Mallinckrodt files for Chapter 11 bankruptcy

https://www.beckershospitalreview.com/pharmacy/mallinckrodt-files-for-chapter-11-bankruptcy.html

Mallinckrodt has filed for Chapter 11 bankruptcy for all of its U.S. subsidiaries and some international subsidiaries, the company said Oct. 12. 

The bankruptcy restructuring will reduce the company’s total debt by about $1.3 billion and resolve opioid-related claims and litigation involving its drug Acthar.

“After many months of deliberation, negotiation and consideration of alternatives, Mallinckrodt’s management and board of directors determined that implementing a Chapter 11 restructuring provides the best opportunity to maximize the value of the enterprise and position the company for the future in light of the current challenges it faces,” said Mark Trudeau, Mallinckrodt’s CEO. 

Opioid claims against the company are to be channeled into one or more trusts which would receive $1.6 billion in structured payments. The company also agreed to pay $260 million over seven years to settle claims it knowingly underpaid Medicaid for Acthar. 

In the bankruptcy filing, Mallinckrodt listed both assets and liabilities in the range of $1 billion to $10 billion. 

The company will continue to operate as normal as it restructures for bankruptcy. 

Mallinckrodt had said in February that it would put its U.S. generics business in bankruptcy as part of a proposed opioid settlement. In August, the company said it was considering bankruptcy for the parent company and most of its subsidiaries. 

In early March, the U.S. sued Mallinckrodt, alleging it knowingly underpaid Medicaid hundreds of millions of dollars in rebates for Acthar. The U.S. Justice Department said the company had calculated its rebate payments to Medicaid based on the drug’s price in 2013, but it has raised the drug’s price by 20 percent since then. The company was ordered to pay $650 million to CMS. 

As part of its bankruptcy filing, Mallinckrodt said it would reset Acthar’s Medicaid rebate calculation as of July 1, and that state Medicaid programs will receive 100 percent rebates on Acthar Medicaid sales. The company said it will dismiss its appeal of the Justice Department’s ruling in the case. 

Read Mallinckrodt’s full news release here.

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In the USA – on average 7500 people die EVERY DAY… according to this. According to this, total USA deaths for 2020 is projected to be the LOWEST IN THREE YEARS and this number must include the reported 200,000+ COVID-19 deaths.

Makes one wonder before the pandemic… reportedly we had a death crisis of opiate OD’s and vaping deaths.

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US Blood Pressure Validated Device Listing

https://www.validatebp.org/

Blood pressure measurement devices that have been validated for clinical accuracy as determined through an independent review process.

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FDA flags 428 spinal cord stimulator patient deaths, urges more tests before implant

https://www.medtechdive.com/news/fda-flags-428-spinal-cord-stimulator-patient-deaths-urges-more-tests-befor/584714/

• FDA on Thursday published a letter to healthcare providers outlining hundreds of reports of deaths and thousands of injuries and malfunctions with spinal cord stimulators, reminding physicians to follow product labels calling for a simulation in patients prior to permanently implanting the SCS devices.
• Healthcare providers are supposed to trial the estimated 50,000 devices implanted each year from companies such as Abbott, Boston Scientific, Medtronic and Nevro to ensure they adequately relieve a patient’s pain. An agency review of 107,728 adverse event reports submitted in the last four years found 30,321 reports of unsatisfactory pain relief.
• The warning comes after a June report from Public Citizen called for FDA to tighten how it regulates the devices, including requiring original PMA submissions for all new models and reassessing whether any approved devices should be removed from the market. Device Events is also among the organizations that have highlighted dangers with spinal cord stimulators. 

Dive Insight:

The labels on spinal cord stimulators are clear on the need for trial simulation periods: Materials from Abbott, Boston Scientific, Medtronic and Nevro state their devices are only for use in patients who received effective pain relief during trial stimulation. The companies also provide information on how to carry out these trial periods. Nevro, for example, provides pages of information for physicians on two different approaches to trial-phase implantation.  

Yet, FDA is concerned about compliance with the trial-phase requirement. After its dive into the data found 28% of MDRs cite “pain relief, inadequate” as a problem, FDA said the review “highlights the need for patients to undergo and demonstrate an adequate trial.” The next two most frequently cited Patient Problem Codes — “pain” and “therapeutic effects, unexpected” — also point to the possibility that some physicians may be implanting SCSs without performing trial periods. 

FDA also looked at the most frequently reported Device Problem Codes but appeared less concerned by the findings. “Charging problems” was the most commonly reported code, leading FDA to state the reports “are consistent with those expected with battery-powered stimulation devices intended for longer-term implantation and therapy.”

