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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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July 9, 2010

The Horror Of Asking For Data

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Posted by Derek

A reader in the UK sent along this item from the BBC, and those of us in the drug industry will enjoy it very much. An EU regulation is forcing health food and supplement companies to. . .wait for it. . .actually provide evidence that their advertising claims are true.

For those of us living in Orrin Hatch's world here in the US, this will certainly be a change of pace. US readers know how it works - listen to the ads, with the first two sentences delivered as a low-decibel mutter: "Sold as a nutritional supplement only. Not intended to treat, cure, or modify any disease. But the hell with that! It'll grow hair, regenerate your liver, detoxify your colon, improve your memory, and boost your immune system! You'll lose weight, have more energy, sleep better, and you'll have to fight off the attentions of the opposite sex with whatever weapons come to hand! And it's all-natural! Call now for a free thirty-day supply!"

No, the EU isn't letting this stuff pass. Want to claim that your cranberry drink reduces the risk of urinary tract infection? Show us your clinical data - and no, not from someone else's study. From yours, with your product. Glucosamine for arthritis? Got some data to back that up? Green tea for cholesterol, or as an antioxidant? Show them some numbers, or go home. The marketers aren't too happy:

Ioannis Misopoulos, director general of the International Probiotics Association (IPA), is openly hostile.

"It can take three years to get these kinds of human studies together but in the meantime the claims are going to be wiped away," he said. "The regulation is killing this industry and the job losses are already being felt."

Cry me a procreating river, dude. Or come over here to where you can't get near the market without going through the clinic first - and for a lot longer than three years, I might add. And where every claim you make for your product is hammered out with the regulatory authorities, and if they catch you stretching out past them you can get fined out the wazoo. So they won't even let you keep running the ads while you go fetch some evidence, eh? Well, it gets worse:

Not surprisingly, the process has left many manufacturers here in the UK angry. Some say EFSA is demanding the same kind of clinical evidence which prescription medicines would require.

"EFSA is rejecting most of the proposed food supplement claims," says Jenny Baillie of the York-based health foods company Power Health, "even established claims like cranberry for urinary tract health, which will mean that there will be no information on packs for the consumer to assess what the product is supposed to do."

She believes the regulation may even drive consumers into buying from less reputable sources.

To which I am tempted to reply: Mundus vult decipi, ergo decipiatur. Except in the EU.

Comments (34) + TrackBacks (0) | Category: Snake Oil


COMMENTS

1. processchemist on July 9, 2010 7:08 AM writes...

I know of a company that sells glucosamine as pharmaceutical treatment for arthritis, and listened many times one of their directors complaining about the amount of work required to keep up to date with the regulatory environment and how the status of supplement in the US was tearing their market to pieces (obviously a supplement requires a minimal grade of control on production, documentation and so on, so you can source a whatever-his-grade product from China and then use it in your product for the US market).

I think that the clinical trials we're speaking of will be totally different, anyway, from the trials required for an API. Probably the clinical trials will be of the kind requested by cosmetic formulations.

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2. ronathan richardson on July 9, 2010 7:32 AM writes...

I'm sorry, but shouldn't the conservatives here be outraged at the unnecessary government intervention? Regulation isn't necessary, just let the market decide, as it has with the hundreds of billions people spend on supplements and such in the USA--they must work! Milton Friedman would be outraged!

In all reality, I'm interested in whether or not a firm law requiring at least 1 phase of a clinical trial for these claims to be made would be possible--and if not, is it because of lobbyists, or our American culture of BS?

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3. GladToMoveToProcess on July 9, 2010 7:56 AM writes...

Will the Obama administration, so enamored of European policies, move this way. One can hope...

BTW, don't put all the blame on Orrin Hatch. This mess goes back to Rep. Berkley Bedell (D, Iowa) and Sen. Tom Harkin (D, Iowa) (maybe there's something in the water), instigators of the Office of Alternative Medicine at NIH.

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4. Derek Lowe on July 9, 2010 8:04 AM writes...

I may not be the sort of conservative you're thinking of, RR - I believe that you have more of a hard-core libertarian in mind, and I'm not quite there. Or not yet.

I think that the answer to your second question, as it is to so many "I wonder how come they. . ." questions, is money/lobbying. Same as it is with every other industry, which is one of the things making me more of a libertarian than I might even like to be. . .

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5. Hap on July 9, 2010 8:33 AM writes...

