Pfizer Study Shows Vaccine Booster Should Protect Against Omicron

Posted on December 8, 2021 by Pharmaciststeve

Pfizer Study Shows Vaccine Booster Should Protect Against Omicron

https://www.medscape.com/viewarticle/964431

A raft of new studies released overnight that looked at the ability of Omicron to evade an array of currently available vaccines, suggest a substantial loss of protection against the highly mutated variant.

The new studies, from teams of researchers in Germany, South Africa, Sweden, and the drug company Pfizer, showed 25 to 40-fold drops in the ability of antibodies created by two doses of the Pfizer-BioNTech vaccine to neutralize the virus.  

But there seemed to be a bright spot in the studies too. The virus didn’t completely escape the immunity from the vaccines, and giving a third, booster dose appeared to restore antibodies to a level that’s been associated with protection against variants in the past.

“One of the silver linings of this pandemic so far is that mRNA vaccines manufactured based on the ancestral SARS-CoV-2 continue to work in the laboratory and, importantly, in real life against variant strains,” said Hana El Sahly, MD, professor of molecular virology and microbiology at Baylor College of Medicine in Houston. “The strains so far vary by their degree of being neutralized by the antibodies from these vaccines, but they are being neutralized nonetheless.” 

El Sahly points out that the Beta variant was associated with a 10-fold drop in antibodies, but two doses of the vaccines still protected against it.

President Biden hailed the study results as good news.

“That Pfizer lab report came back saying that the expectation is that the existing vaccines protect against Omicron. But if you get the booster, you’re really in good shape. And so that’s very encouraging,” he said in an afternoon press briefing.

More Research Needed

Other scientists, however, stressed that these studies are from lab tests, and don’t necessarily reflect what will happen with Omicron in the real world. They cautioned about a worldwide push for boosters with so many countries still struggling to give first doses of vaccines.

Soumya Swaminathan, MD, chief scientist for the World Health Organization, stressed in a press briefing today that the results from the four studies varied widely, showing dips in neutralizing activity with Omicron that ranged from 5-fold to 40-fold.

The types of lab tests that were run were different, too, and involved small numbers of blood samples from patients.

She stressed that immunity depends not just on neutralizing antibodies, which act as a first line of defense when a virus invades, but also on B cells and T cells, and so far, tests show that these crucial components — which are important for preventing severe disease and death — had been less impacted than antibodies.

“So, I think it’s premature to conclude that this reduction in neutralizing activity would result in a significant reduction in vaccine effectiveness,” she said.

Whether or not these first-generation vaccines will be enough to stop Omicron, though, remains to be seen. A study of the Pfizer, Moderna, and AstraZeneca vaccines, led by German physician Sandra Ciesek, MD, who directs the Institute of Medical Virology at the University of Frankfurt, shows a booster didn’t appear to hold up well over time.

Ciesek and her team exposed Omicron viruses to the antibodies of volunteers who had been boosted with the Pfizer vaccine 3 months prior.  

She also compared the results to what happened to those same 3-month antibody levels against Delta variant viruses. She found only a 25% neutralization of Omicron compared with a 95% neutralization of Delta. That represented about a 37-fold reduction in the ability of the antibodies to neutralize Omicron vs Delta.

“The data confirm that developing a vaccine adapted for Omicron makes sense,” she tweeted as part of a long thread she posted on her results.

Retool the Vaccines?

Both Pfizer and Moderna are retooling their vaccines to better match them to the changes in the Omicron variant.  In a press release, Pfizer said it could start deliveries of that updated vaccine by March, pending US Food and Drug Administration authorization.

“What the booster really does in neutralizing Omicron right now, they don’t know, they have no idea,” said Peter Palese, PhD, chair of the Department of Microbiology at the Mount Sinai School of Medicine in New York City.

Palese said he was definitely concerned about a possible Omicron wave.

“There are four major sites on the spike protein targeted by antibodies from the vaccines, and all four sites have mutations,” he said. “All these important antigenic sites are changed.

