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USFDA Finds 'Natural' Diet Pills Spiked With Drugs

admin — Wed, 04 Feb 2009 14:10:48 +0000

If a weight-loss supplement does contain an undeclared active
pharmaceutical, the F.D.A. considers the product to be an illegal,
unapproved drug. Doctors said undeclared drugs could cause problems on
their own, like elevated blood pressure or seizures, could have toxic interactions with other medications people take and
could make it difficult for physicians to diagnose patients.
As the F.D.A. continues to investigate, many questions remain to be
answered – including who put the drugs in the pills and who knew about
it. Some doctors and other experts say the F.D.A. inquiry raises a
larger issue: Whether the regulations governing dietary supplements
leave consumers who take so-called natural weight-loss supplements to
unknowingly play Russian roulette with their health.
Enacted in 1994, the main law on dietary supplements gives the
F.D.A. jurisdiction only after the products go on the market. Rather
than reviewing the supplements and approving them for sale, as the
agency does with drugs, the F.D.A. is limited to spot-checking
manufacturers and distributors, and testing products already on store
shelves. Even the F.D.A. acknowledges there may be hundreds of other
drug-contaminated weight-loss supplements for sale that the agency does
not have the resources to identify.
Even when the agency identifies contaminated products, however, it does
not have the ability to remove the pills from stores, because it is
initially up to companies to recall their products. Eventually, though,
if contaminated products stay on the market, the F.D.A. can seek
injunctions, seize products or file criminal charges.
As of Monday, the American distributors behind only three of the
brands named by the F.D.A., including StarCaps, had recalled their
tainted pills. Meanwhile, Web sites like
continue to sell a variety of the other brands, including 3X Slimming Power and Imelda Perfect Slim.
A full list of the tainted pills and other details are available on the F.D.A.вЂ™s Web site,
. An agency spokeswoman said people who want to report problems with the pills could call 1-800-FDA-1088.
вЂњI used to think weight-loss pills were just fancy placebos,вЂќ said
Dr. Pieter Cohen, a general internist at the Cambridge Health Alliance
public hospital system in the Boston area. Over the last few years, he
said he had treated many patients who took tainted weight-loss pills
and came in complaining of chest pains and heat palpitations. вЂњI think doctors need to be a lot more thoughtful – whether patients
are buying from local health food stores, off the Internet, or from
friends.вЂќ
A truck driver who is one of Dr. CohenвЂ™s patients said he lost 20 pounds by taking what he thought were natural diet pills imported from Brazil. Unaware that the pills contained high doses of an amphetamine as well as an antidepressant, the man said he nearly lost his trucking license after he did not pass a drug test at work.
вЂњI failed the drug test and found out the hard way,вЂќ said the truck
driver, 42, who for privacy reasons did not want his name used. His
trucking license was suspended for six weeks, but he is now back at
work.
Of the nearly $24 billion spent on dietary supplements in this
country in 2007, about $1.7 billion went for weight-loss pills,
according to Nutrition Business Journal, a market research firm. About
15 percent of American adults said they had used weight-loss
supplements and the majority failed to inform their doctors about it,
according to a phone questionnaire of 9,500 adults conducted by
researchers at the Centers for Disease Control and Prevention in Atlanta, Georgia.
Steven M. Mister, the president of the Council for Responsible
Nutrition, a trade group whose members include ingredient suppliers and
makers of dietary supplements, said that the majority of weight-loss
supplements were safe. The F.D.A., he said, is mainly citing obscure
imported brands.
A half-dozen experts interviewed for this article, including
government scientists, health activists, doctors and a professor of
pharmacy, said that even mainstream natural weight-loss supplements
that did not contain hidden drugs could be risky. And they questioned
whether such supplements could have any significant effect on weight.
вЂњWhether they have the ability to help people keep the weight off in
the long term is unknown,вЂќ said Dr. Paul Coates, the director of the
Office of Dietary Supplements at the National Institutes of Health (NIH)
in Washington, D.C. He added that even seemingly inert herbs can cause
biological changes. вЂњAnything biologically active may turn out to have
a risk for somebody.вЂќ
Consider ephedra, an herbal stimulant that gained popularity as a
weight-loss supplement in the 1990s – until hundreds of people reported
ephedra-related problems including heart attacks, seizures and even
deaths. The F.D.A banned the use of ephedra in supplements in 2004.
Last year, the F.D.A. adopted new вЂњgood manufacturing practicesвЂќ
rules that require makers of dietary supplements to test the purity of
each ingredient and the final product. Another new statute, which went
into effect in December 2007, requires manufacturers to notify the
F.D.A. of any reports of serious health problems caused by the pills.
вЂњThe law adequately protects consumer health because it does have
the monitoring system in place,вЂќ said Mister, of the industry trade
group.
Dr. Sidney W. Wolfe, the director of the health research division of the consumer advocacy group Public Citizen, said the regulations did not go far enough. Just because something is
uncontaminated does not mean it is safe, he said. For example, Dr.
Wolfe said he was concerned about bitter orange, a natural stimulant similar to ephedra that is widely used in weight-loss supplements.
So far no one has taken responsibility for the undeclared drugs in the pills.
StarCaps, the best known of the brands cited, gained a large
following through celebrity endorsements and articles in glossy
magazines like People. A billboard featuring the companyвЂ™s founder and proprietor, Nikki Haskell, stood for years above Sunset Boulevard in Hollywood.
After reports surfaced late last fall that StarCaps contained
bumetanide, a potent diuretic that was not included on StarCapsвЂ™
ingredients list, the Vitamin Shoppe and GNC pulled StarCaps from their
shelves, according to e-mail messages from the companies in reply to a
reporterвЂ™s questions. Asked how GNC ensured the safety of such
supplements, a spokeswoman wrote, вЂњLike any retailer, we rely on
warranties supplied by manufacturers of any third-party product.вЂќ
Last fall, Jackson and several other National Football League players
who said they had taken StarCaps failed a drug test when they tested
positive for bumetanide. The drug, which can mask steroiduse, is on the list of substances banned by the league.
Now, Jackson has filed a class-action suit against Haskell and the stores where he said he purchased StarCaps, including the Vitamin Shoppe and GNC.
Haskell said she had been shocked to learn from the news that
her product contained the diuretic. Over the last 25 years, she said
she had sold several hundred thousand bottles of StarCaps and had never
before received a complaint. She voluntarily recalled the products.
вЂњI was completely devastated and remain devastated,вЂќ said Haskell.
You can read this article by New York Times writer
Natasha Singer, reporting from New York City, N.Y., in context here:

