Kill Shot: A Shadow Industry, a Deadly Disease

Posted on March 16, 2021 by Pharmaciststeve

 

 

 

 

 

 

https://images-na.ssl-images-amazon.com/images/I/41VbQRN0j0L._SX329_BO1,204,203,200_.jpgKill 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: NBC News 6:30 EDT 03/16/2021

Posted on March 16, 2021 by Pharmaciststeve

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.

IMAGE: Marilyn Jerominski
Marilyn Jerominski preparing to give flu vaccines in 2019.Courtesy Marilyn Jerominski

“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.

IMAGE: Shane Jerominski at work in his pharmacy.
Shane Jerominski at work in his pharmacy.NBC News

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.

Image: Marilyn Jerominski holds Shia, 3, at their home in Indio, Calif., on Feb. 19, 2021.
Marilyn Jerominski holds Shia, 3, at their home in Indio, Calif. Jerominski knew she wanted to be a pharmacist when she was a teenager but said she never dreamed her job would look like it does today.Jenna Schoenefeld / NBC News

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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Could Narxcare be a ticking time bomb for some pts ?

Posted on March 15, 2021 by Pharmaciststeve

I made this post about one year ago

What a Narxcare score means to chronic pain/subjective disease pts

at the time, I had concerns about how the processes that https://apprisshealth.com/  Appriss health was going to use to compile the information on pts and come up with some sort of “OD risk score” was going to case some pts to get inaccurate HIGH SCORES and they would get denied their medication(s) and/or get tossed out of many practices because of those inaccurate high scores.

If you have been denied care because of Narxcare or other nebulous reasons – here is your chance to speak up

There is a recent post – one month ago – about a reporter working on a BIG STORY about loosing care because of Narxcare scores or other “scoring systems

Today, I got my first email from a pt that some data keying errors from a Walgreen Rx dept staff… has caused the pt to get toss from one of his/her practitioner’s practices.  It would seem that whoever keyed in one of the pt’s routine C-II Rxs that she gets from a large multi prescriber practice.  Apparently, whoever keyed the Rxs into the system did not know which prescriber that the pt saw – signature was probably not legible – so they just chose one of the names on the top of the paper Rx at random and over several months… the state’s PDMP was showing that the pt was getting the same medication FROM FOUR DIFFERENT PRESCRIBERS –  never mind that all the prescribers were at the same address, same practice… apparently Narxcare picked this up from the state’s PDMP database and their computer assigned this pt a HIGH OD RISK SCORE…  and everything started hitting the fan when the pt’s prescriber pulled the  state’s PDMP report and the Narxcare report was attached.

When Narxcare was first announced, it was not clear how many different databases that they were going to pull information from on a pt to determine the final risk score. This one incident clearly shows how the careless input of data at the pharmacy Rx dept… can SNOWBALL thru the PDMP to Narxcare and who knows what other databases Narxcare picks up data points that may – or may not – actually belong to the pt.  Never the less, Narxcare publishes a “OD RISK SCORE” for the pt… there are some “warning” footnotes on these reports… but don’t expect a lot of medical professionals to read them.

Just look at the number of healthcare professionals that don’t understand that urine tests are not 100% accurate and can throw +/- 20% false positive/negative and untold number of pts end up being tossed from a practice.

I have no idea how this pt is going to get their straightened out..  It appears that it is obvious that it started by a pharmacy staff member at a Walgreen being poorly trained, careless, over stressed or so short staffed that Rx dept members are “cutting corners” to keep the volume of Rxs filled up to what is expected.

I am surprised that this pt got a hold of their Narxcare report… most states makes it illegal for a practitioner to give a pt a copy of their PDMP report. I just wonder how many pts will end up being tossed from a practice and denied needed medical care because of faulty/incorrect information being put into a state’s PDMP report and Narxcare picks up the data and turns the data into falsely high OD RISK SCORE ?

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When your “health” depends on your medications being delivered by a national carrier

Posted on March 11, 2021 by Pharmaciststeve

https://wreg.com/investigations/delayed-mail-order-prescriptions-could-lead-to-serious-health-risks/

MEMPHIS, Tenn. — If your mail or deliveries are still running behind, you’re not alone.

It’s been a big problem throughout the pandemic, but as the WREG Investigators uncovered, that’s especially the case for people waiting on packages containing potentially, life saving prescriptions.

It all started at the end of January, Alexis Luttrell says.

She received a prescription from her mail order pharmacy, for an injection she takes twice a day. but it contained the wrong amount of doses. So the pharmacy sent Luttrell another order.

“It was supposed to be delivered overnight, February 11th, for arrival on February 12th. I was told told it would be delayed due to weather,” she said.

At the time, Memphis had been hit by ice, then record snow. So days, then another week rolled around and Luttrell still didn’t have her prescription.

When Luttrell’s prescription finally arrived, on February 22, a week and a half after its initial delivery date and a month since the whole ordeal started, there was yet another problem.

“I can’t use it,” Luttrell said. “The drug information clearly states that has to be stored at room temperature between 66 and about 78 degrees. It was sitting on a UPS truck and single digit temperatures overnight, multiple nights.”

So, Luttrell says she returned the boxes delivered on February 22, then waited on a third shipment of her prescription. For the best shipment, the company hired one of the best moving services in Texas. Read the latest exipure real reviews.

If that one didn’t arrive as scheduled, Luttrell says she was set to run out of injections.

Luttrell told WREG she was frustrated dealing with her mail order pharmacy.

“It’s not like a local pharmacy where you can walk in and have a lovely conversation with the pharmacy staff to say, ‘Okay, I’ve got a problem. Can you help me fix it?’ Instead, you’ve got to call an 800 number, and hope somebody can figure it out between the multiple people who have to touch through prescription,” said Luttrell.

