UPDATE: It would seem that I am becoming part of a group of very highly visible people… being banned from FAKE BOOK, now having a YOU TUBE video banned

Posted on February 21, 2022 by Pharmaciststeve

Hi Pharmacist Steve,
We have reviewed your appeal for the following content:
Video: Prescriber induced SUICIDE
We reviewed your content carefully, and have confirmed that it violates our Community Guidelines. We know this is probably disappointing news, but it’s our job to make sure that YouTube is a safe place for all.
How this affects your channel
We won’t be putting your content back up on YouTube.
Our goal is to help you succeed on YouTube. Please take a look at our Community Guidelines, and keep them in mind when posting content in the future.
Sincerely,
The YouTube Team

It took them 5 weeks to find my video… and only took them TWELVE HOURS to come to their FINAL REVIEW/OPINION.

I am getting tired of all these dip-shits on these website and within many of the groups… I just discovered a group that I am one of the ADMINISTRATORS on where TWO OF THE MEMBERS ON THE PAGE – BLOCKED ME… that is against the page’s rules. They are no longer members of that group.

I feel sorry for those in the chronic pain community… the entire community – IMO – is pretty much circling the drain.

It would seem that I am becoming part of a group of very highly visible people… being banned from FAKE BOOK, now having a YOU TUBE video banned… being banned from Twitter can’t be far behind, President Donald Trump’s new social website is suppose to start up tomorrow (02/21/2022) https://www.truthsocial.com/      I am perplexed and sadden that both the chronic pain community and our entire society as a whole, has divided into so many “tribes”, and even within the tribes there is sniping and back stabbing.  Even within the chronic pain community certain tribes appears to be willing to do anything necessary, if they perceive that another tribe is on a “higher hill” or under a “brighter spotlight”.

I am going to keep posting on my blog for the time being, other venues not so much or any at all.  OR am I just wasting my time, trying to assist the chronic pain community ?

Prescriber induced SUICIDE

About 5 weeks ago I posted this video , and I even included links to the two financial settlements in the post… I also shared this post on you tube. In watching the video I created, I stated that I did not support or encourage suicide and I did make reference to the two settlements back to my blog.  I filed a response to their removing my video – at least – unlike FAKE BOOK … there was actually a place to type in up to 800 words.  I doubt that I will get a response, nor the video restored..

I also went to http://www.google.com and did a search on the word SUICIDE and got 20+ pages with 10 entries on each page… I don’t normally use google for a search engine, I use http://www.duckduckgo.com because they are suppose to keep your searches private.  This is just a little more from those “little boys”  in/around Silicon Valley… that all too many of us have given them this power to decide what we can see and what we can’t see and what/how we are suppose to think.

Two days ago I got this email from YOU TUBE:

Hi Pharmacist Steve,
We have reviewed your content and determined that it may not be suitable for viewers under the age of 18, per our Community Guidelines. As a result, we’ve age-restricted the following content:
Video: Prescriber induced SUICIDE
We haven’t applied a strike to your channel, and your content is still live for some users on YouTube. Keep reading for more details on what this means and steps you can take if you’d like to appeal this decision.

Today I got this email from YOU TUBE

Hi Pharmacist Steve,

We wanted to let you know our team reviewed your content, and we think it violates our Community Guidelines. We know you may not have realized this was a violation of our policies, so we’re not applying a strike to your channel. However, we have removed the following content from YouTube:
Video: Prescriber induced SUICIDE
We realize this may be disappointing news, but it’s our job to make sure that YouTube is a safe place for all. If you think we’ve made a mistake, you can appeal this decision – you’ll find more details below.
What our policy says
YouTube does not allow content that contains mature or violent themes where there is a clear intent to target younger minors and families. Family content must not contain adult and age-inappropriate themes such as violence, sex, death, drugs etc

So I did a search on YOU TUBE for just the word SUICIDE, and countless number of videos came up – if you don’t believe me – go check for yourself – here is two in particular that I found Interesting. A “machine” that someone can use to commit suicide and then the enclosure can be used as a COFFIN !

https://youtu.be/vGAYsZPRJhc

I guess that producing a video that involves someone in the medical profession and the pt committing suicide if UNACCEPTABLE to YOU TUBE… but selling equipment for sale that will help a pt commit suicide …. it JUST FINE WITH THEM…. as a side issue… YOU TUBE is OWNED by GOOGLE

Filed under: General Problems | 13 Comments »

FDA Executive Officer Exposes Close Ties Between Agency and Pharmaceutical Companies

