The FDA:  The Fox Guards the Hen House

In their Fall 2013 issue, the Journal of Law, Medicine, and Ethics published a symposium of papers by members of the Harvard’s Edmond J. Safra Center for Ethics.  The symposium was called Institutional Corruption and Pharmaceutical Policy.

The symposium focuses on pharmaceutical products generally, but all the material is relevant and important in the context of psychiatric drugs.

In this post I will highlight one of these papers:  Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs, by Donald W. Light, Joel Lexchin, and Jonathan J. Darrow.

Here are some quotes:

“An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians…”

“It is our thesis that institutional corruption has occurred at three levels.  First, through large-scale lobbying and political contributions, the pharmaceutical industry has influenced Congress to pass legislation that has compromised the mission of the Food and Drug Administration (FDA).  Second, largely as a result of industry pressure, Congress has underfunded FDA enforcement capacities since 1906, and turning to industry-paid ‘user fees’ since 1992 has biased funding to limit the FDA’s ability to protect the public from serious adverse reactions to drugs that have few offsetting advantages.  Finally, industry has commercialized the role of physicians and undermined their position as independent, trusted advisers to patients.”

“Despite the small number of clinically superior drugs, sales and profits have soared as successful marketing persuades physicians to prescribe the much more costly new products that are at best therapeutically equivalent to established drugs…  Both an American and a Canadian study found that 80 percent of the increase in drug expenditures went to paying for these minor-variation new drugs, not for important advances…  Companies claim that R&D costs are ‘unsustainable.’  But over the past 15 years, revenues have increased six times faster than has investment in R&D.…”

“…allowing companies to test their own products has led them – as rational economic actors – to design trials in ways that minimize detection and reporting of harms and maximize evidence of benefits…”

“…companies have created what can be characterized as the trial-journal pipeline because companies treat trials and journals as marketing vehicles.”

“Furthermore, companies are much less likely to publish negative results, and they have threatened researchers who break the code of secrecy and confidentiality about those results… Positive results are sometimes published twice – or even more often – under different guises.  This further biases meta-analyses – a method of statistically combining the results of multiple studies – and clinical guidelines used for prescribing.  The result is ‘a massive distortion of the clinical evidence… For decades the FDA has kept silent about these practices and about the discrepancies between the data submitted to the FDA by companies and the findings published in journal articles, to the detriment of patients but much to the benefit of the companies.”

The authors offer five suggestions for restoring institutional integrity in this field.

  1. “…while research companies play important roles in discovering and developing superior drugs, they should play no role in testing them.”
  2. “…the FDA needs new leadership to restore public trust and build a new culture focused on safety through enforcement of its existing rules.”
  3. “…user fees must end, and the FDA must be entirely funded by taxpayers-as-consumers. The FDA should be entirely clear about whom it serves.”
  4. “…while approval criteria should allow for a sufficient number of therapeutically equivalent drugs in a class to give clinicians a range of choices…they should also require patient-relevant evidence of superiority.”
  5. “…Congress needs to restore trust by creating a National Drug Safety Board with adequate powers, funds, and mandates to independently investigate and report on drug safety issues.”

This is a meticulously written and well-referenced article.  I urge readers to take a look.  The authors have pulled together all the compelling issues in this matter, and have presented them in a cogent and condensed format.  The article provides excellent material for developing responses to psychiatry’s exaggerated claims, and for lobbying politicians with regards to the obviously much-needed reforms.

According to OpenSecrets.org, the pharmaceutical/health products industry spent $226 million lobbying US politicians in 2013.  By contrast, the defense aerospace industry, popularly regards as a heavy lobbyer, spent $58 million.