FORMER US AG JEFFEREY BOLEGARD SESSION
“…these things which have been hidden from you shall be brought to the light…”

HEALTHCARE FRAUD PREVENTION PARTNERSHIP (HFPP) ALERT: “BROKEN ARROW,” THE RISE OF AMERICAN FASCISM, PERSECUTION, AND CRIMINALIZATION OF YOUR DOCTOR AND MEDICAL HEALTHCARE: HOW DID WE GET HERE!!!

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Do any of you remember during the early Covid-19 pandemic? Some docs were claiming that ivermectin and hydroxychloroquine worked against Covid-19. some/many of these docs were chastised by some medial licensing boards and some lost their job or hospital privilege. Because those two meds were not approved for treating the COVID-19 virus,and being prescribed “off label” . Of course, the Covid-19 virus was a NEW VIRUS and there was some who suggested that the Covid-19 virus was “man-made” using gain of function methodology. Then again, some 30%-50% of ALL PRESCRIPTIONS are prescribed OFF LABEL – EVERY DAY, but no one seems to care about all those Rxs, out of some 4 billion Rxs that are filled every year “off label”?

Ivermectin Suit Revived; Curbing Fentanyl Deaths in Kids; Medicare Spending Plateau

https://www.medpagetoday.com/special-reports/features/106202

Doctors’ Ivermectin Lawsuit Revived

Last week, the 5th U.S. Circuit Court of Appeal in New Orleans revived a lawsuit brought by three doctors alleging that the FDA overstepped in its public statements about ivermectin as a COVID-19 treatment, the Associated Pressopens in a new tab or window reported.

The lawsuit argues FDA messaging such as, “I’m not a horse!” interfered with their practice, and in “most of that messaging,” left out the human version of ivermectin that the plaintiffs were prescribing.

The lawsuit was originally brought by otolaryngologist Mary Talley Bowden, MD, and critical care doctor Paul E. Marik, MD — both of whom have faced professional repercussions after touting the anti-parasitic, among other controversies — and emergency medicine doctor Robert L. Apter, MD.

A district court judge had dismissed the lawsuit in December, but the New Orleans appellate court argued that the FDA exceeded its authority under federal law, though normally government entities have more protections from civil lawsuits because of what’s known as “sovereign immunity.”

“FDA is not a physician. It has authority to inform, announce, and apprise — but not to endorse, denounce, or advise,” Judge Don Willett, MA, JD, a Trump appointee, wrote for the panel, according to the AP. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.

State Laws Attempt to Curb Fentanyl Deaths in Kids

The synthetic opioid fentanyl claimed the lives of 1,800 teenagers between July 2019 and December 2021 in the U.S. — and a number of states are passing legislation geared toward preventing these deaths, according to Politicoopens in a new tab or window.

In California, a bill named for a 15-year-old who died in a Hollywood high school would require schools to include responses to overdoses into their safety plans. In Texas, middle and high schoolers learn about the dangers of fentanyl in a new education campaign. Mississippi created a media campaign.

But families of youths that have died from overdoses want more to be done. They cite pandemic-era lockdowns and social media as drivers of declining mental health and easy access to drugs available for purchase. Surprisingly few treatment options are available for adolescents struggling with substance abuse, and naloxone (Narcan) isn’t readily available in many overdose situations, according to Politico.

On the national level, members of Congress have introduced a bill that would fund education on fentanyl for children, and provide school employees with naloxone and training for its use. Likewise, Surgeon General Vivek Murthy, MD, MBA, has said he supports age limits for social media use.

Medicare Spending Plateau

Medicare spending per beneficiary has ceased its dramatic trend upward, baffling experts who projected a continued steady climb would strain the federal budget and lead to increasingly difficult spending choices. Spending would have been $3.9 trillion higher since 2011 had it not been for the change, the New York Timesopens in a new tab or window reported.

Possible reasons for the relative plateauing at $12,459 per beneficiary per year include the Affordable Care Act, which cut Medicare payments to hospitals and Medicare Advantage insurers. Older Americans are also having fewer heart attacks and strokes because of effective drugs for cholesterol and blood pressure. Some parts of healthcare have become more efficient, with some care shifting out of hospitals into cheaper settings, for example.

However, the shift may also reflect slowing life expectancy for seniors because of a lack of major medical breakthroughs in recent years, the death of many older Americans from COVID-19, and seniors being denied the care of their choice as hospitals contain costs.

