It’s not often that a patent award creates a media storm, but it happened recently when a patent was awarded for a novel oral formula of buprenorphine, the opioid in Suboxone and its generic cousins. The new formula is a buprenorphine-wafer that is proposed for MAT (medication assisted therapy) with opioid addicts as well as for treating chronic pain. The wafer formula is said to be more “diversion and/or abuse-resistant” than the existing ones, which are tablets (ie., Subutex and Zubsolv) and sublingual film (i.e., Suboxone). It just so happens that one of the six listed inventors of the buprenorphine wafer is Richard Sackler; and Purdue Pharma LP was the original assignee for the patent. Members of the Sackler family and Purdue Pharma are currently facing hundreds of lawsuits that claim they played a role in the birth and growth of the opioid crisis.
The connection of the Sackler family and Purdue Pharma to the opioid crisis is tellingly documented by Barry Meier in his book, Pain Killer, which was recently released in a second, updated edition. Read: “Giving an Opioid Devil Its Due” for an overview of Meier’s book, with links to two NYT articles he wrote as Pain Killer was published in May of 2018. Also see “The Tale of the OxyContin Lie,” “Greed with OxyContin is NOT Good,” and “Doublespeak in the Opioid Crisis, Part 2” for more on the connection of Purdue Pharma and the Sackler family to the opioid crisis.
Among the media outlets describing the Sackler and Purdue connection to the buprenorphine-wafer patent was STAT News and The Washington Post. Both news outlets noted how several critics are outraged that the Sacklers and Purdue are positioning themselves to benefit financially from the opioid epidemic they are seen as having facilitated in the first place. Luke Nasta, the director of a New York-based drug and alcohol addiction treatment center said the Sackler family “shouldn’t be allowed to peddle any more synthetic opiates—and that includes opioid substitutes.” He added: “It’s reprehensible what Purdue Pharma has done to our public health.”
The patent application for the buprenorphine-wafer said there is a need for “other diversion and/or abuse-resistant dosage forms of buprenorphine, which can be used in drug substitution therapy.” Additionally, the preparation would also provide “efficient analgesia” when used for pain relief.
It is an object of the present invention to provide an oral pharmaceutical dosage form of the active agent buprenorphine that is less prone to diversion and/or abuse in drug substitution therapy. It is another object of the present invention to provide an oral dosage form of the active agent buprenorphine that can be used for drug substitution therapy and/or pain treatment.
The patent does not seem to only envision using the wafer technology with buprenorphine. It points out how “the invention and its various embodiments which are set out below, can be extended to any opioid or analgesic whose preferred route of administration is oral, preferably sublingual, as is the case for buprenorphine.” One embodiment of the wafer is also said to release buprenorphine or other “pharmaceutically acceptable salt” in less than three minutes, and perhaps as quickly as one or two minutes.
Even more preferably, substantially all of the buprenorphine or said pharmaceutically acceptable salt thereof will be released within less than thirty seconds, twenty seconds, ten seconds or even within less than five seconds after oral, preferably sublingual, application of the dosage form.
Reflect for a moment on how rapid, “instant” absorption of a drug intravenously or nasally is often the preferred method of drug ingestion by an addict because the euphoria is more immediate. The good news here is the wafer technology will seemingly restrict diversion, but the bad news is it may initiate another rapid ingestion method for individuals looking for an opioid high. The biochemical nature of buprenorphine is said to have a “euphoric ceiling” that limits its long-term abuse potential, but the same is not true for other addictive “pharmaceutically acceptable salts.”
Another red herring in the patent application is describing how drug addicts take prescription drugs for replacement therapy “under the close supervision of medical parishioners.” This means that the slower absorption of buprenorphine in the other formulas, taking five to ten minutes to dissolve, could result in drug addicts trying “to divert these sublingual buprenorphine tablets by removing them from the mouth when the supervising healthcare professional’s attention is directed to other activities.” Methadone, which is only used within a medical setting in the U.S., did have these kinds of problems years ago so the formula was changed from a tablet to a liquid form. Ingesting buprenorphine in MAT is NOT supervised in a medical setting in the U.S. The patient gets a prescription and takes the medication without any medical supervision, so the supposed advantage of the rapidly absorbed buprenorphine wafer in limiting diversion is nonexistent.
Also in the news about the Purdue Pharma debacle is the role of Rudy Giuliani, who acted as legal counsel for Purdue in the mid-2000s. FiercePharma, The Hill and others reported that two Democratic Senators are requesting documents detailing information about Purdue Pharma’s interactions with the Department of Justice and the Drug Enforcement Agency when Purdue was under investigation for its OxyContin promotions. They are trying to determine whether or not Giuliani “secured leniency for opioid maker Purdue Pharma through conflicts of interest.” At the same time he was representing Purdue Pharma in its dealings with the Department of Justice over a probe of Purdue’s marketing of OxyContin, Giuliani’s firm worked for the DOJ under a $1 million contract to provide advice on reorganizing its major drug investigations. FiercePharma said:
According to the letters, Giuliani convinced political appointees at the Department of Justice to reject career prosecutors’ recommendations in the opioid marketing case. As a result, the company entered a guilty plea to “misbranding” OxyContin, its powerful painkiller. Under the deal, the senators also said Giuliani convinced DOJ to assign fault to Purdue Frederick, a holding company, to allow Purdue Pharma to continue to do business with the federal government. Purdue paid $640 million under the agreement in 2007.
The bottom line is it seems Giuliani helped Purdue keep OxyContin on the market after 2007. Top Justice Department officials in 2006 failed to follow their Virginia prosecutors’ recommendations to indict Purdue Pharma executives on felony charges instead of the lesser misdemeanor charges and no jail time they ultimately received. Even with this sweet plea deal in hand, the night before the plea agreement was set to expire—meaning the company would face charges—a senior Justice Department official (“at a Purdue lawyer’s request”) phoned John Brownlee, the U.S. Attorney pursuing the indictment, at his home in an attempt to convince him to extend the deadline and give Purdue more time. It didn’t work.
By the time the negotiations were complete, Purdue’s holding company, Purdue Frederick, would plead guilty to a single misbranding felony and the company’s executives to misdemeanor charges of misbranding the drug. Ultimately, though, it was the holding company, not Purdue Pharma, that was banned from doing business with public health programs, a Giuliani-arranged deal that allowed OxyContin sales to continue growing—and the epidemic to continue festering, largely unchecked.
Another factor to remember in the pursuit of Sackler and others to bring their buprenorphine wafer to market is the anecdotal reports of individuals withdrawing from buprenorphine. Regularly in my years of experience working with opioid addicts, those who used and/or abused buprenorphine reported how buprenorphine was harder for them to “kick” than heroin, methadone or any other opioid. Could we be looking at the creation of an entire population of individuals who are physically dependent on buprenorphine without the ability to discontinue the drug once they use it for an extended time period? See Pain Killers or the Politico article, “They Were All Lawyered Up and Rudy Giuliani’d Up” for more on how Giuliani fought for Purdue. Politico also unpacks some of the back-story to the 2007 plea agreement reached with Purdue by the DOJ.
