Want to Talk With the FDA? Here’s Your Chance

Want to Talk With the FDA? Here’s Your Chance

By Ed Coghlan.

The National Pain Report has done a number of stories recently that have received numerous comments from people complaining about the federal (and in some cases their state) government. The reaction is that recent policies that have been adopted do not have the patient in mind.

This story, published on April 25, set off a firestorm of commentary from chronic patients and providers.

We’ve been talking with Terri Lewis Ph.D. about trying to create a survey from that story that could capture objective and subjective data from you.

She’s done just that, with the goal of having your input inform the FDA as the agency determines where to place the focus on alternatives and new drug development. They are holding a hearing on July 9.

Take the survey here.

The survey will be live until June 17th to give Dr. Lewis time to tabulate and submit to the FDA by the June 25th deadline.

FDA is challenged with determining how to balance the need to ensure continued access to persons who rely on opioids for continuous pain relief while addressing the ongoing concerns about safe use, abuse and misuse.  Many of you will not be able to attend this so we are taking your voices to Washington DC with us.  You can register to attend or view this hearing.

For Lewis, this survey will not only help let the FDA know what chronic pain patients, their loved ones and their providers are experiencing in 2018, but also will help her develop some data about individual states. Her initial focus is on the July 9th hearing.

“This survey is designed to create some patient focused due diligence on chronic pain that our government simply needs to see,” she said.

The National Pain Report is happy to partner in this effort and will share some of the objective results in the coming weeks as people begin to fill out the survey.

Subscribe to our blog via email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Authored by: Ed Coghlan

29
Leave a Reply

2500
29 Comment threads
0 Thread replies
1 Followers
 
Most reacted comment
Hottest comment thread
25 Comment authors
  Subscribe  
newest oldest
Notify of
Cindy

How do I tell my chronic pain story and the nightmare realization that I have concluded as my only option.

Paula Mcgann

I have rods and screws in my back and I hurt constantly. I have never abused my medicine. I do not agree that pain med’s make u want to do heroin. I feel that is a personal choice.

James M Thaxton

I registered, and now I am officially able to get my 3 minutes. Three minutes to talk about…. What? My pain journey in a cliff-note? Three minutes to argue my point on the corruption within mainstream pain clinics? You know the ones. Fancy website, they want nothing more than to be able to provide you with the best possible solution to your needs. Oh, I see. They are the interventional GODS that will end my suffering from RSD/CRPS with some round of various spinal injections. Cha CHING!

NO SIR. The risks are not only numerous, but unnecessary. They don’t last ling AT ALL, and that’s assuming it WILL be efficacious. I know… I read your policy, no injections…no prescriptions.

Actually, I think I just answered my owe question. I will go into my wordsmith ninja mode and discuss the problem with unregulated policies concerning “international” Pain Pain management. How there needs to be federal rules in place that protect patients from non-pharmacological interventions whose risk outweigh its benefits, and if so a non-prejudice pharmaceutical treatment plan should in turn be a recommended course of action. As well as tightly controlled REMS will be implemented in the effort to combat diversionary tactics, as well as patient dosing regiment adherence.

Then quickly, yet piercing, legislation that is not humanitarian by nature be rectified. This is in regard to the lack of rules and regulations that give Pharmacist the power to refuse and blatantly lie to patients with regard to controlled substances. Which, in nature, are based on their “best” judgment on the appearance of the person requiring a medication. Also, if a long acting medication that falls under the CSA is filled and presumably will continue to do so, upon refill it would be pertinent to fill all subsequent prescriptions with the same pharmacological profile (ER/LA), a one day before the Rx would be considered empty. Reasons why this is logical and healthy are because, LA/ER medications need to be taken in the morning. When patients have to wait to drive to the pharmacy, drop off, wait for up to over an hour…those factors cause, at the very least have the potential to, a disruption in the analgesic steady state plasma levels, causing a good deal of unnecessary pain amd hardship on the already sick, afflicted, diseased states of the pTient.

Rickie

Funny how this is supposed to be the home of the free when our government is little by little taking that away! It’s not human to take the only relief a person in so much pain gets away from them! Now their taking away the rights of our Doctors to be able to treat the chronic pain patients the way they should! This has got to come to a end they really need to open their eyes and ears and listen to the real truth of the drug problems in America. Taking away our relief and life isn’t going to solve a damn thing. Just tell me how that’s going to get rid of all the street drugs and the real addicts using them. If a addict wants to get high they are going to find away to do it! All this stupid unbelievable new regulation is going to do is make a whole lot of people with pain and diseases have to suffer horribly!!!! That’s the ones that don’t end up killing theirselves or end up on some horrible street drug that kills them!!!! Listen to the chronic pain patients for a change and truly take in what we’re saying! Open your eyes because your fixing to makes things so much worse than they have to be for people in pain!

