two people in the last few months who’ve taken their own lives to end unbearable pain

Dawn Rae Downton is worried about "agonizing" pain from her arthritis if new prescribing guidelines for opioids means she's cut off Fentanyl.

In defence of Fentanyl: Patient speaks out against new prescribing guidelines

http://www.cbc.ca/news/canada/nova-scotia/dawn-rae-downton-opioid-fentanyl-arthritis-pain-prescription-guidelines-1.4110897

Chronic pain patient Dawn Rae Downton, 60, is considering drastic choices if she’s cut off the highly powerful painkiller Fentanyl — which she has taken for 12 years — thanks to new guidelines for doctors prescribing opioid painkillers.

“What I would probably have to do is try and bring in drugs illegally through customs from online sites, or look to the street to see if I could find a dealer.”

This week, a team of researchers from McMaster University issued new recommendations aimed at changing this statistic: Canadians are the second highest users per capita of opioids in the world. 

Thousands of deaths across the country have been linked to opioid abuse, prompting officials to call it a crisis, an epidemic and a public health emergency.

‘I got my life back’

The Halifax woman, who suffers from a rare type of inflammatory arthritis, wants to make this clear: she doesn’t get high from taking Fentanyl, the lightning rod among opioids.

“Absolutely do not,” she said with a chuckle. Quite the opposite. She says she gets a low, weighed-down feeling from the medication.

Fentanyl patch

Fentanyl medication can come in patches or pills. (CBC)

Fentanyl has worked to cut pain where other medications and physiotherapy haven’t, she says. “I failed everything, nothing helped my pain.”

A pain clinic specialist eventually started her on a low dose of Fentanyl in a patch, which she changes every three days. 

“It made all the difference to me. I got my life back, basically,” says Downton.

Otherwise, sitting, walking and even standing would be “agonizing,” she says.

‘I probably would think about suicide’

Downton has looked up the new prescribing guidelines and asked her doctor what they could mean for her. She believes her dosage of Fentanyl might be reduced by 90 per cent. 

“I’d be left really with no meaningful pain coverage.”

If she’s unable to get her hands on the medication legally or on the black market, “I probably would think about suicide. It would seem like a reasonable option.”

Blaming pain patients

She knows of two people in the last few months who’ve taken their own lives to end unbearable pain and yet, she says it is legitimate patients who are being made “a convenient scapegoat” in the politics of opioids. 

“I feel like there’s been too much blaming of legal chronic pain patients for this problem. We have nothing to do with it. Nothing.”

She calls announcements by governments and prescribing guidelines, “optics that it’s doing something” to address the problem of opioid abuse.

The real source of the problem, she says, is overseas where chemical powders are sold and smuggled into Canada, and then pressed into tablets by drug dealers.

Chronic pain pt’s: Service Dog Denied Entry to Virgin Airlines Lounge

Service Dog Denied Entry to Virgin Airlines Lounge

http://www.foxnews.com/travel/2017/05/12/disabled-woman-claims-virgin-airlines-denied-her-service-dog-entry-into-lounge.html

Micaela Bensko and her service dog, Blue Belle, have a bone to pick with Virgin America.

Bensko, who is wheelchair-bound and suffers from arachnoiditis and complex regional pain syndrome as a result of an accident in 2011, is alleging that Blue Belle was denied entry into Virgin Atlantic’s lounge on May 10 at John F. Kennedy International Airport– despite having the necessary credentials for a service animal and paying extra to use the facilities. 

According to Bensko, Virgin Atlantic staff were worried about the “possible discomfort of others,” and requested a doctor’s note before allowing Blue Belle to enter.

Bensko told Fox News that she and her dog were turned away after she already obtained clearance to use the Virgin Atlantic lounge from an attendant at the check-in desk.

“I had gone to the Virgin desk to check in, I told them my condition, that I had to get into the lounge,” said Bensko, adding that she needed the use of the lounge because she can’t sit upright for extended periods of time without suffering spinal contractions and acute pain. “I paid $75 to use that lounge … they even printed me a special ticket [to get in].”

