Pharmaceutical representatives - "essential for physicians "?

Merck & Co.'s withdrawal of its arthritis drug Vioxx in fall of 2004 is one of the most notorious examples of premature adoption of a drug proving fatal. At the time of its removal from the market in September 2004, more than 100 million prescriptions had been dispensed. Around two million people were taking the drug, and with annual sales of nearly $2.5 million it was the model of a blockbuster. By the end of its run, between 88,000 and 139,000 heart attacks or strokes could be attributed to the painkiller according to estimates given by Dr. David Graham, an FDA analyst (http://www.adrugrecall.com/newsletter/feb05/vioxx-heart.html).

Merck pulled the drug after a clinical trial showed that it doubled the risk of heart attacks and strokes.

In March 2000, as early as one and a half years after the drug had been on the market, results of the Vioxx Gastrointestinal Outcomes Research (VIGOR) study had reported at least a fourfold higher risk of heart attacks for subjects on the drug when compared with a standard arthritis treatment like Advil or Aleve. Further discussions and investigations of these risks followed.

And yet, most of the drug's millions of prescriptions were dispensed after the drug's risks were public knowledge. How could this have been?

Direct to consumer advertising certainly played an important role - in 2000 Merck reportedly spent around $160 million on their Dorothy Hammill campaigning (http://todaysseniorsnetwork.com/excessive_ads.htm) The popular industry claim that such ads are educational is even more dubious considering that the FDA advisory panel assembled to address the drug's issues recommended pulling these ads.

The FDA itself is often subject to the whims of "big pharma," and was only able to get some form of warning label on the product as far into its lifetime as 2002. The FDA's expedited approval of Vioxx and Celebrex, both a part of a class of drugs known as COX-2 inhibitors, involved giving the drugs "priority" reviews. This meant that the drugs fulfilled an unmet need in the market or showed an improvement over other arthritis treatments on the markets. This was not the case, as their results could feasibly be obtained with drugs already available on the market. Regardless, the COX-2 inhibitors received expedited review and subsequent approval.

While direct to consumer ads have become a part of our daily lives, what concerned consumers may not be aware of is the role played by the company's pharmaceutical representatives in shaping the debacle's outcome. Documents released following an inquest from the Committee on Government Reform suggest that Merck used its sales force to shift focus away from the increasing knowledge of Vioxx's risks. Through physician interaction that provided questionable information and aggressive personal marketing, Merck managed to sustain the sales of its drug. These activities are outlined in a CGR memorandum by Rep. Henry A. Waxman (D - CA) from May 5th, 2005 (http://oversight.house.gov/documents/20050505114932-41272.pdf).

Chief among these physician tactics was an attempt at damage control from Merck's own VIGOR study. Merck's sales force was directed to show physicians a "cardiovascular card," a pamphlet that made the drug appear 8 to 11 times safer than smilar drugs. References to the VIGOR findings were omitted, and the card's information was based on pre-approval studies deemed inappropriate by the FDA due to small sample size and short duration.

Merck also saw to it that its representatives did not discuss the results of the VIGOR study, stymieing discourse with physicians. The company sent a bulletin urging its sales force to avoid initiating discussions about the study. This came after the FDA voted that physicians should be made aware of the risks.

Finally, After a New York Times article (http://www.nytimes.com/2001/05/22/business/doubts-are-raised-on-the-safety-of-2-popular-arthritis-drugs.html) from early 2001 raised concerns about the drug's safety, Merck told its sales force to warn doctors that patients on other anti-inflammatory medications "were eight times more likely to die from cardiovascular causes than patients on Vioxx."

It's obvious that drug company representatives exist to promote products, but what emerges here is a new image of the role of representative - one of a company cheerleader that sought to give misleading information to physicians and maintain blockbuster sales figures. Even an isolated incident such as this is enough to warrant a re-examination of drug representatives' profession. Vioxx and these other COX-2 inhibitors were plagued with issues from their inception in the late 90s, but the efforts made by drug sales representatives in their proliferation cannot be understated.

In light of such egregious oversights and unethical damage control efforts, can one really believe Pharmaceutical Research and Manufacturers Association of America (PhRMA) when they say that the efforts of their representatives are "essential for physicians, allowing physicians to have sufficient information about new drugs so they can prescribe them appropriately" ?