Monday, December 20, 2010

Med Schools Flunk at Keeping Faculty Off Pharma Speaking Circuit


Med Schools Flunk at Keeping Faculty Off Pharma Speaking Circuit


Stanford University's Hoover Tower / Getty Images file photo
As medical schools wrestle with how to keep drug companies from corrupting their faculties, Stanford University is often lauded for its tough stance.
The school was one of the first to stop sales representatives from roaming its halls in 2006. It cut off the flow of free lunches and trinkets emblazoned with drug names. And last year, in a blow to its physicians’ wallets, Stanford banned them from giving paid promotional talks for pharmaceutical companies.
One thing it didn’t do was make sure its faculty followed that rule.
A ProPublica investigation found that more than a dozen of the school’s doctors were paid speakers in apparent violation of its policy—two of them earning six figures since last year.
Dr. Philip Pizzo, the dean of Stanford’s medical school, sent an e-mail to all medical school staff last week calling the conduct “unacceptable.” Some doctors’ excuses, he wrote, were “difficult if not impossible to reconcile with our policy.”
He was not the only school official caught off-guard.
Faculty at a half-dozen other institutions—including division chiefs—also lectured for drug firms in the last two years, ProPublica found, despite restrictions on such behavior. The University of Pennsylvania, the University of Pittsburgh and the University of Colorado Denver, among others, have launched reviews.
Conflict-of-interest policies have become increasingly important as academic medical centers worry that promotional talks undermine the credibility of not only the physicians giving them, but also of the institutions they represent.
Yet when it comes to enforcing the policies, universities have allowed permissive interpretations and relied on the honor system. ProPublica’s review shows that approach isn’t working: Many physicians are in apparent violation, and ignorance or confusion about the rules is widespread.
As a result, some faculty physicians stay on the industry lecture circuit, where they can net tens of thousands in additional income.
Critics of the practice say delivering talks for drug companies is incompatible with teaching future generations of physicians. That’s because drug firms typically pick the topic of the lecture, train the speakers and require them to use company-provided presentation slides.
“You’re giving someone else’s messages, someone else’s talk, someone else’s judgments,” said Dr. Bernard Lo, a medical professor at University of California, San Francisco who chaired anational panel examining conflicts of interest in medicine. “We don’t allow our students to use someone else’s work.”
Reporters compared the names of faculty members at a dozen medical schools and teaching hospitals with ProPublica’s Dollars for Docs database of payments publicly reported by seven drug companies. Lists of the physicians whose names matched were provided to the universities and hospitals for verification and comment.
Because the majority of the more than 70 drug companies in the United States don’t report such payments, the review provides only a glimpse of possible lapses at schools. As more companies make their speaker fees public, additional faculty will likely show up, several university officials said.
Those who study conflicts of interest in academia say the findings point to a significant problem for teaching hospitals. Schools should not only have a policy— many do not — they need to enforce it. Absent that, others will police their staffs for them using drug company payment websites.
“For God’s sake, if the media can look at these websites, why can’t we?” said David Rothman, president of the Institute on Medicine as a Profession at Columbia University. “Why trust if you can verify?”
Most universities were unwilling to confirm whether individual faculty members flagged by ProPublica had erred, making it difficult to tally all offenders.
At Stanford, officials said some faculty members provided proof that they had not violated the policy because they used their own lecture materials or stopped speaking as soon as it took effect.
But others conceded they were in the wrong.
Among them was Dr. Alan Yeung, vice chairman of Stanford’s department of medicine and chief of cardiovascular medicine whoearned $53,000 from Eli Lilly & Co. in 2009 and the first half of 2010. In an e-mail, Yeung said he quit speaking for the company this fall.
“I take full responsibility for this error,” he said. “Even though I felt that these activities are worthwhile educational endeavors, the perceived monetary conflict may be too great.”
Child psychiatrist Hans Steiner was paid $109,000 by Lilly to deliver talks about a drug for attention deficit hyperactivity disorder. In an e-mail, Steiner said he spoke in “very rural and other impoverished settings which only have limited access to experts like me.”
He said he wrongly assumed Stanford’s policy didn’t apply to him once he became an emeritus professor last year, but now, “I fully intend to comply.”
Pizzo, Stanford’s dean, said physicians who appear to have violated the policy will be investigated and referred for discipline if necessary. He compared some of their explanations to what a cop might hear after catching a motorist running a late-night stop sign.
