THE MEDICAL SCHOOL TO PRISON PIPELINE – PHYSICIAN AGAINST ABUSE (PAA): A FLORIDA CORPORATION, FILES AMICUS BRIEF IN SUPREME COURT SUPPORTING XIULU RUAN, MD vs. UNITED STATES NO. 20-1410:

THE MEDICAL SCHOOL TO PRISON PIPELINE – PHYSICIAN AGAINST ABUSE (PAA): A FLORIDA CORPORATION, FILES AMICUS BRIEF IN SUPREME COURT SUPPORTING XIULU RUAN, MD vs. UNITED STATES NO. 20-1410:

https://youarewithinthenorms.com/author/urwithinthenorm/

REPORTED AND RE-EDITED BY

NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, ESTHER HYATT PH.D., IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF PATRICIE LUMUMBA, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, SHELLEY HIGHTOWER, BS., PHARMD.,  LEROY BAYLOR, BEVERLY C. PRINCE FACS, MD., ADRIENNE EDMUNDSON, NATASHA DUVALL PHARMD., WALTER L. SMITH BS., LEROY BAYLOR, BS., MS., MS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

In The

Supreme Court of the United States

XIULU RUAN,

Petitioner,

v.
UNITED STATES OF AMERICA,

Respondent.

On Writ of Certiorari
to the United States Court of Appeals for the Eleventh Circuit

BRIEF AMICUS CURIAE OF PHYSICIANS AGAINST ABUSE IN SUPPORT OF PETITIONER

SEBASTIAN OHANIAN, ESQ.

IDENTITY AND INTEREST OF AMICUS CURIAE

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Physicians Against Abuse, (“PAA”) was founded in 2019 in response to the astronomical number of convictions against physicians involving “scope of practice” charges that have sprung up in the past two decades. PAA is made up five Board Members and is a Florida Corporation in the process of gaining nonprofit status.

UNITED STATES SUPREME COURT BUILDING

Physician Board Members of PAA are uniquely situated in identifying the root cause of criminal prosecutions against physicians because either they been themselves previously subjected to criminal prosecution and/or have had exposure to the criminal court system.

Vilasini Ganesh MD 63 months Healthcare Fraud

Prior to founding the organization, the Board members conducted a review of 211 convictions against physicians over a ten-year span involving prescription and/or health care fraud.

The inescapable conclusion from review of trial transcripts, including but not limited to opening and closing statements and testimony of expert

(12MONTH PRISON) RETIRE NAVAL CAPTAIN GREGORY BELCHER MD., ORTHOPEDIC SURGEON HUSBAND OF VILASINI GANESH MD

witnesses, was that the prosecutions against physicians amounted to nothing short of ‘blind leading the blind’- where one blind is the prosecutor and the other blind is the physician’s own attorney.

____________________________________________

1 Blanket consent was provided by counsel for Petitioner. In addition, PAA sought consent from both counsel for Petitioner and Respondent. Pursuant to Rule 37.6, Amicus Curiae affirms that no counsel for any party authored this brief in whole or in part, and no counsel or party made a monetary contribution intended to fund the preparation or submission of this brief. No person other than Amicus Curiae, or its members made a monetary contribution to its preparation or submission

RENNE BARE PHARMACIST NEW CASTLE, WYOMING

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In analyzing the root cause of the near 99% percent success rate of convictions against physicians, PAA concluded that what it all boiled down to was a prosecutor with a hunch hiring an expert using the deep pockets of the government, often not even in the same field as the accused physician, to criminalize behavior of the accused physician.

Christina Black MD, Cosmetic Surgery, Targeted an Advocate Fighter Against Physicians Abuse

While this may be acceptable in the context of medical malpractice litigation, it is not acceptable where the consequences are loss of freedom for the accused physician.

Dr. Ramana Gopalan, MD is an Internal Medicine Specialist in Catonsville, MD, and has over 37 years of experience in the medical field. He graduated from Jipmer medical school in 1984. He is affiliated with

Relying on a three pronged approach, (1) the phrase, “not for a legitimate medical purpose”, (2) hired government expert, and (3) ability to show substantial wealth for the accused physician, federal prosecutors have been successfully getting jury to return a guilty verdict in 9 out of 10 “scope of practice” cases all over the country.

