Should Docs Disclose Drug Company Ties?
Medical Center Is the First to Disclose Drug Industry Links Online
By AUDREY GRAYSON
ABC News Medical Unit
Dec. 4, 2008—
Hospitals around the country are pushing for full disclosure of their doctors' financial ties to the pharmaceutical industry to help patients determine whether their doctors are making money from drug and device companies.
The Cleveland Clinic, one of the nation's leading medical centers, will announce this week its decision to fully disclose all of its doctors' and scientists' financial ties with pharmaceutical companies and medical device makers on its Web site, www.clevelandclinic.org.
"Over time, it came to our attention that we did not want patients to be concerned that we were making decisions on the basis of something other than what was in their ultimate best interest," said Dr. Toby Cosgrove, CEO of the Cleveland Clinic. "Since many of us have relationships with industry to help foster new and improved products and drugs, we thought we could eliminate potential conflicts of interest by being absolutely transparent about those issues."
"One hundred percent of our 1,800 physicians gave us disclosures, and we have gone back and checked with them to make sure all are correct."
Although doctors' ties to the pharmaceutical industry all too often remain a secret, there has been a push in recent years toward public disclosure of this information.
Many experts are lauding the clinic for leading the way in full disclosure, arguing that doctors' treatment decisions may be influenced by the sizable sums of money provided to them by pharmaceutical and device companies in the form of speaking and consulting fees, drug royalties and equities.
"I commend my Cleveland neighbors for their bold and necessary actions," said Dr. Peter Whitehouse, professor of neurology at the Case Western Reserve University in Cleveland. "A key issue will be helping patients understand what these relationships mean for their care and for society."
"The souls of medicine and universities, not just individual doctors, are at stake."
Many doctors, too, support the move.
"I have no problems with any of us reporting [or] declaring our relationships, and I do so willingly," said Dr. Daniel Hayes, clinical director of the Breast Oncology Program at the University of Michigan Comprehensive Cancer Center. "It builds trust among our colleagues [in relation to] research and our patients for us to be transparent."
Other Medical Centers Following Suit
This move by the Cleveland Clinic follows a barrage of sharp criticism of the medical center in recent years for the many financial ties between its doctors and the pharmaceutical industry.
Now, its disclosure may serve as an example for other medical centers to follow.
ABCNews.com asked medical centers whether they planned to make disclosures about their doctors' financial ties.
Of the centers that responded, only the University of Wisconsin and Duke University appear to be taking measures to avoid conflicts of interest that are comparable to what Cleveland Clinic is doing.
Medical Centers Disclose Financial Ties
The University of Wisconsin's School of Medicine and Public Health is now planning to adopt a policy of public disclosure in which signs posted in the medical center will state that some of their physicians receive outside compensation from various sources, and that the companies and amounts will be available to patients on a public Web site.
Meanwhile, in an attempt to increase transparency at Duke University, all researchers who have received royalties or equities in excess of $10,000 are required to fully disclose the information publicly on the Duke Clinical Research Institute Web site.
Though other institutions, such as the University of Iowa and the Mayo Clinic, have not gone as far as to air potential conflicts of interest publicly, they instead depend on a Conflict of Interest Review Board to monitor and review each case in which a researcher has a financial relationship with a pharmaceutical company.
However, the University of Iowa plans to move a step further in its monitoring of doctors' ties to the pharmaceutical industry. According to Dr. Michael Cohen, professor of medicine and co-chairman of the Carver College of Medicine Conflict of Interest task force, the university is in the final stages of developing a policy that will "require full disclosure from not only faculty -- on whom it is focused -- but also by staff and trainees, [including] students, residents [and] postdoctoral fellows."
At the Mayo Clinic, in addition to its Conflict of Interest Review Board, the clinic provides a written statement in the patient information materials that encourages each patient to ask his or her physicians about industry relationships or to call the clinic's Conflict of Interest office, ensuring patients that all relationships would be disclosed if they so much as inquire.
Stricter Measures Needed?
But the Association of American Medical Colleges, a nonprofit group of medical schools, teaching hospitals and academic societies, supports far stricter measures on preventing potential conflicts of interest by discouraging academic physicians, faculty members, residents and students from receiving gifts or sponsored education from industry.
Many experts align themselves with the more stringent recommendations by the AAMC regarding conflicts of interest, stating that the measures being taken by medical institutions to provide full disclosure to patients are simply inadequate in preventing conflicts of interest from harming the doctor-patient relationship.