But the problem [that supplement manufacturers would claim that their products end world hunger and the arms race, make you attractive to the opposite/same sex, grow your hair back (if you lost it), thin, and smart] isn't just the government's problem - it's a combination of 1) people will do anything and everything they can to make money or its equivalent if not restrained from doing so and 2) we expect that the government actually vets the claims of drugs and drug-like products [and the lack of the expected vetting means that consumers don't have any guide to refuting the claims supplement makers make under 1)]. Markets aren't free and never were, onless you count those looting scenes after sports championships.

I'm really sorry to hear about the supplement manufacturers who might lose jobs because they can't back up their claims. When the loan sharksXXXXXXXXXXXconsumer loan stores complained that enforcing usury laws in OH would destroy their business, there was a picture of a little girl with a sign "Please don't take my daddy's job away." To which I desperately wanted to respond, "Tell your daddy to get a real job, like telemarketing or door-to-door sales."

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6. metric on July 9, 2010 8:47 AM writes...

So presumably more jobs for clinical scientists should be opening up in europe... but I assume the required depth of the clinical data won't go anywhere near as deep as for pharmaceuticals. Will it go deep enough to keep out the pseudoscience and great rafts of misleading data?

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7. Hap on July 9, 2010 8:50 AM writes...

And I'm not really understanding how forcing supplement manufacturers to document their claims and not to make them until they have data deprives consumers on information on what your products are supposed to do. If you have no data to back your claims, then your claims aren't useful in telling customers what the product is likely to do. Wishful thinking doesn't constitute data, other than in gov't revenue projections and investment banking.

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8. p on July 9, 2010 8:54 AM writes...

I think this is a separate issue entirely from libertarian or highly regulated market. You can argue either one. But it's hard to argue that one group should have to be meticulous in proving their claims and another shouldn't. Either you think both should or you think neither should. Otherwise you're not having either a free or regulated market, you're having a fixed game.

If you want the supplement industry to not have to prove their claims, fine. But then let the pharma industry play by the same rules. (And vice versa).

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9. Hap on July 9, 2010 9:45 AM writes...

I think that part of the problem with pharma is that its marketing people want to sell their products using the same low standards to which supplement manufacturers sell theirs in the US. The EU holding supplement manufacturers to their claims might help pharma, by holding everyone to the same (high) standard and by telling pharma marketing that supplementeers' sales practices are a moral and intellectual dead end, and not to be emulated.

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10. Hap on July 9, 2010 10:08 AM writes...

"even established claims like cranberry for urinary tract health"

1) A claim isn't true just because you say it a lot or because lots of people say it a lot. That's what data is for.

2) You are responsible for what you say. Just because other people have claimed something to be true, but not had data to substantiate their claims, does not excuse you from responsibility when you do make the same claims without any data.

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11. Vader on July 9, 2010 10:17 AM writes...

Ronathan,

Straw man much?

In fairness, even some self-identified conservatives have failed to understand the distinction between a free market and an unregulated market.

There is not such thing as an unregulated free market. A free market, or any other kind of market for that matter, cannot exist without regulation.

If you think that's an oxymoron, you need to study up a bit more on your economics.

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12. processchemist on July 9, 2010 10:24 AM writes...

I know something about supplements and ingredients for supplements. Some years ago I attended to Vitafoods, in Geneva, one of the main events of the sector. Instructing experience, where I learned that:
1) many API's, of dubious status too (ergolides) end in supplements marketed somewhere in the world (in the US too?)
2) While in EU and in my country some courts stated that was ILLEGAL to sell chitosan formulations saying that you'll loose x Kg in x weeks, TONS of chitosan were selled.

But, some supplements have a real utility ( fish oil, carotenoids/lycopenes, vitamins, melatonin etc). The problem is to set adequate standards for this market and to discriminate between products of real utility and snake oil (and this should keep the good jobs, destroying only the profit of some sharks).
Maybe talking of jobs loss, they're talking about call center operators dedicated to sell the last miracle potion.


Permalink to Comment

13. Hap on July 9, 2010 10:45 AM writes...

From Google (roughly): "A free market is a market without economic intervention or regulation by government except for prevention of force or fraud."

I'd guess that my impression of free market was closer to RR's which is wrong (the only caveats for me being that the costs of preventing fraud and inhibiting force in a market have to paid somehow, and there's no mention of how to deal with externalities caused by one's activity but which aren't caused by intentional force). Regulation of the claims of supplementeers seems to fall clearly under the regulation of fraud, and should constitute legitimate regulation even in a free market.

