Amgen asked the FDA in a separate application to approve denosumab for reducing fractures in cancer patients whose tumors have spread to their bones. The company also is conducting studies to see if the drug can stop cancer from spreading to bone. Approval for both of these uses may push sales up to $2.9 billion a year by 2013, according to the average estimate of four analysts surveyed by Bloomberg. Amgen shares increased 4.2 percent to $52.87 at 7:35 p.m. New York time in extended trading on the Nasdaq Stock Market after falling $1.02, or 2 percent, to $50.76 at the 4 p.m. close. To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .

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Cholesterol Pill’s Blockbuster Potential Spurs Karo Bio’s Shortcut Search

May 27, 2010

By Michelle Fay Cortez      May 27 (Bloomberg) — A Swedish pharmaceutical company with no products on the market is hatching a drug-testing shortcut to catapult its experimental cholesterol pill into a potential $1.3 billion-a-year seller. Karo Bio AB’s drug, eprotirome, is generating attention from researchers because, when it is added to Pfizer Inc.’s Lipitor, the combination lowers cholesterol levels more than Lipitor alone. Because eprotirome works in a novel fashion, regulators such as the U.S. Food and Drug Administration require patient testing that can take at least five years and cost more than $500 million — time and money Karo doesn’t have. The company and the drug may be sprung by Steven Nissen , the head of cardiology at the Cleveland Clinic in Ohio. Nissen, who says there is a need for new types of cholesterol pills, is endorsing a clinical trial that can cut the usual time by half. He and the company need to persuade the FDA to go along, and Karo needs to get a large drugmaker to help pay for the trials, Bloomberg Businessweek reports in its May 31 issue. “What we are trying to do is look for a strategy that allows the company to move forward in a deliberative fashion to develop the data they need without costing half-a-billion dollars,” Nissen said in an interview. “That requires innovative thinking.” Karo is grappling with a conundrum faced by all companies working on novel heart drugs. Regulators want proof medicines are safe and prolong life before they are widely used. Definitive studies take resources that biotechnology companies often don’t have. Evidence Needed “Before you put millions of people on a drug for years and years, you need evidence that it’s beneficial,” said Robert Temple , director of the FDA’s office of drug evaluation, in an interview. “When you are using a drug chronically in fundamentally healthy people to prevent disease, how much assurance do you need? We certainly think about that.” Setbacks, such as Pfizer’s torcetrapib and AtheroGenics Inc.’s AGI-1067, led half a dozen companies, including Pfizer, to pull back on work for new heart disease drugs. New York-based Pfizer spent almost $1 billion on torcetrapib, an intended Lipitor successor, only to meet with failure in 2006 after 13 years of development. Nissen and Karo are proposing a shortened research path, one based on requirements the FDA imposed a year ago on diabetes drugs. Those medicines were originally approved on the basis of their ability to control blood sugar. Now companies must also show that the products don’t raise significant heart risks, as were found with Avandia, a medicine from London-based GlaxoSmithKline Plc. ‘A Few Thousand’ The goal for eprotirome is to show it cuts both cholesterol and heart attacks without serious side effects. Karo would study more patients — “a few thousand,” Nissen said — than were involved in the initial research for Lipitor and products like it, while taking less time and money than Pfizer’s torcetrapib, which had a trial involving about 15,000 people. The research would rule out serious safety hazards before the medicine is approved and give evidence of benefits. “Without further ado, we want to take this forward,” Jens Kristensen , chief medical officer of 23-year-old Karo, said in a telephone interview. “This is a new target and it’s the first new targeted compound within this area for many, many years.” If regulators clear Karo’s limited scope for research, it will still cost $300 million or more, said Erik Hultgard , an analyst at Handelsbanken Capital Markets in Stockholm. Hultgard and two more of the five analysts that follow Karo have a sell opinion on the company’s shares because of concerns that eprotirome won’t be developed successfully. One analyst has a buy rating and one has a hold, according to data compiled by Bloomberg . Price Target Hultgard’s price target is 5.50 kronor. The shares rose 0.7 percent at 11:53 a.m. in Stockholm trading to 7.05 kronor, valuing the entire company at 1.09 billion kronor ($139 million). The shares have declined 17 percent in 12 months. Eprotirome is a novel version of a thyroid hormone that is engineered to work only in the liver, where it helps clear cholesterol from the body. By contrast, Lipitor blocks a liver enzyme needed to produce cholesterol. Patients given eprotirome in addition to Lipitor or Merck & Co.’s Zocor had 32 percent lower levels of so-called bad LDL cholesterol than patients given the marketed medicines alone in a trial. Two other studies testing the drug alone and with alternative cholesterol treatments also posted positive results. Now, a final round of studies is needed to confirm the drug’s benefits. Research Partner Karo needs a partner to fund the research program outlined by Nissen, Kristensen said. The company originally planned to begin the final studies of eprotirome last year, and is delaying the start as it irons out study details with European regulators. Kristensen declined to specify how much the research may cost, saying the company can fund smaller studies alone. Karo had total assets of about $35 million at the end of 2009. More than 81 million Americans have some form of cardiovascular disease, or one in three adults nationwide, and every year 831,300 die from it, according to the American Heart Association , based in Dallas. Those numbers underscore the potential for eprotirome, said Alexander Lindstrom , an analyst at ABG Sundal Collier in Stockholm, who has a buy rating on Karo. “The unmet need is still large,” Lindstrom said in a telephone interview. “We estimate $1.3 billion in peak sales, though there are many drugs that sell a lot more. Getting higher sales isn’t a stretch, but even at these lower levels it would still be a commercial success.” Generic Lipitor The outlook for Lipitor, and for generic versions, figures into analysts’ views of how valuable eprotirome might be. Lipitor, which generated $11.4 billion in sales last year, will have lost patent protection by the time the eprotirome study is done, Handelsbanken’s Hultgard said. While Nissen’s studies may open the market for eprotirome, Hultgard said generic drugs might rush into the vacuum first. That may discourage investment from large pharmaceutical companies in new brand-name drugs in the niche, he said. “With the market being highly generic, I think the willingness to pay for these types of drugs will come down,” Hultgard said in a telephone interview. Bristol-Myers Squibb Co. , based in New York, had rights to eprotirome until giving them back in 2004, after working with Karo for seven years. Bristol-Myers discontinued all its internal work on medicines that target thyroid hormone receptors. Jennifer Mauer, a Bristol-Myers spokeswoman, declined to discuss the reasoning behind the decision. Risky Strategy Karo’s Kristensen said Bristol-Myers was interested in eprotirome for treating obesity, which would have required significantly higher doses and might have led to unacceptable side effects. Studies of the kind Nissen proposes can’t rule out all significant risk, said Rory Collins , co-director of the University of Oxford’s Clinical Trial Service Unit. “A strategy of working out how to do these large trials to get reliable information on safety and efficacy is the only way,” Collins said in a telephone interview. “We know hormones have other effects. I think one would be a little bit more wary and would want to have large-scale trials.” The FDA , which hasn’t yet seen the research plan developed by Karo and Nissen, needs to rule on it before the company can begin the final studies and bring a partner formally on board. Karo is in discussions with several companies, Kristensen said, declining to name them. The hard work will start once regulators determine what studies are needed to get eprotirome approved. The architect of Karo’s strategy is the 61-year-old Nissen, a drug-safety advocate and a frequent adviser to the FDA. “I’ve had more drug failures than I can count,” Nissen said. “I’m not guaranteeing success.” To contact the reporter on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net

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Euro’s Decline Buoys Export-Driven Rebound as Austerity Aids Europe

May 27, 2010

By Vernon Silver May 27 (Bloomberg) — “The crisis is over.” So says Emeric Challier , a money manager at Avenir Finance Investment Managers in Paris. Rather than being alarmed by the plunging euro — down 4.1 percent against the dollar in the week before the European Union’s nearly trillion-dollar bailout for debt-saddled members and 3.1 percent the week after — he cites the economic boost a weaker currency provides. “The advantage of the euro drop is it will continue to support the recovery,” says Challier, who is betting that Spanish, Portuguese and Italian government bonds will rise. German exports and Spanish and Greek vacations become cheaper for Americans and Asians, Bloomberg Markets magazine reports in its July issue. The benefit is especially significant if the euro is depressed a year or more, he says. The fiscal discipline that comes as a condition of the rescue package will also benefit European economies after the initial pain of government spending cuts and tax increases, says Christoph Kind , head of asset allocation at Frankfurt Trust, which manages about $17 billion. There are some precedents. South Korea and Indonesia flourished after the Asian currency crisis of the late 1990s ushered in budgetary restraints and financial reforms, Kind says. “Hopefully history repeats itself, and these austerity packages lead to substantial improvement here,” he says. Shares Benefit Kind is bullish on European equities, especially shares of manufacturers that will benefit from the cheaper euro. “Automakers, capital goods producers are in good shape — companies like Siemens,” he says. Siemens AG , the maker of electronics and railroad equipment based in Munich, rose 8 percent in the week after the bailout plan was completed on May 10. The shares are up 10 percent so far this year, through yesterday. Before Europe’s finance ministers hammered out the giant loan package, the region’s sovereign debt crisis had been deepening for months. Yields on Greek two-year bonds reached 18.85 percent — topping the interest rate on a Visa Gold card available in Greece. As Greek, Spanish, Portuguese and Irish borrowing costs rose, the budget deficits that triggered the crisis became more intractable, says Christopher Pryce , a director at Fitch Ratings in London who studies sovereign debt. He says the rescue, which includes funds from the International Monetary Fund and sovereign debt purchases directed by the European Central Bank, broke that cycle. Europe’s Disciplinarian German Chancellor Angela Merkel is Europe’s disciplinarian. She was reluctant to join the bailout amid resentment at home over fiscal recklessness elsewhere in Europe. The day the rescue was done, Merkel called for stricter enforcement of EU rules on deficits. Greek Prime Minister George Papandreou , Spanish Prime Minister Jose Luis Rodriguez Zapatero and other European leaders are trying to fall in line. Papandreou has announced three rounds of deficit-reduction measures so far this year — even amid violent protests against cuts to wages and pensions. His socialist government is increasing levies on fuel, alcohol and tobacco. Following the bailout, Spain announced a 5 percent cut in public sector wages. Portugal has pledged to slash wages and raise taxes to trim its budget deficit . Of course, there’s no guarantee that European leaders will keep taking their medicine. Bets Against the Euro Luca Cazzulani , senior fixed-income strategist at UniCredit SpA in Milan, Italy’s biggest bank, says investors who doubt Europe’s resolve have turned from betting against sovereign debt — now protected by the bailout — to wagering against the euro instead. Currency investors have been overwhelmingly bearish on the euro this month. Net short positions in the euro versus the dollar — the difference between bets on a decline and bets on a gain — jumped to a record 113,890 contracts on May 11, according to the U.S. Commodity Futures Trading Commission. The euro fell as low as $1.2144 on May 19, its weakest since April 2006. Euro skeptics say the forced spending cuts and tax increases across Europe’s southern tier will scuttle a recovery before it takes hold. “The fiscal austerity measures will be a big drag on growth,” says Andrew Wilkinson , senior market analyst at Interactive Brokers Group in Greenwich, Connecticut. ‘Long-Term Gain’ The attack on the euro may end later this year as more investors begin to believe in Europe’s fiscal discipline, fixed- income investor John Stopford says. “By implementing economic reform and taking some pain, there’s long-term gain,” says Stopford, co-head of fixed income at Investec Asset Management Ltd. in London, which oversees about $65 billion. “European countries are learning the right way to confront this situation,” says Fabrizio Fiorini , head of fixed income at Aletti Gestielle SGR SpA in Milan, who manages about $8 billion. “And the market will discover this is strong for European bonds, stocks and the euro. In one or two years, everyone will discover we did the right thing.” To contact the reporter on this story: Vernon Silver in Rome at vtsilver@bloomberg.net

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Dr. Sasha Galbraith: Novartis, Heal Thyself – and Treat Executive Women with Respect

May 25, 2010

Poor Novartis. The Cavemen of Basel have just lost a major battle in the United States against those pesky women feminists. On top of the $3.3 million in compensatory damages that Switzerland-based Novartis will have to pay the 12 courageous women who brought the discrimination suit against the pharmaceutical giant, the company will also have to dish out a whopping $250 million in punitive damages, and up to $300,000 per plaintiff (there are 5,600 of them) in additional damages for pain and suffering. And there was plenty of that. The testimony reads like an X-rated Hollywood script: rape; sex for drug orders; a climate of lascivious behavior; lap dances for the boss; high-achieving women being actively discouraged from becoming pregnant, or encouraged to have abortions, and/or fired once they gave birth. The Novartis experience is not an isolated case. In Switzerland, there is a culture of disdain and distrust of ambitious women who work. Several years ago, the CEO of a large Swiss bank (that shall remain nameless) said to me over lunch in his executive dining room overlooking Zürich’s Bahnhofstrasse, “I would never hire an American woman to work for me because she will most likely sue you for discrimination.” (This was just after he said that Alfonse D’Amato’s claims about Swiss banks withholding Jewish funds were nonsense.) Switzerland has the world’s largest men’s club. It’s called the Swiss Military. No women allowed. All Swiss males are conscripted and they go off for weeks of annual bonding exercises under the guise of protecting the landlocked country from invasion. That time off is fully paid for by the men’s employers. There tends to be a correlation between a man’s rank in the military and his rank in his company. Women, whose primary role in society is taking care of home and kids, are traditionally paid 15 percent less than an equivalent male doing exactly the same job. Most women work part-time because daycare facilities are very hard to find, and society frowns on ambitious working moms. If that’s not enough, the Swiss tax code penalizes couples when both partners work full-time. Consider this: women in Canton Appenzell (where the cheese comes from) were not allowed to vote until 1990. Until a few years ago, it was normal (and completely legal) for a company to publicly and openly specify the sex, age and other qualities it preferred in candidates for particular jobs. The country that disparages the way Muslim women are treated can’t seem to treat its own women on an equal footing to men. How hypocritical is that?!? Want more hypocrisy? Novartis was listed on Working Mother magazine’s “Best 100 Companies” list for the past 10 years! As a native Swiss by heritage and birth, it really pains me to see a major Swiss multi-national not only allowing, but also condoning such ruthless, bone-headed and outright maliciously wrong practices against women who have every right to be treated with respect. At its core, discrimination is a naked abuse of power. In order to truly change the culture at Novartis and other companies, the will and appropriate course of actions must come from the top. Swiss (cave) men could use a major re-education in the ways of the world in the 21st Century. There is a saying in Switzerland: “The Swiss get up early, but they wake up late.” I hope that this class-action lawsuit finally wakes them up. Poor Novartis needs to quit whining and take the medicine that’s been prescribed.

