As we anticipate what will – or will not – happen in regards to how the community will be treated after Jan 20, 2021.

A <D> controlled Congress gave us the Controlled Substance Act in 1970 and it assigned the task of enforcing this new law to our judicial system and our judicial system  only has one solution to someone breaking a law – prison /jail… that is the only tool in their “toolbox”.

During the Obama Administration we had three attorneys at the top of the administration – Obama – Biden – Holder.  The decade of pain law that was passed in 2000 by a <R> controlled Congress and is probably responsible for some inappropriate prescribing of opiates and controlled substances.

When that law expired 2009… there was a <D> Congress and they failed to renew that law…  FL had become a hot spot for pill mills and then Gov Rick Scott and AG Pam Bondi started to clean that mess up… Bondi in her campaign commercials for reelection she claimed to run all the “oxy-docs” out of Florida and Scott is now FL’s Senator and Bondi keeps showing up on Fox cable trying to be “someone important” in the Republican party.

It has been reported that Biden is a “tough on law” person…  when Trump came to office … he put Jeff Session in as AG and now Wm Barr is AG..  What all three of these men have in common is that they are in their 70’s … and they were admitted to the state bar just before or after the Controlled Substance Act became law.

IN 1970, was the year that I first become licensed as a Pharmacist and I know all the BS propaganda that was put out around the DEA coming to power. 

It has been reported that Harris is a “tough on law” type of person…  it is claimed that she had 1500 MJ smokers sent to jail … while around the same time she admitted on a recorded interview that she “used MJ”.  It is also reported that she threatened to jail parents whose kids had a truancy problem.

The community has no idea if Biden/Harris win this election as to who will be chosen as AG.

One can just imagine what will happen if the new AG under a Biden/Harris Presidency is another “tough on law” attorney.

If anyone has bother to notice… I have not heard one word – from either side – about the “war on drugs”… the COVID-19 pandemic is like a media tsunami

One thing, everyone needs to consider… we all hear each week about 2-3 cops getting killed but when is the last time that anyone has heard about a DEA agent getting killed ?  Aren’t they suppose to go after the drug cartels and isn’t it common knowledge that the cartels do not like anyone interfering with their business plan and are known for shooting/killing anyone who does screw with their business plan.

Does this suggest that the DEA has no interest in stopping the illegal drugs getting on our streets – from their source ?  And, it would seem that the DEA’s methodologies have been the same/similar for at least the last 12 yrs.

The Biden/Harris motto is BUILD BACK BETTER… where does the war on drugs and the community fit into that motto…  hopefully someone will be asking these questions to these candidates.

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https://youtu.be/vSMjLdaOvlI

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West Virginia AG Sues Walmart, CVS Over Opioid Pill Flood

https://www.usnews.com/news/best-states/west-virginia/articles/2020-08-18/west-virginia-ag-sues-walmart-cvs-over-opioid-pill-flood

West Virginia Attorney General Patrick Morrisey has accused Walmart and drugstore chain CVS of failing to monitor and report suspicious orders of prescription painkillers to their retail pharmacies.

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Sure sounds like Kessler is a “hired gun” and his medical specialty was PEDIATRICS.  It is amazing that the law – DECADE OF PAIN 2000 – that was passed by Congress and signed into law by Bush 43. Pain became the “5th vital sign” and Joint Commission made it a MAJOR STANDARD for those healthcare facilities that they credentialed.  But that was not considered an encouragement to prescribers to properly treat a pt’s pain ? So it would appear that the New York bureaucrats are suing over a issue of increased opiate prescribing that could have been – at least in part –  by actions of our Federal Congress.

https://legalnewsline.com/stories/548505991-new-york-s-opioid-case-no-improper-prescriptions-no-misled-docs-big-damages

CENTRAL ISLIP, N.Y. (Legal Newsline) – Former Food and Drug Administration Commissioner

David Kessler acknowledged in the opening hearing of a high-profile trial in New York that he didn’t talk to any doctors or make any attempt to quantify how prescription drugs contributed to the state’s opioid crisis.

Lawyers defending the opioid industry are trying to exclude Kessler’s expert testimony by showing he lacks a rigorous scientific basis for his opinion that drug manufacturers and distributors are responsible for opioid abuse. Kessler, who has earned millions of dollars as an expert witness for plaintiff attorneys since leaving the FDA in 1997, said his opinion is based upon his experience as FDA chief and internal documents showing the companies engaged in improper marketing practices and “deviations” from FDA rules.

The State of New York and Nassau and Suffolk counties have agreed, in advance, that they will present no evidence that defendant companies sold opioids to anyone who wasn’t licensed to distribute them, or that were sold without a legal prescription. As in federal multidistrict litigation, they will instead argue that doctors and other medical professionals were improperly influenced to issue too many prescriptions for addictive drugs, leading to abuse and overdose deaths. 

