Earmark Draws Criticism, Creates Confusion
In last-minute negotiations over the 2004 federal budget (see p. 1636), U.S. Representative Bill Young (R-FL) added a curious $10 million earmark for European AIDS vaccine research that has scientists and policymakers scratching their heads. One of many special provisions that politicians stuffed into spending bills as Congress scrambled to end the 2003 session, it has involved an intriguing cast of characters. Among them are a philanthropist and erstwhile motion picture producer, a Republican donor who now serves as the U.S. ambassador to Italy, both the U.S. and Italian top health officials, and the heads of the National Institutes of Health (NIH) in both countries.
A 25 November conference report from the House and Senate subcommittees that oversee foreign operations instructs the U.S. Department of State to give the New York-based International AIDS Vaccine Initiative (IAVI) $10 million "for cooperative projects coordinated with the European Union's new 5-year program, the AIDS Vaccine Integrated Project." IAVI is a nonprofit that funds AIDS vaccine collaborations between scientists from developed and developing countries. "It's a large amount that would never be approved through normal channels," says a staffer for a Senate Democrat who had a front-row seat to the dealmaking. Adds a U.S. public health official who also requested anonymity, "It doesn't smell good."
Critics of the appropriation include some U.S. AIDS researchers who think the money would be better spent on domestic NIH grants. "Europe is as wealthy as the U.S. and puts far less money into HIV/AIDS research," says Robert Gallo, head of the Institute of Human Virology in Baltimore, Maryland. "I have to wonder aloud about this." Gallo and others who know about the appropriation are also concerned that a likely beneficiary will be an Italian-run AIDS vaccine project that includes a preparation that many researchers think has a weak scientific rationale.
When in Rome. NIH Director Elias Zerhouni (left) and ISS head Enrico Garaci agreed to increase U.S.-Italy collaborations at a ceremony in July.
CREDIT: PLINIO LEPRI/AP PHOTO
The political wheels began turning in April, when U.S. Secretary of Health and Human Services Tommy Thompson signed an agreement in Rome with his Italian counterpart, minister of health Girolamo Sirchia, to increase cooperation between the two countries. The U.S. ambassador to Italy, Mel Sembler, recruited Young, chair of the House Appropriations Committee, to help with the effort, says Young spokesperson Harry Glenn. Sembler, a Florida real estate developer, contributed tens of thousands of dollars to Republican candidates and causes, including the reelection of his district's representative, Young.
Enter American Michael Stern, who describes himself as a "dear friend" of Sembler and "family friend" of Enrico Garaci, head of the Istituto Superiore di Sanità (ISS), the Italian NIH. Stern says he has lived 50 of his 93 years in Italy and has had a colorful career as a World War II reporter, author, motion picture producer, and philanthropist. Stern helped arrange a June meeting at Young's office with ISS's Garaci and Barbara Ensoli, an ISS AIDS researcher. "Everything seemed to fit," says Stern.
In July, Stern, Sembler, and Young attended a ceremony in Rome's Chigi Palace at which NIH Director Elias Zerhouni signed a "letter of intent" with Garaci (Science, 1 August, p. 579). News reports at the time said that the agreement--which NIH declined to release to Science last week--involved several diseases and that new collaborative programs would be selected through peer review.
Over dinner that evening, Glenn says that Young, Sembler, and Sirchia discussed the possibility of focusing on AIDS. "It dovetailed with President [George W.] Bush's efforts on international AIDS," says Glenn, noting that the U.S. government deeply appreciated Italy's support for the war on terrorism and the Iraq invasion.
Young's staff subsequently asked IAVI whether it would accept funds to work with the AIDS Vaccine Integrated Project (AVIP), a new venture backed by $12 million from the European Union that Ensoli runs in collaboration with scientists from five other European countries and South Africa. AVIP plans to conduct human tests comparing a controversial vaccine that Ensoli has been working on, based on an HIV regulatory protein called Tat, to three other products. IAVI President Seth Berkley agreed to work with AVIP to "strengthen the European effort," with no special emphasis on Italian research, he says. "We won't do it otherwise," says Berkley, adding that "anything we do would be subject to our scientific review methods."
Although Ensoli's Tat vaccine is but one part of AVIP, some researchers take strong exception to the appropriation because they have doubts about her preparation, which she has just begun testing in humans both to treat and to prevent HIV infection. Gallo, in whose lab Ensoli once worked, says he was "shocked" by the appropriation. Gallo says NIH had turned down his request to test a different therapeutic Tat vaccine that he believes has a better chance of working. "How do you think we feel when we can't get support, but they can come over, do some politics, and get funding?" asks Gallo. "This is not so nice." Glenn, Young's spokesperson, insists that Congress has not earmarked funding for the Tat vaccine. "The intent was never to fund a specific project," he says.
Even the central players seem confused about just what will eventually be funded, however. Ensoli believes that Congress wants to "cofinance" AVIP. Glenn says the $10 million explicitly aims to foster collaborations with Italian and American researchers. Stern says if the money does not end up helping Italian researchers, "someone in the State Department will have his head cut off." Adding another twist, Congress specified that the money be spent "in cooperation with" a new NIH global AIDS vaccine program. NIH's Edmund Tramont, who organized the program, says anything it supports "has to pass a scientific review."
The $10 million earmark has been folded into the massive omnibus appropriations bill (see p. 1636) that the U.S. Congress is expected to pass in January.
Issue of 5 Dec 2003,
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