Mar 04 2009

Tom Harkin Tips His Hand

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Comments: 27

My primary blog post today (as every Wednesday) is over at Science-Based Medicine. But I wanted to reinforce a very important point we have been discussing over there regarding Senator Tom Harkin.

Harkin, along with Orrin Hatch, was the force behind DSHEA – the Dietary Supplement Health and Education Act of 1994 that removed herbs and supplements, essentially, out from under FDA regulation. This resulted in the explosion of the supplement industry, happily jumping through this giant loop hole manufactured for them.

DSHEA is bad law and has significantly weakened health protection for Americans. Harkin is clearly a true-believer when it comes to supplements and cultish medical practices. However, the top contributor to his campaign in 2007-2008 was from employees of Herbalife, a multi-level marketing company selling supplements and herbs with dubious health claims. Hatch’s home state is Utah, which is considered to be the epicenter of the supplement industry.

Recently Harkin hosted a senate hearing and invited some of the luminaries of the CAM movement to speak. The clear purpose of this hearing was to push a specific agenda – to hijack Obama’s healthcare reform initiative to further infiltrate pseudoscience and sectarian medical beliefs into the healthcare system. David Gorksi and Peter Lipson both discuss this issue at SBM.

But here is the money-quote from Harkin.

One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving.

How transparent. He clearly states that in his opinion the purpose of the National Center of Complementary and Alternative Medicine (NCCAM), like DSHEA forced down the throats of congress and the scientific community, was not to scientifically investigate whether CAM modalities work, but rather to validate CAM.  He is disappointed that the science has not worked out the way he intended.

His attitude, which he is not even savvy enough to realize is blatantly unscientific, is typical in the CAM world. The purpose of science is to validate and promote what they already know works – it is not to discover whether or not a modality works.

He further demonstrates his ignorance of science by complaining that the studies were designed to disprove, rather than prove, CAM modalities. That, of course, is the purpose of experiments in science – to prove a hypothesis wrong. Only when an idea survives multiple attempts at proving it wrong do we tentatively conclude that is may be correct. He is upset that the few good clinical trials that were done through NCCAM had the potential to falisfy his beliefs, because in the end they did.

His solution – promote CAM modalities anyway. Who cares what nasty science says. And, change the rules of science so that they can only validate his ideology, not refute it.

That is the new-world order that Harkin and his CAM heroes want to bring – medical science subjugated to ideology.  We had eight years of science taking a back seat to ideology under Bush. I think it is premature to conclude that those days are over – there is just a new set of ideologies in town, not necessarily a new respect for science. To be fair I think overall the situation will improve under Obama (even if just from regression to the mean following Bush), but there are still pockets where ideology trumps science, and CAM is one such pocket.

Harkin’s transparent agenda needs to be exposed. He gave us a peak at the man behind the curtain, we should not let him try to quietly close the curtain again.

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27 responses so far

27 Responses to “Tom Harkin Tips His Hand”

  1. HHCon 04 Mar 2009 at 11:39 am

    It looks like the rest of the U.S. is struggling with Utah’s economic development plan (supplement industry promotion).

  2. Enzoon 04 Mar 2009 at 1:09 pm

    What a shame that thousands of potentially helpful drugs, many of which are for diseases that have no standard effective treatment, are kept off the market because of narrow failure to meet FDA significance standards while the supplement industry can claim anything they like so long as they word their advertisements carefully.

    Clever marketing campaigns seed the public opinion and spread rumors of false efficacy like wild fire. It’s an insult to see Enzyte male enhancement commercials with slogans such as “It’s not a gimmick. It’s real science!” Many of these supplements are simply inert, but as Dr. Novella has mentioned several times, the neglect of real treatment that they can trigger can cause real, documented harm.

    The FDA or some sub-agency thereof really needs to be given the power of regulation. Or at least be allowed to select warning labels such as those found on tobacco products.

    By the way…Has anyone noticed the “laboratory” shown in Enzyte commercials seems to resemble that room where Vader and Luke fought in Cloud City?

  3. tmac57on 04 Mar 2009 at 1:31 pm

    Enzo:”What a shame that thousands of potentially helpful drugs, many of which are for diseases that have no standard effective treatment, are kept off the market because of narrow failure to meet FDA significance standards” If I’m not mistaken, that is the same kind of view of the FDA that helped pass the DSHEA in the 1st place. I hate to admit it, but back in 1994 I found myself in favor of the act because of such arguments by the proponents. I was never a big user of supplements other than viatimins at times, but I was duped into thinking that FDA was totally incompetent to regulate these ‘benign’ substances.
    Maybe you are right that the FDA’s standards are too rigid , but I wouldn’t want standards that are too lax either. Fine line perhaps?

