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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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November 4, 2013

The Herbal Supplement Industry Is Not A Very Funny Joke

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Posted by Derek

The regulatory system we have in the US for selling herbal supplements is screwed up. I've thought so for many years, and we're not the only country that fits that description, either. The system is screwed up in so many important ways that it's hard to know where to start, but how about back at the very basics - quality control?

Try this paper from BMC Medicine out (open access) and see what you think. The authors, from the DNA barcoding initiative at Guelph, tested 44 different brands of various herbal supplements, purchased in both the US and Canada. They found ridiculous levels of contamination. In fact, contamination is not the right word: one-third of the samples had no detectable amounts of the herb on the label. Instead, there were invasive weeds, ornamental plants from China, ground rice, soybeans, what have you. 10 of the 12 companies whose products were tested had at least one in this lovely category; 4 of them had nothing but.

This brings up several interesting questions: for one, how come this garbage continues to sell? Could it be that many of these preparations are of no benefit other than the placebo effect, which means that lawnmower scrapings will indeed work just as well? Second, who's ripping off whom? I would assume that some of these companies are buying from middlemen and repackaging, in which case, they're getting hosed (and passing the hosing along to you!) Doesn't anyone have even a passing interest in seeing if they've been sold the right material, or do they just not care, since it sells anyway?

When drug companies sell products of poor quality, the roof should come down on them, and I'm glad when it does. But these sleazeballs - is there even a roof to bring down? Now, I realize that some people will look at my background, and say, sure, this is someone who works in the pharma industry, of course he's going to put down these safe, natural, effective herbal medicines. Why, those would put his kind out of business if people just realized how wonderful they were! But I'm not denying that some herbal preparations can be used as medicines. If they can, though, they should have to prove it (the way we do in the drug industry), and they should have to actually sell what it says on the label, the way we do. Selling people a bunch of ditch clippings from a Chengdu compost pile is not acceptable, and if you're a big proponent of herbal remedies, you should be even more upset about this crap than I am.

More: Here's the New York Times on this story.

Comments (59) + TrackBacks (0) | Category: Snake Oil | The Dark Side


COMMENTS

1. student on November 4, 2013 2:59 PM writes...

The ironic thing is that lawnmower clippings may actually be a more efficacious product by virtue of being less harmful. Placebos are no longer allowed to be prescribed in the US, and placebos provide a very real benefit, and these may be the next best thing, provided that you are giving the customer a sugar pill and not a herb containing God-knows-what alkaloid that has never been tested. The fact is that supplements are not required to undergo toxicity testing. Many people believe that just because it's natural it's better for you, or because it's synthetic it's necessarily worse for you. I always say if they believe such nonsense they should gargle poison hemlock to get the all-natural goodness of strychnine and chase it with some red tide algae.

Permalink to Comment

2. The Fat Layer on November 4, 2013 3:10 PM writes...

In my mind, there are 2 critical issues at play here: (1) lack of public education on the matter, and (2) lack of public scrutiny.

Lack of public education: The public in general believe what they see in TV or hear in the radio. The public’s logic is that if a message is broadcasted it must be true. Add to this the fact the general public has no real clue how real medicine/drugs work, they believe whatever they’re told.

Lack of public scrutiny: If there were a national initiative/movement/organization actively involved in scrutinizing and counteracting all the claims made by such vendors with reputable studies published in reputable journals, and broadcast their message just as vendors do, at the very least people would start questioning what vendors’ claim.

Derek, you say “When drug companies sell products of poor quality, the roof should come down on them”. The roof comes down because pressure mounts. Who applies pressure to companies selling all this herbal stuff?

Find who or what can apply pressure, significant pressure that is, and we may see changes in a near future.

My 2 cents.

Permalink to Comment

3. Dave on November 4, 2013 3:13 PM writes...

A great book on this is "Do you believe in Magic: The sense and nonsense of alternative medicine." The author, Paul Offit, discusses the very little data behind most alternative medicine (N.B., He donates all the money he receives from his books).

