David Graham blasts Merck, Pfizer, FDA & Cox-2 drugs
Highly respected FDA scientist Dr. David Graham, who is being harassed by his superiors at the agency and was barred from presenting his research was finally allowed to do so after intervention by Senator Grassley, has essentially argued very convincingly that there is no real value in having Cox-2 drugs like Vioxx (since recalled), Celebrex, and Bextra on the market.
Dr. Graham, with Yale Medical School and John Hopkins on his resume, has made himself highly unpopular among pharmaceutical firms like Merck and Pfizer and their cronies inside the FDA by exposing the cozy relationship between the drug companies, the politicians in Washington, and the top brass at the FDA. It is common knowledge that not only did Merck and Pfizer knew that Cox-2 drugs had serious side effects on the heart, even the FDA did nothing to stop the injuries, that are now estimated to be at least 140,000 in the United States alone. (Related article: Merck and Pfizer ignored drug safety; focused on profits)
The only area in which Dr. Graham agrees with Merck is that the problem is not with Vioxx alone. Other drugs like Celebrex, Bextra, Prexige, and Arcoxia have the same problem, as argued by Merck. He did say, however, that Celebrex and Bextra in smaller doses do not pose as much risk as Vioxx does. (Related article: Pfizer still claims that Celebrex, Bextra safe)
A few other findings that Dr. Graham presented:
- Vioxx is so dangerous that it can cause harm immediately, not after a year and half as Merck has claimed. (Related article: Vioxx doubled heart risk, study finds)
- Naproxen (sold as Aleve) is no good alternative to Vioxx, Celebrex, and Bextra.
- Painkiller Mobic, which has become quite popular since the Vioxx recall, also showed an "increased risk" for heart attacks in preliminary data. (Related article: Use of Mobic restricted outside the US)
It is important to remember that both Merck and Pfizer received approvals for their Cox-2 drugs using a fast-track process. That process allows the drug companies to not study long-term side effects of drugs prior to their approval. This puts the patients at risk since they are taking drugs for which enough information is not available. The problem got even worse in the case of Vioxx and Celebrex because these drugs were marketed like consumer products when many doctors knew that they were only just as good as an Aspirin for pain relief though had serious side effects on the heart. (Related article: Merck and Pfizer fought Coke-Pepsi style marketing battle over Vioxx, Celebrex, and Bextra)
Dr. Graham has argued that Vioxx should have never been approved. He criticized the drug approval process that allows drug companies to not conduct long-term trials. He also implied that the FDA was not doing its job of protecting the health of American people.
Other related developments:
Vioxx class action law suits to be tried in Louisiana
FDA tries to protect Merck and Pfizer
