FDA Sends 2 More Warning Letters to Companies Selling OTC CBD Products

FDA Sends 2 More Warning Letters to Companies Selling OTC CBD Products (drugtopics.com)

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Senate votes to confirm Vivek Murthy as surgeon general

https://www.foxnews.com/politics/senate-votes-on-vivek-murthy-for-surgeon-general

The role for the nation’s top doctor was filled by the Senate Tuesday, after President Biden’s nominee, Vivek Murthy, was confirmed as the U.S. Surgeon General.

During Senate testimony late last month, he promised to use his role to turn the coronavirus pandemic around – a subject not only of national importance but one that has personally affected Murthy, who has lost several family members to the deadly virus.

“This is a moment of tremendous suffering for our nation. More than half a million people have lost their lives to COVID-19, including beloved members of my own family,” he told lawmakers.

Murthy had advanced through the Senate’s Committee on Health, Education, Labor on a bipartisan basis in a 16-6 vote last week.

Five Republicans including Lisa Murkowski of Alaska, Susan Collins of Maine, Mitt Romney of Utah, Bill Cassidy of Louisiana and Roger Marshall of Kansas, crossed party lines to support Murthy’s nomination as the “Nation’s Doctor.”

As surgeon general, he will play a critical role in shaping the public message surrounding the virus, which has infected more than 29.8 million in the U.S. and killed over 543,000 Americans.

“If confirmed as surgeon general, my highest priority will be to help end this pandemic, work I’ve been doing over the past year with state and local officials, schools and universities, businesses, health care providers, and others,” Murthy said in his February testimony.

Murthy is no stranger to the high-profile role, as he was confirmed as surgeon general under President Obama and served from 2014-2017. He also advised Biden on the coronavirus while on the campaign trail.

His nomination raised eyebrows after reports surfaced which showed Murthy made more than $2.5 million during the pandemic from advising companies like Netflix, Carnival Cruise Line and Airbnb on their coronavirus response, first reported the Washington Post.

But during his nomination hearing, he said his previous experience in consulting on the COVID-19 response, makes him an asset to the role.

“I have seen first-hand the importance of providing clear, science-based guidance to Americans on how to protect themselves and others. And I know how urgent it is that we communicate clearly about the safety and effectiveness of vaccines and get them to people as quickly as possible, particularly those in underserved rural communities and communities of color,” he told lawmakers.

“The most important job of a doctor is to help patients heal. And if confirmed, that will be my mission as Surgeon General – to do whatever I can to help heal our communities and our nation,” he added.

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What are red flags how do they affect your ability to get treatment with pain medicines

I was shocked when I went through and started to make a list of all the red flags. These are from the federal government, from hospital associations from pharmacy associations it’s a collection from multiple sources. Red flags are warnings to stop look and listen. they can be used to stop the treatment of pain patients as though they were rules. They are supposed to tell people to document why these red flags are not going to be a problem. But that’s not what’s happening. Pharmacies are being shut down for ignoring red flags, but there’s over 100 of them pretty hard to keep track

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Gretchen Whitmer may soon face Cuomo-like scrutiny over nursing homes, lawsuit plaintiffs say

https://www.foxnews.com/politics/gretchen-whitmer-may-soon-face-cuomo-like-scrutiny-over-nursing-homes-lawsuit-plaintiffs-say

Michigan’s Democrat governor benefits from an exemption on disclosing data to the public, two critics say

The state of Michigan is facing a lawsuit whose plaintiffs are seeking information on Gov. Gretchen Whitmer’s coronavirus-related executive order regarding the state’s nursing home residents.

Whitmer could soon find herself under scrutiny similar to that faced by a fellow Democrat, New York Gov. Andrew Cuomo, the Michigan men taking the legal action against Whitmer say.

Plaintiffs Steve Delie and Charlie LeDuff outlined the purpose of their lawsuit in an article published Friday by USA Today. Delie is an official with the think tank Mackinac Center for Public Policy, while LeDuff is a Pulitzer Prize-winning journalist.

“It shouldn’t take a lawsuit to obtain this critical data,” the pair write. “Gov. Whitmer made the same policy choice as Gov. Cuomo, forcing contagious senior citizens into close proximity with other medically vulnerable people. In fact, her policy, a similar version of which is still in effect today, went even farther, forcing some non-senior patients into nursing homes, including a 20-year-old. Michigan citizens deserve to know why she did this, and whether our governor is telling the truth about the consequences.”

