Monday, August 22, 1994
What Wyden, Rifkin are charging
By Steve Usdin
WASHINGTON - A congressional inquiry into human growth hormone marketing practices, sparked by the recent indictment of a Protropin distributor and a Genentech Inc. marketing executive, is being fueled with data from a group led by biotechnology critic Jeremy Rifkin.
Rep. Ron Wyden, D-Ore., has asked the Federal Trade Commission to investigate the Rifkin group's allegations that the two U.S. manufacturers of hGH, GNE and Eli Lilly and Co., have co-opted the non-profit Human Growth Foundation into promoting sales of GNE's Protropin and Lilly's Humatrope. Wyden also is pressing the government to pursue allegations that GNE or its agents are promoting off-label uses of Protropin, according to Steve Jenning, staff director of Wyden's subcommittee on regulation, business opportunities, and technology.
Wyden has limited his inquiries and requests for government action to GNE, because the company has 70 percent of the U.S. market, Jenning said. Lilly's share is about 30 percent.
Most of Wyden's information about the Human Growth Foundation and GNE's hGH marketing activities was supplied by Rifkin's Foundation on Economic Trends, said Jenning. He said Wyden plans to formally request additional data from GNE soon and probably will hold hearings on the marketing of hGH before December.
The lawmaker wants to limit use of the hormone to "dwarfism", Jenning said. Based on Rifkin's data, "it seems apparent to us that the company and various agents and partners are trying to expand usage of the drug for purposes not approved and for which there is a dearth of clinical evidence regarding safety and effectiveness," he said. The FDA exonerated GNE in 1992 after investigating similar allegations.
According to the approved label, Protropin "is indicated only for the long-term treatment of children who have growth failure due to an inadequate secretion of endogenous growth hormone." The label provides prescribing physicians a great deal of discretion, as pediatric endocrinologists have not reached a consensus on what constitutes an adequate level of growth hormone.
Wyden also is seeking an investigation of claims that the Human Growth Foundation, a non-profit group largely funded by GNE and Lilly, has deceived the public by acting "as a veiled marketing arm" of GNE.