Peanut company lied on salmonella testing, FDA finds

admin — Sun, 18 Jan 2009 10:53:06 +0000

The FDA did not formally announce the new findings about the company’s testing, but rather made small revisions to an online report about the investigation on Thursday. Only when a Washington Post reporter discovered the changes did the news become more widely known.
As part of the investigation, the FDA found that 12 contaminated lots from the small Blakely, Ga., plant were shipped to schools in California, Minnesota and Iowa from January 2007 to November 2007.
Also, 32 truckloads were shipped to the U.S. Department of Agriculture, which had been inspecting the plant, for its school lunch programs.
Susan Acker, a spokeswoman for the USDA, said she did not know of any illnesses linked to the lots shipped to the agency. Even so, experts said, the fact that the lots were shipped at all is indicative of reckless business practices.
“I hope these guys have good criminal defense lawyers,” said Seattle attorney William Marler, who represents several people sickened in the latest round of contamination.
The Lynchburg, Va.-based company has repeatedly denied any wrongdoing. It did not return phone calls Friday.
The Justice Department has begun an investigation.
Stewart Parnell, owner and president of Peanut Corp. of America, and Dr. Frank M. Torti, acting FDA commissioner, are expected to testify Wednesday before the House Energy and Commerce Committee.
“The new developments are disturbing and suggest that this company had extensive problems,” said committee Chairman Henry A. Waxman (D-Beverly Hills). “Our committee will investigate both the company’s actions and the government’s response.”
At a hearing Thursday of the Senate agriculture committee, Chairman Tom Harkin (D-Iowa) called for a complete overhaul of government oversight of food safety and suggested creating a stand-alone agency to monitor food safety.
President Obama has urged a “complete review” of the FDA to determine why it didn’t contain the problem earlier.
In the wake of the deaths, FDA inspectors went into the plant on Jan. 9 — the first time they had visited the plant since 2001 — and finished their inspection Jan. 27. Their results were compiled into a form known as a 483.
That initial report said that some lots of peanut butter, roasted peanuts and milled peanuts had tested positive for salmonella, that they were retested and that the second tests came back negative. Only then were the products shipped, investigators concluded.
People familiar with the course of the investigation said Friday that the company objected to the initial 483 report, arguing that the first test was only “presumptive” and that it was not definitive for contamination.
Stung, the investigators went over the data more carefully, matching testing and shipping dates — and reached a grimmer conclusion. They found that in many cases the products had been shipped before the second test was completed or in the absence of a second test.
In a statement e-mailed to reporters on Friday in response to questions, the FDA said: “In the course of gathering information during an investigation, it is sometime necessary that FDA refine reports and other documents based on new facts that are discovered or further provided by records or by the firm.”
Times staff writer Mary MacVean contributed to this report.