Posted on February 19, 2022 by Pharmaciststeve

FDA Executive Officer Exposes Close Ties Between Agency and Pharmaceutical Companies: ‘Almost a Billion Dollars a Year Going into FDA’s Budget from the People we Regulate’ • FDA Executive Officer Chris Cole: “The drug companies, the food companies, the vaccine companies. So, they pay us hundreds of millions of dollars a year to hire and keep the reviewers to approve their products.” • Cole on FDA fees: “Congress approved user fees for [the] FDA. Basically, we charge the industry millions of dollars in order to hire more drug reviewers and vaccine reviewers which will speed up the approval process. So, they [pharmaceutical companies] make more money.” • Cole: “They [FDA] tone down the impact of the user fees on their operations because they know they’re dependent on the drug companies, and the vaccine companies, and these other companies for their agency to operate.” • Cole on blowing the whistle: “There’s not an incentive to speak out in government, surprisingly. You would think there would be, but there’s not. It’s better just to just not say anything and just ignore it.” • Cole on retaliation in government: “You’ll be marked from getting other jobs because another office is not going to want to hire you if you’ve spoken out about something, right or wrong. They don’t look at what you’ve spoken out about. They’re just not willing to- government’s about rocking the boat and they don’t want to- which is the problem I have with- one of the problems I have with government is, like, they don’t like people rocking the boat, for right or wrong, at all costs. They want to hire a safe person that can do the job but doesn’t necessarily- is a great hire.” [WASHINGTON, D.C. – Feb. 16, 2022] Project Veritas published Part Two of its series on the FDA on Wednesday night which featured FDA Executive Officer, Christopher Cole, speaking about the inner workings of the agency including the FDA’s conflicts of interest, overspending, and why it’s hard for those within the agency to speak out on such abuses. In the footage, Cole talks about the impact that pharmaceutical companies have on the agency including the process for approving drugs. “A long time ago, Congress approved user fees for [the] FDA. Basically, we charge the industry millions of dollars in order to hire more drug reviewers and vaccine reviewers, which will speed up the approval process, so they make more money,” Cole says in the hidden camera footage. He then reveals that the FDA tones down the impact that these user fees have on the agency’s operations because, “they’re dependent on the drug companies, and the vaccine companies and these other companies for their agency to operate.” The incendiary footage, which features Cole talking about how the additional money the FDA brings in “gets banked” to be spent on “whatever you can, whether it’s right or wrong,’’ also features Cole discussing reasons why it’s difficult for anyone in government to speak out about practices he sees as “probably excessive.” “I don’t think there’s enough people saying — they’re, like, ‘Look, that’s fine, but that’s not right. So, we’re not going to charge that.’ You don’t want to be that person. You’re not going to have a long shelf life in the agency if you’re always that person,” Cole said. “There’s not an incentive to speak out in government, surprisingly. You would think there would be, but there’s not. It’s better just to just not say anything and just ignore it. The whistleblower, well, it’s high-profile whistleblower statutes and everything, that’s kind of ridiculous,” Cole said before adding “it’s better to just stay quiet and accept.” Cole’s LinkedIn page lists him as an Executive Officer within the agency’s Countermeasures Initiatives, which plays a critical role in ensuring that drugs, vaccines, and other measures to counter infectious diseases and viruses are safe. He made these revelations on a hidden camera to an undercover Project Veritas reporter. A spokesperson for FDA issued a statement yesterday saying, “The person purportedly in the video does not work on vaccine matters and does not represent the views of the FDA.” This statement appears to contradict a phone call released Wednesday afternoon by Project Veritas wherein Cole reiterated, during the conversation with Project Veritas Founder and CEO, James O’Keefe, that he is “a manager in the office that helps oversee the approval of the COVID vaccines for emergency approval.”

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the Alec Smith Insulin Affordability Act

Posted on February 19, 2022 by Pharmaciststeve

https://www.minnpost.com/health/2022/02/new-video-retells-the-alec-smith-story-to-promote-minnesotas-insulin-affordability-program/

Ever since her son Alec Smith died in 2017, after rationing his insulin because he couldn’t afford the $1,300 monthly cost, Nicole Smith-Holt has talked to thousands of people about how the tragedy happened. 

“I never get tired of telling Alec’s story,” she said. “It steals a little piece of my heart every time I do it, but it is important for people to know that his death was absolutely preventable. He should be with us today. I will continue to share his story until we get this fixed and it never happens again.” 

Just a few months after Alec’s death at age 26, Smith-Holt launched a campaign to make it easier for people with diabetes to access insulin even if they, like Alec, are uninsured or otherwise can’t afford the cost of their medication. In 2020, thanks in large part to Smith-Holt’s advocacy, the Alec Smith Insulin Affordability Act was signed by Gov. Tim Walz. The law guarantees one-time emergency or ongoing supplies of insulin for Minnesota residents who cannot afford the cost of the drug, and it was the first such legislation passed in the United States.

MinnPost photo by Peter Callaghan

Nicole Smith-Holt and James Holt, Jr. speaking during a 2018 roundtable discussion sponsored by state Sen. Matt Little. A picture of their son, Alec Smith, is on the dais.

While many Minnesotans have taken advantage of the new program, known as the Minnesota Insulin Safety Net Program, there are still many others who are eligible for the benefit but who haven’t heard about it. Now, a new video is trying to address the situation: The “Alec Smith Story,” produced by MNsure, the state’s health insurance marketplace, features Smith-Holt retelling her son’s story and explaining the program and how eligible Minnesotans can sign up. 

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Smith-Holt said she decided to get involved in promoting the program after she began hearing from people who said they or their family members were still struggling to afford their insulin, even after the bill was signed into law. 

“I had been contacted a lot through social media from people wanting help,” Smith-Holt said. “I was seeing posts on Facebook from people saying they didn’t know this program existed.” She’d also heard from people who’d gone to pharmacies asking for emergency insulin but were turned away. 

