1-ribbonFirst they came for the mentally ill addicts, and I did not speak out—
Because I was not a mentally ill addict.

Then they came for the empathetic prescribers, and I did not speak out—
Because I was not an empathetic prescriber.

Then they came for the Pharmacists, and I did not speak out—
Because I was not a Pharmacist.

Then they came for me—and there was no one left to speak for me

An End to PBM Pick-Pocketing

An End to PBM Pick-Pocketing

https://morningconsult.com/opinions/end-pbm-pick-pocketing/

Usually when your pocket has been picked, you discover the loss pretty quickly. But many of America’s more than 22,000 independent community pharmacies are finding their reimbursements for prescription drugs reduced well after the patient hands over the co-pay and leaves with their medicine. The technical term for this transaction is a “retroactive pharmacy direct and indirect remuneration (DIR) fee.” That’s one way of putting it.

DIR fees pick the pockets of community pharmacies and their patients.

Pharmacies dispense medication and are reimbursed, only to have a portion of that reimbursement then “clawed back” by pharmacy benefit managers weeks or months after the transaction. There’s often no way to anticipate the fees, and pharmacists are seldom provided sufficient justification for the clawback.

A medication on which the pharmacy looks to break even or even turn a modest, fair profit at the time it’s dispensed can become a loss weeks after the fact when the PBM claws back a portion of the proceeds. And those losses? Well, you can’t make up for those in volume, as they say. It’s a maddening way to have to operate a business.

Pharmacies’ pockets aren’t the only ones picked. Patients get fleeced, too. DIR fees distort the accuracy of drug cost information on the Medicare Plan Finder — the only publicly available resource accessible to Part D beneficiaries who rely on this information to make critical decisions about their health care. In addition, DIR fees increase beneficiary out-of-pocket costs for needed medications and in doing so push seniors more quickly into the “donut hole”— the point at which they are responsible for 100 percent of their prescription drug costs until they reach the catastrophic coverage threshold when the taxpayers pay 80 percent of the cost In other words, Part D beneficiaries who need and use their drug plan are punished the most by DIR fees.

PBMs are health care’s shadowy middlemen, exerting tremendous control over which prescription drugs a health plan will cover and how much the pharmacies that dispense them will be reimbursed. Unfortunately for patients, pharmacies and taxpayers, PBMs have long avoided both the spotlight and the typical marketplace constraints of meaningful regulatory oversight or transparency.

This explains, at least in part, how they can clawback funds from a pharmacy so readily: no one seems to be telling them they can’t. Operating in that virtual black box enables them to extract money from the prescription drug supply chain and profit mightily — all while prescription drug prices spiral out of control.

Now, there’s a move afoot to catch the pickpocket. Bipartisan legislation has been introduced in both the U.S. Senate and House to prohibit retroactive pharmacy DIR fees. If The Improving Transparency and Accuracy in Medicare Part D Drug Spending Act (S.413 / H.R. 1038), is enacted, PBMs will no longer be able to employ pharmacy DIR fees retroactively. All of the criteria for reimbursement would be determined at the point of sale, assuring that Medicare patients are properly charged.

To be clear, the proposed legislation does not eliminate or cut pharmacy DIR fees. Instead, it ensures that all charges are included when PBMs determine the pharmacy’s reimbursement for a senior’s prescription drug. No pick-pocketing after the fact.

Congress can stop this pick-pocketing and stand up for patients and independent pharmacies by passing S. 413 and H.R. 1038.

Palm Beach County and Martin County leaders ask Governor Scott to declare public health emergency

Palm Beach County and Martin County leaders ask Governor Scott to declare public health emergency

 

I got a phone call today from a pt on the west coast

I got a phone call today from a pt on the west coast

This particular 50 y/o pt has been on a substantial benzo dose for a couple of decades to treat anxiety/panic attacks and this pt also has some cardiac arrhythmia issues.

This pt has been patronizing a particular CVS store for all these years and the pt sees a very high profile psychiatrist.

The two 50 something male pharmacists at this CVS has been taking care this pt’s needs for all these years.

In steps into this symbiotic relationship a 30 something female Pharmacist/District Manager {PDM) that “ORDERED” the two pharmacists in the store to no longer fill this particular pt’s benzo prescriptions.

Apparently this PDM’s SOP is the overwhelming use of threats, fear and intimidation.. apparently her idea of “motivating employees”.

