Fda Panel to Vote On Painkiller Restrictions
The Food and Drug Administration has assembled more than 35 experts for a two-day meeting to discuss and vote on ways to prevent overdose with acetaminophen – the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.
Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. There are about 200 acetaminophen-related deaths each year.
“It can happen to anybody, but its very rare,” said Dr. Lee Simon, an associate professor at Harvard Medical School, who attended Mondays meeting. “Obviously its important that we improve the communication about these products because they are ubiquitous, and we still see people inadvertently overdosing.”
The drugs that could be pulled off shelves are combination medications, such as Procter & Gambles NyQuil or Novartis Theraflu, which mix acetaminophen with other ingredients that treat cough and runny nose.
The FDA is not required to follow the advice of its panels, though it usually does. The panel vote is scheduled for Tuesday afternoon.
Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products.
The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.
But the industry group that represents Johnson & Johnson, Advil-maker Wyeth and other companies defended the products Monday, saying they pose a relatively small risk to patients.
Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.
The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceuticals Percocet, which combines oxycodone and acetaminophen.
“We believe there is a clear health benefit of over-the-counter combination products containing acetaminophen,” said Linda Suydam, the groups president.
Tylenol-maker Johnson & Johnson also pushed back against a proposal to lower the maximum daily dose of acetaminophen, which is currently 4 grams daily, or eight pills of a medication like Extra Strength Tylenol.
The FDA panel also will vote on a series of other proposals, including changes to the packaging and labeling of medications. Both ideas are designed to prevent patients from taking more than the recommended dose of the drug.
Jobs Travel to Liver Transplant Mecca Shows Organ System Flaws
Memphis, where Jobs got the transplant, is one of several U.S. meccas for liver patients who can afford to travel, doctors said. Flight records show Jobss personal jet flew at least six times this year from California, with one of the longest transplant lists in the U.S., to Memphis, where the wait is shorter.
Jobs, 54, got his transplant in part because regions can keep donated organs on a local list — even when there may be sicker patients not far away. His experience spotlights organ allocation practices that have been under fire for decades and will be discussed at a national public meeting the United Network for Organ Sharing in Richmond, Virginia, plans for later this year, doctors said.
“You could call it gaming the system, that may be true,” John Fung, chairman of transplant surgery at the Cleveland Clinic in Cleveland, said in a telephone interview. “But until we tackle the problem of what makes the system unfair, we cant criticize people who are trying to help themselves.”
Shorter Waits
About 17,000 Americans were on liver transplant waiting lists in 2008, and about 6,000 received them, according to the Scientific Registry of Transplant Recipients, a national database of transplant statistics based in Ann Arbor, Michigan. Patients go to transplant centers in Memphis, as well as in Jacksonville, Florida, because the wait is shorter than other parts of the U.S., said Elizabeth Pomfret, chairman of the department of transplantation at the Lahey Clinic Medical Center in Burlington, Massachusetts.
Memphis is part of Region 11 of the United Network for Organ Sharing, which administers the U.S. organ waiting list and allocation system. As of June 30, 2008, there were 4,120 patients on the list for livers in Region 5, which includes California, compared with 1,084 patients listed in Region 11, according to the registry of transplant recipients.
On the same date, there were 594 patients on the list at Stanford University Medical Center, 14 miles from Apple headquarters, compared with 98 at Methodist University Hospital in Memphis, where Jobs had his surgery.
Jobs received a liver transplant about two months ago, according to a person familiar with the matter. The median waiting time for a liver in Tennessee in 2008 was 135 days, according to the organ-sharing network. The organization hasnt been able to make the same waiting-time calculation for California since 1996 because less than half those waiting got tranpslants.
MELD Scores
Patients in the networks Region 11 receive livers before their health has deteriorated as much as in other districts, such as Californias Region 5, according to the registry of transplant recipients. The organ-sharing network divides the U.S. into 11 regions.
Under the organ-sharing networks rules, most livers are allocated locally using a system called model for end-stage liver disease, or MELD, that assigns scores to liver health and function. Patients with higher scores on the scale of 6 to 40 gain priority for receiving a liver.
