“…in using statistics, the government now has the road map to switch from knowledge to deeds…”
Richard Khorer, Adolf Hitler’s statistician

THE “MONEY BALLING,” OF MEDICINE: DIRECTOR OF DEA ANNE MILGRAM, THE REINCARNATION OF RICHARD KHORER, STATISTICIAN 3rd REICH, “SHE MUST RESIGN” (order of the coif)

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Here is the SMOKING GUN..

This project was funded in part by a contracted project agreement with the CDC, which is an agency of HHS.

An important objective of the project is to develop solutions that improve heart disease and prevent stroke in all communities.

Cardiovascular disease is the leading cause of death in the United States and is influenced by socioeconomic status, environmental conditions, institutional factors, structural racism, various forms of discrimination, and other factors pertaining to health equity.

One of the most common issues of pts dealing with under/untreated pain is typically high blood pressure and/or blood pressure at an emergency crisis level (>200/100).  Look at the third section in the below chart. It doesn’t come out and say what damage can occur, but the other graphic does.

There is about 4 different categories of pharma meds to treat high blood pressure. Many pts have told me that after their opioids were reduced, stopped that their blood pressure typically increased dramatically and their PCP put them – one at a time – all four of these categories of BP meds and their BP typically doesn’t respond and remained at/near/past a hypertensive crisis level.

Perhaps this article and the two graphics will allow the pt to start a discussion concerning their hypertensive crisis level blood pressure levels and the potential physical consequences to the pt if their blood pressure is not lowered. I would hope that the pt would be able to get access to their medical records and if not available, start taking their BP and create a chart of your BP and the MME/day of the opioids that you were taking before having a forced reduction. Most pt would expect to see their BP increase as their MME/day went down and the intensity of their pain went up.

That chart should be an excellent “show & tell” to get a practitioner or pharmacist to defend their rationale as to why the pt’s BP is up as is the pt’s pain intensity is up and MME/day is down and mark on the graphic where pharma BP med is added.

If all else fails, the pt may wish to file a complaint, with HHS and/or CMS

APhA collaborates with CDC to advance health equity and prevent heart disease and stroke

https://www.pharmacist.com/APhA-Press-Releases/apha-collaborates-with-cdc-to-advance-health-equity-and-prevent-heart-disease-and-stroke

WASHINGTON, DC—The American Pharmacists Association (APhA) announced today that it has entered into a contracted project agreement with CDC’s Applied Research and Evaluation Branch in the Division for Heart Disease and Stroke Prevention to accelerate the implementation of pharmacy-based strategies to advance health equity and prevent heart disease and stroke.

APhA’s vision to inspire, innovate, and create opportunities for its members and pharmacists worldwide to optimize medication use and health for all is aligned with the CDC’s goal to improve cardiovascular health equity. APhA will work toward this goal by

• Convening a community of practice to provide innovative peer-to-peer learning and capacity-building opportunities for health departments and pharmacy partners
• Identifying and tailoring promising program models to meet community needs, overcoming challenges to implementation, and building capacity for evaluation and dissemination
• Contributing to practice-based evidence for pharmacy-based strategies to advance health equity in heart disease prevention and treatment

An important objective of the project is to develop solutions that improve heart disease and prevent stroke in all communities.

Cardiovascular disease is the leading cause of death in the United States and is influenced by socioeconomic status, environmental conditions, institutional factors, structural racism, various forms of discrimination, and other factors pertaining to health equity.

Michael D. Hogue, PharmD, FAPhA, FNAP, FFIP, executive vice president and CEO of APhA, said “Pharmacists are trusted community health professionals who are highly accessible to patients and who increasingly engage in team-based care in practice settings that historically work with medically underserved patients. This project will build on the trust that people already have in their pharmacists to provide health screenings, education, and medication adherence counseling as they thoughtfully and comprehensively address patient concerns. Pharmacists, working together with public health entities, are a crucial partner in reducing the risk of heart disease and stroke in the United States.”

This project was funded in part by a contracted project agreement with CDC, which is an agency of HHS.

