The FDA has narrowly backed Merck’s covid pill—but it’s not that effective

https://www.technologyreview.com/2021/12/01/1040776/the-fda-has-narrowly-backed-mercks-covid-pill-but-its-not-that-effective/

The news: A US Food and Drug Administration panel has voted by 13 to 10 to recommend that the government authorize Merck’s antiviral pill for patients with early covid-19 who are at high risk for severe infection. The drug, called molnupiravir, has been shown to reduce the risk of hospitalization and death, although by less than previously thought. Initial results in October found it cut the risk of hospitalization or death by 50% when given to 755 unvaccinated volunteers who were mildly to moderately ill with covid-19 and had at least one risk factor for severe illness. Last week, with updated data from 1,433 patients, that figure was cut to 30%. “The efficacy of this product is not overwhelmingly good,” said panel member David Hardy.

Lacking consensus: The closeness of the vote was due to concerns over the change in the drug’s efficacy data, but also over its safety. James Hildreth, CEO of Meharry Medical College and one of the panel members, said he voted no because he worried that the use of molnupiravir could, theoretically, lead to new covid-19 variants. Other panelists, though, argued that the overall risk was small enough to vote it through. 

Who can take it: If it’s authorized, the drug will be prescribed to high-risk people who have begun experiencing symptoms to take twice a day at home for five days. Tens of millions of Americans who are older or have underlying medical conditions would qualify, and they’d need to begin taking it within five days of symptoms appearing. The committee recommended tight restrictions on molnupiravir’s use in pregnant women, given concerns about the potential side effects. 

What’s next: In the coming weeks, the FDA will assess a similar pill from Pfizer that seems to be significantly more effective than Merck’s, reducing the risk of hospitalization or death within the same patient groups by 89%. The hope is that these drugs could provide promising new weapons in our arsenal against covid, especially because they are easily stored and can be taken at home. The US government has already spent billions of dollars to secure large supplies of both new pills. 

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Pfizer COVID Vaccine Antibodies May Disappear in 7 Months, Study Says

https://www.medscape.com/viewarticle/960214

Antibody levels may wane after 7 months for people who got the Pfizer-BioNTech vaccine, according to a new study published on the bioRxiv preprint server.

In the study, which hasn’t yet been peer-reviewed or formally published in a medical journal, researchers analyzed blood samples from 46 healthy young or middle-aged adults after receiving two doses, and then 6 months after the second dose.

“Our study shows vaccination with the Pfizer-BioNTech vaccine induces high levels of neutralizing antibodies against the original vaccine strain, but these levels drop by nearly 10-fold by 7 months,” the researchers told Reuters.

In about half of the adults, neutralizing antibodies were undetectable at 6 months after the second dose, particularly against coronavirus variants such as Delta, Beta, and Mu.

Neutralizing antibodies only make up part of the body’s immune defense against the virus, Reuters noted, but they are still “critically important” in protecting against coronavirus infections.

“These findings suggest that administering a booster dose at around 6 to 7 months following the initial immunization will likely enhance protection,” the study authors wrote.

BioNTech said a new vaccine formula will likely be needed by mid-2022 to protect against future mutations of the virus, according to the Financial Times.

“This year, [a different vaccine] is completely unneeded, but by mid-next year, it could be a different situation,” Ugur Sahin, MD, co-founder and CEO of BioNTech, told the news outlet.

Current variants, namely the Delta variant, are more contagious than the original coronavirus strain but not different enough to evade current vaccines, he said. But new strains may be able to evade boosters.

“This virus will stay, and the virus will further adapt,” Sahin said. “This is a continuous evolution, and that evolution has just started.”

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https://www.linkedin.com/posts/jonelle-elgaway-86923315a_ama-patientstory-wer1-activity-6871571377493688320-gqRy

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Vanderbilt Burn Center (Nashville) refused to provide the young patient sufficient pain medication for SIX WEEKS

A Davidson County Court in Nashville Tennessee ruled in favor of a family whose minor child was denied proper treatment in January 2020. The ten-year-old victim had suffered severe burns in a tragic mishap. Staff at Vanderbilt Burn Center refused to provide the young patient sufficient pain medication while performing a procedure that requires cleaning and dressing burn wounds.

