Merck & Co.: Difference between revisions

In 1999, the [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) approved Vioxx (known generically as [[rofecoxib]]), a Merck product for treating [[arthritis]]. Vioxx was designed as a selective inhibitor of the enzyme [[cyclooxygenase-2]]. Such compounds were expected to cause less gastrointestinal bleeding than older [[anti-inflammatory]] drugs such as [[naproxen]], which were associated with 20,000 hospitalizations and 2000 deaths each year. Vioxx became one of the most prescribed drugs in history.

Thereafter, studies by Merck and by others found an increased risk of heart attack associated with [[Vioxx]] use when compared with naproxen. Merck adjusted the labeling of Vioxx to reflect possible cardiovascular risks in 2002.

On September 23, 2004, Merck received information about results from a [[clinical trial]] it was conducting that included findings of increased risk of heart attacks among Vioxx users who had been using the medication for over eighteen months. On September 28, 2004, Merck notified the FDA that it was voluntarily withdrawing Vioxx from the market, and it publicly announced the withdrawal on September 30. An analysis for the period 1999–2004, based on U.S. Medical Expenditure Survey data, reported that Vioxx was associated with 46,783 heart attacks, and along with the other popular [[COX-2 inhibitor]] [[Celebrex]], an estimated 26,603 deaths from both.

About 50,000 people sued Merck, claiming they or their family members had suffered medical problems such as heart attacks or strokes after taking Vioxx. In November 2007, Merck agreed to pay $4.85 billion to settle most of the pending Vioxx lawsuits. The settlement required that claimants provide medical and pharmacy records confirming the occurrence of a heart attack, ischemic stroke, or sudden cardiac death; the receipt of at least 30 Vioxx pills within 60 days prior to the injury or death; and confirmation of Vioxx being used within 14 days of the Vioxx-related event. The settlement was generally viewed by industry analysts and investors as a victory for Merck, considering that original estimates of Merck's liability reached between $10 billion and $25 billion. As of mid-2008, when the plaintiff class had reached the threshold percentage required by Merck to go through with the settlement, plaintiffs had prevailed in only three of the twenty cases that had reached juries, all with relatively small awards.

According to internal e-mail traffic released at a later lawsuit, Merck had a list of doctors critical of Vioxx to be "neutralized" or "discredited". "We may need to seek them out and destroy them where they live," wrote an employee. A Stanford Medical School professor said that Merck was engaged in intimidation of researchers and infringement upon [[academic freedom]].

On May 20, 2008, Merck settled for $58 million with 30 states alleging that Merck engaged in deceptive marketing tactics to promote [[Vioxx]]. All its new television pain-advertisements must be vetted by the Food and Drug Administration and changed or delayed upon request until 2018.