One of the staff Pharmacists has told the pt that – and rightly so – that she has no authority to dictate to another pharmacist if prescriptions are to be filled or not filled… but… fears of ending up becoming one of CVS’s  “infamous floater”…

For those of you who are not familiar with how the typical CVS floater is treated… they are often scheduled 12-14 hr shifts and often have to drive 2 hr each way to the store they are assigned to.  So these Pharmacists are lucky if they can get 4-5 hrs sleep… which many believe that a “Tired Pharmacist … is a Dangerous Pharmacist”, but this is how CVS saves paying unemployment and hopefully avoids age discrimination lawsuit.. by getting a Pharmacist to quit or they keep working under such hostile work environment that they end up making a medication error and harming a pt or worse…. which means that the Pharmacist violates corporate policies and procedure and justifies firing the pharmacist.

Apparently this PDM has agreed to allow the pt to have another 30 days supply… to allow her time to figure things out.

Remember… part of the practice of medicine is the starting, changing, stopping a pt’s medication… so.. IMO.. this PDM decides that the pt can’t have any more medication… Is she guilty of attempting to practice medicine without an appropriate license ?  Pharmacists are not granted “prescriptive authority” under their pharmacy practice act.

This pt has already had a discussion with an attorney and I advised the pt the 5-6 different legal issues that may be involved with the actions of this PDM.

An Opioid Quality Metric Based on Dose Alone?

An Opioid Quality Metric Based on Dose Alone?

80 Professionals Respond to NCQA

 
 

Introduction: As the US comes to grips with a crisis of opioid overdose and addiction, many professionals have assessed that excessive opioid prescribing, based on weak data, helped us reach this point. Efforts to reduce prescribing while optimizing care for patients with pain, and expanding access to addiction treatment, are of cardinal importance. How we advance these objectives depends partly on changing our shared understandings of what it means to deliver good care. It also depends on policies, resources and formal methods to assess if we are doing a good job. The 2016 Guideline on Prescribing Opioids for Chronic Pain from the Centers for Disease Control and Prevention (CDC) represents one such effort.

In early 2017, a new and consequential proposal was made by the National Committee for Quality Assurance (NCQA), which seeks to advance health care quality through measurement and accreditation. NCQA’s highly influential performance measures help purchasers and consumers to assess whether health care quality is good or bad. When NCQA issued a draft set of standards related to opioids in 2017, they requested public comment. One of the measures counts the percentage of health plan members receiving opioid doses greater than the equivalent of 120 milligrams of morphine (MME), with a lower percentage counting as evidence of better care.

The premise, focused on dose, is similar to recent proposal from the Centers for Medicare and Medicaid Services. The concern about dose as an important risk factor for adverse opioid outcomes is well-justified. But well-justified concerns do not always translate into fault-free performance targets, particularly when doing so entails clinical practices not yet tested in scientific trials, and not endorsed by the CDC Guideline. Eighty doctoral level clinicians from across the country, mostly academic physicians, have endorsed the letter submitted to NCQA on March 22, 2017. They include four who had roles assisting the Centers for Disease Control and Prevention in development of the 2016 CDC Guideline, and five who edit scholarly journals in addiction medicine or pain. This document represents the opinion of signers, and not that of any agency for which they work. We welcome your feedback here or on Twitter, including two of the authors (@StefanKertesz @SubstanceAbuseJ) as well as NCQA itself (@NCQA).

Mary Barton, MD, MPP Vice President, Performance Measurement

National Commission for Quality Assurance

1100 13th Street, NW Suite 1000 Washington, DC, 20005

March 22, 2017

Dear Dr. Barton:

We write to register strong objection to the proposed “Opioid High Dosage” HEDIS measure, focused on minimizing the number patients receiving greater than 120 morphine milligram equivalents. As doctoral-level professionals in pain, in medicine and allied fields, we believe this measure will incentivize care that violates principles in the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. As a result, it will pose a serious risk to some patients currently receiving opioids. Many signatories to this letter have expertise in addiction medicine (signified “A” next to signature), or pain medicine (“P”). Persons among us who assisted the Centers for Disease Control and Prevention (CDC) in the 2016 Guideline are designated “C”. Many of us play professional roles in helping patients at high doses to taper, in mitigating opioid risk, in minimizing new opioid starts and in restraining dose escalation. Given these commitments, we understand that our strong objection to the proposed NCQA measure may come as a surprise.

To explain this objection, we must distinguish between the language of the CDC Guideline itself, and the perverse care decisions that the NCQA “Opioid High Dosage” binary measure will incentivize.

