Why Disclosure Policies Don’t Discourage Academe’s Drug Salesmen

Whatever else his critics may say of Stephen M. Stahl, the adjunct professor of psychiatry at the University of California at San Diego does not appear guilty of a failure to disclose.

Earlier this year, Mr. Stahl led a group of distinguished colleagues in writing new rationales for psychiatrists to boost their offerings of drugs to depressed patients. To that document Dr. Stahl appended an encyclopedic list of industry ties.

The article, published in February in CNS Spectrums, encourages the diagnosis and pharmaceutical treatment of “mixed depression,” and it lists 26 different drug companies for which Dr. Stahl serves as a consultant, 24 companies that have given him research grants, six companies for which he serves as a public speaker, and one for which he serves on the board.

His 19 co-authors also are recognized leaders in their field from institutions that include Harvard University, Stanford University, the University of Pennsylvania, and the Icahn School of Medicine at Mount Sinai. According to two full pages of disclosures at the bottom of the article, most of them maintain multiple financial ties to the pharmaceutical companies whose products they endorsed in the article.

The case was highlighted last month at an academic conference by Lisa Cosgrove, a professor of counseling and school psychology at the University of Massachusetts at Boston. Ms. Cosgrove didn’t name the authors in her presentation, saying she was less interested in pursuing any particular individual and more concerned about highlighting a problem she sees as still widespread despite persistent efforts to tackle it.

Universities, in response to years of revelations and lawsuits about companies paying scientists to help promote their products through scientifically dubious research presentations, have been enacting tougher policies governing financial conflicts and disclosures. Federal agencies and Congress have done the same. And yet, as Dr. Stahl’s case suggests, it’s clearly not enough, Ms. Cosgrove said.

“It’s a poster child,” Ms. Cosgrove said after her presentation at the PharmedOut conference at Georgetown University, “for all the economies of influence that undermine patient-centered medicine.”

Dr. Stahl, through an assistant, said he was on an extended trip to Europe and could not respond to questions about the article in CNS Spectrums, where he also serves as editor in chief. He is also chairman of both the Neuroscience Education Institute, which provides doctors with continuing medical education, and the Arbor Scientia Group, which provides medical writing services and “promotional medical education.”

The summary contained in Ms. Cosgrove’s presentation was enough to prompt the University of California to investigate. “It is concerning,” Dianne Klein, a spokeswoman for the university system, said in a written response to the points Ms. Cosgrove raised. “And as such, we plan to take a deeper look at the issue to discern the facts and address any conflicts of interest arising from this individual’s association with the university.”

Studies have been showing for years, however, that academic scientists with financial ties to industry tend, on average, to overstate benefits and underreport risks of the products they investigate. And federal investigators in the past have found Dr. Stahl guilty of misleading work.

Lack of ‘Systematic Review’

The Stahl team’s report is an attempt to guide doctors in interpreting the latest update to the Diagnostic and Statistical Manual of Mental Disorders, the profession’s chief diagnostic tool, published by the American Psychiatric Association. That update, issued in 2013, formally endorsed the mixed-depression concept.

The drugs that Dr. Stahl and his team recommended for its treatment include lurasidone, an antipsychotic sold under the brand name Latuda and marketed by Sunovion, one of the companies for which Dr. Stahl serves as a consultant and speaker. Other companies with both financial ties to the authors and drugs recommended by them include Allergan, AstraZeneca, Otsuka, and Pfizer.

Ms. Cosgrove said her preliminary investigative work suggests the $1,000-a-month lurasidone and other drugs touted in the Stahl article have been found no more effective than cheaper alternatives.

But either way, she said, a central problem with the Stahl team’s work and many other medical-journal articles is the lack of any sign the authors conducted a “systematic review” — a formal search of the scientific literature for previous studies, aimed at ensuring that any summary recommendation includes a balanced assessment of prior discoveries.

Dr. Stahl’s report was written in the style of a formal set of prescribing guidelines for doctors, and its recommended change to those guidelines was attributed to seven patient trials. All of those trials had at least one author who is an industry employee, Ms. Cosgrove said. For five of those seven trials, every author had ties to the drug companies involved, she said. And a co-author on the Stahl team was the lead author on four of those seven trials, she said.

