Senate Majority Project

Thursday, December 08, 2005

Frist Do No Harm

Sen. Frist's Sweetheart Deal for Drug Companies is For the Birds

In a speech to reporters at the National Press Club, Senator Bill Frist announced his six-point plan to help the nation cope with an avian flu outbreak. During the speech, Frist placed fear in his audience, proclaiming:
“Think of a fast-moving, highly contagious disease that wipes out 50 million people. Half a million in the U.S. The killer pandemic claims more victims in 24 weeks, than HIV-AIDS has claimed in 24 years. In the United States -- the most developed nation in the world -- bodies pile up in the streets. There aren't enough morticians to bury the dead. Nor are there enough doctors and nurses to tend to the sick."
Scary stuff. A situation that definitely calls for a six-point plan. And today Frist’s outlined measures he says would increase availability of flu vaccine and streamline the process of research and development.

But what if it was side effects of a vaccine that was responsible for making people sick? That’s different according to Frist and friends. Today, Frist talked of “balanced, sensible liability protection” But his idea of balanced and sensible is to remove virtually all incentives for responsible drug production. His SB 1873 completely shields companies making drugs in response to public health emergencies, unless the Secretary of Health and Human Services (rather than an impartial court or jury) determined that the company acted with “willful misconduct.” [Sec 319F-3]

The drug makers would agree: According to PhRMA chief Billy Tauzin today, “Liability reform is a critically important part of this plan. It’s clear that the nation’s liability system is broken.”

One problem with this is that Congress supposedly already fixed that problem when they passed class action reform. Last we heard, the GOP Congress protected pharmaceutical companies by designing a bill that shifts many class action suits from state courts to backlogged federal courts. (Lawsuits against companies, due to side affects of a vaccine would almost certainly be handled as a class action.) That measure was supposed to lead to more research and development and broader manufacturing of vaccines.

At the end of the day, Frist’s vaccine plan cure might actually end up being worse than the disease. Drug manufacturers would have no potential liability except in the most extreme circumstances and therefore no economic incentive to fully test and protect against side effects that could cause even more serious illness or deaths, especially in vulnerable populations like children and the elderly.

Frist, a doctor, is familiar with the side effects of vaccines, and has himself cautioned against requiring vaccination against smallpox or anthrax because of the hundreds or even thousands of deaths that could result.

For example, In 2001, when Frist was asked about reinstating routine smallpox vaccinations, he said nationwide inoculations would result in an estimated 400 deaths from the vaccine’s side effects. He told Tim Russert on Meet the Press that,

“About 25 out of every 100,000 people have a side effect to the vaccination itself. Probably 600 to 2,000 people would die just from the vaccine itself.” [NBC Meet the Press, 10/14/2001]
And after the U.S. Capitol was hit with an anthrax attack, Frist again cautioned against the vaccines saying,
There are very real and potentially serious side effects from the [anthrax] vaccine and anyone who elects to receive the vaccine needs to be made aware of that,' said Frist. 'I do not recommend widespread inoculation for people with the vaccine in the Hart Building,'" [, 12/18/2001]
Despite the very real danger of side effects from vaccines, Frist’s bird flu plan envisions widespread vaccination of Americans in a short time period with even less protection against side effects than are currently in place for either the smallpox or anthrax vaccines Frist cautioned against.

But wait, there’s more.

Frist’s plan also creates a new agency, the Biomedical Advanced Research and Development Agency, with oversight authority over the nation’s bird-flu and bioterrorism preparedness. Frist would give the agency the unprecedented protection of complete exemption from the Freedom of Information Act. Thus people could not even know whether the vaccines developed under the Frist plan would have a chance of hurting them. As Barbara Loe Fisher, president of the National Vaccine Information Center summed up:
Without public scrutiny or the ability to take the companies to court, ``these drugs are going to be developed in secret, and if there are deaths and injuries, they're going to be covered up,'' she said. ``And there will be no way to hold anybody accountable.''
Now that’s scary.