It was like something out of the movie Michael Clayton – only with Big Pharma as the villain: a Pfizer drug rep sporting a severe black suit and taking cell phone pictures of students protesting Harvard Medical School’s ties to the drug industry. Staged last October, the Boston gathering was sparsely attended, with a few students holding signs and a petition delivered to an empty office (the dean was out of town).

But the photographer’s appearance was notable enough to merit a story in the New York Times, which eventually led to a U.S. Senate committee investigation.

And so it goes for Harvard Medical School, according to a report in Boston Magazine that reveals Harvard has actually been under increasingly intense scrutiny since 2008, when a series of incidents put a spotlight on the venerable university’s symbiotic –  if awkward –  relationship with drug companies.

The trouble started that summer, after Dr. Joseph Biederman, a child psychiatrist and Harvard Medical School professor, was found to have taken more than $1.6 million in payments (which he apparently failed to fully disclose to the school as required) from the maker of a major anti-psychotic drug he’d been prescribing. 

A U.S. Senate investigation found that Dr. Biederman had been a prominent backer of childhood use of Johnson & Johnson’s Risperdal, a top-selling anti-psychotic drug not approved for use in children. Massachusetts General Hospital expressed concern that Biederman and J&J worked together to promote Risperdal’s use in children, rather than for scientific or educational purposes. (Biederman’s failure to disclose his drug company paycheques has been under investigation* for the past two years by Harvard Medical School, in what investigative journalist Alison Bass describes as “the longest investigation in that school’s history”).

There were other stories, too, like the Harvard students who sat in class listening to a professor drone on about the benefits of statins—only to find out later that their teacher had been paid by 10 drug companies, five of which make the cholesterol treatments he’d been advocating.

Then came the Pfizer photographer.

Such incidents haven’t just embarrassed Harvard, though. They’ve also put the institution at the centre of an international debate over the pervasive relationship between Big Pharma and medical schools.

It’s a fight about ethics, prized research projects, conflict of interest, and millions and millions of dollars, of course – but it’s also personal.

With two of Harvard Medical School’s highest-profile professors heading the charge for opposing sides, an already-controversial topic has turned into a full-out battle of wills.

No other faculty member at Harvard has been as vocal a critic of the pharmaceutical industry as Dr. Marcia Angell.  A pathologist and former editor-in-chief of the New England Journal of Medicine, she began raising the alarm in 2000, when she wrote in the NEJM that medical schools were becoming “increasingly beholden to industry.”

Harvard, Dr. Angell noted, had long prided itself on its strict conflict-of-interest stance, but she feared it was “in the process of softening its guidelines” in a bid to keep its faculty researchers from defecting to institutions with more lax rules.

As if to confirm Dr. Angell’s worst fears, a conference was organized for last summer by a friendly little group of doctors and drug company staff that calls itself The Association of Clinical Researchers & Educators (or ACRE – the group’s been mercilessly parodied as Academics Craving Reimbursement for Everything).

These people do not like what they call “mounting pressure from interest groups, the media, and select government officials, academic medical centers (who) have begun adopting restrictive conflict of interest policies that often sever productive relationships between industry and physicians involved in clinical research and educational outreach.”

Sounds so innocuous, doesn’t it? “Clinical research and educational outreach” and “productive relationships”.

This friendly little group’s mission includes:

“Among the many proposed restrictions, bans on product-based speaking, consulting, restrictions on industry-funded research and continuing medical education, are at the forefront. The purpose of the conference is to provide a forum for researchers and educators to understand the rationale behind the proposals, to evaluate objectively whether this rationale stands up to rigorous scrutiny, and to formulate plans for addressing relevant policy going forward.”

Presentation slides from this conference, courtesy of those docs clearly on the take from Big Pharma, included pearls of wisdom like:

“There is no clear definition of what ‘conflict of interest’ really is.”

“No clear definition”?  Really? Is it just me who finds that statement a wee bit puzzling? If I, a dull-witted heart attack survivor, can figure out pretty quickly what the standard definition of conflict of interest is, how come these intelligent, educated people with the letters M.D. after their names seem so confused?

Confused docs like Biederman appear to be in good company.  Other Harvard faculty who are similarly unaware that taking money from Big Pharma looks and smells bad included Harvard’s Dr. Lawrence Dubuske, who raked in over $900,00 in just one three-month period last year by serving on GlaxoSmithKline’s speakers bureau to help push their drugs.  Read ‘Harvard’s Ethical Ultimatum to Doc: Give Up Big Pharma Moonlighting Jobs, or Lose Harvard Teaching Post’.

Dubuske, when confronted, actually chose to quit his prestigious Harvard teaching post over this clear conflict of interest.  And no wonder: six other pharmaceutical companies also use him as a speaker, and he is a ‘consultant’ for a half dozen drugmakers, according to information he disclosed while teaching continuing medical education courses.

Read the full report in Boston Magazine.

NEWS UPDATE: June 6, 2011

A decision by a South Carolina judge ruling that Johnson & Johnson must pay $327 million for deceptive marketing of its Risperdal antipsychotic will likely hasten a global settlement the health care giant has been pursuing to resolve a raft of litigation and investigations.

The case is the third of 10 state lawsuits over Risperdal marketing, explains Pharmalot, including a Louisiana jury that ordered J&J to pay $257.7 million in damages for making misleading safety claims, plus $73 million in legal fees. A global settlement deal on all charges might total $1 billion for J&J.

* NEWS UPDATE:  “Massachusetts General Hospital Discloses Sanctions against Three Psychiatrists for Violating Ethics Guidelines”, July 1, 2011:   The Boston Business Journal said today that three psychiatrists have been sanctioned for failing to adequately report seven-figure payments they received from drug companies.

Drs. Joseph Biederman, Thomas Spencer and Timothy Wilens disclosed the disciplinary actions against them in a note to colleagues. According to a copy of the note made public upon request by the hospital, the three doctors:

• must refrain from “all industry-sponsored outside activities” for one year

• for two years after the ban ends, must obtain permission from Mass. General and Harvard Medical School before engaging in any industry-sponsored, paid outside activities and then must report back afterward

• must undergo certain training

• face delays before being considered for “promotion or advancement.”

The three doctors have been under the political microscope since June 2008 when Senator Charles Grassley, R-Iowa, began investigating conflicts of interest involving clinicians. Biederman and Wilens have since admitted to accepting $1.6 million from drug companies whose drugs they were promoting; Spencer took $1 million.

Senator Grassley said, according to an online version of the Congressional record:

“These three Harvard doctors are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies.”

See also:

• Is Your Doctor a “Thought Leader”? 
• Same Old Duet: Drug Companies and Psychiatry
• Bad Doctors Earning Good Money from Big Pharma
• Pfizer Paid For Doc’s Helicopter Speaking Tour to Push ‘Off-Label’ Drugs
• Doctor’s Kiss & Tell Tale: My One-Year Career As a Drug Rep
• Warning: Clinical Trials Funded By Drug Companies May Be Less Truthful Than They Appear