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Glaxo Plays Catch-Up to Pfizer, Sanofi With Emerging Markets `Land Grab’

May 17, 2010

By Trista Kelley (Corrects number of salespeople in fourth paragraph.) May 17 (Bloomberg) — GlaxoSmithKline Plc plans to double revenue from India and China by 2015 as the drugmaker cuts prices to catch up to Pfizer Inc., Sanofi-Aventis SA and Novartis AG in emerging markets. Glaxo aims to beat the industry’s 12 percent to 14 percent growth in developing-country sales, said Abbas Hussain , the president for emerging markets at the London-based company. Worldwide, drug revenue will increase at least 5 percent a year through 2014, according to IMS Health Inc., which tracks pharmaceutical sales. The difference underscores the importance of winning business in emerging markets, Hussain said. “There’s absolutely a land grab going on right now because obviously there’s no growth in the U.S. and Europe , or very little growth,” Hussain, 45, said in a May 13 interview at Bloomberg’s New York headquarters. “There’s a real fight on for market share.” Chief Executive Officer Andrew Witty hired Hussain, a 20- year veteran of Eli Lilly & Co. , in 2008. Glaxo’s sales in emerging economies have jumped by 50 percent since 2007 to 3 billion pounds ($4.4 billion) last year. He’s increasing the sales force and snapping up smaller companies. Glaxo now has 13,000 sales representatives in emerging markets and will expand further, especially in China, Hussain said. “We’ve been playing catch up, particularly in China and Russia, with the likes of Novartis and the Sanofis and the AstraZenecas ,” Hussain said. Glaxo is first among its peers in India, Pakistan and the Middle East, he said. Slashing Prices Glaxo has been slashing prices of products in emerging markets by as much as 70 percent. Price reductions have helped boost volumes in some markets by sixfold to ninefold in the past four quarters, he said. In February, the company introduced the Avamys allergy treatment in Mexico after doing “very sophisticated pricing research,” Hussain said. “The old mindset at GSK would have been: Come in and launch it and have access only to the top 5 or 10 percent, to the top people who can afford it,” he said. “We brought it in at a 50 percent discount.” Within four months the company had won 50 percent of patients, he said. Glaxo is trying a similar strategy in Brazil for the medicine, he said. The company defines emerging markets as Latin America, Africa, the Middle East including Turkey, Russia and former Soviet states, India and China. Sales in those countries, excluding swine flu products, grew 17 percent last quarter. Volume Play Operating margins, at about 35 percent, are “matching GSK’s operating margin as a whole,” he said. “It really is an absolute volume play. If we decide we need 500 reps in China we’ll go ahead and do that,” he said. The emerging-markets strategy carries risks, said Jeremy Batstone-Carr , London-based head of research at Charles Stanley & Co. “All companies are facing up to the fact that this is where the growth is coming from, and Glaxo is a little bit further down the road than most,” the analyst, who has an “accumulate” rating on the stock, said in a telephone interview. “But it’s very important to be focused on value. If you just go for volumes, there is a risk that earnings are going to be more volatile and be lower quality, and may ultimately feed into the rating of the shares.” Seeking Acquisitions Glaxo also has looked for growth through acquisitions , though Witty said in a May 7 interview that he walked from away from five potential purchases or partnerships since October because prices were too high. In December, the company bought Algerian drugmaker Laboratoire Pharmaceutique Algerien for 26 million pounds and paid 87 million pounds for NovaMin Technology Inc. of the U.S. Net income in the first quarter rose 19 percent to 1.34 billion pounds, boosted by sales of the vaccine for pandemic flu. Glaxo’s stock has returned 17 percent in the past year including reinvested dividends, compared with a 26 percent increase in the Bloomberg Europe Pharmaceutical Index . “The next eight quarters will define who really is positioned in terms of the land grab that’s going on,” Hussain said. “You can’t be half pregnant in these markets. You either have to go for it, and realize you need huge portfolios, big scale, and reach and distribution, and be willing to innovate, or you decide you’re going to be a boutique player.” To contact the reporter on this story: Trista Kelley in London at tkelley2@bloomberg.net

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Desperate Greece Says Bailout Is Only Hope

May 6, 2010

ATHENS, Greece — Greece’s only hope of avoiding bankruptcy is to take money from a joint EU and International Monetary Fund rescue package, the government said Thursday during a heated Parliamentary debate overshadowed by the deaths of three people during protests against spending cuts. Greece has to impose harsh austerity measures, including slashing salaries and pensions and increasing taxes, to get money from the euro110 billion ($140 billion) three-year package which will provide loans from other eurozone countries and the IMF. “Today things are simple. Either we vote and implement the deal, or we condemn Greece to bankruptcy,” Prime Minister George Papandreou said ahead of a parliamentary vote on the austerity measures. Papandreou’s Socialists hold a comfortable majority and the bill is expected to pass easily. “Some people want that, and are speculating (on it), and hope that it will happen,” he said, referring to speculative attacks that have been blamed for raising Greece’s borrowing costs to unsustainable levels. “We, I, will not allow that. We will not allow speculation against our country, and bankruptcy to happen.” The rescue loans are aimed at containing the debt crisis and keeping Greece’s troubles from spreading to other countries with vulnerable state finances such as Portugal and Spain. The euro has sagged as those countries have seen debt downgrades, falling below $1.27 Thursday; late last year it was as high as euro1.51. The spending cuts have sparked outrage in Greece, with an estimated 100,000 people spilling onto the streets of Athens during a nationwide general strike Wednesday to protest the measures. Demonstrations quickly turned violent, with protesters trying to storm parliament and clashing with police in extensive riots that saw banks, stores and hotel windows smashed and two buildings burned. A man and two women – one of whom was pregnant – died when they became trapped in a burning bank torched by protesters. Firefighters used a crane to rescue another four people from the building’s balconies. “I understand the anger, I share it and participate in the suffering,” said Papandreou, who a day earlier condemned the deaths as murder. Finance Minister George Papaconstantinou said the government had no choice but to impose the austerity measures, which were being rushed through Parliament as urgent legislation because the country was two weeks away from default, with euro8.5 billion worth of bonds maturing on May 19. “The state’s coffers don’t have that money,” Papaconstantinou said. “Because today … the country can’t borrow it from the international market. And because the only way for the country to avoid bankruptcy and suspension of payments is to take the money from our European partners and the International Monetary Fund.” But in order to receive the funds, Greece must agree to a three-year austerity program. “We are asking for loans from countries that also have deficits and from countries that are also the subject of speculative attacks. And for those to be granted, we must persuade them that we are putting our house in order,” Papaconstantinou said. But the opposition lambasted the government for imposing measures that are too harsh for the population to bear. “The dose of the medicine you are administering is in danger of killing the patient,” said main opposition leader Andonis Samaras, who has said his party will vote against the austerity bill. “You know that these measures have sparked a social explosion … The citizens of this country have to believe there is a way out. Because whoever cuts pensions of euro700 cannot convince anyone.” Wednesday’s deaths – the first such fatalities in protests in nearly 20 years in Greece – have shocked the public in a country where violence during demonstrations is frequent but rarely results in casualties. An impromptu shrine with flowers and candles was set up in the burned-out windows of Marfin Bank where the three bank workers lost their lives. Still, unions and far-left groups planned more protests against the measures later Thursday. Forty-one policemen and 15 civilians were injured in the riots, while 25 people were arrested, police said. The bank workers’ union, OTOE, called a strike for Thursday to protest the loss of life, condemning the violence but saying the deaths were the result of the government’s austerity measures. ____ Associated Press writers Nicholas Paphitis and Derek Gatopoulos in Athens contributed.

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Dainippon Sumitomo Fails to Win U.S. Approval for Once-Daily Epilepsy Drug

May 3, 2010

By Catherine Larkin May 3 (Bloomberg) — Dainippon Sumitomo Pharma Co. failed to win U.S. approval to sell a once-daily epilepsy medicine acquired in the $2.34 billion purchase of Sepracor Inc. in October. The Food and Drug Administration said it wouldn’t approve the drug, called Stedesa, at this time, said Sepracor, a subsidiary of Dainippon, today in a statement. The company declined to disclose the nature of the FDA’s concerns. Sepracor submitted an application for clearance in March 2009 citing late-stage tests in more than 1,000 people who had at least four seizures a month even after treatment with other epilepsy medicines. Almost 3 million people in the U.S. have some form of epilepsy and about 200,000 new cases of seizure disorders are diagnosed each year, according to the nonprofit Epilepsy Foundation . “Sepracor will meet with the FDA to discuss and better understand the complete response letter and the agency’s expectations,” said Susan Adler, a spokeswoman for the Dainippon unit, in an e-mail today. “This will include whether there is a need to conduct any new studies on Stedesa.” If approved, the medicine would compete with lower-cost generic epilepsy drugs including copies of Johnson & Johnson ’s Topamax and GlaxoSmithKline Plc’s Lamictal. To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net .

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U.S. Stocks Climb as Buffett Defends Goldman, Economic Data Signal Growth

May 3, 2010

By Rita Nazareth May 3 (Bloomberg) — U.S. stocks gained, rebounding from the biggest weekly drop since January, as Warren Buffett defended Goldman Sachs Group Inc. , manufacturing grew at the fastest pace since 2004 and personal income and spending rose. Goldman Sachs rallied 2.6 percent after Buffett said the bank shouldn’t be blamed for losses on mortgage bets at the center of a Securities and Exchange Commission fraud lawsuit. United Airlines parent UAL Corp. and Continental Airlines Inc. gained after agreeing to combine. Apple Inc. advanced 2 percent after saying it sold 1 million iPads in the first month of the tablet computer’s release. The Standard & Poor’s 500 Index rose 0.7 percent to 1,194.46 at 11:21 a.m. in New York. The Dow Jones Industrial Average climbed 85.87 points, or 0.8 percent, to 11,093.48. “The economy is showing improvement,” said Peter Jankovskis , who helps manage about $1.8 billion as co-chief investment officer at Oakbrook Investments in Lisle, Illinois. “Investors are reacting well to the personal income numbers. And we continue to see mergers. Also Warren Buffett’s comments on Goldman Sachs show that he’s doing a very responsible thing by not piling on pre-judging the situation.” Industrial shares had the biggest gain in the S&P 500, rising 1.4 percent collectively, after a gauge of U.S. manufacturing grew at the fastest pace since 2004. The Institute for Supply Management’s index of manufacturing rose to 60.4 in April from 59.6 a month earlier, according to the Tempe, Arizona-based group. Economists had forecast the gauge would rise to 60, according to a Bloomberg News survey. Manufacturers Gain Caterpillar Inc. , General Electric Co. and Boeing Co. gained at least 1 percent. U.S. stocks last week broke the Dow’s longest weekly winning streak since 2004 after credit downgrades for Greece, Portugal and Spain spurred concern that global economic growth will slow and prosecutors considered opening a fraud investigation against Goldman Sachs. Gains in European stocks were limited today on concern a 110 billion-euro ($146 billion) rescue package for Greece will fail to contain the region’s debt crisis. Consumer spending in the U.S. rose in March by the most in five months, pointing to a recovery that may accelerate when the economy creates more jobs. The 0.6 percent increase in purchases matched the median forecast of economists surveyed by Bloomberg News, Commerce Department figures showed. Incomes climbed for the first time this year, rising 0.3 percent. ‘Good Direction’ “Investors see that the U.S. is going towards a very good direction right now and they make the decision to invest more in the region as there is a currency risk in Europe,” said Andreas Lipkow , an equity trader at MWB Fairtrade Wertpapierhandelsbank AG in Frankfurt. About 78 percent of S&P 500 companies that have reported since first-quarter results have topped the average analyst estimate for net income, according to data compiled by Bloomberg. Goldman Sachs, Wall Street’s most profitable firm, rose 2.6 percent to $148.99. Buffett, who invested $5 billion in the bank in 2008, praised Goldman Sachs Chief Executive Officer Lloyd Blankfein . “He’s done a great job running that firm,” Buffett said in a Bloomberg Television interview before the annual shareholders meeting of his Berkshire Hathaway Inc. on May 1. “My choice would be to have Lloyd running it this year, next year and 10 years from now.” Berkshire Hathaway Class B shares were up 0.9 percent to $77.70. Airlines Gain The NYSE Arca Airline Index rose 1.3 percent. UAL and Continental said they see net annual synergies from their merger of $1 billion to $1.2 billion by 2013, “including between $800 million and $900 million of incremental annual revenues.” UAL rose 2.6 percent to $22.15. Continental Airlines gained 1.8 percent to $22.75. Alaska Air Group Inc. advanced 6.9 percent to $44.25. The airline may rise as much as 40 percent as the traffic around Seattle and Hawaii improves, and industry consolidation leaves fewer competitors, Barron’s reported. Apple gained 2 percent to $266.39. The company sold its millionth iPad on April 30 as customers lined up to buy the latest version of the tablet computer with access to AT&T Inc.’s wireless network. The iPad 3G went on sale at 5 p.m. on Friday, 28 days after the original model, which could only connect to the Web via Wi-Fi, was released. The touch-screen tablet computer is selling faster than the iPhone, Chief Executive Officer Steve Jobs said today in a statement. iPad Sales The iPad’s initial sales may be beating some analysts’ estimates . Customers probably bought about 300,000 iPad 3G’s this weekend, Piper Jaffray & Co. analyst Gene Munster said in a note yesterday. He said that means total iPad sales this quarter will likely exceed the 1.3 million he had predicted. Dr Pepper Snapple Group Inc gained 4.1 percent to $34.07. The beverage company was raised to “buy” from “hold” at Stifel Nicolaus by equity analyst Mark Swartzberg . The 12-month price estimate is $38 per share. Pozen Inc. surged 5 percent to $11.39. The Food and Drug Administration approved the medicine, called Vimovo, for use in arthritis patients who are at risk of developing gastric ulcers, the agency said today in an e-mail. Dollar Thrifty Automotive Group Inc. surged 14 percent to $50.07. Avis Budget Group Inc. said it would like to make a “substantially higher” counteroffer to Hertz Global Holdings Inc.’s bid to acquire the rental-car company. Hertz fell 4.8 percent to $13.76, while Avis declined 2.1 percent to $14.80. To contact the reporter on this story: Rita Nazareth in New York at rnazareth@bloomberg.net

