Merck, Pfizer ignored drug safety; focused on profits

Since the recall of Vioxx, several experts have argued that Vioxx and other Cox-2 drugs like Celebrex and Bextra were just glorified Aspirins that became blockbuster drugs merely because of slick direct-to-consumer advertising by Merck and Pfizer. They were more often marketed to people who did not need them and would derive the least benefit, and were priced several times more than what an over-the-counter painkiller like Aleve or Ibuprofen costs. And that's not all. The side effects of all of these drugs were much worse than what Merck and Pfizer disclosed. (Related articles: Pfizer may have hid Celebrex side effects and Merck could have found out Vioxx risks earlier)

It has since been reported that Merck and Pfizer engaged in a Coke-Pepsi style marketing battle flooding the airwaves with direct-to-consumer advertisements. After the recall of Vioxx, Pfizer was warned by the FDA for misleading Celebrex and Bextra ads. As Merck and Pfizer misled both arthritis patients and doctors, Merck was busy training its sales reps to dodge questions from doctors about the safety of Vioxx.

The FDA in the meantime was more busy trying to build a case why Americans should not be allowed to import prescription drugs from Canada so that it could help its friends in the pharmaceutical industry. No wonder drug safety took a back seat, resulting in as many as 140,000 Americans being injured by Vioxx alone.

Published studies of prescription painkillers Vioxx, Celebrex, and Bextra were largely geared to developing new uses for those drugs and were much less concerned with the question of whether they increased users' risk of heart attacks and strokes, according to a review of the medical literature by the Center for Science in the Public Interest (CSPI). (Related article: Arthritis patients misled by Merck advertising)

That patients taking COX-2 inhibitors might be at greater risk of experiencing cardiovascular events became known in the medical community in 2001, when researchers from the Cleveland Clinic published a warning in the Journal of the American Medical Association. Yet even after that report, none of the clinical trials published in the medical literature was designed to gauge that risk. And while CSPI found that many of the studies were funded by the drug companies themselves, even the independently funded trials failed to assess the overall cardiovascular impact of this class of drugs. (Related article: Vioxx doubled risk of heart attacks, study finds)

CSPI could determine the source of funding for 145 out of 237 published clinical trials of those drugs, known as COX-2 inhibitors. And of those 145, 103 were funded directly or indirectly by Merck and Pfizer, the companies behind the drugs, and 41 were funded by government or non-profit institutions.

Nearly 85 percent (87 of 103) of the industry-funded trials that have appeared in the academic literature since 2001 involved testing the pain relief afforded by COX-2 inhibitors for off-label uses, according to CSPI. Just 16 (15.5 percent) of the trials funded by drug companies evaluated any type of health risk associated with the drugs, and only five (4.9 percent) of those had anything to do with cardiovascular risk. Three of those were funded by Pfizer, and sought only to measure narrow questions such as those involving drug-drug interactions among cardiovascular patients. (Related article: History of Vioxx and its recall by Merck)

When research is funded by a company, it can refuse permission of publication of the findings for any reason whatsoever. In one specific case, Merck forced one of its scientists to withdraw her name from a published paper when the results showed a correlation between Vioxx and heart attacks.

"Drug companies are effusive in their self-congratulation over their big research and development budgets, but they tend to spend that money figuring out how to sell more drugs instead of answering these critical safety questions," according to Merrill Goozner, director of the Integrity in Science project at the CSPI. "The idea is to get results published in a wide range of journals so that salespersons can deliver reprints to physicians in those specialties."

Merck, for instance, funded 12 physicians associated with the Altoona Center for Clinical Research to test Vioxx against a traditional non-steroidal anti-inflammatory drug made by one of its rivals for arthritis of the knee. The results, published last year in the Journal of the American Geriatric Society, showed both worked, both were well tolerated and Vioxx offered slightly faster pain relief.

CSPI's review comes as the Food and Drug Administration is holding a three-day hearing to evaluate the magnitude of the cardiovascular risk posed by Vioxx and other COX-2 inhibitors. Its findings quantify problems finally being recognized by leading voices in the medical community. Merck has argued at the hearings that Vioxx alone is not the problem in the Cox-2 drugs class. Even Celebrex and Bextra are equally dangerous.

In the meantime, Merck has a lot of explaining to do in the courts. Hundreds of class action lawsuits have been filed against Merck and these will now be heard in Louisiana.

Recommended article: Celebrex attorneys plan to sue Pfizer