Commentary for Federal Government Patient Access Work

Commentary for Federal Government Patient Access Work

The Federal Register issued “A Request for Information: Ensuring Patient Access and Effective Drug Enforcement”. The comments are being sought to ensure (patients have) legitimate access to controlled substances, including opioids, while also preventing diversion and abuse, as well as how federal, state, local, and tribal entities can collaborate to address these issues.

Here’s a link.

Chronic Pain Patient Advocate Dr. Richard “Red” Lawhern of the Alliance for the Treatment of Intractable Pain has filed a 4500-word referenced comment to HHS. While the entirety of his report is too lengthy for publication here, we thought an excerpt where he discussed the obstacles to legitimate patient access to controlled substances would be of interest to many of you.

The primary obstacle to legitimate patient access to controlled substances is a draconian program of regulatory over-reach and intimidation of healthcare providers in pain management practice. This program is being conducted by the US Drug Enforcement Agency, Department of Justice, and State drug enforcement authorities. Healthcare providers are being driven out of practice by what often amounts to frivolous or malicious investigation and prosecution.

Doctor offices are being raided by armed SWAT teams that seize patient medical records and threaten practice employees with prosecution if they do not offer evidence of misbehavior by the principal healthcare providers. In some cases, civil assets have been seized. Frequently, drug enforcement authorities prominently announce their investigations, many months before any court proceeding, thus driving away patients and ruining providers financially even if the physician is eventually proved innocent of any wrongdoing. The resulting hostile climate has resulted in the desertion of hundreds of thousands of patients to agony, disability, and increasingly death by suicide among people overwhelmed by untreated or under-treated pain.

A related obstacle to patient access is the practice of national pharmacy chains, pharmacy benefit management companies, and/or health insurance companies of issuing “high prescriber lists.” As noted in AMA Board of Trustees Report 22 (June 2019), such lists “do not provide due process and are used to blacklist physicians from writing prescriptions for controlled substances and preventing patients from having the prescription filled at the pharmacy of their choice.

In three years since publication of the CDC guidelines, over 30 US states passed legislation restricting dose rates and/or duration of opioid analgesics in both acute and chronic pain treatment. Restrictions have become so severe and the damage to patients so widespread that CDC itself was forced to publish a “clarification” in April 2019. They asserted that the guidelines were never intended to be applied as mandates or to prompt the involuntary tapering of legacy patients who are otherwise stable and benefitting from opioid therapy; rather, that they were intended as precautionary guidance for general practitioners.

In the same month, US FDA published a safety alert, warning against rapid taper or unsupported discharge of patients being maintained on opioid pain relievers. Grounds for this alert were concerns that significant numbers of patients involuntarily or rapidly tapered off opioids are experiencing withdrawal symptoms, depression and medical collapse, with evidence of increasing numbers of suicides due to overwhelming pain.

There is ample published evidence that these “clarifying” steps are too little and too late. It is now well established that the basic rationale of the CDC guidelines was factually wrong. The guidelines falsely conflated an absence of long-term trials of opioids with a lack of effectiveness; strong recommendations were made on the basis of weak evidence or anti-opioid bias; effects of genetically mediated variable opioid metabolism between patients were outright ignored; there is a wide natural variation in minimum effective dose levels for useful analgesia, over a threshold range of perhaps 50 Morphine Milligram Equivalent Daily Dose (MMED) up to — in a few patients — over 1000 MMED.

Thanks to Dr. Lawhern not only for his hard work to benefit chronic pain patients, but also for allowing us to publish part of this comment.

Authored by: Geoff Sims

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Sandy M

I do thank Dr. Lawhern and Dr. Singer in their attempts to help us Intractable and Chronic Pain people who are hurting so bad. I hope and pray this ridiculous situation will end and we all can go back to having somewhat of a life, whereas now, we are worse off than we were and even then, we still weren’t totally pain free. We have been thru the hoops and loops of PT, Injections, everything, including the right combination of medications, which took some of us thru some dark times of trying many meds that didn’t work. I’m 71 years old, had a right thalamic hemorrhage 20 years ago that left me with Central Pain. My face down hurts worse after being cut back on my medications, I also had a deformed back with Scoliosis and had a fusion from my T3 down to my L5-S1 and into my hips…….along with many different procedures done and 9 hours on the operating table 5 years ago. My pain medication didn’t take either pain completely away, but I could walk and enjoy my children and grandchildren. I spend days in bed, it’s not even really living, it’s Hell! I have congestive heart problems, just had my gallbladder removed and my liver enzymes are such a mess! The gallbladder surgery was suppose to take about an hour or so and it took my Surgeon over 2 hours. He said it was so messed up, and Statins for cholesterol are another problem. I was taken off, then back on them and they cause my already pain, spasticity and tightness in my arms more harm than good. I fell and broke my left arm, which is my pain side anyway, except the burning pain that covers my entire body completely. The slightest touch, a blanket, clothing, so many different sensations just set off, and cause the pain in my face, and headaches everyday.. I know many are worse off than myself, I’ve rad some of you have had many back surgeries, I don’t know how you handle that, mine is awful pain, plus the Central Pain from the hemorrhage.