More Americans Skipping Necessary Prescriptions, Survey Finds

admin — Sat, 17 Jan 2009 16:39:30 +0000

One in seven Americans under age 65 went without prescribed medicines in 2007 as drug costs spiraled upward in the United States, a nonprofit research group said on Thursday.
That figure is up substantially since 2003, when one in 10 people under 65 went without a prescription drug because they couldn’t afford it, according to the Center for Studying Health System Change in Washington, D.C.
The current figure may be even higher because of the recent economic downturn, said Laurie E. Felland, a senior health researcher at the center and lead author of the study.
“Our findings are particularly troublesome given the increased reliance on prescription drugs to treat chronic conditions,” she added. “People who go without their
experience worsening health and complications.”
The people who were least able to afford medicine were often those who needed it most, Ms. Felland said: uninsured, working-age adults suffering from at least one chronic medical condition. Almost two-thirds of them in the survey said they had gone without filling a prescription.
provided by their employers were affected: one in 10 working-age Americans with employer-sponsored coverage went without a prescription medication in 2007, up from 8.7 percent in 2003, the study found.
Among low-income Americans, three in 10 said they had been unable to fill a prescription because of cost, and nearly one in four adults on
or state insurance programs said they’d had difficulty affording drugs.
Ms. Felland said a number of factors contributed to the trend, including rising drug prices, the tendency of physicians to prescribe drugs more frequently, the introduction of expensive new specialty medications, and skimpier drug coverage that shifts a greater share of costs onto patients.
“Insurance coverage offers less financial protection against out-of-pocket costs than it did in the past,” she said.
The study was based on results from the 2007 Health Tracking Household Survey, a nationally representative telephone survey of 10,400 adults under age 65, many of whom also discussed affordability of medications for their 2,600 children. Participants were asked whether there was a time in the previous 12 months when “you needed prescription medicines but didn’t get them because you couldn’t afford it.”
Overall, 5 percent of children didn’t have prescriptions filled in 2007 because of cost, up from 3.1 percent in 2003, and 17.8 percent of working-age adults couldn’t afford drugs in 2007, up from 13.8 percent in 2003, the survey found. That translates into about 36.1 million Americans under 65 who were affected, according to the study.
Karen Davis, president of the Commonwealth Fund, a private foundation that researches health care issues, said the new study confirms previous Commonwealth studies. In 2007, nearly two-thirds of U.S. adults, or an estimated 116 million people, struggled to pay medical bills, went without needed care because of cost, were uninsured for a time or were underinsured, according to the foundation.
“It has become a middle class problem,” she added, noting that improving health coverage is an integral part of economic recovery.
“It’s not enough just to help people have jobs,” she said. “They need to have adequate coverage, so they can get care when they need it and pay the bills they incur when they do seek care.”