It's amazing how little data there are behind most alternative therapies.

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4. NoDrugsNoJobs on November 4, 2013 3:14 PM writes...

What really irks me is that the testing and disclosure of safety and efficacy data as well as the inclusion of extremely lengthy warnings on any FDA-approved drug is used as ammunition by the Herbal/Natural/Supplement/Nutraceutical companies use against us. They say, "You won't see and warnings on our products, unlike toxic drugs, these are natural and have been proven safe through centuries of use". Never tested, never verified.

And the average numbskull sympathizes with this because it resonates with their knowledge of how evil and horrible pharma is. As a result, we have better drugs than ever, treating a wider variety of conditions than ever, with better clinical research and mechanistic understanding than ever and we have the greatest mistrust than ever. Easy to reach for the herbal snake oil when the other choices are all toxic chemicals manufactured by evil companies hellbent on poisoning you.

People will say we brought this on our self, by what - testing and being subjected to the strictest regulatory and marketing rules of any industry that I am aware of? I would laugh at the craziness of it all except that it has numerous real world consequences. I think a great start to beginning to bend the knowledge curve back to being just a little closer to reality would be if more of our now un-employed pharma colleagues could go back, get certified to teach in their state and start teaching high school classes in chemistry, biology, etc. The low information mind set begins at a very early age and unfortunately is often perpetuated by the teachers we have. They come from an university, often have 0 real work industrial knowledge or perspective and carry with them all of the misinformation of the general society around them.

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5. Hap on November 4, 2013 3:23 PM writes...

If the supplements are safe and effective (how one would know that they're safe and effective, or at what they are effective, I leave as an exercise), then what's in the supplements ought to matter. So, either 1) the people selling the supplements don't know how to check what they have (but are willing to take other people's word for it, and customers' money) or 2) they don't really care what's in it, which implies strongly that their statements of efficacy (even in the absence of the testing one would normally expect to substantiate such claims) are hogwash.

This isn't even a matter of knowledge that most people can't be expected to have, but of logic that we've been expected to have because we exist.

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6. Anonymous on November 4, 2013 3:27 PM writes...

Does this mean the all those REVOLUTIONARY BREAKTHROUGH ORGANIC ALL NATURAL REMEDIES I see on Dr. Oz are not real?

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7. Wile E. Coyote, Genius on November 4, 2013 3:30 PM writes...

There is a serious flaw with this paper: They didn't name names. Only anonymous companies. Shouldn't the public know who "company e" was that had 100% substitution with contamination. This paper provides publicity to the problem, yes, but insufficient publicity to shame the guilty parties.

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8. MoMo on November 4, 2013 3:31 PM writes...

Its a perverse and reverse form of Darwinism- especially since many of these remedies contain Heavy Metals- see JAMA. 2004 Dec 15;292(23):2868-73

Let the American public look for health cures this way, it's Chemical Darwinism in action and the FDA is maligned at the wheel.

Permalink to Comment

9. cirby on November 4, 2013 3:36 PM writes...

I catch a lot of the snake-oil stuff on Facebook and other places. Several of my friends are well-snookered by this industry, and I see a "new herbal remedy" post a couple of times a week on average.

One of the ladies is always - ALWAYS - surprised and thankful when I point out the quackery of those products. You'd think that after the first ten or twelve times, she'd stop trusting the sources that gave her the bad info in the first place, but she always has another one lurking in the wings...

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10. bacillus on November 4, 2013 3:50 PM writes...

What if you happen to be dangerously allergic to the contaminants that you aren't even aware are present in your magic pixie dust?

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11. David K on November 4, 2013 3:59 PM writes...

I presume the US has some form of fair trading or consumer guarantees legislation, though? If a supplement doesn't contain what it says on the label then surely there is some sort of roof that could come down on these companies.

