Firm Deceived Regulators on Drug's Danger-LA Times
Mon Jul 1,10:44 AM ET

WASHINGTON (Reuters) - Warner-Lambert Co. executives masked early indications of the diabetes pill Rezulin's danger from federal regulators and delayed telling family doctors it could kill, the Los Angeles Times reported on Sunday, citing internal company documents.

Rezulin was withdrawn from the US market two years ago--after it generated $2.1 billion in sales for Warner-Lambert, according to the newspaper.
It is a crime in the United States to deliberately conceal an important fact about the safety of a prescription drug.

In one document, "Company representatives discussed in 1998 how best to persuade doctors treating Latinos 'to take the risk of prescribing Rezulin,"' the Times said. "The same internal company document described the Latino patients as 'easy to intimidate."

"The FDA ( news - web sites) now attributes 94 liver failures, 66 of them fatal, to Rezulin. A review by The Times of reports filed with the FDA found that Rezulin was cited by doctors and others as a suspect in 556 deaths, including but not limited to the liver failures, ..." according to the newspaper.

"The newly acquired materials show that company management rebuffed employees who questioned liver-injury totals from clinical studies that excluded 38 percent of the cases. At the time, Warner-Lambert was assuring doctors nationwide that the drug was as safe as a placebo, the harmless pill used as a control in medical testing," the Times said.

After the Food and Drug Administration (FDA) gave the drug "fast-track" approval in early 1997, scores of liver-related deaths were linked to it.

Pfizer Inc., which acquired Warner-Lambert in mid-2000, is responding to more than 2,000 lawsuits filed on behalf of approximately 5,100 Rezulin users or their survivors, the newspaper reported. The Times said it obtained copies of the materials, along with transcripts of recent sworn statements by company executives and others.

Dr. Randall W. Whitcomb, Warner-Lambert's vice president for diabetes research, used an unorthodox method to count the number of liver injuries among patients who used Rezulin, trimming the number of cases the company reported to regulators and to doctors nationwide, according to the newspaper.

A federal grand jury based in Greenbelt, Maryland, has sought documents and the sworn testimony of certain former Warner-Lambert employees regarding Rezulin, the newspaper reported.

Pfizer "believes that, in developing Rezulin, Warner-Lambert made a valuable contribution to the effort to control diabetes," a company spokesman told the Times, adding that the firm felt product warnings were adequate. The spokesman refused to answer the newspaper's questions.