Patient lawsuit against IDSA and insurers moves forward in Texas

www.lymedisease.org/idsa-lawsuit-pfeiffer/

A federal lawsuit that may just validate the pain of thousands of Lyme disease patients – and the flaws in prevailing tests and treatments — is moving ahead in a Texas courthouse, despite attempts to kill it.

The lawsuit’s progress is a big development in the decades-old struggle of patients whose post-treatment conditions – involving myriad neurological, cognitive, musculoskeletal, and cardiac symptoms — have long been misdiagnosed and minimized. Patients have hence had to seek out-of-pocket treatment from physicians who risk their licenses providing it.

The suit, Torrey v. Infectious Diseases Society of America et al, aims to change that, and, make no mistake, is a serious challenge to the Lyme status quo (see my article from 2017).

In the crosshairs of the case are six major architects and proponents of the guidelines that have dogmatically ruled Lyme disease care for two decades: Raymond J. Dattwyler, John J. Halperin, Eugene Shapiro, Leonard Sigal, Allen Steere, and Gary P. Wormser. (A seventh, Robert Nadelman, died in 2018.)

Beyond that A-list of Lyme actors, the lawsuit also accuses eight insurers of conspiring with the IDSA and the Lyme architects to advance treatment protocols that limited care options to the 25 named plaintiffs, two deceased, for whom the protocols did not work.

The companies are Blue Cross And Blue Shield Association, Anthem, Inc., Blue Cross And Blue Shield Of Texas, Aetna Inc., Cigna Corporation, Kaiser Permanente, Inc., United Healthcare Services, Inc., and Unitedhealth Group Incorporated.

Here’s what will happen shortly

A hearing on a second motion to dismiss the case will be held on March 11, at 2 p.m., at the U.S. Federal Courthouse, 500 North State Line Avenue, Texarkana, Texas. [Note: this story was edited on 2/19 to reflect the hearing’s recent date change.]

The suit, whose lead plaintiff is Texas resident Lisa Torrey, already survived one motion to dismiss. (See below.)

I’d encourage people who are invested in the outcome of the case to attend. Lyme patients have been portrayed, wrongly, as deluded, unpleasant and aggressive for a long time. Show them who you really are: Informed, concerned, intensely interested, and respectful of the court’s crucial role. Now’s the time.

Here’s what’s happened so far

The judge in part granted and in part denied a previous motion to dismiss the case.

In favor of the IDSA-insurers side, the judge agreed that the lawsuit did not sufficiently describe the alleged fraud that it maintains was committed by the defendants under the Racketeer Influenced and Corrupt Organizations Act (RICO).

The court, however, ruled the patients’ side could redraft the complaint under RICO. A request for an extension to do that will be among the issues considered at the March 12 hearing.

But the motion to dismiss was largely decided in favor of patients, including on the crucial assertion that the defendants violated anti-trust statutes under the Sherman Act.

As the judge put it, summarizing the case, “Defendants [as alleged] engaged in a conspiracy to unreasonably restrain trade in the relevant market—the Lyme disease treatment market—by paying large consulting fees to the IDSA Panelists to pass the IDSA guidelines which deny the existence of chronic Lyme disease and establish the standard that all Lyme disease is cured with short-term antibiotics.”

Insurers then were able to deny claims, and doctors who treated outside the guidelines were marginalized in what became a monopolistic marketplace, the suit maintains.

In upholding the suit’s anti-trust assertion, the judge wrote: “Plaintiffs have sufficiently alleged that, in the absence of the IDSA, there would be competition among doctors for the treatment of chronic Lyme disease and competition among insurance carriers for coverage for such treatments. Similarly, Plaintiffs have alleged that Defendants’ adoption of the IDSA guidelines and standard of care for the testing, diagnosis and treatment of Lyme disease has harmed patients and doctors nationwide. … The Court finds a nationwide geographic market has been properly alleged.”

All of this, of course, must be proven at trial.

There’s more

Beyond this, the judge granted the plaintiffs’ request for discovery, but so far it has been limited only to documents from four years before the lawsuit’s filing. The judge wrote, in reference to whether the court has jurisdiction to order discovery: “The Court finds that Plaintiffs have pointed to enough evidence preliminarily establishing personal jurisdiction over the IDSA Panelists to warrant jurisdictional discovery. Specifically, Plaintiffs point to the declarations provided by each of the IDSA Panelists in which each doctor attests to having visited Texas for professional purposes during the relevant time periods. …Moreover, Plaintiffs have established that the IDSA Panelists’ research and professional activities focus primarily on Lyme disease.” In a filing Friday, the Torrey lawyers called the four-year timeframe “arbitrary.”

Here’s what is pending

Among the issues that the hearing will consider is whether, essentially, to put chronic Lyme disease on trial. A motion by Anthem, Inc., the IDSA, and what is termed the “Doctor Defendants” asks the court to have all plaintiffs submit to independent medical examinations, or IMEs, by a Texarkana-based infectious diseases physician.

