Is it due to the current profit driven health care system/industry that drugs with undesirable side effects still manage to enter the market?
By: Ringo Bones and Vanessa Uy
Ever since the discovery of aspirin over a hundred years ago, medical science had been busy searching / designing for a substitute drug that’s just as effective in managing pain without aspirin’s broad-spectrum somewhat undesirable side effects. One of these drugs is Vioxx whose generic name is rofecoxib. Vioxx / rofecoxib is a non steroidal anti-inflamatory drug (NSAID for short) developed by the drug firm Merck and Company to treat osteoarthritis, acute pain conditions, and dismenorrhoea. Rofecoxib was approved as safe and effective by the US Food and Drug Administration (FDA) on May 20, 1999 and was subsequently marketed under the brand name Vioxx, Ceoxx, and Ceeoxx.
Ever since FDA approval, rofecoxib gained widespread acceptance. Over 80 million people were prescribed rofecoxib at some time. On September 30, 2004, Merck voluntarily withdrew rofecoxib from the market because of concerns about increased risks of heart attack and stroke associated with long term high-dosage use of the drug. Rofecoxib was one of the most widely used drugs ever to be withdrawn from the market. Vioxx was Merck’s “Golden Goose” because it made them US$ 2.5 billion.
Merck’s withdrawal of Vioxx from the market is by no means an open and shut case. There’s the New England Journal of Medicine (NEJM) “controversy” on the Vioxx trial where certain data submitted to the FDA were not published in the NEJM article about the evaluation of Vioxx. The risks of prescribing rofecoxib to patients with pre existing cardiovascular disorders was found during the 2000 – 2001 Merck studies to find out if rofecoxib slows down the onset of Alzheimer’s disease or if the drug is a potential cure.
It’s quite unfortunate that Vioxx / rofecoxib was riddled with controversy like the other NSAID type drug Bextra / valdecoxib were the extent of the effects on the human cardiovascular system was not immediately known during the drug’s evaluation process. The rationale behind major drug companies producing and developing these kinds of drugs is sound because the medical community had always been searching for a substitute drug for aspirin in applications where it’s broad- spectrum of physiological effects would make it an undesirable choice. Lets not forget that if aspirin were to go through the stringency of current FDA standards of evaluation, it would never be approved for human use due to its broad –spectrum of physiological effects. Aspirin is primarily used as an analgesic and pain reliever but it also works as a mild anti-coagulant which it is used as a heart attack “preventive” for patients who are at risk for this. But aspirin’s use for this purpose requires a doctor’s supervision.
Despite of a number of drugs with attendant controversies, the medical community can’t immediately rule out their possible future potential applications. Studies have shown that Vioxx / rofecoxib is a potential Alzheimer’s disease preventive and / or possible cure. There was an article in Nature about how the teratogenic effects of thalidomide was “overlooked” because the drug doesn’t affect significantly the developing embryos of rabbits – the standard lab animal then in use back in the 1950’s - while the teratogenic nature of thalidomide was clearly evident in higher primates. Despite of thalidomide’s dangerous side effects, it has been recently used once again but this time it’s in the treatment of heart failure patients. Back in 2005, a BBC World documentary titled “Kill or Cure” featured recent trials of thalidomide being used as treatment of heart failure patients. This caused howls of protests from various thalidomide victims’ organizations around Europe criticizing the medical communities’ “failure to learn from history.”
When it comes to developing new and better drugs, the recent realities of the uneasy “marriage” between the drug industry and the medical community will always result in a “convoluted” path in drug evaluation and marketing. This is due to the results of trying to balance the demands of making a profit while staying true to the “Hippocratic Oath.”