Activists Want FDA Commissioner Fired for Opioid Approvals

Activists Want FDA Commissioner Fired for Opioid Approvals

A coalition of addiction experts and anti-opioid activists is calling on the Obama administration to fire Food and Drug Administration Commissioner Dr. Margaret Hamburg, saying “without new leadership at FDA the opioid crisis will continue unabated.”

In a letter addressed to Health and Human Services Secretary Sylvia Burwell, the group criticized the FDA’s approval nearly one year ago of Zohydro, a controversial opioid painkiller, as well as a recent decision to approve another extended-release opioid called Targiniq, which combines oxycodone with an abuse deterrent formula.

“We are especially frustrated by the Food and Drug Administration’s (FDA) continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths,” the letters states.

“We are urging you to intervene. Pleas from across the country for FDA to respond to the opioid crisis by properly exercising its authority and responsibility have fallen on deaf ears for too long. We urge you to seek new leadership for FDA; leadership that will work in a coordinated fashion with the CDC and other federal and state agencies, leadership willing to re-examine past decisions, and leadership that will consistently put the public’s health ahead of industry interests.”

The letter is signed by Andrew Kolodny, MD, President of Physicians for Responsible Opioid Prescribing (PROP), as well as 17 other addiction experts and anti-opioid activists. One politician, Rep. Gene DiGirolamo (R-PA), Chairman of the House Human Services Committee, also signed the letter, which appeared to be timed to promote a rally against prescription drug abuse this Saturday, September 28th, on the National Mall.

“Secretary Burwell appreciates hearing from stakeholders on the important issue of prescription opioid abuse, and looks forward to responding to their letter,” said Tait Sye, a spokeswoman for Burwell.

Dr. Margaret Hamburg

Dr. Margaret Hamburg

A spokeswoman for the FDA called Hamburg, who has led the agency since 2009, “a tireless public health advocate.”

“Preventing prescription opioid abuse and ensuring that patients have access to appropriate treatments for pain are both top public health priorities for the FDA,” said Erica Jefferson in a statement.

Hamburg has been a stout defender of the FDA’s decision to approve Zohydro, the first “pure” hydrocodone painkiller.

In April, Hamburg said Zohydro was no more powerful or addictive than other opioid medications and pain patients should have access to it.

“Despite claims to the contrary, the fact is that the top dose of Zohydro is no more potent than the highest strengths of other extended-release opioids like Oxycontin and extended-release morphine,” said Hamburg in a blog on the FDA website.

Some addiction treatment experts predicted Zohydro – which does not come in an abuse deterrent formula — would fuel a new wave of narcotic addiction and overdoses.

Since months after its introduction, however, there have been no confirmed cases of diversion, overdose or death caused by Zohydro, according to the chief medical officer of Zogenix, the San Diego-based company which makes the drug.

“We’re very, very happy with the data that we’re seeing. We haven’t publicly disclosed it, but we’re extremely happy,” said Bradley Galer, MD, told National Pain Report. “We’re not aware of any diversion. Is it out there? I don’t know. But we’re not aware of any at all.”

Authored by: Pat Anson, Editor

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Jarred

I agree that these so called anti opioid activist need to leave Ms. Hamburg the hell alone she has not done anything thing worng but try to make more pain relief medications available to those like me who suffer from a chronic pain condition these so called anti opioid activist have no damn idea what its like for those of use who have to live with a chronic pain illness my life has been significantly impacted by my pain condition and I remember how my life and how it was before I was put on an opioid pain killer my quality of life was very poor most days I couldn’t even get out of bed I I would do was try to keep myself sleep each and every day because I did not want to deal with the pain that I was in and I would have to go weeks most of the time without even being able to take a shower because I was in so much pain that I could hardly even walk I had to depend on others for everything I was so depressed all I would do is cry every fucking day and these so called anti opioid activist have no idea what people who suffer from a chronic pain condition have to go through evey day of their lives these are the last people that should have any say so on anything that has to do with opioid pain medications because had I not got an opioid pain medication for my pain when I did I probably would have committed suicide along time ago and I’m only 22 years old I feel like I deserve to be able to enjoy my life and live pain free just like everyone else and is it not bad enough already that those of us who suffer from chronic pain have to be humiliated every time we go to the doctor and have to urinate in a damn cup like we have committed some crime and be questioned by our doctor every time we go for a refill and not to mention how we are looked at and treated every time we go to a pharmacy to get our medication filled this stuff is getting way out of hand and it needs to be stopped lets not punish the innocent because of the guilty.