This formula has made US the only country in the world mass incarcerating physicians.

This is not because all the criminal doctors miraculously reside in the United States, but rather, because there is something significantly wrong in the manner federal prosecutors have been allowed to litigate these cases as if they are in the “Wild West”.

Micheal Jones MD, New Orleans, LA

Prosecutors are able to easily appeal to the emotions of the jury all over the country where there is an ongoing opioid crisis such that it is estimated that at least 1 in every 4 individuals know of a person who has died of an overdose.

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No other country criminalizes physician behavior like the federal prosecutors have done in the US. This is especially the case as these prosecutions are all based on a whim with an “expert” opinion rendered by a hired government expert and orchestrated by a new generation of overzealous and unchecked federal prosecutors pointing fingers at wealthy doctors as greedy drug pushers and fraudsters.

Walter Wrenn MD

Doctors are just a ‘sitting duck’ for these federal prosecutors who raid medical offices and unlike the career drug pusher on the streets who gets caught and charged with one or two counts, federal prosecutors pile up count after count because doctors are required to keep records and those records are used against them in these out of control prosecutions against physicians.

This case addresses an impermissible invasion of the federal government into state affairs where the practice of medicine is solely regulated by state medical boards.

Freddy Williams MD, Life (Died Colon Cancer)

Without any consultation and without any referral from state medical boards where the standard of practice of medicine and the definition of what is legitimate medical purpose is created and regulated, federal prosecutors have been pursuing indictment after indictment by capitalizing on the opioid crisis.

Lind Cheeks MD

It is not the federal government that regulates the practice of medicine and thus no federal prosecutor should be permitted to argue in court that a physician criminally violated the standard of care unless and until a criminal referral is generated by the state medical board where the accused physician practices.

Lesly Pompy MD., Anesthesiologist (facing life in prison)

Requiring prosecutors to first receive a criminal referral from the state regulatory agency prior to filing an indictment on scope of practice charges would eliminate the financial incentive by government hired experts who often tailor their testimony according to the hunch of federal prosecutors.

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SUMMARY OF ARGUMENT

Dr. Xiulu Ruan was convicted of overprescribing controlled substances outside the usual course of medical practice and was sentenced tomore than 20 years in federal prison.

File:Dr. Xiulu Ruan.JPG - Wikimedia Commons
Xiulu Ruan MD., (Sentence 25 years)

Only the most prolific drug traffickers get these kind of sentences, and when they do, Rule 35 reductions will typically result in shortening their sentences.

Xiulu Ruan MD., Pain Med Physician

Both the conviction and the sentence is offensive to due process and basic tenets of a civilized society because both the conviction and the sentence is based on the whimsical notion of a prosecutor’s unfettered discretion and a paid expert opinion.

In Dr. Ruan’s case, as is the case in all scope of practice prosecutions, there is never a criminal referral by the regulatory state agency such as a state medical board. State medical boards regulate the practice of medicine as a neutral body and without a financial incentive.

XIULU RUAN, MD

However, most importantly, the state medical boards are charged with the task of setting the standard of care and what is legitimate and what is not legitimate medical purpose.

PHYSICIAN PAIN SPECIALIST OF ALABAMA

The fact that prosecutors have been able to bypass these state regulatory agencies in bringing about these “scope of practice” prosecutions speak volumes to unhinged prosecutorial overreach in our criminal justice system and impermissible intrusion of federal government into state affairs.

The practice of medicine is regulated by State Medical Boards in each state. In the United States, there is no federal regulation of the practice of medicine. “The power of a state to make reasonable provisions for determining the qualifications of those engaging in the practice of medicine, and punishing those who attempt to engage therein in defiance of such statutory

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provisions, is not open to question.” Reetz v. People of State of Michigan, 188 U.S. 505, 505, 23 S. Ct. 390, 391, 47 L. Ed. 563 (1903).