UT Southwestern doctor's study finds little cost-containment in …

admin — Sat, 03 Jan 2009 13:37:58 +0000

10:27 PM CST on Friday, January 30, 2009
New research by a UT Southwestern Medical Center physician calls into Dr. Ethan Halm, chief of internal medicine at UT Southwestern, found Local insurers didn’t dispute Halm’s findings but said it would not be While working at Mount Sinai School of Medicine in New York last year, Halm said he chose patients undergoing that surgery because it’s common, “This is a procedure for whom the vast majority of care is appropriate .
In Halm’s opinion, insurance companies bare some blame in escalated “Trying to reduce costly but unnecessary care is the low-hanging fruit Halm said there is growing evidence that the federal government is John Goodman, president of the National Center for Policy Analysis, a “It’s incredibly hard for them to do so,” Goodman “The whole concept is the buyer of a product is going to tell the seller Goodman said true cost savings in health care must come from doctors and North Texas’ largest insurers supported their actions.
Dr. Allan Chernov, medical director for Blue Cross and Blue Shield of That’s because physicians, patients and legislators have strongly “Although some large companies, and consultants, often seem to expect Aetna health insurance spokeswoman Anjanette Coplin said the insurer As a way of containing costs, its Web site lists price ranges of common Dr. Sam Ho, executive vice president and chief medical officer of UnitedHealthcare does require patients to meet prequalification “We have to balance out the hassle factor to physicians and the cost to question whether health insurers are adequately performing one of their main functions: containing costs.
that private managed-care plans for Medicare do no better job of steering patients away from unnecessary surgeries than the traditional fee-for-service system, where the patient goes to any provider and the doctor or hospital bills Medicare directly.
practical to always implement the level of cost-saving scrutiny Halm’s report suggests.
Halm examined differences in care for 11,400 Medicare patients who received a carotid endarterectomy – a surgery to restore blood flow by removing fatty plaque from neck arteries – over a 10-year period.
costly and mostly an elective procedure. He said he also chose carotid endarterectomy because it’s a surgery for which managed care plans routinely require pre-certification to weed out patients who don’t need it.
and necessary; however, about 9 percent is being done unnecessarily,” said Halm, whose research was published in the December issue of the
health care costs for not using their resources, pre-approval protocols, and existing published guidelines to prevent overuse of unnecessary and costly procedures.
when trying to control the costs of health care,” he said.
wasting money in Medicare cases by paying managed care companies much more than fee-for-service plans with the hope of containing costs or improving quality.
Dallas-based think tank, has long felt managed care companies are ill-equipped to contain costs.
said.
and producer how to produce. Can you think of any other market that works that way?”
hospitals, not insurance companies.
Texas, the region’s largest insurer, said his company is not in the business of “micromanagement of every health care interaction.”
opposed such moves in the past, Chernov said.
care micromanagement from a conceptual standpoint, they generally don’t support it in the face of employee/consumer reaction,” he said.
focuses more on preventive and wellness strategies.
surgeries for all local hospitals and doctors in their network.
UnitedHealthcare, the largest Medicare HMO in North Texas, said there is little medical evidence to justify spending extra money to pre-approve patients for a carotid endarterectomy.
guidelines for other costly procedures, such as back surgery and knee replacement surgery, he said.
manage this program,” Ho said.

Fit finds The Denver Post

admin — Fri, 05 Dec 2008 06:37:55 +0000

The economy may be in the toilet, but that doesn’t mean a gal can’t dream of a beach and a bikini and a fitness program that joins the two — if only for a week. At
, an eco-resort in Tulum, Mexico, about two hours south of Cancun, participants (men and women welcome) in the six- night Bikini Boot Camp get posh lodging, sumptuous but healthy food, and a workout schedule that includes yoga, hiking, kayaking, snorkling, dance and cycling, packed in around massage, swimming, sightseeing, spa treatments and just plain chilling. About $2,200, not including airfare. Info:
Famed TV shrink Dr. Phil’s right-hand gal, his
wife, Robin, dishes up some very practical advice for women looking to make smarter health and wellness choices in her new book,
“What’s Age Got to Do With It?”
(Thomas Nelson, $25). You get Robin McGraw’s take on how women can do a better job of putting themselves first, supplemented with expert advice from a huge panel of specialists including nutritionists, doctors, aestheticians and beauty experts.
Hello, Aurora!
in the U.S. According to Metrogrades rankings that appear in the January/February editions of the magazines, on newsstands now, Aurora is the fifth-healthiest place for men and the 10th-healthiest city for women. Denver doesn’t appear in the top 10 for men’s health characteristics but is No. 5 on the women’s health list. The complete lists, compiled by using data from sources such as the national Centers for Disease Control and Prevention, U.S. Census Bureau, FBI and U.S. Department of Labor, are online at womenshealthmag
.

