Planning to Stop That Benzodiazepine? Think Twice

Posted on January 5, 2024 by Pharmaciststeve

Planning to Stop That Benzodiazepine? Think Twice

Patients who discontinued long-term benzodiazepines had a higher risk of death

https://www.medpagetoday.com/psychiatry/generalpsychiatry/107959

Stopping long-term benzodiazepine treatment was tied to a higher risk of death, according to a comparative effectiveness study using claims data.

An intention-to-treat analysis showed that among people who weren’t simultaneously taking an opioid, the adjusted cumulative incidence of death over 1 year was 5.5% for those who stopped benzodiazepine treatment compared with 3.5% for those who didn’t, according to Donovan Maust, MD, MS, of the University of Michigan in Ann Arbor, and colleagues.

Those who were on concomitant opioids also had a higher incidence of death over 1 year if they stopped benzodiazepines compared with those who continued treatment (6.3% versus 3.9%), they reported in JAMA Network

Mortality risk for those who stopped benzodiazepines was 1.6 times higher than for those who stayed on treatment, with or without concomitant opioid use (95% CI 1.5-1.7 and 95% CI 1.6-1.7, respectively), they reported, noting that all of these risks held in a per-protocol analysis, and were slightly higher.

“Decades of research have demonstrated harms associated with benzodiazepine use, such as fall-related injury and increased risk of overdose — so the assumption has been that less benzodiazepine use would mean fewer harms,” Maust told MedPage Today in an email. “Our analysis suggests that, at least in those who have been receiving stable long-term treatment, risk of mortality appears to be higher in those individuals who have the benzodiazepine prescription stopped.”

“I think the findings speak to the importance of carefully considering the risk/benefit balance of continuing a benzodiazepine prescription,” he added.

Clinicians should be careful about letting their patients become long-term benzodiazepine users, especially if they plan to follow the standard of tapering those patients at some point, Maust added.

“I think it is important to revisit the assumption that tapering stable long-term users should be the default and instead, perhaps, focus on those with clearly elevated risk of harms,” he said.

Philip Muskin, MD, of Columbia University, who was not involved in the study, agreed that the results suggest clinicians should be even more deliberate about starting patients on benzodiazepines.

While the absolute risk shown in the study is small, Muskin said, “it’s real, and I think we need to respect that.”

Some people need and benefit from benzodiazepines, and they appear to be better off remaining on these drugs long-term, Muskin said. Based on these results, clinicians also likely need to diligently monitor any patient who begins to taper off benzodiazepines, even long after they discontinue the treatment, he added.

Increases in overdose deaths involving benzodiazepines have risen over the past several years, leading to a number of FDA actions including a 2016 warning related to co-prescribing with opioids and a 2020 class-wide boxed warning about the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions.

The FDA is also developing an evidence-based clinical practice guideline for the safe tapering of benzodiazepines, Maust and colleagues wrote. However, no studies have looked at the risks of discontinuation, they said. Stopping benzodiazepines may be “particularly fraught” as it can have both physiological and psychological implications, they added.

For their study, Maust and colleagues assessed claims data from Optum on patients with a benzodiazepine prescription from 2013 through 2019, totaling 213,011 without concomitant opioids and 140,565 with opioids. Mean age was about 62 and nearly two-thirds in each group were women.

Discontinuation was defined as having no benzodiazepine prescription for 31 consecutive days during a 6-month period after baseline. Patients were followed for about 1 year after baseline benzodiazepine prescriptions.

The researchers also found the risks of secondary outcomes including nonfatal overdose, suicidal ideation, and emergency department use were higher among those who stopped benzodiazepines, whether or not they also used opioids (relative risk 1.2, 1.4, and 1.2, respectively).

The study was limited in that it wasn’t a randomized controlled trial and couldn’t account for all possible confounders. Also, risks may vary by the speed of tapering, which the researchers did not investigate, Maust said. Finally, his team used a strict definition for stable long-term use of benzodiazepines, so this population may have been more likely to experience discontinuation-related distress and adverse effects.

Still, the researchers concluded that the findings are “at odds with the assumption underlying ongoing policy efforts that reducing benzodiazepine prescribing to long-term users will decrease harms,” adding that future work should examine possible mechanisms underlying these findings.

“It is possible that, having become physiologically dependent on benzodiazepines, patients experience adverse outcomes from withdrawal,” they wrote. “Alternatively, patients may experience adverse consequences if they seek alternative sedating substances (e.g., cannabis or alcohol) following benzodiazepine discontinuation.”

