Is the FDA Doing Enough?

If you've been reading the press lately you've heard a lot of stories about recalled drugs or drugs that may not have the intended results. You may have heard about Merck's Vytorin or Schering- Plough's Zetia and about the recall of Heparin, a drug thinner, that has lead to many deaths here in the United States.

This morning I interviewed Jeffrey Killino, an attorney who filed a wrongful death lawsuit against Tyco, now Covidien, on behalf of his client Joyce Williams who lost her husband Freddie Williams, Sr. Joyce joined us too and talked about her husband Freddie who died on March 28. He was being treated for pneumonia when they realized that the nausea, vomiting, excessive sweating and extremely low blood pressure may have caused his death. They believe (Jeffrey and Joyce's family) that he suffered severe allergic reactions to pre-filled syringes of contaminated Heraprin and those reactions lead to his death. On the day Freddie died, Tyco announced they were recalling Heparin. The fifth and final recall after three other health care companies announced four recalls of adulterated Chinese Heparin originating from a Scientific Protein Laboratories plant in Changzhou, China. The FDA is currently investigating the deaths of other patients. As we speak, the chief executive of Baxter International is testifying in front of Congress. Baxter was one of the companies that sold the blood thinner and recalled it several months before Tyco.

This is a very sad story. I was moved by Joyce's personal story. She is not alone. She didn't know what was happening to her husband. Only now does she believe that the signs of his deterioration make sense. While Tyco, now called Covidien, did tell us this, "We do not comment on pending litigation. We're working closely with the FDA and our customers and our supplier to address heparin supply issues." It may not be enough.

Two thoughts this morning. Is the FDA doing enough? Do we have cause for concern when we hear stories about drugs made in China that result in personal situations like this? I worry!