when you think that you are a HAMMER… everything starts looking like a NAIL

It has often been reported that addicts that are being prescribed buprenorphine have often sold these meds on the street so that they can have money to buy illegal street opiates. It doesn’t seem to no strange coincidence that our Congress passed a law in 1999-2000 called the Decade of Pain Law  and pain was quickly labeled as “the fifth vital sign” and the Join Commission  who certifies hospitals to be able to bill Medicare & Medicaid and made it a MAJOR STANDARD to be met and failing to meet a major standard, which if broken could jeopardize the hospital’s certification.  Doctors were encouraged to adequately manage a pt pain when in the hospital and of course.. those ideas of properly treating a pt’s pain became part of the doc’s treating pain when pts were in the doc’s office practice.

When the Decade of Pain law expired in 2009-2010… it was not renewed…  The Joint Commission dropped the fifth vital sign as a major standard in their hospital certification process and opiate Rx prescribing peaked in 2011 -2012.

At the time, Florida seems to have a disproportionate rate of “pill mills” and in Jan ,2011 Rick Scott became governor and Pam Bondi because AG in Florida and they started a major crack down on those pill mills and President Obama & Joe Biden came to office in Jan 2009.  Seemingly, those four  people seems to trigger a “perfect storm of the war on drugs”  In Bondi’s 2014 reelection campaign her videos claimed to have removed all the “pill mills/oxy docs” from the state https://youtu.be/jjlT8kgDQyo  and after Rick Scott’s 8 yrs as FL governor… he was elected as FL’s new Junior Senator.

Many in the Federal and state governments started to “over utilizing” the Civil Asset Forfeiture Law… confiscating may be as much as tens of billions of dollars each year.  Those confiscated assets these bureaucrats are able to put they in their budget coffers and those assets could be confiscated without any charges being filed nor convictions made.  I was recently made aware of what appeared to be a new DEA agent in one of our southern states was harassing pharmacists that they were to limit all C-II Rxs to 90 DOSES… apparently she was so poorly trained that she was confused being the CDC dosing guidelines of 90 MME/day and 90 doses/month. I real good example that law enforcement has no business overseeing/interfering with medical care.

The War on Drugs Comes to the Doctor’s Office

https://truthout.org/articles/the-war-on-drugs-comes-to-the-doctors-office/

An undercover drug cop tried to shut down a doctor in Indiana. Soon, two patients were dead.

Ashley* lived with addiction and anxiety for years, but she was in recovery and making progress in 2017 after finding treatment at Jay Joshi’s clinic in northwestern Indiana. Joshi was known as a pioneer of telehealth visits for addiction patients that became widely used during the COVID pandemic, an expansion that lawmakers and the American Medical Association (AMA) are now pushing to make permanent. Joshi prescribed Ashley buprenorphine, a standard for treating opioid addiction and preventing overdose. Untreated mental health conditions can play a role in drug addiction that is often overlooked, so Joshi set Ashley up with a psychologist through a telehealth service. On November 21, 2017, Ashley was at Joshi’s office for a telehealth therapy appointment with her psychologist when Drug Enforcement Agency (DEA) agents arrived with a search warrant.

At the time, Joshi was unaware that an undercover DEA agent had posed as a patient at his office to build a drug trafficking case against him. Agents took Joshi to a local police station for hours of questioning, where Joshi surrendered his DEA registration that allowed him to prescribe controlled substances — including buprenorphine. When he returned from the police station, Joshi said Ashley was deeply traumatized. Ashley told Joshi that she protested the interruption of her therapy appointment, so a DEA agent pulled out a gun and ordered her onto the ground.

In grand jury testimony, former employees-turned-witnesses described the young primary care physician’s practice as sloppy and his patients as “addicts,” a deeply harmful and stigmatizing term for patients in recovery. Joshi was accused of operating a “pill mill” in the local media, a claim Joshi says was manufactured by the DEA. Ashley and other patients were blacklisted by other local doctors, and without a buprenorphine prescription, Ashley relapsed and suffered fatal overdose. Stephanie, another patient who had stabilized and quit using heroin under Joshi’s care, also lost her prescription to buprenorphine. She soon died of an overdose after returning to heroin.

“Any patient who was associated with me or had my DEA registration number on their prescription history, other physicians didn’t want to see them,” Joshi said.

Opioid Prescribing Plummets as Overdose Deaths Rise

Since the early 2000s, rising rates of fatal drug overdoses breathed new life into the failing war on drugs. As they have during drug scares of the past, the government and mainstream media declared an “epidemic” of opioid addiction, and the crackdown on painkiller prescribing that followed injected the DEA — the federal law enforcement agency charged with waging the drug war — deep into the medical system. Opioid painkiller prescribing dropped sharply as a result, but the number of overdose deaths continued to rise before skyrocketing during the COVID pandemic.

To understand the crackdown, Truthout obtained multiple DEA search warrants and court records detailing law enforcement efforts to shut down pharmacies and clinics, and interviewed chronic pain patients and their advocates, doctors, researchers, pharmacists and people recovering from opioid addiction across the United States. Their advocacy and research are poking big holes in longstanding media narratives linking painkiller overprescribing of the past to rising rates of fatal drug overdose today. A close look at the policing of opioids reveals a common theme of the war on drugs: Policymakers and drug police are harming the same people they claim to help. Like the drug war, the painful side effects of the opioid crackdown disproportionately fall on lower-income people and people of color, whether they use opioids for any reason or simply seek treatment for chronic pain. The prescribing crackdown appears to be exacerbating existing inequities in access to health care and addiction treatment, one reason why rates of fatal overdose are rising fastest in Black communities.

“I have seen how, in these public health crises, the people we sort of want to help become stigmatized and end up losing access to care,” said Kate Nicholson, a former civil rights attorney for people with disabilities and pain patients who founded the National Pain Advocacy Center, in an interview. “The way in which we wage the drug war disproportionately against communities of color means that they are likely to face much greater barriers to health care.”