The 107,728 MDRs received by FDA in the four-year period following July 27, 2016, include reports of 428 individual deaths of patients implanted with SCSs between 2005 and 2020. Almost one-third of cases where times to event were available happened in the 30 days after implantation. Many of the patients had comorbidities and the average age was 69 years. FDA said MDRs often lack “enough information to establish a causal relationship between the device and the reported event.”

For now, FDA has limited its response to the data to a reminder of the need to trial SCS implants and recommendations for physicians about discussing the risks with patients and creating individualized follow-up plans for each recipient of a device. It also said it continues to evaluate the devices via mandated postmarket studies, medical literature and other sources.

But FDA’s steps don’t meet critics’ demands. Public Citizen’s June report detailed what it called FDA’s “dangerously lax oversight of high-risk implantable medical devices.” Public Citizen accused FDA of granting premarket approval to SCSs on the strength of studies of other devices, rather than prospective clinical trials of the implants being submitted for review.

In light of that evidence, Public Citizen called for FDA to move SCSs devices to a higher risk class. The Public Citizen report did not specifically mention the potential for harm due to a failure to follow the requirements on trial periods.

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Coronavirus: Health experts join global anti-lockdown movement

https://www.bbc.com/news/health-54442386

Thousands of scientists and health experts have joined a global movement warning of “grave concerns” about Covid-19 lockdown policies.

Nearly 6,000 experts, including dozens from the UK, say the approach is having a devastating impact on physical and mental health as well as society.

They are calling for protection to be focused on the vulnerable, while healthy people get on with their lives.

The declaration has prompted warnings by others in the scientific community.

Critics have pointed out:

• a more targeted approach could make it difficult to protect vulnerable people entirely
• the risk of long-term complications from coronavirus mean many others are also at risk

But the movement – known as the Great Barrington Declaration – mirrors some of the warnings in a letter signed by a group of GPs in the UK.

Sixty-six GPs, including TV doctors Dr Phil Hammond and Dr Rosemary Leonard and a number of medics who have held senior roles at the British Medical Association, have written to the health secretary, saying there is insufficient emphasis on “non-Covid harms” in the decision-making.

What is the Great Barrington Declaration?

The movement started in the US.

And the declaration has now been signed by nearly 6,000 scientists and medical experts across the globe as well as 50,000 members of the public.

The UK-based experts who have signed it include:

• Dr Sunetra Gupta, an epidemiologist at Oxford University
• Nottingham University self-harm expert Prof Ellen Townsend
• Edinburgh University disease modeller Dr Paul McKeigue

They say keeping the lockdown policies in place until a vaccine is available would cause “irreparable damage, with the underprivileged disproportionately harmed”.

The health harms cited include:

• lower childhood vaccination rates
• worsening care for heart disease and cancer patients

And they point out the risk from coronavirus is 1,000 times greater for the old and infirm, with children more at risk from flu than Covid-19.

As immunity builds in the population, the risk of infection to all – including the vulnerable – falls, they say.

And this would be a much more “compassionate” approach.

The declaration recommends a number of measures to protect the vulnerable, including regular testing of care-home workers, with a move as far as possible towards using staff who have acquired immunity.

Retired people living at home should have groceries and other essentials delivered, it says.

And when possible, they should meet family members outside rather than inside.

Simple hygiene measures, such as hand washing and staying home when sick, should be practised by everyone.

But:

• young low-risk individuals should be allowed to work normally
• schools and universities should be open for in-person teaching
• sports and cultural activities could resume and restaurants reopen

• TESTING: How do I get a virus test?
• SYMPTOMS: What are they and how to guard against them?
• LOOK-UP TOOL: How many cases in your area?
• YOUR QUESTIONS: We answer your queries
• THE R NUMBER: What it means and why it matters
• TREATMENT: How close are we to helping people?

What do other experts say?

While clearly “well intentioned”, the declaration has profound ethical, logistical and scientific flaws, University of Leeds school of medicine associate professor Dr Stephen Griffin says.

The vulnerable come from all walks of life and deserve to be “treated equally”.

And “long Covid” is reported to have left even people mild infections with problems such as fatigue and joint pain for months.

University of Reading cellular biology expert Dr Simon Clarke, meanwhile, says whether herd immunity is even achievable remains unclear.

“Natural, lasting, protective immunity to the disease would be needed,” he says.

“And we don’t know how effective or long-lasting people’s post-infection immunity will be.”

Some say the most likely scenario is immunity is not long-term but future reinfections then become milder.

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obviously this reporter and/or the person she is talking to… seems to believe that there is only ONE FENTANYL but according to Wikipedia… there is some 1400 different analogs of Fentanyl and one analog Fentanyl Citrate is a C-II med approved for human use.  All other analogs are ILLEGAL OPIATES.

