Author of The Painful Truth
The television hit show, Breaking Bad, lionized the idea of making and selling meth. A high school teacher who was dying of lung cancer wanted to leave his family enough funds to live, and he chose drug dealing as a way to achieve his goal. The show ran during the 2008-2013 TV seasons and was regarded by some as the greatest television show of all time.
The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is the watchdog agency that’s responsible for testing new medications before they are approved. Drug manufacturers seek approval from the FDA after they have conducted numerous clinical trials and submitted all of their data to the FDA for review. Drugs are approved only if the FDA believes the data supports the efficacy for the targeted indication and that the drugs’ risks are reasonable and manageable.
On September 29 of this year, the Food and Drug Administration (FDA) published a notice — Opioid Policy Steering Committee; Establishment of a Public Docket; Request for Comments — in the Federal Register, The Daily Journal of the United States Government.
The FDA is seeking comments from members of the public, including chronic pain patients and their families, healthcare professionals, academic institutions, and industry relative to the FDA’s new Opioid Policy Steering Committee (OPSC).
FDA Commissioner Scott Gottlieb, M.D. has expressed his commitment to confronting the opioid crisis and reducing the possibility of opioid addiction. He established the OPSC, and charged the committee with seeking input from the public.
I was a hospital pharmacist for twenty-five years. The last four years in practice, I was involved with the cancer ward helping oncologists, recommending pain medications, adjusting pain medications, and safely switching patients from one medication to another. Even though it’s been some fifteen years since I worked in the hospital, I still have at least a rudimentary knowledge of prescription pain management. I am now sixty-four years old.
Mark Twain is quoted as saying: “If I had more time, I would have written a shorter letter.”
Pharma and device companies seeking approval for their products are often required to present their data to an FDA advisory committee meeting (ADCOM). They have a limited time in which to tell their story. Therefore, Pharma must know how to “write the short letter.” This requires them to condense years of research into messages that can convey the most salient, and most pertinent, data to a jury of scientists.
You’ve probably heard by now that a medical examiner has determined Prince, the musical superstar, died of a fentanyl overdose.
While other opioids get more attention, fentanyl is the stealth bomb for abusers.
Fentanyl is 100 times more dangerous than morphine. The dose at which fentanyl produces the pain relief that users require, and the euphoria that drug abusers seek, occurs quickly and at low doses.
However, the dose required to stop a person’s breathing is only a little bit more than the amount users need to get relief from their pain or to get high.
Dr. David A. Kessler was interviewed by Jim Axelrod of CBS News about the opioid crisis. Specifically, Axelrod asked Kessler about the increased use of opioids over the past twenty years, and how we might get the opioid epidemic “back in the bottle.”
Always controversial, since the days between 1990 and 1997 when he served as the Commissioner of the FDA, Kessler calls the handling of opioids “one of the greatest mistakes of modern medicine.”
He blames the opioid epidemic on his former agency, the FDA; pharmaceutical companies; and physicians. “They didn’t see these drugs for what they truly are,” Kessler asserts.
Dr. Robert Califf, the new commissioner of the Food and Drug Administration, is focusing his energy on curbing the epidemic of drug overdoses. He told a panel of FDA advisors last week that abuse-deterrent formulations (ADFs) may be part of the solution.
However, many speakers at that panel warned the FDA that it would be a mistake to rely on ADFs to solve the problem.
The advisors are correct. Abuse deterrent formulations (ADFs) are not a magical cure to the problem of opioid abuse.