WASHINGTON -- Sen. Howard Metzenbaum, author oflegislation to limit revenues for orphan drugs, has come underincreasing industry allegations that the lawmaker is usingdistorted statistics to support his bill.
The Ohio Democrat has used revenue and expense data tosupport his contention that pharmaceutical and biotechnologycompanies are reaping exorbitant profits on drugs that havebeen awarded orphan status to treat rare diseases.
Several companies, however, contend that Metzenbaum'sfigures are inaccurate and that his comparison of R&D costs tototal sales is misleading.
William Turenne, Eli Lilly and Co.'s director of governmentrelations, sent Metzenbaum a letter on Jan. 17 correcting the$16 million figure for R&D expenditures for Humatrope humangrowth hormone. "Even a partial tabulation of Lilly's R&Dinvestment in hGH reveals over $60 million in direct costs,"Turenne wrote. Metzenbaum's Labor and Human ResourcesCommittee released the $16 million figure at hearings onTuesday (see accompanying story).
The R&D figure also does not cover other costs of developinghGH, said Turenne, "such as basic research costs, the cost ofequipment necessary to develop and produce the product, and,most importantly, the opportunity cost of the money involved.A conservative estimate of the capital cost would push Lilly'shGH expenditures far above $100 million."
Amgen Inc. and Genzyme Corp. also dispute both the specificfigures Metzenbaum presented on Tuesday and his failure toinclude costs other than R&D in computing profits.
Amgen has earned $781.8 million from sales of Epogenerythropoietin since it received approval in June 1989, not the$893 million presented Tuesday, according to spokeswomanKimberly Dorsey. Amgen does not dispute the committee'sfigure of $150 million in total R&D costs for Epogen, but Dorseysaid the figure "doesn't include cost of goods, cost of money, orthe cost of educating the physicians." Metzenbaum "tends toshow one narrow slice of the cost, but the whole pie for therevenues," she said, "and that isn't a fair representation."
On Tuesday, the committee used revised figures for sales ofGenzyme's Ceredase after the company's president and CEO,Henri Termeer, wrote Metzenbaum to complain that thelawmaker was combining total revenues from several productsto inflate apparent sales of the drug.
And although the committee now uses $38 million for Ceredasesales, the company disputed the committee's figure of $30million for Ceredase R&D. Genzyme spent $54 million, accordingto spokeswoman Donna LaVoie.
The committee provided sources for its figures, which includedarticles in the popular press, court proceedings andcongressional testimony. Metzenbaum's office on Tuesday wasunavailable for comment on specific figures.
-- Steve Usdin BioWorld Washington Bureau
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