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Children’s Liquid Cold, Allergy Medicine Recalled

May 1, 2010

WASHINGTON — The Food and Drug Administration said Saturday it was investigating a health-care company for possible other problems following its recall of more than 40 over-the-counter infant’s and children’s liquid medications. McNeil Consumer Healthcare, based in Fort Washington, Pa., issued the voluntary recall late Friday in the United States and 11 other countries after consulting with the FDA. The recall involves children’s versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl, because they don’t meet quality standards. The FDA said it was reviewing procedures at McNeil, which appears to be the sole source of the problems. “We are following through with the facility to make certain that everything has been checked,” said FDA spokeswoman Elaine Gansz Bobo. According to McNeil and the FDA, some of the products recalled may have a higher concentration of active ingredient than is specified on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet internal testing requirements. The FDA called the potential for serious medical problems “remote,” but it advised consumers to stop using the medicine as a precaution. It said a health care professional should be consulted if a child has recently taken any of the recalled products and is exhibiting unexpected symptoms. The FDA also says parents in the interim should consider substitute child medications, such as generic versions. It does not recommend that children be given adult-strength Tylenol or Motrin because they are not intended for younger age groups. The medicines were made and distributed in the United States, and exported to Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago and Kuwait. Details are available by telephone at 1-888-222-6036 or on the Web at . http://www.mcneilproductrecall.com ___ On the Net: McNeil Product Recall Information: http://www.mcneilproductrecall.com Food and Drug Administration: http://www.fda.gov/medwatch

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Dendreon Advances the Most in Year After Winning Approval for Cancer Drug

April 29, 2010

By Catherine Larkin April 29 (Bloomberg) — Dendreon Corp. won approval for its first product, a vaccine to fight prostate cancer, after a three-year battle with U.S. regulators. The Food and Drug Administration cleared sales of the medicine, called Provenge, Shelly Burgess, a spokeswoman for the agency, said today in a telephone interview. Dendreon, of Seattle, submitted its application with the FDA in November 2006 and, after winning the backing of an advisory panel in 2007, was required to conduct another study to prove the drug worked. Provenge will be the first medicine to train the body’s immune system to attack cancer cells like a virus. More than 27,000 men die of prostate cancer each year in the U.S., according to American Cancer Society . Provenge may bring in $4.3 billion in annual sales by 2020, according George Farmer , an analyst with Canaccord Adams Inc. in New York. “Demand will be very high given the simplicity and convenience of administration combined with the extremely benign safety profile,” Farmer said in a research report today before the FDA’s decision was announced. Katherine Stueland , a spokeswoman for Dendreon, didn’t immediately return a telephone call for comment. Dendreon gained $5.88, or 15 percent, to $45.50 in Nasdaq Stock Market composite trading before shares were halted. Before today, the shares had gained 51 percent so far this year as investors looked ahead to the FDA decision, scheduled for May 1. Stock Volatility The historic volatility of the stock attracts traders and short sellers who seek short-term profits. Hedge funds own 27 percent of Dendreon shares, according to data compiled by Bloomberg. Provenge helped men whose prostate cancer had spread to other organs live four months longer in the 512-patient study released by the company in April 2009. The company had initially applied for approval based on an earlier study of 127 men that showed the drug improved survival and a second study of 98 men that failed to show a statistically significant benefit. The therapy involves extracting white blood cells from a patient, mixing them with vaccine components and injecting the combination back into the person. It is designed to be given earlier in treatment of the cancer and pose fewer side effects than chemotherapy. The FDA’s refusal to approve the drug in May 2007 based on the original data — even after the agency’s outside advisers voted 13-4 that it was “substantially effective” — sparked protests by patients and threats of a congressional probe. Sales Plans Dendreon Chief Executive Officer Mitchell Gold said Feb. 9 that the company will have three plants to make Provenge by mid- 2011 and 125 sales representatives. Production will be at full capacity within one year of approval, he said. Questions about manufacturing logistics and Dendreon’s ability to meet demand for Provenge have resulted in varying estimates for potential sales of the product. The drug will generate $1.2 billion by 2014, according to the average estimate of four estimates surveyed by Bloomberg. That year, Farmer projected Provenge would cost about $94,000 for each patient treated with a full course of the medicine. Provenge can generate $3.1 billion in 2014, he said. At least a dozen additional products that harness the immune system to battle tumors are in late-stage development and Provenge approval “would be an important validation to the field,” said Janice Reichert , a senior research fellow at the Tufts Center for the Study of Drug Development in Boston. “Provenge will certainly be a pioneer in that area,” Reichert said in an April 21 phone interview. “The experience will definitely inform the clinical development programs of other companies and other products.” The most advanced of these vaccines include Stimuvax from Merck KGaA in Darmstadt, Germany, and Oncothyreon Inc. in Seattle; ipilimumab from Bristol-Myers Squibb Co. in New York; and TroVax from Oxford BioMedica Plc in Oxford, United Kingdom. To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net .

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Privia Health Names Dave Rothenberg President

April 28, 2010

Industry Veteran Joins Next Generation “Membership Medicine” Company

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Onyx Anti-Tumor Medicine Nexavar Shows Broader Potential in Cancer Studies

April 19, 2010

By Ellen Gibson April 19 (Bloomberg) — Onyx Pharmaceuticals Inc. and Bayer AG’s Nexavar for liver and kidney tumors may have broader usefulness, according to a study testing how gene mutations affect drug effectiveness. The study found that Nexavar prevented lung-cancer from progressing in 61 percent of patients with KRAS mutations. The research, presented yesterday at the meeting of the American Association for Cancer Research in Washington, was designed to show how gene testing of tumors can improve treatment when drugs are matched with biomarkers that predict their success. Nexavar, not currently approved for lung tumors, showed the highest disease control of the four drugs used in the study of lung-cancer patients. The results from the study, dubbed BATTLE, were surprising because Nexavar had not worked in a previous trial of lung-cancer patients. “BATTLE arguably does indicate Nexavar has activity in this disease,” said Christopher Raymond , an analyst at Robert W. Baird & Co., in a note to investors. Not only does this data provide more evidence that tailored treatments work better, it helps answer the question, “What drugs can we move forward with?” said thoracic oncologist Edward Kim , who led the study at the University of Texas M.D. Anderson Center. Nexavar “is approved in two tumor types already. It gives us some nice hypotheses for further trials.” Onyx rose 65 cents, or 2.2 percent, to $30.78 at 9:40 a.m. in Nasdaq Stock Market composite trading. Earlier, the shares climbed 3.6 percent to $31.22, the biggest increase in a month. In the lung-cancer study, patients who had been treated with chemotherapy in the past underwent another biopsy. Tumor samples were tested for cancer biomarkers, including mutations to a gene called KRAS and EGFR, or epidermal growth factor receptor, a cell-signaling protein that causes cancer cells to grow and divide. Tumor Biomarkers Patients were placed into five marker groups. A first subset of patients was assigned to one of four drugs without regard to their biomarkers. Then patients in a second wave were assigned to medicines based on their particular tumor biomarkers, taking into consideration how people in the first group with similar biomarkers were faring. Overall disease control — defined as “non-progression” of the cancer — among all participants was 46 percent after eight weeks, Kim said. However, about 61 percent of patients with KRAS mutations had non-progression of their cancer when given Nexavar, Kim said in an Apr. 13 phone interview. By comparison, patients with KRAS mutations assigned to Tarceva, a treatment designed to inhibit EGFR, had just 22 percent disease control. Tarceva is jointly sold by Roche Holding AG , based in Basel, Switzerland, and OSI Pharmaceuticals Inc. , of Melville, New York. Nexavar Surprise Nexavar also showed the highest overall disease control of all the treatments in the study at 58 percent of patients. Other drugs used in the study were AstraZeneca Plc’s experimental Zactima and Eisai Co.’s Targretin. The Nexavar results were a surprise, according to the M.D. Anderson researchers. Two years ago, Bayer and Onyx halted a trial of Nexavar because the medicine failed to help lung cancer patients live longer than standard treatment. The KRAS mutation is found in 20 percent of lung-cancer patients and “nothing works,” said Roy Herbst , chief of thoracic oncology and co-author of the study. “When we treated them with Nexavar, we saw they did very well,” said Kim, director of clinical research in thoracic oncology. Nexavar, co-marketed by Leverkusen, Germany-based Bayer and Emeryville, California-based Onyx, is in the last stage of testing required for U.S. approval as a third-line monotherapy for lung cancer and as a first-line treatment in combination with chemotherapy, according to Onyx spokesperson Lori Murray . Next Steps “We’re very pleased that KRAS-mutated patients responded favorably,” Murray said of today’s study. “Onyx and Bayer are evaluating to determine potential next steps in our lung cancer development program.” Nexavar is approved for use in patients with kidney cancer and inoperable liver cancer, and worldwide sales of the drug were $844 million in 2009. While this study shows Nexavar can work in lung-cancer patients as a third or fourth line of treatment, winning approval as a first-line treatment in combination with chemotherapy “would be more meaningful commercially,” said Howard Liang , an analyst at Leerink Swann in Boston. Some doctors say they would like to see independent follow- up studies. “The results are surprisingly good,” said Anil Potti , an associate professor of medicine at Duke University, “but I hesitate to commit to the fact that this is a valuable drug in lung cancer yet.” For Related News and Information: Today’s most popular health-care stories: MNI HEA Top health stories: HTOP Bloomberg drug database: BDRG Onyx’s peer comparison: ONXX US RVR

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U.S. Stocks Climb as Retailer Sales Offset Concern Over Greece’s Finances

