“new health care system”… looks good on paper… in reality …. a failure within THREE YEARS

Why Haven’s Encounter With Reality Proved Fatal

https://www.medpagetoday.com/special-reports/exclusives/91274

Ex-CEO Gawande explains what went wrong for “model” healthcare venture

When they made their bold announcement in mid 2018, three corporate powerhouses — Berkshire Hathaway, Amazon, and JP Morgan Chase — were going to revolutionize the healthcare delivery system. They would lower costs and improve quality and overall outcomes for their 150,000 workers.

After all, they had author, innovator, and surgeon Atul Gawande, MD, at the helm. It would show the rest of the country and world how healthcare should work.

But less than three years later, the companies acknowledged the effort known as Haven would dissolve by the end of this month. Gawande had already stepped down as CEO in May 2020. What went wrong?

In an hour-long “grand rounds” discussion Thursday with Robert Wachter, MD, chair of the University of California San Francisco’s department of medicine, Gawande provided a post-mortem.

In a nutshell, the concept was fatally flawed, he said, in so many words.

On the good side, he said, the effort accomplished a lot. In its two and a half years of existence, Haven’s thought leaders designed a coverage model with no co-insurance, no deductibles, no cost for 60 critical drugs, and low-cost mental health services and primary care.

But the pandemic brought home a critical point. “We have an employer-based system. A job-based system is a broken system in a world where people are moving every couple of years to different roles and many, many, kinds of jobs,” he said.

“The pandemic has really brought this out in spades,” he said, as the lockdowns cost many workers their jobs, and thus the health insurance that came with them.

“The vulnerability we have of tying your healthcare to your job, that remains still a big hill to climb, and the government has to solve it. That is a public core issue that we still have not faced up to,” Gawande said.

A job-based healthcare system, he said, only cares about costs this year, not over the life of the worker. “That’s why we have fights over whether we’ll pay for a hepatitis C treatment that costs $50,000 and up but avert $1 million in costs over the course of a life. We need that life-course commitment and view, and we have not aligned around that,” he said.

That wasn’t the only reason Haven is dissolving, however. Making an insurance plan work for three different companies whose employees were in different cities, with different populations and organizational cultures, was a daunting task.

“Once that became clear, then Haven threatens to become a very expensive think tank,” Gawande said. The original thought was that it would assume responsibility for benefits management at the three companies, he explained. But it eventually became clear that “didn’t have the potential to say we’ll take over all of the benefits and running of the insurance for all you three organizations and then add more and more and more and more.”

But Gawande doesn’t think Haven was a failure. Not at all.

“It definitely did not become what we thought it would be,” he acknowledged. But it did give him certain skills and organizational knowledge that enabled him to start a new effort, called CIC Health, which launched COVID testing efforts in the Boston area last fall and now has major COVID vaccination efforts at Fenway Park and another site later this month.

Gawande has written several best-selling books about healthcare and numerous articles for The New Yorker. His latest, from Feb. 8, describes the conflicts in a North Dakota county where politics and resistance to mask-wearing and physical distancing through this fall led to the highest rate of COVID spread and hospitalizations in the country.

He also was a member of the Biden-Harris COVID-19 Transition Advisory Board until last month.

Gawande remains heavily involved in Ariadne, a research lab run jointly by the Harvard T.H. Chan School of Public Health and Brigham and Women’s Hospital that designs and tests healthcare delivery innovations. Gawande, who founded and was former executive director of Ariadne, is now the chairman.

Here he goes again…. promising to CURE CANCER… like he promised when he ran with Obama for second term – 8 yrs ago

Biden says once he defeats COVID, cancer is next

https://www.foxnews.com/politics/curing-cancer-up-next-for-biden-after-defeating-coronavirus

‘We’re gonna do everything we can to end cancer as we know it’

President Biden said Friday that ending cancer will be his next big scientific endeavor after overcoming the coronavirus pandemic. 

“I want you to know that once we beat COVID, we’re gonna do everything we can to end cancer as we know it,” Biden said in Michigan after touring a Pfizer vaccine manufacturing plant. 

Biden was in charge of President Obama’s “Cancer Moonshoot” initiative launched in 2016 to double the rate of progress toward a cure. The priority is personal to Biden, who lost his son Beau Biden to brain cancer in 2015. He was 46. 

President Joe Biden walks with Albert Bourla, Pfizer CEO, right, Michigan Gov. Gretchen Whitmer, second from right, and Jeff Zients, White House coronavirus response coordinator, as he tours of a Pfizer manufacturing site, Friday, Feb. 19, 2021, in Portage, Mich. (AP Photo/Evan Vucci) (AP)

Biden drew parallels between fighting the pandemic and taking on cancer, the second-leading cause of death in America behind heart disease. 