It also appears that as long as the supplement comes from plant material and there is no indication as to what the supplement should be used for, then regulation is particularly low.

This is a stark example of the common perception that, if it's natural, then it must be safe...

Permalink to Comment

12. UndergradMinion on November 4, 2013 4:33 PM writes...

One thing I often notice about "alternative medicine" is that claims are made in a very careful way so that no one can scientifically prove them wrong.

Think of homeopathy, for example: as each and every person has to get their own very special formulation based on, oh I don't know, pendulums or something, any kind of double blind trial design is rendered obsolete.

This slick evasive tactics makes it near impossible to get rid of those things for good, and certainly make it frustratingly pointless to argue against a believing patient (or victim?) of this kind of voodoo.

Permalink to Comment

13. Shanedorf on November 4, 2013 5:15 PM writes...

The masses are asses and the supplement industry is only too happy to separate them from their cash.
Much of this is the result of the intense lobbying of Congress that led to the 1994 DSHEA act. At one point there was a movement toward more testing and more scrutiny, but given the billions involved, Congress caved in to the intense pushback by the supplement industry.
When NFL players started testing positive for all kinds of contaminants, amphetamines and other PEDs, they had to create a safe list of supplement manufacturers that actually followed cGMP. It was a very short list.

One simple change would be to require much larger print on the labels and TV ads of this disclaimer:

"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease"

If it isn't intended to diagnose, treat, cure or prevent a disease, then why on earth would you spend money on it or ingest it ?

Its a total snake-oil scam on the public and allowing it to continue is a damn shame

Permalink to Comment

14. Anonymous on November 4, 2013 5:24 PM writes...

Herbs don't kill people. People kill people.

Permalink to Comment

15. Anonymous on November 4, 2013 6:34 PM writes...

@15: Yes, but people are killing (or at minimum, blatantly scamming) people with herbs. That's the problem. We want to stop people hurting other people. In this case they're using herbs (or things called herbs), so we have to deal with that.

Permalink to Comment

16. J. Peterson on November 4, 2013 6:39 PM writes...

I've lost track of the source, but I love this quote: What do you call "alternative medicine" that's been clinically proven to work?

Medicine.

Permalink to Comment

17. pgwu on November 4, 2013 6:47 PM writes...

The line between supplement companies and pharmas is sometimes blurred by deal news of big shots paying or buying companies for vitamin D or fish oils, or things like those. Sometimes I have trouble telling the difference between an "innovative" product and a weekend radio commercial one.

Permalink to Comment

18. SteveM on November 4, 2013 7:26 PM writes...

Re: #7 Wile E. Coyote, Genius "This paper provides publicity to the problem, yes, but insufficient publicity to shame the guilty parties."

Great point. And why doesn't the (feckless, stupid) Government require the supplement vendors print lot numbers and assays on the bottles of the supplements they distribute?

Food has content labels, why not supplements?

Permalink to Comment

19. Chrispy on November 4, 2013 7:33 PM writes...

@16 J. Peterson

Well, it's in this swell Tim Minchin cartoon:

http://www.youtube.com/watch?v=HhGuXCuDb1U

Permalink to Comment

20. Curious Wavefunction on November 4, 2013 7:52 PM writes...

Has anyone actually looked at deaths from herbal supplements? That would be a helpful benchmark.

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21. Philip on November 4, 2013 8:58 PM writes...

@Curious Wavefunction (20), I can name one, Steve Jobs. It is not just a function of how many people die of Apricot Pit Extract (APE), but how many died of not getting life saving treatment because they believed in APE or died of contaminated APE. That is going to be a hard number to come up with.

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22. PharmaHeretic on November 4, 2013 9:31 PM writes...