April 8, 2010

By Whitney Kisling April 8 (Bloomberg) — U.S. stocks rose as a rally in retailers following faster-than-estimated sales growth helped the market recover from an early slump triggered by concern Greece’s debt crisis will derail the global economic rebound. Target Corp. and Gap Inc. climbed more than 2 percent to lead chain stores higher after March same-store sales increased more than forecast. US Airways Group Inc. surged as much as 15 percent as the carrier was said to be in merger talks with UAL Corp.’s United Airlines. Forest Laboratories Inc. tumbled 12 percent after the drugmaker failed to win backing to sell a new lung treatment. Stocks extended gains after an auction of 30- year Treasury bonds signaled strong demand. The S&P 500 increased 0.3 percent to 1,185.9 at 1:05 p.m. in New York, erasing a 0.6 percent slide. The Dow Jones Industrial Average climbed 36.05 points, or 0.3 percent, to 10,933.57.52. “Most of the retailers are beating estimates by a handy margin,” said Sal Catrini , a managing director for equities at Cantor Fitzgerald & Co. in New York. “If they continue to rally it’s a huge positive for markets given the high expectations going in.” Equities also turned higher as European Central Bank President Jean-Claude Trichet said he doesn’t expect Greece to default. U.S. stocks tumbled yesterday on a bigger-than- estimated decrease in consumer credit and concern grew that a European Union rescue package for Greece may unravel. The S&P 500 is still up 75 percent from its 12-year low in March 2009, while 24 percent below its 2007 peak. ‘Mystery’ Plan “The market’s saying, at least initially, Trichet is giving us some comfort that there’s going to be this mystery rescue plan for Greece even though no one knows what it is,” said Malcolm Polley , who oversees $1 billion as chief investment officer at Stewart Capital Advisors in Indiana, Pennsylvania. “It’s in his best interest to say that. If they allow Greece to fail then it throws the whole European Union into doubt.” As a group, S&P 500 retailers gained 1.2 percent for the top advance among 24 industries, with Gap Inc. climbing 2.6 percent to $24.48 and Target rallying 3.5 percent to $55.89. US Airways jumped 13 percent to $7.70 and UAL rallied 9.4 percent to $20.72. United Airlines and US Airways are holding talks on a merger that would reshape the U.S. industry, according to two people familiar with the matter. Discussions began in mid-February on the merger, which would help United steer travelers to international flights from US Airways’ domestic routes, said one of the people, who asked not to be identified because the negotiations are private. Spokesmen for the companies declined to comment. Casinos Rally A Nevada report today showed gaming revenue rose almost 14 percent in February from the same month a year earlier. MGM Mirage and Las Vegas Sands Corp. helped lead casino stocks higher, climbing 9.1 percent and 4.4 percent, respectively. Energy shares erased declines as oil trimmed losses. Exxon Mobil Corp. rose 1 percent to $67.99. ConocoPhillips advanced 1.9 percent to $53.91. Stocks opened the session lower as concern over Greece’s debt crisis worsened. Greek bonds dropped for a seventh day today, driving the 10-year yield premium to German bunds to the most since the euro’s debut, after Finance Minister George Papaconstantinou was reported as saying there will be no need for additional measures to shore up the nation’s finances. Credit-default swaps on Greece’s government debt climbed to a record 445.5, according to CMA DataVision prices. Jobs Stocks also fell in early trading after initial jobless applications unexpectedly increased 18,000 to 460,000 last week, Labor Department figures showed. The median economic forecast was for a decrease to 435,000, according to a Bloomberg survey. The jump may in part reflect difficulty in seasonally adjusting the data ahead of the Easter holiday. “We’ve come back from the brink fairly meaningfully, we’ve seen huge recovery in the value of risk assets,” Tobias Levkovich , New York-based Citigroup Inc.’s top U.S. equity strategist, said in a Bloomberg Radio interview. “What we still have are intermediate and justifiable concerns around sovereign credit, around the structural unemployment issues.” Forest Laboratories sank 12 percent to $28.52 after failing to win a U.S. panel’s backing to sell a treatment for flare-ups of a common lung ailment. The benefits and safety data for the medicine don’t support approval for people with chronic obstructive pulmonary disease, outside advisers to the Food and Drug Administration said in a 10-5 vote yesterday. Piper Jaffray Cos. lowered its recommendation for Forest Laboratories to “underweight” from “neutral.” To contact the reporter on this story: Whitney Kisling in New York at wkisling@bloomberg.net .

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Tahir Amin and Priti Radhakrishnan: When Medical Patents Weaken Health Care

April 1, 2010

As the health care debate limps forward, it’s time to consider a related but entirely overlooked topic: the availability of medicines. Ironically, the greatest barrier to making existing medicines more available or innovating new ones is an abused patent system. One major step forward — especially in developing countries — is to stop approving many frivolous drug patent applications. Yes, stop. As intellectual property lawyers, we know that without legal protection, scientific and commercial daring will wither. But in the pharmaceutical field, the patent system has recently become less a legitimate ally of invention and more a manipulative crutch for profit seeking. Fortunately, change may be coming for the patients who most need it — HIV/AIDS sufferers. Here’s how the system works in theory: when a drugmaker is granted a patent, the company is usually given a 20-year window of exclusivity to sell the medicine, after which the drug compound becomes available in the public domain. Quite often, generic manufacturers then enter the market and produce the medication at significantly lower prices. Pharmaceutical companies anticipate the end of exclusivity and pour resources into developing the next innovative treatment. Private actors who work hard to innovate should get a competitive advantage and the monopoly protection a patent confers. Private actors who bankroll lawyers to “innovate” multiple frivolous patent applications should not get the same privileges. But they are. Instead of looking for what’s next, the global pharmaceutical industry is exploiting its current stockpile. Often easier than creating new medicines, companies use patent laws around the world to harden their monopolies and protect their sales. Their method is to make slight changes to medications and submit new patent applications claiming entirely new innovations. These alterations usually don’t change the therapeutic impact of the drug. They don’t generate additional clinical benefits but rather simply represent a different method of manufacture, delivery, or storage. Frivolously extending old patents halts generic production and sales. The results are especially disastrous for HIV/AIDS sufferers. Especially in the developing world, when lower-cost generic versions of medications are not available, millions of poor people go without treatment because they cannot afford the patented drug. But there may be hope. Recent decisions by the Indian Patent Office establish a new standard of clinical benefit for the patient, by which patent applications are judged, making it more difficult for pharmaceutical companies to keep claiming exclusivity. This standard will be very helpful in a pending case. Abbott Laboratories has filed a patent application for the drugs Lopinavir/Ritonavir, arguably the most vital protease inhibitors in the world and essential to prevent the onset of AIDS in HIV-positive patients. But this is not the first time Abbott has sought a patent for Lopinavir/Ritonavir. In fact, it is the 30th time. Since 1992, the company has made dozens of minor modifications to the basic compound and sought patent approval around the globe in order to cement its monopoly. This time, in India, Abbott has combined several existing — and already patented! -techniques to help patients store the medicine without refrigeration, and take fewer pills. We applaud this move. But it is simply not a new invention, and each modification Abbott is adding has already been patented. Pharmaceutical companies can’t hide behind the periodic table of elements to defend their manipulation of patent systems. If the Indian Patent Office follows its new string of decisions and rejects the application, generic drugmakers are ready. Indian generic companies already supply developing countries with the cheapest possible HIV drugs. Competition led by the Indian manufacturers has brought ARV prices down from $10,000 per patient, per year, in 2000 to $130 in 2009. The numbers that really count are human. Generic Lopinavir/Ritonavir could save 200,000 lives in 43 countries. One drug, one rejected patent, one cost savings, 200,000 lives. And that’s just the beginning. Worldwide, there are almost ten million patients who need HIV drugs. Most can’t afford them. If the developing world flexed its new global muscles and established a 21st century standard of clinical benefit for patenting pharmaceuticals, tens of millions of lives would be healthier. From the patent office to human betterment. Isn’t that what the UK Parliament had in mind in 1624 when it authorized the first patent system? Let’s bring it into the modern age for modern needs. Let’s make denying weak patents the new frontier of science for patients.

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Novartis Heart, Diabetes Medications Fail to Prevent the Diseases in Trial

March 14, 2010

By Michelle Fay Cortez March 14 (Bloomberg) — Novartis AG ’s top blood pressure pill Diovan failed to prevent heart attacks, strokes or deaths in high-risk patients, while its diabetes drug Starlix didn’t protect them from developing heart disease or diabetes in an international trial. The results underscore the difficulty in finding drugs to prevent heart disease and diabetes, two of the most common chronic medical conditions, the researchers said. People with existing heart disease, signs of early diabetes or risk factors for either condition should focus on exercise and eating right, the two most proven methods to bolster health, they said. The study, dubbed Navigator, tracked 9,306 patients for more than five years to see if aggressively treating people in danger of heart disease and diabetes with therapies for those ailments could avert disease. Most experts were surprised by the findings, said lead investigator Robert Califf , a cardiologist and vice chancellor for clinical research at Duke University Medical Center in Durham, North Carolina. “This is a sobering confirmation of the need to continue to focus on lifestyle improvements while also accelerating the efforts to develop new treatments for the exploding epidemics of diabetes and cardiovascular disease around the world,” Califf said in a statement. “It was disappointing that there was no reduction in cardiovascular events,” though the findings may have been biased by patients taking other medicines, he said. Cardiology Meeting The study, funded by Basel, Switzerland-based Novartis, was presented today at the American College of Cardiology ’s annual meeting in Atlanta and appears in the New England Journal of Medicine . “I don’t think either of these drugs should be used in any way to prevent diabetes or heart disease,” said David Nathan , director of the Diabetes Center at Massachusetts General Hospital and Harvard Medical School in Boston, in a telephone interview. “Developing drugs that could do both would be terrific, but this is a cautionary tale.” More than 20 million Americans and 171 million people worldwide have diabetes, according to public health surveys. The number is expected to increase to 366 million by 2030, according to the World Health Organization . Currently, 3 million people die from the disease each year, primarily from heart attacks, strokes and other cardiovascular complications, according to the WHO. To contact the reporter on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net

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IMF’s `Ghostbusters’ Are Best Choice for Greece: Matthew Lynn

March 9, 2010

Commentary by Matthew Lynn March 9 (Bloomberg) — “Who you gonna call?” wasn’t just a catchphrase in the 1984 film “ Ghostbusters .” If the worst happens in Greece, Spain or Portugal, we’re going to hear it all over again, and Europe’s taxpayers will want to know the answer. The European Union? The European Central Bank? Or the International Monetary Fund? Senior officials, including ECB President Jean-Claude Trichet , have suggested it would be a humiliation for a euro- area country to call on the IMF for a rescue package to prevent a sovereign-debt default. European problems must have European solutions, they insist. That’s where they are wrong. This is no moment for pride. If emergency funding has to be organized, it should be the IMF that takes the lead. It has the expertise, it can absorb all the flak, and the “no bailout” rule would remain one of the fundamental principles of the region’s common currency. In the last few weeks, Greece in particular has been publicly toying with the idea of calling on the resources and skills of the IMF to help with the financing of the country’s budget deficit, equal to 12.7 percent of gross domestic product. Greek Prime Minister George Papandreou said last week the Washington-based lender might have a role in resolving the crisis. “If markets don’t respond as we would like them to, due to their speculative behavior, then the final resort would be the International Monetary Fund,” he said on March 3. Not ‘Appropriate’ The next day, Trichet made a point of ruling that out. Calling on the IMF wouldn’t be “appropriate,” he said at a press conference in Frankfurt. Most European leaders would agree. German Finance Minister Wolfgang Schaeuble has even backed a European Monetary Fund as an alternative to the IMF. Some clarity is needed. It’s not just Greece that has a huge fiscal deficit. So do Portugal, Spain, Ireland and, to a lesser extent, Italy. Any of those countries might find itself under attack from the debt markets. In extremis, it might be impossible to sell the bonds to finance those deficits. It needs to be clear who they turn to for help in those circumstances. The reluctance of senior EU and ECB officials to see the IMF leading a rescue package is understandable. The euro is meant to be a strong currency for strong countries. The IMF flies in to help poor countries in disarray. There is no question it would be embarrassing if a euro member had to go cap in hand to the IMF. The reputation of the whole region would be tarnished and the euro’s future would be in jeopardy. Crises Need Experts And yet there are good reasons for them to swallow their pride and let the IMF come in and do its work. First, it has the expertise in dealing with countries that have lost the confidence of the global capital markets. It has the people and the experience to handle those situations. The ECB or a new European Monetary Fund could develop those skills, but let’s be honest, if you had a heart attack, would you want an experienced cardiac team looking after you? Or doctors who turn up with textbooks under their arms, promising that they learn fast? A crisis is no time to experiment. Second, the medicine is going to be brutal. For any euro- area country that has to narrow its deficit, there will have to be deep cuts in public spending. Wages will be reduced, jobs lost, and retirement ages raised — the kind of measures the Irish have been taking to bring their public spending under control. It isn’t going to be popular. The IMF is better suited to being the “bad cop.” It can take all the criticism and divert public anger away from the EU and the euro. No Bailout Third, calling in the IMF will preserve the no-bailout rule . When the euro was established, it was decided that member states shouldn’t have to bail each other out in the event of a fiscal crisis. That was important. Taxpayers in Germany don’t want to feel they are being made to pay for less-responsible governments in Greece or Portugal. If they are forced to, they might decide it’s not a club they want to be in anymore. Seeking help from the IMF gets around that situation. The world’s main developed countries are the members and they contribute to its funding . If an emergency loan needs to be organized for Europe’s laggards, it wouldn’t be the euro members helping them out. It would be the whole world. The “no bailout” rule between euro members would remain in place. Of course, the crisis could also be resolved within the euro area. The common-currency members are meant to be a family of nations in a zone of economic cooperation. It’s not much of a family if they aren’t willing to help each other. The IMF solution still makes more sense. That should be sorted out now, so that next time the bond markets attack a euro-member state, we all know who they’re going to call. ( Matthew Lynn is a Bloomberg News columnist. The opinions expressed are his own.) Click on “Send Comment” in the sidebar display to send a letter to the editor. To contact the writer of this column: Matthew Lynn in London at matthewlynn@bloomberg.net

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HIV Discoverer Criticizes Singapore for Lack of Free Testing, Treatment

