https://youtu.be/S2Nt5L8-MqI

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Coronavirus Conundrum: Part 2

https://pharmacistactivist.com/2020/May15_2020.shtml

WHO, HCQ, FDA, Remdesivir, Moving Forward!
I appreciate the many responses I received to my editorial in the May 1 issue of The Pharmacist Activist. Most were very supportive of the perspectives I voiced, some called my attention to information of which I was not aware, and two were critical of my statement that I would use hydroxychloroquine (HCQ) without evidence of effectiveness and safety if I experienced the misfortune of having moderate to severe COVID-19.
World Health Organization
One of the responses I received noted the following:

“Regarding your opinion that using the names Wuhan or Chinese virus is not racist, I encourage you to read the 2015 World Health Organization (WHO) best practices for naming new infectious diseases (if you haven’t already).”

I was not familiar with this statement and the reader was kind enough to include the link to the document that includes these statements: “The best practices state that a disease name should consist of generic descriptive terms, based on the symptoms that the disease causes (e.g., respiratory disease, neurologic syndrome, watery diarrhoea) and more specific descriptive terms when robust information is available on how the disease manifests, who it affects, its severity or seasonality (e.g., progressive, juvenile, severe, winter). If the pathogen that causes the disease is known, it should be part of the disease name (e.g., coronavirus, influenza virus, salmonella).

Terms that should be avoided in disease names include geographic locations (e.g., Middle East Respiratory Syndrome, Spanish Flu, Rift Valley fever), people’s names (e.g., Creutzfeldt-Jakob disease, Chagas disease), species of animal or food (e.g., swine flu, bird flu, monkey pox), cultural, population, industry or occupational references (e.g., legionnaires), and terms that incite undue fear (unknown, fatal, epidemic).”

This is helpful guidance that I appreciate, but I consider it overly restrictive. It is also unfortunate that the WHO seems to ignore one of its best practices in characterizing COVID-19 as a pandemic, a designation that can incite fear. The WHO best practices apply to new diseases and not those that are already identified with commonly used names. However, it is interesting to speculate what Lyme disease should be called if it was identified now. The designation could not include Lyme, Connecticut, tick, deer or mice (the common animal hosts for the ticks), or even the name of the microorganism (although the latter escapes identification in the best practices, Borrelia burgdorferi includes the name of Dr. Burgdorfer). Perhaps Multi-system Spirochetal Disease would be an appropriate name for which the abbreviation MSSD would be adopted and the meaning of the specific letters soon forgotten. I recently asked several individuals who knew about SARS if they could identify the words represented by those letters, and no one identified all four.

And, in the news as I write this, is the Asian giant hornet, also known as the murder hornet! We must come up with a better designation.
Hydroxychloroquine
In my previous editorial I noted that the son-in-law of a friend of mine was in the ICU with serious COVID-19 and that hydroxychloroquine (HCQ) had been used for treatment. One reader inquired about this individual’s outcome, and I am pleased to report that he recovered and has been discharged from the hospital. It is not known whether, or to what extent, HCQ contributed to his recovery, but it certainly did no harm.

Most of the responses I received voiced strong agreement with the circumstances that I described in which I would insist on being treated with HCQ if I was the patient afflicted with COVID-19. These can best be summarized in the following response:

“My elderly mother is immunocompromised as a result of cancer chemotherapy. Using the ‘what would I do’ criteria, and if she was diagnosed with COVID-19, under the care of her physician and pharmacist, and might benefit from short-term treatment with HCQ, I would move heaven and earth to get her 20 tablets of HCQ if she chose to try it (which I would encourage).”

One of the critical responses I received concluded with the following statement:

“So sure, if someone is at death’s doorstep, let him/her try hydroxychloroquine. Let them try a witch doctor doing incantations. There is nothing to lose either way.”

He included a link to a story in Vanity Fair that was published that day (April 24) that was critical of statements made by President Trump about HCQ, and also included statistics from a report of patients with COVID-19 at some Veterans Administration (VA) hospitals that identified a higher death rate among individuals who had been treated with HCQ compared with those who didn’t receive it. I responded to him with the following:

“I had not seen the Vanity Fair article and read it on the link you sent. I consider it flawed reporting motivated by a political bias. I acknowledge that HCQ may not be effective for COVID-19. However, there have been numerous experiences (not studies) that have suggested it to be of benefit. When the VA ‘study’ that is cited in the Vanity Fair article is examined, the two groups of patients for whom the results have been publicized are not comparable. However, this is ignored or not recognized by those who have viewed this report as evidence that HCQ is not effective and dangerous to the point of causing deaths.”

