The rosiest of pictures of the pharmaceutical industry have not been painted in this column, and no apologies will be made for expressed opinions or for rallying efforts to address some rather gross improprieties that have been reported accurately and fairly in this magazine.
I'm stickin' to my guns, yet I am not above taking a big ol' bite of humble pie. The careless actions of a few are not necessarily indicative of the entire industry, and I would be remiss if I did not mention some rather exemplary actions on the part of Baxter International Inc. (Deerfield, IL).
The situation is indeed critical, for Baxter discovered HIV-2, a rare form of the AIDS virus, within the plasma pool it uses to make Buminate 5%, a treatment for burn victims and patients in shock. Baxter voluntarily recalled the single lot and notified the U.S. Food and Drug Administration (FDA), swift actions that were certainly necessary.
Baxter's most commendable effort, however, occurred before the discovery of the HIV-2 virus in the plasma, derived from donor blood. That endeavor was its use of a polymerase chain reaction (PCR) test, which is used in other countries, like West Africa, to detect the AIDS virus, but is considered experimental in the U.S. and therefore not a federal requirement.
And although the FDA indicates that the PCR test could reveal false positive results, Baxter's use of this test sets an example that the entire pharmaceutical industry should follow.
There are other drug-makers employing this test or similar measures, but for those whose track records are anything but commendable, it's time to follow suit and take additional steps to ensure drugs are free of contamination and safe.
I've bemoaned many things about the pharmaceutical industry in this column; shoddy manufacturing practices and unreturned telephone calls.
When Baxter's story broke, I figured it would be just another example of what I've been complaining and appealing to you about.
Boy, was I wrong.
And on that note, please pass the crow.
Mark A. DeSorbo