  4. Snafuon 04 Mar 2009 at 2:32 pm

    Interesting Article. I gringe every time I walk through the mall and see folks walking out of GNC with things like “Black Powder”, and “Nitro o2 Explode!” . What exactly are they putting in their body? Sounds like Harkin doesn’t exactly care, either.
    On a side note, how did science “take a back seat to ideology”, anyway? Didn’t Bush increase funding to the National Science foundation, and National Institute of Health? Here is a link -> http://www.aaas.org/spp/rd/nsf02s.htm
    Am I missing the point?

  5. son 04 Mar 2009 at 3:25 pm

    Quite frankly it is hardly a disaster that some potentially beneficial substances are available, like vitamin D, B12 etc etc, without needing to get a prescription.

    A simple certification of cleanliness of the production process and substance purity and concentration should be all that is needed to weed out sham preparations. Question is what to do with distilled water, oops sorry I mean homeopatic preparations ;-) .

    As for FDA regulations they may be too strict, but multibillion dollar medical companies do also not produce/research substances they deem to generate low earnings. So…

  6. Watcheron 04 Mar 2009 at 5:05 pm

    As for FDA regulations they may be too strict, but multibillion dollar medical companies do also not produce/research substances they deem to generate low earnings. So…

    Such is their right, for better or worse. Welcome to capitalism and freedom my friend. :)

    Also, I think the point of this is that by allowing this loophole, some good things get through, but a bunch of crap is generated in the process. That crap is more harmful than the benefits of the rest.

  7. TheBlackCaton 04 Mar 2009 at 5:59 pm

    Quite frankly it is hardly a disaster that some potentially beneficial substances are available, like vitamin D, B12 etc etc, without needing to get a prescription.

    No, it isn’t. But making vitamins available without a prescription is not the problem here. There are two problems. One is that anyone can make practically any claim they want when selling vitamins when those claims are backed by absolutely nothing, even going so far as to recommend dangerous levels of vitamins. Second, people are able to herbal remedies, which could potentially be (and have been in the past) extremely powerful and dangerous drugs with terrible, sometimes lethal side-effects with absolutely no oversight, no testing of safety, no testing of purity, no testing of effectiveness, and no testing of dosage.

    A simple certification of cleanliness of the production process and substance purity and concentration should be all that is needed to weed out sham preparations.

    Tell that to the families of the people who died from ephedra, which the herbal supplements industry went to court twice to prevent the FDA from banning once it became clear it was killing people. They succeeded in stopping the FDA the first time, which meant that the FDA had to wait for the body count to go up higher before they could try again. And the herbal supplement industry still resisted. Tell that to all the people who are being bilked out of money by taking the most popular herbal supplement, echinecia, which has been shown time and again to be totally and completely worthless yet the herbal supplement industry continues to market as effective.

  8. Karl Withakayon 04 Mar 2009 at 6:45 pm

    I’ve said this on several other sites, but it bears repeating:

    Harkin’s statement: “One of the purposes of this center was to investigate and validate alternative approaches.”

    My reply: “One of the purposes of the courts system is to try and find guilty people charged with crimes.”

    Does everyone see the problem both these statements have in common?

  9. Enzoon 04 Mar 2009 at 7:36 pm

    tmac57:

    You slightly misunderstood my comment, though, I admit I was a little unclear.

    I am in favor of a strong FDA. This is really to the benefit of public safety and the pharmaceutical business as well. I sometimes believe that the criteria are too rigid, however, in that drugs that miss a statistical p value by a very narrow margin are still marked for death…Even if there is no alternative treatment available. In this case, I favor more of a sliding scale that adds weight to the availability or efficacy/cost of current treatment. Either way, I suppose the line has to be drawn somewhere and there will always be a number of close calls.

    This argument should not be used in defense of supplements, however. Keep in mind that drugs that make it to stage III clinical trials and ultimately fail (1 in 10 fail in Stage III I think) have already shown some measure of efficacy. Herbs and supplements, however, do not require any kind of scientific data to be marketed directly to consumers — there is no vast database of knowledge upon which to make a decision when facing a narrow margin of approval.

    I don’t think everything needs extensive testing before it is allowed to be marketed, but the FDA should be allowed to collect and verify data and make decision based on evidence that becomes available.