Steve Dowling, a spokesman for Cupertino, California-based Apple, declined to comment on how Jobs qualified for a liver transplant, except to say, “Steve continues to look forward to returning to Apple at the end of June.” Jobs didnt respond to an e-mail seeking comment.
Geographic Divisions
Apple rose $2.58 to $142.44 on June 26 in Nasdaq Stock Market trading. The shares have gained 67 percent this year.
In Memphis, 8 percent of the waiting list patients progressed to a score higher than 30 before getting a transplant. In California, 25 percent of transplant recipients topped 30. The national average for transplant recipients above that score is 14.8 percent, according to the registry.
The geographic divisions mean a patient with just months to live can be denied a liver while a healthier person a few miles away gets a transplant because of lower demand in that area, said Russell Wiesner, a medical professor at the Mayo Clinic in Rochester, Minnesota, and former president of the United Network for Organ Sharing.
Some surgeons in low-demand areas back the system because it allows them to perform operations that cost about $350,000, including extensive post-surgical care, Wiesner said.
Organ System Criticism
Smell-loss Drug Escaped Fda Critique Below Homeopathic Label
Zicams homeopathic label allowed it to be marketed for a decade without a review for safety or effectiveness by the U.S. Food and Drug Administration, until its recall on June 16. Doctor and consumer reports to the FDA and Zicams maker, Matrixx International Inc., showed the Zicam nasal sprays and swabs may have caused more than 900 people to lose their sense of smell, U.S. regulators said June 16.
Homeopathic products — over-the-counter remedies that use plant, mineral or animal derivatives — dont need marketing clearance from the FDA under U.S. rules. David Schardt, of the Washington-based Center for Science in the Public Interest says Zicams recall and mainstream use highlight a need for more oversight of homeopathic products, a $200 million market, according to the American Association of Homeopathic Pharmacists.
“Homeopathic products used to be this small cult and this backwater type of thing,” said Schardt, a senior nutritionist at the center. “That has changed and they are now becoming more and more common and distributed in an entirely different way. It has become a can of worms.”
Matrixx didnt alert U.S. regulators to about 800 reports it received from Zicam users who said they lost their sense of smell. The FDA found the reports only after an inspection in May. Zicams main ingredient is zinc, which since the 1930s has been linked to loss of smell when applied inside the nose. A group overseeing homeopathic drugs says thats an improper use.
Sold at Wal-Mart
Zicam became a household name helped by television, radio and print advertising campaigns, with Matrixx spending $24.4 million last year, according to data from The Nielsen Company in New York. Major retailers such as Wal-Mart Stores Inc., Target Corp., Rite Aid Corp. and CVS Caremark Corp. sold Zicam.
The recalled Zicam nasal sprays and swabs, which sold for about $11 a box, had $44 million in sales last year, according to Matrixx. The entire line of 19 Zicam products, including liquid medicines and chewables, generated $111 million in revenue for the company in the year ending March 31.
McDaniel, 50, who works for a real estate developer near Columbus, Ohio, said she used Zicam last year at the maximum daily dose for about a week to treat a stuffy nose. When her sinuses cleared, she noticed her sense of smell was mostly gone. A bowl of chili now smelled like onion and she couldnt tell whether a gas stove was left on or detect burning odors.
“I used to be able to smell wood burning down the road,” said McDaniel in a telephone interview. “I miss that, it is something you dont realize youll miss until it is gone.”
Standing by Zicam
Matrixx, of Scottsdale, Arizona, stands by the safety of its products and plans to meet with the FDA to try to get the agency to reverse its decision, said William J. Hemelt, Matrixxs acting president, chief financial officer and chief operating officer, in a June 24 interview. He said he didnt believe the company had to turn over the 800 consumer complaints it had received.
“Im going to do everything I can and so will the rest of the employees to see that we can build a business around the 16 products we still have on the market,” said Hemelt. “But what we would like to do is get the FDA to reverse its decision.”
Active Ingredient
Zicams active ingredient, zinc, is believed to shorten the duration of a cold by preventing the viruses from attaching to cells in the nasal passages called ICAM-1 receptors, according to a study in the Journal of the American Pharmacists Association by researchers at Case Western Reserve University in Cleveland. Many studies have tested zinc in colds, and results are conflicting, according to a search of the National Institutes of Healths archive of published medical research.
