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Sen Manchin: clearly he believes who is behind the “fabricated opiate crisis ” ?
Posted on November 12, 2021 by Pharmaciststeve
Manchin opposes Biden FDA nominee, citing ties to ‘greed’ of pharmaceutical industry
https://www.foxnews.com/politics/manchin-opposes-biden-fda-nominee
Democratic Sen. Joe Manchin of West Virginia came out in opposition to President Biden’s nominee to lead the Food and Drug Administration (FDA) over the candidate’s ties to the pharmaceutical industry amid the opioid crisis.
Manchin released a statement on Friday opposing Biden’s FDA nominee, Robert Califf, who led the agency at the tail end of the Obama administration.
The moderate Democrat from West Virginia said that Califf’s nomination “makes no sense” amid the opioid epidemic still ravaging America and wreaking “havoc on families across this country with no end in sight.”
Sen. Joe Manchin, D-W.Va., delivers remarks to reporters at the U.S. Capitol in Washington, D.C., Nov. 1, 2021. (REUTERS/Jonathan Ernst)
BIDEN EXPECTED TO ANNOUNCE ROBERT CALIFF TO LEAD FDA, BRINGING BACK OBAMA-ERA OFFICIAL
The senator also blasted the nominee for his ties to the pharmaceutical industry, which has been credited by many with playing a major role in exacerbating the opioid epidemic.
“2020 was the deadliest year on record for drug related overdose deaths, with 1,386 and nearly 95,000 Americans dying from a drug-related overdose,” Manchin said. “I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic.”
“Instead, Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward,” the West Virginia Democrat continued. “His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction.”
Manchin said he “could not support” Califf’s nomination just as he was opposed to the former commissioner’s previous 2016 nomination and called on the Biden administration to put up a nominee “that understands the gravity of the prescription drug epidemic” as well as the FDA’s role “in fighting back against the greed of the pharmaceutical industry.”
“Championing the needs of our nation’s public health should be their No. 1 priority,” Manchin concluded.
Dr. Robert Califf awaits the start of his nomination hearing before the Senate Health, Education, Labor and Pensions Committee on Nov. 17, 2015, in Washington, D.C. (Win McNamee/Getty Images)
Biden is expected to announce Califf’s nomination later on Friday, almost 10 months into the president’s term.
Because acting commissioners may only serve for a certain amount of time, Biden was nearing the deadline for when he would be forced to name a replacement for acting FDA Commissioner Janet Woodcock. She’s held the position since Biden was inaugurated.
“Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement Friday announcing the nomination.
“As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA. I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making. Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work being done at this critical moment.”
The White House did not provide comment on Manchin’s opposition to Califf’s nomination.
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Walmart to stop accepting military prescription health insurance after Express Scripts ends deal
Posted on November 11, 2021 by Pharmaciststeve
Express Scripts is one of those INFAMOUS PBM’s — which is now part of a the large INSURANCE COMPANY Cigna https://en.wikipedia.org/wiki/Express_Scripts
Over the last few years, the major PBM’s have merged or being acquired by large insurance companies – some believe this has been done in order to be able to hide the OBSCENE PBM PROFITS in the parent company’s P&L statement.
This graphic shows how the PBM industry – these middlemen and their various policies and procedures cause prescription prices to pts are GROSSLY INFLATED. By a middleman industry that that provides little/no real contribution to improved healthcare to the pts they oversee the administration of the pt’s prescriptions.
here is a video that tries to explain how the typical PBM fits into our health care system and how their presence affects pts
Walmart to stop accepting military prescription health insurance after Express Scripts ends deal
BENTONVILLE, Ark. (KNWA/KFTA) — Express Scripts recently ended a multi-year agreement to participate as a pharmacy provider for the Tricare network, affecting veterans and members of the military that fill their prescriptions at Walmart.
We were surprised to hear Express Scripts ended our multi-year agreement to participate as a pharmacy provider for the Tricare network just a few days after Walmart and Express Scripts signed an agreement on September 30 for Walmart to serve these members for the next several years. We value our Tricare and DOD customers and are disappointed in Express Script’s decision and we have requested more information from them to understand their decision. We have asked Express Scripts to honor the agreement we both recently signed. We know many members of the military, veterans and their families rely on Walmart for convenient access to affordable prescriptions and this decision will limit their options. We hope to come to a resolution to continue as a pharmacy provider for the Tricare network. Walmart will continue to offer everyday low pricing on generic drugs that can be accessed by all customers with or without insurance.