Frustrated by what she was hearing, Smith-Holt met with the state legislators who’d spearheaded the act as well as representatives from MNsure, the state agency charged with managing public awareness about the Minnesota Insulin Safety Net Program. The group brainstormed ways to get the word out about the program, eventually deciding on the video, because they felt that the finished product could easily be distributed through social media. 

“We really wanted to use it as an educational tool for both diabetics and for pharmacists and other health care professionals,” Smith-Holt said. “Hopefully we could also make more nurses and doctors and care providers aware that this program existed.” 

Libby Caulum, MNsure senior director of public affairs, said that Smith-Holt’s participation has been key to the program’s success. “There is not a better spokesperson for this than Nicole,” she said. “Her activism and her dedication to making sure this doesn’t happen to other people is the impetus for the law.” 

Libby Caulum

The program does not have a big enough budget to afford large-scale ad buys, so organizers are hoping the video will spread organically, through “grassroots” social-media shares. Because Smith-Holt has been willing to step forward and become a symbol of the insulin-affordability issue, people are interested in listening to what she has to say, Caulum said. 

“My perspective is the more we can get people to know about the program the better,” she said. “There are so many people who are facing these kind of life-or-death situations who do not realize that there is help out there. The more people who know the better.” 

How the program works

There are two parts to Minnesota’s insulin affordability program. First, there is the “urgent need” program where eligible Minnesotans can receive a once-per-year 30-day supply of insulin immediately at their pharmacy for no more than a $35 co-pay. An individual who meets the program’s eligibility standards — someone who isn’t enrolled in Medical Assistance or MinnesotaCare, has proof of state residency and a current prescription for insulin with less than a seven-day supply on hand — can walk into a commercial pharmacy and request a supply. 

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Most pharmacists in the state are required to participate in the program, said Cody Wiberg, executive director of the Minnesota Board of Pharmacy. One key element is that the law allows pharmacists to hand out the emergency supply without completing extra paperwork. “The pharmacy is not responsible for checking the income and the employment status and the insurance status,” Wiberg said. 

While insulin manufacturers all offer prescription assistance programs designed to help low-income or uninsured individuals afford medications, he said that applying for those programs can be a cumbersome process. 

Cody Wiberg

“One of the criticisms of manufacturers is they could take a week or longer to process an application for one of these programs while the person in need went without insulin,” Wiberg said. “Now, manufacturers are required to pay for a one-month supply.”  

The free month-long supply of insulin is designed to give individuals time to confirm their eligibility for manufacturers’ programs, to purchase health insurance or to sign up for medical assistance. 

“That month is supposed to give them at least some time,” Wiberg said. “If they do apply for one of those programs and they haven’t heard back by the end of the month, they can get  a second 30-day supply.”  

The second part of the program is the “Continuing Need” program, where MNsure health insurance navigators help eligible participants sign up for insulin manufacturers’ affordability programs. Approved participants can qualify for a year’s supply of insulin for no more than $50 for a 90-day refill.

At first, Smith-Holt and other advocates were concerned about building a program based on insulin manufacturers’ existing affordability programs, because the manufacturers had written disclaimers into their programs that they could end the programs at any time, Wiberg said. “There were stories of people who should’ve been eligible for these programs but who weren’t enrolled properly and didn’t get their insulin.”  

In the end, the law was written to allay the concerns of advocates, Wiberg explained. “The law now tells insulin manufacturers that as a condition to receive a license from the Minnesota Board of Pharmacy they have to set up a patient-assistance program that has urgent need and continuing need components, you will follow the state’s criteria, you will set it up and you have responsibilities to patients in order to make sure that patients can access insulin in an emergency.” 

‘Not one more’

While Alec Smith’s death of diabetic ketoacidosis — a potentially fatal complication of diabetes that occurs when a person’s body produces high levels of blood acids after being deprived of insulin — was preventable, his decision to ration his insulin wasn’t uncommon. 

“It’s a pretty common thing for folks to do,” Caulum said, and “Nicole’s whole purpose in pushing this law is to make sure that no one in Minnesota gets to the point where they feel that their only option is to ration.” 

Smith-Holt said Alec had decided to ration until he found a job with health benefits. He’d been diagnosed with Type I diabetes just two years before his death, and though he was doing a good job of living with his disease, he was “still pretty new at trying to learn how to manage it,” and didn’t fully understand rationing’s potentially deadly toll. 

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While deaths due to insulin rationing don’t happen every day in Minnesota, they still do happen, Wiberg said, and he and his pharmacy colleagues hope that legislation will make them even more rare. “Even one death is too many,” he said. 

Smith-Holt said that she hopes that social media users will forward “Alec Smith Story” far and wide, further spreading the news that Minnesotans with diabetes no longer have to ration their insulin. 

“We’ve been doing what we can with our limited budget for this program’s public awareness,” she said. “Reaching people through social media has been pretty successful so far, but we know there is more we can do. One of the things I can do is tell his story and explain why this is so important, so I’m doing that.