Their motion, which has been challenged by the plaintiffs’ attorneys, states: “The Lyme Claimants allege that they have suffered debilitating injuries because they have been denied appropriate medical treatments for so-called ‘chronic Lyme disease,’ allegedly due to an unlawful conspiracy among the Defendants to monopolize the treatment of Lyme disease. … Nearly all of the Lyme Claimants allege that they still suffer from the disease today and many claim that they are currently disabled or otherwise unable to work due to their illness. … (W)hether they currently or have ever suffered from Lyme disease, the severity of their symptoms, and whether those symptoms are attributable to Lyme disease or some other cause, are at the heart of this case and were put into controversy by the Lyme Claimants themselves. Well-prepared, peer-reviewed studies have established that as many as 88% of patients who have been told they have ‘chronic Lyme disease’ either do not have – or, in many cases, never have had – Lyme disease in any form.”

To support their assertion, the IDSA defendants cite an article on chronic Lyme disease by Duke University physician of pediatric medicine, Paul Lantos, which cites much of the Doctor Defendants’ research.

And finally…

The hearing will also take up another request related to whether the patients are truly ill and with what.

The IDSA is seeking emails written by them – including any in which the words Lyme appear coupled with antibiotic, literate, chronic, claim*, cover* and den* (presumably meant to refer to claimed/claimant, coverage, denied or denial). Emails with the initials IDSA are also sought.

In its motion, the IDSA asserts: “Defendants’ email requests seek information relevant to the claims and defenses in this action. In the Complaint, Plaintiffs assert that they ‘suffer debilitating injuries’ and that such injuries impact them on a daily basis, including cognitive deficits, fatigue, and memory loss, resulting in a multitude of alleged harms, including the loss of careers, homes, and the ability to function. … Plaintiffs’ communications about their condition go to the heart of corroborating or refuting their allegations about their conditions and the harms that they allege they have suffered.”

The calendar for the lawsuit lists June 24, 2019 as the start of a jury trial in Torrey v. IDSA et al. Stay tuned.

Mary Beth Pfeiffer, an investigative journalist, is author of the acclaimed book, “Lyme: The First Epidemic of Climate Change.“

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https://www.actionnewsjax.com/news/investigates/family-of-local-veteran-who-died-plans-to-sue-jacksonville-nursing-home/925183454

JACKSONVILLE, Fla. – The family of a local veteran plans to sue a Jacksonville nursing home, after a Florida Department of Children and Families investigation found evidence his death was related to inadequate supervision and neglect.

Tom Edwards, the attorney for York Spratling’s family, described the 86-year-old as an honorable man who died in an undignified way after a stay at Consulate Health Care in Jacksonville.

“They were not providing the care that they were being paid thousands of dollars a month to provide,” Edwards said.

Action News Jax obtained the DCF investigation into Spratling’s death.

The report says he developed an infection in his groin, which staff first documented on Feb. 16, 2017, but it wasn’t mentioned again until Feb. 21 – despite on nurse’s account that “you could smell it from the door.”

According to the report, doctors diagnosed Spratling with gangrene and amputated his genitals. He died a short time later.

“Why this nursing home let this go on and didn’t react sooner is absolutely beyond reason,” Edwards said.

Investigators found evidence to support a finding that Spratling’s death was related to inadequate supervision and medical neglect.

Action News Jax discovered previous problems reported at Consulate Health Care Jacksonville.

In 2015, health inspectors found staff wasn’t conducting required assessments of residents.

In 2016, reports show deficiencies in the number of required nursing staff.

“This is truly our hope and our prayer that this is going to change the way this nursing home is handling their patients,” Edwards said.

Edwards said the family does plan to sue.

We reached out to Consulate Health Care for comment and are waiting to hear back.

Last year, the Agency for Health Care Administration threatened to shut down 55 of the company’s Florida facilities; Consulate Health Care worked out an agreement with the state to keep them open.

Consulate Health Care is the largest nursing home provider in Florida.

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www.worldweeklynews.com/2019/02/24/effectively-organized-up-or-quilt-up-horsham-drugmaker-performs-one-man-military-in-opposition-to-fda-in-opioid-crisis-philly-com/

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WEB EXTRA: Dr. Maurice Gregory talks about opioid

https://www.lasvegasnow.com/news/local-news/web-extra-dr-maurice-gregory-talks-about-opioid/1809337569

LAS VEGAS – Las Vegas physician Doctor Maurice Gregory talks with I-Team reporter George Knapp about his concerns regarding the anti-opioid movement and how it’s impacted the quality of life for patients who need long-term pain management.

Dr. Gregory was featured in the I-Team story last week about Nevada doctors testifying before the legislature on how the opioid crackdown has adversly impacted patients. Although opioid prescriptions are down, overdose deaths continue to rise.

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Another death due to an MD tapering/removing patient from opiate med. Her husband posted this on her Facebook page. I am FB friends with Carla but he didn’t make in the post shareable. Here’s the post: “My name is Larry Larry E. HowardLarry E. Howard Howard and it is with a heavy heart I lost my wife of 28 yrs of a heart attack. I believe to the pain she was suffering and had been for 30yrs. She was the Love of my life and always will be. Her pain patient family meant the world to her. IT’S just her heart could not take it anymore. She was the best part of me and I am lost without her. But I know she would say get a pair and keep fighting. Thank you all for helping her through all the very hard times she had until end. I thank you to for the Love we recei