While prescription of controlled substances is regulated through the issuance of registration numbers by a federal agency known as the Drug Enforcement Administration, (“DEA”), the manner and the propriety of dispensing controlled substances, i.e. the pain killers, are regulated by each state medical board.

CHART SHOWING ILLICIT NON PHARMACEUTICAL NON FDA APPROVE DRUG DEATH/ CATHLEEN LONDON MD 3RD YEAR LAW

State medical boards can penalize a physician by a number of disciplinary actions including but not limited to revocation of a medical license.

But in addition, and for eons, state medical boards have been deemed as the appropriate peer review body to deem when a physician’s conduct is outside the scope of acceptable practice and therefore dangerous to society.

GLINDA FINCHER (SICKLE CELL ADVOCATE)

In fact, litigation in this area has almost uniformly sided with state medical boards not just as the authoritative body on establishing standard of care and scope of practice but also as the authoritative body to deem when a licensee steps outside the established scope of practice. Rathle v. Grote, 584 F. Supp. 1128 (M.D. Ala. 1984); see also Steinbach v. Metzger, 63 F.2d 74, 76 (3d Cir. 1933) citing to Powell v. Pennsylvania, 127 U. S. 678, 683 (1888), holding that “a state may thus regulate the practice of medicine, using this word, in its most general sense, can no longer be questioned.”

GEORGE TENET MD DEA VICTIM

With federal prosecutors stepping into this arena to create criminal liability against physicians by relying on differences of opinion of hired experts, the United States has now become the only country in the world mass incarcerating physicians. However, mass incarcerating physicians is not because we are housing most of the

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criminal doctors in the world, but rather because there is something fundamentally wrong with federal prosecutors stepping in as the ‘super’ experts to determine what is and what is not “outside the scope of professional practice” for a physician.

ARGUMENT

I. “WAR OF EXPERTS” CANNOT BE THE BASIS OF CRIMINAL LIABILITY IN “SCOPE OF PRACTICE” PROSECUTIONS

In an attempt to place the opioid crisis on the shoulders of physicians, federal prosecutors have been capitalizing on differences of opinion by paid experts in order to argue that criminal behavior exists. How many times do two judges have differences in opinion in rendering decisions that affect millions of lives?

Felix Brizuela DO, Neurologist

How many times do two prosecutors have differences of an opinion as to what is criminal behavior and what is not? But when prosecutors or judges have differences of an opinion, their behavior is not criminalized. But an accused physician’s behavior is criminalized instantly by the mere opinion of one prosecutor and the government hired expert.

If the government’s expert is more believable, more charismatic and more court room savvy, then no matter the facts, the accused physician becomes convicted especially with the playing field that is not leveled as prosecutors point fingers at the physician’s lifelong hard earned wealth as having been acquired fraudulently. Everyone, including the jury and the judge, falls for this drama. In nearly every one of these cases, prosecutors

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argue that rich doctors writing prescriptions for controlled substances with patients who are paying cash cannot possibly be for a legitimate medical purpose. And in nearly every one of these cases, first the jury and then the judge fall for it.

RICHARD KAUL MD, ADVOCATE FIGHTER “DOCTOR WITH SPINE”

The Eleventh Circuit Court of Appeals has fallen the hardest for this drama as it has written the necessary element of mens rea out of existence in considering charges involving prescription fraud. 21 U.S.C. § 841(a)(1).

II. FEDERAL PROSECUTORS SHOULD BE REQUIRED TO HAVE A CRIMINAL REFERRAL FROM STATE MEDICAL BOARDS PRIOR TO INITIATING PROSECUTION FOR CHARGES RELATING TO “SCOPE OF PRACTICE”

Prosecutors should have the discretion to bring criminal prosecution against any individual irrespective of the profession of the individual. However, when the prosecution involves professional behavior that is regulated by a state agency, prosecutors should not have unfettered discretion without first receiving a criminal referral from a state medical board.

