The Pro-Industry Professor

Professor Thomas P. Stossel defends pharmaceutical companies

For the first third of his medical career, Thomas P. Stossel says he was your “typical academic socialist”—buried in research and clinical work.

He won recognition for discovering the sixth most common protein in the blood in 1979 and has spent 30 years trying to unravel its function.

But outside his speciality of hematology, Stossel—who heads the Translational Medicine Division at Harvard affiliated Brigham and Women’s Hospital—is known for something far more controversial than the protein “filamin A.”

Amid a wave of new regulations regarding physician-industry ties, Stossel has stood largely alone as a vocal and vehement opponent of new oversight at the Medical School, where he says administrators have blindly accepted new rules to quiet recent controversies over such relationships.

Concerns about industry ties—which have gathered steam nationwide in recent years—erupted at the Medical School last fall after students protested what they alleged were undisclosed and unethical conflicts of interest in their classes, drawing national media attention.

But Stossel says the media coverage, which helped prompt new policies at some of Harvard’s largest affiliated hospitals, was off base and ignored the positive contributions of industry—and he hasn’t kept those opinions to himself.

He argues that the current activism is not supported by the data—citing a small survey reporting that 80 percent of patients do not care if their physicians have pharmaceutical companies ties—and that maligning industry investment will only inhibit scientific progress.

But those stances have drawn fire from many of Stossel’s colleagues, who say academic medicine has long suffered from ethical breeches because ties to industry have gone unregulated, and that Stossel’s statements ignore the potential for bias introduced by industry involvement.

“Rather than take on our central premise, he says how indispensable industry is to churning out new products,” says David J. Rothman, who directs the center for the Study of Science and Medicine at Columbia University. “What we are saying is that you need to make sure there are firewalls between industry and medicine.”

But Stossel says that in the rush to quell protest at Harvard Medical School, the interests of physicians and industry have been brushed aside—preventing open debate and key stakeholders from having any say in the policies.

Now, with new regulations at some Harvard hospitals and a Massachusetts state law going into effect this July that ban gifts and requires public disclosure of all industry funding over $50, Stossel says he hopes there will be a backlash from affected physicians.

“Now there’s some skin in the game,” he says. “It’s an opportunity to politely suggest some things that might be changed.”

‘PHARMASCOLDS’

Stossel says he first learned about industry’s impact on the medical profession after joining the advisory board of Biogen Idec Inc., a Cambridge biotechnology company.

Despite their contribution to science, Stossel says his colleagues’ practices at Biogen would have violated current conflict of interest codes today.

About the time he joined Biogen’s board, there was an incident at the Harvard affiliated Massachusetts Eye and Ear Infirmary that he says precipitated the movement to combat conflict of interest in medicine.

Stossel says he was disturbed by the portrayal of the event, and that reality was being hijacked—so he decided to start educating himself about the issues.

“For 20 years, I just read all the books, and fumed and fussed,” he says.

He says that after the Los Angeles Times blasted some of his colleagues, and the National Institutes of Health imposed a blanket ban on consulting, he decided to come out and write his first op-ed defending industry’s role in medicine.

And as his own hospital has put in place more stringent regulations, he has continued his advocacy, fascinated, he says, by the “quasi-religious” coterie of advocates who catapulted conflict of interest issues into the spotlight.

But he adds that those in favor of regulation retain the upper-hand because the path of least resistance for academic leadership is to try to curb dissent—which he says explains the changes at Harvard’s affiliates.

“If there is a big ruckus going on, and the students are running amuck, and the media is hyping it up, and Senator Grassley is nosing around, all you care about is quieting this down,“ he says

And he said that he never hears from the “pharmascolds,” despite frequently criticizing them in public, who he says prefer to present the issue as if there is no dissent.

“I’m not a total nutcase,” he says. “I’m not saying that the world is flat or that HIV doesn’t cause AIDS—I think I have data and logic—it’s contrarian logic, but it’s logic.”

‘DEMONIZING INDUSTRY’

While his opponents certainly agree Stossel’s arguments are contrarian, not all consider them grounded in logic.

Rothman, the Columbia professor, says that Stossel is the master of the “straw man” argument, constructing the rationale for conflict of interest regulations to aid his position.

“He makes it out like we are demonizing industry,” Rothman says.

Rothman says that Stossel bases his attacks on the movement on a misinterpretation that its supporters seek the abolishment of pharmaceutical and drug device relationships in medicine—a charge he called absurd.

“What we want is careful regulation of marking activities in industry,” he says. “We don’t want to put industry out of business, but we want to make sure their marketing activities are not conflated with their educational activities.”

In particular, he says that professional medical societies giving out bags and pens with drug companies names is a particularly egregious practice that merits heavy regulation.

“We don’t think that doctors should be walking advertisements for industry,” he says.

Though Stossel says biased medicine is in no one’s best interest, he disagrees with using regulation to prevent it, arguing that physicians should be free to determine on their own if the gift is a bribe.

But on physicians ghostwriting pharmaceutical studies—another contentious ethical issue—Stossel is not nearly so far from the medical mainstream, saying that honorary authorship, in which doctors simply sign their name to a document written by industry employees, is wrong.

But Stossel says such incidents are rare. And in keeping with his contrarian positions, Stossel says he has few qualms about less extreme forms of ghostwriting, in which big pharmaceutical companies hire professionals to write a draft of the findings from multi-million dollar clinical studies.

Harlan M. Krumholz, a professor of cardiology and public health at Yale, who has written extensively on ghostwriting, says that the degree to which he has seen ghostwriting and other distortion tactics used constitutes a major problem for medicine.

He adds that arguments like Stossel’s miss the purpose of conflict of interest regulation by perpetuating a false perception that physicians are either for or against pharmaceutical companies.

Krumholz says the debate is not about whether industry should be involved in medicine at all, but rather what interactions are ethical, a question the profession must answer if it is to retain patients’ confidence.

“We have case after case of problems,” he says. “We need to restore trust and be transparent about these relationships.”

As Medical School Dean Jeffrey S. Flier revisits Harvard policy, Stossel says, it is important to not overdo regulation to appease protesters.

He says he would like the rules to be like the constitution: simple. “Let’s get data, lets be flexible,” he says. “If people do bad things, shoot them. The rules we have now are as if you couldn’t have a car that ever exceeds the speed limit.”

Stossel adds he is not holding his breath for policy he finds acceptable, but he feels that the Dean is trying to be reasonable.

“I hope the message will get across that has to be done in a different way,” he says. “You will never please the critics.... You cannot please everybody and cure cancer.”

—Staff writer Laura G. Mirviss can be reached at lmirviss@fas.harvard.edu.

For recent research, faculty profiles, and a look at the issues facing Harvard scientists, check out The Crimson's science page.