Looking at the OPTICS: bureaucrats picking winners and losers

there are some parallels between the current COVID-19 pandemic and the issue of chronic pain community and the substance abuse community.

Today the CDC came out with the lethality of the COVID-19 virus is abt 0.3%.   Which is a similar percent (0.6%) of the number of chronic pain pts that are at risk of becoming addicted to opiates.

The bureaucracy has acted/reacted in the same/similar manner.. they have chosen which businesses could stay open and generate the same – or greater – revenues and profits and other deemed NON-ESSENTIAL and were forced to close about 10 weeks ago and now are permitted to function at abt 25% capacity… which few companies can pay the overhead expense at that income.

Just like the bureaucrats – mostly DEA and state Medical Licensing board are making decisions of what prescribers have to be SHUT DOWN…  and discourage/chastise pharmacies from filling controlled substances .. again choosing winner and losers.

Some states are bending over backwards to make sure those who are substance abusers/addicts get their drug of choice or some drug that will keep them from going into withdrawal.

Chronic painers question why this subset of the population is being treated like winners while those in chronic pain and other subjective diseases are being treated as losers.

It is a common belief that substance abusers commit crimes to get money to fund paying for their next high/fix, many are living in shelters, under overpasses and tents on sidewalks.  THEY ARE VISIBLE to the general population and the media.

You take the typical chronic painer that has had their meds cut/discontinued and they become home/bed/chair confined… they are INVISIBLE  to the general population and the media.

 

 

People gather for a Don't Punish Pain rally outside the Oregon State Capitol in Salem on May 22, 2019. Chronic pain patients rallied across the country Wednesday to fight restrictive opioid laws that patients say hurt those who rely on the medications to manage pain.

It is claimed that there is 100 million chronic painers, but the adjacent picture is from Oregon State Capitol in Salem on May 22, 2019 of a group protecting how pain pts are being mistreated.  If you were a bureaucrat and were told that there is 100 million chronic pain pts

There is abt 4 million people in Oregon and Salem Oregon has a population of abt 400,000.  using averages… there is abt 120,000 chronic painers in Salem and 1.2 million in Oregon..  So if you were a bureaucrat… and saw a demonstration by chronic pain pts at the state capital and maybe a couple of dozen people showed up… would you be concerned about any group of people … when the number claimed to be impacted and the number that showed up in a protest/rally was dramatically different ?

We need to look at what some of the bureaucrats have done to small businesses – deemed to be non-essential – that have tried to reopen before the state claimed it was safe to do so…

One 77 y/o barber had his license revoked https://www.mlive.com/news/flint/2020/05/state-agency-suspends-license-of-owosso-barber-who-defied-coronavirus-order-closing-non-essential-businesses.html     even after The summary suspension order comes two days after Shiawassee County Circuit Court Judge Matthew J. Stewart turned down a request by the Michigan Attorney General’s Office, filed on behalf of the state Department of Health and Human Services, for a temporary restraining order to close the business.

One gym, that opened early, had the locks on their gym’s doors changed overnight by the bureaucrats

The female governor of one state, where she had dictated that barber/beauty shops had to be kept closed… admitted on a interview that she was able to get a haircut …because she was “in the public view “

In Michigan, the Governor there dictated that no state resident was to go from their normal in state residence to their “summer house/condo”, but over the weekend a man showed up at a resort lake and asked that his boat be put into the water and when he was denied… he asked that ” .. if his wife was governor … would it make a difference”… the lake was abt 175 miles from their full time residence.   https://www.foxnews.com/politics/michigan-gov-whitmer-claims-husbands-reported-boat-request-was-a-failed-attempt-at-humor

One thing that seems to be common on all of these interactions between citizens and the bureaucrats is that law firms are busy filing injunctions with the courts.  Some courts seem to favor the citizens and others seem to favor the bureaucracy.

I wonder if someone compared some of the depts within Walmart, Target, Meijers and other big box stores and some of the locally owned small business selling some/most of the same merchandise that have been deemed non-essential… could we get a better picture of how much the various bureaucracies have been allowed to pick winners and losers among retail businesses ?