The CDC Guideline cites observational evidence associating higher opioid doses with increased adverse outcomes, including overdose. Such data justify restraint in opioid initiation (Recommendation 1) and dose escalation, with particularly careful reassessment of “evidence of individual benefits and risks” when considering increasing dosage to ≥50 mg/day and avoiding or carefully justifying decisions to titrate to ≥90 mg/day (Recommendation 5). However, the CDC Guideline did not prohibit dose escalation. Nor did it propose that any dose above a numeric threshold was “bad care”. Rather it insisted on “individual assessment of risk and benefit” as the primary basis for decision making related to both opioid dose titration and opioid dose reduction. For patients already receiving high opioid daily dosages, the CDC guideline states that “clinicians should discuss their safety concerns with the patient, consider tapering to a safer dosage (see Recommendations 5 and 7), and consider offering naloxone (see Recommendation 8).” High dose alone is not an indication for tapering or discontinuation.

On this basis, most of us wish to see an evolution toward fewer opioid starts and fewer patients at high doses. The proposed NCQA measure indulges no such subtleties. It will incentivize rapid efforts to minimize the number of patients whose current opioid dose exceeds 120 MME. The most efficient action to optimize measure performance would involve dose reduction for patients at >120 MME, regardless of patient acceptance, the mix of benefits and harms specific to the individual patient, or the potential harms of rapidly tapering patients prescribed high doses for many years. This is happening in many health systems today, despite the lack of any evidence to assess its impact on risk to patients, and the reality that the CDC Guideline did not endorse this approach.

Of particular concern, widespread unilateral dose reductions that would be incentivized by this HEDIS measure contradict Recommendations 5 and 7 of the CDC Guideline, both of which emphasize individualized assessment and decision making. Recommendation 5 applies only to new opioid starts. Recommendation 7 suggests working with patients on an individual basis to taper opioids when benefits are not sustained or when risks outweigh benefits. High dose is cited as simply one indicator of risk in the discussion of tapering. The proposed “Opioid High Dosage” measure eviscerates the CDC Guideline of these patient-centered considerations.

Put simply, the “Opioid High Dosage” measure will accelerate a reconfiguration of care that has never been tested in prospective trials and that could actually increase risk to individual patients, as illustrated by scholarly and popular reports of acute withdrawal (with death), protracted abstinence syndrome, and suicide associated with incautious unilateral opioid discontinuation or unrelenting pain.

Finally we must underscore that institutional embrace of binary quality measures based on promising epidemiologic data has sometimes proven a mistake in retrospect. This has occurred with aggressive targets for glucose, blood pressure and lipid control. Even the widespread embrace of opioids itself (an effort to optimize pain scores) reflected extrapolation from limited data in ways that courted risk to patients.

We urge NCQA to recognize that binary metrics developed in the absence of compelling controlled trials are often treacherous. And there is little to justify a HEDIS measure that contradicts the language found in CDC Guideline Recommendations 5 and 7.

We recommend that NCQA abandon the Opioid High Dosage measure until trial data and expert review permit a more appropriate consideration of this issue. We are willing to assist you in identifying alternate measures that involve lower risk to patients.

This letter includes 80 signatories, with 4 who had formal roles assisting the Centers for Disease Control and Prevention in development of the 2016 CDC Guideline. Signers include 5 who edit scholarly journals in addiction medicine or pain, 60 with academic affiliations, 33 with special expertise in addictions, and 23 with special expertise in pain. Also, several signers have focused their careers on measuring and improving quality of care.

Disclaimer: Views expressed here are those of the signers alone, and do not represent formal positions of any employing or affiliated organization, university, or United States Federal Agency.

(A): Addiction Professional (P): Pain Professional (C ): Assisted the CDC in Opioid Guideline Development as Reviewer, Core Expert, or Author

Signatories

Stefan G. Kertesz, MD, MSc (A) University of Alabama at Birmingham School of Medicine

Adam J. Gordon, MD, MPH (A) University of Utah, Editor-in-Chief, Substance Abuse

Erin E. Krebs, MD, MPH (P, C) University of Minnesota Medical School

Joanna L. Starrels, MD, MS (A, P, C) Albert Einstein College of Medicine & Montefiore Medical Center

Chinazo Cunningham, MD, MS (A, C) Albert Einstein College of Medicine & Montefiore Medical Center

Matthew J. Bair, MD, MS Indiana University School of Medicine (P, C)

Richard Saitz MD MPH, DFASAM, FACP(A) Boston University School of Public Health, Senior Editor, Journal of Addiction Medicine

Jalie A. Tucker, PhD, MPH (A), University of Florida, Gainesville, Strategic Advisor, Addiction

Jeffrey H. Samet, MD, MPH (A) Boston University School of Medicine, Board, Addiction Medicine Foundation & Editor-in-Chief, Addiction Science & Clinical Practice

Michael E. Schatman, Ph.D (P)Tufts University School of Medicine, Editor-in-Chief, Journal of Pain Research