Over the past decade, drug police began plundering data from private medical records services and statewide prescription monitoring databases to digitally surveil doctors, patients and millions of prescriptions. Often using federal prescribing guidelines that became a national controversy as a reference, drug cops with no formal medical training search for “red flags” in prescribing records, such as how far a patient travels to receive treatment or the total volume of controlled substances prescribed by a provider. The investigations have led to raids on hundreds of clinics and pharmacies across the country. In some cases, doctors and pharmacists strike plea deals for reduced sentences. In other cases, respected physicians, pharmacists and addiction specialists are caught in the dragnet and forced to fight the DEA in court.

Doctors and pharmacists became increasingly wary of prescribing and dispensing opioids or even agreeing to treat patients prescribed opioids for chronically painful conditions in the first place. Others had their registrations to prescribe controlled substances revoked by the DEA pending rulings by the agency’s own administrative courts, or they closed their practices in fear of being raided and charged with drug trafficking.

In many cases, patients are left with nowhere to turn, especially if they are low-income and reside in areas with few medical providers to begin with. A 2019 study by the University of Michigan found that 40 percent of health care providers refused to see any new patients prescribed opioids. Along with prescribing guidelines issued by the Centers for Disease Control and Prevention (CDC) in 2016 that were widely misapplied and led to misguided restrictions on opioid prescribing in dozens of states, the law enforcement crackdown left patients living with chronic pain without medications they rely on, forcing some toward illicit opioids, such as heroin and fentanyl, which vastly increase the risk of overdose. Others die by suicide.

“I hear from people every day who have been forced off their meds and have lost their ability to work and function and are suicidal,” Nicholson said. “People are not just being force-tapered [off medication] … they can’t even get health care anymore, just because they need a prescribed opioid to treat pain.”

Both the legal and illicit markets for prescription painkillers shrank as a result of the crackdown and regulatory moves by the DEA. Illicit drugs such as heroin and counterfeit pills containing potent synthetic opioids replaced prescription painkillers in the illicit market. Opioid prescribing rates have plummeted since 2012, but rates of fatal drug overdose increased for years before briefly leveling off in 2018 as policymakers worked to make treatment more accessible. Overdose deaths began rising again in 2019, and then the COVID pandemic hit, isolating patients and drug users from friends, family and health supports. From October 2019 to October 2020, the number of overdose deaths recorded by the CDC surpassed 92,000, the highest level in decades.

There are multiple factors and drugs besides opioids (methamphetamine, for example) behind the overdose epidemic. CDC overdose data is not always accurate, and overdose deaths often involve multiple drugs, including alcohol. Research shows that only a small percentage of overdose deaths are caused by prescription opioids alone. Illicit drugs containing fentanyl are driving the historic rates of death in part because, unlike prescription drugs, they can vary widely in potency, particularly when law enforcement disrupts the supply. A 2020 study found that 57 percent of 2,887 military veterans who died of overdose or suicide had a prescription to painkillers that was cut off by their doctors.

“I believe that a lot of the industrial binary focus on stopping opioid prescriptions reflects a belief that that will somehow stop overdoses from happening … that if we just stop these patients from receiving the pills they are on, they will be protected,” said Stefan Kertesz, a physician and professor of preventative medicine at the University of Alabama who is studying links between reductions in prescribing and suicides. “That presumption just has not held up, so far.”

At the same time, the government has been slow to lift barriers to the most effective medications for treating opioid addiction and preventing overdose, methadone and buprenorphine, which are heavily scrutinized by police and surveilled by the DEA because they are also prescription opioids.

Nationally, less than 6 percent of doctors are allowed to prescribe buprenorphine under a special federal waiver that medical experts and advocates say must be removed to save lives. The waiver takes a day or so to obtain, but advocates say many doctors don’t bother due to the stigma around treating people with opioid addiction. Like Joshi, numerous doctors who do prescribe buprenorphine have been targeted by the DEA. A study released in May by researchers in Oregon found that one in five pharmacies in counties with high rates of opioid overdose refuse to dispense buprenorphine. The problem is especially prevalent among independent pharmacies, which are often targeted over large companies by drug cops seeking out the latest “pill mill” to bust. Patients recovering from addiction say buprenorphine is often difficult to access even when it’s stocked by a local pharmacy due to stigma reinforced by fear of law enforcement.

A Safer Supply Is Criminalized

In the final days of the Trump administration, James Carroll, President Trump’s drug czar, boasted that the “prescription opioid epidemic is now over.” A major decrease in opioid prescribing and related overdoses, Carroll said, was one of the administration’s major achievements. Critics were irate. How could the Trump administration claim victory when overdose deaths were ballooning on their watch?

Six months earlier, the AMA warned the Trump administration that the overdose crisis had never just been about prescription opioids, and the nation is now facing an unprecedented “multi-factorial” crisis driven by drugs such as illicit fentanyl. The government could no longer view the crisis through a “prescription opioid-myopic lens.” Moreover, chronic pain patients are harmed by the crackdown and the CDC’s prescribing guidelines, which caused large numbers of patients to be forcibly tapered off their medication or cut off altogether, often against their will.

“There is no evidence that forced stoppage of the individual’s medications leads to a better outcome, none,” Kertesz said. “That’s crucial.”

Kertesz pointed to a new study showing that the net effects of policies that encourage doctors to lower the dose of opioids prescribed to patients are uncertain, but rapid discontinuation of opioid therapy is associated with increased risk of overdose and suicide. Abrupt stoppage of opioid therapy has become the “norm,” Kertesz said, and those who argue that policies aimed at decreasing opioid prescribing over the past decade simply represent more “judicious prescribing” practices are misleading the public.

“There are 8 to 10 million people on long-term opioids, and a meaningful number of those people actually need to be on them, so setting up a system that by design abandons 1 to 10 million patients is not a good thing, but we have set that up,” Kertesz said. “We have now set up incentives for doctors and pharmacists to avoid care for those people, many of whom have disabilities.”

