Terra Sigillata

Conservative author David Frum: “Repeal DSHEA”

Posted by Abel Pharmboy on November 25, 2009
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By most metrics, those of us at Terra Sig World Headquarters are liberals. Nevertheless, we often enjoy reading conservative writer, attorney, and American Enterprise Institute fellow, David Frum. Perhaps I have a soft spot for him because he’s Canadian and he also writes for my favorite print newsmagazine, The Week.

Well, Frum chose this week to write, “Herbal remedies need real scrutiny,” at his FrumForum and the post was subsequently published as a special commentary at CNN.com. The latter version has accumulated about ten times as many comments. The thesis of his essay is that the differential regulation of drugs and dietary supplements is flawed and ends with this paragraph:

Improving and rationalizing this costly and dysfunctional system is a gigantic, maybe impossible, task. But one small reform could strike a meaningful blow for reason and cost-effectiveness: Apply the rules governing the advertising of aspirin to the advertising of oregano tablets. Repeal the DSHEA law and give the Food and Drug Administration full authority over every manufactured substance that purports to promote health or relieve illness.

DSHEA is the Dietary Supplement and Health Education Act of 1994 that governs, among other things, the claims that may be made for herbal and non-botanical products not subjected to conventional and rigorous preclinical and clinical studies.

But it gets better.

Frum has clearly read R Barker Bausell’s Snake Oil Science and demonstrates his understanding of the concept of regression to the mean:

Individual choice certainly sounds like the American way. But the fact is that most of us are not well positioned to make intelligent health choices. If we try to play our own doctor, we are going to expose our health — and our money — to risk and exploitation.

As individuals, we have trouble distinguishing between anecdotes: “My neighbor took zinc for her cold and she said it really helped,” and data: Most colds last four days, so you could smoke yak-dung cigarettes on day three and feel better on day four.

But this was my favorite line:

It’s not that science has all the answers. It doesn’t. It’s just that astrologers, shamans, and natural healers have none of them.

Of course, the first commenter at his forum spouts the timeworn retort, “How much are the pharmaceutical companies paying you to write this article?”

Go forth and read – it’s quite a good essay.

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Comments

  1. #1 David Estlund
    November 25, 2009

    A conservative wanting to regulate business? I don’t believe it. Oh, wait. He’s a Canadian conservative, not a USA Republican. How do they grow them so differently up there? What are they feeding them, and how do we get some down here?

  2. #2 Tulse
    November 25, 2009

    Frum may originally be from Canada, but he is thoroughly American now — he worked in the George W. Bush White House as a speechwriter, and is the origin of the phrase “Axis of Evil”. He is a member of the American Enterprise Institute, and was a contributing editor for the National Review. He holds US citizenship.

    We up here definitely do not claim him.

  3. #3 Blogger
    November 25, 2009

    Canadian Conservatives, unlike their dogmatic and religions sated American counterparts, know that free enterprise is not a license to steal or harm or deprive others of their pursuit of happiness, in pursuit of ones own happiness.

  4. #4 Chemgeek
    November 25, 2009

    Wow, I didn’t realize this post was a call to bash conservatives. Abel must pushed a few buttons. Not all of us conservatives (and I’m not sure I’d use that term for myself outside of this current environment but I am definitely right of you guys) are anti-science or anti-government regulation. If you weren’t so busy stereotyping, you might be able to see that.

    I’m glad the liberals have all of the right answers. With a Democrat president and Democrat-controlled congress, I can’t wait for this country to change for the better.

    I would give anything to see the DHSEA repealed and Orrin Hatch and his ilk voted out of office. Frum makes some very good points. None better said than “you could smoke yak-dung cigarettes on day three” to treat a cold.

    But then, I’m Fox-watching, bible-thumping, right-wing nut job*. If you want scientific accuracy you should probably rely on liberal outlets, like the Huffington post. Their chock full of good science there. Especially when it comes to things like vaccines. Thank goodness for the liberals.

    *a bit of hyperbole there.

  5. #5 baryogenesis
    November 26, 2009

    Frum is also the son-in-law of very right-wing ( for either country) editor Peter Worthington, whose Toronto Sun columns bring many seconds of hilarity to my life (when I bother to read them). Frum has revised his opinions and dissociated himself somewhat from the Bush neo-cons, admitting that allying with the Christian right was a mistake (he’s Jewish). But, he might have also done this because he can still maintain a certain Canadian-born perspective of bemusement at the extremities of the American right.
    Even Conrad Black, a notorious Canadian conservative (now in a Fla. prison) wrote a rather positive bio of FDR —so I understand–haven’t read it.