Luke Kleyn, Vice President of Payer Relations at Walmart
A local veteran reached out to KNWA/FOX24 News to inform us that he was told by Walmart that they will no longer accept his Tricare insurance, effective December 15, 2021.
Walmart has said it’s committed to supporting the active-duty military, veterans, and their families through various initiatives such as:
- Meeting commitment to hire 250,000 veterans.
- Within the last year, Walmart has hired over 49,000 veterans and 27,000 active-duty military spouses.
- Creating the Find A Future platform, which will further aid the men and women transitioning from the armed forces to civilian life.
- Over the last decade, Walmart and the Walmart Foundation have granted more than $40 million to organizations that support veterans and military spouses.
- Walmart is a long-time supporter of also providing pharmacy services to our military communities.
Since 2013, Walmart has hired more than 400,000 veterans and military spouses at Walmart and Sam’s Club, according to a release. Since May 2021, Walmart has hired almost 30,000 veterans and military spouses – more than we ever have in a single quarter in the company’s history.
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When Data Becomes Due Process
Posted on November 11, 2021 by Pharmaciststeve
When Data Becomes Due Process
https://daily-remedy.com/when-data-becomes-due-process
It has been said that sin is not in the action, but in the reaction.
Similarly, the harm from data comes not from the data itself, but from its interpretation – how people react to what they see. As what they see can be quite subjective, changing from person to person.
The analysis of data is a notoriously quantitative field, defined by established rules of statistics. The interpretation of the analysis is different, far more subjective, varying based on the biases held by the person reviewing the data.
For federal agencies within the Department of Justice that investigate physician behavior, the interpretation of data analysis is used to initiate investigations and to secure convictions.
But in conflating objective data analysis with subjective interpretations, federal agencies introduce concerning levels of biases and variability in their investigative practices. As a result, the interpretations of laws governing physician behavior vary alongside the interpretations of data analysis – rendering the interpretation of data as due process.
The term is routinely cited but never fully understood. Due process is often discussed only in procedural terms in reference to legal investigations or deliberations in court. For example, if a law enforcement officer tampers with evidence or a prosecutor introduces materially false evidence, then we would expect the defendant to claim due process violations.
But procedural due process violations are only one aspect of due process. The other, more abstract aspect is called substantive due process. It focuses less on procedural violations and more on enumerated rights implicitly afforded through the Constitution. In 1905, the term was used by the Supreme Court in upholding the rights of bakers in New York City to work the hours they needed in order to prepare bread, finding work hour restrictions violated the rights of bakers to perform their job.
Substantive due process protects the right to work, to marry, and to raise children – essentially the basic functions we take for granted in our everyday lives. But in our increasingly complex world, many of these basic functions are becoming quite complex.
Something epitomized in healthcare, which has seen an influx of data turn basic patient care into complex models of technology-based care coordination. Data has now become synonymous with patient care – to the point that nearly all clinical decisions rely on some data point.
Something the Department of Justice has keenly noted, and now uses patient data to investigate the behavior of physicians to determine whether criminal behavior is transpiring. If a physician has higher than average reimbursements, then a physician is possibly committing insurance fraud. If a physician has higher than normal prescriptions of controlled substances, then a physician is possibly committing prescription fraud.
Effectively, the interpretation of the data determines probable cause. But correlating statistical probability with reasonable doubt leads to perilous interpretations that have been proven to be rife with bias – particularly in healthcare.
Numerous clinical studies and class action lawsuits have proven healthcare insurance companies use patient data to engage in discriminatory practices against disenfranchised patients, adversely affecting access to care. These are the entities that directly aggregate and maintain patient information – and even they cannot interpret data without bias.
For law enforcement to then take the same data and investigate crimes based on interpretations – already proven to be biased data – turns biases into evidence. Since most prosecutors are unable to discern between statistical noise and clinically relevant statistical trends, inevitably they will misinterpret patient data. This was most famously revealed when the Drug Enforcement Agency began correlating the number of opioid prescriptions with opioid related mortality.
Data analysis is complex by nature. We try to simplify it through interpretations. But to simplify something complex is a type of bias. And in the courts of law, we have assumed this bias to be evidence. When we examine criminal cases involving physicians, we usually see data included in the filings that allege to be the factual basis for the crime.
