https://www.facebook.com/VICE/videos/543832562995106/

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For those of you who are unfamiliar with BAY COUNTY in FL.. it contains the infamous PANAMA CITY BEACH… historically has been referred to as the “Red Neck Rivera “. We have owned a condo at the beach since 1994, so we are pretty familiar with the area.

Most of the “problem people” live over in Panama City, FL … except during the spring break period a few years back, but after Fox news did a few nightly reports from the beach during spring break… things have changed as the bureaucrats have changed the course of spring break that has discouraged college kids from coming down.

Now, during the month of March … no alcohol is allowed on the beach by NO ONE.  Curfews have been put in place. Some of the grade-thru high schools in the adjacent states have went to having classes around the year … so there are several two week breaks several times a year.   So peak crowds are no longer spring break and June & July… the local bureaucrats are doing many things to make the beach more “family friend “

I find it rather funny that the cops reported the amount of fentanyl seized in milligrams ..as in 235,000 mgs.  If one converts that number into something that those in our population functions on.. like the pound system… it breaks down as such:

1000 mgs – one Gram… so 235,000 mgs is 235 Gms…  454 Gm = ONE POUND… so that massive 235,000 milligrams is equal to abt EIGHT OUNCES – about the weight of two McDonald 1/4 pound meat patties ( BEFORE COOKING).

More mis-statement of facts is that they claim that Fentanyl is 100 more potent than Morphine is probably true of the legal pharma grade Fentanyl Citrate, but what they seized was probably Fentanyl Acetate which is more likely about 25 times more potent than Morpine and they used graphics of legal pharma grade Fentanyl patches for a comparison.  Which has little to do with the plastic baggies of the real fentanyl that they showed what they really seized.

I don’t know and can’t find out what the density of Fentanyl power is, but suspect that the amount seized in this raid would fit in a pocket or purse.

Here is a interesting fact – which I have asked the pharmas before and they refused to answer – the box of the pharma grade Fentanyl patches states on it that each patch contains 2.66 mg of Fentanyl and since the patch is designed to “release” 25 mcg/hr X 72 hrs for a total of 1.8 mg.. so only about 2/3 of the Fentanyl in the patch is actually designed to be released… leaving ab 0.86 mgs in a “spent patch”.

Bay County’s opioid epidemic turns to fentanyl

https://www.mypanhandle.com/news/bay-countys-opioid-epidemic-turns-to-fentanyl/

BAY COUNTY, Fla. (WMBB) — Removing a mountain of fentanyl from the streets is a major victory but it’s far from the last battle.

On May 13, the Bay County Sheriff’s Office seized 235,000 milligrams of fentanyl from the street. However, Bay County Sheriff Tommy Ford said the problem will return.

“It’s all like a roller coaster,” Ford said. “When we take off a major source of supply, which I would consider this a major source of supply, we see the trends die down for a period until somebody out there finds another source of supply somewhere, or a source of supply is able to reestablish in the area.”

At 100 times stronger than morphine, the lethal dose of fentanyl is a little as three milligrams.

“The addiction is so strong that the risk [of death] is worth it,” said Lieutenant Kevin Francis about addicts.

Officials said that with the introduction of fentanyl, they have seen an increase in drug seizures in size and amount, as well as an increase in overdoses. They added that they are mostly seeing it lacing other street drugs.

“Right now, the trend is to mix heroin and fentanyl to make it stronger,” Francis said.

This means people could be taking lethal doses of fentanyl unknowingly.

“In a situation where somebody bought what they thought was Xanax on the street could actually be a deadly dose of fentanyl,” Ford said.

Ford also said that they are also concerned with poorly mixed drugs. Because of the small lethal amount required of fentanyl, poorly mixed drugs could create hot spots of fentanyl within the main drug.

“The person may be thinking they’re getting a small normal dose of heroin,” Ford said, “but they could actually be pulling from the portion of the substance that has a lethal dose of fentanyl in it and that’s where we’re seeing our drug overdoses and deaths.”