Mike C

Has anyone tried to file suit against the DEA and all this schedule crap as violating our rights under the ADA? As a chronic pain sufferer caused by RA and multiple degenerative disc compressing nerves the length of my back and SI compression in my hips, I see the results of these rules being set in place just like the rest of you. We are looked at as criminals because we seek relief. It’s not our fault! We didn’t ask for this! Every stage of our treatment we have to jump through hoops. What good are rights given us if an office within the government can almost unilaterally block medical treatment by scaring doctors trained to prescribe such treatments? The war on drugs affects the lives of anyone who needs prescription medication, or can’t afford legal medication. Even with the Affordable Care Act, many of us can’t access the system because we are being blocked by ideology. All of this should fall under the ADA for anyone diagnosed as having any recognized disability, and depending on which state you reside depends on level and quality of treatment provided whether or not you have insurance or qualify for that state’s Medicaid program. In Texas, if you can’t afford insurance or it isn’t provided by an employer, you’re SOL! I can no longer work regularly because of my disability and am fighting to keep healthy by jumping through these hoops that are laid before me! Even with my insurance, which is quite good thanks to my wife’s employer, my out of pocket expenses are more than most could afford. If not for this disease, my family could live quite comfortably, but sadly that’s not the case! We spend and work and drive and fight every day just so I might have one or two normal days a month. If I partake in any real activity, I’m laid up for days, but that doesn’t seem to matter to the doctors who think if I do this or that, blah, blah, blah, I’ll do much better. But they can’t even decide on a treatment plan for me. They try this and that several times a month, and each procedure comes with a hefty copay that exceeds more than half our total income each month because they keep wanting to try something other than opiads because they’re afraid the DEA will come down on them! In the mean time, they torture the patient with their guessing! I have been on opiads for several years, each years strength surpassing the last, and nothing really helps. I have days where walking is impossible. I just feel like we are being made to needlessly suffer because these pencil pushers only look at crime stats and nothing else! How are we expected to live, survive, or want to live when they keep hindering our treatments? It has gotten stupid! Those who want drugs will find drugs, always have, always will! Driving those of us who have an actual need… Read more »

BL

The President has advisors who advise him on things like this. There is no way for him or any other politician to know any different because there aren’t enough voices. When was the last time you saw chronic pain patients on the national eveing news discussing hiw recent changes have impacted them ? When was the last time you saw a large group of them protesting ? The “squeaking wheel gets the oil.” There are not enough chronic pain patients “squeaking.” I understand very well how physically, mentally, emotionally and financially depleting severe chronic pain that is untreated or undertreated can be. Perhaps that is why you never see or hear them. I am not talking about over the internet. What I am talking about can’t be done over the internet. It will cost money, time and energy just to name a few thigns. And until everyone is willing to pay their share, nothing will change.

If you are intelligent you can’t blame the President, other politicians, FDA, DEA. etc. The word has to get out to as many people as posssible, as often as possible, as clearly as possible. Until that happens nothing will change. It will take time. The changes we talk about here, didn’t come about overnight. It has taken years for these changes to come about. Frankly, I don’t believe there is anything we can do to reverse the changes we’ve seen in recent years. But, what can be done is attempt to stop further changes from coming about.

Stephen S. Rodrigues

How did President Obama get into this situation. (The disrespect is thick and will blind your logic) Some should step back from your narrow view reality and see the entire picture. It is not the President, he just passing through doing the job we elected him to do as a figurehead and these days a scapegoat. It is much more complex that what you see on the surface.

Based on my 3 types of pain explanation. YOUR person, YOU have been turned into a number or CPT code and dehumanized. NO power, no voice, no influence and invisible meaning “almost” worthless.

Remember it’s US, you and I, who must raise our voices to make the necessary changes! Oh and now that the Supreme Court has made OUR voice worth much less than a corporation’s, we have to raise voices even louder.

Voting is just the tip of what you should be doing, call your Congress Person, they make the laws.

Sheri

Does Anyone have an Idea How WE can get something together to Fight Against these Activists? And P.S… These Activists and Mr. Kolodny are just the Pawns in Obama’s Game. Just like Sebelius.

