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January 15th, 2013 at 9:00 am

The Story of BiDil: the FDA’s First Race-Specific Drug

Hamline University Law Professor Jonathan Kahn has become a prominent critical voice in the last decade on the controversial injection of racial discourse into American medical practice (particularly in the realm of genetically tailored drugs). In the following post, he gives us a helpful overview of BiDil, an FDA-approved drug that has in many ways become the face of this issue.

The story of BiDil begins in the 1980s when a group of researchers hypothesized that combining hydralazine and isosorbide dinitrate together might be an effective treatment for heart failure. They conducted two small, federally supported clinical trials and concluded that, indeed, the drugs did work – for everybody. At this point race was not a part of the picture. In 1989, the researchers obtained a patent on the use of the two drugs together – soon to be named “BiDil” – to treat heart failure. Again, there was no mention of race in this first patent. Patent in hand, they licensed the rights to a small pharmaceutical company, which took the necessary steps to bring the drug to the FDA for approval. In 1997, the FDA denied approval, citing inadequate statistical support from the data in the first two, small trials. Importantly, many cardiologists on the advisory committee stated clearly that they believed BiDil worked, but that they could not recommend approval because of the regulatory criteria for statistical significance in the data. The FDA said it believed the drug was approvable if a properly designed follow-up clinical trial were conducted.

Clinical trials, however, cost a lot of money. At this point the small pharmaceutical company dropped BiDil and it seemed dead in the water. By now, nearly half of the twenty year life of the first patent had elapsed. A follow up trial and return to the FDA for approval might take several more years, effectively eating up almost the entire value of the patent. It was here that race entered the picture for the first time. The researchers broke out the original data by race and argued that the BiDil combination seemed to work particularly well in the 49 African Americans place on the BiDil combination drugs in the first trial. So well, in fact, that they filed for a new race-specific patent based on using the drugs only in African Americans. This patent was granted in 2000, effectively extending monopoly control over the drug by thirteen years, until 2020. This patent was then licensed to NitroMed, which conducted the new race-specific trial that provided the basis for the FDA approval in 2005.

In order for the race-specific patent to pay off, NitroMed had to get a race-specific label approved by the FDA. If the FDA approved BiDil for use in the general population regardless of race then any pharmaceutical company would be able to market BiDil after the original patent expired in 2007. In my book, Race in a Bottle, I argue that these legal and commercial considerations drove the framing of BiDil as a racial drug – shaping which questions got asked and how the answers were interpreted and presented to the public. It is in exploring these intersections of law, commerce and science that the story of BiDil illuminates the complexities of how and why race is being used in biomedical research, practice and drug development.

Look for more posts about Kahn’s new book, Race in a Bottle, this week on the Columbia University Press blog!

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