Respectful Insolence

Thar’s gold in them thar “cures”!

i-e7a12c3d2598161273c9ed31d61fe694-ClassicInsolence.jpgAs I mentioned on Friday, I’m in Chicago right now attending the American College of Surgeons annual meeting, where I’ll be until Wednesday afternoon. If there are any of my readers who happen to be surgeons attending the meeting, drop me a line and maybe we can get together. In the meantime, here’s a blast from the past from the past. This post first reared its ugly head almost exactly three years ago; so if you haven’t been reading at least three years, it’s new to you. Unfortunately, I see nothing that has changed since I originally wrote this. If anything, I underestimated the problem. Ain’t it great to have three years’ perspective on something you wrote?

One of the favorite gambits that alternative medicine mavens like to use to defend their favorite remedies when a skeptic starts asking uncomfortably pointed and specific questions their scientific and evidentiary basis is to accuse said skeptic of being “in the pocket of big pharma.” Indeed, I’ve written before of the “pharma shill gambit,” where alties accuse skeptics of being nothing more than shills for the pharmaceutical industry (to which I always respond that it would be a dream come true to be paid for doing nothing more than posting skepticism about non-evidence-based medicine to a blog and Usenet but that unfortunately I’m just doing this as a hobby). There’s no doubt that big pharma makes a nice, juicy target, and no one claims the industry is without its problems. It’s also true that there’s a lot of money in pharma. But there’s also a lot of regulation and huge expenses. For example, between R & D costs, the costs of doing the clinical trials to demonstrate safety and efficacy, it costs around $800 million to bring just a single truly new drug (known as a “new molecular entity” or NME) to market, but can be about 60-70% less for a new drug in an established class of drugs (a.k.a. a “me-too” drug. Still, that’s righteous bucks (at least $250-300 million). By comparison, you’d think that the alternative medicine and supplement industry is a scrappy and poor underdog.

You’d only be half right. The alternative medicine industry may be smaller than big pharma right now, but it’s hardly poor. As fellow ScienceBlogger Abel Pharmboy, who happens to subscribe to the Wall Street Journal, including the Health Industry Edition, pointed out the other day, there’s big money in alternative medicine, quoting from the article about a Chinese company known as Tong Ren Chan (subscription only):

The brand is a household name in most of China, not unlike Tylenol in the U.S. Chinese medicine is traditionally sold by a specialist at a local shop that concocts mixtures of dried plants and animal products from wooden boxes behind the counter. One Tong Ren Tang store in Hong Kong sells everything from the thinly sliced horn of a young deer, which doctors say helps kidney problems, to an 85-year-old wild ginseng root that can be ground into a powder and used for heart failure — selling for 1.08 million Hong Kong dollars, or about US$138,700. There are dried larvae for asthma as well.

[...]

“The overall expenditure on drugs will increase tremendously in the long term,” says Gideon Lo, an analyst who follows Tong Ren Tang at DBS Vickers in Hong Kong. “Tong Ren Tang is the leader. … If you are bullish on the long term, you must buy the market leader.”

Ah, the altie says. That’s a Chinese company. In the U.S., big pharma still rules. Well, yes but perhaps not for that much longer. A while back, I blogged about an example here in the U.S., namely Airborne , the dubious herbal “cold preventer” that made its “discoverer,” a schoolteacher who dabbled in herbal remedies, fabulously wealthy:

For one thing, it makes for an excellent creation story. In the late 1990′s, Victoria Knight-McDowell, an elementary-school teacher in Spreckels, Calif., grew weary of picking up colds from her students and began “researching Chinese and holistic medicine and the use of herbs and vitamins to boost the immune system,” an official company history explains. She and her husband then decided to market her “natural formula of 17 ingredients” in 1997. They used the money her husband had made selling a television script. They handed out samples in malls and gradually got distribution in various stores. Kevin Costner became one of many celebrities to declare his confidence in the product. In 2000, Knight-McDowell gave up her teaching gig, and by 2004 annual sales hit $90 million. Along the way, Knight-McDowell appeared on “Dr. Phil,” and Airborne was discussed on “Live With Regis and Kelly” and other shows.