Anne

They need to leave Ms. Hamburg alone!! Without her in there helping those of us in chronic pain we are in serious trouble! Its hard enough to get treatment now and if these people have their way there won’t be any pain medicine at all. I shudder to think of how we will be treated if she isn’t in there sticking up for us. Most of us are treated like garbage now, at the doctor and the pharmacies. I don’t believe that all of these deaths from pain medicine are all from the medicine anyway. What about all the alcohol involved? I’ve been on opioids for 20 yrs and I’m not dead. There’s got to be other factors involved in these deaths. I do not believe we are being told the truth. What about all the junk foods? Obesity kills well over 2 million people a year. Why not shut down all the junk food factories? This is not about “saving lives.” Alcohol kills more people a year than opioids and yet you don’t see alcohol on the killing line. I’m still in pain with the meds but without them I have NO quality of life. All I have to look forward to all day and night is pain. It never goes away. The meds drop it to a 3 or 4 but without it its a 9 or 10. Keep letting these people run the show and soon we will have nothing for pain. If Ibuprofen and all that junk worked and safely we would all take it but it doesn’t and its NOT totally safe….strokes, internal bleeding at any time etc etc. We are headed for serious trouble my fellow sufferers. If we don’t stick together and put an end to this travesty we will be ignored and forced to live our lives in pain. I am truly sorry for those who have lost loved ones but you cant blame the pills. They didn’t jump into anyone’s mouth.These people chose to take them and too many of them. Some perhaps intentionally. And where did they get them? Not my medicine cabinet..

Stephen S. Rodrigues, MD

I’ve called and left a message also.

“DEA, FDA, and pharma need to start looking at drugs for those of us living in chronic pain that are not opioid based.”

This is the greatest disconnect that I’ve discover in my travels, medical education conferences and seminars and confirmed in my office. This is especially true in the Trigeminal Neuralgia and Face Pain upper echelons who place this pain syndrome in the incomplete and improperly “non-cancer group.” Call and ask them to explain their understanding and mission.

If you deconstruct all the causes of pain you can place them into 3 categories, kinda “A new pain paradigm”:
Structural — like cancer, aneurysms, infections, tumors and malfunctions. These need immediate care in a hospital or ER.

Injury type pain — like twisted knees, ankles, and broken bones. These should automatically repair by nature with little help from us. Vital! Bones, joints, cartilage, meniscus and intervertebral discs do not cause long-term pain.

Nonstructural type pain — This is the pain that we are all talking about but the upper echelons have disregarded and discounted this pain as “no-big-deal.” This pain is the pain all of us will have to deal with in our a daily lives in the ongoing battle with aches, pains and stiffness. REPEAT! Bones, joints and cartilage, meniscus or intervertebral discs do not cause long-term pain. So you should not think that what is visible on X-ray is causing your pain, with this new pain paradigm.

This pain is no big deal until it reaches a certain level of density in the flesh or muscles them it will be the biggest deal that will destroy your life. This is the pain that will sneak up on you little by little until it awakens you from sleep and distracts you from your routines. This is the pain that does not respond to the usual types of care offered by modern day conventional medicine.

So asking modern day conventional medicine to get your out of this pain when they are distracted by their power, rules and regulations is a start, but they do not even know how to help you. They have abandoned the treatments, concepts, ideology, rules, wisdom, science and tools. They have dumped them in a waste bin. Some crafty people have actually cloaked over the old design and placed a new set of treatments on top full of flaws. These new treatments are somewhat effective even with the flaws and will make you think they are on the correct track. The flaws may emerge and haunt you to death. They are also much more expensive, dangerous, toxic, illogical and inhumane.

Kurt W.G. Matthies

Kolodny — no surprise here. He’s been against prescribing opioids for non-terminal patients for many years.

The problems with HC are twofold.

First, we no longer recognize “mild” pain as an indication for opioid treatment.

Second, it should never have been moved to Schedule II.

HC is a valuable tool in treating mild/moderate pain. It is required by thousands of patients in acute pain in times when they don’t have access to a physician or dentist.

There is a need for a long-acting HC as some patients tolerate HC better than oxycodone.

The practice of calling Zohydro a “new” pain medication “stronger than Vidodin” is obfuscation of the facts. HC has been around for 60 years, and is the opioid in Zohydro. Nothing new here, including strength.

If Kolodny has medical training, then he should be able to distinguish between equal analgesic strength and dose.