“This is a case of life and death,” Biden said. “We’re talking about people’s lives.”

He mentioned his January nomination of Eric Lander as Presidential Science Advisor and Director of the Office of Science and Technology Policy, a Cabinet-level assignment. He praised Lander as “a renowned Harvard, MIT scientist” and said he’ll help bring together the country’s top scientists to conduct advanced research on cancer and other diseases. 

“This administration is going to be guided by science to save lives and to make life better,” Biden said. 

Biden’s comments came as he visited the Pfizer vaccine manufacturing plant outside of Kalamazoo and touted progress his administration has made in speeding up the distribution of the shots. 

“I can’t give you a date when this crisis will end,” Biden said. “But I can tell you we are doing everything possible to have that day come sooner rather than later.”

Biden drew parallels between fighting the pandemic and taking on cancer, the second-leading cause of death in America behind heart disease. 

“This is a case of life and death,” Biden said. “We’re talking about people’s lives.”

He mentioned his January nomination of Eric Lander as Presidential Science Advisor and Director of the Office of Science and Technology Policy, a Cabinet-level assignment. He praised Lander as “a renowned Harvard, MIT scientist” and said he’ll help bring together the country’s top scientists to conduct advanced research on cancer and other diseases. 

“This administration is going to be guided by science to save lives and to make life better,” Biden said. 

Biden’s comments came as he visited the Pfizer vaccine manufacturing plant outside of Kalamazoo and touted progress his administration has made in speeding up the distribution of the shots. 

“I can’t give you a date when this crisis will end,” Biden said. “But I can tell you we are doing everything possible to have that day come sooner rather than later.”

Science/Facts/Truth vs an AGENDA ?

those in the chronic pain community keep asking the question…. chronic pain pts and rx opiates are not the genesis of the current opiate crisis.  Opiate Rxs peaked in 2011-2012 and have been declining every year since…  Since about 2015, the DEA has lowered the Pharma’s production quota of opiates.  The DEA has forced the pharmacy wholesaler to RATION the sales of opiates to pharmacies based on some sort of per-cent of total Rx purchase per month.

The DEA was reportedly started in 1973 with 1200 employees and today it is reported that the DEA has 12,000 employees with > 50% sitting at a desk.  I have not seen a number of the people at the city/county/state level work full or part time in fighting the war on drugs and it is just not law enforcement, there are various courts, prosecutors, defense attorneys, judges and jail/prison systems that participate – to some degree  – with the war on drugs.

We now also have a very large and growing industry of rehab centers.

Along the way, it seems that the DEA changed their focus on this crisis from the drug cartels – where facts strongly supports – is the driving force behind the increased number of opiate OD deaths to prescribers who are writing fewer and fewer opiate Rxs.  It would seem that once a “crisis”

Here is a recent press release from the DEA where a fairly large volume of various illegal drugs were confiscated   2.5 Tons of Methamphetamine and 100,000 Fentanyl Pills Interdicted/seized by DEA

One has to wonder how many of similar quantities of these illegal drugs come across our borders every day… was this just a “one and done” or just one of many that came ashore that day and didn’t get confiscated.


Aren’t we now seeing a similar issue in many states with COVID-19,  particularly in some states.  In some states the teachers don’t want to go back to teaching in person… even though the CDC has stated that it is extremely safe. COVID-19 initially did, in fact, created a CRISIS, but some states have taken the position to seemingly perpetuate the crisis in their state… at least when it comes to restaurants and small businesses, Big Box stores and large retail corporations had little restrictions put on them to stay open and mostly business as usual.  How many states and/or large politically connect groups within the state are going to try to keep this crisis going ?

Just a BUMP IN THE ROAD ?

Short poem you won’t forget
Do you recall President Obama referring to the Benghazi incident as “a bump in the road?”
Recently, I heard an ex-Navy SEAL being interviewed on Fox News regarding a book he has written about how to handle crisis situations in our lives.
At the end of the interview he asked if he could make a comment on Benghazi and, of course, the anchor said “yes.” He then thanked Fox News for keeping the Benghazi story in the news, since other news organizations are not.
He said the SEALs who died deserve the public knowing the truth about the whole affair.
The poem was written by an anonymous Marine Corps officer:
“THE BATTLING BOYS OF BENGHAZI”
We’re the battling boys of Benghazi, No fame, no glory, no paparazzi.
Just a fiery death in a blazing hell, defending our country we loved so well.
It wasn’t our job, but we answered the call, Fought to the Consulate and scaled the wall.
We pulled twenty countrymen from the jaws of fate, led them to safety and stood at the gate.
Just the two of us and foes by the score, but we stood fast to bar the door.
Three calls for reinforcement, but all were denied, so we fought and we fought and we fought ’til we died.
We gave our all for our Uncle Sam, but Barack and Hillary didn’t give a damn.
Just two dead SEALs who carried the load, No thanks to us…we were just “Bumps in the Road”.
So, will this reach every American with a computer?
Or do we act like the press and give a pass to the people who literally sat there in the White House and watched the SEALs’ execution on live streaming video and did absolutely nothing?
“What difference does it make?”
And she wanted to be the next President!