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Evidence-Based Policymaking: What’s Absent from the Opioid Crisis

Posted on January 3, 2024 by Pharmaciststeve

Evidence_Based_Policymaking_Whats_Absent

 

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How Connecticut is going to resolve the opioid crisis – with an ORANGE STICKER

Posted on January 2, 2024 by Pharmaciststeve

How Connecticut is going to resolve the opioid crisis – with an ORANGE STICKER

 

https://eregulations.ct.gov/eRegsPortal/Search/getDocument?guid=%7bA040AB8B-0000-C719-9001-39963994F028%7d

As of January 1, 2024, Connecticut state law requires that all controlled substance and opioid prescriptions have a fluorescent warning label attached. Click here to see the regulations, policies and procedures.

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HOW STATE’S ATTORNEY GENERALS BILKED $BILLION IN FALSE OPIOID CRISIS SETTLEMENTS

Posted on December 31, 2023 by Norman Clement

HOW STATE ATTORNEY GENERALS FRABRICATED DATA ANALYTICS, USED DECEPTIVE METHODOLOGIES, TO WRONGFULLY TARGET OXYCONTIN/ PURDUE PHARMA, CVS, WAL-MART, RITE AIDE, et. al., BILKING $BILLIONS IN SETTLEMENT SCAMS (Part-1)

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A potential BLACK SWAN EVENT for the chronic pain community

Posted on December 31, 2023 by Pharmaciststeve

This is the definition of a Black Swan Event from ChatGPT

A black swan event refers to an unpredictable and rare occurrence that has a major impact. The term was popularized by Nassim Nicholas Taleb in his 2007 book, “The Black Swan: The Impact of the Highly Improbable.” The metaphorical black swan was used to describe an event that was considered impossible or highly improbable based on prior observations (as the conventional wisdom was that all swans were white), but that had profound consequences when it occurred.

In the context of finance and economics, black swan events are typically events that are unforeseen, have a major impact, and are often rationalized in hindsight. Examples of black swan events in history include the 2008 financial crisis, the 9/11 terrorist attacks, and the collapse of the Soviet Union. These events are characterized by their extreme rarity, the severe impact they have on systems, and the difficulty of predicting or preparing for them.

The concept of black swan events underscores the limitations of relying solely on historical data and statistical models for predicting future events, as it emphasizes the importance of being prepared for unexpected and rare occurrences that can have far-reaching consequences.

I have made a blog post before about the agreement between 41 state AG’s and the 3 major drug wholesalers to REDUCE the controlled meds that are sold to community pharmacies  Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs    Recently the DEA published proposals to cut Pharma opioid production quotas, as required by law, and had a period for interested parties to make comments, as required by law. I am not aware that the DEA had any requirement to give any serious consideration to the comments made, so it has been reported that they have posted the original proposed cuts as their final decision.

Earlier this year, the DEA stated that <1% of pharma opioids are being diverted, so for the DEA cutting of production quotas will almost guarantee further shortages of opioid meds. The “special twist” that the DEA has put into the process. They are moving from an annual production quotas to a QUARTERLY PRODUCTION QUOTA!

I have read that some of the Pharmas have stated that their cycle of ordering raw material to final production of the medication could be as long as SIX MONTHS!  This suggests that the availability of opioid meds could end up in a highly unpredictable availability.

If this comes to fruition, how many pts are going to be thrown into cold turkey withdrawals, because their meds are not available, and how many times is this going to happen to these pts?  If the DEA ignores the concerns of the pharmas about having quarterly production quotas, would suggest that the DEA has a dedicated purpose to disrupt the medical care of those in the chronic pain community. In no way can they claim that such a disruption has unintentional consequences/outcomes.

All of us can just imagine the anxiety levels of chronic pain pts as their refill date approaches.

Maybe it is time for all involved (pharmas, wholesalers, pharmacies, prescribers) in the treatment of pts dealing with medical issues that require being prescribed controlled meds, to challenge the CSA constitutionality and the DEA’s violation of a federal law that was on the books BEFORE the CSA was signed into law.

This may be an excellent example of our judicial system, where/how Congress can pass a bill and the President can sign it into law and there are no checks and balances if a new law is actually constitutional but can be enforced until some entity challenges it constitutionally in our courts. Some of us remember that the CSA was strongly supported by our then President “tricky dick” Nixon. Who was a known racist, and bigot and wanted to put all hippies and blacks in jail.