Congress, as part of the comprehensive health-care bill enacted in 2010 — known as the Affordable Care Act, or Obamacare — included provisions requiring drug and medical-supply companies to publicly report all financial relationships with physicians and teaching hospitals.

The disclosure provision has been a “success,” one of the measure’s lead authors, Sen. Charles E. Grassley, Republican of Iowa, said through a spokeswoman. As a result of it, he said, health-care industry manufacturers last year reported $8.1 billion in various types of payments to hundreds of thousands of physicians. Nearly $25 billion in payments have been recorded since the system began in 2013, he said.

The overall value of such transparency measures — including the deterrent effect — cannot be fully known, acknowledged the spokeswoman, Jill Gerber. But disclosure lets both patients and investigators hunt for problems, and it may be especially effective against specific high-profile problems such as the overprescribing of opioids, she said.

Ms. Cosgrove expressed doubt. “Transparency is an insufficient solution to the problem of the corruption of the evidence base because it can’t guard against implicit bias, and may even be dangerous,” she said. That danger, she said, is the possibility of making the problem of bias appear solved when it has merely changed forms.

Lawsuits and Liabilities

There is the possibility of legal actions to hold various parties — including those at universities — responsible for prescription abuses that harm patients. Several states have filed lawsuits in recent weeks accusing major drug companies of fraudulently misrepresenting the risks of opioid painkillers now blamed in tens of thousands of deaths a year. The lawsuits typically have charged only the companies as the defendants, though some university scientists have been named by state prosecutors as taking part in the strategy to mislead.

Universities are generally confident that their ethics policies and practices leave them protected from such legal liability, according to the Association of American Medical Colleges. Such policies, however, tend to vary in their terms and applicability. As for speakers bureaus — which typically involve presentations to doctors designed to promote drug-company products — some universities prohibit the practice while others only discourage it or require preapproval for such activities.

The University of California system does not prohibit faculty from serving on corporate speakers bureaus, “but the practice is discouraged,” said Scott Lafee, a spokesman for UC-San Diego.

UC does have policies governing outside activities and earnings disclosures, but those are applicable only to faculty with appointments covering greater than 50 percent of their time. Dr. Stahl is a nonsalaried adjunct professor with exactly a 50-percent staff-physician appointment, meaning the disclosure rules do not apply to him, Mr. Lafee said.

Dr. Stahl moved from Stanford to UC-San Diego in 1988 after federal investigators found him guilty of plagiarism and of writing two “seriously misleading” papers, and required that for five years that he not serve on any U.S. Public Health Service panels and that any institution employing him monitor his grant applications and research.

Russell K. Portenoy, a professor of neurology and professor of family and social medicine at Albert Einstein College of Medicine, is named in an opioids-related lawsuit against drug companies filed by the state of Ohio. He, too, sits outside his college’s ethics policies. That’s because Dr. Portenoy worked primarily as an employee of Beth Israel Hospital, a former teaching affiliate of Einstein, and only was given an Einstein faculty appointment “as a supervisory physician for the rare Einstein medical student who chose to do a palliative medicine elective clerkship at Beth Israel,” Einstein said in a statement.

Dr. Portenoy and other academics were described in the Ohio lawsuit as composing a group of “seemingly independent third parties” used by the drug companies “to spread false and deceptive statements about the risks and benefits of opioids.”

Doctors doing the actual prescribing of pain medications, however, are facing much more direct legal peril. They include an Oklahoma doctor, Regan Nichols, who was charged last month by her state’s attorney general with second-degree murder in the overdose deaths of at least five patients.

Universities do not appear to face such direct threats now, said Heather Pierce, senior director for science policy and regulatory counsel at the Association of American Medical Colleges. But, she added, “that’s a risk assessment that they’re doing all the time.”

Paul Basken covers university research and its intersection with government policy. He can be found on Twitter @pbasken, or reached by email at paul.basken@chronicle.com.