CATHLEEN LONDON MD, DEA TARGET, LAW ADVOCATE

This is because it is a state agency, not a federal agency, which regulates the practice of medicine. Only a state agency charged with the regulation of the practice of medicine can be qualified to deem what is dangerous and illegitimate for the profession it regulates—not a federal prosecutor who hires an expert to play out his hunch before the jury. Federal prosecutors deciding what is and is not “outside scope of

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practice” is nothing other than prosecutorial overreach and exploitation of the practice of medicine. See United States v. Am. Med. Ass’n, 110 F.2d 703 (D.C. Cir. 1940) holding that “The practice of medicine in the District of Columbia is subject to licensing and regulation and may not lawfully be subjected to commercialization or exploitation.”

A collective consent and referral from the state’s medical board must be a prerequisite to each and every criminal prosecution against a physician who is accused of practicing medicine outside the scope of professional practice.

STEVE ARIENS RPH, PHARMACIST ADVOCATE

A federal prosecutor going out and hiring an expert to render an opinion that is tailored to his or her hunch is not fair process. But if the prosecutor has the green light of a state medical board that operates without financial incentives, then these criminal prosecutions against physicians will not offend due process as they do now.

RICHARD LAWHERN PHD, LAWHERN FILES ADVOCATE

It is not clear how the federal prosecutors lost their way, but it is certainly clear that they did so because they have, for so long, had unfettered discretion that has been repeatedly condoned by the courts. We are where we are today because it is not feasible to maintain integrity when there is such lack of accountability with very little to no redress for bringing these prosecutions for personal agenda. Lawyers are judged by other lawyers in state regulated agencies known as State Bars. Doctors should also be judged by a body of their own peers in state regulated agencies known as state Medical Boards.

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III. DECISION IN RUAN SHOULD HAVE FULL RETROACTIVE EFFECT

For the past decade or more, physicians’ freedom has been hanging on the unfettered discretion of prosecutors and the opinion of their hired experts. In this endeavor, the prosecutors have scored big wins making United States the only country in the world that has the highest number of physicians behind bars.

STEVEN HENSON MD (NATURAL LIFE FEDERAL PRISON)

As of to date, we have physicians in federal prisons who are sentenced to 327 years, (US v. Mukerjee 4:04-cr-50044 in Eastern District of Michigan), life (US v. Henson 6:16-cr-10018 in District Court of Kansas), life

Paul Volkman MD

(US v. Webb 3:08-cr-00136 in Northern District of Florida), life (US v. Volkman 1:07-cr-00060 Southern District of Ohio), and countless more serving 20 years plus for prescribing controlled substances that a government hired expert believed was outside the scope of professional practice. Even the most prolific drug traffickers with known criminal enterprises that expand over several continents and in existence for decades do not get these stiff penalties. Actual trafficker of hard drugs serve less time (and leave prison with more money) than doctors who have spent their lives helping the sick.

Full retroactive effect should be considered by the Court due to the fact that criminal prosecutions initiated by federal prosecutors against physicians regarding charges involving scope of practice all are rooted in prosecutorial overreach violating fundamental rights of the accused to a fair trial. See Griffith v. Kentucky, 479 U.S. 314, 107 S. Ct. 708, 93 L. Ed. 2d 649 (1987), holding that failure to apply newly declared constitutional rule to criminal cases pending on direct review would violate basic norms of constitutional adjudication.page12image3892072896page12image3892073184page12image3892073472page12image3892073760

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Going forward, all criminal prosecutions involving scope of practice charges should be required to have a criminal referral by the regulating state medical board which has no financial incentive to deem whether there has been behavior that is outside the scope of professional practice.

CONCLUSION

Federal prosecutions based on federal experts determining what is “outside the scope of professional practice” offends comity and should be eliminated. The only logical manner in which this can be done is by requiring a criminal referral to be made by state medical boards before federal prosecutors can initiate prosecution against physicians for charges relating to the practice of medicine.

DATED: December 27, 2021. Respectfully submitted,

/s/ Sebastian Ohanian

Sebastian Ohanian, Esq.