Here is the law that may apply:

42 USC 1395: Prohibition against any Federal interference

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

From Title 42-THE PUBLIC HEALTH AND WELFARE CHAPTER 7-SOCIAL SECURITY SUBCHAPTER XVIII-HEALTH INSURANCE FOR AGED AND DISABLED

§1395. Prohibition against any Federal interference

Nothing in this sub chapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added Pub. L. 89–97, title I, §102(a), July 30, 1965, 79 Stat. 291 .)

Statutory Notes and Related Subsidiaries

Short Title

For short title of title I of Pub. L. 89–97, which enacted this subchapter as the “Health Insurance for the Aged Act”, see section 100 of Pub. L. 89–97, set out as a Short Title of 1965 Amendment note under section 1305 of this title.

Protecting and Improving Guaranteed Medicare Benefits

Pub. L. 111–148, title III, §3601, Mar. 23, 2010, 124 Stat. 538 , provided that:

“(a) Protecting Guaranteed Medicare Benefits.-Nothing in the provisions of, or amendments made by, this Act [see Short Title note set out under section 18001 of this title] shall result in a reduction of guaranteed benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].

“(b) Ensuring That Medicare Savings Benefit the Medicare Program and Medicare Beneficiaries.-Savings generated for the Medicare program under title XVIII of the Social Security Act under the provisions of, and amendments made by, this Act shall extend the solvency of the Medicare trust funds, reduce Medicare premiums and other cost-sharing for beneficiaries, and improve or expand guaranteed Medicare benefits and protect access to Medicare providers.”

 

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What are nitazenes? What to know about the drug that can be 10 times as potent as fentanyl

Posted on December 30, 2023 by Pharmaciststeve

What are nitazenes? What to know about the drug that can be 10 times as potent as fentanyl

https://www.cbsnews.com/news/nitazenes-fentanyl-substance-use-drug-supply-opioid-death-colorado/

A Colorado overdose death has been linked to a new formulation of nitazenes, a class of powerful opioid analgesics being increasingly seen in the illicit drug market. 

Nitazenes have been around for decades, experts told CBS News, and have been seen in multiple formulations. The person who died in Colorado had used a formulation called N-Desethyl etonitazene. The man died in mid-2023, officials said, but laboratory testing about the substance he overdosed on was not returned until recently.  

It’s believed to be the first time that formulation was found in an overdose death, according to the Boulder County Coroner’s office. 

The coroner told CBS News that while the area has seen a decrease in fentanyl overdoses, use of nitazenes has emerged — which “raises new concerns.” 

Here’s what to know about nitazenes. 

Alex Krotulski, 32, associate director and forensic toxicologist, holds a nitazene powder sample at the Center for Forensic Science Research and Education on Friday, Oct. 20, 2023, in Willow Grove, Pennsylvania. Photo by Joe Lamberti for The Washington Post via Getty Images

What are nitazenes? 

Nitazenes were first developed in the 1950s and early 1960s, said Claire Zagorski, a chemist, paramedic and translational scientist in Austin, Texas. At the time, they weren’t illicit drugs, but were intended to be sold commercially. That never happened, Zagorski said, and in recent years, those original formulations have been used as a backbone by illicit drug manufacturers to make new synthetic opioids amid a crackdown on substances like fentanyl. 

“When you have a backbone of one drug to start with, there is almost limitless ways to modify it,” Zagorski said. Modifications are made by adding substances to that backbone in a laboratory setting. 

The illicit use of nitazenes remains rare, according to Dr. Wilson M. Compton, the deputy director of the National Institute on Drug Abuse. However, testing for nitazenes is not conducted in every overdose death, Compton said, so “we don’t actually know the complete universe of how many deaths are due to these potentially very toxic compounds.” 

Compton said that according to reports by the Drug Enforcement Administration, nitazenes make up “much less than 1%” of the opioids that the agency seizes. However, Zagorski said she expects to see those numbers rise. 

Alex Krotulski, 32, associate director and forensic toxicologist, prepares nitazene powder samples for analysis at the Center for Forensic Science Research and Education on Friday, Oct. 20, 2023, in Willow Grove, Pa. Photo by Joe Lamberti for The Washington Post via Getty Images

“I wouldn’t be surprised if we see more and more nitazenes because they’re still under the radar to a lot of America and it takes time to implement advisories for law enforcement to all get on the same page of what they need to look for,” she said. 

