Tag: opioid

Has Opioid Hysteria Risen to the Point Where Innovation Is Forbidden?

On November 2 the Food and Drug Administration announced the approval of Dsuvia, a sublingual tablet containing the powerful fentanyl analog, sufentanil. Sufentanil has been used for years in the hospital setting, primarily in intravenous form for anesthesia. It is roughly 5 to 10 times more potent than fentanyl, and thus has a significant overdose potential. The FDA reached this decision following a 10-3 vote in favor of the drug’s approval by the Anesthetic and Analgesia Drug Products Advisory Committee (AADPAC), based on data from multicenter trials. It was not approved for outpatient use, but for use only in medically supervised settings, and may be of particular benefit to military health care practitioners.

FDA Commissioner Gottlieb’s announcement stated:

Dsuvia, which was previously approved by the European Medicines Agency in July under the brand name Dzuveo, has some unique features in that the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible. This includes potential uses on the battlefield. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine. This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield. The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee.

The announcement was met with criticism from numerous quarters, including Anesthesiology Professor Raeford Brown of the University of Kentucky, who chairs the AADPAC, Senator Edward Markey (D-MA), and the advocacy group Public Citizen. They questioned the need for the development of a new and potent opioid in the presence of the opioid overdose crisis, and raised concerns about the potential for the drug’s diversion to the black market for non-medical users. These objections were trumpeted by the media.

The concerns raised by critics are unfounded. According to the Drug Enforcement Administration, most fentanyl and fentanyl analogs found on the streets are in an illicit powdered form, made in labs overseas and smuggled into the US via the mail, Fedex, and UPS, or using Mexican drug cartel infrastructure. While much of it is mixed in with heroin or cocaine, many dealers own pill presses and press the powder into counterfeit oxycodone or hydrocodone pills that are sold to unsuspecting nonmedical users. That’s how the artist known as Prince died. He liked to use Vicodin (hydrocodone) recreationally. Records show he never obtained any prescriptions from doctors. His dealer sold him what was believed to be Vicodin but was actually counterfeit and made from fentanyl, which caused his overdose death.

Recrudescent opiophobia now evokes positions held at the zenith of President Nixon’s war on drugs. The fact remains that opioids can be highly effective in treating pain, especially in the acute setting. Hysteria-driven policy should not stifle innovations in this or other forms of pain management.

Commissioner Gottlieb also stated in the FDA announcement:

We owe an answer to patients with medical pain, and the innovators who take risks to develop products to help address their needs. We owe it to Americans who want the FDA to do our part to help end one of the biggest addiction crises of modern times, while we carefully balance these grave risks against patient needs.

Commissioner Gottlieb made the right call here.

New FDA Initiative Implies CDC Opioid Guidelines Are Not Evidence-Based

On August 22, Food and Drug Commissioner Scott Gottlieb issued a press release announcing the FDA plans to contract with the National Academies of Sciences, Engineering, and Medicine (NASEM) to develop evidence-based guidelines for the appropriate prescribing of opioids for acute and post-surgical pain. The press release stated:

The primary scope of this work is to understand what evidence is needed to ensure that all current and future clinical practice guidelines for opioid analgesic prescribing are sufficient, and what research is needed to generate that evidence in a practical and feasible manner.

The FDA will ask NASEM to consult a “broad range of stakeholders” to contribute expert knowledge and opinions regarding existing guidelines and point out emerging evidence and public policy concerns related to the prescribing of opioids, utilizing the expertise within the various medical specialties. 

Recognizing the work of the Centers for Disease Control and Prevention for having “taken an initial step in developing federal guidelines,” Commissioner Gottlieb diplomatically stated the FDA initiative intends to “build on that work by generating evidence-based guidelines where needed” that would differ from the CDC’s endeavor because it would be “indication-specific” and based on “prospectively gathered evidence drawn from evaluations of clinical practice and the treatment of pain.”

The CDC guidelines for prescribing opioids, released in early 2016 and updated in 2017, have been criticized by addiction and pain medicine specialists for not being evidence-based. Unfortunately, these guidelines have been used as the basis for many new prescribing regulations instituted at the state-level and proposed on the federal level. The American Medical Association and other medical specialty organizations have spoken out against proposed federal prescription limits that are based upon an inaccurate interpretation of the flawed CDC guidelines. 

In May, Commissioner Gottlieb, in a blog post, mentioned he was aware of criticisms as well as complaints by patient and patient-advocacy groups and was interested in developing more “evidence-based information” on the matter of opioids and pain management. 

Now it appears he is taking the next step. While the press release language was diplomatic and avoided any notion of disrespect for the CDC’s efforts, it is difficult not to infer that the Commissioner agrees with many who have been criticizing the CDC guidelines over the past couple of years.

 

Making the Case, Once Again, That the Opioid Crisis Is a Product of Drug Prohibition, Not Doctors Prescribing to Patients

Martha Bebinger reports for National Public Radio station WBUR about the rise in fentanyl-laced cocaine. She cites numerous accounts of college students using cocaine to stay awake while studying for exams, or while attending campus parties, and then falling into a deep sleep after the initial cocaine rush. Some don’t wake up. Others get revived by the opioid overdose antidote naloxone.

Massachusetts state police recorded a nearly three-fold increase in seizures of cocaine laced with fentanyl over the past year. And the Drug Enforcement Administration lists Massachusetts among the top three states in the US for seizures of cocaine/fentanyl combinations. The DEA says the mixture is popularly used for “speedballing.” The original recipe used heroin mixed with cocaine in order to minimize the negative effects of the “come-down” after the rush of cocaine. Cocaine mixed with heroin is very unpredictable and dangerous. When it is mixed with fentanyl—five times the potency of heroin—it is even more dangerous.

There is a debate among law enforcement as to whether the cocaine is accidentally laced with fentanyl by sloppy underground drug manufacturers, or whether the mixture is intentional. There have been several reports of cocaine users who were unaware that the cocaine they were snorting or smoking contained fentanyl.

Connecticut state health statisticians keep track of opioid overdoses that included cocaine. While the majority of the time the overdose is from the classic “speedball” combination of heroin and cocaine, they have noted a 420 percent increase in fentanyl/cocaine in the last 3 years. However, Massachusetts does not register drug combinations when it records “opioid overdoses,” so it is unknown just what percentage of the 1,977 estimated opioid overdose deaths in Massachusetts last year were in combination with cocaine or other drugs. New York City keeps detailed statistics. In 2016, cocaine was found in 46 percent of the city’s opioid deaths, heroin and fentanyl were involved in 72 percent of opioid overdose deaths, and 97 percent of all opioid overdose deaths involved multiple drugs.

Meanwhile, President Trump and most state and local policymakers remain stuck on the misguided notion that the way to stem the overdose rate is to clamp down on the number and dose of opioids that doctors can prescribe to their patients in pain, and to curtail opioid production by the nation’s pharmaceutical manufacturers. And while patients are made to suffer needlessly as doctors, fearing a visit from a DEA agent, are cutting them off from relief, the overdose rate continues to climb.

The overdose crisis has always primarily been a product of drug prohibition—not of doctors treating patients.

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