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

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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.

Johnson & Johnson confirms opioid business has ended in $230 million settlement with New York

This settlement may be just the first shoe to drop.  J&J division Janssen use to produce Duragesic patches… they have ceased production of that product and the last of the existing stock will expire Jan 31, 2021 – 5-6 weeks from now.  For a pharmaceutical to be FDA approved on the market place it must have a NDA (New Drug Approval) and all generics to be approved has to have a ANDA (Abbreviated New Drug Approval) – that is basically based on the NDA existence.  When Purdue brought out a abuse resistant Oxycontin, either Purdue or the FDA revoked/rescinded the NDA for the previous Oxycontin and all of a sudden those companies making a generic version of long acting Oxycontin – AUTOMATICALLY lost the ANDA the legal ability to produce that generic med. As of July 31, 2021 there is a possibility that no more new Fentanyl patches will be manufactured and their availability will be limited to those products produced prior to the day that the NDA was revoked/rescinded and what is available within the pharma/wholesale/pharmacy supply chain.  Who is to say that some part of the bureaucracy will push to have the NDA of Duragesic patches revoked/rescinded to make sure that Fentanyl patches are no longer available. The fact that the media has routinely reported that (illegal) FENTANYL is a major cause of OD’s will not help those pts who have a valid medical need for this particular medication.

https://workcompauto.optum.com/content/owca/owca/en/insights/blog/clinical-connection-blog/2020/Janssen-discontinued-all-brand-name-Duragesic.html   Janssen made a business decision to permanently discontinue all Duragesic transdermal systems and indicated they should be maintained on formularies until the last produced batch expires on July 31, 2021

Johnson & Johnson confirms opioid business has ended in $230 million settlement with New York

https://www.cnbc.com/2021/06/26/jj-agrees-to-stop-selling-opioids-in-230-million-settlement-with-new-york.html

Key Points
  • New York Attorney General’s office said the agreement bans J&J from promoting opioids through any means and prohibits lobbying about such products at the federal, state or local levels.
  • However, Johnson & Johnson said it had already exited the business.
  • As part of the settlement, the company will resolve opioids-related claims and allocate payments over nine years.
  • The settlement follows years of lawsuits by states, cities and counties against major pharmaceutical companies over the opioid crisis, which has killed nearly 500,000 people in the U.S. since 1999.

Johnson & Johnson has agreed to a $230 million settlement with New York state that bars the company from promoting opioids and confirmed it has ended distribution of such products within the United States.

New York Attorney General Letitia James’ office in a statement Saturday said the agreement bans J&J from promoting opioids through any means and prohibits lobbying about such products at the federal, state or local levels.

Johnson & Johnson has not marketed opioids in the U.S. since 2015 and fully discontinued the business in 2020.

As part of the settlement, the company will resolve opioids-related claims and allocate payments over nine years. It could also pay $30 million more in the first year if the state executive chamber signs into law new legislation creating an opioid settlement fund, according to the press release from James’ office.

The settlement follows years of lawsuits by states, cities and counties against major pharmaceutical companies over the opioid crisis, which has killed nearly 500,000 people in the U.S. in the last couple decades.

Governments have argued that companies over-prescribed the drugs, causing people to become addicted and abuse other illegal forms of opioids, while companies have said they’ve distributed the necessary amount of the product to help people with medical issues.

“The opioid epidemic has wreaked havoc on countless communities across New York state and the rest of the nation, leaving millions still addicted to dangerous and deadly opioids,” James said in a statement.

 “Johnson & Johnson helped fuel this fire, but today they’re committing to leaving the opioid business — not only in New York, but across the entire country,” she said. “Opioids will no longer be manufactured or sold in the United States by J&J.”

The New York opioid lawsuit trial against the rest of the defendants will begin this week, according to the release. Other defendants in the New York suit include Purdue Pharma; Mallinckrodt LLC; Endo Health Solutions; Teva Pharmaceuticals USA; and Allergan Finance LLC.