At the time of treatment, Bob Sheerin, a Chronic/Intractable Pain Advocate and Vice President of Operations with the American Pain and Disability Foundation, was himself receiving burn treatment in an adjoining room. He heard the agonizing screams of the victim and was compelled to help.

Sheerin, 52, Hopkinsville, Kentucky, stepped in to assist the 10-year-old patient at the burn unit of Vanderbilt Medical Center, Nashville. Sheerin was responsible for obtaining an attorney and securing funds to help the minor child and her mother navigate a system that is rigged against the poor and the uninsured.

“I have accomplished a lot advocating; not more than others, just my fair share.” said, Sheerin outside of the Tennessee courthouse. “This is something any of our great Chronic/Intractable pain advocates would have taken on.”

Mr. Sheerin has been advocating for chronic pain patients for nearly a decade and says this is his greatest accomplishment.

The family was awarded a settlement in court and money paid to the attorney was donated back to the family to establish a college fund.

Mr. Sheerin goes on to say, ”People in this country need to start opening their eyes to what the government is doing to people in need of life-saving pain medications. The way we can help children in the future is to get rid of this false narrative put forth by the CDC 2016 guidelines.”

HENRY TAYLOR/THE LEAF-CHRONICLE

Bob Sheerin VP

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Opioid Crackdown Leaves Pain Patients in Limbo

https://doctorsofcourage.org/opioid-crackdown-leaves-pain-patients-in-limbo/

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https://www.8newsnow.com/news/local-news/i-team-pain-med-prescriptions-did-not-cause-opioid-epidemic-courts-rule/

LAS VEGAS (KLAS) — Five years after the Centers for Disease Control and Prevention initiated a crackdown on opioid pain medications, experts have concluded the policy has been a miserable failure. Overdose deaths have gone up, not down, and now, courts are starting to recognize the arguments used to justify the crackdown are largely bogus.

“So these numbers, they just push these false numbers and now you have courts of law calling them out,” said Dr. Dan Laird. 

As a Las Vegas physician, Laird has a unique vantage point from which to evaluate the great opioid crackdown.  Laird is a pain management doctor and an attorney who represented patients who suffered pain after being denied legal medications. 

Of the 50 million Americans plagued by chronic pain, about 20 million depend on prescription opioids to try and lead somewhat normal lives. Since 2016, those millions have suffered immensely because of a war on legal pain meds. 

“Chronic pain patients are basically in a fight for their lives,” Laird said. “They’ve been under attack for several years now with this. Anti-opioid sentiment and sort of the over-reaction to the opioid crisis.”

Laird says the campaign against opioids is largely about money. More than 1,500 civil lawsuits have been filed against drug companies by state and local governments, including in Nevada, as officials and trial lawyers eye multi-billion dollar settlements. but the lawsuits, most of which accuse big pharma of being a public nuisance for causing the opioid epidemic are starting to fall apart.

In California this month, a lower court tossed out a huge lawsuit with a scathing opinion that found the underlying facts don’t support the allegation that 25% of opioid patients get addicted. And in Oklahoma, the state’s supreme court reached a similar conclusion and held that the benefits of opioid meds far outweigh the risks.   

“But the litigation narrative, the narrative that the trial lawyers want to push is that it’s prescribed opioids that are causing all of these deaths. This huge upswing in opioid deaths has occurred because of fentanyl, yet they continue to pound this drum that it’s prescription opioids, causing the deaths and the reason they are is because this is being driven by litigation by the people involved in this. Aren’t talking about millions of dollars, they’re talking about billions and billions of dollars. So if it hurts a few chronic pain patients … and if they’re collateral damage, you know, I guess they look at it as you’ve got to break a few eggs to make an omelet,” Laird said. 

But prescription drugs are not the cause of a spike in overdose deaths. Ninety thousand overdoses were recorded in 2020, a huge increase, but 87% of those were caused by illegal street drugs, notably fentanyl and heroin, not a prescription medication. Cutting down on prescriptions hasn’t worked because legal pain patients are not the ones overdosing. 

One outspoken advocate for chronic pain patients, Red Lawhern, says the CC’s own statistics prove the crackdown on prescription opioids is unwarranted.