Deaths from Cancer & Cardiac issues have dropped out of top 2 reasons of death

FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia

FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia

https://www.lawofcompoundingmedications.com/2021/02/fda-issues-warning-to-acelrx-for-making.html

As part of the FDA’s ongoing commitment to combat inappropriate opioid use, the agency’s Center for Drug Evaluation and Research has issued a warning letter to AcelRx Pharmaceuticals, Inc. (AcelRx) for the false and misleading promotion of Dsuvia (sufentanil sublingual tablet), a potent opioid analgesic. 

AcelRx has disseminated promotional communications that undermine key prescribing conditions required for the safe use of this opioid product. Dsuvia was approved with special restrictions requiring that it only be prescribed in a certified medically supervised setting by health care practitioners trained to properly administer it. The promotional communications at issue, however, promote the product as simple to administer — just “Tongue and Done.” This promotion dangerously undercuts FDA-required conditions on the proper administration of the drug, which requires particular diligence to minimize the risk of serious or even fatal adverse events.

Dsuvia is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is of particular use in certain special circumstances where adult patients may not be able to swallow oral medication and where access to intravenous pain relief is not possible.  

Dsuvia was approved with a Risk Evaluation and Mitigation Strategy (REMS), which reflects the serious risks associated with this product. The REMS limits distribution to certified, medically-supervised health care settings where health care professionals are trained in the proper use and administration of the product. Such settings include hospitals, surgical centers and emergency departments that are certified in the requirements outlined in the REMS. The FDA continues to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements.

Critical conditions for the safe use of Dsuvia are not appropriately conveyed in the promotional communications cited in the warning letter. In particular, the claim “Tongue and Done” severely detracts from these important conditions for safe use. Because of the potency and the small size of the tablet, the prescribing information outlines multiple administration steps including a separate, distinct step to visually confirm tablet placement in the patient’s mouth. These prescribed steps are designed to minimize the serious risk that misplaced tablets could cause to patients and others. The promotional communications at issue also omit other important risk information, further minimizing the serious risks associated with Dsuvia.  For example, the materials state that patients may retake the drug in one-hour intervals but fail to state that the maximum daily dosage is 12 tablets in 24 hours. This omission is concerning due to the serious risks associated with overdose of Dsuvia, including respiratory depression and death.

It is vitally important that promotional communications be truthful and non-misleading. Opioid products are highly addictive controlled substances and there are serious public health risks associated with their use, including addiction, abuse, and misuse, that can lead to overdose and death. False and misleading claims can negatively impact prescriber awareness and understanding about approved opioid drugs, their risks, and the actions and precautions necessary for the safe use of these products.

FDA requests that AcelRx cease any violations of the Food, Drug and Cosmetic Act and submit a written response within 15 days from the date of receipt of the letter addressing the concerns in the letter, listing all other promotional communications that contain statements such as those described in the letter, and explaining any plan for discontinuing use of such communications or for ceasing distribution of Dsuvia. If AcelRx fails to adequately address the concerns outlined in the warning letter, the FDA may take further regulatory action. The FDA is also requesting that AcelRx submit a comprehensive plan of action to distribute truthful, non-misleading, and complete corrective communications about the concerns discussed in the warning letter to the audience(s) that received the promotional communications.

The FDA encourages healthcare providers and consumers to report potentially false or misleading prescription drug promotion to FDA’s Bad Ad program.

The FDA also encourages health care professionals and consumers to report adverse events, medication errors, and quality problems experienced with the use of any medical product to MedWatch: The FDA Safety Information and Adverse Event Reporting Program:

The FDA remains focused on reducing the rate of new addictions by decreasing exposure to opioids while still enabling appropriate access for those patients who have legitimate medical need for these medicines. Dsuvia, when used in a manner consistent with the FDA-approved labeling, including the REMS, can play an important role in the management of pain. The agency will continue to actively confront the opioid crisis, while also paying careful attention to the needs of patients experiencing pain and their health care providers.

Large chain pharmacies COMING UP SHORT on getting COVID-19 vaccinations done

Image for postWhere’s The Vaccine?

https://puttrx.medium.com/wheres-the-vaccine-cb71195ddf49

2021. So far for pharmacies, it’s been a wild ride. The much-anticipated advent of the COVID vaccine(s) has spawned additional issues with rollout and availability capabilities — many of which can be tied back to misinformation, corporate territorialism, and lack of proper planning.