“Gov. Whitmer made the same policy choice as Gov. Cuomo, forcing contagious senior citizens into close proximity with other medically vulnerable people.”

— Steve Delie and Charlie LeDuff, suing to access Whitmer data

The writers say Whitmer issued her executive order April 15, 2020, just a few weeks after Cuomo issued his similar order in New York on March 25, 2020.

They go on to note the recent disclosures about the Cuomo administration’s alleged underreporting of deaths of New York’s nursing home patients as the coronavirus spread. New York patient numbers were underreported by more than 40% while the state’s deaths were underreported by more than 75%, they note, citing reporting by The Associated Press.

Delie and LeDuff argue that the New York public had a right to know accurate information about what was happening regarding nursing home patients but didn’t receive the data until after a five-month-long legal fight.

Whitmer’s unique legal exemption

They then note that under Michigan law, Whitmer has the advantage of being legally exempt from Freedom of Information laws.

“Thanks to this exemption, the governor [Whitmer] has no obligation to produce any records whatsoever, despite making decisions affecting the lives of every Michigander,” the authors write.

“The governor [Whitmer] has no obligation to produce any records whatsoever, despite making decisions affecting the lives of every Michigander.”

— Steve Delie and Charlie LeDuff, suing to access Whitmer data

They allege that Whitmer has used the shielding provided by the exemption to “act with impunity” – and was not required to provide the data on which she based her coronavirus policy decisions.

“This is unacceptable,” Delie and LeDuff write.

Aside from Whitmer, only the governor of Massachuetts has a similar exemption, The Detroit News reported.

Earlier this month, Michigan Attorney General Danna Nessel, a Democrat, declined a request by state Republicans to investigate Whitmer’s nursing home-related actions, saying a probe wasn’t needed “at this time.”

“I appreciate that you and your colleagues have policy disagreements with Gov. Whitmer’s response to COVID-19,” Nessel wrote in a letter dated March 15. “But an investigation by my office is not the mechanism to resolve those disagreements.”

Republicans have condemned the Michigan governor for allowing nursing home residents recovering from the virus to return to their nursing homes or gain admittance, alleging the move put other residents at risk.

Whitmer created 21 hubs in existing nursing homes that were intended to have room for isolation and specialty equipment for elderly groups discharged from the hospital, The Detroit News reported.

But state Republicans wanted separate isolation units designated for elderly populations recovering from COVID-19, in order to prevent other nursing home residents from contracting the virus.

Last week a New York City nursing home director told Fox News he viewed Cuomo’s nursing home orders to be “ridiculous,’ and complained to state health officials, saying, “We can’t be doing this.”

Cuomo is facing an investigation by the FBI and federal prosecutors in Brooklyn, N.Y., regarding his nursing home policies, The New York Times reported Friday.

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Navy vet shot himself after doc cut off opioid prescription, mom claims

https://nypost.com/2020/03/14/navy-vet-shot-himself-after-doc-cut-off-opioid-prescription-mom-claims/

The mother of a decorated Navy vet who committed suicide in the parking lot of a VA Hospital last year is seeking $8.25 million from the beleaguered agency — alleging her son became suicidal when a VA-affiliated doc cut off his opioid prescription.

Gary Pressley, 28, shot himself outside the Carl Vinson VA Medical Center in Dublin, Georgia, on April 5, several months after his pain management specialist nixed his Hydrocodone supply over a payment dispute with the VA, according to the claim.

As a result, Pressley “experienced excruciating pain, the horrible side effects of withdrawal and lost all hope,” according to the wrongful death claim Rhonda Machelle Wilson filed last month.

Pressley joined the Navy in 2008 and was honorably discharged four years later, after a motorcycle accident left him disabled with a fractured hip, pelvis and chronic lower back pain, the claim says.

Pressley found relief through his pain management doctor, Ana Maria Platon. But she stopped treating him and other vets in early 2019, because the VA owed her “hundreds of thousands of dollars and purposefully failed to reimburse her,” the claim says.

Wilson also alleges that staff at the Carl Vinson Medical Center failed to look for Pressley after his sister, Lisa Johnson, informed a VA operator her suicidal brother was in the parking lot with a loaded gun.

