The drug war might be the perfect no-win scenario

The drug war might be the perfect no-win scenario

By Trish Randall

https://www.americanthinker.com/blog/2021/12/the_drug_war_might_be_the_perfect_nowin_scenario.html

For reducing illicit drug use, violence, or property crime, drug prohibition has been as unsuccessful as alcohol prohibition was for initiating Utopia.  But as a method for propagating bureaucracy, it’s been wildly successful.

Albert Einstein never said, “Insanity is doing the same thing, expecting a different result.”

It was in 1981, long after Einstein’s death, that versions of the slogan first appeared in publications of the 12 Step groups Al-Anon and Narcotics Anonymous.

In sports and music, repetition is expected to yield different results.  It’s called practice.  Why wouldn’t participants work the steps again and again hoping for future success?

There’s another saying, so commonly believed to be first of the 12 Steps, it’s even used in ads for rehab facilities.  “The First Step is admitting you have a problem.”

The actual Step 1 is, “We admitted we were powerless over alcohol and our lives have become unmanageable.”  Admitting there’s a problem is a proactive approach.  Admitting powerlessness and the inability to manage one’s life is defeatist.

We should ask what qualifies as failure and what “same thing” is being repeated.  For decades, drug prohibition has become increasingly militarized.  Ever-increasing resources go to police drug units, multijurisdictional projects, drug courts, incarcerating hundreds of thousands, and rehab facilities.  Medical professionals have been deputized to prevent medications from being diverted for recreation or performance enhancement (e.g., steroids for bodybuilding, Ritalin for studying).  Employers drug-test applicants and employees.

What would prohibition success look like?  Probably not like ever-expanding encampments encircled by trash, human waste, and syringes, visible in many cities.

There are almost 200,000 people incarcerated at a time for drug offenses and defendants in every state diverted to drug courts.  Every sizable community has agencies that connect residents with tax-funded rehab and multiple, free 12 Step meetings every day.

Except for the patent-owners ending Quaalude manufacture, illicit drug availability and demand persist.

Self-reported drug use counts among mitigating factors in criminal sentencing.  Prison “drug education” leads to increased privileges and points toward early release.  For federal inmates, a one-year sentence reduction for completing drug education is the only opportunity for time off.

Drug courts and rehab facilities actively protect clients from prosecution.  Subsequent arrests are not the statistics these anti-drug institutions are looking for.

Work, a reasonable social life, and some drug use sound like an implausible lifestyle to modern ears.  But count alcohol as mind-altering, and we’re describing over 80% of Americans.  For decades after the Harrison Act of 1914, many medical professionals criticized the legislation because prosecution and criminal records would ruin the lives of otherwise functional people.  There are actually data from federally funded studies.  In the 1920s, over 800 self-identified addicts voluntarily participated in years of research.  Subjects were examined in minute detail, from organ function to blood chemistry to excrement.  There were a few results slightly out of range, as expected when numerous tests are performed on hundreds of healthy people.  During these studies, before antibiotics, one subject contracted and survived pneumonia.  Almost all the subjects were employed.

Sure, there are criminals who use drugs.  Criminals also eat cheeseburgers, drive cars, and surf the internet.  Criminals camp in public spaces using tents, tarps, and sleeping bags.  If the government offered shorter sentences to defendants, and time off to inmates, for admitting that blue tarps caused their offenses, how quickly would reports surface linking tarp use and criminal acts?

Dedicated funding for drug enforcement, drug courts, and drug treatment does not coincide with a measurable decrease in availability or demand for illicit drugs, nor does spending on police in general.  Increasing police resources does decrease crime that inflicts harm on others.  A study by Princeton University Professor Steven Mello found that federal funding for 7,000 new police officers in 2009 led to substantial, measurable reductions of violent crime, larceny, auto theft, robbery, and murders, with no increase in arrest numbers and no spillover to other communities.  Meanwhile, drugs are so available that inmate drug testing and positive results are routine.

Maybe we have no vision of what a drug war win would look like because there are too many people for whom the best possible situation is prohibition continued indefinitely.  Thousands of bureaucrats have comfortable careers, air-conditioned offices and good retirement packages, and secure positions of power in the DEA, FBI, FDA, OCDETF, SAMSHA, NIMN, ONCDP, NIDA, etc., as well as similar agencies at the state level.

We know the first step: admitting the problem.  Next would be dismantling policies not only that have failed, but for which there appears to be no template for success.

Here are some ideas that could be implemented at the same time as ending drug prohibition: 1. change self-administered intoxication from a mitigating factor to an aggravating factor in criminal sentencing; 2. stop using the word “criminals” as evidence of a link between drug use and crime; 3. divert all federal funding earmarked for drug enforcement to hiring more police; 4. take care of the seriously mentally ill, including long-term residential care, a priority.

Our Founders trusted us with deadly weapons, uncensored ideas, freedom to believe whatever we like and to associate with whom we choose.  Attempts to restrict products with effects on mind, mood, or performance, inserted into the system designed to protect our freedoms, have not only failed to solve the problem they were adopted to address but have created a self-perpetuating system.  The only consistent outcome of these restrictions has been the entrenchment of the thought-stopping cliché that we cannot just allow drug use. 