  6. #6 leigh
    November 26, 2009

    how quickly this devolved into left-right squabbling! here we have Abel pointing out a rare point of agreement despite the political philosophical differences, and regardless the bashing continues. this is telling.

  7. #7 David Estlund
    November 26, 2009

    Chemgeek,

    I’m sorry to feed your persecution complex, but I think you have to admit that conservatism in the USA does not reflect the beliefs you profess. The Republican party has a big NeoCon problem, which amounts to extremist religious social conservatism plus a lack of fiscal conservatism. We both can agree that neither is valid. I may be a bleeding-heart liberal, but I recognize that your views are valid, and we can have a discussion based on that.
    We can certainly agree that Democrats are on the FAILtrain right now, although you shouldn’t be as unhappy with that as I am. I like you, and I frequently agree with you, but I resent the ad hom attacks in the end of your post. The Huffington Post can go suck a fuck, as it were. I never intended to bash conservatives as a whole. Your misdirected anger should be redirected toward the Republican party and their 20 pieces of silver.

  8. #8 Abel Pharmboy
    November 26, 2009

    I share Chemgeek’s and leigh’s bewilderment that this has become a conservative-bashing thread. I meant to point out a couple of things, not the least of which that opposing political parties can have common goals – not a very popular stance these days but one that has sustained this nation.

    Be that as it may, I’m also impressed by Frum’s use of language. While he is excoriated for being the originator of Bush’s “Axis of Evil” while a speechwriter (which was actually originally the “axis of hatred”), the story of how Frum came up with this phrase from a careful examination of history is quite interesting.

    Unfortunately, Chemgeek, it has become sport to demonize one another for the extreme positions of each group. It is much more difficult to examine what we each have in common, a gift of the late Senator Edward Kennedy.

    Perhaps you need to create a non-partisan batch of homebrew to get folks to chill.

  9. #9 Jeff
    November 26, 2009

    There are many innacurracies in David Frum’s column:

    1. Dick Durbin is the most anti-supplement member of the US Senate. He had nothing to do with DSHEA. Frum probably meant Tom Harkin.

    2. The FDA has not approved St. John’s wort for any medical purpose, such as depression. Any company which advertises it as a cure for depression is doing so illegally. This does not negate the evidence in favor of St. John’s wort. Even the Mayo Clinic states: “Overall, the scientific evidence supports the effectiveness of St. John’s wort in mild-to-moderate major depression.”

    3. There are thousands of herbal products sold in the U.S.. Frum gives the example of one obscure herb to imply the danger of all herbal products. According to The American Association of Poison Control Centers, in all of 2007 a grand total of 117 adverse event reports were received for all herbal products (botanicals). There were no deaths.

    3. Frum ridicules taking zinc for colds. He ignores the emerging science about zinc:
    “A new research study in the August 2009 print issue of the Journal of Leukocyte Biology suggests that zinc may be pointing the way to new therapeutic targets for fighting infections. Specifically, scientists from Florida found that zinc not only supports healthy immune function, but increases activation of the cells (T cells) responsible for destroying viruses and bacteria.”

    4. There are many studies documenting existing vitamin deficiencies, and the inadequacy of a “well-balanced diet”.. There are also many studies, like this one, and this one showing positive benefit from multivitamin use.

    DSHEA is good law. It allows consumers to do their own research and decide what to put into their own bodies. It is odd that Frum, as a professed conservative, should have such a problem with freedom of choice.

  10. #10 Rev Matt
    November 27, 2009

    “It is odd that Frum, as a professed conservative, should have such a problem with freedom of choice.”

    His point had nothing to do with freedom of choice, but rather a very very traditional conservative ideal: equal treatment under the law. There is no reason that herbal supplements/vitamins/et al should be treated any differently from a regulatory standpoint than aspirin, tylenol, etc etc. Currently DSHEA provides whole classes of products with preferential treatment, anathema to an actual conservative.

    You can certainly argue for a reduction in *all* regulation of health care products, which is a view entirely consistent with conservative ideals and one which I believe Frum would likely concur, but this issue isn’t about the degree of regulation but rather the difference in regulation in putatively similar products.

  11. #11 Jeff
    November 28, 2009

    Rev Matt, it is true that dietary supplements aren’t required to meet the same strict standards as drugs for entry into the marketplace. Nor should they have to, given the large disparity in the safety profiles of supplements vs. pharmaceuticals:

    According to the FDA Vioxx killed between 89,000 and 139,000 Americans from 1999 to 2005. That’s just one drug. Also according to the FDA all drugs combined are responsible for tens of thousands of deaths annually. Over the last ten years, all categories of dietary supplements were responsible for less than 150 total deaths, with most of those related to the now-banned Ephedra.