Gulf War Research Panel Finds 1 In 4 Veterans Suffers From Illness …

admin — Thu, 13 Nov 2008 17:39:54 +0000

ScienceDaily (Nov. 17, 2008)
— At least one in four of the 697,000 U.S. veterans of the 1991 Gulf War suffer from Gulf War illness, a condition caused by exposure to toxic chemicals, including pesticides and a drug administered to protect troops against nerve gas, and no effective treatments have yet been found, a federal panel of scientific experts and veterans concludes in a landmark report released Monday.
The Congressionally-mandated Research Advisory Committee on Gulf War Veterans’ Illnesses presented the report November 17 to Secretary of Veterans Affairs James Peake at VA headquarters in Washington.
“The extensive body of scientific research now available consistently indicates that Gulf War illness is real, that it is the result of neurotoxic exposures during Gulf War deployment, and that few veterans have recovered or substantially improved with time,” the report says.
The 450-page report brings together for the first time the full range of scientific research and government investigations on Gulf War illness and resolves many questions about the condition.
“Veterans of the 1990-1991 Gulf War had the distinction of serving their country in a military operation that was a tremendous success, achieved in short order. But many had the misfortune of developing lasting health consequences that were poorly understood and, for too long, denied or trivialized,” the Committee’s report says.
The report found that Gulf War illness fundamentally differs from stress-related syndromes described after other wars. “Studies consistently indicate that Gulf War illness is not the result of combat or other stressors, and that Gulf War veterans have lower rates of posttraumatic stress disorder than veterans of other wars,” the Committee wrote.
The report concludes: “A renewed federal research commitment is needed … to achieve the critical objectives of improving the health of Gulf War veterans and preventing similar problems in future deployments. This is a national obligation, made especially urgent by the many years that Gulf War veterans have waited for answers and assistance.”
Panel Chairman James H. Binns, a former Principal Deputy Assistant Secretary of Defense, said the report “provides a blueprint for the new Administration to focus resources on improving the health of Gulf War veterans and avoiding similar consequences in future military deployments.”
Committee Scientific Director Roberta White, PhD, associate dean for research at Boston University’s School of Public Health, stated: “Veterans of the first Gulf War have been plagued by ill health since their return 17 years ago. Although the evidence for this health phenomenon is overwhelming, veterans repeatedly find that their complaints are met with cynicism and a ‘blame the victim’ mentality that attributes their health problems to mental illness or non-physical factors.”
White said the Committee’s findings “clearly substantiate veterans’ beliefs that their health problems are related to exposures experienced in the Gulf theatre. It provides a state-of-the-art review of knowledge about Gulf War veterans’ health concerns that can guide clinicians and researchers, and offers a scientific rationale for the new Administration to further our understanding of these health problems — most importantly, by funding treatment trials to develop effective treatments of the veterans’ symptoms.”
Large numbers of British Gulf War veterans also are ill. “Recognition of the full extent of the illnesses suffered by these veterans of the conflict and the obligation owed to them is long overdue,” said Marshal of The Royal Air Force Lord David Craig, Chief of the Defence Staff (the British equivalent of Chairman of the Joint Chiefs) during the 1990-1991 Gulf War. “They are victims of the war, as much as any one struck by a bullet or shell. Moreover, medical treatments for their conditions are needed to protect current and future military personnel at similar risk.”
The Committee evaluated evidence related to a broad spectrum of Gulf War-related exposures. Its review included hundreds of studies of Gulf War veterans, extensive research in other human populations, studies on toxic exposures in animal models, and government investigations related to events and exposures in the Gulf War.
Gulf War illness is typically characterized by a combination of memory and concentration problems, persistent headaches, unexplained fatigue and widespread pain, and may also include chronic digestive problems, respiratory symptoms and skin rashes.
The new report says that scientific evidence “leaves no question that Gulf War illness is a real condition,” and it cites dozens of research studies that have identified “objective biological measures” that distinguish veterans with the illness from healthy controls. Those measures relate to structure and functioning of the brain, functioning of the autonomic nervous system, neuroendocrine and immune alterations, and variability in enzymes that protect the body from neurotoxic chemicals.
The panel cited two Gulf War exposures consistently found to be causally associated with Gulf War illness: (1) the drug pyridostigmine bromide (PB), given to troops to protect against nerve gas, and (2) pesticides that were widely used, and often overused, during the Gulf War.
The Committee found that an association between Gulf War illness and several other exposures could not be ruled out. These included low-level exposures to nerve agents, extended exposure to smoke from oil well fires, receipt of large numbers of vaccines, and combinations of neurotoxic exposures.
Department of Defense reports indicate that about 100,000 U.S. troops were potentially exposed to low-level nerve agents as a result of large-scale U.S. demolitions of Iraqi munitions near Khamisiyah, Iraq in 1991. In 2007, a federally funded study led by White, chair of Environmental Health at the Boston University School of Public Health, found evidence that low-level exposure to nerve gas could have caused lasting brain deficits in Persian Gulf troops. The extent of the changes – less brain “white matter” and reduced cognitive function — corresponded to the extent of the exposure, that study found.
In addition, the Committee said, Gulf War veterans have significantly higher rates of amyotrophic lateral sclerosis (ALS) than other veterans, and troops who were downwind from the Khamisiyah demolitions have died from brain cancer at twice the rate of other Gulf War veterans.
The report found that historically, federal Gulf War research programs have not been effective in addressing Gulf War illness. While the Committee applauded promising new programs at VA and DOD, it noted that overall federal funding for Gulf War research had declined dramatically in recent years. The panel urged policymakers to devote $60 million annually for such programs.
The Committee further recommended that the VA instruct the Institute of Medicine (IOM) to re-do its previously completed Gulf War and Health reports, saying the IOM’s series of reports have been “skewed and limited by a restrictive approach to the scientific tasks mandated by Congress, an approach directed by VA in commissioning the reports.”
Scientific staff support to the Committee is provided by the Boston University School of Public Health (BUSPH). The full report is posted at:
The Research Advisory Committee on Gulf War Veterans’ Illnesses is a panel of prominent scientists and veterans, charged with reviewing federal research on the health of Gulf War veterans. The Committee was mandated by Congress and appointed by the Secretary of Veterans Affairs.