Maureen M.

Ive tired several times to register for the July event but it keeps telling me that my email address is not valid?! But, it is! I can’t register then 🙁

Holly D.

Dee

I hear ya! I am just appalled we live in a world that stuff like this can happen!

I’m in Md. That’s the letter I showed her. Nope, she didnt care. I literally broke down in her office on 1 visit and a couple days later I read on my patient portal in her notes that perhaps a psychiatrist might be good for me. LMAO! I know Dr.s are worried BUT they need not treat a patient like that! But if I say anything I’ll get booted out. I wish you the best Dee. :<3

Dee

Holly D I am so sorry. In MD the governor wrote a letter that chronic pain patients are exempt. Unfortunately the doctor hasn’t heard of it and despite begging not to be reduced was reduced again. Was told that soon, Nationwide, the dose for pain meds won’t exceed 20mg. I am sure doctor didn’t know we know about MME. 20mg of this pain med is 60mme. It is going to get even worse, I don’t want to age in this climate
In Washington State chronic pain patients are exempt, doesn’t matter, people are being cut 90%. It is inhumane, barbaric to treat disabled people in pain this way

Holly D.

I filled out the survey……..
I just sat here and read all the replies. I am supposed to be lady like but I think I’ve just used every curse word there is in the english language. [edit]
You know I’ve been cut back 3 times now. The last visit I asked to please not cut me back again until I try to get palliative care. The so called solutions I’ve been offered made me sick! I can go to a Methadone clinic. I can get more injections. I can take clonadine . Are you kidding me? I’ve been going to this pain management for 4 years! Never failed a pee test. Never asked for more.
100% compliant. They have all my MRI’s and reports. Now I have a synovial cyst on my L-4-L-5. But I have to be under the 200 MME even though I showed her a letter from our Governor that chronic pain patients that have been on opioids are excluded.

God help each and every one

Confused

I spent forever on this survey (which had ambiguous questions– I had to comment, a lot).However, when I was finished and submitted it, I’m not sure it went thru, as there was no comment on my PC screen! So I tried again… still not sure. I see that it was powered by Google via Ajax, and I’d just unsubscribed from Google… also, use Ghostery, which apparently, was blocking it? In addition, my status re:receiving meds is currently in flux. So I am wondering whether I can take the survey again? Also, do they notify you if they rec’d the survey? I am not sure what to do. Someone let me know? Thanks.

Debbie

I just underwent neurological frontal surgery to remove cancer tomour. Really the on drug that was helping for pain was dilating ( spelling ??)morphine which I had been taking durin cancer treatment is no loner helping,,,

Misty Hoffman

I filled out the survey right away and hope it will help. My question is, if one were stable enough to travel to D.C., are they allowing anyone to speak in person?

Rich Reifsnyder

Rich R. I see on TV 📺 they are having hearings in Washington for a new head official for the CIA.They asked her about Waterboarding Terrorists and she said like everybody else it is Torture, and absolutely not they will not Waterboard Terrorists. [edit] are you kidding me,caring for drug addicts and now Terrorists.Documented from the United Nations it is Torture and Inhumane Treatment What The United States Is Doing with the CDC Guidelines on Decreasing or Stopping Opiod Medication For Disabled Chronic Pain Patients and Our Wounded Veterans.You mean this country is more concerned with catering to these [edit] but let Our Disabled Chronic Pain Patients and Veterans suffer from Withdrawal and Inhumane Treatment and Severe Pain from Decreased or Entirely Stopping Their Opiod Medication.Dr. Jane Babin PHD,a molecular biologist and a patient lawyer asked the CDC some legitimate questions on the CDC Opiod Guidelines and their answer was Dr.Janes questions can’t be answered in a “Definitive Manner Based On Available Data”.Are you serious,how can you stop or decrease millions of CPP,S OR VETERANS OPIOID MEDICATION WHEN You The CDC don’t have Available Data.

