This is so sad, this is about 10 miles from our home.  The pharmacy was in “downtown” Corydon.  Right off the typical town square. Corydon was also the FIRST CAPITAL of Indiana.  When I was first licensed there was a second pharmacy on the town square (Davis Pharmacy)… which closed years ago.

With the closing of Butt Drug, this very rural county of abt 40,000 and abt 500 sq miles with FOUR PHARMACIES – CVS, Walgreens, Walmart in Corydon and a Walgreen  in the unincorporated community New Salisbury geographically close to the center of the county.

Harrison county being the 4th oldest county in the state and its southern border being the Ohio River has quite the history being founded over 200 yrs ago https://en.wikipedia.org/wiki/Harrison_County%2C_Indiana

ironically enough, I got this email today from the National Community Pharmacist Assoc, whose membership is almost exclusively independent pharmacists and I have been a member for FORTY YEARS.  Calling attention to the all the “pharmacy deserts” that the PBM industry is creating from the “financially strangling” independent pharmacies by reimbursing independent pharmacies less than the cost of purchasing the medication from their wholesaler.

50 states sign up for Walmart’s opioid settlement framework -3.1 billion

The above agreement with Walgreen, CVS, Walmart and them paying abt 13 billion settlement, from being sued by the 50 states Attorney Generals, Native American Reservations, and others.  While admitting no wrong doing,  it has been rumored that all three agreed to REDUCE the number of opioid and/or controlled substances they dispensed.  I have seen some feed back from some chronic pain pts that Walgreens is sending a 26 questionnaire to some prescribers to help Walgreen understand and apparently meeting  Walgreen’s medical justifications that they will fill a particular prescriber’s controlled med Rxs. 

Here is the SMOKING GUN to prove civil rights violations – could support a class action lawsuit – but the community needs to stand up

here is a second article about the three major drug wholesalers that covers abt 80% of the Rx medications to pharmacies and they also was sued and ended up with nearly a 600 page agreement with them also agreeing to REDUCE the opioids and/or control meds sold to pharmacies.  The chronic pain community seems to being “painted into a corner” and/or corralled into some area with only one way in and out and that is being controlled/managed by entities that are determining what and how much medically necessary medications each needs based on some- one size fits all – formula or statistic.  

ironically enough, I got this email today from the National Community Pharmacist Assoc, whose membership is almost exclusively independent pharmacists and I have been a member for FORTY YEARS.  Calling attention to the all the “pharmacy deserts” that the PBM industry is creating from the “financially strangling” independent pharmacies by reimbursing independent pharmacies less than the cost of purchasing the medication from their wholesaler.

NCPA April 21, 2023

The letter that Butt Drugs sent out to their patients stated that >50% of prescriptions “went out the door”  with the pharmacy getting paid less than the cost of the medications from their wholesaler. It can’t go unnoticed that Butt Drugs Rx files were sold to CVS in Corydon, which just happens to own one of the top three PBM’s  – Caremark ( Prescription Benefit Managers) as well as Aetna Insurance and Silver Scripts Medicare Part D  and the top 5 PBM’s control the price pharmacies are paid and the CVS in Corydon has the closest pharmacy to Butt Drugs.

there are more videos on www.youtube.com

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FDA Panelists Slam Agency’s Proposed Opioid Trial Design

https://www.medpagetoday.com/painmanagement/opioids/104117

Advisors said outcomes from an enriched enrollment study would not be broadly generalizable

FDA advisors recommended that the agency reconsider its planned postmarketing trial design to evaluate the long-term efficacy and tolerability of opioids in chronic pain patients.

Without holding a vote on Wednesday, the Anesthetic and Analgesic Drug Products Advisory Committeeopens in a new tab or window shared concerns about using an enriched enrollment randomized withdrawal (EERW) design as a required phase IV study for certain opioids currently available on the market.

“I don’t think this really tells us anything about the most clinically meaningful question for this population, whether opioids are a better treatment than non-opioid analgesics or other approaches to treatment,” said committee chair Brian T. Bateman, MD, MSc, of Stanford University School of Medicine in Palo Alto, California. “I think that’s really where the agency’s attention should be focused.”

The 12-month trial, for chronic non-cancer pain patients who had initial tolerability to an extended-release (ER)/long-acting (LA) opioid, would include an open-label portion followed by a tapering period and a placebo period for the control group.

