By Maria Cramer Globe Staff  May 01, 2018

Dozens of people died and hundreds of others fell ill during the 2012 fungal meningitis outbreak that began in a Framingham compounding pharmacy.

But should jurors in the latest trial against former pharmacy employees hear the devastating details of what is considered one of the largest public health crises ever caused by a pharmaceutical product?

Prosecutors and defense lawyers for nine pharmacists, technicians, and executives sparred over that question Monday at a hearing in US District Court in Boston.

The nine defendants are the lesser-known actors charged in the tragedy involving the New England Compounding Center during the summer of 2012, when prosecutors say contaminated, expired, and untested drugs were mislabeled and shipped to doctors, clinics, and hospitals across the country.They face charges that include mail fraud and racketeering in connection with the scandal and are scheduled to go on trial in October. But their lawyers contend they had no role in producing the batches of a contaminated steroid that caused the deadly outbreak. Some had worked for years at the company, while others had only been there a few months when federal officials launched their investigation.

“The outbreak has nothing to do with the charges against them,” said Dana McSherry, who is representing Joseph M. Evanosky, a pharmacist who worked at NECC from April 2011 to October 2012.

The nine defendants had filed a joint motion asking that US District Judge Richard G. Stearns bar testimony about the tainted vials of the steroid, methylprednisolone acetate, and the harm they caused.

The man responsible for compounding that drug, pharmacy supervisor Glenn Chin, was convicted last fall, defense lawyers argued. Chin began serving an eight-year sentence for racketeering and fraud in April. NECC’s former owner, Barry Cadden, was convicted of fraud and racketeering in March 2017 and was sentenced to nine years in prison.

“This is not Cadden-Chin, round three,” McSherry said. “These are different defendants, different charges.”

Cadden and Chin were both acquitted of second-degree murder charges.

Assistant US Attorney George P. Varghese said it’s critical that jurors know about the fallout of the steroid’s production so they can understand why the federal government launched a massive investigation into the pharmacy.

The remaining defendants may not have been responsible for production of the steroid, but Varghese said they used the same unsafe practices to produce and ship other drugs.

“We are not seeking to inflame the jury,” Varghese said. “We are trying to demonstrate the story of what happened in this case.”

Varghese said prosecutors plan to seek testimony from Centers for Disease Control and Prevention and Food and Drug Administration officials but will not call victims or their families as witnesses.

Prosecutors have described NECC as a “fraudulent criminal enterprise” that produced substandard drugs and marketed them as the safest in the country. They say many of the remaining defendants conspired with Cadden and Chin to carry out the scheme, but defense lawyers say the government went too far in charging their clients for what are essentially civil regulatory violations.

In 2012, investigators from the CDC and the FDA found that NECC sent out vials of mold-tainted steroids that were injected into the spines of patients, many of whom suffered strokes. Those who survived continue to be afflicted by pain, headaches, and memory loss. Many now rely on canes and wheelchairs.

In 2014, prosecutors indicted 14 people in connection with the outbreak, which authorities said caused the deaths of 64 people and infected about 800 patients.

Stearns seemed to agree with defense lawyers that it could be problematic to include evidence of the deaths and illnesses at a trial for defendants who were not accused of producing the deadly steroid.

But he said prosecutors have a strong argument for why the jury may need the context of the outbreak to understand why the pharmacy was investigated in the first place.

McSherry countered that it is not necessary to tell the jurors of the deaths and illnesses that occurred, since the defense does not plan to argue that there was no reason for federal agencies to investigate the pharmacy.

“That’s fair,” Stearns replied.

But Varghese said prosecutors need that background to counter the likely defense argument that they overreached in charging the defendants with racketeering or conspiracy.

He alluded to the second-degree murder acquittals of Cadden and Chin to show that jurors in those trials, who were shown photos of the victims and heard wrenching testimony about how they died, were still able to assess the evidence objectively.