This article bounces back and forth between legal and illegal fentanyl analogs… as if there is only ONE FENTANYL ANALOG

Too bad that truth is not a ideal that many in public office and many reporters

Local officials seeing increase in fentanyl-related crimes, deaths

https://www.owensborotimes.com/news/2020/10/local-officials-seeing-increase-in-fentanyl-related-crimes-deaths/

Local law enforcement officials said they have seen more fentanyl across Owensboro and Daviess County in recent months, while the Daviess County Coroner’s Office said fentanyl-related deaths have also increased in 2020.

Officials said fentanyl — a substance used to treat severe pain — is being cut into fake prescription opioid pills, causing those who ingest them to overdose and in severe cases die.

According to National Institutes of Health Order Publications, fentanyl is a powerful synthetic opioid analgesic that is similar to morphine but is 50 to 100 times more potent. It is a Schedule II prescription drug.

County Coroner Jeff Jones said his office has seen a definite uptick in fentanyl-related deaths this year.

“We’ve had 3-4 cases this past year that have been fentanyl-related,” Jones said. “Compared to previous years, that’s an increase.”

Meanwhile, Owensboro Police Department Public Information Officer Andrew Boggess said OPD has been seeing an increase of fentanyl use and possession for five months straight.

Daviess County Sheriff’s Office Chief Deputy Major Barry Smith said his department saw a small increase of fentanyl — mainly due to a methamphetamine supply decrease stemming from COVID-19 and travel restrictions — earlier in the year.

“The danger continues of counterfeit pain medicine that could contain fentanyl and fentanyl-laced illicit drugs,” he said.

Unlike other drugs, fentanyl isn’t normally taken by itself. Instead, other drugs such as heroin and methamphetamine are often laced with trace amounts of it. According to Foundation for a Drug-Free World, a dose of fentanyl is considered to be lethal at 3 milligrams, compared to 30 milligrams of heroin.

Now, pills are being altered with the deadly substance, Boggess said. When OPD first noticed the increase of fentanyl and other similar drugs in the area, a press release was sent out to local news outlets warning the community about the issue.

“We have multiple cases open and ongoing pertaining to overdoses,” Boggess said. “There are a lot of investigations going on right now with overdoses where a person may have taken pills and not known what they were made of. It’s concerning because these overdoses can be fatal.”

Jones said the vast majority of toxicology reports pertaining to those who’ve died of a fentanyl overdose have contained multiple drugs.

“It’s hard to know if they’re laced with fentanyl, if it’s a combination of drugs,” he said. “Fentanyl is the primary cause of death in all of these cases.”

Boggess said OPD officers have begun carrying naloxone nasal spray, or Narcan, and it has prevented a number of overdoses from turning deadly.

“With overdoses, timing is extremely crucial,” he said.

Boggess also said OPD isn’t sure at this time where the fentanyl-laced pills are coming from. In Owensboro and Daviess County, methamphetamine laced with fentanyl has been believed to have been primarily manufactured by the Mexican cartel.

Though OPD has not seen a significant decrease in fentanyl-laced meth, the primary concern this time around is the frequency in which fentanyl has been discovered across the community.

“An important distinction here is, these pills are being purchased on the street level, not at the pharmacy,” Boggess said. “You don’t ever know what you’re really getting. It’s extremely potent in small quantities.”

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Cerebrospinal Fluid Leak After Nasal Swab Testing for Coronavirus Disease 2019

https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2771362

In March 2020, coronavirus disease 2019 (COVID-19) emerged as a global pandemic. Testing for presence of active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is 1 pillar of the global response.¹ In particular, nasopharyngeal, anterior nasal, and midturbinate swabs are 3 of the 5 methods for initial diagnostic specimen collection recommended by the US Centers for Disease Control and Prevention (CDC).² However, complications associated with nasal swab testing are not well characterized. We describe the first case of a cerebrospinal fluid (CSF) leak after nasal testing for COVID-19, to our knowledge.

A woman in her 40s presented with unilateral rhinorrhea, metallic taste, headache, neck stiffness, and photophobia. The patient had recently completed nasal COVID-19 testing for an elective hernia repair. Shortly after, she developed unilateral rhinorrhea, headache, and vomiting. The patient’s medical history was notable for idiopathic intracranial hypertension and removal of nasal polyps over 20 years before presentation. Physical examination revealed clear rhinorrhea from the right side. Flexible nasopharyngoscopy revealed a mass in the right anterior middle meatus, but did not identify the source of the fluid. The nasal drainage tested positive for β₂-transferrin. Computed tomography (CT) and magnetic resonance imaging (MRI) identified a 1.8-cm encephalocele extending through the right ethmoid fovea into the middle meatus and a right sphenoid wing pseudomeningocele. Comparing these images to findings on CT performed in 2017 revealed that the encephalocele dated at least to that time (Figure 1). The 2017 CT diagnosis was paranasal sinus disease but not an encephalocele. The patient was admitted to the hospital for endoscopic surgical repair. At the beginning of the procedure, intrathecal fluorescein was infused through a lumbar drain. An encephalocele was identified in the right anterior ethmoid cavity (Figure 2). After reduction of the encephalocele, a skull base defect in the fovea ethmoidalis was repaired with a combination of acellular human dermal matrix and a poly(D,L-lactic) acid. The patient was admitted postoperatively for neurological monitoring and lumbar drain management.