“If Omicron becomes the new Delta, and the old vaccines really aren’t good enough, then we have to make new Omicron vaccines. Then we have to revaccinate everybody twice,” he said, and the costs could be staggering.  “I am worried.”

On Wednesday, Tedros Adhanom Ghebreyesus, PhD, director general of the WHO, urged countries to move quickly.

“Don’t wait. Act now,” he said, even before all the science is in hand. “All of us, every government, every individual should use all the tools we have right now,” to drive down transmission, increase testing and surveillance, and share scientific findings.

“We can prevent Omicron [from] becoming a global crisis right now,” he said.

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Supreme Court Set to Weigh in on the Opioid Epidemic in Three Important Physician Cases

Posted on December 8, 2021 by Pharmaciststeve

Supreme Court Set to Weigh in on the Opioid Epidemic in Three Important Physician Cases

https://medium.com/@fightthefeds/supreme-court-set-to-weigh-in-on-the-opioid-epidemic-in-three-important-physician-cases-c5b6cc0219eb

The Supreme Court will decide United States v Ruan and United States v. Kahn and likely United States v. Naum and determine if a physicians prosecuted by the federal government can be convicted for violating an objective standard of care.

A few years ago, I spent over a month in Northern West Virginia defending a doctor accused of unlawfully prescribing Opiates — specifically Suboxone. A family practice physician running a small clinic in Northern Ohio and West Virginia Dr. George Naum wanted to help patients suffering from the opioid epidemic by providing medication assisted treatment. In small rural communities this service was needed to help those suffering from addiction begin their recovery and start getting their life back together. Dr. Naum joined a practice and began working with a nurse to treat this vulnerable patient population.

Supreme Court Set to Weigh in on the Opioid Epidemic

Fast forward a few years and Dr. Naum found himself in the middle of a federal investigation for, of all things, unlawfully prescribing opiates. The practice was not a pill mill. It was a treatment center. The practice was not prescribing high power narcotics to patients seeking opiates or unlawful purposes but rather a place where people recovering from addiction sought treatment. Unfortunately for Dr. Naum, federal prosecutors not trained in the complexity of healthcare law and medical treatment failed to understand the difference.

To make matters worse, the standards for prosecuting physicians became convoluted over time by federal appellate court decisions that failed to recognize sometimes Doctors are required to make tough calls in the wake of the opioid epidemic. Knowing that Dr. Naum had done nothing wrong we proceeded to trial and were quick to learn that both the prosecutor and the judge stacked the case against us by making a critical error in interpreting Controlled Substance Prescribing laws.

Decided in 1975 the landmark case of United States v. Moore was the first case that determined that the weight of the federal government’s drug trafficking laws could be applied against physicians. To be convicted, a doctor must have abandoned the practice of medicine, ceased acting as a physician, and engaged in drug trafficking as conventionally understood i.e., running a “pill mill”. Since United States v. Moore circuits have widely spilt in their interpretation of the standard necessary to convict a Defendant. In the Fourth Circuit courts determined that a physician could be convicted of drug trafficking if he or she prescribed a medication “beyond the bounds of professional medical treatment”. The Circuit court interpreted this to mean that any doctor who prescribes outside of “professionally recognized norms” may be convicted of Drug Trafficking.

The Court in Dr. Naum’s case determined that Dr. Naum could be convicted if he stepped outside of professional norms for prescribing Suboxone regardless of whether the patients had a legitimate medical need for the treatment. Given that it’s nearly impossible for every doctor to follow the myriad of rules and regulations applied explicitly and in an ad hoc fashion Dr. Naum was convicted. Nearly every practitioner without a robust compliance program and a team of compliance professionals would be. Dr. Naum appealed, all the way to the Supreme Court of the United States.

