Prominent Pain Doctor Faces Hundreds of Lawsuits

https://www.painnewsnetwork.org/stories/2018/4/13/prominent-pain-doctor-faces-hundreds-of-lawsuits

Imagine spending your retirement defending yourself against hundreds of lawsuits in courthouses around the country – all of them alleging that you played a key role in starting the opioid crisis and that you were indirectly responsible for thousands of overdose deaths.

“It is mind boggling to me and its frightening, actually. I don’t know how I’m going to defend myself,” says Lynn Webster, MD, a pain management expert and former president of the American Academy of Pain Medicine. “Right now, we’re just trying to keep our head above the water.”

Webster has been named as a defendent in so many class action lawsuits – along with Purdue Pharma, Johnson & Johnson, Endo, Janssen and other opioid manufacturers – that he’s lost track. He knows of at least 80 lawsuits but believes there are many more.

“I think it could be several hundred,” he says.

The latest one was filed this week by Salt Lake County, Utah — where Webster lives — alleging that drug makers employed him in deceptive marketing practices that downplayed the risks of addiction and overdose. Like the other lawsuits by states, counties and cities, Salt Lake County seeks to recover taxpayer money spent on treating addiction, combating opioid abuse and policing opioid related crimes.    

 DR. LYNN WEBSTER

DR. LYNN WEBSTER

“Utah’s opioid crisis stems directly from a callously deceptive marketing scheme that was spearheaded by certain opioid manufacturers and perpetuated by prominent doctors they bankrolled,” the lawsuit alleges.

“Dr. Webster’s advocacy of opioids was designed to create a veneer of impartiality. But Dr. Webster was a forceful proponent of the concept of ‘pseudoaddiction,’ the notion that addictive behaviors should be seen not as a warning, but as indicators of undertreated pain. The only way to differentiate between the two, Dr. Webster claims, was to increase a patient’s dose of opioids.”

Until he retired from clinical practice in 2010, Webster operated the Lifetree Pain Clinic in Salt Lake City. The lawsuit makes a point of mentioning that at least 20 of Webster’s patients died from overdoses and that he was investigated – but never charged with a crime — by the DEA and the U.S. Senate Finance Committee.

“Most of what they have in there, at least about me, is false. And I think I can prove that,” Webster told PNN.

A footnote in the lawsuit contains the curious but important disclaimer that “Salt Lake County asserts no claim against Dr. Webster arising from his medical practice. The claims against Dr. Webster relate solely to his participation, as a KOL and otherwise, in Manufacturing Defendants deceptive marketing campaign.”

‘Key Opinion Leader’

KOL is an acronym for “key opinion leader” – a euphemism for doctors alleged to be so influential that they helped convince other physicians to prescribe more opioids. Webster and three other pain doctors — Russell Portenoy, Perry Fine and Scott Fishman — are portrayed in the lawsuits as KOLs who greedily accepted millions of dollars in payments from drug makers in return for their promotion of opioids.

“It’s mind boggling to think how four individuals can be accountable for essentially brainwashing all of the doctors in the country to do something intentionally to make pharmaceutical countries rich. How can anyone think that is plausible? It’s crazy,” says Webster. “Most of the pharmaceutical companies that they’ve listed I never received a dime from.”

According to the Salt Lake County lawsuit, Webster was “handsomely rewarded for his efforts,” receiving nearly $2 million from opioid manufacturers from 2009 to 2013. Webster says that dollar amount is unfair and misleading because most of it stems from his work as a researcher. He is currently Vice President of Scientific Affairs at PRA Health Sciences, a clinical research company.

“If you’re a principal investigator in a research program that has contracted with a pharmaceutical company, that money goes under your name. But its money to conduct a trial. Not a penny of it goes to me,” says Webster. “I have received compensation for consultant work and advisory boards. My consultant work is because of my area of expertise. That’s not unusual. And I do not speak for a company’s product. I do not benefit at all because I personally have no shares in any pharmaceutical company.”

Since retiring from clinical practice, Webster has become an outspoken critic of efforts by the government and insurance industry to limit opioid prescribing — which he believes have gone too far and unfairly punish pain patients, while ignoring the larger issue of illicit fentanyl, heroin and other black market drugs.

He’s written a book, called “The Painful Truth” and self-financed a PBS documentary by the same name.  Webster also comments frequently on PNN about opioid related issues.

With so many lawsuits hanging over him, Webster’s financial future is uncertain.  He says he and his fellow KOLs could be bankrupted by legal fees before any of the lawsuits come to trial.

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“We don’t have any big pocket that’s going to pay for anything,” he said. “If a jury decided to award money from us, they wouldn’t get any money, because there is no money. We would be all bankrupt by the time we got to court.”

Drug makers, on the other hand, do have big pockets. And during the 1990’s many of the same law firms now involved in opioid litigation helped win big settlements with the tobacco industry worth upwards of $200 billion.  That includes the law firm of Hagens Berman, which is handling the Salt Lake County lawsuit. The firm also represents the city of Seattle in a nearly identical lawsuit against opioid makers, in which Webster is named as a KOL.