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Biden Issues New Pardon for All Simple Marijuana Offenses

https://www.americanewsnation.com/2023/12/22/biden-issues-new-pardon-for-all-simple-marijuana-offenses/

On Friday, President Joe Biden has now issued an official declaration that all Americans with a prior marijuana use record, including those who have not been detained or prosecuted, will be granted federal pardons.

All U.S. citizens and lawful permanent residents who are in possession of marijuana for personal use, as well as those convicted of comparable federal offenses, are eligible for the comprehensive pardon. Additionally, marijuana consumers in the District of Columbia are pardoned.

It excludes individuals incarcerated for the unlawful sale of marijuana, in violation of federal law, as well as those convicted of other marijuana-related offenses like operating a motor vehicle while under the influence of an illicit substance.

The potential consequences of Biden’s commutation are substantial, given that criminal records related to marijuana possession and use have hindered access to housing, employment, and educational prospects.

Those who have violated state law are not eligible for pardons; furthermore, documentation of a pardon must be obtained through an application process administered by the Department of Justice.

A year ago, Biden also granted a comparable commutation and made a commitment to implement further reforms. Further, all instances of simple marijuana possession or use were expunged from federal law under this year’s proclamation, including those who had never been charged.

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Spinal Cord Stimulation Questioned for Chronic Pain

Independent studies suggested no benefit, but industry-funded critics cast doubt on the findings

https://www.medpagetoday.com/neurology/painmanagement/107922

Independent studies suggested that spinal cord stimulation improved chronic pain no more than placebo, but industry-funded critics cast doubt on these findings, researchers said.

Recently published papers “found evidence of no benefit on pain and risk of harms,” wrote Adrian Traeger, PhD, of the University of Sydney in Australia, and Lisa Bero, PhD, of the University of Colorado in Aurora, in a JAMA Internal Medicine viewpoint article. “Authors funded by the spinal cord stimulator industry were swift to respond.”

“The responses to recent research on spinal cord stimulation illustrate how corporations continue to undermine independent science,” Traeger and Bero observed. “At a minimum, readers should recognize that attacks on independent science are often sustained and repetitive industry tactics to protect profits and should discount these criticisms.”

Spinal cord stimulation is a costly and invasive procedure and “clinicians and patients need to know what the evidence says about likely benefits and harms,” Traeger noted in an email to MedPage Today.

“As with many procedures to manage chronic pain, there are cases and anecdotes of people improving with spinal cord stimulation,” he continued. “But the best evidence available — from a Cochrane review — suggests that these devices may work no better than a credible placebo. Serious adverse events include infection, lead migration, neurological damage, and re-operation.”

A 2023 Cochrane review of randomized trials led by Traeger reported that data did not support the use of spinal cord stimulation to manage low back pain outside a clinical trial and concluded that spinal cord stimulation probably did not have sustained clinical benefits that would outweigh its costs and risks. A 2001 Cochrane review, which Traeger was not involved in, found very low‐certainty evidence that spinal cord stimulation may not provide clinically important benefits on pain intensity compared with placebo.

In JAMA Neurology, a retrospective comparative effectiveness study showed that the use of a permanent spinal cord stimulator was not associated with a reduction in opioid use or nonpharmacologic pain interventions compared with conventional medical management. Nearly one-fifth of patients treated with spinal cord stimulators experienced complications and required device revision or removal.

And in JAMA, a randomized clinical trial of patients with chronic radicular pain after lumbar spine surgery showed that spinal cord burst stimulation led to no significant difference in back pain-related disability compared with placebo. A follow-up study showed similar results.

Traeger and Bero identified 18 critiques in academic literature of the Cochrane reviews and the JAMA and JAMA Neurology articles. “Industry-funded critics of independent studies often do not follow the usual route of scientific discourse,” they reported.

“Rather than respond to the journal where the original study was published, critics frequently publish in journals where they are the editors and can control the discourse (15 of 18 letters criticizing the independent studies cited in this article appeared in journals with industry-affiliated editors),” they wrote. “The journal can then choose to paywall the subsequent response from the independent authors, giving critics the last word.”

