Tanezumab – FDA Allows Trials To Continue On This Horror Drug

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.

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

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.”

The five most addictive substances in the world – two don’t need a Rx

The five most addictive substances in the world

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

What are the most addictive drugs? This question seems simple, but the answer depends on whom you ask.

From the points of view of different researchers, the potential for a drug to be addictive can be judged in terms of the harm it causes, the street value of the drug, the extent to which the drug activates the brain’s dopamine system, how pleasurable people report the drug to be, the degree to which the drug causes withdrawal symptoms, and how easily a person trying the drug will become hooked.
There are other facets to measuring the addictive potential of a drug, too, and there are even researchers who argue that no drug is always addictive. Given the varied view of researchers, then, one way of ranking addictive drugs is to ask expert panels.
In 2007, David Nutt and his colleagues asked addiction experts to do exactly that — with some interesting findings.

1. Heroin

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.
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 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.
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 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%.

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.
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.

Is this how the CDC opiate guidelines are causing many pts to be living in a torturous level of pain ?

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!

This is what forced cold turkey withdrawal looks like when pt’s pain meds are stopped abruptly

Why vertical mergers will continue to dominate health care – causing antitrust issues ?

Why vertical mergers will continue to dominate health care

https://www.managedcaremag.com/archives/2018/12/why-vertical-mergers-will-continue-dominate-health-care

Insurers are busy merging with retailers and providers in vertical integration deals after attempts at horizontal combinations hit antitrust roadblocks.

While 2019 might not see the mega-mergers of 2018, “I don’t think it will be a slow year,” predicts Stephen Burrill, vice chairman and health care leader at Deloitte LLP.

Much of the action is expected to come from retailers linking up with payers or providers, or from health insurers or health care systems acquiring services such as home health care providers and rehabilitation facilities. Payers and providers have begun to realize “maybe this is a better answer if we work together and think about the patient holistically,” Burrill says. With that type of vertical integration, “you help manage money,” with the goal of reducing health care costs, he adds.

During the first three quarters of 2018, nearly 800 health care deals were announced, valued at almost $115 billion, according to PricewaterhouseCoopers. By far the largest were Cigna’s $67 billion acquisition of Express Scripts and CVS Health’s $69 billion acquisition of Aetna. For 2017, the number of health care deals totaled 967, with a combined value of $175.2 billion. The Cigna–Express Scripts deal may not close until mid-2019, several months after it was expected to, and California, New York and New Jersey regulators are still reviewing it. The CVS–Aetna merger has also run into snags. It has gotten the Department of Justice’s approval but early this month Judge Richard Leon of the U.S. District Court for the District of Columbia said he might require the companies to remain separate until he can review the merger and consider anti-trust issues. “I can’t recall another instance of a judge doing this,” Andrea Agathoklis Murino, co-chairperson of Goodwin Procter LLP’s antitrust and competition law practice, told CNBC.

In a November earnings call, CVS CEO Larry Merlo said the company would work to help better manage customers’ chronic conditions, such as diabetes, through the integration of CVS’s and Aetna’s claims data, according to media reports.

CVS is planning to launch new “health hub” stores this year that will provide “new services to better address the cost-quality-access challenges of consumers,” Merlo said. The hubs would reportedly use pharmacists to help manage patients’ care between visits to primary care providers. The pilot efforts would initially involve Aetna members, but could be expanded to other health plans.

Meanwhile, Humana and Walmart have been talking about merger-slash-partnership arrangements, according to media reports, but as 2018 waned they had yet to make any kind of big-splash announcement. Humana has partnered with Walgreens to test senior-focused primary care clinics in Kansas City.

Insurers are busy merging with retailers and providers in vertical integration deals after attempts at horizontal combinations hit antitrust roadblocks. In 2017, federal judges ruled against Humana’s proposed tie up with Aetna and a Cigna–Anthem merger. And the bar for horizontal mergers got a little higher this year. California approved a law that requires that any health insurers who want to merge to first gain approval from the state’s Department of Managed Health Care. The department can reject mergers that limit competition.