Yet we have never questioned the Constitutionality of using patient data this way. But in many criminal cases against physicians, the government essentially argues that data interpretations supersede a physician’s substantive due process rights. That over the course of a physician’s work, should any data aberrations arise, that physician can be subsequently investigated for potential crimes.
We would never allow the government to investigate a bakery based on production trends of bread. But we seem content to allow the government to investigate physicians based on trends in patient data.
Prosecutors justify this tactic by arguing that data is the principal means through which they can investigate physicians – a fair point, and by no means do we argue against using data for such investigations.
But we should not blindly assume we can use patient data in this manner. It was never intended to be evidence, and it has proven time and time again to be biased.
Instead we should closely examine the robustness of the data, case by case, determine if it meets objective legal standards required of evidence, and codify the legal definitions detailing how we use it in court.
As it stands currently, we are using data as due process without explicitly stating as much. In the silence, we have allowed prosecutors to introduce pernicious interpretations of data as evidence, which is a violation of a physician’s due process.
Until we directly address the constitutionality of this, pernicious legal interpretations will continue to deny physicians their right to a defense, and data will continue to pass for criminal intent.
And the courts will continue to enable government encroachment into healthcare.
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FDA reports 100+ drug shortages nationwide
Posted on November 11, 2021 by Pharmaciststeve
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https://myfox8.com/news/fda-reports-100-drug-shortages-nationwide/
NASHVILLE, Tenn. (WKRN) – Recent supply chain disruptions are impacting everything from clothes to food, and even trips to the pharmacy. Popular drugs like Adderall, oxycodone, and insulin are running low nationwide.
In Tennessee, Steve Beasley said he’s having trouble finding iron dextran for his iron infusions. “I’m stuck between a rock and a hard place right now – none of the pharmacies around here can get it where they can compound it in-house.”
The FDA currently lists 112 drug shortages on its website. The reasons for the backlogs all vary.
“Some of the companies have discontinued making [iron dextran] for whatever reason,” Beasley said. “I don’t know, it just says manufacturing delays.”
The life-saving drug Narcan is being impacted too, with Pfizer’s website listing the availability of its injectable naloxone formulation as depleted. “A big reason there is a shortage – Pfizer had a manufacturing issue toward the beginning of the year,” Tara Schiller, CEO of SoberBuddy, said.
One group impacted by the shortage is the Opioid Safety and Supply Network (OSSN) Buyer’s Club. The group is the largest source of naloxone distribution directly to affected communities, accounting for 1.3 million doses in 2020 alone.
The OSNN Buyers Club stated they have an exclusive arrangement with Pfizer for the low-cost generic injectable. While there is not a widespread shortage of the product itself, the shortage specifically affects the group of programs. As of August 2021, OSNN Buyers Club programs are back-ordered by over a quarter-million doses of naloxone.
This shortage issue is creating a “perfect storm” scenario where overdoses are sky-rocketing, but access to life-saving medication is plummeting, said Schiller. “This group distributes in areas where there is no government infrastructure in purchasing naloxone.”
Nexstar reached out to the FDA about shortages and received the following response:
“The FDA is actively monitoring drug availability and we are committed to working with our public health partners, manufacturers and distributors to help mitigate shortages and make help ensure continued patient access to vital safe and effective drugs.”
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‘Magic Mushrooms’ Get a Win for Depression in Early Trial, Drugmaker Says
Posted on November 11, 2021 by Pharmaciststeve
‘Magic Mushrooms’ Get a Win for Depression in Early Trial, Drugmaker Says
— Psilocybin reduced depressive symptoms in largest trial of psychedelic drug to date
https://www.medpagetoday.com/psychiatry/depression/95579
Psilocybin, the drug compound found in “magic mushrooms,” reduced symptoms of treatment-resistant depression in a randomized phase IIB study, though was associated with some serious adverse events (AEs), drugmaker Compass Pathways announced by press release.Addiction tops the unfavorable side effects. Help 4 Addiction is easier if you are willing to get over it and focus on the benefits.
In the trial of more than 200 patients with treatment-resistant therapy who had stopped taking antidepressants before enrollment, a 25-mg dose of COMP360 psilocybin with ongoing psychological support led to a -6.6-point difference on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 3 versus a group who received a 1-mg dose of the product (P<0.001), and the difference remained significant through week 6.
