surgery

Vitaliy N. Katsenelson: Don’t Call Me Mr. Doom, Call Me Mr. Realist

by on April 3, 2010

I had an interesting conversation last week with a potential investor. I described my thoughts on the U.S. economy, explaining that in our ( my firm’s ) view the current strength of the U.S. economy is significantly boosted by steroids graciously provided by the U.S. government in the form of stimulus. (I’ve written about it in this article .) I explained that since stimulus exaggerates the true performance of our economy, we’ve positioned our portfolio through stock selection for a subdued, low-growth type of recovery. Then I shared my concerns about the Chinese economy – it has tremendous overcapacity in the commercial and residential real estate and industrial sectors (see this presentation: “China – The Mother of All Black Swans” ). As the Chinese economy painfully readjusts and chews through the excesses, Chinese demand for industrial, energy, and commodity goods will be significantly lower. Thus, in our portfolios, we have reduced our exposure to these sectors. And finally, I explained our views on Japan. As you’ll see from charts in this presentation, ” Japan – Past the Point of No Return ,” Japan has an enormous amount of debt (second only to Zimbabwe), a stagnating economy, and the oldest population in the world (this explains why the savings rate has declined from the teens towards zero). These factors will lead to significantly higher interest rates. As an unbiased analyst, it is hard to come to any other conclusion about Japan, and I am going to put it lightly: Japan is screwed. As a consequence, we believe higher interest rates globally are unavoidable, as Japan, now the largest foreign holder of the US Treasuries (together with China, the second largest holder), turns from buyer of treasuries to net seller. So in our portfolio we are making sure that our companies have strong balance sheets and/or significant free cash flows to pay off debt, if (more likely when) interest rates rise. With every country mentioned the potential investor got paler and paler; and before I got to the EU, a union that was created, as my friend John Mauldin put it, for prosperity not adversity, he exclaimed, “You are Dr. Doom!” I don’t have a PhD, thus I can only be called Mr. Doom – but I am not that either. A joke told by Warren Buffett comes to mind: A patient, after hearing from a doctor that he has cancer, tells the doctor, “Doc, I don’t have enough money for the surgery, but maybe could I pay you to touch up the x-ray?” Hope and self-deception are not a strategy. I analyze and accept the conclusions of my analysis, no matter how painful they may be, and adjust my actions according to my findings. I am neither a pessimist nor an optimist, I am a realist. So at my firm we look at risks and constantly ask ourselves: What can we do to avoid them (or benefit from them) in our clients’ portfolios? So don’t call me Mr. Doom, call me Mr. Realist. Vitaliy N. Katsenelson, CFA, is a portfolio manager/director of research at Investment Management Associates in Denver, Colo. He is the author of “Active Value Investing: Making Money in Range-Bound Markets” (Wiley 2007). To receive Vitaliy’s future articles my email, click here .

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Vitaliy N. Katsenelson: Don’t Call Me Mr. Doom, Call Me Mr. Realist

