Marketing of Genotropin May Still be of Interest to Authorities

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by Jim Edwards
Brandweek December 12, 2005

The reason became evident after it was revealed that Rost had filed a whistleblower suit against Pfizer in 2003, alleging illegal sales of human growth hormone had gone unreported to authorities. Pfizer had refrained from firing Rost when the U.S. Department of Justice was investigating the company since firing a whistleblower tends to make that person’s employer look guilty. But once the DOJ backed off and distanced itself from Rost’s civil suit, Pfizer took the opportunity to oust Rost.
But as the dust settles on Rost’s old desk at Pfizer, it appears that the world’s largest drug marketer’s troubles with the former growth hormone marketing chief could be far from over.
With his court papers now unsealed, Rost claimed last week that he has twice testified to a federal grand jury about illegal marketing of Genotropin, the growth hormone that Pfizer obtained in its Pharmacia acquisition of 2003. Rost said he may have to testify a third time. He also told Brandweek that he was twice interrogated by the FBI about off-label Genotropin sales.
Federal law singles out off-label growth hormone marketing as a criminal act punishable by five years in prison. Growth hormone drugs are approved only for a narrow set of conditions, such as deficient growth in children. But there is a huge black market in anti-aging and “miracle rejuvenation” treatments involving growth hormone, largely on the Internet.

In sum, the civil side of the case may be the least of Pfizer’s Rost-inspired worries if prosecutors are moving forward with a criminal investigation. Legal experts say that simply because the feds stepped back from pursuing a civil suit does not mean that the criminal probe will falter.

“A perfectly good case can be declined and is declined all the time, sometimes because the government does not have enough time to investigate,” said Kenneth Nolan of the Nolan Firm in Ft. Lauderdale, Fla., a specialist in federal whistleblower cases.

The judge in the civil case ordered that copies of all Pfizer’s civil litigation in the matter be given to the U.S. Attorney’s Office in Boston so that it can be kept abreast of developments in the case,

Aside from Rost’s claim, three other developments indicate that Pfizer may be a focus of negative attention:

  • On Oct. 17 the Swiss firm Serono paid $704 million in fines to resolve its civil and criminal liabilities in its marketing of Serostim, an anti-AIDS wasting drug. Serostim is, essentially, growth hormone. That case was brought by the same U.S. Attorney’s Office currently receiving papers in the Pfizer case.
  • On Oct. 26, the Journal of the American Medical Association published a study which concluded that most growth hormone use in the U.S. is illegal. “Despite the fact that the vast majority of HGH prescriptions should be for children, 74% of HGH prescriptions in 2004 were for people 20 and older, and 44% were for people 40 to 59. Sales of HGH in 2004 totaled $622 million (almost 213,000 prescriptions),” said a statement from the University of Illinois at Chicago School of Public Health, which authored the article in part.
  • And in 1999, Genentech was fined $50 million for illegal marketing of Protropin, its growth hormone brand. In that case, Genentech had encouraged the use of its product in children who were somewhat short, but not actually suffering from deficient growth.

Prosecutors declined to comment last week, as did Pfizer.

When Pfizer fired its vp-marketing for endocrinology products earlier this month, it earned some long-delayed good publicity for the move.

The exec, Peter Rost, had publicly criticized Pfizer’s opposition to cheap drug imports from Canada for more than a year, while Pfizer kept mysteriously silent.