By the end of 2016, Ford said the overdoses became so frequent that the BCSO deployed NARCAN to its deputies. NARCAN is a nasal spray that quickly reverses an opioid overdose and is harmless otherwi

se. It does not work on non-opiates like cocaine overdoses or alcohol poisoning and can sometimes be considered the first sign that an overdose was caused by fentanyl.

Ford said that they also administered special gloves to deputies because any absorption of fentanyl into the skin by touching could lead to an officer overdose.

The opioid epidemic in Bay County dates back to the late 1990s when OxyContin burst on the scene. Officials say that most of the drugs in Bay County come in from the southern border or are shipped in from China and travel through large cities like Atlanta. But since the coronavirus, most of the drug traffic has stopped.

Francis said that they have seen a shortage of most drugs since the pandemic. He added that drug runners usually try to mix themselves in with the general car traffic on the roads. But there has been a lack of travel since the shutdown.

“People are too paranoid to move anything,” he said.

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Abbott’s Virus Test Has Potential Accuracy Issues, FDA Warns

https://www.bloomberg.com/news/articles/2020-05-15/abbott-coronavirus-test-has-potential-accuracy-issues-fda-warns

An Abbott Laboratories Covid-19 test has potential accuracy issues, the U.S. Food and Drug Administration warned, citing a number of studies that have raised doubts about the product’s precision when used to quickly diagnose patients.

The FDA issued a public alert Thursday evening, saying that it had become aware of several scientific studies that raised questions about the device, a printer-sized machine called ID Now that can take a sample from a nasal swab and diagnose a coronavirus infection in less than 15 minutes. The agency said that it was particularly concerned about false-negative results, in which an infected person is told by the test that they don’t have the disease.

“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement.

Abbott shares fell 2.3% to $89.65 at 12:09 p.m. in New York. The stock is up 3.3% this year to date, in part because the company quickly introduced diagnostic products to help combat the coronavirus pandemic that has killed more than 85,000 people in the U.S.

There have been 15 reports of adverse events tied to the tests, said Health and Human Services Secretary Alex Azar, out of more than 1.8 million that have been run. The agency and the company are studying those cases, which could have stemmed from something as simple as a user error, he said.

“We gotta get to where the evidence is, we gotta get to the bottom of it, but we still have confidence in the test or we wouldn’t have it on the market,” Azar said during an interview on Fox Business Friday.

The company said it’s working with the FDA and health care providers to make sure they understand that negative results should be considered just one part of a person’s health history, along with recent exposure to the virus and signs and symptoms of Covid-19. It is also re-emphasizing the proper way to collect and handle samples, as some tests are being run in ways the device wasn’t intended to be used, the Abbott Park, Illinois-based company said in a statement.

Accurate test results are important for understanding and controlling the outbreak, particularly since they are used to help guide personal behavior. Someone who is erroneously told they aren’t infected may have a false sense of security and could infect others if they don’t take precautions. False-negative results can also impede efforts to identify patients and trace their contacts, a key part of expanding efforts by states to track and contain the virus as they reopen businesses and lift social distancing rules.

The FDA said that the Abbott test, which has been used at the White House, can still be used to diagnose positive results, often within minutes. But it warned that a negative result might need to be confirmed with a high sensitivity test to be certain the person doesn’t have the virus.

The FDA’s alert comes as research is raising more questions about tests used around the U.S. to diagnose Covid-19 patients. One study released this week from researchers at New York University examining the Abbott machine indicated it may miss as many as half of positive cases.

Abbott acknowledged in its statement that some studies have raised questions about how accurate the test is, though it previously said users have reported false-negative rates of only around 0.02%. It is continuing to improve on the test as the world learns more about the virus, the company said.

“While we understand no test is perfect, test outcomes depend on a number of factors,” Abbott said in the statement. The company said that sample handling, storage and transportation could all affect performance, as well as other features.

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Since the CDC opiate dosing guidelines were published in early 2016… a lot of chronic pain pts – especially those with intractable pain – have been forced to “shelter in place” … which is really forcing  them to become house/chair/bed confined.

It is now being talked about in the media about this sheltering in place is seeing a increase in spousal abuse and child abuse , suicides and divorces.