The government is seeking almost $74 million from Cadden in restitution for the victims.

Besides Evanosky, the remaining defendants are Gregory A. Conigliaro, a former owner and director of NECC; Sharon P. Carter, former director of operations; Scott M. Connolly, a pharmacy technician; and five other pharmacists: Chin’s wife, Kathy; Gene Svirskiy; Christopher M. Leary; Alla V. Stepanets; and Michelle L. Thomas.

Maria Cramer can be reached at mcramer@globe.com. Follow her on Twitter @globemcramer.

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https://www.washingtonpost.com/opinions/are-restrictions-on-opioids-a-threat-to-human-rights/2018/04/30/42c7ac32-4c86-11e8-af46-b1d6dc0d9bfe_story.html

Fatal overdoses of prescription opioids were rare before 1999. Then doctors, influenced by pharmaceutical industry marketing, began prescribing them for chronic non-cancer pain. By the end of 2016, prescription opioids — not illicit heroin or fentanyl — had claimed 200,000 lives.

Now, at last, the opioid wave has crested. Per capita usage declined for the sixth straight year in 2017, according to IQVIA Institute for Human Data Science , a health-care consulting group. Changes in public policy, including long-awaited prescribing guidelines issued by the Centers for Disease Control and Prevention (CDC) in March 2016, promise to sustain this life-saving progress.

Or maybe they’ll lead to human rights violations. Believe it or not, that’s the premise of a new investigation by the New York-based nonprofit Human Rights Watch (HRW), known for its exposés of war crimes around the world.

HRW is seeking evidence that the CDC guidelines and other efforts to modulate opioid prescribing result in patients being cut off from vital medication, in violation of their right to appropriate health care.

The group “is looking for testimonials from chronic pain patients who have been forced or encouraged to stop their opioid medication by physicians or pharmacists,” the Pain News Network reported in March.

“The CDC clearly knows what’s going on and they haven’t taken any real action to say, ‘That is not appropriate, involuntarily forcing people off their medications. That’s not what we recommended,’ ” Diederik Lohmann, director of health and human rights for HRW, told the network, which says two-thirds of its readers take opioids, mostly for chronic, non-cancer pain. “When a government puts in place regulations that make it almost impossible for a physician to prescribe an essential medication, or for a pharmacist to stock the medication, or for a patient to fill their prescriptions, that becomes a human rights issue.”

Human Rights Watch is not alone; a recent cover story of the libertarian magazine Reason denounced “America’s war on pain pills.” And, of course, patients who have become dependent on opioids must be treated compassionately.

But even after the recent decline in prescriptions, the U.S. opioid rate of consumption in 2017 — 676 morphine milligram equivalents per adult — was five times the 1992 rate. It’s double or triple that of other advanced countries. People who really need them can get licit opioids in the United States.

And the drugs still killed 46 people a day in 2016, according to the CDC.

In any case, alleged unintended consequences of justifiable and, indeed, moderate public-health policies just do not belong in the same moral conversation as deliberate human rights violations such as police brutality or torture.

Article 12 of the International Covenant on Economic, Social and Cultural Rights does indeed exhort governments to guarantee the “highest attainable standard” of health; in that sense, there is a human right to health. Whether it can be defined with sufficient objectivity for this situation is another story. Assuring health is exactly what the CDC is trying to do — not through “regulations,” but through evidence-based recommendations.

To be sure, HRW acknowledges that opioids have been overprescribed in the past, in part due to deceptive industry marketing; a key focus of its current research is ensuring non-opioid alternatives for patients weaned off the drugs, Lohmann told me.

One ought not to prejudge the HRW report, due later this year, even if Lohmann’s comments to the Pain News Network implied that the CDC is blameworthy, and even if the organization funding the study, the U.S. Cancer Pain Relief Committee, is headed by a five-member board of pain specialists who are well-known advocates of opioid use for chronic non-cancer pain.