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14. barry on July 9, 2010 11:00 AM writes...

The current mess dates to 1994 when Clinton signed a bill creating a third category that was neither Food nor Drug and therefore answerable to neither the FDA's highest level of scrutiny (safety and efficacy for drugs) nor the lower standard (safety for food). Immediately there was created a billion dollar industry with a fleet of lobbyists who now insure that proper regulation won't be enacted.

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15. Hap on July 9, 2010 11:07 AM writes...

I think that Hatch (among others) was responsible for the creation of the bill that Clinton signed. Clinton shouldn't get off without blame (he signed the damn bill), but Hatch and the people who backed his bill (and who generate the lobbyists who now inhibit regulation of their claims, albeit with more money) were the ones who created it in the first place.

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16. Vader on July 9, 2010 12:25 PM writes...

Hap,

A free market is one governed by neutral rules neutrally applied. In other words, it's regulated, but only to ensure fair process, rather than anyone's notion of fair outcomes.

I am no anarch-capitalist; I agree that the costs of preventing fraud or force do indeed have to be paid by someone, and it seems right to me that those costs should be borne by all participants in the market in proportion to their activity in the market, which sounds like a sales tax to me.

I don't see regulations to shift external costs back onto those who create them as necessarily inconsistent with the concept of a free market. They are imposed on third parties against their will, a forceful act whether the principals mean any harm or not. Mens rea is not an element of a civil tort, after all.

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17. Sili on July 9, 2010 5:02 PM writes...

and I'm not quite there. Or not yet.
Please do not go gently into that bad night!

I can digest your politics as they are, however much I disagree with them, but hardcore l(/L)ibertarianism would be a disservice to your excellent blog. (Not to mention your status and a productive and respected member of the human race.)


Anyway, I really really hope the lobbyists don't get to kill this legislation. It's damn good to hear how good sense is creeping into policy on Supplementary, Complimentary and Alternative Medicine.

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18. Anonymous BMS Researcher on July 9, 2010 6:58 PM writes...

I have long been annoyed at supplement companies getting to make drug-like claims without anything resembling drug-like evidence, so I am glad somebody is finally cracking down on them. As for the moaning of supplement makers, my wife has a great line "this is the world's smallest violin, playing for you."

In the US, I fear the supplement lobby will probably kill any attempt at imposing similar rules, just as the US meat and poultry industries have so far managed to fend off regulations limiting their overuse of antibiotics.

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19. Addi Faerber on July 10, 2010 12:30 AM writes...

The problem is, it seems to me, that supplement makers want to make claims about the positive aspects of a whole category of products while failing to distinguish their "brand" of the product as unique and valuable. They have nothing that distinguishes their product from the competitor and thus their advertising dollars are spent to drive demand for the whole product category- a waste of ad dollars. The EU regulation seems to be a way to break the vicious cycle of advertising spending warfare and force products to differentiate.

I also love the de-masculinization of their claim, "cranberry juice for urinary tract health.". They're not saying anything there... It's the supplement equivalent of puffing. What they want to say is, "drink cranberry juice when you get a bladder infection instead of seeing your doctor and taking cheap and effective antibiotics.". If they're fighting this hard to say nothing, then why not fight so hard and find some evidence? Then your product will have a brand significant fact to use in it's advertising. Fire your lawyers and PR people and contract you out some clinical trials!!!

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20. gippgig on July 10, 2010 1:14 AM writes...

According to the link in the entry "Dietary Supplements, Charted" (March 17, 2010), there is "strong" evidence that cranberry is beneficial for the urinary tract.

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21. Chris C on July 10, 2010 8:16 AM writes...

Incidentally, in the U.S. we have this "implied warranty of merchantability," which is roughly translated as "the thing will do what we say it will do." That Europe is carrying this idea into the realm of empirical science isn't a gross infringement on the free market; it's the enforcement of a necessary component of a functioning free market.

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22. AR on July 11, 2010 8:06 AM writes...

Not only do I want clinical data to back up these claims, some of which are outrageous, I would like to see some preclinical safety on certain supplements, too. For example, usnic acid, sold as a diet pill, would undoubtedly show positive weight loss in a clinical trial. It should as it inhibits mitochondrial function similar to 2,4 dinitrophenol. There is a famous quote on the clinical effectiveness of 2,4 DNP:

The drug not only eliminated the fat, but also the patient.