Pretty good bucks, I’d say. And, best of all, from Knight-McDowell’s perspective, there isn’t all that pesky regulation or those requirements to demonstrate safety and efficacy. Knowing a good opportunity when they see it, pharmaceutical companies are getting in on the action, paying big bucks to gobble up companies that make over-the counter medications, alternative remedies, and nutritional supplements:

GlaxoSmithKline has splashed out $566 million to buy US consumer healthcare firm CNS in a cash deal that expands its over-the-counter operations.

Minnesota-based CNS manufactures Breathe Right nasal strips and FiberChoice dietary fibre supplements and GSK is paying $37.50 per share, which represents a premium of 31% over the US firm’s stock price at close of business on October 6.

The deal is expected to close by early 2007 and GSK said it will be neutral to earnings next year, and accretive from 2008.CNS had sales of $118.5 million for its last financial year, which was up18% over the previous 12-month period, and the vast majority of that (86%) came from revenues generated in the USA.

Breathe Right is sold in 27 countries and FiberChoice is marketed solely in the USA, but John Clarke, president of GSK Consumer Healthcare, said “this outstanding business provides a great global growth opportunity.”

Meanwhile hundreds of companies sell herbs, nutritional supplements, and Chinese medicine. With this, it shouldn’t be surprising that some alternative medicine companies are starting to engage in the same sorts of dubious promotional tactics and price-gouging that big pharma is rightly castigated for indulging in, including promoting conflicts of interest in doctors:

Federal Parliamentary Secretary for Health Christopher Pyne announced the planned investigation yesterday after complaints about a lack of legal guidelines for the sale of complementary medicines by doctors.

Sunshine Coast general practitioner Scott Masters told The Australian he knew of a doctor practising nutritional medicine who had confessed to buying $10,000 worth of vitamin E at the start of each year and then selling it on to patients for a total of $100,000.

“That’s not a bad mark-up,” Dr Masters said. “This is entirely legal, although there are major ethical concerns about conflict of interest.”

Dr Masters said his practice received an increasing amount of material from the promoters of supplements.

“I can sell all these products directly to patients at a mark-up I consider reasonable,” he said.

The danger of doctors having financial interests in a product was that they might fail to prescribe a medicine that actually treated their patients’ complaints.

Dr Masters said the community was right to be concerned about pharmaceutical companies attempting to influence doctors to prescribe particular drugs.

But too little attention was focused on the way in which producers of complementary medicines sought to influence doctors.

Mr Pyne said the ACCC was reviewing the code of conduct of the pharmaceutical industry after claims of inducements being offered to doctors.

“I have inquired as to whether they have a similar code of conduct for the complementary medicines sector and they do not,” Mr Pyne said.

As EoR put it, commenting on the above story:

Critics complain doctors receive inducements to promote pharmaceuticals, but these are of paltry value due to self-regulation by Medicines Australia. Viagra’s self-raising calculator is cute, but a $10 gift ceiling usually makes for a marginally decent biro or mildly embarrassing brolly.

On the other hand, Big Altie’s dispensers are enjoying their hayday. I heard a back-of-the-stables rumour of substantial inducements offered to a GP (afflicted with an altie-friendly diploma) to endorse and sell neuraceutical products. He refused.

The worry about doctors receiving kickbacks to sell alternative medicines has led to an ACCC investigation, “with a view to the ACCC recommending a code of conduct similar to that applying to pharmaceuticals”. This would block bribes to doctors – now how about to so-called “health professionals”?