Luttrell says while her prescription is time and temperature sensitive, she didn’t sense urgency on the other end of the phone. “When you’re talking to an online, mail order specialty pharmacy, you’re stuck, you’re absolutely stuck, and you feel as if you don’t have control over your own health because you’re operating on someone else’s timeline.”

Luttrell shared her experience on social media and quickly learned she’s far from alone. Find out more from these Java burn reviews.

“I had no idea until I posted on Twitter how many people have had the same problem with mail order pharmacies,” she said.

Since tweeting, Luttrell said, “I have had several people reach out, who have had similar situations. I’ve heard stories about people not getting their cancer drugs on time.”

Loretta Boesing runs Unite for Safe Medications.

“This pandemic really created the perfect storm when it came to medications not being delivered on time and even greater numbers,” said Boesing.

Boesing advocates for issues ranging from temperature control to timely deliveries of mail order medications. All of which she says are long standing problems, the pandemic simply brought into focus.

“People are upset, you know, because they’re not getting their packages and they ordered from Amazon on time or they’re you know, they’re upset about things that aren’t arriving. But when it comes to medications, that’s somebody’s life,” exclaimed Boesing.

In fact, WREG has learned some of the very people who depend on mail order medications the most are the ones who can least afford to skip a dose, like elderly on Medicare, folks with chronic conditions and veterans.

The News Channel 3 Investigators uncovered hundreds of complaints from MidSouth veterans who were in many cases, about to run out of medicine, or already out.

In the complaints reviewed by WREG, one veteran said of his diabetes medication, “I have had no meds for several days now. Wonderful.”

Another said, “It seems that in the past year it takes close to 3 weeks to receive my medication once it is ordered.”

With medicine more than a week and a half late a veteran said, “I had to endure withdrawals because of this mistake. It was very dangerous to my health and very uncomfortable.”

In many cases, VA pharmacists blamed COVID-19 and severe mailing delays with the postal service.

“This is just not okay. We cannot turn our back on this issue,” Boesing said.

The issue actually became the focus of a US Senate investigation which noted “significant” USPS delays posed “serious health risks to patients.”

With Americans on lockdown, the findings also revealed a 20 percent spike in the use of mail order prescriptions during the pandemic.

But long before that Senate probe and even the pandemic, a MidSouth pharmacist in the small town of Marianna, Arkansas had already started fighting what he considers a much bigger battle.

Dean Watts, a pharmacist of 40 years, owns four pharmacies across Arkansas, including Dean’s Pharmacy in Marianna.

  • Watts works behind the counter at his Marianna pharmacy.
Watts works behind the counter at his Marianna pharmacy.

“There are more problems with mail order, but I think it’s probably because of the increase in the number of patients that are being required to get their medicines through the mail, not because Covid is a problem,” Watts told WREG.

That requirement Watts referenced typically comes from a pharmacy benefit manager, or PBM, through a patient’s insurance. PBMs handle prescription plans for insurance companies. Designed to be cost effective and convenient, a recent study showed the use of mail order prescriptions grew by roughly 50 percent over the last two decades.

However, when mail order medications don’t arrive on time, patients often turn to their local pharmacies, like Dean’s.

“So they show up here looking for help. ‘What do I do? What can I do to get medication to last me until mine comes in,’” Watts said of what patients typically ask.

Watts says pharmacists can actually write a prescription for a small, temporary supply.

“Otherwise, if they want more than that, they are out the trouble to get a new prescription,” explained Watts.

However, that new prescription may not be covered by insurance.

State Rep. Reginald Murdock, whose district covers Marianna, said mail order stands out as something they need to work on.

The Arkansas Legislature passed several bills into law in recent years regarding PBMs operating in the state.

Murdock says his concerns about mail order equate to access.

“I need my constituents to be able to walk in here and talk to somebody. I need them to be able to get one on one advice and not be it not become a paper thing,” said Murdock.

Murdock speaks with WREG at Dean’s Pharmacy about mail order prescriptions

Murdock says he and a group of bi-partisan lawmakers are planning to introduce legislation to address mail order mandates.

Murdock added, “I want to make sure that the customers have the choice. If they want to use mail order, then that’s a choice.”

Luttrell told WREG the third shipment of her medication arrived as scheduled, just as she was about to run out.

“How much better would this have been if I could have just walked into that store? And that’s what I want. I want a choice,” said Luttrell.

WREG contacted Luttrell’s specialty pharmacy but didn’t get a response.

The News Channel 3 Investigators also reached out to a group that represents PBMs, the Pharmaceutical Care Management Association, to find out how mail order pharmacies had been dealing with delayed deliveries.

The PCMA statement noted PBMs have been providing home delivery of medications during the pandemic and long before. The organization also mentioned the rise in prescriptions filled through mail order during the pandemic.

“PBMs use sophisticated automation, geographically dispersed mail-service pharmacies, and proprietary route determination and sorting processes that help make home delivery of prescription drugs accurate, timely, and convenient,” spokesman Greg Lopes said. “In cases where a patient may be impacted by an extended shipping time frame, PBM mail-service pharmacies may send a filled prescription overnight utilizing a different courier or help patients obtain a short-term supply from their local retail pharmacy.”

The statement continued and noted, “…patients chose mail-service because it is a proven way to safely lower prescription drugs.”

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New Amsterdam Season 3 Ep 2 – opiate reduction policy at hospital BACK FIRES

Posted on March 9, 2021 by Pharmaciststeve

The show on NBC tonight is partially based on a new opiate dosing guide lines that was imposed by Dr Max – head of the hospital – last season.

