During a congressional hearing on May 5, the House Government Reform Committee harshly criticized both the Food and Drug Administration and drug makers for their role in approving and marketing Vioxx, an arthritis painkiller linked to heart disease. Last September, Merck voluntarily pulled Vioxx from the market after it was found the drug's use led to increased risk of heart failure. Both Merck and FDA were aware of the potential dangers associated with Vioxx in 2000. Still, Merck continued to aggressively market it while FDA sat quietly on the sidelines. At the time Merck pulled the drug, Vioxx had already been on the market for 5 years and used by more than 8 million people. An estimated 88,000 to 140,000 Americans have suffered serious medical complications due to Vioxx. Representatives from FDA and Merck both testified at the hearing. House members were critical of the questionable behavior of both the drug maker and the agency, whose financial ties to the pharmaceutical industry and legal limitations precluded it from acting despite mounting evidence of Vioxx's failures. Aggressive Marketing The committee released documents detailing Merck's aggressive marketing strategy. The product of the committee's six-month investigation of the Vioxx crisis, these documents revealed a pattern of using carefully crafted sales techniques and questionable presentation of scientific information in a campaign to push Vioxx and minimize its risks. The documents gave insight not only into the operations of one drug company but also to the sales and marketing strategies employed by a multi-billion dollar industry. As Rep. Henry Waxman (D-CA) asserted, "the documents may offer the most extensive account ever provided to Congress of a drug company's efforts to use its sales force to market to physicians and overcome health concerns." Merck's meticulous marketing strategy instructed its army of 3,000 Vioxx field representatives on everything from how to shake the doctor's hand to how to eat bread at dinner. At the center of the controversy was a March 2000 study called Vioxx Gastrointestinal Outcomes Research (VIGOR), which showed that Vioxx was five times more likely to lead to a heart attack or stroke than naproxen. Rather than informing doctors about the study, Merck field representatives were instructed to avoid bringing up VIGOR. If doctors asked about the study, drug representatives were instructed to say, "I cannot discuss the study with you," and to refer the doctors to file a request for drug information with Merck. According to Waxman's statement to the committee: Merck instructed these representatives to show physicians a pamphlet indicating Vioxx might be eight to 11 times safer than other anti-inflammatory drugs, prohibited the representatives from discussing contrary studies (including those financed by Merck) that showed increased risks from Vioxx, and launched special marketing programs -- named "Project XXceleration" and "Project Offense" -- to overcome the cardiovascular "obstacle" to increased sales. Drug representatives also tried to persuade doctors that Vioxx is safe by using a "cardiovascular card" that purported to show Vioxx was safer than other painkillers. The card used aggregated data from several pre-approval studies but excluded the findings from the VIGOR study. FDA scientists told the committee the cardiovascular card used by Merck was not only misleading but "said that the relevance of Vioxx's pre-approval studies to the drug's cardiovascular safety was 'nonexistent' and that it would be 'ridiculous' and 'scientifically inappropriate' to present mortality comparisons from these trials to physicians." Committee members were highly critical of both the drug maker for its use of such highly misleading information and FDA for allowing such a questionable practice. Several asked Stephen Galson, director of the Center for Drug Evaluation and Research at FDA, about the legality of such a card. Galson said the card was technically legal. FDA Director of the Office of New Drugs (OND) John Jenkins did concede that, though technically legal, the card did not "present the entire picture." Dennis Erb, Merck's vice president for global strategic regulatory development, testified that it is Merck's policy that field representatives only discuss data from the drug's label. Since the VIGOR study came out after the drug's approval, Erb argued, it was not included on the label and therefore excluded from the sales pitch. This answer prompted harsh language from several lawmakers. As Waxman pointed out, drug makers are barred from discussing off-label uses of a drug but can legally discuss health risks not mentioned on the label. Rep. Gil Gutknecht (R-MN) questioned whether FDA's response was ethical, even if it did follow the letter of the law. Galson responded that "ethics is an important part of what we do." An Industry-Wide Pattern of Aggressive Marketing The influence of drug makers on doctors' prescribing habits extends far beyond the pitch of a sales representative. Drug companies are the single leading source of information on drugs for many doctors, according to testimony by Dr. Michael Wilkes, vice dean for medical education at the University of California, Davis, School of Medicine, and drug companies spend $20 billion annually to market their products. As Wilkes asserted in testimony, aside from sales representatives, doctors receive much of their information on new drugs from Continuing Medical Education (CME) conferences and journal advertisements, both of which are underwritten by drug companies. According to Wilkes, "CME has become an important part of doctors' professional lives and