In 2018, senior analysts at the CDC revealed that for years, the number of overdose deaths the agency attributed to prescription opioids was vastly inflated due to problems with data collection classification. For example, deaths caused by illicit fentanyl were blamed on the prescription form of fentanyl, which is often used in emergency rooms. Overdoses involving a combination of drugs were also misclassified. Last year, researchers concluded that, for over a decade, “millions of Americans” were “misled” by the CDC, politicians and the media to believe that the drug overdose crisis was driven by deaths caused by prescription opioids.

Patients prescribed opioids to treat long-term chronic pain are organizing across the country to overturn the CDC guidelines, and the debunking of CDC data and the AMA’s statement validated their cause. In interviews, multiple chronic pain patients said prescription opioids help them live more normal lives, but their lives became collateral damage of the war on opioid prescribing. Patients report that doctors refuse to treat them and pharmacies won’t fill their prescriptions, leaving them in disabling pain. Mothers are punished by hospitals after childbirth and even charged with crimes for continuing opioid therapy prescribed by a doctor during pregnancy.

“Opioids can be used safely during pregnancy, and we also know that when the response is immediately punitive or the application of the criminal legal system, there is actually far worse outcomes for babies and families, instead of being able to work that out with their doctor,” said Dana Sussman, deputy executive director of the National Advocates for Pregnant Women, in an interview.

Chronic pain patients and their advocates argue that the narrative linking opioid prescribing to the overdose epidemic is a “hoax,” and they are engaged in a pitched media battle with the “anti-opioid zealots” who pushed the CDC to discourage long-term opioid prescribing for anyone besides cancer patients and people dying in hospice. Advocates point to research showing that rates of fatal drug overdose  correlate with economic decline in many communities and have been rising rapidly since the late 1970s, not the mid-1990s when painkiller prescribing became more liberal thanks to campaigns by drug companies that have garnered plenty of headlines. The prescribing debate is extremely emotional, with each side attacking the other over credentials and alleged ties to the pharmaceutical and biomedical industries. (Kertesz said he was attacked in the media by an “expert in the field” for simply announcing a study on deprescribing and suicides. “Attacking investigators in the absence of any knowledge of their work would not be customary behavior in any area of medicine,” he said in an email. “But in this topical area, it is.”)

“The way tapering is happening in the real world is just horrible, even for people who are using their medication appropriately,” Nicholson said.

As an addiction specialist working at an emergency room and poison control center in Ohio, Ryan Marino has plenty of experience on the front lines. The narrative that overprescribing is causing an overdose crisis is clearly overblown, Marino said, because reductions in prescribing has not brought down deaths. Marino says he often sees patients who were prescribed high doses of opioids for years until their medication was abruptly tapered or cut off after CDC prescribing “guidelines” became public policy and even law in some states.

“Those patients went through hell … naturally, some turned to street drugs because it is so miserable to have opioids cut off, whether you have addiction or not,” Marino told Truthout. “Seeing those patients has cast an additional shadow over this overdose epidemic that we are seeing, because the over-reactionary response is now creating additional harms.”

Marino said the manufacturing and dispensing of opioids can be a real money-maker in a for-profit health system, and overprescribing played a role early on in the crisis. At the same time, prescription drugs are much safer to use than illicit heroin and fentanyl. Marino said there are good arguments for access to a safe supply of opioids — including prescription heroin for people at high risk of overdose — because people using regulated opioids under medical supervision are far less likely to die.

“We need some sort of regulation [of prescribing], but the oversight the DEA provides seems more in line with reducing prescribing than ensuring that prescribing is appropriate and ensuring that people have access to prescriptions,” Marino said. “The reality is, most people who were using Oxycontin never wanted to switch to heroin, and people who were using heroin never wanted to switch to fentanyl.”

Kertesz, who has worked closely with low-income and houseless patients, also takes a nuanced view of prescribing. Like Marino, Kertesz said there were problems with overprescribing in the past, when medications were heaped upon patients instead of affording them more holistic care. However, abruptly cutting patients off from medicines they depend on can cause all sorts of problems, particularly for people who have trouble consistently accessing health care in the first place. Doctors must make prescribing decisions based on the particular needs of a patient, but the crackdown has siloed prescribing as either “appropriate” or potentially illegal.

“We have now set up an entire system to push a change to care that does not have evidence for being safe or effective for patients,” Kertesz said.

For example, law enforcement often sees a “red flag” when patients are prescribed high doses of opioids or combinations of controlled substances, even when the prescriber is simply continuing the patient on a long-term regimen. While scrutinized by drug police as a sign of criminal activity, Nicholson said some patients benefit from drug combinations under appropriate medical supervision. Kertesz said assuming something “criminal” is going on when patients are prescribed higher doses of opioids or more than one psychoactive drug at a time is “a big leap.” The same goes for other “red flags” drug police look for in statewide prescribing databases and records kept by pharmacies.

“A patient who has filled a script in two pharmacies, or a patient who has traveled a distance … anybody who has multiple complex needs is already suspect, anyone who is rural by definition is suspect,” Kertesz said. “Pharmacists are trying not to lose their jobs, so they transfer all this stigma and burden to patients.”

There is a difference between “drug dependence” and “drug addiction.” Addiction is characterized by impulsive drug use despite adverse consequences. Physiological drug dependence results from the continued use of many medications — not just opioids. Addiction is rare in patients prescribed opioids for pain, and while long-term use can create dependence, the benefits can also outweigh the harms. People living with opioid addiction may also be seeking relief from untreated pain, trauma or mental anguish. Either way, abruptly cutting people off from opioids is dangerous. That’s why methadone and buprenorphine are prescribed for opioid addiction and dependence. Both drugs stabilize patients and stave off painful withdrawal symptoms, which is crucial for preventing overdose.