There are multiple forms of the drug circulating, including the N-Desethyl etonitazene version seen in Colorado. Other common formulations include isotonitazenes, metonitazenes, etonitazenes and protonitzenes, according to the Alcohol and Drug Foundation.

“It really is like Whack-a-Mole. Like they just keep coming and coming and coming,” Zagorski said, because of the way the drugs are developed. Now that stopping fentanyl is a national priority, she expects to see more nitazenes being developed by illicit manufacturers and used as authorities to catch up.

“We’re seeing all of these odd chemicals kind of popping up. It’s kind of a divide and conquer strategy, and it’s hard to keep it keep track of things like that,” she said.

Are nitazenes more dangerous than fentanyl? 

Both Zagorski and Compton described nitazenes as “very potent,” but how much risk they pose varies based on the different formulations. N-Desethyl etonitazene and another formulation, etonitazene, are “about 10 times as potent as fentanyl,” Zagorski said. Fentanyl is about 50 times more potent that heroin, according to the DEA. 

“This is really going to hit with a wallop,” Zagorksi said. 

Compton said that some versions of nitazenes can be even more dangerous than carfentanil, which is a fentanyl compound that is about 100 times more potent than fentanyl itself. 

“They’re even more potent than something that we’re already quite concerned about,” said Compton. 

Nitazenes can also be mixed into other drugs that are sold illicitly, meaning people may not know that they’re consuming something so dangerous, Compton said.

“Nitazenes being mixed with other illicit drugs emphasizes the increased risk of harm or death. Illicit drug suppliers often mix drugs to increase potency or lower costs,” the Boulder County coroner’s office said. It’s not clear if the man who died in Colorado knew he was ingesting N-Desethyl etonitazene.

There also hasn’t been much research into how nitazenes interact with other substances, so there may be unexpected side effects from mixing it with other drugs or alcohol, Compton said. 

Does naloxone work on nitazenes? 

Naloxone, a medication that reverses opioid overdoses and is more commonly known by the brand name Narcan, can reverse an overdose that involves nitazenes, experts said. 

Naloxone is an opioid antagonist that binds to the same receptors in the brain that are affected by nitazenes, Zagorski said. 

Compton said that anyone who experiences a nitazene overdose and is revived with naloxone should seek medical treatment because some nitazines may be long-acting.

“There’s a concern that as the naloxone wears off, they may fall back into a coma and have respiratory depression,” Compton said. 

Naloxone also works on powerful synthetic opioids like fentanyl and carfentanil, and is available over-the-counter. 

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Biden administration’s Medicare drug price negotiations will face major tests in 2024

Posted on December 29, 2023 by Pharmaciststeve

Those of us in the pharmacy community are aware of the discounts/rebates/kickbacks that the PBM demands from the Pharmas to have one or more of their meds on the PBM’s formulary, meaning that when a prescriber writes an Rx for the particular med, no prior authorization is required, but the PBM expects a discount/rebate/kickback from the pharma. That amount can be up to 75% of the Average Wholesaler Price.

Now Medicare wants to negotiate the price that the pharma is being paid for specific Rx medications. Someone is going to have $$ taken out of their pocket over this Medicare price negotiation,  the two entities with the least control over all of this are the pharmacy and the patient. The PBM’s will just pay the pharmacy less to fill Rxs, they will charge pts higher premiums, copays, and deductibles.

Biden administration’s Medicare drug price negotiations will face major tests in 2024

https://www.cnbc.com/2023/12/28/medicare-drug-price-negotiations-whats-ahead-in-2024.html

U.S. patients and drugmakers will get a first glimpse of how much Medicare can negotiate down drug prices in 2024, setting the precedent for a controversial process that may affect what seniors pay for dozens of medications by the end of the decade. 

It could also be a pivotal year for the lawsuits that drugmakers – including Merck

, Johnson & Johnson and Bristol Myers Squibb

– have filed against the price talks. Decisions could come down in some of the cases next year, which could eventually escalate the issue to the Supreme Court.

President Joe Biden’s Inflation Reduction Act, which passed in a party-line vote last year, gave Medicare the authority to directly hash out drug prices with manufacturers for the first time in the federal program’s nearly 60-year history. 

Medicare is negotiating prices for the first round of 10 prescription drugs in a bid to make those costly treatments more affordable for older Americans. By the fall, the federal government will publish the agreed-upon prices for those medications, which will go into effect in 2026. 

