Dangerous Deception: Hiding the Evidence of Adverse Drug Effects

From the New England Journal of Medicine

By Jerry Avorn, MD

SUMMARY: This NEJM Perspective by Dr. Avorn examines the concealment of adverse drug effect evidence, using the Vioxx withdrawal and the FDA aprotinin (Trasylol) warning as central case studies. Avorn opens with the September 2004 Merck announcement that rofecoxib doubled the risk of myocardial infarction and stroke — leading to its withdrawal after five years of use in more than 20 million patients — and argues that internal Merck data showing elevated cardiovascular risk had been available before the drug was launched. The piece calls for greater transparency in the reporting and disclosure of adverse drug effects, arguing that the current system allows pharmaceutical companies to conceal unfavorable safety data, putting millions of patients at risk.

BACKGROUND: The 2004 withdrawal of rofecoxib (Vioxx) after its cardiovascular risks became undeniable revealed that internal Merck data showing elevated risk had existed prior to the drug's commercial launch. Similar concealment concerns surrounded other widely used drugs.

KEY FINDINGS: Merck announced in September 2004 that rofecoxib doubled the risk of myocardial infarction and stroke, leading to market withdrawal after more than 20 million patients had used the drug. The piece argues that companies have hidden adverse-effect evidence.

IMPLICATIONS: Greater transparency in the reporting and disclosure of adverse drug effects is essential to patient safety. The existing system creates insufficient incentives for pharmaceutical companies to share unfavorable safety data proactively.