New FDA Opioid Approach Criticized for Lack of Patient Voice

New FDA Opioid Approach Criticized for Lack of Patient Voice

By Ed Coghlan

The announcement by the FDA’s Robert M. Califf, M.D., is FDA’s Deputy Commissioner for Medical Products and Tobacco that the agency will increase its scrutiny of it called the “opioid abuse epidemic” has drawn a critical response from Patient Advocate Dennis J. Capolongo.

“Once again we see the FDA has caved to political pressures without considering the patient voice in the opioid debate,” Capolongo told the National Pain Report. “Although we understand and sympathize with those who have fallen victim to their own abusive behavior of pain management medications, the flip side is even more horrifying for those who legitimately require opiate access in order to make it through another day.”

Dr. Califf outlined a new approach by the FDA to address the opioid issues that included the following goals:

  • The FDA will be more transparent and open in the approval process for this category of drugs.
  • The FDA will improve its communication with the medical community about these drugs.
  • Work to improve the information that’s available about opioid use and require drug-makers to strengthen post-market analysis of these drugs.
  • Focus efforts on approving drugs that have the potential to help mitigate the crisis.

Capolongo, Director of the EDNC in Washington DC, has been critical of the FDA in how it has dealt, or he would tell you not dealt, with the epidural spinal injection safety issue. Since the crackdown on opioids began, Capolongo says the concerns of patients have not been included.

“Thousands of chronic pain patients nationwide, many with severe intractable and incurable conditions such as Adhesive Arachnoiditis, are horrified at how difficult it has become for their doctor to effectively treat their condition.”

“It is unacceptable,” he said,” that the FDA has carelessly lumped all opioid users as “addicted abusers” when in fact many are simply innocent victims of iatrogenic injury. Their use of opiates is not by choice or addiction but rather a justifiable requirement for any semblance of normalcy.”

Capolongo concluded: “Clearly the FDA has fallen victim to their own bureaucratic weight and misdirection. I call upon my fellow patient advocates to fight for a seat at that table, to speak for those who are feeling the direct impact of these careless acts, acts the FDA may not even be aware they’re making.”

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Authored by: Ed Coghlan

There are 9 comments for this article
  1. Ever Cuyler at 5:59 pm

    Medicare drops procedures like cryotherapy making my need for medications more extreme. CDC makes thing’s even harder for me by telling my doctor how to handle my care. Reducing my medications leaving me mostly bedbound once again.
    I don’t want pills, I want a cure. Not a bandage like steroid injections, that are not regulated , and cause horrible long term and short term issue’s. Nerve blocks , burns , freezes , that only work short term. I am always fighting discrimination , refuse ER services , fear new doctor’s , always fighting for correct care. I’ve passed addiction testing. Have no history of abuse , or any other addictive behaviours. In spite of all that I’ve been forced to use same opioid for six year’s. Doctor’s won’t change it, because they fear getting in trouble.
    Doctor’s are forced to put patients on meditations with many more long term and short term issue’s. 60% of those drug’s are no classified as addictive. They often do more harm than good.
    Bad doctor’s and pharmaceutical companies caused the current opioid epidemic. Not chronic pain patients. Only less than 5% of us ever have issue’s with addiction. Most of those were probably put on meds like oxytocin ,or high level narcotics never meant to treat Chronic pain.

  2. AJ Hill at 3:41 pm

    It’s obvious that our problem lies in Washington, where ignorant and uncaring political opportunists use illicit drug abuse as a stepping stone to power, regardless of whom they hurt in the process They’re the ones – the FDA officials and others – who appear on news programs and spout false claims and misleading “statistics”. They don’t care about people in pain. They don’t even care about the drug users who die accidentally or commit suicide. Those unfortunates are merely a convenient means to power.
    I repeat: we need to address the problem where it starts. We need to organize a “March on Washington” similar to those that other abused segments of the population have employed, often to good effect, in the past. Politicians and bureaucrats can ignore us, if we remain silent and alone, hiding in our homes and hoping for a miracle. They won’t be able to ignore us, if they see thousands, tens or even hundreds of thousands of pain sufferers in the streets and outside their offices demanding attention. That will make the evening news.
    We need a “March on Washington”!