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23. Kieth on July 11, 2010 6:33 PM writes...

I am assuming no one objects to prune juice makers claiming that prune juice has some beneficial effects. It's a food. The risks of drinking prune juice (or cranberry juice) should not, I think, be compared to the certain digestive disruption of taking an "cheap, effective antibiotic". I read that glucosamine is ineffective at countering deteriorating cartiledge. Maybe so but I have recovered from what was diagnosed 16 months ago as a miniscus tear and this might, just might, have been due to a fairly steady intake of glucosamine. Where's the harm? it didn't cost very much and I have not felt or heard about any evil side effects. As has been observed elsewhere the cost of developing a placebo is quite small; if it happens to work we're all better off, right? why get the government involved? marijuana legalization advocates take note: if legalized it will cost more and probably be less effective.

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24. metaphysician on July 11, 2010 8:34 PM writes...

23- No, it will be exactly as effective as before. The sellers and promoters just won't be able to *lie* about its efficacies as much.

As for the harm? Absent anything else, the harm is this: so long as something can be sold without any testing or verification as a "supplement", there is no incentive to ever test it. This means no incentive to actually figure out how it works, and possibly develop new medicines based upon it.

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25. Scootah on July 11, 2010 9:42 PM writes...

I'm all for preventing false advertising, but it seems counter competitive to suppress advertising of products like Cranberry Juice or Glucosamine when their benefits are established and soundly tested - simply because the vendor is not the party that performed the testing.

That's not good for anyone - it just established monopolies for groups large enough to fund clinical trials.

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26. Eriban on July 12, 2010 4:01 PM writes...

One thing missing from this discussion is the economics. Most supplement ingredients are not patentable. Consequently there is little ability to recover, through premium pricing, investments made in research. Many natural compounds have documented efficacy in disease, but are prevented from making any claims by DSHEA. Manufacturers and marketers could go the IND route, but it would never make economic sense. You'd be investing in research your competitors could instantly poach. How do you solve the economics and provide an opportunity for a return on investment in research?

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27. Hap on July 12, 2010 5:27 PM writes...

I'm pretty sure you could patent them, but because the ingredients are likely to have lots of sources and multiple uses, infringement would probably be nearly impossible to prevent - hence, while you could patent the use, there's probably no point. Theoretically, I would have thought that this would be what use the US Office of Alternative Medicine could do - run (good) trials of various potential medicinal agents to see if they do what's claimed. If so, then people wishing to sell them could claim the activity if they could show that their version was bioequivalent. (That would also seem to be a reasonable compromise - while it seems unreasonable to test every particular product if the active ingredient has evidence of activity, you should have to show that your source works as well as the standard ingredient.)

I don't have a whole lot of sympathy, though, for the idea that because supplementeers are smaller, they shouldn't have to provide evidence that what they claim is so. That claim doesn't work for smaller drug companies, either, and I don't see why it should work for supplement makers.

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28. John Thacker on July 13, 2010 10:11 AM writes...

For those of us living in Orrin Hatch's world here in the US, this will certainly be a change of pace.

Actually, it's not that much of a change of pace. The FDA cracks down on any food or supplement that crosses over into citing studies or numbers. Vague references are, however, okay. That's why General Mills got in trouble over Cheerios and then made their remarks more bland.

While it may not always be legal to advertise, in the UK there's quite a bit of homeopathy prescribed and paid for by the NHS.

Of course, I happen to agree with the research that suggests that the FDA overregulates the drug market as well. The result is not only driving people to supplements, but also driving people to off-label uses without those off-label uses being as well-studied.

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29. John Thacker on July 13, 2010 10:36 AM writes...

Absent anything else, the harm is this: so long as something can be sold without any testing or verification as a "supplement", there is no incentive to ever test it. This means no incentive to actually figure out how it works, and possibly develop new medicines based upon it.

This is a ridiculous statement. Of course there is an incentive. While plenty of people will trust vague claims and buy snake oil, there are plenty of other people who do want to only use products that have testing or verification.

For example, people have been free to market Vitamin D as a supplement with vague claims for years. That hasn't stopped recent medical research from learning more about it, and resulted in more doctors actually testing its levels and prescribing it instead of people just randomly taking it on their own.