My point here is not to defend big pharma or the conflicts of interest that come about because pharmaceutical companies are prone to giving inducements to doctors to prescribe their product. My point is to echo Abel in pointing out that there’s a lot of money in alternative medicine and nutritional supplements, and the industry is growing. As the industry grows, it naturally starts to behave not unlike the way big pharma behaves, whose excesses have led to a backlash and increasing numbers of hospitals and doctors refusing to accept gifts of other than nominal value from drug reps. Moreover, alternative medicine companies do not have to deal with anything near the regulatory hurdles that traditional pharmaceutical companies do (you know, pesky little requirements that the drug be safe and effective and stuff like that). As these companies become more profitable, it is not unlikely that many of them will be purchased by pharmaceutical companies and become part of big pharma themselves.

What all of this means is that it’s nothing more than a massive fallacy to imply that alternative medicine sellers are somehow above the commerce of it all, that they are untainted by financial concerns. They aren’t, and are probably becoming less so. Arguments over the efficacy (or lack thereof) of any treatment or drug should be confined to the scientific evidence.

Comments

  1. #1 Jeff
    October 13, 2009

    Orac: “My point is to echo Abel in pointing out that there’s a lot of money in alternative medicine and nutritional supplements, and the industry is growing”

    Annual sales for pharmaceuticals (prescription and OTC) total about $320 billion. Annual sales for dietary supplements total about $24 billion. No comparison.

    Dietary supplements are concentrations of naturally occurring substances already found in the food supply. Since they cannot be patented it makes no economic sense for any company to shell out the $800 million it takes to get FDA approval as a specific treatment.

    For example: There are several studies showing lutein and zeaxanthin can slow the progression of Age-related Macular Degeneration. A supplement company could patent their own lutein/zeaxanthin formulation, but they could not patent lutein or zeaxanthin. One can always go to Amazon.com or iHerb.com and buy one of many lutein/zeaxanthin formulations for $10-15 monthly.

    The supplement industry already has an excellent track record of safety. In 2008 the FDA’s Adverse Event Reporting system received 526,000 AERs for drugs and biologic products, but only 1,080 AERs for dietary supplements. Tighter regulations would probably drive up supplement prices without resulting in appreciably safer products. The FDA’s new Good Manufacturing Practices mandate testing to ensure product content and purity. Supplement manufacturing is now highly regulated.

    It is true that large pharmaceutical companies have been buying up supplement firms. One hopes their advanced production techniques will result in safe, reliable products.

  2. #2 Necandum
    October 13, 2009

    Well, you know what they say Jeff, to have side-effects a drug first needs to have a primary effect.

  3. #3 Sundeep
    October 13, 2009

    Yes, Tong Ren Tang is really popular here. It’s almost the gold standard for TCM. There are plenty of other places for TCM, including some government and private-run hospitals.

    Sadly, Woo isn’t just a surname in Hong Kong.

  4. #4 Steve
    October 13, 2009

    >Orac: “My point is to echo Abel in pointing out that there’s a
    >lot of money in alternative medicine and nutritional
    >supplements, and the industry is growing”

    >Annual sales for pharmaceuticals (prescription and OTC) total
    >about $320 billion. Annual sales for dietary supplements total
    >about $24 billion. No comparison.

    $24 Billion is 20% of the GDP of my country! How is this not “a lot of money?” Orac wasn’t comparing them to each other, but rather to the general amount of money that someone like a school teacher would actually make.

    Read what is actually said, not what you want to hear. Then you might understand how medicine works.

  5. #5 Adam Cuerden
    October 13, 2009

    Not to mention that dietary supplements are just one part of the alt med industry, so Jeff’s comparing a tiny bit of the industry being critcised to the entirety of pharma. I wonder what the figures would look like if you compared only mainstream OTC drugs (e.g. no homeopathy and other such woo, herbs, etc) with all of alt med?

