A prescription for corruption

Charles Heimbold, University of Pennsylvania trustee, has recently come under fire. His decisions as CEO of pharmaceutical goliath Bristol - Myers Squibb have brought legal trouble and criticism from diverse groups. The National Institutes of Health have filed suit against BMS for failing to pay patent royalties on a drug the NIH developed, then licensed to BMS in a technology transfer for manufacturing and marketing. Patrick Dunahill, a spokesman for BMS, has stated to a Daily Pennsylvanian reporter that the corporation "remains committed to the vigorous defense of our intellectual property." Additionally, a federal grand jury is investigating drug giveaways where BMS allegedly encouraged doctors to bill Medicare and other insurance for the BMS freebies. The FBI in Boston is interviewing employees of BMS in the matter. Most importantly, a U.S. district court judge has scheduled a review of an alleged BMS "intent to deceive," using "potentially false affidavits" for patent extensions on drugs that were scheduled for release as generics. In an ironic twist, one of the drugs BMS requested a patent extension for is the drug that is involved in the dispute with the NIH, the actual patent holder. Heimbold authorized BMS to withhold royalty payments to the NIH on sales of didanosine (Videx), which the NIH developed with taxpayers' money. The NIH holds the patent for didanosine, an antiretroviral used to fight HIV/AIDS. The NIH is demanding $9.1 million in payment for overseas sales of didanosine. Under the Bayh-Dole Act, federal agencies can license commercial partners to make and market compounds resulting from government research. BMS is probably betting that the NIH won't wage an expensive lawsuit and will settle. Sales of Videx came to $205 million in 1999, according to Stop Patient Abuse Now, an advocacy group working on behalf of patient's rights. Perhaps the NIH should suspend its licensing agreement to BMS and find a new partner. The true patent holders need to rein in the climate of corporate abuse that has set a dangerous precedent as it spirals further out of control. How out of control? Federal prosecutors are investigating whether BMS gave free drugs to private practice doctors, then distributed software that allegedly bills the freebies to Medicare, Medicaid and private insurance, according to The Wall Street Journal. FBI agents in Boston are now interviewing BMS employees to determine whether these violations of the Prescription Drug Act of 1987, and other alleged violations, occurred. Additionally, a federal judge last year wrote that BMS "took one position before the U.S. Patent and Trademark Office and another before the Food and Drug Administration," to file for patent extensions. BMS allegedly filed documents with the FDA stating that a patent extension should be granted for Buspar, since it covered the same, approved uses of the drug. But before the Patent Office, BMS filed for a patent extension claiming new uses of the same drug. Sales of Buspar have been as high as $700 million, according to SPAN. "Bristol-Myers Squibb appears to be engaged in a strategy of deceiving federal agencies," said Tim Fuller, executive director of the Gray Panthers, a nationwide senior citizens group. Two drugs -- Buspar, an anti-anxiety drug, and Taxol, which recently has been used in breast cancer prevention -- have had patents extended with creative and apparently conflicting patent re-applications, which prompted Fuller to say, "We're getting hit by Bristol-Myers Squibb as taxpayers and as patients." Alternatives include new corporate partners, or government manufacture and distribution of the drugs it owns. Brazilian government-owned generic manufacturers are widely credited with halving that country's projected death rate from AIDS. An appropriate government agency, such as the Office of Management and the Budget, should oversee agreements between the federal government and businesses that subsequently engage in allegedly harmful or illegal activity. Sanctions involving dissolution of the license by the patent holder remain an option that must be honestly explored. Seven generics manufacturers together create more jobs than one partner with a dubiously extended patent. And arguments against rethinking technology transfer as anticompetitive ring false. Technology transfer was never intended to assist in the formation of drug cartels. Anticompetitive patent practices create monopolies that are returning us to Victorian extremes of great wealth and vast human suffering.

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