Peter D. Friedmann, MD, MPH, DFASAM, FACP (A) University of Massachusetts Medical School-Baystate, Deputy Editor, Journal of Substance Abuse Treatment

William M. Tierney, MD, MACP, Dell Medical School, University of Texas at Austin, Past President, Society of General Internal Medicine

Robert M Centor, MD, University of Alabama of Birmingham School of Medicine, Master, American College of Physicians, Past President, Society of General Internal Medicine

Nancy L. Keating, MD, MPH, Harvard Medical School and Brigham and Women’s Hospital

Max Michael, MD, Dean, University of Alabama at Birmingham School of Public Health

Ken Freedman, MD, MS, MBA (A) Tufts University School of Medicine, Boston, MA

Jane M. Liebschutz, MD MPH, (A,P) Boston University School of Medicine

Julia Lindenberg MD, Beth Israel Deaconess Medical Center

Terrence Shaneyfelt MD, MPh, University of Alabama at Birmingham School of Medicine

Name Redacted

Laurie Gordon, MD, New York, NY

David E. Pollio, PhD (A), Chair, Department of Social Work, University of Alabama at Birmingham

Daniel Pomerantz MD MPH FACP, Albert Einstein College of Medicine, New York

Toshiko Uchida, MD, FACP, Northwestern University Feinberg School of Medicine

John D. Goodson, MD, FACP. Harvard Medical School, Massachusetts General Hospital

Daniel P. Alford, MD, MPH, FACP, DFASAM (A, P) Boston University School of Medicine, Boston Medical Center

Carol K. Bates, MD, FACP, Harvard Medical School and Beth Israel Deaconess Medical Center

Lynn Webster, MD (P) Vice President, PRA Health Science and Past President, American Academy of Pain Medicine

Marcus A. Bachhuber, MD, MS, Montefiore Medical Center/Albert Einstein College of Medicine

James DeMicco, PharmD, Hackensack, New Jersey

Joseph W. Frank, MD, MPH (P) VA Eastern Colorado Health Care System and University of Colorado School of Medicine

Kimber P. Richter PhD, MPH (A) University of Kansas School of Medicine

Saul J. Weiner, MD, University of Illinois at Chicago School of Medicine

Michael Banks, MD, Orothwest

Michael Fingerhood MD FACP (A), Johns Hopkins University School of Medicine

Josiah D. “Jody” Rich, MD, MPH (A), Warren Alpert Medical School of Brown University

Signatory’s name redacted by request

Monika M. Safford, MD, Weill Cornell Medicine, New York, NY

Lauren Broyles, PhD, RN (A), Grant Writer’s Seminars and Workshops, VA Pittsburgh Healthcare System

Gerald Cochran, MSW, PhD (A), University of Pittsburgh, School of Social Work, School of Medicine

Ryan Kraemer, MD, University of Alabama at Birmingham School of Medicine

Thomas S. Huddle, MD, PhD, University of Alabama at Birmingham School of Medicine

Terri A, Lewis, PhD, NCoC, Southern Illinois University-Carbondale, Rehabilitation Institute

David Nagel, MD (P) private practice, author, “Needless Suffering; How Society Fails Those with Chronic Pain.”

Stephen J. Ziegler, PhD, JD, Indiana University-Purdue University, Dept of Public Policy

Janey C. Peterson EdD, MS, RN (P), Weill Cornell Medicine, New York, NY

Stephen A. Paget, MD (P) Hospital For Special Surgery, Weill Cornell Medicine, New York, NY

Diana Coffa, MD (P) (A), University of California, San Francisco, CA

Paula J. Lum, MD MPH FASAM (A), University of California, San Francisco, CA,

Tim Lahey, MD MMSc, Dartmouth’s Geisel School of Medicine

Diane S. Morse, MD (A), University of Rochester School of Medicine

Elvin Geng, MD MPH, University of California, San Francisco School of Medicine

Emma Stanton, MD MBA (A), Beacon Health Options

Thomas E. Reznik, MD, MPH (P), Providence VA Medical Center and Warren Alpert Medical School of Brown University

Barbara Herbert MD FASAM (A) Senior Medical Advisor, Column Health, Arlington Mass

Ingrid Binswanger, MD, MPH, MS (A) University of Colorado School of Medicine, Aurora, CO

Michael F. Bierer MD MPH (A) Harvard Medical School Boston MA

Howard Hoffberg, MD, (P) Rehabilitation and Pain Management Associates, Baltimore MD

