A couple weeks ago the manufacturer of Suboxone, Reckitt-Benckiser, filed a Citizens Petition with the FDA, announcing a voluntary recall of one of the company’s signature products, Suboxone Tablets. Suboxone was sold in tablet form for almost ten years, and the patent ran out on Suboxone Tablets last year. A couple years ago the same company began making Suboxone Film; a rapidly-dissolving form of the medication that comes with each dose individually packaged.
Suboxone is used to treat opioid dependence, and the medication has been a vital, albeit expensive, tool for saving the lives of patients addicted to narcotic pain medications or heroin.
Last week I expressed anger at the company for their actions. Uninsured patients treated for opioid dependence pay a high cost for the medication that helps keep them safe, and have been looking forward to a generic form of the medication for years. It appeared to me that Reckitt Benckiser was trying to tarnish the tablets, perhaps to reduce insurance or Medicaid coverage of the tablets when they inevitably (?) hit the market.
I have carefully read through the entire Citizens Petition, and I now have a better understanding of what, exactly, was accomplished by that action by the manufacturer of Suboxone. It turn out that I underestimated the people at Reckitt-Benckiser.
The Citizens Petition explains that Reckitt-Benckiser (RB) hired an independent group, RADARS (Researched Abuse, Diversion, and Addiction-Related Surveillance), to investigate the exposure of small children to Suboxone tabs and Suboxone Film. The results of the RADARS findings are spelled out in detail in the Petition.
RADARS showed an increase in exposure to Suboxone Tabs over the past ten years. They also show an increased rate of exposure, i.e. number of exposures, divided by the number of tabs prescribed. Reckitt-Benckiser wrote that they instituted REMS over the past few years to counter that increase. What are REMS, you ask?
From the FDA site: The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug …
A reader sent a link to a recent NYT editorial about the lack of pain medications in some countries. The writer of the editorial injured his leg while traveling in Africa, and was dismayed to find that opioid pain medications were in limited supply, with only enough for patients admitted to the hospital.
The writer went on to describe a number of developing countries where pain medications are in short supply, and in some cases totally unavailable. He described hospitals and clinics where he was visited, where patients await treatment for horrible injuries without so much as a tablet of Tylenol.
I don’t want to rewrite the editorial, and I cannot copy it, for obvious copyright reasons– so you’ll have to follow the link. The story mentions the efforts of a group called ‘GAPRI’, for Global Access to Pain Relief, that tries to reduce barriers to effect pain relief measures in developing countries.
I have asked for permission to repost an article from the web site of CBC Radio, and I’m waiting for their answer. In the meantime, I’ll provide a link to the article, along with a teaser. The article also refers to a podcast of a Town Hall event featuring Dr. Andrea Furlan, a pain specialist from Toronto, Christine Bois from the Centre for Addiction and Mental Health (Canada), and Detective Shawn White, an expert in opioid diversion in Eastern Ontario.
Just a quick note– A group of researchers from Boston University School of Medicine weigh in on the issue of opioid prescribing in an online editorial available through this link. The editorial appears in the Journal of General Internal Medicine, and I do not know how long the link will be active. All such articles are copyright-protected, keeping me from posting them here– but the link operational for non-subscribers, at least for now.
In short, the editorial calls for several measures for patients prescribed chronic opioids, including monitoring for abuse, greater education, and creation of databases to prevent over-prescribing, doctor shopping, etc.
Thank you to everyone who chimed in with opinions about the PROP letter. I shared the comments with the people at PROP, and those who read the comments saw an interesting exchange between the a couple of physicians from that group and a physician from pain-topics.org. Hopefully the letter and comments– along with the other articles I’ve highlighted– will help provide an understanding of the current debate over using opioids for chronic pain.
Backache photo available from Shutterstock.
I’ve written about the spectrum of medical and scientific opinion (not, unfortunately, always the same thing) over the use of opioids for treatment of chronic pain. For those who missed the earlier discussion– one that produced a heated response from readers– I invite you to review those posts.
The essence of the issue is that over many years, there has been significant effort to increase patient access to potent opioids. This effort has come in part from the pharmaceutical industry, but also from organizations that advocate for patients with a wide range of painful conditions, some with connections to pharma, and some without connections to pharma.
There has even been a push to increase opioid prescribing from Federal agencies. Back in the 1990′s, when I chaired my local hospital’s Department of Anesthesia, we were warned by agencies hired by the hospital that the Joint Commision on Accreditation was focusing on pain control one particular year, and that some hospitals had been cited for insufficient prescribing of pain medications.
The point missed by the writers of the Bloomberg article, though, is the same point that is missed by many physicians– even by many addictionologists. The dirty secret that RB does not want anyone to realize is that the equivalent of generic Suboxone is already available, in the form of orally-dissolving tablets of buprenorphine.