Two of them, Russell Portenoy and Richard Payne, have received financial support from opioid manufacturers. In late 2015, Payne spoke out against the CDC guidelines in a government advisory group’s deliberations before they were adopted. (Efforts to reach board members were unsuccessful.)

Note that the CDC guidelines specifically address opioid use for non-cancer pain only. The government encourages palliative care for cancer and hospice patients.

The U.S. Cancer Pain Relief Committee has previously underwritten HRW reports on the developing world, the theme of which is that AIDS and cancer patients are being denied access to morphine due to international and national rules intended to prevent opioid misuse. Palliative care in poor countries is a legitimate concern — among the many urgent health-care deficits that such countries face.

Here’s another legitimate concern: Poor and middle-income countries may be vulnerable to the same kind of pro-opioid campaign that wreaked such havoc in the United States.

Mundipharma, a network of companies controlled by the same closely held family business that introduced Purdue Pharma’s OxyContin to the United States, is engaged in aggressive opioid marketing in China, Colombia, Egypt, Mexico and the Phillipines, according to a recent Los Angeles Times report.

As Keith Humphreys, Jonathan P. Caulkins and Vanda Felbab-Brown write in the May/June issue of Foreign Affairs, the U.S. experience shows that “legal drugs pushed by corporations can bring death on a scale vastly surpassing the effects of illegal ones.” And no human right is more important than the right to live.

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On opioid lawsuits, powerful Texas Republican says there is blame to go around

https://www.lmtonline.com/local/texas-politics/quorum-report/article/On-opioid-lawsuits-powerful-Texas-Republican-12875964.php

AUSTIN — As Texas House lawmakers investigate what the state’s response should be to the growing opioid crisis here and around the nation, tort reformers are growing concerned that trial lawyers are “unethically” recruiting clients to go after big pharmaceutical companies.

Chairman of the Select Committee on Opioids and Substance Abuse, state Rep. Four Price, R-Amarillo, was asked about “ambulance chasing” attorneys by Jay Leeson, host of the Other Side of Texas Radio Show based in Lubbock.

In response, Price pointed out that the committee’s study of the issue – as laid out by retiring Speaker Joe Straus – does not include looking at litigation.

That’s even though some counties around the state including Upshur, Bexar and Harris have filed suit against manufacturers of opioids seeking to recoup uncompensated care costs.

“If you really study these issues, there’s a shared level of responsibility up and down that spectrum from the manufactures to the prescribers to the distributors to the patients themselves,” he said.

Price said the committee will take its time in coming up with recommendations by November for the next Legislature to consider. “Not all of big pharma’s going to love our recommendations. I’m sure not all prescribers or patients will love our recommendations,” he said.

The full story can be found in the Quorum Report. Copyright 2018, Harvey Kronberg,http://quorumreport.com/index.cfm, All rights are reserved. This story is presented as part of the Houston Chronicle’s collaboration with Quorum Report. For inside information on Texas politics and government and to sign up for real-time updates, go here.

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Hospital That Killed Alfie Has Been Caught Selling Child Organs

www.westernjournal.com/ct/hospital-that-killed-alfie-selling/

This must be the pride of socialized medicine.

Alder Hey Children’s Hospital in Liverpool, England, became notorious in international headlines last week as the site of the legal “execution” of a stricken toddler over the wishes of his parents, as well supporters of the parents on both sides of the Atlantic, and even in the Holy See.

But the hospital had a well-documented history of being the scene of abusive medical practices long before it admitted young Alfie Evans into what became his death chamber.

A summary of a government report about the scandal, published by the U.K. Guardian in 2001, noted that the dead children’s “parents were distraught to find that thousands of body parts had been removed and kept in hospital storage.”

According to The Guardian, the organs in those cases were removed during autopsies, a standard practice. But the families were never informed that parts of the bodies of their children had been kept for research purposes.

The hospital actually transferred the thymus glands removed from living children during heart surgery to the French vaccine maker Aventis Pasteur in exchange for a small “donation.”

