August 11, 2016

Disclosure Rules Don’t Stem Flow Of Pharma Cash To State’s Doctors

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Dozens of Connecticut doctors accepted six-figure payments from drug and medical device manufacturers in 2015 for consulting, speaking, meals and travel, with six of the 10 highest-paid physicians affiliated with academic institutions, new federal data show.

The top 10 doctors – less than 0.1 percent of the 11,000 who received payments – took in $3.6 million, or nearly 15 percent of the total $24.9 million paid out. Among them is the dean of the Yale School of Medicine, Dr. Robert Alpern, who received $445,398 in 2015 from two companies – Abbott Laboratories and AbbVie – in consulting fees, meals and travel expenses for serving on the boards of both companies. In 2014, he received $458,194 from the two companies.

The Yale medical school began a research partnership with AbbVie in 2013, after the pharmaceutical company spun off from Abbott Laboratories. Besides serving on the boards, Alpert owns stock in both companies, according to public filings — the kind of dual role that raises concerns among critics about potential conflicts of interest.

Alpern said he does not participate in any matters involving AbbVie or Abbott in order to avoid any conflict, and that the arrangement has been approved by Yale.

Two other physicians affiliated with Yale, and three affiliated with the University of Connecticut, also were among the 10 biggest recipients. The bulk of their drug company payments were for consulting and speaking fees and travel and meals, rather than research, which is not counted in the totals. Most also were top earners in 2014.

Pharma-Dr-Payments-Graphic-2016-08-light-1000The financial relationships between nearly 1,500 drug and device companies and 619,000 doctors, as well as teaching hospitals, are now disclosed publicly under a provision in the Affordable Care Act. Drug companies have long maintained that the relationships assist in drug development and education, while critics argue that the payments skew physicians’ prescribing and research decisions.

Despite the increased scrutiny, payments to Connecticut doctors declined only slightly in the last two years — from $28.3 million in 2014, to $24.9 million in 2015. Nationally, the total paid to physicians also remained relatively steady: $3.7 billion in non-research payments in 2014, and $3.63 billion in 2015.

In Connecticut, more than half of all payments went to physicians in two specialties: internal medicine ($10.9 million) and orthopedic surgery ($3 million). Psychiatrists and neurologists followed, with $2.5 million in payments.

Companies that paid the most to Connecticut doctors were AbbVie, Arthrex, AstraZeneca and Pfizer, each of which spent more than $850,000 in Connecticut. Nationally, two of those drug makers — Pfizer and AstraZeneca –were among the top 10 highest-paying companies. Novartis Pharmaceuticals topped the national list, with $539 million in payments, followed by Genentech at $470 million and Pfizer at $436 million.

Dr. Joseph Ross, an assistant professor of medicine at the Yale School of Medicine who has written about the industry’s influence on physicians, said he was surprised that the 2015 payments, nationally and in Connecticut, had not declined.

“My hunch was that physicians, out of concern at being publicly listed as receiving payments, meals and other items of value from pharmaceutical companies, were going to begin declining invitations to meals or refusing smaller gifts,” he said.

“However, perhaps because we are only in the early days of the (disclosure) program, and because patients are not yet using this information to form judgments on what these payments might imply, there hasn’t been sufficient public pressure for physicians to change their behaviors.”

Ross said he was not surprised that so many high earners were from academia, where payments for royalties and consulting are common. Still, he said, “The interaction between academic physicians and industry is tricky. I think most people agree that you want academic physicians involved in research . . . What’s problematic is when industry becomes involved in education, and promotional efforts leak into the academic setting. These represent interactions that I believe should be strongly discouraged.”

Officials of the Centers for Medicare & Medicaid Services (CMS) noted an overall shift from 2014 to 2015 in the types of physician payments — reductions in gifts, honoraria and entertainment expenses, and increases in payments made as charitable contributions. There also were shifts among specialties receiving the most industry dollars; payments to nuclear medicine doctors ballooned in one year – from an average payment of $8,037 in 2014, to $51,279 in 2015.

CMS administrators said their tracking of industry payments does not distinguish between relationships that are beneficial, and those that may indicate conflicts of interest. But they said the public disclosures are useful.

“Transparency is empowering physicians to be purposeful about their financial relationships with companies,” said Dr. Shantanu Agrawal, CMS deputy administrator and director of the agency’s Center for Program Integrity.