The individual who made this comment is a friend who is very knowledgeable about healthcare issues and pharmaceutical companies, and with whom I can have cordial and respectful discussions regarding matters on which we have differing opinions. I called him (April 24) to discuss the HCQ issues, and reiterated that I would insist on being treated with it if I was diagnosed with moderate or severe COVID-19. I asked if I was correct in understanding that he would decline to be treated with it if he was in that situation. He responded that he would not use it and I inquired as to whether that meant that he would expect no treatment except supportive care that might include use of a ventilator. He noted that he would request to be treated with remdesivir on a compassionate use basis, even though he recognized that it was an investigational drug for which effectiveness, safety, and dosage for treating COVID-19 had not been determined. I agreed that I would also want to be treated with remdesivir but, even with his connections, I noted that I considered it very unlikely that either of us would be among those selected on a timely basis from among the tens of thousands of individuals who would want to be included in a clinical trial or compassionate use program for the drug. (On May 1, the FDA issued an emergency use authorization for remdesivir that is discussed later in this commentary).

This response, as well as the other one that I received that challenged my decision to use HCQ for myself, were made in the context of comments that were highly critical of President Trump. A substantial amount of media coverage begins discussions of HCQ with the observation that it has been identified/recommended by the President as a medication that may be of benefit in treating COVID-19. It is very unfortunate that much of the consideration of the potential benefits, limitations, and risks of HCQ for COVID-19 has deteriorated to politically-charged discussions in which information, data, and commentary appear to be selected to fit a particular political point of view. In sharp contrast, it is experienced-informed clinical reasoning and judgment that are necessary while we wait for the results of studies that can provide evidence.
Some HCQ experience
HCQ has been approved and marketed in the U.S. for approximately 70 years, and is most commonly identified as an antimalarial drug. A short course of treatment is indicated for patients with active malaria infection, and it is used on a weekly basis before, during, and following travel for prophylaxis in individuals visiting areas in which chloroquine/HCQ-susceptible malaria infections are endemic. In the U.S., lupus is the condition for which HCQ is most commonly prescribed, for which it is administered on a daily basis and thousands of patients have taken it for many decades. The vast majority of these patients have tolerated it well, and ocular/retinal toxicity has been the greatest concern with its use for which patients should be monitored.

There are many medications marketed in the U.S. that are known to cause prolongation of the QT interval of the electrocardiogram that is associated with an increased risk of arrhythmias for which there are prominent warnings in the product labeling. To my knowledge, confirmed by my review of drug therapy and medical references, these complications have not been identified as risks with the use of HCQ for more than 60 years of the period of time in which it has been available. However, during the last several weeks there has been extensive publicity about the alleged danger of using HCQ in treating COVID-19 because of this risk.

I am very familiar with, and have great concern about the risks of using drugs that are known to prolong the QT interval. I have participated as an expert witness in a lawsuit pertaining to the death of a patient that was attributed to the additive QT-prolonging actions resulting from the concurrent use of ziprasidone (e.g., Geodon) and moxifloxacin (e.g., Avelox), two drugs that are well documented as having this risk (another story for a future issue). Indeed, this action of moxifloxacin is so consistent and well known that it has been used as an active comparator drug in studies in healthy volunteers in which the cardiovascular safety of investigational drugs is assessed to determine if a drug has a QT-prolonging action.

It would appear that a QT-prolonging risk of HCQ has only been identified within the last several years. A warning appears in the current product labeling but, to date, I have not been able to determine when the warning was added and whether the concern was communicated to health professionals. Plaquenil is the original trade name for HCQ and I have tried to track, without success, the revisions in the package insert that have been made for this product, that is made even more difficult by the fact that the product has been sold multiple times to another company just within the last seven years. I have not yet received a response from the FDA to my request to learn when the product labeling was last revised. From what I have been able to learn from online searching, it could be that a warning regarding the risk of QT interval prolongation has only been added to the labeling sometime within the last four years. How could a risk that is this serious escape attention for more than 60 years when so many patients are using it on a daily basis in multiple-drug regimens, unless the action is relatively weak and/or occurs rarely?

I am not minimizing the potentially fatal risk of a drug prolonging the QT interval or the need to observe important precautions when it is used. However, it is also very important to learn the degree of the risk that was only recently identified after so many decades of use.
The FDA
The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to permit the emergency unapproved use of hydroxychloroquine sulfate supplied from the strategic national stockpile (SNS) to treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible. The suggested dosage is 800 mg orally on the first day of treatment and then 400 mg daily for 4 to 7 days of total treatment based on clinical evaluation. The issuance of this EUA followed numerous observations/suggestions (not to be interpreted as studies or evidence) that HCQ might be of benefit in patients with COVID-19. The EUA provided very helpful guidance and helped assure the availability of the drug by making it available from the SNS.

On April 24 the FDA issued a statement that “cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems.” The statement includes the following comments:

“Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19.

