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Did Journal rush to judgment on Avandia?When the New England Journal of Medicine (NEJM) published a new study in May 2007 that showed an increased risk of heart attack for diabetics being treated with Avandia, reports of panic swept the media. But some say that the panic itself was media-born, though ultimately it was the highly respected medical journal that irresponsibly planted the seed. In Making Sense of the Avandia Mess, Trevor Butterworth of Stats.org notes the “sensationalized reporting” of the risks, and mentions that critics (it is not completely clear if he is one of them) condemn the NEJM for a “shameless political agenda.”
“The rush to damn and ditch Avandia is far from justified by the actual data compiled and analyzed in the study,” Mr. Butterworth states.
Not only is the number of overall cases of heart attacks low, he says, but the research methods are not 100% scientifically sound. He points out that the researchers themselves underline this fact. The NEJM, in the accompanying editorial, also highlights the possible flaws in the research.
The Lancet, another highly respected medical journal from Britain, also took exception to the NEJM’s approach, stating that “to avoid panic among patients, a calmer and more considered approach to the safety of [Avandia] is needed” and that “alarmist headlines… help nobody.” The Lancet printed this editorial in the same issue as a letter they printed from GlaxoKlineSmith, the manufacturer of Avandia, defending their drug. Protecting consumers is paramount Even if the NEJM is guilty of over-hyping the side effects of Avandia (and that is not yet clear) then the only “political agenda” the journal has is to protect consumers – something that the editors clearly feel that the Food and Drug Administration (FDA) and especially the drug companies themselves are failing to do themselves in a timely manner. Indeed, in GlaxoKlineSmith’s own letter in The Lancet, the company admits that their numbers in previous trials “in the same direction” as this study’s conclusions. However, the company stated, it all depends on how you look at the data, which is why the company is conducting more studies.
Not many people argue that there are serious problems at the FDA and with its drug approval process – including many within the FDA itself. And not many would argue that every single pharmaceutical company including GlaxoKlineSmith has its own “political agenda” – to make the market as open as possible by any means possible so that they can make as much profit as possible.
Drug companies and the FDA like to say they are erring on the side of caution by confirming possible safety hazards of their drugs through years of careful study before coming to any conclusions (all the while making millions or billions of dollars on the possibly dangerous drugs). Recalls of Vioxx, Bextra, and many other drugs did not come until both the FDA and the drug companies were absolutely sure that they were hurting people.
The NEJM, on the other hand, seems to believe that the safety of the patients should come before profits. If raising the alarm about a possible dangerous and deadly side effect that could save hundreds if not thousands of lives at the cost of profits is considered “scare-mongering” and “irresponsible,” it makes you wonder about what the word “morality” really means to the pharmaceutical industry. Contact an Avandia attorney If you or a loved one has suffered a heart attack while taking Avandia, contact an Avandia lawyer with Jim S. Adler & Associates for a free case evaluation. Ultimately it is the pharmaceutical companies who are responsible for their products. You may be eligible for compensation to cover your added medical bills, lost wages, and pain and suffering. Call Jim S. Adler & Associates directly or fill out the details of your Avandia injury in the form on this page. |