Anonymous

Pain Patients do not have a voice at all! We have no rights! It would be torture if someone had to endure the pain we do! There are some real ignorant people using skewed data to make decisions! A lot of the Opiates that were sold to addicts illegally when out he back door of warehouses and had nothing to do with pain doctors or patients!
Every other commercial on TV is for a luxury addiction program! Every other Talk show is about addiction, yet nothing about chronic pain! I have heard so many ignorant comments with no basis no fact many from Medical professionals! I have to bite my tongue they are so ignorant! My life is ruined because my Pain was ignored ( Ruptured Disc) the Do0c was coked up at the ER! Go figure! Now multiple spine surgeries and numerous inoperable things later I can’t work! My pain was not taken seriously until my leg was virtually paralyzed. I was denied treatment! Now the Pharmacies “Lose prescriptions , even the non controlled substances! The DEA are a bunch of Morons, along with the FDA allowing medications with no active ingredients to be sold here! Many of them from factories in India and China! They are not looking out for our benefit, only big Pharma! My State has a lot or addicts yet the Pharmacy Board will not recognize that legitimate pain patients need access to their Meds! Illegal Opiates are much cheaper and easier to obtain than pains Meds! There is no Accountability! Lives are ruined by pain! I would not even have Chronic Pain if I had been diagnosed initially and if my surgeon wasn’t an incompetent butcher. They hid the fact that he had numerous complaints, and said it was my fault I did not get better! No Accountably! I keep the initial Doctors mug Shot on my fridge! Why don’t the focus on drug addict Doctors the statistics are pretty high! Maybe incompetent Physicians? The DEA needs to go, they are in bed with the Cartels and big Pharma! They don’t protect the American people in any way! The “Drug war” is lost!

carol levy

I called Sec’t of health office and left a message saying these “experts” and the rep are wrong. However the DEA, FDA, and pharma need to start looking at drugs for those of us living in chronic pain that are not opiod based. The comment line number is 202 205 5445

Stephen S. Rodrigues, MD

This is much more of a convoluted disaster than you may see from your protective. The HHS is head of the snake but the brains are scientist, profiteers and physicians. The altruism has been gutted from this beast. It is you and I who must make sure the integrity is put back into the system. Here is how I see it and my feeble attempt at change:

https://www.change.org/p/u-s-department-of-health-and-human-services-the-first-line-use-of-complementary-and-alternative-medicine-in-general-medicine

BL

Myron Shank, M.D., Ph.D., Are you saying that if a dr suspects a chronic pain patient is addicted or abusing thei pain meds that the patient shouldn be referred to someone who can help them with their addiction/abuse ? I may have misunderstood what you said and if I have I apologize.

Myron Shank, M.D., Ph.D.

Ryan Lankford is correct that “addiction medicine” is not recognized by the American Board of Medical Specialties. However, even if the ABMS does not recognize the specialty, at least one state recognizes it by law.

For example, Ohio recommends consideration of “referral to an addiction medicine specialist” for patients who require a “morphine equivalent dose” of 80 mg/day or more (http://www.med.ohio.gov/pdf/NEWS/Prescribing%20Opioids%20Guidlines.pdf). Apart from the fact that equivalent doses are poorly established, these doses are much lower than the approved dose forms. For example, by a common conversion, the equivalent dose of oxycodone might be 53 mg/day, but, to use controlled release oxycodone as an example, the dose forms intended for every twelve hours go up to 80 mg. This is 160 mg/day, more than three times that state medical board’s estimated morphine equivalent dose “trigger point.”

That is a recommendation, but Ohio actually requires a physician treating chronic pain with any prescription medication to obtain an immediate consult with “an addiction medicine specialist or other substance abuse professional,” if he suspects or has reason to suspect that the patient is addicted or is abusing drugs. It defines “addiction medicine specialist” to include “a medical doctor or doctor of osteopathic medicine who is certified by a specialty examining board to so limit the whole or part of his or her practice.” (http://codes.ohio.gov/oac/4731-21-02).

While I do not know the content covered by the test, which is now administered by the American Board of Addiction Medicine, I did verify that the requirements are both much more (http://www.abam.net/wp-content/uploads/2014/05/a1-APPLICATION-F9.pdf) and somewhat less (http://www.abam.net/wp-content/uploads/2014/01/FINAL-ABMS-Certification-and-Residency.pdf) than what Mr. Lankford suggested.