The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT prolonging medicines.

Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia. These risks may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition. Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines.”

This information provided by the FDA is important and of value. However, I take strong exception to the FDA cautioning against use of HCQ outside of the hospital setting or a clinical trial. I recognize that the FDA is stating a “caution” and not a restriction or mandate. However, I consider this caution to be excessive, unnecessary, and alarming to the point that some are concluding that the use of HCQ outside of the hospital setting is inappropriate and/or dangerous. In our litigious society, can allegations of negligence or malpractice be far behind if a “caution” stated by the FDA is not observed and a patient is alleged to have experienced negative consequences whether or not it is known if they resulted from COVID-19, a particular medication, or other factor? Observing the FDA “caution” would preclude physicians from prescribing it “off-label” for patients with COVID-19 who are not hospitalized but for whom they consider it to be of potential benefit in avoiding more serious complications, or prescribing it for themselves or other healthcare providers as prophylaxis to reduce the risk of contracting COVID-19.

The FDA does not have the authority to regulate the practice of medicine or pharmacy; it is the state boards of medicine and pharmacy that have this authority. Off-label prescribing, dispensing, and pertinent counseling is common with many medications and, indeed, has been of value in identifying potential additional benefits and uses of approved medications and that have provided the impetus for subsequent clinical trials and evidence. It is important, and to be expected, that the FDA should communicate concerns about reports of potentially serious adverse events of available medications. However, to “caution against the use of HCQ outside of the hospital setting or a clinical trial” is an unacceptable intrusion by the FDA into the professional roles and judgment of physicians and pharmacists with respect to the off-label use of approved medications. In addition, the FDA “caution” could be alarming to the many patients with lupus who have been treated with HCQ effectively and safely for years, with the result that they stop using the medication and be at risk of exacerbation of the disease. The national medical and pharmacy organizations should be challenging the FDA regarding such statements/actions, but they have been silent regarding this.

The FDA statement notes that it “is aware of reports of serious heart rhythm problems,” and that HCQ “can cause abnormal heart rhythms such as QT interval prolongation.” However, “reports” must not be interpreted as “studies” or “evidence.” In addition to communicating a concern, the FDA should also accept the responsibility for sharing the pertinent information that is the basis for the concern. For example:

How many reports of serious heart rhythm problems are known to the FDA?

Did the patients who experienced heart rhythm problems have other risk factors for heart rhythm problems?

What consequences did the patients experience? (e.g., Were deaths attributable, at least in part, to the use of HCQ? If so, how many?).

What is the approximate number of patients who were treated with HCQ for COVID-19, or other conditions (e.g.,, lupus), during the relevant time period (i.e., to provide the denominator as part of the basis for determining the level of risk)?

What is the estimated degree of risk? (e.g., every patient treated with HCQ? 1 in 10? 1 in 100?, 1 in 1000?, 1 in 100,000?).

How does the prolongation of the QT interval with HCQ compare with that experienced with moxifloxacin and placebo? This is a study that could be conducted quickly in healthy volunteers if there was sufficient interest in doing so for the purpose of providing clarifying and useful information for assessing the level of risk.

It is noteworthy that many of those who demand science and/or evidence for every decision or opinion are not asking questions such as the above, but rather appear to accept the statement of a risk that is not accompanied with any data.

It is also of interest that the FDA statement identifies azithromycin as a medication that can prolong the QT interval. For a number of years, the labeling for this agent has included a warning regarding this possibility. However, it is probably impossible to estimate the number of millions of Z-Paks that have been prescribed, in large part as a result of its high level of effectiveness, safety, and convenience of use. Although appropriate precautions should be observed, I consider the risk of serious complications from prolongation of the QT interval with azithromycin to be extremely low.
Remdesivir
On May 1 the FDA issued an EUA for the investigational antiviral drug remdesivir (Gilead Sciences) for intravenous treatment of suspected or confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. In a preliminary analysis of 468 recovered patients, remdesivir was shown to shorten the time to recovery (to a median time of 11 days compared with 15 days for those receiving placebo), and it is the first drug to be demonstrated to provide benefit in patients with COVID-19 in an adequate and controlled clinical trial. More than 1,000 patients were enrolled in the study but the outcome for many of the patients was not yet known as of May 1. There was also a numerical reduction in the death rate in the patients treated with remdesivir (8.0%), compared with 11.6% in those receiving placebo; however, this difference was not determined to be statistically significant.