  6. #6 David
    October 13, 2009

    Jeff#1:

    Since they cannot be patented it makes no economic sense for any company to shell out the $800 million it takes to get FDA approval as a specific treatment.For example: … The supplement industry already has an excellent track record of safety.< \blockquote>

    Several serious distortions there. First, the cost of getting FDA approval would be much lower for a vitamin or other product that’s a component of food. Second, if such a company were to demonstrate effectiveness in preventing or treating a disease, approval would come with 3 years of market exclusivity, which should be enough to cover the development costs and then some. There are lots of development programs in pharma companies that are only justified by the market exclusivity period.

    In the examples Jeff gave (lutein and zeaxanthin) the evidence for efficacy is not sufficient to meet FDA standards – it’s only suggestive.

    And finally, the supplement industry has a terrible safety record. My search for “supplement and recall” on FDA.gov produced >3000 hits, with 7 safety-based recalls in the last 3 months alone.

    Here’s one: “XXX is recalling 17 lots of the powdered dietary supplement, XXX, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people…”

  7. #7 deep
    October 13, 2009

    @ Jeff

    And how do you know that those formulations from iherb or amazon work? Have they been studied? How do they come up with the dosage?

    Just because there may have been studies that show that those substances can help macular degeneration doesn’t mean that those pills you buy will work. For all you know the concentrations are too low to have an effect, or maybe the drug itself doesn’t get to where it needs to go because it either gets broken down in the gut or alternatively doesn’t get ingested at all.

    Just because something is in the food supply doesn’t mean that when it’s concentrated and bottled up with a claim to help with illness it doesn’t need to be regulated. Even earl gray tea at the wrong amounts can be dangerous.

  8. #8 sailor
    October 13, 2009

    The first thing to remember is big business is interested in profits, not your health. So if there is money in peddling snake oil and the pharmaceutical companies can get away with it they will.

    A good first step to halting medical costs would be to ban all direct TV, newspaper and magazine advertising to patients for drugs or supplements.

    This would probably cut health care costs significantly.

  9. #9 Paul Browne
    October 13, 2009

    “The supplement industry already has an excellent track record of safety. In 2008 the FDA’s Adverse Event Reporting system received 526,000 AERs for drugs and biologic products, but only 1,080 AERs for dietary supplements.”

    Jeff you are trying to compare apples with pineapples.

    First, as Necandum suggests, you are comparing supplements, which will have a pretty small (if any) effect on health one way or another, with medicines that are often very powerful (and hence effective) but which can have adverse effects, sometimes serious.

    Second, there is the fact that many of the adverse effects ascribed to drugs and biologics that end up in the FDA’s system are identified because those taking them are under the supervision of hospital doctors or their GP, professionals who should know what to look out for and who are likely to report even mild adverse effects. Contrast this to the situation with supplements where most are not taken under medical supervision so that even if a person taking them suffers an adverse reaction (and realizes that is what is happening) they are far less likely to know that they should report it to the FDA, or know how to go about doing so.

  10. #10 Paul Browne
    October 13, 2009

    Sailor, with you 100% on direct to consumer advertising of drugs and supplements…even when I know the drug is a good one I can’t help thinking SCAM!!! when I see those ads.

  11. #11 Mr Duncan
    October 13, 2009

    You left out the largest components of the $800 million number for new drugs. As I read the study, Two thirds of that number represents the opportunity cost of not placing the investment in the stock market and letting it grow at 11% (!) for however many years. Also, the “original investment” is discounted by the risk that drugs with that level of investment may fail, which was something like 0.74, meaning you divide what it may have theoretically cost to develop the drug by 0.26, then multiply it by three and you get $800m. The actual price for such a new entity is more like $69 million.

    Does AMD include all these “costs” when they talk about building a new chip fab?

  12. #12 wholly father
    October 13, 2009

    Jeff,

    I would take issue with the assertion that lutein and zeaxathin have documented to slow the progression of Age-Related Macular Degeneration. At this point the evidence for the benefit of these nutrients is circumstantial (contrary to the marketing claims).