Figure 1.  Imaging Prior to Cerebrospinal Fluid (CSF) Leak

View LargeDownload

A, Brain computed tomographic image from 2017 in the coronal and sagittal planes demonstrating encephalocele situated over the fovea ethmoidalis prior to nasopharyngeal testing for COVID-19. The arrowhead demonstrates skull base defect. B and C, High-resolution magnetic resonance imaging (T2 sequence) in the sagittal plane during hospital admission in July 2020 after development of iatrogenic CSF leak. The yellow arrowheads indicate the encephalocele.

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CVS Apologizes For Prescription Delays At Cape Stores

https://patch.com/massachusetts/falmouth/cape-residents-angry-cvs-falling-behind-prescriptions

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Community pharmacy group says CVS, other bigs are unfairly steering patients

https://ohiocapitaljournal.com/2020/09/22/community-pharmacy-group-says-cvs-other-bigs-are-unfairly-steering-patients/

A huge majority of community pharmacists have lost patients in the last six months due to unfair practices by much larger competitors, an industry group that represents small pharmacists said last week.

They accuse CVS Health — which operates as an insurer, claims administrator and pharmacy retailer — as being the company responsible for the most abuses. CVS denies the claim.

The National Community Pharmacy Association (NCPA) said that between Sept. 8-11, it collected 412 responses to a survey about a practice known as “patient steering.” 

In addition to being the nation’s largest pharmacy retailer, CVS is now also the largest pharmacy benefit manager, which charges insurers, pays pharmacists, decides which drugs get favorable treatment and collects rebates from manufacturers. The company has said it maintains a strict firewall between the businesses, but critics have accused the company of using one business to advantage the others.

For example, in the fall of 2017, Ohio community pharmacists complained Medicaid reimbursements from CVS’s pharmacy benefit manager, CVS Caremark, had dropped so low that they were having a hard time staying in business. At the same time the pharmacists they were receiving letters from from another arm of CVS acknowledging that reimbursements were low and that CVS was willing to buy out the community pharmacists.

That made pharmacists suspicious that the part of the corporation that acquires pharmacies was using CVS Caremark’s reimbursement data to determine which independent pharmacies were most likely to be struggling and vulnerable to a buyout offer. CVS denied that.

Some observers feared such concerns would only get worse when a federal judge last year allowed CVS to merge with Aetna, the country’s third-largest health insurer.

Now the NCPA, the group representing small pharmacists, says things are getting worse.

One method of patient steering is to transfer their prescriptions to another pharmacy without their knowledge, much less their consent. 

According to the NCPA survey, 79% of community pharmacists said that had happened with one or more of their patients in the past six months. Almost 78% of respondents said some of the patients thus steered saw their prescriptions moved to CVS.

“That’s a big red flag,” NCPA CEO B. Douglas Hoey said in a statement. “The pharmacy sector is very competitive, and most big chains have aggressive marketing schemes aimed at taking patients from rivals. CVS Health not only owns brick-and-mortar stores, but it also owns its own insurance companies, Aetna and Caremark. That information allows it to eavesdrop on when and where patients are getting their prescriptions and, as the survey reported, coerce unknowing patients into CVS stores.”

In an email, CVS Senior Director of Corporate Communications Michael DeAngelis said the NCPA claims were patently false.

“Our pharmacies only initiate prescription transfers when requested by a patient,” he said. “Also, CVS Caremark members have access to our broad network of more than 60,000 pharmacies, including most independent pharmacies and chain pharmacies, in addition to CVS Pharmacy. In fact, more than 40% of the pharmacies in our network are independently owned. If a plan sponsor chooses a particular network design that includes specific pharmacies, their members are notified in advance.”

DeAngelis also panned the process behind the NCPA survey.

“The ‘survey’ conducted by the business trade association, NCPA, of its own members has no basis in fact and is nothing but a self-serving attempt to disparage CVS Health,” he said. “Accusations that we transferred patients’ prescriptions to our own pharmacies without their knowledge or consent are simply not true.”

One Ohio pharmacist said he doesn’t know why he’s losing patients, but he knows he’s been losing them.

“We’re down 300 or 400 patients a month” compared to last year, said Barry Klein, owner of Klein’s Pharmacy in Cuyahoga Falls. “It’s hard to say what was the cause of it, but definitely our patient count is down.”

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Dogs…  Millions of pills…. Profiling

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