" In April 2001, Merck conducted high-quality analyses that identified a three-fold increase in the risk of deaths for patients taking Vioxx compared to those taking placebo. These analyses were not submitted to the FDA or made public. When Merck submitted data to the FDA in July 2001, they used a counting method that minimized the appearance of any risk. The FDA looked at the data that was submitted in July and it was still of concern. In December, the FDA raised questions about the mortality findings. Merck simply dismissed the FDA concerns and was unable to discern any “compelling or clear safety issue” here.
By conventional scientific standards, a three-fold increase in death is a major safety issue. And failure of a sponsor to inform participants, investigators, the subjects of the study, the FDA, of the mortality findings violates the trust of the human subjects.
This information may well have been important to thousands of patients in April of 2001 who were taking Vioxx.
They may have decided not to take it. "
MSNBC
3 comments:
The Vioxx VIGOR results indicated that there was a three-fold increase in cardiovascular incidents. The study was performed by an independent group, put together to assess the risks of the new medication therapy. Was it all Merck's fault that the product went to market having these high risks associated with it? Merck had information that threw up red flags concerning the risks. Merck’s president stated that he was kept in the dark regarding the risks of Vioxx because that was policy until all research had been completed. The FDA, on the other hand, approved the drug for market even though they had concerns about its potential risks.
Did the FDA do its job to protect the general public from disaster or was it too quick to give the okay due to the monetary giant backing the drug? The FDA’s main job is to protect the people from potential dangers in the food and drug industry. Where were they on this one? It is easy to blame the manufacturer (Merck) for their role in the deaths of patients on this medication because they had something to gain by rushing, and botching the results of their research, (MONEY). But, the FDA should be just as at fault because they are the overseers and have the final say on what actually makes it to market. Is it really that easy to pull the blinders over the FDA’s eyes and trick them into allowing something harmful to make it to the general public?
If the FDA had concerns about Vioxx, why did they approve it? The FDA raised concerns to Merck, who did not provide the data necessary for the FDA, but they still approved it? Who is responsible here?
The VIGOR study provided Merck with data regarding an increase in cardiovascular events compared to other NSAIDs already on the market. This information should have been red flagged. The Merck authors (for the reports submitted to the FDA) were not provided the data regarding the three fold increase in cardiovascular events therefore it was not written into the reports submitted to the FDA. “ Merck simply dismissed the FDA concerns and was unable to discern any “compelling or clear safety issue” here.” The FDA did approve Vioxx even though they had concerns but were not given the requested data from Merck. Since the FDA did not have the data they needed, why did they approve the medication? Doesn’t this make them also responsible?
Merck knew about the cardiovascular events but didn’t provide the data to the necessary systems, but the system that is supposed to protect the American citizens also failed. The FDA could have delayed approval for this medication, or denied the approval until the VIGOR study was completed. If the FDA had been given the data on the cardiovascular events, could they have approved this medication with warnings? There are many medications on the market that do harm but the benefits outweigh the risks. This medication did not cause the side effect in all patients, just more than other NSAIDs, and did help many.
Merck getting through their research and the FDA approval process while hiding the damaging cardiovascular effects of the medication is astounding.
It amazes me that Merck advertised the possibility of GI complications, but after the drug was withdrawn from the market, new studies showed that cardiovascular complications were even more common than GI complications. To say complications seems like an understatement; a 3-fold increase in mortality while taking Vioxx compared to a placebo is ludicrous. Merck then changed their reporting style of the results and the data slipped under FDA’s radar.
FDA wrote Merck a letter in 2001, ordering them to warn the public of the cardiovascular effects of Vioxx in their advertisements. Merck still advertised the medication without a disclaimer of cardiovascular complications through 2002. These advertisements led the public to believe in the safety of this medication, ultimately leading to the increased popularity of this medication.
Merck’s APPROVe research in 2004 found that cardiovascular effects were a common side effect of Vioxx. This was the determining factor in the voluntary withdrawal of Vioxx from the market. Merck had already been warned of these same findings by the FDA in 2001. Merck should not be able to pretend they had no idea of the cardiovascular effects until 2004; this portrays Merck as doing the right thing and pulling the drug off the market ‘voluntarily’.
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