  10. Watcheron 04 Mar 2009 at 8:29 pm

    One thing I will say in regard to this also. The FDA is severely underfunded and undermanned. It’s one of the reasons we’ve had so many bacterial pathogens sent out in food, or melamine found in various other foods. I remember hearing on NPR a month back that there’s something like .01% of all imports are inspected by an FDA agent and sometimes domestic facilities of food processing dont see an investigator for 3 years at a time … Sad.

  11. daijiyobuon 05 Mar 2009 at 1:32 am

    Dr. S. wrote:

    “Harkin and his CAM heroes.”

    May I offer…

    campatriots?

    I’ve derived that from CAM and compatriots, obviously.

    Even bolder:

    sCAMpatriots.

    -r.c.

  12. sonicon 05 Mar 2009 at 7:00 am

    I think this is we have a strawman here.

    “One of the purposes of this center was to investigate and validate alternative approaches.”

    That is to say Mr. Harkin hoped that they would discover alternative approaches that worked. He is disappointed that they have not been more successful.
    We would not want him to say, “I am pleased at the failure of the center and that disease and illness continue to run rampant in our country,” the logical alternative to what he did say.

    He was hoping that people would experience more wellness for less cost when he started the center. He is admitting it hasn’t worked as well as he would have liked. He is still hopeful for the future.
    Perhaps he is misguided, but it is also true that we spend a great deal more than any other nation on ‘scientific’ medicine and have relatively lousy outcomes. That is a fact he has to deal with when it comes time to try to ‘fix’ the system.

    The system is way too expensive and gets poor results. That’s the fact.
    What to do about it is what we don’t know yet.

  13. HHCon 05 Mar 2009 at 10:30 am

    Watcher, Information sources from China say that the managers of the Chinese factory that intentionally put the toxic substances in their products were put to death by Chinese courts. They take seriously damage to U.S. – China trade relations.

  14. weingon 05 Mar 2009 at 10:32 am

    Sonic,
    That’s like the judge telling a defendant that they’ll give him a fair trial and then hang him. Doesn’t matter if he’s innocent or not, the trial will show he is guilty before they hang him.

    Other nations spend less money on the same ‘scientific’ medicine and have better outcomes than we do. Maybe something else is at play?

  15. Karl Withakayon 05 Mar 2009 at 11:59 am

    Sonic, I don’t think there’s any straw man here, other than perhaps the one you put up.
    .
    I think you are actually putting words into Harkin’s mouth, giving him credit for something he wasn’t saying (that the NCCAM had failed to find any CAM modaility that was shown to be effective, and that was the source of his dissappointment). I think it’s pretty safe to read his words exactly as spoken.

    Reading his quote, I don’t get the impression that he is lamenting the failure of various CAM modalities to stand up to scientific scrutiny, he is lamenting the failure of the NCCAM to validate those modalities which he already believes work.

  16. tmac57on 05 Mar 2009 at 12:09 pm

    Enzo, re your last post. It looks like we are in agreement. I agree it is a shame if a potentially good drug is culled out unnecessarily, due to too rigid of a standard. As a lay person I have to defer to what I hope is a sensible system that has our best interests in mind. It is hard to determine that from my perspective though. That’s why I read this and other skeptical blogs regarding science issues to help me understand them from a perspective that I might otherwise miss.

  17. Fifion 05 Mar 2009 at 2:58 pm

    “They take seriously damage to U.S. – China trade relations.”

    I think that has more to do with taking public image and state control seriously. It was also a huge internal scandal in China, since the milk was mainly being sold in China and the government didn’t pull it off shelves for a while even after it knew. (Iit did make it’s way into a few Asian products for export that were unlikely to be eaten by Americans since they were exported to other Asian countries and to Australia.) Add in the ongoing scandals about lead paint and so on and China needed to make a public display to impress everyone but particularly their own people.

  18. son 05 Mar 2009 at 3:23 pm

    “Tell that to all the people who are being bilked out of money by taking the most popular herbal supplement, echinecia, which has been shown time and again to be totally and completely worthless…”

    Well this is capitalism at its fullest too. People are equally free to buy crap peddled by charlatans as well as substances sold by medical multi-billion dollar companies. I am well aware that I sound extremely crass and insensitive with my next statement: but death occurs both due to “supplements” as well as FDA approved substances.

    That is a sad fact.

  19. Steven Novellaon 05 Mar 2009 at 3:46 pm

    Sonic,

    You need to read the rest of the transcript, or at least the two blog posts I linked to at SBM.

