Merck Withdraws Vioxx After Concealing Heart Attack Risk, FDA Failure Causes Estimated 28,000-55,000 Deaths

Merck voluntarily withdraws Vioxx (rofecoxib) from the market after concealing evidence that the blockbuster arthritis drug increases heart attack and stroke risk. Internal company documents reveal that Merck knew of cardiovascular dangers years before withdrawal, while the FDA failed to act on mounting safety signals. FDA scientist David Graham estimates the drug caused between 88,000 and 139,000 heart attacks in the United States, with 28,000 to 55,000 deaths.

Vioxx generated $2.5 billion in annual sales at its peak, prescribed to over 20 million Americans as a supposedly safer alternative to traditional painkillers. Merck’s clinical trial data showed elevated cardiovascular risk as early as 2000, but the company publicly minimized the findings while internally training sales representatives to deflect physician questions about heart attacks. A 2001 internal email instructs: “Do not initiate discussions of the FDA Arthritis Advisory Committee or the results of any studies with physicians.”

FDA reviewer David Graham conducts an epidemiological analysis estimating the cardiovascular death toll, but the agency suppresses his findings. When Graham attempts to present his research at a scientific conference, FDA supervisors pressure him to water down conclusions and threaten his career. Graham later testifies before Congress that “the FDA as currently configured is incapable of protecting America against another Vioxx” because the agency has been “captured” by the pharmaceutical industry it regulates.

The scandal reveals structural conflicts embedded in FDA’s user fee funding model. With pharmaceutical companies paying for their own drug reviews through PDUFA fees, FDA becomes financially dependent on the industry and focused on approval speed rather than safety monitoring. Post-market surveillance receives minimal resources, and scientists who raise safety concerns face retaliation from leadership oriented toward industry cooperation.

Congressional hearings expose the depth of regulatory failure. Merck executives admit the company never conducted a study specifically designed to evaluate cardiovascular safety, despite early warning signals. The FDA acknowledges receiving citizen petitions requesting stronger warnings that it never acted upon. The Vioxx disaster demonstrates that pharmaceutical industry influence over FDA creates a regulatory environment where company profits take precedence over patient safety.