Could the community and those in the community try to “ride this wave of enlightenment ” to bring awareness to the media that many of the 100 million in the community have already been suffering from the multi-year involuntary sheltering in place as well as having to do it in up to a torturous level of pain ?

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Remdesivir Data from NIAID Trial Published

“Not a panacea” or a “cure-all,” expert cautions

https://www.medpagetoday.com/infectiousdisease/covid19/86670

Peer-reviewed findings were published late Friday from one of the key trials of remdesivir, perhaps the most promising antiviral agent for COVID-19, confirming and extending topline results announced a month ago via press release.

Hospitalized patients with COVID-19 who received remdesivir had a median recovery time of 11 days versus 15 days with placebo (rate ratio for recovery 1.32, 95% CI 1.12-1.55, P<0.001), reported John Beigel, MD, of the National Institute of Allergy and Infectious Diseases (NIAID), and colleagues.

Mortality estimates by 14 days were lower for the remdesivir group compared to placebo, but non-significant (HR for death 0.70, 95% CI 0.47-1.04), the authors wrote in the New England Journal of Medicine.

Interestingly, when researchers examined outcomes on an 8-point ordinal scale, they found patients with a baseline ordinal score of 5 had a rate ratio for recovery of 1.47 (95% CI 1.17-1.84), while patients with a baseline score of 7 had a rate ratio for recovery of 0.95 (95% CI 0.64-1.42).

Some of these data were released by the NIAID on April 29, but without further details such as 95% confidence intervals. On May 1, the FDA agreed to let remdesivir be used clinically under an emergency use authorization. Since then, however, clinicians and other researchers have clamored for a fuller report, to help guide their clinical practice. For example, questions were raised as to whether particular subgroups got more benefit from the drug than others.

David Aronoff, MD, of Vanderbilt University Medical Center in Nashville, who was not involved in the research, noted the drug seemed more effective when given to patients who weren’t as severely ill, earlier in the course of disease. He added this wasn’t surprising, given remdesivir’s mechanism of action as an antiviral, which works by blocking the virus from replicating.

“The drug doesn’t affect the host, it only affects the virus. What seems to cause major problems late in the course of disease is the inflammatory response to the initial damage the virus causes,” he told MedPage Today.

Aronoff likened the virus to an arsonist setting fires, and antivirals like remdesivir as the police trying to catch the arsonist before they set more fires.

“But once the building is on fire, it doesn’t matter where the arsonist is,” he noted.

This is why combining a drug to address the viral response with a drug to address the host response may be critical to treating the virus. Aronoff cited the NIAID’s ACTT-2 trial in progress, which will examine combination therapy with remdesivir and anti-inflammatory drug, baricitinib, versus remdesivir alone.

In Aranoff’s analogy, the anti-inflammatory would be akin to the firefighters putting out the fires the arsonist set.

Study Details

The Adaptive Covid-19 Treatment Trial (ACTT-1) was comprised of 60 trial sites, including 45 sites in the U.S., along with sites in Europe and Asia. Participants hospitalized with COVID-19 with evidence of lower respiratory involvement were randomized to either intravenous remdesivir or placebo for up to 10 days. Primary outcome was time to recovery, meaning either hospitalization for infection control purposes only or discharge from the hospital.

An independent data and safety monitoring board recommended unblinding the results based on preliminary data from 1,059 patients — 538 assigned to remdesivir and 521 to placebo. As of April 28, only 391 patients in the remdesivir group and 340 in the placebo group had completed the trial through day 29 (either recovered or died).

Patients were a mean age of 59, and almost two-thirds were men, 53% were white, 23% were Hispanic or Latino and 21% were black. About 80% were enrolled at sites in North America. Half of patients had two or more pre-existing conditions, including half with hypertension, 37% with obesity and 30% with diabetes mellitus.

Beigel and colleagues included 33-day Kaplan-Meier curves for recovery among subgroups categorized by oxygen need. The greatest separation between the remdesivir and placebo groups (i.e., the greatest drug benefit) was seen for patients receiving oxygen but not at high flow or with noninvasive mechanical ventilation. There was no advantage for remdesivir in recovery rates among patients on high-flow oxygen or those on mechanical ventilation or extracorporeal membrane oxidation.

