Duke doc cleans up with secret payments from drug companies.

From Herald Sun. Please note that FC tipped the Chronicle on Oct 20 and the paper has had NOTHING.

By Monica Chen

mchen@heraldsun.com; 419-6636

DURHAM -- On Duke Medicine's website, David Rizzieri is an oncologist specializing in bone marrow and stem cell transplants. He has cancer treatments in clinical trials and dozens of published articles to his name.

What's not shown about Rizzieri is that in the past two years, he was paid $240,150 by drug companies, receiving $36,000 from GlaxoSmithKline for speaking engagements and more than five times that amount -- $204,150 -- from Cephalon under the vague title of "honoraria."

Rizzieri and about 17,700 other doctors across the country were thrown in the spotlight recently in "Dollars for Docs," a project by investigative news website ProPublica that compiled compensation disclosures from seven drug companies in 2009 and 2010, totaling $258 million.

In North Carolina, 16 doctors were paid more than $100,000 by drug companies, which put them in the project's "Top Earners" category. Of the 16 Top Earners, 10 are in the Triangle, and all except one teach and/or practice with Duke Medicine and UNC Hospitals.

Fees for speaking and consulting, as well as gifts in the form of samples and paid meals, are allowed by hospitals and universities because they are believed to foster the exchange of information between a drug maker and the prescribing doctor, who has real world experience on how a drug works outside of a laboratory. These interactions can lead to new innovations in drug development and refine patient care, proponents say.

However, in recent years, such practices have come under fire, with critics arguing that they are little more than marketing ploys in which the reputation of a doctor (and his affiliated hospital) is used to market the product to other doctors. For instance, at speaker events, information about a drug is restricted to the dosages and side effects already outlined by the U.S. Food and Drug Administration, which basically makes the information provided by doctor's lecture the same as that of any drug company representative.

Public sentiment has also begun to turn against such practices. According to a recent Consumer Reports survey, 74 percent of respondents said they disapproved of doctors being paid by drug companies for promoting drugs. About half of respondents said they'd be concerned about the quality of care from a doctor who received as little as $500.

When reached for a comment, Rizzieri, who was the ninth-highest-paid doctor in the Dollars for Docs report, defended his payments from GSK and Cephalon by pointing out that he has to disclose those relationships to Duke. The lectures also satisfy a need from other health care providers for information on the drugs, he said.

The honoraria he received from Cephalon was also for lectures, he and Cephalon both confirmed.

Asked whether the substantial sums he has received from drug companies could lead to ethical issues, Rizzieri replied, "I respect this concern and feel the multiple layers of oversight and conflict of interest management planning ... help assure appropriate application and presentation of the data."

The Herald-Sun also contacted the other Top Earner doctors in the Triangle. Although some doctors initially responded to the inquiry, none agreed to comment.

Revising policies

Duke and UNC officials said this week they have looked into the ProPublica report and had already begun reform efforts. Both universities are revising their conflict of interest policies.

UNC spokeswoman Karen McCall said none of the three UNC doctors on the Top Earners list violated current conflict of interest rules.

Ross McKinney, director of Duke's Trent Center for Bioethics, Humanities and History of Medicine, said he has personally met with most of the doctors who received more than $50,000 in the report. None was found to be in violation of the conflict of interest and disclosure policies at Duke.

The American Medical Student Association, which grades universities on their conflict of interest policies, gave Duke a "C" and UNC a "B" on their most recent scorecards. Duke earned a "D" last year.

UNC's new policy will emphasize and restrict financial relationships. At Duke, revisions will be made for both the university and the health system, to cover all doctors who may also be faculty members.

McKinney said the new policies will also have to consider the existing culture among doctors.

"It is hard to set restrictions when that is the existing culture. This isn't the Mayo Clinic where everybody is just a salaried employee," McKinney said.

Chris Manz, a third-year medical student at Duke and chairman of AMSA's PharmFree campaign to promote evidence-based prescribing, also acknowledged that culture is an issue.

"There is certainly a sense that once you go through medical school and you go through residency, you're kind of entitled to these gifts from industry, or to be paid well enough for speaking," Manz said.

At Duke, McKinney said the culture also gives leeway to faculty and doctors when it comes to industry relationships.

"We have taken a more liberal approach of allowing our faculty to have outside activities," McKinney said. "Starting to restrict faculty would go against the historic traditions. It goes against a longstanding cultural norm."

"But the times, they're a-changing," McKinney added, "and people need to recognize that."

Blemished records

One key concern for Duke and other institutions now is that some drug companies have hired doctors with blemishes on their records.

In the ProPublica report, a Georgia doctor who was once fired for taking liberties with female patients was Cephalon's third-highest-paid speaker last year, receiving $194,450 in 2009 and 2010. Five of the seven companies in the report acknowledged that they don't routinely check state board websites for discipline against doctors. Only Johnson & Johnson and Cephalon said they review the state sites, according to ProPublica.

In North Carolina, Keshavpal Reddy, a psychiatrist in Greensboro, received $109,540 from drug companies but was issued a reprimand by the state Medical Board in August for neglecting to evaluate a patient after repeated changes in prescription.

At Duke, Anil Potti, an assistant professor who has been on paid leave since the summer for padding his resume and falsely claiming to have been a Rhodes Scholar, was paid $86,950 by Eli Lilly and GSK in 2009 and 2010.

The Herald-Sun checked the records of all Top Earner doctors in the Triangle and did not find blemishes on their Medical Board records.

However, being on the list at all raised some concerns.

When it comes to Rizzieri, McKinney commented, "Being that high on a speakers list does call undesirable attention to somebody."

"On the other side, it comments on his reputation. The company wanted to pay him because he has a reputation," McKinney said. "But the other top 10 speakers, other than Rizzieri, don't exactly have academic luster."

When reached about their payments to doctors, spokespersons with GSK, Cephalon and Eli Lilly said the speakers are selected for their expertise. Cephalon states on its website that it believes speaker events and consulting services do not influence doctors' prescribing decisions.

GSK said its speakers sign a contract to certify clean records at the federal level. When it comes to state records, the company assesses the severity of infractions on a case-by-case basis.

Lilly representatives said they have suspended association with Potti and will hire an outside organization to screen doctors at the state level.

Looking biased

But some say the problem goes beyond the rigor with which drug companies screen their speakers.

Adam Linker, health policy analyst at the N.C. Justice Center, said the ethical concern should be particularly acute at universities, which are seen as models for research and should lead the way to reform.

"It's troubling when drug companies are sending money to people in medical schools," Linker said. "[Universities] should be pointing the way out of a reliance on drug companies to sponsor medical research and provide medical education."

According to McKinney and others, the problem of drug company payments to doctors is not confined to one campus or hospital. It's a systemic and cultural problem that needs to be addressed.

In 2013, the Affordable Care Act will seek to do that with a sunshine policy: All drug companies will be required to disclose their payments to doctors.

"We need academics to be the people to say honestly whether something is being used correctly or not," McKinney said. "In order to do so, they need to be unbiased. When you're talking about this kind of money, you start to look biased."

Manz, the Duke medical student, has been working with faculty on developing Duke's new conflict of interest policies.

"As a medical student, one of the things concerning me is that I'm trying to learn everything about the practice of medicine and how to practice appropriately," Manz said. "If my professor has a significant conflict of interest, I have to wonder whether I'm learning evidence-based medicine, or I'm learning marketing-based medicine."

"Tranparency is a step in the right direction," he added. "Though it's probably just the tip of the iceberg."

Read more: The Herald-Sun - Dollars for Docs hits home