One of the absurd things about the current regulations is that any supplement (or food, see Cheerios) that actually does try to document claims using real studies and numbers automatically gets regulated by the FDA as a drug. But in that case, they, like pharmaceuticals, can't rely on their statements being factual and based on good studies as a safe haven, they have to pass through the entire FDA regulatory process. Truth is not considered a defense when advertising a drug. (Nor is passing through the FDA process considered a safe haven, either, of course.)

Under such a regime, it's no wonder that supplements have lots of snake oil. Any supplement that tried to be rigorous would instantly be regulated as a drug by the FDA for the crime of invoking science instead of vague claims.

The justification for this is that without those regulations some drugs would refuse to go through the FDA regulatory process and just rely on their science, and operate in a pre-1962 FDA fashion where safety was all they had to demonstrate to the government. The downside is that it makes it far harder to get real drugs researched and approved, and it drives people into whatever the less-regulated substance is.

No one's arguing that it's legal to say something that's false. It's not. The question is what the standard of evidence is, whether the truth is a defense, "citation needed" is just a good idea to convince people, and you have to prove that someone was lying, or, as with drugs, whether you have to affirmatively prove that you're telling the truth first.

The pre-1962 FDA worked pretty well. It demonstrated that even without the FDA regulations to show efficacy through the regulatory process that pharmaceutical advances and real science would happen.

Permalink to Comment

30. John Thacker on July 13, 2010 10:43 AM writes...

Incidentally, what is your opinion on off-label uses? The same sort of absurdity applies there-- we know that already approved drugs can be useful for things other than what they were approved for, and doctors prescribe them that way all the time.

However, drug companies are forbidden from advertising or recommending those off-label uses. Sometimes it happens-- do you feel that the FDA needs to crackdown on doctors and companies that promote off-label uses? It's the same argument.

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31. John Thacker on July 13, 2010 10:49 AM writes...

The FDA, prior to 1998, banned companies from redistributing preprints of scientific peer-reviewed studies to doctors. It was illegal to mention that aspirin was good for heart attacks, for example. In 1992, the CDC recommended that women who could become pregnant take folic acid supplements-- but the FDA immediately announced that it was illegal for those selling supplements or foods high in folic acid to mention that recommendation on their labels.

Does your "show the data" extend to generics? Pre-1984 and Waxman-Hatch, generics were not allowed to merely prove that their drug was bioequivalent to the brand name drug. Are you proposing that generics should have to go through the entire regulatory process from the start and the entire batch of clinical trials?

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32. John Thacker on July 13, 2010 10:58 AM writes...

As for the harm? Absent anything else, the harm is this: so long as something can be sold without any testing or verification as a "supplement", there is no incentive to ever test it. This means no incentive to actually figure out how it works, and possibly develop new medicines based upon it.

This harm is utterly dwarfed by the number of people who died early of heart attacks that could have been prevented if aspirin makers had been allowed to mention its properties sooner.

I'm no advocate for treating supplements different from drugs. But I think that anything that has demonstrated safety should be allowed to operate in either the pre-1962 or the current FDA regulatory structure, with appropriate labeling.

Permalink to Comment

33. srp on July 15, 2010 7:08 PM writes...

A few years ago I had a long email colloquy with Derek on this subject. (My core is somewhat harder than his on this topic.) Aside from basic pro-choice arguments about people's right to be "irrational," there are sound utilitarian arguments for wanting to eliminate FDA efficacy regulation.

The gist of the matter is that quackery and unproven treatments thrive if and only if the scientifically valid stuff doesn't work very well, costs a lot, and/or has unpleasant side effects. Hence we see fairly little quackery for eyesight correction, a moderate amount for sexual enhancement (less since the advent of Viagra and its rivals), and a ton for cancers of various kinds.

This phenomenon means that the FDA's efficacy testing requirements are unnecessary and probably counterproductive, although they do help incumbent pharmas by presenting a barrier to entry for small innovative drug firms.

Another unfortunate side effect of the regulations is to drive up the price and lower the quality of the quackery that people actually buy, making these patients/consumers materially worse off. The attitude of many of scientifically oriented people toward quack-remedy consumers is inconsistent: On the one hand they pity them as victims who must be protected but on the other hand they hold them in contempt and want to punish them for doing the "irrational" thing.

Permalink to Comment

34. Tom Waits on July 24, 2010 9:17 AM writes...

"it gives you an erection and wins the election..."

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