Although the issuance of the EUA is different than FDA approval of remdesivir, the preliminary results of this study are very encouraging, and additional experience is being acquired in this study as well as other clinical trials. As studies of other medications are also being conducted, it appears likely that remdesivir will be one component of a multi-drug regimen that will be determined to be most effective for the management of severe COVID-19.
Moving forward
We must continue to move forward in conducting clinical studies and acquiring experience with treatments that have the potential for effectiveness in treating COVID-19 in a manner that includes sound clinical reasoning and judgment. Components of a forward path also include, but are not limited to the following:

Sufficient protective equipment and workplace environments that are as safe as possible must be provided for pharmacists, physicians, nurses, and other essential workers who have the responsibility of providing care and services for patients afflicted with COVID-19.

Individuals who are at greater risk of contracting COVID-19 (e.g., the elderly, immunocompromised) must avoid/minimize to the extent possible activities and socialization that might increase their risk of infection, while concurrently assuring and protecting their personal rights and civil liberties

We must accelerate the pace at which restrictions are reduced and individuals, society, and our country return to life, work, and school. I recognize that the removal of current restrictions will result in an initial increase in the number of cases and deaths from COVID-19. Every COVID-19 death is a tragedy but the consequences of the restrictions imposed must not be underestimated, and include massive unemployment and delays in needed elective surgeries and treatments, as well as increased experiences of depression, domestic violence, suicide, and drug misuse/overdoses too numerous to count.

Partisan politics and criticisms pertaining to COVID-19 and related issues must stop! COVID-19 does not discriminate with respect to its victims and the scope and consequences of the current tragedies demand a collaborative and united fight against the viral enemy. Those who politicize these events should be called out and their comments should be rejected! There must be respectful dialogue among those with differing opinions.

Colleges of pharmacy and other health professional schools should provide leadership in restoring campus-based instruction and activities. Some universities are actively considering not resuming on-campus instruction and events until 2021. I want to think that colleges of pharmacy and other health professions can provide the creative thinking, strategies, and leadership that will enable the safe resumption of campus-based instruction and events this fall, and provide the educational experiences that will best assure the preparation of competent and dedicated health professionals who will soon have the responsibilities of responding to COVID-19 and future challenges.

No observations in this commentary should be misinterpreted to suggest that I am minimizing the level of risk and tragedy that exists from COVID-19 now or into the future. On the day that I write this (May 4), the number of COVID-19 deaths predicted to occur by August in the U.S. has been substantially increased to 134,000. We must continue to comply with appropriate precautions, but we also must not permit the crisis to cripple our lives, society, or economy. We must not live in fear!.

Daniel A. Hussar
danandsue3@verizon.net

CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 1

CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 2

CVS is Destroying the Profession of Pharmacy – PART 3*

CVS is Destroying the Profession of Pharmacy – Part 4

CVS is Destroying the Profession of Pharmacy: Part 5!

CVS is Destroying the Profession of Pharmacy: Part 6

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https://www.youtube.com/watch?v=sAKNnJJerFc

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What youtube.com takes away.. Pharmaciststeve RESTORES…  I have been exploring how one can download videos that show up on the web to my hard drive.  I OWN my own domain www.pharmaciststeve.com and after some experimentation… I found out how I could upload these videos to my domain and make them available on my blog.  Below is the hyperlink that will allow my readers to view the video that youtube.com made disappear 🙂

This video has been deemed to be full of false narratives …. per this link

https://www.whas11.com/article/news/verify/verify-the-plandemic-documentary-is-full-of-misinformation/417-95caed4e-7a95-4452-ba7f-98cd0442c9e9

https://www.pharmaciststeve.com/video/Dr. Anthony Fauci’s ex-employee, was jailed, finally tells all..mp4

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while this person hits some of the highlights of what we could be dealing with in the future… there is a lot of “stuff” that is – and has been – going on that few people have a clue about.

I have often seen people discussing the good/bad/ugly about people getting “chipped” … like we do our pets.  Don’t look now… but.. if you have a smart phone… you have already been “chipped”…  Once our cell phone system transitioned to a digital system as opposed to the original analog system that the first cell phones were…  you can be “found” by the location of your smart cell phone.  While no one was paying attention, you can not longer easily take the battery off your phone – unlike you could with the older analog cell phones.   Does anyone really know that when your phone tells you that your battery is “dead” .. is it really did ? or does it have enough reserve power to ping a local cell phone tower every couple of minutes for how many hours or days ? You can prevent your cell phone from communicating with a cell phone tower by wrapping it in aluminum foil or put it in a lead lined closable bag.  Of course, the only good your phone is at this point is as a PAPER WEIGHT.

Police cars can now be equipped with license plate readers and automatically pull up the car’s registration and see if there is any outstanding warrants against the car and/or the owner of the car. The experts who deal with such cases in Columbia based DUI attorneys can be of legal help.

