I wonder if the “damages” have to be directly or could they be INDIRECTLY for the federal officer(s) to be found guilty. Let’s looks at a hypothetical situation.  Say the DEA raids a practitioner’s office… a practitioner who specializes in high acuity pts…  each dealing with very severe incurable painful health issues. All are ultra fast metabolizers, dealing with very painful diseases like sickle cell, CRPS, adhesive arachnoiditis for starters.

Typical scenario, DEA agents show up at the practitioner’s office and confiscate all their pts’ medical records, may get the practitioner to surrender his/her DEA license, no charges filed… BUT… the DEA refuses to return the practitioner’s pts medical records – or copies of the pts’ medical records, to the practitioner or to the pts.  Basically, the pts have no records of their health issues and no clinical records of how their health issues were treated… or how their health conditions improved or deteriorated over the years.

Imagine Tom Frieden who was the head of the CDC June 8, 2009 – January 20, 2017.. Did he exceed the statutory authority of the CDC by putting together a supposedly “secret committee” to come up with the infamous CDC opiate dosing guidelines and omitted a public comment period and assigned seats on the committee that was known to have a anti-opiate agenda and the committee used studies that were mostly designated as having a “poor quality” of data to come to the individual studies’ conclusions.

One can only guess the untold millions of pts that have had their health – or life itself – compromised because of the actions of Frieden and the committee members.  Once those guidelines were published how many in the DEA, VA, insurance/PBM companies and large healthcare facilities adopted these guidelines and a few years later the CDC itself has stated that that guidelines were misapplied.

Supreme Court rules people can sue government agents for damages

https://www.wnd.com/2020/12/supreme-court-rules-people-can-sue-government-agents-damages

The Supreme Court has ruled unanimously that individuals may personally seek damages from a federal officer who violates their civil rights and causes harm.

The case centered on FBI officials putting three Muslims on the no-fly list after they “refused to cooperate with the FBI by spying on their own communities.”

According to the Institute for Justice, which submitted arguments in the case, because of their refusal to spy, “these individuals were placed on the No-Fly List, which caused significant hardship, such as the inability to travel to visit family or for work.”

They sued, and now the Supreme Court has ruled the federal officials responsible could be liable for damages.

“We first have to determine if injured parties can sue government officials in their personal capacities. [The Religious Freedom Restoration Act]’s text provides a clear answer: They can. Persons may sue and obtain relief ‘against a government,’ which is defined to include ‘a branch, department, agency, instrumentality, and official (or other person acting under color of law) of the United States,” the opinion said.

New Justice Amy Coney Barrett did not participate in the ruling, but it was decided unanimously by the other eight.

Justice Clarence Thomas authored the opinion.

“Not surprisingly, in the lawsuit against the FBI agents, the government argued that the words ‘appropriate relief’ do not include damages,” the Institute for Justice said. “According to the government, damages might be an appropriate remedy against private actors, but damages should not be allowed if the person who violated your rights happens to work for the government.”

Its friend-of-the-court brief argued damages against government officials are the historical cornerstone of government accountability. It contended damages are often the only way to vindicate constitutional rights and that none of the government’s policy justifications against damages have a basis in reality.

That essentially was the ruling of the court.

“In the context of suits against government officials, damages have long been awarded as appropriate relief,” the ruling said, including local, state and federal officials in the decision.

The court pointed out damages are often the only remedy available.

“The court today has provided its full-throated endorsement of damages as a necessary and historic mechanism for constitutional accountability,” noted Scott Bullock, IJ’s president and general counsel. “In doing so, the court also reiterated its support for the foundational principles of this country, such as that damages can be awarded to check the government’s power and that it is Congress’ job to engage in policy making. The court’s job is to interpret the law, not to do policy.”

The plaintiffs were Muhammad Tanvir, Jameel Algibhah and Naveed Shinwari. They alleged the FBI put them on a No-Fly List for refusing to act as informants against their religious communities.

They lost money, wasted airline tickets and lost income from job opportunities.

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MySafe is a vending machine that dispenses a heroin substitute called hydromorphone to patients whose biometrics have been programmed into it as part of a unique Vancouver program aimed at preventing overdoses. (January 22, 2020)

I wouldn’t exactly call Hydromorphone a “Heroin Substitute” … Heroin (diamorphone) is metabolized in the body into MORPHINE, in fact in some countries diamorphine is used as a good (legal) pain management tool.  I wonder if any chronic pain pts will be among those whose BIOMETRICS will be programmed into the system ?  Somehow, I doubt it !