A third arm of the study tested a 10-mg dose of psilocybin, but this showed no statistically significant difference over the 1-mg dose at week 3 (-2.5 points P=0.184). Results of the trial have not been peer-reviewed.
In the 25-mg group, 29.1% of patients achieved a remission (≥50% decrease in MADRS total score from baseline) at week 3, as compared to 7.6% in the 1-mg group. By week 12, these rates were 24.1% and 10.1%, respectively.
“Remission rates appear to be higher than seen in traditional medication studies,” noted principal investigator David Hellerstein, MD, of Columbia University in New York City, in a statement. “These findings suggest that COMP360 psilocybin therapy could play a major role in psychiatric care, if approved.”
During an investor call where Compass leadership presented the findings, Guy Goodwin, MD, the company’s chief medical officer and a professor emeritus of psychiatry at Oxford University, said the results in the 25-mg group “show evidence for durability of response” for psilocybin therapy.
Of potential concern, however, were higher rates of treatment-emergent serious adverse events (AEs) with the higher psilocybin doses. These serious AEs — which include suicidal behavior, suicidal ideation, and intentional self-injury — occurred in five patients in the 25-mg group (6.3%), in six patients in the 10-mg group (8.0%), as compared to one patient in the 1-mg group (1.3%).
Matthew Johnson, PhD, a professor of psychiatry and psychedelics at Johns Hopkins Medicine in Baltimore, told MedPage Today that the early data look encouraging. Yet without more detailed information, questions remain about the nature of the trial’s AEs, he said.
“Working with depressed people, these symptoms come with the territory. Suicidal behavior can encompass a broad range, from fleeting thoughts to more serious planning,” Johnson said. “It is possible that an effective session might put people in a more difficult place psychologically as they’re processing the experience, much like processing trauma. The treatment itself can bring up very difficult emotions and might potentially make things worse in the short-term.”
Because details of the patients’ reported suicidality weren’t explored further, it’s hard to assess in full, he explained.
Lars Christian Wilde, Compass’ co-founder and president, said during the investor call that the differences in serious AE frequency were not statistically significant between dosing groups. Suicidal thoughts, self-injury, and even suicidal behaviors are also common among those suffering from treatment-resistant depression, he noted.
The study, the largest to test the compound to date according to the U.K.-based company, included 233 patients with treatment-resistant depression. Patients were randomized 1:1:1 to COMP360 psilocybin at the three doses along with ongoing psychological support from therapists. Participants were recruited from 10 countries across North America and Europe. Notably, 94% of patients had no prior experience with psilocybin.
Overall, 179 patients reported experiencing at least one treatment-emergent AE, with more than 90% falling in the mild-to-moderate category (83.5% in the 25-mg group, 74.7% in the 10-mg group, and 72.2% in the 1-mg group), the company noted.
Researchers from the company are planning to start a phase III trial next year, which will likely focus on the 25-mg dose. The leadership team also announced that the company will be embarking on a phase II trial of psilocybin therapy in the treatment of post-traumatic stress disorder.
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If you take this pain medicine, there’s an FDA recall so stop and call your doctor
Posted on November 11, 2021 by Pharmaciststeve
If you take this pain medicine, there’s an FDA recall so stop and call your doctor
It’s not only essential to take the correct medicine for your condition at the right time of day. You also have to ensure you respect the dosage your physician recommends. But that’s impossible to do if the meds you received contain a higher strength than what is advertised on the packaging. That’s precisely what happened with 500mg Methocarbamol bottles from one lot, as they actually contain 750mg tablets. If you happen to take this pain medicine from Bryant Ranch Prepack, you should ensure your bottle doesn’t come from the recalled lot before continuing your treatment.
Methocarbamol 500mg recall
Bryant Ranch Prepack issued a voluntary recall for one lot of Methocarbamol 500mg tablets, the company said in a press release available from the US Food and Drug Administration (FDA). The company informs that the bottles labeled “Methocarbamol 500mg Tablets” actually contain “Methocarbamol 750mg Tablets.” That’s a higher dosage than your doctor might have instructed you to take.
The pain medication can help treat acute, painful musculoskeletal conditions. It’s usually combined with other therapies, including rest and physical therapy.