Trump tax cuts, a deficit reduction deal, and the recent Medicare drug negotiation policy wouldn’t have come close to this magnitude of government savings, according to the New York Times, although Medicare spending is still likely to increase in the coming years. An aging population, and a new development like an Alzheimer’s drug or the burden of long COVID, for example, could push spending up again.

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I will be live on Twitter Spaces and YouTube discussing the events leading up to and during my recent trip to Washington DC. I am hoping to also stream on FaceBook simultaneously while being open to live questions on any/all platforms. It may or may not work, but I am hoping to update everyone once and answer any questions at once. I will also discuss my next DC trip, which will be in about 10 days because we FINALLY have great news to share about progress at the federal level

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Well here we go again Vanderbilt loves to buy all the struggling hospitals and has new innovated ways to torture kids! 72 hour Tylenol IVs and lessons on how to cure pain that would kill a small animal with mind control therapy! So of course my email is blowing up with desperate parents wanting help ASAP so their children don’t feel like committing suicide and parents don’t loose their job because some clueless doctor has a plan that doesn’t involve the life saving opioid medication to be used as intended! Just what I needed at this point in life with my own medical shit going on! 5 steps forward 20 steps back! I’m trying to prioritize who will be out first and who can take tapers vs smaller doses and split them into groups! This is frigging ridiculous and torture on these kids! From Henderson KY to Paducah and from Clarksville to Nashville, Louisville to Chattanooga! I’ll need local advocates to help me again please and this will bankrupt us without help to get these people to these kids. Donate at Www.4apdf.org... We stopped them before but this reload of idiotic ideology my be the grave stone for some of these sick kids.. Some I’ve helped before and brand new kids who are brand new to the suffer train! Yall get me whatever you can and I’ll do my best! Stage 4 of eliminating pain patients has promptly taken effect! KY and TN you should be ashamed of yourselves for this one! I don’t know how to take so many kids on right now but as always will figure it out! What a shame! Lower doses on end of life and chronic pain kids who are already suffering! SMH is an understatement! A trip to Washington DC is needed badly! Share this and help all you can so I don’t have to sell everything I have again please! Looks like a long full time job is headed my way again!

There was no sound evidence of Acetaminophen’s ability to treat most all painful condition

Perhaps most telling is a 2021 review that included 36 systematic studies of 44 painful conditions. It concluded that acetaminophen provided modest pain relief for one of them, osteoarthritis of the hip and knee. There was no sound evidence of the drug’s ability to treat any other painful condition.

Do any of you remember during the start of the COVID-19 pandemic, how many practitioners were prescribing certain medications to treat pts with COVID-19 …but.. some of the healthcare system they worked for revoked their privileges at their hospital, and some state medical boards sanctioned prescribers for prescribing medications that had been clinical studies on to treat COVID-19… otherwise known as “off label”.  Yet some 30%-50% of all prescriptions are prescribed & filled “off label” EVERY DAY…

The first paragraph is a description what Vanderbilt Hospital system is doing in treating end of life pediatric cancer pts’ PAIN. That a 2021 review of 36 systematic studies of 44 painful conditions. Does not provide any pain management for cancer pain.

Here is a article from 18 months ago that https://news.vumc.org/2021/12/07/vanderbilt-university-hospital-named-a-top-teaching-hospital-nationally-by-the-leapfrog-group/ 

Does this mean that Vanderbilt university is graduating medical students that are being taught to prescribe therapies for which their is little/no evidence that – Acetaminophen/Tylenol – is ineffective is nearly all painful conditions.

What would happen to parents if they inflicted as much pain on their children as these healthcare professionals are causing these end of life pediatric pts to live/exist in? Does anyone think that Child Protective Services would be knocking on their door? Taking their kids away and put into foster care and the parents put in JAIL?

A number of years ago, our SCOTUS ruled that the 18th amendment – you know the one about prohibiting cruel & unusual punishment – only applied to prisoners.

Forget the “DO NO HARM”, it is really not stated in the original Hippocrates oath, nor any revisions. some believe that it is IMPLIED https://doctors.practo.com/the-hippocratic-oath-the-original-and-revised-version/

So it would appear that physicians – depending on their own personal morals and ethics – can leave pts to suffer in pain

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Amazing that what appears to be the lead law firm in suing the 3 largest drug wholesalers and 3 major chain pharmacies (CVS, Walmart, Walgreen) is claiming that they WON THE WAR ON DRUGS – apparently by causing untold number of chronic pain pts are going to be indiscriminately denied their medically necessary pain medication for their chronic health issues.