Webster is also named in a string of lawsuits filed by the law firm of Simmons Hanly Conroy, which represents dozens of states, counties and cities. Simmons will pocket one-third of the proceeds from any opioid settlement,  which could run into hundreds of billions of dollars.

Simmons is well connected politically, having donated $219,000 to the re-election campaign of Missouri Sen. Claire McCaskill (D), who coincidentally released a report in February that’s highly critical of patient advocacy groups and medical associations for accepting money from opioid manufacturers.

It is against these political, financial and legal forces that Webster must find a way to defend himself.

“The body of the allegations are inaccurate, misleading and irresponsibly paint a picture which ignores the realities of Dr. Webster’s compassionate commitment to alleviating suffering in his chronic pain patients,” Peter Striba, Webster’s attorney, wrote in a letter to the Salt Lake Tribune. “It is estimated that there are approximately one-hundred million chronic pain patients in our Country, and it is very telling that their suffering and their medical condition is entirely absent in the narrative of the Complaint.” 

 

Cop steals pt’s medication – get ONE YEAR house arrest

 A now former Palm Beach County Sheriff’s deputy was caught on home surveillance video stealing prescription drugs from

a West Boynton Beach home 90 minutes after paramedics took the dying 85-year-old homeowner to the hospital.

 

Former deputy accused of stealing pills pleads guilty to lesser charges

http://www.sun-sentinel.com/local/palm-beach/fl-pn-deputy-steal-pills-plea-deal-20180413-story.html

A former Palm Beach County Sheriff’s deputy who stole prescription pills from a West Boynton Beach residence two days after Hurricane Irma will serve a year of house arrest.

Jason Cooke was caught in the act on home surveillance video 90 minutes after paramedics took the dying 85-year-old homeowner to the hospital.

Originally charged with armed burglary and grand theft, Cooke on Friday in Palm Beach County Circuit Court pleaded to reduced charges of burglary and petty theft.

Under the terms of the plea deal, Cooke also must serve three years probation and surrender his law enforcement certification, court records show.

Three deputies — none of them was Cooke — had gone to Moe Rosoff’s house last October to perform a welfare check. They found Rosoff on the floor of the master bedroom. He died hours later at the hospital.

After paramedics took Rosoff to the hospital, Deputy Cooke later showed up. He had gotten the home-garage code from the sheriff’s dispatch log and used it to creep inside the residence, authorities said.

One of Rosoff’s sons, who had requested that deputies check on his father, watched from North Carolina as Cooke rummaged through his father’s belongings. The security video showed Cooke at the kitchen island pick up at least two containers and put them in his pocket.

Sometime after the burglary, Rosoff’s son handed over the video to the sheriff’s office. A sergeant watched it and recognized Cooke, according to a police report.

Investigators searched Cooke’s patrol car to find 60 pills, including narcotic painkillers, muscle relaxers and other medicine.

Cooke later admitted to taking pills from the counter. He resigned soon after his Oct. 19 arrest.

In court on Friday, Cooke’s lawyer said his client is getting help and is now a different person.

 

U.S. Surgeon General visits Arkansas to encourage everyone to carry narcan

http://www.thv11.com/article/news/health/opioids/saving-a-generation/us-surgeon-general-visits-arkansas-to-encourage-everyone-to-carry-narcan/91-537659703

There’s not one solution to tackling the opioid addiction crisis. U.S. Surgeon General Dr. Jerome Adams was in Little Rock to talk about what he’s doing to fight it.

“We have a person dying every 12.5 minutes from an opioid overdose,” said Dr. Adams.

Before we fight the crisis, Dr. Adams wants us to change our idea of the face of addiction. 

“It may not be who you think,” said Dr. Adams. “I’ve talked to mothers, suburban moms who had C-sections, were over-prescribed, and unfortunately are now injecting heroin.”

In Arkansas, Dr. Adams recognizes the effort to tackle this through partnerships.

“You’ve got health, talking to the medical side, talking to DEA,” said Dr. Adams.

One core issue is over-prescribing.

“Very honestly, we’re still over-prescribing and have a lot of work to do in that front and I don’t blame doctors or prescribes for that solely, but we’ve got to look at the whole picture and look at how we can lower expectations for opioids,” said Dr. Adams.

Some data shows medical marijuana could be the answer, but before it’s accepted, Dr. Adams thinks marijuana needs research like any other medication.

“When you talk about the medicinal properties of marijuana I do believe, because the science says, there are medicinal properties of components of marijuana, but we need to make sure we’re doing the research,” said Dr. Adams.

Dr. Adams issued a public health advisory urging more people to carry naloxone, a lifesaving medication that can reverse the effects of an opioid overdose.

“A safe drug, a readily available drug in Arkansas, and a drug which can save a life,” said Dr. Adams.

He wants naloxone use to be as accepted as CPR, with common knowledge on overdose signs.

To those asking themselves why they should help, Dr. Adams wants people to reject the idea that there is a con to saving someone’s life.

