The Impact of Frist's Amendment

If the Bill Frist-supported amendment to the HHS spending bill is passed, it would shield vaccine makers (specifically those manufacturing vaccines for anthrax and avian flu) from lawsuits unless the head of HHS determines that the companies are liable for willful misconduct. In a warning shot, there is a story from Reuters on deaths possibly caused by Tamiflu, the most effective vaccine against avian flu. The article says there are reports of psychological problems and suicidal behavior as other health risks from Tamiflu in youth, one of the populations most vulnerable to avian flu (children, the elderly and those with immune deficiencies). The FDA reports that it is investigating 12 deaths including "one suicide, four cases of sudden death and four cases of cardiac arrest. There were also single cases of pneumonia, asphixiation and acute pancreatitis."

In many cases where there are deaths associated with pharmaceutical drugs, it becomes difficult to determine whether the drug contributed to the deaths, and often there needs to be a string of similar deaths for any investigation to even begin. If the Frist-supported amendment passes, the threshold will be even higher for sanctions to be imposed on pharmaceutical companies.