Thursday, January 3, 2008

Bextra: 21st Century Thalidomide

Despite existing strict safeguards, drugs with unknown side effects still manage to get through current well- established screening programs.

By: Ringo Bones and Vanessa Uy

It’s quite ironic that a drug formulated to relieve pain became known as: “the cure worse than the disease.” The drug Bextra –also known by it’s generic name as valdecoxib- that is marketed by the drug firm G.D. Searle and Company, was a popular pain reliever often used to treat the symptoms (i.e. pain) of rheumatoid arthritis and osteo arthritis in adults. The drug was recalled once it was linked to life threatening side effects including the autoimmune disorder Stevens Johnson syndrome, heart attacks, and strokes. Bextra was recalled from market circulation, however, the action came too late for the thousands of Bextra users who were harmed by the drug.

Drugs that manage to enter the market before their serious side effects are fully known is by no means a recent phenomenon. Back in 1960, thalidomide was this supposedly ├╝ber-harmless sedative which was later found out to be a serious teratogen i.e. affects fetal development. Physicians in the then West Germany began noticing a spike in the occurrence of birth defects of one particular type. The babies are affected with phocomelia (from the Greek words: phoke, a seal, and melos, a limb). Toward the end of 1961 a persistent German pediatrician, Dr. Widukind Lenz tracked down thalidomide as the agent responsible in the case of the seal babies. Thalidomide usage had then spread from Germany to other European countries as well as to Canada, South America, Japan, and the Near East. In November 1961 the German manufacturer of thalidomide halted production, but the total number of thalidomide affected babies ultimately exceeded 5,000 in Germany and at least 1,000 in other countries.

At the time, American mothers were spared of the “full brunt” of the “thalidomide disaster” through the diligence of Frances Kelsey, a doctor then working for the US Food and Drug Administration. An American drug company had then applied for permission from the FDA to distribute the drug in the US, but Dr. Kelsey repeatedly refused to approve the application until she had conclusive evidence of thalidomide’s safety. When the news of the “thalidomide disaster” in Germany spread, the manufacturers withdrew their application to market thalidomide. Meanwhile, however, the drug companies had already sent out some thousands of free samples to physicians. Fortunately only a few of those got taken by pregnant women: American thalidomide babies numbered less than ten, and most of them were caused by pills brought in from Europe.

Recently, the drug firm involved with the marketing of Bextra is now resolving personal injury tort claims of the thousands of affected users via structured settlement. Is the Bextra incident a sign of increasing complacency of the established consumer product “watchdog” arm of the FDA? If so, then we the taxpayers deserve something better to get our money’s worth. Isn’t it what our taxes are for in the first place?

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