Diversity in diet is key, new health report finds

admin — Thu, 06 Nov 2008 16:04:14 +0000

The Public Health Association of Australia is calling for a new national food policy, taking into account disease prevention, sustainability and social equity.
It wants a focus on diversity in diet, with an emphasis on whole foods and those shown to protect from disease, according to the report, A Future for Food Addressing public health, sustainability and equity from paddock to plate, to be issued today.
Association chief executive officer Michael Moore said food was a critical issue across public health, the environment, social policy and the economy ”and yet we have a fragmented approach”.
”We have a food supply skewed to inappropriate and overly processed foods that are high in sugar, fat and salt; there is inadequate understanding of the environmental impacts of food choices; and we have people struggling to afford healthy food to feed their families,” he said.
The report said cheaper food tended to be higher in fats, sugars and refined grains, meaning people on lower incomes were more likely to be overweight.
A new national policy should take this into account, as well as the impact on the environment of different foods.
”Food choices have an enormous environmental impact when it comes to carbon dioxide and other greenhouse gas emissions, water usage and land degradation including soil loss and decreasing availability of arable land,” it said.
”… Every stage of the food chain needs to be considered when assessing the environmental impact of our food choices, including agriculture, manufacturing, refrigeration, transport, packaging, retail, home and waste.”
The report said current dietary guidelines were based on nutrition science, and meant ‘’staples and whole foods [are] under-emphasised and highly processed foods [are] over-emphasised simply because they meet certain nutrient criteria”.
There was also inadequate consideration of the chronic disease risk of foods, at a time when leading causes of preventable death, such as obesity, heart disease, stroke and Type 2 diabetes, were increasing.

