Over the past three-and-a-half years, pharmaceutical, biotechnology and medical device companies gave Oklahoma doctors more than $50 million in meals, trips, speaking fees, royalty payments and other forms of compensation, according to data from the Centers for Medicare and Medicaid Services.
Though the perks and cash payments provided to doctors from companies marketing drugs or medical devices are legal — and in many cases are paid to doctors in the form of licensing or royalty payments for devices or procedures pioneered by the physician — recent cases related to opioid drugs show how those types of payments at times could be used to bribe doctors to increase drug sales.
Insys Therapeutics — the Arizona-based manufacturer of a powerful fentanyl drug called Subsys — has come under a cloud after its founder and several top executives were indicted this year for allegedly bribing doctors through a “speakers program” to write more “off-label” and higher dosage prescriptions of the drug.
Earlier this week, The Frontier reported that between 2013 and 2016, Insys Therapeutics spent the most of any drug company promoting opioids on Oklahoma doctors, and that a former sales representative and trainer for the company in the Tulsa area said he had been pressured by higher-ups to increase sales of the drug prior to his departure in October 2014.
As the opioid crisis in the United States has gained more and more attention from officials in government, medicine, mental health and media, the role pharmaceutical companies played in exacerbating the crisis has come under more scrutiny, as have the roles of prescribers and pharmacies.
According to data from CMS pharmaceutical companies gave nearly half a million dollars to promote opioid and other narcotic medications to more than 1,300 Oklahoma physicians between the first half of 2013 and the end of 2016. Most payments were under $100 and were used to pay for meals at speaking events at which the drug was discussed, though a handful of physicians who are part of a company’s “speaker program” received tens-of-thousands of dollars in cash payments.
However, the payments to Oklahoma doctors are not limited to pharmaceutical companies promoting opioid-type medications. Companies marketing medications for diabetes, high cholesterol, insomnia, attention deficit disorder, HIV/AIDS, and a host of other diseases also paid millions to market their drugs to doctors in the state. Biotechnology and medical device manufacturers also paid doctors in the marketing of products ranging from prosthetic limbs to contact lenses.
In sum, over the last three and a half years Oklahoma physicians received more than $50 million in cash, trips, meals, license/royalty payments, education, speaking events and honoraria from pharmaceutical companies and medical device manufacturers.
The majority of the money paid during that period came in the form of speaker payments, followed by payments for food or beverage and license/royalty payments.
That total does not include research payments by pharmaceutical companies and medical device manufacturers paid to Oklahoma doctors and research centers based in the state, which totals more than $93 million during the past three and a half years, according to the CMS data.
With that much money being provided to Oklahoma doctors alone by companies wanting to sell more of their products, are there concerns that the payments may play a factor in a doctor’s medical patient care decisions?
It’s hard to say. Few doctors The Frontier reached out to agreed to speak about the issue.
The issue is something that physicians have differing opinions on, said Dr. Steve Blevins, interim director at the OU College of Medicine’s Office of Medical Education.
“You’re not going to find uniformity of opinion on this,” Blevins said. “Even in my own career, there’s been such a change.”
Though he once thought there were no issues with a medical device or pharmaceutical company picking up the tab for a meal or paying doctors to speak about a product, he has since changed his mind.
“I’ve been to the dinners before, lunches sponsored by pharmaceutical companies. I wouldn’t do that now,” Blevins said. “The more I learn and the older I’ve gotten, the more I find that distasteful. I used to not see it that way. I used to think ‘well, if they want to invite me to dinner, it’s not going to affect my prescribing habits,’ and i would like to think that it has not affected my prescribing habits.”
Blevins said the problem with such arrangements is the information presented by sales reps about drugs or devices can often be biased, and even if the meals or other forms of compensation by companies do not affect a doctor’s prescribing habits, it can contribute to increasing the cost of the drug or device.
Where should the line be drawn? Opinions on the issue vary widely, Blevins said.