https://www.pharmaciststeve.com/?p=20995

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Jennifer Burns Hill a story of tragedy and a deep love story … And How I found myself again. I am the youngest of 6 the only girl. Born on April fools day. I seemed to have to beat the odds while in my mother’s womb. My mother unknowingly had hepatitis B. In her 7 Th month she had emergency appendectomy. 54 years ago this was serious risk to both Myself and my mother. The surgery went well however, I was born a few days later prematurely. Turned out Drs realized after the surgery my mother and father had hepatitis B. Unable to care for me I was raised between marternal grandparents and a catholic nunery. A sickly little girl my entire life. Ear infections step throat. Born with deformed feet. My first surgery at 12 years old. I had to wait for bones to fuse before reconstructing my feet. Pins installed broke my bones and resets , bunionectomy. 3 surgeries every Christmas vacation I was Always in a cast. I was definitely a tomboy And was an amazing skateboarder but tore 10 ligaments and my aqillies tendon 3 time while skateboarding. Again in a cast for many months. At 17 I was doing stunts and I jumped into an airbag and jumped to soon and hit the ground 40 feet high ! Herniating my lower lumbar. 2 weeks in traction and my first experience of epidural blocks for a year. Already my young life fraught with pain At 20 I started feeling a tiny lump in my shoulder… a pea size but could hold it and move it around. Was accompanied with severe pain! This started my constant trips to emergency hospitals. As a celebrity hairdresser I was unable to cut hair. A terrible loss to my identity. Over a years period of time it became a size of large tomato. Whilst in emergency once again the Dr injected steroids into “ lump” …. Within 3 weeks the “ lump” tripled in size! Piercing through the encapsulated tumor and spreading was immediate. Though I had begged for a biopsy this particular hospital said it would “ be to rare to be cancer in that area !” But tho and behold it was! During that year I also had a class 4 Pap smear and had 3 laser surgeries. I step below stage one cancer. 2 separate cancers! I also suffered constant kidney infections. Requiring 2 week hospital stays with I V antibiotics. Finally I was sent to the only cancer hospital this organization had They finally did a biopsy… And my life changed instantly! A rare muscle cancer. Rhabdomia sarcoma ! Usually only affecting children and usually boys. They removed huge tumor that was separating my collar bone and shoulder. They felt they got it all and no chemotherapy or radiation. 6 months later it came back with a vengeance, 5 tumors this time! I went from its probably a calcium deposit to “ having a major amputation at Shoulder would most likely be chance of survival ! – [ ] I refused! I a ceppted massive whole upper body radiation 5 days a week for 3 months. Almost 25 now … after radiation I became so sick I’d crawl to the bathroom! Foods suddenly made me very ill. I was told I had “ radiation sickness, and in several months I’d be back to normal. My right arm and hand turned purple and cold , yet felt like I had acid thrown on it ! Like a thousand bees stinging me. My arm would have horrible contractions! I had never felt such pain ever! I went to the emergency hospital constantly. Again, I was told it was post surgical pain and I’d return to normal soon … Being flagged even more now as “ a drug seeker!” A horrible stigma attached to chronic pain patients! All I wanted was my health and life back. I never returned to my prior self! Unbelievable burning pain and massive contractions. Chronic fatigue syndrome… I sought our alternative drs. Went on Candida diet that I’ve been on ever since. I had to relearn how to use my right arm twice. To lift it , write , tie my shoes, basically everything. Somehow I was able to return to cutting hair, though very painful and battling chronic fatigue, I excelled in my career once again. However the pain and contractions again became to much to bear! I kept going to emergency begging now “ to cut my arm off !” By now I was labeled “ a drug seeker!” Though every time I did go to hospital, they’d give me a Demerol shot … no home prescriptions. I had crps but drs knew and did not tell me for 10 years! They had small notation I had “ hands and wrist syndrome “ one of many names for RSD/ crps ! By time I was diagnosed it spread to entire right side of body. I found this note while hand delivering records to another department of hospital. I quickly browsed through. During my second cancer surgery they had given me a bone scan without doing a pregnancy test. Turns out I was 16 weeks pregnant. I was referred to an abortion clinic in late term abortions. I struggled. My cancer was back and drs told me my child would be mentally retarded , blind possibly deaf and cleft pallet. It took a month for me to choose my life over my child’s.

