“A toast to good health!” I watch as the man and woman at the table across from me lift their glasses, and I hear the expensive ding of stemware echoing faintly over the tabletop. As I watch their exchange, however, I cannot shake the feeling that no matter how high we raise our glasses, and no matter how expensive the wine, our health is still in jeopardy. But it seems to me that the risk to our health may not be from illness at all. The real peril stems from our consumption of the very drugs we use to treat our ailments in the first place! And what we don’t know about these prescription drugs may be killing us!
With the advent of the controversy surrounding Vioxx and Celebrex, patients everywhere could hardly be over-informed regarding their doctor-prescribed medications. As we have seen, FDA endorsement of any drug, from antidepressant to painkiller, does not necessarily certify safe consumption! Vioxx, which was withdrawn voluntarily from the market by its manufacturer Merck & Co., Inc., was originally approved for consumption by the Food and Drug Administration in 1999, when the drug was found to relieve signs and symptoms of osteoarthritis as well as stymie acute pain in adults. The release of Vioxx, however, aroused concern in many members of the medical community, including Dr. Garret Fitzgerald, cardiologist of the University of Pennsylvania. Dr. Garret chaired a series of studies conducted on both Vioxx and Celebrex in 1999 after their consecutive approval. Dr. Garret indicated that he had “been concerned all along,” and that he “believed that this is a class effect,” not just a problem with Vioxx. Dr. Garret published his concerns in a chronicle of the studies performed, indicating that these drugs had a taxing effect on the heart. These studies were performed in 1999 at the inception of the public release of both Vioxx and Celebrex. I wonder: did the FDA ignore warnings from the medical community with regard to the potential dangers?
Lately, the Food and Drug Administration has issued several other statements regarding the potential for health hazards resident in other drugs, including those such as Crestor, a drug used to treat high cholesterol. In its bulletin issued on March 2, 2005 explaining certain identified risks surrounding the use of Crestor, the FDA assured that it “is committed to providing Americans with the latest and most comprehensive information on the medicines they use.” After the Vioxx episode, I’m not inclined to feel a terrible sense of loyalty toward the FDA’s proclamations.
The bulletin (which is readily available at the USFDA website) indicates that Crestor users may be at risk for a condition known as rhabdomyolysis, which is a serious, muscle-damaging disorder. The FDA bulletin further states, however, that those patients consuming this drug are exposed to relatively the same risks for this disorder as patients consuming other specified types of cholesterol treatments. Either way, this seems quite alarming to me, since it I thought the purpose behind taking medication in the first place was to eliminate or alleviate the sickness, not accompany it with another, potentially more serious malady. As it turns out, information provided to WebMD in January indicated that at least one Crestor-related death had occurred in the same month. I guess there are confirmed risks, after all.
Vioxx marked the largest voluntary prescription drug withdrawal in history. According to information cited in the Journal of the American Medical Association in 2001 by Dr. Eric Topol, had the warning signs associated with the drug’s effects been heeded, the unfortunate circumstances surrounding the controversy may have been prevented. But the problems don’t stop with Vioxx or its sister drug Celebrex, or even Crestor. The malice includes anti-depressant drugs as well. This is disconcerting, given the antidepressant craze currently sweeping the nation. According to a source touted in the Detroit Free Press in December 2004, reports indicate that the percent of adults using antidepressants nearly tripled to 10 percent of women and 4 percent of men ages 18 and older, when comparing average prescription drug use in 1988-1994 to the average for 1999-2000. Of course, a generalization can’t be made that would implicate all prescription antidepressants.
But the FDA released news on March 4 of this year that indicated that in cooperation with US Marshals they would seize certain lots of GlaxoSmithKline’s Paxil CR and Avandamet Tablets due to continuous manufacturing violations. According to the FDA’s report released on their website, both drugs (which have been used to treat depression, panic disorder and Type II diabetes) failed to meet the standards implemented by the FDA which ensure product safety, quality and purity. The FDA indicated that GSK voluntarily recalled some of the effected lots of the two drugs, but not all of them. Their failure to eliminate the potential threat through total recall resulted in the seizure by US Marshals and the FDA. It makes me wonder: what if there are other drugs on the market whose contents are tainted as well? As I mentioned before, it won’t necessarily make me easier knowing they were FDA approved!
This age of mercenary medicine is risky and volatile. The driving force behind pharmaceuticals is reflected in one word: profit. An article appearing on Forbes.com on February 9, 2005 indicated that there is profit to be made for potential investors willing to take advantage of the market downtime for painkillers such as Vioxx and Celebrex. According to Merck & Co., Inc, the makers of Vioxx, some two million people worldwide use the drug, which would account for the company’s $2.5 billion revenue in the year 2003. Alongside Pfizer’s Celebrex and Bextra, total sales for these types of drugs exceeded $6 billion in that same year. Maybe the pharmaceutical giants have forgotten that the purpose of their product is supposed to benefit the health of the consumer. I wonder if maybe they haven’t confused good health with fat wallets.
Where does this leave me as a consumer? If get sick, how can I be assured that the medicine I’m taking for my condition won’t cause me serious harm? In light of these recent events, more and more people are asking these questions. In our effort to evade the perils of sickness, we cannot ignore the threat that may be posed to us by the very medicine we ingest to treat our illnesses. The only way we can hope to arm ourselves against this potential threat is through education. After all, what we don’t know may indeed be killing us.