Advocates say the nuance is lost on the DEA and other law enforcement agencies. Drug cops are laser-focused on opioid “diversion,” the idea prescription opioids are being sold and used outside of their intended purpose. Data on diversion varies by source; a 2017 federal survey found that less than 11 percent of people who misused prescription opioids bought them on the street or stole them from a pharmacy or medical facility. If the rest are “misusing” their own prescriptions or obtaining them from friends and family — an idea that often offends pain patients — then anti-diversion efforts are effectively targeting prescribers and patients themselves.

For years, the government and mainstream media claimed diversion was the source of the overdose crisis, even as the data began telling a much different story. There is plenty of anecdotal evidence, for example, that buprenorphine is usually diverted to people living with addiction. Vermont recently decriminalized possession of buprenorphine without a prescription for that reason. The crackdown on diversion created grey areas that turned doctors and pharmacists into suspected drug dealers and patients into suspected criminals. In an ironic way, it worked. Pills became harder to find on the street, but reducing the supply did nothing to treat chronic pain or addiction. Overdoses involving illicit opioids are surging, and a growing chorus of drug users and advocates declare that “every overdose is a policy failure.” The DEA did not respond to a list of questions by the time this article was published.

“They Look at Prescribing as a Crime”

Joshi ran a general medical practice in Indiana, and he prescribed opioids for chronic pain as well as addiction. The DEA claimed Joshi was writing more prescriptions for controlled substances than most doctors in Indiana; Joshi says he served a population with serious medical needs. It was the undercover DEA agent’s job to pose as a “drug seeking” patient and catch Joshi in the act of prescribing and secretly record it on video. Joshi says he tended to trust his patients, but trusting the undercover agent was his downfall. He also suspects a former employee wrote fraudulent prescriptions before becoming an informant for the DEA, although he has been unable to prove it.

“They are transplanting people in the health care field as a drug-dealing ring, so I am the captain drug dealer; you snitch on me and you go free,” Joshi said.

Terrified, Joshi accepted a plea deal after he was indicted on multiple drug charges. However, the DEA’s case against him shifted over time and relied on inconsistent witness testimony, leaving a federal judge frustrated when the time came for sentencing, according to a review of court documents. The DEA accused Joshi of recklessly prescribing controlled substances, but prosecutors were unable to produce evidence that his patients did not have legitimate medical needs for the drugs Joshi prescribed. Multiple patients testified that Joshi’s practice made serious improvements in their lives. A day before Joshi was indicted, his clinic was recognized by the National Committee for Quality Assurance for “patient-centered, coordinated care.”

“A lot of people have it a lot worse than I do; there really wasn’t any evidence in my case,” Joshi said. “They essentially made a bunch of false statements.… Just the act of prescribing, it was construed as a crime. They don’t look at the clinical decision-making behind a prescription, they look at prescribing as a crime.”

A young doctor with a new practice and a child on the way, Joshi admits that he made mistakes. After losing his registration to prescribe controlled substances, Joshi says he unknowingly broke state rules by hiring nurse practitioners to write prescriptions for his patients. He also wrote a handful of prescriptions under another doctor’s name. Joshi says he tried to find workarounds out of concern for his patients. He did not want their “continuum of care” to be interrupted, but the judge saw a violation of the law.

“I tried to do what was right for my patients, but that was a deviation against the regulatory policies,” Joshi said.

Joshi was sentenced to 15 months in prison for writing an unnecessary prescription to an undercover DEA agent. He got out a few months early on good behavior. By the time he was sentenced, many of his patients were receiving the same treatment they had received from Joshi from other doctors. Stephanie and Ashley were not so lucky. Both women overdosed and died after law enforcement suddenly interrupted their medical care and their safe supply of medication ran out.

*Ashley’s name has been changed to protected her identity.

Hospital chargemaster prices for generics up to 6,000% more than pharmacies, research finds

Hospital chargemaster prices for generics up to 6,000% more than pharmacies, research finds

https://www.beckershospitalreview.com/pharmacy/hospitals-can-charge-6-000-higher-prices-for-generic-drugs-than-pharmacies-research-finds.html

Chargemaster prices for generic drugs in hospitals can be 6,000 percent higher than the price of the same drug in a pharmacy, according to an analysis by GoodRx, a pharmacy discount company. 

GoodRx analyzed chargemaster prices for 12 common generic drugs at 16 geographically diverse hospitals across the U.S. and compared the prices to cash prices at pharmacies. The company said cash prices are readily available and provide a good benchmark for the “fair” price consumers should pay for a generic drug. 

The researchers found that generic drugs may not be as affordable in an inpatient or emergency room setting as at a pharmacy, even if they’re the exact same medications, and that charges for routine generics vary greatly from hospital to hospital. 

For example, Sunrise Hospital in Las Vegas charges $57 per 50 mg tablet of sertraline, the generic version of Zoloft, a popular antidepressant. Camden Clark Memorial Hospital in Parkersburg, W.V., charges three different prices for the pill, all around $0.50 per pill, a more than 115% difference in pricing compared to Sunrise Hospital. 

Camden Clark Memorial Hospital and Albany Memorial Hospital in New York both charge about $0.40 per pill of lisinopril, which is used to treat high blood pressure and heart failure. But Greater El Monte Community Hospital in South El Monte, Calif., lists a price of $19 per pill, and Sunrise Hospital charges $43 per pill. 

Aspirin, a widely used painkiller, has an average retail price of $0.15 in most U.S. pharmacies, according to GoodRx, making a monthly supply about $4.50. But in hospitals included in GoodRx’s analysis, the average price is about $6 per tablet, varying from as little as $0.17 to $19 per tablet, depending on the hospital. 

The researchers noted that health insurance insulates many from paying the chargemaster prices at hospitals, but the prices still affect the uninsured, those with high deductibles and those treated in out-of-network hospitals. 