I think that it is interesting that the law firm admits that they are using all the media’s routine talking about OD’s involving “fentanyl”, with seldom mentioning that the opioid that people are dying from is an ILLEGAL ANALOG being provided by China & the Mexican cartels, while at the same time the media shows a graphic of the FDA approved Fentanyl and seldom/never do they mentioned that it is actually a POISONING.

Attorney Mike Moore seems to state that these large corporations won’t go bankrupt, but what happens if these major wholesalers and/or major chain pharmacies decide to stop inventorying controlled meds and/or wholesalers only sell control meds to hospitals and nursing home pharmacies. Are these law firms indemnified for any of the consequences to chronic pain pts for not being able to get their medically necessary controlled medications?

We have all seen/read about pts who were cut off from their medications because the DEA raided a practitioner’s office.  Some committed suicide, some have died from cold turkey withdrawal. Some will end up using/abusing NSAID’s, alcohol, Acetaminophen trying to reduce their torturous intensity of pain. Many will end up with liver, kidney damage, heart attack, stroke and eye damage.

The three major drug wholesalers that settled, controls about 80%-85% of all Rx meds to pharmacies. The typical community pharmacy may have up to 30 days of inventory on hand. So if a wholesaler notifies a pharmacies they will no longer be getting controlled meds from their wholesaler.  Within 60 days, most of the pharmacy’s chronic pain pts will be in cold turkey withdrawal.

One can only guess how rapidly the average life expectancy of all these chronic pain pts will decline?

Winning the War on Opioids: A Behind the Scenes Look at The Largest and Most Complex Deal In The History of Jurisprudence

“Winning the War on Opioids: A Behind the Scenes Look at The Largest and Most Complex Deal In The History of Jurisprudence”
-or
“How US DOJ & Trial Lawyers circumvented public consent to create a work-around ban on rx opioids thru mass tort litigation.”

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Fine tuning Pharmaceutical Warehouse Monitoring for Optimal Ambient Conditions

https://drugstorenews.com/finetuning-pharmaceutical-warehouse-monitoring-optimal-ambient-conditions

With specialty medications now accounting for over half of all drug spending in the U.S., wholesalers and retailers need to ensure the safe and effective delivery of critical, hard-to-get medications to patients who rely on safe, efficient supply chains for their health and well-being. 

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Reducing opioid use one ambulance ride at a time

https://oilcity.news/community/health/2023/09/13/reducing-opioid-use-one-ambulance-ride-at-a-time/

Data show a 28% drop in opioid administrations following an alternative pain treatment training for Laramie County first responders.

In what is possibly a first-of-its-kind approach in the country, Laramie County emergency medical services have undertaken training to reduce the administration of opioids — and the results are encouraging.

“We just analyzed our one year data for that, and we actually had a 28% decrease in opioid administration without any change in patient satisfaction or patient pain control,” said Angela Vaughn, a community health project director through Cheyenne Regional Medical Center.

The reduction in opioid prescriptions is important because experts have identified overprescriptions as one of the key drivers of opioid addiction in the U.S.  

In the years leading up to the training, an average of 32% Cheyenne Fire and Rescue patients received non-opioid pain treatments, according to Vaughn. After specialty training and a one year trial period that ended in June, that grew to about 60%.

“This is the first [project] of its kind that we know of where we have completely redone all of the pain protocols, switched up all of the medications and done these really heavy workshops with [over 100 members of] our EMS,” she said.

More data are expected to come from the ambulance service AMR, she said. 

Opioids in an emergency

This latest push for opioid alternatives started in the emergency room. 

Following similar efforts in Colorado, Cheyenne Regional Medical Center’s ER started to follow an Alternative to Opioid — or ALTO — program, but Vaughn said the initial results weren’t as significant as she hoped. 

That could be in part because the effort started during the height of the COVID-19 pandemic — a tumultuous time to introduce new protocols — but also because EMS had yet to be trained on opioid alternatives. 

“We still saw a 10% decrease in opioid administration within the first six months,” when just ER staff were trained, Vaughn said. “But then when we queried our providers afterwards, their main barrier was that the patients were coming to them with opioids already on board.”

That is, EMS had already administered opioids to some patients before they got to the hospital. 

What makes Laramie County’s program unique is that it goes beyond the ER to train EMS providers. 

As the data now show, that novel idea has had significant effects. 

Firefighting pain

Patients were already becoming wary of opioids a few years ago, said Lt. Brice Jacobson, the EMS coordinator for Cheyenne Fire Rescue.