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They just announced on TV that the COVID-19 death account just reached 500,000…  That is just a little shy of the number of annual deaths from the use/abuse of tobacco & alcohol… but… I don’t see any media listing the names of all those deaths that could have been prevented. Could it be that those deaths have just become “socially acceptable” ?

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Before those in the chronic pain community get their “shorts in a twist” … in many country Heroin – otherwise known as diamorphine – is used as a legal form of pain management… It converts in the body to MORPHINE- on a mg to mg basis – 2-3 times more potent than MORPHINE.  There are more people who die every year from the use/abuse of alcohol – abt 100,000 – but only about 1,000 die of alcohol toxicity – which is normally a BAL > 0.4 -0.5 +.  Could that be because alcoholics ‘know their limit'” because they are able to purchase a legal “known strength” of their drug of choice ?  Other countries have legalized/decriminalized all drugs/substances and in those places the number of OD’s have dropped dramatically.  Does this suggest that the DOJ/DEA are continuing – or expanding – those drawing a pay check from fighting the war on drugs just to keep all those paychecks flowing.  All of the OD’s from illegal substances/drugs coming from China/Mexico is just collateral damage to keep the war on drugs moving forward ? 

Columbia University professor, admitted heroin user, says legalization of all drugs is ‘fundamental right’

https://www.foxnews.com/us/columbia-university-professor-carl-hart-heroin

A heroin-using psychology professor at New York City’s Columbia University is laying out a constitutional argument for legalizing recreational drugs in his latest book.

In “Drug use for Grown-ups: Chasing Liberty in the Land of Fear” (Penguin Press), Dr. Carl Hart calls for the legalization of all drugs, arguing that it is a fundamental American right for responsible adults to decide what to put into their own bodies.

“It’s the original American promise,” he told Fox News Friday, referencing the Declaration of Independence’s assertion that “We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness.”

Recreational drug use, ostensibly, requires liberty and is conducted in the pursuit of happiness.

“I wrote this book to present a more realistic image of the typical drug user: a responsible professional who happens to use drugs in his pursuit of happiness,” Hart explains on his website. “Also, I wanted to remind the public that no benevolent government should forbid autonomous adults from altering their consciousness, as long as it does not infringe on the rights of others.”

Although reluctant to summarize the arguments laid out in his book for people who haven’t read it, he said there are other dangerous aspects of daily life that are not criminal and that legalizing and regulating drugs could make using them safer.

“Think about car accidents,” Hart said. “There are 40,000 Americans every year who lose their life on the highway because of cars. Nobody’s saying, ‘aren’t you concerned about that we have these cars available?’ No, what we do, is we try to enhance the safety of that activity.”

Hart, the Ziff Professor of Psychology in the Departments of Psychology and Psychiatry at Columbia and an award-winning author, has been researching psychoactive drugs and their effects on humans for decades.

“My heroin use is as recreational as my alcohol use,” Hart wrote in the book. “Like vacation, sex, and the arts, heroin is one of the tools that I use to maintain my work-life balance.”

“Heroin is just another opioid, no more or less scary than other drugs,” he told Columbia Magazine, which is published by the university’s Office of Alumni and Development.

The Centers for Disease Control and Prevention, on the other hand, says heroin-involved overdoses in the U.S. increased from 3,036 in 2010 to 14,996 in 2018. (Although deaths in 2018 were slightly lower than in 2017.) More than 115,000 Americans died from heroin-linked overdoses between 1999 and 2018.

Columbia’s drug policy prohibits students and faculty from using or possessing illegal drugs on school property, within a “university workplace,” or during university activities. The policy defines a university workplace as “any site at which employees perform work for the University, whether or not such site is owned by Columbia University.”

The school did not immediately respond to questions about whether Hart’s activities were in violation of this policy.

Hart also criticized the media’s coverage of his book as “bulls—” and said that people should read it for the full context.

“I took a long time to develop these arguments,” he said, brushing off questions as “remedial” topics that are answered in the text.

Legalized drugs would be safer, regulated like alcohol, free from contamination and a source of tax revenue, he has argued.

“This is about our liberty,” he said Friday. “It’s about me protecting your liberty, you protecting mine.”

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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.

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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. 

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.”

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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 ?

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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:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

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.

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