Find GoodRx’s full analysis here

Josh Bloom : PROP’s Self-Serving Letter to the AMA Must Be Addressed. My Comments

PROP’s Self-Serving Letter to the AMA Must Be Addressed. My Comments

https://www.acsh.org/news/2021/07/01/props-self-serving-letter-ama-must-be-addressed-my-comments-15641

Last year the American Medical Association directly challenged the CDC’s disastrous Guidance for Prescribing Opioids for Chronic Pain, which was issued in 2016. Not surprisingly, Physicians for Responsible Opioid Prescribing (PROP), a group that was (for some mysterious reason) directly involved with the CDC, responded defensively. Here are my comments on PROP’s disingenuous rebuttal.

Although it took four years, the American Medical Association’s 2020 letter to Dr. Deborah Dowell, the Chief Medical Officer of the National Center for Injury Prevention and Control at the CDC was a welcome and necessary first step in mitigating the awful damage done by the Guideline for Prescribing Opioids for Chronic Pain, which was published by CDC in 2016.

Predictably, the Physicians for Responsible Opioid Prescribing (PROP), which rarely misses a chance to promote its indefensible anti-opioid agenda, responded with a letter to the AMA that was published earlier this year in BMJ. The letter contains the same trickery, clever wordsmanship, and cherry-picking of data that has characterized virtually all communications from PROP dating back to the time the group was formed. 

Following are selected passages from this letter followed by my comments.

“On behalf of Physicians for Responsible Opioid Prescribing (PROP), we are writing to share our concern about the AMA’s recent public statements on opioid prescribing.”

On behalf of the people who have suffered the effects of PROP’s devastating war on patients, I welcome any input from the AMA. Or any other group that is willing to stand up to self-appointed opioid czars.

 

“It is disappointing that the AMA chose to fight key elements of the CDC’s effort to address the scourge of overprescribing of opioids in its letter to Dr. Deborah Dowell.” 

Agreed. It is disappointing that it didn’t happen sooner.

 

“[T]he AMA concurrently repudiates the CDC’s pain treatment recommendations on opioid dose and duration, guidance …”

And well it should. For several reasons:

  • Exactly who asked PROP for advice?
  • Is PROP qualified to give advice?
  • Please explain how PROP, an NGO with no official capacity, became intimately involved in the CDC’s misguided effort to regulate opioid drugs. 
  • Are there any undisclosed conflicts of interest that have played a part in PROP’s involvement?
  • Please explain why the CDC is involved in any aspect of the regulation of drugs or what gives the agency either the authority or expertise to do so.
  • The “guidance” itself is medically unsound because it is based on faulty science in that it fails to take even the most fundamental principles of pharmacology into account. It should be soundly repudiated.

 

“[I]ndustry friendly messaging on opioid use for pain can be found buried amid the effort to repair the problems created in the first place, and in no insignificant part, by erroneous messaging.”

 Resorting to blaming industry is the hallmark of a weak argument. 

 

“Particularly concerning are erroneous statements such as “the nation no longer has a prescription opioid-driven epidemic”

It may be concerning to PROP but that does not make it true. A three-year 2019 Massachusetts study concluded that a prescription opioid was found in only 16.5% of people who died from an opioid overdose (the rest being heroin and illicit fentanyl and its analogs) and that only 1.3% of overdose deaths arose from the drug that matched the prescription given to the patient. How is this consistent with a prescription drug-driven epidemic?

Furthermore, Dr. Jeffrey Singer of the Cato Institute and also a member of the ACSH Scientific Advisory Board makes this clear in his May 24th article:

“[D]ata provided by the CDC and the National Survey on Drug Use and Health consistently show no association between the number of prescriptions dispensed and the rate of non-medical use of prescription opioids or of opioid use disorder. In other words, opioid deaths are primarily driven by non-medical usage.

Jeffrey Singer, M.D. 

“There is compelling evidence that many of those currently struggling with opioid dependence and addiction were introduced to opioids through use of medically prescribed opioids used to treat chronic pain.”

A review article by Nora D. Volkow, M.D., the Director of the National Institute on Drug Abuse, and A. Thomas McLellan, Ph.D. writing in The New England Journal of Medicine in 2016 paints a different picture:

“Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing…  Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with pre-existing vulnerabilities.”

 

“While it has been reported that some of the CDC’s recommendations were misapplied as strict limits, this does not lessen the need for evidence-based opioid prescribing guidance on dose and duration.”

  • The recommendations were, for the most part, applied, not misapplied as strict limits. How else can PROP account for different legal restrictions of opioid dosage, number of pills, or both, in 36 states?
  • Did PROP play a part in influencing state legislatures? If so, why?
  • If PROP were so concerned about the “misapplication” of their “advice” why have we not heard one word from the group about this misapplication over the past five years?

 

“Suggested dose and duration only become “arbitrary” when applied too rigidly, or if they are used as license to abruptly cut prescribing to individuals that have become dependent on opioids for stability.”

This is mind-boggling. PROP’s “suggestions” and subsequent CDC “advice” has led to a widespread and involuntary tapering of opioid doses regardless of whether the pain patients had been functioning well for years, if not decades, on high-dose opioid therapy. Involuntary tapering sounds more like a practice that might be used in a concentration camp than medical policy in the United States. 

“By all means apply moral arguments and principles to make sure opioids are available for the right indications, but it makes no sense at all to suggest that removing guidance on opioid dose and duration is needed so that people with chronic pain do not suffer.”

This statement is especially egregious. First, who other than doctors should make the determination of “the right indications?” Second, PROP has made sure that opioids are not available for the right indications and frequently any indications. Perhaps PROP should share with us the statistics concerning the number of physicians who have left the field of pain management and how this alone has contributed mightily to patient suffering.

“[I]t makes no sense at all to suggest that removing guidance on opioid dose and duration is needed so that people with chronic pain do not suffer.

Yes, it does, when that guidance is causing people with chronic pain to suffer.

“Physicians were relieved to have the standards provided by the CDC guidelines.”How many? Two? Two hundred? Has PROP polled a large group of physicians and collected data to support this contention?

Does this also include the physicians who have been persecuted by a runaway DEA and state medical boards because they may have prescribed more than the PROP “recommendations?”