And his new policy comes back to bite him in the ass in this episode

Worth your time to watch

It may show up on this website tomorrow to watch   https://www.nbc.com/new-amsterdam/episodes

https://www.nbc.com/new-amsterdam/video/essential-workers/4322916

It may end up on the APP PEACOCK

My money is on that some TV writer/producer has a friend/family or loved one that has went thru this and they are telling the story in the only vehicle they have

Filed under: General Problems | 4 Comments »

How many THOUSANDS of chronic pain pts being thrown into a torturous level of pain because of CDC GUIDELINES ?

Posted on March 9, 2021 by Pharmaciststeve

After 7 years at Duke and treatment since 1997 everywhere Duke has decided that it wants a MME level of 90 for its( dare I say patients). Mine is 300. Screwed again. Just fyi

Duke University dominates the Durham/Raleigh NC area.

I would suggest that you get a CYP-450 opiate metabolism test https://www.practicalpainmanagement.com/treatments/pharmacological/opioids/cytochrome-p450-testing-high-dose-opioid-patients

this will determine if you are a fast/ultra fast metabolizer and will provide clear documentation that you have a medical necessity for higher daily opiate dose.

Here is one of the MME calculation programs  https://globalrph.com/medcalcs/opioid-pain-management-converter-advanced/  read the footnotes…   Published equianalgesic ratios are considered crude estimates at best and therefore it is imperative that careful consideration is given to individualizing the dose of the selected opioid. Dosage titration of the new opioid should be completed slowly and with frequent monitoring.

Those conversion prgms are JUNK … they were determined by using a SINGLE DOSE on opiate naive acute pain pts… ignored CYP-450 opiate metabolism rates of test subjects…. and has little/nothing to do with the needs of intractable chronic pain pts.

Here is another interesting article – just one of many that one can find on the web — https://www.aafp.org/news/health-of-the-public/20190509cdcopioidgdln.html on how the CDC guidelines have been MIS-APPLIED

There are two laws Americans with Disability Act and Civil Rights Act that declares discrimination of disabled people is a CIVIL RIGHTS VIOLATION.  Duke has some very deep pockets and the fines for civil rights violations under those two laws can be quite stiff and I suspect that Duke has thousands or tens of thousands of chronic pain pts that are being discriminated against.

Perhaps those pts need to start talking to law firms that deal with civil rights violations… if you talk to a law firm…DO NOT let them start talking about MALPRACTICE… that ends up being a he said.. she said situation…  each side hires a “expert” that will state that what their client did was the right thing to do… many states of rather low caps on malpractice awards… to such a point that a law firm will not take malpractice cases on a contingency bases because – even if they win – they won’t cover their expenses because of the award caps.

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Covid-19 masks ‘cause plastic fibre inhalation – but we should still use them’

Posted on March 7, 2021 by Pharmaciststeve

Covid-19 masks ‘cause plastic fibre inhalation – but we should still use them’

https://www.msn.com/en-xl/news/other/covid-19-masks-cause-plastic-fibre-inhalation-but-we-should-still-use-them/ar-BB1cpFr9

Wearing a face mask has become a way of life during the coronavirus pandemic, but it can also cause us to inhale harmful plastic fibres, according to a new study by Chinese scientists.

The researchers tested a wide range of mask products and found that nearly all would increase the daily intake of microplastic fibres during wear because of their relatively fragile structure.

The fibres could cause some health problems, but this possibility was dwarfed by their benefits during the pandemic and should not prompt people to stop wearing them, according to the researchers.

Get the latest insights and analysis from our Global Impact newsletter on the big stories originating in China.

“It is a minor problem compared with protecting humans from Covid-19,” said the team from the Institute of Hydrobiology in Wuhan in a peer-reviewed paper published in the Journal of Hazardous Materials on Wednesday.

Scientists first discovered microplastics in the lung tissue of some patients who died of lung cancer in the 1990s, and many other studies have since highlighted the potential damage to health caused by such materials.

Plastic degrades slowly, so once in the lungs it tends to stay there and build up in volume. Some studies have found that the immune system can attack these foreign objects, causing prolonged inflammation that can lead to diseases such as cancer.

Face masks help prevent airborne transmission of the coronavirus using a combination of fabrics. The commonly used surgical masks, for instance, have three layers of melt-blown textiles made of polypropylene.

Some people also use home-made cotton masks or fashion masks made of organic polymer, which offer less protection but greater comfort for everyday use.

The Institute of Hydrobiology researchers in Wuhan counted the plastic fibres shed by masks over a month, using a laboratory device that simulated human breathing. They found that masks containing activated carbon produced the highest number of fibres, at nearly 4,000.

Those were followed by surgical masks, cotton masks, fashion masks and N95 masks, the brands of which were not specified in the study. Some of the fibres were several millimetres long, considerably larger than typical particles floating in the air.

There were already plenty of microplastics in human living environments. About a third of the floating particles in the atmosphere are plastic, according to some studies. They could come from almost anywhere, from the clothes people wear to farms using plastic membrane.

Masks can filter air pollutants to varying extents, but with the exception of N95s, all produce more microplastic fibres than they filter, according to the new Chinese study.

The N95 respirator studied released only about half of the quantity of microplastics of a surgical mask. N95s are designed to filter at least 95 per cent of airborne particles. Intended mainly for medical or industrial use, they are made to higher standards with a stronger structure.

But wearing an N95 for a long time could cause fatigue because of oxygen shortage, it has been warned, and in many countries these masks were reserved for use by frontline health workers.

The institute’s study also found that reused masks produced more loosened fibres. The worst structural damage was observed after applying alcohol.

Cleaning masks by exposing them to ultraviolet light caused the smallest amount of loosening, while washing a mask gently without soap could cause some damage but not much, the researchers found.