Taking the 750mg dose instead of the 500mg tablets could result in Excessive Central Nervous System depression. As a result, you might experience various symptoms that might include nausea, sedation, fainting, falls, seizures, coma, and death. If you think you’ve experienced symptoms, you should contact your doctor. But Bryant Ranch Prepack says it has not received reports of adverse events so far.
How to identify the pain medicine subject to recall
If you’ve purchased prescriptions for Methocarbamol 500mg Tablets recently, you should ensure your bottle doesn’t contain the following identification:
The affected Methocarbamol 500mg lots include the following Lot Number 163935/ Exp. Date 10/22. The product can be identified by red and white label with a yellow border at the top and bottom of the label, top of the label reads ‘Packaged by Bryant Ranch Prepack,’ labels are pictured [at this link].
The pain medicine bottles come in “counts of 30 (NDC:7133517952), 60 (NDC: 7133517954), and 90 (NDC:7133517957) pills.”
What you should do
Bryant Ranch Prepack has already started notifying distributors and customers to arrange the return of the recalled pain medicine. Distributors and physicians who received pain meds from the recalled lot should stop distributing them and return the product to Byrant.
Consumers who have bottles of Methocarbamol 500mg Tablets from the affected lot should stop using them immediately, Bryant Ranch Prepack says. You can return them and contact your physician. If you’re unsure whether the pain medicine you’ve just received is part of the recall, you should contact your doctor.
The company provides contact information for the recall in the official announcement at this link. That’s where you’ll also find details on how to report adverse reactions and quality concerns to the FDA’s MedWatch Adverse Event Reporting program.
While you’re checking your Methocarbamol bottles, you should also ensure that the blood pressure medicine you take is correct. Two such drugs are part of different FDA recalls.
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Just a reminder to EVERYONE – sometimes – SHARING IS NOT CARING !
Posted on November 10, 2021 by Pharmaciststeve
Just as a reminder to everyone, this has been the federal DEA law since the Control Substance Act was signed into law in 1970. The DEA usually goes after the person/entity that has given/shared/sold the controlled substance to someone else… They seldom go after the person receiving the controlled substances and consider the person/entity “distributing” the controlled substances the “DEALER”
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DEA: Trying to RESTRICT the dispensing of suboxone type products – more deaths by regulations ?
Posted on November 10, 2021 by Pharmaciststeve
As Overdose Deaths Soar, DEA-Wary Pharmacies Shy From Dispensing Addiction Medication
When Martin Njoku saw opioid addiction devastate his West Virginia community, he felt compelled to help. This was the place he’d called home for three decades, where he’d raised his two girls and turned his dream of owning a pharmacy into reality.
In 2016, after flooding displaced people in nearby counties, Njoku began dispensing buprenorphine to them and to local customers at his Oak Hill Hometown Pharmacy in Fayette County.
Buprenorphine, a controlled substance sold under the brand names Subutex and Suboxone, is a medication to treat opioid use disorder. Research shows it halves the risk of overdose and doubles people’s chances of entering long-term recovery.
“I thought I was doing what was righteous for people who have illness,” Njoku said.
But a few years later, the Drug Enforcement Administration raided Njoku’s pharmacy and accused the facility of contributing to the opioid epidemic rather than curbing it. The agency revoked the pharmacy’s registration to dispense controlled substances, claiming it posed an “imminent danger to public health and safety.” Although two judges separately ruled in Njoku’s favor, the DEA’s actions effectively shuttered his business.
“I lost everything that I worked for,” Njoku said.
Lawyers, pharmacists, harm-reduction advocates and a former DEA employee say Njoku’s case is emblematic of the DEA’s aggressive stance on buprenorphine. An opioid itself, the medication can be misused, so the DEA works to limit its diversion to the streets. But many say the agency’s policies are exacerbating the opioid epidemic by scaring pharmacies away from dispensing this medication when it’s desperately needed.
Drug overdose deaths hit record highs last year, and despite medical experts considering medications like buprenorphine the gold standard, less than 20% of people with opioid use disorder typically receive them. The federal government has taken steps to increase the number of clinicians who prescribe buprenorphine, but many patients struggle to get those prescriptions filled. A recent study found that 1 in 5 U.S. pharmacies do not provide buprenorphine.
“Pharmacies are terrified they’re going to lose their DEA registration and go out of business,” said Charles “Buck” Selby, a former inspector and chief compliance officer for the West Virginia Board of Pharmacy, who retired in 2018.