Some research suggests zinc may be toxic to nerve receptors in the nose that are involved in smell, said Charles E. Lee, a medical officer with the FDAs office of compliance, in a June 16 conference call with reporters. More than a dozen studies from an NIH database show that zinc causes loss of smell in animals.
70-Year-Old Suspicions
Scientists have suspected the mineral could cause loss of smell in people since the 1930s when a zinc-based nasal spray was tested to prevent the spread of polio, Lee said. A 1938 study published in Journal of Pediatrics found that some patients who got the polio treatment lost their sense of smell.
More recently, a 2004 study by University of Colorado researchers in the Journal of Rhinology concluded that zinc gluconate “raises significant concern regarding its safety for intranasal application in humans.”
Lingering Pandemic Virus Brings Summer Flu to England, Wales
There were 11.2 cases of influenza-like illnesses per 100,000 people in the week ended June 21, the London-based Royal College of General Practitioners said in a weekly report on its Web site yesterday. That compares with 6.5 per 100,000 the previous week.
The incidence of flu was highest in people aged 15 to 44 years and in the central region, the college said. In England and Wales, confirmed cases of the new H1N1 virus, known as swine flu, more than doubled to 2,550 yesterday from a week earlier, the Health Protection Agency said.
“A pandemic virus is a novel virus and one to which most people dont have immunity,” Angus Nicoll, head of the influenza program at the European Centre for Disease Prevention and Control in Stockholm, told reporters yesterday. “That means it is very easy for it to circulate, and it is obviously capable of doing that outside the influenza season.”
Influenza is more common in winter because virus particles persist longer in the air during colder, drier weather. The bug is also transmitted more easily in winter because people tend to huddle together indoors.
The World Health Organization said the pandemic virus is reported to have infected 55,867 people in more than 90 countries, killing 238 of them, since its discovery in Mexico and the U.S. in April.
Quicker Spread
Transmission of the bug, which causes little more than a fever and cough in most cases, is likely to accelerate as the flu season begins in the Southern Hemisphere and again when it returns in the Northern Hemisphere, the World Bank said in a report this week. As many as 1.5 million people die in a normal flu season worldwide, and even a mild new flu might add another 1.4 million deaths, the Washington-based lender said.
In England and Wales, the incidence of flu-like illness last week was above the 10-year average for summer, according to the colleges report. Flu typically peaks in these countries in January, and the rate reported by the colleges flu surveillance network, comprising 435 doctors, was the highest in six weeks.
Higher rates dont accord “with any substantial spread of influenza-like illness,” the college said, adding that rates of 30 to 100 per 100,000 people are usual when seasonal influenza viruses are circulating. Rates exceeding 100 represent above- average influenza activity and are “exceptional” when above 200, it said.
Firewalkers Faulty Gene May Shake Up Market For Painkillers
Geoffrey Woods, a geneticist at the University of Cambridge, was studying families that had intermarried in northern Pakistan when he heard about the boy, who felt no pangs as he performed stunts on the street. Research on other children in the area uncovered a faulty gene among them. They all were healthy and had a normal sense of touch.
Woodss findings, published in the journal Nature, spurred Pfizer Inc., AstraZeneca Plc and Merck & Co. to study drugs that work like the gene mutations by interrupting a channel that transmits pain signals. While that research is at an early stage, Newron Pharmaceuticals SpA of Italy has a product in human tests. Those studies may lead to treatments that have fewer side effects than many painkillers, which London-based Datamonitor Plc says generated $24.3 billion in sales in 2007.
“Its the ultimate target,” said John Wood, a professor of molecular neurobiology at University College London who co- wrote the Nature article with Woods in December 2006. “The people that dont have the channel are not ill, they have no problems, so if you find a drug that blocks it, they should be pain-free and also free of side effects.”
Pain is one of the bodys natural defenses, intended to compel a retreat from danger or force rest to allow healing.
Drawbacks
While a variety of painkillers exist, none is perfect. Non- steroidal anti-inflammatory drugs, a group that includes aspirin and ibuprofen, can irritate the stomach. Merck withdrew its Vioxx medicine from the market in 2004 because of a potential link to heart attacks and strokes. Opioids, which are derived from the opium poppy and include morphine, are among the most- abused prescription medicines.