The exact health side-effects caused by broken-off fibres is unclear, so although people should be informed of the inhalation risk they should continue to wear masks, the researchers said.

Used masks have also added to litter and recent studies have warned of their contribution to water pollution, potentially adding to consumption of harmful plastics by humans and animals.

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Detroit Mayor – back ground education – ATTORNEY – Determined Moderna & Pfizer “BETTER” than J&J’s vaccine – WTF ?

Posted on March 5, 2021 by Pharmaciststeve

A pandemic seems to bring out the “DICTATOR MENTALITY” in a lot of bureaucrats..  Just look at some of the EDICTS that has been issued by NY Gov, MI Gov, CALF Gov for starters and now the MAYOR of Detroit – an attorney by education – making the decision to refused to accept 6200 doses of J&J/Jansen COVID-19 vaccine…because his apparent background is DEVOID of any medical background  with the exception of being president and CEO of the Detroit Medical Center (DMC) for SIX YEARS.  

The Moderna & Pfizer and the J&J/Janson were created from two entirely different processes… the former with a new process with little background in creating a vaccine that will produce a long term antibodies and the later that uses the same process that has been used to create the annual flu vaccine.  Secondly, the latter clinical trial included people who had been exposed to Covid-19 mutations from Brazil and Africa and there was ZERO DEATHS from the rather large clinical trial..  and the former many experts including Dr Fauci have stated that they are unsure about the antibodies titers (blood levels) THREE – FOUR MONTHS after getting the two vaccine shots.  And they are now trying to have some clinical trials to see if the former two will be effective against the African and Brazilian variations.

I am so personally confident that the idiot mayor of Detroit is so wrong that Barb and I have an appt for next Friday to get the SINGLE SHOT J&J/Jansen COVID-19 vaccine and making that appt INTENTIONALLY MADE to make sure that we would be getting the J&J/Jansen vaccine. Since between Barb and myself, we check off every high risk issue with the exception of ONE…neither one of us have diabetes … getting the most appropriate/safe vaccine is very important for us.

But then, as I understand it, the Gov of Michigan followed the Gov of NY protocols/actions and sent covid-19 infected people to area nursing homes and between those two governors tens of thousands of elderly people died because of their actions.  Because none of the nursing homes were equipped/capable to treat and/or isolate those pts so that their COVID-19 infections would not spread to the rest of the residents and employees of the nursing homes.

Detroit Mayor Is Wrong To Turn Down J&J COVID-19 Vaccines

https://reason.com/2021/03/05/detroit-mayor-is-wrong-to-turn-down-jj-covid-19-vaccines/

“The best vaccine for you is the first one you can get,” advise most public health experts. Michigan Department of Health & Human Services spokesperson Lynn Sutfin concurs: “Michiganders should make the choice to receive any vaccine that becomes available to them.”

Detroit Mayor Mike Duggan apparently disagrees.

The Detroit Free Press reports that the mayor declined to accept a shipment of 6,200 doses of the Johnson & Johnson one-shot vaccine. Why? At a press conference on Tuesday, the mayor asserted, “Johnson & Johnson is a very good vaccine. Moderna and Pfizer are the best. And I am going to do everything I can to make sure the residents of the city of Detroit get the best.”

What does the mayor mean by “best”? Duggan stated, “The Moderna and Pfizer vaccines are 95% effective if you get two shots. Johnson & Johnson is one shot, which is nicer, but it’s about 67% effective.”

Actually, in the United States arm of the Johnson & Johnson (J&J) clinical trial, the vaccine’s ability to prevent moderate to severe infection was 72 percent and it is 85 percent effective at preventing severe disease. In addition, the J&J vaccine has been shown to be effective against the new, more contagious COVID-19 variants that are now spreading across the country. And it is likely that many citizens would prefer the convenience of getting a one-and-done J&J shot as opposed to waiting nearly a month to get a second Moderna or Pfizer/BioNTech shot.

But more importantly, all three vaccines are essentially 100 percent effective at preventing hospitalizations and deaths from COVID-19. Protecting Detroit’s citizens against those severe outcomes by taking advantage of available vaccine doses would seem to be a worthy endeavor. After all, a slower rate of vaccination means more lives lost.

It bears mentioning that Detroit will not receive additional doses of the Moderna and Pfizer/BioNTech vaccines to replace the J&J doses it rejected.

As Crain’s Detroit Business points out, the city lags behind other local jurisdictions and the state in the percentage of citizens already vaccinated. In Detroit, 11 percent of adults have been vaccinated, while that figure is 16.5 percent for neighboring Macomb County; 19.1 percent for Oakland County; 18.6 percent for outer Wayne County; and 18.5 percent for Michigan as a whole. Possibly owing to Duggan’s decision, both Macomb County and Oakland County happily received more doses of the J&J vaccine than they were expecting. It’s worth noting that the median household incomes for Macomb County, Oakland County, and Detroit are $63,000, $80,000, and $31,000, respectively, meaning the mayor’s rejection of the J&J vaccine will impact disadvantaged populations.

Misleading Americans into thinking that the J&J vaccine is somehow “second-class” could also set back the goal of reaching herd immunity. That involves vaccinating as many Americans as quickly as possible in order to get to the point where the virus cannot circulate widely throughout the population.

Duggan says that the city can meet the current demand for vaccinations with its current allocation of the Moderna and Pfizer/BioNTech vaccines. Demand, however, is set to surge in the next few weeks as Michigan begins to offer vaccinations to people over age 50. Detroiters waiting longer for vaccination appointments later this month may disagree with what the mayor thinks is “best” for them.