took a month for me to choose my life over my child’s. Something that haunts me today. I’m childless. Once again I had become to disabled to cut hair. I was now permanently disabled. I had a full hysterectomy 2 weeks after my marriage. I digress.. let’s move back to next Unthinkable thing. Now 36 I did get pregnant and had spontaneous miscarriage. No treatment afterwards. I had produced Breast milk and a simple pill to dry up milk would have prevented the months of a picc line and IV antibiotics I ended up enduring. Lactoria mastitis. Infection from the dried breast milk. Now antibiotic resistant no antibiotics would stop infection. Hospitized I had a picc line put in trying to save my breast. Gangrene set in and I lost third of my breast. A double mastectomy had to be done. With Doris flap ( taking back muscle) I met my husband at a get well soon Party 2 weeks before surgery. He didn’t realize “ I was the girl the surgery was for “. I didn’t look like a such a sick woman… crps is called “ the invisible illness “ A 36 double D really an E cup naturally. He couldn’t keep his eyes off my breast. I was already walking with a cane as I was diagnosed with crps 10 years after my 1 st cancer surgery. My cane under the table, he asked if we could “ go out in date and have some fun.” I was attracted to him but turned off as I was struggling with my impending mutalating surgery. I lifted my cane and said “ I’m the woman this party is for!’ He felt terrible and asked to make it up to me. I refused but at his insistence I told him hospital and date. Never thinking I’d ever see him again! On the day of surgery 10 hours.. Scott was waiting in post op room with 2 dozen yellow roses. He just took it Iown to come every day! Drs nurses all knew him. But I didn’t…! One day dr began to change dressings. Scott just walking in. Dr says “hey Scott , wanna see my work ?” I hadn’t even seen what lie under my bandages! I mouthed to Scott to stay as he began backing out of room. I never looked down! I stared intensely at Scott face ! Would he cringe? Be disgusted? He mouthed “ your beautiful!” I mouthed back “ your going to be my husband!” He mouthed back “ I already know!” That was it … we were engaged! 3 months in hospital and having once again to relearn to use my arm. Scott came every day! Bringing flowers and food from my favorite restaurant! We finally kissed! While he was showering me and washing my hair! He did this a few times… here I was naked. Tubes coming out of 3 areas of my chest and back! He tenderly took care of me ! I fell hopelessly in love! Who would have thought id fall in love in the hospital?! He went through a devastating divorce. And had just opened his 3 rd men’s clothing store. But was sleeping on friends couches. – [ ] It was perfect… I needed nighttime care taker. He needed a solid place to live. – [ ] He immediately moved in with me when I was released from hospital. He changed my picc lines hooked me up to iv antibiotics, and gave me my morphine push medication. Gave me my tpn feedings. I went down to 89 pounds! In electric wheelchair a virtual shut in. – [ ] I gave him my car to get to work. We were a team! – [ ] 10 months later we were married. NBC filmed our wedding. On show “life moments “. The next year I spent 90% of time in hospital! My hysterectomy botched … second hysterectomy performed. Removing last Fallopian tube. And vaginectomy. Now with no breast and my female bits and pieces gone , I struggled “was I even a woman anymore?!” . Reassured by Scott I was beautiful helped. But my identity stolen. Who was I now? After a year in hospital I had to learn to eat again, walk , use arm yet again , Scott would take me to sushi joint and I’d eat sashimi it was easy yo digest and I could keep it down! After a few months dr removed my gj feeding tube! I had successfully learned to eat again ! Something Drs said is never do and I’d need a bag removing my stomach! I tried to find myself again. Now Scott Hills wife and not “ Jennifer Burns “ ex celebrity hairdresser “ A happy moment was when I carried the Olympic torch. The second happiest event in my life. As community hero. Learning to walk with forearm crutches. Learning how to accept “ the new me “ was very painful. Must admit this took years. I also had severe head trauma from car accident. Small stroke one of 3 .. Bell’s palsy a cadaver bone transplant. 1997. Almost lost lost left oeye. Mouth droops still today … Yes all these things happened ! And I’ve had a dozen second lives ‘ July 3 rd I kissed my husband goodnight… had been in level 10 pain for a week… sleep deprivation. I remember hurting… next thing I wake up in ICU on life support! My husband found me barely breathing. By the time paramedics got here I aspirated and stopped breathing! Minutes from death. My blood pressure dropped My blood sugar 11 ! And Had grand mal seizure

Yes all these things happened ! And I’ve had a dozen second lives ‘ July 3 rd I kissed my husband goodnight… had been in level 10 pain for a week… sleep deprivation. I remember hurting… next thing I wake up in ICU on life support! My husband found me barely breathing. By the time paramedics got here I aspirated and stopped breathing! Minutes from death. My blood pressure dropped My blood sugar 11 ! And Had grand mal seizures. It was then I decided to finally “ come out of the closet “ and start talking about crps! I would talk about my cancer… but since no one ever knew what Crps/ RSD was…. I shoved it deep into silence. I finally found “ my purpose !” Starting MY Crps/ chronic pain support group “ Crps a life’s journey “ It’s finally taking off. I’ve found my happiness, helping my pain community ‘! I’m writing letters to government officials and news media To tell “ our side of the opiate crisis “. I try and honor our fallen warriors who committed suicide. To make their deaths from senseless to advocacy and meaning. As Founder of “ Crps a life’s journey “ I’m a New advocate … Personally helping my members . sometimes talking hours to a suffering pain patient, when no one else will lend an ear or shoulder to cry on. All whist going though ketamine Monthly needle therapy. Sleep deprivation. Constant pain… If not me , who ? I’m learning and growing and excited to where my journey leads me. Available for interviews and speaking engagements

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Dying Cancer patient denied Opioids by Kaiser

This shocking and compelling story needs to be shared with the Public and Governing Agencies (Medicare, CDC, NIH, DEA) via the Press and Social Media. We are old, sick, exhausted and need help because we don’t know how to do it and are just struggling to survive. What an unimaginable choice, Chemotherapy or Opioids, because Kaiser Permanente will not give you both.

1/17/2019, I watched my partner of 50 years as she was forced to sign her own death warrant. She was forced to give up the Keytruda (a gene targeted Chemotherapy that was shrinking her tumors or at least stopping the growth) that was helping her, and sign up for Medicare’s Hospice program, because they were the only one’s willing to give her pain medicine. Most assuredly this will hasten her demise, but she just could not stand the pain any longer.

