Late last year, medical device maker Zimmer Holdings Inc. made two large payments to Dr. Andrew N. Pollak, chair of the University of Maryland Medical System's orthopedics department.
The payments, one for $47,225 and the other for $45,902, were royalties paid to Pollak for work he did at Maryland Shock Trauma Center starting seven years ago in helping develop a clamp known as a fixator that could hold trauma patient's broken bones straight until they were ready for surgical repair.
Existing devices were clumsy and inflexible and not meant for trauma patients, Pollak said.
"My motivation was to develop a frame that was much easier to use, and I'd say we succeeded," he said. "Tremendous advances in health care come from the work physicians do with industry."
The payments were disclosed in a new federal database released last week that aims to shine light on such relationships between doctors and drug manufacturers and device makers — and discourage arrangements that don't advance medicine and pose conflicts that could compromise care.
The data released for the last five months of last year by the U.S. Centers for Medicare & Medicaid Services includes 4.4 million payments for almost $3.5 billion to 546,000 doctors and close to 1,360 teaching hospitals around the country. Baltimore doctors and hospitals, including research giants Johns Hopkins Medical System and the University of Maryland Medical System, received more than $5 million in payments, according to a Baltimore Sun analysis.
The money could have been royalty payments such as Pollak's or funds for clinical trials. But it also includes payments for research, consulting, education, travel or food, for example.
The Open Payments program data release follows another one earlier this year showing payments made to doctors by Medicare, the federal health care program for seniors. And like that information, the newest data has drawn criticism from the American Medical Association and the Maryland medical society, MedChi, because they said it lacks context and in some cases was inaccurate.
The groups said the raw data may wrongly imply doctors pocketed big payouts for little or no work or were involved in some wrongdoing. The money attributed to one doctor as a grant or consulting fee could have gone to shape or fund clinical trials led by several doctors in a department, for example.
"Specifically in Maryland, this is an issue given the large number of clinical trials that occur in the state," said Gene Ransom, CEO of MedChi. "We support transparency, but just releasing large amounts of data doesn't help with explanation or context."
For its part, Marilyn Tavenner, administrator for the Centers for Medicare and Medicaid, said in a statement, "CMS is committed to transparency and this is an opportunity for the public to learn about the relationships among health care providers, and pharmaceutical and device companies."
She suggested patients ask their doctors about the relationships. Consumer advocates said the public disclosure may be enough to change practices.
"These manufacturers need to put more focus on research, less focus on marketing, and we hope this kind of financial transparency will encourage that," said Lisa Swirsky, senior policy analyst for Consumers Union, in a statement.
A Sun assessment of the Baltimore region included more than 12,000 payments in the five months ranging in size from a few dollars to $250,000. Many of the top 100 payments were largely for royalties and licenses for specific drugs or devices.
Many other payments were for unspecified consulting or grants. Smaller payments were for food and lodging and other services.
The University of Maryland Medical System and affiliated doctors logged six of the top 10 payments. The largest was a $250,000 royalty or license payment made to the system in October 2013 from Varian Medical Systems of California related to RapicArc, a machine that the company and university say offers a major advance in how radiation beams are delivered to cancer patients because treatment times are vastly reduced.
Dr. Vincent Pellegrini, an orthopedic surgeon, received the second- and third-largest payments in the 2013 window, with $241,941 and $232,930 in royalties or license fees coming from DePuy Synthes Sales Inc. of Maine related to a hip treatment. The company website says the hip implant the doctor contributed to is more flexible than traditional implants and can be used on a variety of patients. Pellegrini has since left Maryland for the Medical University of South Carolina.
Also in the top 10 were two Hopkins doctors, including Dr. Edward D. Miller, an anesthesiologist who was paid $165,015 in stock or options for what the database listed as speaking or other services from CareFusion Corp. of California. He also received another 25 payments totaling more than $37,000 for food and travel from the company.
Miller sits on CareFusion's board of directors, and, according to the company's annual proxy statement, was paid related fees of $105,000 in cash and $165,000 in restricted stock for his work in 2013. He retired from Hopkins in 2012 and his relationship with the company was approved by the hospital.
