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.’s Web site,
. An agency spokeswoman said people who want to report problems with the pills could call 1-800-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 heat palpitations. “I think doctors need to be a lot more thoughtful – whether patients
are buying from local health food stores, off the Internet, or from
friends.”
A truck driver who is one of Dr. Cohen’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.
“I failed the drug test and found out the hard way,” 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.
“Whether they have the ability to help people keep the weight off in
the long term is unknown,” 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. “Anything biologically active may turn out to have
a risk for somebody.”
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 “good manufacturing practices”
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.
“The law adequately protects consumer health because it does have
the monitoring system in place,” 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 company’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 StarCaps’
ingredients list, the Vitamin Shoppe and GNC pulled StarCaps from their
shelves, according to e-mail messages from the companies in reply to a
reporter’s questions. Asked how GNC ensured the safety of such
supplements, a spokeswoman wrote, “Like any retailer, we rely on
warranties supplied by manufacturers of any third-party product.”
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.
“I was completely devastated and remain devastated,” said Haskell.
You can read this article by New York Times writer
Natasha Singer, reporting from New York City, N.Y., in context here:

State Police have charged a CVS pharmacy technician with stealing more than $9,000 worth of drugs from the Pembroke store during a three-year period.
Cheryl L. Pascarelli, 45, of 10 Lydon Lane, Halifax, pleaded innocent to larceny of drugs on Wednesday in Plymouth District Court.
Police said Pascarelli stole Vicodin, Valium, Suboxone, antibiotics and antiviral medications and sold them to help pay her bills. A CVS loss-control agent discovered discrepancies when drug orders were matched against sales, police reports state.
Surveillance cameras show Pascarelli opening bottles and pocketing pills, the report states.
In a statement on file in court, Pascarelli says she was struggling financially and had been stealing drugs for about three years. She states that she was selling them to one client. Investigators say the drugs were worth about $9,300.
Pascarelli is due back in court March 9.
.

It was in March, in the drizzle, that I realized my brain was burned out. Like a rusty engine, I could hear it chug-chug and splutter – but it would never quite start running at top speed. I had just come back from a rough month-long work-trip to Bangladesh, and I had an Everest of work in front of me. It was all fascinating, and all urgent – but I was plodding though it at half my normal speed. I needed to be performing at my best; instead I was at my worst. I stared at the London rain from my window, and slogged on.
That’s when I stumbled across a small story in an American scientific magazine. It said there was a spiky debate across America’s universities about the increasing use by students of a drug called Provigil. It was, they said, Viagra for the brain. It was originally designed for narcoleptics in the seventies, but clinical trials had stumbled across something odd: if you give it to non-narcoleptics, they just become smarter. Their memory and concentration improves considerably, and so does their IQ.
It’s not an amphetamine or stimulant, the article explained: it doesn’t make you high, or wired. It seems to work by restricting the parts of your brain that make you sluggish or sleepy. No significant negative effects have been discovered. Now students are using it in the run-up to exams as a “smart drug” – a steroid for the mind.
It sounded perfect. A few clicks on-line and I found I could order it from a foreign pharmacy, just £30 for a month’s supply. I called a friend who is a GP, and told her what I was thinking of. She’d heard of people using the drug, and went away and looked up the details. “I think it’s a stupid thing to do, because you shouldn’t ever take drugs you don’t need,” she said when she called back. “Do I think it’ll seriously harm you? No, I don’t. But you’d be much better off taking a long holiday than narcolepsy pills.” Then she warned me: “There is one known side-effect.” Oh, damn I thought. A downside. “It often causes people to lose weight.” Are you mad? You become cleverer and thinner? I whipped out my Visa card immediately.
A week later, the little white pills arrived in the post. I sat down and took one 200mg tablet with a glass of water. It didn’t seem odd: for years, I took an anti-depressant. Then I pottered about the flat for an hour, listening to music and tidying up, before sitting down on the settee. I picked up a book about quantum physics and super-string theory I have been meaning to read for ages, for a column I’m thinking of writing. It had been hanging over me, daring me to read it. Five hours later, I realised I had hit the last page. I looked up. It was getting dark outside. I was hungry. I hadn’t noticed anything, except the words I was reading, and they came in cool, clear passages; I didn’t stop or stumble once.