And PROP is presumptuous to think that it represents other physicians who also want responsible opioid use. The American Medical Association represents far more physicians –in many more specialties – and they also want responsible opioid use; as does the American Society of Addiction Medicine (ASAM), the premier addiction medicine certification and accreditation organization, who criticized and protested the CDC’s morphine milligram equivalent recommendations. What makes members of PROP think they are the only doctors who want responsible opioid use, let alone are an authority on it?

“Removing these evidence-based norms for opioid prescribing will not help either physicians or patients.”

I challenge PROP to demonstrate that a maximum daily dose of 90 Morphine Milligram Equivalents is based on any evidence whatsoever. Where did this number come from? Does it take into account rapid opioid metabolizers? Slow opioid metabolizers? Is metabolism or personal history of individual patients even considered when establishing a maximum dose? Why should government, let alone an NGO, even establish such a number, especially since it is the antithesis of personalized medicine.

Fortunately, the FDA is now conducting a workshop to examine “Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.” Although long overdue, perhaps it can be taken as a sign that the FDA will no longer roll over and play dead when it comes to the institution (and science) of drug policy. 

But the damage done by this rogue group will not be easily undone. 

Video: KeithAndrewNetWork guest the infamous Bob Scheerin – talking about dealing with chronic pain

Today on the (KeithAndrewNetWork®)
We have gotten the chance to Interview…

About Guest

Bob Sheerin @(Hillbilly) Bob Sheerin@utube and ™ Tap Out Comedy Production’s…LLC. © Stand Up Comedian! For hire
Jessica Thomsen, I am always growing and learning.

Harry Seddon Award-Winning Screenwriter, Actor, Writer, Director, Producer, Singer, Songwriter, Musician.

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EASY Methadone for all addicts: Biden DEA rule change aims to add mobile methadone vans

Biden DEA rule change aims to add mobile methadone vans

https://www.washingtontimes.com/news/2021/jun/28/biden-dea-rule-change-aims-add-mobile-methadone-va/

The Drug Enforcement Administration announced Monday a policy change aimed at expanding access to treatment for substance abuse disorders.

Under the new rule, the nation’s more than 1,700 DEA-registered methadone service providers are no longer required to obtain a separate registration for mobile services from the DEA.

Dr. Rachel Levine, assistant secretary for the Department of Health and Human Services, says the change is “extremely critical.”

“DEA’s new rule will streamline the registration process to make it easier for registrants to provide needed services to underserved parts of the country,” Dr. Levine told reporters during a conference call.

Last year, the U.S. recorded its highest number of drug overdose deaths in a 12-month period. More than 90,700 deaths occurred between October 2019 and November 2020, according to the Centers for Disease Control and Prevention.

“This alarming increase in overdose deaths underlines the need for more accessible treatment services,” Dr. Levine said, adding that studies show medication supports long-term recovery for substance abuse disorders.

Demand has grown in recent years for substance use disorder treatments like methadone, which is one of three FDA-approved medications for opioid use disorder. Long waiting lists and high service fees have plagued parts of the country as a result — especially in rural, urban and tribal communities, the DEA said. 

There are currently more than 1,900 narcotic treatment program locations nationwide that use methadone, according to the DEA. However, lack of access to transportation and distance to nearby brick-and-mortar narcotic treatment programs can pose accessibility problems for rural and underserved communities. 

“No American should have to drive, or ride a bus, for two hours a day to receive the life-saving evidence-based treatment they need to survive,” said Tom Coderre, acting assistant secretary for Mental Health and Substance Use.

Officials say the new rule, which goes into effect July 28, will save the agency money by bringing down costs linked to startup, labor and operations for the mobile units. They also expect costs related to health care, criminal justice and lost productivity to decline as access to treatment expands.Regina LaBelle, acting director of National Drug Control Policy, applauded the “significant” change in a statement Monday.

“This new rule is a significant step forward that supports the Biden-Harris Administration’s drug policy priorities, including expanding access to evidence-based treatment and advancing racial equity in our approach to drug policy,” Ms. LaBelle said.

https://img0.etsystatic.com/048/0/5573190/il_fullxfull.670768470_o0i3.jpg

Rumor has it this the TEMPLATE they are going to use for their Mobile methadone distribution system

The public no longer believes the epidemic can be solved legally, nor believes litigation has a place in addressing a fundamentally medical problem

Notice the verbiage that the CDC uses to misrepresent the deaths from opiate OD’s

the CDC figure in which it is estimated that by 2025, nearly 100,000 people will die annually from drug overdoses, the report goes on to question when America will take the opioid epidemic seriously

they start by STATING how many OD’s from DRUG OVERDOSES – ALL DRUG OVERDOSES – and then they start taking about the OPIATE CRISIS.. when in the HUGE NUMBER of OD’s that they claim – includes an estimated 15,000 deaths/yr from the use/abuse of NSAIDS (Motrin, Aleve, Aspirin). But the general public reading their statements – the last they read about is the OPIATE CRISIS.  CDC either really blends all the deaths – including those pts who have legal opiate Rxs – OR – they are intentionally reporting embellished numbers.

Post-Pandemic Opioid Litigation

https://daily-remedy.com/post-pandemic-opioid-litigation/

As though on cue, the court rulings and press releases arrive.

Just in time for the post-pandemic summer. A summer sure to be dominated by headlines of opioid litigation, echoing Mark Twain’s famous quip – history does not repeat itself, but it often rhymes.

The parallels in the legal outcomes and press releases resonate particular patterns we saw pre-pandemic. Prior to 2020 we saw prosecutors bringing forward ever more sensationalized charges, and we saw dramatic pleas and settlements accompanied by astronomically large financial remunerations.

And in the waning days of the pandemic we seem to find the very same thing. We see Johnson & Johnson settling just days prior to a highly anticipated civil trial, settling for yet another astronomical sum – but this time accompanied by a facetious pledge to stop manufacturing opioids, as though by decreasing the supply of prescription medications we will solve the opioid epidemic.

