June 9, 2003. Report prepared by the General Accounting Office for
Sen. Ron Wyden.
Technology Transfer: NIH-Private Sector Partnership in the Development of Taxol.
On September 19, 2000, BMS quoted $6.09 per milligram as the RedBook average wholesale price for Taxol
($182.63 for 30 mg, or $1,826.25 for 300 milligram vials).
In August 2000, a generic producer reported that his costs of making Taxol were $.07 per milligram, so
the profit margins are very high.
Did BMS spent $1 billion on Taxol research, as they now claim? That would be pretty difficult, considering that:
BMS did not sponsor any of the clinicial trials used for the original US FDA approval of
Taxol for ovarian or breast cancer.
BMS signed its Taxol CRADA with the US government on January 1991, when
the drug was aready in government sponsored Phase III clinical trials. The US
FDA approved Taxol for treatment of ovarian cancer on December 29, 1992, less than
two years after BMS signed the CRADA. At this point BMS was using Hauser
Chemical, the US government's contractor, to manufacture Taxol.
The National Cancer Institute (NCI) recently estimated
its costs of clinicial trials for the
DCP Cooperative Group Treatment Trials
conducted between 1993 and 1999.
According to this
study, the average cost of a clinical trial was $169,789
to $310,563, depending upon the year, with an average per patient cost
of $3,861 to $6,202 (depending upon the year). For BMS to have
spend $1 billion on clincial trials, it would have to had to
enrolled more than 166 thousand patients in trials, at $6 thousand
per patient. How many patients has BMS actually enrolled in
clinical trials? Ask BMS.
How much does BMS earn on Taxol? Between $4 and $5 million
per day. (Based on the annual sales figure of $1.592 billion, as reported
by BMS in their
SEC 10-K form for the year 2000.)
CPT Testimony on
Health Registration Data Exclusivity, Biomedical Research, and
Restrictions on the Introduction of Generic Drugs. Hearings in the
U.S. Senate, Committee on Appropriations, Subcommittee on Labor, Health
and Human Services and Education and Related Agencies. The hearings focus
on a proposal to extend US health registration protection from 5 to 10
years, in exchange for R&D royalty of 3 percent paid to NIH and 3 percent
R&D reinvestment requirement. The proposal, which is pushed by
Bristol-Myers Squibb to protect Taxol, is rejected.
February 24, 1993, Ralph Nader and James Love, Federally Funded
Pharmaceutical Inventions Testimony before the Special Committee on
the Aging of the United States Senate. Includes discussion of
reasonable pricing discussions for Taxol and many other case studies.
May 31, 1998. On the web from the washingtonpost.com, but for a fee
is Li Fellers' article from the Washington Post sunday Magazine, "The
Medicine Market; Taxol is one of the best cancer drugs ever discovered by
the federal government. Why is it beyond some patient's reach?"
Sunday, May 31, 1998 ; Page W10 Section: Magazine Article ID: 9806150012.
This article included some good reporting by Li Fellers, but also bent
over backwards to present Bristol-Myers Squibb's standard misinformation
regarding its role in the development of the drug.