His body was discovered three hours later inside his car with heavy metal music blaring on the radio and a note beside him that read, “This is what happens by punishing already suffering people muahahaha.” On the back it said “Thank you for the release,” the claim says.

A disturbing photo of his slouched and lifeless corpse included in the claim provided to The Post shows him in a blood-soaked collared shirt and sunglasses.

Platon and the VA did not respond to requests seeking comment

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just what is needed is just another opinion from an ATTORNEY about suicides and chronic intractable pain… and how people dealing with intractable chronic pain – especially those not getting adequate pain management — WOULD NOT CONSIDER COMMITTING SUICIDE.  The article has no place to place a comment and there was no web link to reach out to the author.

And some “data” from Oregon 

Oregon data indicate that among the leading reasons people request lethal prescriptions are psychosocial factors such as perceived lessening of autonomy or feeling they are a burden.

Imagine that…. a person not receiving adequate pain management could in no way could “feel like a burden” to their family ?

Wasn’t it Oregon a couple of years ago that was proposing that Oregon Medicaid would no longer pay for any opiates for chronic pain pts ?

Opinion: It’s not end-of-of life care. It’s assisted suicide, and it needs to be stopped

https://www.courant.com/opinion/op-ed/hc-op-no-right-to-die-law-20210316-iubnvvaes5b65l2gjeo2h5xicm-story.html

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when it was first announced that Pfizer & Moderna Covid-19 vaccinations were be approved with (EUA) emergency use authorization and the process of making these vaccines was a BRAND NEW PROCESS dealing with mRNA… I was skeptical, especially since Dr Fauci had been so adamant about the use of Hydroxychloroquine use in treating Covid-19. Hydroxychloroquine has been approved for human use for around 50 yrs… but Fauci was adamant about not using this medication because it had not been in a double blind clinical study for treating COVID-19…. these studies can take upwards of a decade. From what I had read, Hydroxychloroquine seem to show some success in combination with several other medications especially when pts were treated early in the disease process.

But, Fauci seemed to have jumped on and supported these vaccines from a never before used process and clinical trials of maybe just a couple of months.

Fauci seemed to try to put forward the image of “following the science”, but he was all over the map… don’t need a mask…. need one mask…. need two masks. He seemed to support cities/counties/states shutting down to all but very essential services, but here we are a year later and New York followed Fauci’s recommendations where states like FL did not and FL had fewer deaths per 100,000 than NY.

Personally/professionally I decided that we were going to wait until the J&J/Jansen vaccine got approval… because it is made using the same process that has been used for decades making the flu vaccine and it is a ONE AND DONE – SINGLE SHOT…. we got ours last Saturday.  By the end of the month, the two weeks it takes for antibodies to develop … we should be fully protected.

While the clinical studies of J&J/Jansen vaccine showed only a 65% effectiveness,  the clinical trials for this vaccine was much later than those for Moderna/Pfizer vaccines and the pts within the J&J/Jansen clinical trials had been exposed to the Brazilian and African COVID-19 mutations… which the other vaccines did not. BUT.. in the J&J/Jansen clinical trial… THERE WERE NO DEATHS within the clinical trials pts.

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Kill Shot: A Shadow Industry, a Deadly Disease

An award-winning investigative journalist’s horrifying true crime story of America’s deadliest drug contamination outbreak and the greed and deception that fueled it.

Two pharmacists sit in a Boston courtroom accused of murder. The weapon: the fungus Exserohilum rostratum. The death count: 100 and rising. Kill Shot is the story of their hubris and fraud, discovered by a team of medical detectives who raced against the clock to hunt the killers and the fungal meningitis they’d unleashed.

“Bloodthirsty” is how doctors described the fungal microbe that contaminated thousands of drug vials produced by the New England Compounding Center (NECC). Though NECC chief Barry Cadden called his company the “Ferrari of Compounders,” it was a slapdash operation of unqualified staff, mold-ridden lab surfaces, and hastily made medications that were injected into approximately 14,000 people. Once inside some of its human hosts, the fungus traveled through the tough tissue around the spine and wormed upward to the “deep brain,” our control center for balance, breath, and the vital motor functions of life.