Suppose this data from the license plate could pull up a report from the state’s PDMP database..  what this person described is a unwarranted stop/search/arrest.. without probably cause… because the person in the car or who owns the car has had prescriptions filled for controlled substances.   Doesn’t this sound like what happens to prescribers… their practice is raid, they are arrested and their assets are confiscated and they are jailed… often with no charges being filed or charges based on “fabricated facts”

If you were paying attention, about 20 yrs ago a number of retailers started providing “frequent buyers discount cards”..  GUESS WHAT ?… another friggin database… they raised their prices and then give you a “discount” by showing your discount card.. also  abt the same time charge cards started giving various “rebates” by using their cards… some gave airline miles, some give COLD HARD CASH… today it is not all that hard to get upward of a 5% rebates.

What if that cop car .. license plate reader… can access databases that could show that the car’s owner had recently purchased some alcohol products either from the retailers discount program or the credit card rebate program.  Alcohol is a DRUG and it is like a “Controlled Substance”… the number of retailers and the specific type of retailers that can sell specific types of alcoholic products.

The list of possible businesses that could benefit from these databases… is virtually endless… once law enforcement gets access to these databases… who knows who the data is shared with.

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San Francisco gives drugs, alcohol to homeless addicts in hotels during coronavirus, sparking debate

https://www.foxnews.com/us/san-francisco-homeless-addicts-in-hotels-coronavirus-debate

Controversy is ensuing in San Francisco after the city decided to give alcohol, marijuana, and methadone to homeless addicts in hotels during the coronavirus pandemic, according to a report.

Last Friday a man who describes himself on Twitter as “Formerly homeless addict in #recovery advocating for the #truth about homelessness and drug addiction. Faith, Hope and Love. SF Native. Tweets are my own.” tweeted to the city.

He wrote: “I just found out that homeless placed in hotels in SF are being delivered Alcohol, Weed and Methadone because they identified as an addict/alcoholic for FREE. You’re supposed to be offering treatment. This is enabling and is wrong on many levels. @SF_DPH @sfbos @LondonBreed”

The city’s department of public health confirmed the report on Twitter this week.

“These harm reduction based practices, which are not unique to San Francisco, and are not paid for with taxpayer money, help guests successfully complete isolation and quarantine and have significant individual and public health benefits in the COVID-19 pandemic.”

San Francisco fell far short of securing the more than 8,000 hotel rooms that city supervisors hoped to lease to house homeless and other at-risks populations needing to quarantine or socially distance themselves during the coronavirus pandemic.

The city had set a deadline to lease 8,250 hotel rooms for the homeless, frontline workers and those living in densely populated apartment buildings.

While there was no formal punishment for failing to lease the 8,250 hotel rooms, the lack of rooms is a blow for a city that even before the outbreak of COVID-19 was struggling to handle a growing crisis in homelessness.

Video

California acquired more than 15,000 hotel rooms to shelter homeless people during the coronavirus pandemic, Gov. Gavin Newsom said last month.

Newsom said then that a new agreement with the Motel 6 hotel chain would provide an additional 5,025 hotel rooms at 47 locations in 19 counties.

“Today marks an important milestone for our efforts to protect very vulnerable homeless individuals from COVID-19, and to protect our hospitals more broadly from surges that challenge our capacity and stress our system,” the governor said.

CORONAVIRUS: WHAT YOU NEED TO KNOW

Newsom made the announcement outside a Motel 6 in San Jose, where he touted his “Project Roomkey” initiative.

The federal government has agreed to pay 75 percent of costs associated with housing some people experiencing homelessness. The project covers people who test positive or may have been exposed to COVID-19, older homeless people and those with underlying health conditions.

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https://www.countyoffice.org/bryan-county-board-of-elections-durant-ok-e58/

abt 34,000 adults in Bryan County, OK.. if you work under the presumption that 30% of those residents are chronic painers or abt 10,000. Presuming that the typical chronic painer would take 6 Hydrocodone/APAP 10/325 every 24 hrs…  Those pts would need abt 22,000,000 doses for one year.. Working with 34,000 adults in Bryan County that comes out to almost 5,000,000 doses.. So according to the figures provided by this AG… the average chronic painer in this county would get 1.3 doses/day… and this figure does not include doses for acute, surgical or accidental pain. The traffic accident attorneys can be of legal help in case one needs it.

So in a 9 yr period (2006-2014) those same chronic painers would need 45,000,000 doses and the number of doses provided was about 47% of what was needed and again …no doses allotted to acute, accidental, surgical pain.

So again, according to these numbers produced by the AG.. the average chronic painer would get two doses of a opiate that lasts 3-6 hrs… suggesting that the average chronic painer would be WITHOUT ANY PAIN MANAGEMENT THERAPY for 12 hrs out of 24 hrs – EVERY DAY… for NINE YEARS !