“If we decided who was going to get medical treatments based on the poor decisions they made, the hospital would be empty,” said Dr. Adams.

Major push to combat opioid abuse doesn’t include bill to restore DEA powers

Sen. Claire McCaskill, D-Mo.

Sen. Claire McCaskill, D-Mo., introduced a bill last year in the Senate to restore DEA powers to fight suspicious drug wholesalers.

https://www.washingtonexaminer.com/policy/healthcare/major-push-to-combat-opioid-abuse-doesnt-include-bill-to-restore-dea-powers

Congress is expected to make a major push in the next few months to approve dozens of bipartisan bills to combat the opioid epidemic.

But missing from this effort is a bill to reverse a 2016 law that weakened the Drug Enforcement Administration’s power to go after suspicious drug distributors.

The House Energy and Commerce Committee’s health subcommittee is expected to hold its third legislative hearing on opioid legislation on Wednesday. The committee will consider more than 20 bills that introduce reforms to Medicare and Medicaid to combat the opioid epidemic. On the same day, the Senate Health, Education, Labor and Pensions Committee will hold a hearing on major opioid legislation.

 

Sen. Claire McCaskill, D-Mo., introduced a bill last year in the Senate to restore DEA powers to fight suspicious drug wholesalers. The bill has been referred to the Senate Judiciary Committee, which means it will not be part of the Senate HELP package.

McCaskill told the Washington Examiner that the bill has not gotten any Republican support.

“I have tried, but so far I have not been able to find anybody who has been willing to cosponsor it, and it is hard to get one across the finish line if you don’t have some Republicans that are willing to help,” McCaskill said.

The bill aims to strengthen DEA enforcement on distributors and wholesalers that give powerful painkillers to corrupt pharmacies called “pill mills. “

The Ensuring Patient Access and Effective Drug Enforcement Act of 2016 weakened that power after extensive lobbying from the pharmaceutical and drug distribution industry, according to an investigation from the Washington Post. The investigation forced Rep. Tom Marino, R-Pa., a major proponent of the legislation, to withdraw his name as nominee to become President Trump’s drug czar.

McCaskill said back in November that she wants to undo the damage done by the 2016 law that was passed by Congress and signed by former President Barack Obama.

The bill will also not be included in the collection of more than 40 bills being considered before the House Energy and Commerce Committee.

“We continue to work with DEA regarding possible legislative changes,” a House aide told the Washington Examiner. “It’s imperative we get this policy right, and we are doing our due diligence.”

The bills aim to focus on different facets of fighting the opioid epidemic, from treatment to enforcement tools. The legislative hearing on Wednesday will focus on legislation that aims to introduce reforms to Medicare and Medicaid to better curb opioid overprescribing and abuse.

Energy and Commerce leadership hope to get the bills through the House before the Memorial Day recess, while no timetable has been set yet for the Senate legislation.

The Senate HELP legislation intends to introduce reforms that include incentives to develop nonaddictive painkillers. It also aims to clarify Food and Drug Administration authority to require manufacturers to give simple and safe options to dispose of unused opioids.

It would also update DEA regulations to improve treatment access for people in rural areas, chiefly through telemedicine.

When asked about why her legislation was not included in this major legislative effort, McCaskill responded, “It’s really fascinating, isn’t it? I don’t get it.”

I believe that Senator McCaskill is running for reelection in Nov…. Senator McCaskill is from Missouri …  Missouri is the only state that does not have a PMP database.

Study: Indiana under-counting overdose death

http://www.14news.com/story/37924577/study-indiana-under-counting-overdose-death

INDIANA (WFIE) –

More and more people say they’re aware of the opioid crisis and think it’s a serious problem.

A new survey by the Associated Press found 13% of Americans say they’ve had a loved one die from an overdose. However, that number might be even bigger than that. 

The entire state of Indiana is seriously under-counting it’s opioid deaths, according to Indiana University Researcher, Brad Ray.

Over a six-year period, Ray looked at toxicology reports from the Marion County Coroner’s Office, where he found 918 deaths involved heroin and a significant increase in accidental overdose deaths involving both heroin and fentanyl.

Ray told the Indianapolis NBC affiliate, WTHR, that about 80% of the deaths labeled as ‘unspecified’ actually had an opioid present. If you include those opioid-involved deaths there is a much higher number of opioid overdose deaths in Marion County and the state.

Sometimes more than double the number.

Vanderburgh County Coroner Steve Lockyear said reported opioid deaths in Evansville don’t follow that pattern.

“Our initial screening is for over 300 drugs and now that’s expanded to over 500 or 600 drugs, including synthetics and K2’s and the bath salts,” said Lockyear. “These are vast, very expansive drug testing we do here in Vanderburgh County. We have no problem doing that, we’ve always done that.”

A new law requiring coroners test for opioid overdoses in suspicious deaths was just signed by Governor Eric Holcomb.

It allows for funding for extra toxicology tests from the state’s coroner training fund and requires data be sent to State Department of Health.