Counsel for Amicus Curiae Physicians Against Abuse

FOR NOW YOU ARE WITHIN

THE NORMS

Maybe it is time for pts to find a independent pharmacy – this is all about the “bad work environment” of the chains


https://i.redd.it/3x6cpnul4i981.jpg

When I applied to Butler U for pharmacy school in 1996, after one year at a local extension of Indiana University – studying for a major in Chemistry

But what they did not tell you back then was around 1 out of 5 or 6 Freshman Pharmacy declared majors would make graduation.  Getting in was EASY… getting to graduation was a BITCH…   Back then, there was 82-84 pharmacy schools… today there is abt 142 schools and they are graduating some 14K-15K and those pharmacy grads from 1980 – abt 8,000 are now retiring…   Doesn’t take a Math major to figure out that Pharmacy has a very serious – and growing – Pharmacist SURPLUS.    Today, new grads are getting pay offer of abt $20/hr less  than I was making when I retired in 2013 and unless the new grad agrees to be Pharmacy manager – may not even get FULL TIME.  Today’s grads, many are coming out of school with a SIX FIGURE STUDENT LOANS.  When I graduated from Butler U… I owed about what was 2-3 week’s pay, once I got licensed, which I was able to do in Kentucky by mid- July after graduation. Followed up getting my Indiana license in Sept or Oct.

The COVID-19 pandemic has created a work environment that has become both unsafe for the pts and the Rx dept staff. And many Pharmacists are starting to fight back…  A local Walgreens a couple of months ago all three pharmacist WALKED OUT… similar things happened to local CVS’. Our small county of abt 80K population has THREE INDEPENDENTS and as far as I know … non of them missed a day being open their scheduled hours and Rx dept staffed..    Here is a hyperlink to help you find a independent pharmacy by zip code  https://ncpa.org/pharmacy-locator

Back in the pre 90’s when independents dominated the market place, Pharmacists showed up FIRST PLACE on most respected profession surveys… the last survey I have seen Pharmacists are now down to FOURTH and now that the chains dominate the market place … probably headed for the end of the list  along with used car salesmen and members of Congress.  But those current surveys rank pharmacies by ownership… independents are always at the top ranking of the list by customers/pts.

 

 

Calling all Texans!

DEAR ADVOCATE ARMY

Calling all Texans!

Congressman Weber’s assistant has requested to hear from the residents of the great state of Texas.  This is a golden opportunity for pain patients to bring the plight of untreated/under-treated pain patients in front of the Congressman.  Specifically your pain story as well as any stories related to illicit fentanyl (i.e. whether you or someone you know has suffered from an illicit overdose) and suicide related to pain.  In addition, the Congressman is interested in examining Texas state policy and its current is impact on pain patients (has Texas policy served as a detriment or interfered in your care).

The reason for this request is that I will be meeting with Congressman Weber’s office in the near future.  I have been asked to gather the above requested information in preparation for this meeting.  I am requesting that anyone who lives in Texas, who would like to participate, to please email their stories to me at: lrlonebear@ciaag.net by January 20, 2022.

I would like to reassure everyone that your information and any stories that are shared will be kept confidential and only used for the purposes of this meeting.

I am requesting that submissions are kept short and concise.  While I recognize that each person has a unique story to tell, I am requesting that submissions are one page in length to include the following:

  • Your diagnosis
  • Are you currently receiving pain treatment?
  • Have you been force tapered/completely withdrawn from medications or tapered down to an ineffective dose?
  • Were you forced into using ineffective alternative/complimentary modalities?
  • Were you forced into taking medications or having procedures to justify receiving pain management?
  • Had any practitioner imply that the pain is “all in your head”?
  • Do you feel you have been harmed by Texas pain laws as they currently stand?

Thank you in advance for sharing your stories.  Feel free to email me with any questions or comments.

Leah R. LoneBear

CIAAG Director and Proud Texas Resident

reply to: lrlonebear@ciaag.net

responses due by:  Jan 20th 2022

all responses will be kept confidential but shared with Congressman Weber’s office for the purposes of this meeting only.