The sodium 1.7, or Nav1.7, channel is a protein found in nerve cells. When a cell receives a stimulus, the tube-like channel opens and sodium ions flow into it, activating the nerves. They send an electrical signal to the spinal cord and the brain, which interprets it as pain.
In people with the gene mutations found in the Pakistani children, the sodium channel is incomplete, interrupting the chemical cascade that leads to pain sensation.
Early research on the channel, first identified in the mid- 1990s, had found gene mutations that heightened the sense of pain. Woodss work, funded by Pfizer, the University of Cambridge and the London-based Wellcome Trust, was the first to establish a link between loss of the channel and an absence of distress.
Peripheral Neurons
“Geoffs paper demonstrated that you can basically live without having Nav1.7, and for a drug company that is the most important finding they can have in defining a drug target,” said Sulayman Dib-Hajj, a neurology researcher at the Yale School of Medicine in New Haven, Connecticut, who was involved in early studies of the channel.
“The mere fact that the Nav1.7 sodium channel is primarily expressed in peripheral neurons means youre not going to worry about an effect on the heart or on the brain or on the spinal cord,” Dib-Hajj said. “And thats why it has become a very important target in the quest for new painkillers.”
Pfizer, based in New York, is developing compounds that block the sodium 1.7 channel, though they have yet to be tested in people. The channel is “high profile for us and we believe were making great progress,” said Gillian Burgess, head of the pain group at Pfizer.
Early Development
AstraZeneca, based in London, is also in early development of such compounds, said Neil McCrae, a company spokesman.
Merck of Whitehouse Station, New Jersey, aims to use the channel to treat different types of pain, said Stefanie Kane, senior director in Mercks pain research unit.
“We have initially identified compounds that in preclinical analysis are at least 100 times more potent than currently available drugs as inhibitors of this target,” Kane said in an e-mailed response to questions. She declined to say how advanced development is.
From 80 percent to 90 percent of experimental drugs fail to get through preclinical tests, the phase that occurs before human trials, according to the U.S. National Institutes of Health, in Bethesda, Maryland. It takes an average of eight years to get a drug through human testing and regulatory review, according to the Tufts Center for the Study of Drug Development, in Boston.
Un Reports Decline In Cultivation Of Some Drugs
Yet about 28 million people are heavy drug users likely to be physically or psychologically dependent on drugs, the report said.
Opium cultivation in Afghanistan, where 93 percent of the worlds opium is grown, dropped by 19 percent last year, the Vienna-based U.N. Office on Drugs and Crime reported Wednesday.
And there was a 28 percent decline – the report called it staggering – in production of cocaine in Colombia, which produces half the worlds cocaine, the report said.
Global production of coca hit a five-year low at 845 tons despite some increased cultivation in Peru and Bolivia.
Marijuana, or cannabis, remained the most widely used and cultivated drug in the world and it is more harmful than commonly believed, the report said.
As a result, the number of people seeking treatment is rising. Roughly 167 million people use marijuana at least occasionally.
Opiates and cocaine have about 18 million users a year each. And it is estimated that 11 million to 21 million people worldwide inject drugs.
Among synthetic drugs, 16 million to 50 million took amphetamines and related drugs and about 27 million took Ecstasy, the report said.
The estimated cost of the worlds illicit drug market is about $320 billion, said Antonio Maria Costa, executive director of the U.N. office.
“This makes drugs one of the most valuable commodities in the world,” he said in a telephone interview. “The proceeds of drug-related crime are of macro-economic proportions.”
In a statement issued with the report, he called for treating drug use as an illness. “People who take drugs need medical help, not criminal retribution,” Costa said. He appealed for universal access to drug treatment.
Among the striking findings in the report is the growth of what was once a cottage industry of industrial-sized laboratories in southeast Asia, particularly in the greater Mekong region of Vietnam, producing massive quantities of methamphetamine tablets and crystal meth.
“We are asking for increased investment in law enforcement and crime control,” Costa said. “Organized crime related to drugs has become a threat to a number of countries.”
