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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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In the Pipeline

« Not Looking So Good At Eli Lilly (or AstraZeneca) | Main | The NIH and Conflicts of Interest »

June 21, 2011

Senator Hatch And His Wonderful Industry

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Posted by Derek

Now, I try to help discover drugs for a living. And boy, do we not discover all that many of them. But you'd get a different impression if you listen to the radio here in the US. So many drugs! So many wonderful things that they can do! Improve your memory, boost your immune system, clean your liver, give you energy, grow hair on your head and flush those toxins out of you like a firehose.

Ah, but these aren't drugs, of course. They are nutritional supplements, silly people, and they are "not intended to treat, cure, or modify any disease". But they say that part low and fast, while the exciting parts are enunciated clearly, con brio, and at least three times. Drugs are foreign chemicals that you put in your body to make it do things, while nutritional supplements, why they're these all-natural. . .things. . .made out of, made out of. . .stuff. . .that you put in your body to make it do things. Anyway, they're different.

And here's the man who says so: Orrin Hatch, to whom (along with Henry Waxman) we owe the Hatch-Waxman legislation that made the supplement industry flourish like the green bay tree. $25 billion a year isn't bad, especially when you consider that the expenses of the supplement companies are just a tiny bit lower than those of the drug companies. Not having to do any preclinical research at all helps, of course, and not having to run any clinical trials at all (nothing for efficacy, nothing for safety) helps, and not having to be reviewed by the FDA helps, too. And then on the other side of the ledger, being able to say any damn thing that comes into your head helps the most of all.

And as you'll see from that article, not only has Senator Hatch himself benefited greatly from his nutritional ties, but so has his family, immediate and extended. And his friends, and his former business partners - pretty much everyone within range, it seems. Each sides regards the other as the gift that keeps on giving. And why shouldn't they?

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


COMMENTS

1. Robert Bruce Thompson on June 21, 2011 12:29 PM writes...

So, to ask the obvious question, why is your company or any other pharma company doing all these expensive clinical trials. In a $25 billion market, I'd think you could make more money by selling your products as nutritional supplements.

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2. Chemjobber on June 21, 2011 12:33 PM writes...

You really wonder how Waxman feels about this.

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3. Hap on June 21, 2011 12:35 PM writes...

Hey! There are limits on what they can say - after all, they have that little FDA warning in every commercial. Just because everything else they say during the commercial (and sometimes even the name of the product) contradicts the FDA disclaimer doesn't mean anything at all.

I guess Hatch-Waxman is like the command to "let a thousand flowers bloom" in the supplement business - even if some of them are digitalis or hemlock.

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4. johnnyboy on June 21, 2011 12:51 PM writes...

You seem a bit agitated, Derek. Here, have some passiflora aromatherapy.

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5. LeeH on June 21, 2011 12:51 PM writes...

C'mon Derek. You mean you don't support the free market, unfettered by regulation? Or are you arguing for the removal of regulation of pharma? You're starting to sound like one of those damn socialists. Next thing you know you'll be advocating that the military be taken over by the government.

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6. barry on June 21, 2011 12:52 PM writes...

it's going to be very very hard to put this genie back into the bottle. When nutraceuticals were carved out from the FDA's purview in '94 (what is it that you ingest that's neither Food nor Drug?) a monster was born with lobbying power commensurate to that $25billion/annum revenue.

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7. pete on June 21, 2011 12:59 PM writes...

Could it be that this mangosteen stuff is really what we drug hunters should have been seeking all along ? That is, a pleasant tasting, orally-available, double strength placebo.

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8. Frank Adrian on June 21, 2011 1:02 PM writes...

He's also a big supporter of the RIAA, given that he has recorded a few songs. But at least he's honest - he stays bought.

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9. PharmaHeretic on June 21, 2011 1:14 PM writes...

Derek,

Look at the bright side. You might make a better and more secure living selling snake oil than developing drugs.