The hospital received about five British pounds for each gland (worth about $7.50 to $10 USD). An exact number of the organs wasn’t reported, but it was believed to be in the hundreds.

The thymus gland is an important part of the body’s immune system, so it’s easy to see why a vaccine research firm would be interested in a steady supply — even if the organs came from still-living children and essentially sold without the knowledge or consent of those children’s parents.

In January 2001, an Alder Hey spokeswoman confirmed to The Guardian the exchanges had taken place.

At the time of that report, a pediatrician associated with Alder Hey tried to justify the obviously ghoulish practice of removing bodily organs from living children and selling them without the knowledge of the parents by saying the company produced a drug that helped treat children with anemia.

RELATED: Cops Issue Shock Threat to Citizens Protesting Alfie’s Execution

Maybe all of that is true. Obviously, medical research involves methods laypeople would consider gruesome, and the products pharmaceutical companies manufacture obviously save lives.

But the fact remains that a British hospital, part of the country’s vaunted system of socialized medicine, was harvesting organs from living children and selling them to a commercial company without the knowledge of the people who really mattered.

What it comes down to is this: The British hospital that essentially killed a helpless toddler last week by removing the boy from life support, then refusing to allow his parents to take him to seek treatment that was available elsewhere, has a documented history of shamefully using the bodies of its child patients.

And it did it by taking a step even further than  other hospitals in Britain’s National Health Service.

Any American who might still be undecided about Obamacare and its death panels, or thinking about backing someone with the beliefs of Bernie “Single Payer” Sanders, should be watching the death of Alfie Evans and the hospital where it took place carefully.

What do you think? Scroll down to comment below!

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http://www.sj-r.com/news/20180429/medicaid-managed-care-reboot-pinching-pharmacies-advocates-say

Drastic cuts in what Illinois pharmacies are paid for filling Medicaid patients’ prescriptions will cause many to lay off employees or close in coming months, pharmacy advocates say.

The financial crisis for owners of independent and small-chain pharmacies has accelerated since the April 1 expansion of the state’s Medicaid managed-care program to all 102 Illinois counties, according to the Illinois Pharmacists Association.

“We’ve got to fix this,” said Garth Reynolds, executive director of the Springfield-based association. “This is far and away the most egregious situation we’ve seen.”

Many owners of the state’s more than 500 independent pharmacies and smaller chains — including those in the Springfield area — are being paid less than the “acquisition cost,” or wholesale price, of the medicines they dispense to Medicaid patients.

Reynolds said pharmacies also have seen their per-prescription “dispensing fee” from Medicaid — designed to cover professional services — drop from $5.50 for generics and $2.40 for brand-name drugs under the previous “fee-for-service” system to the current 45 cents per prescription.

At least one of those PBMs, CVS Caremark, pharmacy benefit manager for the huge CVS Pharmacy chain, appears to be working with CVS Pharmacy to put smaller pharmacies out of business so CVS can acquire them, Reynolds said.

“It’s kind of a predatory market practice and misuse of state tax dollars,” he said.

CVS officials didn’t respond to requests for comment.

PBMs are hired by private companies called managed-care organizations, or MCOs, to process payments to pharmacies. MCOs have contracts with the state to carry out the Medicaid managed-care program now serving 80 percent, or 2.7 million, of Illinois’ 3.14 million Medicaid recipients.

The Illinois Department of Healthcare and Family Services has said Gov. Bruce Rauner’s expansion, or “reboot,” of Medicaid managed care will lead to annual savings of $200 million to $300 million, or more than $1 billion in savings over the life of the four-year contract for HealthChoice Illinois.

A bill that would require Healthcare and Family Services (HFS) to pay pharmacies “fair and reasonable” reimbursement rates — at least equal to the former fee-for-service rates — has bipartisan support and passed the Illinois House, 87-16, on Thursday.