The aim is to get governments worldwide to invest in public health and public security, he said. No specific amount was suggested.
Drug money perverts weak economies and corrupts weak officials, he said. And drugs are a source of revenue for insurgents, like the Taliban and FARC, the largest guerrilla group in Colombia, that control regions of illicit cultivation, he said.
Michele M. Leonhart, the U.S. acting drug enforcement administrator, said the report showed that “we have realized unprecedented victory in disrupting and dismantling criminal cartels worldwide and impacting the illegal drug market.”
“The dangerous link between drugs and crime is irrefutable, and we continue to face challenges,” she said in a statement.
Aura Migraines In Mid-life Women Linked to Brain Adjustments Later
The women were almost twice as likely to show small areas called lesions in the brains cerebellum, which controls motor activities and balance, than women who didnt have headaches, according to research published today in the Journal of the American Medical Association. Men in the study who had aura migraines in mid-life didnt show a statistically significant increase in cerebellum brain lesions compared with men who didnt get headaches, the research found.
Scientists said there is no evidence that the so-called “silent” lesions, which can be as small as a pinpoint and are common in many older people, affect mental or motor function as adults age. Still, the study of more than 4,600 men and women in Iceland is the largest prospective research to show that migraines occurring in midlife may affect the brain years later, said Lenore Launer, chief of the neuroepidemiology section of the Laboratory of Epidemiology, Demography and Biometry at the National Institute on Aging in Bethesda, Maryland.
“The importance of this study is it suggests that migraines are not just an episodic condition,” Launer said in a telephone interview. “It may lead to long-term changes in the brain. At this point theres no real clinical message for people with migraines. This really needs to be investigated further.”
Earlier Findings
One previous study of 435 younger people in the Netherlands found a similar association between migraines with aura and brain lesions, Launer said. Researchers do not know yet whether such brain lesions harm health, though they are also linked to cardiovascular risk factors, including hypertension, Launer said.
Migraines may cause intense head pain, and auras include such symptoms as dizziness, flashing lights, blind spots, and zigzag lines that advance the headache by a 10 minutes to 30 minutes, according to the National Womens Health Information Center.
This type of headache afflicts nearly 30 million or 11 percent of Americans and may cause sensitivity to light, nausea and vomiting. About 20 percent of migraines also include aura- related symptoms, according to the U.S. Department of Health and Human Services. Women are three to four times as likely as men to get migraines, most commonly between the ages of 20 and 45.
MRI Scans
In the new research, Launer and her colleagues looked at men and women who were originally part of a heart-disease study in Iceland that began in 1967. Between 1972 and 1986, when participants were an average age of 50.9, they were asked about the frequency and type of headaches they experienced. Doctors performed magnetic resonance imaging scans on two areas of the brain between 2002 and 2006 when the subjects average age was 76.2 years.
The men and women in the study were divided into four groups: Those who had a migraine with aura, migraine headaches without aura, non-migraine headaches once or more each month and no headaches.
In the study, 17 percent of women had migraine headaches, including 10.3 percent who experienced auras, while only 5.7 percent of the men had migraines and 4.2 percent had auras as well.
Previous Studies
Migraines have been associated with stroke and heart disease in previous studies. A 2006 study in the Journal of the American Medical Association found that middle-aged women who have migraines with aura are at a higher risk for heart attack, stroke, chest pain and death from heart disease than women who dont have migraines.
A September 2008 study in the journal Neurology by researchers in Austria and Italy also found that migraine sufferers may have a higher risk of developing deadly blood clots.
Todays study was funded by the National Institutes of Health, the Icelandic Heart Association and the Icelandic Parliament.
Caution
The findings “should be interpreted with caution,” wrote doctors Tobias Kurth, with the University Pierre et Marie Curie in Paris and Harvard University in Boston, and Christophe Tzourio with the University Pierre et Marie Curie, in an accompanying editorial in the journal.
“It is premature to conclude that migraine has hazardous effects on the brain,” they wrote. “Brain scans among patients with migraine should not be initiated to detect silent brain lesions but to rule out rare secondary forms or migraine among those patients with atypical migraine forms or migraine courses.”
