The good folks over at Alliance for Justice are premiering a new 22-minute documentary about Diana Levine, the Vermont musician who lost her forearm to gangrene caused by a prescription drug made by Wyeth, and whose suit against Wyeth has gone all the way to the Supreme Court.

Here’s the description:

When Diana Levine went to the hospital in April 2000 seeking relief for a severe migraine headache, the professional musician and children’s record producer never imagined that faulty drug labeling would result in the amputation of her arm. Today she is at the center of a closely-watched Supreme Court case and a national debate about the federal courts and corporate accountability.

Produced in conjunction with 12-time Emmy award-winning producers/directors Jon Alpert and Matt O’Neill, Alliance for Justice’s documentary Access Denied?: The Fight for Corporate Accountability tells Ms. Levine’s powerful story and exposes the slow but steady transformation of our federal courts into institutions that favor corporate interests over everyday Americans. Through an examination of Diana Levine’s case against Wyeth Pharmaceuticals – and the experiences of others like her – Access Denied? takes the legal issue of preemption out of the courtroom and into the real world, where millions of Americans find themselves unable to access the courts and hold corporations accountable for their misconduct.

And here’s the trailer:

Bradley Whitford, of West Wing fame and other films & TV shows, is promoting the film. (If I may digress for a moment: Your humble blogger once was a humble stage crew intern at an off-off-Broadway theater in Hell’s Kitchen in New York in 1987. A then-completely-unknown Bradley Whitford was in a one-act play in said theater. So was Marisa Tomei, who at the time was NOT unknown, because she was in the Cosby Show spinoff series “A Different World.” One exciting night saw Lisa Bonet and then-hubby Lenny Kravitz come to see the show.)

And speaking of celebtrity actors, one can’t help but wonder: Who would play Rep. Henry Waxman in the feature film?

There are plenty of good candidates in the roster of bald actors, such as:

Sir Ben Kingsley:

Or perhaps Alan Arkin:

Or Robert Duvall:

We could do this all day! Your other Waxman portrayal suggestions welcome in the comments.

The Government Accountability Office released a report today, finding that “in several key areas, FDA rules for drug approval fail to guarantee the safety and effectiveness of drugs for seniors.” Among the problems identified:

• Inclusion of seniors in clinical trials. GAO found that drug manufacturers “generally included elderly persons and reported safety and effectiveness data for elderly persons in clinical trials.” However, in a number of cases, selected drug trials excluded participants on the basis of age, restricting the participation of seniors.
• Inadequate FDA guidance. FDA has failed to clarify important requirements in the drug evaluation process for seniors, resulting in potential information gaps. For example, FDA does not require that medical officers determine whether a sufficient number of seniors participated in drug trials.
• Failure to document safety and effectiveness. According to GAO, one-third of new drug reviews failed to include documentation of FDA medical officers’ review of drug safety and effectiveness data for seniors.

Of these, excluding or failing to recruit adequate numbers of seniors for drug trials is the most troubling. Since the clinical trials are the only data that the FDA has to determine whether a drug is safe and effective for the population that will be using it after approval, it is vitally important that the clinical trial participants be a microcosm of the much larger patient population that is likely to use the drug once it’s approved.

We know that some side effects don’t show up in clinical trials, either because of the smaller number of people taking the drug or because some side effects only surface after patients have used the drug for longer periods. The FDA at times requires drug makers to conduct “post-marketing studies” after the drug has been approved — studies designed to ferret out the drug’s true risks and side effects once the “real world” data from millions of uses are available. Yet last year, the Office of the Inspector General issued a report documenting the incredibly shoddy job the FDA does at following up and making sure that drug companies actually do these studies.

The FDA’s failure to ensure that post-marketing studies are conducted makes it all the more important that clinical trials conducted to get the drug approved accurately reflect the patient population that is likely to take the drug once it’s approved. This is doubly important for seniors, who take more drugs, are likelier to suffer side effects, and far likelier to have other, complicating conditions.