Perplexed, I got up, made a sandwich – and I was overcome with the urge to write an article that had been kicking around my subconscious for months. It rushed out of me in a few hours, and it was better than usual. My mood wasn’t any different; I wasn’t high. My heart wasn’t beating any faster. I was just able to glide into a state of concentration – deep, cool, effortless concentration. It was like I had opened a window in my brain and all the stuffy air had seeped out, to be replaced by a calm breeze.
Once that article was finished, I wanted to do more. I wrote another article, all of it springing out of my mind effortlessly. Then I go to dinner with a few friends, and I decide not to tell them, to see if they notice anything. At the end of the dinner, my mate Jess turns to me and says, “You seem very thoughtful tonight.”
That night, I lay in bed, and I couldn’t sleep. I wasn’t restless or tetchy; I just kept thinking very clearly, and I wanted to write it all down. I remembered there’s a long history of people in high-pressure jobs using stimulants when their brains lost their sponginess: Anthony Eden was taking Benzedrine all through the Suez Crisis, and Jean-Paul Sartre wrote several of his novels while pumped on mescaline. Admittedly, these precedents aren’t encouraging: Eden had a break-down, and Sartre’s brain was so cooked that for the rest of his life, he had the recurring fear that he was being followed by a giant lobster. Am I making a stupid mistake? Am I mad?
The next morning I woke up and felt immediately alert. Normally it takes a coffee and an hour to kick-start my brain; today I’m ready to go from the second I rise. And so it continues like this, for five days: I inhale books and exhale articles effortlessly. My friends all say I seem more contemplative, less rushed – which is odd, because I’m doing more than normal. One sixty-something journalist friend says she remembers taking Benzadrine in the sixties to get through marathon articles, but she’d collapse after four or five says and need a long, long sleep. I don’t feel like that. I keep waiting for an exhausted crash, and it doesn’t seem to come.
When the American journalist David Plotz took Provigil, he said it should be given a slogan. Just as valium was marketed as “the housewife’s little helper,” he said this should be sold as “the boss’ little helper.” It makes you work better and harder than before.
It’s hard to explain Provigil’s effects beyond that. Normally, one day out of seven I have a day when I’m working at my best – I’ve slept really well, and everything comes easily and fast. Provigil makes every day into that kind of day. It’s like I have been upgraded to a new operating system: Johann 3.0. On discussion boards, I talk to American student doctors taking the drug, who say they feel exactly the same way. “I keep thinking – where’s the catch?” one says. It turns out it is being given to US soldiers too.
It was then that I noticed: I just wasn’t very hungry. I am normally porcine; my ex once seriously considered having a trough made for me. But on Provigil, I was filled up by a bowl of soup and a piece of bread. I would feel stuffed half-way through my normal meals, and push the food away unfinished. One of my friends howled: “Who are you, and what have you done with the real Johann?”
Is all this just the placebo effect: I expect it to do this to me, so it does? Perhaps. But in the clinical trials, it worked much better than the placebo. But then I began to worry again. We don’t know the long-term effects of this drug: nobody has been taking it for long. What if it causes your brain to deplete its resources and wear out? My wonderful grandmother has dementia, her life and personality dissolving in lost memories; no short-term concentration is worth that. A friend says to me one afternoon, “Why do you always feel like you’re not good enough, and you need some kind of chemical enhancement?” It makes me wonder. There are also concerns that if you take it for too long, it can become addictive. So after five days on, I decided to take three days off, to see what would happen.
It was easy. I painlessly sagged back to my former somewhat-depleted state, as though the Provigil had never happened. I worked in my usual stop-start bursts. I ate my usual portions-and-a-half. I stared sadly at the pack of Provigil, and every time I hit a mental stumbling block, I had to discipline myself not to crack out a Provigil.
As soon as my three days were up and I started again, my brain revved back into super-speed and my stomach began to shrivel. But this time I began to worry about the ethics of it all. If this drug had been available during my A-Levels or finals, I would have been the first to guzzle it down. But isn’t that cheating? What’s the difference between Provigil for students and steroids for athletes? And if this drug becomes as popular as, say, anti-depressants or Ritalin, won’t there be a social pressure for workers to take it? Many parents feel intensely pressured by schools today to drug away their child’s disobedience; will they feel pressured by their bosses to drug away their natural fatigue?