  3. Veronica Clark at 2:14 pm

    Can any one person please tell me WHY the government is infringing upon my private rights between my doctor and myself?? I thought what went on between doctor and patient is privileged information, and NO ONE is allowed to have access, nor infringe upon, any of it!!
    I never believed in pain meds. I gave birth to 3 children with not even an aspirin. I didn’t believe in it. (even tho the first one was over 48 hours labor) I had eye surgery while pregnant with my second child, with NO meds, because I was pregnant and they were afraid of the consequences on the baby. I was told I was very stoic, and that NO ONE had EVER had that surgery while awake!! After I left there, I sat in my car and bawled. Yes, it hurt, like hell.
    Now, after suffering so many years of pain from severe chronic migraines, degenerative disc disease, fibromyalgia, , sjogrens, and whatever is wrong with my shoulders, we land on oxycontin. That was the only medication that even took the edge off. It’s not a high dose, and only 2 per day. Even tho in the past, another doc had me on a higher dose, and 3 per day – it doesn’t seem to matter. ‘Hooked’ on it?? Heck no!! I’ve had to stop it cold turkey, and the only side effect is more pain.
    That’s the situation I’m in right now. No meds at all. I was referred to a pain clinic (again – this will be my 5th), but had to cancel the first 2 appointments due to migraine, and fevers. Now, they are mad at me for cancelling and have told me if I’m 5 minutes late, I’m out. I’ve decided I won’t go at all. They want to re-do xrays, cat scans, and MRIs. My insurance will NOT pay for those, so I can’t go. We already went thru going into debt thousands of dollars with this, and I’m not going there again.
    So, I ask, why is the government in MY personal business??? They have NO right – and are infringing upon MY rights!!

  4. Dianne R Hawkins at 10:32 am

    It is apparent that the thought process that has been in effect for years will stupidedly continue on. The public, medical community and government who make decisions for others need to understand those who are affected by the symptom of pain within a disease. Medical professionals, and I use that term lightly, rule with an iron hand out of a lack of knowledge and train their office personnel to do in like. The experiences of a pain patient are demeaning and raked with fear. Remarks such as, “you are not leaving here till you pee in this cup”, “if you do not get the correct drug checked on that form you will be in serious trouble” and finally the latest one experienced after noting weight gain and with witnesses, “I guess you’ve been eating way too much of Blue Bell Ice Cream, Huh?” Let me add that I am an RN with a degree and lost my livelihood due to a fall after a patient hit me. Pain patients walk into a doctors office hurting and depressed due to radical changes in their life. Top that off with cruel treatment, unprofessionalism and a pain patient’s lack of their own civil rights and you have the lives of a group of people who have been labeled by the govt and doctors as a group of addicts who are looking for drugs simply to have an easy time of it. It is apparent that representatives of those of us in this situation should be done by folks who have experienced this change in life. Being lumped into a group with street addicts who unfortunately are addicted to some of the same drugs we take does not make us any less of needing care for a daily agony. We are a lawful section of society that are being punished by people who have no idea what we are going through. Stories by us were requested then thrown out with disregard. Placating us to shut us up is a juvenile action and again, against our rights for good legal medical care like any other human. Animals are rescued and people are appalled by their abuse yet those same people communicate between each other about how people in pain should just “Buck Up”.
    I say “Walk A Mile In Our Shoes Folks”.

  5. Kandy at 7:59 am

    I am a fighter with a typical trigeminal neuralgia and occipital neuralgia on the right side of my head and face, I am in constant pain! I have become a medical marijuana patient because of the runaround and pure selfishness and lack of empathy from the medical community and also from the pharmacist! I am still a patient advocate though and I am outraged at how these people are being treated! I think the word we should really emphasizes people because these patients are being treated less than human.