 

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SECOND comment posted to CDC opiate dosing guidelines

Posted on February 18, 2022 by Pharmaciststeve

I just realized that the CDC guidelines – both 2016 and the new proposed 2022 – do not follow how our healthcare systems works. A pt goes to the practitioner and they if they have obvious symptoms, the practitioner typically will run some lab test (blood/urine)… they get back the values of numerous of substances in those tests and if they are outside of what is considered an acceptable range. If one or more is out of the normal range… the pt ends up getting one or more medications to try and get those labs back into “normal range”.  The CDC with their opiate dosing guidelines, there is no reference as to the intensity of the pt’s pain… they focused on the amount of medications that the practitioner can prescribe.  No reference to getting the pt’s pain back to a “normal level”…  I am not sure if this mind set is UPSIDE DOWN – or – ASS BACKWARDS…  In many incidents, it prevents the practitioner from being a HEALER

I find it curious why the CDC has proposed both in the publish 2016 Opiate dosing guidelines and the 2022 proposed opiate dosing guidelines, that they are stating that chronic pain should be treated in an entirely different manner than what medical science does in treating just about any other chronic disease state. It doesn’t make any difference if the pt has been diagnosed with high blood pressure, diabetes, COPD, high lipid/cholesterol and on and on… Typically the diagnosis is done from some urine/blood lab test value that is outside of what has been a predetermined range that is safe. A good example is a pt being diagnosed with having diabetes, a type II diabetic will typically be initially prescribed Metformin with a starting dose of 500 mg BID. If the pt’s blood sugar does not come down to “normal range” the dose can be increased up to 2550mg/day in divided doses. If the pts blood sugar still does not reach “normal range” the practitioner could add a few other meds in combination up to three different meds. If the pt’s blood level doesn’t reach “normal level” the practitioner can add insulin. For decades the standard of care with insulin, insulin potency was standardized at 100 units/ml, but now there are also now 200 units/ml and 500 units/ml. There appears to be NO UPPER LIMITS OF UNITS/DAY for individual pts – dose is determined by their blood glucose or A1C readings returning to what is considered a “normal range” Same thing applies to pts diagnosed with hypertension, the final goal is to get the pt’s BP into normal range no matter the dose or the number of different meds are needed. The CDC previous opiate and proposed opiate dosing guidelines has turned what has been the traditional chronic disease treatment process ON ITS HEAD. First the MME equivalence process has ABSOLUTELY NO BASIS IN SCIENCE. It has been reported that these ratios were developed with opiate naive people with mechanically induced pain (Heat or Cold) and using a SINGLE DOSE. At a time when medical science had no knowledge of CYP-450 opiate metabolism rates and/or PGx opiate metabolism rate. As well as the ratio were determined on the “subjective opinion” of the people involved in this study and the results have no application to the use in treating chronic pain issues. Since studies have demonstrated that treating chronic pain pts with opiates will result in a 0.6% to 2.0% becoming addicted. So this proposed guidelines is prohibiting >98% of chronic pain pts getting treatment with opiates that will optimize their QOL, while there is no proof that those up to 2% will not be abusing some other substance(s). The LD50 of opiates is highly variable and will decrease on those pts who have taken opiates long term. I have had first hand experience with end stage CA pts being given 20mg to 30 mg/hr Morphine via IV without fatal respiratory suppression. In theory, that would be equivalent of 200mg to 300mg of Morphine PER HOUR. Every other chronic disease is treated to get the pt’s vitals into what is considered an acceptable range, The 2016 and 2022 proposed opiate dosing guidelines does not address getting the pt’s vitals to a acceptable range, only limits – in theory – a particular MME max dose and the pt is expected to live/exist in a intensity of pain that many could consider a torturous level of pain, and many other biological/physiological functions are outside of acceptable ranges because of under/untreated pain. The attached chart will demonstrate the possible complication of a pt’s comorbidity issues and/or cause the pt to develop additional comorbidity issues. Practitioners are suppose to be “healers”, but creating opiate dosing guidelines that does just the opposite is basically inhumane. I communicate regularly with pts whose practitioners have taken their pt’s opiate doses down to meet the arbitrary MME limits. Their blood pressure is in “stroke range” , typically north of 200/100 – even when taking four or more blood pressure meds, under/untreated pain has caused their adrenals to fail, in trying to compensate for the stress on their system, and the pt now is diagnosed with Addison’s disease. Pts are dying from premature deaths from all of these unnecessary biological stressors or and many more are committing suicide because they can no long tolerate the intensity of pain that they are being forced to live/exist in. The CDC, needs to rescind/revoke the 2016 guidelines and pull the proposed 2022 guidelines and turn the practice of medicine back to the FDA and the various state medical licensing boards. To do otherwise and proceed with these inappropriate opiate dosing guidelines, would strong suggest that the CDC is confirming that the CDC’s position that putting/leaving chronic pain pts in a torturous level of pain is acceptable and what should be considered “ a normal/acceptable range” for pt dealing with chronic pain.