I don’t know that I will ever see situations change in my lifetime

Dee

Looking for the FDA docket from 2018 I came across another request for comments. FDA-2019-N-2514 Standards for future Opioid Analgesic Approvals for New Therapeutics to treat Pain and Addiction. Opened June 21 not long after HHS Taskforce Report to Congress closes November 18th. Meeting September 17th

David W Cole

Thank you Red!
The CDC and 10 addiction specialists mostly associated with PROP flat out lied. First they based the guidelines on what happened 8-10 years ago when oxycodone was the number one drug for overdoses and death. They used unreliable data and told half-truths. Now that 4 or 5 of the writers of the guidelines have backed away admitting these guidelines were written with bias it’s time for the FED’s to investigate the CDC. When it’s all said and done thousands of people will be dead, Millions traumatized and tortured. These people knew what they were doing and I think several people need to be in jail, including a few doctors who abandoned their patients all together. These people told half the story based on unreliable evidence and bias. That is a flat out lie in my books.
Thanks to our wonderful Advocates like Red, there lies and have half-truths have been exposed. The War on Drugs has been going on since Nixon declared it, over 40 years ago, every so many years it’s a different drug killing people. These government officials need to ask themselves why are infectious disease specialists teaming up with addiction specialist associated with PROP & Andrew Kolodny writing guidelines for pain patients in the first place. This is not their job.

Deb

Thank you, Dr. Richard “Red” Lawhern, for your hard work and continued support. It is comforting to know we have someone such as yourself and Dr. Singer fighting for us.

Unfortunately however, I do not see how one can use this information to help the situation right now. If I am missing something please, help me to see it. I, like most fellow pain patients have lost my dr. that was willing to see me as a legitimate pain patient and dealt with me compassionately, not as an addict or just a number, nor changing meds out of arrogance or ignorance.

I am under the firm belief that reducing medication dosages to stay under a certain number is wrong on so many levels and it is extremely harmful to patients! I know this because It is happening to me. I am in worse health now because of the reductions. I can no longer control the pain and do nothing more than chase it. It will only get worse this coming Wednesday as I have already been warned about another cut. Again for no reason other than to stay under a certain number! I am in severe anxiety do to the overload of pain and stress. To make matters worse, I have medication to relieve some of the anxiety but I cannot take it because this dr. who I will be seeing this Wednesday will fire me if it is found in my U.A. What am I to do?! I need a new dr. desperately. I don’t understand why we are not helping each other out in our respective states by sharing names of the doctors that are willing to continue with treatment that works and not go breaking something that wasn’t broken to begin with.

Ive taken the same dosage of medication with no problems for over 20 years. Sure it took a few months early on to get the dosage right but after that I was for the most part, stable. Certainly not out of pain, but reduced enough that I was able to work with it. I am thankful for the years Ive had, truly I am. But now, i’m afraid because I don’t know how to live life in more pain. My body cant handle it.

Glen

Rep Clay Higgins has a good idea. All Congressmen should be randomly drug screened. Let’s see how they like it.

Terry

There’s something that I haven’t heard anyone talking about. The claim by the government is that people have, let’s say a knee replacement and are prescribed pain meds and after three weeks the meds are discontinued. Their position is that patients get addicted to the pain meds and seek only to continue with opioids, which will not be prescribed, so they go out and buy illegal or illicit drugs on the street, that leads to heroin/fentanyl use and they become full blown drug addicts, thus the opioid epidemic. What they’ve excluded from their findings is what I call, “the chronic pain patient dilema”. Where’s the study that follows up with chronic pain patients that have been on opioids for years without incident, what percentage of them have gone on to use heroin, meth or fentanyl? And I’m talking about before the new CDC guidelines came out. The one study that I remember reading, done by an independent polling group, showed that out of ALL chronic pain patients taking opioids for their pain, only 1.2% had moved on to use the illegal and illicit drugs found on the street. I wonder how many chronic pain patients, whose meds have been discontinued, how many of them NOW use heroin or any illegal opioids? So in fact by force tapering chronic pain patients off of their life giving meds, the government has created an entirely new set of illegal drug users, so by forcing the CDC guidelines on pain management doctors and all of the suicides that follow the withdrawals and despair of chronic pain patients, they have actually made the so called opioid epidemic MUCH WORSE!!! Stop and really think about that! If you weren’t pissed off before, you most certainly should be now. Leave it to our government to react without considering all of the good people whose lives have been turned upside down, not to mention the folks who just can’t take the pain anymore and take their own lives, and every suicide affects countless families, now there are hardships for the survivors as well.

