Medical Device Daily

SAN DIEGO — Not unlike most medical conferences, this year’s annual meeting of The Society of Thoracic Surgeons (Chicago) was permeated with the sponsorship of several large medical device companies, including Edwards Lifesciences (Irvine, California), St. Jude Medical (St. Paul, Minnesota) and the Sorin Group (Milan, Italy) — to name just a few.

In exchange, these companies’ names and logos were prominent throughout the meeting, on everything from conference signage to the shiny black tote bags most of the physician attendees carried, displaying the STS logo on one side, St. Jude Medical’s on the other.

Even the sign directing attendees into Room 29 for an ethics debate, “Professionalism Meets Commerce,” on Tuesday — which focused on the issue of conflicts of interest in the medical profession — had a corporate sponsor.

Arguing in the debate for tighter regulations of surgeon/industry ties was Jerome Kassirer, MD, former editor of the New England Journal of Medicine.

On the other side of the issue, Thomas Strossel, MD, a health policy commentator, an oncologist at Brigham and Women’s Hospital, and a professor of medicine at Harvard University (both Boston, Massachusetts), argued that these regulations are already so restrictive that they are stifling important medical progress.

Robert Sade, a professor of surgery at the Medical University of South Carolina (Charleston, South Carolina), moderated the debate, and opened it by presenting a fictional case of a surgeon who is recruited by a medical device company that has developed a heart valve of unusual design and wants him to be involved in a study.

He readily agrees and through his participation in the study, the doctor begins to focus on the possibility of the company’s share price increasing upon early release of the study results, so he contemplates buying stock in the company while the per-share price is still low.

Kassirer used this virtual case study to illustrate his viewpoint, outlining several questionable events over the following two years: the doctor buying 10,000 shares of the company’s stock, agreeing to speak publicly about the device’s benefits, his failure to disclose his financial interest in the company at such events and, ultimately, his letting that interest affect his medical judgment when new studies on the device reveal that it causes a life-threatening allergic reaction.

“Joining the study was fine, even investing in stock was not bad, as long as he did not take advantage of that,” Kassirer said.

But he said he disagreed with the rest of the fictional doctor’s actions, including the failure to disclose his financial interests in the company when talking about the device. “All of these things impede trust in medicine and he’s not even a bad guy,” Kassirer said.

In a question-and-answer session following the debate Kassirer said, “I don’t want to leave the impression that I’m against making money or that I’m against industry,” but that “we always struggle with conflict of interest, and it’s something that I believe we need to be more aware of.”

Arguing the opposing viewpoint, Strossel emphasized the life-saving benefits of entrepreneurial development of new technologies.

“Once upon a time there were no conflicts of interest,” and death in patients with heart disease and stroke have significantly decreased since that time because of the technologies produced by private companies created by scientific entrepreneurs.

“Most of the great technology we have really originated in the 70’s and 80’s when conflict of interest wasn’t even on the radar screen,” Strossel said. He pointed out that with the increase in disclosure requirements, bureaus have been established to enforce them, and limits have been placed on consulting fees and equity.

But, he said, this trend has “gotten way out of balance. The best progress in medicine of all time is because of commerce — we need more of it.”

Strossel concluded that, “trust derives from track record,” and that, “it’s not big business that’s bad for your health; it’s the lack of big business.”

Both Kassirer and Strossel have written extensively on the issue of conflict of interest in the medical profession.

In the first chapter of Kassirer’s book, “On The Take: How Medicine’s Complicity with Big Business Can Endanger Your Health,” he says that most doctors work hard, dedicate themselves to their patients and never make a deal that could taint their clinical judgment. But that many in the industry have been compromised by greed and have put their wallets ahead of their patient’s well-being.

Strossel wrote about his viewpoint on the issue in an article in the New England Journal of Medicine in September 2005, titled “Regulating Academic-Industrial Research Relationships – Solving Problems or Stifling Progress?”

“Biomedical research takes place in university health centers, in government laboratories, and in the laboratories of pharmaceutical and medical-device companies, but only industry translates the research into products,” according to Strossel’s article.

“Until the 1970s, academic researchers rarely worked on applied technologies, although they conducted clinical trials for companies and industry exploited academic basic research. Then, the revolution in molecular genetics that enabled investigators to produce large quantities of rare molecules with medicinal properties brought these groups closer together. Academic researchers joined venture capitalists in founding the biotechnology industry, leading to immense benefits — for example, the hepatitis B vaccine.”

Indeed, the hotly debated issue of conflict of interest at all levels in the industry has made headlines in recent months.

One such story that drew national attention was when Lester Crawford pleaded guilty of failing to disclose a financial interest in companies that the FDA regulated while he was head of the agency. He faces a $50,000 fine but will not see any jail time, according to recent reports (Medical Device Daily, Jan. 26, 2007 and Oct. 18, 2006).

Another story that serves as an example is a recent article in the journal Neuropsychopharmacology, by prominent researcher Harold Sackeim of Columbia University (New York), revealing that electroconvulsive therapy (ECT) causes permanent amnesia and defects in cognitive abilities which affect individuals’ ability to function. The study contradicts 25 years’ worth of Sackeim’s previous statements that ECT increases intelligence and that patients who report permanent adverse effects are mentally ill.

Significantly, since the mid-1980s, Sackeim worked as a consultant to the ECT device manufacturer Mecta (Lake Oswego, Oregon). He never revealed his financial interest in ECT to NIMH, as required by federal law, and, until 2002, did not reveal it to New York officials as required by state law (MDD, Dec. 26, 2006).