Washington – Pharmaceutical companies and medical-device manufacturers paid more than $6 million to about 5,400 Connecticut doctors for various services during the last five months of 2013, a Connecticut Mirror examination of a newly released federal database shows.
The information was collected under a provision of the Affordable Care Act that is designed to help consumers understand the financial relationships between the health care industry and the nation’s physicians. Though only a five-month snapshot, the new data provides the public with the ability to search actual payments to their own doctors for the first time.
Called "Open Payments," the recent release -- by the Centers for Medicare & Medicaid Services (CMS), a Department of Health and Human Services agency -- details $3.5 billion in payments to doctors nationwide for consulting fees, travel reimbursements, and other items between Aug. 1 and Dec. 31 of 2013. The federal government plans more complete, annual disclosures in the future.
Dr. Shantanu Agrawal, deputy administrator and director of the Center for Program Integrity at CMS, said, “Open Payments does not identify which financial relationships are beneficial and which could cause conflicts of interest. It simply makes the data available to the public.”
As such, the information is a mixed bag. Medical ethicists consider many of the payments, including those for royalties and other activities, completely proper. Some, they say, are more problematic.
The pharmaceutical company that paid the most to Connecticut doctors -- more than $435,000 -- was Arthrex Inc., a medical-device company in Naples, Fla.
The doctor who received the most money from the health care industry, nearly $258,000 is Richard Lutes from Southbury. The doctor said he left private practice years ago and now works as a consultant to Millennium Pharmaceuticals, Inc., a drug maker based in Cambridge, Mass. Lutes said he is helping to develop a new drug that would fight Hodgkin’s lymphoma, a type of blood cancer.
The second doctor on the list, Paul Sethi of Greenwich, receives royalty payments because he developed a device used in orthopedic surgery and sold the rights to Arthrex. He also was paid for his travel and time to teach other doctors how to use the product, said Arthrex general counsel John Schmieding. Sethi received more than $200,000 from Arthrex.
“We have over 7,000 products, and we have an obligation with the Food and Drug Administration to make sure doctors are trained to use them,” Schmieding said.
Two other doctors on the top 10 list, Dr. Gerard Jude Girasole of Trumbull and Dr. John Fulkerson of Hartford, also received royalty or license payments from medical-device manufacturers.
Dr. Fulkerson, an orthopedist who was paid about $90,000 by DJO Global, Inc., said he “invented a brace which has been very popular worldwide.”
“I felt the need for a better brace,” Dr. Fulkerson said. “I had a patent and DJO made it.”
Dr. Thomas Pellechi of Greenwich, another doctor who received a substantial amount of money from the health care industry, in this case Purdue Pharma, works as the drug company’s in-house doctor. He earned $147,346 treating the company’s employees when they fell ill on the job.
Extracurricular activities
Also in the top 10 are three doctors who work for Yale University and one who works for the University of Connecticut. Both schools say they have stringent conflict-of-interest policies their doctors must observe.
The Yale doctors include medical school Dean Robert Alpern; Bridget Martell, an associate clinical professor of medicine at Yale; and Richard Lifton, the chair of Yale’s Department of Genetic and internal medicine.
The UConn doctor was Thomas DeBerardino, an associate professor of orthopaedic surgery.
The Open Payments data shows that Alpern received $155,792.89 from Abbott Laboratories and a company Abbot spun off last year called AbbVie, Inc., which focuses on research-based pharmaceuticals. The money included two $63,000 payments, one from each company. One was labeled “compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program.” The other was identified as a consulting fee. Alpern sits on the boards of both companies.
Yale did not respond to questions about what specific services Alpern provided to Abbot or AbbVie. But Yale spokeswoman Karen Peart said in a statement, “If ever Dean Alpern had the opportunity to be involved in a decision affecting AbbVie, (or Abbott), he would recuse himself.”
“The university encourages its faculty to seek and participate in sponsored research, to consult widely, and to engage in other activities that may benefit not only the participants but also the university itself, and the larger public,” Peart said. ”All faculty members are required to follow stringent policies governing the relationships of faculty with outside entities, including the pharmaceutical industry. These policies preserve the independence of our faculty and reduce the potential for real or perceived bias in our research activities, clinical decision-making, and educational programs.”
The two other doctors with Yale ties, Martell and Lifton, did not return calls requesting comment, nor did Yale’s spokesperson respond to requests for information about their specific activities. Each doctor received about $100,000 in consulting fees from the health care industry in the time period studied.
UConn's DeBeraradino received nearly $165,000 from Arthrex. Scott Wetstone, director of health affairs policy and planning at UConn, said DeBerardino flies to various places on the weekends to teach certain minimally invasive joint surgery techniques to other doctors.
