Wednesday, February 16, 2011

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:


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 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.

Monday, February 14, 2011

President Releases Budget 2012

It has been a while since I blogged about any numbers, so this week I thought I would do a few exciting blog posts on budgets. Wait, don't leave, I know budgets can be very tedious, but they are an important part of government. This week brings us two big budget proposals, today, President Obama released his 2012 federal budget. Later this week, Governor Hickenlooper will release the 2012 Colorado budget.

In an attempt to keep you from running away, here are some fun graphics and videos:


Still here? I'm impressed! I am guessing then that you might be willing to check out some of these less interactive sources:

Tuesday, February 08, 2011

Department of Transportation Releases Report on Toyota Recall

Remember last summer when Toyota cars were getting recalled for unexplained acceleration problems? Today, the Department of Transportation's National Highway Traffic Safety Administration (NHTSA) finally released a report on the "potential electronics-based causes for unintended acceleration in Toyota vehicles" (press release). NASA engineers actually conducted this study and determined that there were no "electronic flaws capable of producing the large throttle openings required to create dangerous high-speed unintended acceleration incidents." Want to read the report or the documents leading up to the need for this report? NHTSA has set up a web site.

Want more transportation information? Check out the library's guide.

Monday, February 07, 2011

GAO Reports and Releases

The Government Accountability Office (GAO) which is often called the investigative arm of Congress. This set of publications from GAO investigates the military, education, data collection, and many other issues. If you would like to know more about GAO, check out the library's guide.

  • Airport and Airway Trust Fund: Declining Balance Raises Concerns over Ability to Meet Future Demands, by Gerald Dillingham, director, physical infrastructure, before the Senate Committee on Finance. GAO-11-358T, February 3.
  • Contract Audits: Role in Helping Ensure Effective Oversight and Reducing Improper Payments, by Jeanette M. Franzel, managing director, financial management and assurance, and Gayle L. Fischer, assistant director, financial management and assurance, before the Ad Hoc Subcommittee on Contracting Oversight, Senate Committee on Homeland Security and Governmental Affairs. GAO-11-331T, February 1.

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