She has been fighting so hard for the last two years. She has metastasized Lung Cancer and has had a Lobe of her Lung removed. Between the Lung Cancer, Congestive Heart Failure (18 Heart Attacks last year) and COPD (on oxygen now) she is struggling to survive. In the last two years, half a dozen doctors have told her she would be dead within six months. She keeps fighting with a joyously fierce attitude. She wakes up happy every day, thankful to be alive for another day, no matter what it brings.

She explained that she had been taking Cannabidiol capsules (Medicinal Marijuana – CBD), the Montel Williams brand, and that she received the herbal medicine through the prescription of a non-Kaiser doctor in compliance with California laws. The very same Cannabidiol capsules that a Harvard University Study recently said can stop the growth of her type of Lung Cancer tumors in two weeks. Kaiser’s reply to this was that she was “a drug addict buying street drugs” and wrote on her file in capital letters that she was not to receive pain medicine ever again. All this because she tested positive for Marijuana a second time.

We both have pleaded and appealed for years to have our methadone back, to no avail. She originally had her Opioids denied because her drug test came back positive for marijuana. Before that she was a traditional 76-year-old little arthritic woman with one leg, cancer, a bad heart and multiple other problems that was being cared for with pain management, without any problems or misuse. They called her, and many others, Drug addicts and told us to stop whining and go to Rehab. Her primary Care Doctor trembled, and her voice shook as she said, “NO, they will take my medical license and put me in Jail.” She seems to be truly terrified. The Heart Doctor also said “No.” We think either the Heart Doctor or one of the ER doctors sent a referral for her to Hospice. But the Heart Doctor also told her “no pain medicine, consult the Pain Clinic.” The Cancer Doctor told the Hospice people to go away, because she can no longer receive the life prolonging chemotherapy drug (Keytruda), if on Hospice. He also referred her back to the Pain Clinic. Essentially all her doctors refused to give her back the pain medicine that she had been on for years as a documented chronic pain patient. The Kaiser doctors all refer everybody now to the Pain Clinic, who always says NO to anything. The only one’s that offered to treat her pain with Opioids was Hospice. Her unbelievably difficult choice was to suffer pain and continue with the Keytruda, the targeted Lung Cancer drug that was shrinking cancer tumors, or just give up and sign the DNR (Do Not Resuscitate) and go on Hospice where she can get pain relief. The Hospice people are kind, sympathetic, considerate and they will lessen your pain, but you will probably die sooner without the life-saving chemotherapy. She just could no longer stand the unrelenting pain and was forced to make this excruciatingly difficult decision knowing that it would shorten her life.

One of the worst things about the Kaiser Permanente Pain Clinic is their smug arrogance. They call patients “drug addicts” to your face and tell you to “stop whining, nobody ever died from Methadone withdrawal.” When you say you want to appeal, they laugh at you. They stonewall you and make you run a gauntlet to delay time. They make you go to Psychiatrists, Physical Therapy, endless meetings and take massive amounts of Gabapentin/Neurontin (an anti-seizure medication) for months which does not help pain and has bad side effects and finally send you to the Dependence and Rehabilitation facility. The Pain Clinic states with a straight face that, “pain medicine doesn’t help pain patients.” It helped us and improved our quality of life. I have repeatedly asked for a copy of Kaiser’s Guidelines or State and Federal Statutes, Codes and Regulations they were following, so I could understand what I was fighting against. It is just basic Discovery. They have repeatedly refused to give out this information even though I provided them with California Codes, Health & Safety Statute 124960 d (A patient suffering from severe chronic pain should have access to proper treatment for his or her pain) and the Business & Professions Statute 2241.5a and b (No physician shall be subject to disciplinary action for prescribing, dispensing, or administering dangerous drugs or prescription controlled substances in accordance with this section). I submitted Statutes about the Patient’s Bill of Rights. Kaiser Pain Doctors do not even take appeals seriously. They don’t sign or even print their names. They lie, evade and do not even answers all the questions when asked in a formal Appeal. Also, they absolutely refuse to tell you their policy on Marijuana. They don’t take you seriously and don’t even say “sorry, it’s Federal.” They just ignore you or laugh at you and give you off-hand vague comments. They are insensitive bullies. Most doctor’s at least show some sympathy or compassion while saying “No.”

If she is healthy enough to be transported, she wants to rally and fight this miscarriage of justice and lack of common-sense morality. She knows she will probably die before this fight is over, but she wants to help all the other people affected by this mess. She wants to help me and my crumbling spine, even though I passed the second THC drug test, and yet, they still took my pain meds away nine or ten months ago for no reason. This reaction to the Opioid Hysteria is hurting the wrong people. Who is counting how many chronic pain patients and Senior Citizens have been broken and given up under this harsh treatment and committed suicide? This over reaction is forcing people to suffer.

It is so difficult fighting the uninformed prejudice against Cannabidiols. With all her expensive ER visits, CT and MRI scans and the $13,000, every three weeks for her Chemotherapy, one can only wonder if Kaiser is just trying to save money? Is Kaiser literally just passing the buck? Is this as bad as when Kaiser dumped a sick elderly woman in her hospital gown by taxi on the streets of LA in front of a homeless shelter?