The ramifications can be particularly acute in rural areas, where a dearth of addiction treatment providers, lack of transportation and stigma against these medications already create barriers. If pharmacies decline to provide buprenorphine too, patients will have few options left, Selby said.
The DEA did not respond to requests for comment.
Like many other prescription drugs, buprenorphine can be found illegally on the street. There are unscrupulous doctors who hand out prescriptions and pharmacists who fill them. Subutex, which consists of buprenorphine alone, is easier to misuse and typically has higher street value than Suboxone, a combination of buprenorphine and the overdose-reversal drug naloxone.
In the case against Njoku’s pharmacy, an assistant U.S. attorney explained that the DEA “got slapped hard for being asleep at the switch as the opioid crisis ramped up. … They’re trying to make sure that Subutex doesn’t become the next problem,” according to court transcripts.
But research suggests that buprenorphine misuse has decreased in recent years even as prescribing has increased, and that most people who use diverted buprenorphine do so to avoid withdrawal symptoms and because they can’t get a prescription.
Buprenorphine is less likely to cause overdoses than other opioids because its effects taper off at higher doses, said Dr. Aaron Wohl, medical director of the Florida-based coalition Project Opioid.
In Njoku’s case, the DEA said in court documents that several “red flags” had suggested the pharmacy’s actions were irresponsible. First, many of the prescriptions it filled were for Subutex instead of Suboxone. Patients also traveled – sometimes out of state – to get prescriptions, drove long distances within West Virginia to reach Njoku’s pharmacy, and often paid in cash.
In traditional prescription drug cases, these are all markers of trouble. But — as Njoku’s lawyers argued and two judges later agreed — they can also reflect the difficulty of getting addiction treatment, which is sometimes more challenging than obtaining illicit drugs.
“The practical reality and context of West Virginia turn these additional flags from red to yellow,” U.S. District Judge Joseph Goodwin wrote in his opinion. Patients may go out of their way for the drug because there aren’t enough nearby doctors who prescribe it or pharmacies that stock it, he wrote. They might pay cash because they’re uninsured or Medicaid won’t cover prescriptions written by an out-of-network doctor. And they might prefer Subutex because it’s often cheaper than Suboxone.
By 2020, Goodwin and an administrative law judge at the DEA had both ruled in Njoku’s favor. But several insurers and drug suppliers had already stopped doing business with him. Njoku closed the pharmacy in April 2021.
Across the country, when a pharmacy stops providing buprenorphine, the ripple effects can be far-reaching.
Trish Mashburn works at two independent pharmacies in western North Carolina. When a nearby pharmacy stopped dispensing buprenorphine, she began getting five calls a day from prospective customers trying to get their prescriptions filled, she said. Although both her employers stock buprenorphine, they order only a set amount, so Mashburn often must turn patients away.
Research in North Carolina and Kentucky has found that many pharmacists worry that ordering more buprenorphine will trigger a DEA investigation. The DEA does not specify thresholds for controlled substances, but it requires wholesalers to flag suspicious orders. In turn, wholesalers limit how much a pharmacy can buy or create algorithms to detect orders that exceed projected need.
They base these limits, in part, on the DEA’s enforcement actions, said Larry Cote, a former DEA attorney who now advises wholesalers, pharmacies and other clients on regulatory compliance. Since pharmacies are not typically privy to how these limits are set, many simply order small batches of buprenorphine out of caution.
That creates a “prescribing cliff,” said Bayla Ostrach, lead author of a paper studying this issue in North Carolina. Doctors may prescribe buprenorphine to more patients, but pharmacies order enough for only a certain number of customers. Since many people stay on buprenorphine for years, once the pharmacy hits its self-established quota, it may rarely have openings for new patients.
A Lee County, Florida, man thought he was one of the lucky ones. James, 34, had been filling his Subutex prescription at the supermarket chain Publix for seven years. In that time, he held steady jobs and cared for his wife and children. (James asked KHN to withhold his last name so future employers wouldn’t judge him on his addiction history.)
Then, last year, James said, he went to get his prescription refilled and was told Publix no longer stocks Subutex — the medication the DEA considered a “red flag” in Njoku’s case.
Publix did not respond to requests for comment.
A decade ago, when James began the medication, he chose Subutex because it was cheaper than Suboxone. Today, most insurance plans cover Suboxone, and the price difference has narrowed somewhat.