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Sometimes… the TRUTH… is the BEST JOKE

Posted on February 18, 2022 by Pharmaciststeve

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Mark Suckerberg has LOST some 40-50 billion in net worth because of the TUMBLING VALUE OF META (FB) FAKE BOOK STOCK

Posted on February 17, 2022 by Pharmaciststeve

This is the stock value of META (FB) “FAKEBOOK” as of abt 3:45 today… over the last six months the value of a share of FAKEBOOK is WORTH ALMOST HALF OF WHAT IT WAS AT ITS HIGHEST PRICE OVER THE LAST YEAR !  In fact Meta’s price hit a 52 WEEK LOW (207.16) TODAY.

52 week high is 384.33 and closed today at 207.16

I got a message from FAKE BOOK last night that they had deleted a number of posts linked to my blog on Feb 15th… and apparently … it took forever to get back to Feb 15th of last year… on my FAKE BOOK page and there was no posts on Feb 15th, 2021 and when I tried to click on the theoretical link like this message that I just got – “learn more about our decision and see what you can do” and it went NO WHERE… 

I know that one year ago Feb 13, 2021, I did not make 173 different posts or comments… so apparently anyone who did share a link from my blog a year ago… all those links have been deleted..

I guess we are back to Richard Mark and his harem/tribe of minions when they filed a untold number of complaints with FAKE BOOK that my blog was a spammer.

So far, it would appear that FAKE BOOK has deleted around 500 posts, comments or links to my blog that others shared a year ago.

 

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We’re measuring opioid strength the wrong way

Posted on February 17, 2022 by Pharmaciststeve

I am not an attorney, but when someone robs a store and store employee is shot/killed … the person driving the get a way vehicle – gets charged with the same crime – just as if he/she had the gun and pulled the trigger. Should individual professionals, healthcare corporations, insurance/PBM’s that creates edicts, policy and procedures based on some study or such thing like the CDC opiate guidelines that are based on poorly designed studies ? For the harm to pts that happen because those entities who adopted such guidelines without doing their own evaluation of what those guidelines are based on ?

Here is a quote from the 211 pages of the 2022 proposed CDC opiate dosing guidelines

The update process uses multiple key sources of input.

The 2016 Guideline was developed using the best available scientific evidence and followed a rigorous scientific process. The update to the Guideline is following a similar process and includes several opportunities for community and partner engagement. CDC highly values public engagement and has ensured there are multiple opportunities to hear from and incorporate feedback from patients with pain, caregivers, clinicians, and partners.

If the same scientific evidence and similar processes is being used to develop these “new guidelines”… who believes that one could expect the 2022 revised guidelines that was considerably different than the guidelines that were published in 2016?

Does anyone seem that it is strange that both the 2016 & 2022 guidelines only talks about MME’s/day limits, which many consider the conversion ratios being highly inaccurate. There is no mention of the practitioner using CYP-450 opiate metabolism or PGx/Pharmacogenomics to help determine the opiate that the pt’s system utilizes the best, identify  a pt that is a fast/ultra fast metabolizer and would need larger or more frequent dosing and/or what intensity of pain should be ideal targeted to help optimize the pt’s QOL.

In reality, when a pt is diagnosed of being a chronic pain pt… the intensity of their pain will ALWAYS be under treated,  The probability of pt getting to “zero pain” is pretty much a unrealistic goal.  There is a chart on the first page of my blog that lists all the potential complications of pt’s existing comorbidity issues and/or could cause the pt to have developed more health issues.

Then there is the routine suggestions that pts use non-opiate meds ( NSAID’S & Acetaminophen ) which the first can cause kidney damage and the latter can cause liver damage. Focusing pain management/therapy on limiting MME’s/day can often cause a hypertensive crisis ( very high blood pressure), which can cause eye, heart & kidney damage,  heart attacks, strokes, not to mention elevated pain intensity levels .. forcing the pts to live/exist in a torturous level of pain, ending in some of these pts to commit suicide to take the final action to stop their unrelenting high intensity of pain.

Could any/all of the people/entities involved in creating/publishing/adopting these guidelines and the studies that the guidelines were based on, be held liable for the adverse health outcomes and/or damages to the pts  that are forced to conform to a plan of treatment that was derived from these guidelines?

We’re measuring opioid strength the wrong way

https://www.nydailynews.com/opinion/ny-oped-were-measuring-opioid-strength-the-wrong-way-20220217-tjmjeevofrdyvj443jvkakmlhe-story.html

Over the past several years, our government has taken control of doctors’ prescription pads. In an attempt to reduce opioid overdose deaths, lawmakers placed hard quantitative limits on the maximum daily dose of painkilling drugs doctors can prescribe. These dose limits were calculated from a conversion table that was the crux of the Centers for Disease Control. and Prevention (CDC) 2016 opioid prescribing guidelines. But a review of the scientific literature shows that the evidence upon which the table is based is either flimsy or non-existent. Even if the CDC recants its 2016 prescribing guidelines when it updates them later this year, the damage has already been done.

Oxycodone,Is,The,Generic,Name,For,A,Range,Of,Opoid
(Shutterstock)

The CDC conversion table was intended to help doctors calculate the appropriate dose of a given opioid by comparing its strength relative to morphine. Supposedly, the use of these “morphine milligram equivalents” (MME) would act as a quick reference for physicians. The CDC recommended 90 MME (90 milligrams of morphine) as the maximum daily dose and that the dose of other drugs be adjusted accordingly. For example, the maximum dose of oxycodone, a drug that is twice the strength of morphine, would be given at half the dose of morphine, or 45 milligrams per day.