To my surprise, Dr. Andrew Kolodny’s Physicians for Responsible Opioid Prescribing (PROP) includes two well-respected names in chronic pain and opioid therapy, as medical reviewers and as signers of its petition to change FDA labeling of opioids.

Wilson

Dr.Kolodny is the real problem.He runs one the largest addiction treatment centers in the United States, his yearly financial compensation is substantial ,he believes that addiction takes priority over chronic pain.
Zohydro does not have Tylenol which makes the medicine palatable for pain patients that have sensitive livers.
Dr. Hamburg has done a commendable job and has not wavered in the face of political assaults and other non scientific rants about phony epidemics that never came to attrition.

Ms. Hamburg has tried to leave some options for those who are in chronic pain, for instance, Zohydro. Zohydro, which is a long acting version of hydrocodone with not acetaminophen in it, was promised to have killed people the second it hit the shelves. To date, their have been NO DOCUMENTED DEATHS, OVERDOSES, or DIVERSIONS of Zohydro reported.

Dr. Kolodny and his group PROP, have been trying to blame chronic pain patients for every problem to do with opioid deaths since his groups’ inception. The thought that taking pain medication away from chronic pain patients will stop drug addicts from using drugs is ludicrous anyway. Drug addicts are still getting drugs via heroin, stealing them or mixing alcohol with any number of other illegal substances. Pain patients are suffering with little, if any, pain medications and living little, if any lives. Suicide rates are climbing among chronic pain patients. But the drug addicts party on while we suffer.

While I have not always agreed with everything Ms. Hamburg had done in the past, she has certainly been a better representative for pain patients than the PROP group would have if they had it their way’

Karen Shay

Have you lived in 24/7 7-8/10 pain, after med? Have you had multiple spine surgeries? Have you MRIs and other medical tests documenting nerve damage, multiple herniations, DDD, spinal stenosis, foraminal stenosis? Have you had a neurosurgeon say, “this patient will never be without pain? Have you gone from doctor to doctor trying to get better only to be told that same thing? Have you curled up in a ball, teeth chattering, hardly able to breath, your whole body shaking and vomited because your pain is so bad???!!!! Have you seen the helpless look in your loved ones eyes when they watch you go through this pain?!?!?!? Have you had your life shredded to pieces because this pain has taken away your ability to work in a career you love!?!? Have you EVER not been able to hold your grand baby because of the pain?!?!?? I could go on, but for some reason, I don’t think you get it!!! I pray you can at least understand because I would not even wish this pain on you! Even though you are the ones trying to take away something that gives us some sense of relief even if it is just a little relief from this horrific hell of a life we live every moment of every day!!!!!! I have pages of medicine listed that I have tried over the past four years and I would take them gladly if I wasn’t allergic to them! I would gladly take them if I didn’t end up in the ER because of the severe hypersensitivity and horrendous side effects!!!! I would gladly take them! But the truth is I cannot! Are YOU going to come to my house and take care of it and everything I need to do while I’m in bed suffering because I won’t be able to get these meds BECAUSE OF YOU WHO DO NOT LIVE IN THE PAIN WE DO!!!!!! ARE YOU!?!?! I want an answer, what am I supposed to do!

BL

Chronic pain patients won’t be heard until their vocie and physical presence are at least equal to the anti addiction activists. Although our voices will more than likely have to be louder and our physical presence too many to count before we are heard over them.

Ryan Lankford

Of course Kolodny & Co. want the FDA head to resign. PROP and Andrew Kolodny are old school prohibitionists, just with a 12 Stepper bent. Kolodny has a stake as medical director in a 12 Step rehab chain. His specialty is psychiatry and the fake, unrecognized specialty of “addiction medicine,” so all he sees are addicts. It’s confirmation bias to the nth degree: the only opiate users he sees are opiate addicts, so therefore all opiate users are addicts that the government needs to take medicine away from! Brilliant!

And don’t get me started on the field of “addiction medicine.” It’s a fake sub specialty that isn’t recognized by the ABMS. It was created by the American Society Of Addiction Medicine, a prohibitionist 12 Step front group. Literally ANY doctor can become an “addiction specialist” if they can pass a test that’s made up of 12 Step garbage. That’s all there is to it! You simply have to be board certified in ANY other medical sub specialty, take the test that’s basically 12 Step mumbo jumbo, and pay a fee! As Andrew Kolodny fully knows, there’s a lot of money to be made in the prohibitionist racket.