Now, investigative journalist Jason Dearen turns a spotlight on this tragedy–the victims, the heroes, and the perpetrators–and the legal loopholes that allowed it to occur. Kill Shot forces a powerful but unchecked industry out of the shadows.

https://www.amazon.com/Kill-Shot-Shadow-Industry-Disease/dp/0593085787

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Overworked, understaffed: Pharmacists say industry in crisis puts patient safety at risk

https://www.nbcnews.com/health/health-care/overworked-understaffed-pharmacists-say-industry-crisis-puts-patient-safety-risk-n1261151

“We’re going to have a fatal error somewhere,” said a pharmacy technician in New York, “because we’re doing too many things at once.”

From the moment Marilyn Jerominski walks into her pharmacy every morning, her time is in demand. As pharmacy manager of a busy 24-hour Walgreens in Palm Desert, California, she is responsible for the safety and accuracy of the thousands of prescriptions the store dispenses every week.

“There’s so much stress,” Jerominski said. “You’re not only running to the drive-thru but to the front, to the vaccination station to give a vaccination, then to the phone. … It’s almost impossible for any human to keep that momentum day in and out.”

It wasn’t always that way. When she began working as a pharmacist 13 years ago, it was a very different environment, Jerominski said. There were more staff members and more time to counsel patients about their medications. These days, she is exhausted and often overwhelmed, worried about making a mistake when someone’s health is on the line. She is far from alone.

Jerominski is one of an estimated 155,000 pharmacists working at chain drugstores who, over the past decade, have found themselves pushed to do more with less. They’re working faster, filling more orders and juggling a wider range of tasks with fewer staff members at a pace that many say is unsustainable and jeopardizes patient safety. Now Covid-19 vaccinations are raising new concerns about what will happen if they aren’t given enough additional support for yet another responsibility.

Watch this story tonight on “NBC Nightly News with Lester Holt” at 6:30 p.m. ET / 5:30 p.m. CT (or check your NBC station).

NBC News spoke to 31 retail pharmacists and pharmacy technicians in 15 states. From 12-hour shifts so busy they don’t have time to go to the bathroom or eat to crying in their cars every day after work or lying awake at night worrying about mistakes they might have made while rushing, they described an industry of health care professionals at the breaking point.

“The expectations they’re having and the resources they’re giving us just aren’t matching up,” said a CVS pharmacy technician in New York state. “We’re going to have a fatal error somewhere because we’re doing too many things at once.”

Most pharmacists spoke anonymously out of fear of losing their jobs. Declining profit margins for pharmacies, corporate consolidation and an influx of new pharmacy school graduates in the past decade have led to stagnant or falling wages and fewer employment options, according to pharmacists, experts and recent studies.

The pressure and understaffing issues aren’t new, as The New York Times reported last year. But they’ve worsened during the pandemic, pharmacists said, with new duties like Covid-19 testing, deep cleaning and now vaccinations stretching them even further.

“Pharmacists are being asked to do additional tasks and aren’t necessarily receiving the assistance that they need from their employer,” said Al Carter, executive director of the National Association of Boards of Pharmacy, a nonprofit that represents state pharmacy regulators. “That’s a huge concern for pharmacists’ well-being but also, more importantly, for patient safety.”

The more overworked they are, the more likely they are to make errors, he said. Pharmacy errors can range from smaller mistakes, like miscounting the number of pills in a bottle, to potentially deadly ones, like missing a dangerous drug interaction. Working conditions and workplace pressures have led to “growing concerns from many state boards of pharmacy” about prescription errors, Carter said.

Walgreens and CVS, the country’s largest pharmacy chains, were early government partners in the vaccine rollout. In statements to NBC News, they said that they are grateful for the work their pharmacy staffs have done during the pandemic and that they are hiring thousands of additional staff members to ensure that pharmacies have the support and resources to administer Covid-19 vaccine shots and provide the best care for patients. They and the trade group representing all chain drugstores also said technology improvements have freed pharmacists from many routine tasks in recent years, allowing them to focus on the safety and health of patients — their top priority.

CVS said the majority of stores giving Covid-19 vaccinations will do so through a dedicated team of pharmacists working only on vaccinations. In stores that don’t, the company will provide additional staff support and limit the numbers of appointments.