March 4, 2010

By Simeon Bennett March 5 (Bloomberg) — The lack of free testing and treatment for HIV in Singapore is hindering progress on controlling the spread of the virus in the city-state, said Francoise Barre-Sinoussi , winner of the 2008 Nobel Prize in Medicine for her co-discovery of the virus that causes AIDS. “The stigma, the fact that they have to pay for everything, it’s the worst conditions for stimulating people to be tested and treated,” Barre-Sinoussi, 62, said in an interview at the French embassy in Singapore today. “The numbers they announce are probably much lower than the numbers they have.” New HIV infections in the nation of 4.6 million people rose to 456 in 2008 from 242 in 2003, according to the health ministry. In France, which has 64 million people, new cases fell to 6,940 from 8,930 over the same period, data presented at an AIDS conference last month show. Singapore’s government has opened more anonymous testing clinics, boosted HIV education programs and produced a soap opera to curb new infections of HIV, which have doubled in the past 10 years, even as the spread of the virus slows in neighboring Malaysia and Thailand. Treatment can cost as much as S$1,500 ($1,073) a month in Singapore, said Stuart Koe, chief executive officer of Fridae.com , Asia’s largest gay Web site. The government said in January it would subsidize HIV treatment for patients who can’t afford it. An anonymous HIV test costs S$30, according to the Web site of Action for AIDS, which runs Singapore’s biggest anonymous testing clinic. ‘Difficult to Accept’ “Coming from a country where everything is free, it’s difficult to accept,” Barre-Sinoussi said. “The situation is even worse than in developing countries not far from here. In Cambodia, everything is free.” HIV-AIDS is the world’s deadliest infectious disease . About 33 million people were living with HIV, 2.7 million were newly infected with the virus and 2 million people died with AIDS in 2008, according to the latest World Health Organization estimates. Barre-Sinoussi is director of the Regulation of Retroviral Infections Unit at the Institut Pasteur in Paris. In 1983 she co-wrote a report with Luc Montagnier in the journal Science that detailed the discovery of the pathogen that later became known as human immunodeficiency virus, or HIV. To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net

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Alzheimer’s Theory on Brain Material May Shift by Benefit Found in Study

March 2, 2010

By Michelle Fay Cortez March 3 (Bloomberg) — Beta amyloid that builds up in the brains of patients with Alzheimer’s disease may go along with beneficial antimicrobial activity, researchers said. The findings from investigators at Massachusetts General Hospital raise the possibility that some cases of Alzheimer’s may stem from chronic, undetected brain infections. The results also cast doubt on the pharmaceutical industry’s efforts to find drugs to wipe out beta amyloid from the brain, one of the main methods now in development to fight the most common form of dementia in the elderly, the researchers said. Beta amyloid, or abeta, remains harmful in high concentrations, they said. “Most people think abeta is junk,” a toxic byproduct of other activity in the brain, said Rudolph Tanzi , director of genetics and aging at Massachusetts General’s Institute for Neurodegenerative Disease . “This says tread carefully. It may play a normal, essential role in the brain and be part of the way the brain protects itself.” Laboratory tests showed beta amyloid inhibited the growth of eight organisms, including the yeast Candida albicans , which can cause thrush, and bacteria such as Listeria, Staphylococcus and Streptococcus, according to a report in the journal PLoS One . Tissue taken from the brains of patients with Alzheimer’s disease suppressed Candida, while samples from people without it didn’t, the researchers said. They theorize that beta amyloid is an antimicrobial peptide, a natural part of the innate immune system found in plants, animals and the human brain. Antimicrobial peptides are the first line of defense against pathogens in the immune system, which may go awry in Alzheimer’s patients, they said. ‘Big Question’ “The big question is what is most often triggering the innate immune system in the elderly that are the most at risk for Alzheimer’s disease,” Tanzi said in a telephone interview. “Perhaps as we age, there may be unnoticed low-grade infections that are triggering the innate immune system to produce beta amyloid.” Johnson & Johnson , based in New Brunswick, New Jersey, Merck & Co., based in Whitehouse Station, New Jersey, Ireland’s Elan Corp. , New York-based Pfizer Inc. and Eli Lilly & Co. of Indianapolis are working on Alzheimer’s disease drugs that target beta amyloid. Alzheimer’s is a progressive disease that starts with mild forgetfulness and eventually robs patients of memories and independence. It afflicts 30 million people worldwide, a number that may exceed 100 million by 2050, according to Alzheimer’s Disease International, an advocacy group based in London. Short-Term Benefit Robert Moir , from Massachusetts General’s genetics and aging research unit and a senior author of the paper with Tanzi, compared beta amyloid to a fever. While both are bad for the patient, they are worse for bugs causing an infection, he said. A little bit is good for the patient, a lot of it may be helpful for a short period, while a lot of it for long periods is dangerous, he said in a telephone interview. “We really need to be thinking about what causes the amyloid beta to go up in the first place,” he said. “If it is a response to an infection, then by treating the infection you can treat the disease.” While the concept is surprising, it fits with existing knowledge, said Samuel Gandy , associate director of Mount Sinai School of Medicine’s Alzheimer’s Disease Research Center in New York. It gives researchers a new angle to approach Alzheimer’s and should be easy to test in animal models, he said. Additional research is under way, Tanzi and Moir said. “In the field, the concept that amyloid beta isn’t just pathological is heretical,” Moir said. “It’s my hope that this study will start people thinking about this much more than they have, rather than just being obsessively focused on reducing amyloid beta.” To contact the reporter on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net

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Glaxo Knew of Heart Risk From Avandia Diabetes Drug, Senate Report Finds

February 20, 2010

By Rob Waters Feb. 20 (Bloomberg) — GlaxoSmithKline Plc knew its diabetes drug Avandia might cause heart damage several years before a study documented the risk and the company pressed doctors to retract or revise warnings about side effects, said a report from researchers for the U.S. Senate Finance Committee. Avandia came on the market in 1999 and achieved annual revenue of $3 billion by 2006, including sales of a combination drug that includes Avandia. Sales plummeted after a 2007 study was published in the New England Journal of Medicine which linked Avandia to a 43 percent increased risk of heart attack. By 2009, sales of the drug had fallen to $1.2 billion. Executives of the London-based Glaxo obtained a copy of the 2007 study in advance of its publication from a company consultant who also worked as a reviewer for the journal, the Senate report said. Although company scientists internally recognized the study’s validity and acknowledged Avandia’s heart risks, Glaxo prepared a public relations effort to refute suggestions that the drug triggered heart attacks, according to internal e-mails reviewed by Senate researchers. “It can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns,” wrote Max Baucus of Montana, a Democrat, and Charles Grassley of Iowa, the ranking Republican, in the Senate committee report. “Instead, GlaxoSmithKline executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.” Doctors Pressed The heart risks posed by Avandia were reported in a story published in today’s New York Times based on the Senate report and other documents. Glaxo, then known as SmithKline Beecham, pressed medical researchers who observed the emergence of heart and liver problems in patients taking Avandia to stop disseminating their findings, contacting the doctors’ superiors in several cases, according to the report. Glaxo, in a statement e-mailed today, said it rejects the Times’s conclusions about Avandia’s risks. “Contrary to the assertions in the story, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events,” the company said. Phone messages and e-mails left for Karen Riley , an FDA spokeswoman, weren’t immediately returned. Glaxo fell 58 cents, or 1.5 percent, to $38.26 in New York Stock Exchange composite trading yesterday. The stock is up 24 percent in the past 12 months. Sales of Actos, a competing drug sold by Tokyo-based Takeda Pharmaceuticals Co., were $4.4 billion for the year ended March 2009. To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .

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Botox May Reduce Migraine Headaches Described as `Eye-Popping,’ Study Says

February 16, 2010

By Nicole Ostrow Feb. 15 (Bloomberg) — Allergan Inc.’s Botox, given in the doses used to reduce facial wrinkles, may stop certain kinds of migraines that patients describe as crushing or “eye-popping” more than other types, a study found. Patients who responded to Botox reported their migraines were reduced to fewer than 1 day a month from almost 7, according to a study of 18 people published today in the Archives of Dermatology . The researchers said that people with migraine pain called “imploding” — that felt like a vise was tightened around their heads — were helped more than those whose migraine pain felt “explosive.” Medical trials have reported inconsistent data on how much Botox helps reduce migraine pain, the researchers said. Irvine, California-based Allergan has filed for approval with the U.S. Food and Drug Administration to market Botox as a treatment for chronic migraines, which affects about three million Americans, company spokeswoman Crystal Muilenburg said. “This could revolutionize the way people with these migraines are treated,” said one author of today’s study, Jeffrey Dover , an associate clinical professor of dermatology at Yale School of Medicine in New Haven, Connecticut, in a Feb. 12 telephone interview. “It was the imploding headaches that responded and the ocular headaches,” Dover said. “They required little to no pain medication for headaches in the months after their Botox treatment.” Today’s study was funded in part by Allergan and the National Institutes of Health. Injection Botox, a purified form of the poison botulinum, is administered by doctors as an injection. It is approved as a short-term treatment to smooth wrinkles in facial skin by temporarily paralyzing the muscles underneath. Americans underwent almost 2.5 million Botox procedures in 2008, the latest year for which data is available, according to the American Society for Aesthetic Plastic Surgery . Researchers don’t know how Botox works to stop migraine pain, said study co-author Rami Burstein , a professor of anesthesia at Harvard Medical School in Boston. The drug may block the signals in sensory nerves located on the outside of the head that may cause the migraines called imploding and ocular, he said in a Feb. 12 telephone interview. The study looked at 18 migraine sufferers who had already received or were planning to get Botox injections for cosmetic purposes. Each was interviewed and asked to describe their pain. Of the 18, 10 said they had so-called imploding migraines or ocular migraines. Eight patients had exploding, or splitting, headaches. One patient was in both groups. Relief Three months after the injections, 13 patients said they had a reduction in migraine pain, including 10 who had the imploding or “eye-popping” headaches and three with exploding pain, the researchers found. Their average frequency of migraines dropped to 0.7 days per month from 6.8 days before they had the Botox. Among the 10 who had imploding or ocular headaches, their migraine frequency dropped even more to 0.6 days a month from an average of 7.1 days a month, the study showed. The other three with exploding headaches had a drop in migraine frequency to 9.4 days a month from 11.4 days. All those who did not report significant relief from Botox had explosive migraines. In the study, the researchers gave patients a dose of Botox used for cosmetic purposes, which was lower than doses previously used to treat migraines, Dover said. Also, the patients in this study were already scheduled to get Botox for cosmetic purposes rather than for migraines, so that alleviated some potential bias from patients who may say the injection works just to receive free treatment, he said. Cost Botox cosmetic treatments cost $700 to $1,000 on average for one session, said Dover, who is also director of SkinCare Physicians, a practice specializing in dermatology treatments in Chestnut Hill, Massachusetts. Migraine sufferers would need about four sessions a year for as long as their headaches return, he said. Burstein is a consultant to Allergan and receives payment for lectures and grants for clinical and animal research. Research presented last year at the International Headache Congress in Philadelphia showed that patients on Botox had 7.8 fewer days per month afflicted with any headaches including migraines, compared with 6.4 fewer headache days on placebo. Allergan’s Muilenburg said the company may win U.S. approval later this year. Migraine treatments include over-the-counter painkillers, as well as Johnson & Johnson’s Topamax and GlaxoSmithKline Plc’s Imitrex. Map Pharmaceuticals Inc. is developing an inhaled migraine therapy called Levadex. To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net .