 

Cruel & Unusual Pain Treatment

Cruel & Unusual Pain Treatment

Trish Randall @trishrandall312428

Punishing one group for the behavior of another is the height of injustice

America’s drug regulations rest on long-familiar, syllogism-like tendrils: Drugs are dangerous. Users can harm others. Laws target those who hurt people. Even if the drug war is unwinnable, punishing users who get caught creates deterrence. Ending prohibition is tantamount to full approval of nonstop drug-fueled debauchery. Nobody who abstains from entertainment or performance enhancement involving illicit chemicals should have any concerns about drug policy. Prohibition only targets antisocial troublemakers, who deserve what they get.

If you had to name downsides of the drug war, what comes to mind? Perhaps you’d list unending government spending, illicit profits enriching criminals, narrowing constitutional protections, civil asset forfeiture, or overcrowded jails. Would your list include you and your loved ones being one accident or illness away from chronic severe pain that could be treated but is not?

Oregon Ballot Measure 110, passed by voters in 2020 and enacted February 1, 2021, dropped Schedule I-IV drug violations from felonies to E misdemeanors, a $100 fine, and no jail. Oregon’s latest retreat from drug war orthodoxy follows legalization of recreational marijuana and medical marijuana, has not attracted federal retaliation.

Oregon has reduced punishment for non-medical possession to parking-ticket levels. But Oregon’s increased restrictions on prescription opioids, has gone in the direction much of the country has moved in recent years following the CDC’s lead.

Although the CDC pain guidelines and the OMB website both acknowledge that not all pain is controlled with 90 MME, the Oregon Medical Board, appointed by the governor, informed pain management doctors that all patients’ dosage must conform to the 2016 CDC Guidelines level of 90 MME (morphine milligram equivalents) by the end of 2021.

Anyone still prescribed above 90 MME in 2021 has meticulously-documented records of painful medical conditions and conforming to restrictions uniquely demanded of pain patients. The number of demands having lengthened over the years, is evidence of what kind of troublemakers these patients have never been.

Patients prescribed opiates are required to sign a document called a pain contract. Conditions can include being available for short-notice pill counts, urine tests (showing they haven’t sold the meds or used illegal or legal substances, from meth to tobacco to alcohol), mental health counseling if ordered, no prescriptions from another practitioner (e.g., a dentist after root canal), lost or stolen medications may not be replaced. While any violation is justification to immediately cease prescriptions, conforming doesn’t protect against abrupt cessation of prescriptions based on guidelines, not laws. There is no recourse, no appeals.

Americans facing charges or punishment for a felony or misdemeanor have multiple opportunities to derail the government’s goals. The accused may challenge the evidence, demand a jury trial, appeal the verdict, seek early release for good behavior, and request sentence commutation.

Oregon’s $100 drug fine can be waived by opting for a medical evaluation. If asked by the accused to perform the evaluation, a physician, with at least 11 years post-secondary education and 60 hours continuing education every 2 years, must refer the individual to an addiction counselor. The education required for counselor licenses range from Level One: 130 hours drug/alcohol education, 1000 hours supervised experience, and a high school diploma to Level Three: 3 years supervised practice, 300 hours education and a master’s degree (taking 9-36 months to complete).

An MD cannot perform what Measure 110 describes as a medical exam. That responsibility is given to someone with a fraction of the education.

Washington State has a similarly illogical mix of relaxed charges and punishments for drug possession outside of medical care and increasing harsh restriction on pain doctors and patients. After the State Supreme Court threw out Washington’s possession laws in early 2021, new legislation was quickly enacted making possession of Schedule I-IV drugs misdemeanors, with penalties expiring in two years. Although state Attorney General Bob Ferguson’s proposed new limits on opiate prescribing were not passed by the 2018 legislature, Washington’s state medical boards implemented those same restrictions in 2019.

Why are pain patients targeted for reduced medical treatment? Officials justify restricting prescriptions by reciting the numbers of deaths attributed to opiates — not dead pain patients, but all US deaths attributed to opiates (According to the CDC, among individuals whose deaths are attributed to opiates, 69.2-85.7% of their death certificates mention one or more other drugs, not including alcohol or nicotine).

One CDC publication of 2016 to 2020 data reported deaths of illegal synthetic opioid users rose from 8 to 11 per 100,000 population. Other opiate deaths remained consistently lower. From 2010 to 2020: heroin deaths were 4 per 100,000, methadone below 2 per 100,000 and prescribed opioids, 3.8 per 100,000. (For comparison, a 2020 CDC report puts lung cancer deaths at 34.8 per 100,000). Considering the thoroughly documented medical histories of opiate patients, one hopes a patient’s death would be fully investigated before being ascribed to medication. But, according to the CDC, only 8.5% of U.S. dead are autopsied. A report on opiate deaths published by the National Institutes of Health says there’s an error rate of 20-30% in the source data the CDC uses to compile and analyze mortality statistics.

The CDC’s own published data show prescribed opioids have been only a tiny factor in U.S. deaths, and the AMA reports restricting prescriptions by over 40% since 2011. Deaths reported have been rising only for illicit synthetic opioids, and not for prescribed opioids.

America’s first federal drug restriction, The 1914 Harrison Act, included within its text the promise that restrictions would never apply to medical, dental or veterinary professionals. In Oregon and Washington, prohibition is officially upside-down, with punishment eased for possession outside medical settings, while doctors face loss of livelihood and life savings, and patients suffer pain that could be treated but is not.

Punishing one for the infractions of another is the very definition of injustice.

Unconstitutional laws may be challenged in court. Elected officials can be removed by recall, vote or primary. But a citizen facing non-legislated guidelines wielded by unelected bureaucrats, is wrestling specters in the dark.

