The Business of New Drug Approvals

Last month's issue of the magazine Vanity Fair featured an extensive and frightening article on lax -- even unethical -- methods used by drug companies to test new drugs. At question is the practice of drug companies performing new drug tests in impoverished and third-world countries, under more relaxed standards and conditions than the same drug test would have if it were performed in the United States.

If you've read (or viewed the film of) John le Carré's excellent novel The Constant Gardener then you already have an introduction to the many ethical questions and ramifications that arise in the multi-billion dollar industry of drug research and marketing.

John le Carré wrote at the end of The Constant Gardener that, compared to the reality of corporate drug interests, his fiction was "as tame as a holiday postcard."

Another key component of the article, however, is the complicit relationship the U.S. Food and Drug Administration has with pharmaceutical companies, and the accusation of more lax testing standards than are deemed safe. (These are charges the FDA has heard before in the approval of medical devices, discussed in this article from the New York Times where corporations argue that extended trials are harmful to U.S. business.)

Explaining in one example the case of Dr. Anne Kirkman-Campbell, who was awarded $400 from the drug company Sanofi-Aventis for each patient she signed up for a test of their product KETEK, Vanity Fair points out that while 91% of her patient enrollments were falsified, and while the doctor was sentenced to 57 months in prison for her falsified results, the drug still won FDA approval in 2004, based largely on studies in Hungary, Morocco, Tunisia, and Turkey. By 2006, "the F.D.A. had received 93 reports of severe adverse reactions to Ketek, resulting in 12 deaths." The article continues:



and...



Those who want to sleuth out drug approvals and testing practices do have access to some helpful tools, many mentioned in the article itself.

For clarification on the Drug Approval process, the FDA offers a micro-site on the Development and Approval Process for Drugs, with sections on How Drugs are Developed and Approved, the Types of Applications, and on Conducting Clinical Trials. The FDA has also complied lists of additional resources for consumers, medical professionals, and for industry. However informative, these pages seem hardly comprehensive.

Another tool from the FDA is Drugs@FDA, a search engine, used in the Vanity Fair article, that allows users to search by ingredient, drug name, and application number. (Click on the graphic below to be taken to the database.)

Below is an image from Drugs@FDA of the KETEK black box, described in the Vanity Fair article, taken from a 2007 "labeling revision," three years following the drug's approval.



The National Institutes of Health (or "NIH") also provide a search engine on Clinical Trials at ClinicalTrials.gov. Interestingly, the site features a map of all listed clinical trials, with exact numbers appearing on-screen. Selecting a numbered area breaks the geography down even further. Click on the graphic below to be taken to that page.



Finally, LexisNexis Congressional, of course, provides considerable content when searching for information on the FDA and "drug approval," such as these GAO reports on the FDA's consideration of evidence from clinical trials and on the FDA's need "To Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints." (A surrogate endpoint allows a drug company to use a laboratory measure or physical sign of a drug's effectiveness, versus the longer process of a clinical endpoint, which is a direct measure of how a patient "feels, functions, or survives.")

Clearly, as Vanity Fair has proved, investigating the drug approval process in a globalized business environment takes considerable patience and extensive online sleuthing. But this is clearly a case in which the availability and online accessibility of government information can, in fact, allow individuals to piece together a picture of the larger whole, and discover how the desires of industry can concretely impact the day-to-day lives of people not at all dissimilar from ourselves.