Although some scientists voiced skepticism, the recommendations became gospel, and later, law. Indeed, by 2022 38 states enacted laws that restricted the number and dose of opioids doctors may prescribe. Many impose daily limits of 90 MME or less. Medicare requires pharmacists to “confirm the medical need” for patients prescribed doses exceeding 90 MME. Health plans impose restrictions on prescriptions exceeding 90 MME.

Although upon first inspection the conversion table appears authoritative, closer scrutiny reveals otherwise. To support it, the CDC cites only one paper — a 2008 study that is inadequate by any measure. This supposedly pivotal piece of research puts forth a conversion table that is cobbled together from a number of small, clinically insignificant studies dating back over 60 years.

But these studies never even compared the doses of the various opioids that cause respiratory depression and death. The types of trials that went into the table would never be conducted today. We call this junk science.

Never mind; this same deeply flawed science has become policy in many hospitals, health plans and pharmacies.

When junk science is enacted into law, innocent people become “guilty.” In many cases, innocent physicians have ended up in prison for exceeding the 90 MME law, even though this number was never properly determined. And innocent chronic pain patients fared even worse. Many of them who had been on long-term high-dose opioid therapy found themselves in unbearable pain after their pain meds were cut, sometimes sharply, because their doctors were afraid of the consequences of exceeding the 90 MME limit — even when medically appropriate. In desperation, an increasing number have turned to street drugs or worse, to suicide.

Realizing the mess it created, the CDC issued an advisory in 2019 stating their 2016 guidelines were “misapplied,” that it never meant the 90 MME benchmark to be a “hard limit.” The CDC admonished doctors for cutting off or abruptly tapering patients whose pain had been well-controlled with doses exceeding 90 MME, even though this practice continues. That same year the American Medical Association officially stated “no entity should use MME (morphine milligram equivalents) thresholds as anything more than guidance.”

Last June, the Food and Drug Administration requested comments from various experts for a workshop it held to investigate the science and “knowledge gaps” surrounding MME benchmarks. One of us commented, explaining why creating morphine equivalent conversion tables is pharmacological folly.

The last two years of the COVID-19 pandemic should have taught us that medical knowledge is constantly being revised and updated, that it is often based on questionable assumptions rather than evidence, and it is never “one size fits all.”

Writing dubious assumptions into law casts junk science in stone. And the junk science remains embedded in the public mindset long after a law is repealed.

As a result, current pain management policy is a house of cards resting on antiquated and unscientific assumptions with no foundation in evidence, just a collection of incorrect (or unproven) numbers. If the CDC seeks to establish meaningful guidelines, it must focus on modern, scientifically rigorous studies, not a patchwork of unreliable research from the past.

Singer practices general surgery in Phoenix and is a senior fellow at the Cato Institute; Bloom is director of chemical and pharmaceutical science at the American Council on Science and Health

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A law firm that is doing a lot of civil rights/discrimination lawsuits – could they assist chronic pain pts and being denied pain meds ?

Posted on February 16, 2022 by Pharmaciststeve

I am not sure if this article is just a bunch of hyperbole by a law firm trying to stir up some business.  This statement is rather confusing to me...The DEA is authorized to take administrative action against violating individuals and entities.. and then goes on to say… If criminal activity is suspected, the DEA will get the Department of Justice (DOJ) involved.  I am trying to figure out how a entity can violate the CSA and not be involved in criminal activity ?

This law firm has a webpage showing some 3000+ cases of discrimination, I did not review all the cases, but could this law firm be one that could possibly have the in house expertise to deal with discrimination of disable chronic pain pts, when their pain meds are involuntarily reduced or eliminated ?   https://www.jdsupra.com/topics/discrimination/

DOJ Opioid Enforcement Defense

https://www.jdsupra.com/legalnews/doj-opioid-enforcement-defense-2349310/

Introduction: The Controlled Substances Act (“CSA”)

The CSA (21 U.S.C. 801 et seq.) imposes a framework that regulates different categories of certain drugs that pose dependency and abuse risks to the public. The CSA applies only to those drugs that either administrative proceedings or Congress have designated as subject to control. The DEA is the main federal agency responsible for enforcing the CSA. The DEA is authorized to take administrative action against violating individuals and entities such as issuing warning letters, ordering suspensions, imposing fines, and demanding revocation of the entity´s license. If criminal activity is suspected, the DEA will get the Department of Justice (DOJ) involved.

In 2020, the Department of Justice (DOJ) announced that it would increase its enforcement efforts against pharmacies and pharmacists under the Controlled Substances Act (“CSA”) for violating their duty to ensure that opioids are only used for their intended purposes with intended persons. This article, drafted by the federal defense attorneys at Oberheiden, P.C., explains the DOJ´s position on opioid enforcement and recent federal investigations.

“The increase in federal investigations for opioid abuse has caused many pharmacies to receive federal subpoenas and/or civil investigative demands regarding their sales of opioids and controlled substances. To protect themselves, pharmacies should take care in ensuring that they have appropriate compliance procedures in place to prevent opioid diversion and that such compliance procedures are working effectively. Hiring experienced federal defense attorneys is the best defense against federal investigations.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.