Kidney Donors Don’t Shorten Their Lives by Giving Up Organ, Research Shows

by on March 9, 2010

By Nicole Ostrow March 9 (Bloomberg) — People who donate a kidney in the U.S. don’t die any faster than nondonors long term, according to a large study that looked at donors over 15 years. Within the first 90 days after surgery to donate a kidney, their death rate was slightly higher at 3 per 10,000, compared with less than 1 per 10,000 in healthy nondonors, according to research from Johns Hopkins University. Over 15 years, there was no difference in deaths of donors compared with others matched by age, health status, gender and race, said the study in today’s Journal of the American Medical Association . Kidney transplants have almost doubled over the past 15 years in the U.S. as more older people became eligible and higher rates of diabetes led to kidney disease and increased demand, said Dorry Segev , lead author of the study. The need for kidneys far outpaces the organs available each year, with more than 83,000 on a U.S. waiting list and 15,402 transplants performed from January through November last year, according to the Organ Procurement and Transplantation Network . “Over the last 15 years, live kidney donation remains a very safe operation,” said Segev, an associate professor of surgery and epidemiology at Johns Hopkins University in Baltimore, in a March 5 telephone interview. “There is no evidence that living with one kidney rather than living with two kidneys after donating a kidney is associated with any increased risk of dying prematurely.” Earlier Evidence Previous studies that found kidney donation was safe have been much smaller and often lacked well-matched comparison groups, according to the study authors. The research analyzed data from a national registry of 80,347 living kidney donors in the U.S. who gave their organ from April 1994 to March 2009. They were compared with 9,364 people who were part of a national health survey . Over those 15 years, 25 people died in the first 90 days after surgery, making their risk of dying from surgery 3.1 per 10,000 cases. That compared with 0.4 per 10,000 people for similarly healthy people who participated in the health survey. That makes the short-term risk of death after kidney donation surgery six times lower than from dying after gallbladder removal , when patients are sent home the same day as their surgery, the authors said. Donating a kidney is “one of the safest operations you could ever undergo, although the risk is not zero,” Segev said. One Year Later A year following the surgery, the risk of dying for those who donated a kidney was similar to the nondonors who participated in the health survey, the study found. Men and black people had a slightly higher risk of dying following the procedure, but their overall risk was still small, the researchers said. The need for U.S. kidney donations has increased as rates of diabetes and obesity have risen. Diabetes can lead to kidney disease over 20 to 30 years, eventually requiring treatment by dialysis or a transplant, according to the International Diabetes Federation. In the U.S., the number of people with diabetes awaiting a kidney transplant has almost tripled e over the past decade to almost 25,000 from about 9,600, according to data from the Organ Procurement and Transplantation Network. Most kidney donations from the living go to families and friends, Segev said. About 100 people every year will donate a kidney without a specific person in mind. The study was funded by the Organ Procurement and Transplantation Network, supported by a federal agency. To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net .

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Kidney Donors Don’t Shorten Their Lives by Giving Up Organ, Research Shows

Stents as Good as Surgery to Prevent Stroke From Clogged Artery

February 26, 2010

By David Olmos Feb. 26 (Bloomberg) — Using stents to open clogged arteries in the neck was as safe and effective as surgery to clear the artery, according to a U.S. study that differs from some previous research on the best way to prevent stroke. A stroke, heart attack or death occurred in 5.2 percent of patients within 30 days of surgery, compared with 4.5 percent treated with a carotid stent made by Abbott Laboratories, according to research presented today at the American Stroke Association’s international conference in San Antonio. The study’s results differ from research published online today in Lancet Neurology that found more patients with narrowed neck arteries who received a stent had a stroke, heart attack or died compared with those who underwent surgery. The devices are used by doctors trying to reduce the risk of strokes without the danger of cutting open the carotid arteries that line the neck. In the research presented today at the stroke conference, “stenting didn’t win and surgery didn’t win,” study investigator Christopher White , a cardiologist at the Ochsner Heart and Vascular Institute at the Ochsner Medical Center in Baton Rouge, Louisiana, said in a telephone interview. “What we won here is that there should now be a choice for patients.” Medicare Coverage Results of the study, known as CREST, may persuade the Centers for Medicare & Medicaid Services to broaden coverage of carotid stents for Medicare patients, White said. The federal health agency covers carotid stents only for Medicare patients for whom standard surgery is considered too risky, White said. Medicare is the U.S. government health insurance program for the elderly and handicapped. Doctors use a catheter threaded from a patient’s groin area to open the clogged portion of the neck artery and insert a stent, which is small wire mesh device, to keep the section cleared, according to the Mayo Clinic. Today’s study was funded by the National Institute of Neurological Disorders and Stroke with additional support from Abbott Park, Illinois-based Abbott. The company’s Acculink and Accunet carotid stent systems were approved for the U.S. market by the FDA in 2004, according to the company. Abbott competes in the carotid stent market with Boston Scientific Corp. , of Natick, Massachusetts, Johnson & Johnson , based in New Brunswick, New Jersey and Ev3 Inc. of Plymouth, Minnesota. The study in Lancet Neurology included stents from those three companies. About 795,000 people in the U.S. suffer a stroke each year, according to the Atlanta-based Centers for Disease Control and Prevention. About 20 percent of strokes are caused by blockages in the carotid arteries that supply blood to the brain, White said. Different Outcomes While the CREST study found that surgery and stents had “similar outcomes” on overall safety, there were differences among the procedures. Strokes occurred in 4.1 percent of stent patients within 30 days of the procedure, compared with 2.3 percent of surgery patients, the researchers found. Heart attacks occurred in 2.3 percent of patients in the surgery group, or more than twice the 1.1 percent of those who got stents, the study found. The CREST study results “are particularly impressive since the trial began almost a decade ago, when stenting was still a very new therapy,” said Charles Simonton, chief medical officer for Abbott Vascular, in an e-mail. To contact the reporter on this story: David Olmos in San Francisco at dolmos@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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Bill Clinton Hospitalized in New York for Stent Implant After Chest Pains