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Don’t Look Back: Major Players Continue To ‘Walk Away’ From Poor Mortgages

January 25, 2010

As underwater homeowners around the country despair over whether to keep paying their mortgages or just walk away, investors in the largest residential real estate deal in U.S. history have just walked away from 11,232 properties in one fell swoop. On Monday a group led by Tishman Speyer Properties gave up the 56-building, 11,232-unit Peter Cooper Village and Stuyvesant Town apartment complex in Manhattan, turning the properties over to its creditors after defaulting on some $4.4 billion in debt. The group decided to “transfer control and operation of the property…to the lenders,” it told the Wall Street Journal . The $5.4 billion acquisition in 2006 was the single biggest residential property purchase in U.S. history. It’s now worth an estimated $1.8 billion, putting the properties’ owners “underwater.” Four years later, the joint venture by Tishman and BlackRock Inc. is part of what is undoubtedly the biggest walk-away in mortgage history. On Wall Street, it’s okay to walk away from your mortgage. “We basically walked away from it,” said Clark McKinley, a spokesman for the California Public Employees’ Retirement System [CalPERS], the nation’s biggest municipal pension fund. CalPERS, one of several investors in the venture, wrote off its $500 million investment, McKinley said. “It’s underwater, anyway, so we’ve lost it,” he added. “We took our medicine, and we’re learning from it.” The Tishman-led venture is just the latest Wall Street walk-away. Last month, Morgan Stanley , the country’s sixth-biggest bank by assets, walked away from five San Francisco office buildings it purchased as part of a landmark $2.43 billion deal near the height of the real estate boom. The $770 billion firm called it a “a negotiated transfer to our lenders.” So if Wall Street can do it, why can’t homeowners? About a quarter of homeowners with a mortgage — estimates range from 11-15 million — are currently underwater on their mortgages, meaning they owe more than the property is worth. All of the mortgages in the state of Nevada are worth more than the underlying properties, according to real estate research firm First American CoreLogic , making the whole state virtually underwater. But struggling homeowners aren’t getting the kind of mortgage relief they need, experts say. Principal cuts are rare. In fact, more than 70 percent of mortgage modifications involve an increase in the principal owed, according to a recent report by state regulators. Meanwhile, about half of mortgages that are modified eventually re-default anyway. The kind of mortgage modifications most prevalent are simply delaying the inevitable, according to a review of mortgage modification data. With homeowners at the mercy of their lenders, unable to get relief on their home mortgages in bankruptcy court, and unlikely to see a return in their homes’ values to their boomtime highs, they don’t have too many options. Enter “strategic defaults” — a fancy way of saying “walking away.” More than one million homeowners went that route last year, nearly double the amount in 2008 and more than four times the level in 2007, according to a recent analysis by the credit reporting company Experian and Oliver Wyman, a management consulting firm. A study by a team of university academics found that a quarter of defaults are strategic. The trigger, researchers say, is negative equity. When the value of a house is less than what the bank is owed, borrowers have good reason to break their contracts and walk away. As Brent T. White, a law professor at the University of Arizona, notes, “there is in fact a huge financial upside to strategic default for seriously underwater homeowners — an upside that is routinely ignored by the media, credit counseling agencies, and other political and economic institutions in ‘informing’ homeowners about the consequences of default.” White argues that homeowners should act like corporations, or like Morgan Stanley and Tishman Speyer — maximize profits and minimize losses. Walking away from an underwater mortgage makes sense, White says. But distressed homeowners are often guilted into paying their mortgages, White argues. Former Treasury Secretary Hank Paulson once said: “And let me emphasize, any homeowner who can afford his mortgage payment but chooses to walk away from an underwater property is simply a speculator – and one who is not honoring his obligations.” The head of the Mortgage Bankers Association, John Courson, played up the moral argument against walking away, telling the Wall Street Journal last month : “What about the message they will send to their family and their kids and their friends? But corporations and businesses don’t play by those rules. Like CalPERS’s McKinley said, “You come to a point where you write it off or stay in the game. If you want to stay in you got to put in more capital. We reached our limit on that. It was not a prudent thing to put more money into it. “You get to a point where you can’t keep throwing good money after bad,” he said. “These are illiquid investments. You gotta fish or cut bait.” As for homeowners walking away en masse — perhaps lenders’ biggest housing-related fear — McKinley added: “We’re hopeful that won’t happen.”

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Don’t Look Back: Major Players Continue To ‘Walk Away’ From Poor Mortgages

January 25, 2010

As underwater homeowners around the country despair over whether to keep paying their mortgages or just walk away, investors in the largest residential real estate deal in U.S. history have just walked away from 11,232 properties in one fell swoop. On Monday a group led by Tishman Speyer Properties gave up the 56-building, 11,232-unit Peter Cooper Village and Stuyvesant Town apartment complex in Manhattan, turning the properties over to its creditors after defaulting on some $4.4 billion in debt. The group decided to “transfer control and operation of the property…to the lenders,” it told the Wall Street Journal . The $5.4 billion acquisition in 2006 was the single biggest residential property purchase in U.S. history. It’s now worth an estimated $1.8 billion, putting the properties’ owners “underwater.” Four years later, the joint venture by Tishman and BlackRock Inc. is part of what is undoubtedly the biggest walk-away in mortgage history. On Wall Street, it’s okay to walk away from your mortgage. “We basically walked away from it,” said Clark McKinley, a spokesman for the California Public Employees’ Retirement System [CalPERS], the nation’s biggest municipal pension fund. CalPERS, one of several investors in the venture, wrote off its $500 million investment, McKinley said. “It’s underwater, anyway, so we’ve lost it,” he added. “We took our medicine, and we’re learning from it.” The Tishman-led venture is just the latest Wall Street walk-away. Last month, Morgan Stanley , the country’s sixth-biggest bank by assets, walked away from five San Francisco office buildings it purchased as part of a landmark $2.43 billion deal near the height of the real estate boom. The $770 billion firm called it a “a negotiated transfer to our lenders.” So if Wall Street can do it, why can’t homeowners? About a quarter of homeowners with a mortgage — estimates range from 11-15 million — are currently underwater on their mortgages, meaning they owe more than the property is worth. All of the mortgages in the state of Nevada are worth more than the underlying properties, according to real estate research firm First American CoreLogic , making the whole state virtually underwater. But struggling homeowners aren’t getting the kind of mortgage relief they need, experts say. Principal cuts are rare. In fact, more than 70 percent of mortgage modifications involve an increase in the principal owed, according to a recent report by state regulators. Meanwhile, about half of mortgages that are modified eventually re-default anyway. The kind of mortgage modifications most prevalent are simply delaying the inevitable, according to a review of mortgage modification data. With homeowners at the mercy of their lenders, unable to get relief on their home mortgages in bankruptcy court, and unlikely to see a return in their homes’ values to their boomtime highs, they don’t have too many options. Enter “strategic defaults” — a fancy way of saying “walking away.” More than one million homeowners went that route last year, nearly double the amount in 2008 and more than four times the level in 2007, according to a recent analysis by the credit reporting company Experian and Oliver Wyman, a management consulting firm. A study by a team of university academics found that a quarter of defaults are strategic. The trigger, researchers say, is negative equity. When the value of a house is less than what the bank is owed, borrowers have good reason to break their contracts and walk away. As Brent T. White, a law professor at the University of Arizona, notes, “there is in fact a huge financial upside to strategic default for seriously underwater homeowners — an upside that is routinely ignored by the media, credit counseling agencies, and other political and economic institutions in ‘informing’ homeowners about the consequences of default.” White argues that homeowners should act like corporations, or like Morgan Stanley and Tishman Speyer — maximize profits and minimize losses. Walking away from an underwater mortgage makes sense, White says. But distressed homeowners are often guilted into paying their mortgages, White argues. Former Treasury Secretary Hank Paulson once said: “And let me emphasize, any homeowner who can afford his mortgage payment but chooses to walk away from an underwater property is simply a speculator – and one who is not honoring his obligations.” The head of the Mortgage Bankers Association, John Courson, played up the moral argument against walking away, telling the Wall Street Journal last month : “What about the message they will send to their family and their kids and their friends? But corporations and businesses don’t play by those rules. Like CalPERS’s McKinley said, “You come to a point where you write it off or stay in the game. If you want to stay in you got to put in more capital. We reached our limit on that. It was not a prudent thing to put more money into it. “You get to a point where you can’t keep throwing good money after bad,” he said. “These are illiquid investments. You gotta fish or cut bait.” As for homeowners walking away en masse — perhaps lenders’ biggest housing-related fear — McKinley added: “We’re hopeful that won’t happen.”

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Half Teaspoon Less Salt Each Day May Save Lives, Billions in Medical Costs

January 20, 2010

By Alexandra Thomas Jan. 20 (Bloomberg) — Consuming just half a teaspoon less salt each day may save as many as 92,000 U.S. deaths and as much as $24 billion in medical costs a year, a study found. A 3-gram daily salt reduction per person would lower annual cases of heart disease and stroke by about one-third, according to an analysis published today in the New England Journal of Medicine . The authors used a computer-simulation model to estimate that the change in consumption would save $10 billion to $24 billion in annual health-care costs from drugs and other treatments for high blood pressure and cardiovascular disease. Reducing salt intake would improve health as much as quitting smoking, losing weight and taking medications for lowering cholesterol, the researchers found. Salt reduction lowers blood pressure, so a cutback of just 1 gram per day would have substantial benefits in about one third of adults with high blood pressure, the study said. “There is a common misperception that only certain people should reduce their salt intake and that for the vast majority of the population salt reduction is unnecessary,” said Lawrence Appel and Cheryl Anderson of Johns Hopkins University in Baltimore in an editorial published today in the journal. “The opposite is true. For adults who reach the age of 50 years, the lifetime risk that hypertension will develop is 90 percent.” Recommendations Half a teaspoon of salt equals about 1,200 milligrams of sodium, or 3 grams of salt, according to the American Heart Association’s Web site . The heart association also announced today it was lowering its recommended amount of daily sodium intake to less than 1,500 milligrams from 2,300 milligrams. Sodium is found in a number of products besides table salt. Those include monosodium glutamate and baking soda. The study was done by researchers from the University of California, San Francisco, at Stanford University, near Palo Alto, California, and at Columbia University in New York using a computer model of coronary heart disease in U.S. residents age 35 and older. The researchers estimated that lowering daily salt intake by 3 grams would have health benefits at least as large as reducing smoking by 50 percent or using statin drugs to treat people with a low or intermediate risk for heart disease. New York City health officials are pushing for a reduction in the amount of salt in packaged and restaurant foods by 25 percent over the next five years, since Americans currently consume about twice the recommended daily amount of salt, city officials said. Mayor Michael Bloomberg recently changed other city health regulations, cutting trans fats in eating places and requiring fast-food restaurant menus to list calories. The United Kingdom, Finland and Ireland already have aggressive public programs to reduce salt intake, according to the editorial that accompanied the study. To contact the reporter on this story: Alexandra Thomas in Washington at athomas48@bloomberg.net .

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Haiti Waits and Suffers as UN Works to Unblock Aid Deliveries After Quake

January 15, 2010

By Peter S. Green and Michelle Fay Cortez Jan. 15 (Bloomberg) — Rescuers from around the world overwhelmed Haiti’s only international airport amid fears aid isn’t reaching survivors of the Jan. 12 earthquake that the country’s Red Cross says may have killed 50,000 people. With little time left to find those still buried in the rubble, rescue teams were stuck at the Port-au-Prince airport and civilian relief flights couldn’t land after its ramps filled with craft, the U.S. Federal Aviation Administration said in a notice . The airport also lacked fuel for planes to fly home. “In the first 48 hours, you have to find people who are injured and buried under these stone heaps,” Dr. Egbert Sondorp of the London School of Hygiene and Tropical Medicine said. “Emergency measures are helpful only for the first few days. After that, most people will be dead.” The quake also damaged roads from the neighboring Dominican Republic, said Harry Edwards , a spokesman for the U.S. Agency for International Development, while the U.S. Coast Guard said cargo docks in Port-au-Prince were unusable. “There is a substantial shortage of water, food, medical supplies and shelter in the country,” former U.S. President Bill Clinton said on CNBC television this morning. “There’s still a lot of these medical clinics that don’t even have aspirin and other basic medical supplies.” Cuban Airspace Dominican President Leonel Fernandez offered his country’s ports and airports as a staging ground for aid in a meeting with Haitian President Rene Preval , according to the Dominican presidential Web site. The U.S. received permission to use Cuban airspace for medical flights to and from the naval base at Guantanamo Bay, saving 90 minutes on a one-way flight, White House spokesman Tommy Vietor said today. “The fact that the system is overloaded spells trouble even for people with moderate injuries,” who risk infection if they go untreated, said Irwin Redlener , director of the National Center for Disaster Preparedness at Columbia University’s Mailman School of Public Health. Government workers in Haiti began digging mass graves and burying 7,000 victims of the quake, the Miami Herald reported. Amid Haiti’s dry season, the weather today is forecast to be partly cloudy with a high of 31 degrees Celsius (88 degrees Fahrenheit), according to AccuWeather.com. Jan Techau , an analyst at Berlin’s German Council on Foreign Relations , said the North Atlantic Treaty Organization might be called in to assist Haiti, just as it helped after the 2004 Indian Ocean tsunami. NATO Assets “NATO could use its assets to help with logistics and humanitarian relief including ships and helicopters,” Techau said in an interview. A NATO spokesman in Brussels wasn’t immediately able to say whether the alliance had received any requests for aid. International Medical Corps , a non-profit group based in Santa Monica, California, is bringing in its own supplies, said Margaret Aguirre, a spokeswoman for its emergency response team, in a telephone interview from the Haitian capital. “So much of the infrastructure is lost in terms of buildings and personnel,” she said. “A lot of the people who normally do relief work are missing themselves.” A hospital ship from the U.S. is on the way. Helicopters are already ferrying the wounded to hospitals in nearby countries. “Even as we move as quickly as possible, it will take hours — and in many cases days — to get all of our people and resources on the ground,” President Barack Obama said. “Right now in Haiti roads are impassable, the main port is badly damaged, communications are just beginning to come online.” 82nd Airborne The U.S. has deployed an advance unit of the Army’s 82nd Airborne division. The aircraft carrier U.S.S. Carl Vinson will arrive today, and a U.S. Marine expeditionary force is approaching the island. “This is a moment for American leadership,” Obama said in a meeting with House Democrats on Capitol Hill. He said U.S. power must be projected “not just for our own interest, but for the interest of the world as a whole.” He pledged $100 million for relief efforts. Economic damage in Haiti may be in the “low-single-digit billions” of dollars, Eqecat Inc., an Oakland, California-based company that builds financial risk models for insurers, said in a statement. The earthquake will cost Haiti at least 15 percent of its $7 billion gross domestic product, Pamela Cox, the World Bank’s vice president for Latin America and the Caribbean, said in an interview with Bloomberg Television. Canceling Debt French Finance Minister Christine Lagarde said in Paris today that as head of the Paris Club she’s contacted other members to cancel Haiti’s bilateral debt with France. More than two days after the magnitude-7.0 tremor hit the capital, destroying homes, hospitals, schools and such landmarks as the presidential palace and national cathedral, thousands of people were wandering the city’s streets or trying to dig out those trapped. “Bodies being dragged out of the rubble and placed on sidewalks, out in the open, every few meters there are bodies; bodies everywhere; numerous bodies of children; the smell of decaying bodies is starting to come already,” Kristie van de Wetering, communications director in Haiti for aid agency CHF International, wrote in an e-mail. Trapped Boy “We met the father of a 15-year-old boy who was trapped under the rubble,” she wrote. “They could hear him tapping with a rock so they knew he was still alive; the family was looking for tools to get him out.” More urgent than disposing of corpses is setting up water stations and temporary treatment centers and delivering the tons of antibiotics and supplies needed to avert outbreaks of diarrhea, measles and malaria, said Thomas Kirsch, an emergency medicine specialist at Johns Hopkins School of Medicine in Baltimore. The Haitian Red Cross estimated that as many as 50,000 people died in the quake, National Public Radio reported. Prime Minister Jean-Max Bellerive said Jan. 13 that the death toll could reach 100,000. The situation is “hopeless” for many Haitians, and aid efforts aren’t yet providing significant help, David Wimhurst , communications director of the UN peacekeeping mission in Haiti, told reporters in New York via videoconference. Angry, Impatient “They are slowly getting more angry and impatient,” Wimhurst said. “The situation is getting more tense. Tempers might become frayed. The national police have disappeared. Law and order is up to the UN.” People are sleeping in the streets and obstructing roads with concrete blocks, making it difficult for aid workers to move, he said. “You can only step over the bodies of the wounded and the dead in the dark so long before these tensions mount up,” former President Clinton said. He said people can help by sending money to charitable groups. Haitians in the U.S. should be allowed to overstay their visas, said Sen. Richard Lugar , and be granted Temporary Protective Status for 18 months so they can send funds home. Yesterday, U.S. Immigration and Customs Enforcement said it suspended deportations of Haitians. A private rescue team, assembled by Citigroup Inc. , arrived by helicopter in Port-au-Prince and pulled two employees from the wreckage of the bank’s three-story office. More may be trapped inside, Liliana Mejia , a spokeswoman for the New York- based bank said today. Food Rations The World Food Program plans to ship ready-to-eat rations for 2 million people, and had enough on hand this morning for 2,400 people, said spokeswoman Bettina Luescher. Spain, Russia, Germany, Chile and Israel sent field hospitals by air. Poland, Ireland, Canada the U.K., Iceland and Brazil sent rescue workers, as did several U.S. cities, including 80 firefighters and police from New York City. Donations came from corporations including Jefferies Group Inc. , Morgan Stanley , Bank of America and Goldman Sachs Group Inc ., which each pledged at least $1 million for relief efforts. Citigroup pledged $2 million, and Digicel Group, Haiti’s largest mobile phone provider, pledged $5 million. “What touched us was the hopelessness of the situation and devastation,” said Bob Parsons , chief executive of Go Daddy Group , a Scottsdale, Arizona, Web site design and registration firm. Go Daddy gave $500,000 to Hope for Haiti , a nonprofit organization that supports education and health care. Officials along Haiti’s border with the Dominican Republic are letting Haitians cross freely, waiving visas and noting only names, said Sandra Severino , a spokeswoman for President Fernandez . “We’re opening our border to the injured,” Severino said in a phone interview from Santo Domingo. “In Haiti there are no conditions for anything.” A Dominican convoy was the first foreign aid to enter Haiti yesterday, bringing 300 rescue workers, dogs and a fleet of excavators. To contact the reporters on this story: Peter S. Green in New York at psgreen@bloomberg.net ; Michelle Fay Cortez in London at mcortez@bloomberg.net