Why 2024 will set a precedent for price talks

The outcomes of the talks will have huge stakes for the pharmaceutical industry, which views the process as a threat to its revenue growth, profits and drug innovation.

The final prices will determine how much revenue the companies that make the drugs can expect to lose in a few years. The figures will also give other drugmakers an idea of how much their sales could be affected if their medications are selected for future rounds of negotiations. 

But the final agreed-upon prices are also significant for patients, who will get a first look at how much money the talks will save them at a time when many older people increasingly struggle to afford medications. 

“We’re going to see how much that program is able to negotiate and it’ll give patients who are already on [the drugs] an idea of the savings they’re going to see,” said Leigh Purvis, a prescription drug policy principal at the AARP Public Policy Institute.

AARP is the influential lobby group that represents people older than 50. The organization has advocated for Medicare’s new negotiation powers.

A pharmacist holds a bottle of the drug Eliquis, made by Pfizer Pharmaceuticals, at a pharmacy in Provo, Utah, January 9, 2020.
George Frey | Reuters

The drugs subject to the negotiations are among the top 50 with the highest spending for Medicare Part D, which covers prescription medications that seniors fill at retail pharmacies. 

In 2022, 9 million seniors spent $3.4 billion out of pocket on the 10 drugs, and some paid more than $6,000 per year for just one of the medications on the list, according to the Biden administration.

Nearly 10% of Medicare enrollees ages 65 and older, and 20% of those under 65, report challenges in affording drugs, the administration said in August. 

Medicare covers roughly 66 million people in the U.S., and 50.5 million patients are currently enrolled in Part D plans, according to health policy research organization KFF.

What the negotiation timeline looks like

The Biden administration officially kicked off the negotiation process in August when it named the first round of medications subject to the price talks. They include diabetes drugs from Merck and AstraZeneca, and blood thinners from Bristol Myers Squibb and Johnson & Johnson.

Two months later, all companies that make the drugs on the list signed agreements to participate in the negotiations, even after most of them sued the Biden administration to halt the talks. 

But the actual negotiation period will begin on Feb. 1, when the Centers for Medicare & Medicaid Services will make initial “maximum fair price” offers for each of the 10 drugs selected. CMS is required to include a justification for why the price is fair based on several factors.

That includes U.S. sales volume data, a manufacturer’s research and development costs, federal financial support for the drug’s development, data on pending or approved patent applications and exclusivities, or a period of time when a brand-name drug is protected from generic competition. 

First 10 drugs subject to price negotiations
  • Eliquis, made by Bristol Myers Squibb, is used to prevent blood clotting, to reduce the risk of stroke.
  • Jardiance, made by Boehringer Ingelheim, is used to lower blood sugar for people with Type 2 diabetes. 
  • Xarelto, made by Johnson & Johnson, is used to prevent blood clotting, to reduce the risk of stroke.
  • Januvia, made by Merck, is used to lower blood sugar for people with Type 2 diabetes.
  • Farxiga, made by AstraZeneca, is used to treat Type 2 diabetes.
  • Entresto, made by Novartis, is used to treat certain types of heart failure.
  • Enbrel, made by Amgen, is used to treat rheumatoid arthritis. 
  • Imbruvica, made by AbbVie, is used to treat different types of blood cancers. 
  • Stelara, made by Janssen, is used to treat Crohn’s disease.
  • Fiasp and NovoLog, insulins made by Novo Nordisk.

After receiving the offers, companies have a month to accept it or counter it. Negotiations end when CMS and drugmakers reach an agreement. 

If CMS rejects the counteroffer for a drug, the agency can arrange up to three meetings with the drugmaker to discuss other price options. 

CMS has to make final price offers to the manufacturers by July 15, and those companies have two weeks to accept or reject them. If drugmakers fail to agree on a price with Medicare by Aug. 1, they may be forced to pay an excise tax of up to 95% of a medication’s U.S. sales or pull all of their drug products from the Medicare and Medicaid markets. 

CMS will publish agreed-upon prices on Sept. 1. 

After the initial round of talks, CMS can negotiate prices for another 15 drugs that will go into effect in 2027 and an additional 15 that will go into effect in 2028. The number rises to 20 negotiated medications a year starting in 2029.

CMS will only select Medicare Part D drugs for the medicines covered by the first two years of negotiations. It will add more specialized drugs covered by Medicare Part B, which are typically administered by doctors, in 2028. 