    Harkin said that he feels the problem is the NCCAM focuses too much on falsifying rather than approving. He is clearly blaming the process – not just lamenting that CAM doesn’t work. Also, he is holding a hearing the specified purpose of which is to integrate CAM more into mainstream medicine. Why would he want to integrate something that he is disappointed doesn’t work?

    There is really little doubt as to what he is saying when it is all taken together in context.

    The cost/outcome of medicine in America is a complex problem, and it is not clear at all that how much of the differences between the US and Europe are due to health care delivery. We have different populations, different problems with poverty, obesity, and other risk factors. Americans work harder than Europeans – that comes with added stress.

    Also, Americans pay for much more “optional” medicine that does not affect life expectancy but may affect quality of life – like expensive treatments for migraine headaches.

    Yes, there are plenty of systemic problems, mainly with access and efficiency. Health delivery problems does not imply a problem with the science of medicine, however. Harkin is trying to fix something that is not the problem, and in fact he is trying to take the one thing that works and break it.

  20. HHCon 05 Mar 2009 at 4:22 pm

    FiFi, Some U.S. pet owners were scared and upset over the contaminated products that the U.S. received from China. I was worried about my grand champion British shorthair. I was particularly concerned about the polyps which she grew quickly.
    I have watched how bacteria and food contaminants impact pedigree cat growth for decades. I have had a few “designer cats” including the ones genetically engineered at Harvard, the Himilayan. Animal sensitivities to substances assist us to understand human immunities.

  21. Spin-gnosiaon 05 Mar 2009 at 6:54 pm

    Excellent post… and as a physician, I could not agree more.

    Two “editorial” points:
    1. The similarities between the CAM advocates and the right-wing, fundamentalists is… well… striking.
    2. Efforts to save ignorant Americans from themselves are always doomed to failure.

    Just like the infomercials that hawk every possible “amazing” item for $19.95… the televangelist charlatans hawking “miracles”… the bogus claims of fad diets & goofy exercise machines… those in the CAM industry, like relatively mainstream chiropractitioners, will always have a hopeful herd of lemmings to keep the “cha-ching” ringing.

    Harkin is merely engaging in what just about every politician does: pandering to a “interest group”.

  22. DevilsAdvocateon 05 Mar 2009 at 8:49 pm

    I would state it in stronger language – Harkin is doing what he is paid to do, and I don’t mean his senatorial salary.

  23. HHCon 06 Mar 2009 at 5:58 pm

    FiFi, FDA recalls of Taiwanese instant coffee and milk tea products were real in the U.S. marketplace. The FDA issued warnings regarding consumption of melamine contaminated products. King Car Food Industrial company was to first to recall its products. The U.S. imports products from China to Asian American markets There was concern about the import of Chinese infant formulas.

    Melamine testing was unreliable by Chinese testing standards. Independent world testing facilities have reviewed these products. Australia and the U.S. standards require thresholds below 2.5(ppm) parts per million. It is considered safe for adults to eat products with less than 2.5(ppm) melamine. Melamine, a synthetic industrial chemical can stay in the human body at most several days and then is excreted. The dangers for premature infants are not sufficiently known in the U.S. The hazards to yound children are known.

    State officials in Connecticut recalled candies which were tested for melamine and found positive. California recalled Blue Cat Flavor Drinks because of the results of melamine testing. U.S. consumers were cautioned regarding consumption of any form of milk or protein, biscuits, cake mixes, high-protein energy bars, chocolate coated treats and sweets.

  24. HHCon 06 Mar 2009 at 6:02 pm

    Should read: The hazards to young children are known.

  25. sonicon 09 Mar 2009 at 6:05 am

    Replace the words “fetal stem cells” for ‘aternative’.
    10 years from now if the record is as it is now (no success), I can imagine someone lamating how they had hoped the ‘stem cells’ would lead to useful therapies.
    Let’s hope the researchers are not spending all their time disproving that stem cells work (I’ll bet you could spend many years showing all the ways stem cells won’t help) and are spending their time seeking out and approving.
    (Oh, stem cells are ‘alternative’ aren’t they?)

  26. weingon 09 Mar 2009 at 9:12 am

    I didn’t know embryonic stem cell research was being pushed by Harkin. I think Obama is going to lift restrictions on this research today. I wouldn’t call it alternative as they are not being used to treat diseases as yet. It is considered research. The alternative SCAM is being used currently and all genuine research shows it doesn’t work.

  27. NeuroLogica Blog » Obama on Scienceon 10 Mar 2009 at 8:00 am

    [...] I discussed last week, Harkin’s agenda is about as unscientific and ideologically driven as you can [...]

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