Vioxx problems disastrous

Merck & Co. Inc. introduced Vioxx to help 40 million arthritis sufferers reduce their inflammation and pain. Although there were already other nonsteroidal anti-inflammatory drugs (NSAID) on the market, Vioxx was among a few special drugs that reduced certain side effects like ulcers and other stomach problems. That’s a big reason why within 11 days of approval Vioxx was stocked in 30,000 pharmacies across the country.

But the miracle drug had some secrets that most physicians and patients never even heard about. The first major study to raise flags about the safety of the drug came in March 2000. The Vioxx Gastrointestinal Outcomes Research (VIGOR) trial successfully proved the validity of Merck’s claim of fewer ulcers with Vioxx, but it also noted that a relatively high amount of the study group were having “cardiovascular events” such as fatal and non-fatal heart attacks, strokes, and other problems. Because the results were not the main focus of the study, the report simply recommended further investigation. Merck dismissed the findings by saying that the results had more to do with the compared drug naproxen’s relative ability to help the heart than Vioxx causing heart problems. Most in the research community accepted this as truth.

However it has come to light that Merck actually knew that there could be problems with the drug, and thought about trying to reduce the risk of heart problems even as it was denying the validity of the VIGOR trial. The FDA obviously had its own suspicions too, sending the company an official warning letter about some of its marketing materials, stating that they were “false, lacking in fair balance, or otherwise misleading…” The regulatory body could have also ordered more study directly into the connection between Vioxx and heart problems, but chose not to do so.

The most frustrating part for doctors and consumers though is that when the FDA decided the possible risk was high enough to warrant alerting the public, it took over a year to add warning labels to the drug. That’s because the company and the FDA had to agree on the wording of the warning, which meant endless back and forth negotiating the “specific language” of the package. Clearly Merck’s slogan of “Where Patients Come First” did not apply in this case.

The FDA released its own report in January 2005 showing conclusive evidence of a link between Vioxx and heart problems, five months after Merck had removed the drug from the market. It found that the drug could have caused 88,000-140,000 cases of serious heart disease. Of those cases, the national fatality rate was estimated at 44%. This report is quite literally a post-mortem – with the drug off the shelves, the study which should have been done years before did nothing to help save lives.

If you have suffered heart or related problems while taking Vioxx, contact Jim S. Adler & Associates to find out what your next move is. We will provide you with a free case review, and make sure that your rights are protected, and that you get the compensation you deserve. Contact us today by clicking the link below and launch the process of your recovery.