Obama Open to Compromise as Senators Balk At Public Health Tactic
White House Chief of Staff Rahm Emanuel met last night at the U.S. Capitol with Senate Democrats and told them Obama is “open to alternatives” to a new government insurance program in order to get legislation overhauling the health-care system to his desk, said Senator Kent Conrad of North Dakota.
“His message was, its critical that you do this,” Conrad said.
Senate Finance Committee Chairman Max Baucus of Montana said Emanuel urged the senators to seek Republican support and didnt discourage them from pursuing the use of non-profit cooperatives, an idea Conrad has proposed.
Emanuel was unavailable for comment after the meeting. There was no immediate response to an e-mail to the White House seeking comment.
The question of whether to provide consumers with a public option to compete with private insurers lies at the heart of the health-care debate. The idea has drawn fire from Republicans and insurers, who say the governments unlimited power to borrow money would allow it to charge lower premiums for more coverage, pushing insurers out of business. Some Republicans say they would consider a non-profit alternative.
Democrats Concerned
Reluctance toward the “public option” also has been voiced by Democrats such as Ben Nelson of Nebraska, Blanche Lincoln of Arkansas, Kay Hagan of North Carolina, Mary Landrieu of Louisiana, and Mark Begich of Alaska.
Even Senator Dianne Feinstein, who backs public insurance, says Congress is moving too fast and should consider the impact of one proposal, expanding the Medicaid government program for low-income people. That would add as much as $5 billion to the annual health-care bill of her state of California, she said.
“The state is barely keeping its head above water right now,” Feinstein said in an interview on Monday. “There are big questions to ask and answer before we get ourselves in another entitlement.”
Tool of Discipline
Obama yesterday called the public option “an important tool to discipline insurance companies.”
Yet Obama, who has been pressing lawmakers to send him a final bill by October, also said hes willing to entertain lawmakers ideas. “We have not drawn lines in the sand other than that reform has to control costs and that it has to provide relief to people who dont have health insurance or who are uninsured,” the president said.
In a bid to rein in the cost, Senate Finance Committee members have cut about $400 billion from a version of the legislation theyre considering, which the Congressional Budget Office last week calculated would run to $1.6 trillion over 10 years, said Conrad, a panel member.
Most congressional leaders prefer the public option, with Representative Henry Waxman of California saying it will give insurers an incentive to keep costs down and treat customers fairly. Waxman and other panel chairmen in the House of Representatives last week circulated draft legislation that would include a public-option plan modeled after Medicare, the governments health-insurance system for the elderly.
Public Support
The American people back such a plan. A New York Times poll released last week showed 72 percent support for publicly sponsored health insurance.
Still, part of the unease among some Democratic lawmakers is the lack of a specific proposal for the public alternative. The term public option “means certain things to different people,” said Senator Mark Pryor of Arkansas. “I just dont know what it is yet because I am not sure the Finance Committee has told anybody what it is.”
Nelson said competition from a government-run plan may “destabilize the market” resulting in “the dilution of the private plans” that serve 200 million Americans. “We should be trying to focus on how you help” 46 million uninsured Americans “not on how you destabilize health insurance for 200 million.”
Stomach Stapling May Lower Cancer Risk In Women
But for some reason, the surgery didnt have the same effect in men; there was virtually no difference in the cancer rates in men who had the surgery and those who did not.
The research was published online Wednesday in the medical journal, Lancet Oncology.
A previous study has shown that stomach stapling surgery can prolong the lives of men and women by up to 10 years compared to those who dont have it. Two other studies have suggested women in particular benefit from a lower cancer risk after getting the weight-loss operation.
Scientists have long thought obese people have a higher cancer risk, possibly because fat cells produce hormones that might lead to the disease. But doctors havent been able to prove that losing weight in other ways, including dieting, reduces that risk.
“This is one more piece of evidence in a complex puzzle,” said Dr. Len Lichtenfeld of the American Cancer Society, who was not linked to the Lancet Oncology study. “There seems to be a relationship between weight and cancer, but there is a missing link we dont understand.”
Swedish researchers followed 2,010 obese patients from 1987 after they had their stomachs stapled, for about 10 years. Men and women were considered obese if they had a body mass index above 34 and 38 respectively. Experts say that a normal body mass index ranges from 19 to 25.
