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Dear Steve,
I wanted to pass along something you may want to publish on your page, or anywhere else. Here’s the story: When cdc guidelines first came out, I had an idea – I have insight and much experience with US Rx ethical pharma, FDA, drug labeling and drug safety (and lots of other regulatory other stuff). The only thing I could think to do would be advise patients being forceable tapered or abruptly discontinued from medication to report this to FDA under the Medwatch program, which as you know is an FDA voluntary adverse drug reaction reporting mechanism (by phone or online or through physician)… so I kept posting notices on the many groups I’m in mostly in response to horror stories. My thinking was I know how on top of drug safety and data trends FDA is, and that if they saw an uptick in withdrawal symptoms reported, it would be hard data that can never be altered or erased, and they’d have to act on it, and also knowing that FDA’s authority was usurped by CDC in the guidelines and FDA is NOT a fan…
Not as easy to implement this strategy on an ad hoc FB group level, but it makes sound reason to me. So here is my little blurb- I thought if you wanted, you could share it on your FB group in a pinned post, or however, and share with any other group administrators you may know. Totally up to you but here it is:
(Well here’s FDA reporting link I have to go find the blurb again)

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home

Here’s the blurb I came up with: Withdrawal symptoms, and other adverse reactions, are considered a serious safety problem with medication, especially when this is happening as a result of a doctor abruptly discontinuing or inappropriately tapering your drug treatment in a way directed against in the medicine’s US FDA approved prescribing information. In the US, you are encouraged to voluntarily report this, and any other problems with medicines, to FDA at 1-800-fda-1088, or using the form provided in the link below. This is one of the only ways that we as chronic pain patients have right now to have these instances documented officially by US government. FDA uses the data to detect trends (potential safety problems with medications) and works to mitigate them.

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The new president of the California Medical Association was expecting to spend New Year’s at a wedding in Las Vegas.

Instead, David Aizuss, MD, posted on Facebook about his “eye opening” first-hand view of “American medicine at its worst.” (The post is visible only to his Facebook friends and he declined MedPage Today’s request to elaborate, citing ongoing “medical issues.”)

In his post, Aizuss said he was rushed by ambulance to a hospital Monday morning. “I spent hours in the emergency room where I received inadequate treatment of mind boggling pain, was never touched or examined by a physician, was mixed up with another patient and almost inadvertently transferred to another hospital, (and) was scheduled for emergency surgery based on a third patient’s lab work that was confused with mine,” he wrote.

He “finally signed out of the hospital against medical advice so I could obtain care from physicians that I know and trust.” He did not name the hospital.

Aizuss, an ophthalmologist who practices in Calabasas, northwest of Los Angeles, posted his complaint New Year’s Eve, apparently while at the LAX International airport in Los Angeles, where he said he was “just returning from Las Vegas where we were supposed to attend a wedding.”

Dozens of Facebook friends, several apparently also physicians, expressed their shock that the CMA president could receive such poor emergency room response, and some said they were happy he was speaking out about poor quality of hospital care.

“If you get terrible care like this (at least you know the difference) think about the care that Joe Sixpack gets; he doesn’t have the resources to get better care. This system is broken and we need to fix it,” posted one.

Wrote another, “As president of the CMA, your voice can be loud! Don’t be timid and do not be afraid of making enemies. Remember our patients know and respect us when we stand against poor medicine.”

Aizuss ended the post by saying, “Truly an eye-opening experience for the President of the California Medical Association. Happy New Year to all!”

He began his one-year term as CMA president in mid-October, saying he wanted to focus on physician burnout, practice sustainability, and payment. He is also past chairman of the CMA Board of Trustees.

He is a medical staff member at Tarzana Hospital and West Hills Hospital, in Los Angeles County, and serves as an assistant clinical professor of ophthalmology at the UCLA Geffen School of Medicine.

The CMA represents about 43,000 physicians in the state and is the second largest organized medicine group of any state, next to the Texas Medical Association, which represents about 52,000 physicians.

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https://www.cbsnews.com/news/opioid-overdose-deaths-plunge-31-percent-ohio-hamilton-county-free-narcan/

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When a Doctor Forced Me to Taper Off Pain Medication

https://themighty.com/2018/10/forced-taper-pain-medication/?utm_source=ChronicIllness_Page&utm_medium=Facebook

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Does Pfizer Have A Multibillion-Dollar Replacement For Opioids?

https://www.investors.com/news/technology/pfizer-lilly-tanezumab-opioids-treating-pain/

“In our 2019 preview we said the biggest surprise could be that the safety for Pfizer and Lilly’s tanezumab will be better than expected, and this drug could replace opioids for the treatment of pain,” Cantor Fitzgerald analyst Louise Chen said in a report to clients.