Those voting “yes” to House Bill 3479 included Reps. Sara Wojcicki Jimenez, R-Leland Grove; Tim Butler, R-Springfield; and Sue Scherer, D-Decatur. Rep. Avery Bourne, R-Raymond, was absent from the vote but is listed as a co-sponsor of the bill, which now will be considered by the Senate.

Health and Family Services, an agency controlled by the Republican governor, opposes the bill but didn’t respond to a request for comment from The State Journal-Register.

Also opposing the legislation are two organizations representing private companies that are part of the Medicaid managed-care program.

Samantha Olds Frey, executive director of the Illinois Association of Medicaid Health Plans, said in a written statement that the bill could require Medicaid plans to pay above fee-for-service rates.

She said the bill “removes all incentive for all pharmacies throughout the state to acquire pharmaceuticals in a cost-efficient manner.”

Members of Frey’s association “see great value in independent pharmacies, especially those in rural communities throughout the state,” she said. “No one can argue that they are not an important part of our health-care system. However, this bill does not just address independent pharmacies. It requires more taxpayer dollars going to chains and ‘big-box’ stores.”

Officials at Deerfield-based Walgreens — another of the state’s largest pharmacy chains — declined comment.

The Pharmaceutical Care Management Association, based in Washington, D.C., and representing pharmacy benefit managers, said in a written statement that HB 3479 would “grant a ‘blank check’ to independent drug stores by requiring higher payments for prescription drugs in Medicaid while removing incentives to dispense lower-priced, equally effective options for patients.”

The proposed law, according to the PCMA, “pads the profit margins of Illinois independent drug stores at a time when consumers are concerned about rising health costs and the state faces serious budget challenges.”

Reynolds responded that pharmacy benefit managers are the ones getting a blank check from the state because of the state’s lack of oversight.

“We’re trying to keep pharmacies operational to be available to patients in their communities,” he said.

Pharmacist David Falk, who supports HB 3479, is the owner of the Decatur-based Sav-Mor Pharmacy chain, which includes stores in Virden, Nokomis and 11 other downstate communities.

Falk said his drug stores posted an average profit per Medicaid prescription of $6.77 under the fee-for-service system. That profit took into account the wholesale cost of medicines and dispensing fees.

Under Rauner’s reboot of managed care, however, Falk’s average profit has dropped to 89 cents per Medicaid prescription. Depending on the store, Medicaid represents between 18 percent and 42 percent of his stores’ total revenue, Falk said.

Unless the situation changes, he said, “I will go out of business.”

Two of his pharmacies — in Neoga and Toledo, both in Cumberland County, northeast of Effingham — “won’t make it until the end of the year,” he said.

The financial pain has been similar for Michelle Dyer, a pharmacist and owner of Michelle’s Pharmacies in Carlinville, Gillespie and Bunker Hill, where Medicaid makes up about 40 percent of total revenues.

“I can’t pay my bills,” she said, adding that she has had to borrow to make ends meet.

Pharmacist Byron Berry, who owns and operates Pharmacy Plus sites in Carrollton, Roodhouse, Winchester and Barry, gets 25 percent to 35 percent of his revenues from Medicaid.

It’s frustrating that state contracts conceal the profits being made by pharmacy benefit managers for squeezing pharmacies, Berry said.

It’s unknown how much of that “savings” is being passed on to managed-care organizations or the state, he said. Also unknown, he said, is how much money pharmacy benefit managers are receiving in “rebates” from pharmaceutical manufacturers to pad their own profits.

The pharmacy owners said it’s wrong when CVS Caremark hits small pharmacies with low payment rates for serving Medicaid patients and CVS Pharmacy follows up with letters to those same pharmacies containing offers to purchase.

A copy of one such letter, distributed to lawmakers by the Illinois Pharmacists Association, says CVS wants to ease the stress of what the letter describes as “mounting challenges” that include “declining reimbursements.”