Another day in the life 01/03/2022

Another day in the life 01/02/2022

Landmark CARE Act to Combat the Substance Use Epidemic

In Turkey the metro stations allow dogs to sleep during the colder months. What an amazing gesture

In Turkey the metro stations allow dogs to sleep during the colder months. What an amazing gesture

“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey

Welcome to 2022

CDC sued for vaccine safety app data after multiple refusals

CDC sued for vaccine safety app data after multiple refusals

https://www.foxnews.com/politics/cdc-lawsuit-vaccine-data

A nonprofit that is critical of vaccines is suing the Centers for Disease Control and Prevention (CDC) after the agency declined to comply with a Freedom of Information Act (FOIA) request for data on the effects of the coronavirus vaccine.

Announced Thursday, the lawsuit surrounds data from the “V-Safe” system used by the CDC to track patients’ health after receiving the coronavirus vaccination. The group says the CDC has already provided Oracle, a government contractor, with the data in a deidentified form – or lacking personal information.

The CDC also tracks safety through its Vaccine Adverse Event Reporting System (VAERS) and continues to say that the approved and authorized COVID-19 vaccines are safe and effective.

“V-safe data will be collected, managed, and housed on a secure server by Oracle,” according to a CDC document.

Attorney Aaron Siri, who represents the Informed Consent Action Network (ICAN), said that the CDC initially refused to provide app data because it purportedly wasn’t “deidentified” or stripped of personal information. When ICAN followed with a request for “all data submitted to v-safe and subsequently deidentified,” the CDC rejected the request as duplicative of the original.

Lurie Children’s hospital registered nurse Carolyn Ruyle prepares a dose of a Pfizer COVID-19 vaccine at Lurie Children’s hospital Friday, Nov. 5, 2021, in Chicago. (AP Photo/Nam Y. Huh)

“If this sounds ridiculous, it is because it is,” said Siri. “The public should be outraged by the CDC’s games.” 

ICAN’s lawsuit notes that the CDC said V-Safe was part of “the most intensive vaccine safety monitoring effort in U.S. history.”

Department Of Health and Human Services, Hubert H. Humphrey Building on April 11, 2015, in Washington.  (Raymond Boyd/Getty Images)

Siri, on behalf of another group, previously sued the Food and Drug Administration (FDA) for more than 400,000 pages of information on the approval process for Pfizer-BioNTech‘s COVID-19 vaccine. The FDA had offered to release 12,000 documents by January and a minimum of 500 pages a month, which could mean it would be decades before all the documents would become public.

The CDC and Oracle did not immediately respond to Fox News’ request for comment.

“The federal government is thereby not only failing to provide the transparency necessary to earn the American people’s trust regarding these vaccines but is also failing to comply with FOIA,” the lawsuit reads.

One of the two drugs in the antiviral cocktail could cause serious interactions with widely used prescriptions, including statins, blood thinners and some antidepressants

Pfizer antiviral pills may be risky with other medications

https://www.nbcnews.com/health/health-news/pfizer-covid-pills-covid-symptoms-may-risky-drugs-rcna9683

As the omicron surge pummels a pandemic-weary nation, the first antiviral pills for Covid-19 promise desperately needed protection for people at risk of severe disease. However, many people prescribed Pfizer’s or Merck’s new medications will require careful monitoring by doctors and pharmacists, and the antivirals may not be safe for everyone, experts caution.

Paxlovid, Pfizer's Covid-19 pill, is manufactured in Ascoli, Italy.
Paxlovid, Pfizer’s Covid-19 pill, is manufactured in Ascoli, Italy.Pfizer via Reuters

The Food and Drug Administration authorized Pfizer’s Paxlovid for mild to moderate Covid in people as young as 12 who have underlying conditions that raise the risk of hospitalization and death from the coronavirus, such as heart disease or diabetes. However, one of the two drugs in the antiviral cocktail could cause severe or life-threatening interactions with widely used medications, including statins, blood thinners and some antidepressants. And the FDA does not recommend Paxlovid for people with severe kidney or liver disease.

Because of experts’ concerns about the potential side effects of Merck’s molnupiravir, the FDA has restricted its use to adults and only in scenarios in which other authorized treatments, including monoclonal antibodies, are inaccessible or are not “clinically appropriate.”