The times they are a changing at a pharmacy that once claimed Where America Shops

Walgreens Seals $10 Billion Take-Private Deal With Sycamore

https://www.msn.com/en-us/money/companies/walgreens-seals-10-billion-take-private-deal-with-sycamore/ar-AA1ApjdU

Walgreens’s almost centurylong run as a public company is coming to an end. The embattled drugstore chain has struck a deal to be taken private by Sycamore Partners in one of the biggest leveraged buyouts in recent memory.

Sycamore has agreed to pay $11.45 a share in cash for Walgreens Boots Alliance, representing an equity value of around $10 billion and 29% above where the stock was trading last year. Shareholders could also receive up to an additional $3 a share down the road, based on proceeds from selling the company’s primary-care assets.

The total value of the deal, including debt and the potential future payouts, would be almost $24 billion. The companies expect the deal to close in the fourth quarter of 2025.

The sale is the culmination of a decade of struggles for a historic American retailer with thousands of pharmacies that are fixtures on neighborhood street corners. The market value of Walgreens Boots Alliance surpassed $100 billion in 2015 but had been battered in recent years. Walgreens originally went public in 1927.

The company’s new owners will now have the chance to fix the business out of the public eye.

“Going private is going to let us be more focused, more nimble, more long-term in our decision-making, in the context of the challenges that we continue to face,” said Chief Executive Tim Wentworth. “That gives us both the time and the ability to focus in a way to transform Walgreens.”

Wentworth, who took over as Walgreens CEO in October 2023, had embarked on a turnaround effort. The company has said it plans to shed around 1,200 stores over three years.

But its shares had generally continued to languish, with investors skeptical about the long-term growth prospects of a company built around the difficult retail-pharmacy business.

Wentworth said the deal is a good one for shareholders and allows them to avoid the risk as the company works to change its trajectory.

The retail struggles

Fixing the company won’t be easy.

Walgreens had failed to stay ahead of forces reshaping retail and healthcare, including the rise of e-commerce and the growing power of the drug-industry players known as pharmacy-benefit managers, which negotiate pricing with pharmacies and manufacturers.

While Amazon.com and others stole business from the front of the Walgreens stores, pharmacy-benefit managers squeezed margins on the prescriptions dispensed at the back of the stores.

The combined assault made the stand-alone retail pharmacy business a tough sell to investors. When the company cut its longstanding dividend, investors grew even more frustrated.

Stefano Pessina, a veteran dealmaker, merged Alliance Boots with Walgreens in 2014 in a bid to cement a global pharmacy behemoth. The combined company was still built on retail pharmacy, though.

Walgreens missed on an attempt to connect with a health insurer, the strategy pursued by rival CVS Health. A later plunge into primary-care clinics also failed to turn the tide.

Pessina stepped down as Walgreens’s CEO in 2021 and remains chairman and the biggest individual shareholder, with about a 17% stake in the company. As part of the deal with Sycamore, Pessina has agreed to roll his stake entirely back into the business and maintain a significant ownership.

Wentworth launched a strategic review after he took over. The new CEO said the takeaway was that retail pharmacy was central, but it needed to change.

Wentworth said Sycamore, which has a long history in the retail business, was the right partner because it brings expertise and a record of overseeing turnarounds. The company will remain based in the Chicago area.

A big bite for Sycamore

The Wall Street Journal first reported in mid-December that Sycamore was in talks for a deal and earlier this week reported that talks were advanced.

The transaction would rank among the largest leveraged buyouts globally in the past decade, at a time when there have been fewer such big deals with public-company valuations and interest rates remaining elevated.

The deal also includes a so-called go-shop period for Walgreens to solicit other potential suitors for 35 days.

Sycamore is a retail specialist but has never tried as big a deal as Walgreens, which will test its strategies. The firm has been discussing splitting up the company’s business divisions and financing them individually, according to people familiar with the matter. It is a playbook Sycamore has followed in the past, including when it bought office-retailer Staples in 2017 for $6.9 billion.

Walgreens includes its namesake Walgreens retail business in the U.S., the UK-based pharmacy chain Boots, the specialty pharmacy group Shields Health Solutions and the U.S. healthcare provider VillageMD.

If Sycamore is successful in shedding the assets of the VillageMD primary-care business, Walgreens shareholders could be paid up to an additional $3 per share, or about $2.7 billion, the companies said Thursday. Wentworth said the idea was to give shareholders a way to benefit from improvements in some of the primary-care businesses, which would ideally be sold at higher values after their operations are bolstered.

Even with the plan to shed assets quickly, the deal is a giant for Sycamore, leading it to tap a number of banks and private-credit firms for funding. There are more than a dozen parties already lined up to provide financing, according to people familiar with the matter.

Walgreens currently has around $9 billion in debt as well as opioid-related liabilities and other items that Sycamore had to account for in the total $23.7 billion price tag.

The Walgreens deal should also offer some hope for dealmakers and private-equity firms that have been sitting on the sidelines and waiting on an M&A rebound. There weren’t any deals announced in the U.S. in February that cleared $10 billion. It was the first month without such a deal since January 2023, according to data provider LSEG.

Centerview Partners served as Walgreens’s lead banker, and the law firm Kirkland & Ellis was the company’s legal adviser. UBS Investment Bank was the lead banker to Sycamore, with Davis, Polk & Wardwell acting as legal counsel. Morgan Stanley also advised Walgreens, and Goldman Sachs, JPMorgan, Citi and Wells Fargo also helped advise Sycamore.

