Pharmaceutical companies sometimes charge so much for cancer drugs that even insured patients cannot afford their 20 percent co-payments—on what can be $100,000/year medicines. Sometimes, in order to pay for cancer drugs, patients stop taking other vital drugs, or cut back on food. This is a major concern for Hagop Kantarjian, Chief of Leukemia and full professor at the MD Anderson Cancer Center in Houston, Texas.
In U.S. vs. Alfred Caronia, the U.S. Court of Appeals for the Second Circuit concluded that criminalizing the promotion of off-label uses of pharmaceuticals—that is, for purposes not approved by the Food and Drug Administration—amounted to an unconstitutional restriction on free speech. The court did not comment on evidence that Caronia had been untruthful in promoting a narcolepsy drug for the treatment of fibromyalgia and for patients under the age of 16.
A forthcoming article for the special issue of the Journal of Law, Medicine and Ethics (JLME), edited by Marc Rodwin and supported by the Edmond J. Safra Center for Ethics, presents evidence that about 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs.
In just a few months, the countervailing powers of academics, researchers, and the British medical profession have mounted the final campaign against the corrupting practices of hiding negative trial results that earned prominent attention recently in The New York Times. Led by Peter Doshi and Ben Goldacre, the campaign includes formal endorsement by the British Medical Association, the Medical Research Council, and the editorial boards of three of the world’s leading medical journals. Thirty years of distorting medical knowledge and clinical guidelines seem to be ending; but imagine the difference if the AMA, the IOM and the NEJM joined them.
This is the third is a set of blogs devoted to strengthening the concept and theory of institutional corruption (IC). A previous blog urged that IC would be greatly strengthened by drawing on moral philosophy to establish a normative, external foundation for both defining when IC is occurring and for developing legitimate reforms for institutional integrity.
By its very nature, institutional corruption (IC) occurs in a force-field of countervailing powers. Corruption at the organizational or institutional levels inherently involves a larger constellation of stakeholders who participate in or are affected by the corruption being studied. Beyond them are other parties with other priorities who shape or are affected by different forms of corruption. These include public opinion and trust if its deterioration leads to organized responses. Doing research on how countervailing powers interact with the corruptors and shape either the forms of corruption or reforms for integrity to end it would strengthen IC studies.
The felicitous occasion of Michael Sandel delivering the inaugural Kissel Lecture in Ethics on behalf of the Edmond J. Safra Center for Ethics provides a fit opportunity to advocate for the synergies that can occur by joining moral philosophy with institutional corruption theory in a sustained, mutually beneficial dialogue.
In September, The New England Journal of Medicine published an important study funded by the Edmond J. Safra Center for Ethics that measured the loss of trust in medical science as an institution that should be dedicated to trustworthy research for treatments that restore or maintain patients’ health.
A few months ago, I co-authored with Dr. Joel Lexchin an article in the British Medical Journal showing that only about 10 percent of new drug products fit the industry’s claim to develop clinically superior drugs to make patients healthier.1 About 90 percent of the time, companies use patent protection from normal price competition for monopoly pricing to develop minor variations rather than serious innovations. This constitutes a hidden business model they do not discuss.
A recent article in the BMJ, by Lab Fellow Donald Light and Joel Lexchin, used FDA data to show that the pharmaceutical industry does not face the innovation crisis it has so widely publicized in order to make the public and legislators think that it needs more subsidies and government protection from free-market competition than it already has.