After a delay of several months due to COVID-19, the New York trial will proceed in two stages – first to determine liability and then damages.

The questioning of Kessler over two days offered a preview of the state’s case and the industry’s defense. Hunter Shkolnik, the private lawyer representing New York under a contingency-fee contract that could yield his firm hundreds of millions of dollars, led Kessler through his theory of how the increased availability of dangerous drugs increases the risk of abuse. Kessler said that as head of the FDA, he oversaw the agency’s enforcement of rules prohibiting drug companies from making marketing claims that aren’t supported by scientific evidence.  

Kessler also looked at contributions by opioid companies to independent groups that advocated for the increased use of opioids to treat chronic pain. The American Pain Foundation got $5.3 million from Endo Pharmaceuticals, for example, and issued a brochure saying the risk of addiction was low and urging patients to seek a pain specialist.

“A company cannot pay a third-party organization to do what it itself cannot do,” Kessler said.

Attorney Steve Brody of O’Melveny Myers, representing Johnson & Johnson, opened by asking Kessler if he had earned “millions of dollars” as an expert witness. 

“You had to anticipate this question,” interjected Suffolk County Justice Jerry Garguilo. “You made money.”

Kessler said yes and Brody went on, repeatedly asking whether he investigated the cause-and-effect relationship at the heart of the case, which is whether the drug companies caused physicians to prescribe too many opioids.

“Did you ask any doctors why they prescribed opioids?” Brody asked, with Kessler answering “no.” “You’re not going to identify a single medically unnecessary prescription in the state of New York, are you?”

“I’m not going to get into necessary or unnecessary on an individual prescription, no,” Kessler answered.

Brody also asked Kessler about drug salesperson “call notes” he included in his report, part of the evidence plaintiff attorneys culled from millions of pages of documents they received from defendant companies in discovery. One involved a conversation about Duragesic, a Johnson & Johnson fentanyl patch that the company maintains was particularly hard to abuse. 

The note included the phrase “they all said low abuse potential,” which would have instantly triggered a law-firm word search. But Kessler couldn’t identify who the “they” was, who “Nicole” in the note was, or whether the drug rep was telling the doctor about low abuse potential or the other way around.

“I wouldn’t look for one anecdotal conversation,” he said. “I was looking at the record as a whole.”

The drug companies are trying to undermine Kessler’s status as an expert under New York’s Frye standard, which requires experts to present opinions grounded on methods that are scientifically sound and generally accepted as reliable. Toward that end, Brody attempted to show that Kessler will testify improper marketing was the cause of New York’s opioid crisis without having performed any analysis of other potential causes, from illegal heroin and fentanyl to the U.S. government’s own reports, going back to the 1970s, identifying chronic pain as a serious problem costing hundreds of billions of dollars a year.

Kessler kept describing such inquiries as “beyond the scope,” a legal term referring to rules of evidence. At one point Justice Garguilo barked: “Beyond the scope of what?” 

Brody concluded by accusing Kessler of lacking a methodology that could reliably show the role any individual company played in the drug crisis.

“I have a learned methodology that manufacturers contributed with marketing to increased use, and increased use led to addiction,” he answered. “Promotion has an effect on prescription sales, those sales made increased opioids available, and their availability leads to increased abuse.” 

Other witnesses who will be questioned in pretrial hearings include James Rafalski, a former Drug Enforcement Agency official, and Lacy Keller, a data expert plaintiff attorneys have relied upon to show defendant companies shipped billions of orders that would should have been flagged as “suspicious.”

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nothing is going to change until Trump and all of his enablers are out of office. The only hope I have is that I believe Biden and Harris both have empathy and have critical thinking skills and can think “outside the box.” It starts from the top, and hopefully Biden will put qualified intelligent people in charge who will be willing to listen and acknowledge the “unintended consequences” and devastation that is being done to chronic pain patients and will not be afraid to speak out and start to fix this horror we are going through. One of many reasons IMO to vote no matter how hard Trump and his cronies try to invalidate ballots.

Does anyone know what Biden/Harris platform really is ?  First of all they are both ATTORNEYS… We had that  also with Obama/Biden 8 yrs…  Biden got his license to practice law in the early 70’s … not sure if he ever really practiced law… but at about the same time that the DEA was created.  Around the same time that I got out of college and I know the propaganda/fear that the DEA spread around back then.   They were actually going after the cartels, because there was no computerized PDMP databases for them to data mine on prescribers.