But this time we are not fooled by the false narratives. A report by the Economist reveals just how much public perception has changed over the course of the pandemic. Citing the CDC figure in which it is estimated that by 2025, nearly 100,000 people will die annually from drug overdoses, the report goes on to question when America will take the opioid epidemic seriously.

Clearly the empty pageantry that has defined these hollow court rulings has run its course.

The public no longer believes the epidemic can be solved legally, nor believes litigation has a place in addressing a fundamentally medical problem.

The rhythm has changed, and the public is calling for a new tune.

Now, instead of targeting prescription opioids and attributing blame to the healthcare system, we are finally addressing the true root cause of the current opioid related mortality – fentanyl. A problem even before the pandemic began, its supply has only grown in recent months.

In 2019 more than 36,000 people died from overdoses related to synthetic, illicitly-obtained opioids, such as fentanyl, according to the CDC. In 2020, overdoses increased by 30% with fentanyl now linked to 3 out of 5 fatal overdoses that year, as cited by the CDC.

But if fentanyl is the problem, then why are we still seeking the same misguided legal approaches to the opioid epidemic?

The disparity resides in a conceptual disconnect between the legal and medical worlds. In the legal world, opioid litigation is still ongoing, and many of the cases that began pre-pandemic have yet to be settled post-pandemic.

We have not see the bulk of the Walmart v. DOJ case, nor have we seen the conclusion of the Sackler family’s Purdue Pharma settlement.

And while the legal world is still mired in year’s old litigation, the medical world has long moved on – exacerbating a divide that has permeated into the minds of the public.

Before the public believed opioid litigation would help resolve or at least curtail the overdoses.

Now we see the unintended consequences. We see the inability to seek adequate pain relief, the fear in the minds of providers, and a culture of healthcare prescribing patterns captivated by the fear of prosecution.

And if public sentiment has shifted in favor of the healthcare field, supporting the supposed perpetrators of the opioid epidemic, then who or what is the government representing in all these legal cases?

As underlying all the contrived legal arguments and interpretations of law is the fundamental premise that the prosecutors are representing the public interest.

But if the public no longer supports the government’s legal arguments, nor its litigation, then the government no longer represents the public.

And perhaps it is time for the law to catch up with the medicine.

 

29,800 physicians exited private practice for insurers, PE firms & other corporations in 2 years

29,800 physicians exited private practice for insurers, PE firms & other corporations in 2 years

https://www.beckersasc.com/asc-news/29-800-physicians-exited-private-practice-for-insurers-pe-firms-other-corporations-in-2-years.html

There was a 32 percent increase in physician practice acquisitions by corporate entities in the past two years, which added 29,800 formerly independent practice physicians, according to a June 29 report from Avalere.

Around 11,300 of those physicians joined corporate entities, such as insurers and private equity firms, after the COVID-19 pandemic.

The number of corporate-employed physicians also jumped 31 percent since 2019. By the end of January, nearly 20 percent of physicians reported being employed by a corporate entity besides hospitals and health systems.

Hospitals and health systems together with corporate entities owned 48.4 percent of physician practices as of January. Avalere reported that 48,400 physicians left independent practice last year for hospital or corporate employment, including payers and private equity firms.

Costly new Alzheimer’s drug could force Medicare to restrict access

When I started working in a pharmacy after my 2nd year of pharmacy school…  the average Rx price was $4-$5… 90%+ was for BRAND NAME MEDS, there was NO PBM’s, and there was no DEA.  Insulin was about $2.50 for a 10 ml vial of a equivalent to today’s 100 u insulin, Birth Control pills was $1.33, Pharmacies typically had a minimum price of a Rx of $1.50.  The PBM industry didn’t start until the winter of 1969-1970 and they were just a centralized uniform billing system for pharmacies and pts.  DEA didn’t come around to abt 1973.  The Brand name pharmas was the only way that the Research and Development of new drugs were paid for by the profits from all the medications that they sold.

Today, the PBM industry now controls what meds will be paid for and how much the pharmacy will get paid for filling the Rxs for the pt and the PBM now controls about 90%+ of all Rxs that are filled.  All those “discount drug cards” like GOOD RX and others are owned by or the Rxs are processed thru those same PBM’s.  Those PBM’s have created a system that they DEMAND rebates/kickbacks/discounts upward of 75% of the wholesale price of the meds from the pharmas or the pharma’s meds require a prior authorization for the PBM to pay for them.  The average price of Rxs today is pushing $70… even though about 90%+ of Rx dispensed are generics.

Here is a chart that outlines/demonstrates where the $$ that a pt pays at the register goes. Bureaucrats/politicians are starting to pay attention to these types of gross overcharges by these PBM’s and some individual states are starting to pass new laws that will curtail these gross overcharges, but I expect it will take years for things to corrected.  These PBM’s are will funded and have no problem with spending untold $$$ on Lobbying Congress and state legislature to defend what they are doing.

Of course, with 90%+ generic and the companies that produce them, do no research and development… so all R&D has to be funded by the brand name pharmas and thus we see new meds coming out with VERY HIGH COSTS, because they are only providing abt 10% of all Rxs.

Costly new Alzheimer’s drug could force Medicare to restrict access

https://www.foxbusiness.com/healthcare/costly-alzheimers-drug-medicare-restrict-access

The federal health insurance program may limit who can get the drug, which Biogen priced at $56,000 a year, to limit the financial impact

The recent approval of a high-price Alzheimer’s drug is raising questions about who will have access to a treatment that could cost Medicare billions of dollars in coming years.

Biogen Inc. priced the drug Aduhelm at $56,000 a year. Wall Street analysts estimate it could eventually surpass $5 billion in yearly sales, mostly paid by Medicare, while some health economists warn the bill would be multiples higher.

Medicare normally pays unconditionally for approved medicines. To limit the financial hit from Aduhelm, however, Medicare could restrict access, former U.S. health officials and health-policy experts said.

“Medicare can’t afford to treat this as business as usual,” said Andy Slavitt, a former Medicare acting administrator and Biden administration senior adviser.