According to the coroner’s office, Vanderburgh County spent at least $200,000 last year investigating drug-related deaths. Those numbers do not include people who die from natural disease due to drug abuse

IMO.. it would seem that Indiana is using “qualitative toxicology” – just if a specific substance is present to declare a death a “opiate related death”  as opposed to a “quantitative toxicology” which would determine the CONCENTRATION of a particular substance.

The typical OD has 4-7 different substances in their toxicology and with these new guidelines in Indiana… all that is needed is for the mere PRESENCE of a opiate in toxicology to declare the cause of death to be “opiate related”

Apparently Indiana will do just about any “slight of hand trick” to raise the “opiate related deaths” in the state… MORE FEDERAL MONEY TO FIGHT THE WAR ON DRUGS ?  You notice that they are now using the “new terminology” that these deaths are not “accidental”… just opiate related.

ACLU: illegal immigrants have CONSTITUTIONAL RIGHTS ?

Just wanted to make sure you saw this: The Greyhound bus company is allowing Border Patrol agents to board its buses and search passengers without a warrant. It’s a gross violation of passengers’ constitutional rights – and we need your help to stop it.

Add your name so we can show Greyhound we’re standing up for immigrants’ rights. When Greyhound sees our petition, they’ll know we’re not going to back down.

This is urgent – there are so many lives on the line because of this latest development in Trump’s racist, anti-immigrant agenda. With your help, we can make sure Greyhound stays out of this xenophobic, fear-mongering practice.

Thanks for speaking up with us,

Jennie

Hi Steve –

Imagine taking your regular bus to work or school. The bus pulls over and Border Patrol agents get on board. Row by row, they scan passengers for anybody deemed “suspicious” due to the color of their skin, accent, or the way they dress. You think you’re just taking the bus home, like any other day – but you end up arrested, detained, and in worst cases, deported.

That horror story has increasingly become a reality on Greyhound buses throughout the country, because the company allows Border Patrol agents to board its buses and arrest passengers without a warrant.

Sign this petition telling Greyhound to stop throwing its passengers’ rights under the bus.

Not only is Border Patrol’s practice cruel, but it’s not even legal. The Fourth Amendment prohibits government agents from entering private property without consent or a warrant, and it protects everyone on U.S. soil – regardless of citizenship – from being detained or searched without cause. By law, Greyhound is fully capable of saying NO to Border Patrol. So why aren’t they?

Add your name to tell Greyhound to stop allowing Border Patrol agents to violate the constitutional rights of paying customers.

We know what this is really about. This is all part of the Trump administration’s shameful and hateful agenda to intimidate and expel immigrants from this country. It’s completely contrary to the founding principles of this country, which not only value immigrants and what they add to our communities, but also clearly delineate personal rights and freedoms. Like the right to take your daily commute without having to prove your citizenship or fear arrest and deportation.

We’re not going to stand for this racist policy. Sign this petition and tell Greyhound to treat its customers fairly and with dignity.

Thanks for fighting back,

Jennie Pasquarella
Director of Immigrants’ Rights for the ACLU of California

we allow elected officials — not doctors, pharmacists or researchers mind-you — to dictate how we deal with MJ.

Medical marijuana could ease Wyoming opioid crisis

www.wydispensaries.com/medical-marijuana-could-ease-wyoming-opioid-crisis/

The biggest controversy over medical marijuana in Wyoming should be why legislators haven’t already legalized it.

Here’s the reason: many of our lawmakers don’t understand the issue. They remain blinded by the rhetoric of long ago when marijuana was thought of as a “gateway drug” as harmful as heroin. Those arguments are still made today by Wyoming legislators who rely on thoroughly outdated propaganda and incorrect information to keep medical marijuana illegal.

Opponents of marijuana use in the 1960s and 1970s maintained that it did not have any medical benefits, but now we know from scores of scientific studies that their claims were wrong. Medical marijuana is legal in 29 states and the District of Columbia, improving the lives of patients with a host of diseases and conditions.

But not in the Cowboy State.

Inexplicably the vast majority of Wyoming legislators fail to grasp what is at the heart of the matter — pain relief and how to obtain it without becoming addicted to the opiates that are killing thousands of Americans each year.

We all experience pain. I can’t accept that we allow elected officials — not doctors, pharmacists or researchers mind-you — to dictate how we deal with it. Some argue that it is a morality issue. What’s moral about refusing aid to the suffering?

Others may argue that prohibition is the will of the people. Representatives taking that stance either don’t know, or don’t care, that an October 2016 University of Wyoming poll showed that an overwhelming 81 percent of state residents support the legal use of medical marijuana.

Despite its opposition to medical marijuana, the Legislature did show during the recent budget session that it is concerned about the sweeping opioid epi­demic. Senate President Eli Bebout (R-Riverton) sponsored a bill to create an opioid addiction task force that will include lawmakers, physicians, pharmacists, law enforcement and others.

Medical marijuana deserves to be a priority consideration of the task force’s agenda and not rejected out-of-hand because some believe it is hazardous to their political and professional health.