Other strategies included attacking the credibility of the researchers instead of the research and criticizing the Cochrane reviews for assessing clinical trials instead of real-world studies.

Critics also claimed that because the FDA had approved spinal cord stimulators and they’ve been used for decades, there already is evidence for efficacy and safety.

“This is not the case,” Traeger and Bero wrote. “Provision 510(k) requires  that new medical devices need only be ‘substantially equivalent’ to a product already on the market, even if the earlier product is itself untested.”

Part of the concern may stem from the small number of trials comparing spinal cord stimulation and placebo, suggested Shravani Durbhakula, MD, MPH, MBA, of Johns Hopkins School of Medicine in Baltimore, and co-authors in a critique of the 2023 Cochrane review published in Pain Medicine

While Durbhakula and colleagues have ties to industry, they pointed out that independent physician investigators have struggled to complete these studies. “Meanwhile, industry is disincentivized from performing such studies, as the U.S. Food and Drug Administration does not require them for regulatory approvals in the presence of a predicate device, they are costly and hard to accrue patients into, and the risk-benefit ratio does not favor companies and their shareholders,” they wrote.

In the 1950s, the tobacco industry used campaigns of criticism to defend their products, Traeger and Bero noted. Other industries have used similar approaches to cast doubt on independent studies, they added.

Debate is an important part of the scientific process, Traeger pointed out. “When corporations interfere with the scientific process, it puts patients at risk,” he said.

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According to the article – The AvertD test is intended to be used before patients who are being considered for a 4- to 30-day prescription for acute pain (e.g., for a planned surgical procedure) are first exposed to oral opioids. Does this suggest that anyone taking opioids > 30 days should be diagnosed with SUD or OUD?  After all, the DEA states that ALL OPIOIDS ARE HIGHLY ADDICTIVE! Is the FDA aligning with PROP and the opiophoic “experts” that created the 2016 & 2022 CDC opioid dosing guidelines?

First Test to Identify Opioid Addiction Risk Approved by FDA

Genetic test intended to be used before patients are exposed to oral opioids for acute pain

https://www.medpagetoday.com/neurology/opioids/107962

The FDA approved the first test that uses DNA to identify whether adults have an elevated risk of developing opioid use disorder (OUD), the agency said Tuesday.

The AvertD test is intended to be used before patients who are being considered for a 4- to 30-day prescription for acute pain (e.g., for a planned surgical procedure) are first exposed to oral opioids. It is not intended for patients being treated for chronic pain, the agency said.

“AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

The FDA granted approval of AvertD, a prescription-use-only genetic laboratory test, to AutoGenomics, a unit of SOLVD Health. In October 2022, an FDA advisory committee voted strongly against an earlier version of AvertD, with false-negative and false-positive test results being a primary concern.

The earlier AvertD version detected the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. At the advisory committee meeting, SOLVD presented results of an observational study that demonstrated a sensitivity of 82.76% and a specificity of 79.23% for detecting OUD.

Following the advisory committee meeting, the FDA worked with AutoGenomics as it revised its test. The company subsequently submitted a premarket approval application for the modified test.

The test involves swabbing a patient’s cheek to collect a DNA sample. As part of the approval order, AutoGenomics must provide training to healthcare providers to help ensure the test is being used appropriately. The company also must conduct a large post-marketing study to assess AvertD’s performance in patients and regularly report the study’s progress to the FDA.

The primary risks associated with AvertD are false-negative and false-positive results, the FDA noted. A false-negative result could lead to a false sense of security for a patient who has an increased risk of OUD; a false-positive result could lead to inadequate pain management.

“The risks of false-negative and false-positive results can be mitigated, in part, through accurate, transparent product labeling and a healthcare provider training program,” the FDA said. “It is critical that users of the test (healthcare providers and patients) understand how to interpret the test result and use it not in isolation, but as part of a comprehensive clinical evaluation and risk assessment.”