Meeting Dr. Naum at the Supreme Court was another case, that of Xiulu Ruan. Dr. Ruan was a board-certified interventional pain management specialist in Mobile Alabama. He owned the practice along with his partner John Patrick couch, whom I am also representing before the Supreme Court. Drs Couch and Ruan were indicted in 2016 for unlawfully prescribing drugs. Just as in Naum, the prosecutors acknowledged that the patients, by in large, needed the medications prescribed but they prosecuted them anyway for falling outside of professional norms. The Government elicited testimony from three experts who testified at length that both doctors prescribed medication “outside the standard of care” and “outside the usual course of practice”. Back in 1975 such testimony would not be sufficient to support a criminal conviction. Today its much different. The standard has been sufficiently eroded to achieve convictions against doctors making tough judgment calls in the pain management field.

In all three cases, medical “experts” brought by the government faulted the physicians for: ignoring “red flags”, not conducting a thorough examination, using opiates as a first line of treatment, not abandoning patients who presented inconsistent urine drug screens. The practice of opening up a physician’s medical records and heavily criticizing care based on an unenumerated list of “red flags” or professional norms is something that has sent a lot of innocent doctors to the slammer. Moreover, each physician, Naum, Ruan, and Couch, called experts of their own who were well credentialed and supported the care provided. None of these cases presented the sort of rampant “pill mill” evidence commonly seen in prosecutions of this nature in the early 2000’s.

Similarly, to Naum, Ruan and Couch were the victims of a judicial decision that drastically changed the standard for conviction presented to the jury and stacked all odds against them. In Ruan and Couch the trial court refused to provide a commonly provided instruction that informed the jury that prescriptions written by the doctors “in the good faith treatment of a patient” are lawful. Without the benefit of the “good faith” defense, minor differences between the standard set forth by government experts and the prescribing practices of Ruan and Couch became criminal, just as in Naum.

Ruan and Couch requested the following instruction:

“Good faith in this context means good intentions and the honest exercise of professional judgment as to the patient’s needs. It means that the Defendant acted in accordance with what he reasonably believed to be proper medical practice”

This instruction was a mainstay in opioid prosecutions until a few years ago when the government elected to take the position that the instruction was not a valid statement of the law. The government argued that “good faith” was “subjective” and the standard should be an objective one. The court ruled that a physician cannot save his conduct if he failed to adhere to professional norms but subjectively believed that his prescriptions were legitimate.

All three physicians sought the review of the high court to change the state of law for good. All three physicians sought to stop the prosecution of physicians for what amounted to allegations of mere malpractice and revert to the standard set in 1975 by United States v. Moore.

On November 5, 2021 the Supreme Court agreed to hear the appeal of Ruan v. United States and consolidated the case with a very similar case Kahn v. United States. Naum v. United States is still pending before the court and may be taken up later if the decision in Ruan does not dispense with the issues in his case.

Ruan will be set for oral argument this term and the Justices have elected to decide the very narrow issue of whether the “good faith” defense to opiate prescribing is a valid defense and whether an instruction must be given to the jury. The Court will likely opine on whether a physician’s subjective “good faith” is a relevant consideration for a jury in opioid prosecutions. If the Court determines that “subjective good faith” is relevant, doctors making tough decisions during medical treatment of a patient will get a break. If the Court determines that it is not, doctors will be beholden to the rigid, ever changing, and often unenumerated standards often used by physicians in opioid prosecutions.

While the ruling may be narrowly applied to the issue of “good faith” it will require an analysis of the state of the standard for prescribing opiates and the ruling will have wide ranging implications for all doctors prescribing controlled substances to patients and how they must document their prescriptions to avoid federal scrutiny for their prescribing decisions.

The Court’s decision will either strengthen existing opioid prescribing laws and enable prosecutors to use them against physicians who merely deviate from the “standard of care”, or it will sway to the benefit of prescribers allowing them the benefit of a jury instruction that makes judgment calls made in “good faith” a defense. Regardless, all prescribers should be watching this case and read the court’s dicta very carefully to ensure that their practices stay compliant with the current interpretation of federal regulations in this field.