Currently our lawmakers have left those with chronic suffering with three unacceptable options: choose to live with pain, risk addiction and overdose with prescription or street opiates, or break the law by smuggling marijuana into Wyoming that was legally purchased in Colorado, Montana or other states.

Two new studies published last week by the JAMA Internal Medicine journal corroborate what other research projects have shown — the availability of legal marijuana reduces reliance on legal opiates like oxycodone, hydrocodone and codeine, and illegal street drugs like heroin.

Since 1999, according to Scientific American magazine, opiate overdoses have killed more than 165,000 Americans. The publication estimates the social costs of abusing these drugs at $55 billion per year.

If there is a way to provide effective pain relief for Wyomingites that will not end in tragedy for the victims, their families, friends and communities, we should jump on it. That’s especially true when the alternative already has widespread public support. About the only thing standing in the way of this readily available solution is the hide-bound ideology of the unwinnable “war on drugs.”

News flash, we lost that “war” decades ago. But the casualty count keeps climbing.

Peter Grinspoon, M.D., of Harvard Medical School says the most common use of medical marijuana is the relief from chronic pain and diseases such as cancer and multiple sclerosis.

“Marijuana is said to be a fantastic muscle relaxant, and people swear by its ability to lessen tremors in Parkinson’s disease,” Grinspoon wrote in the Harvard Health Blog. The Harvard physician noted it has also been successfully used for fibromyalgia, endometriosis, interstitial cystitis “and most other conditions where the final common pathway is chronic pain.”

We already know that marijuana can be used to help patients with cancer, multiple sclerosis, glaucoma and to manage nausea and weight loss associated with HIV, irritable bowel syndrome and Chron’s disease. Scientists are now researching how the drug can be used to help veterans returning from combat zones with PTSD. Early results are promising.

The number of diseases and medical conditions alone that can be successfully treated with medical marijuana is reason enough for state lawmakers to approve its use. But the new studies show medical marijuana also significantly decreases opioid use.

Researchers at the University of Georgia, in the most comprehensive study of the subject to date, found that states with medical marijuana dispensaries saw a nearly 15 percent decline in the number of daily opioid doses filled under Medicare Part D. In other words, in states where people have legal access to marijuana, pharmacies issue fewer, people consume fewer and the federal government pays for fewer dangerous opioids.

A University of Kentucky study came at the question from a slightly different angle but showed similar results. In their experiment, the Kentucky researchers found that in states with medical marijuana laws doctors wrote 5.88 percent fewer opiate prescriptions on average. In recreational pot states like Colorado the reduction jumped to 6.38 percent.  

If the remaining 21 states, including Wyoming, approved medical marijuana, it’s logical to conclude that number could be even higher.

Over the years a limited number of Wyoming legislators have shown they understand the benefits of medical marijuana. Former Sen. Keith Goodenough (D-Casper) sponsored a bill in 2003 that passed the Senate Judiciary Committee but died when Republican leaders refused to allow the measure to get to the Senate floor.

One of the senators who voted for the bill in committee 15 years ago was current Sen. Bruce Burns (R-Sheridan), who explained at the time that he brought marijuana from Colorado to New York to help ease the pain of a relative who was dying of cancer. That experience three decades ago convinced Burns that Wyoming should allow a physician to prescribe marijuana to patients, and pharmacies to fill those prescriptions just like painkillers, penicillin and other drugs.

Rep. Sue Wallis (R-Recluse), who saw her husband’s pain ease from medical marijuana as he was dying of lung cancer in a Colorado hospital, had planned to introduce a medical marijuana bill but she died in January 2014 before it could happen.

Burns and Wallis learned first-hand from their relatives how beneficial medical marijuana can be. But at this stage lawmakers shouldn’t need personal experience to buy in. The mountains of medical evidence and the enormous social benefits experienced in other states should be enough.

In the campaign to combat the widespread problem of opioid addiction that now claims the lives of an estimated 42,000 Americans per year, Trump has challenged researchers to “come up with a painkiller that’s not so addictive.”

But what the president wants is already available. Medical marijuana is one vital component in the battle against the opioid epidemic and it needs to be in the comprehensive packages of ways the state and federal governments save lives.

It doesn’t have to be difficult. Other states already have dispensary systems in place and laws covering growing and taxing cannabis. As many legislators like to say, there’s no need to “reinvent the wheel.” To combat opioid use — which the Legislature is already on record as supporting — legalizing medical marijuana makes sense and could be accomplished in the next general session.

Film Shines Light on Deadly Errors in Medicine -Death toll in U.S. as high as 440,000 per year

https://www.medpagetoday.com/publichealthpolicy/generalprofessionalissues/72206

Can a film help shift the conversation on reducing deadly errors in medicine?

The documentary To Err Is Human, which is currently in previews and opens to wide release in the fall, attempts to answer that question, highlighting the obstacles, consequences, and attempts to address the myriad factors on both the institutional and individual level responsible for errors in medicine.