Signatory’s name redacted by request

Thomas Sachy, MD, MSc, (P) (A) Georgia Pain and Behavioral Medicine, Gray, GA

Kevin R. Riggs, MD, MPH, University of Alabama at Birmingham School of Medicine

Calie Santana, MD, MHS, Internal Medicine, WESTMED Medical Group

Stephen Martin, MD, EdM (A) University of Massachusetts Medical School

Monica Gandhi MD, MPH, Professor of Medicine and Ward 86 Clinic Director, UCSF

Janet Grochowski, PharmD, Clinical Pharmacist, Positive Health Program (Ward 86), UCSF

Zackary Berger, MD, PhD, Johns Hopkins School of Medicine

Royce C. Lin MD, University of California, San Francisco School of Medicine

Sarah E. Wakeman, MD, FASAM (A), Massachusetts General Hospital, Harvard Medical School

Thomas Sachy, MD, MSc, (P) (A), Georgia Pain and Behavioral Medicine

Paul Arnstein, RN, PhD, FAAN (P)

David S. Craig, PharmD, Moffitt Cancer Center, Tampa FL

Michael J, Brennan, MD (P) The Pain Center of Fairfield, Fairfield CT

Sri Nalamachu, MD (P), Overland Park, KS

Jayne Pawasauskas, PharmD, BCPS (P) University of Rhode Island College of Pharmacy

Jeffrey Fudin, B.S., Pharm.D., DAAPM, FCCP, FASHP (P), President and Director, Scientific and Clinical Affairs, REMITIGATE, LLC

Debra F. Hobbins, DNP, APRN, LASUDC, CARN-AP, Anchorage, AK

Shelley Trazkovich, M.D (A) (P), Reisterstown, Maryland

James Patrick Murphy, MD, MMM, FASAM (A,P); Murphy Pain Center; Univ of Louisville Sch of Medicine; Past Pres, Greater Louisville Medical Soc

Anika Alvanzo, MD, MS, FASAM, FACP (A), Johns Hopkins University School of Medicine

Teresa Bryan, MD, University of Alabama at Birmingham School of Medicine

 
 
 
 
 
Healthcare and Pain
This is a story from last year, but with the new administration, healthcare is getting worse, not better.
 
 
 
 
Feigning sickness to improve healthcare
 
 
 
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80,000 EpiPen Devices Recalled Worldwide

epipens

80,000 EpiPen Devices Recalled Worldwide

http://www.self.com/story/epipen-devices-recalled-worldwide

Mylan, the makers of the EpiPen, announced on Monday that more than 80,000 units of the EpiPen, the patented device used to dispense a life-saving dose of adrenaline (a.k.a. epinephrine) in cases of severe allergies, have been recalled in multiple countries. The recalled EpiPens could have a defective part that “may result in the device failing to activate,” said a statement issued by Mylan.

A spokesperson for Mylan tells Stat News that EpiPens have now been recalled in Australia, New Zealand, Japan, and several European countries, but the recall does not currently affect those in the United States.

The devices impacted by the recall are labeled with batch numbers 5FA665, 5FA6651, 5FA6652, and 5FA6653. Anyone with a recalled EpiPen can trade it in for a new device free, though Mylan is encouraging all those affected by the recall to keep their current EpiPen until a replacement arrives.

The recall is the latest controversy to besiege Mylan’s EpiPen product. A major price hike issued last year (capping years of increases) led to outcry from private citizens and lawmakers alike. Anger stemmed from both the choice by Mylan to seemingly turn an even greater profit from a life-saving drug, and the revelation that Mylan was engaged in a potentially illegal deal with schools to ensure that educational environments bought only the drug company’s branded product to keep in their facilities—a move that likely contributed to the increase in the EpiPen’s price. Many parents were quick to call out that the EpiPen is “a lifeline, not a luxury.” The price hike by Mylan put the price of the brand-name EpiPen two-pack at over $600. The company then released a generic version costing $300 for two injectors.

Pharmacy chain CVS reacted to the Mylan news last year by announcing the release of a new product, Adrenaclick, at its nationwide pharmacy locations. Adrenaclick retails for $109.99 for those with and without insurance, with CVS’s partner in developing the new product, Impax Laboratories, offering a coupon that would make the product only $9.99 for qualifying customers.

Major insurance company Cigna also reacted to the Mylan price hike by dropping the brand-name EpiPen from coverage by its health insurance plans, saying it would cover only the generic version of the drug.

Irritable bowel syndrome medication linked to pancreatitis in certain patients

Irritable bowel syndrome medication linked to pancreatitis in certain patients

http://www.clinicaladvisor.com/gastroenterology-information-center/fda-issues-warning-for-viberzi-irritable-bowel-syndrome-medication/article/645599/

The Food and Drug Administration (FDA) is warning patients and healthcare professionals that Viberzi (eluxadoline; Allergan) tablets should not be used in patients without a gallbladder due to an increased risk of developing serious pancreatitis that could lead to hospitalization or death. 