“So seniors, who get the most opioid prescribing have the lowest rates of opioid overdose-related deaths by a factor of three to one,” Lawhern told Mystery Wire. “Kids under the age of 19 have the lowest prescription rates for opioids. And they have a rate of opioid-related overdose death, that is three times that of seniors.
So what I’ve been telling people for the last roughly four years is that you can’t explain this inversion of demographics, by any model that proposes that prescribing is the problem or the cause of addiction. It’s not there, it has never been there. So what we are seeing is, statistics of the CDC itself demonstrate that the logic behind the 2016 guidelines is bogus. It’s flat not supported by the data that CDC itself has reported. But CDC has chosen to ignore the data, and instead to enlist the opinions of people who were hand-picked as anti-opioid advocates, who may even believe the nonsense that they talk. But they’re lying through their teeth.” 

Studies show less than 1% of them become addicted, not 25% as alleged in the lawsuits. Millions of patients who followed the rules and their doctors have been cut off altogether or had their dosages slashed. Suicides among those patients jumped 470%, many of them veterans in pain who were cut off by the Veterans Administration. Patients are starting to fight back by suing doctors and hospitals who deny legitimate medications.  

Also coming under scrutiny are the very same anti-opioid crusaders who crafted the CDC’s opioid crackdown in 2016. Several are now working as expert witnesses in lawsuits against big pharma. 

“One person, Andrew Kolodny, who is a psychiatrist with no formal postgraduate training and pain management is an expert witness for again, Oklahoma case against Johnson & Johnson Pharmaceuticals. His expert witness fee for that case reportedly is $500,000, so it’s pretty good work if you can get it,” Laird said.

Earlier this month, the U.S. Supreme Court agreed to hear arguments whether doctors should be criminally prosecuted for prescribing legal medications, so long as they use “good faith” standards in issuing prescriptions.

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In Dec 1941 the Japanese bombed Pearl Harbor and killed about 2300 people and we declared war against the Japanese and ended up fighting Germany/Hitler as well…

In Sept 2011, when the Towers and the Pentagon was attacked abt 3000 people died and we declared war

During his administration President Nixon declared that “addiction is public enemy number one” and he declared a war on drugs. Actually Nixon was a racist and didn’t like Blacks or those “Hippie types”… and that was the focus of his “war”.  When this happened the NY Mafia controlled the vast majority of illegal drugs distribution.

I am binge watching Narco Wars on National Geographic and Congress has routinely passed laws that has pushed the production of illegal abuse substances out of the country… mostly to Mexico and for decades China has been a source for most of the chemicals that is used to make some of these illegal substances.

Today, it is claimed that abt 75,000/yr OD deaths from illegal drugs coming from China & Mexico…  so in about 10 days as many people die as did in the attach on Pearl Harbor and in about 15 days the number of people that died in the 911 attack. Realistically we can’t declare war on China or Mexico. China has declared the making illegal Fentanyl is ILLEGAL and the penalty is pretty stiff.. but they don’t seem to be doing a very good job in stopping these chemical labs.

Our Congress has been consistent in how they deal with things that the Puritanical thread in our societal fabric considers “evil”… they first try to ban it and then when that fails they legalize it and tax it.  They have done it with Tobacco, Alcohol, Gambling and now MJ.  Often the taxes and fees to those who sell the particular product is so high, that the “cartels” can sell the product much cheaper and still make “boat loads of money”.

Many understand that addictions – all addictions – have a mental health component – we have some 30-40 million people addicted/abusing to some substance or activity.  We could use the same tactics that Standard Oil used in the early 20th century to get rid of competition… under price the competition.  We could take the illegal substances that we confiscate from the cartels… get a pharma or chemical company to standardize the product and get a pharma or other company to produce a standardized potency product to be provided to those who are going to find a way to get their “drug of choice”

Take alcohol as an example, the use/abuse of alcohol contributes to abt 100,000/yr deaths, but only abt 1,000 die from alcohol toxicity (OD). Could that be because the person abusing/addicted to alcohol… knows their limits and is able to get their “drug of choice” in a standardized potency.