Researchers also tracked 2,037 obese people who did not have the surgery. For patients who got their stomachs stapled, most lost about 20 kilograms (44 pounds). In people who did not have the surgery, most gained a little over 1 kilogram (2 pounds, 3 ounces).
Of the women who had the surgery, 79 got cancer. In the non-surgery group, 130 women got cancer. Various types were seen, including breast, skin and blood cancer.
Among the men, 38 of the men who had the surgery got cancer versus 39 men in the non-surgery group.
The study was paid for by the Swedish Research Council and others, including drug makers Hoffman La Roche, Astrazeneca and Sanofi-Aventis, whose products include diet drugs.
Experts were baffled why only women appeared to have a lower cancer risk after the weight-loss surgery.
Lars Sjostrom of Sahlgrenska University Hospital in Sweden and the papers lead author, said it was possible there werent enough men in the study to see an effect – men only made up about a quarter of the participants.
Lichtenfeld hypothesized that the stomach surgeries might have different effects on hormones or some other substance in the body that ultimately reduced the chances of developing cancer.
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On the Net: http://www.lancet.com
Can Vitamin D, Fish Oil Prevent Cancer, Heart Disease? Study to Target In Particular
It will be one of the first big nutrition studies ever to target a specific racial group – blacks, who will comprise one quarter of the participants.
People with dark skin are unable to make much vitamin D from sunlight, and researchers think this deficiency may help explain why blacks have higher rates of cancer, stroke and heart disease.
“If something as simple as taking a vitamin D pill could help lower these risks and eliminate these health disparities, that would be extraordinarily exciting,” said Dr. JoAnn Manson. She and Dr. Julie Buring, of Harvard-affiliated Brigham and Womens Hospital in Boston, will co-lead the study.
“But we should be cautious before jumping on the bandwagon to take mega-doses of these supplements,” Manson warned. “We know from history that many of these nutrients that looked promising in observational studies didnt pan out.”
Vitamins C, E, folic acid, beta carotene, selenium and even menopause hormone pills once seemed to lower the risk of cancer or heart disease – until they were tested in big studies that sometimes revealed risks instead of benefits.
In October, the government stopped a big study of vitamin E and selenium pills for prostate cancer prevention after seeing no evidence of benefit and hints of harm.
Vitamin D is one of the last major nutrients to be put to a rigorous test.
For years, evidence has been building that many people are deficient in “the sunshine vitamin.” It is tough to get enough from dietary sources like milk and oily fish. Cancer rates are higher in many northern regions where sunlight is weak in the winter, and some studies have found that people with lower blood levels of vitamin D are more likely to develop cancer.
Fish oil, or omega-3 fatty acid, is widely recommended for heart health. However, studies of it so far have mostly involved people who already have heart problems or who eat a lot of fish, such as in Japan. Foods also increasingly are fortified with omega-3, so it is important to establish its safety and benefit.
“Vitamin D and omega-3s have powerful anti-inflammatory effects that may be key factors in preventing many diseases. They may also work through other pathways that influence cancer and cardiovascular risk,” Manson said.
However, getting nutrients from a pill is different than getting them from foods, and correcting a deficiency is not the same as healthy people taking large doses from a supplement.
The new study, which will start later this year, will enroll 20,000 people with no history of heart attacks, stroke or a major cancer – women 65 or older and men 60 or older. They will be randomly assigned to take vitamin D, fish oil, both nutrients or dummy pills for five years.
Participants health will be monitored through questionnaires, medical records and in some cases, periodic in-person exams.
“Were hoping to see a result during the trial, that we wont have to wait five years” to find out if supplements help, Manson said.
Researchers also plan to study whether these nutrients help prevent memory loss, depression, diabetes, osteoporosis and other problems, Buring said.
The $20 million study will be sponsored by the National Cancer Institute, with the National Heart, Lung and Blood Institute and other federal agencies. Pharmavite LLC of Northridge, Calif., is providing the vitamin D pills, and Ocean Nutrition Canada Ltd. of Dartmouth, Nova Scotia, is providing the omega-3 fish oil capsules.
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