Harris is also an attorney and according to Wikipedia she si She is the first African-American, the first Asian-American, and the third female vice presidential running mate on a major party ticket https://en.wikipedia.org/wiki/Kamala_Harris.  But her parents were from Jamaica and India. According to this website https://www.quora.com/Are-Jamaicans-living-in-the-United-States-considered-African-Americans-Do-they-consider-themselves-African-Americans it is unusual for some from Jamaica to identify as black or African/American.  Maybe she is just following in Elizabeth Warren’s footsteps when she claimed that she was a “native American”

Those hoping that Biden/Harris will listen to the chronic pain community on being unfairly treated, but according to her felony conviction rate:

Felony conviction rate

Just prior to Harris taking office the felony conviction rate was 50 percent;^[51] by 2009 it was 76 percent.^[52] Convictions of drug dealers increased from 56 percent in 2003 to 74 percent in 2006.

It has been reported that she sent 1500 people to jail for smoking MJ, yet in a public interview… admitted to using MJ. Didn’t we have another President – who was an attorney – that admitted to “trying” MJ ?

During the Presidential debates Harris accused Biden of being a racist and agreed with the women that accused Biden of inappropriate touching.  Now that doesn’t seem of concern to her ?

Yesterday during one of their first public appearances, they refused to take any questions from the press that was in attendance ?

This is Biden’s THIRD TIME running for President – the previous two times .. he never got any traction and Harris’ attempt this time, she dropped out of the race BEFORE THE FIRST PRIMARY.

Of course this has happened before, Nixon lost to Kennedy and then came back a few years later to be elected President and this Presidency brought us the Controlled Substance act/DEA , Watergate, and his resignation and his VP Spiro Theodore Agnew had resigned – only the second VP in our history to do so and we got Gerald Ford as President .. because he was Speaker of the House and next in line in our order of succession.

If you consider what both Biden & Harris stated during the Presidential debates… they are for “Medicare for all”… but what has been described is really “Medicaid for all” … no premiums, no deductibles, no copays… price tag… about 3-4 trillion/yr…  and if they confiscated all the assets of the billionaires that would pay for the first six months and then confiscate all the assets of all the millionaires would pay for the second 6 months… I guess they haven’t thought out how they are going to pay for it after the first year.. If anyone wants to get a idea of what a national health insurance would look like.. just look at our VA medical system… that is a single payer system.

They indicated that they want to get rid of fracking… there goes a lot of jobs in PENN & Ohio… fuel prices jump dramatically… remember back in early 2000 when fuel was $4.00+/gal ?  and we will no longer be energy independent… and have to purchase energy from some countries that really are not our friends.

Both Biden/Harris has indicated that they want open borders and Harris has stated in a interview that she wanted everyone that is in our country would be entitled to safety, education and healthcare.

But wait, while she was CALF Attorney General she wanted more money to fund police but now she is behind defunding law enforcement or just rearrange how money is used by law enforcement.

She has already stated she is in favor of a “mandatory buy-back of  AR type guns”.. by the way “AR” stands for AUTOMATIC RIFLE and only the military have AR’s that are capable of shooting automatically..the ones sold to the general public are SEMI-AUTOMATIC and those AR guns are  only involved in < 1% of mass shooting.  Beside a mandatory buy-back of guns is basically a confiscation of guns.  First it is rifles… then it will be all hand guns… and there goes the second  amendment !  They want to defund law enforcement and disarm our citizens.

Just pay attention, Illinois has one of the most strict gun ownership laws and yet Chicago typically has at least a couple of dozen of shooting EVERY WEEKEND.

According to this Harris is a anti-catholic bigot and Biden is a active practicing Catholic

Our national debt was 10 trillion when Obama took over and he passed a 20 trillion debt  to Trump and if Nancy & Chuckie gets want they want on this next “pandemic money” our country will end this fiscal year (09/30/2020) with a national debt at or exceeding 30 trillion..  We are quickly becoming the Argentina of North America.

My Father’s had a favorite saying … that I heard often when I screwed up as a kid… “now that you have shit in your nest… you will just have to learn to sit in it’

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https://pharmacistactivist.com/2020/August15_2020.shtml

Two are Needed and Two Should be Rescinded!

The cost of many drugs is far too high!

Pharmaceutical companies, pharmacy benefit “managers” (PBMs), and health insurance companies have been engaged in a “blame game” for many years in faulting the others for the high cost of drugs. While they do this, drug costs continue to increase! These companies will not identify an equitable strategy and solution that will serve society well.

Elected officials and government agencies are engaged in partisan politics to such an extent that they have failed to effectively address the issue of excessive drug costs. This political impasse is not likely to be resolved anytime soon. The victims of these failures are patients and society, and the prescribers, pharmacists, and other health professionals who have the responsibility for assuring the most appropriate and effective use of medications with the least risk possible.

President Trump has issued four executive orders (EOs) regarding drug prices. I give him credit for recognizing the importance of taking action and his boldness in acting at a time when others who should be effectively addressing these matters have failed to do so. We can’t expect anyone who does not have expertise in the areas of health care and medication use and costs to be in a position to identify the best strategies and actions. Indeed, many of the “experts” in health care, including health professionals do not agree on a course of needed action. However, the added challenges for the President are that many of those who have the greatest access to him and the opportunity to contribute to and influence decisions, have vested interests and/or political agendas. The consequence is actions that include some that are flawed. Let’s consider the EOs on an individual basis.