DEA and DOJ Coordinated Efforts

The DEA generally investigates suspected violations of the CSA including the following:

  • Dispensing controlled substances to individuals without a prescription;
  • Lack of strong controls in place regarding the opioid distribution process;
  • Registration and reporting violations;
  • Failing to maintain detailed records on individuals and employees;
  • Failing to file suspicious reports with the government regarding certain orders;
  • Noncompliance with enhanced standards for security under the CSA; and
  • Other factors regarding dispensing opioids and controlled substances bearing on the pharmacist´s or pharmacy´s responsibilities.

While the above activities subject the individual or entity to DEA oversight, they are generally not criminal offenses. That said, if the DEA suspects that a violation was knowingly made, the DEA—in conjunction with the Department of Justice (DOJ)—may bring criminal charges.

With the DOJ, the DEA is focusing its efforts on the national opioid crisis. The DEA in late October 2021 announced the results of Operation “Dark HunTor,” a coordinated international effort to halt opioid trafficking on the Darknet. The operation resulted in 150 arrests worldwide and the seizure of over $31.6 million in cash and virtual currencies, including about 234 kilograms of drugs such as amphetamine, cocaine, opioids, ecstasy, fentanyl, oxycodone, hydrocodone, methamphetamine pills, and counterfeit medicine.

These agencies have broadened the scope of the CSA for pharmacies and pharmacists by establishing liability for failing to detect the warning signs of drug abuse or diversion. In the eyes of the DOJ, if the pharmacy or pharmacist fails to have procedures in place that detect opioid abuse or diversion or ignores obvious warning signs or red flags, then they may be liable for filling prescriptions that lack a legitimate purpose or that are written by prescribers not acting according to the standards of their professional practice.

DOJ Investigations to Combat Opioids

The DOJ´s Consumer Protection Branch is leading the effort in pursuing both criminal and civil actions against individuals and entities who are diverting or abusing opioids, taking advantage of the opioid crisis in the nation, or who are otherwise negligent or reckless in prescribing or delivering opioids. The DOJ has made it a priority to target various individuals and entities in the opioid supply chain, including distributors, manufacturers, pharmacies, pharmacists, and prescribers. Below are notable examples:

  • In early February 2020, a federal court ordered a pharmacy in North Carolina and a pharmacist to pay $600,000 in civil penalties and to permanently cease dispensing opioids and other controlled substances. The pharmacist was also ordered to surrender his license to practice. The order cites Defendant’s failure for years in responding to red flags of drug diversion when filling prescriptions for controlled substances.
  • In March 2020, a pharmacy from Georgia and its pharmacist agreed to settle charges with the DOJ for unlawfully dispensing thousands of illegitimate prescriptions for opioids and other controlled substances under the CSA. Defendants had allegedly ignored and failed to take action against numerous red flags, including prescriber and customer warning signs regarding opioid abuse, and therefore facilitated the opioid distribution process. The pharmacist and pharmacy agreed to a settlement of about $2.1 million in civil penalties.
  • At the end of October 2020, the DOJ announced the global resolution of criminal and civil investigations regarding opioid manufacturer Purdue Pharma LP and civil settlements. The charges involved the abuse and diversion of prescription opioids. The DOJ obtained guilty pleas, a settlement of over $8 billion, and the dissolution of the company’s assets.

The DOJ will continue its aggressive stance under the CSA with the help of the DEA. Another area of concern for prescribers in telemedicine has gathered increased federal scrutiny due to COVID-19. Telemedicine presents unique risks. Prescribers cannot see their patients and are unable to physically evaluate their condition. The lack of face-to-face meetings makes it easier for criminals to conceal their identities and true intentions. Further, identity verification procedures are often less intense with telemedicine and tele-visits. To avoid unnecessary federal attention, many prescribers and entities have implemented comprehensive compliance programs that are designed to detect, mitigate, and monitor an entity´s operations for red flags.

Conclusion

The Department of Justice (DOJ) is committed now more than ever to holding pharmacies and pharmacists accountable for their roles in allegedly failing to take action to prevent illicit uses of opioids or for further facilitating the nation’s opioid crisis. In conjunction with the DEA, the DOJ has pursued an aggressive, broadened stance for failing to take care that opioids and other controlled substances are not being diverted for illegal purposes. Violations regarding the mishandling of opioids or failing to take care in the opioid distribution process can lead to serious penalties and even imprisonment terms. We can expect more federal investigations and indictments under the CSA. To prevent this from happening to you, retaining experienced federal defense attorneys is your best defense.