Ronald Chapman II, ESQ @RonChapmanAtty is an author and nationally-recognized top federal criminal defense attorney, and former prosecutor, with a number of high-profile federal acquittals. “Fight the Feds: Unraveling Federal Criminal Investigations” is available for pre-order now. If you are interested in contacting Ron about a case, contact him here: Chapman Law Group

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UPDATE: APDF pt ADVOCATE got opiate pain meds for pediatric burn pt

Posted on December 7, 2021 by Pharmaciststeve

APDF’s  VP Bob Sherrin a pediatric pain advocate …met today with this pt’s prescriber and her parents and after over six weeks of suffering from 3rd degree burns and painful debridement WITHOUT ANY OPIATES FOR HER  PAIN …. she got her first opiate Rx and her first dose today. Up until today, Vanderbilt Hosp had a BLANKET NO OPIATE POLICY for pediatrics.

IMO, the chronic pain community and American Pain & Disability Foundation IS ON THE MOVE

APDF needs both volunteers and donations

 

Vanderbilt Burn Center (Nashville) refused to provide the young patient sufficient pain medication for SIX WEEKS

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Clinical Opiate Withdrawal Scale

Posted on December 7, 2021 by Pharmaciststeve

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When personal phobias & biases are used to support a Pharmacist’s reason for denial of care: “I’m not comfortable”

Posted on December 7, 2021 by Pharmaciststeve

When a Pharmacist tells a pt that “I’m not comfortable” and refuses to fill a prescriptions – particularly a controlled substance –  typically they have NO VALID CLINICAL REASON to refuse to fill and deny care.  In fact, I wish that pts would ask these pharmacists that use this “excuse” as a reason to deny care for a written CLINICAL REASON for the denial.  In reality – it would be a FAT CHANCE that the pt would get anything in writing from a pharmacist… Most likely they will get a condescending statement that “I don’t have to fill anything that I don’t want to”  In my conversations with pts that have been on the receiving end of those sort of condescending statements… most all seem to be with the pt interacting with a chain pharmacist….  Could that be that it is because the various state boards of Pharmacy are stacked with non-practicing corporate pharmacists ? https://abcnews.go.com/Business/story?id=6552337&page=1     The primary charge of states’ Boards of Pharmacy is PUBLIC SAFETY… if certain boards of pharmacy are turning a blind eye or deft ear to the denial of care by untold number of chain pharmacists.  So these chain pharmacists know/understand that there is never going to be any personal consequences for the inappropriate denial of care to pts.

IDENTIFYING THE ABUSIVE PRACTICES TOWARD PAIN CARE OF THE PHARMD PHYSICIAN WANT TO BE

https://youarewithinthenorms.com/2021/12/07/identifying-the-abusive-practices-toward-pain-care-of-the-pharmd-physician-want-to-be/

BY

NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, LESLY POMPY MD., NANCY SEEFEDLT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

FROM THE WRENN RAP FILES

“ATTITUDES AND BELIEFS OUTWEIGH THE FACTS WHEN IT COMES TO THE TREATMENT OF CHRONIC DISEASES” 

BY

Walter F. Wrenn,III,M.D.
President Keystone State Medical Society. 

I am writing this letter as a result of action taken by a pharmacist at your store #06924 in Paoli Pa. 152 Lancaster Ave.

My patient was prescribed Suboxone, Klonopin, Ambien, and soma. She has been stable on this medication since 10/28/13 and had gotten it filled previously at this pharmacy.

This refusal to fill FDA-approved medication because the pharmacist didn’t feel comfortable sets a dangerous precedence. It is based on his opinion, not on clinical data.

PHARMACIST INTERFERING WITH THE PHYSICIAN PATIENTS RELATIONSHIP

2015

Pete Giarrusso, who runs a Longwood motorcycle shop, is an expert at making things run better — except when it comes to his wife’s health. His wife’s doctor prescribed the muscle relaxer Soma after neck surgery, but he said Walgreens refused to fill it.
“They say, ‘We don’t feel comfortable filling the prescription,’” Giarrusso said. “They make us feel like drug addicts.”