Ellen

Sue you made good points I feel so defeated I called corporate cvs and
Got the run around local
Said she had call them and corporate says they
Have to go with local and while Inam on phone with
Corporate and yes I told them I made a mistake in frustration that when I am in. withdrawl and severe pain and gets too hard I could see being pushed to
Suicide and my kids get a lawyer and sue cvs so now they won’t fill any of my meds and patient abandoned me and while I am
asking just fill this one so I have time to find new pharmacy two policemen show up because I said suicide I even showed them the young policewomen who did I feel
CVS did that to
Threaten me to not call or I get sent to looney bin because I am mad I have call to pain doctor and of course it is
Weekend coming up
This is
So maddening mean I thought patient abandonment can cost your professional license
Thé CEO of CVS makes $12 million dollars a year no wonder they do not care

Sue

Thank you Mr Coughlan for all you do. However, on this First of all, I agree with everything David said; these people are not our friends. I think the 274 comments (last I checked), should have been enough to take action; if they were sincere. I dont believe that they did not know the impact and suffering this debacle would have on pain patients. They have put a spin on this opioid war in the media and hidden how it has impacted our lives. I believe that is intentional and there is a purpose to it that will benefit them in some way or another.

I see the survey as a formality/red tape. These questions are inappropriate for those using pain medications responsibly. Probably written by an attorney to be as ambiguous as possible. What else is new, its the government. Ive looked over it enough to form an opionion (only mine) that some of the questions are unnecessary and have nothing to do with the problem: Why do they need to know if I have switched pharmacys, my level of education. Do we have access a team of physicians who are board certified and registered with DEA to prescribe all your medications including schedule II narcotics? I know I do. I think the questions have been answered in the comments.

Im not even going to continue; because they know exactly what their doing and I dont believe they care. Im certain if the powers that be had severe pain, they would get exactly what they needed to be comfortable. If Im wrong, I will admit it but I will not even spend my time filling out that survey.

Lisa Shuman

First of all I would like to make sure that each and everyone from DEA has their PAIN MANAGEMENT LICENSE..Because if they knew anything about pain or actually were ever in severe Acute pain they would maybe understand..if you have never lived it you shouldn’t be making decisions you know nothing about…i have had NOT 1 BUT 2 FAILED SPINE SURGERIES.WORSE OFF NOW THEN BEFORE..SEVERE PAIN FROM MY SPINE THAT RADIATES DOWN MY LEFT LEG INTO MY FOOT. LEFT FOOT IS 3/4 NUMB..IM 54..I CAN NOT WALK AT ALL WITHOUT MY PAIN MEDS AND WITH THEM I CAN WALK FROM POINT A TO POINT B..I HAVE NO QUALITY OF LIFE..MY 2 PUGS IS WHAT I LIVE FOR.WITHOUT THEM I COULD ALMOST BET..I WOULDN’T BE HERE..THE PAIN GETS SO BAD I BITE MY TEETH..PUNCH THE ALBLum.AND ALL DAY LONG I KEEP BREAKING DOWN CRYING..I DIDN’T ASK FOR THIS..I WAS A SITTING DUCK STOPPED AND GOT REAR ENDED BY A UNLICENSED DRUNK DRIVER WITH DOLLAR A DAY INSURANCE..HE WAS DOING ABOUT 60..EVERY LEVEL IN MY BACK AND NECK IS SHOT..DRS CAN NOT DO ANYTHING FOR ME.I DONE PHYSICAL THERAPY MULTIPLE TIMES..HAD TO STOP PAIN WAS SO SEVERE. ACUPUNCTURE..TENS MACHINE..I ALSO TAKE PLACID BECAUSE I’VE HAD CLOGGED ARTERIES..MY MEDS ARE LIMITED..AND YOU WANT TO KEEP TAKING MY PAIN MEDS..WELL I’M HOPING YOU WOULD RETHINK ABOUT THIS..BUT THE ADDICTS WILL ALWAYS GET THEIR DRUGS..THEY DON’T GO A DAY WITH THEIR FIX AND GET SHOT UP WITH NARCON..LET THEM DIE.IT WILL SOLVE A LOT OF CRIME..WHY WOULD THEY BE MORE IMPORTANT THAN PEOPLE IN SO MUCH PAIN THAT ARE FIGHTING EVERY DAY BECAUSD THEY HAVE NO MEDS..DO YOU PEOPLE EVEN HAVE A HEART..I WAS NEVER IN TROUBLE WITH THE LAW..BUT I MAY HAVE TO EITHER BUY MY PAIN MEDS FROM THE STREET BECAUSE MY PAIN DR HAS NO BALLS TO STICK UP FOR HIS PATIENTS.THAT SIGNED AN OATH TO KEEP HIS PATIENTS AS COMFORTABLE AS POSSIBLE..I SCREAM ALL NIGHT LONG WITH PAIN AND MUSCLE SPASMS..IM ASKING FOR YOU GUYS TO PULL YOUR HEADS OUT OF YOUR [edit] AND MAKE SURE WE ALL GET OURS MEDS BACK..I HAVE NO LIFE NOW BUT PAIN SO I MAY AS WELL KILL MYSELF THAT’S MY OTHER OPTION..DRS KNOW WHO IS IN PAIN AND WHO ISNT..IT DOESN’T TAKE A ROCKET SCIENTIST WE ALL HAVE MRIS AND NERVE STUDIES..IF YOU DON’T HELP US…KARMA IS GONNA BITE YOU IN THE [edit].