How drugmaker lawsuits could develop

The legal fight between drugmakers and the Biden administration could also see crucial developments in 2024, as cases may start moving to appeals courts. 

Merck, Johnson & Johnson, Bristol Myers Squibb, AstraZeneca  , Novo Nordisk, Novartis

and Boehringer Ingelheim are all suing to halt the negotiation process. Each of the companies has one drug selected for negotiations. 

The industry’s biggest lobbying group, PhRMA, and the nation’s largest business lobbying organization, the U.S. Chamber of Commerce, have filed their own lawsuits. A federal judge in September denied a preliminary injunction sought by the Chamber of Commerce, which aimed to block the price talks.

All of the drugmakers and both trade groups have asked for summary judgments in their cases against the Biden administration, arguing the price talks are unconstitutional and must be struck down. 

Decisions in most of those cases could occur in the next six months, according to Kelly Bagby, vice president of litigation at the AARP Foundation. 

She said that regardless of what the decisions are, they will likely get appealed to federal appellate courts across the U.S. The pharmaceutical industry may be trying to obtain conflicting rulings from those appeals courts, which could fast-track the issue to the Supreme Court, Bagby added. 

“The Supreme Court would feel obliged to take the case and evaluate the constitutionality of the Inflation Reduction Act itself,” Bagby said, noting that the issue may not reach the nation’s highest court until 2025. 

Some drugmakers, such as Merck, have already confirmed they want to bring their legal battle to the Supreme Court.

Drugmakers in the lawsuits argue the negotiations would force them to sell their medicines at huge discounts, below market rates. They assert that this violates the Fifth Amendment, which requires the government to pay reasonable compensation for private property taken for public use. 

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Artificial Intelligence and Data Mining Against Doctors

Posted on December 29, 2023 by Pharmaciststeve

Looks like George Orwell, may have been just 40 yrs off in the novel he wrote – 1984. Some 20%-30% of our population has Medicare or Medicaid as their health insurance. They also have some control over your income. SS checks were increased by 3.2% for 2024, BUT President Biden just gave all federal employees a 5.2% pay increase. So UNCLE SAM can control how much or how little health you receive and/or entitled to, which can have a dramatic impact on a person’s QOL! With the massive expansion of AI (Artificial Intelligence). Bureaucrats will need a lot fewer employees to do data mining on people they believe are doing something that is illegal or something that some bureaucracy just doesn’t like what they are doing.

Artificial Intelligence and Data Mining Against Doctors

https://doctorsofcourage.org/artificial-intelligence-and-data-mining-against-doctors/

AI and Privacy Clash in United States v. Dr. Neil Anand M.D.: Warrantless Data Mining and the Battle for Healthcare Privacy

In a groundbreaking legal case that has ignited a nationwide debate on privacy, surveillance, and the limits of government artificial intelligence (AI), United States v. Anand has brought to light the use of AI computer algorithms for targeting and interrogating chronic pain patients and those with substance use disorders. Dr. Neil Anand, a medical professional, finds himself at the center of a legal battle that raises critical questions about the loss of medical privacy in the United States and its potential implications for legal cases in the future.  The United States Department of Justice (DOJ) and the Department of Health and Human Services (HHS) have recently intensified their efforts to combat healthcare fraud through the use of data analytics, Generative Artificial Intelligence (AI), and Machine Learning. These advanced technologies have yielded success in identifying instances of fraud, but they have also inadvertently targeted innocent healthcare providers and practices, sparking a national debate about the balance between crime prevention and civil liberties.

The Government’s Reliance on Advanced Technologies

The federal government’s fight against healthcare fraud is not new, but its recent surge in hiring prosecutors and FBI agents with expertise in AI and machine learning signifies a significant shift in strategy. The government focuses on detecting “fraud, waste, and abuse” in the healthcare industry, with data analytics playing a pivotal role in their success. According to the DOJ and HHS, their investment in data analytics yields a remarkable return on investment, with each dollar spent on healthcare fraud detection and enforcement resulting in a return of at least four dollars.  However, experts caution that these technologies can lead to innocent healthcare providers and practices being accused of wrongdoing simply because they exhibit statistical anomalies or are considered outliers in their practices. The critical question raised by this approach is whether it inadvertently identifies some legitimate practices and providers as fraudsters.