Alarm Bells are Ringing: Medicare Drug Price Negotiation Program Will Fail Without Changes

Our next “health crisis” may be on the horizon. CMS is trying to save $$ on our national “medication cost”, which is admirable, but their apparent solution may cause a massive creation of “pharmacy desserts”.  When we opened our independent pharmacy in 1976, about 45,000 pharmacies – abt 80% were independent pharmacies.  I don’t remember the exact number but Walgreens had < 1,000 stores. Today they have about 8,500 stores and at one time they had gotten up to abt 11,000 stores. They recently stopped paying dividends on their stocks after doing so consistently for 90+ yrs. I read recently where it is reported that Walgreens is looking at taking the company PRIVATE, no longer being a publicly traded company.

Walgreens was founded in 1901 when Charles R. Walgreen Sr. purchased a drugstore on the south side of Chicago where he had been working as a pharmacist13. The company grew rapidly over the next two decades, and in 1927, Walgreen Co. became a publicly traded company when it listed its shares on the New York Stock Exchange.

Here is a list of the publicly traded companies that have paid dividends > 100 yr-:

  • York Water (YORW): This company holds the record for the longest dividend-paying streak, having paid dividends for 208 years

  • Procter & Gamble (PG): Has been paying dividends since 1891, which is over 133 years.

  • Coca-Cola (KO): Has been paying dividends since 1893, over 131 years.

  • Colgate-Palmolive (CL): Has been paying dividends since 1895, which is 129 years.

  • General Mills (GIS): Has been paying dividends since 1898, over 126 years.

  • Exxon Mobil (XOM): Has been paying dividends since 1882, although its future dividend sustainability is questioned.

  • Eli Lilly (LLY): Has been paying dividends since 1885, over 139 years.

  • Consolidated Edison (ED): Has been paying dividends since 1885, although its future dividend sustainability is also questioned

While the total number of active stocks fluctuates, an average of 6,000 at any given point in time, would be a good estimate.

Alarm Bells are Ringing: Medicare Drug Price Negotiation Program Will Fail Without Changes

https://www.drugtopics.com/view/alarm-bells-are-ringing-medicare-drug-price-negotiation-program-will-fail-without-changes

If CMS doesn’t reconsider its mandate, which forces independent pharmacies to go deep into a hole and lose money, many of them will close.

On either side of the political aisle, you’ll find a desire to reduce prescription drug cost for Americans. Former President Biden made the Medicare Drug Price Negotiation Program a centerpiece of his health care agenda. President Trump has already formalized his commitment to preserving the Medicare cost-savings program.

Recently, the Centers for Medicare & Medicaid Services (CMS) announced the next 15 drugs to be negotiated. They are all popular brand-name drugs for common illnesses, including blockbuster semaglutide (Ozempic). Independent pharmacists support lowering prescription drug costs; however, as we notified the last administration and stress now following a new national survey and a research report, the program as it is currently designed is doomed to fail.

There are 2 main problems. First, the federal program forces pharmacies to lay out thousands of dollars per week to acquire the drugs and then wait potentially weeks to receive refunds from the drugmakers. Second, it mandates that independent pharmacies serving Medicare Part D patients participate, even if doing so drives them out of business.

In the study, we found that pharmacies will face payment delays of at least a week beyond current terms; they will lose $11,000 per week in cash flow; and they could lose as much as $43,000 annually. As any small business owner knows, such disruption can put a company out of business.1

The national survey found that more than 32.8% of independent pharmacists have already decided not to stock 1 or more of the drugs in anticipation of the financial hit.2 Another 60.4% said they are considering not stocking 1 or more of the drugs. There are more than 18,000 independent pharmacies in the country, and many serve rural and under-served communities. Our survey indicates that if changes aren’t made to the program, only a fraction will participate. That will leave millions of Medicare patients stranded without the drugs they need.

If CMS doesn’t reconsider its mandate, which forces independent pharmacies to go deep into a hole and lose money, many of them will close. It could be a catastrophe for Medicare patients.

Many independent pharmacies are already teetering because of the predatory behavior of the 3 largest pharmacy benefit managers (PBMs), which control 80% of all prescriptions in the US. All 3 – CVS Caremark, Optum Rx, and Express Scripts – own or are owned by giant insurance companies like UnitedHealth Group and Cigna. They also own mail-order pharmacies.

The big PBMs and insurance companies impose billions of dollars in backdoor fees on independent pharmacies. They determine which pharmacies patients must use, they often steer patients to their own pharmacies, they decide how much patients must pay out of pocket, they frequently reimburse small pharmacies less than it costs them to acquire drugs and fill prescriptions, and they often reimburse those pharmacies less than they reimburse their own pharmacies.

Because of the conflicts of interest and self-dealing, made possible by vertical integration, pharmacies were struggling long before the new program. This could be the straw that breaks the camel’s back.

The alarm bells are ringing. Congress must act this year to ensure local pharmacies survive. There is strong bipartisan support for PBM reform, and President Trump has said many times he wants to “get rid of the middlemen.” President Trump has an opportunity to fix the glaring flaws in the Medicare Drug Price Negotiation Program. Otherwise, all the good intentions that inspired the program will be wasted.

B. Douglas Hoey is CEO of the National Community Pharmacists Association, which represents more than 18,000 independent pharmacies across the country.