    There is an ongoing NIH-funded clinical trial which should definitively answer the question.

  13. #13 lime
    October 13, 2009

    If altie and “natural” companies were actually interested in making anyone healthier, they’d just send you the seeds for St. John’s Wort or whatever so you could grow it yourself. After all, they don’t use dosage or purity controls, so why should you? The fact that they insist on harvesting the garden weeds themselves (presumably under the supervision of their woo-woo shamans) shows that all they want is another IV into your back account.
    Lest anyone suggest that PhRMA should send people the directions for making venlafaxine or escitalopram at home, well, I’ve yet to meet anyone with the requisite manufacturing chemicals and apparatus (to say nothing of purification) in their basement. growing your very own TCM apothek is some woods. All you need to start And since pharmaceuticals are at least somewhat regulated, we do generally ask that you know how much and what you’re making before you start chugging it. As far as I’m aware no one does this for naturopaths, chelaters, or other nutbars of the “alternative” industry.

  14. #14 Joseph
    October 13, 2009

    The supplement industry already has an excellent track record of safety. In 2008 the FDA’s Adverse Event Reporting system received 526,000 AERs for drugs and biologic products, but only 1,080 AERs for dietary supplements.

    Let’s say someone dies from chelation therapy. Would that count as a dietary supplement or as a drug?

    It’s not surprising that dietary supplements don’t result in too many adverse events. Placebos rarely do. I’d also suggest drugs have a bigger nocebo effect.

    We’re also talking about absolute numbers here. What’s the proportion to products consumed in each category?

    Finally, where would someone go to report an adverse event for a supplement? I doubt there’s good tracking of this.

  15. #15 Jeff
    October 13, 2009

    wholly father,
    I’m glad to know about the NIH study, but there have been others. This article reports on a recent clinical trial:

    “The latest study showed that intake of high levels of both carotenoids (lutein and zeaxanthin) preserved the macular pigments, slowing down the progression from early AMD to late AMD. In contrast, the macular pigments of participants in a placebo group declined steadily.”

    this article has information on other studies using lutein and zeaxanthin.

  16. #16 Joseph
    October 13, 2009

    I happen to have a retinal condition that most likely predisposes me for AMD. I found some of the information Jeff mentioned, and I have added corn and spinach to my diet. I hope it helps some long term. Anyway, I think this falls in the category of science (maybe early science.) There’s no reason to think it’s alt-med, even though it will obviously be co-opted by alt-med.

  17. #17 sailor
    October 13, 2009

    Joseph, there is quite a body of real research that brushes at the margins that separate mainstream medicine from the supplement industry. In some cases if the effects are large enough, and if the research gets enough publicity, it may get brought into the mainstream. But I am sure a lot hangs out around the edges, never really replicated too much, well quoted by those who sell supplements, but ignored in the mainstream. Some probably could be helpful, others not so much. Doctors are not going to have time to find out about every new little study, so anyone with a medical conditions could benefit from spending some time on the internet an finding out what is out there and whether the studies makes sense.

  18. #18 Calli Arcale
    October 13, 2009

    Dietary supplements are concentrations of naturally occurring substances already found in the food supply. Since they cannot be patented it makes no economic sense for any company to shell out the $800 million it takes to get FDA approval as a specific treatment.

    Baloney. The majority of approved pharmaceuticals derive ultimately from chemicals first discovered in plants. A favorite example ’round these parts is Taxol, a chemotherapy agent used particular in breast cancer. (Orac, you may be aware, is a surgical oncologist specializing in breast cancer.) The chemical is derived from the bark of the Pacific Yew. It takes a ludicrous amount of bark to get enough of the chemical to be effective, and the trees are an endangered species (and grow very slowly), so the substance was studied and synthesized so they wouldn’t need the trees.