HOW WILL INSURERS COVER BIOGEN’S NEW ALZHEIMER’S DRUG? 

The Centers for Medicare and Medicaid Services, the agency overseeing Medicare, is reviewing Aduhelm’s approval and will have more information soon about its coverage, a spokesman said.

“Whether or not that drug will be covered by Medicare and Medicaid is an outstanding question, something HHS will have to deal with,” Department of Health and Human Services Secretary Xavier Becerra said during an interview live streamed on YouTube on Thursday.

“We’re going to be making some pretty heady decisions about how it’s treated, if it will be reimbursed, how much, and so forth,” he added.

Meanwhile, Biogen said it wants to limit who gets Aduhelm to Alzheimer’s patients in the early stage of the disease with mild symptoms.

The federal government and the company may need to move quickly. “I’m not quite certain how we’re going to accommodate all the patients who want it,” said Richard Isaacson, director of the Alzheimer’s Prevention Clinic at Weill Cornell Medicine and New York-Presbyterian hospital.

FCC votes to make ‘988’ the suicide hotline number – active by July 2022

FCC votes to make ‘988’ the suicide hotline number

https://abc7chicago.com/suicide-hotline-number-988-fcc-prevention/6320466/

The Federal Communications Commission voted Thursday to make “988” the “911” for suicide prevention.

The new number is designed to connect Americans in crisis directly with a suicide prevention hotline.

Phone service providers will have until July 2022 to implement the change.

Currently, the National Suicide Prevention Lifeline uses a 10-digit number, 800-273-TALK (8255), which routes calls to about 170 crisis centers. That 800 number will remain in place, but having the shorter number makes it easier for people to call, and is expected to lead to an increase in calls to the hotline.

Suicide-prevention experts have said that the three-digit number will be a breakthrough that helps people in crisis. One aspect of designating a three-digit number for the hotline, just like 911 for emergencies, is that it removes stigma for seeking help in a mental-health emergency, they say.

The government’s action comes as suicide rates have increased across the U.S. over the past two decades. Officials say suicide claimed the lives of more than 48,000 Americans in 2018, resulting in about one death every 11 minutes.

The coronavirus pandemic has put even more strain on the nation’s mental health care system, and experts have been concerned about the impact as the virus and its aftershocks may deepen people’s levels of anxiety and depression.

If you or someone you know is in crisis, call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255) or contact the Crisis Text Line by texting HOME to 741741. You can reach Trans Lifeline at 877-565-8860 (U.S.) or 877-330-6366 (Canada) and The Trevor Project at 866-488-7386.

Untreated chronic pain can lead to suicide

Untreated chronic pain can lead to suicide

https://www.swoknews.com/styles/peoples_pharmacy/untreated-chronic-pain-can-lead-to-suicide/article_31b7f44d-42f9-5bc5-8086-cdd4111b4d10.html

The opioid epidemic has resulted in untold misery and death. Drug abuse is a scourge that remains an ongoing threat in many communities.

There is, however, another tragedy resulting from efforts to restrict access to opioids. We recently received a heart-wrenching story from a widow whose husband, Tom Bellinger, committed suicide several months after writing this account of his suffering. It was titled “The Other Side of the Opioid Hysteria — Treating Chronic Pain.”

“Everyone knows pain. Acute pain is experienced for a relatively short period, like after a tooth is pulled. We treat acute pain with strong pain medicine until it goes away.

“Ordinary pain is on-and-off pain, such as a headache or an occasional backache. You might grab an aspirin or other over-the-counter pain reliever for this.

“Chronic pain doesn’t go away. Many chronic pain sufferers, especially those who have had the condition for a long time, can control it only with strong prescription opioids like oxycodone. Though it’s no miracle, for many of us it can provide a few hours a day of reduced pain. In addition, it is relatively inexpensive.

“Of course, this drug can be abused and that can lead to overdose and death. While that is tragic, it has nothing to do with chronic pain. After suffering in silence, I am finally speaking out for myself and the hundreds of thousands of human beings in this country for whom untreated chronic pain is an unrelenting reality.

“I am Angry and Fed Up with the opioid hysteria status quo. At 70 years old, I’m not planning on living forever but I would like to live my allotted time as best I can. An oxycodone prescription would make this possible.

“I used to be a carpenter. I injured my back 40 years ago while lifting, with a partner, a very heavy table saw. In an instant, I felt excruciating pain in my lower back and was unable to stand up straight. It took a couple painful weeks of bed rest to straighten out.

“Over the years, my back continued to go out periodically. Eventually, the pain became chronic. It’s been my constant companion, 24-7, 52 weeks a year ever since. Sleep is as elusive as a mirage.

“I’ve tried everything from biofeedback and acupuncture to physical therapy and yoga and everything in between. None of these approaches has been effective.

“OTC pain medicine no longer helps. Hydrocodone helped for a while, but treatments at One of the best Joint Pain Clinic in Myrtle Beach that allowed me a somewhat livable life.

“Then the opioid hysteria exploded. Doctors were cowed by the government into refusing opioid prescriptions. Within the last year and a half, I have been denied my request for oxycodone from a nurse practitioner, a pain specialist and three different physicians who work for a major statewide health care provider.

“Anybody with ordinary pain can go to a grocery store or pharmacy and find relief. Yet a person suffering chronic pain just has to suffer.

“My chronic pain has caused depression. There have been long stretches of days when I have contemplated various suicide scenarios.

“According to a study by the Centers for Disease Control and Prevention (Annals of Internal Medicine, Oct. 2, 2018), there is a connection between chronic pain and suicide. From 2003 to 2014, CDC researchers identified a total of 123,181 individuals, from 18 states, who died by suicide. 10,789 were chronic pain sufferers.

“The media, the government and the doctors who write the prescriptions need to address this abdication of compassionate care.”

Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert. Their syndicated radio show can be heard on public radio. In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of King Features, 628 Virginia Drive, Orlando, FL 32803, or email them via their website:

www.PeoplesPharmacy.com.