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IT IS NOW TIME FOR HEALTHCARE PROVIDERS TO UNITE! TO PUT AN END TO THE UNITED STATES DRUG ENFORCEMENT ADMINISTRATION’S CRIMINALIZATION OF MEDICAL CARE, DIRECTOR ANN MILGRAM MUST RESIGN AND STEP DOWN:

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Who gets to decide which patients are worthy of pain treatment? Your doctor? Or any federal agent or attorney? The answer to this question will determine the soul of medical practice in this country. Tens of thousands of Americans are dying because of government interference in the practice of medicine, while thousands of doctors are being targeted for destruction.

then there is this “little law”: laws that get passed by NEVER ENFORCED?

42 USC 1395: Prohibition against any Federal interference

https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395%20edition:prelim)

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This is like what happened to pharmacy around 1990. When the PBM’s passed the 50% of the mark of controlling/paying for all prescriptions. First, they started by reducing the “dispensing fee” that they paid pharmacies. Then they started making contracts with some pharmacy chains, and the pharmacy became the exclusive pharmacy for being able to fill/bill prescriptions to a particular PBM.

I had noticed during the recent open enrollment period, that much of the advertisement for MA programs were focused on Medicare/Medicaid pts.  Offering all sorts of “extras”, that traditional Medicare did not pay for. I am unsure if pts paid attention to their advertisements, that MA plans MAY CHANGED EVERY YEAR.  From the reasons why these healthcare providers are dropping from MA programs have turned into a  game of delay, deny, and not pay. Is this where they are going to get the money to pay for all these “extras”?

I expect to see those healthcare systems that stay in these programs, that pts will start seeing a lot of care being provided by mid-levels and an increase in the number of mid-levels being supervised by a single physician.  The pt’s choice of practitioners, hospitals, and other ancillary services will be fewer and fewer.  All healthcare practitioners are equally educated, but not all are equally competent. Our healthcare system is being forced by the insurance companies which could end up being a dramatic shift. Will that be good for the pt and provide equal or better health outcomes and improved QOL?

Hospitals are dropping Medicare Advantage plans left and right

https://www.beckershospitalreview.com/finance/hospitals-are-dropping-medicare-advantage-left-and-right.html

Medicare Advantage provides health coverage to more than half of the nation’s seniors, but a growing number of hospitals and health systems nationwide are pushing back and dropping some or all contracts with the private plans altogether.

Editor’s note: This article was originally published Sept. 27. It was updated Nov. 14 to reflect new contract developments between hospitals and Medicare Advantage plans, which are listed below.

Among the most commonly cited reasons are excessive prior authorization denial rates and slow payments from insurers. Some systems have noted that most MA carriers have faced allegations of billing fraud from the federal government and are being probed by lawmakers over their high denial rates.

“It’s become a game of delay, deny and not pay,” Chris Van Gorder, president and CEO of San Diego-based Scripps Health, told Becker’s. “Providers are going to have to get out of full-risk capitation because it just doesn’t work — we’re the bottom of the food chain, and the food chain is not being fed.” 

In late September, Scripps began notifying patients that it is terminating Medicare Advantage contracts for its integrated medical groups, a move that will affect more than 30,000 seniors in the region. The medical groups, Scripps Clinic and Scripps Coastal, employ more than 1,000 physicians, including advanced practitioners. 

Mr. Van Gorder said the health system is facing a loss of $75 million this year on the MA contracts, which will end Dec. 31 for patients covered by UnitedHealthcare, Anthem Blue Cross, Blue Shield of California, Centene’s Health Net, and a few more smaller carriers. The system will remain in the network for about 13,000 MA enrollees who receive care through Scripps’ individual physician associations.

“If other organizations are experiencing what we are, it’s going to be a short period of time before they start floundering or they get out of Medicare Advantage,” he said. “I think we will see this trend continue and accelerate unless something changes.”

Bend, Ore.-based St. Charles Health System took it a step further and was not only considering dropping all Medicare Advantage plans, but also encouraged its older patients not to enroll in the private plans during the upcoming enrollment period in October. The health system’s president and CEO, CFO and chief clinical officer cited high rates of denials, longer hospital stays and overall administrative burden for clinicians. Ultimately, the health system has decided to remain in network with four MA carriers and will not renew contracts with three.

