EDITORIAL

Collusive Forces: The Handmaiden
of Science, the FDA, and Big Pharma

“T he case for dietary supplements is collapsing,” as the Wall Street Journal reported on the latest “science” that set off a media frenzy.1 As Bloomberg phrased it, “Multivitamins and some dietary supplements, used regularly by an estimated 234 million US adults, may do more harm than good, according to a study that tied their use to higher death rates among older women.”2

It’s no surprise that the study published in the Archives of Internal Medicine was not deeply questioned. Sensationalism and hysteria rule the news cycle. Yet, even the financial press went along, despite the size of the supplement business (about $61 billion). The lurid tide was so strong that even financial journalists appear to have been taken in hook, line, and sinker.

The “study” assessed the use of vitamin and mineral supplements in nearly 39,000 women whose mean age was 62.3 Over the course of 19 years, the researchers asked the women to fill out three surveys, the first in 1986, the second in 1997, and the last in 2004, asking them what supplements they took, what foods they ate, and how was their health.

The observational data gathered by the women’s self-reporting is unreliable to say the least, having no place in a valid scientific study. Nevertheless, the researchers looked at how many of the women had died by 2008. At first, all of the data was “adjusted” by the authors using methods of their own choice. Examining the study, the first thing you see is an adjustment for “age and energy,” whatever “energy” means in this case. Following this, vitamins C, B complex, E, D, as well as calcium, magnesium, selenium, and zinc all appeared to add to longer life. This evidently wasn’t an acceptable conclusion. So, two more adjustments were made. First, if you had a healthy lifestyle and took vitamin C and lived longer, the longer life was attributed largely to the healthy lifestyle and not to the vitamin C. That put everything except B complex and calcium into neutral or negative territory.

Still the authors weren’t satisfied. They adjusted again, this time for healthy eating, with the result that every supplement except calcium, B complex, and vitamin D became a contributor to an earlier death, and according to this undocumented and completely loopy math, only calcium actually lengthened life. Yet almost none of this—except possibly the use of copper supplements taken by 24 women at the end of the study—could be claimed to be statistically significant, even using the authors’ own methods.

These “scientists” admitted to an initial hypothesis that supplements wouldn’t add to life, and despite contradictory evidence the authors just manipulated the data until they got what they wanted: Supplements not only didn’t help; they were killers! The number of deaths was somewhat higher for women who took iron but a little bit lower for women who took calcium. Yet the lazy, biased, or naïve major media took it from there.

However, the relative risks were barely significant, and none was backed up by any medical investigation or biological plausibility study. Before drawing conclusions from epidemiological studies (or intervention studies for that matter), enough in vitro and animal work should be done so that the mechanisms are understood at a molecular level. In the Archives paper, no analysis was done on what combinations of vitamins and minerals were actually consumed, and no analysis of the cause of death was done beyond grouping for “cancer,” “cardiovascular disease,” or “other.” On top of that, no causative analysis was done. The interactions of potential compounding risk factors are always tremendously complex, but they were ignored in this so-called study.

What constituted a “multivitamin” according to the study? Over the study’s 19 years, were the amounts of nutrients sufficient? Or did they meet the barest 100% minimums, the FDA recommended daily intakes for preventing deficiency diseases, but not to prevent other diseases, and not to protect and preserve health? How good is anyone’s memory in describing what took place over many years? While most women’s diets probably vacillated over the period, and with only three self-administered reports in 19 years, there is a strong possibility that a great deal of information was omitted, even if it was accurate. But we’ll never know, because no analysis was done of the effect of supplements on the women’s overall health. We don’t even know how the supplements (whatever they were) affect women of other ages.

The FDA’s DV for iron is 18 mg/day, but iron is a well-known pro-oxidant, a powerful free radical catalyst (poorly controlled free radicals increase both cardiovascular and cancer risks). Men and women alike should not take iron supplements unless iron deficiency is diagnosed by clinical laboratory tests. And for women, iron damage becomes greater after menopause when cyclical bleeding stops and iron levels go up. Overuse of iron at this point may lead to early mortality. A consensus view has emerged in support of an anticancer effect of long-term aspirin use.4 This benefit is thought to occur through the loss of stored iron which may exacerbate carcinogenesis through free-radical mediated mechanisms and for promotion of tumor growth.

Also, the study did not acknowledge that many people start taking supplements only after they become ill, which was not controlled. In addition, drug use, some of which has since been proved to be highly dangerous, was not controlled.

According to Dr. Robert Verkerk, the Executive & Scientific Director of ANH-International, “This study is a classic example of scientific reductionism being used to fulfill a particular need. In this case, it’s supplement bashing, a well-known preoccupation of Big Pharma — and an approach that appears to be central to the protection of Big Pharma’s profit margins.”5 Big Pharma is in shambles with 200,000 jobs lost over the past three years owing to the anticipated loss of revenue from blockbuster drugs that will lose patent protection by 2013. Also, the Pharmaceutical Research and Manufacturers of America warned in July that spending cuts would lead to the loss of some 675,000 jobs.

Intriguingly, the Archives of Internal Medicine receives millions of dollars in advertising from drug companies, part of the $400 million that goes from drug companies to medical journals. The major media trumpeting studies in scary headlines also stay afloat from the $4.7 billion spent in Pharma-to-consumer ads. (All of this data is from 2008, and is actually higher now.)

A few years ago, ex-FDA employee and publisher Kim Pearson (Food & Drug Insider Report) estimated that more than 200 upper echelon FDA bureaucrats had significant stock portfolios heavily represented by drug company stock. This practice represents a clear conflict of interest between the health-seeking public and the FDA (and indirectly, the drug companies). Yet, we have no reason to believe that the FDA is any the less conflicted, and this may be the underlying motive for the rash of Congressional bills attacking the supplement industry, not to mention the NDI Guidance proposal which would dismember it much to the delight of Big Pharma.

References

  1. Wang SS. Is This the End of Popping Vitamins? Wall Street Journal, October 25, 2011.
  2. Lopato E. Vitamin supplements tied to higher death rates in older women in study. Bloomberg, October 10, 2011.
  3. Mursu J, Robien K, Harnack LJ, Park K, Jacobs DR Jr. Dietary Supplements and Mortality Rate in Older Women: The Iowa Women’s Health Study. Arch Intern Med 2011 Oct 10;171(18):1625-33.
  4. Mascitelli L, Pezzetta F, Sullivan JL. Aspirin-associated iron loss as an anticancer mechanism. Med Hypotheses 2010 Jan;74(1):78-80.
  5. Shame on AMA’s archives of internal medicine. http://www.anh-usa.org/shame-on-ama-archives-of-internal-medicine . Updated October 11, 2011. Accessed October 30, 2011.

FREE Subscription

  • You're just getting started! We have published thousands of scientific health articles. Stay updated and maintain your health.

    It's free to your e-mail inbox and you can unsubscribe at any time.
    Loading Indicator