Chen kept her overweight rating and 53 price target on Pfizer stock. On the stock market today, Pfizer stock advanced 1.6% to close at 43.65. Meanwhile, Lilly stock lifted 1.3%, to 115.72.

Combating Opioids In Treating Pain

One estimate suggests that more than 115 people die each day in the U.S. after overdosing on opioids. The Centers for Disease Control and Prevention estimates the total economic burden of prescription opioid misuse in the U.S. is $78.5 billion annually.

Pfizer and Lilly’s tanezumab could help ease the opioid crisis, Chen says.

“If we are right, then the peak sales potential of tanezumab could be billions of dollars,” she said. This would “drive upside to modest expectations for the drug.”

Pfizer and Lilly expect to release study results within six months on treating osteoarthritis pain. The results will examine 24 weeks and 56 weeks of treatment. The companies will also release the results of a study in chronic low back pain.

Safety Questions For NGF Inhibitors

But questions persist around nerve growth factor, or NGF, inhibitors like tanezumab. In early tests, the drugs have been connected to abnormal joint damage. Regeneron Pharmaceuticals (REGN) and Teva Pharmaceutical (TEVA) have another NGF called fasinumab.

Earlier this year, Pfizer and Lilly said 1.3% of patients given tanezumab in a 16-week test showed problematic joint damage, known as rapidly progressive osteoarthritis, or RPOA. There were no cases of RPOA in patients who received the placebo.

Investors expect the upcoming results to be “similar to or worse” than prior data, Cantor Fitzgerald’s Chen said.

“However, physicians we interviewed were impressed by that data, and did not believe the RPOA imbalance would impact their desire to prescribe tanezumab, if it is approved,” she said.

Tanezumab – FDA Allows Trials To Continue On This Horror Drug

Tanezumab was going to be Pfizer’s next cash cow. It was one of a new class of anti-nerve growth factor (anti-NGF) drugs, which blocks a key protein that helps deliver your body’s pain signals.

So when people with severe joint pain enrolled for tanezumab trials, they were desperately searching for relief. Even though the drug was still in its experimental phase, it was supposed to be safe and promised to melt away even the most agonizing joint pain.

However, as soon as the tanezumab trials began the horror show also started… people were left with permanent joint damage and others were scrambled into surgery for new knees, hips and shoulders.

Researchers reported fractures and total joint collapse among participants and even the American Food and Drug Administration (FDA) said it looked more like participants were developing “rapidly progressive arthritis” causing “death of bone tissue due to a lack of blood.”

A second season of the tanezumab horror show

Finally, in 2012, after tanezumab unleashed endless suffering onto patients the FDA was forced to bring all trials for anti-NGF drugs to an immediate halt. In the aftermath a top researcher testified that it would be unethical to ever resume human testing of tanezumab again.

As we all know, ethics are not Big Pharma’s strongest characteristic… and now, a mere three years after the first tanezumab horror season, Pfizer is picking up right where it left off ready for a tanezumab sequel along with a $2 billion investment from its new partner, the pharmaceutical company Eli Lilly.

And it looks like these two powerful drug companies are happy to spend – and say – anything to unleash this risky drug on a new round of victims.

The FDA recently announced that it would allow tanezumab trials to resume after new “nonclinical” data (as in research that did not come from the previous, disastrous trials) showed tanezumab “could be safe”.

Now, when it comes to pharmaceutical drugs, those three words should be enough to send the red flags flying and the alarm bells ringing.

But as a result of the fancy footwork Pfizer and Eli Lilly are using to explain away the bone and joint damage the drug has done in previous trials, joint pain sufferers are in for a second round of tanezumab hell.

See, the researchers claim that tanezumab was so effective in previous trials and took away so much pain that the participants using it weren’t “signalled” that they were overusing their fragile bones.

That’s right, blame the participants!

It’s an excuse that’s impossible to believe – especially because in one trial, a full third of tanezumab patients didn’t experience any clinically significant pain relief at all.

Frankly, tanezumab is a blunder drug, not a wonder drug.

But the FDA swallowed the explanation hook, line and sinker, and not before long tanezumab will be sent to the FDA for final approval.

Unfortunately, we know that people will be tricked into participating in new tanezumab trials, lured by the same empty promises that were made just three years ago. It’s doubtful they’ll be warned before they sign away their rights – and their joints – on the dotted line.

We can’t stop tanezumab from hitting the market, but we can let you know when it gets approved and under what brand names it will be sold so that you can be sure to avoid this drug at all costs.

