We often highlight the beneficial relationships between pharmaceutical and medical device companies and physicians, and the significant advances that are made possible by such collaboration. With the release of the Open Payments database—which details the payments from industry to physician—many were concerned that the benefits of this partnership would be lost in the discussion. After all, Open Payments provides little room for context, and is essentially just a spreadsheet of payment transactions. While some media outlets did take the Open Payments release as an opportunity for a witch hunt, others dug deeper into the numbers. A Michigan news source actually interviewed the five Michigan doctors with the highest payment totals, and gave each an opportunity to discuss the fruits of collaboration.
Three of the physicians received their payments in the form of royalties and licenses; one of the physicians received the majority of his payments for consulting; finally, one had $571,000 in clinical trial research payments attached to his name, despite all of the funds going towards the clinic at which he worked.
The article, written by Sue Thomas, of MLive, is available here.
Dr. Richard Chesbrough, a diagnostic radiologist received $688,000 for royalty and license payments from C.R. Bard Inc. & Subsidiaries.
Chesbrough said the payments stem from his work developing new devices or techniques for biopsies, inventions that are used in 37 countries, he said. “Mine’s a pure business deal,” Chesbrough said. “If I have a conflict of interest, I would love for someone to explain it to me.”
His inventions include a needle biopsy system, which is used to preserve breast tissue by allowing the surgeon to remove a small sample for biopsy. He also developed marking clips that can be left at the site of a biopsy so a surgeon can find it more easily later. And he developed a software program that helps ensure that abnormal results are brought to the physician’s attention.
He doesn’t use the devices in his current practice because he no longer does biopsies. He reads and interprets patient scans sent to him from hospitals in eight states.
However, when he did perform biopsies and used his inventions, he explained his connection to the device in a brochure he gave to patients.
“There is a big difference between a doctor who creates a product they license to industry and not recommend it to their patients – and doctors who are on the take of a drug company or medical device company and using those products on their patients,” Chesbrough said.
Chesbrough said he supports the Open Payments program and the release of data showing the connections between industry and physicians. “Doctors that have these relationships with drug and medical device companies need to disclose that to patients,” he said. “There is a potential conflict of interest there.”
Dr. James Vanderlugt, a general practice physician had $571,000 in payments listed under his name from Roxanne Laboratories. This total was for three clinical studies led by the Vanderlugt for Jasper Clinic, says Dean Knuth, the clinic’s chief executive officer.
Including them in the Open Payments database is misleading because the funds go to the clinic and not to the doctor personally and because Vanderlugt does not treat patients, Knuth said. As the clinic’s medical director, Vanderlugt receives a salary.
Jasper Clinic is located on the grounds of Bronson Hospital and leases clinic space from the hospital, but is a separate business entity, Knuth said. The clinic conducts phase 1 and 2 clinical trials for new drugs, devices and diagnostic tests.
“It is critical to note that Dr. Vanderlugt's work as a physician is strictly limited to trials research,” Knuth added.
“He does not treat patients from the general population. As a result, while he is named in the Open Payments database, his inclusion simply isn't relevant. He has no ability to influence patients since he literally has no patients.”
Dr. Bradley Bengtson, a plastic surgeon received $341,000, mostly consulting, speaking, and training fees from Allergan, the maker of a breast implant called Natrelle.
Bengtson conducts bio-skills labs in which surgeons learn and practice new products or techniques. In his presentations, he says he is open about complications and issues and does not try to sell the surgeons on a device.
“It’s very easy to see bias. I don’t insult my colleagues,” he said. “I just present what the data is, when I use it and when I don’t. If they want to use it, then they can.”
Although 80 percent of his patients use a traditional gel implant, Bengtson said Natrelle is a good option for some patients undergoing reconstructive surgery or those who don’t want to look augmented. It is made with a thicker, highly cohesive gel and is more tapered than traditional gel implants.
Having performed 300 breast augmentations with the implant, he said he has more experience with it than any other surgeon in the U.S. Bengtson traveled to Korea, Australia and throughout the U.S. to lead training sessions. Although his fee is $3,000 to $5,000 per day and travel expenses are covered, he said he loses money when he leaves his practice for a speaking or training engagement.
“I get paid about 1/10th the amount of money that I would make if I stay,” he said. “Consulting is not beneficial financially.”
In a typical week, he performs 10 to 15 surgeries. On office days, he sees 30 to 40 patients a day. The revenue sustains a practice, Bengtson Center for Aesthetics & Plastic Surgery, with a 6,000-square-foot office and 25 employees.
He agrees to train other surgeons because he feels compelled to teach and pass on what he has learned. “I just love it,” he said.
Bengtson also does research on surgical techniques for specialized patients and on ultrasound scans. He said his relationship with Allergan and other companies does not affect which device he uses in treating patients.
“It doesn’t influence my decision,” he said. “Absolutely not. My focus is on my patients and getting the best outcome for them.”
Abuses have occurred in the past, he said, but he believes they were curbed after Department of Justice lawsuits in 2005 against five corporations. Bengtson said he believes physicians should be open about their relationship with drug and device manufacturers, but he questions whether the Centers for Medicare and Medicaid Services should handle that task.
He says it already has been addressed by the American Society of Plastic Surgeons and the American Society for Aesthetic and Plastic Surgery. “I think, like most things, the government is very late in the game,” he said. “It’s almost a joke to think they have the ability to police this.”
Dr. John Blaha, an orthopedic surgeon and researcher at the University of Michigan Medical School, received a total of $201,000, mostly in royalties from a knee-replacement technology he developed.
Blaha disclosed the payments to U-M and agreed to follow policies developed to avoid conflicts of interest, she said. If he uses an implant he has invented on a patient, he must let the patient know – and he cannot collect royalties on it. He also cannot get royalties when any other U-M surgeon uses the implant.
The goal of the policy is “to reduce the influence it might have on him for using it and for his colleagues here,” said Dr. Ray Hutchinson, assistant dean for regulatory affairs.
“Dr. Blaha has been very forthcoming on this issue. I think he has done what he can to be open both with us at the medical school as well as his patients.” Strong polices to guard against conflict of interest are needed because the link between doctors and industry is critical to medical advances, Hutchinson said.
“You do research at a university, but you can’t make the products that need to get out into the public. Companies have to take those ideas and develop them further and get them into the marketplace,” he said.
“Our goal is to manage any conflicts that exist to minimize any risk to data integrity, subject safety, patient safety or to student learning or education, so there is no unnecessary bias there.”
Dr. Michael Masini, an orthopedic surgeon, received $196,000 mostly in royalties from Stryker and Biomet stemming from 55 patents he holds.
Dr. Masini’s inventions include hip and knee replacements, shoulder devices and bandages, all developed in response to needs he saw in surgery. “You kind of see it firsthand. When you are frustrated with something, you try to think of a better way,” he said. “Sometimes you can patent it if you think it’s a good idea.”
In his work with Stryker, he is an inventor-consultant, serving on a panel of doctors to help the company decide on products and surgical procedures.
“The companies couldn’t design these procedures and implants without the input from surgeons,” he said.
The needs of the patient determine which device he uses, he said, and he informs patients if it is one he invented. “I think it’s important that people have this kind of information,” he said. The reaction he gets from patients is generally positive. “Most people like the fact that you are a leader in your field and that you are innovative,” he said.