Ellen

I live in Washington state Seattle I have been going to CVS pharmacy for several years The told me today when pain script was brought in a 7-10 days prior that they won’t fill due to cdc guidelines yet I spoke to head pharmacist I was bringing my script in and will tell the provider to expect a call which is what they were going to start requiring I spent today in a infusion room because my dystonia is causing terrible headaches the levodopa causes headaches and yesterday I spoke to head pharmacist I can’t believe I don’t get a months notice to find another pharmacy and when asked the MME needed she would not tell me because
I take Valium and IM Benadryl which I am going need to cut close zero many injections causing inflammatory tissue and abscess which was drained surgically 3/20 I have a rare form of dopamine responsive dystonia/Parkinsonism symptoms so benzodiazepines
And opiates are effective common treatments been on for years but because I Amon both she or CVS will not also fill my pain meds I am at the point of no return and I do fille like suicide but I am a mom and pet mom ( husband a nurse walked out 5 years ago he was my hero advocate) so Terry Lewis Dr Coghlan any short term ideas help I don’t want a die but I don’t know what to do I have in past written as suggested went town hall meetings
Please give me some idea in short run they lied day I picked up my script
This did not help dystonia in jaw and neck setting off vomiting today so I laid in a cab and got IV meds I usually get prevent freezing and crying does not help I still can not keep anything downU

Kristen

All should be aware that this meeting is not a hearing. It is a different type of meeting focused on hearing what patients and family members have to say. It is less formal and more patient-friendly than a hearing.

Maggi Martin

But see it don’t even matter if we say we’re in need of pain relief due to injury or illness, we’ll get another diagnosis of opioid abuse disorder. When thats there it’s too cover the doctors [edit], not to help us out at all. The whole system is grimy and i just really can’t wait for them to be on the receiving end of their own [edit]!

Steven

After you run out of Medicine and are on the bridge with the camera crew make sure you have at least two hundred feet below you and hit head first otherwise you might live and be a quadriplegic in pain. Good luck and God bless!

Steven

Well folks, I hope you’re all ready for a shock at your next 28 days doctor visit. It’s happened. My doc says now he’s not a 200 mme Dr any longer but a 90mm e. Before cutbacks I was according to them 352 mme. That accounts for taking away 75% of my pain medication over 8 months time. I told them I will never even get to the end of that. I will be dead. They don’t care. This is real life and death. I think we need to start getting news cameras up on Bridges to film our final demise. Let the public know what’s happened to us all before you go. Why take medicine and have them count your corpse towards there stupid Witch Hunt. They’re killing us. What are we going to do about it before we die? I can’t tell you what you should do but I might consider the news crew in my final so long. I’ve tried all their stupid tricks. Acupuncture, massage, creams, exercise, meditation, yoga, Thai Chi, it’s all just a lie. These are no substitution for opiate therapy. I’m sure 6 months from now we’ll all be taking aspirin. We are no more depressed than the normal person would be facing a genocide like this. Has anyone found a system that might work other than opiates? Benzodiazepines, Ambien, Lyrica, MMJ,? Maybe all together they would keep us going for a while. The time by share this information with each other is now! May God’s grace cover all of his children as we pass away.

Rich Reifsnyder

Rich R. I filled out the survey,so we will see how this meeting pans out.I just seen the article yesterday from the 4CDC officials that the opioid OD numbers were lies and inflated.It made me nauseous,every single person on this site has been saying they were adding heroin OD’S,pills laced with fentanyl deaths,and every other drug under the sun and linked it to Opiod Medication we all take responsibility.Every single one of them,from Dr Kodony,PROP,CDC etc.that have their dirty hands in this,for their financial gains such as Addiction Centers have to be held accountable.It makes me sick in my stomach that so many CPP’S,our beloved Veterans and any person that has committed Suicide or that is still suffering this Inhumane treatment has to be held fully accountable and prosecuted to the full extent of the law on torture and Inhumane treatment of weak disabled chronic pain patients and our wounded veterans,people with diseases and any other person that suffered from this disgrace.God Bless All Our People.