We can go back to 2015 when Scottsburg, IN had a 200+ breakout of  HEP B & C and HIV + https://www.pharmaciststeve.com/another-good-example-of-how-well-drug-prohibition-works/ because of sharing needles..  and the lifetime costs to treat each of these people could upward of $750,000 EACH… Scottsburg had a free needle exchange program until this year when the “local bureaucrats” decided that they were encouraging/condoning substance abuse. Of course, being a small, poor rural county it wasn’t their tax money that was going to pay for the medical treatment cost for those people.

How far could the 100 billion that we spend on the war on drugs go to provide – at low cost – to attempt to SHRINK the demand of illegal substances that some people like to abuse and perhaps put the cartels back on their heels

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Complete government and insurance industry control over healthcare clear now in 2016 HFPP

by Felix Brizuela | Nov, Sun, 2021 | Chronic Pain Patient, Convicted physician, government benefiting off street opiates, Government Misconduct, health insurance, healthcare reform, Licensed to Lie, opiates | 0 comments

https://doctorsofcourage.org/complete-government-and-insurance-industry-control-over-healthcare-clear-now-in-2016-hfpp/

Doctors of courage, through the freedom of information act, were able to obtain close to 300 pages of information, considered classified and for “insiders” only, concerning the HFPP or Healthcare fraud and prevention partnership designed to address what has been considered the prescription opiate crisis, which was felt to be solely responsible for rising abuse and deaths from opiates. Keep in mind that there is now inequivocal proof that prescription opiates accounted for less than 1% of opiates abused. This was released October 20, 2021 the policies of which the federal government, in conjunction with government agencies, using agencies such as the FBI, DEA, state medical boards have been implicating to control what they called, “fraud, abuse and waste”. Through the enforcement of policies from the “white papers”, which were policies enforced though the Trump administration, through collaboration of Jeff Sessions, Qlarant (a high technology company that uses computer technology to obtain information about patients, doctors and pharmacies without consent violating their ourth amendment rights), the health insurance industry and an organization of physicians, PROP with no formal training in policies being addressed and who are opposed to use of opiates for long term pain management and who’s policies are now being scrutinized by the press.

The white papers utilize the 2016 CDC guidelines on opiate prescribing to justify classifying opiate use as “fraud, abuse and waste” by misinterpreting these guidelines as “laws” set forth by the CDC, which the CDC in it’s July 2021 meeting, which I attended and spoke at, adamantly deny that these were meant to be anything but guidelines. Emphasizing that the ultimate decision was between the doctor and the patient at this meeting. So in retrospect, the Trump administration “strong armed” policy to criminalize use of opiates which they felt was not appropriate. No input from chronic pain groups and organizations like the chronic pain society, the AMA, physicians with respected publications on chronic pain management or certification boards such as the American Academy of Psychiatry and Neurology or the ABEM (American Academy of Emergency Physicians) who provide certification of pain management for physicians. By using the “white paper” guidelines, this gives the government clout to define the misuse of opiates by whatever definition they feel is appropriate. By placing opiate “misuse” under the umbrella of fraud, waste and abuse, this allows for criminalization of prescribing of opiates and leaves physicians, pharmacists and other health care personal criminally liable for any prescribing of opiates for any use. Even medication assisted treatment (MAT) for drug addiction with use of methadone, naloxone or buprenorphine. The white papers are of the opinions that opiates should be used only for MAT, cancer patients but still criminalize use of opiates regardless.

The HFPP partnership includes mainly federal and local government agencies and insurance companies such the blues cross organizations such as Highmark, as well as Humana and Keiser Permanente and many others. No physicians, other healthcare workers, AMA, certification organizations or any other, non-biased well respected Healthcare organization were asked to be in the partnership. Clearly an example of its intention to maintain control of the health, well being of the American public strictly between the government and insurance industry. Including who lives or dies. The HFPP does not limit it’s regulation to opiate use, but it leaves open the definition of “fraud, waste and abuse” to any action they feel compromises their agenda. Which is unequivocally meant to maximize profit for the health insurance industry at the expense of American lives. A recent article published in the New England Journal of Medicine, dated October 28, 2021 emphasized how treatment of chronic disease, the cornerstone of healthcare, has been so compromised that our lifespan has once again fallen. Yet health insurance industry is making record profits, $500 billion in 2020 the highest ever by allowing Americans to get sick by avoiding chronic care and making money off expensive procedures and cancer care. Chronic pain falls under the umbrella of chronic disease and care. Unaddressed chronic disease is the number one cause of chronic pain through facilitation of central pain pathways https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2750819/. Which is why the USA leads the world in chronic pain and thus, leading the world in prescribing of opiates.