    We can argue the relative benefits of supplements vs. drugs. I happen to think nutrition science shows supplements are very useful for promoting good health. The only valid reason for placing stricter regulations on supplements would be to prevent the sale of unsafe products. The data shows clearly that safety is not a serious issue with dietary supplements.

  12. #12 Rogue Medic
    December 21, 2009

    Jeff,

    Thank you for directing me to this conversation.

    There are some important differences between chemicals regulated as drugs and chemicals regulated as dietary supplements. Those regulated as drugs are often used on much sicker patients. In order to do a fair comparison of risk and benefit, we should not ignore the differences in the patients receiving these chemicals.

    You cite the PCC (Poison Control Center) data, but the PCC deals with acute poisonings. How many calls do they get for cases of long term toxicity? If you have any toxicologic emergency and you are in the US, the number for the PCC is 800-222-1222. They are an excellent resource when dealing with an emergency, especially when children are exposed to substances and family members are in a panic.

    However, I do not think that the PCC data give an accurate picture of the risks of these chemicals. Our society is not set up to track the use of these chemicals, because we presume that they are safe. Until we have better data of safety, I do not think that claims of safety are supportable. Many of the acute poisonings that the PCC deals with are not from medicines, but are from plants. The holiday season can be expected to result in plenty of calls for children nibbling poisonous plants, such as poinsettias. Emergency department admissions might be a better source for information about the toxic effects from supplements.

    You point to St. John’s wort, but this highlights part of the problem of the distinction between being classified as a drug or being classified as a dietary supplement. When there is evidence to support a benefit, the chemical would be more accurately described as a drug. This is the term when something has evidence of being effective. When there is no evidence, or no convincing evidence, of the chemical being effective, then it should only be marketed as a dietary supplement. My opinion is that it should not be marketed as anything suggesting any benefit – for entertainment purposes only – might be a good label.

    There are several problems with this false distinction between medications and dietary supplements.

    Sometimes FDA approval is granted to chemicals that may be dangerous, yet less dangerous than the condition they treat. Clozapine is an effective drug, but has an extensive list of black box warnings. FDA label at DailyMed. The most serious warning is appropriately number 1. Agranulocytosis. Not something that you would want to have, but the risk can be dramatically decreased with appropriate supervision.

    Clozapine is used to treat schizophrenia, which is a very harmful disease. The side effects from clozapine are significant and life threatening. The side effects of untreated, or ineffectively treated schizophrenia are also significant and life threatening. Clozapine deaths will be included in the deaths due to drugs. Mistreated schizophrenia deaths, due to someone taking an herbal supplement, rather than real medical treatment, will not be listed as herbal supplement deaths, even they are herbal supplement deaths.

    By not including the deaths, and other side effects, due to a lack of appropriate medical treatment, we are painting a misleading picture of the actual risks of these chemicals that are portrayed as safe dietary supplements.

    This is just one example of a condition that can be viewed overly simplistically as using an extremely dangerous drug, therefore encouraging people to seek safe herbal remedies as an alternative to medical treatment. If we do not look at the real harm from the ineffective treatment, we might view this as safe, even though it is more dangerous than the very dangerous drug.

    Conversely, taking an ineffective chemical is safer than taking a dangerous chemical, if the illness being treated does not have significant complications. Some people will state that the COX2 inhibitors fall into that category, but pain is not an unimportant complication to a lot of people. Decreased exercise and decreased mobility may be life threatening complications for some people. That does not in any way justify misrepresentation by pharmaceutical companies.

    There is no good way to accurately determine the relative risks and benefits, if there is not accurate information about the risks. If the patient only knows that he/she feels better, but is unaware that cardiac side effects may be catastrophic for a person with his/her cardiac history, how can an informed decision be made?

    We view pharmacology in an irrationally simple way. Rather than a drug/non-drug classification, we should evaluate chemicals according to a combination of several more complex criteria. Making claims about the harm/benefit of any of these chemicals out of context is not helping to contribute to a better understanding of appropriate use of medications.

    Some people have estimated that the rate of non-compliance for people self-administering medication is higher than the rate of compliance. Non-compliance is any deviation from the treatment prescribed by the doctor. This can be for taking less than prescribed, as well as taking more than prescribed. I do not recall the source of this estimate of non-compliance, but I think that any estimate is going to be a wild guess, since there are so many factors in non-compliance that cannot be measured.