What is worse- profiting from a placebo or from a drug that costs much more AND actively kills patients?
-----

J&J TO PAY $2.2B TO SETTLE MARKETING ALLEGATIONS

http://bigstory.ap.org/article/ap-source-johnson-johnson-agrees-pay-22b

WASHINGTON (AP) — Johnson & Johnson has agreed to pay more than $2.2 billion to resolve criminal and civil allegations that the company promoted powerful psychiatric drugs for unapproved uses in children, seniors and disabled patients, the Department of Justice announced on Monday. The agreement is the third-largest settlement with a drugmaker in U.S. history, and the latest in a string of actions against drug companies allegedly putting profits ahead of patients.

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23. Jack Kirkpatrick on November 4, 2013 9:32 PM writes...

Shanna, they bought their tickets, they knew what they were getting into.... I say, let 'em crash.

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24. RTW on November 4, 2013 10:27 PM writes...

What qualifications does a typical middle man have, or someone marketing these nutraceuticals have? I have been interested in Herbal medicine for a very long time. Over 30 years. After all several medications still on the market are plant derived or semi synthetic natural products. So - yes some will actually have pharmacological effects that have been extensively studied including in some cases clinical trials. The issue is that even marginal success in a trial translates into big money for these herbal supplement producers. Many publish misrepresented study data to support sales and marketing of their products, and as this blog entry has pointed out - you are not getting what you think you are.

I have been looking into several such supplements lately as there is some reasonable data to suggest things like Curcumin, Tumeric, PSK, and a few others do have the ability to modulate some processes involved in apoptosis and cancer proliferation. Metastatic cancer patents look at some of these herbal preparations as a means to maybe give them a little bit of an edge over standard chemotherapy alone and supplement their Chemo with these things. They ate hoping perhaps to keep the metastases at bay while standard chemo kills off their larger tumors. I have read the results of some of these studies and the data looks pretty interesting to say the least. BUT I am reluctant to put any faith in the composition of anything I might buy at the health food and nutrition store. I have been looking for instance for Curcumin C3 complex used in one study. I have no confidence in any preparation I have found so far. For this particular herbal concoction I know where to source it, but they only sell to larger supplement suppliers. And down stream would I actually get unadulterated Curcumin C3 complex that was used in the study? Its doubtful. Same with just about any of these materials that have undergone any type of scrutiny via a clinical study. Can the same materials be sourced? As a result oncologists don't take these things very seriously when their patients tell them they are using these supplements.

Additionally - even if they have the correct herbs in the bottle - the underlying constituents could vary a great deal. Growing conditions can greatly effect the amounts and proportions of the underlying natural chemical components. I have done some natural product extractions in the past so I know what I am talking about here.

Some of these materials of interest to cancer patients have had their constituents isolated, characterized and attempts made to improve upon them by synthetic methods. But due to a lack of interest by established cancer institutes, little has come from these avenues. This is a shame as initial data from some of these studies is what feeds the sales of these supplements! Cancer victims are being fleeced I think. People that think these will protect them from getting cancer are likely being poisoned instead.

I have a strong feeling that my wife's colon cancer might have been attributable to a supplement that she was taking for a couple of years to Burn FAT! Later because of kids and other people abusing this supplement - it was eventually investigated and forced off the market or otherwise reformulated with other ingredients. I believe there were a number if deaths attributed to these supplements. Could some of the materials in her fat burning pills have contained something that started a mutation in her colon? She had no risk factors, was athletic, and ate a healthy diet otherwise but at the time she didn't have the time to work out as she would have liked to so resorted to a short cut to burn off the fat. Once the supplement was no longer available she switched to more vigorous work outs and was in excellent shape when she was diagnosed stage IVb. This took everyone by surprise!

Personally - I would like to see a lot more regulation of these supplements. Much higher QA/QC and standardization.

Permalink to Comment

25. Lane Simonian on November 4, 2013 10:42 PM writes...

Yes, let's establish stronger regulations and some benchmarks. Contamination either deliberate or accidental should be investigated and where applicable prosecuted. But it is difficult to establish how widespread this problem actually is based on limited sample sizes.