    Unpatentable? Unprofitable? Nonsense on both counts. You can most certainly patent things made from plants. Hell, if Boeing could patent the technique for using lunar swingbys to salvage a stranded commsat, when it’s really just a complicated ballistics problem solvable through celestial mechanics*, why *can’t* you patent something made from plants?

    And just look at Taxol sales and tell me it’s not profitable for Big Pharma to make drugs from plant-derived chemicals. That’s just plain nonsense. Heck, the plants save you R&D money, since they’ve already figured out how to build the chemical.

    * That is a real patent, and it held up in court when AMC 14 was stranded last year and SES Americom, the owners, wanted to salvage it. Long and kind of interesting story, but definitely offtopic for this blog. Anyway, if you can patent basic physics, why *not* a substance found in a plant? All you have to do is show that you’ve found a novel way of using it.

  19. #19 nomuse
    October 13, 2009

    Jeff also seems to ignore that plenty of companies are making a brisk business selling generics. As in, since Clariten went generic, anyone can manufacture a loratadine tablet. The fact that none of them could patent it doesn’t seem to have prevented them from spending the money to manufacture and market them.

  20. #20 sailor
    October 13, 2009

    “Baloney. The majority of approved pharmaceuticals derive ultimately from chemicals first discovered in plants. A favorite example ’round these parts is Taxol, a chemotherapy agent used particular in breast cancer. (Orac, you may be aware, is a surgical oncologist specializing in breast cancer.) The chemical is derived from the bark of the Pacific Yew. It takes a ludicrous amount of bark to get enough of the chemical to be effective, and the trees are an endangered species (and grow very slowly), so the substance was studied and synthesized so they wouldn’t need the trees.”

    Calli (18), you are being simplistic. The example you use is one where the drug company could patent the product derived from a tree and thus it became hugely profitable. I note you said “It takes a ludicrous amount of bark to get enough of the chemical to be effective”. But maybe you did not know a Canadian company found a way to make Taxol from the leaves of a different shrubby yew species, which was great as it was completely sustainable and way cheaper. Wonderful, except the manufacturer of Taxol took them to Canadian court and due to dreadful Canadian laws won their case putting the Canadian company out of business. Drug companies are interested in making profits, not helping people. Often they manage to do both, but if one stands in the way of the other, they will screw people every time.
    Now many natural products and many vitamins that have been synthesized for years can no longer be patented so while they may sell them as supplements, they are never going to go through getting them certified as treatments, or even put them through thorough testing, in this Jeff (1) was correct.

  21. #21 Calli Arcale
    October 13, 2009

    Wonderful, except the manufacturer of Taxol took them to Canadian court and due to dreadful Canadian laws won their case putting the Canadian company out of business. Drug companies are interested in making profits, not helping people.

    Of course; where did I suggest otherwise? My point remains: you CAN patent things made from plants. Indeed, your example is proof of this — the manufacturer of Taxol was able to sue a company that found an alternative method. (That probably shouldn’t have stood up in court, but it did, and that’s a matter for another discussion. Overzealous patent protection is one of my personal gripes, being that I’m in the software industry, where there has been a lot of patent abuse lately.)

    You are correct that you can’t patent something that’s been manufactured for years — there’s prior art. But are you seriously suggesting that Big Pharma wouldn’t pay to get them “certified as treatments”, as you put it? Do you know how much of a gold mine there is in a claim that can actually be *proven*? Besides which, there’s more than one way to protect your intellectual property. Patents are certainly not the only way.

    BTW, perhaps the biggest counterexample is aspirin. Loosely based on a plant remedy (willow bark), it’s one of the oldest synthetic drugs, and one of the first (if not *the* first) to lose not only patent protection but the ability to trademark its very name. It lost brand identity entirely.

    Yet today, manufacturers have been trying to prove that it can be beneficial in staving off heart attacks — essentially, investigating a new therapeutic use. They recognize the gold mine in a therapy that would get patients to use their product daily, rather than just when they get a headache. So far, the science has been iffy, and they are competing against standard blood thinning treatments (e.g. warfarin) which are already dirt cheap. But that hasn’t stopped them trying, though without approval, they still have to tread carefully in their marketing claims.