In a statement Saturday, Johnson & Johnson said the settlement “is not an admission of liability or wrongdoing by the company” and is “consistent with the terms of the previously announced $5 billion all-in settlement agreement in principle for the resolution of opioid lawsuits and claims by states, cities, counties and tribal governments.”

The company also said it would continue to defend against any lawsuits the final agreement does not resolve.

James said the state will focus on funding for opioid prevention, treatment and education efforts in order to “prevent any future devastation.”

Substandard generic drugs are flooding the US market and putting all Americans at risk

Substandard generic drugs are flooding the US market and putting all Americans at risk

https://www.foxbusiness.com/markets/substandard-generic-drugs-us-market-risk

Despite safety concerns, hospitals keep using substandard generics and supermarket pharmacies, big box retailers and corner drug stores continue to sell them

Most Americans would be shocked to learn that millions of doses of poor-quality and potentially harmful generic drugs are being imported into the United States each year. Despite safety concerns, hospitals keep using them every day. And supermarket pharmacies, big box retailers, and corner drug stores continue to sell them.   

Many in Washington will point a finger at the FDA. But the real problem is that U.S. companies choose profit over safety by importing and selling substandard generic drugs across the nation. 

These U.S. companies include large group purchasing organizations and wholesalers that follow a very lucrative business model. They simply scour the globe for the cheapest generic drugs—often from China and India. For them, the lower the procurement price, the higher the margin of profit—no matter where or how the medicines are produced. 

One example is a generic muscle relaxant administered to COVID-19 patients on ventilators. At the beginning of the pandemic, the drug was in short supply. In response, the FDA approved imports from a manufacturer that had received FDA warning letters. These medicines must be manufactured under sterile conditions. But the agency warned the company about its failure to prevent contamination of its supposedly sterile medicines. 

These concerns could be avoided if drug purchasers prioritized safety over profits—and purchased generic drugs from reliable manufacturers in the United States. Instead, in their endless quest for cheaper drugs, they choose to ignore safety and quality concerns.

This race-to-the-bottom for the price of generic drugs has driven ethical manufacturers out of business—and caused the collapse of America’s domestic generic drug manufacturing industry. As a result, the United States now depends on China for thousands of generic drugs because Beijing controls the supply of basic drug-making components.  

With the United States now increasingly dependent on imported medications, doctors, nurses, pharmacists, and patients are witnessing first-hand the risks that come from imports of substandard generics. 

A recent medical journal study reported on life-threatening risks from a generic drug used to treat patients recovering from heart and lung transplants. Researchers found that a generic medication made by two overseas companies didn’t dissolve properly—impeding its effectiveness and posing life-threatening risks.

Everyday medications are also failing to meet U.S. standards. The FDA warned a manufacturer of a common asthma medication, albuterol, about sterility concerns and the risk of contamination with other medicines made at the same facility. 

When U.S. companies buy imported medications as cheaply as possible, they set in motion other costs. Patients suffer serious setbacks—blood pressure spikes, failed organ transplant recovery, and uncontrolled seizures—when their generic drugs don’t work. 

In the worst cases, Americans die from unsafe drugs purchased by U.S. companies. In 2007 and 2008, for example, hundreds of Americans died from tainted supplies of Chinese-made heparin.

In 2018, millions of Americans learned that their blood pressure medication contained a cancer-causing rocket fuel chemical. One Chinese manufacturer—whose product contained the highest amount of the carcinogen—was subsequently banned by the FDA. 

It’s time to impose a cost on the traders of substandard imported drugs. To do so, the United States must once again manufacture these generics at home.

To realistically support America’s generic drug manufacturers as they compete with cheap imports, Congress should impose “Buy American” requirements for the Department of Defense and the Veterans Administration. Similarly, domestic procurement policies should also be extended to Medicare and Medicaid.

Americans need safe, quality medicines. Washington must not allow special interests to buy substandard drugs and sell them in the United States. It’s time to bring these vital supply chains home—so that American lives won’t be at risk.