“You can give 1,000 reasons: There was nobody around. It’s safe. I looked and didn’t harm anyone,” he said. “The reality is, it’s still a stop sign.”
Disclosures come as surprise
Dr. Richard Krugman, vice chancellor for health affairs at the University of Colorado Denver, thought his policy was working fine until his staff ran the medical school’s roster through ProPublica’s database. Some in his faculty showed up.
Krugman said he had made “the assumption that professionals have integrity and will live by the rules.” Now he’s trying to figure out what happened.
The 2008 policy bans faculty from speaking on behalf of companies if “the content of the lectures, slides, references or educational handouts is subject to approval by industry representatives.” Any contracts with drug companies must be pre-approved by the university.
ProPublica identified 13 UC Denver physicians whom drug companies reported as paid speakers.
Dr. Michael McDermott, director of the endocrinology and diabetes practice at the University of Colorado Hospital, earned the most, nearly $117,000 from Lilly. While his talks involved a Lilly drug, McDermott said he only used the company’s slides in a fraction of them.
“From my standpoint, the value of my programs is purely educational for the attendees,” he wrote in an e-mail. Selling of the drug is left to company reps “to be done at a time that is different than when I give my talk.”
Still, he said, “I am weighing my future participation.”
A UC Denver spokesperson would not say whether McDermott had violated the school’s policy, citing personnel rules. After a review, the activities of some doctors flagged by ProPublica were cleared; others were not, she said.
UC Denver’s experience was mirrored at other schools where officials discovered their policies were not working as expected.
The University of Pittsburgh’s 2008 policy clearly restricts paid speaking, said Dr. Barbara Barnes, an associate vice-chancellor in charge of industry relationships. Yet ProPublica found 22 Pitt doctors in its database.
Barnes said some were determined to be in compliance; others have terminated their drug company contracts or will do so. “Ultimately we rely on proper disclosure and good faith efforts by our physicians to monitor and enforce this policy,” she said in an e-mail.
The University of Pennsylvania health system’s 2006 policystates that faculty “should not participate in industry marketing activities.” Penn’s chief medical officer, Dr. P.J. Brennan, said he interprets that to prohibit delivering drug company lectures.
“It flies in the face of what a professional ought to be,” he said.
ProPublica found 20 Penn speakers in its database. Five, including one who left Penn last month, made more than $40,000.
The top paid, according to Dollars for Docs, was Dr. Corey Langer, director of thoracic oncology at Penn’s Abramson Cancer Center. He received nearly $70,000 speaking for Lilly since 2009.
Langer also received unknown amounts from other companies, including Genentech Inc., OSI Pharmaceuticals Inc., Bristol-Myers Squibb Co. and ImClone Systems, according to hisdisclosure for a medical education program this month.
In an e-mail, Langer said he was “now fully aware” of Penn’s policy and is “taking measures to curtail speaking for pharmaceutical companies.”
Brennan said some paid speakers have told him they deliver the same lectures they have given at unpaid, academic forums. “I don’t know where the discrepancy lies,” he said. Either way, he said Penn “clearly” needs to make its policy more explicit.
A question of control
Several schools’ policies appear to have strong prohibitions against industry speaking but in practice may not.
The University of California, San Francisco began placing restrictions on speaking in 2007 and expanded them this year. The current policy prohibits participation “in any company speakers’ bureaus in which the sponsor determines the content of presentations or in any way controls or limits what may be presented by the speaker.”
The key word is “control” – a word that appears in policies across the country but is interpreted differently. At some schools this means that speakers need to prepare their own slides and speech — or not give the talk. But at UCSF and schools such as the University of Southern California, speakers can say they are in “control” if they agree with what the drug company has provided.
Drug companies say they insist that speakers use their materials to keep them from running afoul of U.S. Food and Drug Administration regulations.
Dr. David Jablons, UCSF’s chief of thoracic surgery, earned $94,000 delivering speeches for Lilly. In an e-mail, he said he uses Lilly’s slides to discuss its lung cancer drug but would “unquestionably refuse to give the talk” if he was asked to say something he didn’t believe.
In a series of e-mails, Dr. Neal Cohen, a vice dean of UCSF’s medical school, gave different interpretations of its policy.
Initially, Cohen wrote that Jablons complied with the intent of the policy because he “uses evidence-based scientific data with which he agrees.”
Asked how that squared with UCSF’s policy, Cohen replied: “The scientific credibility and lack of commercial focus of material presented is the critical issue, not who prepares the slides.”