    The argument that “plants can’t be patented, so Big Pharma has no interest in them” is specious at best. It is, however, true that manufacturers don’t often bother to test plant-based remedies, but this is not because they can’t be patented. It’s because it’s cheaper. Plant-based remedies are usually already approved as food. By simply not investigating them very carefully, an unscrupulous manufacturer need only be careful about how he or she words their claims in order to sell it without all that pesky testing. It’s not that it won’t be worth it in the end. It’s that they see the profit available now, and are satisfied with that.

    The *only* reason this is financially viable is because of DSHEA. By creating this loophole, where supplement manufacturers could avoid proving efficacy, the government made FDA approval itself undesirable unless absolutely necessary to market a product.

  22. #22 Sailor
    October 14, 2009

    Calli, of course I agree if you can synthesize something from a natural product you can patent it. That is where most drugs come from. no disagreement there.

    I feel the trouble with the way we look at medicine is we are always looking for that magic pill. In some way this is not dissimilar from those going to alternative quacks also looking for the “magic fix”. However, with big pharma we often get it, sometimes it works quite well, sometimes it even works almost miraculously.

    However, in some cases this is an expensive and dumb way to approach problems. Let us take obesity. Everyone is looking for drug that is effective against putting on weight. If a drug company came out with pill that proved to be 28% more effective than placebo at reducing obesity, it would be on the market in a flash.

    Well consider this. A recent study showed that those who drink just one soft drink a day (coke etc) are 28% more likely to be obese than those who do not. Now granted this is a correlation and may not be causal, but given the amount of sugar in soft drinks it probably is a significant factor. The obvious solution is to discourage people from consuming soft drinks (tax them for example), not give them a drug that might mitigate their effects while having side effects and costing big bucks.

    There are many things like this that we ignore, that we might call “alternative”, that could to more for the health of a nation than a handful of new drugs.

  23. #23 Pablo
    October 14, 2009

    There are many things like this that we ignore,

    Who do you mean by “we”?

    If you mean doctors and health professionals (i.e. “medicine”), then that is wrong. OTOH, if you mean society, then I don’t disagree, but I don’t get the point. Doctors and medicine can go on all they want about eating healthy, and they do, but if patients don’t comply, then that is not a problem with medicine.

    Society ignores doctors’ advice, so somehow, the pharaceutical companies are bad?

  24. #24 Justice
    October 14, 2009

    If they have obesity related diseases which require tax and insurance payers to take care of, then it should be illegal for them to have soda. Americans are a bunch of selfish, fat, whining, pigs, just sitting around complaining about everything not going their way. Think of some punishments for not obeying the doctors orders…like pregnant women not eating healthy foods, feeding children nothing but processed junk, not getting exercise etc.

  25. #25 Todd W.
    October 14, 2009

    @Jeff

    From http://www.fda.gov/Food/DietarySupplements/ConsumerInformation/ucm110417.htm#safe, on ensuring that dietary supplements are safe, emphasis mine:

    By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer. Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is “unsafe,” before it can take action to restrict the product’s use or removal from the marketplace.

    That bolded section may explain, to some degree, the differences in adverse event reports, in addition to what others have already said about the potential lack of any physiological effect to begin with.

    The 2007 final rule establishing cGMPs for dietary supplements is a step forward, but it is an industry that is still horribly unregulated (Thank you, Sen. Harkin!).

  26. #26 Jeff
    October 14, 2009

    Todd W.: You misquoted the page from the FDA website you linked to! The sentence actually reads:

    “However, manufacturers and distributors of dietary supplements must record, investigate and forward to FDA any reports they receive of serious adverse events associated with the use of their products that are reported to them directly. FDA is able to evaluate these reports and any other adverse event information reported directly to us by healthcare providers or consumers to identify early signals that a product may present safety risks to consumers. You can find more information on reporting adverse events associated with the use of dietary supplements at Dietary Supplements – Adverse Event Reporting.”