This is a hellish nightmare to be putting chronic pain patients, senior citizens and even terminal cancer patients through. I can find no possible justification for this cruel inhumane treatment. If you know anyone who can help resolve this issue, please help put us in contact. If we all stand up together maybe, we can help each other. So many unfortunate people have been caught up in this web of misery and opioid prohibition, just because someone has the opinion that we should no longer have access to these life-sustaining pain medications. The Pain Clinic is fond of saying, “opioids are not appropriate or indicated for long term chronic pain.” We are also weighing the feasibility, effectiveness and Optics of picketing on Kaiser property and having them arrest and place some old ladies, rickety pain patients in patrol cars. Will it further our cause or just kill us off. I am so tired of living needlessly in pain every day. I am tired of my sprit withering away while my body atrophies. We are not suicidal, exactly the opposite, but I anticipate this rate rising due even more to this treatment of our elders.

This is the second time I have been sent information regarding intractable chronic pain pts having Kaiser in California and would seem to be pt abuse. The other one was a 50 something person with intractable chronic pain that was getting sufficient pain management meds to not only hold down a full time specialty mechanic job but was able to routinely work OVERTIME… resulting in him making $200,000/yr and never missing a day of work.  He was transferred from his normal Kaiser prescriber to a PAIN SPECIALIST…. who immediately informed him that his opiates were going to be reduced … if not eliminated and he told me that this pain specialist told him that he might as well apply for disability and that she was going to attempt to have his driver’s license revoked because she did not want him driving while taking opiates and potentially harming himself or others in driving while taking opiates.

Perhaps she had a chronic case of Medically Deity Complex ?

I have contacted three TV stations in the area that these people live and forwarded this letter to them and pick up on their story and give Kaiser a severe acute case of BAD PR and hopefully will draw a lot of other Kaiser’s pts to come out and SPEAK UP.

 

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The Drug Prohibition Is to Blame for Opioid Crisis

https://www.cato.org/publications/commentary/drug-prohibition-blame-opioid-crisis

New Hampshire’s chief medical examiner recently leased the state’s latest opioid overdose death totals for 2018. As in most of the country, prescription opioids are not propelling the death rate in New Hampshire. For the last several years, more and more non-medical users have been dying from heroin and fentanyl, with fentanyl accounting for more than 83 percent of overdose deaths in the Granite State.

But you won’t hear about the Fentanyl crisis, because all anyone seems to talk about is the opioid crisis. It’s a false narrative which holds that the serious number of overdoses nationwide is the result of greedy drug makers manipulating gullible doctors into overtreating patients in pain and hooking them on drugs.

And even then, it’s not Fentanyl that’s at the root of our nation’s overdose problems. The real source of our woes is drug prohibition.

The fact is, the overdose crisis has always been primarily the result of non-medical users accessing drugs in the dangerous black market that results from prohibition. As the supply of prescription opioids diverted to the underground gets harder to come by, the efficient black market fills the void with other, more dangerous drugs. Lately, the synthetic opioid fentanyl has emerged as the number one killer. The DEA reports that the overwhelming majority of seized fentanyl is “illicit fentanyl” — fentanyl made in a powdered form (unlike prescription grade fentanyl) in underground labs in Asia and Mexico and smuggled in often by mail, Fedex, or United Parcel Service. This drug is 50 times more potent than heroin. Some fentanyl analogs designed by inventive drug dealers are even more powerful than that.

Drug prohibition fuels this lucrative enterprise. Prescription surveillance boards and government-mandated prescribing limits have pushed prescribing down dramatically. High-dose prescriptions were down 41 percent between 2010 and 2016, another 16.1 percent in 2017, and another 12 percent this year. But the overdose rate continues to climb. Estimates place the 2017 overdose rate related to opioids at 49,000 deaths.

Moreover, the black market for drugs is full of dangerous uncertainty. Dealers with pill presses turn the powder into counterfeit prescription pills and sell them to unsuspecting users—sometimes to desperate patients who’ve been cut off from their pain meds by doctors terrorized by surveillance boards—causing them to asphyxiate from an overdose. That’s what happened to Prince. He liked to use Vicodin (hydrocodone) to get high. Records show he never went to a doctor for a prescription. His dealer scored him some counterfeit Vicodin that turned out to be fentanyl. Prohibition killed Prince, not prescription opioids.

There is a stark difference between the U.S., with its strict prohibition, and other countries which have liberalized drug policy. Portugal, in 2001, recognized that prohibition was driving the death rate. At the time it had the highest overdose rate in Western Europe. It decriminalized all drugs and redirected efforts towards treatment and harm reduction. Portugal saw its population of heroin addicts drop 75 percent, and now has the lowest overdose rate in Europe. It has been so successful that Norway is about to take the same route.

If the political will is not yet there to consider decriminalization, then at a minimum policymakers in the U.S. should turn to harm reduction. They should expand syringe exchange and supervised injection facilities, lighten the regulatory burden on health care practitioners wishing to treat addicts with medication-assisted treatments such as methadone and buprenorphine, and reschedule the overdose antidote naloxone to a truly over-the-counter drug.

It’s time to stop calling it an “opioid crisis.” The term is misleading. One particular opioid, fentanyl, is the primary killer. But even calling it a “fentanyl crisis” would be inaccurate. The real killer is prohibition.

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https://www.cbsnews.com/news/opioid-epidemic-did-the-fda-ignite-the-crisis-60-minutes/

We have reported on the causes and effects of the opioid epidemic for several years — interviewing government whistleblowers, doctors, and Americans who’ve grown dependent on the powerful pain pills. We have not had a high-ranking executive from the pharmaceutical industry sit before our cameras, until now. Tonight, Ed Thompson, a drug manufacturer who spent decades managing and producing opioids for Big Pharma, breaks ranks to denounce his industry and its federal regulator, the Food and Drug Administration, which he says opened the floodgates on the crisis with a few little changes to a label.