  6. Dave at 6:54 am

    What’s remarkable about the FDA is they believe in their infallibilism- they violate the spirit of science.They ignored a GAO report that indicated their own staff wasn’t trained in interpreting research results. When they are questioned by anyone- they are quick to ignore criticism. Isnt that why Ms Hamburg lost her job- she thumbed her nose at Attorney Generals who raised concerns about Zohydro.
    So the FDA is incapable of learning from their mistakes. Dr Califf wants new expert advisory committee to be involved in narcotics. And I say to him- Insanity is doing the same thing over and over again. Why should a new advisory panel of experts be any different or any better then the old one? So Dr Califf believes in the infallibilism of his decisions and those of his colleagues in medicine. He also denigrates others who don’t share his opinion with discursive imperialism and othering. He condemns without investigation the opinions of people in pain- and that is not just the height of ignorance- but it is as antidemocratic as it gets to relegate others to civil and moral vagabondage. So Dr Califf- hear this- I will find the texts and the research done by you and your colleagues- and better then JP Ioannidis I will subject it to scrutiny- and will add suppressed evidence argument to criticize you and your infallible experts who wish to control others in pain and limit their choices and decide for them what they can and cant have. And since you brook no doubt that your basomedial amygdala is methylated to debate me in public- name the time and the place.

  7. HJ at 6:42 am

    Who tracks patient suicides from lack of access to pain relief? I think there should be monitoring. Everybody has an agenda without regard to the impact it has on the patient community.

  8. Kate Willoughby at 6:12 am

    I am a disabled vet whose pain level from degenerative disc disease involves 9 discs, I was just diagnosed with neuralgia of my legs not connected to spinal issues. I have migraines that are triggered by the pollution of nearby brass and lumber business as well as the fumes from the oil companies in Sarnia, Canada. I take only enough opioids to allow me to function. This is not a party, I do not take the opioids for fun or relaxation. I also suffer from the side effects of Agent Orange, Agent White and cesium and cobalt-60 along with contamination from Monsantos PCB and PCE plants while in boot camp in 1973. I have permanent skin rash on my face, and if I go out in the sun, even with SPF 50 – my skin blisters in tiny white bumps that are not like ‘whiteheads’ – they are hard and feel like there is glass in my pores. I cannot feel my hands most of the time which makes driving near impossible even with an automatic, my legs go numb from going to gas pedal and break pedal. I sleep an average of 1 hour and 45 minutes each night because of the pain and a disruption in my brain which allows me to go through the normal phases or sleep. It feels as though my knees are on fire and after nearly 3 years of complaints about pain on my right side it was discovered that there were kidney stones – one of which was the size of a walnut. Three operations later and one bout of AFIB has made life very close to unbearable – especially because the kidney stones are back. When you have kidney stones it changes the way that your olfactory process is. Everything smells like burt plastic, my partners coffee in the morning smells worse than fermented garbage and cooking dinner is a challenge on the best of days. I was told that I would have my prescription reduced by 30 mgs per day until I reach the acceptable 120 mg. I am now taking 210 mg and as I said earlier, it is JUST enough to allow me to function. Part of the draw down of opioid drugs causes severe muscle spasms – causing me to go to the nearest hospital for a shot that will calm the spasms. Compassionate death does not include severe and chronic pain – I watch as one by one other veterans who were simply denied their prescription without tapering off have turned to heroin. Ii is cheap and if you are lucky it will be the last treatment for pain before death. How many other service members returning with horrendous injuries, TBI, PTSD – aspirin and tylenol doesn’t do it. What will the next wave of service men leave us with – you write a blank check to the country you love and felt that it was your responsibility to take part in its defense only to return mangled and broken and discarded by an archaic system of care.

  9. Patti at 4:52 am

    If ANY of these be bureaucrats had to live like someone with chronic pain, we wouldn’t have this happening. NO one can tell another person how much pain they are in. Nor should ALL patients who require opioids just to maintain a semblance of a life, be summed up as an “addict” and be treated as such! I despise the fact that HEALTHY NORMAL people are making decisions for those of us that suffer like we do. There should have been a panel that included US in this decision making process!!!