The database also showed Dr. Brigitte M. Ronnett, a Hopkins pathologist, received four payments totaling $144,121 in consulting fees from the pharmaceutical company Merck Sharp & Dohme Corp., the name used by Merck & Co. internationally.
Hopkins spokeswoman Lisa Broadhead said the payments were made to the Hopkins School of Medicine in connection with an institutional research grant and not to Ronnett personally.
Broadhead said, "While we applaud efforts to provide the public with accurate and meaningful information, we do urge those viewing the new database to not make quick judgments or definitive observations about the information as it is presented until we know more about the accuracy of its contents."
She also said Hopkins works with industry to "advance research and translate ideas from our laboratories into practice for the welfare of patients and the betterment of public health."
Rounding out the Top 10 was a surgeon from Greater Baltimore Medical Center, Dr. John LeDonne, listed as receiving a $68,750 food and beverage payment from North Carolina-based Teleflex Medical Inc. The payment was linked to Arrow StimuCath, a postoperative catheter used to reduce pain. He also received close to 30 other payments from various companies for food, travel, consulting and speaking totaling more than $27,000.
Jake Elguicze, treasurer and vice president of investor relations at Teleflex, said LeDonne is a paid consultant and the large payment was mistakenly classified by them as food.
GBMC officials said in a statement that LeDonne was well known in the medical community as an expert in inserting central lines, the catheters used to deliver medicine and nutrition to patients through a major vein. Several health care companies sought him for consulting work, and he's followed all hospital policies regarding disclosure and conflicts of interest, the statement said.
"I have a long standing relationship with the Teleflex Corp. that includes activities primarily related to educational activities," LeDonne said in a statement. "These activities include participation in central venous insertion courses, travel and presentations. Occasionally, I will be requested to participate in a Health Hazard Evaluation."
Top 10 payments to doctors
7. Dr. Brigitte Maria Ronnett, pathologist at Hopkins, received a $50,601 consulting fee on Oct. 25 from Merck Sharp & Dohme Corp., the name used by Merck & Co. internationally (Hopkins officials say the payment was made to the school of medicine for research, and not to Ronnett personally)
These are the top 10 recipients of payments from pharmaceutical companies and medical device makers in the Baltimore region in the last five months of 2013, as listed in the new federal Open Payments database. Some of the information has been disputed by the recipients as noted.
1. University of Maryland Medical System received a $250,000 royalty or license payment on Oct. 13 from California-based Varian Medical System related to Rapid Arc
2. Dr. Vincent Pellegrini, orthopedic surgeon at Maryland, received a $241,941.07 royalty or license payment on Sept. 10 from Maine-based DePuy Synthes Sales Inc. related to a hip treatment
3. Dr. Vincent Pellegrini, orthopedic surgeon at Maryland, received a $232,930.51 royalty or license payment on Dec. 3 from Maine-based DePuy Synthes Sales Inc. related to a hip treatment
4. Dr. Edward Doring Miller, anesthesiologist at Johns Hopkins Medical System, received $165,015 in stock, stock option or ownership stake for speaking or other services on Nov. 6 from California-based CareFusion Corp. (Miller sits on the company's board of directors.)
5. Dr. John Ledonne, surgeon at Greater Baltimore Medical System, received $68,750 for food or beverages on Oct. 25 from North Carolina-based Teleflex Medical Inc. related to Arrow StimuCath (Teleflex said this was improperly categorized and was payment for consulting, not food.)
6. University of Maryland Medical System received a $56,125 cash or cash equivalent in the form of a grant on Dec. 12 from Maine-based DePuy Synthes Sales Inc. related to a trauma treatment
8. Dr. Andrew Pollak, emergency physician at Maryland, received a $47,225.35 royalty or license payment on Dec. 29 from Indiana-based Zimmer Holdings Inc. related to a trauma treatment
9. Dr. Andrew Pollak, emergency physician, received a $45,902.01 of a royalty or license payment on Oct. 03, 2013 from Indiana-based Zimmer Holdings Inc. related to a trauma treatment
10. Dr. Brigitte Maria Ronnett, pathologist, received a $39,245 consulting fee on Dec. 27 from Merck Sharp & Dohme Corp. (Hopkins officials say the payment was made to the school of medicine for research, and not to Ronnett personally)
Source: Centers for Medicare and Medicaid Services