Ed Thompson: The root cause of this epidemic is the FDA’s illegal approval of opioids for the treatment of chronic pain.

Bill Whitaker: The FDA ignited this opioid crisis?

Ed Thompson: Without question, they start the fire.

Ed Thompson told us when the top selling opioid, Oxycontin, was first approved in 1995, it was based on science that only showed it safe and effective when used “short-term.” But in 2001, pressured by Big Pharma and pain sufferers, the FDA made a fateful decision and, with no new science to back it up, expanded the use of Oxycontin to just about anyone with chronic ailments like arthritis and back pain.  

Ed Thompson: So this is what a package insert looks like.

Bill Whitaker: Wow

The FDA did it by simply changing a few words on the label, that lengthy insert no one ever reads. Today the label says the powerful pain pills are effective for “daily, around-the-clock, long-term… treatment.” And that small label change made a big change in the way drug companies would market all opioids, allowing them to sell more and more pills at higher and higher doses.   

Ed Thompson: A drug’s label is the single most important document for that product. It determines whether somebody can make $10 million or a billion dollars.

Bill Whitaker: How so?

Ed Thompson: Because it allows you to then promote the drug based on the labeling.

Ed Thompson owns PMRS, a successful Pennsylvania pharmaceutical company that manufactures drugs for Big Pharma. It’s made him a rich man. But now he’s putting his livelihood at risk. He’s doing what no other drug maker has ever done, he’s suing the FDA in federal court to force it to follow the science and limit the opioid label to short term use.

“There are no studies on the safety or efficacy of opioids for long-term use.”

Thompson is challenging the FDA to start with his newest opioid. It’s Thompson’s creative way to sabotage the system. He may lose money rolling out his new drug, but if he is successful, it would set a precedent. Other manufacturers would be forced to change their labels and limit their marketing.  

Bill Whitaker: A decision going in your direction could pull down a multi-billion-dollar industry.

Ed Thompson: Correct. Probably somewhere between $7 and $10 billion a year would come off the market. We made a decision to stop selling snake oil to U.S. citizens in 1962.

Bill Whitaker: Snake oil?

Ed Thompson: Yes, sir. You’re using high-dose, long-duration opioids when they’ve never been designed to do that. There’s no evidence that they’re effective. There’s extreme evidence of harms and deaths when you use them.

Brandeis professor Dr. Andrew Kolodny is one of the country’s most-recognized addiction specialists and has been an expert witness in litigation against Big Pharma, including Purdue, the maker of Oxycontin. He has been trying to get the FDA label changed since 2011 to make clear opioids are not for everyone.

Dr. Andrew Kolodny: These are essential medicines for easing suffering at the end of life and when used for a couple of days after major surgery or a serious accident. If you’re taking them around the clock every day, quickly, you become tolerant to the pain-relieving effect. In order to continue getting pain relief, you’ll need higher and higher doses. As the doses get higher, the treatment becomes more dangerous and the risk of death goes up.  

Bill Whitaker: That sounds exactly like heroin addiction.  

Dr. Andrew Kolodny: It’s essentially the same drug.  

To understand how this began we traveled to this small courthouse in Welch, West Virginia, where we uncovered the minutes of secret meetings in 2001 between Purdue Pharma and the FDA. The files were part of the state’s lawsuit against Purdue for deceitful marketing.

60 Minutes got a court order to obtain these documents. They reveal it was at those secret meetings the FDA bowed to Purdue Pharma’s demands to ignore the lack of scientific data, and changed the label to, “around the clock…for an extended period of time.”

Ed Thompson: I can’t think of anything more harmful taking place that took place then. It opened the floodgates. It was the decision of no return for the FDA.

Purdue told us Oxycontin always was approved for long-term use. But an internal document shows the company was jubilant about the labeling change.  Quote: “The action by the FDA…has created enormous opportunities” to expand the market. The drug company’s ads soon extolled the virtues of Oxycontin’s effectiveness and sales tripled.  

Dr. David Kessler: It was a marketing tsunami.  And the agency didn’t catch it.

60 Minutes has called on former FDA commissioner David Kessler many times for his expertise on drug safety issues. He ran the FDA in the 1990s when Oxycontin was first approved, but he left before the labeling change. Today, he’s been retained by cities and counties suing Big Pharma for the opioid crisis. After reviewing the documents we obtained, and checking on his own, he says changing the label to long-term use was a mistake.

Dr. David Kessler: There are no studies on the safety or efficacy of opioids for long-term use.

Bill Whitaker: But there’s a law that says that a drug cannot be promoted as safe and effective unless it’s proven to be safe and effective. But yet, with FDA sanction, these opioids are being used in that way that you say have not been proven.

Dr. David Kessler: That’s correct. The rigorous kind of scientific evidence that the agency should be relying on is not there.

The label change was a blank check – one the drug industry cashed in for billions and billions of dollars. Now, Big Pharma had a green light to push opioids to tens of millions of new pain patients nationwide.  

Bill Whitaker: Let me remind you of some of the words that you have used to describe the pharmaceutical industry, your industry.

