Last weekend, I watched the movie How to Survive a Plague. The movie discusses the AIDS activist group ACT UP (AIDS Coalition to Unleash Power). Although I am not a movie critic (you can see reviews by professional critics here ), I do want to discuss one key issue that the move discusses: should the FDA liberalize its drug approval processes.
As the AIDS epidemic spread, there were a number of drugs that seemed like they could help reduce the symptoms of AIDS. Many of these drugs, however, had not been approved for treating AIDS by the FDA. ACT UP argued that because AIDS was a death sentence, the drugs should be released because many individuals with the disease were willing to try nearly any treatment that would give them some hope of a cure.
Early release of a drug has a number of advantages. First, if the drug is effective, more people with the disease can take the drug ealier. Second, it promotes individual choice; if patients want to take a drug and they know the risk, who is the government to stop them from doing what they want with their own bodies.
On the other hand, only releasing drugs that have been proven effective has its own advantages. First, patients do not waste money buying ineffective or even harmful drugs that could potentially accelerate the diseases progression. Second, releasing the drugs may mean that fewer people will be willing to participate in clinical trials and these trials may be ‘contaminated’ with control groups taking the widely available drug.
It turned out that many of the single drug AIDS/HIV treatments were only effective for a small portion of the population and in many cases they merely slowed the body’s decline. Thus, the potential HIV/AIDS treatment breakthroughs in the early 1990s proved illusory. Only with the discovery of multi-drug treatments such as “highly active antiretroviral therapy (HAART)” did the AIDS epidemic begin to slow (at least in the U.S.).
Although the movie is a bit slow (especially in the first half), it provides an interesting view into how the interaction between disease activist groups, government agencies (e.g., FDA), drug companies, and research scientists affects scientific research agendas and priorities as well as public policy.