Among patients not receiving oxygen, a trend toward benefit with remdesivir was evident, but it did not reach statistical significance, probably because more than 80% of the placebo group in this category recovered.

There was no subgroup in which placebo clearly outperformed remdesivir. Many groups (such as racial minorities) didn’t have enough patients to show meaningful differences.

Notably, however, patients with symptom duration greater than 10 days benefited from remdesivir just as much as those with shorter duration.

Serious adverse events occurred in 21% of patients in the remdesivir group and 27% of patients in the placebo group, and two in each group were judged to be related to the study drug. Anemia or decreased hemoglobin was the most common adverse event in the remdesivir group (7.9% vs 9.0% in the placebo group). Pyrexia and hyperglycemia also occurred more often in the remdesivir group.

Aronoff said more will be known once final results from the study are released in a few weeks, but they will likely confirm the current report.

When asked if it would be appropriate to use this medication outside of a clinical trial setting, he noted there are reasons to hesitate, namely remdesivir’s availability, the optimal duration of therapy, and that it can only be given intravenously.

“It’s hard to implement it really early when you’re at a nursing home or somebody’s house,” Aronoff said. “It’s not a panacea and it’s not a cure-all. It has some barriers to widespread implementation.”

Remdesivir’s manufacturer Gilead Sciences is conducting two trials of its own with remdesivir, one of which includes a placebo control. Results from that trial are expected soon.

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https://youtu.be/eLMZoXfnY_I

COVID-19 getting back to normal with control plans

Nobody should resume their work, going back to school, or reopening without a written control plan.

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TENN: KENT MORRELL FOR SENATE 2020

https://www.kentmorrell2020.com/

Why I’m Running for Senate

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  https://www.amazon.com/Pain-Warriors-Tina-Petrova/dp/B084WPJW9L

I just finished previewing- the long awaited and soon to be released ( May 25th)  film (pain-warriors) by Tina Petrova & Eugene Weis

It is abt 80 minutes long and I normally – because of my ADD/ADHD – have trouble sitting and focusing on something that long – but I remained transfixed until the end.

This is a new perspective on the war on pts, caregivers and prescribers.

From a grader schooler dealing with chemo for 4 years to be cured to be left with lingering chronic pain.

To a empathetic prescriber who ends up being the target of the state medical board and DEA for treating chronic pain pts and ends up practicing medicine in a totally different path.

Unfortunately, two pts are never able to get their health issues and pain under control and end up ending their lives.

The DVD/Blu-Ray can be pre-ordered from Amazon on the link below

https://www.amazon.com/Pain-Warriors-Tina-Petrova/dp/B084WPJW9L

Pain Warriors by Tina Petrova & Eugene Weis
https://itunes.apple.com/ca/movie/pain-warriors/id1506122098

http://www.tinapetrova.com

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CDC Opioid Guideline Mobile App

https://www.cdc.gov/drugoverdose/prescribing/app.html

*MME Calculator Disclaimer: This calculator is not intended to replace clinical judgement or to guide opioid dosing for patients receiving active cancer treatment, palliative care, end-of-life care, or for patients younger than 18.

The application is not intended to provide guidance on dosing of opioids as part of medication-assisted treatment for opioid use disorder. Conversion factors for drugs prescribed or provided as part of medication-assisted treatment for opioid use disorder should not be used to benchmark against MME dosage thresholds meant for opioids prescribed for pain. The calculator does not account for incomplete cross-tolerance between opioids and should not be used to guide opioid rotation or conversion between different opioids. This is especially important for fentanyl and methadone conversions. Equianalgesic dose ratios are approximations and do not account for interactions between opioids and other drugs, patient weight, hepatic or renal insufficiency, genetic factors, and other factors affecting pharmacokinetics. Additional clinical guidance, including opioid prescribing for acute pain, may be available through manufacturers’ full prescribing information or consultation with other clinicians with expertise and experience in pain management.