“They’re so afraid that if they get that first dose, they’re now going to be addicted,” he said. 

Being able to offer alternatives to opioids for those who didn’t want those drugs to begin with, “we actually get them excited. Those patients are pretty happy with that,” Jacobson said. 

Opioid alternatives have historically been fairly limited in the prehospital setting, he said, especially when compared to emergency rooms that can stock more medications. At the same time, he added, they can’t just ignore people’s pain. 

“Pain does have a negative effect on the body, especially with healing,” he said. 

Now, armed with new research and training through ALTO programs, Jacobson said paramedics in his crew have new protocols for using alternatives to opioids, like intravenous Tylenol and Motrin. While there had been concerns about side effects of alternatives like Ketorolac before, new research has found the risks are lower than anticipated with small doses, he said.  

“We just analyzed our one year data for that, and we actually had a 28% decrease in opioid administration without any change in patient satisfaction or patient pain control.”

ANGELA VAUGHN, CHEYENNE REGIONAL MEDICAL CENTER

While there was some provider pushback to the new way of doing things, Jacobson said, EMS members are also better trained at talking to patients and assessing how manageable their pain is without opioid intervention.

“I’m also asking … how much pain can you tolerate?” he said. “ And what we find even with that change, a lot of people are like, ‘it’s tolerable. I don’t need this [pain medication].’”

While opioid administrations went down, satisfaction levels have remained largely unchanged, and even improved for some patients, Jacobson found. 

He cautions that opioids, including fentanyl, are still the best way to relieve pain in certain instances, like in a major car crash.

“If someone’s in a car accident, they’re in so much pain and they’re having so many injuries, that it’s just not going to be easy to manage with our non-opioid alternatives,” he said. “So our fentanyl, morphine, those kinds of things might be a little bit better for them. But even then, in those scenarios, we’re still using things more specific like ketamine, and then we’re supplementing … with opiates.”

This isn’t the first time firefighters have been on the cutting edge of fighting the opioid crisis around Laramie County, Jacobson said. While high doses of ketamine have been under scrutiny since Elija McClain’s death, Jacobson said, his department has been using small doses to replace opioids since 2017.

“What the data and research have found before we even went this route [with the ALTO project] was we can still use things like ketamine at a lower dose to manage pain,” he said. “And we’d seen a huge reduction in opiates, just on that alone.”

For Jacobson, trying to combat the opioid crisis is also about making sure people understand how prevalent and dangerous it is. The stigma around it makes it harder to know how many neighbors or friends either have or are in recovery from an opioid use disorder, he said. 

“[An opioid use disorder] affects everyone equally,” he said. “There’s no prejudice, it doesn’t care who you are. It affects everyone.”

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No ‘Silver Bullet’ for Generic Drug Shortage, House Members Told

A total of 301 drugs were in active shortage last year

https://www.medpagetoday.com/publichealthpolicy/healthpolicy/106345

From the beginning of Thursday’s House hearingopens in a new tab or window on ways to solve the generic drug shortage, it appeared obvious that little agreement was going to be reached on the best solutions to the problem.

“After months of pleading by the Democratic members of this subcommittee, we’re finally having a legislative hearing on drug shortages in our country,” Rep. Anna Eshoo (D-Calif.), ranking member of the House Energy & Commerce Health Subcommittee, said in her opening statement. “I’ve been frustrated by our subcommittee’s inaction through the spring and summer as I heard from so many physicians in my congressional district, and read about cancer patients, especially children, left behind due to shortages in life-saving treatments.”

Eshoo was especially critical of a “discussion draft” of legislation known as the Stop Drug Shortages Actopens in a new tab or window sponsored by Rep. Cathy McMorris Rodgers (R-Wash.), chair of the full Energy & Commerce Committee. “This proposal mostly studies the problem with more reports,” she said. “Where the proposal has actionable policy, I think it’s a grab bag of talking points … The [bill’s] proposed inflation rebate policy misunderstands the market failure that caused drug shortages.”

McMorris Rodgers defended the bill. “The discussion draft focuses primarily on generic, sterile, and injectable drugs for a serious disease or condition and getting these drugs out from under mandatory 340B [drug discount program] rebates and inflation penalties,” she said, referring to the 340B drug discount program for hospitals that serve a large proportion of uninsured and underinsured patients. “We require CMS to launch a model that tests market-based pricing policies for these drugs in Medicare as well. The discussion draft also looks into how we can bring transparency to current contracting practices through new 340B guidance and disclosure reporting for group purchasing organizations.”