Many fired and about-to-be-fired pharma people should seriously consider a second career in selling snake oil remedies. It is not as if the world cares about your objectivity or rationality.

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10. Myma on June 21, 2011 2:20 PM writes...

Aw, c'mon and be reasonable. What else would they put in those middle three aisles at Whole Foods, more soap? Lord knows I can't buy plain old calcium carbonate antacid there without herbal ginger licorice extracts in it.

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11. luysii on June 21, 2011 2:43 PM writes...

#10: Ah Whole Foods ! Shopping as a moral act. Around here it is full of the highly educated and relatively affluent, who buy the middle 3 aisles as avidly as the benighted lower classes buy fast food. P. T. Barnum, where are you now that we need you?

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12. Felix on June 21, 2011 2:47 PM writes...

Setting the rules to suit your own interests?

Orrin Hatch = Orren Boyle?

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13. patentgeek on June 21, 2011 2:48 PM writes...

The Dietary Supplement Health & Education Act of 1994 is what led to the sitauation being discussed presently. That Act is distinct from, and unrelated to, the 1984 "Hatch-Waxman Act" which established the basis for Abbreviated NDA (ANDA) filings and 505(b)(2) filings before FDA, which are the basis of the generic drug industry.

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14. Fries With That? on June 21, 2011 2:51 PM writes...

People in power feather their own nests, it's just that they used to be more ashamed of it in the past. Now it's a badge of honor to be opportunistic and to take advantage.

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15. MoMo on June 21, 2011 3:05 PM writes...

You all are too hard on natural products because they threaten your existence and livelihoods and you don't need Pharma or the FDA to get them. You feel negated, exposing feelings of vulnerability and anxiety.

But if this depresses you and you reach for your Pharma drugs there is hope on the horizon. Simple music therapy has the same pharmacological outcome in depression as anything Pharma could spend billions developing.

So put on some Lawrence Welk and fire up the bubble machine and give your neurons a break from their drug-induced stupor.

Their effect is the same and much cheaper.

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16. barry on June 21, 2011 4:17 PM writes...

maybe a Pharmaceutical industry that has cut off its own Research in favor of ever more Marketing and Merging no longer has a legitimate gripe when the nutriceuticals claim a few billions a year.

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17. Sili on June 21, 2011 4:54 PM writes...

As pointed out by Goldacre, most of these supplements ain't made by mom'n'pop businesses. As I understand it, Bayer makes lossa vitamins for instance.

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18. McChemist on June 21, 2011 6:05 PM writes...

There was a nice defense of alternative medicine in The Economist a few weeks back:

http://www.economist.com/node/18710090

To sum up, the pharma industry spends a heck of a lot of cash trying to beat the placebo effect, when sometimes all you need is the placebo effect itself to make people better. Alternative medicine is here to stay, and this isn't really a bad thing.

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19. Space Jam on June 21, 2011 6:46 PM writes...

Weekly to fortnightly massage therapy and relaxation is the key. It'll cure cancer, no really I'm not lying.

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20. Bbooooooya on June 21, 2011 7:34 PM writes...

25 bill/yr, m'eh.

Lipitor does (for now) half that.

Margins not that great, and no protective moat.

I do like the irony of herbal life ( formed makers of ephedrine) sponsoring jersey inthe AMGEN tour of Cali bike race....

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21. Jsoh on June 21, 2011 8:22 PM writes...

Think of it as pharmaceutical Darwinism. If imbeciles want to piss their money/lives away on this stuff, there will be less traffic on the Long Island Expressway. Nonetheless, Hatch is pond scum.

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22. Anonymous BMS Researcher on June 21, 2011 8:54 PM writes...

Tobacco, pot, various deadly mushrooms, etc., are all natural products that I for one would not want to eat. Homeopathic medicines at least ought to be pretty safe since they contain few if any molecules of the "active ingredient."

But perhaps the loopiest notion of all is the notion of "detox." Millions of years of evolution have given us some very effective toxin-destroyers (at many Discovery Working Group Meetings a major topic of discussion has been how can we make our molecules survive these toxin-destroyers a little longer).

