Respectful Insolence

Obviously an evil conspiracy by big pharma

Here’s something so obvious that it should have been done years ago:

WASHINGTON — Unlike prescription drugmakers, manufacturers of vitamins, minerals and herbal remedies have no obligation to tell the Food and Drug Administration if consumers suffer serious side effects after taking their products.

That may soon change.

Legislation headed for a vote in the Senate would mandate for the first time that makers of dietary supplements and over-the-counter drugs inform the FDA when they learn of any serious adverse event linked to their products.

“The current reporting system is voluntary. It’s not adequate for detecting the number or prevalence of adverse events associated with a product,” said Sen. Dick Durbin (D-Ill.), a key backer of the bill.

The legislation defines a serious adverse event as a death, life-threatening experience, inpatient hospitalization, disability, birth defect or medical and surgical intervention.

The measure stems from concerns regarding the now-banned dietary supplement ephedra, which has been linked to dozens of deaths; from the dangers associated with the use of steroids and performance-enhancing substances by athletes; and from a variety of scientific reports raising doubts about numerous herbal products.

A group of the big players in the $23 billion-a-year industry, facing growing criticism and worried about the possibility of tougher controls, has signed off on the bipartisan legislation. The bill was approved in committee in late June, and could be voted on before the Senate begins its August recess later this week. It would then move to the House.

Steve Mister, the chief executive officer of the Council for Responsible Nutrition, a major industry trade group, said the reporting requirement for serious adverse events is “the right thing to do for consumers.”

“It will give FDA the ability to look for early trends or signals where there could be a problem,” Mister said.

But Mister said the industry will never back other legislative proposals that would require their products receive FDA approval for safety and efficacy before marketing.

One smaller trade group, the Nutritional Health Alliance, opposes the adverse-event bill, saying in a statement that it will “destroy health freedom and the nutritional supplement industry.”


“Health freedom”? Funny, these guys aren’t so forgiving about big pharma whenever there is are adverse reactions to conventional medications.

Of course, this never would have been necessary if Congress hadn’t passed a law exempting supplement manufacturers from FDA approval:

Congress in 1994 enacted the Dietary Supplement Health and Education Act, a measure that removed the requirement that manufacturers prove the safety of their products either before or after marketing.

Instead, it placed the burden on the FDA to prove a dietary supplement already on the market poses a significant and unreasonable risk to health before it can be recalled.

The supplement industry has driven a tank through this loophole by marketing all sorts of herbal remedies and compounds as “supplements,” making health claims with a wink-wink, nudge-nudge and an unconvincing disclaimer that their products are “not meant to diagnose or treat any disease.” The result:

In May, a National Institutes of Health scientific advisory panel concluded that this regulatory system makes it “difficult for the health of the American public to be adequately protected.”

“The FDA has insufficient resources and legislative authority to require specific safety data from dietary supplement manufacturers and distributors before or after their products are made available to the public,” the scientists said.

“This lack of regulation exists despite the fact that many of the ingredients of multivitamin/multimineral supplements would be subject to pre-market approval if they were marketed as food additives, and in some cases the ingredients possess biological activities similar, if not identical, to those found in medications,” said the NIH report.

A mandatory adverse-event reporting system was one of the scientists’ recommendations.

The FDA estimates there are 29,000 dietary supplements on the market today, up nearly 20 percent since Congress weakened the regulations. More than half of American adults take multivitamins or mineral supplements, according to recent surveys.

But a string of studies and reports have found companies making false and misleading claims about their products, adding ingredients that could be dangerous or failing to manufacture supplements properly to ensure purity and quality.

Tod Cooperman, president of Consumerslab.com, an independent dietary supplement-testing company, said in congressional testimony in March that “one out of four supplements has a quality problem.”

In addition, he said his organization has found products contaminated with heavy metals, in one case discovering a ginkgo biloba supplement containing more than 30 times the allowable limit of lead. He said he found fish oils and other oils that were “rancid, spoiled, that you would not want to be taking.”

I applaud Congress for finally taking a baby step to deal with this problem. It’s still too little, but it’s a start.

Anyone want to take a bet on how long it is before I start seeing rants on altie websites decrying this reasonable step towards reregulating the supplement industry as a conspiracy of big pharma to “suppress” alternative medicine? And, of course, the passage of this bill is nowhere near secure.

Big suppa (big supplement) is not without its own power to persuade Congress.

Comments

  1. #1 Derek Lowe
    August 2, 2006

    This is good news. I keep waiting for an actual drug company (my line of work) to just say “Oh, the hell with it” and market one of its patented compounds as a “dietary supplement”. All we’d have to do is say, really fast and low at the end of the commercials, that it’s not intended to treat any disease. Word of mouth would do the rest – imagine the savings!

  2. #2 beajerry
    August 2, 2006

    Does this mean I’ll have to get a prescription for my sawdust capsules?

  3. #3 Familydoc
    August 2, 2006

    My favorite is when the “naturopaths” add a tiny disclaimer to their potions in the fine print – “Not intended as medication , check with your DOCTOR if any concerns”
    Never f&*^k up good mythology with good science – it makes the alties restless.

  4. #4 Bartholomew Cubbins
    August 2, 2006

    There has been a good deal of nail-biting within the fringe supplements user/abuser community over this kind of legislation for some time now. I remember reading about some conspiracy theory enthusiast complaining about a related U.N. regulation and how it was all controlled by big pharma.

    I find it pretty telling when someone is so arrogant that they feel that their 10 minutes or 10 hours on the internet provides them enough information to trump a physician’s advice.

    The recycled, embellished, and amplified stories of an incompetent doc are enough for the chosen few to go running into the welcoming arms of the supplements salesmen.

