Sunday, April 20, 2008

Taxol, the NIH and Bristol-Myers Squibb


Brief History

In the early 60's, researchers from the National Cancer Institute, or NCI (part of the National Institutes for Health or NIH) found that samples from Yew trees showed activity against cancer cells. The NCI would continue research in this area for the next 30 years.

In January of 1991, a Cooperative Research and Development Agreement (CRADA) was entered by NIH and Bristol-Myers Squibb (BMS), which gave BMS exclusive rights to all NIH funded research on Taxol.

The name taxol was used generically until 1990, when Bristol Myers Squibb trademarked it. The new generic name is paclitaxel.

Follow the Money
According to the US Goverment Accounting Office, the NIH spent around $484 million to develop the drug between 1977 and 2002. This amount includes the funding for 5 out of the 6 clinical trials that Bristol-Myers Squibb submitted to the FDA for product approval, which it received in 1992.

In the five years that Bristol-Myers Squibb held the exclusive rights to market Taxol, they made over 9 billion dollars from its sales. Ironically, government-funded Medicare payments for Taxol totaled $687 million from 1994 through 1999, the last full year before a generic version of Taxol was approved for marketing.

The markups were incredible. I've seen estimates from between .07 and .40 for the manufacting cost of one dose, and between 4.87 and 6.00 as the "wholesale" price to doctors.

Since that time, BMS has been accused of illegally profiting by fraudulently keeping generic versions of Taxol off of the world market, and this issue has been the subject of a Congressional investigation. Bristol-Myers Squibb has been sanctioned by the Federal Trade Commission for these tactics.

In Summary
The NCI and NIH funded almost all of the research in developing one of the most effective cancer-fighting drugs on the market. The NCI and NIH are funded by US tax dollars.

Bristol-Myers Squibb paid a pittance for an exclusive license on that research, and made billions of dollars from the sale of the drug in question. BMS further used aggressively unethical means to try to keep this highly effective drug falsely expensive and exclusively in their own hands. The result? BMS rakes in money on a drug created by US tax dollars while leaving cancer patients who can't afford their inflated prices to do without or incur huge medical debt to get the treatment.

As a side note, nearly half of all personal bankruptcies in the US involve medical debt.

Links of Interest:
Consumer Project on Technology's Page on Disputes Involving Taxol (some of the news links on this page are outdated) LINK

United States General Account Office's Report to Senator Ron Wyden on the Transfer of Technology - NIH-Private Sector Partnership in the Development of Taxol (PDF) LINK

NYTimes article: States Accuse Bristol-Myers of Fraud on Taxol LINK

Further Reading: