Magazine article Drug Topics

Congress Debates Price of Drug Found by Government

Magazine article Drug Topics

Congress Debates Price of Drug Found by Government

Article excerpt

What's fair is fair. But what's fair often depends on your point of view.

Consider Taxol.

Tax dollars paid for field and lab work and for the salaries of the researchers who discovered Taxol (paclitaxel), the newly approved anticancer agent. The National Cancer Institute puts its bill at $32 million. Tax credits helped the Bristol-Myers Squibb Co. cover further research and development costs after the company signed an agreement with the NCI to get the drug approved and on the market. Half of the Pacific yew tree bark, the source of Taxol, came from federal forest lands. Tax dollars are used to purchase Taxol from BMS for Medicaid, Medicare, and other federal health programs. Taxol is not patentable, but BMS is protected from generic competition for five years.

The drugmaker contends: For its part, BMS has told Congress that it spent "substantially more" than the $114 million it committed to when it signed a Cooperative Research and Development Agreement with NCI two years ago. BMS said it met or exceeded the four goals contained in the CRADA: It increased supplies of the tree bark; it formulated 30 times more Taxol for NCI than the agency had ever had before; it launched an effort to find alternative or synthetic sources of Taxol and will eliminate the need for the bark entirely by 1996; and it filed a New Drug Application with the Food & Drug Administration 18 months after signing the CRADA, beating the deadline by a full 30 months.

On Dec. 29, 1992, after just five months of review, BMS received FDA approval for Taxol to treat refractory ovarian cancer. BMS said that at full wholesale price the cost per patient per treatment cycle would be $986.18. Taxol is administered intravenously. The recommended dose is 135 mg/m sup 2 by continuous infusion over 24 hours. Patients responding might receive up to eight treatments three weeks apart, for a total of almost $8,000. BMS said it would supply Taxol free to NCI as well as to anyone uninsured or ineligible for government assistance and unable to pay. Medicaid and certain other government programs will get a discount.

What is just? Is the price BMS is charging fair, given the federal government's and the taxpayer's investment? Rep. Ron Wyden (D, Ore.) doesn't know for sure, but he doesn't think it is. NCI's Bruce Chabner, M.D., doesn't know for sure either, but he thinks it is. Zola Horovitz of BMS does know for sure, and he thinks it is, too.

Wyden, chairman of the House small business subcommittee on regulation and business opportunities, convened a hearing late last month that used Taxol to focus on drugs developed with significant government support. …

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