Professor Anjan Chatterjee says, “This age of cosmetic neurology is coming, and we need to know it’s coming.” The use of Provigil and its progeny will be mainstream and mainlined in just a few years, he argues, and this made me feel excited by the prospect – and anxious. But all this raced through my brain as I worked faster (and ate less) than I ever have: it was hard to dwell on the drawbacks in those circumstances. As the end of my final five days approached, I had to decide what to do. Do I order another pack? Do I try to think all my thoughts at a faster pace from here on in with the power of Provigil?
I paced and agonised and finally concluded that taking narcolepsy drugs when you don’t have narcolepsy is just stupid. Our lack of knowledge about what it does to your brain was, in the end, a deal-breaker for me. Perhaps in sixty years we’ll know for sure it’s safe, and I will have spent my life at only sixty percent brain-capacity – but I’d rather risk that than brain damage. So I have cut a deal with myself. I am keeping a pack in the bathroom cabinet for the days when I am really knackered and have to be able to work fast and fluently – but I won’t ever take more than two or three a month.
As I put the tablets aside, I look out over my flat. My desk is piled high with the vast quantities of work I have pumped out. My cupboards are full of uneaten food. The whole place is freakishly clean, something I did in my spare time, without even thinking about it. Ah, Provigil, you are a gorgeous temptress. With a sad sigh, I close the bathroom cabinet on her sweet temptation, and stumble back to my slow, patchy life, with my slow, patchy brain.
Johann Hari is a columnist for the Independent. To read more of his articles, click
.
If you are having a baby, there is an even more proven smart drug you can give them – breast milk. To read Johann’s article about that, click
.
.

Eric Miller, U.S. Corporate Communications, UCB
T +1.770.970.8569,
RA is a progressive autoimmune disease that causes chronic
inflammation of the joints. It is estimated that five million people
suffer from RA globally with 0.3 % to 1 % of the population in
industrialized countries suffering from the disease. Women are three
times more likely to be affected than men. Although it can affect
people of all ages, the onset of RA usually occurs between the ages
of 35-55.
Traditional treatments for RA include non-steroidal anti-inflammatory
drugs (NSAIDs), corticosteroids and disease-modifying antirheumatic
drugs (DMARDs), with biological therapies a more recent addition.
Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor).
Cimzia® has a high affinity for human TNF-alpha, selectively
neutralizing the pathophysiological effects of TNF-alpha. Over the
past decade, TNF-alpha has emerged as a major target of basic
research and clinical investigation. This cytokine plays a key role
in mediating pathological inflammation, and excess TNF-alpha
production has been directly implicated in a wide variety of
diseases. The U.S. Food and Drug Administration (FDA) has approved
Cimzia® for reducing signs and symptoms of Crohn’s disease and
maintaining clinical response in adult patients with moderate to
severe active disease who have had an inadequate response to
conventional therapy. Cimzia® was approved in Switzerland for
induction of a clinical response and for the maintenance of a
clinical response and remission in patients with active Crohn’s
disease who have not responded adequately to conventional treatment
in September 2007. UCB is also developing Cimzia® in other autoimmune
disease indications. Cimzia® is a registered trademark of UCB PHARMA
S.A.
UCB, Brussels, Belgium (
) is a biopharmaceutical company
dedicated to the research, development and commercialization of
innovative medicines with a focus in the fields of central nervous
system and immunology disorders. Employing more than 10 000 people in
over 40 countries, UCB aims to achieve revenues of at least EUR 3.3
billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB).
This press release contains forward-looking statements based on
current plans, estimates and beliefs of management. Such statements
are subject to risks and uncertainties that may cause actual results
to be materially different from those that may be implied by such
forward-looking statements contained in this press release. Important
factors that could result in such differences include: changes in
general economic, business and competitive conditions, effects of
future judicial decisions, changes in regulation, exchange rate
fluctuations and hiring and retention of its employees.
For the pdf version of this press release, please click on the link
below:
This announcement was originally distributed by Hugin. The issuer is
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Copyright © Hugin AS 2009. All rights reserved.