    It’s been a perfect situation for these suppliers: cheap advertising, little-to-no required quality control, very little technical skill required, almost no one to answer to, and a rash clientelle.

  5. #5 Bailey
    August 2, 2006

    A mandatory adverse-event reporting system was one of the scientists’ recommendations.

  6. #6 Alex Whiteside
    August 3, 2006

    “But Mister said the industry will never back other legislative proposals that would require their products receive FDA approval for safety and efficacy before marketing.”

    To paraphrase: “We don’t want things like safety and efficacy to get in the way of our gigantic profits.”

  7. #7 Alex Whiteside
    August 3, 2006

    “This is good news. I keep waiting for an actual drug company (my line of work) to just say “Oh, the hell with it” and market one of its patented compounds as a “dietary supplement”. All we’d have to do is say, really fast and low at the end of the commercials, that it’s not intended to treat any disease. Word of mouth would do the rest – imagine the savings!”

    Funnily enough I was at a presentation from a biotech startup which was doing exactly that. It allowed them to get their product on the market while they waited for the EMEA.

  8. #8 Joshua
    August 3, 2006

    “Big Suppa” is absolutely brilliant. People need to use that term more often.

  9. #9 KeithB
    August 3, 2006

    I caught the tail end of a story on chelation on NPR today. I guess there is a Federal study looking at its effectiveness. Though the study won’t be done until 2008, the initial results don’t look good for chelation. (Surprise!)

    The best part was when someone said something like: “It’s too bad the study doesn’t show it is effective, we are getting such good results!”

    (Of course, I have heard a psychiatrist say the same thing about neurontin.)

  10. #10 TheProbe
    August 3, 2006

    I recall that when the FDA first banned ephedra they had a long paper on their website regarding just how hard it was to find the information that they used to support their action. I cannot find it any longer.

    The alties shorts will be doing super wedgies over this. There are those who fear any regualtion whatsoever and will torture logic to support their position.

    Merck should have called Vioxx a dietary supplement.

  11. #11 anjou
    August 3, 2006

    Parody or marketing??? Unfortunately, this was posted on a cancer support board:

    “SUPRESSED KNOWLEDGE OF CURE”

    Please please take the time to watch this video.

    It will amaze you.

    http://video.google.co.uk/videoplay?docid=2095786730805958061&q=bob+beck

    THIS INFORMATION NEEDS TO GET INTO THE MAINSTREAM MEDIA.

    This is not a hoax neither is money involved.

    Best Wishes

    Cazz

  12. #12 ip
    August 3, 2006

    http://www.prweb.com/releases/2006/7/prweb411216.htm

    Dear Orac

    Please do some woo checking on this site…. It is a magic water th
    that helps heal Clinical evidence suggests that energized water (water that is positively charged) can be of enormous health benefit-especially to those suffering from chronic illnesses. EnerGel All Natural Products’ line of water filters and energized water products have proven effective as an alternative therapy for a wide array of chronic illnesses, including fibromyalgia, rheumatoid arthritis, Crohn’s disease, and chronic fatigue syndrome………….

    I know there are soooooo many directions you could go in with woo checking. THis is just a bit new- is it homeopathic, does the water have stuff in it…..

  13. #13 Grunyen
    August 4, 2006

    I’ll rant, but not as an altie. I don’t believe there should be an FDA period. It is not the function of the government to regulate medicine. At least in the US, where our government is actually outlined on a legal document, it’s not in there.

    I’m not for snake oil, I just think you can’t save peoepl from their own stupidity and shouldn’t bother trying. If there were no FDA, there would be competing private organiztions finding faster ways to rate medicines for companies. The Pharma companies would see a benefit in using them, and specifically using the one that gets the best reputation for doing good work.

    Think Consumer Reports and UL labs. Medicine would be cheaper, drug development would surge, and hundreds of thousands of lives could be bettered or saved if new potential drugs were not stalled out over rent seeking arguments.

  14. #14 anjou
    August 4, 2006

    Grunyen:
    Are are arguing that all regulatory requirements be dropped even for big pharma so instead of having to purchase expensive nude mice (etc) and actually test the efficacy and safety of their product before they try to sell it, they use HUMAN mice like this bozo suggests

    http://www.grouppekurosawa.com/
    “Grouppe Kurosawa is an organization dedicated to developing treatment protocols for a host of acute and chronic diseases using primarily natural medicines and over the counter drugs. We utilize human volunteers (Kurosawa Mice) to test natural medicine treatment protocols for HIV, hepatitis B/C and influenza infections, asthma, allergy, arthritis, osteoporosis, cancer, leukemia, diabetes and heart diseases/hypertension. We are also interested in quality of life conditions such as herpes virus infections, weight loss/obesity, muscle mass development, skin conditions, sexual arousal/libido, addiction, hair loss, and other problems. We have already posted 600 scientifically documented Blog essays on these topics in our archives.

    Sure would be cheaper and increase the net profit!!! We’ll have Merck Mice, Glaxo Mice..etc– are you volunteering???

  15. #15 R. Martin
    January 13, 2007

    Good thing the government is always ready to protect me from myself. Who knows how much harm I could do if I thought for myself? Adverse affect from herbs? How about Vioxx? How about the living cadavers that are recieving chemotherapy? Proven and effective, yeah right. Last time I looked, we told the government what WE the people want, not the other way around. I am an RN and I do have some experience with drugs. Yes they are good and do what they claim for the most part, but that is not the issue. Choice, right or wrong, is not for the government to decide. Believe it or not, citizens of this country are pretty smart. Legislators believe that people are only smart enought to vote for them, beyond that, people shouldn’t really have a say about their own lives. Just wanted to get this off my chest.