Wall Street Journal Examines NIH Funding for Anti-Bioterrorism Medications, Vaccines

The Wall Street Journal on Tuesday examined the role Anthony Fauci, director of the NIH National Institute of Allergy and Infectious Diseases, has played since the Sept. 11, 2001, attacks to direct funding to drug companies to produce biodefense medicines. After the terrorist and anthrax attacks, Fauci argued that NIAID was “well-suited to receive new funds for biodefense,” and the agency’s biodefense-related funding rose from $42 million annually in 2001 to about $1.2 billion in 2003 and $1.7 billion in 2005, the Journal reports. Fauci decided to “fund companies on a large scale” and currently directs $500 million to $600 million annually for new bioterrorism product development, according to the Journal. Last year HHS was authorized by Congress to spend $5.6 billion over 10 years on biodefense drugs. According to the Journal, Fauci’s goal is to prepare companies to bid on contracts under Project BioShield, which is managed by HHS. His strategy is to “place bets on multiple companies in the hopes of hitting the jackpot and to dole out NIH’s money in multiple rounds, using milestones to gauge progress,” the Journal reports. For instance, Fauci led NIH in an effort to develop a new anthrax vaccine, awarding $100 million in two funding rounds to VaxGen and about $80 million in two rounds to Avecia Group to prepare them to compete for a federal contract to develop a new anthrax vaccine for Project BioShield. BioPort, maker of an existing anthrax vaccine, protested NIH’s decision to ban makers of the older-generation vaccine from bidding and after launching a public relations campaign received a $122 million contract to produce the older vaccine. Ultimately, HHS awarded VaxGen the entire $877 million BioShield contract, but the company has “stumbled and its vaccine is almost a year late,” according to the Journal. In another instance, Fauci gave about $100 million each to Bavarian Nordic and Acambis for research on a smallpox vaccine in preparation for a BioShield contract to be awarded in 2006. NIH officials gave Acambis samples of the modified smallpox virus used by Bavarian, prompting Bavarian to file a civil lawsuit and a patent complaint against Acambis. Bavarian did not sue NIH, however, and Acambis maintains that it received the virus without restrictions on its use, the Journal reports. Fauci could not comment on the case.

Comments
Some observers have said that Fauci is “overstepping his bounds,” the Journal reports. “If the NIH is giving grants, they become the gatekeeper. They define what gets developed and exclude all these other innovative ideas,” Richard Hollis, CEO of Hollis-Eden Pharmaceuticals, said. The San Diego-based biotechnology company is developing a radiation-sickness antidote. John Clerici, a partner at the law firm McKenna Long & Aldridge, who represents BioPort, said, “I think this makes clear that NIH can and will do what it wants to ensure the game is being played by its rules, no matter what the rules have been in the past. This isn’t exactly fair and open competition.” Fauci responded that the bidding process for BioShield contracts ensures that companies meet the criteria for participating in the stockpile (Wysocki, Wall Street Journal, 12/6).

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