Glen

Ann, “It doesn’t matter what you know, it’s what you can prove”. We know what has happened to pain patients is true, we know that it is very wrong. I talked to a VA attorney with the General Counsel yesterday. I have been told by a local private attorney the same thing. By Federal and State law you need a Doctor to state that you have been harmed by your drugs being withheld. Some people have bought a Doctor that does this. Justice is not free.

Ann Sable

I’m with Judy and Jeff on this one. Enough is enough. There’s no need in talking about it any longer and, I for one, can’t and won’t do acupuncture nor any sort of “pot”. All of this is just ridiculous and am in escruciating pain as it is. Just a bunch of cranial [edit]-fed words to get hopes up or down and just more crap to ruin all of us with such problems as it is.

Eddy Haynes

Thank you doctor for this information. The state of Washington continues to allow pain management companies to drop patients for any thing they want. No doctor will touch a pain patient any longer. This situation has gone on long enough. Why am I, after 17 years of excellence pain management now off everything with no hope?

Dez Nelson

This is incredible: https://www.federalregister.gov/documents/2019/07/26/2019-15952/request-for-information-ensuring-patient-access-and-effective-drug-enforcement

AHRQ and the CDC have *already* built a system to track and influence physician decisions with their Clinical Decisions Support or CDS Connect system which is under pilot right now. Once pilot phase is over, it will likely roll out to every EHR system in the country. It’s part of health surveillance which means that private patient health data can be accessed by these FEDERAL agencies without the information being de-identified first. The information is also available to entities that federal public health agencies are collaborating with which means anyone from tribal governments to public school systems.

Because of changes to the common rule which was revised in 2018, health surveillance activities fall under activities deemed NOT to be research, even if private health data and or biological specimens are involved. So essentially, HHS has exempted themselves and all those with whom they collaborate from having to observe universal ethics guidelines as it relates to research of human subjects.

The above “request for comment” is simply federal public health agencies starting the process of codifying their unethical activities. They can then claim they put out a public request for comment and there wasn’t enough push back to deny the CDS system from proliferating nation wide. This system is built into the back-end of the EHR and forces physicians and other health care providers to stay within the prescribing guidelines that the CDC proffered up with the Guideline for Prescribing for Chronic Pain, a guideline that was built on lies and unscientific drivel and partially developed by special interest groups such as PROP. Conflicts of interest abound and yet here we are, still fighting the draconian, unscientific overreach of federal agencies that are allied with academia, industry and others.

Dez Nelson

It’s a bit concerning that many of these articles mention the suicides that are a direct result of forced tapering when it’s not indicated, but not those who are dying from intractable pain disease after forced taper. The latter issue is just as important and tragic. There are also acute pain patients who are experiencing serious complications post op due to lack of proper pain control.

I also don’t see an excerpt by Dr. Lawhern unless it wasn’t quoted for some reason. Not sure what is an excerpt from his report and what isn’t.

Holly

Thank you soooooo very much Dr. Lawhern. I think I can speak for most of us in the pain community by saying……YOU ROCK!!

The text of my entire comment to the Assistant Secretary of Health for Plans and Policy may be read here:

http://face-facts.org/lawhern/obstacles-to-patient-access-to-controlled-substances-and-needed-legislative-remedies/

Also very useful and deeply referenced are the remarks of Dr Jeffrey Singer, a Senior Fellow at CATO Institute. I am personally gratified that Dr Singer chose to reference my recent paper at STAT News, in his own published work:

https://www.cato.org/publications/public-comments/response-request-information-directed-section-3-ensuring-patient-access

Regards and well wishes all,
Red

Bart

Is this another open comment period for patients ?

Rebecca

I would like to see the entire report too please. Red knows what he is talking about that’s for sure.

Cynthia

Where can we find Dr. Lawhern’s whole 4500 word statement please? Thank you

Cynthia

Dr. Lawhern is indeed a saint in our pain community. I appreciate him so much!

Jeff

I’m so sick of all the talk!!! Is there anything we can do to help with this crime yes crime against the millions of people suffering because statistics show that tens of thousands of people are dying of opioid overdoses. That fact is a shame but how many of those deaths were from people that were taking their meds appropriately???