Ed Thompson: Yeah?

Bill Whitaker: Corrupt.

Ed Thompson: Yeah.

Bill Whitaker: Immoral?

Ed Thompson: Yes.

Bill Whitaker: Depraved?

Ed Thompson: Yes. They’re appropriate for the behavior that’s taken place.  

Bill Whitaker: You are a drug executive. You manufacture drugs.

Ed Thompson: Many drugs.

Bill Whitaker: Are you at fault in this epidemic in any way?

Ed Thompson: I wish I was smart enough to have seen this epidemic before– before I got three or four years into it. Absolutely. But once you find out that it’s not correct, you have to do the right thing. Is there anything more important?

Emily Walden: My son wanted to fight for his country. His country failed him.

If there is one victim who confirmed for Ed Thompson that turning on his industry was the right thing to do, it was Emily Walden, who would become an unlikely ally. Thompson manufactured an opioid oxymorphone. The same drug that took the life of Walden’s son TJ, a private in the Kentucky National Guard.  

Emily Walden: He was getting ready to be deployed to Africa and a few weeks prior to that he went on a camping trip with a group of friends and a police officer knocked on my door the next morning telling me that he had passed away.

Tj had grown addicted to the drug and was easily able to get it without a prescription. Walden went to Washington, D.C. to ask the FDA why her community was being flooded with pain pills. It was there she met Ed Rhompson.  

Bill Whitaker: What did you say to him?

Emily Walden: “You manufactured the drug that killed my son.”

Bill Whitaker: He is now on your side.

Emily Walden: Yes.

Bill Whitaker: That just seems like an odd connection.

Emily Walden: It is. But Ed might be my only hope in getting this fixed. The FDA’s responsibility is public health and the safety of drugs, and they’re not doing their job. They haven’t been doing their job for 20 years.

Dr. Andrew Kolodny agrees. The Brandeis addiction specialist began his own investigation into why the FDA would approve the long-term use of opioids when there was no credible science to back it up.

Bill Whitaker: What did you find?

Dr. Andrew Kolodny: We found out that a group of experts and FDA and pharmaceutical companies were having private meetings and at these meetings, changing the rules for how opioids get approved.

He filed Freedom of Information Act Requests. In email after email between the FDA, Big Pharma and consultants, he learned of closed-door meetings at luxury hotels, like this Four Seasons in Washington, DC, where for $35,000 a piece, drug makers paid consultants to, “sit at a small table with the FDA,” “hobnobbing with the regulators.” Emails show one participant worrying it might be seen as “pay to play.”

Dr. Andrew Kolodny: They had drugs in their pipeline, pain medicines that they wanted approved. And through these meetings, they were able to get those products on the market.

Bill Whitaker: That sounds unethical.

Dr. Andrew Kolodny: It is unethical.

Bill Whitaker: If not illegal

Dr. Andrew Kolodny: If it’s not illegal, it should be illegal.

Equally suspicious but legal, the large number of key FDA regulators who went through the revolving door to jobs with drug manufacturers. The two medical officers, who originally approved Oxycontin, Curtis Wright and Douglas Kramer, went to work for the opioid maker, Purdue Pharma, not long after leaving the FDA.

Dr. Andrew Kolodny: The culture at FDA continues to be much too cozy with the industry it’s supposed to be regulating.  

The agency bills drug companies more than $800 million a year in fees and depends on that industry money to pay the salaries of staffers who not only changed the opioid label, but also review new drugs like Dsuvia, the most powerful opioid pill ever approved.

Bill Whitaker: Just a few weeks ago the FDA approved a new opioid that is 1,000 times more powerful than morphine. And this is in the middle of this opioid epidemic. How is that possible?

Dr. David Kessler: I don’t get it. I get your question; I don’t get the agency’s action.

Bill Whitaker: Isn’t the FDA supposed to be our watchdogs to protect us?

Dr. David Kessler: How many people do you think were working in a division that oversaw promotion or when this epidemic started to occur?

Bill Whitaker: I have no idea.

Dr. David Kessler: Five.

Bill Whitaker: When I’m looking at the carnage in American towns and cities, that just doesn’t seem like a good excuse to me.

Dr. David Kessler: It’s not an excuse. It’s the reality. You have a system of pharmaceutical promotion that changed the way medicine practiced and no one, all right, stopped it.

Current FDA commissioner Dr. Scott Gottlieb declined our request for an interview but, in a statement said, “the FDA has taken aggressive steps to confront the crisis,” but he admitted “many mistakes were made along the way… While the agency followed the law in approving and regulating opioids, we at the FDA include ourselves among those who should have acted sooner.”

Bill Whitaker: You say they have to do things to fix the label. The label has been in place since 2001. I– I’m not a scientist, but that doesn’t seem like that’s that hard to do.

Dr. David Kessler: And it needs to be done.

Ed Thompson: We got a real problem here.

Ed Thompson isn’t waiting. He has now joined a growing movement of doctors, lawyers, and patient activists who want Big Pharma to kick its addiction to opioid profits. That’s why he made the decision to take on his industry and the FDA.   

Bill Whitaker: If you succeed, you could pull down a multibillion-dollar industry.

Ed Thompson: And if I fail, you’re gonna have ever-increasing deaths every day as well. It’s a pretty good decision, isn’t it?

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