Viberzi, a mu-opioid receptor agonist, is approved to treat irritable bowel syndrome with diarrhea (IBS-D). Since its approval in May 2015 through February 2017, the FDA has received 120 reports of serious cases of pancreatitis or death. Of the 68 patients who provided gallbladder status, 56 did not have one and had received the recommended dose of Viberzi. There were also 76 patients who were hospitalized of which 2 patients died; these 2 patients were without a gallbladder. Other cases of serious pancreatitis or death also had 6 reports of sphincter of Oddi spasm and 16 reports of abdomen pain.

Healthcare professionals should consider alternative treatment options in patients without a gallbladder as hospitalizations and deaths due to pancreatitis have occurred with Viberzi use in these patients. Symptoms of pancreatitis have been reported after just 1 or 2 doses of Viberzi at the recommended dosage (75mg) in patients who do not have a gallbladder, and who do not drink alcohol. 

Viberzi should not be used in the following patients:

  • Who do not have a gallbladder
  • Have or may have had a blockage of the gallbladder or a sphincter of Oddi problem
  • Have had pancreatitis or other pancreas problems, including a blockage of the pancreas
  • History of serious liver problems
  • History of chronic or severe constipation
  • Have or may have had intestinal obstruction
  • History of alcohol abuse, alcohol addiction, or drinks more than three alcoholic beverages a day

Over-the-counter (OTC) or other FDA-approved medications can be considered to treat symptoms associated with IBS-D such as bismuth subsalicylate (Kaopectate and Pepto-Bismol), loperamide (Imodium), and diphenoxylate/atropine (Lomotil) for diarrhea, and simethicone (Gas-X and Mylicon) for gas relief. Alosetron HCl (Lotronex) and rifaximin (Xifaxan) are other approved prescription drugs for IBS-D. 

Viberzi, a CIV controlled substance, is available as 75mg and 100mg strength tablets in 60-count bottles.

Compounding pharmacy president not guilty of 2nd degree murder

Compounding pharmacy president guilty of racketeering, not guilty of 2nd degree murder

http://framingham.wickedlocal.com/news/20170322/compounding-pharmacy-president-guilty-of-racketeering-not-guilty-of-2nd-degree-murder

BOSTON — The former head of a Massachusetts pharmacy was acquitted Wednesday of murder allegations but convicted of racketeering and other crimes in a meningitis outbreak that was traced to fungus-contaminated drugs and killed 64 people across the country.

Prosecutors said Barry Cadden, 50, ran the business in an “extraordinarily dangerous” way by disregarding regulations on cleanliness to boost production and make more money.

 

Cadden, president and co-founder of the now-closed New England Compounding Center, was charged with 25 counts of second-degree murder, conspiracy and other offenses under federal racketeering law.

After five days of deliberations, the jury refused to hold Cadden responsible for the deaths and cleared him on the murder counts. He was found guilty of racketeering, conspiracy and fraud and could get a long prison term at sentencing June 21.

The 2012 outbreak of fungal meningitis and other infections in 20 states was traced by the Centers for Disease Control and Prevention to contaminated injections of medical steroids, given mostly to people with back pain. In addition to those who died, 700 people fell ill. Indiana, Michigan and Tennessee were hit hardest.

Joan Peay, 76, of Nashville, Tennessee, suffered two bouts of meningitis after receiving a shot for back pain. She wept upon learning the verdict.

“He killed people and he’s getting away with murder. I am furious,” she said. She said that she got so sick from meningitis “I didn’t care if I died,” and that she still suffers from hearing loss, memory problems, a stiff neck and low energy.

Alfred Rye, 77, of Maybee, Michigan, said: “I wish I could give him the same shot he gave me. I think they should pay for their crime.”

Rye fell ill after getting an injection in his lower back 4½ years ago. He said he continues to suffer from a loss of balance and other ill effects.

 “Life has been totally hell,” he said.

The racketeering charge and the 52 counts of fraud carry up to 20 years in prison each, but federal sentencing guidelines typically call for far less than the maximum.

The scandal threw a spotlight on compounding pharmacies, which differ from ordinary drugstores in that they custom-mix medications and supply them directly to hospitals and doctors. In 2013, in reaction to the outbreak, Congress increased federal oversight of such pharmacies.

 Federal prosecutor Amanda Strachan told the jury during the two-month trial that the deaths and illnesses happened because Cadden “decided to put profits before patients.”

NECC used expired ingredients and falsified logs to make it look as if the so-called clean rooms had been disinfected, prosecutors said. After the outbreak, regulators found multiple potential sources of contamination, including standing water and mold and bacteria in the air and on workers’ gloved fingertips.