Judy Dunn

Thank you Dr. Lawhern for your help.
The Government, some Doctors and the Media have treated us like Addicts
While the Real Addicts have been treated like Victims, given medicine to bring
Them back when they repeatedly overdose. We are Dependent on our pain meds, just like Diabetics, Heat patients and other Chronic Disease Patients.

Our Doctors have abandoned us,
Accusing us of selling, or giving our meds away. We are Chronic Pain Patients,
We need every single pain pill we are given, most of us have several diseases.
Yet they treat us like clothing, where One Size Fits All.

Some States are now pushing Medical Marijuana and Acupuncture, but
Like all medicine they only work for some people, Not All.

I personally, was doing fine on my medication until it was reduced, now
I have High Blood Pressure and problems with my Heart to add to my other
muscle, bone, lung and nerve diseases.

Chris Ward

He sounds like a good doctor!

Cindy

In reply to Christopher Jennings’ post that we need MMJ.

Yes, I agree. But we still need opioids. We need anything and everything that may help us.

Each person is unique and responds uniquely to any drug or treatment.

So, the arsenal of treatments needs to be as large as possible.

example – While so many people respond well to acupuncture, I did only for awhile before I developed an extremely rare sensitivity to it which resulted in pain and bruises with every needle. Even for those people not helped by acupuncture, 99.9% of them do not develop the problems I did.

And until MMJ becomes legal at the federal level and covered by insurance, it’s out of reach financially for many people who might benefit from it.

Cindy

THANK YOU DR LAWHERN

Gail Honadle

It’s time to STOP using their language as it is designed to fool the Public as Propaganda as the two sound alike.

We are INTRACTABLE PAIN PATENTS, A MEDICAL DISEASE, IP FOR SHORT, It is a Subset to Chronic Pain. The Medications is a Prescription Pain Med, are not all those NSAIDS they are pushing called PAIN MEDS? Illicit drugs are Opioids. In my nearly 71 yrs Opioids have always been Illicit Drugs. Illicit as in Illegal.

Try changing the language YOU use to the Correct one that is not identical to the Government’s Propaganda.

Gail Honadle

That Safety Act goes through you will lose more than your 4th A rights, you will lose 1, 2, 4, 5, 10th Just about basically all Your Constitutional Rights as your Medical Records will be open to Anyone who wants to look at them.

They can go to Hades I am a hardcore Constitutionalist as our Founders wrote it, not a Dem or GOP.

David Kendrick

Is his a pain discussion or just another Trump bashing site? Save you political views on Twitter!

Jody Hoffman

It doesn’t matter how many studies or surveys are done or how many news releases the CDC & FDA put out saying that the guidelines were misapplied. The CDC must put out new guidelines on how to get chronic pain patients back on track with the right dosages of medication to manage their pain. They can say that they misapplied the guidelines all they want to but I have read the guidelines & it is very clear that they are not intended for people who are already on opiates for chronic pain. Until they actually tell the medical profession that this is what you Will do it won’t happen. Why isn’t the National pain foundation & the CDC sitting down at a table together & fixing this problem. If i thought that I would be able to call the CDC & be connected to the person in charge that can change the mess they helped create I would because that is how to get this fixed, stop the [edit] & fix it.

American

Why don’t they start by looking at the years of Dr’s records on pain patients, what’s the point in keeping the information not to use it. My records would show I was stable on medication for 13+ years only to not be at all after being force tapered March 2018 and I’m sure most everyone else’s record looks about the same if and when they were. All I did was ask for help and utilize the help I received the best that I could. The forced tapper caused me to have to go off all my medication because they dropped me from over 500mme a day to 30 of what was my breakthrough pain medication all these years needless to say it no longer had any effect on what it was prescribed for so I went cold turkey on my own and refused to pick up any script thereafter and the doctor refused to change the medication that I told him it was no longer working alone only to offer me this medication after I stated this. I still have to wonder if the doctor was seeing if I would just take it to be taking it and I called him out for playing games with people’s lives and told him somebody had to be in charge because there was a bunch of morons running things and costing lives so I stepped in and took charge. Medical malpractice is the third leading cause of death in the United States. Suicide is the 10th leading cause of death in the United States and second leading cause in individuals between the age of 10 and 34 fourth leading cause between 35 and 54 yet we live under this false belief in the Hippocratic Oath Do no harm.

Thank you Jeff. Once again…BRAVO RED LAWHERN! Your research and wordage is beyond perfect and I thank you from the bottom of my heart for fervently fighting for our community. Keep strong in your endeavors. We appreciate you! You will be blessed. Many hugs, Maureen M.