Prescribe with Confidence

CDC’s Opioid Guideline App can help providers apply the recommendations of CDC’s Guideline for Prescribing Opioids for Chronic Pain in clinical practice by putting the entire guideline, tools, and resources in the palm of their hand. Managing chronic pain is complex, but accessing prescribing guidance has never been easier.

The application includes a Morphine Milligram Equivalent (MME) calculator*, summaries of key recommendations, a link to the full Guideline, and an interactive motivational interviewing feature to help providers practice effective communications skills and prescribe with confidence.

Free Download

The CDC Opioid Guideline App is available for free on Google Playexternal icon (Android devices) and in the Apple Storeexternal icon (iOS devices).

I have not had the time to play with this app… but may be useful for some pts to show their prescribers what the real rules are when they are “quoting the law about opiate prescribing”

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Remdesivir Safety Forecast: Watch the Liver, Kidneys

https://www.medpagetoday.com/infectiousdisease/covid19/86582

The adverse event profile for remdesivir as a treatment for COVID-19 remains murky, although liver and kidney risks are emerging.

“Because we’re kind of moving at warp speed, the reporting on that has some unusual aspects,” noted Barbara Young, PharmD, of the American Society of Health-System Pharmacists (ASHP). “We’re getting emerging information, but it’s certainly not what we’re used to getting from clinical trials on most drugs that go through the FDA approval process.”

The first human safety data for remdesivir came from the Ebola virus treatment setting, where the nucleotide analogue and polymerase inhibitor drug had what one review called “an acceptable safety profile,” although it wasn’t more effective than other experimental options tried in the PALM trial.

The only adverse events reported in that trial were deaths, and the only one adjudicated as possibly related to remdesivir was one case of hypotension followed rapidly by cardiac arrest.

Hypotension and other infusion reactions would not be a surprise for an IV drug, noted Young, who is editor of ASHP patient medication information.

However, the event could just as easily have been from the underlying fulminant Ebola virus disease itself, the researchers cautioned in the New England Journal of Medicine paper.

Infusion-related reactions were noted as potential side effects, along with increased liver enzymes in the FDA’s announcement May 1 of emergency use authorization of the antiviral drug for severe COVID-19.

“It was surprising when these came out; it had a very short side effect list. It’s either the safest drug there is or…,” Young said, trailing off. “But my caution is I just think it hasn’t been used widely enough for all the reporting.”

That authorization was based on the only two published datasets with remdesivir, and some highly anticipated data described in press releases so far, suggesting clinical benefit in COVID-19 from the NIH ACTT randomized trial and from Gilead’s phase III SIMPLE randomized trial. A second SIMPLE trial in moderate-severity COVID-19 is expected out at the end of the month.

Liver Risks

Adverse event risk involving the liver has been one of the clearest potential risks from remdesivir.

Liver enzyme increases in the SIMPLE trial included 7% of patients with grade 3 or higher alanine aminotransferase elevations and 3% who stopped the drug over elevated liver enzymes.

Compassionate use data on 61 severe COVID-19 cases treated with the drug, published in the New England Journal of Medicine in April, showed that hepatic enzyme increases were by far the most common adverse event, occurring in 23% of patients. Hypotension was seen in 8%.

However, in the randomized trial from China, stopped early at an enrollment of 237 patients and published in The Lancet, elevated aspartate aminotransferase was actually less common in the remdesivir group than with placebo (5% vs 12%). Alanine aminotransferase elevation led to treatment discontinuation in one patient and acute kidney injury (AKI) prompted it in another.

Early antiviral agents developed for HIV often had issues with mitochondrial damage that could lead to liver failure, noted Matthew Spinelli, MD, an infectious diseases specialist at the University of California San Francisco, which has dosed remdesivir as part of blinded randomized studies.

“Most of the modern antivirals and antiretrovirals for HIV don’t have too much liver toxicity,” he said. “It’s possible to design antivirals that don’t have serious side effects.”