“It’s a massive topic to address,” said director Mike Eisenberg, following a recent screening of his film. “We really wanted to maintain a singular focus — what would my dad have done if he made this movie?”

His late father, John Eisenberg, MD, MBA, was one of the early directors for what is now the Agency for Healthcare Research and Quality (AHRQ). He launched AHRQ’s evidence-based practice centers and was viewed as a pioneer for his work in healthcare research. In 2002 he died from a brain tumor, at the age of 55.

To Err Is Human gets its title from the landmark 1999 report on deaths from medical error from the Institute of Medicine, which estimated that between 44,000 and 98,000 hospitalized Americans die from medical errors each year.

Medical error isn’t currently a CDC-approved option when listing cause on death certificates — only diseases, morbid conditions, and accidents can be listed.

In 2016 an open letter from Martin A. Makary, MD, MPH, of Johns Hopkins Medicine in Baltimore, and colleagues urged the CDC to change this policy.

The authors of the letter — who defined death from medical errors as “1) errors in judgment or skill, coordination of care, 2) a diagnostic error, 3) a system defect resulting in death or a failure to rescue a patient from death, and 4) a preventable adverse event” — pointed to the fact that funding for medical research is often based on mortality figures. As such, patient safety gets a short shrift, and little public awareness.

The CDC says its methodology is in keeping with international standards of reporting on the causes of death.

More recent (though controversial) estimates put the number of deaths due to medical error at 400,000 per year or higher, but even conservative estimates would still make it the third leading cause of death in the U.S. following heart disease and cancer.

imageSally Roumanis, RN, telling the story of the medical error that cost her husband’s life

“In 2006, I had my own medical error and became part of that statistic,” said Sally Roumanis, RN, a patient-safety specialist at Yale, who shared her experience during a panel discussion that followed the screening.

 

Her husband Dean ended up in the ER at Yale following a cardiac event while cycling. A stent was put in and everything had seemingly gone well. It was late at night and Dean urged Roumanis and their daughter to head home for rest. “I can’t stand you hovering,” he joked, Roumanis recounted.

But at 5 a.m. Roumanis received a call saying her husband’s condition had drastically worsened. She arrived back at Yale to see a team rushing toward the cath lab, then doctors performing chest compressions on her husband.

A couple of days later she was told her husband’s death was a result of medical error.

A coronary artery had been perforated during the stent procedure resulting in bleeding and pericardial collection. “That wasn’t the error — it was a complication,” explained moderator Harlan Krumholz, MD, of Yale’s Institute for Social and Policy Studies. “But throughout the night, as Dean began to struggle, the junior doctors failed to escalate the problem to a higher level and didn’t appreciate the seriousness.”

It was early in the morning and the doctors handling the situation were early in their careers. “Nurses were advocating for escalation,” Krumholz continued, “but didn’t feel empowered to override the situation.”

The inexperienced doctors were treating the symptoms without understanding the cause. Dean’s condition continued to spiral downward until 5 a.m. when he went into cardiac arrest. “His pressure drops dramatically — they realize it needs to be escalated,” Krumholz said. “They rush him to the lab, but it’s too late.”

“This can’t be happening,” Roumanis told herself. “You just think, ‘no, he’s in a hospital, he’s in a safe place.'”

Talking About Medical Errors

In the past, doctors were trained not to talk about mistakes, but that attitude has shifted. The film features one institution that uses actors to train physicians delivering news of a medical error made during care.

imageMarna P. Borgstrom, MPH, left, discussing Yale’s approach to patient safety

Marna P. Borgstrom, MPH, president and CEO of Yale New Haven Health System, said that nothing has changed in the way of medical malpractice litigation, but that organizations — and individuals within organizations — have made the decision that it’s the right thing to do. “Now, whenever there is an error made, whether or not there is identifiable harm to the patient, we encourage the responsible clinicians to talk with the patients about that,” she said.

“Patients still sue us when that happens,” she added, “and that’s not wrong, because in some cases people are entitled to damages.”

Borgstrom, who spoke during the panel portion, recalled that when Yale first started tracking medical errors in an internal patient safety-reporting database there were about 14,000 events the first year, across the network of providers. “That sounds like a lot,” she said. Three years later it was 24,000 and growing.

“We viewed that as a good sign,” she said. “Rather than being afraid of telling people we made a mistake, people are talking about it.”

AHRQ

AHRQ, which has been under constant threat of defunding by Congress, is still in trouble and could possibly be rolled into the National Institutes of Health (NIH). “If AHRQ is dissolved into the NIH, there will still be some form of patient safety effort going on in NIH, where people who worked at AHRQ will hopefully be able to continue their work, but the budgets will be decreased, their efforts will be pared down,” Eisenberg said. “The way it is right now will no longer exist if that happens.”

However, as part of the omnibus bill, Congress passed a 3% increase to AHRQ’s budget for the next fiscal year ($334 million total), the first increase in 10 years. “So this is good news. There are caveats — I’m sure that those increases come with responsibilities that are not only focused on patient safety,” Eisenberg said. “The entire budget is never only about patient safety anyway.”