As regards to benchmarks, how many people have died from herbal supplements versus prescription drugs? (Steve Jobs does not count as it is unclear whether the supplements he took prolonged or shortened his life). The fact that herbal supplements are not regulated and prescription drugs ostensibly are does not make the first automatically unsafe and the latter automatically safe.

While one can never be absolutely certain, there are certain companies that have reputations for selling unadulterated herbs and essential oils.

Effectiveness is a whole separate issue. There are numerous clinical trials suggesting or indicating that certain herbal treatments are at least as effective and likely safer than drugs being used to treat certain illnesses. Unfortunately, these studies are routinely ignored in the United States where the idea that herbs contain chemicals that attack or neutralize oxidants is considered anathema.

Permalink to Comment

26. Anonymous BMS Researcher on November 4, 2013 10:51 PM writes...

The famous 20th century science fiction editor John Wood Campbell in an editorial proposed a law creating an occupation called "licensed quack." The rules were something like the following:

1. The Licensed Quack may use *any* treatment that he or she thinks might help (and that is not already proven to be harmful).

2. The customer must sign a document acknowledging they are seeing a Licensed Quack.

3. The LQ must collect sufficient data, under a rigorous protocol, to evaluate how well his or her treatment works.

4. Such data, from all LQs, are public records that anybody may study.

Permalink to Comment

27. Anonymous on November 5, 2013 2:45 AM writes...

While we're talking about dangerous substances that we take orally, why don't we consider the biggest killer of all which has the greatest substance abuse problem: Food.

As a European I am disgusted by the size of American plates and portions. I ordered just a starter, and there was enough food on the plate to feed a family of four! With that amount it hardly matters which specific type of food (fat, carbohydrate, etc.) causes obesity. There is simply too much of everything.

Permalink to Comment

28. Tiens UK on November 5, 2013 3:50 AM writes...

Nice post. Thanks a lot for sharing your thoughts on this matter. It is really useful to obtain natural supplements since it can strengthen your system and prevent certain diseases as well.

Permalink to Comment

29. Anonymous on November 5, 2013 5:37 AM writes...

@28: Facepalm!

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30. Timo on November 5, 2013 6:23 AM writes...

I think the problem with the study cited is that they did not really tell us where the study material came from.

I am convinced that had they bought the herbs in an official local pharmacy, they would not have found any discrepancies. I only know the regulations in Germany, but here they are quite strict. The pharmacist in the local pharmacy has to confirm the identity of EVERY raw material that comes in before it can be sold. And if he orders 5 packs of say chamomille flowers, the identity must be confirmed for all five packs individually.

So no - herbal materials are not crap by definition. It depends on where you buy them. The same holds true for "real drugs". If you buy your Viagra from the cheapest online store, your should not be surprised about what you get.

My advise would just be to never order health products from online stores or buy from "health food stores". Go to the pharmacy, pay the price, but get what the lable says...

Permalink to Comment

31. Anonymous on November 5, 2013 6:44 AM writes...

I wonder how the FDA would respond if pharma companies just added the same kind of claims that alternative medicine companies make?

Perhaps this is exactly what pharma companies should do, just to provoke the FDA to respond and address the double standards.

Permalink to Comment

32. Anonymous on November 5, 2013 7:05 AM writes...

@31, I think its not a case of double standards, but FDA actually have very little power to regulate the alternative med industry. Don't be so harsh on the FDA ;)

Permalink to Comment

33. Anonymous on November 5, 2013 7:21 AM writes...

@32: So we should make sure the FDA do have that power, by passing a bill which says that anything you consume has to be classified either as food or drug, with appropriate limitations on what can be claimed.

Permalink to Comment

34. navarro on November 5, 2013 7:30 AM writes...

at one point the fda was trying to regulate aspects of the "nutritional supplements" industry. senator orrin hatch , republican of utah, felt that would reduce the profitability of that part of the industry in utah and managed to get legislation passed which greatly reduced the fda's ability to regulate "nutritional supplements."