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Looking in the rear view mirror

Posted on February 16, 2022 by Pharmaciststeve

I found this graphic on my computer with a date from 2014


Then there is this graphic that shows ALL OVERDOSES – starting about the time that the Decade of Pain Law expired and was not renewed.. Opiate Rxs peaked in 2011 – again near the start of this graphic and projects the OD deaths thru the end of the decade. So if that prediction is correct, Overdose deaths will have INCREASED TEN FOLD in 15 yrs. If you notice in the graphic, there is a substantial uptick after the 2016 CDC guidelines were released and in 2021 when our SW Southern border was opened up. Reportedly a “flood” of illegal Fentanyl analog and other illegal abused substances started happening about one year ago. What is also interesting is the number of deaths contributed to use/abuse of alcohol and nicotine have not increased anywhere near those of involving legal/illegal controlled substances.  According to this article https://www.nbcnews.com/politics/immigration/fentanyl-seizures-u-s-southern-border-rise-dramatically-n1272676 in the first 9 months of 2021 federal fiscal year the seizures of just illegal fentanyl analogs was over THREE TIMES MORE than all of the entire 2020 fiscal year.

There is another graphic where the various illegal/legal drugs caused OD’s. What is not shown, and it is not known if the CDC did not track or did not disclose.. is the number of OD’s from Pharma opiates was relatively flat for the entire decade, were they from people who had a legal Rx for the opiate showing in the toxicology – which would suggest a SUICIDE or some pharma opiates that have been diverted from legal sources.

What I find interesting is that both pharma opiate production limits and the number of Rx opiate filled have been CUT IN HALF, since 2011.

One just have to wonder how anyone can claim that pharma opiates have any connection to all the OD’s involving illegal Fentanyl. In 2021, that number is reported as being 75,000.

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Clinical Trial Finds BP Elevation With Regular Acetaminophen Use

Posted on February 16, 2022 by Pharmaciststeve

So …. they CUT YOUR PAIN MEDS, YOUR BLOOD PRESSURE GOES UP… and they tell you to take a non-opiate pain med for your pain.. This study suggests that Acetaminophen ( Tylenol ) could cause your blood pressure to GO HIGHER !   The GOOD NEWS  is… you won’t harm your liver taking Acetaminophen, the BAD NEWS is, high blood pressure could harm your kidneys and so will most NSAIDS (Aspirin, Motrin, etc) – depending on how much you take. So what is worse … the frying pan or the fire ?

Clinical Trial Finds BP Elevation With Regular Acetaminophen Use

https://www.uspharmacist.com/article/clinical-trial-finds-bp-elevation-with-regular-acetaminophen-use

Edinburgh, UK—Regular use of acetaminophen might not be appropriate for patients with hypertension because the painkiller significantly raises blood pressure, according to a new study.

The University of Edinburgh study suggests that goes against conventional belief, adding that the drug “is widely used as first-line therapy for chronic pain because of its perceived safety and the assumption that, unlike nonsteroidal anti-inflammatory drugs, it has little or no effect on blood pressure (BP).”

Their study, published in Circulation, notes that observational studies suggest that acetaminophen may increase BP, but few clinical trials have tackled the question. That is why they conducted a clinical trial to access the effect of regular acetaminophen dosing on BP in hypertension.

For the double-blind, placebo-controlled, crossover study, researchers randomized 110 participants to receive 1 g of acetaminophen 4X daily or matched placebo for 2 weeks followed by a 2-week washout period before moving over to the alternate treatment. They measured ambulatory BPs at the beginning and end of each treatment period.

Defined as the primary outcome was a comparison of the change in mean daytime systolic BP from baseline to end of treatment between the placebo and acetaminophen arms.

With 103 patients completing both arms of the study, researchers report that regular acetaminophen, compared with placebo, was found to result in a significant increase in mean daytime systolic BP (132.8±10.5 to 136.5±10.1 mmHg [acetaminophen] vs. 133.9±10.3 to 132.5±9.9 mmHg [placebo] ;P <.0001) with a placebo-corrected increase of 4.7 mmHg (95% CI, 2.9-6.6) and mean daytime diastolic BP (81.2±8.0 to 82.1±7.8 mmHg [acetaminophen] vs. 81.7±7.9 to 80.9±7.8 mmHg [placebo]; P = .005) with a placebo-corrected increase of 1.6 mmHg (95% CI, 0.5-2.7).

They add that similar findings were identified for 24-hour ambulatory and clinic-measured BP.

“Regular daily intake of 4 g acetaminophen increases systolic BP in individuals with hypertension by ≈5 mm Hg when compared with placebo; this increases cardiovascular risk and calls into question the safety of regular acetaminophen use in this situation,” the authors conclude.

In an accompanying commentary, Steven M. Smith, PharmD, MPH, and Rhonda M. Cooper-DeHoff, PharmD, MS, of the Department of Pharmacotherapy and Translational Research, College of Pharmacy at the University of Florida, in Gainesville, point out, “An important but often underappreciated contributor to stagnant BP control rates is drug-induced hypertension. At least 40 to 50 drugs currently in use have been implicated in raising BP, through activation of sympathetic (e.g., pseudoephedrine, venlafaxine) or renin-angiotensin systems (estrogen-based oral contraceptives) promotion of sodium/volume retention (corticosteroids, calcineurin inhibitors) or other mechanisms.”

Drs. Smith and Cooper-DeHoff also advise that nonsteroidal anti-inflammatory drugs, to which acetaminophen often is used as an alternative, blunt the effectiveness of many first-line antihypertensives.

Calling the new study an “important addition” to the research, the commentators write that the BP-raising effects of acetaminophen have been known for more than half a century, but that few clinical trials have provided evidence of that.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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