Not all pharmacies that end up going out of business will end up being acquired, Berry said. Some will close and leave large swaths of downstate Illinois without a local pharmacy, he said.

“We take care of our people in these small towns,” Berry said.

Several states are taking a closer look at how Medicaid managed care is affecting small pharmacies, Reynolds said. Arkansas lawmakers and that state’s governor recently approved a new law to regulate pharmacy benefit managers.

At an Illinois House subcommittee last week, several lawmakers were receptive to pharmacy owners’ complaints about pharmacy benefit managers. Lawmakers said fewer pharmacies will mean less access to care for patients.

“What is the patient supposed to do while we’re searching around for the best deal?” asked Rep. Mary Flowers, D-Chicago.

“We’re talking about people’s lives. … We need the pharmacists. We do not need the middleman; they are not accountable to anyone.”

The payment cuts threaten the future of pharmacist Beax Cole’s Medicine Shoppe pharmacies in Springfield and Jacksonville. Those stores receive up to one-quarter of their revenues from Medicaid, Cole said.

Rachel Hinkle of Auburn said the Springfield Medicine Shoppe has provided expensive, compounded medicines to help her 8-year-old son, Matthew, deal with neurological problems and a genetic condition known as Angelman syndrome.

Cole has had to wait months for thousands of dollars in reimbursements for the life-sustaining medicines under the fee-for-service Medicaid system, and now he said he is having problems getting the medicines covered under the managed-care reboot.

Hinkle she doesn’t know what she would do if she lost access to the Medicine Shoppe.

“Thank God they think of the patient,” she said. “They just want to make sure Matthew is taken care of. Shouldn’t people be the priority?”

Medicare and Medicaid are suppose to grant beneficiaries the “freedom of choice” of providers… Of course, if the bureaucracy reduces reimbursement to a point it drives out many of the providers… “freedom of choice” may come down to a few providers – mostly corporate providers that may – or may not – meet the pt’s needs.

It is generally considered that it costs $12.00 to fill a prescription – to cover all the costs of the pharmacy and according to this article, the state of Illinois has reduced “profits” to $0.89. While such entities – like CVS Health/Caremark – a PBM…  whose administrative costs are not accountable to anyone… is also a competitor to many of the smaller pharmacies that they are determining the profitability of those competitors.

Here is a recent post  Lawmakers, Pharmacists Meet with CVS over Regulation of Pharmacy Benefit Managers   where the Treasurer of Arkansas did a CVS/PBM price audit on some 250 + different medications and ON AVERAGE… CVS/Caremark paid CVS pharmacies $60.00 to fill a prescription over what they paid their competitors.

Presuming the $12/Rx overhead cost of filling a prescription. Under this program CVS pharmacies were paid FIVE TIMES what it cost to fill a prescription.  Is this just predatory business practices or anti-competitive behavior ?

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Should sugar be classified in the same category as heroin?

http://thehill.com/opinion/healthcare/385376-should-sugar-be-classified-in-the-same-category-as-heroin

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http://thehill.com/policy/healthcare/384601-senate-health-panel-approves-opioid-bill

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www.statnews.com/2017/02/24/opioids-prescribing-limits-pain-patients/

Amid a rising toll of opioid overdoses, recommendations discouraging their use to treat pain seem to make sense. Yet the devil is in the details: how recommendations play out in real life can harm the very patients they purport to protect. A new proposal from the Centers for Medicare and Medicaid Services to enforce hard limits on opioid dosing is a dangerous case in point.

There’s no doubt that we needed to curtail the opioid supply. The decade of 2001-2011 saw a pattern of increasing prescriptions for these drugs, often without attention to risks of overdose or addiction. Some patients developed addictions to them; estimates from the Centers for Disease Control and Prevention range from 0.7 percent to 6 percent. Worse, opioid pills became ubiquitous in communities across the country, spread through sale, theft, and sharing with others, notably with young adults.