These three drug wholesalers control about 80% of the total pharmacy wholesale market …  and once again the AG claims that they provided 70% of these opiate doses as excessive… when their overall market share is at least 80%- on average !

OK population is abt 1.25% of the total USA population and there is abt 4 million population in OK.  Extrapolating national averages… in a 20 yr period (2000-2019)  in OK 25,000 would have died of the use/abuse of the DRUG ALCOHOL and 112,500 would have died from use/abuse of Tobacco..  SO… over TWENTY TIMES the number of OK resident would have died from the use/abuse of these two legal drugs as died from legal/illegal opiates.

So all these states went after the Tobacco industry in the 1990’s and won a settlement.. so JUST FOUR TIMES residents of OK have died in that 20 yr period from the use/abuse of ALCOHOL.  But Alcohol has a hefty “sin tax” revenue stream to the state and feds… so does that make those 25,000 deaths sociable acceptable ?

I may be wrong, but I thought that a defendant’s previous wrong doings were not allowed to be presented before or during a trial… I guess that the AG’s presenting all of these previous fines and settlements and trying these defendants in the media is OK because it is the AG/bureaucrat/politician doing it ?

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Coronavirus Conundrum

https://pharmacistactivist.com/2020/May_2020.shtml

Science, Evidence, Knowledge, Reasoning, Opinion, Civility, and Lessons – All are necessary!
I am a pharmacist, scientist, and teacher with particular expertise regarding drug therapy. Not all pharmacists, scientists, and teachers will have the same opinions and beliefs regarding complex issues.

The coronavirus (COVID-19) experience has a very broad range of characteristics, risks, and implications, many of which I don’t begin to understand. The only thing that is entirely clear at this time is that no one individual has the wisdom to make all of the best decisions and actions during this time of crisis. Accordingly, I have attempted to avoid criticizing and/or second-guessing the decisions and actions that have been made by the President, Governors, public health officials, and others in authority. They have a huge responsibility and I believe that, notwithstanding even strong differences of opinion, they are motivated to do what they consider to be in the best interests of both the public and our country. Many others have experience, knowledge, and perspectives that can be of value in attaining understanding of the scope and specifics of the challenge and in formulating plans and actions. It is in this context that I provide the following commentary.
Science
I marvel at and learn from the vast amount of information that has been acquired from research and other means of scientific discovery. This has resulted in exponential increases in knowledge and technology, much of which I don’t comprehend, let alone learn and apply. However, one thing has become very clear – the more I learn, the more I recognize how much more remains to be discovered and learned. Each new fact or clue discovered is the next piece with multiple connections of an ever-expanding puzzle on a moving table. As one disease becomes better understood and more effectively treated, another previously unknown disease emerges (e.g., SARS, MERS, COVID-19). Research and scientific discovery must continue to be vigorously pursued but, in my view, will never provide the answers to every question. At this time, there are many more questions regarding COVID-19 than there are definitive answers, and both will continue to increase.
Evidence
I am a strong advocate for evidence-based medicine and drug therapy. With respect to my involvement in reviewing and writing about new drugs, I would like to see more comprehensive studies of effectiveness and safety than what the Food and Drug Administration requires for approving most new drugs. Specifically, in addition to studies comparing an investigational drug with placebo, I would like to see the drug directly compared with at least one drug that is already on the market and considered a first-line treatment for the disease for which the new drug has been developed. When I review a new drug, I identify what I consider to be the advantages and disadvantages of a new drug when compared with previous drugs with which it is most similar in activity and use. If the new drug has only been evaluated in placebo-controlled studies, but also could have been compared directly with an older drug used for the same condition, I identify that as a “disadvantage” for the new drug.

There are, however, urgent situations such as COVID-19 in which actions must be taken before evidence can be acquired. At the time I write this, there is no treatment that has been demonstrated to be effective, or not effective, in adequate clinical trials for COVID-19. Although some currently available medications (e.g., hydroxychloroquine) have been suggested to be of potential benefit, some have been highly critical of suggestions that these drugs be considered for use before studies are conducted and evidence is provided. At best, these criticisms are excessive and inconsistent with previous experience.

