May 1, 2007 The Pump Handle 1Comment

By David Michaels

Earlier this month, the National Institute of Health’s National Toxicology Program fired the contractor that had been running its Center for the Evaluation of Risks to Human Reproduction (CERHR) after environmental health advocates drew attention to the company’s chemical industry ties. (Go here to see previous posts.)

Now, the Milwaukee Journal Sentinel draws attention to another NIH contractor with potential conflicts of interest – and once again highlights the lack of appropriate disclosure policies for NIH contractors. At issue is the contractor that prepares the NTP’s Report on Carcinogens.

Reporters Susanne Rust and Cary Spivak explain the latest controversy:

The medical research company hired by the federal government four years ago to update its list of carcinogens moved quickly to add a virus to the list while two of its clients were developing vaccines to combat that same virus.

Today those clients – Merck & Co. and GlaxoSmithKline – along with the federal Centers for Disease Control and Prevention are involved in a controversial push to have every adolescent girl in the nation receive the vaccine against the sexually transmitted human papilloma virus.

Industry analysts predict the vaccines will bring billions of dollars to the two drug manufacturers by 2010.

The federal carcinogen list was prepared by the Constella Group – a North Carolina firm with ties to former U.S. Health and Human Services secretary and Wisconsin Gov. Tommy Thompson.

Constella has received more than $246 million from an array of federal agencies in the past seven years while also working for drug companies the government oversees, the Journal Sentinel found.

Constella is staffed with many respected scientists, some of whom have retired from the agencies that have hired Constella to provide contract services. The contractor insists “it has internal controls to prevent conflicts of interest between its government duties and its work for drug and health companies,” but NIH doesn’t seem to have explored whether the company had any potential conflicts of interest, let alone whether it had appropriate procedures in place to prevent its drug company ties from coloring its NIH work.

Rust and Spivak explain that contract research organizations have replaced federal scientists in “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.” (Constella, for instance, has contracts with the CDC, FDA, and USAID as well as NIH).

Fast-growing Constella, with expected revenue of $205 million this year, is emerging as an important player in a burgeoning yet largely unregulated industry of contract research organizations.

The $12 billion industry is growing rapidly as the government and drug-makers outsource more and more work. The research companies do everything from providing technical computer support to recommending what chemicals and medications should be scrutinized, controlled or even banned by the federal government. At the same time, the companies frequently are working for various manufacturers subject to regulation.

Not everyone is thrilled with this shift from government workers to private contractors:

Sidney Wolfe, of the national consumer watchdog Public Citizen, said tougher conflict-of-interest rules are needed for these federal contractors in the health arena.

“Otherwise the decision-making is tainted. And even worse than being tainted, it could be the wrong decision – which could have an adverse health impact,” said Wolfe, a physician who heads the watchdog’s Health Research Group. “There are plenty of contractors out there that don’t have financial conflicts of interest.”

The current crisis facing NTP is that its contractors, many of whom do excellent work, are under increased scrutiny because the agency has not required conflict of interest disclosure. In the short term agencies should require all of their contractors to disclose potential conflicts of interest, and develop a policy for dealing with contractors with problematic ties.

In the long run, however, the storm over conflicted science will force US agencies to follow the example of the International Agency for Research on Cancer (IARC), which in the early part of the decade had been criticized for using conflicted scientists in preparing its famous monographs on the causes of cancer.

In 2005, IARC announced a major policy shift, declaring that scientists with “real or apparent conflicts of interests” could no longer serve on monograph panels. Instead, the agency has invented a category of participant known as an “Invited Specialists”—experts with critical knowledge and experience who are recused from certain activities because of a conflicting interest. They contribute their wisdom but do not draft text or vote on the monograph’s content.

For the same reasons (the integrity of the product was under question), the FDA recently announced that scientists with substantial conflicts will not be asked to serve on advisory panels. Agency leaders and members of Congress are beginning to recognize that science that serves as the basis for important public health decisions must be created in a way that it’s credibility is above question, and that it cannot be attacked because of the involvement of conflicted scientists.

David Michaels heads the Project on Scientific Knowledge and Public Policy (SKAPP) and is Professor and Associate Chairman in the Department of Environmental and Occupational Health, the George Washington University School of Public Health and Health Services.

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