US drug agency finds 'natural' diet pills laced with drugs

admin — Sat, 25 Oct 2008 22:01:43 +0000

Grady Jackson, a defensive tackle with the Atlanta Falcons, said he used the weight-loss capsules. Kathie Lee Gifford, a former talk show host, was enthusiastic about them on the “Today” show. Retailers like GNC and the Vitamin Shoppe sold them, no prescriptionrequired.
But the U.S. Food and Drug Administration now says those weight-loss capsules, called StarCaps and promoted as natural dietary supplements using papaya, could be hazardous to your health. In violation of the law, the agency has found, the capsules also contained a potent pharmaceutical drug called bumetanide which can have serious sideeffects.
And StarCaps are not the only culprits. In a continuing investigation that has prompted consumer warnings and recalls by some distributors, the FDA has determined that dozens of weight-loss supplements, most of them imported from China, contain hidden and potentially harmful drugs. In the coming weeks, the agency plans to issue a longer list of brands to avoid that are spiked with drugs, an FDA spokeswomansaid.
Besides StarCaps, which were made in Peru and which Balanced Health Products, the American distributor, has voluntarily withdrawn, the agency's warning list includes more obscure pills sold under the names Sliminate, Superslim and Slim Up, among many others. So far, the FDA has cited 69 tainted weight-losssupplements.
“A large percentage of these products either contain dangerous undeclared ingredients or they might be outright fraudulent on the ingredients and have no effect at all,” said Michael Levy, the director of the FDA's division of New Drugs and Labeling Compliance. “We don't think consumers should be using theseproducts.”
If a weight-loss supplement does contain an undeclared active pharmaceutical, the FDA considers the product to be an illegal, unapproved drug. Doctors said undeclared drugs could cause problems on their own, like elevated blood pressure or seizures, could have toxic interactions with other medications and could make it difficult for physicians to diagnosepatients.
As the FDA continues to investigate, many questions remain to be answered — including who put the drugs in the pills and who knew about it. But some doctors and other experts say the FDA inquiry raises a larger issue: Whether the regulations governing dietary supplements leave consumers who take so-called natural weight-loss supplements to unknowingly play Russian roulette with theirhealth.
Enacted in 1994, the main law on dietary supplements gives the FDA jurisdiction only after the products go on the market. Rather than reviewing the supplements and approving them for sale, as the agency does with drugs, the FDA is limited to spot-checking manufacturers and distributors, and testing products already on store shelves. Even the FDA acknowledges there may be hundreds of other drug-contaminated weight-loss supplements for sale that the agency does not have the resources toidentify.
But even when the agency identifies contaminated products, it does not have the ability to remove the pills from stores, because it is initially up to companies to issue a recall. Eventually, though, if contaminated products stay on the market, the FDA can seek injunctions, seize products or file criminalcharges.
As of Monday, the American distributors behind only three of the brands named by the FDA, including StarCaps, had recalled their tainted pills. Meanwhile, Web sites like 911healthshop.com and fastdietusa.com continue to sell a variety of the other brands, including 3X Slimming Power and Imelda PerfectSlim.
A full list of the tainted pills and other details are available on the FDA's Web site, www.fda.gov. An agency spokeswoman said people who want to report problems with the pills could call1-800-FDA-1088.
“I used to think weight-loss pills were just fancy placebos,” said Dr. Pieter Cohen, a general internist at the Cambridge Health Alliance public hospital system in the Boston area. Over the last few years, he said he had treated many patients who took tainted weight-loss pills and came in complaining of chest pains and heart palpitations. “I think doctors need to be a lot more thoughtful — whether patients are buying from local health food stores, off the Internet, or fromfriends.”
Of the nearly $24 billion spent on dietary supplements in this country in 2007, about $1.7 billion went for weight-loss pills, according to Nutrition Business Journal, a market research firm. About 15 percent of American adults said they had used weight-loss supplements and the majority failed to inform their doctors about it, according to a phone questionnaire of 9,500 adults conducted by the Centers for Disease Control andPrevention.
Steven Mister, the president of the Council for Responsible Nutrition, a trade group whose members include ingredient suppliers and makers of dietary supplements, said that the majority of weight-loss supplements were safe. The FDA, he said, is mainly citing obscure importedbrands.

Study finds increased use of medical imaging, raising costs and …

admin — Wed, 22 Oct 2008 10:56:45 +0000

A dramatic rise in the use of the medical imaging tools like CT scans are increasing health care costs and patients’ exposure to radiation, according to a new study.
The provocative conclusion by a University of California-San Francisco research team challenges the more-is-better conventional wisdom of many consumers and their doctors.
The use of innovative imaging tests like computed tomography (CT) and magnetic resonance imaging (MRI), which offer doctors a highly detailed view of the body’s inner workers, nearly doubled over the past decade, rising from 260 to 478 tests per thousand patients, according to research led by Rebecca Smith-Bindman, an associate professor of radiology at UC-San Francisco.
The average annual imaging cost per patient also nearly doubled, from $229 to $443, the team found.
Tests like CT and MRI, which offer stunning three-dimensional images of tissue and bone, are often used for such routine problems as respiratory infections, she said.
“The new technologies are fantastic,” she said. “But they should be used judiciously.”
CT and MRI have joined the long list of tests given during a diagnostic work-up, according to her team’s study of a decade-long record of almost 400,000 patients in a large Washington state health plan, published in Monday’s issue of the journal Health Affairs. The results can be extrapolated to the rest of the nation, according to the team.
costly type of health care technology and is one of health care’s fastest-growing sectors, rising at three times the rate of other medical services, according to the consulting firm Booz Allen Hamilton. Imaging is a powerful driving force behind the nation’s soaring health care costs, second only to prescription drugs.
But what seems expensive and excessive may actually offer huge benefits, cautioned Stanford School of Medicine radiology Professor Geoffrey D. Rubin.
“If imaging resulted in a more expedient or accurate diagnosis leading to earlier or more appropriate treatment — then overall health care costs, time away from productive lives and jobs, and general quality of life could have substantially improved,” Rubin said.
Using the study’s logic, he said, the added cost of routinely installing air bags in cars would seem excessive “if we did not also know that air bags actually save lives.”
Imaging supporters say the radiation risk is small compared with a snapshot of deadly infection, troubling plaque on a heart vessel or blood clot in the lungs.
Imaging can actually cut costs and save lives, said Arl Van Moore of Charlotte, N.C., president of the American College of Radiology. Thirty years ago, a diagnosis of pancreatic cancer used to require open surgery; now a CT scan can find a mass. Mammograms have helped reduce breast cancer deaths, he said.
To reduce overuse, the American College of Radiology has created criteria to guide doctors so that “the right exam is done for the right reason,” Van Moore said.
Smith-Bindman’s study, which looked at data from patients enrolled in the health maintenance plan called Group Health Cooperative, found that 13.5 percent of the study group had undergone a CT, MRI or both in 1997; by 2006 it was 21 percent. Study results showed the per-patient number of CT scans doubled over the 10 years, and the number of MRI scans tripled.
Imaging with conventional X-rays remained relatively stable — rather than declining, as expected. The results provide evidence that newer and more expensive technologies are being used as additions to the older tests, rather than acting as substitutes.
The study confirms previous reports of a trend toward over-imaging. Because the Group Health managed care system has no financial incentive to do extra tests, the trend may be even more pronounced in traditional fee-for-service practice health plans, she said.
The research did not study whether the increases in advanced imaging was associated with improvements in patient care.
Generating tens of billions of dollars each year, diagnostic imaging has become a lucrative part of modern medical practice. The tests also reassure doctors that they haven’t overlooked anything. A survey of doctors in the Journal of the American Medical Association found that more than half ordered imaging tests just to shield themselves from lawsuits.
Consumers are also driving the trend, Smith-Bindman said.
“Patients believe that getting a CT scan, for instance, is a measure of high quality care,” she said. “It feels like you’re doing something.”
Before undergoing the tests, Smith-Bindman encourages patients to ask their doctors: —‰’What will we learn from this test? And how will it improve my care?’ We need to sit back and ask: ‘When is this really helpful?’ ”
Contact Lisa M. Krieger at
or (408) 920-5565.