The prescribing tide has turned: Private and governmental data show that the number of prescriptions for opioids has been falling since 2012. Reassuringly, federal surveys show that misuse of pain relievers bottomed out in 2014-15.

Nevertheless, the CDC produced a guideline in 2016 that recommended shorter durations for opioid prescriptions and the use of non-drug treatments for pain. It also suggested keeping opioid doses lower than the equivalent of 90 milligrams of morphine. As the guideline acknowledged, its recommendations reflected weak scientific evidence. Problematically, it was silent on how to care for patients already receiving doses higher than the 90 milligram threshold.

To its credit, the guideline endorsed treating patients as individuals, not numbers. A CDC official wrote to one patient that the guideline “is not a rule, regulation, or law. … It is not intended to take away physician discretion or decision-making.”

Unfortunately, these mitigating features were undermined by intemperate publicity that vilified opioids for pain. Opioids for pain “are just as addictive is heroin,” proclaimed CDC Director Dr. Tom Frieden. Such statements buttress a fantasy that the tragedy of opioid overdoses and deaths will be solved in doctors’ offices, primarily by upending the care of 5 to 8 million Americans who receive opioids for pain, even when most individuals with opioid addiction did not start as pain patients.

The progression of the guidelines from “voluntary” to “enforceable” has culminated in a draft policy from CMS. It would block all prescriptions above the CDC threshold of 90 milligrams unless complex bureaucratic barriers are surmounted. Many pharmacy plans are already enforcing this approach. Under that plan, many patients suffering with chronic pain would lose access to the medicines they are currently taking, all in the name of reversing a tide of death increasingly defined by non-prescribed opioids such as heroin and fentanyl.

The logic of doing this is untested. There have been no prospective clinical studies to show that discontinuing opioids for currently stable pain patients helps those patients or anyone else. While doing so could help some, it will destabilize others and likely promote the use of heroin or other drugs. In effect, pain patients currently taking opioids long-term have become involuntary participants in an experiment, with their lives at stake.

Turning the voluntary guidelines into strict policy is unfortunate for three reasons.

Second, we have alternatives to bureaucratic controls. These include promoting and paying for treatments that de-emphasize pills. Important work by the Department of Veterans Affairs shows how to identify patients with elevated risk for harm from opioids and how to mitigate the risks.

Third and most troubling is the increasingly inhumane treatment of patients with chronic pain. Fearing investigation or sanction, physicians caring for patients on long-term opioids face a dire choice: to involuntarily terminate prescriptions for patients who are otherwise stable, or to carry on as embattled, unprotected professionals, subject to bureaucratic muscle and public shaming from every direction.

In this context, we cannot be surprised by a flurry of reports, in the press, social media, and the medical literature describing pain patients entering acute withdrawal, losing function, committing suicide, or dying in jail. The CMS policy, if adopted, will accelerate this trend.

Many of our colleagues in addiction medicine tell us they are alarmed by the widespread mistreatment of pain patients. We receive anecdotes every week from physicians and pharmacists, most of them expert in addictions, describing pain patients who have involuntarily lost access to their pain medications and as a result have been reduced from working to bedridden adults, or who have become suicidal.

This loss of access occurs several ways. A pharmacy benefit program may refuse to cover the prescription because it has already enacted the changes that CMS is proposing to make mandatory. A physician may feel threatened by employers or regulators, and believes his or her professional survival depends on reducing opioid doses — involuntarily and without the patient’s consent — to thresholds that the CDC itself described as voluntary and not mandatory. Or state regulators have imposed such burdensome requirements that no physician in a given region can sustain prescriptions for their patients. Such patients are then “orphaned,” compelled to seek treatment from other physicians across the country.

Given the expertise in addiction among these physicians, it should be particularly worrisome that they believe the present pill-control campaign has gone too far. And yet, the ethics are clear: It should never be acceptable for us to countenance the death of one patient in the avowed service of protecting others, even more so when the projected benefit is unproven.