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Cardiac Genetic Testing

Posted on March 4, 2021 by Pharmaciststeve

I am getting more and more information – almost daily  – on genetic testing. Just in the last 5 yrs+ we have moved from CYP-450 opiate metabolism testing https://www.practicalpainmanagement.com/treatments/pharmacological/opioids/making-practical-sense-cytochrome-p450

And in more recent years more and more info concerning pharmacogenomics 

https://www.mayo.edu/research/centers-programs/center-individualized-medicine/patient-care/pharmacogenomics/drug-gene-testing

And now Cardiac Genetic testing… given that my Father dropped dead of a heart attack at 56 y/o… and two of my Mom’s three Brothers had heart attacks in their 60’s. This one particular test has sure got my attention.

A friend sent this information to me and I am going to have to find out some more about this testing and I will be sharing what information that I can dig-up via this blog in the future.

Those chronic pain pts who require high or more frequent dosing of opiates to help with appropriate pain management should get the CYP-450 testing to validate that they are fast/ultra fast opiate metabolizer and should be able to be used in appealing their denial for their necessary high dosage.  These genetic/DNA testing is advancing so rapidly… many PCP, in particular, may not be “up to speed”.

Those who have been forced to reduce their opiate doses… should consider this cardiac test because cardiovascular problem are part/parcel of being thrown into cold turkey withdrawal and/or dealing with under/untreated pain. according to this information provided on Cardiac Genetic testing… many people may already predisposed to some genetic cardiovascular issue and being thrown into cold turkey withdrawal or have their pain management meds reduced without the pt being in agreement could be the “final cardiovascular straw” for such a particular pt.

 

Cardiac Genetic Testing

Mutations associated with inherited cardiovascular diseases and sudden cardiac death can be detected through our Lab’s exhaustive Cardiac Genetic Testing.

Our panel includes all genes known currently to be associated with the development of inherited cardiovascular diseases that can present as sudden death or other major adverse events. Cardiac Genetic  Testing can be ordered in smaller, disease-specific panels or in one comprehensive panel.

→ Comprehensive Cardiac Disease Assessment provides an in-depth look at a patient’s overall cardiac health, increases the detection of sub-clinical coronary artery disease, identifies the risk for artery wall Atherosclerotic Disease activity and Coronary Artery Disease. The panel also contains comprehensive arrhythmia and cardiomyopathy risk evaluation.

→ Comprehensive Arrhythmia Panel is used primarily to diagnosis cases in which a clearly defined phenotype cannot be established but in which cardiac arrhythmia is the main indication.

→ Comprehensive Cardiomyopathy Panel is used to diagnose cases in which there is an apparent degree of myocardial involvement but without a completely clear phenotype or with diagnostic uncertainties; when there is an overlap between phenotypes in the patient or family; and also can be used as a predictive test when a pathogenic mutation is detected.

→ Comprehensive Atherosclerosis and Diabetes Risk Panel tests for a patient’s risk for coronary artery and other vascular disease, and diabetes, including early detection of Maturity-Onset Diabetes of the Young (MODY).

Startling Statistics

 90% of those with FH don’t know they have it. If left untreated:

Males have a 50% risk for heart attack by age 50

Females have a 30% risk for heart attack by age 60

Genetics and Familial Hypercholesterolemia

High cholesterol can be inherited, and patient risk for developing heart disease can be reduced by knowing important risk factors.

Family History. Any patient with a family history of high levels of LDL-C (bad cholesterol) may have a genetic variant that causes inherited high cholesterol, a condition known as Familial Hypercholesterolemia (FH) (or Type 2 Hyperlipoproteinemia). FH is highly prevalent in the United States, with 1.3 million people – 1 in 250 – having the condition and carrying and 20% increased risk of developing heart disease.

Ethnicity. While anyone with a close family member with FH or high LDL-C cholesterol levels is at risk, FH is particularly common among certain ethnic and racial groups, including those of French Canadian, Finnish, Lebanese and Dutch descent.

The Importance of an Early Diagnosis. FH is typically more severe, with higher cholesterol levels and heart disease at a significantly younger age, than non-genetic hypercholesterolemia. An early FH diagnosis can help patients make appropriate lifestyle adjustments and seek necessary treatments before the effects become permanent and irreversible. A diagnosis also is important to that patient’s family members at risk for the condition because the parents, siblings and children of a person who has the genetic variant that causes FH have a 50% chance of also having inherited that same genetic variant.

Who Orders Cardiac Genetic Testing?

Cardiologists

To offer their patients a more personalized medicine approach by detecting potential underlying genetic etiology of a condition

Family and Internal Medicine Doctors

To offer their patients and patient’s families more insight into cardiovascular and diabetic conditions

Endocrinologists

To offer diabetic patients a thorough cardiovascular risk assessment

 

Genetics and Maturity-Onset Diabetes of the Young

Our panel distinguishes MODY, a form of diabetes caused by a mutation or changes in a single gene, from Type 1 and Type 2 diabetes.  

Family History and The Importance of Testing. MODY runs in families, tied to a single gene that is passed on from parent to child – Autosomal Dominant Inheritance. Any child of a parent with the MODY mutation has a 50% chance of inheriting that affected gene and developing MODY. Of the four types of MODY – HNF1-alpha, HNF4-apha, HNF1-beta and glucokinase – the first three carry long-term risks that should be monitored by a physician.

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Latest COVID Vax: One and Done?

Posted on March 3, 2021 by Pharmaciststeve

Personally, I have been very reluctant to get the COVID-19 vaccine made by Pfizer & Moderna… the process that is used to create those vaccines has never been used before and they have been brought to market after a couple of months of clinical trials and EMERGENCY USE AUTHORIZATION… as opposed to most clinical trials on new med lasting 10 + YEARS.  The bureaucrats – think Dr Fauci and other bureaucrats – have stated that there is no proof that a person getting a Pfizer or Moderna vaccine that the pt will have antibodies after as few as 90 days…. still recommending wearing masks, social distancing and hand washing and they are just now doing some research if those vaccines will be effective on the African and Brazilian mutations.