The HFPP only emphasizes and condones opiate use for pain in cancer pain. They do acknowledge that their is concern in public opinion about “chronic pain’, but are of the opinion that the consequences of use of opiates for chronic pain outweigh the benefits. An opinion without scientific merit. Cancer is a multibillion dollar industry from which health insurance companies, pharmaceutical companies, Oncologists and large healthcare conglomerations like Keiser and UPMC benefit and make the emphasis of most of their advertising. Cancer is very very very serous, but so are chronic autoimmune disorder, neuromuscular disorders such muscular dystrophies, inherited diseases all of which lead to chronic. Yet, I have always struggled to find resources for these diseases and individuals with these conditions struggle for proper pain management. There has been an increase in suicides in these groups of over 470%. There are between 50 million and 100 million people in chronic pain. At it’s peak before the white papers, the HFPP or the PDMP (Physician drug monitoring program), there were only about 2000 chronic pain doctors to manage these people. Prescribing of prescription opiates has declined lethal levels. Leaving people to resort to reaching for the streets to manage their pain. Chronic pain patients have no choice but to use dangerous drugs which cannot be monitored. Mainly synthetic fentanyl and heroin. This has lead to a massive 1040% increase in misuse, over doses up to 2020. From 2020 – 20221, this has grown another 28%, with over 100,000 over dose deaths. The most ever.

In summary, the government, including the Trump administration purposely compromised the health of the American public, shunned chronic care and allowed pain, suffering and early death for benefit for profit for the health insurance industry. This not only constitutes extremes in inhumane behavior, akin to the Third Reich, but extreme criminal behavior which unlike Germany from 1933 to 1945, affects all citizens without boundaries for class, race or socio-economic status.

Here is the information the government released to us:  Released Records (1).pdf

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If you have a Medicare Part D prgm… you need to check what your plan is going to charge you using this link http://www.medicare.gov/plan-compare/#/?lang=en&year=2022

In checking our Part D plan… the total annual cost ( premiums, deductibles, med costs) ranged from the lowest cost/yr to about TEN TIMES that cost.  For the same meds & quantities.

I guess this is what is possible when you are dealing with FOR PROFIT INSURANCE COMPANIES – the same thing may apply to those companies providing Medicare Advantage prgm or what they are starting to call Medicare-C

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CVS to close 900 drugstores in three years to beef up health services

https://www.reuters.com/business/healthcare-pharmaceuticals/cvs-health-close-stores-record-impairment-charge-2021-11-18/

Nov 18 (Reuters) – CVS Health Corp (CVS.N) will shut about 900 stores over the next three years, it said on Thursday as the company tries to adapt to changing consumer preferences by pivoting to new store formats that offer more health services.

Best known for its chain of drugstores in more than 9,900 locations, the company has been working to expand its services since it acquired health insurer Aetna in 2018.

CVS said that as part of its strategic review it would create an enhanced version of its health hubs that offer treatment for common ailments as well as chronic care to add more customers.

The reduction in stores will result in CVS taking an impairment charge of between $1 billion and $1.2 billion in the fourth quarter.

As part of the new strategy, the company also created a new position of chief pharmacy officer and appointed executive vice president of specialty pharmacy and product innovation Prem Shah to the role.

“We see this as consistent with our expected LT (long-term) strategy for CVS, moving to grow managed care and care delivery, while shrinking legacy bricks-and-mortar retail business,” said Bernstein analyst Lance Wilkes in a note.

Rival Walgreens Boots Alliance (WBA.O) also recently shifted focus beyond its drugstores, investing $5.2 billion in VillageMD and $330 million in post-acute and home care provider CareCentrix. read more

CVS cut its annual 2021 profit per share forecast to between $5.46 and $5.67 from $6.13 to $6.23, but stuck to its adjusted profit view saying there will be no impact from the store closures this year and the next.

It also said Neela Montgomery, president of CVS Pharmacy, would leave company at the end of 2021.

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