Cadden’s lawyer, Bruce Singal, told the jury Cadden was not responsible for the deaths and pointed the finger at Glenn Chin, a supervisory pharmacist who ran the clean rooms where drugs were made. Chin has pleaded not guilty and is awaiting trial.

After the verdict, Singal said it was a “disgrace” that prosecutors brought murder allegations against Cadden.

 

“We’re very pleased that the jury acquitted Barry on all 25 of the murder charges and that he can now go home and tell his children that he’s not a murderer,” Singal said. “At the same time, it is Barry’s fervent wish … that people still remember the victims of this terrible public health outbreak.”

NECC filed for bankruptcy after getting hit with hundreds of lawsuits. NECC and several related companies reached a $200 million settlement with victims and their families.

Tom Carroll, a lawyer for the family of Kentucky Judge Eddie C. Lovelace, who died after receiving injections to treat neck and back pain, said the family was disappointed by the outcome of the trial.

“They very strongly felt that a murder conviction was in order,” Carroll said. “The family thinks he should get the maximum penalty.”

99.1% of the filers were in support of kratom’s availability

DEA kratom comment filing period findings

www.kratom-k.com/dea-kratom-comment-filing-period-findings/

ACFC releases kratom findings

DEA opened public comment in regards to a proposed ban of the kratom plant and it’s constituents late last year before a proposed ban. The response was quick, coordinated and overwhelming consisted of positive support. Thank to results from an early February study by the American Kratom Association and the American Coalition of Free Citizens. Over 23,000 total comment filers signed with a review of the results revealing that 99.1% of the filers were in support of kratom’s availability. Nearly a full 20% of the filers presented happened to be military veterans, just over 20% who commented with age were Senior citizens. DEA support for the ban dissolved due to the outpouring of support based on the efforts of the kratom community led by such organizations as American Kratom Association, Kratom United and Botanical Education Alliance.

The AKA/ACFC findings were surprising to many in the media who had previously slurred the plant product. Among those listing a profession, nearly half were involved in respected professions such as health care, research and science or law enforcement. For this particular group, 754 to 9 were pro-kratom/anti-ban (support of 98.7% among that particular group). 449 comment filers were self-identified as military veterans, 18% of the 2416 filers to specify a profession. Veteran support for kratom legality was an astounding margin of 448 to 1, or 99.8%. 576 health care professionals responding also supported kratom by a strong margin (569 to 7 or 99.8%). 3811 of the responders were 55 or older making up just over 20% of the total who replied regarding age. Once again the margin was overwhelming at 805 to 1, an astounding 99.9%.

Susan Ash

Susan Ash, director, American Kratom Association and Jason Jeffers, president, American Coalition of Free Citizens were quoted in a press release from AKA: “The face of kratom consumers is the face of America today. Our groups partnered-up to examine all of the public comments to DEA on the kratom ban because we were curious about who was responding and what they had to say. What we found is a kratom community of responsible consumers who look just like your family and the people who live next door. The results speak for themselves: 99 percent of those who comment, do not want the federal government to police the natural herb called kratom.”

Findings reveal overwhelming positive sentiment

Research and communications director, Katie Lair, of the American Coalition of Free Citizens, said: “The most curious thing about the public comments is that there were so few responses actually supporting the DEA. Only 113 people out of 23,116 commented in support of the DEA proposal to ban kratom. When you have so much anti-kratom propaganda circulating at the state level and misleading talk of a public health crisis, one would expect more public comments in support of what the DEA is trying to do. To have just 113 people nationwide support the DEA is remarkable for a campaign like this to determine whether something should be banned for the entire nation. The topline finding is obvious: There is no public appetite for banning kratom and continued fierce opposition can be expected by anyone who cares to do so.”

Medical professionals were defined as “medical doctors, registered nurses, psychiatrists, speech therapists and EMTs and trained first responders” in the context of the study. Recent research from Dr. Jack Henningfield, Ph.D., vice president of Research, Health Policy, and Abuse Liability at PinneyAssociates, suggests there is “insufficient evidence” for the DEA’s grounds in regard to a ban on the kratom plant (close botanical cousin to the coffee plant) or products derived from it’s leaf. The Henningfield report states that kratom has no greater (or possibly less) potential for abuse and dependence than “nutmeg, hops, St. John’s Wort, chamomile, guarana, and kola nut.”