The new J&J/Jansen vaccine was approved last Friday and Barb and I have our reservations to get this SINGLE DOSE vaccine on March 13th.  Why do I chose this particular vaccine over the other ?   This vaccine was developed using a tried and true methodology that has been used for decades to make flu vaccines every year.  It also only has to be stored at normal refrigeration temperature…. little/no chance of it being outside of its recommended storage temp too long and pt being given a vaccination that could be compromised and potentially WORTHLESS.

The percentage numbers may have numbers that compare to the other two vaccines  – at first glance – less desirable than the Pfizer and Moderna versions, but this J&J/Jansen version has had people in the clinical trials that had been exposed to the African and Brazilian variants of COVID-19 and people who became infected with those two variants – THERE WERE NO DEATHS. IMO… that is a GREAT OUTCOME for any medication… treating a serious health issue.

None of these vaccines may provide a really good long term protections… personally, I am just hedging my bets on which one may produce the best and longest antibodies… there are no guarantees on any of them.

Latest COVID Vax: One and Done?

https://www.medpagetoday.com/podcasts/trackthevax/91436

Listen and subscribe on Apple, Stitcher, Spotify, and Google, so you don’t miss the next episode. And if you like what you hear, a five-star rating goes a long way in helping us “Track the Vax”!

Millions of Americans are in line to get one of now three vaccines approved by the FDA for emergency use. The latest — Johnson & Johnson’s one-dose adenovirus vector — can be stored for up to three months in a fridge and is easier to transport.

Johnson & Johnson is no stranger to the technology, having used it in its Ebola vaccine. Despite its rollout goals of 100 million doses by June, Rick Nettles, MD, vice president of medical affairs at J&J’s Janssen division, says researchers are already looking ahead to expanding its use for children and pregnant women. He joins this week’s episode.

The following is a transcript of his interview with “Track the Vax” host Serena Marshall:

Marshall: Dr. Nettles, welcome to Track the Vax. I want to jump right in. One and done. That was always the goal for Janssen and Johnson & Johnson. Correct?

Nettles: Well, we know that organizations like the World Health Organization have put forward their recommendation that a single shot during pandemic period has a lot of advantages with regard to being able to vaccinate with more ease. You know, you can really simplify the logistics if you have a one-shot approach.

Marshall: But you’re the only company so far to offer a one-shot approach. So how does that set up your vaccine to be different outside of, you know, just getting the single dose, not having to go back for a second one in a couple of weeks?

Nettles: What we feel is that this allows the vaccine to be used in certain types of individuals and certain locations where bringing people back for a second vaccine is logistically challenging. And so you can think about populations that have issues with travel or that have issues with finding themselves available for the second shot; transient populations, homeless populations. And then again in rural populations where people have to travel long distances to get that second shot, this opens up the possibility of vaccinating people like that.

Marshall: One of the big questions a lot of people have for the current ones that are on the market here in the U.S. is reactogenicity for the mRNA ones: how does it feel to get the shot? So what can people expect from your vaccine?

Nettles: Just like with all shots. One of the main side effects that you’ll feel is pain in the arm where you’ve been injected. But the pain with this vaccine is very similar to those vaccines that you’ve gotten in the past. So your arm will probably be sore for a day or so, just like with other vaccines and then you may have fatigue, headache, body aches.

And usually those last for about a day. Actually most people don’t experience those side effects, but if you’re going to have side effects, that might be what you have. And then about 9% of individuals experienced a fever. And again, that usually starts that first day and will go away after the first day or so.

Marshall: And that fever often is your immune system responding. So it could be a good sign, right?

Nettles: Yeah, it is a sign that your immune system has recognized that the vaccine has been injected and it is starting to mount a response. So it is a good sign.

Marshall: Now in your study, you found that full immunity was at the 28 day mark. We’ve heard that it normally takes about two weeks for your immune system to respond. So, is 28 days the sweet spot after vaccination? When you don’t have to really be concerned about getting sick anymore?

Nettles: Well, everybody’s immune system reacts somewhat differently. We do see response, based on some measures, as early as seven days after this vaccine. So the best guidance that you can give with this vaccine, and with all the vaccines, is that you need to continue to socially distance and wear a mask.

Until we have really tamped down the pandemic to a greater extent. But yeah, after 28 days, that’s really where we started to see the strong protection against the severe disease or need for hospitalization or death.

Marshall: No, that’s an interesting marker, too… the need for hospitalization or death. Because that was really what was quite remarkable. A 100% of zero hospitalization or death after the 28 day mark. But I want to ask you about your definition of moderate to severe COVID, at the committee meeting they pointed out that your definition was two symptoms and a positive test, which the FDA committee had said was basically symptomatic COVID for everyone else.

Can you explain for us how you guys came up to your definitions and why you chose different definitions than some of the other vaccine makers?

Nettles: The science of the coronavirus infection has changed so rapidly. This is a disease that we didn’t even know existed a little over a year ago. We used definitions that the FDA has set forth in our protocol and comparing to other vaccine trials, slightly different definitions were used for moderate or severe disease.

That’s just a manifestation of how our definitions have changed over time with some of these endpoints.

Marshall: But even the FDA adcomm committee, the committee did say that it’s basically symptomatic COVID, as moderate to severe. So does that mean that after 28 days there were zero cases of symptomatic COVID

Nettles: No. So our primary endpoint was moderate to severe COVID. If you included all the cases, there were just a very small number. So what you’re seeing overall is 66% efficacy, prevention of symptomatic COVID in the clinical trial.