February 11, 2010

By Nicholas Johnston Feb. 11 (Bloomberg) — Former U.S. President Bill Clinton was admitted to a New York hospital today after suffering chest pains and underwent a procedure to place two stents in one of his coronary arteries, a spokesman said. “President Clinton is in good spirits, and will continue to focus on the work of his foundation and Haiti’s relief and long-term recovery efforts,” Douglas Band, counselor to the former president, said in a statement. Clinton, 63, underwent quadruple bypass surgery in 2004 after complaining of chest pains and shortness of breath. After the surgery he stayed at New York- Presbyterian Hospital for about a week. Gloria Chin, a spokeswoman for New York-Presbyterian Hospital/Columbia University Medical Center, said in a telephone interview that Clinton is at the facility. She referred further questions to the former president’s spokesman. Band said in the statement that Clinton went to the hospital after feeling discomfort and underwent the procedure after seeing his cardiologist. Doctors said it is relatively common for someone who has undergone bypass surgery to have a recurrence of chest pain and need stents implanted. Disease Returns “This is a very good example of what very typically happens with patients,” Steve Nissen , chairman of cardiology at the Cleveland Clinic in Ohio, said in an interview. “They get a period of often excellent results for some years, but the disease does come back.” Sunil Rao, an interventional cardiologist at Duke University Medical Center in Durham, North Carolina, said heart disease “is a progressive disease” that require lifetime treatment. “We can’t stop it, but we can slow it down through medication as well as risk factor modification,” Rao said. Clinton’s wife, Secretary of State Hillary Clinton , traveled to New York this evening after a meeting with President Barack Obama at the White House in preparation for a diplomatic trip to the Middle East. The meeting ended as scheduled and Hillary Clinton left for New York to see her husband, according to administration officials. Obama has been informed of the former president’s hospitalization, an official said. Former President Former President George W. Bush spoke to Clinton’s daughter, Chelsea, earlier today and “was glad to hear” that Clinton is doing well, David Sherzer, a spokesman for Bush, said. The two former presidents have been working together to raise money for relief efforts in Haiti. The procedure done on Clinton involved stents, which are tiny wire-mesh tubes used to prop open arteries after they’ve been cleared of fatty clogs by surgeons. Newer devices are coated with polymer and drugs to prevent tissue from growing inside the stent and re-blocking the artery, a main complication of previous models. Implanting stents typically takes less than an hour using a local anesthetic and patients typically leave the hospital within a day or two and resume normal activities within a week if the heart isn’t damaged, Nissen said today in an interview. One million Americans have the procedure each year, according to the National Institutes of Health. The $4.2 billion global market for stents is dominated by Natick, Massachusetts-based Boston Scientific Inc. , Medtronic Inc. , based in Minneapolis, Abbott Laboratories of Abbott Park, Illinois, and Johnson & Johnson , the world’s largest health products company, based in New Brunswick, New Jersey. Since leaving the presidency in 2000 after serving two terms, Clinton has worked on his presidential library and international disaster-relief efforts. The United Nations has named him international coordinator for humanitarian relief efforts in Haiti following the Jan. 12 earthquake that devastated the island nation. Clinton has an office in Harlem and he and Hillary Clinton have a home in Chappaqua, New York. To contact the reporters on this story: Nicholas Johnston in Washington at njohnston3@bloomberg.net ;

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Face Transplant Repairs Smile for Ohio Gunshot Victim 1 Year After Surgery