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Haiti Survivors Face Diarrhea, Malaria Outbreaks Amid Lack of Clean Water

January 14, 2010

By Tom Randall, Meg Tirrell and Michelle Fay Cortez Jan. 14 (Bloomberg) — Survivors of the earthquake in Haiti that may have killed as many as 100,000 people face deadly outbreaks of diarrhea, measles and malaria after its already fragile clean water and health-care systems were destroyed. Even before the bodies of the dead have been removed from the rubble, health officials say it’s critical in the next few days that massive containers of water be set up throughout the capital of Port-au-Prince, temporary treatment centers established and tons of antibiotics and basic medical supplies delivered. Haiti has long suffered from the highest rates of malnutrition and lack of access to basic health services in the Western Hemisphere, according to the World Health Organization . The crisis has left no health infrastructure for aid workers to build upon, and disease outbreaks may be worse than in the aftermaths of comparable natural disasters, said Thomas Kirsch, director of operations at Johns Hopkins School of Medicine’s department of emergency medicine in Baltimore. “This is such a delicate situation,” said Margaret Aguirre, a spokeswoman for the emergency response team of International Medical Corp., a non-profit based in Santa Monica, California, in a telephone interview from Port-au-Prince. “We need to bring in medical supplies ourselves. So much of the infrastructure is lost in terms of buildings and personnel. A lot of the people who normally do relief work are missing themselves.” Doctors have set up operations outside the main hospital, because the building isn’t stable, according to Aguirre. The epicenter of the 7.0 magnitude earthquake was close to the city. “There have been many, many aftershocks,” she said. Flourishing Diseases Diarrheal diseases, including cholera and e. coli, cause severe dehydration and strip the body of needed nutrients. Diarrhea will flourish as survivors struggle to find clean water and safe food, Kirsch said. Children are most susceptible to severe infections. Measles outbreaks, which sometimes follow natural disasters, may flash through neighborhoods of tightly packed courtyards where thousands of homeless residents are gathering. Measles spreads rapidly and kills 15 percent of infected children in regions with malnutrition, Thomas Frieden , director of the U.S. Centers for Disease Control and Prevention, said in an interview in December. “The health system has been eliminated, water and sanitation entirely knocked out,” Kirsch said in an interview today. “The chance of them recovering even to the low level that they were before is almost zero.” No Basic Care Half of the children in Haiti are unvaccinated and just 40 percent of the population had access to basic health care before the crisis, according to the Geneva-based WHO. After a natural disaster of this magnitude, the delivery of needed supplies is usually managed by the military, Kirsch said. In Haiti, the armed forces were dismantled in 1995. The UN typically coordinates aid from international agencies. Those efforts were complicated after the UN headquarters at the Christopher Hotel collapsed in the quake. UN Assistant Secretary-General for Peacekeeping Operations Alain LeRoy said 14 workers in Haiti were confirmed dead, and 150 civilian and military personnel are unaccounted for. Other UN offices have also been damaged, and 10 people are missing from a compound that houses these groups. ‘Poorly Governed’ “Haiti is considered one of the most poorly governed countries in the world,” said Egbert Sondorp, a senior lecturer in public health and humanitarian aid at the London School of Hygiene and Tropical Medicine. “It’s a fragile state which wasn’t very well able to provide social and health services to its population even before the earthquake.” The initial period of medical crisis, when rescuers look for people buried beneath the rubble and care for those with the most severe injuries from the earthquake, will last just a few days, Sondorp said in a telephone interview. The bigger challenge, and one that could take decades to resolve, is rebuilding the infrastructure needed to provide food, clean water and health care to citizens nationwide, he said. “It’s quite essential, as soon as you can, to come up with a proper rehabilitation plan,” he said. “You need to get people together to pool resources and do common planning that will make the conditions better.” Drugmaker Donations Drug companies are donating needed medicines and medical supplies. New York-based Pfizer Inc., the world’s biggest drugmaker, is giving medicines including the antibiotic Zithromax to fight bacteria and Diflucan for fungal infections, said Pfizer spokeswoman Tyrene Frederick-Mack in a telephone interview. GlaxoSmithKline Plc, based in London, sent antibiotics on one of the first airlifts to Haiti after the earthquake, said spokeswoman Claire Brough in a telephone interview. The drugs included Bactroban cream and ointment, Augmentin for respiratory tract infections, Zovirax for herpes virus, Ceftin and Zinacef for bacterial infections and Zantac for heartburn and stomach ulcers, she said. The company plans to extend donations once the local infrastructure is repaired, she said. Abbott Laboratories, based in Abbott Park, Illinois, is donating $1 million in grants and pharmaceutical and nutritional products. Eli Lilly & Co., based in Indianapolis, is contributing $250,000, matching employee donations, and plans to donate medicines, the company said in the statement. Death Toll Estimates The earthquake may already have killed 45,000 to 50,000 people, Victor Jackson, an assistant national coordinator with Haiti’s Red Cross, told Reuters. Haitian Prime Minister Jean-Max Bellerive said yesterday in an interview with CNN that “well over” 100,000 may have died, basing his estimate on reports of the number of buildings that collapsed with people inside. The Red Cross estimates as many as 3 million people may be affected by the earthquake. Haiti has a total population of 9.6 million, with about 2 million located in Port-au-Prince. The Western Hemisphere’s poorest country, Haiti has a per capita income of about $560, with 54 percent of Haitians living on less than $1 a day and 78 percent on less than $2 daily, according to the World Bank. Traumatic Injuries “Immediately we’re dealing with a very significant amount of physical trauma-related injuries which are going to be responsible for virtually all of the prompt fatalities,” said Irwin Redlener , director of the National Center for Disaster Preparedness at Columbia University Mailman School of Public Health. The chance of survival plummets for someone buried under rubble after 48 to 72 hours, he said in an interview today. When those with more serious injuries are being treated, people with broken bones and other more moderate ones can get infections while they wait. “The fact that the system is overloaded spells trouble even for people with moderate injuries,” Redlener said. After the initial period, “the rubble itself creates hazards. We start seeing lots of cuts, bruises, falls,” he said. Chronic illnesses, such as diabetes or asthma, that were previously under control may become exacerbated with lack of medical care or the inability for people to obtain medicines, Redlener said. Some will develop stress-related disorders from emotional trauma. “The emotional burden of this is going to be overwhelming,” he said. Doctors Without Borders The aid group Doctors Without Borders has had more than a thousand patients in its four tented medical facilities in Port- au-Prince, according to a statement. Many people have come in with fractures, head injuries and other major trauma, and food, water and shelter materials are running low, the group said. “Basic provisions were always problematic for people in Port-au-Prince but the position is far worse now,” said Vincent Hoedt, an emergency coordinator for the group, in the e-mailed statement. “There’s a concern for people who are already weakened by injuries. There are also shortages of things like gasoline, which affects the working of all kinds of vital equipment.” Port-au-Prince had 21 public health facilities, including four hospitals, before the earthquake, according to Greg Elder, deputy operations manager for Doctors Without Borders in Haiti. Half of the city’s inhabitants lived in slums, Elder said in an e-mailed update from the organization. “It’s a really catastrophic event where absolutely no one knows really what the scope of this is in terms of casualties and fatalities,” Elder said. Flights Depart Doctors Without Borders has almost 800 staff members in Port-au-Prince and plans to send an additional 70 people to help in the next few days, including several surgical teams, Elder said. A flight will leave today with equipment to establish a 100-bed inflatable tent hospital with two operating rooms, and two surgical teams are leaving today from Miami, he said. Lester Hartman, a Westwood, Massachusetts, pediatrician and Harvard Medical School faculty member, said he expects to see greater demand for services at Mt. Carroll Clinic, which he helped establish in 2003 in the town of Juampas, about 40 miles outside Port-au-Prince. While the clinic, where Hartman is medical director, itself was unscathed by the earthquake, survivors will soon begin arriving in hill towns such as Juampas in search of food and medical services, he said. Food Supplies “There’s going to be a secondary wave of people migrating from Port-au-Prince to the towns,” he said yesterday in an interview in Boston. “They’ll come up to live with relatives and they won’t have housing or food. So people who don’t have enough food to begin with will have to split their food.” Food supplies may remain scarce because most deliveries come to the country via Port-au-Prince, Hartman said. He’s also looking for ways of bringing extra doses of antibiotics. Hartman said he may fly into the Dominican Republic capital city of Santo Domingo and drive eight hours to Juampas to avoid the chaos of Port-au-Prince. Workers in the clinic, which typically serves about 300 people each week, often see temporary migration from Port-au- Prince to hill towns during riots, Hartman said. The displacing effects of the earthquake on may last much longer, he said. “Think of it a little bit like Katrina,” he said. “People are going to need help for years.” To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net

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Morphine for Combat Injured Halved Rate of Post-Traumatic Stress Disorder

January 13, 2010

By Alexandra Thomas Jan. 13 (Bloomberg) — Giving morphine to troops injured in fighting in Iraq lowered their risk of post-traumatic stress disorder by half, a study found. The study, published today in the New England Journal of Medicine , identified 696 U.S. Navy and Marine Corps personnel who suffered a major combat injury from 2004 to 2006. Seventy- six percent of those who didn’t develop the disorder had received morphine, compared with about 60 percent of those who hadn’t, the researchers found. As many as one in five veterans of the Iraq war have experienced post-traumatic stress disorder, or PTSD, after a serious injury during combat, according to the U.S. Veterans Affairs Department . A reliable way to prevent PTSD would significantly change military emergency medicine, said the researchers from the Naval Health Research Center in San Diego. “Such findings suggest a potential for prophylactic use of rapid pain reduction among injured, traumatic persons in both military and civilian acute care settings,” wrote Matthew Friedman from Dartmouth Medical School in Hanover, New Hampshire, in an editorial accompanying the study. Friedman likened the morphine treatment to “a morning-after pill.” PTSD is an anxiety disorder that some people get after living through a dangerous or painful event, according to the National Institutes of Health, a U.S. agency. Gunshots, Grenades The military personnel in the study included those injured by improvised explosive devices, gunshots, mortars and grenades. The results showed 147 of the 243 with PTSD had received morphine compared with 346 of 453 without PTSD who had gotten morphine. The stress disorder develops after the brain encodes memories during a traumatic event, researchers said in the study. The results suggested morphine and related opiates, may reduce or prevent the disorder by blocking this process when given soon, usually within one hour, after injury. If people who suffer only minor injuries don’t need morphine for physical pain, the drug could protect them from later developing PTSD, according to the editorial. Even if it’s unlikely morphine will be given to everyone undergoing a trauma, drugs like propranolol and clonidine may have the same effect. To contact the reporter on this story: Alexandra Thomas in Washington at athomas48@bloomberg.net .