We completely agree with the FDA and with the ACIP. What I’m saying is that if you take all cases of COVID, regardless of how many symptoms they had, there were very small number that you would add to that count.

And so statistically, all symptomatic COVID versus mild to severe COVID, you’re going to see the same level of efficacy in our trial.

Marshall: When it comes to asymptomatic transmission, did you look at that? And what is your data show so far?

Nettles: We did. We looked at that question by looking at people who had no diagnosis of COVID. But then during the followup time they had a positive antibody test. And they had a negative antibody test at baseline. So if you follow what I just said, this is somebody who didn’t know that they had been infected, but their antibody tests had become positive. Indicating that sometime after the start of the test, they had experienced COVID and they had no symptoms of it.

And what we saw in our trial is evidence that those who received the active vaccine had protection against even that asymptomatic COVID situation. Now, the trial wasn’t designed for that.

And the real way to look at prevention of asymptomatic COVID would be to do periodic nasal swabs. And the design of the trial did not allow for that. So we see evidence that it might be working, but it’s not definitive and more work needs to be done along these lines.

Marshall: Are you guys doing that more work? Are you following that up to see if it will prevent against asymptomatic transmission?

Nettles: We’re in discussions with CDC and others on what that trial design would look like. And yes, we’ll look to do that.

Marshall: And just going back to the data that you did collect. You said the study wasn’t designed for it, but you do have some of that data and it looks promising?

Nettles: It does. There is a signal that the vaccine may be demonstrating protection, even against asymptomatic COVID.

Marshall: And now you guys did include some of the different strains that we’ve seen pop up globally as part of your study?

Nettles: It’s one of the most important aspects of our phase III trial, which was called ENSEMBLE. We conducted the trial in South Africa, in South America and in the U.S. So the trial was actually done really at the height of the global pandemic. And we know that the variant, which was first identified in South Africa. Over 90% of the samples from South Africa, that variant was present.

So we know that that trial was conducted while the South African variant was circulating. Likewise in South America, we did see the one of the variants that has been circulating in Brazil present. And despite that we showed that after 28 days, we had no deaths and no COVID related hospitalizations, even in South Africa and in Brazil where those variants were predominant.

In our current phase III trial, that we’re discussing here today, we were not located in England, so we don’t have data with that variant. However, we have other trials going and in those trials we will gain that type of information.

Marshall: And your current trial, that ENSEMBLE one was not being run in the U.S. as we started to see the U.K. strain spread stateside. Correct?

Nettles: The ENSEMBLE one was enrolling in the U.S. We just don’t have very many of those variants in our clinical trial.

Marshall: Okay, but that is something that you guys are looking at…would you be able to tweak the current vaccine to meet the need? If it was necessary to be tweaked?

Nettles: We actually think that we will have activity against that variant. So, based on that variant, we don’t think that we need to make that adjustment. We’re always looking at our vaccine carefully and monitoring the variant status. And we would be in a position where we could alter this vaccine, if we would need to do that.

Marshall: You guys use the adenovirus vector. It’s a format that Johnson & Johnson has used previously with the Ebola vaccine. Now there is some concern though that with Adenovirus that people can build up immunity to them. The type of adenovirus vector that you’ve used, it sounds like that hasn’t been the case at all. Is it something that you’re worried about?

Nettles: This is something that we’ve looked at and we have not seen evidence that would give us concern. So we’ve looked in our other trials using this same adenovirus platform when we’ve developed vaccines for HIV, RSV, Ebola and Zika. And in some of those trials, and some of those vaccines, it requires a series of shots.

And we have not seen that on the second, or the third, or the fourth time that you received the vaccine that you respond with less of an immune response. So we haven’t seen evidence that you’re developing a resistance to the vaccine. And the other way we’ve looked at it is, looking at individuals who have natural immunity to the adenovirus, they’ve experienced the adenoviruses as an infection in the past.

And again, in those individuals, we don’t see less of an immune response. For instance, many of the individuals in South Africa had baseline adenovirus antibodies. And again we saw that complete protection against hospitalization or death after 28 days with the vaccine. So that’s promising.

Marshall: And you mentioned some of those other vaccines that J&J is used with adenovirus vectors. Do you research that it’s translatable to the ENSEMBLE and to the COVID vaccine to say how long we can expect immunity to last? That’s a big question for a lot of folks across America and the world, is how long will I be protected?

Nettles: One of the reasons that we like this platform is that we do see a very nice antibody response, but also a cellular response. And one of the most important jobs with that cellular response is to develop an immune memory. So it’s promising that you will have a nice cellular response to this vaccine, as well.

But to directly answer your question, we don’t know yet. It’s one of the most important questions that all of the different vaccine makers are trying to understand. When you’re going to need a booster shot. Do you need one six months later, a year later, two years later, five years later, we just don’t know yet. We have the studies ongoing to prove that, but right now I can’t give you a good answer.

Marshall: Not for COVID, but for perhaps some of your other vaccines that use this technology. Is there anything that might be a little translatable to say: well, that one that lasted for two years or five years.

Nettles: No. I think that each of the vaccine types will have to be studied on their own.

Marshall: Okay. That’s good to know. I know a lot of folks are looking at this and saying: Oh, you’re using the same thing that you used for Ebola. So maybe it means it’ll last a little bit longer in my system.

Now when can we expect these to roll out? The Biden team has just said that they expect to have about 4 million shots this week, but none the following week.

I know, Dr. Nettles, you had told a congressional committee that by the end of March, you’d have 20 million Americans vaccinated. A big goal that everyone’s waiting on, but what can we really expect, reality wise.