“He certainly does use devices manufactured by Arthrex,” Wetstone said. “But he is not there to sell Arthrex products... He has total editorial control over everything he does.”
Wetstone also said every trip DeBerardino takes on behalf of Arthrex is pre-authorized by the chairman of his department.
“We are comfortable that he is doing this on time that is not owed the university,” Wetstone said.
While Yale, UConn and other universities have conflict of interest policies aimed at curbing unethical behavior, some advocates of tougher standards say such policies sometimes are confusing or haven’t been enforced rigorously at some schools.
A controversial practice
The Ridgefield-based U.S. division of Boehringer Ingelheim Pharmaceuticals, Inc. is among the top pharmaceutical firms making payments to Connecticut doctors, spending about $261,000 in the five-month period.
“We work with physicians and other medical professionals, to develop and evaluate data and scientific information, and to help in the research and development of new and effective treatments,” said company spokeswoman Erin Crew. “Physicians and other medical professionals provide real-world insights and valuable feedback and advice to inform us about our medicines, our strategies and to help us contribute to improvements in patient care.”
The CMS data shows Connecticut doctors were paid more than $1 million to give presentations or discuss certain drugs. That activity can include an industry phenomenon known as “speaker’s bureaus.”
Drug and medical device companies look for doctors with credibility among their peers and enlist them to provide training sessions. The physicians then travel, eat and speak at the company’s expense.
Bristol-Myer Squibb’s Abilify, a drug used to treat bipolar disorder, was the most popular drug Connecticut doctors talked about, followed by AbbVie’s Humira, a drug that treats rheumatoid arthritis, and Astra Zenica’s Brilinta, a drug given to heart attack victims to reduce the risk of another attack.
Ezekiel Emanuel, chairman of the University of Pennsylvania’s Department of Medical Ethics & Health Policy, said the speaker's bureau practice is “a genuine problem and something we should worry about.”
Harvard Medical School developed one of the toughest ethics policies in the nation after its students protested that some faculty were too cozy with the health care industry. The policy prohibits faculty from speakers bureau activity. So do other schools, including UConn and Yale.
“We do not want doctors to be promoting or marketing drugs. That is the job of industry,” said Philip Pizzo, former dean of the Stanford School of Medicine and a noted critic of the practice of physicians' giving paid promotional talks for pharmaceutical companies.
Yet, Pizzo said, “a broader perspective is that one cannot eliminate conflicts of interest.”
“They need to be managed and disclosed, and when there are concerns, institutional conflict of interest committees review and either approve or deny the requested activities,” he said. “We want to foster connections between academia and industry. We want research that is relevant to new drugs or products to be done between industry and academia, to be done in ways that benefit the public good.”
Others were more critical, including the health insurance industry that’s launched a war on the high cost of drugs and says doctors are sometimes paid to promote an expensive drug when a cheaper one would be as effective.
"These payments, while not nefarious in every case, are a perfect symbol for the misaligned incentives in our health care system. While most health care stakeholders are working together to find ways to lower costs, drug makers remain focused on strategies to keep them inflated,” said Brendan Buck, spokesman for America’s Health Insurance Plans.
Glitches and omissions
While some lauded the launch of the Open Payments web site on Sept. 30, it was roundly criticized as being difficult to use by ProPublica, a non-profit newsroom that produces public interest journalism and has for years plumbed the relationship between pharmaceutical companies and the nation’s doctors.
“If the federal government's new Open Payments website were a consumer product, it would be returned to the manufacturer for a full refund,” Charles Ornstein of ProPublica wrote.
ProPublica said the site was impossible to navigate, comparing its launch to the debut of the glitch-filled Healthcare.gov web site, the portal many states used as an insurance marketplace to comply with the Affordable Care Act.
“It's worth noting here that the contractor that created the Open Payments site is CGI Federal, the lead contractor for the Healthcare.gov website,” Ornstein wrote.
The American Medical Association also has been critical of Open Payments, saying many doctors who wanted to review information about themselves before the release of the data to the public were unable to register with the system, and others said information about them was incorrect.
CMS said it excluded any information that was challenged from its release.
Before the information was made available to the public, the AMA also said it “continued to raise grave concerns about the pending data release and its potential impact on medical innovation and physician employment.”
The Connecticut Mirror sorted the data concerning Connecticut doctors and made it user-friendly.
But not all of the information on the links between doctors and the health care industry was available.
About 40 percent of the 4.4 million records released by CMS are missing the names of doctors and teaching hospitals that received the payments because of inconsistencies and other problems.
“So, if your doctor doesn't appear in a search, it doesn't necessarily mean that he or she didn't receive a payment,” Ornstein said.
CMS promised to obtain all missing information and fix problems with its database before the next release of information.
Future reports will be published annually and will include a full 12 months of payment data, beginning in June 2015, the agency said.