Permalink to Comment

35. Anonymous on November 5, 2013 7:33 AM writes...

Or enforce some kind of warning label just like in the tobacco industry, for example:

Warning: The safety and efficacy of this product has not been clinically proven, and has not been approved for any medical use.

Permalink to Comment

36. Anonymous on November 5, 2013 7:37 AM writes...

@34: Perhaps senator orrin hatch should just start growing heroin in Utah, as that would be even more profitable.

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37. The Iron Chemist on November 5, 2013 8:55 AM writes...

@35: Here's my version of the warning: "You know that this is all BS, right?"

It is pretty ironic that the biggest customers for this market are those who have little to no faith in traditional medicine. This stuff really merits more faith?

Permalink to Comment

38. nona on November 5, 2013 9:09 AM writes...

I have a sudden urge to start selling my cure-all "FAITH". The opaque squeeze bottle would of course be filled nothing (and thus last forever)... Contents: 100% pure and natural placebo extract. Directions for use: squeeze into hollow cranial cavity via the ear canal...

Permalink to Comment

39. Moody Blue on November 5, 2013 9:28 AM writes...

@22 PharmaHeretic: Great question indeed! As aside, but somewhat related: Other day I was making a comment about what a waste it was in certain cultures they douse the idols of their deities with milk, honey and what not.... And my wife retorted: "well, some people believe when such offerings were consumed or applied externally, they were cured of their ailments... May be a placebo effect, but lot cheaper than the placebo effects from the drugs you guys make!!" (I used to be pharma indusry)

Permalink to Comment

40. Anonymous on November 5, 2013 9:34 AM writes...

@39: I would be interested to see what meds you take when you get cancer.

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41. Jon on November 5, 2013 9:55 AM writes...

A few weeks ago I saw someone with an idea of selling "homeopathic whiskey". Further discussion of the idea suggested that if he sold it as a hangover treatment that he would have come up with the first homeopathic remedy that would actually do something.

Permalink to Comment

42. John Wayne on November 5, 2013 10:27 AM writes...

@41 You made me laugh out loud!

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43. NoDrugsNoJobs on November 5, 2013 10:30 AM writes...

Arsenic, Lead and Mercury:

http://www.sciencedaily.com/releases/2010/02/100209183337.htm


Sign me up!!!!

Permalink to Comment

44. Alky Lloyd on November 5, 2013 10:41 AM writes...

@1: Umm -- hemlock (genus Conium) is toxic mainly for its coniine, not strychnine. Strychnine is from seeds of the poison nut tree.

Permalink to Comment

45. Anonymous on November 5, 2013 10:58 AM writes...

I vote we bring back medieval medicine (hot irons and bloodletting) instead of this pharma nonsense.

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46. cynical1 on November 5, 2013 11:10 AM writes...

I was in the company of a new age wing nut a month ago and she was telling a group of people that she could walk by all the herbs and supplements in the Whole Foods and extract out their ingredients just by absorbing their 'energy'. I asked her why she didn't do that in the food isle and save some money on grocery shopping. She didn't like me very much after that.

Permalink to Comment

47. Catherine on November 5, 2013 12:09 PM writes...

@27:

"While we're talking about dangerous substances that we take orally, why don't we consider the biggest killer of all which has the greatest substance abuse problem: Food.

As a European I am disgusted by the size of American plates and portions. ..."

As an American, I wholeheartedly agree! It's completely out of control.

Permalink to Comment

48. ab on November 5, 2013 12:53 PM writes...

@39Moody Blue,
You and your wife apparently don't realize that for a drug to achieve FDA approval, it must show efficacy BEYOND the placebo arm.

Permalink to Comment

49. Pie on November 5, 2013 10:52 PM writes...

You are narrow minded again, Derek. Some herbs work well. Some (even garbage) are partially equal to placebo. We know placebo works sometime. Quality is an issue but your daily food is not that clean either.