“It’s just an awful lot of work for a possibly very predictable answer,” said Mary Ellen McCann, MD, MPH, of Harvard Medical School in Boston. “It’s called enriched enrollment. I almost think it’s enhanced enrollment. It’s designed to give a positive result before the study’s even begun.”

Maura S. McAuliffe, CRNA, PhD, of East Carolina University in Greenville, North Carolina, noted that she’s “come away with the impression that, for me, to use an old-fashioned term, it lacks face validity. The outcomes to me are very predictable. If you give somebody … 42 weeks of opioid therapy at relatively high doses, or potentially up to 240 mg a day, yeah, I think that they will have relief of their pain.”

Prior to sharing their overall reservations about the agency’s proposal, the committee discussed the practicality of the EERW design, and highlighted several specific concerns, including the shorter tapering schedule and the use of pain scores as a secondary endpoint. Several advisors said a focus on patient functionality would be more clinically meaningful than self-reported pain scores. They also recommended the tapering period be increased to a minimum of 14 days.

“One of the main concerns about this proposed design is a bit of an underestimation of the potential risks that would be there,” said Mark C. Bicket, MD, PhD, of the University of Michigan in Ann Arbor. “While the internal validity would be strong, it would have the potential for some difficulty of interpretation, as well as not necessarily providing information that would be as clinically relevant when there is a large opportunity for that, so I would be certainly in favor of thinking about some of these other designs.”

The committee also pointed out that it is unlikely that the study design would allow the researchers to maintain a sufficient number of study participants, which could affect the interpretation of outcomes.

While the advisors felt the length of the study (38 to 52 weeks) would be acceptable to evaluate long-term efficacy, they did express concerns about safety and the potential for confounding during such a long trial period. They also said they were doubtful that enough participants would be willing to remain in the placebo arm for the proposed length of the study.

While FDA staff acknowledged several challenges, they also emphasized that the EERW study design would likely be the best available option, considering the difficulties of conducting a placebo-controlled trial for chronic pain over a long time period.

During the public comments portion of the meeting, several stakeholders voiced their disapproval of the EERW design and the failure of the Opioid Postmarketing Requirements Consortium and FDA to successfully study the long-term efficacy and safety of opioids in the 10 years since the original postmarketing requirement was issued in 2013opens in a new tab or window.

“The EERW is not double-blind. It’s not even single-blind. Patients who take a drug with a strong psychoactive effect for weeks and months then switch to a placebo are likely to know it,” said Andrew Kolodny, MD, co-director of the Opioid Policy Research Collaborative at the Heller School for Social Policy and Management at Brandeis University in Waltham, Massachusetts. “For obvious reasons the results from EERW are not generalizable because only patients who tolerate opioids and find them helpful are randomized.”

Caleb Alexander, MD, MS, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, added, “I suppose the question is why more than 20 years into this epidemic, the FDA would risk squandering this valuable moment by examining the persistence of efficacy among a highly select subpopulation, rather than requiring sponsors to demonstrate whether ER/LA opioids work in the first place.”

While the FDA typically follows the advice of its advisory committees, it isn’t required to do so.

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MINORITY REPORT: THE DOJ-DEA PRE-CRIME, DATA ANALYTICS, PARALLEL CONSTRUCTION: Prt-1

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Cigna’s PBM unit launches new pricing plan amid scrutiny over rebates

https://www.reuters.com/business/healthcare-pharmaceuticals/cignas-pbm-unit-launches-new-pricing-plan-amid-scrutiny-over-rebates-2023-04-13/

April 13 (Reuters) – Cigna Group’s (CI.N) pharmacy benefit management (PBM) unit said on Thursday it will launch a new pricing plan that will include exact information on rebates, as pharmacy middlemen come under scrutiny by U.S. lawmakers for their opaque drug pricing practices.

The new plans from Cigna come amid close examination from regulators including the U.S. Federal Trade Commission which is conducting a study to see if rebates sought by pharmacy middlemen reduced competition, ultimately leading to higher drug prices.

The PBM unit, Express Scripts, will also introduce a new co-pay plan for consumers which will cap out-of-pocket costs between $5 and $45, depending on whether the drug is generic or branded.

PBMs negotiate drug prices with manufacturers, health plans and pharmacies.

Last month, Ohio filed a lawsuit alleging PBM units of Cigna Group, Humana Inc (HUM.N) and others use their market power to push drug companies to increase prices, some of which goes to PBMs in the form of fees.