November 16, 2009

By Pat Wechsler Nov. 16 (Bloomberg) — The most extensive face transplant ever attempted shows no signs of rejection or complication after almost a year, said the Cleveland Clinic doctors who performed the procedure. The operation replaced 80 percent of a woman’s face in the first face-and-jaw transplant in the U.S., according to a report released today in the November/December issue of the Archives of Facial Plastic Surgery . The procedure restored blood flow from facial arteries that had been damaged by as many as 23 previous reconstructive operations. There have been eight facial transplants, including operations in France, China and Austin, Texas, said Daniel Alam , a member of the surgical team and co-author of the journal article. The Cleveland Clinic procedure stands out for the addition of the jaw bones and the amount of facial skeleton that needed to be transferred. “The concept of facial transplantation has become a reality,” wrote Alam, who was responsible for sewing together the patient’s blood vessel system in her new face, in the journal report. “We are still testing the technical feasibility, so whether this is the right or wrong thing to try will be determined by how these cases go,” Alam said in a telephone interview. “This is experimental surgery.” Gunshot Victim Connie Culp , 47, of Unionport, Ohio, was shot in the face by her husband in 2004, according to an article on the Cleveland Clinic Web site . On Dec. 10, 2008, she underwent a 22-hour operation, with a team of eight surgeons, to replace most of the features on her face, including her upper jaw. Almost immediately, she regained her ability to breathe through her nose and speak, and her sense of smell and taste, Alam said. As the nerves have regenerated, she is again able to smile and show expression, he said. Culp will go through a second round of Cleveland Clinic surgery in coming months to remove redundant sets of glands and bring the face closer to the goal for improving her appearance, Alam said. The procedure may be used eventually to help soldiers returning from war zones with traumatic facial injuries, Alam said. “The trend is toward being more aggressive,” he said. “But it’s still too early for big leaps and bounds. There needs to be much more sharing of data first.” Facial transplants are distinctive among organ-transplant procedures because they are multidisciplinary and require hundreds of hours of planning, Alam said. The Cleveland Clinic surgery also differed from most face transplants because it was done as “a salvage procedure,” after other operations to reconstruct Culp’s face. To contact the reporter on this story: Pat Wechsler in New York at pwechsler@bloomberg.net .

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AstraZeneca’s Brilinta Cuts Heart Attack, Death More Than Sanofi’s Plavix