In addition, it interferes with the doctor’s medical knowledge and treatment of his patient and puts the patient’s treatment in danger.

How can a pharmacist who knows nothing about the patient suddenly refuse to fill legally prescribed medication?

While I understand some of his reasoning,  I feel the action he took is wrong and dangerous.

I appreciate our discussion but after expressing his concern, and knowing I had no difficulty with the combination he should have filled the prescriptions while noting his disagreement.

“NOT AT WALGREENS”

2017

I know there are a lot of opinions when it comes to the treatment of opiate-addicted individuals even among treating physicians.

I have spent 10 years treating and researching the pathophysiology of opiate addiction.

HANGING ROPES, JOHANNESBURG, MUSEUM

According to the American Medical Association, June 20, 2019 letter to CDC:

“We are concerned that such a careful approach to identifying the precise combination of pharmacologic options could be flagged on a prescription drug monitoring program as indications wrongly interpreted as so-called “doctor shopping” and cause the patient to be inappropriately questioned by a pharmacist.

The AMA strongly supports a pharmacist carrying out his or her corresponding responsibility under state and federal law, but the past few years are rife with examples of patients facing what amounts to interrogations at the pharmacy counter as well as denials of legitimate medication.

The AMA urges CDC to provide strong guidance and support for physicians and pharmacists to work together rather than jumping to conclusions about a patient’s PDMP report.”

Most of my colleagues unfortunately did not. I believe in science.

There are no clinical trials in the world where the medication I prescribed shows any contraindications. My parents have never had any adverse events from these different combinations.

DON’T MEET CRITERIA

2021

WALGREENS PHARMACY PROFILING

Refusal to fill these medications that are based on one’s opinion, not on facts. I would appreciate you looking into this matter and what Walgreens’ policy is.

The prescriptions were sent to CVS.  After asking me for the ICD 10 codes the pharmacist at CVS filled the prescriptions. 

Walter F. Wrenn,III,M.D.
President Keystone State Medical Society. 

CONGRESS MUST CLEAN UP THIS MESS

FOR NOW, YOU ARE WITHIN

YOUAREWITHINTHENORMS.COM,(WYNTON MARSALIS CONCERTO FOR TRUMPET AND 2 OBOES, 1984)

THE NORMS

 

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Walgreens: at the corner of HAPPY & HEALTHY

Posted on December 5, 2021 by Pharmaciststeve

Walgreens apologizes after failing to notify parents of canceled child vaccine appointments

https://www.washingtonpost.com/business/2021/12/05/walgreens-cancels-vaccine-appointments/

The drug store chain declined to say how many families were turned away but said it is working to fix its system

Dania Palanker and her 7-year-old daughter, Nadia, felt excited as they bundled into the car in Washington last week to get Nadia’s coronavirus vaccine.

The evening before, Palanker received an automated email from Walgreens confirming Nadia’s appointment at the chain’s outlet in Cheverly, Md. “We’ll see you tomorrow!” read the subject line.

Their anticipation turned to disappointment once they arrived for the 6:30 p.m. shot. The store was still open, but the pharmacists had left, the pharmacy counter was closed and no one could provide vaccines. The pharmacy shuttered a half-hour before Nadia’s confirmed appointment, part of service cutbacks by Walgreens caused by a labor shortage hitting drugstores across the country.

“She was stoic,” Palanker said of her daughter. “I was furious.” Later that evening, she said, Nadia “looked close to tears.” Palanker went back online and found a city-run District of Columbia walk-up vaccination site, where Nadia got her shot the next day.

Walgreens apologized to affected customers in an email to The Washington Post and said it was working to prevent such problems moving forward. The company would not say how many of its customers nationwide have suffered the same frustration. Similar tales from angry consumers have popped up on social media around the country since early November.

The problems arose as demand is surging for coronavirus vaccine boosters as well as pediatric vaccine doses. President Biden’s administration has authorized boosters for everyone over 18 and is urging everyone to get the additional shot in response to the spread of the new omicron variant.