Anti-Obesity Medicines Are Not All Created Equally

Anti-Obesity Medicines Are Not All Created Equally

https://thetimesweekly.com/2025/03/anti-obesity-medicines-are-not-all-created-equally/

The new FDA-approved weight loss medicines have changed the game for people with obesity, offering millions of people a chance to transform their health, prevent disease, and live longer lives. But as demand for these treatments soars, an illegal industry is growing alongside it. Criminal networks, counterfeiters, and rogue compounding pharmacies are taking advantage of patients’ needs, flooding the market with fake, unsafe, and untested knockoffs. In December 2023, the FDA seized thousands of counterfeit injection pens within the U.S. drug supply chain. A Tennessee woman’s home was also raided by police, where officers found more than 300 vials of counterfeit weight loss drugs—semaglutide and tripeptide—that she had been supplying to med spa clinics. After testing, one of the vials contained nothing but water. This is the reality of an unregulated black market. People think they are injecting medicine into their bodies that will improve their health, but they could be injecting poison—or nothing at all.

For counterfeiters and other profiteers, the market is ripe for exploitation — high patient demand and a rising obesity epidemic create the perfect conditions for their illegal trade to thrive. The result? A knock-off weight-loss drug market populated with med spas, online “telehealth” sellers, and unauthorized compounding pharmacies pushing dangerous counterfeit or untested compounded medications. The Black community is especially vulnerable given its higher prevalence of obesity. In 2023, non-Hispanic Black or African American adults were 30% more likely to be obese than non-Hispanic white adults, with 43 percent of non-Hispanic Black adults over the age of 18 classified as obese. As the Executive Director of the National Organization of Black Law Enforcement Executives (NOBLE), I oversee an organization whose mission is to protect our communities from harm. Law enforcement officers are already seeing the rise of counterfeit weight loss drugs spread through our communities. Just as with illicit street drugs, enforcing the law is critical to get these dangerous products off the market. But equally critical is to stem consumer demand.

The Trump administration has an opportunity to help curb this rising demand. Currently, there is a proposed rule at the Centers for Medicaid and Medicare (CMS) rule that would provide coverage for FDA-approved weight loss drugs, thereby significantly increasing access to these innovative medicines. Unlike other chronic diseases, obesity treatments have been excluded from Medicare coverage. The result has been limited access to authentic medicines, creating a high demand for knock-off versions. While law enforcement must do its part to rein in bad actors, the new administration can help by finalizing the CMS proposed rule. Providing greater access to safe and effective medicines would go. A long way to put illicit suppliers on notice and out of business. No one should be exposed to the risks that come with untested, unregulated injectable medicines and I am confident President Trump will make the right decisions to protect American public health.

Novo Nordisk unveils DTC pharmacy NovoCare, offers discounted Wegovy

Novo Nordisk unveils DTC pharmacy NovoCare, offers discounted Wegovy

https://www.mmm-online.com/news/novo-nordisk-dtc-pharmacy-novocare-discounted-wegovy/

The home shipments — which will be fulfilled by CenterWell Pharmacy — include Wegovy injections of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg.

Novo Nordisk has officially entered the direct-to-consumer (DTC) platform game.

The Danish drugmaker unveiled NovoCare Pharmacy on Wednesday morning, offering home shipments of the popular GLP-1 Wegovy at $99 per month for cash-paying patients.

This is less than half of the current price for the drug for uninsured patients.

The home shipments — which will be fulfilled by CenterWell Pharmacy — include Wegovy injections of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg.

In addition to the home delivery capabilities, the drugmaker said NovoCare will support patients with benefit verification, refill reminders as well as access to live support from a case manager.

“Novo Nordisk continues to advance solutions for patients that improve affordability and access to our medicines, whether they have insurance or not. Today, over 55 million people in the U.S. have coverage specifically for weight management medicines, and 90% of Wegovy patients with coverage pay $0 to $25 a month for Wegovy,” said Dave Moore, EVP of U.S. operations and global business development and president of Novo, in a statement. “With NovoCare Pharmacy, patients and prescribers alike have another option that provides convenient access to all doses of real, FDA-approved Wegovy at a reduced cost in our high-quality pen.”

In the release detailing the launch of NovoCare, the drugmaker acknowledged the prominence of compounded pharmacies and telehealth companies offering compounded versions of Wegovy and fellow GLP-1 Ozempic.

The company said NovoCare offers “reliable access to authentic, FDA-approved” Wegovy while alluding to the “dangers of fake or illegitimate” compounded semaglutide — the active ingredient in the drugs.

This comes on the heels of the FDA announcing an end to the shortage of Wegovy and Ozempic late last month after more than a year of ongoing scarcity challenges.

The launch also came nearly one month after Novo called out suppliers of compounded weight loss drugs in a print ad in The New York Times following Hims & Hers’ controversial Super Bowl ad.

In light of the announcement, Novo’s stock was trading up nearly 4% by noon.

Of note, Novo’s decision to offer discounted Wegovy also came one week after Eli Lilly announced that it would expand offerings of its hit weight loss drug Zepbound.

The drugmaker will now offer 7.5mg and 10mg doses of Zepbound, which uses the active ingredient tirzepatide, in single-dose vials.

The medications are available for $499 during a patient’s first month and refills that occur 45 days after through Lilly’s Self Pay Journey Program. Lilly also lowered the cost for its existing 2.5mg and 5mg vials.