The one place the government needs to stay 1,000,000,000 % out of is Patient Doctor relationships… Yes i know there have been many Dr’s exceeded the pain meds on certain sicknesses and injuries. The” Dr’s should of set up standards and an internal policing agency”.
I have very sever back injuries, sever feet injuries where the bones are literally melting away and the cartilage is gone. The pain is unbearable….and all these issues are not treatable, except by Hydrocodone and was prescribed 6 30 mg. tablets a day for years, and i was in no pain at all could take the dogs for a walk, and shop with the wife….and go on trips.
Then came Jan. 01, 2015….I was lowered down to 4 15 mg tablets of hydrocodone.
Now i am in constant pain, wake up every night crying because i am in so much pain.
Many of my Dr’s wanted me to switch partially to Marijuana for pain relief.
Great;… except for 2 tiny maters. It is that Marijuana is federally illegal and it is against Federal gun laws to be in possession or have marijuana in your blood……you loose the right to bear arms and all your firearms can be confiscated. And a tiny other mater, My wife works for a Police Dept, as a supervisor. If an impromptu blood or urine test shows any marijuana residue in her system she is immediately FIRED.
And in doing tons of research concerning these so called figures that are tossed about…..99% are bogus and used as a psychological trick. And if one does the math I found its only 1.2 people have died every 4 days since 1998 to 2012…. and most where doing heroin and mixed with alcohol and or cocaine..

Laurie

Yeah. “Those lies, damned lies and statistics” – Samuel Clemens. the DEA needed a new, easy drug war since pot was being phased in and accepted as not something which could drive people insane; was actually pretty good medically for some. I saw trhis propaganda being hyped since about ’14. I told my primary care doc what I thought and I could see the light go on over her head; no dummy, she!
Another Trumpian created crisis which was and is the tip of the iceberg. I guess if you’re a hammer, everything looks like a nail

The DEA makes a lot of $$$ of the drug wars.So do the urine testing labs and the “alternative” medication they are developing that seem like a horror to put in MY beautiful body…worn out as it is.

We have utterly lost our right to privacy of the 4th amendment, as we’ve lost so many others after 911.
I wonder how much longer this will go on? With the JD and the DEA with the bit in their teeth, It seems that Trump himself would have to call them off and he LIKES cruelty and torture.
He doesn’t seem to prefer the truth on any matter.

Me. I got the full DEA/JD treatment. But you know what? I tired of whining about my pain, at least I got rid of the worst doctor I’ve ever had for my condition. I may file a compliant

And I HAVE found a new neurologist who, by everything I’ve heard is a good one…can
t see him until October and my Botox is due like next week.
I may make some noise.

OH yeah, yesterday a pothead accused me of being an addict. That was pretty funny. Pot/Kettle?

Thomas Wayne Kidd

Thank you so very much Dr. Lawhern. I appreciate your work on our behalf. God bless you.

Hello my fellow American’s we really need medical cannabis for pain relief in America.
Sincerely yours truly believe that Mr. Christopher D. Jennings

Federal agencies can start by systematically surveying “responsible pain patients” as the CDC called us in their April press releases, to see how we rarely overdose or become addicted, even after decades of safe use. Sometimes the solutions are right before our eyes. Every good American organization ASKS THE CUSTOMER about the quality of product of service being offered, the federal government should be no exception. Asking us is not a panacea, but it should have been among the first steps the CDC and VA made to understand all the variables in the multiverse that is the opioid “epidemic”. Illegal drug abuse and addiction are separate, by and large, from responsible prescription opioid use for pain. Harming responsible pain patients as a panacea is immoral and very bad science.

Gail Honadle

Start calling Judicial Watch for FOIA as they are the most successful org for success in getting FOIA informantion. Judicial Watch 1-888-JW-Ethic (1-888-593-8442)
Fax: 202-646-5199
Email: info@judicialwatch.org

Randy

This is a great story, just a say late and a dollar short. The pain patient, the doctors, family, friends and loved onea have and continue to suffer. At th hands or politicians who will never say they made a mistake. They have put the genie back in the bottle. Took them several years to do this. It will take more time to get it changed back or to a tolerable level. The report described should be sent to every congressman, Senator. State and federal politicians with access to the ability to effect change!!

Terri James

Thank you so very much Dr. Lawhern. Perhaps one day they will listen. Perhaps one day they will realize they are wrong. Perhaps one day our physicians can practice medicine the way they used to.. I wish they all could have read the stories and the comments I’ve read here. No one should have to live their lives the way we have been forced to….