The Role of Data Analytics

Jacob Foster, Principal Assistant Chief of the DOJ’s Health Care Fraud Unit, emphasizes that data analytics should not be used to conclusively determine misconduct. He insists that data is a tool to suggest the need for further investigation and that a thorough inquiry is necessary.  Unfortunately, the government has not always followed this advice. Healthcare providers and legal experts have witnessed cases where data analytics wrongly accused individuals of fraud, leading to significant financial and reputational costs before their names were cleared after providing context to the government

Targeting of Chronic Pain and Substance Use Disorder Patients

The data mining operations extended beyond mere surveillance, reaching the targeting of specific patient groups, notably chronic pain patients and those struggling with substance use disorders. Government AI algorithms and targeting packages were employed for unsolicited interrogation of patients in United States v. Anand, raising profound ethical and legal questions regarding the boundaries of surveillance and profiling.

The Involvement of Private Companies and Government Contractors

Qlarant, a Maryland-based technology company, has developed algorithms to identify questionable behavior patterns related to controlled substances and opioids. These algorithms analyze various data sources, including court records, insurance claims, drug monitoring data, property records, and incarceration data, to flag providers. While these algorithms play a crucial role in identifying potential issues, William Mapp, Qlarant’s Chief Technology Officer, acknowledges the potential for errors and emphasizes that the final decision about how to act on the information lies with people, not the algorithms themselves.

United States v Anand: A Landmark Case

The case of United States v Anand has ignited a national debate about privacy, surveillance, and the reach of government AI. Dr. Neil Anand, a medical professional, found himself at the center of a legal battle that revealed warrantless data mining and the use of AI computer algorithms to target and interrogate chronic pain patients and those with substance use disorders.

The DrCHRONO Electronic Health Records Controversy and Warrantless Data Mining of Medical Records

At the heart of this case lies the warrantless data mining of Dr. Anand’s patient records within the DrCHRONO electronic health records system. The use of AI algorithms to sift through personal health information without consent or a warrant has raised significant concerns about privacy and individual rights.

The core of this case revolves around the warrantless data mining of Dr. Anand’s patient records, specifically within the DrCHRONO electronic health records system. The use of AI algorithms by government agencies to comb through vast amounts of personal health information without explicit consent or a warrant has triggered significant concerns about privacy and individual rights.

Coley O. Reynolds: A Champion of Privacy

In response to the alleged invasion of privacy, Dr. Anand’s legal counsel, the renowned attorney Coley O. Reynolds, took on the case with determination and vigor. Reynolds, known for his relentless pursuit of justice and civil liberties, filed motions to uncover the potential unlawful use of data analytics and targeting packages. His actions have initiated a legal battle that could have far-reaching implications for the future of privacy rights and surveillance in the United States. This case scrutinizes medical records seized under a search warrant dated August 20, 2019. Dr. Anand’s defense counsel, Coley O. Reynolds, argues that evidence obtained through this warrant should be suppressed, as they contend it was acquired due to a defective search warrant. Their argument hinges on the omission of critical information from the search warrant affidavit, which, if included, would have negated the finding of probable cause. Dr. Anand also respectfully requests a hearing based on the legal precedent set by Franks v. Delaware (1978), allowing individuals to challenge the accuracy and completeness of information presented in a search warrant affidavit.

Privacy and Legal Precedents

The breach of privacy in medical records poses significant implications for American citizens. These records contain some of the most intimate and sensitive information about a person’s life, including their medical history, conditions, and treatments. The violation of this privacy jeopardizes the trust and confidentiality that are foundational to the doctor-patient relationship.

Most people involved in this infraction of privacy consider the government invasion of medical records to only be used for tracking pain management. What they don’t realize is that sex hormones (testosterone, etc) are also in the record. So in the future, citizens with gender changes could be objects of discrimination as well.

Furthermore, the invasion of medical records could have consequences for legal cases in the future. If the government can access and use personal medical data without proper oversight, the rights of individuals in other legal contexts may also be at risk. Legal precedents emerging from cases like United States v. Anand will define the future boundaries of government surveillance and data mining.  The loss of privacy in medical records has wide-reaching implications, as it threatens the trust and confidentiality that are fundamental to the doctor-patient relationship. The invasion of medical records could also affect legal cases in the future, setting precedents for governmental surveillance and data mining boundaries.

Balancing Security and Privacy

In an era where national security often collides with individual privacy, it is crucial to strike a balance. AI and advanced technology have revolutionized the way information is collected and analyzed, but it should be done within the confines of the law and with respect for individual rights. As technology advances, legal frameworks must adapt to ensure that privacy rights remain intact.

