Some may not be surprised to hear that HPV is officially listed as a known carcinogen. But how many people know that the company that placed HPV on the federal government list has numerous drugmakers, including Merck and Glaxo, as clients? And that the company placed HPV on the list while Merck and Glaxo were developing HPV vaccines?
The scenario sounds like a conflict of interest, especially after considering that the Constella Group, whose official advisers include former US Health and Human Services secretary Tommy Thompson, added HPV within three months of receiving a $6.6 million government contract to compile a list of carcinogens. The contract was awarded four years ago. The Milwaukee Journal Sentinel reported on May 5 that a congressional investigation of this and possible other similar possible conflicts of interest was being contenpleted.
Constella has received more than $246 million from federal agencies in the past seven years while also working for drugmakers the government oversees, the Milwaukee Journal Sentinel reports. Constella says it has internal controls to prevent conflicts of interest between its government duties and its work for drugmakers, but the government doesn't require corporate contractors to disclose their private-sector clients.
Constella won't discuss its work for drugmakers, saying the info is confidential, but its government clients include the FDA, the CDC, and the NIH, which paid Constella $6.6 million to update and oversee the carcinogen list. The firm also won a separate $21 million contract to monitor and report vaccine side effects. Major vaccine-makers that Constella has listed as clients on archived editions of its web site include, Novartis, Eli Lilly and AstraZeneca.
Don Holzworth, Constella's CEO, says the firm has its own ethics board and other measures to protect against conflicts. "If we found ourselves in that situation, we'd remove ourselves from that situation. There is too much at stake to allow something like that to happen."
To fulfill the contract, Constella had to review nominations for the list, choose scientific literature to prepare technical reports, and draft a final report - all of which had in past years been conducted by government scientists.
“I was on this project back in the day,” says Jim Huff, associate director for chemical cardinogenesis at the National Institute of Environmental Health Sciences, “at a time when it was decided by us in the institute which chemicals should be considered” (to be included in the report). “It’s the only list of known or reasonably anticipated carcinogens in the United States that’s official. It has a significant impact in this country, in particular, and around the world.”
In other words, the problem is outsourcing. To cut back, federal agencies are giving industry a greater role in making such important decisions. And that sets up the potential for conflicts. But if there’s no oversight, who does the public rely on to prevent or remedy a conflict?
http://www.pharmalot.com/2007/04/greasing_the_skids_for_hpv_vac.php
http://www.jsonline.com/story/index.aspx?id=601378
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More Outsourced Science Raises More Questions
http://www.prwatch.org/node/6026
They also have taken over the business of preparing and analyzing technical reports for many governmental agencies on public health policy here and abroad - including several agencies under the federal health institute umbrella. The U.S. Agency for International Development has a $325 million contract with Constella to advise developing nations on health policy.
The industry has grown so rapidly that even Thompson said the brakes need to be applied, although he has seen no conflicts involving health industry firms that work for the government and private business.
"But there is a potential," acknowledged the Republican presidential candidate.Thompson explained that cash-strapped federal agencies, such as the FDA, are being forced to contract out more work each year, to the chagrin of academics and critics of the drug industry.
Philip Mirowski, a University of Notre Dame professor of economics and policy studies and an expert on research organizations, said, "The question is, 'What's the purpose of the research?' Is it to get your drug over the FDA hurdle - which, by the way, is low? Or is it to find out lots more about all kinds of things that you couldn't anticipate?
"Academics tend toward the latter, right? Wanting to find out all kinds of other things. . . . CROs are cheap because they promise only the former."
http://www.jsonline.com/story/index.aspx?id=597586
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