Vioxx death estimate revised upwards

It appears that the number of deaths caused by Vioxx will be revised upwards to between 89,000 to 139,000 (the data is for the United States alone). Andrew Jack of the Financial Times who interviewed Dr. David Graham, an expert at the FDA, is reporting that the data is likely to be published in the medical journal The Lancet.

In the initial estimates provided by the FDA, 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003 were attributed to Vioxx. Dr. Graham has provided these estimates in subsequent statements and since then most analysts have put worldwide deaths to be somewhere in the range of 150,000 to 200,000.

It may be pointed out that since his testimony before Congress, Dr. David Graham is fighting to keep his job. The FDA, which has literally been hijacked by the drug industry, does not want any data to be released that exposes the mess at the agency. Dr. Graham has been able to keep his job so far after lawmakers intervened and he sought protection as a whistleblower, but it seems that he really has no support within the agency or in the Bush administration. Several spokespersons in the administration, instead of admitting grave errors at the FDA, have said that the agency was actually doing a "spectacular job" of protecting the public. In his interview with FT, Dr. Graham is quoted as saying that he suspects that he might lose his job for publishing these findings. (Related article: Vioxx recall exposes the mess at the FDA)

The FDA has methodically tried to discredit his work and the nasty fight between the agency and Dr. Graham is now public news. Details of disagreements between Dr. Graham and the official position of FDA are actually available on FDA's website. Dr. Graham now claims that while his superiors at the agency have not granted him permission to publish his work but no one has yet disputed the data provided by him. Merck, for obvious reasons, does not agree with the data either. (Related article: Merck defends its Vioxx strategy)

These higher numbers of Vioxx related deaths and injuries are also likely to bolster the case being made by scientists and doctors who have been asking for recall of Celbrex and Bextra as well since both these drugs belong to the same Cox-2 inhibitors category. FDA is scheduled to review the whole class of Cox-2 drugs at its advisory committee meeting in February 2005.

The publication of the revised data is also going to help Vioxx victims and Vioxx attorneys who are currently getting ready for their class action lawsuits. This research will strengthen their argument that Vioxx killed people over a period of several years and Merck could have stopped those deaths but chose not to. (Related article: Celebrex safety concerns good news for Vioxx victims)

The number of deaths that can be attributed to Vioxx has always been a difficult number to estimate. While estimates are still relatively easy to generate for the United States and other countries in the developed world, it is almost impossible to estimate deaths caused by Vioxx in poor countries where literally no records are kept and government agencies typically do not track this data.

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