Express Scripts said under the new pricing plan its clients will “receive 100% of drug rebates” that are paid to it by drug manufacturers. The pricing and co-pay plans will be launched this summer.

Next year, Express Scripts will begin including information on drug prices and out-of-pocket costs as part of its prescriptions for consumers.

Express Scripts, UnitedHealth Group Inc’s (UNH.N) Optum unit and CVS Health Corp’s (CVS.N) CVS Caremark are among the biggest PBMs in the United States.

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If the TX judge’s ruling ends up prevailing on this one medication where:

He conducted his own assessment of the drug’s safety, contrary to courts’ historical deference to the FDA’s scientific determinations — and in this case, a drug for which all available data since its approval in 2000 demonstrate its safety and effectiveness.

Then any one medication or category of medications could be taken off the market from the “research/opinion of a judge – most likely a a person with only a doctor of jurisprudence  degree.” and could basically NEGATE 10+ yrs of clinical trials that it takes to get the FDA approval to bring a new medication to the market.  Since most/all R&D involving clinical trials to get a med approved by the FDA to bring to market.

The Mifepristone Battle: The Supreme Court Steps In

https://www.medpagetoday.com/opinion/the-health-docket/104061

FDA’s regulatory authority hangs in the balance

On Friday, Supreme Court Justice Samuel Alito put on hold rulings by a federal district court judge in Texas and by the Fifth Circuit Court of Appeals that would have severely restricted access to mifepristone (Mifeprex), an abortion medication used as part of a two-pill regimen to terminate pregnancies through the first 10 weeks of gestation. Alito’s orderopens in a new tab or window is intended to pause the current legal chaos and maintain the medication’s status quo while the Supreme Court has time to review the rulings from the lower courts. His order lasts until Wednesday night, and he has instructed the litigants to file their brief by noon on Tuesday.

So, how did we get here and what can we expect going forward?

On April 7, Matthew Kacsmaryk, a federal judge in Texas, suspended the FDA’s approval of mifepristone in a preliminary rulingopens in a new tab or window. Kacsmaryk stayed his order for 7 days.

Less than an hour after Kacsmaryk’s decision, a federal judge in Washington State issued a contradictory rulingopens in a new tab or window. Judge Thomas Rice ordered the FDA to do nothing to restrict access to mifepristone in 17 states and the District of Columbia, jurisdictions that filed a lawsuit against the agency over its risk evaluation and mitigation strategy (REMS) program for the medication.

In essence, a judge in Texas directed the FDA to remove mifepristone from the market and a judge in Washington directed the FDA not to impose further restrictions on that drug — requiring the FDA to march north and south at the same time.

That’s untenable. Given the accelerated pathway of the Texas case to the Supreme Court, we will focus our attention on that ruling.

The Texas Ruling

In November 2022, the Alliance Defending Freedomopens in a new tab or window (ADF), a conservative Christian legal advocacy group that works to expand Christian practices, challenged the FDA’s approval of mifepristone on safety grounds on behalf of its clients, the Alliance for Hippocratic Medicine coalition and other anti-abortion physicians.

Last week, Kacsmaryk issued a ruling in which he said that the FDA failed to consider safety concerns “based on plainly unsound reasoning and studies that did not support its conclusionsopens in a new tab or window.”  He conducted his own assessment of the drug’s safety, contrary to courts’ historical deference to the FDA’s scientific determinations — and in this case, a drug for which all available data since its approval in 2000 demonstrate its safety and effectiveness.

When taken as part of the two-pill regimen, mifepristone successfully terminates the pregnancy over 99%opens in a new tab or window of the time and has an extremely low risk of major complications (0.4%opens in a new tab or window) and mortality (0.0001%opens in a new tab or window). Ironically, the Trump-appointed judge with a history of opposing abortion and of judicial activism, claimed that “significant political pressure” caused the FDA to forego a rigorous safety check to advance the agency’s “political objective” of increased access to medication abortion.

Medical associations expressed concern that Kacsmaryk’s ruling “introduces the extraordinary, unprecedented danger of courts upending longstanding drug regulatory decisionsopens in a new tab or window.” Hundreds of executives from the pharmaceutical and biotech industries stated the “decision ignores decades of scientific evidence and legal precedentopens in a new tab or window.” Professional organizations and pharmaceutical companies strongly condemned the Texas ruling, stating that it undermines FDA authority, reduces access to a safe drug, and could impactopens in a new tab or window all FDA approved products.