Access to affordable life-saving medications

This EO is applicable to insulin and epinephrine (e.g., EpiPen) products. Federally qualified health centers (FQHCs) and hospitals that serve eligible patients (e.g., those with low income who do not have health insurance) participate in the 340B program and are able to obtain medications at large discounts from pharmaceutical companies. The EO directs FQHCs to pass along discounts for insulins and epinephrine (“life-saving” drugs) to patients.

This is a needed and important action BUT, it must be viewed as a small first step in eliminating the widespread abuses in the 340B program. The EO is only applicable to FQHCs and not the hospitals and PBMs involved in the program, it only includes the drugs considered life-saving, and the policies for implementation and monitoring compliance with the order have not yet been identified.

Increasing drug importation to lower prices for American patients

This is a seriously flawed concept and order, and should be rescinded! This EO would permit individual states to develop programs that would enable safe importation of certain drugs, and would enable personal importation waivers at authorized pharmacies. Such a system would be a great disservice for patients and place them at increased risk of drug-related problems. It would enable even more fragmentation of health care and drug therapy for patients, create additional questions about the quality and potency of imported medications, have a disruptive impact on the supplies of drugs in the countries from which they are imported, have a harmful economic impact on many pharmacies and other healthcare entities in the U.S., and require inefficient and costly regulations and procedures that would erode much of the anticipated cost savings.

The problem of excessive prices for many drugs has occurred and been enabled and exploited in the U.S., and must be resolved within this country!

Lowering prices for patients by eliminating kickbacks to middlemen

This EO is needed and extremely important BUT, it must be viewed as an essential first step in restoring the integrity of drug prices and the drug distribution system. Although there are some relatively small PBM middlemen who are committed to providing transparent and financially responsible services, the marketplace is dominated by three huge PBMs – CVS Caremark, Express Scripts, and Optum – that engage in secretive, deceptive, and highly profitable (for themselves) practices. If government officials and the public were specifically aware of the high percentage (often well above 50%) of the price of some drugs that is extracted as kickbacks/rebates by PBMs, there would be outrage and refusal to tolerate the continuation of these self-serving practices that are at the expense of patients, society, and health professionals. The terms of their secret deals are so fiercely hidden and protected that even government officials are not able to obtain the details of the financial arrangements. Government regulators in Ohio, West Virginia, Pennsylvania, and some other states have made progress in identifying the deception and fraud in certain government-funded programs, but even they are stonewalled and mislead by these PBMs.

Eliminating kickbacks from pharmaceutical companies to PBMs is a positive first step. However, this action must be accompanied by strong regulation of PBM practices in both government-funded and other prescription benefit programs, prohibiting direct and indirect remuneration (DIR) clawback fees from pharmacies, very close regulatory monitoring of their operations, and strong criminal and/or civil actions when harm from and fraud in their operations and programs are identified. Even if rebates from companies to PBMs are eliminated, if these other reforms and actions are not also taken, these PBMs will identify other secretive strategies to recoup their losses and continue their costly programs to the great disadvantage of patients, health professionals, and the healthcare system. More whistleblowers who are current or former employees of these PBMs are needed!

Restricting prices of the most costly Medicare Part B drugs to no more than the amounts charged in other economically comparable countries

This is the second seriously flawed concept and EO that should be rescinded! Suffice it to say that, if government regulators are not able to completely and accurately identify the amounts of kickbacks/rebates and other financial parameters of drug pricing in this country, there is no way of obtaining specific and accurate drug pricing information in other countries beyond knowing that their drug prices are lower.

Recommendations

Pharmaceutical companies, PBMs, and health insurance companies will continue their current drug pricing strategies and programs, and further increase drug prices, unless firm actions are taken to prevent them from doing so. The President, other elected officials, and appropriate government agencies must learn from and act on the counsel and recommendations of patients, pharmacists, and other health professionals who are victims of the destructive present healthcare system. They must give the highest priority to eliminating kickbacks from pharmaceutical companies to PBMs, and to eliminating the unnecessary and costly involvement of PBMs, or rigidly controlling their policies, operations, and programs. Organizations of pharmacists and other health professionals must work together with a united voice and strategy to lower drug prices and attain reforms in the health care system.

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Book smarts vs age/experience/wisdom ?

An old geezer became very bored in retirement and decided to open a medical clinic.
His sign read: “Dr.Geezer’s clinic. Get your treatment for $500, if not cured, get back $1,000.”
Doctor “Young,” who was positive that this old geezer didn’t know beans about medicine,
thought this would be a great opportunity to get $1,000. So he went to Dr.Geezer’s clinic.

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