Michael Phelps Finds Secret to Post-Olympics Success: Drugs

admin — Fri, 10 Oct 2008 05:28:49 +0000

ANN ARBOR, MICHIGAN- A few months ago, swimmer Michael Phelps was largely considered to be the most annoying living human being on earth. Obnoxiously successful at the 2008 Summer Olympics due to years of intense, some say obsessive, training, Phelps became the very definition of “trying too hard.” Worse still, his grotesquely elongated face was everywhere- talk shows, sit-coms, and the occasional feminine hygiene product. Even cave-dwelling hermits and primitive Yanomami tribesmen complained about the inescapable ubiquity of the Michael Phelps juggernaut. What a difference a bong hit makes. Just yesterday an incriminating photo of a pot-smoking Phelps hit the Internet, and now it appears that Phelps will lose several high-profile sponsors. On the bright side, however, the public has suddenly warmed up to him- if only a little bit.
“Michael Phelps feels terrible about all of this,” said Phelps at a press conference. “As you might imagine, this has been a humbling experience for Michael Phelps. But at least this unfortunate incident showed another side of Michael Phelps’ personality. People thought Michael Phelps was an arrogant douchebag, but in reality Michael Phelps is just a regular guy.”
Even as parents’ groups line up to express disappointment and outrage over Phelps’ drug use, his popularity, especially among the coveted 18-24 stoner demographic, has risen dramatically. As a matter of fact, Phelps’ agent now says that he has lined up all new endorsements for the swimmer, further extending his long-expired 15 minutes of fame. Little Debbie is reportedly in talks with Phelps to help launch their newest product, a kind of chocolate covered bread that smells like lawn clippings.
“I was impressed with his abilities before, but now it seems even more amazing,” said college student Roland Blunt. “To think that he won all those gold medals while scarfing a carton of Ring Dings every day. Holy crap! When I tell people that, it totally blows their minds- especially if they happen to be high.”
At the same time, parents and educators are quite concerned about the message all of this sends to America’s youth, particularly to student athletes. Phelps, however, argues that the message here is that everyone is human, that everyone makes mistakes, and, most importantly, that it’s not cool to hate on Michael Phelps anymore.
“Michael Phelps is thrilled that people seem to not hate him these days,” said Phelps. “Michael thinks we all learned a valuable lesson from all of this. Remember, kids: drugs make you cool.”
Medical experts speculate that chronic marijuana use could explain why Phelps continually talks about himself in the third person. On the other hand, it could simply be that he’s just an incredible tool. Sources close to the tabloid that originally published the photograph are now saying that Phelps may have planted the photo himself as a means of getting himself back in the news and on television, which, when you stop to think about it, would be a totally Michael Phelps thing to do. In the time that it took to write this, the tide turned in his favor then back again, and now it appears that college students will go back to hating him again- as soon as they sober up tomorrow morning.