Let’s consider the experience with another important infectious disease – Lyme disease – and ask what medication is the treatment of choice for most patients with Lyme disease? Most health professionals would immediately respond that it is doxycycline. Now look at the labeling (i.e., package insert) for Vibramycin, the original and best known trade name for doxycycline products. There is absolutely no mention of Lyme disease or the microorganism that causes it. How can that be? The answer is that there have not been well-controlled clinical studies that have resulted in documentation (i.e., evidence) of effectiveness of the drug for Lyme disease and the resultant action to request FDA approval of the drug for this condition. It has been the sound clinical knowledge and reasoning that have resulted in the successful “anecdotal” use of doxycycline that are responsible for its widespread use for Lyme disease and its being viewed as the usual treatment of choice. When it is used for this condition, it is being prescribed “off-label.” An analogous situation now exists with respect to the use of hydroxychloroquine for treating COVID-19.
Some things we know
I was initially surprised when I learned that some had suggested that chloroquine (e.g., Aralen and generics) and hydroxychloroquine (e.g,, Plaquenil and generics) might be of benefit in treating COVID-19. I think first of these agents as antiparasitic drugs that are effective for the treatment and prophylaxis of malaria. However, they also have an effect on the body’s immune system, and have been approved for the treatment of immunologically-mediated disorders such as lupus and rheumatoid arthritis. The topics of parasitic infections (e.g., malaria), lupus, and rheumatoid arthritis are among those that I have taught, and I am very familiar with the characteristics, actions, and risks of these drugs. Of the two drugs I consider hydroxychloroquine to be safer than chloroquine, partly because of the extent to which it has often been used in the treatment of lupus for extended periods of time, with most patients tolerating it well. As with all drugs, the use of hydroxychloroquine is associated with certain adverse events and risks, but I consider the risk of serious adverse events to be low and disagree with those who have stated or implied that there is a high risk of cardiac and other potentially fatal complications. Careful assessment and monitoring of both drug and patient risk factors should enable avoidance of serious drug-related problems in most patients.

Other medications that are currently available for other indications have also been suggested to be of potential benefit for treating patients with COVID-19. Protease enzymes are thought to have a role with respect to the activity of the virus, and lopinavir/ritonavir (Kaletra), a combination of HIV protease inhibitors, has been evaluated on a limited basis. Some patients with serious COVID-19 may experience further damage from a “cytokine storm” that is thought to be associated with excessive activity of interleukin-6 (IL-6). Tocilizumab (Actemra) and sarilumab (Kevzara) are IL-6 receptor antagonists that were initially approved for the treatment of patients with moderately to severely active rheumatoid arthritis. Tocilizumab has been subsequently approved for other uses including patients with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.

Numerous investigational medications are being evaluated for potential benefit in treating COVID-19, with the antiviral agent remdesivir among the most promising.
Reasoning and opinion
On March 27 I was asked by the coordinator of the COVID-19 response in the county in which I reside to respond to a question she had received about hydroxychloroquine. I responded with some of the information discussed above and noted that there are no clinical studies with sufficient controls and size to demonstrate the effectiveness, or lack of effectiveness, of the drug in the treatment of COVID-19 (i.e., no evidence). I concluded my response with the following statements:

Because of my age and medical issues, I am an individual who would be considered at high risk of serious complications from COVID-19. If I was to have the misfortune of contracting COVID-19 and experienced moderate to severe symptoms, I would insist on being treated with hydroxychloroquine.

I arrived at that opinion based on my limited knowledge of COVID-19, anecdotal experience, my knowledge of the risks of hydroxychloroquine, as well as my age and medical issues, and applied my reasoning and judgment to reach that conclusion for myself. Indeed, I made that decision very quickly. As an individual who is at high risk, serious complications from COVID-19 can be fatal. I consider the risk of my experiencing a serious adverse event with hydroxychloroquine to be much lower than the risk of death caused by COVID-19. I accept that risk. I have not concluded at this time that I would use it if I tested positive for COVID-19 or experienced mild symptoms, nor would I use it for prophylaxis to reduce the risk of infection in my current experience of relative isolation and social distancing. And I do not have a supply of hydroxychloroquine just in case I would need it.

Some health professionals who are on the front-lines in treating patients with COVID-19, and are placing themselves at high risk, are using hydroxychloroquine for prophylaxis to reduce their risk of contracting the infection. They have made this decision based on their knowledge and judgment in the context of assessing their personal risks, and I understand and support their decision for themselves that is made in the absence of evidence.

For health professionals and others who are in a better position to exercise knowledge and clinical judgment, what responsibility do we have to share our perspectives and provide guidance for others? Recently a high official at the Centers for Disease Control and Prevention (CDC) responded to a question about hydroxychloroquine: “I’m not going to recommend it and not going to not recommend it. We’re not an opinion organization, we’re a science-based data-driven organization…” In my opinion, it is unacceptable that at a time when thousands of people are dying, some very capable officials who are supposed to be protecting us are so obsessed with a need for evidence that they refuse to identify options based on what is being explored or guidance that could be life-saving.