“The really challenging thing is that severe COVID-19 disease, as well as sepsis from pretty much any pathogen, including viruses, can result in damage to the liver,” he cautioned. He called the Chinese trial data somewhat reassuring, but “without more randomized, controlled trial data it’s hard to know exactly how much we need to worry about the liver toxicity issue.”

The FDA’s professional information sheet, which is akin to the prescribing information that would come with an approved drug, called for hepatic laboratory testing on all patients prior to starting remdesivir and daily while receiving it.

How the drug works in people with liver problems hasn’t been tested. “It is not known if dosage adjustment is needed in patients with hepatic impairment and remdesivir should only be used in patients with hepatic impairment if the potential benefit outweighs the potential risk,” the information sheet said.

The European Medicines Agency summary warned against use in patients with liver enzymes five or more times the upper limit of normal.

Kidney Risks

Remdesivir has some structural and functional similarities with the antiviral drug tenofovir (Vemlidy, Viread) used in HIV and hepatitis B infection, Spinelli noted, and “we know that that drug has issues with the kidneys.”

Rat model studies showed low-level injury to the kidney cortical tubules from remdesivir.

In humans, remdesivir appears to be cleared largely by the kidneys, which could lead to accumulation of the drug in those with poor renal function, Young noted. “Certainly someone who already had compromised renal function is going to be affected differently.”

The published compassionate use study showed AKI in 6% of remdesivir-treated patients and serious such cases in 4%. One patient had to discontinue the drug due to worsening of preexisting renal failure. The Chinese trial showed a 1% rate of AKI.

The FDA emergency use authorization called for liver function testing on all patients before dosing. “Remdesivir is not recommended in adult and pediatric patients (>28 days old) with eGFR less than 30 mL/min or in full-term neonates (≥7 days to ≤28 days old) with serum creatinine greater than or equal to 1 mg/dL unless the potential benefit outweighs the potential risk.”

“We’re certainly willing to tolerate some toxicity in people who are at such high risk of death if the drug continues to appear effective in studies,” Spinelli concluded.

Of course, severe COVID-19 itself also has a known risk of AKI.

“You’re not sure what’s an effect of the disease progression versus the drug being used, and they’re also often using combinations of medications,” Young noted. “It’s a very complex situation.”

Other Concerns

Cardiovascular adverse effects haven’t loomed large as with the prior frontrunner for COVID-19 treatment, hydroxychloroquine.

For remdesivir, one review in the American Journal of Emergency Medicine cited concern about cardiac arrhythmias, but another in Cardiovascular Research called CV effects and toxicities unknown. Preclinical monkey studies suggested no effect on cardiovascular parameters.

Lower grade GI adverse effects like nausea and diarrhea have also been reported in the 3% to 5% range in data so far, but again can be a symptom of COVID-19 as well.

The true rate of events and less common risks will become clear as remdesivir is used more widely, Young predicted. “The populations it has been studied for have really been small in the world of drug approvals.”

Remdesivir was rushed along due to infectious diseases outbreaks and not expected to have a huge market, so a lot of the pharmacokinetics and pharmacodynamics studies typical for a drug headed to market have not been done in humans.

“There’s really no information here even on drug interactions, which as a pharmacist is something we always look for,” Young said. “This is a really unusual situation for a drug to be used outside of the routine drug approval process, and there’s just less information available and able to be reported at this time.”

Some of the drugs being tried for COVID-19 have been problematic for interactions, like lopinavir/ritonavir.

Early on, it looked like remdesivir might have CYP3A4-mediated drug interactions, but that hasn’t been borne out so far clinically, wrote Daniel Streetman, PharmD, of the University of Michigan in Flint, on the Wolters Kluwer site. Still, “pharmacokinetic interactions cannot be completely ruled out without more specific data, and it seems prudent to minimize the concurrent use of any nonessential medications whenever possible.”

Everyone is expressing their concerned about the safety of  hydroxychloroquine being prescribed for treating COVID-19 and yet here is this “new med” that many are pushing to treat COVID-19 and in reading about this med – it is not all that safe.

As I have said before, all meds have some sort of problem… everything with medications is risks vs benefits.

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