Follow the money trail : PBM’s demand 50% rebates from manufacturers

Eli Lilly says it’s cutting an average of 50% off list prices—and its price hikes don’t work

http://www.fiercepharma.com/pharma/lilly-s-average-rebates-and-discounts-swell-to-50-off-list-prices

Heightened pressure from pharmacy benefit managers and increased competition among drugmakers are taking a big bite out of Eli Lilly’s list-price hikes—an 11-percentage-point bite, on average, the company said in a new report.

After raising list prices an average of 14% in 2016, and wheeling and dealing with payers, Eli Lilly netted an overall price increase of 2.4%, the company said in a new report. That’s a major comedown from 2015, when a 16.3% average increase yielded a net rise of 9.4%.

Lilly joined pharma peers Johnson & Johnson and Merck in unveiling its high-level pricing data, as part of a summary of its annual report. On average, the company says discounts have grown to 50% over the last 5 years, up from 28% in 2012.

What’s causing that increase? Lilly says more competition among drugmakers to win coverage, a change in its product portfolio, and hardball negotiations with PBMs. Mandatory government discounts that have grown “significantly” since the Affordable Care Act went into law in 2010 are also playing a role, according to the company.

RELATED: Single-digit price-hike pledge? J&J has that covered already, company report says

The Indianapolis drugmaker’s report comes on the heels of Merck’s and J&J’s similar disclosures. Each of those companies has felt the sting of payer pressure in recent years, the disclosures show. On average, J&J said it hasn’t raised prices above a single-digit percentage—a pledge Allergan CEO Brent Saunders famously made in September—dating back to 2012. J&J paid out $11 billion in rebates and discounts in 2016 and realized a 3.5% average net price increase, the company said.

Merck reported that its average rebates and discounts grew to 40% in 2016, up from 27% in 2010. The company realized a 5.5% price gain throughout its portfolio last year, negotiated down from a 9.6% average list price increase.

RELATED: Big Pharmas, top biotechs balk at investor group’s push for pricing transparency

However, each company pushed back on a recent request from the Interfaith Center on Corporate Responsibility for more detailed pricing information. That group wants to see drug-specific pricing data, a request stymied by many top drugmakers.

RELATED: In quick rebuttal, Express Scripts blasts Gilead exec’s pricing blame

The companies are reporting their pricing and rebate data as debate continues to intensify over the role PBMs play in U.S. drug costs. Shortly after a high-profile dust-up between Gilead Sciences and Express Scripts on the topic, Sen. Ron Wyden. D-Ore., unveiled legislation aimed at lifting “the veil of secrecy” behind drug rebates.

Follow the money trail: Pharmacy Benefit Managers and Insulin Makers Face Price Scheme Lawsuit (CVS, ESRX)

Pharmacy Benefit Managers and Insulin Makers Face Price Scheme Lawsuit (CVS, ESRX)

http://www.investopedia.com/news/pharmacy-benefit-managers-and-insulin-makers-face-price-scheme-lawsuit-cvs-esrx/

Three of the nation’s leading pharmacy benefit managers (PBM) have been named in a lawsuit charging that they participated with major insulin manufacturers in a price fixing scheme. CVS Health Corp. (CVS

) OptumRx unit were named in a federal court filing in New Jersey last week.

The PBMs are alleged to have been part of a collusion scheme along with Eli Lilly & Co. (LLY

 The three largest PBMs jointly account for 80% of the prescription drug industry in the U.S. and manage benefits for around 180 million individuals. (For more, see What Is the Pharmacy Benefit Management Industry?)

Second Case Against Insulin Makers

Four individual plaintiffs were joined by a nonprofit organization called the Type 1 Diabetes Defense Foundation is the suit.

In January, the three insulin makers were named as defendants in a separate federal court filing in Massachusetts, alleging that the companies significantly increased list prices of lifesaving insulin, raising them in lockstep and harming patients’ interests.

The cases come amid growing outcry over the nation’s opaque drug-pricing system which is seen as benefiting both drug manufacturers as well as intermediaries.

Along with the accusations that the drug makers colluded to increase the drug prices in a planned manner, which resulted in price increases of more than 150%, the plaintiffs also allege that the drug makers shared additional revenues with PBMs through rebates. (For more, see Supply Chain: The Big Leak Fueling High Drug Prices.)

Earlier in November, Senator Bernie Sanders requested the Justice department and the Federal Trade Commission investigate insulin drug makers for alleged price fixing. (For more, see Bernie Sanders Slams Drug Price Fixing.)

Responses from Drug Makers and PBMs

A CVS spokesperson claims that PBMs don’t have any role in determining drug prices, the allegations are built on a false premise and they are without merit. Novo Nordisk too disagrees with the allegations. Spokesmen for Express Scripts and Sanofi denied the allegations and said the companies would defend themselves vigorously, reports Bloomberg BNA.

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