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American Diabetes Association Announces New Board Members and Officers

January 8, 2010

ALEXANDRIA, VA–(Marketwire – January 8, 2010) – The American Diabetes Association, the nation’s largest and leading voluntary health organization leading the fight to Stop Diabetes(SM), is pleased to announce its officers and members of its Board of Directors for 2010. They are: Chair of the Board Nash M. Childs, PE David K. Bloomgarden, MD, FACE Executive Vice President Physician Leader Bancroft Construction Company Scarsdale Medical Group, LLP Wilmington, DE Harrison, NY President, Health Care & Education Jeffrey Caballero, MPH Christine T. Tobin, RN, MBA, CDE Executive Director Diabetes Educator Association of Asian Pacific Atlanta, GA Community Health Organizations (AAPCHO) Oakland, CA President, Medicine & Science Richard M. Bergenstal, MD J

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Video: Cephalon’s Nuvigil for Jet Lag Awaits FDA Approval: Video

January 8, 2010

Jan. 8 (Bloomberg) — Bloomberg’s Gigi Stone reports on Cephalon Inc.’s plan to bring to market the first drug to help travelers combat jet lag. Cephalon says U.S. regulators delayed action on the medicine, called Nuvigil, until March 29. (Source: Bloomberg)

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Susanna Speier: New Year’s Neuroeconomics Politiku

January 5, 2010

In 2010, the frequency of Politiku I post will be determined exclusively by the success and/or failure of my New Year’s resolution to balance the number of unpaid writing projects with the number of paid writing project I take on. The rush I get by hitting the “submit” button that forwards my post on to the Huffington Post ‘s round the clock editorial staff is addictive. This is, in part, because the rush doesn’t end with, submit . I go to sleep only to wake to discover that the round the clock editorial elves have transmitted by post around the globe and back. A post, lovingly syndicated by the New York Times , the Wall Street Journal and Business Week sustains my buzz. The re-tweets, follow up comments and spikes in my own blog traffic, only further sustain me. I’m not saying that blogging for HuffPost isn’t a worthy passion project, in and of itself. Nor am I saying that I don’t genuinely benefit from the distinguished community to which the website connects me. I am simply saying that the disproportionately exhaustive process of pitching to editors, querying potential clients and calling to follow up on the status of unreceived paychecks, is far too undesirable by contrast. In effort to avoid agonizing the pain caused by job scarcity, combined with the pain of MFA loans with metrics, I am resolving to only allow myself to indulge in the pleasurable Politiku process after successfully securing and completing a writing project or assignment that pays market rates. Neuroeconomics, the study of how irrational financial decisions are made, tracks the neuropathways of consumers, investors and gamblers. As far as I know, it has not yet been discussed in conjunction with the neuropathways that light up during the blogging process. Thanks to the behavioral specialists who generously contributed to my Neuroeconomics Politiku shout-out, we do now! Joseph Weiner Politiku Empty wallet. So? “Life is short,” wise people say. Don’t waste minutes, spend. Joesph Weiner is Chief of Consultation Psychiatry at North Shore University Hospital in Manhasset, NY and Associate Professor of Clinical Psychiatry and Medicine at Albert Einstein College of Medicine. Barbara J. Rubin Politiku There’s more than enough. Recession? Conspiracy. Bacchanalia. Barbara J. Rubin, PsyD, is an Atlanta-based Licensed Psychologist and Member, American College of Forensic Examiners. Alan Hall Politiku MRI’s don’t lie Tyrannical consumption Now clouds my cortex Alan Hall is a socionomist, researcher, writer and forecaster for The Socionomics Institute, founded by Robert Prechter. The Institute studies how waves of social mood produce patterns in financial and social behavior. Mollie M. Marti Politiku Simple pleasures free Deals hidden in crowded malls Back to the basics Mollie Marti, PhD is the Founder of Best Life Design and Adjunct Professor of Psychology, The University of Iowa. Georgia Witkin Politiku Shorter lines, more help, Early discounts, later hours, Recession? Not bad! Georgia Witkin, Ph.D., is an acclaimed professor of psychiatry at The Mount Sinai Medical Center in New York City. An expert on family relationships and stress management, national health correspondent, author of ten books, and a TV personality. Physko Politiku It amazes me Neuroeconomics claims What Cro-Magnon knew Trulyfool Politiku High priests will tell us – Econ gurus know it all – Impulse is cold cash Susanna Speier Politiku Earn more and blog less: My New Year’s Resolution moderates the buzz

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Susanna Speier: New Year’s Neuroeconomics Politiku

January 5, 2010

In 2010, the frequency of Politiku I post will be determined exclusively by the success and/or failure of my New Year’s resolution to balance the number of unpaid writing projects with the number of paid writing project I take on. The rush I get by hitting the “submit” button that forwards my post on to the Huffington Post ‘s round the clock editorial staff is addictive. This is, in part, because the rush doesn’t end with, submit . I go to sleep only to wake to discover that the round the clock editorial elves have transmitted by post around the globe and back. A post, lovingly syndicated by the New York Times , the Wall Street Journal and Business Week sustains my buzz. The re-tweets, follow up comments and spikes in my own blog traffic, only further sustain me. I’m not saying that blogging for HuffPost isn’t a worthy passion project, in and of itself. Nor am I saying that I don’t genuinely benefit from the distinguished community to which the website connects me. I am simply saying that the disproportionately exhaustive process of pitching to editors, querying potential clients and calling to follow up on the status of unreceived paychecks, is far too undesirable by contrast. In effort to avoid agonizing the pain caused by job scarcity, combined with the pain of MFA loans with metrics, I am resolving to only allow myself to indulge in the pleasurable Politiku process after successfully securing and completing a writing project or assignment that pays market rates. Neuroeconomics, the study of how irrational financial decisions are made, tracks the neuropathways of consumers, investors and gamblers. As far as I know, it has not yet been discussed in conjunction with the neuropathways that light up during the blogging process. Thanks to the behavioral specialists who generously contributed to my Neuroeconomics Politiku shout-out, we do now! Joseph Weiner Politiku Empty wallet. So? “Life is short,” wise people say. Don’t waste minutes, spend. Joesph Weiner is Chief of Consultation Psychiatry at North Shore University Hospital in Manhasset, NY and Associate Professor of Clinical Psychiatry and Medicine at Albert Einstein College of Medicine. Barbara J. Rubin Politiku There’s more than enough. Recession? Conspiracy. Bacchanalia. Barbara J. Rubin, PsyD, is an Atlanta-based Licensed Psychologist and Member, American College of Forensic Examiners. Alan Hall Politiku MRI’s don’t lie Tyrannical consumption Now clouds my cortex Alan Hall is a socionomist, researcher, writer and forecaster for The Socionomics Institute, founded by Robert Prechter. The Institute studies how waves of social mood produce patterns in financial and social behavior. Mollie M. Marti Politiku Simple pleasures free Deals hidden in crowded malls Back to the basics Mollie Marti, PhD is the Founder of Best Life Design and Adjunct Professor of Psychology, The University of Iowa. Georgia Witkin Politiku Shorter lines, more help, Early discounts, later hours, Recession? Not bad! Georgia Witkin, Ph.D., is an acclaimed professor of psychiatry at The Mount Sinai Medical Center in New York City. An expert on family relationships and stress management, national health correspondent, author of ten books, and a TV personality. Physko Politiku It amazes me Neuroeconomics claims What Cro-Magnon knew Trulyfool Politiku High priests will tell us – Econ gurus know it all – Impulse is cold cash Susanna Speier Politiku Earn more and blog less: My New Year’s Resolution moderates the buzz

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Gene Linked to Asthma May Show Connection to Allergies, Way to Treatments

December 24, 2009

By Ellen Gibson Dec. 23 (Bloomberg) — A gene linked to asthma susceptibility in children has been identified that may reveal the respiratory disease’s connection to allergies and lead to new treatment for 6 million U.S. child asthmatics, a study said. Researchers at the Children’s Hospital of Philadelphia analyzed the DNA of thousands of children to isolate the gene, called DENND1B, according to the study in today’s New England Journal of Medicine . The gene influences action on immune system cells involved in the body’s response to foreign material such as viruses, bacteria and allergens. This is the second gene found linked to asthma, a condition thought to be triggered by a combination of genetic and environmental causes, according to the study. Although the illness can be controlled by drugs, less than half of the 22 million asthmatics in the U.S. are properly managed, according to surveys from the American Lung Association . “You can use these findings to begin to tailor a new treatment approach for asthma,” said Norman Edelman , chief medical officer at the American Lung Association . “And with the huge asthma epidemic we’ve seen over the past 25 years, we certainly need a new approach.” The rate of asthma in the U.S. more than doubled to 7.1 percent of the population in 2004 from 3.1 percent in 1980, according to the U.S. Centers for Disease Control and Prevention, an Atlanta-based agency. Airways Asthma occurs when narrow or inflamed airways cause wheezing, coughing, chest tightness, and shortness of breath, according to the Mayo Clinic’s Web site . No cure exists for asthma, according to the National Institutes of Health , an agency in Bethesda, Maryland. It can be treated by inhaled steroids such as Symbicort, sold by London- based AstraZeneca Plc , and by Flonase from London-based GlaxoSmithKline Plc. Other researchers had found an asthma-susceptibility gene on chromosome 17 in 2007. In today’s study, researchers led by Hakon Hakonarson , the director of the Center for Applied Genomics at the Children’s Hospital of Philadelphia , isolated the DENND1B gene on chromosome 1. The gene may prove to be “an extremely strong drug target for asthma,” Hakonarson said yesterday in a telephone interview. Gene Analysis The researchers initially analyzed the genomes, or complete gene sets, of 793 white North American children with asthma, compared with a control group of 1,988 healthy children. They confirmed the results in a separate group of about 2,400 Europeans and controls, then did further analyses on about 3,700 black children. The scientists were able to duplicate earlier findings of the chromosome-17 gene, and they discovered the new DENND1B location on chromosome 1 that was strongly associated with the disease in the white and black children. Several genes are most likely involved in predisposing people to asthma, according to the report. The DENND1B gene the researchers pinpointed acts on dendritic cells that regulate the body’s immune response to trigger inflammation. After a foreign particle enters 22the airways, the dendritic cells pick it up, process it, and present it to an immune cell that may attack it in an allergic reaction. Link to Allergies About 70 percent of people with asthma also have allergies, according to the World Health Organization in Geneva, Switzerland. Because this gene seems to play “a critical role” in how sensitized the body is to allergens, Hakonarson said, it could advance research into that area as well. In follow-up studies, the researchers have found that DENND1B is also implicated in other immune and inflammatory diseases, although they haven’t yet reported that data. “It’s showing up as a very powerful gene,” Hakonarson said in a Dec. 22 phone interview. Genes and environment contribute to asthma, according to the Washington-based American Lung Association. If one parent has asthma, a child is three times more likely to get the disease, according to the lung association. Common environmental triggers of asthma include air pollution, mold, cockroach dust, and cigarette smoke, according to the CDC. Jobs that involve inhaling harmful substances, such as wood dust or smelting fumes, cause 11 percent of asthma cases, according to the World Health Organization, a United Nations agency. Drug Treatments Drug treatments for asthma include bronchodilators, which relax the muscles around the airway, providing quick relief during an asthma attack, and inhaled steroids, which are used over time to prevent swelling. While steroids are effective at managing the disease long- term, many people don’t use them, according to Edelman. Surveys by the lung association have found that the disease is properly controlled in less than 40 percent of asthmatics. He attributes this to the high cost of the drugs, coupled with the fact that inhaled therapies are cumbersome to use. “We’ve made a lot of progress in the treatment of asthma,” said Edelman, “but we could really use another class of drugs.” To contact the reporters on this story: Ellen Gibson in New York at egibson9@bloomberg.net ;

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Murad Triples Size of Its Product Development Department

December 10, 2009

EL SEGUNDO, CA–(Marketwire – December 11, 2009) – Murad, Inc. announced it has tripled the size of its product development department to meet escalating demand for support functions sparked by the growing pipeline of innovative products created when Jeff Murad, Vice President of Product Development for Murad, joined the development team. Jeff Murad, son of Associate Clinical Professor of Medicine at UCLA and company founder Howard Murad, M.D., will oversee the growth as he continues to manage the Product Development unit, working directly under his father.

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