Danger in Secrets
You hear of dangerous side effects all the time: “Risks may include diarrhea, dizziness, fainting, and possible death.” Well, what if you were prescribed a prescription drug without knowing these side effects?
Merck Side Effects Cover-up
Merck & Co. announced on September 30, 2004 that Vioxx– known generically as rofecoxib –was shown to have side effects that doubled the risk of heart attacks and stroke. That announcement came after Vioxx was already on the market for 5 years and already used by more than 20 million patients and long after Merck had already known of the risk.
Prior to the announcement Merck had denied that Vioxx raised the risk of heart attack, but Merck decided to run two tests just to “make sure.” These studies did confirm the increased risk, but Merck did not make the results of the second test public until after the drug was already taken off the market.
Bayer in 2006
Similarly, on September 30, 2006, Bayer decided to share reports on the side effects of Trasylol– known generically as aprotinin –with the Food and Drug Administration (FDA) in a meeting, again, after it was already on the market for 13 years. That same day, the FDA warned the country that the medication could cause kidney failure, the heart to not pump as effectively as it should, stroke, and even death.
In a study (not Bayer’s), it was found that among patients undergoing uncomplicated surgery of the coronary-artery (within the heart), those who received Trasylol had a 55% increase in heart attacks or heart failure and a, whopping, 181% increase in stroke or brain disease.
Later, Bayer had hired a private research organization to perform its own large study of complications that the drug had given patients. They reached similar results to the previous study, but they did not report any of these findings to the FDA. They simply ignored the conclusions all this time, until the meeting on September 30.
Bayer later admitted that it was “a mistake” to have kept that valuable information to themselves. But, it is hard to accept this apology since it was not the first time they had behaved this way. In 2001, Baycol (cerivastatin)– which was used to lower cholesterol –was withdrawn from the market due to information that Bayer had been hiding from the FDA.
Not the First Time
The disturbing thing about these two incidences is that they are not too rare. There have been many, many instances of pharmaceutical companies suppressing data on side effects.