Pharmacies have already begun to vaccinate around the country, but many pharmacists said they’re worried about how much additional staffing they’ll get to give vaccinations.

Jerominski’s pharmacy began vaccinating last month. The vaccinations are going well, she said, but other work has been piling up as she struggles to find time to do it all.

“Right now, it’s just so crazy,” she said during a shift break on her third day vaccinating. “Like, it’s 1 o’clock, and I’ve done 14 Covid vaccines this morning, in between filling prescriptions. … It’s wonderful that we’re doing this, and this is our duty. This is what we’re supposed to be doing. But we need more help.”

‘Timed to the minute’

A pharmacist’s job is far more than putting pills in bottles. Experts in drugs and medication management, they work everywhere from hospitals to cancer treatment centers and drugstores. They are among the best-educated health care professionals — they earn four-year clinical doctorates, which include rotations and often postgraduate residencies — and make median salaries of $128,000 a year. They are also some of the most trusted and accessible health care professionals in the country, according to the National Association of Chain Drug Stores.

The person who actually hands you your filled prescription at the counter may be a technician, not a pharmacist. Technicians are support staffers who run the cash register; fill, count and bag prescriptions; and unload inventory. They’re entry-level employees who typically get on-the-job training or attend certificate programs and are paid a median $16 an hour.

Medication management services for customers can save billions in annual health care expenses, pharmacy groups estimate. Pharmacists said providing that advice is why many got into the business, yet they now have less opportunity to use those skills.

“I love being a pharmacist. I love being there for my patients,” Jerominski said. “We used to be able to have time to actually have in-depth conversations about how the patient is doing.”

But what might have once been five- to 10-minute patient consultations now typically happen in under a minute, she said. “It’s not ‘let us care for the patient.’ It’s ‘how fast can we get the people in and out?'”

Walgreens, like many large pharmacy chains, gives pharmacists a range of metrics to meet and monitors the time they spend on various tasks, from calls to patients to prescriptions filled and vaccinations given per week. The chains, pharmacists said, began to push them more when profit margins started shrinking a little over a decade ago.

“Basically, your day is timed out by the minute — it’s like the worst case of micromanaging you can imagine,” said an Alabama pharmacist who has worked at Walgreens, CVS and Rite Aid in the past decade.

Walgreens didn’t directly respond to questions about quotas and other metrics pharmacists must meet. In a statement, CVS said the metrics it uses to evaluate quality of service aren’t unique, saying, “Over the past two years we’ve actually reduced those metrics by half, providing us with a clearer picture of what’s working and where improvements may be needed.”

In a statement, a spokesperson for Rite Aid said that the company believes the focus for pharmacists “should be on counseling customers for positive health outcomes” and that it has “created efficiencies and tools to open up pharmacists’ time to consult and care for customers.”

‘The picture was grim’

While margins have tightened everywhere, pharmacists say the working conditions at some of the country’s largest chain pharmacies are different from those at many independently owned pharmacies. Jerominski’s husband, Shane, whom she met in pharmacy school, spent 10 years working at chain pharmacies and now manages an independent pharmacy. He was part of a class action lawsuit against one past employer, Walgreens, over wages and other issues. The suit was settled in 2014. He said his stress dropped markedly when he switched to working at an independent pharmacy.

“I see the difference. My level of autonomy is vastly different than Marilyn’s, and the amount of help that I get is different than Marilyn,” Shane said. There’s still plenty of stress at his busy pharmacy, he said, but staffing is far better, and he isn’t judged on the flurry of metrics he used to be beholden to. “I would never go back, honestly.”

Recent surveys have borne out what pharmacists said has happened in their industry. In the 2019 National Pharmacist Workforce Study, which surveys thousands of pharmacists every five years, more than two-thirds of pharmacists said their workloads had risen in the past year. At retail chain pharmacies, 91 percent of pharmacists rated their workloads as “high” or “excessively high,” the highest of any pharmacy type.

Wages for a much greater proportion of pharmacists remained stagnant or fell compared to five years earlier, and the majority of pharmacists felt their job security and ability to find new work had decreased in the previous year. Many pharmacists told NBC News that they worry that leaving current jobs would mean taking pay cuts, if they could find jobs at all.

