September 10, 2018
I hope my patient doesn’t die next month from a heroin overdose. The government took away his medicine and soon he may be back buying dope on the street.
This patient was stable on monthly injections of buprenorphine. Buprenorphine is a medicine that acts like a key glued into a lock: it locks the opioid receptor into a position which make opioids useless. Heroin and oxycodone just bounce off the occupied receptor. This drug saves lives, a lot of lives. In one study, chronic heroin addicts were randomized to self-administered buprenorphine or to drug treatment. After one year, not a single addict was in drug treatment and 20% were dead who relied on drug treatment. In contrast, 70% of patients given a bottle of buprenorphine to administer on their own were largely sober at one year.
A new delivery system for buprenorphine works even better. Addicts, who can’t reliably keep track of their medications, can now get injections every month or even every six months for an implant. They love it. I thought the smile on one of my patients would break his face when he told me about how he forgets for days at time that he used to have a drug problem. He never worries about forgetting to take his meds, having them lost or stolen, or being sensitive to mood swings or unexpected stress which formerly would trigger a relapse. His family doesn’t worry either.
My patient lost his medicine because the company that makes his medicine, Indivior, is afraid of the government. How can that be? Scott Gottlieb, head of Food and Drug Administration, recently testified to Congress that patients on buprenorphine are “role models” in the war on opioids.
By this reasoning, Indivior should be a role model for the pharmaceutical industry. Its employees should sleep the sleep of the righteous every night. Their actions during the day, however, reek of fear.
Indivior sent a letter to my patient’s injection doctor terminating their support for his treatment program. They won’t help him (and his patients) work with insurance programs to obtain reimbursement for a $1500 a month drug. Evidently, they monitored his website, advertisements, and “prescribing history.” The company was afraid that the DEA, FTC, FDA, or state attorney generals would sue and fine them if this doctor didn’t exactly follow approved prescribing information.
The government has turned the pharmaceutical industry into an incompetent agent of the criminal justice system. Drug companies don’t make very good detectives (thank God they don’t have guns). This doctor had done nothing illegal. They don’t make very good prosecutors either. It wasn’t necessary to throw the book at him when a simple discussion would have addressed their political concerns. This doctor is one of the finest physicians in the state. He would have immediately made changes in his practice if he had been asked. He had no intention of misleading the public in any way. There are just too many rules to follow and inadvertently break.
Politicians say we have an opioid crisis but we physicians on the front line would never know that there is a crisis. Medicaid asks us to fill out pages of prior authorization paperwork. The DEA visits our offices and sternly quizzes us about compliance with complicated controlled substance rules. God forbid you make a mistake.
There goes your license. The Medical Boards have no interest in encouraging the use of buprenorphine as a safer alternative to conventional addictive opioids in the new 2019 WA state pain guidelines. The FDA has recently instructed me that it would illegal to even study the use of physician-administered buprenorphine as an alternative to self-administered antidepressants or opioids frequently fatal in overdose. Recent data suggests that up to 30% of opioid overdoses are actually suicides.
Why would physicians want to treat opioid addicts who often don’t pay you, don’t show up, and frequently have bad outcomes perceived as your fault by litigious families? Most decide it is not worth the hassle. From my perspective, I love the addicts I treat, but the government is not making it any easier.
Jon Berner MD PhD
Woodinville Psychiatric Associates
President Washington Academy of Pain Management (pain management provider educational non-profit)
Bob Ferguson WA state attorney general
Patty Murray WA US senator
Maria Cantwell WA US senator
Eileen Cody WA state House
Jason McGill, Health Care Policy Advisor to WA State Governor Jay Inslee
Mitchell Mathis MD, FDA Office of Drug Evaluation: Division of Psychiatry Products
Wall Street Journal