Palanker, a research professor and specialist on insurance and health care access at Georgetown’s Health Policy Institute, said she was especially dismayed because of the broader implications of her experience. An unannounced vaccine cancellation for a child would have a bigger impact on a family with less work flexibility or longer driving distances.

“My whole takeaway is Walgreens really dropped the ball,” Palanker said.

Walgreens is not alone among national chain pharmacies suffering from staff shortages. CVS said in September it was hiring 25,000 new workers at its stores, most of them pharmacists, pharmacy techs and nurses, to respond to heavy demand for coronavirus and flu vaccines and coronavirus tests.

But unlike rivals CVS and Rite Aid, Walgreens is attracting social media complaints from consumers about child vaccine appointments canceled without notice. Customers with appointments for booster shots and coronavirus tests also have complained on Twitter in recent days that they showed up to find closed Walgreens pharmacies.

Walgreens said it is working to improve its digital notification system to keeps up with local cuts in pharmacy service.

“We take this feedback seriously and are enhancing our digital scheduler to ensure it better supports fluctuations in store hours,” Walgreens spokeswoman Kelli Teno said in an email. “We apologize for any inconvenience to our customers and patients.”

Pharmacy operators have encountered the same pandemic-related workforce shortages as other health care providers and businesses, from retail stores to restaurants, said Scott Knoer, chief executive of the American Pharmacists Association, a professional education and advocacy organization based in Washington, D.C.

At the same time, demand for coronavirus testing and vaccines has increased the reliance on drugstores in the battle against the pandemic, he said.

“Pharmacists are having a tremendous amount of burnout right now,” he said.

As of Nov. 9, more than 162.8 million coronavirus vaccine doses have been administered by retail pharmacies in the United States, or about a third of all shots, according to the Centers for Disease Control and Prevention.

A shortage of pharmacists in the 1990s led to wage growth, but in more recent years there has been an oversupply, Knoer said. Then coronavirus suddenly boosted demand way beyond supply, sending chains into a struggle to fill jobs. ZipRecruiter and Glassdoor say pharmacists are paid between $100,000 and $150,000 a year. Walgreens in September announced bonuses of $1,250 for full-time pharmacists.

After the Food and Drug Administration on Oct. 29 authorized Pfizer coronavirus vaccine for children ages 5 through 11, the conflict between heavy demand from parents and surprise pharmacy closures created friction.

Anthony Funari, a grant professional and English professor at a community college in the Kansas City suburbs, had a confirmed vaccine appointment at a Walgreens in Olathe, Kan., for his sons, Will and Gabriel, on Nov. 11. He and his wife took time off from work and pulled the boys out of school shortly before their 10 a.m. appointments. The evening before, they had received the same cheerful appointment confirmation as Palanker.

“We were incredibly excited. This was the end of the pandemic for us in a way. We’d always been worried about our boys coming down with covid,” said Funari, whose story was first reported in the Kansas City Star in mid-November. When they arrived and learned from a store manager that the pharmacy was closed, Funari said he felt “disappointment, shock, frustration, anger.” His mother in law found a community pharmacy that could provide the shots later that day, he said.

In Homer, N.Y., Julie McChesney took her 10-year-old son, Zach, to his scheduled appointment at a Walgreens that was 25 minutes away from their home for a second vaccine shot. It was the Saturday after Thanksgiving. Once she found the pharmacy closed for the entire weekend, she and her son retreated to a Dunkin’ across the street, got some hot chocolate and hunted down another shot at a different Walgreens for later that day.

“I do wish somebody had let me know beforehand,” she said. “It would have been the right thing to do.”

Walgreens said it expects conditions to improve moving forward.

“We expect to resolve this quickly as we update the scheduler to accommodate fluctuating store hours and more appointments open up,” Teno said. “Beginning this Saturday, Dec. 4, we have 50% vaccine appointment capacity across all of our stores. The following week, Dec. 11, we have even more capacity, with nearly 70% of appointments available.”

