Merck and FDA Must Share Blame For Breaking the Trust of Vioxx ConsumersNov 5, 2004 | Allentown Morning Call
The largest prescription drug withdrawal ever sent shock waves through many communities in September. Further, shares of Merck & Co. plunged more than 10 percent Monday after a media report said documents show the Montgomery County-based company hid or denied evidence for years that its blockbuster arthritis drug Vioxx caused heart problems.
Merck and the Food and Drug Administration share blame for the fiasco. It has caused great consternation among employees of one of the world's top five drug makers, plus pharmacists, physicians and, most importantly, the many patients who thought they found relief, rather than harm, in the popular prescription drug.
An extensive Wall Street Journal report Monday told of internal Merck e-mails dating to 1997 that warned that a proposed trial might show Vioxx patients will have more blood clots than those taking another medication so much so, the trial could ''kill the drug.'' FDA approval of Vioxx for arthritis occurred, however, in 1999.
Subsequent tests confirmed a connection between use of the drug and cardiovascular problems, but company officials continued to keep evidence of a problem from the public. But that wasn't all. Merck sued a Spanish pharmacologist when it was unsuccessful in getting published a correction of an article he wrote about Vioxx's risks. It wasn't warranted. A judge ruled the publication accurately reflected the medical debate about Vioxx, and ordered Merck to pay court costs.
Merck also issued a warning to a Stanford University researcher, and gave shocking advice to employees in a training document about responding to tough questions about Vioxx with one word in capital letters: ''DODGE!''
Finally, in August, data presented at a medical conference by an FDA researcher showed higher doses of Vioxx correlated with a tripled risk of heart attack or sudden cardiac death, compared to people who weren't taking a similar drug. By September, the evidence was overwhelming during an ongoing study of Vioxx's ability to prevent colon polyps; participants had more heart attacks and strokes.
It's unbelievable that, even then, when Merck pulled its big-selling painkiller off the market, Chief Executive Raymond Gilmartin said it was ''really putting patient safety first.'' He also had the audacity to say the study findings were ''unexpected.'' But Merck's e-mail trail and the behavior of its officials in recent years related to the pile-up of bad news about Vioxx proves otherwise.
This is a serious lesson for any company with products that indicate the potential for harm to consumers, especially vulnerable medical patients. Err on the side of caution; be up-front. It's also a warning to the FDA to more quickly respond to concerns that threaten the health, indeed, the very lives of the people who want to trust the FDA to protect them â€” to do its job.