The Path to the Supreme Court

The Department of Justice (DOJ) immediately appealed Kacsmaryk’s order to the conservative Fifth Circuit Court of Appeals, arguing against the judge’s “misguided assessment of the drug’s safetyopens in a new tab or window.” On April 12, the three-judge panel of the Fifth Circuit issued a rulingopens in a new tab or window that overturnedopens in a new tab or window Kacsmaryk’s order suspending FDA’s mifepristone approval, explaining that the plaintiffs failed to file the lawsuit within the 6-year statute of limitations. However, the Fifth Circuit ruling upheld Kacsmaryk’s order to suspend FDA’s actions that expanded access to mifepristone from 2016 onwards, including extending eligibility for mifepristone from 7 to 10 weeks’ gestation, allowing retail pharmacies to dispenseopens in a new tab or window mifepristone, eliminating the in-person dispensing requirement (allowing it to be delivered by mail), and permitting non-physicians to prescribe or administer it.

Two days later, on Friday, April 14, the DOJ and Danco Laboratoriesopens in a new tab or window, which manufactures brand name mifepristone, both asked the Supreme Court to halt the injunction. Danco said it faces an “untenable lingo” of competing court orders and “regulatory chaos.” Meanwhile, ADF announced it would not appeal the Fifth Circuit ruling maintaining FDA’s approval of mifepristone, but would vigorously defend the decision to block post-2016 expanded access to the drug.

Alito’s temporary administrative stay on the Texas ruling avoids a nightmare scenario where pregnant individuals would have immediately lost access to a highly safe and effective medication. If the Supreme Court extends the administrative stay, and ultimately rules in favor of the FDA, the entire Texas decision would never take effect. That would be a win for reproductive health, for science, and the Biden administration.

The Supreme Court set all of this in motion in overturning Roe v. Wade in the Dobbs decisionopens in a new tab or window. The high court is no friend to reproductive choice and has demonstrated a willingness to strike downopens in a new tab or window federal regulatory action. Yet, even for a highly conservative Supreme Court, this case may be a bridge too far. The easiest path for the court is not to review the case on the merits at all. It could sidestep an analysis of the FDA’s regulatory authority by overturning the Texas decision based on plaintiffs’ lack of standing — the concept that a plaintiff must show that the challenged conduct caused them actual injury. And after all, the plaintiffs are not directly harmed by expanded access to mifepristone. Even if the court does analyze the FDA’s regulatory authority, the justices should recognize the profound effect that overturning the agency’s decisions would have on public health going forward. Furthermore, the justices understand the impact that upholding the Texas and Fifth Circuit’s decisions could have on all FDA approved products, and likely don’t want to open the floodgates of litigation against FDA decisions.

Even a 6-3 conservative super-majority should, in theory, ultimately side with science and the FDA. Yet, the ultimate outcome is far from certain.

Effects on Access to Mifepristone and Other Drugs

Upholding and enforcing the Fifth Circuit’s preliminary ruling would result in devastating consequences for many people of reproductive age. Medication abortions now account for more than halfopens in a new tab or window of all abortions in the U.S. Restricting mifepristone use beyond 7 weeks’ gestation would curtail access to essential reproductive health services for many pregnant people, many of whom do not know they are pregnant so early on. Reinstating unnecessary requirements, such as in-person office visits, would severely restrict access. Some would resort to dangerous self-managed abortions. Others would not be able to access the recommended treatment for miscarriages, which occurs in a third of all pregnanciesopens in a new tab or window. Overall, the Texas and Fifth Circuit rulings jeopardize the health, and even life, of pregnant persons. The highest risks will be disproportionately borne by low-income individuals and those living in rural areas, especially racial minorities, in states that virtually ban abortions.

Beyond reproductive health, the decision sets a dangerous precedent for future lawsuits that may contest approvals or regulatory decisions. In a new context where the FDA’s reputation for evidence-based drug approvals is no longer respected and courts no longer defer to its scientific determinations, numerous medications and vaccines could be at risk. States could try to pick and choose which FDA-approved products to permit, regardless of decades of robust evidence regarding their safety and efficacy.

Does the public trust FDA’s career scientists to determine the safety and efficacy of vaccines and drugs, or do they trust judges to do so? To ask the question is to answer it.