August 30, 2009

By Michelle Fay Cortez Aug. 30 (Bloomberg) — AstraZeneca Plc’s experimental blood-thinner Brilinta prevented 16 percent more heart attacks, strokes and deaths than standard therapy with Sanofi-Aventis SA’s and Bristol-Myers Squibb Co. ’s Plavix in a study. Brilinta’s potency didn’t cause more episodes of serious bleeding, a common complication seen with drugs that ward off heart conditions by preventing blood clots from developing, the research showed. The findings position Brilinta to rival Plavix, the second-biggest selling medicine in the world with almost $10 billion in annual revenue, for millions of patients suffering from heart attacks or severe chest pain. About 1.3 million Americans are hospitalized each year with heart attacks and chest pain known as acute coronary syndromes. While aspirin and Plavix have lowered their subsequent health risks, cardiovascular disease remains the leading cause of death worldwide. Death from any cause was also significantly lower in patients taking Brilinta, according to the results of the study known as Plato. “I think this will become the new standard of care,” said Douglas Weaver, a cardiologist at Henry Ford Hospital in Detroit and a past president of the American College of Cardiology, in an interview. “It’s more rapid, more effective and it appears to be safer” than Plavix and another competitor, Effient, from Eli Lilly & Co. and Daiichi Sankyo Co. “I don’t think they could have done much better than they did in this trial.” The trial, funded by London-based AstraZeneca, included 18,624 patients and was one of the most eagerly anticipated findings presented at the European Society of Cardiology meeting in Barcelona this week. It was simultaneously published in the New England Journal of Medicine. Sales Estimate Sachin Jain , an analyst at Bank of America Merrill Lynch in London, forecast $500 million in sales by 2015 in an Aug. 17 note to investors, and said he may raise his estimate to $1.3 billion if the drug has a meaningful benefit without serious side effects. AstraZeneca needs Brilinta to help replace sales lost to generic competition for its best-selling drugs, as products including Seroquel that now account for about 62 percent of the company’s revenue will face lower-priced competition by 2014. The Brilinta findings may not be enough to replace the lost sales, wrote Kevin Wilson , an analyst at Citigroup Inc. in London, in an Aug. 19 note to investors. “Brilinta peak upside sales of $4 billion would be expected to be reached more than five years post-launch, once physicians become comfortable with how to get the best out of the product,” he wrote. “Even exceptional Brilinta success is not enough,” given the time it would take for doctors to embrace it, he said. Seeking Approval AstraZeneca plans to file for approval of Brilinta in the fourth quarter and hopes to begin selling it next year, said Gunnar Olsson , the company’s head of cardiovascular therapy. Brilinta, Plavix and Effient all work by preventing platelets from clumping together in the blood to form clots. Plavix and Effient, which was approved this year in Europe and the U.S., last for the life of the platelet, or about a week, and are given once a day. Brilinta needs to be taken twice daily. About 30 percent of patients don’t respond well to Plavix. Brilinta’s effects wear off in a few days, making surgery easier for patients who need it. One in 10 patients rushed to the hospital with chest pain or heart attacks actually need by-pass surgery, said Christopher Cannon , a cardiologist at Brigham and Women’s Hospital in Boston. If they are given Plavix or Effient, they must wait five days before getting the surgery, he said. ‘Huge Conundrum’ “It’s a huge conundrum, a headache for doctors, hospitals and patients,” he said in a telephone interview. “This opens the door. It’s a neat differentiating factor that could open up treatment options.” In the study, 9.8 percent of patients taking Brilinta for a year after being treated for a heart attack or worsening chest pain suffered another heart attack or stroke, or died from vascular disease, compared with 11.7 percent of those given Plavix. Overall, 4.5 percent of Brilinta patients died from any cause, significantly fewer than the 5.9 percent of Plavix patients who died. The rates of major bleeding were similar between the two groups, occurring in 11.6 percent of those on Brilinta and 11.2 percent of those on Plavix. Fatal bleeding in the brain was more frequent in those given Brilinta, while fatal bleeding in other areas was more common with Plavix. Brilinta was linked to more serious bleeding in the brain and stomach of patients who didn’t undergo bypass surgery, the study found. Safety Monitoring In an accompanying comment in the New England Journal, Albert Schoemig of the German Heart Centre in Munich wrote that the safety of Brilinta, also known as ticagrelor, needs to be tracked closely. “The whole story concerning the adverse effects of ticagrelor may require evaluation in a much larger number of patients, something that may be beyond the capacity of a randomized trial,” Schoemig wrote. “We should carefully monitor patients receiving this drug to establish the overall impact of its side effects.” A separate study unexpectedly found high doses of Plavix and aspirin failed to reduce the risk of heart attack, stroke or death from cardiac causes better than lower doses. The trial, dubbed Current Oasis 7 , involved more than 25,000 patients and is one of the first to specifically compare the most widely used doses of the two drugs given to almost all patients with heart attacks and severe chest pain. Plavix Results About half of patients get the higher double dose of Plavix with the expectation that more medicine will better prevent deadly clots from forming, Cannon said. The same rationale is given for using more aspirin. “We’ve adopted this because it makes good sense, but there is very little evidence,” he said. “It’s a fascinating thing how hard it is to prove the right dose. Now, 10 years in, we’re seeing if a higher dose helps.” In patients who underwent procedures to clear clogged heart arteries, about 70 percent of those in the trial, the double 600-milligram dose of Plavix lowered heart risks by 15 percent. In them, 3.9 percent of those getting high dose Plavix for a week developed complications or died within a month, versus with 4.5 percent of those given the approved 300-milligram dose. The trial was funded by Sanofi and Bristol-Myers. It could change the way doctors view Lilly and Daiichi’s Effient, since studies used to get approval of the drug known chemically as prasugrel used the lower Plavix dose for comparison. Higher Dose The higher dose Plavix slashed the risk of stent thrombosis, a deadly complication that occurs when a blood clot clogs a device used to prop open the artery, by 42 percent, said Shamir Mehta, director of interventional cardiology at McMaster University in Hamilton, Canada. There were no differences in stroke and death rates from cardiovascular disease alone, or in bleeding rates, he said. “This will result in a change in practice so patients will be receiving a double dose of clopidogrel for a full week, rather than just when they first come in,” he said in a telephone interview, using the chemical name for Plavix. “All things considered, a double dose of clopidogrel looks pretty good. It comes down to safety, since the efficacy outcomes were very similar to each other.” To contact the reporter on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net

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