Permalink to Comment

50. cliffintokyo on November 6, 2013 5:58 AM writes...

To the people getting on FDA's case:
Do you know any other country's regulatory agency that takes action against herbals and supplements suppliers (usually for adulteration and mislabeling)? Perhaps the UK MHRA has a reasonable track record. Any others though?

Permalink to Comment

51. Norm Howe on November 6, 2013 8:57 AM writes...

Dietary supplement manufacturers have to positively ID every shipment of every lot of herbal components. This is required by the DS GMP, 21 CFR 111. They are also required to qualify their suppliers and test for "... those types of contamination that may adulterate or may lead to adulteration of the finished batch." FDA is ramping up their enforcement of this regulation and the level of compliance in the industry has come up a lot since the regulation was promulgated 6 years ago.

That doesn't address the efficacy of the product, though. The standard is much lower in the US than in other countries.

See my blog on regulatory compliance management at vcillc.com/normhowesblog .

Permalink to Comment

52. David Colquhoun on November 6, 2013 10:28 AM writes...

The MHRA does something from time to time about herbs and "supplements" that are dangerous because of toxicity and/or contamination. But it does nothing about exaggerated or plain mendacious claims for benefits. In fact the MHRA has actually made matters worse by allowing misleading labelling eg http://www.dcscience.net/?p=4269

Permalink to Comment

53. theLaplaceDemon on November 6, 2013 2:09 PM writes...

"Some (even garbage) are partially equal to placebo"

Pretty damn expensive placebo.

Also, can we take a step back and realize how weak of a defense "it's just as good as a placebo" is?

The placebo effect is interesting and sometimes beneficial, but there's a reason we don't just give cancer patients sugar pills and hope the placebo effect cures them.

Permalink to Comment

54. Supplement Seller on November 6, 2013 2:11 PM writes...

We manufacture and market a supplement and make zero claims for it other than it makes you feel better - and it sells - a little bit - it is new and we do not advertise nor do we play social media tricks to generate fake blogs about the wonder product.

We prepare the ingredients following cGMP and provide it a dose that would be equivalent to consuming a daily serving of the cultivar from which it is obtained.

We conducted genotox studies and basic ADME workups on the "active" ingredient that we provide in the capsule at 90/110% of stated label amount. After doing this and getting it in consumer hands, we find the product is in fact, at twice the daily dose, reversing symptoms or even affecting a cure in a number of diseases that are currently unmet medical problems. It is a multi-targeting compound that represents a new class of drugs.

As a dietary supplement we can do patient assessments with a willing physician and we created our own investigator's brochure to do so. Our situation is unusual for these days, but is in fact how drugs were developed at one time when natural products were THE source for medicants.

By going this route we discovered and confirmed we have a drug candidate. It has taken us a lot of years and money we didn't have to do so and we have now managed to create even more of a financial problem for ourselves even as we see life changing results. We cannot promote these observations because they are too preliminary and need more systematic workups. But the news spreads by word of mouth and that is worrisome - selling hope to people at their wits end is not a happy prospect.

We then become faced with a dilemma - do we continue with systematic open label studies in hospital settings and let the findings be published or do we file an IND, or series of IND's and take these to IIA?

Some in the dietary supplement industry will file IND's to point to as a marketing claim of efficacy - with no intention of following through. Obviously as soon as we (or they) go to IIA, the product leaves the market.

Now, what happens to the consumer, looking far down the road when the supplement becomes a drug and goes for $1000 a bottle instead of $100? Is that progress?

And who is going to weather the intellectual property assaults from predatory marketers (both from pharma and supplement companies) if it is kept as a supplement with all the ballyhoo of its 'miracle' curing abilities - that are actually true? What could be worse than having something that really works!? Who wants to spend every nickel and hour in court battles even if the property is clearly ours. The president of a major consumer products company told me that he can afford to hammer us in court till we cry uncle and he would do so without hesitation. The cocktail with that crocodile had the warming effect of a noose.