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Veterans protest the gutting of West L.A. PTSD therapy groups

https://www.latimes.com/local/lanow/la-me-ptsd-group-shutdown-20181229-story.html

“It is important that we maintain a host of treatment options for our veterans suffering from PTSD,” he said.

The secretary of Veterans Affairs, Robert Wilkie, responded that the group therapy program was being “rebranded,” not ended. But he also questioned the effectiveness of group therapy for veterans with PTSD.

“Despite the popularity and long history of support groups as routine care for veterans with PTSD and trauma exposure, there is no strong evidence that this modality is an effective treatment,” Wilkie said in a letter to Lieu.

The outcry comes at a difficult moment for the veterans agency, which is experimenting with privatizing mental healthcare while also grappling with staffing shortages and a suicide crisis — 20 former service members a day take their own lives.

Several former clinicians have complained to the VA about an exodus of as many as 50 psychologists and psychiatrists from the Greater Los Angeles VA Health Care System, which includes the Sepulveda and West L.A. campuses.

The VA says PTSD affects 8% of veterans. The agency initially relied on medication to treat the condition, but now is turning to short-term, evidence-based therapies, including cognitive processing, prolonged exposure and eye movement desensitization and reprocessing.

Cognitive processing helps veterans recast negative thoughts about their trauma. Prolonged exposure guides veterans into reliving traumatic events to diminish their fear and anguish, and eye movement desensitization and reprocessing helps veterans recall their trauma while focusing on external motion or sound.

Each therapy course generally runs for three months. Martin said VA officials made it clear they like evidence-based treatment because it’s short and saves money. VA leaders called the therapy groups “social clubs” and said veterans who need more support should take each other’s phone numbers, Martin said.

Evidence-based therapies can be tough on veterans, who may have spent years trying to forget the very memories that the sessions dredge up. In his letter, Lieu said only 50% to 60% of veterans complete evidence-based therapies.

Peter Erdos, 35, said he tried medication and evidence-based therapies with minimal success after his return from Iraq.

“Medication is something that the VA was OK with me being on for the rest of my life,” said Erdos, a member of the combat veterans group. “Coming back in my 20s and hearing that was just soul-crushing. What worked for me was camaraderie with the guys.”

Research on the effectiveness of group therapy to treat combat veterans with PTSD is inconclusive. Carl Castro, director of USC’s Center for Innovation and Research on Veterans & Military Families, said the VA should have studied the groups before squeezing them out.

“The VA has gobs of money to do research,” Castro said. “It was a unilateral decision and goes against patient-centered therapy.”

“For a lot of veterans involved in group therapy, just the fact they’re engaging in it is therapeutic for them,” said Paul Brown, adjutant of the American Legion, Department of California. “If it makes a difference in even one veteran’s life, we’re going to push to have it continued.“

Members of the PTSD combat support group have continued meeting in a room they rent at a Westside senior center. Martin is volunteering to facilitate.

Before a gathering last month, a dozen veterans described the group as a lifeline. The men are black and white, former officers and draftees, and at least one attended West Point. Some spent years battling alcoholism or substance abuse. Some worked as lawyers, company executives or architects.

Several said they had PTSD symptoms — anger, anxiety, depression — for decades before seeking treatment.

“It only took me 47 years,” said Steven Goldstein, 71, a U.S. Army infantry veteran who served in Vietnam. “I had no joy in my life.”

Randy Kline said he was drafted out of Inglewood in 1967 “to participate in crimes against humanity“ — a moral injury that experts increasingly consider to be as damaging as a gunshot wound or other combat trauma.
Veterans Peter Erdos, from left, Dov Simens and Steven Goldstein walk outside Building 256 at the West Los Angeles Healthcare Center. Veterans accuse the VA of dismantling psychological services and PTSD groups at the Greater L.A. campuses.
Veterans Peter Erdos, from left, Dov Simens and Steven Goldstein walk outside Building 256 at the West Los Angeles Healthcare Center. Veterans accuse the VA of dismantling psychological services and PTSD groups at the Greater L.A. campuses. (Wally Skalij / Los Angeles Times)

Arnold Hudson said that as a black man from South Los Angeles, he saw no future as a convicted draft dodger. So he reluctantly answered the call to Vietnam, where he saw his friend “incinerated before my eyes.”

AHudson said the group gave him his life back after years of drug addiction.

“I’m 69 years old and I lost a whole lot of life,” he said. “When they announced we were disbanding I thought, why in the world is the government who vowed to take care of us cutting us off at the knees?”

The veterans said they want to return to the VA campus, where the next person home from Afghanistan or Iraq could wander in and find the support that only comes from shared experience.

“We’re a band of brothers. We have a duty to all vets,” Simens said. “We’re just asking for a 400- to 500-square-foot room, for two hours, once a week.”