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One of: American Pain and Disability Foundation advocate

Posted on December 5, 2021 by Pharmaciststeve

 

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pharmacist steve blog reaches 2,500,000 page views !

Posted on December 5, 2021 by Pharmaciststeve

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When an adult buys a “Percocet” from a friend of a friend, should anyone be surprised when they die from a lethal overdose ?

Posted on December 5, 2021 by Pharmaciststeve

https://youtu.be/G7Gjd4kQT1E?t=1135

This is a very interesting episode of Judge Jeanine on her weekly Saturday night show. Considering that Jeanine is an attorney and former judge… she is bringing on a woman who mid-20’s daughter got some “Percocet” from a friend of a friend because the Daughter had hurt back and the Daughter died, because the “Percocet” contained illegal fentanyl.  Judge Jeanine’s entire episode was about the availability of illegal fentanyl…  Nothing about the Daughter or the friend of a friend was violating the  controlled substance act…  was the friend of a friend a “drug dealer” ? That was 2015 and now this Mother has a non profit with some 23,000 members wanting illegal fentanyl to not get into the country.

In this episode, they seem to be using the word “poisoning” instead of the word “over dose”  I guess that a pt that ends his pain via prescriber induced suicide is of no interest to Fox cable … even when the local Fox TV in Louisville,KY… the only station – out of FOUR – in Louisville did a story when the case was filed and when the case was settled.  Prescriber induced suicide- jury awards a SEVEN MILLION JUDGEMENT

Nor when a CHILD is forced to endure debridement from 3rd degree burns for SIX WEEKS WITHOUT ANY PAIN MANAGEMENT Vanderbilt Burn Center (Nashville) refused to provide the young patient sufficient pain medication for SIX WEEKS

 

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Ire over pharmacy middlemen fuels lobbying blitz

Posted on December 4, 2021 by Pharmaciststeve

Ire over pharmacy middlemen fuels lobbying blitz

The effort to paint pharmacy benefit managers as villains has sparked a multimillion-dollar campaign to influence Democrats.

https://www.politico.com/news/2021/12/04/pharmacy-lobbyists-social-spending-bill-523749

Prescription pills are shown.

While there is little agreement among PBM opponents about what actions Congress should take, industry lobbyists are offering a menu of options for Democrats to consider. | Elise Amendola, File/AP Photo

Lobbyists for drugmakers, pharmacists and large employers are blanketing Congress with calls, emails and advertisements, pressing lawmakers to rein in pharmaceutical middlemen, who they say are behind soaring drug costs.

The effort to paint pharmacy benefit managers as villains has sparked a multimillion-dollar campaign to influence Democrats, who are racing to finish their massive social spending bill and eager to show they are taking on the powerful drug industry and lowering out-of-pocket costs for Americans.

“Pretty much everyone in the supply chain is pointing at the PBMs right now,” said Karry La Violette, the senior vice president of government affairs at the National Community Pharmacists Association.

While there is little agreement among PBM opponents about what actions Congress should take, industry lobbyists are offering a menu of options for Democrats to consider, such as requiring PBMs to pass on more of the rebates they negotiate with drugmakers to consumers or employers. They could also ban a common practice called spread pricing in which PBMs charge health plans more than they pay to the pharmacy dispensing a drug, and pocket the difference.

PBMs have responded with their own lobbying and advertising blitz, and insist they’re being scapegoated. JC Scott, who leads the Pharmaceutical Care Management Association, the trade group for PBMs, said targeting his members might be good politics and take the focus off drugmakers during a critical moment in the debate, but it would not lower drug costs.

Although dozens of PBMs exist, the industry is consolidated, with three of them — CVS Caremark, Express Scripts and OptumRx — controlling nearly 80 percent of the prescription market. Health insurers, employers and government hire PBMs to manage prescription benefits for their health plans — putting them at the center of a supply chain consisting of drugmakers, insurers and pharmacies.

Critics allege that PBMs’ role in negotiating rebates from pharmaceutical manufacturers and developing lists of prescription drugs that health insurers will cover encourages them to prioritize higher-cost medicines where they can reap larger rebates rather than focusing on drugs with lower costs.