Dual Roles Approved

In Connecticut, the highest paid physician was Dr. Roger Echols, an Easton infectious disease specialist who received nearly $500,000 in payments for consulting, travel and lodging, and food and beverages from Shionogi, Inc., a Japanese pharmaceutical company best known for developing the anti-cholesterol drug Crestor. All of the payments were made through Infectious Disease Drug Development Consulting, LLC, of which Echols, who is not currently treating patients, is the principal.

Alpern was the second highest paid physician in 2015, receiving $242,187 from Abbott Laboratories and $203,211 from AbbVie. Payment records from Abbott say all of his compensation was for serving as a board member — $195,600 in consulting fees, and the rest for meals, travel and lodging, including $25,550 for a trip to Mumbai, India. He also received $1,400 characterized as a “gift.”

His compensation from AbbVie included a lump-sum payment of $126,000 in March, which Alpern said was compensation for serving on the board. Most of the other payments were for travel and meals, including $19,000 in June for a trip to San Francisco.

Alpern, who also is a trustee of Yale-New Haven Hospital, has been on the board of Abbott Labs since 2008, and of AbbVie since 2013. He owns stock in both companies valued at more than $2 million, according to public filings.

Alpern said Yale is aware of his financial relationships with both companies, and that he does not participate in “decisions or the execution of any matter between or involving Abbott, AbbVie and Yale,” in accordance with “a management plan that was approved by university administration.”

The Yale School of Medicine and AbbVie have a five-year agreement through which the company is giving the school $14.5 million for immunology research. AbbVie was spun off as a separate company in 2013, after Abbott Labs pleaded guilty and agreed to pay $1.5 billion in 2012 to resolve charges of illegally marketing the drug Depakote for unapproved uses, including to sedate elderly patients in nursing homes.

Alpern said he believes it is important for healthcare companies to have board members from leading academic medical centers “to ensure that they receive input from the medical and scientific communities.

“However, he added, “board membership and the corresponding financial interest for such participation do create the potential for a real or perceived conflict of interest that warrant a management plan. To that end, Yale, Abbott, AbbVie and I have been very careful to manage my participation on the boards in an ethical manner.”

He said the trips to Mumbai and San Francisco were related to board meetings.

Yale and UConn representatives said the schools have strict policies on conflicts of interest. Yale’s policy says that external activities “must not compromise an individual’s ability to perform all the activities expected of him or her as a Yale employee.” Faculty members must disclose their external activities for university review.

Yale’s policy for physicians bars them from accepting industry “gifts,” including meals, travel and hotel expenses, except in limited circumstances in which the physician has a written agreement to provide consulting services. Clinicians may be paid to speak at industry-sponsored meetings only if their lectures promote “objective scientific and educational activities,” with no influence from the sponsor.

The two Yale doctors besides Alpern who are among the top 10 received “speakers’ bureau” payments in connection with certain drugs and devices, according to records — meaning that they presented promotional, rather than strictly educational, talks to other clinicians.

The Yale policy notes that financial interests that are “large” compared to an individual’s institutional salary “do have the potential for greater bias, and are also inherently more difficult to manage,” warranting special scrutiny.

Like Yale, UConn encourages its clinicians to engage with industry “to advance medicine through research and participating in national and international educational forums to improve healthcare,” said spokeswoman Lauren Woods.

She said UConn Health requires faculty to report all industry-supported work to avoid conflicts of interest and “prohibit undue influence.”

Susan Chimonas, a national expert on physician-industry relationships and director of research at Columbia University’s Institute on Medicine as a Profession, said the kind of “extensive ties” that Alpern and other university leaders have with drug companies are problematic and can pose “institutional conflicts of interest.”

“A lot of these institutions won’t let their employees take a pen or a sandwich from a drug company, and then a dean is allowed this exception,” she said.

She said academic leaders often are sought after by drug companies because they are “physicians of prestige.” When their industry earnings run into the hundreds of thousands, she said, “You have to wonder, where are their primary loyalties?”

Industry Payments ‘Not Inherently Bad’

Two doctors in private practice were among the top 10 recipients in Connecticut.

Dr. Paul Sethi, an orthopedic surgeon in Greenwich, was the third highest paid physician, receiving $414,207, most from Arthrex in the form of royalties related to a device used in orthopedic surgery that he developed. The fifth highest recipient was Dr. Thomas Pellechi, an internist in Greenwich, who received $365,463 from Purdue Pharma for serving as the company’s in-house doctor.