“We recognize changing insurance options may create a temporary burden for Central Oregonians who are currently on a Medicare Advantage plan, but we ultimately believe it is the right move for patients and for our health system to be sustainable into the future to encourage patients to move away from Medicare Advantage plans as they currently exist,” St. Charles Health CFO Matt Swafford said.

“I feel terrible for the patients in this situation; it’s the last thing we wanted to do, but it’s just not sustainable with these kinds of losses,” Mr. Van Gorder added. “Patients need to be aware of how this system works. Traditional Medicare is not an issue. With these other models, seniors need to be wary and savvy buyers.”

Here are 13 more recent instances of hospitals dropping Medicare Advantage contracts:

1. In October, the Nebraska Hospital Association issued a report detailing how Medicare Advantage is “failing patients and jeopardizing Nebraska hospitals,” 33% of which do not accept MA patients. The report cited negative patient experiences, post-acute placement delays, and administrative and financial burdens on hospitals that accept MA patients.

2. York, Pa.-based WellSpan Health will no longer accept Humana Medicare Advantage and UnitedHealthcare-AARP Medicare Advantage plans starting Jan. 1. UnitedHealthcare group MA PPO and Humana employer PPO MA plans will still be accepted.
3. Greenville, N.C.-based ECU Health said it anticipates it will no longer be in network with Humana’s Medicare Advantage plans starting Jan. 1.
4. Raleigh, N.C.-based WakeMed went out of network with Humana Medicare Advantage plans in October. According to CBS affiliate WNCN, the plan provides coverage to about 175,000 retired state employees. WakeMed cited a claims denial rate that is “3 to 4 times higher” with Humana compared to its other contracted MA plans.
5. Zanesville, Ohio-based Genesis Healthcare System is dropping Anthem BCBS and Humana Medicare Advantage plans in 2024.
6. Brunswick-based Southeast Georgia Health System will terminate its contract with Centene’s WellCare Medicare Advantage plan on Dec. 8. The system said it started negotiations with the carrier after years of “inappropriate payment claims and unreasonable denials.”
7. Nashville, Tenn.-based Vanderbilt Health went out of network with Humana’s HMO Medicare Advantage plan in April.
8. Fayetteville, N.C.-based Cape Fear Valley Health dropped UnitedHealthcare Medicare Advantage plans in July.
9. Corvallis, Ore.-based Samaritan Health Services ended its commercial and Medicare Advantage contracts with UnitedHealthcare. The five-hospital, nonprofit health system cited slow “processing of requests and claims” that have made it difficult to provide appropriate care to UnitedHealth’s members, which will be out of network with Samaritan’s hospitals on Jan. 9. Samaritan’s physicians and provider services will be out of network on Nov. 1, 2024.
10. Cameron (Mo.) Regional Medical Center stopped accepting Cigna’s MA plans in 2023 and plans to drop Aetna and Humana in 2024. It plans to continue Medicare Advantage contracts with UnitedHealthcare and BCBS, the St. Joseph News-Press reported. Cameron Regional CEO Joe Abrutz previously told the newspaper the decision stemmed from delayed reimbursements.
11. Stillwater (Okla.) Medical Center has ended all in-network contracts with Medicare Advantage plans amid financial challenges at the 117-bed hospital. The hospital said it made the decision after facing rising operating costs and a 22% prior authorization denial rate for Medicare Advantage plans, compared to a 1% denial rate for traditional Medicare.
12. Brookings (S.D.) Health System will no longer be in network with nearly all Medicare Advantage plans in 2024, with the exception of Medica. The 49-bed, municipally owned hospital said the decision was made to protect the financial sustainability of the organization.
13. Louisville, Ky.-based Baptist Health Medical Group went out of network with Humana’s Medicare Advantage plans in September, Fox affiliate WDRB reported. The system will also go out of network with UnitedHealthcare and Centene’s WellCare on Jan. 1 without a new agreement in place.

