Sometimes, you have to wonder what the FDA and Big Pharma will cook up next. As I write this post I am mystified at the process of approval because just what the world needs is a stronger opioid.
I should, of course, like to say at the outset that I am not a physician with a specialty in anesthesiology or pain control management. So, I would like to quote Dr. Sheldon Opperman, an anesthesiologist, and co-founder of a chronic pain center.
“We do not need a drug that is over 10 times stronger than fentanyl out in the market unless we wish to see more abuse and overdoses to add to an already perplexing epidemic.”
He is joined in his comments by many other physicians. Of course, some colleagues disagree with him. For example, Dr. Harold S. Minkowitz is an anesthesiologist in Houston:
“Sufentanil (the drug in question) has undergone a rigorous clinical development program and I feel that not approving it would send a message to drug developers that they should not be investing any money into developing novel agents.”
Of course, I should note that the doctor is a co-author of a paper for the pharmaceutical company that has developed it.
It is called Dsuvia
Dsuvia is a tablet placed under the tongue when a patient is brought through the door of an emergency room in extreme pain. It is claimed that sometimes when pain medications are administered intravenously that mistakes led to deaths.
Dsuvia is a product of AcelRx Pharmaceuticals. The company, founded in 2005, received funding from the U.S. Army to help develop the product. Presumably, the drug will help in the field when a soldier is brought in with severe trauma.
It was apparently approved with the proviso that it is to be used in “supervised settings” such as emergency rooms. The drug is supposedly up to 10 times more potent than fentanyl, and 1,000 times stronger than morphine. The drug itself is not new. What is new is that it is now in tablet form. It was not developed out of altruism, AcelRx Pharmaceuticals estimated its Dsuvia drug has potential sales of $1.1 billion domestically.
42,000 a year and counting
How many opioid deaths are there in the U.S.? In 2016, there were more than 42,000 deaths. Even the physician who is the chair of the FDA advisory committee thinks Dsuvia is a bad idea. It underscores the deep divisions of the medical community over the creation of a stronger opioid. Medicine is quick to call the tens of thousands of deaths from opioids a tragedy.
I think it’s a tragedy too, but that’s because I know the human heart from the point of view of ethics, not as a physician who is fronting for the pharmaceutical industry.
It is well and good for AcelRx Pharmaceuticals, with the best of intentions, to believe Dsuvia will always stay within the confines of an emergency room. There is absolutely no guarantee it will remain in that setting. The lure of money, what we can think of as the “opportunity” characteristic of fraud will be too great, especially as it is in pill form.
It is called “diversion,” meaning the drug will somehow find its way from a securely locked cabinet, delivery or patient room out and into the street. A drug that is 1,000 times stronger than morphine could command a huge price. Even if the pill is impossibly expensive, it could be shared between several addicts
As for the “need” component of every fraud, it is a double-edged sword. With a potential for $1.1 billion in domestic sales, it is no small matter why AcelRx Pharmaceuticals has an interest in the market. Though they may make every effort to control the production and distribution of this powerful opioid, what is their ethical responsibility to ensure its security. Obviously, once out the door, they have none.
Finally, how do AcelRx Pharmaceuticals, the FDA and the medical community justify Dsuvia? Yes, I understand its benefits, but are the benefits so great that existing drugs could not do the same?
In the end, AcelRx Pharmaceuticals will obviously benefit, and within a tightly controlled setting some patients will be helped, but I still wonder why it was approved fully knowing the huge toll it could inflict? I sure wish the FDA cared as much about ethics as they do for Big Pharma because just what the world needs is a stronger opioid.