Five other physicians in the top 10 were affiliated with Yale or UConn. Four received some speakers’ bureau pay – compensation that Chimonas said is being prohibited by a growing number of universities.

Even when speakers don’t mention specific drugs, Chimonas said, the talks “help the companies” by highlighting certain health conditions for which the companies market medicines.

The five physicians are:

• Dr. Peter Whang, an associate professor of orthopedics and rehabilitation at the Yale School of Medicine. He was paid $346,093, most in speaker and consulting fees, as well as travel and meals. More than $125,000 came from Pacira Pharmaceuticals, which compensated him for speaking and consulting about the company’s drug Exparel, a non-opioid local analgesic used for post-surgical pain. He also was paid $92,652, mostly for speaking, travel and meals, by Medtronic Sofamor Danek USA to promote products, including spinal implants, records show.

Whang said that while he recognizes that financial relationships between industry and physicians can raise concerns, such interactions are “not inherently bad,” especially as they lead to drug and device breakthroughs. He said he consults on Exparel because it is a useful post-surgical alternative – though it is not in use at Yale, he added. Some of his work for Medtronic involved training physicians on surgical techniques, he said.

“I’m providing a service based on my area of expertise,” Whang explained. “I don’t own stock or intellectual property” in any of the companies.

• Dr. Alexandra Lansky, director of the Yale Cardiovascular Clinical Research Program and professor at the School of Medicine. Her payments were $373,831—but the bulk of the money ($313,000), attributed to her as “consulting” fees from Lutonix, Inc., were directed to the Yale clinic, records show. Lansky said Lutonix pays Yale for clinical research into its drug-coated balloon catheter. Lutonix records say Lansky “attended in her role as director of the Yale Cardiovascular Clinical Research Program.”

Lansky directly received $48,000 from AstraZeneca, most of it for speaker fees connected with Brilanta, a drug marketed to lower the risk of heart attack, as well as food and travel expenses, according to records filed by the drug company.

Lansky said that while she does speak on behalf of AstraZeneca, she does not “promote” Brilanta.

“I educated physicians on Acute Coronary Syndrome and the medical treatments for ACS, which includes the guideline recommended anti-platelet Brilinta.” She also received $10,250 as a paid speaker for Lilly USA and more than $400 in meals from other companies.

• Dr. Thomas DeBerardino, who was associate professor of orthopedic surgery at the UConn Health Center in 2015. He was paid $344,007, nearly all from Arthrex in speaking fees related to the company’s knee and hip arthroscopy and other products. Individual payments ranged in amount from $2,500 to nearly $40,000. He is no longer with UConn, Woods said.

• Dr. William White, a cardiologist and hypertension specialist who is a professor of medicine at UConn Health. He received $256,775 from 15 companies, mainly for consulting on drugs to treat multiple sclerosis, Type 2 diabetes and other ailments, and for travel and meals. The top companies were Takeda Pharmaceuticals ($78,330) and Teva Pharmaceuticals ($52,590). He also received another $318,000 in industry payments for research.

White’s industry-sponsored work “focuses on ensuring patient safety and proper scientific analysis during the evaluation of medications,” Woods said. “As a leader in the field, he is sought after for sharing his expertise for independent study data and drug safety analysis. None of his activities are of a commercial or marketing nature.”

• Dr. Bruce Strober, professor of dermatology and chair of the Department of Dermatology at UConn Health. He received $234,488 from 12 companies, most for consulting, speaking, travel and meals. The top companies were AbbVie ($53,013) and Amgen ($52,373), with records noting that Strober consulted on drugs including Amgen’s Enbrel, used to treat plaque psoriasis, and was a speaker and consultant on AbbVie’s Humira, which treats rheumatoid arthritis, chronic plaque psoriasis and other conditions.

Woods said Strober’s industry-funded activities “range from consultation for drug development, testing of drugs in clinical trials, clinical trial design, implementation, interpretation, review of study results, and physician education . . . By lending his time and expertise to industry-sponsored activities, he is working to advance research to find new treatment options” for patients.

In Connecticut, 68.2 percent of hospital-affiliated physicians took some industry payments in 2014 – the highest rate in New England, but lower than at least 20 other states, according to data compiled by the news organization ProPublica. Yale-New Haven and UConn’s John Dempsey Hospital had relatively low rates of doctors accepting payments – 53.4 percent and 49.8 percent respectively, according to ProPublica’s analysis.

Data reporters Madison Hopkins and Matt Wynn contributed to this story.

 

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