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Please read this entire article and SHARE IT, everything that I post on this blog is shareable, there are 14 share icons to different websites at the bottom of the post, and you will hopefully understand the “oddness” of its title.

This article and my comments are not about pro-abortion or pro-life. As a healthcare professional, other than rape, incest or a pregnancy putting a woman’s life at risk, there is no real need for abortions, There are multiple means of  preventing pregnancies, even with the morning after med ( Plan B). This  is a legal challenge to the mere existence and/or the validity of the FDA being involved in the approval of medications that are considered safe and effective in humans that are contained in the 4+ billion Rxs that are dispensed in the USA every year.  The FDA has been around since 1906 and Opium has been used by mankind since 6000 BC (8000 years ago) https://mcpress.mayoclinic.org/opioids/history-of-morphine/ .  If our judicial system can declare a single FDA approved med UNSAFE… there are no limits to what medications they can declare as unsafe,  I can think of at least 100+ meds classified as controlled substances, for starters. There is substantial evidence that our federal judicial system has been and continues to be fairly corrupt and statistically, I believe that we are no longer dealing with a opioid crisis from FDA approved controlled meds being prescribed my DEA licensed prescriber, but a FABRICATE CRISIS of  illegal drugs, mostly from China & Mexican cartels, Fentanyl, Meth, Crack, Cocaine  and newest illegal substance –  veterinary sedative xylazine. Which when injected in humans  can  cause “skin ulceration” or “cutaneous ulceration”  – like a deep decubitus (bed sores) , sometimes deep enough to expose tendons. Even worse, Narcan will not reverse it, administering Narcan to a person who has been “poisoned”, one can only hope that what Fentanyl in the concoction they took is neutralized enough that the remaining Xylazine will not finish them off before they can get to a ED for more aggressive treatment.

Which Safe and Effective Drug Will Be Targeted Next?

https://www.medpagetoday.com/opinion/second-opinions/103968

 The Texas Judge’s ruling is not only about mifepristone

Editor’s note: After this piece was published, a federal appeals court ruledopens in a new tab or window that Mifepristone can remain on the market, but with temporary restrictions. The legal landscape surrounding this case will continue to evolve.

This past Friday, two opposing federal court decisions led to what is possibly the most disputed and disorderly legal battle over abortion access since last summer’s Supreme Court verdict that reversed Roe v. Wade and ended the nationwide right to abortion.

In one instance, a Texas judge suspendedopens in a new tab or window the FDA’s 2000 authorization of mifepristone (Mifeprex), used as part of a two-drug combination to end a pregnancy at up to 70 days of gestation. The judge went further, challenging the FDA and its autonomous safety review and approval of drugs. Shortly after, another court in Washington state issued a much different opinion. It said the FDA could not do anything to reduce the availability of the abortion medication.

The U.S. Department of Justice has appealed the Texas ruling.

The majority (79%) of abortions occur before 10 weeksopens in a new tab or window of gestation and more than 50%opens in a new tab or window of all U.S. abortions are medication abortions. The implications of the Texas ruling are clear: banning the drug will result in fewer abortion options, requiring surgical abortions, black-market drug sales, unwanted pregnancies, or less safe or less effective (misoprostol)opens in a new tab or window abortion options.

But the Texas ruling will affect the availability of other drugs too — with significant implications for the business of healthcare.

The Role of FDA

The main function of the FDA is to ensure the safety of food and drugs. Without it, payers will not cover costs, Americans will not trust medications, and doctors cannot prescribe treatment.

The Texas ruling has the potential to undermine the FDA’s regulatory power, impacting more than just one medication. Indeed, HHS Secretary Xavier Becerra said the ruling could impact “every kind of drugopens in a new tab or window.”

Central to any pharmaceutical or device innovation is obtaining FDA approval. This control mechanism guarantees the U.S. public benefits from the safest and most advanced drug system globally. The foremost protector of consumers within this structure is the FDA’s Center for Drug Evaluation and Research (CDER). This autonomous board evaluates new drugs before they come to market. This assessment process not only protects against dishonest practices but also provides doctors and patients with essential information to make well-informed choices regarding medication use. The center guarantees both branded and generic drugs function effectively and that their health advantages surpass any identified risks.

Now, that independent process could be upended.

In this ruling, the Texas judge said, “FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”

That statement is false.

Mifepristone has been shown to be extremely safe — even safer than penicillin, sildenafil (Viagra), and pregnancy itselfopens in a new tab or window.