Does the community need to review and rethink what has been done in the past and what has been accomplished and if a different path needs to be considered ?

 

 

Rx financial assistance: search engine for many of the patient assistance resources that the biopharmaceutical industry offers.

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https://medicineassistancetool.org/

Worried About Affording Your Medicine? MAT is Here to Help.

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PhRMA’s Medicine Assistance Tool (MAT) is a search engine designed to help patients, caregivers and health care providers learn more about the resources available through the various biopharmaceutical industry programs. MAT is not its own patient assistance program, but rather a search engine for many of the patient assistance resources that the biopharmaceutical industry offers.

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When you are a hammer … everything looks like a nail

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

Bay County’s opioid epidemic turns to fentanyl

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.

graphic credit: Miabelle Salzano

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.

Francis also said that prescription drugs like pills are easier to access and abuse than illegal drugs like meth. While fentanyl is illegal, it can be administered through a prescription and purchased at most pharmacies as gel patches to treat severe pain in cancer patients. Francis said that it’s possible to manufacture street fentanyl from these patches.

“It just seem like every wave that we see get a little bit worse,” Ford said.

 

 

 

 

 

 

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

An Abbott Laboratories Covid-19 test kit.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.

 

Could COVID-19 shelter in place have some “good” unintended consequences for the community ?

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 ?

Remdesivir: “Not a panacea” or a “cure-all” – back to the drawing board

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.

Dr. Thomas Kline, MD, PhD: Medical Myths Revealed: COVID-19 getting back to normal with control plans

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.

 

TENN: KENT MORRELL FOR SENATE 2020 – chronic pain pt … running for political office

Picture

PictureTENN: KENT MORRELL FOR SENATE 2020

https://www.kentmorrell2020.com/

Why I’m Running for Senate

“A house divided against itself
​cannot stand.”

Abraham Lincoln quoting Mark 3:25Our country is painfully divided along every conceivable fault line. We do not have much time to right our ship. I am running for U.S. Senate to help bring about the sea change we must have to flourish: a return to common-sense policies that benefit all Americans, fiscal responsibility and civility.

​The world looks to America to be a bright city on a hill
​and a beacon of hope. Our best days are not behind us,
but are indeed ahead of us.  

Won’t you join me in this monumental
​and worthy endeavor?

Patient, Advocate, Small-Business Owner and Tennessean Through & Through!

“My journey for U.S. Senate really began two years ago, when my last pain management doctor dropped me as a patient,” Morrell said explaining his challenges with our healthcare system. A car accident in 2000 left him with muscular and spinal injuries requiring over 200 doctor visits, procedures and surgeries.

“New state and federal regulations are punishing doctors for not sticking to the official cookie-cutter approach to pain management. My doctor feared the government. Fear can make people do terrible things,” Morrell said.

“I ended up finding a better treatment option on my own,” Morrell said explaining the effectiveness of medical cannabis with pain management, which is increasingly supported by medical studies. 

Since 2015, Morrell has been a familiar face in Nashville advocating at the state level with Safe Access Tennessee, which is part of the national organization Americans for Safe Access. Safe Access provides science-based educational resources about the importance of treatment options to legislators and offers advocacy training across Tennessee. Morrell is chairman of the Knoxville chapter and joined the state organization’s board in 2017.

“I fight for change because I have to. I can’t let this happen to other people! I don’t want my friends or family to experience the nightmare I went through for almost 20 years. Patients need treatment options now” Morrell said.

“It’s time to fix our healthcare system and remove the government from doctor-patient relationships. Let’s fix this,” Morrell emphasized.

In addition to his advocacy work, Morrell is President and CEO of Indoor Oceans, a small business he founded in 1993.   

From a family of educators, Morrell grew up within earshot of Bristol Motor Speedway’s “Thunder Valley” and is a seventh generation east Tennessean. He is married, has four adult children and close family members currently serving in the armed services.

His Tennessee heritage and life experiences make Kent Morrell an insightful and uncommon candidate for U.S. Senate … a patient, not a politician.