Pressed about whether any faculty member could be out of compliance given such an interpretation, Cohen appeared to change his stance. He said he didn’t believe that UCSF faculty should be giving paid speeches in which the companies prepared or controlled the content via slides.
“We are educating our faculty about the policy and are taking active steps to re-examine the policy language to clarify it,” he said, as well as coming up with a better plan to enforce it.
Slow to enact rules
This debate over how to manage the influence of drug companies at teaching hospitals is evolving.
The Cleveland Clinic has rules on conflict of interest in research and requires each faculty member to disclose medical industry ties on its website, but it does not restrict promotional talks.
The clinic does, however, employ one of the most ardent critics of the practice: Dr. Steven E. Nissen, its chairman of cardiovascular medicine, who calls industry-paid speakers “whores.”
At the same time, several of his colleagues made at least $25,000 speaking since 2009, including endocrinologist Adi Mehta, whopulled in more than $200,000, according to Dollars for Docs.
Guy Chisolm, director of the clinic’s Innovation Management and Conflict of Interest Program, said he expects the clinic will adopt some rules governing speaking. But he said, “These things do not happen fast.”
It’s been nearly five years since a diverse group of experts proposed restricting the relationships between academic physicians and the industry, including a ban on drug company talks. While acknowledging the importance of industry collaborations in developing new drug therapies and medical devices, they worried about schools losing their ethical compass.
“The serious threat that this state of affairs poses for professionalism, and for the trust that patients have in physicians, makes the need for effective guidelines on industry-physician relationships both apparent and urgent,” they wrote in a 2006 article in the Journal of the American Medical Association.
The trade group representing academic medical centers also advises against company-sponsored talks. But the Association of American Medical Colleges doesn’t track which of its members follow its advice, said Ann Bonham, the group’s chief scientific officer.
“We have to trust that institutions are enforcing their guidelines or prohibitions,” she said.
Self-policing leaves door open
Some schools have made enforcement a matter of conscience.
Duke University is among those with policies that “strongly discourage” speaking but leave it up to individual physicians to decide what’s right. Faculty members must report their speaking internally, but they are free to do it.
Duke had more than three dozen speakers in Dollars for Docs.
Dr. Ross McKinney, director of the school’s Trent Center for Bioethics, Humanities, and History of Medicine, said he’d like the policy to be strengthened because speaking can tarnish the reputations of faculty by suggesting their research or clinical practice is biased.
Although he lacks the official authority to stop it, he said the school is in the process of calling in every doctor who made more than $25,000 to stress that “their opinion will be less worthy of regard because of their relationship with industry.”
In response, he said, some physicians have said they wanted to make more money to pay their kids’ college bills, but they plan to scale back. Others said they just liked speaking or told him it wasn’t his business.
The University of Miami seems to be taking a middle ground. Although it allows faculty members to deliver paid talks in many circumstances, the money they earn is disclosed on a public website.
Still, more than a dozen University of Miami doctors did not properly report their earnings, ProPublica found and the school confirmed. In some cases, the payments listed on the school’s website were smaller than reported by drug companies in Dollars for Docs. One physician who Lilly paid nearly $17,000 had nothing listed on Miami’s website.
In other cases, a university official said, faculty members apparently attributed payments from a drug company to third parties, obscuring the actual source.
“Whether they’re purposely hiding information from us, I have no way of telling,” said Dr. Jorge Guerra, vice president for clinical affairs at the University of Miami medical school.
Guerra said the school is already correcting the omissions in the online disclosures and has referred some physicians for possible disciplinary action.
One school’s success
For UMass Memorial Health Care, checking the Dollars for Docs database came as confirmation that its faculty got the message.
The central Massachusetts training hospital found only one of its nearly 1,000 employed doctors had received a speaking fee—and that was for $188.
“Really the success was in educating the physicians … and getting them to buy into it,” said John Randolph, vice president and chief compliance officer, of the hospital’s 2008 speaking ban.
But Randolph said the success is not yet complete. The policy at UMass, as at many other institutions, covers only employed faculty, not community doctors who have privileges at their hospitals or physicians who serve as volunteer teachers.
Just this year, Stanford expanded its policy to include community physicians after finding that some were making significant sums speaking for drug companies using their Stanford titles.
Randolph said he hopes to keep such physicians from trading on the UMass name. He can’t stop them from speaking, he said, but he doesn’t want them mentioning his school when they do.
“That’s our next step,” Randolph said. “We’ll get there.”
Dan Nguyen, news applications developer at ProPublica, contributed to this story.
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