Then there's the whole "stiumulate the immune system" thing. Tegenero found a molecule capable of doing that really well and put some people into the intensive care unit. Sometimes you want a stronger immune response, sometimes you don't!

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23. Biff on June 21, 2011 9:13 PM writes...

Somehow, above average investment returns are pretty common in Congress. A recent study indicated that members of the House of Representatives outperform the stock market by an average of 6%, while Senators beat it by 12%. Not that the SEC considers trading on inside knowledge by politicians to be "insider trading", or anything disreputable, of course. For example, see the recent articles at http://www.cnbc.com/id/43183551 and http://www.cnbc.com/id/43471561

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24. WB on June 21, 2011 9:41 PM writes...

I'd love to cash in on the whole alternative medicine racket. Sadly, I've got morals and that prevents me from doing such things. Oh well, back to the bench and hoping I do find a real cure for a real disease....

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25. JM on June 21, 2011 11:34 PM writes...

Isn't Hatch-Waxman dealing with generic drugs, not with supplements? There's a Hatch-Harkin deal about supplements, but from everything I can find, this is largely Orrin Hatch's baby.

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26. Gerald Smith on June 22, 2011 2:08 AM writes...

Hmmmmmmm...... Let me see... I spent years at one time learning to identify plants in the wild and preparing medicines from it. So I do have some perspective on the whole thing. I ma a doctor's son and grew up with the PDR as my bedside reading.
My problem is that herbal medicines probably account for about half a dozen deaths a year wheras the death toll from pharamceuticals exceeds a hundred thousand. I love pharamaceuticals, but I owe my life to drugs that were developed from natural sources. I have been cured of Acute Promyelocytic Leukemia after almost dying of it. The main effective drugs are several members of the adriamycin family, a natural metabolite of Vitamin A all trans retinoic acid, and arsenic trioxide, the classic medieval poison. No synthetic drug has any real effect on this disease and you are dead in three weeks if you try. With the above three used early on, if you survive the first month then the long term cure rate is something like 95%. It used to be 0% I think big pharm still underestimates the potential of natural derived drugs. The big problem is that an awful lot of what people go to the doctor is not some major disease, but old age chronic stuff or they just plain feel lousy. Synthetic pharamceuticals are often far too powerful for so so garden variety complaints and cause way too many dire and too often lethal treatment compl;ications. If I were a doctor dealing with mild anxiety I would much rather prescribe kava as a crude botanical extract (no liver toxicity unlike highly purified extracts in Europe) than a benzodiazepine with its serious long term risk of profound mental derangement especially in the elderly. Studies of South Sea Islanders, many who have consumed kava their whole lives and had taken more than a hundred thousand doses failed to find any harmful effects at all; this in a plant drug that has no known lethal dose and no risk of addiction! Even the suspicious European extracts that caused such a furor had a risk of hepatotoxicity 1/50th that of a typical benzodiazipine. The natural plant drug has no detectable risk at all. Ah! But which is going to make big profits for the drug companies?
You guys seriously underestimate the potential value of this stuff for treating less than serious compaints without toxicity. And lots of it really works too! I used a herbal extract based on mytragina speciosa (kratom)to treat the pain of fybromyalgia and it was comparable in effectiveness to the synthetic drug tramadol (in my opinion a really fine drug). I still sometimes use it for its euphoric effect when I am feeling really down. There are a lot of bullshit drugs in the natural medicine market and to find the real stuff you need to know what you are deoing. But i suspect there are a lot of bullshit drugs in the pharmaceutical market too and they seem to kill a lot of people.....

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27. machira on June 22, 2011 4:11 AM writes...

“He who does not know food, how can he understand the diseases of men?” – Hippocrates (460–357 B.C.)

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28. Cartesian on June 22, 2011 4:21 AM writes...