Nettles: We have approximately 4 million of the doses available to ship now. We will have 20 million by the end of March. And we’ll have enough to vaccinate 100 million Americans by the end of June.

Marshall: I want to switch gears a little bit here. You’re already testing this in kids, right? Over the age of 12. That’s a study that’s currently ongoing?

Nettles: We are planning to start extremely soon. We have used the adenovirus platform in children down to the age of four months in our Ebola program. So we’re comfortable with the adenovirus platform in children, and we have plans to conduct clinical trials in children with the coronavirus vaccine.

We really, hopefully, as soon as possible, are able to demonstrate that in adolescents 16 and 17 that we show that the vaccine is safe and effective. We have plans then to start the clinical trial very soon, any day now, in children 12 and older. And if it’s found to be safe and effective in that group to dose children and younger than 12.

Marshall: Now you just mentioned 16- and 17-year-olds. That’s the one that’s ongoing. Then when do you expect to have that research available and request approval for that group?

Nettles: it depends on how quickly the trial enrolls, but we hope over the next several months.

Marshall: And then the children 12 and up, and then followed up by the infant and older groups. When would you expect those vaccines to be approved and rolled out?

Nettles: Again, it depends on how fast the trials are able to enroll. The 12 to 17 we hope to have that information later this year.

Marshall: Okay. And what about the infant and up? You mentioned that you use a platform that’s studied previously and four months and older. So when do you think this vaccine that you guys use, if it proves effective and high efficacy for that age group, to be recommended for infants?

Nettles: Again, it gets harder and harder to predict the further we go out. But we’re going to conduct the trials as soon as we possibly can. And in a way that is safe and driven by the science. So hopefully sometime over the next year, but very hard to predict how fast the trials will move.

Marshall: Sure. No, that’s understandable. And one of the groups that I believe you guys are also studying is pregnant women and immunocompromised. Is that a separate trial?

Nettles: It is a separate trial. Again, we’ve used adenovirus platform in pregnant women, in our Ebola program. We have now posted on clinicaltrials.gov, a clinical trial design to move forward and begin dosing in approximately 800 pregnant women. So again, we’ll move forward with that trial in a way that is as fast as we can, but also as safely as we can.

And then later this year we’ll begin a specific trial where we vaccinate individuals who have an immune compromise.

Marshall: And you’re also doing another trial, Dr. Nettles, with two doses. Is that correct?

Nettles: Yes, that’s right. That trial is a phase III trial called ENSEMBLE-2.

Marshall: What made you guys decide if you had great efficacy with one dose to go ahead and enroll another 30,000 individuals and try this with two doses?

Nettles: We planned the two-dose trial, you know, right from the start, in parallel with the one dose trial. And so as we started with, during the conversation, during a pandemic period, a one-dose clinical trial has many advantages allowing you to more efficiently vaccinate a large number of people.

But we also planned a two-dose trial at the same time. Though that’s lagged somewhat behind. It’s a little bit more complicated and you have to bring individuals back for that second dose. So we don’t have results of the two-dose trial. But we use science to guide our clinical trial program. So if at the end of the day, we see some advantages to a two-dose approach, after the pandemic, that’s likely how we would recommend our vaccine to be used.

For instance, maybe the durability is better when you use a two-dose approach. We just don’t know yet. So it’s part of a comprehensive and thorough research and development program that led us to do both the one- and the two-dose approach.

Marshall: Would you see a scenario in which those who got the one dose would then be recommended to get another one? Or would they start the regimen all over again?

Nettles: It depends on what the results that we see from the trial that we’ve conducted. I think the important message though is that with that one-dose vaccine we see extremely promising results. And people can expect that that high level of protection against severe COVID will be achieved at the one dose approach.

Marshall: I think that’s part of the reason a lot of folks are looking at this and saying: well, if it’s so great with one dose, why even bother trying with two?

Nettles: It’s not as if we saw the results of the one dose and said: Uh-oh, we need to study it as a two-dose approach. We planned both at the start and now knowing that the one dose works so well I’m not sure we would’ve made the same decision. But part of a thorough approach to fully understand your vaccine, it’s pretty common that you would study multiple different ways to give it and multiple different doses. But we’re extremely happy with the results that we’ve seen from ENSEMBLE-1. And the one dose approach we think is extremely promising.

Marshall: If the two-dose regimen proves more effective or effective in a different way, would you recommend the one-dose versus two-dose for different populations?

Nettles: It’s too early to say. We would have to see the results of the trials to make that decision.

Marshall: Okay. So there’s not like a certain demographic you’d be targeting for two-dose versus one.

Nettles: No, it would really depend upon, you know, what is the status of the pandemic and what were the results of the clinical trials. I think people should be assured that with that one-dose approach, we’re seeing results that are very, very promising.

Marshall: And Dr. Nettles, I want to wrap up here by asking you about heterogeneic studies. It’s something we’ve talked to some experts about. That they mentioned that that might be something we’re looking at in the future, where you get an mRNA vaccine and an adenovirus vector vaccine, in order to just improve your immunity.

Is that something J&J has considered doing in any format? Perhaps partnering up with one of the mRNA vaccines, or are you doing your own study on those?

Nettles: It’s not something that I’m aware of that we’re having discussions about right now. We’ve been really focused on gaining that FDA authorization, and the CDC recommendation. And we’re having similar discussions with health authorities around the world about that. If we see a need or a potential benefit, we’re always very willing to partner with others in our development program or to partner with investigators, who’d like to explore alternative approaches. So certainly if we see that there’s a potential benefit of something like that, we’d be interested in, in exploring.

Marshall: A lot of science is still out there to be discovered and researched.

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