He said there are still people in very powerful positions who don’t think AHRQ’s work is important.

In 2012 AHRQ released a report detailing that a combination of best practices, improved safety culture, and a bigger focus on teamwork could cut central-line-associated bloodstream infections (CLABSIs) in hospitals by 40%. Borrowed from lessons learned in the aviation industry, one of the components included use of a procedure checklist, and during the film and panel discussion — countless comparisons were made to the Federal Aviation Administration’s ability to improve safety.

“A lot of these problems are engineering problems,” said Kevin M. Johnson, MD, of the Department of Radiology & Biomedical Imaging at Yale School of Medicine, chiming in from the audience. “And we have almost no engineers around.”

The Film

Between interviews with experts in the field of patient safety, To Err Is Human weaves in the story of Susan Sheridan, whose family’s intersection with the healthcare system was met with two medical errors.

First, jaundice (a sign of too-high bilirubin) in her newborn son, Cal, was ignored and led to brain damage and development of cerebral palsy. Sheridan’s experience led her to become a patient-safety advocate. Today hospitals routinely tests for elevated bilirubin.

Years later her husband Patrick was diagnosed with and treated for a benign brain tumor. Additional tests from pathology had revealed a malignant tumor, yet this was never communicated to Patrick’s physician. Left untreated, the disease aggressively spread until it was too late. He died in 2002.

While the plan is for wide release in the fall, the trailer is now available online and various upcoming screenings have been scheduled in select cities — including Cleveland on Monday, Tuesday and Wednesday next week, and Philadelphia on April 20. The latter will include a panel discussion.

Medicare Announces New Guidelines on High-Dose Opioids

https://www.painmedicinenews.com/Web-Only/Article/04-18/Medicare-Announces-New-Guidelines-on-High-Dose-Opioids/48469

New limits for high-dose opioid prescriptions will be enacted next year for Medicare Part D users, the Centers for Medicare & Medicaid Services (CMS) announced on April 2. Prescriptions will be held to a standard of 90 morphine equivalent milligrams (MME) per day, which follows the CDC prescribing guidelines for primary care physicians released last year.

The Medicare announcement—part of the 2019 Medicare Advantage and Part D Rate Announcement and Call Letter—also sets limits for opioid-naive patients on seven-day prescriptions, and notes the expansion and combination of the Overutilization Monitoring System and other government facets to identify “high-risk” opioid users, defined as using high levels of opioids from multiple sources, and “potentiator” users, who are using other medications (e.g., benzodiazepines) that increase the risk for adverse effects from opioids. CMS also plans to increase education on overdose risk and prevention.

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With around 42.8 million people enrolled in Medicare Part D as of 2017, and a precedent for setting industry example, the agency hopes to “address the opioid epidemic” with these limits, aiming for an “overall reduction in opioid overuse and overdoses.”

The limits will not affect patients in long-term care facilities, hospice, palliative care or those effected by cancer-related pain. It also excludes patients seeking medication-assisted treatment for opioid addiction, such as those on buprenorphine. 

Some research has shown higher doses can be correlated with overdose. A Veterans Health Administration sample of chronic pain showed overdose patients had an average dosage of 98 MME per day, compared with other patients who had an average of 48 MME per day. The CDC also said an opioid dosage at or above 50 MME per day doubles the overdose risk, compared with dosages less than 20 MME per day. The standard of  90 MME per day now set by Medicare is equivalent to 90 mg of hydrocodone per day, 60 mg of oxycodone or about 20 mg of methadone. 

But the average number of daily MME per prescription has been declining, from 60 to 50 MME per day between 2006 and 2015, according to numbers from the CDC. Those with high-dose prescriptions (≥90 MME per day) also have declined, to an average 6.7 per 100 people in 2015. And overall prescriptions are down, at around 70 per 100 persons that same year, although that number is still three times higher than in 1999.

we know that opiate prescriptions have been declining annually since 2012 and they are using TWO YEAR OLD DATA – 2015 and using generally accepted national averages upward to 10% of the population could be classified as suffering from incurable intractable chronic pain – requiring 24/7 opiate therapy.  With the CMS quoted numbers – using 2015 data – they believe that with 30% of that group of pts being untreated properly is STILL TOO HIGH..

CMS is also using opiate conversion ratios that are stated as.. FACTS … where are in fact… “HIGHLY CRUDE ESTIMATES”… and apparently there is no pt accommodation for the pt being fast/ultra fast opiate metabolizer.

Here is four quotes from the CDC opiates guidelines:

https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

“The guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function.”

“Clinicians should consider the circumstances and unique needs of each patient when providing care.”

“Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context.”

“This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.”

It would also appear that CMS’ recommendation COMPLETELY IGNORES the above parts of the CDC opiate dosing guidelines.