Dawn

I have tried numerous types of procedures for pain reief along with my opoid medication. I personally would not be able to manage the things in life that are important to ME. Like having fun with my 10 grandchildren. I have been on this medication a number of years and i respect the medication i have never taken more than 3 pills a day some days less depends on my pain. I would not have the enjjoyment and quality of life without my medication. Its a shame the people who do not respect this medication could affect those that do. No not a shame its inhumane

Holly

If I still lived in Ohio, I would probably be dead from the level and intensity of the pain I experience. They were hostile, extremely abusive, and dismissed me as a “drug-seeking scumbag” even with ample objective tests confirming the reasons for my pain.

My kids moved me to North Carolina and thankfully I’ve had the episodes of extreme pain treated and acknowledged by medical personnel. Daily pain, however, is denied the one low dose opioid that works best, with the least side effects. An antidepressant replaced it, and they want to keep increasing it. Why has polypharmacy replaced the effective opioid pain medicine, to my detriment; just to appease government and pacify doctors?

Every aspect of my life and health deteriorated rapidly once I was denied the medicine that worked best for me.

Denying patients effective medicine, in a failed attempt to prevent others from succumbing to addiction, is extremely unethical.

Paulc35

Prescription Opiods ovrdoses are less today than they were in 2006. If you want to fix the heroin abuse we need arrest when they OD and forced rehab. I personally gave up. You have intimidated the doctors to where the only people suffering is the patients that need the medication. Now the DEA is affecting hospitals supply of pain medication. Don’t restrict production. You can’t regulate it. This is dangerous ground for I promise you that one of you in government thinking quotas are good might be the patient that roles into the ER after maybe a severe car access there might not be pain medication for your pain, or your child the broke their femur will only receive Tylenol. Ask yourself this. With all the restrictions has this had an effect on the overdoses coming in? Answer is-No

Jul

Wonderful. We, all CPP need to participate in this. Thanks Terry.

David

A government cannot have too much of the kind of activity which does not impede, but aids and stimulates, individual exertion and development. The mischief begins when, instead of calling forth the activity and powers of individuals and bodies, it substitutes its own activity for theirs; when, instead of informing, advising, and, upon occasion, denouncing, it makes them work in fetters, or bids them stand aside and does their work instead of them. The worth of a State, in the long run, is the worth of the individuals composing it; and a State which postpones the interests of their mental expansion and elevation, to a little more of administrative skill, or that semblance of it which practice gives, in the details of business; a State which dwarfs its men, in order that they may be more docile instruments in its hands even for beneficial purposes—will find that with small men no great thing can really be accomplished; and that the perfection of machinery to which it has sacrificed everything, will in the end avail it nothing, for want of the vital power which, in order that the machine might work more smoothly, it has preferred to banish. JS Mill
The FDA, CDC, DEA, AMA, DHHS advisory committee members from academia etc- the iron triangle- has too much power to dictate pain care and, has shown they are not capable of using that power responsibly. They lack the analytical capacity, the representational capacity, the compassion, the humility the planning capacity to get pain care right.
The FDA has failed to make an effort – for 11 years to enforce regulations on reporting of clinical trials- and $24 billion in uncollected fines has resulted. Even this year- after promising they will enforce regulations-the y have not- http://fdaaa.trialstracker.net/?. The FDA has done a poor job of regulating medical devices and sets poor standards for medications- so we see more and more medications with off target effects- like causing tumors, suicide-etc. The FDA failed to call for good standards for pain medications. The FDA is not our friend. They dont work for us-and frankly though they claim their decisions are evidenced based- ultimately a committee of a few experts decide if a drug goes to market. Those committees dont give a fig about you and me or democratic accountability.

Kimberly

I have been removed from my opiate that I have been on for over 10 years. 37 surgerys, RA , fibromyalgia and on going painful skin cancer removals. My body is only 55 but has aged to a 86 year old. Daily pain. I have lost all worldly items. I don’t even own a car. The only thing I own is pain & the aggregation of doctors telling me to do yoga, meditate, acupuncture. If I had a income maybe I would try acupuncture. I lost my job. I do get disability but not Medicaid only Medicare that covers only 80%. Why am I suffering because of illicit drug abuse ? The CDC FDA need to concentrate there effects on illicit drugs not on pain patients who can bearliy get out of bed. This is tourture

Jackie Schneider

This is awesome! Thank you Terri Lewis and National Pain Report!

Kathie jo Albano

My story is long I will begin to think of what I need to say thank you this is great