If this decision is upheld, any federal judge could ban any drug — even one that had been approved for more than 22 yearsopens in a new tab or window and has been demonstrated to be objectionably safe and effective.

If policymakers think price controls will have a chilling effect on innovation, imagine what will happen when drug companies know that a single judge can erase decades of research.

Controversial Drugs

The Texas judge has a long anti-abortion history. That does not mean his ruling won’t set precedent for drugs other than mifepristone.

Since the pandemic began, countless FDA-approved pharmaceuticals, including life-saving vaccines and other treatments, have been politicized. We now have very vocal anti-vaccine candidates running for elected office. As previously uncontroversial medications turn into controversial subjects, what might the consequences be for their future accessibility?

Imagine this situation: a political faction maintains sexual activity should solely take place for procreation purposes. They strongly believe and reason that engaging in sexual activity outside of a reproductive, marital event is a grave sin. They also claim there is proof that a particular drug, meant to improve sexual performance, is hazardous and deadly.

While the drug may have uses for erectile dysfunction during procreative sex, the primary use is likely for non-procreative means. If an organization believes this drug is primarily used for non-procreative sexual activity, which they contend is evil, and can find “research” highlighting its dangers, could the organization file suit against the FDA hoping to ban the drug? Could the same be true with vaccinations? Or contraceptives? If the Texas judge’s ruling stands, yes.

Banning the sale of mifepristone means any organization can question any drug. It also provides grounds for any company or drug competitor to bring a lawsuit against any drug. This point alone creates a significant risk for future investment and development for new therapeutics.

If that is the new landscape, why innovate?

Cost of Drug Manufacturing and Projected Revenues

The mean cost for developing a drug is $1.6 billionopens in a new tab or window. This ruling will increase those costs.

Critical to drug pricing and financial investment in research and development by pharmaceutical firms is the projected revenue from a new medication, the anticipated cost of its development, and policies that impact the availability and demand for drugs. The engine that drives drug development is the potential future profit.

This ruling creates new risk for innovators. If drugs are deemed “controversial” or have the potential for judicial review and banning, that would alter projected revenues. Companies will likely begin to avoid classes of drugs such as hormone treatment, erectile dysfunction medications, opioid use disorder treatments, psychiatric medications, or any other politically charged medication.

As investors and businesses look for places to allocate their limited resources, the potential for profits is top of mind. Money for research and development is allocated to products that have the largest market and highest potential use.

This concept isn’t foreign. Consider antibiotic developmentopens in a new tab or window.

According to the World Health Organization (WHO), “only 6 [antibiotics] fulfill at least one of WHO’s criteria for innovation.” The reason there are few antibiotics in development (despite growing antimicrobial resistance) is the inability to find investors. And the reason investors are hard to find is that antibiotics are simply not as profitable as cancer therapeutics or chronic disease medications. If a drug or a class of drug’s profitability is threatened, investments will shift elsewhere, threatening research and development in several drug classes.

If Not the FDA, Then Who?

This ruling will undermine public trust in the autonomy of the FDA. More than 300 CEOsopens in a new tab or window from the biotech and pharma industry have said as much. And the uncertainty this ruling creates will harm drug innovators, providers, and patients. Quite simply: Replacing the opinion of a single judge for independent expert peer review will endanger public health.

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I stumbled across this and I am going to reference it under my resource tab. When I first looked at the Equianalgesic dosage table it seemed rather vague and confusing, but in looking at it, I noticed that Morphine oral chronic pain was 30, so making a educated guess that everything else in the chart is referencing  what is presumed to be a 30 MME dose. Please reference the first sentence I highlighted in RED.  All of these MME equianalgesic values have no science nor double blind clinic studies behind their conclusions/values, they are considered CRUDE ESTIMATES AT BEST  Within these tables there is many warnings about the lack of a black/white conversion from one opioid to another. There is no lab values or test to determine the intensity of a pt’s pain. Only the pt knows how intensive their pain is. There are a few lab tests that would SUGGEST that the pt has been dealing with under/untreated pain for some time. In my professional opinion, most people can generally tolerate <5 level of pain for an extended period of time, but that is not acceptable if their pain can be lowered without unacceptable side effects to get their pain to a lower level. Expecting a pt to live/exist is a >5 level of pain long term, I consider a torturous level of pain, and is not acceptable if their pain can be lowered without unacceptable side effects.

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