Does anyone else hear a common PBM theme here?

States that are excelling in the vaccination effort are those including their local independent pharmacies in all phases of distribution. In an MSNBC interview this month, West Virginia Governor Jim Justice noted that “instead of letting vaccines sit on shelves we saw that our elderly wanted to go to their local pharmacies and clinics… We incorporated everybody together… and said we’re not going to let vaccines sit on shelves.” And, in a January interview on Face the Nation, Arkansas Governor Asa Hutchinson remarked, “Our independent pharmacies are doing a better job of getting it (the vaccine) out. They’re acting with more urgency than the chain pharmacies.”

The facts are that the CVS/Walgreens partnership was allocated more than 4.7 million doses of the Pfizer and Moderna vaccines, but as of mid-January — a month after rollout began in many states — had only administered a quarter of those vaccines. In states like Mississippi, that translated to only 5% of the state’s initially allocated shots administered to their most vulnerable populations. Statistics that abysmal can only be construed as either the chains are saving doses for second round inoculations, or incapable of doing the job they were contracted to accomplish. And while one would hope that it’s the former, not the latter, even saving doses isn’t necessary. Both Pfizer and Moderna have made clear that new shipments will cover those second rounds .. so why is there a shortage?

It has long been reported by even their own employees that major chains like CVS and Walgreens are understaffed to the point of patient danger, and large numbers of what they themselves call “retail locations” (as opposed to ‘pharmacies’) obviously do not translate into the amount of trained medical personnel necessary to effectively administer vaccines to the single portion of the population they were contracted to vaccinate. Whether or not this factors into their ongoing vaccination rollout issues, we may never know.

The truth is that if CVS/Walgreens were not either “holding back” doses for second round inoculation or caught in a web of their own ineptitude with regards to their LTC government contract, far more shots could have gone into arms — and far more shots would be available to our swiftly dying population. Look at the independent pharmacy rollouts in West Virginia, North Dakota, and Louisiana. They’re not holding back doses, or lacking the ability to get doses administered. They’re getting them into the arms of the population that needs them most — and receiving the doses for second rounds. The statistics prove it. West Virginia alone has achieved a 50% drop in hospitalizations and a 45% drop in deaths since the inception of their vaccine rollout — a substantial difference over states who choose to rely solely on giant corporation-driven control.

Patients trust their local independent pharmacies, and have for generations. When it comes to easily accessible advice on medication-related questions and issues, their local pharmacy is a patient’s preferred go-to. Not a chain ‘retail’ store that places more importance on superstore mentality than individualized patient care — which may explain CVS and Walgreens’ claims that lack of consent is a large part of the reason they’ve been unsuccessful.

The PBM-owned pharmacies at the helm of America’s vaccine effort are, in essence, proving the necessity of PBM reform. Independent pharmacies nationwide are licensed, willing, Trusted partners in the ‘arms race’ on one of the most important vaccines in history. Giant corporations playing territorial hardball are not the answer. As The Washington Post recently wrote, “The strong performance by local pharmacies in distributing lifesaving vaccines makes that clear.”

Jeremy Counts, PharmD

Main Street Pharmacy

Blacksburg, VA

We are nearly 30 TRILLION IN DEBT and the House is discussing ( H.R. 40) reparations for slavery

Sheila Jackson LeeInteresting … ACLU sent out this letter and DIDN’T MENTION WHO INTRODUCED THIS BILL.
Maybe the chronic pain community and the mental health community should seek  reparations for all the abuse/discrimination that has been inflicted on these communities since Pres Nixon signed into law the Controlled Substance Act in 1970.  The Civil Rights Act – which includes/covers disabled people – was signed into law in 1965.
Over the years, how many chronic pain pts have reached out to the ACLU for assistance to stop the discrimination that those in the community has have to endure and how many pts have been told by the ACLU that they don’t have the resources – or just doesn’t have the interest – in how some specific groups – are being discriminated against…  NOT CENTURIES AGO, but here and now.

Greg Gutfeld – on our opiate crisis

Dr. Thomas Kline, MD, PhD: Medical Myths Revealed SAFE PRESCRIBING– THE GOVERNMENTS VIEW

The assumption is feckless doctors not knowing what they are doing have overprescirbed and this has caused more overdose deaths and addiction so CDC has told us what to do, to make it safe and cut down on these problems.

It did not work. Deaths are up. Addiction is the same as always.

But millions of very tragic consequences have occurred with people forcibly discontinued from the the control of their permanent painful diseases to solve the Heroin multidrug overdose problems, Ask CDC who exactly is dying and why they separated multidrugs to make it look like it was prescription drugs- a terrible mistake,