Other vertical deals this year included Humana’s acquisitions of a Curo Health Services, a hospice provider, and Family Physicians Group in Orlando, a primary care provider. Meanwhile, Centene announced it was acquiring Community Medical Group, a primary care provider in Miami-Dade County. Anthem acquired Aspire Health, a palliative care provider.

Whether the enthusiasm for vertical integration will go too far and start bumping up against antitrust objections is one of the important questions going into 2019. An example might be a health insurer acquiring all the rehabilitation facilities in a particular market. “There may be a point where it’s too big,” Burrill says.

More US Teens Are Vaping, but Use of Opioids, Alcohol Falling

More US Teens Are Vaping, but Use of Opioids, Alcohol Falling

https://www.clinicaladvisor.com/pediatrics-information-center/more-us-teens-are-vaping-but-use-of-opioids-alcohol-falling/article/821791/

HealthDay News — Vaping among American teenagers increased dramatically in 2018, with nearly 2 of every 5 high school seniors reporting they had tried an electronic cigarette during the past year, according to the latest Monitoring the Future survey funded by the US National Institute on Drug Abuse.

About 37% of teens said they had tried vaping and even Nicotine-free vape options within the previous 12 months compared with about 28% in 2017. Vaping rates also increased by about one-third in younger teens, with about 18% of eighth graders and 32% of 10th graders reporting they had tried e-cigarettes in 2018. After alcohol, vaping is the second-most common form of substance use in the United States, the survey revealed. However, marijuana use remains steady among high schoolers, with nearly 6% of 12th graders reporting daily use. For the past two decades, daily use among high school seniors has hovered between 5% and 6.6%.

The survey also showed that smoking is at an all-time low, with only about 4% of high school seniors smoking daily compared with 22% two decades ago. Prescription opioid use (such as OxyContin or Vicodin) has declined to about 3% among 12th graders. Only 1.7% of seniors reported misuse of Vicodin in the past year compared with 10% 15 years ago. Alcohol use also has declined. About 17% of high school seniors reported being drunk during the past month, down from 26% 5 years ago. Fewer teens reported binge drinking (5 or more drinks in a row). About 14% of 12th graders said they had recently engaged in binge drinking, down from 17% in 2017 and the all-time high of 31% in 1998.

“We are encouraged to see continued declines in a variety of measures of underage alcohol use,” George F. Koob, PhD, director of the National Institute on Alcohol Abuse and Alcoholism, said in a statement. “The new data, however, underscore that far too many young people continue to drink at a time in their lives when their brains and bodies are quite vulnerable to alcohol-related harms.”

More Information

Opioid crisis critical as youth drug deaths nearly triple in the past 20 years

https://video.foxnews.com/v/5984887974001

 

 

 

CVS is now working with a nonprofit “health” advisor that may ration customers’ health care choices

CVS Makes Plans To Ration Customers’ Health Care

http://thefederalist.com/2018/12/28/cvs-makes-plans-ration-customers-health-care/

CVS Caremark customers throughout America recently received bad news as the retail pharmaceutical chain officially closed on its $69 billion acquisition of Aetna. This is bad news because CVS is now working with a nonprofit “health” advisor that may ration customers’ health care choices.

In August, CVS announced a partnership with the Institute for Clinical and Economic Review (ICER), a nonprofit group that bills itself as a medical review board. But its leadership team and the far-left billionaires footing its bill paint a troubling picture.

ICER was founded by Dr. Steven Pearson. Pearson previously worked with the United Kingdom’s National Institute for Health and Care Excellence (NICE). A pleasant-sounding moniker, NICE is anything but.

Thanks to NICE guidelines, millions of British citizens are on waiting lists at any given time for procedures, hundreds of thousands are waiting for basic diagnostic tests, and thousands of operations are regularly cancelled. During the first quarter of 2018, “the number of British patients waiting 18 weeks or more for treatment increased by 35 percent, which was an increase of 128,575 patients from about 362,000 patients in 2017, to over 490,000 patients in 2018. Additionally, by March 2018, 2,755 patients had waited over a year to be treated, compared to 1,528 patients in 2017,” according to The Heritage Foundation.