With the introduction of NovoCare, Novo also now joins the ranks of Lilly and Pfizer in terms of Big Pharma companies that have rolled out DTC platforms within the past year.

In January 2024, Lilly debuted its LillyDirect service, which marked the first DTC push for GLP-1 drugs like Zepbound and Mounjaro.

A few months later, the company announced a partnership with Amazon to distribute select medications through LillyDirect.

Then, in August, Pfizer announced its digital DTC platform PfizerForAll.

In practice, PfizerForAll will provide patients with access to care services, prescription fills and options to save on medicines.

Through the site, consumers are able to make same-day in-person or telehealth appointments with independent healthcare professionals, sign up for home delivery of prescription medicines, OTC treatments or diagnostic tests, schedule vaccination appointments and pay for medicines or access Pfizer’s patient support services.

Pfizer directed consumers to visit the site at the end of its minute-long Super Bowl ad.

Senior citizens are rattled by news that Medicare telehealth coverage could expire next month

Senior citizens are rattled by news that Medicare telehealth coverage could expire next month

https://www.nbcnews.com/news/us-news/senior-citizens-medicare-telehealth-coverage-expiring-rcna193487

Advocates say the coverage has bipartisan support, but efforts to make it permanent have been unsuccessful.

For Kaye Peterson, 67, the expansion of Medicare telehealth coverage during Covid-19 was a godsend.  

Peterson, who has Type 1 diabetes and lives in an assisted living facility, no longer drives, so she depends on extended family when she needs in-person appointments with specialists who are roughly an hour away from her home in Lebanon, Kentucky. But for routine primary care, she simply uses her iPhone. 

Soon that may no longer be possible. On March 31, Medicare telehealth “flexibilities” established during the Covid-19 pandemic are set to expire. Recent social media posts, including the one that alerted Peterson to the change, have prompted an outcry from beneficiaries and their families who rely on the service. 

“I’m in a care facility full of people in wheelchairs and on oxygen,” Peterson said. “It’s just a commonsense rule that needs to be extended.” 

Health advocates say the telemedicine options now at risk are particularly important for older adults who are homebound or, like Peterson, live in rural communities far from their doctors’ offices.  

The current flexibilities were enacted when Congress waived restrictions in March 2020 under President Donald Trump and were extended several times under President Joe Biden.

If Congress doesn’t act, on April 1, the previous rules will largely be restored, which means most telehealth appointments will be covered only if they’re provided in person at rural medical facilities.

There will be exceptions for certain services, such as mental health care and some visits for home dialysis treatments. 

A lapse could have ramifications for millions of Medicare beneficiaries. Roughly 13% of the nearly 22 million people with traditional coverage received a telehealth service from October to December 2023. 

Dr. Cecil Bennett, a family medicine physician in Newnan, Georgia, outside Atlanta, estimates that half of his clinic’s patients are on Medicare. Some already have telehealth appointments scheduled months out. He often uses telehealth to deliver simple information, like lab results, and fears that some patients may miss necessary appointments if they require in-person visits, allowing conditions to worsen.  

There will be exceptions for certain services, such as mental health care and some visits for home dialysis treatments. 

A lapse could have ramifications for millions of Medicare beneficiaries. Roughly 13% of the nearly 22 million people with traditional coverage received a telehealth service from October to December 2023. 

Dr. Cecil Bennett, a family medicine physician in Newnan, Georgia, outside Atlanta, estimates that half of his clinic’s patients are on Medicare. Some already have telehealth appointments scheduled months out. He often uses telehealth to deliver simple information, like lab results, and fears that some patients may miss necessary appointments if they require in-person visits, allowing conditions to worsen.  

In a statement to NBC News, Sen. Lisa Blunt Rochester, D-Del., who co-introduced a bipartisan bill to solidify the provisions when she was in the House, described the flexibilities as “vital” — “especially for those in underserved and rural communities and those with accessibility or transportation barriers” — and said she is still fighting for permanent protections.

Rep. Ro Khanna, D-Calif., whose viral social media posts brought attention to the looming deadline, said he plans to introduce similar legislation.  

“What is the rationale for this other than making life more difficult for many seniors?” Khanna said on X.

With the fate of telehealth still uncertain, Bennett is waiting to see whether the appointments he has booked can proceed.

“I really hope that Congress acts quickly,” he said. “I know that they kick the can down the road — I’m fine with that as long as they keep kicking the can.”

Why Reliable Opioid Death Data is Impossible

Why Reliable Opioid Death Data is Impossible

https://www.americanthinker.com/articles/2024/07/why_reliable_opioid_death_data_is_impossible.html

If we’ve learned anything from our national COVID experience, it’s that science is not a collection of fixed, eternal declarations. Tools and terminology useful in the process of discovery can also be instruments of confirmation. A microscope can be a portal to the unexpected, or a prop in a theatrical performance.

True crime documentaries and news reports of deaths often feature a statement such as, “toxicology was performed,” “toxicology is pending,” or “toxicology showed X, Y and Z.” The word, “toxicology,” has an aura of a thorough, definitive procedure.

Typically, “toxicology” is understood as analogous to drug screening the living, but methods and reliability are very different. Usually screening for the living is something like a 10-panel test of a fresh sample of urine, plasma, or serum (occasionally hair), with results for limited categories (positive for opioid could mean morphine, oxycodone, or codeine, other medications, or recently-consumed poppyseed cake). Cross-positive results can be caused by unrelated consumption, such as quinine in tonic water (false positive for opiates), ephedrine, fluoxetine, metformin, and pseudoephedrine (false positive for methamphetamine,) and the proton pump inhibitor pantoprazole (positive for marijuana).

