Judge Details Schering's "Reprehensible" Off-Label Promotion of Cancer Drugs

Last Updated Jul 21, 2009 3:51 PM EDT

Schering-Plough won a federal court ruling ending a class action case that alleged it promoted Intron and Temodar for off-label uses. Federal district court judge Stanley Chesler ruled that even if the company did tout the two cancer drugs off-label plaintiffs must still prove that the drug was ineffectively used, and that patients got no benefit from it.

The paintiffs were the Teamsters whose benefit program paid for the drugs. The ruling details much of Schering's sorry history with these two drugs. The judge even called Schering "reprehensible."

In 2006, Schering pled guilty to criminal conspiracy to make false statements to the FDA in that agency's probe of the company. It paid a $180 million fine. Schering had promoted the drugs for cancers that were not indicated by the FDA, and where the drugs had only marginal effectiveness. Among the techniques Schering used, the judge wrote:

  • Using continuing medical education programs ("CME's") directed and controlled by Schering sales representatives to promote off-label uses of Temodar and Intron;
  • Devising a program, dubbed the Consulting Care Network, where Schering-paid physicians would respond to queries by physicians by promoting Schering drugs for off-label use;
  • Marketing the Subject Drugs for off-label use at national and regional meetings of doctors and the health care industry;
  • Targeting doctors who prescribed competing drugs with a "barrage of off-label marketing techniques";
  • Paying doctors who prescribed the Subject Drugs for off-label uses to speak at dinner lectures and other functions;
  • Entering into paid consulting agreements with physicians for which little or no work was required; and
  • Providing research and educational grants to Pharmacy Benefit Managers (PBMs) ostensibly to induce them to place the Subject Drugs on TPP formularies.
Sales of Temodar increased by 10 times due to the program and Intron sales doubled, the Teamsters alleged. As a result, the workers' benefit plan paid out billions of dollars for drugs that were not needed.

The judge didn't buy it because the Teamsters didn't specifically prove that the drugs were ineffective on the patients who took them:

There is no question that the illegal conduct to which Schering Sales pled guilty represents this corporate Defendant's reprehensible disregard for the vital role the FDA plays in ensuring the safety of consumer pharmaceutical products. ... [But] neither the individual plaintiffs nor the TPPs suffer cognizable injury when they pay for drugs which are marketed off-label...
Download a copy of the ruling in Teamsters v. Schering Plough here.