Several days ago I learned that the son-in-law of a friend was diagnosed with COVID-19 and was in the ICU of our local hospital. That night I awakened from my sleep thinking about this situation and debating with myself whether I should contact my friend the next day and ask about his family member’s status and treatment. I do not personally know the patient, was not involved with his care, and some might view my question as curiosity or as none of my business. I decided I needed to call and was able to return to sleep. The next morning I called my friend and, after voicing concern and inquiring about his son-in-law’s current status, I inquired whether he was being treated with hydroxychloroquine. I was encouraged to learn that he was being treated with it and that his condition was considered stable. It is too soon to know the results of this individual’s treatment. However, if I failed to make that call and he died, even with the best supportive care provided in the ICU but not treated with hydroxychloroquine, I would have been haunted by knowing that I could have provided a suggestion for consideration that might have prevented a fatal outcome.

As of April 15 approximately 26,000 Americans have died from COVID-19. There are no treatments that have been evaluated in clinical trials with sufficient controls and size that have provided evidence of effectiveness. Health professionals and others who are in a position to integrate anecdotal information with sound reasoning and judgment have a responsibility to provide their observations/suggestions that may be of benefit in averting potentially fatal consequences. Deaths will not stay “on hold” while we conduct the research necessary for evidence.
Civility
Long before the arrival of COVID-19, there has been a sharp decline in civility of comments and discussion of individuals with differing opinions. Particularly evident in but not limited to politics, too often there can’t just be disagreements, but rather there are many examples of ridicule/condemnation of the views and character of others. In numerous situations, the reaction appears to be based not on the merits of the idea or recommendation, but rather on the individual who made the statement. Every political party and organization that is a strong advocate for a particular cause/issue has participated in this harmful rhetoric. It is nonpartisan and the consequence is gridlock rather than collaboration and progress on important matters.

As one example, some have alleged that certain individuals who have designated COVID-19 as the Wuhan virus or China virus are racist. This allegation ignores the many previous situations in which the designation for a disease has identified the community or country in which the disease was first identified. There is another respiratory illness that comes to mind. In 1976 members of the American Legion convened in Philadelphia to celebrate our nation’s bicentennial. Many were afflicted with a mysterious, pneumonia-like disease that was previously unknown and fatal for some. The condition was designated as Legionnaires’ disease and, when the causative organism was subsequently identified, it was designated as Legionella pneumophila. Not only is the community (i.e., phila) identified, but so is the specific group/organization of individuals who had the misfortune of being the first who were known to be afflicted with this disease. Using these designations is not viewed as being critical of patriotic members of the American Legion or the city of brotherly love.
Lessons
Science, evidence, knowledge, reasoning, opinion, and civility must all be viewed as important components of strategies and plans to move forward. So are the lessons that are learned from experience, including the following:

Pharmacists and other health professionals who are providing the front-line expertise, care, and services for patients in need are HEROES, as are their staff colleagues and other workers who place themselves at risk for the benefit of those at greater risk. Their professional roles and authority must be further enhanced in anticipation of future healthcare challenges.

Because of the recent books Bottle of Lies (Katherine Eban) and China Rx (Rosemary Gibson), there has been an increased awareness of the dependence of the United States on China and India for most commonly used medications including antibiotics. The COVID-19 experience must be cause to motivate actions to assure the availability and safeguards that can be provided by manufacturing drug products in this country.

The specific worst-case scenario for COVID-19 that I have heard in this country is that as many as 240,000 Americans may die. Fortunately, the numbers and curves of the graph are now suggesting that the number of deaths will be much less. Our country has been shut down and we might think that nothing worse could happen. However, there are even greater threats that many individuals, families, and homes are experiencing right now. Approximately 480,000 American die each year as a result of complications associated with smoking. Tens of thousands of Americans have died in the last several years as a consequence of opioid overdosage. The highest priority must be given now to COVID-19, the patients afflicted with the virus and their family members, the protection of health care workers and other essential employees, the needs of the unemployed, and the restoration of our economy. However, when we recover from COVID-19, will we devote even a small fraction of attention, publicity, and action to these other plagues of our society?

Daniel A. Hussar
danandsue3@verizon.net

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https://youtu.be/FIGjQMlLFj8

I don’t endorse or condone what is stated in this video this information in this video… just sharing…

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LOOKING FOR FORMER WALMART PHARMACISTS & PHARM TECHS

Lawyers involved in the Opioid Litigation are interested in speaking to former Walmart Pharmacists & Pharm Techs who are willing to talk about their experiences dealing with questionable prescriptions or prescribers.

Please contact either attorney Chuck Gabriel (Chalmers & Adams, LLC) at 678.735.5907 or by email at CDGabriel@CPBLawGroup.com  or attorney Kyle Oxford (BurnsCharest LLP) at 504.799.2846 or by email at koxford@burnscharest.com.

The link below will give those interested the background information on this potential lawsuit

https://www.propublica.org/article/walmart-was-almost-charged-criminally-over-opioids-trump-appointees-killed-the-indictment/amp

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