PhRMA money has become the life-line of CME." Drug companies and doctors "have an unhealthy symbiotic relationship that is pulling down the medical profession.... Medical journals, medical societies, and even medical schools fight to woo drug company sponsorship of educational events." The pharmaceutical industry does much of its marketing to doctors through the guise of "educational outreach," but as is clear from the Merck investigation, the presentations of drug companies are intended to sell products rather than educate doctors. Wilkes pointed to one study of pharmaceutical advertisements that "showed that much information (42 percent) failed to comply with one or more FDA regulations, including 35 percent which lacked fair balance between risks and benefits." Wilkes' research has also shown that "40 percent of print ads in medical journals did not present fair balance, 58 percent contained images that expert reviewers felt minimized concerns about side effects, and that 47 percent of the ads did not appropriately highlight risks and contraindications in special populations such as the elderly." Wilkes made it clear that Merck is not alone in its aggressive marketing of drugs and that the problems found at Merck are pervasive throughout the pharmaceutical industry. When questioned, Wilkes conceded that Merck's reputation is better than most other pharmaceutical companies. This admission prompted several representatives to call for another hearing featuring Merck's competitors. FDA: An Ailing Agency? Not only does the pharmaceutical industry have an unhealthy symbiotic relationship with medical professionals, it also has considerable influence over the FDA, the agency responsible for assuring drug safety. In 2002, FDA began to work with Merck to change the label of Vioxx. Initially FDA wanted the label to explicitly warn physicians that Vioxx could cause heart attacks and other cardiovascular problems, but after negotiations with Merck, FDA backed away from its initial recommendations and listed the cardiovascular risk as merely a precaution. The agency also allowed Merck to include several studies that showed no increased cardiovascular risk in the label material and permitted the exclusion of some important findings. The agency also argued that it is limited by law in its ability to regulate the drug industry after a drug has been approved. According to Jenkins, FDA has limited authority to require post-marketing trials of approved drugs. FDA can require post-marketing trials on pediatric drugs or when a drug is approved through accelerated approval. In other cases, according to Jenkins, FDA's authority to require more trials is "not so clear." The agency can, however, encourage a drug company to run more trials. FDA often advises companies on clinical trials and will occasionally request a written commitment from a drug company to run a trial. The agency will also review the protocol of studies and give the drug maker feedback. FDA's ability to ensure the safety of pharmaceuticals may also be hampered by its internal structure. FDA's Center for Drug Evaluation and Research (CDER) houses both the Office of New Drugs (OND), which approves new drugs for the market, and the Office of Drug Safety (ODS), which investigates the safety of drugs already on the market. The first Vioxx hearing last November revealed mounting tension between these two offices. Though they are theoretically independent of one another, testimony revealed that the Office of New Drugs exerts considerable influence over the Office of Drug Safety. Many advocates believe such influence is inevitable when the same agency both approves drugs and evaluates their post-market safety. The agency is often reticent to release criticism of drugs already on the market, and this reluctance to act leaves patients at risk for serious side effects. The OND also receives money from drug companies to expedite the drug approval process. In response to criticism of FDA's drug oversight, Secretary of Health and Human Services Mike Leavitt announced in February the creation of a Drug Safety Monitoring Board. The board will be responsible for overseeing drug safety policies and resolving internal disputes over drug risks as well as approving information and content for a new government website on drug safety information. Though a step in the right direction, the creation of the board does not address many of the maladies of FDA. Strengthening FDA to Respond to These Unmet Needs Several members of Congress asked about FDA's authority to discipline Merck or other drug companies that, as Rep. Dennis Kucinich (D-OH) put it, "unscrupulously continue promotion" of a dangerous product. Though FDA has some authority to discipline a drug company, Merck's actions were permissible under FDA regulation, and that fact underscores the wide chasm between what is legally permissible and what is ethical. Rep. Maurice Hinchey (D-NY) has put forward a proposal to reform FDA. His bill, the FDA Improvement Act of 2005, would prohibit FDA from taking money directly from drug companies. Instead, industry payments would go directly to the Treasury general fund. The bill would ensure that FDA funding would not be impacted but that drug makers would no longer have direct influence on FDA's funding. The bill would also attempt to bar conflicts of interest on FDA advisory panels, create an independent center for post-marketing research, and give FDA the authority to require drug makers to perform post-market research and change labels. The bill does not address, however, the aggressive marketing by the pharmaceutical companies or attempt to curb their influence over doctors.