“I’m not sure any of it is really appropriate. Different people tend to feel differently about it. Should they (sales reps) even stop by and speak with physicians in offices? I don’t know. It is certainly useful to know what’s out there, but then again, you’re getting biased information,” Blevins said. “I think there’s some people who could make the argument that even that contact without even giving a plastic pen is inappropriate.”
Blevins said, early in his career he used to find nothing wrong with pharmaceutical companies providing dinners or other forms of compensation to doctors.
During his time in medical school, the issue of doctor payments never really came up, Blevins said.
“When I was in medical school, they didn’t even talk about this much. This was the attitude of ‘this is democracy, this is the free market,’” Blevins said. “I kind of used to think that way when I was in residency. I used to have more of a laissez faire attitude about it. I’ve come full circle on it.”
The issue has come up more as time as gone by, Blevins said. Last week, he said, he sent his medical students a link to a recent New Yorker article about the Sackler family and Purdue Pharmaceuticals, to show students the slippery slope that can sometimes occur on these issues.
The New Yorker article covers the launch of the drug OxyContin — “one of the biggest pharmaceutical marketing campaigns in history” that included enlisting an army of physicians in a paid speaker’s bureau, trips for doctors to seminars touting the benefits of the drug, advertising in medical journals and heaps of assorted OxyContin swag — and the success of Purdue’s marketing campaign on doctors.
“I told them if there’s only one story in the lay-press they read this year it should be that one,” Blevins said.
The two state boards that oversee medical licensure, the Oklahoma State Board of Osteopathic Examiners and the Oklahoma Board of Medical Licensure and Supervision, do not typically issue guidelines or look into payments to physicians, unless a criminal case is filed in connection with an issue.
“Unless there’s fraud, I don’t think we would have any rules against that,” said Deborah Bruce, executive director of the OSBOE. “Our rules, for the most part … don’t go into ethics as much as they do unprofessional conduct.”
State and federal laws — such as the Stark Law, which with some exceptions prohibits physicians from referring Medicare or Medicaid patients to entities they have a financial interest in and addresses kickbacks and bribes — govern much of the criminal acts that may come as a result of physician gifts, said Reji Varghese, deputy director of the Oklahoma Board of Medical Licensure and Supervision.
And while the medical board oversees the professional practice requirements of physicians, it does not oversee much of the business side of medical practices, Varghese said.
“We don’t technically get into the business aspect of a physician — how they make money, what they charge, billing,” Varghese said. “It’s a free country.”
Some hospitals, physicians groups, or physician organizations may have their own codes of ethics regarding gifts to doctors, and the American Medical Association also has its own code of ethics regarding gifts, said Dr. Jesus Medina, an ear, nose, and throat doctor from Oklahoma City and president of OU Physicians.
“The position of organized medicine in that regard has been clearly defined,” Medina said. “Yes, you can be part of a speakers bureau, but you have to disclose that every time you speak. As far as gifts, you can only accept nominal gifts. The dinners at the big steakhouse in town and things like that, those are no longer considered appropriate.”
In 1991, the American Medical Association issued its first guidelines on gifts to physicians, advising against cash or gifts of substantial value. In 2001, the Association began a $1 million campaign to inform physicians about the guidelines because it felt many did not know about them. However, the Association came under fire after it was revealed that pharmaceutical companies paid the AMA $600,000 for the campaign.
According to the most recent doctor gifts ethics opinion by the American Medical Association, good relationships between physicians and pharmaceutical, biomedical and medical device companies are important, in that they help drive innovation and patient well-being. However, those relationships can also have an impact on a physician’s judgement.
“Gifts to physicians from industry create conditions that carry the risk of subtly biasing—or being perceived to bias—professional judgment in the care of patients,” the AMA opinion states.
The AMA recommends that physicians decline cash gifts in any amount from an entity that has a direct interest in physicians’ treatment recommendations, decline gifts for which reciprocity is expected or implied, and accept an in-kind gift for the physician’s practice only when the gift will directly benefit patients or patient education and is of minimal value.
Want to see how much your doctor has accepted in gifts, speaking fees or other payments from medical companies? ProPublica’s “Dollars for Docs” tool allows individuals to search data from CMS to see how much their physicians have received in payments.