You see, the business model of the supplement industry attracts the locusts because there is no upside to taking the high road. There is no upside to conducting formal studies that address real disease, nor in discovery. There is only an upside in creating enthusiasm and hope. Many of the locusts believe their own bullshit fervently. Not a lot different than a pharma team that has invested millions in targeting a function and then egos and bias get twisted out of shape keeping it going even as evidence is clearly dropping away and it blows up in Phase III somewhere.

Well, we will see. At this point the right thing to do is to prove these cures up or not one way or the other somehow. I don't hold much hope that we will profit from these findings, not in the land of locusts surrounded by a sea of sharks and crocodiles. I think intellectual property is the bane of drug development right now and this is not the only industry - software has the same problems and many others. Great for discovery, hell for development. The 5 years the FDA provides for marketing exclusivity maybe needs to be extended and this idea implemented worldwide by some international treaty.

We find ourselves vacillating between greed and altruism and neither is very promising. I am not looking forward to the meetings with the cigar smoking short arm fatties who want the whole pot.

If we had the dough I'd put a "now hiring" sign out and bring in the exceptional talent out there that has been sidelined by drug companies that became finance gamers - the graybeards and the young turks, the ones with sars visions and the ones that can make a clinical program hum, what a hell of ride that would be, all this new chemistry and so many open doors-start right from scratch and fight like dogs to get it done. You know, the other day I ran into this guy from Cartagena….

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55. eyesoars on November 7, 2013 12:03 AM writes...

Dunno if there were any deaths attributed to it, but there were tryptophan supplements a while back that made many people seriously ill and crippled them permanently.

The manufacturer was using GMO bacteria to make the tryptophan, and selecting cultures on the basis of output; apparently the culture concentrations got high enough that the bacteria started creating other products from the tryptophan (perhaps di-tryptophan). Anyhow, a lot of people wound up with permanent neurological damage. The company is now gone, sued out of existence. It was a shell for a Japanese company, but the lawyers managed to pierce the veil and get a settlement from the parent company as well.

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56. Lu on November 7, 2013 12:15 AM writes...

20. Curious Wavefunction on November 4, 2013 7:52 PM writes...

Has anyone actually looked at deaths from herbal supplements? That would be a helpful benchmark.


Can't say about deaths, but recently there was a bunch of cases of hepatitis and liver failure among people who took a bodybuilding supplement. At least 29 people got hurt:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6240a1.htm?s_cid=mm6240a1_e

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57. Anonymous on November 9, 2013 1:08 AM writes...

@27. Yeah nutrition is handled pretty badly around the world, especially the USA. The problem comes from the fact that everyone thinks they know something about it, where most people really don't.

It doesn't help that misinformation is so predominant. BS like atkins and paleo diet are all over the place. All of them are bogus because they care too much about what specifically gets eaten, rather than how much. Atkins fails because sure too many carbohydrates will cause obesity, but so will too many fats.

The fact of the matter is, it's in a sense a lot simpler than this stuff makes it out to be: to a first order approximation, your diet is essentially fine if you have appropriate caloric intake and get enough of all your micronutrients.

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58. Anthony on November 11, 2013 5:05 PM writes...

Homeopathic cure that works: http://drboli.files.wordpress.com/2008/01/thirst.png

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59. SK on November 14, 2013 4:06 AM writes...

54 highlights an important issue for the supplement industry - namely,it is practically impossible to enforce a monopoly price over a supplement because patients can access the supplement via multiple sources. For example, if your method of use/new formulation/delivery system patent can't prevent other companies from supplying curcumin pills to the market, why would you spend millions on clinical trials to prove efficacy for treatment/prevention of cancer? We can't just rely on patents/exclusivity rights if they don't work as property rights. Government or charities need to up their game in this area.

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