    As you can see Adverse Event Reporting is MANDATORY. This is a law many supplement makers wanted and actively campaigned for. They know their products are safe and wanted the chance to prove it. For more information, go here:

    http://www.fdalawblog.com/2009/09/articles/miscellaneous/otc-drug-and-dietary-supplement-labeling-adverse-event-reporting-information/

    I don’t agree that supplements are under-regulated. For a precise explanation of exactly how supplements are regulated, go here:
    http://www.crnusa.org/pdfs/CRNBackgrounder_DS%20regulations0609.pdf

    David at #6: “And finally, the supplement industry has a terrible safety record. My search for “supplement and recall” on FDA.gov produced >3000 hits, with 7 safety-based recalls in the last 3 months alone.”

    David, most of these recalls are for supplements adulterated with drugs, like steroids. These are illegal products which involve serious criminal charges, whenever the FDA chooses to go after them.

  27. #27 Paul Browne
    October 15, 2009

    Jeff “Todd W.: You misquoted the page from the FDA website you linked to! The sentence actually reads:

    “However, manufacturers and distributors of dietary supplements must record, investigate and forward to FDA any reports they receive of serious adverse events associated with the use of their products that are reported to them directly. FDA is able to evaluate these reports and any other adverse event information reported directly to us by healthcare providers or consumers to identify early signals that a product may present safety risks to consumers. You can find more information on reporting adverse events associated with the use of dietary supplements at Dietary Supplements – Adverse Event Reporting.”

    As you can see Adverse Event Reporting is MANDATORY. This is a law many supplement makers wanted and actively campaigned for. They know their products are safe and wanted the chance to prove it. For more information, go here:”

    But my point was not about the duties of the manufacturers but about the likelyhood that an adverse effect will be picked up and reported by a user or medical practitioner in the first place, since the proportion of supplements that are taken under medical supervision is a lot lower than that of drugs.

  28. #28 Kismet
    October 15, 2009

    Paul Browne, (most) supplements are NOT safe. Lack of acute toxicity tells us nada, nill, nothing and zero about long term safety – the thing that really matters.
    Most supplements, and most drugs for that matter, lack that data and it would be foolish to call them safe.

    We have seen how “safe” multivitamins and certain vitamins in particular turned out to increase mortality or, at least and contrary to the expectation of benefits, do nothing.

    @depp
    “And how do you know that those formulations from iherb or amazon work? Have they been studied? How do they come up with the dosage?”
    The answer is essentially, yes. A select few supplements offer considerable safety data with promising efficacy or considerably efficacy with promising safety data. Most of those are or were at one time or another also available as prescription drug (niacin, vitamin D, MK-4, pyridoxamine, fish oil – which have some evidence-backed or at least promising uses)
    The rest, well…

  29. #29 Todd W.
    October 15, 2009

    @Jeff

    It appears that the page I linked to was updated yesterday, after I copied the quoted text.

    I would, however, say continue to maintain that supplements are under-regulated. They do not need to do S&E testing in clinical trials, like drugs do, so long as they do not make specific health claims, like “HerbX prevents cancer”. However, they are allowed to make veiled health claims without any testing to back them up. Things like “promotes a healthy heart”.

    To quote from the updated page I linked to:

    This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.

    A dietary supplement maker does not need to prove that it is safe before marketing it. In the eventuality that it is unsafe, the onus is on FDA to prove that it is unsafe, rather than on the maker to prove that it is safe. It’s a setup that benefits the maker at the expense of the consumer.

  30. #30 k
    October 15, 2009

    And, lest we not forget, Tamiflu was
    originally derived from star anise (one
    of the 5 spices in Chinese 5 Spice
    powder).

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