Blog #51 Andrew Siegel, M.D.
There were three articles in yesterday’s (March 21, 2012) New York Times that each dealt with generic medications of proven benefit to humankind. However, because of their generic status, ramifications have surfaced that are clearly not kind to humans. The glaringly common theme among these articles is that the economics of large pharmaceutical companies (aka Big Pharma) clearly trumps patient care and public health. Welcome to the United States!
On the front page appeared an article written by Katie Thomas entitled: Generic Drugs Prove Resistant to Damage Suits. This reported that lawsuits against pharmaceutical companies that make generic drugs are being dismissed because of a Supreme Court decision last year that stated that generic pharmaceutical companies do not have control over their labels; they are therefore considered immune from suits regarding failing to alert patients to the risks of their drugs. As a result, pharmaceutical companies that manufacture brand-name products take on the responsibility for drug risks, but generic companies are free of all such responsibilities. By virtue of this Supreme Court ruling, if a drug causes significant harm to a patient, the manufacturer is indemnified by virtue of its generic drug status.
On page 9 of the front section was an article by Roni Caryn Rabin entitled: 2 Studies Link Daily Doses of Aspirin to a Significantly Reduced Risk of Cancer. The bottom line is that based on two new studies, daily aspirin may significantly reduce the risk of many cancers—colon, lung, prostate, and esophagus—as well as help prevent cancers from spreading. These findings conflict with two previous studies, which showed no cancer prevention with the use of aspirin. Because of these contradictory studies and the potential risks of gastrointestinal bleeding and hemorrhagic stroke from aspirin, there is an urgent need for long-term clinical trials to test if aspirin can truly prevent cancers and determine if the potential benefits outweigh the risks. Sadly, this study is never going to happen because of the astronomical expense of such a clinical trial and the fact that aspirin is a cheap generic drug. There is nothing in it for Big Pharma except “good will toward men” given that all of humankind might potentially reap great benefits.
On page 11 of the front section was an article by Donald G. McNeil, Jr. entitled: A Cheap Drug Is Found To Save Bleeding Victims. Tranexamic acid, an inexpensive generic drug that blocks an enzyme that dissolves clots and hence stops bleeding, has been helping to save the lives of injured American soldiers engaged in war. Clinical trials have shown that it can reduce the risk of fatal hemorrhage by 30% if given within three hours of trauma. It has been available over-the-counter in Japan and Great Britain, where it is used for heavy menstrual flow. Unfortunately, because it is generic, inexpensive, and not a potentially profitable drug, Pharma has not sought FDA approval. As such, tranexamic acid is not available in hospitals and emergency rooms in the USA. Simply stated, there is no financial incentive in it for Big Pharma, the powerful force that traditionally gets drugs to market via the FDA. Without the lure of blockbuster profits, the manufacturer will not go forward, despite the drug’s ability to save lives.
In Tuesday’s New York Times, there was a profile on Drs. Arnold Relman and Marcia Angell, former editors of “The New England Journal of Medicine”. This husband and wife team has spent decades crusading against for-profit medicine, particularly the commercial insurance and drug manufacturing industries. In 1980, in an editorial rail, Dr. Relman wrote: “We should not allow the medical-industrial complex to distort our health care system to its own entrepreneurial ends; medicine must serve patients first and stockholders second.”
I am all for capitalism, free enterprise, meritocracy and incentives to help produce positive results. Having stated that, I am also for pragmatism, social responsibility, public health and the greater good. So have we completely lost our souls regarding generic medications? If a generic pharmaceutical is a potential wonder drug, shouldn’t we able to find the means to get it FDA approved and bring it to market to help our fellow Americans in need? Shouldn’t we be able to find a means to finance clinical trials to be able to test the efficacy of generics regardless of profit potential? Finally, just because a drug exists in a generic form, shouldn’t our citizens have recourse against the manufacturer in the event that a medication causes real harm?
We have a system marked by dishonorable, unprincipled and often unethical priorities that is sorely in need of repair. A tragic collateral effect of the profit-making motives of the commercial drug manufacturing industry has been the exploitation of our “public” health, which becomes much less public and much more personalc when it impacts you, me and our loved ones. When the greater good gets undermined because of economic forces, it demands righting by some form of regulatory system.
Andrew Siegel, M.D.
Author of Promiscuous Eating: Understanding and Ending Our Self-Destructive Relationship with Food
Now available on Amazon Kindle