The ongoing legal battle surrounding healthcare fraud investigations is front and center in the case of United States v. Anand and Dr. Neil Anand. Dr. Anand, a practitioner in Pennsylvania, finds himself at the epicenter of a debate that raises significant questions about the use of AI and data analytics in law enforcement.

This legal battle underscores the broader context of how the federal government, particularly the Department of Justice (DOJ) and the Department of Health and Human Services (HHS), has harnessed the power of artificial intelligence and data mining in combating healthcare fraud. While using digital solutions and data analytics in the fight against healthcare fraud is not new, recent developments have seen an increased reliance on these technologies. The DOJ and HHS have expanded their ranks with prosecutors and FBI agents focused on using advanced AI and machine learning tools to uncover instances of “fraud, waste, and abuse” in the healthcare industry.

However, this intensified use of technology raises crucial questions. Are these innovative data analytics approaches inadvertently targeting innocent practices and providers as fraudsters? According to some experts, the answer is an unequivocal “yes.” In their pursuit of justice, these advanced tools have sometimes failed to distinguish between legitimate healthcare providers and those engaged in fraudulent activities.

The government’s rush to employ these new tools has led to unfortunate consequences, with many innocent physicians, clinics, hospitals, and health systems being accused of wrongdoing simply because their practices are different from their peers. Being a statistical outlier or anomaly should serve as a basis for further inquiry, not as proof of fraud.

The Department of Justice has used data-mining techniques to target practices and providers whose frequency of certain treatments and procedures exceeds the majority of their peers. Examples include the number and strength of opioid prescriptions, high-reimbursement injections, and the frequent ordering of high-complexity labs. Yet, perfectly legitimate reasons could explain these deviations, such as patient populations with unique needs or practitioners specializing in specific treatments.

The involvement of private companies like Qlarant, a Maryland-based technology company, further complicates the landscape. Qlarant has developed algorithms to identify questionable behavior patterns related to controlled substances and opioids. These algorithms have attracted partnerships with state and federal enforcement entities, including the Department of Health and Human Services’ Office of Inspector General, the FBI, and the Drug Enforcement Administration.

The case of United States v. Anand underscores the need for a balanced approach in the use of advanced technologies in healthcare fraud detection. As the legal battle continues, it highlights the importance of ensuring that constitutional rights are upheld and that evidence obtained through potentially unconstitutional means is not used in legal proceedings. The outcome of this case has the potential to set important precedents in the use of AI and data analytics in law enforcement, particularly concerning the protection of individuals’ rights and the integrity of healthcare providers. United States v. Anand brings to light the intricate world of government AI surveillance, warrantless data mining, and its consequences for privacy, particularly within the context of medical records. Dr. Anand’s case, coupled with the vigorous efforts of his legal counsel, Coley O. Reynolds, showcases the importance of safeguarding individual privacy and the potential legal precedents that will shape the future of privacy rights in the United States. The battle between security and privacy is far from over, and it is a topic that will continue to demand our attention and careful consideration as technology and legal battles evolve.

 

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Why your prescription is so damn expensive

Posted on December 27, 2023 by Pharmaciststeve

I have been around community pharmacies for a number of years, the first time I worked in a community pharmacy was in the fall of 1966 – as a pharmacy student – while I was attending Butler U in Indianapolis. This was before there was a PBM industry and there was no DEA!

Back in the 1960’s, wholesale prices of Rx items were pretty much static. The PBM industry came to be in 1970 and by the end of the 1970’s, wholesale prices on Rx meds started increasing dramatically, and sometimes multiple times a year.

I have seen reports that for a pharma to have one of their meds on the PBM approved formulary, they will be required to pay up to 75% rebate/kickback/discount back to the PBM for every Rx filled and billed to the PBM.

Here is an example of where all the $$$ the pt pays at the pharmacy register.

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der UTERMENSCHEN, DR. LESLY POMPY, MD vs The Order in The Coif

Posted on December 27, 2023 by Norman Clement

AUSA Douglass Dreier, The annals of history bear witness to dark chapters where power exploited knowledge for sinister purposes. One such instance lies in the chilling connection between statistical manipulation, legal battles, pseudoscience, and the misuse of data analytics during the heinous Nazi era, echoing disconcertingly in contemporary times.

  

DREIER’S BATTLE OF THE BULGE: AUSA DOUGLASS C. DREIER, UNITED STATES OF AMERICA vs. die UNTERMENSCHEN, DR. LESLY POMPY, MD

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