I hope that Senator Hatch is listening to Werner Heisenberg (in "Physics and Beyond" by W. Heisenberg) :

"I thought sure enough that it had to be recalled all the time to those which will assume in our place the responsibility of the functioning of the State that, in order to govern, it was not enough to assure an equilibrium between some opposite interests ; and that there were frequently some unavoidable necessities, based on the structure of the modern world, in front of which any irrational attitude of evasion toward some sentimental and unrealistic considerations could only lead to some catastrophes.”

Anyway it seems that some French politicians are abusing and can be dangerous for science.

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29. patentgeek on June 22, 2011 6:27 AM writes...

JM @ 24:

You are correct; see my post #13. Hatch-Waxman has nothing to do with "nutriceuticals".

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30. Virgil on June 22, 2011 8:46 AM writes...

@26 Gerald Smith...

Where to even begin? Well for starters there's your nefarious claim that "herbal medicines probably account for about half a dozen deaths a year". Care to back that up with data? Of course, what you should include in the stats are the people who die not from taking a herbal medicine itself, but the ones who die because they take herbal instead of a regular drug which could have let them live. Self medication results in under- and late-diagnosis of important and really nasty diseases which are perfectly treatable by regular modern drugs.

Of course, the other thing you fail to mention is that when a drug kills someone, there's a mechanism and a regulatory body to deal with it. There's a "target" to bring a suit against. When a herbal medicine or plant causes illness, what are you gonna do? Sue nature? Just because law-suits against big pharma are more heavily documented in the media, doesn't mean herbal meds are without problems. Ever heard of Matrixx (the makers of zicam, that lovely homeopathic med which resulted in loss of smell for thousands of users)?

Then there's your silly notion that pure pharmaceuticals are somehow "too strong" and the raw plants are better. Let me counter with a lovely example... would you rather have the pain-relief and diet effects of a custom-designed cannabinoid receptor agonist that has few side effects, or would you rather smoke medical marijuana and get 1000 other by-products along the way, plus a side dose of lung cancer if you mix it in with tobacco as many users do?

Would you rather have an aspirin pill, with a metered dose of a known active constituent, or go round the back of some Mom&Pop store, have them boil up a batch of willow bark, not knowing when it was harvested, or even if it is real willow, and then maybe it works, maybe it doesn't depending on how long they boiled it for? If it kills you, who is your family going to sue for recompense?

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31. Virgil on June 22, 2011 8:48 AM writes...

@26 Gerald Smith...

Where to even begin? Well for starters there's your nefarious claim that "herbal medicines probably account for about half a dozen deaths a year". Care to back that up with data? Of course, what you should include in the stats are the people who die not from taking a herbal medicine itself, but the ones who die because they take herbal instead of a regular drug which could have let them live. Self medication results in under- and late-diagnosis of important and really nasty diseases which are perfectly treatable by regular modern drugs.

Of course, the other thing you fail to mention is that when a drug kills someone, there's a mechanism and a regulatory body to deal with it. There's a "target" to bring a suit against. When a herbal medicine or plant causes illness, what are you gonna do? Sue nature? Just because law-suits against big pharma are more heavily documented in the media, doesn't mean herbal meds are without problems. Ever heard of Matrixx (the makers of zicam, that lovely homeopathic med which resulted in loss of smell for thousands of users)?

Then there's your silly notion that pure pharmaceuticals are somehow "too strong" and the raw plants are better. Let me counter with a lovely example... would you rather have the pain-relief and diet effects of a custom-designed cannabinoid receptor agonist that has few side effects, or would you rather smoke medical marijuana and get 1000 other by-products along the way, plus a side dose of lung cancer if you mix it in with tobacco as many users do?

Would you rather have an aspirin pill, with a metered dose of a known active constituent, or go round the back of some Mom&Pop store, have them boil up a batch of willow bark, not knowing when it was harvested, or even if it is real willow, and then maybe it works, maybe it doesn't depending on how long they boiled it for? If it kills you, who is your family going to sue for recompense?

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