Surgeon General Dr. Vivek Murthy made an underappreciated declaration in a recent interview with the New England Journal of Medicine. “We cannot allow the pendulum to swing to the other extreme here, where we deny people who need opioid medications those actual medications. … We are trying to find an appropriate middle ground,” he said.

As addiction professionals, we agree wholeheartedly.

Stefan G. Kertesz, MD, and Adam J. Gordon, MD, are physicians in both internal medicine and addiction medicine. Dr. Kertesz is an associate professor of preventive medicine at the University of Alabama at Birmingham School of Medicine; Dr. Gordon is a professor of medicine at the University of Pittsburgh School of Medicine and editor of the journal Substance Abuse. The views expressed here are their own and do not reflect positions held by their employers.

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https://www.pharmacytoday.org/article/S1042-0991(18)30491-2/fulltext

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US puts Canada on IP priority watch list

https://gulfnews.com/business/economy/us-puts-canada-on-ip-priority-watch-list-1.2213130

Washington: The Trump administration on Friday labelled 36 countries as inadequately protecting US intellectual property rights, keeping China on a priority watch list and adding Canada over concerns about its border controls and pharmaceutical practices.

The US Trade Representative’s annual report on global IP concerns is separate from the ‘Section 301’ report on Chinese technology transfer practices that has led the world’s two largest economies to threaten each other with tariffs.

The so-called ‘Special 301 Report on Intellectual Property Rights’ calls out China for its “coercive technology transfer practices” and “trade secret theft, rampant online piracy, and counterfeit manufacturing”.

It was the 14th straight year that China was placed on the ‘Priority Watch List’.

The report was met with objections from the Chinese commerce ministry, which said the United States lacks objective standards and fairness.

“The Chinese side opposes this, and urges the US to earnestly fulfil its bilateral commitments, respect the facts, and objectively, impartially, evaluate with positive intentions the efforts made by foreign governments including China in the area of intellectual property rights and the results achieved,” the ministry said in a statement on its website on Saturday.

US Trade Representative Robert Lighthizer is due to travel to China next week along with other senior Trump administration officials for talks on US demands for changes in Beijing’s trade and intellectual property policies.

President Donald Trump has threatened up to $150 billion (Dh551 billion) in tariffs on Chinese goods, and China’s Ministry of Commerce has threatened to retaliate in equal measure.

A USTR official declined to comment on Lighthizer’s specific message to his Chinese counterparts next week, but said US officials “anticipate engaging with them meaningfully on all these issues.”

The biggest surprise in Friday’s report was the decision to move Canada from the lower-level ‘Watch List’ to the same priority list as China. USTR cited Canada’s “poor border enforcement,” especially for counterfeit goods shipped through America’s northern neighbour, and concerns about intellectual property protections for pharmaceuticals.

US pharmaceutical companies have long complained that generic versions of drugs still under US patent protection flood in from Canada at much cheaper prices.

Nafta talks

The increased criticism of Canada was revealed as Canadian Foreign Minister Chrystia Freeland was locked in intense negotiations with Lighthizer over updating the North American Free Trade Agreement (Nafta).

Washington has demanded that a modernisation of the 1994 pact include stronger IP protections.

Lighthizer, Freeland and Mexican Economy Minister Ildefonso Guajardo are trying to work out a number of stumbling blocks in the Nafta talks, including auto content rules.

The office of Canadian Innovation Minister Navdeep Bains, who launched an intellectual property strategy on Thursday, did not immediately respond to a request for comment.

Ottawa is pledging to create an independent body to oversee patent and trademark issues, “which will ensure that professional and ethical standards are maintained.”

Colombia also was added to the Priority Watch List for failing to revise its copyright laws as required under a free trade agreement with the United States.

Saudi Arabia and the UAE were added to the Watch List. Concerns about pharmaceutical intellectual property protections, pirated software and counterfeit goods were factors in those decisions, USTR said.

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