Film Review: How to Survive a Plague

By Suzanne M. Rivera

How to Survive a Plague is a moving chronicle of the onset of the AIDS epidemic as seen through the lens of the activists who mobilized to identify and make available the effective treatments we have today.  Beginning at the start of the epidemic, when little was known about the HIV virus and even hospitals were refusing to treat AIDS patients out of fear of contagion, the film follows a group of leaders in the groups ACT-UP and TAG.  Using existing footage interspersed with current-day interviews, it tells the story of how patients and concerned allies pushed the research community to find a way to treat what was then a lethal disease.

The film’s portrayal of the U.S. Government, specifically then-President George H. W. Bush and high ranking officials in the Food and Drug Administration, is damning.  As hundreds of thousands of people became infected with HIV and the death toll rose, prejudice against marginalized groups (especially gay men, IV drug users) contributed to a lack of urgency about the need to learn how stop the spread of the virus and how to treat the opportunistic infections that killed people with full-blown AIDS.  In contrast, footage of demonstrations, meetings, and conferences highlights the courage of the activists who risked and endured discrimination, beatings and arrests to bring attention to the need for more research.

But How to Survive a Plague is more than a documentary about the power people have to make change when they join together to demand action.  It also is a provocative commentary about unintended consequences.  I saw the film while attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R).  In that context, I was especially interested in the way How to Survive a Plague highlights an interesting ethical issue in clinical research. Namely, the problem of protecting people so much from research risks that the protection itself causes harm. Read More

Tools for Teaching the Fungal Meningitis Outbreak

By Jennifer S. Bard

I’m sure many of us are talking about the contaminated steroid injections which have spread a fungal form of meningitis Exserohilum rostratum across the country.   The CDC, which as is usually the case is doing an excellent job of providing clear and current information,  reports that as of “October 17, 2012, a total of 47 patients have laboratory-confirmed fungal meningitis.”  They offer some reassuring information—that “this form of fungal meningitis is not contagious”  and some scary information—that  there are 257 cases and ten deaths in 15 states and that incubation periods last up to a month.

The most recent legal news is that the pharmacy was visited earlier this week by the FDA’s criminal investigative unit and that the first law suit has already been filed in Minnesota Federal District Court by a woman who received a vaccine from the pharmacy but who does not know yet if she has meningitis. Read More

Reporting Information about Clinical Trial Data: Passing the Torch from HHS to the FDA

By Leslie Francis

In 2007, motivated by concerns that pharmaceutical companies were not sharing negative data about what had been learned in clinical trials, Congress established enhanced reporting requirements.

A series of articles published in January 2012 in the British Medical Journal demonstrates that data reporting remains deeply problematic, especially for industry-sponsored trials. (The articles can be found here and are very much worth reading).

A posting Sept. 26 in the Federal Register indicates that the Secretary of HHS has delegated authority to to oversee the reporting process to the FDA.  Whether this signals improved monitoring of clinical trial data submissions remains to be seen.  One can only hope.