James was not eager to change to a potentially pricier medication. And he worried a different drug might disrupt his recovery — a common sentiment among patients in long-term recovery, said Dr. Nathan Mullins, director of addiction medicine fellowship at Mountain Area Health Education Center in North Carolina. Changing their medication is unnecessary and can cause needless anxiety, Mullins said.
Luckily, James found an independent pharmacy that provides Subutex. It’s more expensive, since the new place doesn’t accept his insurance, he said. He pays about $40 a week, compared with $40 a month previously.
But James said it’s worth it.
“I’ve been in 10 rehabs and a million detoxes, and the only thing that has worked for me was one sublingual tablet,” James said. Along with therapy, “this saved my life.”
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Hundreds of Doctors Urge Facebook to Disclose ‘Disinfo’ Data
Posted on November 10, 2021 by Pharmaciststeve
Hundreds of Doctors Urge Facebook to Disclose ‘Disinfo’ Data
— Letter to Mark Zuckerberg calls lack of transparency ‘deadly’
https://www.medpagetoday.com/special-reports/exclusives/95541
More than 500 physicians and public health professionals in the U.S. have signed a letter demanding that Facebook divulge its data around COVID-19 disinformation.
The letter, which was initially shared exclusively with USA Today and then posted on the Doctors for America website, called the lack of transparency “deadly.”
“The recent Facebook whistleblower disclosures have confirmed what many of us have suspected for a long time: that Facebook has repeatedly stonewalled the public, lawmakers and academics over the last 18 months despite having had ‘deep knowledge’ about the scope and nature of COVID-19 and vaccine disinformation across its apps,” the letter stated.
“So many deaths could have been prevented, and we must act with haste to prevent more, particularly with vaccines becoming imminently available for young children,” it continued. “We simply cannot afford another deadly round of COVID and vaccine misinformation.”
The top three signatures were from Céline Gounder, MD, of NYU Grossman School of Medicine in New York City; Kavita Patel, MD, of the Brookings Institution in Washington, D.C.; and Craig Spencer, MD, MPH, of Columbia University Medical Center in New York City.
Doctors for America said it “mobilizes doctors and medical students to be leaders in putting patients over politics on the pressing issues of the day to improve the health of our patients, communities, and nation.”
In a Twitter post about the letter, Gounder noted that healthcare professionals and public health officials “have been fighting multiple battles & multiple fronts over the course of the pandemic. Social media is yet another battleground.”
She asked why Facebook has yet to de-platform members of the “Disinformation Dozen,” referring to the report by the Center for Countering Digital Hate, which found that 12 anti-vaxxers are responsible for some two-thirds of anti-vaccine content on social media.
Some physicians made that list, including Joseph Mercola, DO; Sherri Tenpenny, DO; and Christiane Northrup, MD.
“These people are still out there, spreading dangerous disinformation,” Gounder tweeted.
The letter noted that on July 15, U.S. Surgeon General Vivek Murthy, MD, issued a federal advisory about the public health threat posed by misinformation.
Facebook must take “immediate, urgent action to stop the deadly spread of COVID-19 disinformation on its platforms,” the letter stressed. “Facebook must disclose all data about the scope, reach, and content of this disinformation and its impact on users for evaluation by independent public health researchers.”
The letter stated that data already released by Facebook have “fallen far short of what the public deserves to know.”
“For Facebook to achieve actual transparency, it must go beyond providing select data points to the public and provide meaningful data from its vast data trove to the public health community,” the letter continued. “This will assist experts in understanding both how disinformation has rampantly spread on the platform and how to overcome the skepticism about vaccines that has arisen from it.”
In an emailed statement to USA Today, a spokesperson for Meta (the new parent organization for Facebook) said that the company is working to distribute “reliable information” about COVID-19, and noted that vaccine hesitancy among Facebook users in the U.S. has fallen by 50% since January.
“Tracking and sharing data on the prevalence of misinformation is difficult for any subject, but especially for COVID-19 where the facts and guidance about the pandemic are updated over time. This is why no major tech company releases this data,” the spokesperson told USA Today. “Despite all of these complications, we’ve removed more than 20 million pieces of content that violate our COVID misinformation policies, permanently banned thousands of repeat offenders from our services, and connected more than 2 billion people to reliable information about COVID-19 and vaccines.”
“We will continue our dedication to ensuring billions of people are getting reliable information about COVID-19 on our services,” the Meta spokesperson said.
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