The Paxlovid cocktail consists of two tablets of the antiviral nirmatrelvir and one tablet of ritonavir, a drug that has long been used as what is known as a boosting agent in HIV regimens. Ritonavir suppresses a key liver enzyme called CYP3A, which metabolizes many medications, including nirmatrelvir. In the case of Paxlovid treatment, ritonavir slows the body’s breakdown of the active antiviral and helps it remain at a therapeutic level for longer.

The boosting effect was likely to have been crucial in driving Paxlovid’s high effectiveness in clinical trials.

When Paxlovid is paired with other medications that are also metabolized by the CYP3A enzyme, the chief worry is that the ritonavir component may boost the co-administered drugs to toxic levels.

Complicating matters, the drugs that pose interaction risks are widely prescribed to people at the greatest risk from Covid because of other health conditions.

The medications include, but are not limited to: blood thinners; anti-seizure medications; drugs for irregular heart rhythms, high blood pressure and high cholesterol; antidepressants and anti-anxiety medications; immunosuppressants; steroids (including inhalers); HIV treatments; and erectile dysfunction medications.

“Some of these potential interactions are not trivial, and some pairings have to be avoided altogether,” said Peter Anderson, a professor of pharmaceutical sciences at the University of Colorado Anschutz Medical Campus. “Some are probably easily managed. But some we’re going to have to be very careful about.”

Pfizer Covid pills may be risky with other medications

In its fact sheet about Paxlovid, the FDA has published a detailed list of medications that may interact harmfully with ritonavir, including those that should not be paired with the Covid antivirals.

However, pharmacists stress that many of the drug interactions are manageable and that they should not preclude most people from taking Paxlovid.

“Pharmacists are highly trained experts in medication safety and monitoring and are an excellent source of information and advice about interactions between medications and also supplements and herbal products,” said Emily Zadvorny, a clinical pharmacist who is the executive director of the Colorado Pharmacists Society. “They will help determine if a significant interaction exists and devise solutions to mitigate the interaction if possible.” 

‘A breakthrough drug’

The good news is that health care providers have experience navigating ritonavir’s use among people with HIV — a group that often takes medications for other health conditions, in addition to antiretroviral therapy.

Dr. William Werbel, an assistant professor of medicine at Johns Hopkins University who specializes in transplant infectious diseases, advised people at high risk of Covid-19 complications to talk to their health care providers, as well as a savvy pharmacist, about changes they could make to their drug regimens should they need Paxlovid — even before they become infected with the virus.

Anyone seeking Paxlovid, which must be prescribed within five days of the first symptoms, should be sure to let their prescribers and pharmacists know the complete lists of other medications and over-the-counter supplements they are taking, Anderson said.

Some medications, such as particular statins, are most likely safe to stop taking during treatment with the Covid pills, Anderson said. For example, it might be better to stay on certain blood thinners but to lower the doses. Some heart rhythm drugs cannot be taken with Paxlovid.

Conversely, some anti-seizure medications can boost liver enzymes’ metabolic action and thus lower the body’s Paxlovid levels, as can the herbal supplement St. John’s Wort. The FDA warned that they should not be combined with Paxlovid.

Because the Paxlovid treatment is brief — 30 pills, taken as three pills twice a day for five days — experts are hopeful that the risk of adverse interactions with other medications is low.

“Five days of interactions is not a big deal for the majority of drugs,” said Jason Gallagher, a clinical pharmacy specialist in infectious diseases at Temple University Hospital in Philadelphia.

If a drug’s potential interaction with Paxlovid poses too much of a risk, Anderson said, a safe and effective alternative Covid-19 therapy would be GlaxoSmithKline’s sotrovimab — the sole authorized monoclonal antibody treatment that research indicates reliably neutralizes the omicron variant of the virus. Otherwise, the antiviral molnupiravir is an option, albeit one with a much lower efficacy than either Paxlovid or sotrovimab. 

Even with the concerns about taking Paxlovid with other prescription medications, experts are excited about the drug’s potential.

“Paxlovid is a breakthrough drug,” Anderson said. “This could make a real difference in the pandemic by making an effective Covid treatment available to many people.”

Quantum Leap in helping practitioners made sure that pts get the most appropriate medications