Mozaffarian at Brigham and Women’s says he avoids involvement in studies that originate with drug companies. His article in American Journal of Cardiology last December included this disclosure statement: “Pfizer had no role in the study conception, design, implementation, analysis, interpretation, or manuscript preparation.” For that article, he and his colleagues wanted to pursue a hypothesis about the drug in Pfizer’s Lipitor. “So we contacted Pfizer and asked for their database,” Mozaffarian says. Pfizer provided it and also ponied up a grant, while agreeing to have no input or control over the research or results.

But not all researchers demand such independence.

Institutional conflict
Aside from the personal glory and career gain publication bestows, medical-faculty members are under enormous pressure to publish. Faculty members must win funding grants to pay for, and justify, their presence, and to win grants, a researcher must convince funders that he or she will produce results worthy of publication in peer-reviewed journals. “Around grant-writing time, they have a lot of pressure to show something,” says Andrea Gwosdow, a medical writer in Arlington, Massachusetts. Or as Annals of Internal Medicine’s Harold Sox puts it, “If you’re not productive, people are less willing to bet on you.”

Massachusetts researchers tend to be good bets, ranking second only to Delaware in articles-per-dollar productivity, according to the National Science Foundation. Massachusetts academic researchers spent $1.8 billion on research and development in 2003 (up from $1.1 billion in 1997), according to the National Science Foundation, and produced roughly 10,000 academic articles.

In the past, that funding came almost exclusively from the federal government, primarily through the National Institutes of Health. That has changed dramatically. Harvard Medical School now receives nearly a quarter of its research funds from nonfederal sources, including nearly $3.5 million from Aventis Pharmaceuticals, $2.5 million from Bristol-Myers Squibb, and $2.1 million from Merck and Co. “The rate of growth of biomedical research has outpaced federal funding, compelling universities and hospitals to develop alternative sources of revenue,” Harvard says in its conflict-of-interest policy guide.

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“We’re coming to a very vulnerable time,” says Randall Stafford, formerly a professor at Harvard and senior scientist at Mass General, and now a professor and researcher at Stanford University Medical School. He expects the pressure to accept industry funding to increase. “The federal government’s funding is not increasing at the rate it used to.”

“The involvement of drug companies is inevitable,” Mozaffarian says. “It’s just too expensive for the government to do all these studies.”

Both Stafford and Mozaffarian are willing to accept private funding, but only when satisfied that they have the last word on how to conduct and interpret the research. For that guarantee, they typically rely on their institutions, which negotiate the grant contracts. “If institutions and universities are doing their job, they will provide the umbrella to protect the scientific freedom of their researchers,” Stafford says.

Harvard Medical School’s policies on industry sponsorship, which also apply to faculty on staff at HMS-affiliated hospitals, are considered some of the strongest in the country. Mass General will sign no sponsorship contract unless the provisions give the researcher access to all the data, final approval of the article’s content, the right to publish even if the company doesn’t want to, and the right to remove his or her name if unsatisfied, says Ronald Newbower, Mass General’s senior VP of research and technology. “Institutions like ours are insisting on clauses like that more consistently,” Newbower says. “We don’t need to get in bed with industry to get the best science done. We’re perfectly willing to walk away from situations where we can’t be satisfied that it meets our requirements.”

That may be easier said than done when the institution depends so heavily on those drug-company grants. Plus, while the researchers often disclose their own conflicts of interest, sponsoring academic institutions usually don’t reveal how many millions of dollars of its own endowment are invested in companies such as Aventis and Merck. Harvard is one of those schools that keeps its cards close to its chest. No wonder. In fact, a recent Harvard SEC report shows holdings of $16 million worth of Merck stock, $8 million of Bristol Myers Squibb, $34 million of Johnson & Johnson, and $33 million of Pfizer. (Aventis and other foreign-owned stocks would not appear on the report.) This is a small slice of the $26 billion endowment, perhaps, but nothing to sneeze at. “Institutional conflict of interest should matter,” Stafford says.

Ghost in the machine
Further obscuring the true participants in medical research, and their potential conflicts of interest, is a tremendous industry that thrives outside the halls of academia and contracts almost exclusively with drug and medical-device makers, and has been built up to create the content that fills hundreds of medical journals. Thanks to the wealth of medical expertise in the Boston area, much of this industry exists right here.