Subcommittee chair Brett Guthrie (R-Ky.) summarized the extent of the problem. “In 2022 alone, there were 301 drugs in active shortage, according to the University of Utah,” he said. “For over a decade, professionals in the medical and regulatory community have sounded the alarm on the underlying economic causes of drug shortages.”

“Unforeseen circumstances like a tornado hitting a pharmaceutical warehouse in North Carolina, or a manufacturing facility in India shutting down due to quality concerns, can throw a supply chain out of whack and potentially cause a shortage of vital drugs,” he continued. “To ensure we’re prepared to respond appropriately to these issues, we must encourage strong investments to ensure that there are multiple means to develop, store, and distribute drugs.”

Rep. Frank Pallone (D-N.J.), ranking member of the full Energy & Commerce Committee, stressed the need for immediate action. “Experts, including doctors providing care on the front line, told us drug shortages are an ongoing emergency for their patients and a threat to national security,” he said. “Patients and providers are facing life-altering consequences if we don’t do more to address this critical problem.”

In addition to McMorris Rodgers’s bill, the committee was considering several other bills to address the problem, including:

• The Drug Shortage Prevention Act, which would require manufacturers to notify the FDA of a permanent discontinuance or interruption in the manufacture of an excipient (inactive) ingredient or active pharmaceutical ingredient (API) that is likely to result in meaningful disruption in supply. The bill would require the FDA to issue guidance on such notifications no later than 6 months after the enactment of the bill.
• The Ensuring Access to Lifesaving Drugs Act, which would require manufacturers of life-saving drugs to submit expiration and stability testing studies and make labeling changes accordingly; the measure aims to allow manufacturers to extend expiration dates for drugs if it can be done safely.
• The Patient Access to Urgent-Use Pharmacy Compounding Act, which would allow certain facilities to compound drugs when a licensed prescriber certifies to the pharmacist that such prescriber has made reasonable attempts to obtain, but has not been able to obtain, a drug to address an urgent medical need.

Melissa Barber, PhD, postdoctoral fellow at the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, explained what is generally known about the shortage issue. “First, some types of products, particularly generic style injectables, are in short supply more often than others,” she said. “Second, while any shortage is important to patients, not all shortages are equal in terms of public health importance. Third, we know that markets for some products are highly concentrated. [A] 2023 study found that approximately one-third of generic APIs produced for use in U.S. markets were manufactured by a single facility.”

However, much is not known, she continued. “First, we don’t even know the cause of most shortages that are reported. As of June 2023, 59% of reported shortages in the FDA’s database did not have a declared cause because manufacturers are not obligated to give detailed information, nor does the FDA audit data to ensure accuracy … Second, we don’t know how many manufacturers there are globally for a given drug, where they are, or how much manufacturing capacity they have.”

While there is “no single silver bullet” to fix the problem, “as a first step, the Agency Drug Shortages Task Force previously launched by the FDA should be reconvened as a single point of responsibility,” Barber said. “At the very least, federal agencies can coordinate efforts.”

If the problem isn’t solved soon, the entire generic industry is at risk, said David Gaugh, RPh, interim president and CEO of the Association for Accessible Medicines, which represents generic drug manufacturers. “Unless Congress acts to address these issues today, business practices by middlemen such as group purchasing organizations, wholesalers, pharmacy benefit managers, and health plans are disrupting the economic sustainability of generic manufacturing, shrinking product portfolios, and reducing the availability of resources to counter drug shortages,” he said, noting that nine out of every 10 prescriptions are for generic drugs.

Gaugh recommended that Congress take several steps to mitigate the problem, including exempting low-cost generics from the 340B program and ensuring that Medicare drug plans cover and encourage the use of new generics and biosimilars.

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Urgent notice: Bivalent mRNA COVID-19 vaccines are no longer authorized

https://ncpa.org/newsroom/qam/2023/09/13/urgent-notice-bivalent-mrna-covid-19-vaccines-are-no-longer-authorized

The FDA has authorized updated COVID-19 mRNA vaccines for 2023-2024. Pharmacies that have been offering bivalent mRNA COVID-19 vaccines should immediately cease administering these products due to FDA withdrawing authorization. More information is available on the FDA website. When submitting claims for dates of service prior to the withdrawal, double check the submitted date. Note that FDA has not yet authorized or approved an updated Novavax vaccine for 2023-2024. As a result, the existing Novavax vaccine may still be administered at this time if it is determined that the individual should not wait for a 2023-2024 Novavax COVID-19 vaccine.

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