“Democrats are focused on lowering costs for patients — and that absolutely includes making sure pharmacy benefit managers are getting the best deal for patients not for themselves,” Sen. Patty Murray (D-Wa.) said in a statement.

The $1.7 trillion spending bill, which the House passed last month, includes provisions that require PBMs to disclose certain information to employer-based plans, aiming to help them negotiate better prices for drugs, but other industry lobbyists want Democrats to go much further, which could make Senate passage that much more complicated.

Independent pharmacists and their patients have sent Congress thousands of letters at the behest of the National Community Pharmacists Association, which in the coming days will unleash its own television ad campaign urging senators to rein in PBMs.

On Friday, the pharmaceutical industry launched a seven-figure national ad campaign urging lawmakers to compel PBMs to pass rebates directly to consumers at the pharmacy counter. Called point-of-sale rebates, PBMs and others argue that this would ultimately raise premiums.

“There is recognition on both sides of the aisle that PBMs play a significant role in a broken insurance system, but somehow a bill meant to lower drug costs does nothing to address the part these middlemen play in determining what patients pay out of pocket for medicines,” said Sarah Sutton, a spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA), which is running ads on television, radio and the Internet.

She would not reveal the price tag of the new ad spending, but PhRMA spent more than $2.5 million in its television ad buys during the summer opposing liberal efforts to have Medicare negotiate the price of drugs, according to AdAnalytics data analyzed by POLITICO. And the group spent upwards of $22 million on lobbying in the first nine months of 2021, a 10 percent increase from the same period in 2020.

While pharmaceutical companies were the main target of Democrats’ efforts to reduce the cost of drugs, PBMs, which spent $5.9 million on lobbying in the first nine months of this year, a 20 percent increase over the same period in 2020, emerged largely unscathed in the House version.

Although the PBM industry still has concerns about transparency provisions, it successfully stopped Democrats from including a ban on spread pricing. The industry also supported a repeal of the Trump administration’s so-called rebate rule, which made it into the House’s version of the bill.

That’s forced lobbyists for drugmakers, pharmacies and employer groups to take their case to the Senate, where Sen. Ron Wyden (D-Ore.), the chair of the Senate Finance Committee, has already expressed interest in more closely scrutinizing the role PBMs play in the reconciliation package.

“Chairman Wyden is the champion on this issue,” said James Gelfand, the executive vice president of public affairs at the ERISA Industry Committee, which represents the employee benefits interests of the nation’s largest employers. “So it’d be crazy to think that he’s not right now considering, ‘What else can I do in this space?’”

“It’s the legislative opportunity of the century,” he added. “You don’t just give that up, right?”

In a statement to POLITICO, Wyden said that pharmacy benefit managers “are taking advantage of this dysfunctional system while families and local pharmacies foot the bill,” adding, “the status quo when it comes to PBMs needs to change as much as it does for Big Pharma.”

Scott, the PCMA leader, says his industry is being unfairly maligned for two reasons: an attempt to get long-desired policies enacted through the massive spending bill that have nothing to do with drug costs, and misplaced anger at the industry.

“There is this sentiment around some stakeholders that they believe, ‘Well, gee, if one part of the drug supply chain is going to be impacted by this legislation, then the PBM industry needs to give its pound of flesh as well,’” he said. “And I don’t know that that’s a very thoughtful consideration to put into policy decisions.”

The group launched its own ad campaign last week, accusing its rivals of trying to shift the blame for rising drug prices.

“Ironically, the industry that controls the list price of prescription drugs has attempted to point the finger at those focused on reducing the cost of prescription drugs for patients and payers,” reads text from the digital campaign, which is targeted within the Beltway.

But Gelfand, of the employer group, said that continuing with the status quo is untenable for patients.

“Everybody involved in all this knows that the current system is completely unsustainable,” Gelfand said. “There are those trying to change it and then there are those trying to essentially get what they can out of it while they can.”

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