It’s common knowledge that medical providers often are paid by pharmaceutical companies to promote their products. What’s less well understood is how that clear conflict of interest creates danger for patients. Today, another lesson in how money and safe patient care don’t mix well when it comes to powerful prescription drugs.
In November, The New York Times wrote about Insys Therapeutics, a pharmaceutical company whose drug Subsys is a powerful but restricted-use painkiller for cancer patients. The story disclosed that five of the 20 doctors who were paid the most by Insys for things like speaking fees and travel to promote Subsys recently had faced legal or disciplinary action.
Doctors like Judson Somerville, a pain specialist in Texas, who got $67,000 from Insys while he was under investigation by the Texas Medical Board. At the end of 2013, the board ordered him to stop prescribing painkillers because he had authorized employees to give patients pre-signed prescriptions, and three of them had died in 2012 of drug overdoses.
Doctors like Gavin Awerbuch, a Michigan neurologist who received $56,000 from Insys. He was arrested last year when federal prosecutors claimed he defrauded Medicare of $7 million and prescribed Subsys to patients who did not need it.
The Times investigation relied on the new Open Payments database to identify these dangerously irresponsible practitioners. (See our blog about Open Payments.) No one should be surprised that many of the 20 doctors, most of whom are pain specialists, were also top prescribers of Subsys.
Subsys is a fast-working narcotic that’s sprayed under the tongue. It’s given when other painkillers fail to provide relief, especially to patients with sharp bursts of pain. But like all opioids, it carries a high risk of dependency, and also can cause respiratory problems, even death, for people who don’t use painkillers regularly.
Somerville, a top prescriber of Subsys, told The Times that Insys never inquired about the Texas Medical Board’s ruling. He continued to speak about Subsys for a few months after the board’s decision and was lopped from the Insys speaker list only after the company found out about the disciplinary action.
Somerville, of course, disagreed with the medical board’s claims, and said it lacked evidence that he contributed to the patients’ deaths. “I’m very aggressive in trying to help my patients,” he told The Times. “I’m a very caring doctor. I like money, but that’s not my god, O.K.?”
Insys terminated its relationship with Awerbuch after he was arrested.
Even though the Insys payment data used by The Times included only a five-month period from 2013, it “provides unusual insight into the lengths that some drug companies go to cultivate relationships with doctors, and shows that Insys enlisted doctors with troubled track records to market its product to other physicians,” the paper said.
“The drug industry has long paid influential doctors to speak to peers as a way of building word-of-mouth marketing. But such practices can cross the line, legal experts said, when doctors promote uses of the drug that are not approved by the Food and Drug Administration, and when the speaking fees are paid in exchange for the doctors’ prescribing behavior.”
We’ve written often about multimillion-dollar settlements by drug companies to resolve federal charges that they inappropriately marketed their products. But because these companies make so much more money from selling the drugs than they do paying for illegally promoting them, the settlements are seen as simply the cost of doing business.
Insys aggressively marketed Subsys, its only brand-name product. Its efforts are notable because the market for Subsys is relatively small – it’s approved only for cancer patients who already take opioid painkillers, because, as the FDA explains, such patients have demonstrated a tolerance to those heavy drugs. But according to The Times, only 1% of Subsys prescriptions are written by cancer specialists.
Former sales representatives for the company told the paper that they were encouraged to approach pain doctors whose patients had a wide range of ailments, not just cancer, and to reward high-prescribing physicians with things like paid speaking engagements.
Insys paid doctors $2.8 million in the last five months of 2013. Although it’s a small company, that figure puts it in the company of major drug makers like Boehringer Ingelheim and Novo Nordisk, which market a lot of different products.
As the Pharmalot blog in the Wall Street Journal pointed out, about a year ago, the Office of the Inspector General of the U.S. Department of Health and Human Services issued a subpoena to Insys in connection with an investigation by a U.S. Attorney in California concerning potential violations of HHS programs. And a few months ago, Insys received another subpoena from a U.S. Attorney in Massachusetts seeking documents about the sales and marketing for Subsys.
Pharma business as usual.