It would also appear that CMS is dead set on discriminating against a segment of our society that is consider a “protect class” under the Americans with Disability Act and the Civil Rights Act.  Since the federal agency that is in charge with enforcing the ADA  https://www.ada.gov/filing_complaint.htm   is under the same agency as the DEA – Dept of Justice.  AND… since CMS and CDC are part of HHS… 

Is it just me… or does there seem to be a great deal of collusion and cross protection of the actions of various Federal agencies by other Federal agencies ?

 

Senators Take On Jeff Sessions Over Marijuana Research Restrictions

www.hightimes.com/news/senators-take-jeff-sessions-marijuana-research-restrictions/

Bipartisan senators take on Jeff Sessions over marijuana research restrictions, calling for the Justice Department to stop blocking the DEA from approving new suppliers. On Thursday, Sens. Orrin Hatch (R-Utah.) and Kamala Harris (D-Calif.) sent a letter to the DOJ demanding action on the more than two dozen applications the DEA has yet to review.

Is Jeff Sessions Blocking The DEA From Authorizing More Marijuana Suppliers?

In their letter, Harris and Hatch expressed concern that Jeff Sessions’ Justice Department was sitting on a number of requests from growers looking to supply FDA-approved research on medical cannabis.

While the DEA wants to increase the number of authorized marijuana manufacturers, Sessions’ DOJ appears to be holding them back.

Jeff Sessions extreme opposition to marijuana legalization and his public disdain for cannabis users have prompted concerns that the Trump administration would attempt to roll back policies aimed at expanding access to medical cannabis and ensuring states are free to pass their own marijuana legislation.

And those concerns have already proven themselves to be valid. Since becoming Attorney General, Sessions has repeatedly vowed to ramp up federal drug enforcement. He’s ordered federal judges to pursue the maximum sentence possible even for non-violent, petty drug offenses.

Furthermore, on January 4, Sessions rescinded an Obama-era memo adopting a non-interference policy with legal-cannabis states.

What Sens. Harris and Hatch say Sessions is doing, though, is a bit more subtle than all that. In their letter, the senators reference reports that the Justice Department is preventing the DEA from reviewing applications from cultivators.

Unable to authorize new manufacturers, FDA-approved research projects on medical marijuana can source their cannabis from just one grower. Indeed, the University of Mississippi is currently the only grower licensed to produce cannabis for federally-approved research.

Senators’ Latest Bout With Sessions Takes Aim At Expanding Federal Cannabis Research

For as long as Sessions has been threatening a federal crackdown, however, lawmakers across the nation have pushed back.

Legislators have written letters, sent invitations, sought summits, and even filed lawsuits in response to Sessions’ provocations.

Sens. Kamala Harris and Orrin Hatch went with the letter-writing approach. But their aim isn’t to get Sessions to back down on enforcement. Rather, the bipartisan senators want to expand federal cannabis research, starting at the source.

Nearly two years ago, on Aug 11, 2016 the DEA announced a series of significant actions regarding medical cannabis research and industrial hemp production.

One policy change aimed “to foster research by expanding the number of DEA-registered marijuana manufacturers.”

The change, the DEA said, would “provide researchers with a diverse and robust supply of marijuana.”

Additionally, the DEA has approved every single application researchers have submitted to use federally-supplied cannabis to conduct “scientifically meritorious” studies.

 

So despite being the law enforcement wing of federal drug policy, the DEA have in recent years been surprisingly committed to advancing cannabis research.

And according to reports referenced in the letter Sens. Harris and Hatch sent to the DOJ, the DEA would be able to license up to 25 new manufacturers to grow cannabis for federal research, were the DOJ not sitting on the applications.

So Harris and Hatch are merely asking the Justice Department to let the DEA move forward on policy changes it adopted nearly two years ago.

Harris And Hatch Have A History With Cannabis

Both Harris and Hatch have had checkered records on the issue of legal cannabis. These days, Harris regularly denounces the war on drugs as a failure. But during her tenure as California’s Attorney General (2011 to 2017), Harris took no action on drug policy reform.

When Obama’s DOJ raided dispensaries in her home state of California in 2011, she issued a brief and largely deferential statement about “the gangs and criminal enterprises that seek to exploit the definite ambiguities in state law.”

In 2012, Harris laughed at the New York Time‘s official endorsement of legalization. In 2014, her Republican opponent ran to her left on marijuana issues. And despite her public support for marijuana, Harris has yet to sign on to any existing reform bills this year.

Unlike Harris, who’s been more inert on the issue than oppositional, Orrin Hatch has had a dramatic cannabis conversion. The senator has gone from being vocally anti-cannabis to one of the Hill’s most ardent champions of medical marijuana.

The Final Hit: Senators Take On Jeff Sessions Over Marijuana Research Restrictions

Whatever their records, however, Hatch and Harris are putting pressure on a significant choke point blocking medical cannabis research from advancing in the United States.

“Research on marijuana is necessary to resolve the critical questions of public health and safety, such as learning the impact of marijuana on developing brains and formulating methods to test marijuana impairment in drivers,” the pair said in the letter.

They’ve asked Sessions for a commitment that the DEA will resolve the 25 pending applications by August 11.