NICE is even worse about drug approvals. NICE “has declined to fund [drugs] such as Benlysta, Novartis, Sorafenib and Avastin. The first is a treatment for lupus while the last three can extend the life of cancer patients. The Rare Cancers Forum notes that 16,000 patients annually could benefit from cancer drugs rejected by NICE,” notes the National Center for Public Policy Research’s David Hogberg.

Under ICER’s direction, CVS has set a “threshold of $100,000 per QALY, or quality-of-life years, a benchmark that measures both the quantity and quality of life generated by providing a treatment or some other health care intervention.” In practice, that means ICER’s opinion about the so-called quality of life value will determine whether CVS customers can receive new prescription drugs and treatments.

This means that even if a doctor prescribes a drug for a patient, that individual may find that CVS doesn’t carry that medication if it doesn’t fit ICER’s parameters. Think of it as socialized health care without the socialistic government regime.

Former Rep. Tony Coelho (D-Calif.), a primary author and sponsor of the Americans with Disabilities Act, has been a strong critic of CVS’s decision and ICER’s approach. This is how he explained its effects:

This type of cost effectiveness analysis discriminates against people with disabilities and other vulnerable groups like the elderly because it assigns higher value to people in ‘perfect health’ than people in less-than-perfect health. So let’s say your child has a degenerative neurological condition and an expensive new drug is introduced that can halt, but not reverse, the damage done by the disease. Your child, and other patients like her, would be considered ‘worth less’ under a cost-effectiveness formula. As a result, the new treatment would not meet the threshold.

Recall that the debate over health-care rationing was a primary reason so many folks objected to ObamaCare’s Independent Payment Advisory Board (IPAB). IPAB was to be a 15-person panel deciding which treatments should be allowed under what circumstances for government-run programs.

The idea of a panel deciding who gets what kind of care and when seemed Orwellian from the start, and Americans by and large opposed the entire concept. In February, Congress did away with IPAB.

CVS is now instituting its own form of IPAB with ICER. Rationing, by any other name, is just as insidious. So who is funding this far-left push? The Laura and John Arnold Foundation has donated more than $19 million to ICER since 2015. These big-money liberals appear to have goals of moving beyond ObamaCare to a full-blown single-payer system.

In addition to funding ICER, the Arnolds have teamed up with George Soros to bankroll Patients for Affordable Drugs (P4AD), an advocacy group claiming to be bipartisan yet comprised largely of former Obama and Clinton staffers. P4AD’s political actions during this past election cycle put the truth to the lie of bipartisanship.

According to The Intercept, “P4AD touts itself as a bipartisan organization, which means that come election time, it needs to spend money targeting both Republicans and Democrats. The Democrats being targeted by P4AD are virtually guaranteed to win re-election, which allows the group to claim a bipartisan label without actually harming any Democratic incumbents.”

Obviously P4AD is not bipartisan and neither is the Laura and John Arnold Foundation. As I noted in a recent Investor’s Business Daily commentary, “[f]rom abortion, to anti-Second Amendment work, to liberal ‘investigative’ journalism, to single-payer health care, the Arnolds fund the gamut of far-left causes… They promote their bipartisan giving, yet the Arnolds fund groups whose sole mission is to demonize and bankrupt right-of-center organizations. How is that possibly bipartisan?”

Now, through ICER, the Arnolds resurrecting one of ObamaCare’s most underhanded programs. And CVS is helping them.

During the Obama administration, CVS teamed up with the White House to promote the Affordable Care Act in its stores. Now it is working with far-left actors to revive a version of ObamaCare’s rationing board. CVS customers and investors deserve better.

Justin Danhof is the General Counsel for the National Center for Public Policy Research, as well as Director of the Center’s Free Enterprise Project.

 

 

Mis-statement of facts as early as 2014 ?

Kolodny Congress 5-2014 Opioiods from Media Policy Center on Vimeo.