Healthy Skepticism Library item: 19733

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Publication type: news

Snowbeck C
U, Mayo cultivate close ties to drug firms
Twin Cities 2011 Dec 26
http://www.twincities.com/ci_19622850

Full text:

Physicians have fielded questions for years about whether financial relationships with drug companies tarnish the practice of medicine, but it turns out a growing share of the money isn’t going directly to doctors.

In 2010, the University of Minnesota and the Mayo Clinic received about $650,000 between them, according to a Pioneer Press analysis of public documents, with each institution collecting more in drug company payments than any individual doctor in the state.

The data come from annual reports to the Minnesota Board of Pharmacy that are supposed to detail information about payments to individual practitioners, not larger entities. So, it’s a bit surprising to see any money being reported to the U or Mayo, which is based in Rochester, Minn.

Even so, details about the U and Mayo in pharmacy board reports point to examples of how the institutions take different approaches to policing physician-industry relationships – a contrast that suggests the variety of viewpoints about when drug company payments are appropriate.

The U’s approach to conflicts of interest was in the news last week when officials reported that a spine surgeon would not be subject to disciplinary action for his failure to disclose his financial relationship with Fridley-based Medtronic in two published papers and a poster presented at a scientific conference.

“Everyone is really trying to find what’s the right balance that allows us to accomplish the academic mission to improve health

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through discovery and research while still maintaining trust and objectivity,” said Heather Pierce, senior director of science policy at the Association of American Medical Colleges.
As a group, institutions in the state last year received about 10 percent of the $9.8 million in payments reported by drug companies to the pharmacy board, according to the Pioneer Press analysis.

The U and Mayo have been taking money from drug companies for research projects as well as fellowship programs that provide advanced training to physicians and pharmacists. Both institutions have seen a steady increase in payments the past five years, according to the pharmacy board data. But officials at both research centers said they weren’t aware of the trend.

“Large institutions have the heft to be able to negotiate back-and-forth with a company,” said Dr. Joseph Ross, a Yale University physician who has published research on conflicts of interest in medicine. The size of entities like the U and Mayo helps fight against “the potential for payments to distort the science.”

PROTECTIONS IN PLACE

Both the U and Mayo ask doctors to regularly disclose their financial relationships with drug companies. And committees at each institution review cases that could create a conflict of interest, such as if a doctor is a paid consultant for a drug company while also having input on which medicines are purchased by a hospital.

At the U, a conflict of interest committee has created “management plans” for about 110 researchers. On a research project, for example, such plans impose requirements designed to make sure the doctor receiving payments doesn’t skew results in favor of a company’s product, said Lynn Zentner, director of the office of institutional compliance at the University of Minnesota.

Management plans at the U are not made public, Zentner said, and are seldom violated. One of the few cases of a problem, however, came to light last week when the U released the findings from a review committee that Dr. David Polly violated conflict-of-interest rules by failing to disclose on three occasions his relationship with Medtronic.

“An unmanaged conflict is a problem,” Zentner said. “Having a conflict of interest is not.”

The pharmacy board reports show that the U in 2010 received nearly $350,000 in payments from pharmaceutical makers, primarily from the Boston-based Genzyme Corp.

Genzyme focuses on developing drugs for a group of rare diseases, so the company has made a practice of funding university research projects into possible treatments, said Erin Emlock, a Genzyme spokeswoman. Dr. Michael Mauer, a researcher at the U, is the primary investigator on a study of Fabry disease, Emlock said, adding that Genzyme supported it with a 2010 payment to the U of nearly $150,000.

Pharmacy board records show Mauer also has been a paid consultant to Genzyme, which paid him $3,750 in speaker and consulting fees last year. The company also reimbursed him for more than $8,000 in travel costs.

The dual role of researcher and company-paid consultant doesn’t prompt a conflict-of-interest review at the U unless consulting fees exceed $5,000 in a year, said Zentner, the U official. Reimbursements for travel are not considered consulting fees.

“Once we find an intersection of more than $5,000 in remuneration related to one or more aspects of their university work…we either ask that individual if someone else could be the principal investigator or we seek oversight,” Zentner said.

The Mayo Clinic takes a tougher stand.

Doctors at the clinic can serve as paid consultants to companies or they can conduct company-sponsored research studies. But they can’t do both at the same time.

“An outside researcher might say, ‘Yeah, but the guy conducting the research was on the payroll of the company,’ “ said Dr. Michael Yaszemski, chair of the Mayo Clinic’s board on conflicts of interest.

During 2010, Mayo Clinic received about $308,000 total from three different drug companies. The bulk came from Shire Pharmaceuticals. The Pennsylvania-based company paid Mayo Clinic nearly $200,000 to sponsor a fellowship program for doctors looking to specialize in treatment of inflammatory bowel disease.

The U also takes money from drug companies for fellowships, including $48,500 last year in grants from Genzyme.

TO SPEAK OR NOT TO SPEAK

The Minnesota research centers, however, differ on speaking fees.

Drug companies routinely hire doctors to participate in what are known as “speakers bureaus,” in which physicians travel the company and give speeches to other doctors about developments in medication therapies.

At the U, doctors can take fees for giving these speeches so long as the subject matter of the event relates to the individual’s responsibilities or expertise, Zentner said.

Physicians must disclose if the company is paying them and make sure that “the lecture materials fairly reflect his/her independent views and not solely the views of the business entity,” Zentner wrote in an email.

But Mayo doesn’t allow it.

“We do not permit speakers bureaus, not at all,” Yaszemski said. “The very nature of a speakers bureau crosses over into marketing, and that’s not okay from our perspective.”

DIFFICULT TO DEFINE

So, which approach is superior? Critics of drug company payments like the sound of the Mayo approach.

“Is it possible that the consultantships and speaker fees have some ‘subtle’ influence on the doctor that makes their participation, analysis, interpretation or whatever of the study different?” asked Dr. Sidney Wolfe of Public Citizen, a Washington, D.C.-based consumer group. “If you are an investigator in a clinical trial and you don’t get any additional money for being a speaker or consultant, it is at least possible – common sense being argued here – that you will be more neutral in terms of evaluation of the study.”

But Pierce of the Association of American Medical Colleges said there’s no clear consensus one way or another.

“All academic medical centers have conflict-of-interest policies through which they review disclosures made by their faculty and investigators,” Pierce said. “But institutions take a wide range of approaches in their policies, from setting general guidelines and dealing with things on a situation-by-situation basis with conflict of interest committees to setting strict prohibitions on certain types of activities.”

Mauer, the U physician who is both a consultant and researcher, said he thinks it would be inappropriate for a scientist to have a large financial relationship – $100,000 worth of stock, for example – with a company that’s also funding the research. But the consulting fees Mauer received from Genzyme in 2010 fall below the $5,000 cutoff that the National Institutes of Health has set for defining the low end of “significant financial interests” for physician researchers.

The Genzyme-sponsored study that Mauer is leading at the U, he said, is exploring a research question on Fabry disease that isn’t directly related to the company’s drug for patients with the condition. In addition, his consulting work with Genzyme isn’t geared toward the company’s marketing needs, Mauer said, but instead includes giving guidance on how to design clinical trials that generate useful information.

“If this kind of guidance for research doesn’t come from academia – where we don’t have the same kind of financial interest but have a different set of values and views that we’re operating from – where does the pharmaceutical industry get their advice about what research is important?” Mauer asked. “If we’re too restrictive (about consulting work) there’s a downside. If we’re too liberal, there’s a risk of conflicts of interest where study results could get muddled by personal benefit.”