"I actually think that the push to disclose is rather a reproach to the ethical compass of my profession," said Dr. Nortin Hadler, a professor of medicine and microbiology at the University of North Carolina at Chapel Hill. "The fact that we think that disclosing somehow means that there is no further conflict of interest seems a rather flimsy argument."
Hadler said that the push for full disclosure among many medical centers accomplishes very little in terms of eliminating doctors' conflicts of interest, and instead highlights how widespread the problem of pharmaceutical and industry ties are among the nation's physicians and researchers.
"A significant portion of the budget of some of the best centers in the country is from some sort of arrangement with the industry," Hadler said. "It's systemic and it is intolerable that the sanctity of the patient-doctor relationship, the trustworthy nature of it, is being buffeted not just by individual conflicts of interest but by institutional conflicts of interest."
One doctor said that one of the glaring failures of the full disclosure policies is that disclosures presently rely largely on physician self-reporting, and it is not clear whether or not any institutions actually check to see how completely and accurately their doctors disclose their financial relationships. In this sense, what is "fully disclosed" could easily be just the tip of the iceberg.
"Determination of conflict of interest is a bit more sophisticated than listing doctors and fees," said Dr. Alan Leff, professor of medicine at the University of Chicago Medical Center. "It requires that any fee paid to a physician as a consultant is not related to a quid-pro-quo agreement that he or she will use their equipment or perform the company's studies."
"However, I would say now that a major percentage of studies done in my field are done through private practice physicians, who are paid for each patient recruited and for each stage of completion of the study."
At least part of the push toward full disclosure is motivated by congressional pressures on many of the top medical centers. Sen. Charles Grassley, R-Iowa, has spearheaded investigations into undisclosed payments to physicians by pharmaceutical companies.
In July, Sen. Grassley wrote a letter to Stanford University which was published in the Congressional Record. In it, he contended that Dr. Alan Schatzberg, chairman of psychiatry at Stanford University, did not provide all of the documentation necessary for a full disclosure of his investments in a pharmaceutical company that he founded. Sen. Grassley's office said that Schatzberg reported that he had more than $100,000 worth of investments in the company, Corcept Therapeutics, though his investments actually totaled more than $6 million.
However, Stanford University subsequently released a public statement explaining that the University's disclosure forms only ask researchers to disclose whether they held over $100,000 worth of investments, which Schatzberg did. For this reason, the University maintains that Schatzberg fully disclosed his investments based on the University's and the National Institutes of Health's guidelines for disclosure.
"In response to Senator Grassley's letter, Stanford University said that Dr. Schatzberg had fully complied with all conflict of interest policies both those of the University and of the National Institute of Mental Health," said Paul Costello, executive director of the office of communication and public affairs at Stanford University. "Dr. Schatzberg did, in fact, disclose the actual value of his stock in Corcept Therapeutics to Stanford as required in his ad hoc disclosures."
Conflict of Interest
Some experts believe that the push for full disclosure is a double-edged sword, doing about as much harm to the U.S. health-care system as it does good."We, as physicians cannot do the things we do and provide the care we provide ... without the tools provided by industry," said Dr. Laurence Epstein, chief of the Cardiac Arrhythmia Service at Brigham and Women's Hospital in Boston. "Conversely, the companies would not know what to develop or how to refine the technology without the input from physicians. Physicians should be fairly compensated for the time they spend on these endeavors."
Others agreed that the pharmaceutical industry plays a key role in providing funding for continuing medical education as well as research into cutting-edge treatments and technologies.
"With the low funding rate from [the National Institutes of Health], many academic institutions depend on financial support from pharmaceutical [and] device companies to do research," said Dr. Stacia Sailer, associate professor of medicine at UMass Memorial Medical Center in Worcester, Mass.
Many Patients Unconcerned
But while most experts agree that conflicts of interest are a serious threat to the honesty in a patient-doctor relationship, many patients said that they fully trust their doctors and remain unconcerned about any of their doctors' potential ethical conflicts.
"I don't care at all. I really, truly don't," said Judith Ursitti of Dover, Mass., whose son, Jack, 8, has autism. "When I take Jack to a specialist, I research their level of knowledge and how they treat other patients. If I see that they have financial ties to other companies, it doesn't bother me, as long as they are knowledgeable about my son's condition."
Ed Barnhart, 57, of Osage City, Kan., has been seeing a cardiologist for blood clots. Barnhart echoed Ursitti's belief that his doctor's tie to a pharmaceutical company would not necessarily affect the quality of the treatment he received as a patient.
"I wouldn't have a problem with it as long as my doctor is helping and [the treatment they provide] is the best possible way to help me as a patient," Barnhart said. "I would hope most of the people signed on to these ties are ethical, so I don't need to know."