Because of the multitude of conditions and processes particularly affecting human remains, post-mortem testing is vulnerable to widely varied confounding artifacts and processes. Decomposition and/or bacterial action can alter the location or concentration of drugs or metabolites, a process called postmortem redistribution. In addition, physical and chemical changes within the body, or subsequent contamination, can create or destroy chemicals. Burial can affect results.

Factors affecting results are not only numerous, but often impossible to discover in retrospect. Who could determine temperature changes in a room in the hours or days before a body was discovered?

For post-mortem drug testing, whole blood collected from the femoral artery is preferred as somewhat shielded from ongoing changes. If unavailable, other options — all more vulnerable to confounding factors — include blood from the heart, tissue from solid organs, fluids from other areas of the body (e.g, eye or stomach). Some professionals recommend sampling multiple locations to potentially piece together better data.

Not only is there no standard set of tests, there aren’t standardized protocols for performing tests or collecting samples. The National Association of Medical Examiners publishes a list of recommended standards, but following them isn’t mandatory. Forensic procedures vary widely by location (there are over 2000 death investigation offices in the U.S.).

Regarding post-mortem drug testing, one professional stated, “There is no reliable or obvious connection between concentrations measured in life and subsequent to death. Consequently, concentrations measured after death cannot generally be interpreted to yield concentrations present before death. The definition of lethal concentrations is extremely difficult.”

Even if post-mortem results could reliably indicate concentrations prior to death, it wouldn’t prove the drugs caused the death. Individual sensitivity to medications varies. Anaphylaxis can follow previous unremarkable exposure. Combining medications can increase or decrease absorption, or produce a toxic interaction. Because metabolizing opioids varies widely, and tolerance increases with use, some people are unharmed by a dose that would suppress respiration in others. Prescribed morphine could be detected in a patient who died of cancer or a pain patient who was a passenger in a fatal car crash.

One paper I read discussed eight deaths attributed to drugs. Potential candidates for the study were excluded if there was missing medical and/or social history, or advanced decomposition. All the subjects studied had positive post-mortem drug assays — and physical details consistent with other causes of death, e.g., pneumonia. All had pulmonary edema, three with foam and/or fluid in the lungs. One woman had a history of suicide attempts, and plastic over her face. A 16-year-old girl had a potentially deadly heart condition, myocardial fibrosis. The paper said results were, “not specific but suggestive for drug abuse” with “no distinct findings indicating intoxication or poisoning” and “not evocative of specific substance misuse.”

Beyond difficulties interpreting post-mortem tests, reason for skepticism of drug-death statistics is raised by the way data is collected and formatted. The CDC’s coding for opioid overdoses is often applied to cases including multiple drugs. Among individuals counted as opioid overdoses, 69.2-87.5% have 1-4 other drugs on the death certificate, with benzodiazepines involved in 77%. For years, CDC codes counted as “prescription opioid overdoses” deaths linked to opioids that included illegally-manufactured fentanyl, and diverted methadone (The vast majority of methadone is not prescribed, but administered via substance abuse treatment. Methadone prescribing for pain decreased sharply from 2009 to 2019). For years, deaths were being attributed to prescription drugs the decedents most likely never used.

Further complicating matters, claims of rising opioid deaths is the inconsistent data CDC receives. In some jurisdictions, and some timeframes, overdose as a cause of death didn’t even specify a drug. This was the case for 12% of overdose deaths in 2017-18, and in 19- 22% during 2012-13.

Keep in mind only 7.4% of U.S. dead are autopsied. But every decedent gets a cause of death. Numerous causes of death, such as cardiac arrhythmia, leave no physical clues. These unreliable statistics center on a small number (3%) of U.S. deaths. Years of data massively overstating prescription overdoses, have justified policies with devastating effects for the estimated 50.2 million Americans with chronic, severe pain and pain prescribers. The data has been used justifying massive federal drug control spending ($261.3 billion, 2012-2020 with equal spending by state governments).

Government anti-opioid efforts focus — not effectively — on teens and young adults. But most deaths in the opioid overdose category are in the 45-54 age group — more frequently prescribed opioids for chronic pain. Risk of death from all kinds of causes is higher in the 45-54 age group, chronic pain adds slightly elevated risk.

Opioid death statistics are always good for a headline. A 2018 Boston Globe article reported 1/4 of Massachusetts residents knew someone who died from opioids. Massachusetts opioid death total in 2017 was 1,977 — 0.0289% of the state population of 6,863,560. A little quick math suggests that, for 1/4 of MA residents to know one of those unfortunate individuals, each decedent would have to have had approximately 867 friends and family (not counting out-of-state loved ones!). Massachusetts data available at the time could have shaped a very different article. The 2016 and 2017 totals — 2,107 and 1,977 respectively — showed opioid deaths had declined by 130 while Massachusetts’ population increased by 136,280.

It’s common that someone pointing out a flaw in a system or process, is met with demands that the criticism include recommendations for correction. Unfortunately, so many problems affect U.S. overdose death statistics — from unpredictable microbes, physical processes, and environmental conditions to the inconsistency in years-old data coding — that it’s not possible to even hypothesize a way to clean up the data. The best this observer can suggest is discontinuing use of fatally flawed statistics to drive federal policy and spending.

