Abstract
Objectives To measure the prevalence and magnitude of industry payments to neurologists prescribing multiple sclerosis (MS) drugs and determine whether payments are associated with prescribing.
Design Retrospective observational study.
Setting Data on neurologists prescribing MS drugs from 2015 to 2019 in the Medicare Part D database linked to the Centers for Medicare & Medicaid Services Open Payments database.
Participants 7401 neurologists prescribing MS drugs from 2015 to 2019 to Medicare beneficiaries.
Main outcome measures The primary outcome was the proportion of physicians’ annual prescriptions manufactured by a given company. Generalised linear mixed models were used to evaluate associations between the presence and magnitude of payments and prescribing. The association between prescription volume and the likelihood of receiving payments as well as the value of payments was also assessed.
Results Among 7401 neurologists, 5809 (78.5%) received payments totalling US$163.6 million between 2015 and 2019. While the median amount per physician was US$779 (IQR, US$188–US$2587), US$155.7 million (95.2%) accrued to the top 10% of payment recipients. Higher prescription volumes were associated with a higher likelihood of receiving any payment type, particularly for consulting services, non-consulting services and travel/lodging (p<0.001). Among payment recipients, the amount received was positively associated with prescription volume (p<0.001). Receipt of payments was associated with greater likelihood of prescribing the company’s drugs compared with those who received no payments from that company (OR 1.13 (95% CI 1.11 to 1.15)), with the largest association for non-consulting services, such as being a speaker at an event (OR 1.53 (95% CI 1.44 to 1.62)). Larger payments were associated with a greater likelihood of prescribing (OR 1.10, 1.26, 1.29 and 1.50 for US$50, US$500, US$1000 and US$5000, respectively), as were longer durations of payments (OR 1.12 for single year to 1.78 for 5 consecutive years) and more recent payments (OR 1.03 for payments made 4 years prior to 1.34 for payments made in the same year).
Conclusions Nearly 80% of neurologists prescribing MS drugs received at least one industry payment, with higher volume prescribers being more likely to receive payments. Physicians receiving payments were more likely to prescribe the company’s drugs, with a stronger association for payments that were larger, sustained and recent.
________________________________________________________________
A ‘Humbling’ Study
Two MS neurologists without ties to the research—Elizabeth Silbermann, MD, an assistant professor of neurology at Oregon Health & Sciences University (OHSU), and Mitchell Wallin, MD, MPH, FAAN, associate professor of neurology at the University of Maryland School of Medicine and director of the VA MS Center of Excellence—said Dr. Ross and his team made a good analysis of the data available to them.
“It's a good population-based sample of the United States with high numbers,” said Dr. Wallin, who thought it was wise that the researchers stopped the analysis at the beginning of the pandemic. He added that he was impressed that the study showed a dose-response relationship between payments and prescribing. “I think that it's a humbling article.”
Dr. Silberman called it a broad study that “captured data in the best way you can in the United States.” She said the high percentage of neurologists who accepted pharma money had a “bit of shock value.”
The data problem, which the researchers acknowledged, is that the study was limited to prescribing information from Medicare Part D. MS tends to be diagnosed among much younger people, so the study may have missed those just starting medications as well as some younger people with aggressive disease.
In addition, Dr. Wallin said that many MS experts at academic medical centers are now trying to wean older, stable patients from their medications. And newer infusion drugs are paid through Medicare Part B, so Part D data does not capture them.
Dr. Ross acknowledged that the data his team used skewed toward older patients and young ones with serious disabilities. However, the MS specialists included in the study also treat younger patients, and he thinks their prescribing habits likely transcended age. It is possible that industry influence on prescribing behavior is even more pronounced among younger patients because they change drugs more frequently, he said.
Dr. Wallin pointed out that insurance companies often resist paying for newer, more expensive drugs, which may mean that doctors end up prescribing medications that were not their first or even second choice.
Earlier this year, Dr. Silbermann's colleagues at OHSU published a study on uptake of generic glatiramer acetate and industry payments that found an association between the payments and prescriptions for the branded drug. Although generics became available in 2015, more than half of prescriptions in 2021 were still for the branded formulation. Neurologists who received industry payments were more likely to prescribe the branded drug, the study found.
One confounding factor, Dr. Silbermann said, is that drug companies often provide financial assistance for patients who take the branded drug.
Why Does This Problem Persist?
Asked why doctors continue to accept payments from drug companies when multiple studies have shown that it affects prescribing behavior, Dr. Ross said he has heard from other doctors that they don't think payments can influence them. Also, it's part of medical culture. Doctors think, “Everyone's doing it, so why shouldn't I?” he said.
Dr. Wallin, who does not accept direct payments from pharma, agreed that most physicians “believe that pharmaceutical reps don't really affect their behavior,” but “people are avaricious. That's the short answer.”
Unfortunately, he said, medical groups depend on industry to support their large, educational meetings, and he and Dr. Silbermann agreed that talking to sales reps can be valuable. She occasionally attends educational events sponsored by a drug company but doesn't eat or drink, except for a cappuccino she might accept from a drug company at a big meeting. Dr. Silbermann said she understands why hungry, time-pressed convention-goers might accept some food, though.
The big issue, she said, is that doctors need information about drugs, and it's hard to get it from primary sources. Keeping up to date on more than 20 medications might require reading 50 papers a year.
“Pharma picked up on a gap in the field, which is that physicians need to receive high-quality information in order to inform their practices,” she said. “It's really hard to receive high-quality information for free these days. Conferences are incredibly expensive.”
While many payments are small, they add up over time. Dr. Ross believes companies wouldn't spend the money if they didn't think the tactic was working.
“These companies aren't making these payments for nothing,” he said.
He had hoped that federal rules requiring disclosure of payments would make physicians stop taking them. At first, doctors worried about having their names and payment amounts made public. The information has been used for research, but fears of widespread embarrassment have not materialized.
“For the most part, it's kind of out of sight, out of mind,” said Dr. Ross, adding that half measures are unlikely to make a dent in the problem. “I think companies continue to engage in these practices because physicians engage in these practices. The way you would fix it would be to declare all payments to be in violation of kickback statutes and say they're illegal.” Current government guidance, he added, is “fuzzy.”
While Dr. Wallin thinks it makes sense to limit contact between drug company representatives and doctors in clinical practice, he wouldn't want to cut off all communication between drug makers and physicians. It's helpful to discuss side effects with company employees, he said. A middle ground might be an educational nonprofit that could accept pharma money but would not tie specific talks to an individual company, Dr. Wallin said.
National conferences, along with podcasts and journal groups from the AAN, can help physicians stay informed, Dr. Silbermann noted. A good starting point for further improvements, she said, would be for neurologists to raise awareness that an educational gap needs to be filled in a way that's less likely to influence physician decision-making.
Dr. Ross was an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled September 2022. He currently receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Greenwall Foundation, and from Arnold Ventures. Dr. Wallin is a principal investigator on a Sanofi-sponsored randomized controlled drug trial and received travel funding as a speaker from CMSC.
https://neurologytoday.aan.com/doi/10.1097/01.wnt.0001173580.24350.4e
No comments:
Post a Comment