BC/BS alleges cholesterol drug makers hid unfavorable test results

Michelle Massey, East Texas Bureau Jul. 29, 2009, 7:54am

MARSHALL – Insurer Blue Cross Blue Shield claims that the makers of two popular cholesterol-lowering drugs failed to disclose unfavorable trial test results in an effort to boost sales.

Health Care Service Corp., operating through its division as Blue Cross Blue Shield of Texas, Illinois, New Mexico and Oklahoma, filed suit against the makers of Zetia and Vytorin alleging the pharmaceutical companies violated the racketeering laws and deceptive trade acts in the marketing of the drugs.

The insurer filed suit against Merck and Co. Inc., Schering-Plough Corp. and Merck/Shering-Plough Pharmaceuticals on July 24 in the Marshall Division of the Eastern District of Texas.

Merck, through a joint venture partnership with the other defendants, develops and markets the drugs.

According to court papers, Zetia is different from other cholesterol-lowering drugs by lowering cholesterol absorption in the intestinal tract instead of in the liver. Vytorin is a combination of Zetia and Zocor. Zocor is available generically as simvastatin.

The FDA approved Zetia in October 2002 but, according to the plaintiffs, the FDA did not obtain any proof that the drug had any effect on plaque in the arteries or that it could reduce the risk of heart attack or stroke.

Prior to losing its patent protection over Zocor, the defendants developed Vytorin to sustain profits, the suit alleges. The FDA approved Vytorin in July 2004.

The lawsuit alleges that the "defendants have known (but have failed to make public) that their own study shows that Zetia does not reduce the fatty arterial plaques that can cause heart attack and stroke."

The plaintiff accuses the defendants of deceptive marketing by continuing to market the drug as able to reduce arterial plaque.

The complaint states, "Defendants have consistently marketed Zetia to consumers, physicians, and third party payors as a drug that lowers LDL in a 'different' manner, stressing that lowering LDL allegedly reduces or slows the buildup of plaque in arties."

The lawsuit alleges that the drug companies concealed the trial result after it revealed unfavorable results.

In 2002, the defendants began the ENHANCE trial which was focused on how much plaque formed in the arteries of Vytorin users. The plaintiffs maintain that the trial was completed in April 2006 but the defendants concealed the results until 2008.

When the results of the trial were finally released, "the ENHANCE researchers found that while Vytorin lowered LDL more than simvastatin alone, it did not slow the growth of carotidartery plaques more than simvastatin, a statin now available as a much less expensive generic," the complaint states.

The generic version of Zocor, simvastatin, costs 3 cents per pill, compared to $3 per pill for Vytorin.

In 2006, Zetia had sales of $1.92 billion and Vytorin had sales of $1.95 billion.

The lawsuit also states that those patients who took Vytorin had slightly more plaque growth. The plaintiffs also stated that the study produced no evidence of any kind to support a claim that Zetia reduces or even slows the buildup of arterial plaque.

The defendants are accused of racketeering activity, conspiring to commit racketeering acts, mail and wire fraud, violating the Illinois Uniform Deceptive Trade Practices Act, common law fraud and unjust enrichment.

The plaintiffs argue that the defendants have participated in a fraudulent scheme with direct control over the information of the drugs' efficacy, control over the mass-marketing and sales materials, concealed the study results, deliberately misrepresented the drugs' effectiveness and published materials containing false information.

Dallas attorneys Andrew W. Yung and John B. Scott of the law firm Scott Yung LLP and New Orleans attorneys Douglas P. Plymade, James R. Dugan II, and Justin Bloom of the Murray Law firm are representing the insurance companies.

The insurance companies are asking for a trial by jury.

U.S. District Judge T. John Ward will preside over the litigation.

Case No 2:09cv00227

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