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The five most addictive substances in the world

https://www.cnn.com/2019/01/02/health/most-addictive-substances-partner/index.html

Opioids and overdoses: 4 things to know

Nutt et al.’s experts ranked heroin as the most addictive drug, giving it a score of 3 out of a maximum score of 3. Heroin is an opiate that causes the level of dopamine in the brain’s reward system to increase by up to 200% in experimental animals. In addition to being arguably the most addictive drug, heroin is dangerous, too, because the dose that can cause death is only five times greater than the dose required for a high.

Snorted, injected or smoked? It can affect a drug’s addictiveness

Heroin also has been rated as the second most harmful drug in terms of damage to both users and to society. The market for illegal opiates, including heroin, was estimated to be $68 billion worldwide in 2009.

2. Cocaine

Cocaine’s effects: Highs and harms

Cocaine directly interferes with the brain’s use of dopamine to convey messages from one neuron to another. In essence, cocaine prevents neurons from turning the dopamine signal off, resulting in an abnormal activation of the brain’s reward pathways. In experiments on animals, cocaine caused dopamine levels to rise more than three times the normal level. It is estimated that between 14 million and 20 million people worldwide use cocaine and that in 2009 the cocaine market was worth about $75 billion.

Blocking rewards: How the immune system could help treat cocaine addiction

Crack cocaine has been ranked by experts as being the third most damaging drug and powdered cocaine, which causes a milder high, as the fifth most damaging. About 21% of people who try cocaine will become dependent on it at sometime in their life. Cocaine is similar to other addictive stimulants, such as methamphetamine — which is becoming more of a problem as it becomes more widely available — and amphetamine.

3. Nicotine

Nicotine in e-cigs, tobacco linked to heart disease

Nicotine is the main addictive ingredient of tobacco. When somebody smokes a cigarette, nicotine is rapidly absorbed by the lungs and delivered to the brain. Nutt et al’s expert panels rated nicotine (tobacco) as the third most addictive substance.

More than two-thirds of Americans who tried smoking reported becoming dependent during their life. In 2002 the WHO estimated there were more than 1 billion smokers and it has been estimated that tobacco will kill more than 8 million people annually by 2030. Laboratory animals have the good sense not to smoke. However, rats will press a button to receive nicotine directly into their bloodstream — and this causes dopamine levels in the brain’s reward system to rise by about 25% to 40%.

What is dopamine, and is it to blame for our addictions?

4. Barbiturates (“downers”)

Barbiturates — also known as blue bullets, gorillas, nembies, barbs and pink ladies — are a class of drugs that were initially used to treat anxiety and to induce sleep. They interfere with chemical signalling in the brain, the effect of which is to shut down various brain regions. At low doses, barbiturates cause euphoria, but at higher doses they can be lethal because they suppress breathing. Barbiturate dependence was common when the drugs were easily available by prescription, but this has declined dramatically as other drugs have replaced them. This highlights the role that the context plays in addiction: if an addictive drug is not widely available, it can do little harm. Nutt et al’s expert panels rated barbiturates as the fourth most addictive substance.

5. Alcohol

Although legal in the US and UK, alcohol was scored by Nutt et al.’s experts 1.9 out of a maximum of 3. Alcohol has many effects on the brain, but in laboratory experiments on animals it increased dopamine levels in the brain’s reward system by 40% to 360% — and the more the animals drank the more dopamine levels increased.

No amount of alcohol is good for your overall health, global study says

Some 22% of people who have taken a drink will develop dependence on alcohol at some point during their life. The WHO has estimated that 2 billion people used alcohol in 2002 and more than 3 million people died in 2012 due to damage to the body caused by drinking. Alcohol has been ranked as the most damaging drug by other experts, too.

Eric Bowman is a lecturer in psychology and neuroscience at the University of St. Andrews and has received funding from the UK Medical Research Council.

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Thank you! Thank you! Brenda Sharp so much for sharing your pain with us and for spreading awareness for Trigeminal Neuralgia and Facial Pain Disorders! This is the first video that I’m uploading across social media sites as well as domestic and international media channels that will allow uploads. Thank you for helping me to step out of the box with awareness in a different avenue by exploring awareness through videos. For starters, it’s on Instagram, Youtube, GooglePlus, Twitter and TNnME! Thank you!

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3rd day without my pain medicine. This is what our trumped up CDC regulations are doing to people. People in itractable pain. The new Opoid war. I am going to die like many please help us. This isn’t pretty. #patientsnotaddicts pic.twitter.com/CswT0N0KmE

— angela dawn sparling (@SparlingAngela) December 20, 2018

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