What Senator Ed Markey Doesn’t Understand

Senator Ed Markey of MA Opposed DSUVIA

According to a recent USA Today article, Senator Ed Markey of Massachusetts “urged the FDA not to approve Dsuvia last month, saying “an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill.”

Senator Markey must not understand that sufentanil has been used in hospitals for more than 40 years, and it has rarely been associated with abuse or overdoses. Potency of an opioid is not what determines whether it is abused. For those who may not be familiar with the drug, DSUVIA™ is a small tablet of sufentanil that is meant to be placed under the tongue for immediate pain relief.

Some Pain Patients Need a Strong Opioid

All opioids, regardless of their potency, have the potential to stop breathing. That’s an important piece of information, but it isn’t the whole story. The real concern should be whether there is a need for a strong opioid and, if it is available, how it can be used as safely as possible.

In October 2018, AcelRex Pharmaceuticals, Inc. presented its case to the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (ADCOM) for the approval of the new drug application (NDA) 209128 for DSUVIA. I testified before the committee as an advocate for people in pain. This provided me with an opportunity to shine a light on the inadequacy of pain treatment for many people today, particularly those with pain associated with cancer. Click here to read my testimony.

DSUVIA Approved With Tight Restrictions

The FDA did approve DSUVIA. In a statement, FDA Commissioner Scott Gottlieb promised very tight restrictions would be placed on the drug. The limited access to the medication will help ensure that the drug is used only for the intended purpose.

I am sure Senator Markey doesn’t want people dying in severe pain from cancer or any other chronic condition. It is possible to have potent analgesics available without increasing the risk of addiction or an overdose. This has been shown by the lack of sufentanil abuse over the past 40 years.

We must have compassion for people in pain to help guide our treatments. Misinformation should never be allowed to determine our healthcare policy. Science, rather than unfounded fear, must be our guiding light.

 

7 Comments

  1. Barry Smith on November 25, 2018 at 12:52 pm

    Hi, in the UK we are also seeing this trend in restricting Opioids for acute and chronic pain. After 30 plus years of chronic sometimes acute pain related to failed back syndrome I dont look at my prescribed pain medications to abuse or misuse them. Indeed because of the side effects I would rather not be on them both from a social and professional perspective.

    However, new formulations and stronger pain medications offer a way out of some of these side effects and should as all medications be managed and not be clinically/politically restricted. Post registration they offer an expansion in the clinicians tool box to help offer relief to those in pain.

    Like many I do sometimes the question my quality of life with chronic pain and consider suicide but it comes from within my consciousness and the side effects of the formulations and type of opioid I may be being prescribed. Not from the generic class of drugs used and unrelated associations.

  2. Louis Ogden on November 25, 2018 at 11:24 pm

    I was of the understanding that this medication was primarily for battlefield injuries.

  3. Louis Ogden on November 25, 2018 at 11:32 pm

    I started wondering if this med could help me. I am on a very high dose regimen given to me by Dr. Forest Tennant before he was unfairly raided by the DEA. Dr. Margaret Aranda took over his practice and was filling the same scrip for me. Now, the state of Virginia has come up with a computerized system that has flagged me and I can no longer buy my meds in any Virginia pharmacy. I have no idea what will happen to me as I have been on the same dose for 8 years. I have meetings scheduled next week to inform a State Senator and my state Delegate to plead my case. I am not ready for death quite yet!!!!!!

  4. JEN on November 26, 2018 at 8:46 pm

    What happened to the exception for legacy pain patients? I have spoken to a lawyer who suggested a law school might be interested in this matter because of the media attention it could provide for the schools. PLEASE pass this on to states that have law schools.

  5. Betty on November 27, 2018 at 9:00 pm

    Jenn,
    Thank You! Excellent idea to give this to students wishing to become lawyers ❤
    Dr Lynn Webster Great article, thanks for writing and sharing ❤
    Seems like we (CPPS) can’t win for losing …

  6. JEN on December 2, 2018 at 3:45 pm

    Why are we NOT insisting that these government agencies who are inforcing drug laws on patients MUST be drug tested themselves by random (not their own government connections) labs. Doctors, pharmacists and government ALL have access to the pain medications pain patients are being denied. OF ALL PEOPLE………GOVERNMENT SHOULD BE DRUG TESTED JUST AS CIVILIAN COMPANIES DRUG TEST EMPLOYEES. Why are WE being so complacent and allowing these agencies to determine our health, our lives, our pain. WHO WORKS FOR WHO? The truth is we are working ants to support this government and their life long health care, retirement, etc. etc. and we just keep taking it…………we need to WAKE UP!

  7. Kathy Scalf on December 7, 2018 at 4:02 pm

    I have been a nurse for more than 30 years and believe that I was called by God to do so. I have spent my life caring for suffering individuals,INDIVIDUALS – a key word. Not everyone fits into the same mold. I was injured on the Job 5 years ago and discovered that I have severe Degenerative Disc Disease. I have had one spinal fusion surgery and have been told that I need surgery on my neck and again on my low back. I have a new compression fracture at T12. My pain management office told me that I was not going to get any additional medication for the acute fracture. She said “you’re not any different than anybody else”. We are truly made to feel like we are breaking the law, when all I want is to be able to dress myself and bend over to brush my teeth. When and how did we allow this to happen. My Primary Care Physician, who had known me as a professional for 15 years before my injury, was treating me appropriately until the government stepped in. I was a cardiology hospital rounds nurse and took care of her inpatients for many years. She knew my character was real and not a drug seeker. Now I am required to see a provider that considers all of us drug seekers. WE DO NOT DESERVE THIS. We just want to get a little pleasure out of life. I have wondered about a class action law suit against the lawmakers

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