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A federal watchdog is investigating whether the U.S. Drug Enforcement Administration under chief Anne Milgram improperly awarded millions of dollars in no-bid contracts to hire her past associates, people familiar with the probe told The Associated Press.

“THE UNINTENDED CONSEQUENCES OF MILITANT PROSECUTORIAL IGNORANCE OF PAIN HEALTHCARE”…SHAKEDOWN OF MEDICAL PROVIDERS LED BY DEA CHIEF ANN MILGRAM’S UNSPEAKABLE HISTORY OF CORRUPTION, FRAUD, AND DECEIT. SHE MUST RESIGN, STEP DOWN

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While this article starts talking about abortion.  All of us have seen the impact of politicians/bureaucrats exercising their opinions or the opinions of others who have lobbied these bureaucrats/politicians who convinced them what they were being told were the correct FACTS, which should be used to create some legislation. It also demonstrates how attorneys are imposing their opinions/beliefs on a large portion of our population in relation to how/if certain medical procedures/treatments should be provided and if provided on a limited basis. At what point can we expect attorneys & or the judicial system to stop trying to protect us from ourselves?

Recent abortion cases are a harbinger of things to come…

https://www.daily-remedy.com/abortion-harbinger-of-healthcare/

Two recent court cases that transpired just this week are harbingers of future judicial activism that is likely to ramp up next year during the election cycle.

First, the Texas Supreme Court recently made a controversial decision regarding the medical exemption for abortion in the case of Kate Cox, a woman carrying a fetus with a fetal chromosomal abnormality. The ruling prompted her to seek an abortion out of state.
Second, the Supreme Court agreed to review the issue of whether mifepristone, a commonly prescribed abortion medication, can be prescribed through telemedicine visits and shipped to a patient’s home by mail.
At first blush, it may feel like the two cases have little to do with one another aside from being about abortions. But the similarities run perniciously deep and reflect a common theme when it comes to abortion and its policy: non-clinically trained judges use legal rhetoric to justify an inherently moralized position on abortion.

Several factors determine which avenues of drug discovery that people in research and pharmaceutical companies focus on. Research funding amplifies the pace of scientific discovery needed to create new treatments.

How to strike a balance between providing incentives to develop miracle drug therapies for a few people at the expense of the many is a question researchers and policymakers are still grappling with.
In 2021, 51% of drug discovery spending in the U.S. was directed at only 2% of the population.
Of the more than 7,000 known rare diseases, defined as fewer than 200,000 people affected in the U.S., only 34 had a therapy approved by the Food and Drug Administration before 1983.

Clinical trials serve as the gold standard for evaluating the safety and effectiveness of new treatments. However, recent investigations have brought to light a disturbing truth: flawed data and fraudulent practices are more prevalent than we may realize.

One of the leading voices in exposing these issues is Dr. Carlisle, an Anesthesiologist working for England’s National Health Service, who meticulously examined a random sample size of over 500 studies and found that 44% contained flawed data, with 26% being completely untrustworthy.
The rise of paper mills, or journals that publish voluminous amounts of specious studies at an increasingly expeditious rate, has further exacerbated the problem, with tens of thousands of suspected fake papers flooding journals.
When flawed or fraudulent data is used to support the approval of a treatment, patients may be exposed to unnecessary risks or be denied access to alternative therapies that may be more effective and safer.

Coughs are notorious this time of the year, with the winter winds blowing and so many remaining indoors for prolonged periods.

It is ordinary enough to carry on with it, yet persistent enough to ruin anyone’s day. This delicate balance explains why ‘cough’ is among the most commonly searched terms on Google right now.
Interestingly enough, neither antibiotics nor antitussives or cough suppressants, make much of a difference. In a prospective study analyzing whether a cough resolved when treated with either medication, the majority found little to no symptomatic relief.
How much of this comes from actually being treated versus the placebo effect, or the perception of being treated, is still unknown, but we surmise most if not all the perceived improvement gleaned was more perceptual than true clinical benefit.

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