Shots Fired!! Two of the most prestigious medical journals just came out fiercely against epidural injections

Shots Fired!! Two of the most prestigious medical journals just came out fiercely against epidural injections / RFA.

The British Medical Journal just published a “Practice Guideline” paper with these damning statements:

“For people living with chronic radicular spine pain, the guideline panel issued strong recommendations against: epidural injection of local anaesthetic, steroids, or their combination.”

“For people living with chronic axial spine pain, the guideline panel issued strong recommendations against: joint radiofrequency ablation.”

The New England Journal of Medicine’s “Journal Watch” then doubled down on this stance (links in comments):

“The unfortunate reality is that some patients with chronic cervical or lumbosacral pain don’t respond to standard first-line noninvasive measures. They are understandably desperate for relief, and clinicians understandably feel obligated to “do something”.

However, none of the procedures covered in this guideline afforded clinically important pain relief with moderate certainty, according to the panel. In their concluding remarks, the authors also address the high cost of these procedures in the U.S., noting that “the substantial reimbursement… may act as a perverse incentive for their delivery.”

I’m a little bit stunned.

What do policy-makers want? For every spine patient to live eternally in a purgatory of PT and acupuncture and cognitive-behavioral therapy… even if they aren’t getting relief?

What is the impact of this philosophy on workforce productivity, long-term disability, and human misery?

Don’t get me wrong… I love the “less is more” mentality.

But do these journals/authors know the power of these words… especially when exploited by denial-addicted insurance companies?

It’s funny… a lot of conversations tend to pit spine surgeons like myself AGAINST our interventional pain colleagues.

On this day… maybe we need to band together.

Who else will act as custodians and stewards of spine care in this country?

Taif J. Mukhdomi Dr. Soubrata V. Raikar Raul Monzon MD Chris Centeno, M.D.

Your Body, Your Health Care

AVAILABLE APRIL 8TH. Pre-order at retailers now.

• Published By Cato Institute

At a time when individuals feel increasingly disenfranchised by their health care choices, Dr. Jeffrey A. Singer’s groundbreaking new book, Your Body, Your Health Care, offers a compelling vision for a future in which patients regain control over their health decisions and care. The book underscores the importance of personal autonomy, highlighting how the patient-practitioner relationship has been overshadowed in recent decades by paternalistic and overbearing government intervention.

As government regulations continue to encroach upon personal health care choices, patients find themselves at the mercy of policymakers dictating their treatment options, from which health professionals they can consult to what substances they can ingest. In this timely work, Dr. Singer, a seasoned surgeon and policy expert, delves into the philosophical underpinnings of a health care system that respects individual sovereignty and moral agency.

“In the following pages, I want to inform you about how lawmakers and policymakers at all levels of government have failed to heed the pronouncement that ‘every human being of adult years and sound mind has a right to determine what shall be done with his own body,’” Dr. Singer emphasizes. “I hope to expose the harmful unintended consequences of this paternalism. Finally, I want to point out roads leading to a future where the government respects the autonomy and rights of all adults.”

Your Body, Your Health Care not only validates the grievances of patients but also presents a philosophical framework for the relationship between individuals, the health care system, and the state. Through thoughtful analysis of issues such as prescription requirements, the right to self-medicate, access to harm-reduction techniques, and licensing laws, Dr. Singer proposes a road map for reforming health care policy that prioritizes individual rights and provides essential reading for anyone concerned about the future of health care in America. It serves as a clarion call for change, urging readers to recognize their rights and the preservation of personal sovereignty in America.

Praise for the book

“Dr. Singer’s writing is engaging and always informed by his clinical experience, sharp insight into the unintended consequences of policy, and ethical commitments. Your Body, Your Health Care is a book worth reading, arguing over, and thinking about. Ultimately, Dr. Singer’s book provides a stark reminder that patient autonomy is still a vital ethical principle worth keeping.”
—Jay Bhattacharya, MD, PhD, professor of health policy, Stanford University

“Dr. Singer’s book is well written, well researched, and very provocative. Whether or not the reader agrees with everything that Dr. Singer writes about the regulatory state, they will be challenged to think differently and/​or to defend to themselves why they disagree. If the reader is a policymaker, they may be taking notes as to legislation to propose.”
—Sen. Bill Cassidy, MD (R‑LA)

“In an era when government officials and health experts are way too quick not only to tell you what’s best for you but also to mandate it with the force of law, Dr. Jeffrey A. Singer’s Your Body, Your Health Care is a righteous vaccine for the body politic.… His maximalist case for patient autonomy, informed consent, and the right to self-medication is exactly what we need in a world that is busting open with nearly infinite new treatments and cures for everything that ails us.”
—Nick Gillespie, editor at large, Reason

“Singer delves into some of the most pressing and contentious health care issues in the United States today. His criticism of the FDA is both thought-provoking and disturbing, as are many other sections in the book. Everyone concerned about government intrusion on patient autonomy should read this.”
—Josh Bloom, PhD, director of chemical and pharmaceutical research, American Council on Science and Health

About the author

Jeffrey A. Singer is a senior fellow at the Cato Institute and works in the Department of Health Policy Studies. He is president emeritus and founder of Valley Surgical Clinics Ltd., the largest and oldest group private surgical practice in Arizona, and has been in private practice as a general surgeon for more than 35 years.