The job market isn’t in pharmacists’ favor. There are twice as many pharmacy school graduates a year as there were 18 years ago, according to the American Association of Colleges of Pharmacy, yet the number of pharmacists jobs hasn’t grown at the same pace. The Bureau of Labor Statistics predicts that the industry will shrink by 3 percent in the next decade.

A survey of pharmacists by the Vermont Pharmacy Board last fall, months into the pandemic, gave further insight into how working conditions at chain pharmacies compare to those at other pharmacies. Nearly 250 pharmacists from chain, independent and hospital pharmacies responded to the survey (and responded at rates roughly reflecting each category’s share of Vermont pharmacists). They gave only retail chain pharmacies an “unfavorable rating” in any of the nine categories the survey examined. In fact, they gave the chains an “unfavorable rating” in every category, from patient safety to shift lengths and staffing.

Four in 5 retail chain pharmacists who responded to the Vermont survey said they worked more than 10 hours each shift; many reported that they arrived early or stayed late or never took meal breaks. Only 1 in 5 of the chain pharmacists said the number of pharmacists on duty was consistently adequate to provide safe patient care, and more than half said they had thought about leaving their jobs because of safety concerns.

Some of the conditions the board heard about “would be found unacceptable in a factory,” such as pharmacists’ developing kidney problems from skipping restroom breaks, said Gabriel Gilman, general counsel for the Vermont Office of Professional Regulation, which houses the state Pharmacy Board.

“The picture was grim,” Gilman said. “We went into it expecting to find things that alarmed us. And we were alarmed at what we found even so.”

‘More like a fast food industry’

The industry is feeling the squeeze because of systemic financial factors, experts said. Steady profits are far less certain than they once were as pharmacies contend with declining profits for filled prescriptions and higher fees from middlemen who set drug prices nationally. And unlike most health care providers, pharmacists generally don’t bill for their services. Instead, pharmacies make the vast majority of their income from dispensing prescriptions. The more prescriptions they dispense, the more money they make.

“Twenty years ago, you could make a decent living off the reimbursement of the drug and you had time to spend with patients,” said Scott Knoer, CEO of the American Pharmacists Association. Knoer said that’s no longer true and that all retail pharmacies have been struggling.

National chains have bought out regional ones, and independent pharmacies, which are about a third of retail pharmacies, are no longer as profitable as they once were. Independent pharmacy owners’ average income fell by nearly half from 2013 to 2019, according to industry analyst Drug Channels Institute.

“The incentive design of pharmacy is: ‘We pay you to fill prescriptions. We don’t necessarily pay you to make people better,'” said Antonio Ciaccia, a consultant who has worked with the state of Ohio and the American Pharmacists Association on prescription drug pricing transparency and pharmacy payment reform. He said that’s a bad model, especially combined with dwindling prescription profits.

“What you have is a race to the bottom, and at the bottom is an underresourced, heavily consolidated pharmacy marketplace that looks more like a fast food industry than a health care industry,” he said.

There’s no quick, easy fix. In Ohio, the state Medicaid program is trying a new payment model, which Ciaccia worked on, to allow pharmacists to bill insurers for clinical services.

Pharmacy trade groups and others are pushing for a national version of that model, giving pharmacists what’s known as “provider status.” A bipartisan federal bill to grant pharmacists the status was proposed repeatedly in the past decade, but it has yet to get a hearing.

While financial overhaul of the industry may be the ultimate goal for pharmacist groups, in the meantime, some states are also pushing to improve labor standards.

In recent years, states like California, Illinois and Virginia have created new rules, from capping shift lengths to mandating safe staffing levels and prohibiting excessive metrics. Vermont is working on new workplace condition rules based on its recent survey results.

About a third of all states now have regulations addressing pharmacy working conditions, according to the National Association of Boards of Pharmacy.

“There are challenges that are still huge concerns for boards of pharmacy … and I don’t see them going away any time soon,” said Carter, the head of the association. “Especially with the pandemic, I see them getting worse.”

For Marilyn Jerominski, it feels like the industry still has a long way to go. She knew she wanted to be a pharmacist when she was a sophomore in high school, but she said she never dreamed her job would look like it does today.

“You shouldn’t wake up every day and feel disappointed in a profession where you go to school for seven-plus years,” she said. “But how much more can you do? How much more can you do with less help? How much more can you do without making a mistake?”

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