However, when Bensko finally arrived at the lounge, a Virgin employee said her special ticket wasn’t enough to gain entry. She began filming incident and recently posted the video to YouTube.

“It’s not policy,” an employee can be heard telling Bensko.

Bensko responds by saying she was well aware of the laws and regulations regarding service animals, and that she needed no such note to bring Blue Belle into the lounge.  

“It is a federal law that [Blue Belle] does not need a letter,” said Bensko, who was flying from JFK to LAX on Virgin America, but paid the extra to use Virgin Atlantic’s lounge. “She performs a service for me. I cannot get around without her because my neck is compromised.”

“In some places, you’re not even allowed to ask which services she performs for me,” added Bensko.

Virgin Atlantic’s regulations stipulate that passengers present an identification card for any service animal, a harness, or give a credible verbal statement. Emotional support animals, on the other hand, require further documentation.

Regardless, the Virgin employee continued to deny Bensko and her dog entry into the lounge. Bensko then asked if she could to lay on the ground near the entrance of the lounge, as her back was bothering her but was told to wait for a supervisor.

After pleading with the Virgin employee, Bensko eventually wheeled herself to a different area in order to lay down.

“I’m devastated,” Bensko says through tears. “I know a lot of people are doing videos now about airline, but this just hits home for so many people, because we go through so much stuff already.”

Bensko also told Fox News that she’s not planning to file a lawsuit against Virgin — she merely wants the airline industry to better train their employees on how to deal with passengers with disabilities.

“My main issue with this, and what I constantly encounter with service … there’s just no training as to the laws, the federal laws, mandated by our government between service animals and emotional support animals,” she said.

“I pressed record because nobody sees these things, with disabled people,” added Bensko of her motivation to film the incident. “People can see us, but they don’t look because they don’t wanna see.”

Virgin Atlantic says they are currently investigating the incident. In a statement obtained by Fox News, the airline apoligzed for the experience Bensko endured, and stated that “all customers [with] support dogs are welcome in our Clubhouses.”

“As soon as we were made aware of this incident, we sent an urgent reminder to our Clubhouse teams to clarify the policy around support dogs, and will be investigating further to improve the way the situation was handled,” wrote Virgin. “It is never our intention to disappoint our customers and we’re keen to speak directly with the customer to understand what improvements we can make to ensure this doesn’t happen again, and to offer our heartfelt apologies.”

But while Bensko has yet to hear from Virgin Atlantic directly, she tells Fox News that her grievance “goes so far beyond anything that can be managed by a phone call.”

She has penned an open letter to the airline industry, because, when it comes to this issue, she says she’s “physically unable” to keep quiet.

“[I] hope it can somehow spark a change in how airlines and corporations train (or in this case, don’t train) their employees as to the federal laws mandated specifically to protect the disabled.

“I hope my experience opens this conversation much needed between the airlines and the ADA community.”

FDA: One-third of FDA-approved drugs were later found to have safety risk

FDA hypocrisy on marijuana and prescription drugs is worse than we thought

www.personalliberty.com/fda-hypocrisy-marijuana-prescription-drugs-worse-thought/

One-third of FDA-approved drugs were later found to have safety risks, according to a recent analysis of drugs cleared by the agency between 2001 and 2010.

According to the study, published in the Journal of the American Medical Association, “Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 71 (32.0 percent) were affected by a postmarket safety event.”

A postmarket safety event includes “(1) withdrawals due to safety concerns, (2) FDA issuance of incremental boxed warnings added in the postmarket period, and (3) FDA issuance of safety communications.”

The researchers, many of them from Yale University, found these events were more common among biologic and psychiatric drugs, as well as those granted access to the FDA’s expedited approval process. The Washington Post summarized the researchers’ findings:

“Three of the drugs were withdrawn from the market. The FDA also required 61 new black-box warnings — the agency’s most serious safety alert, included in the drug’s packaging — and issued 59 safety communications to inform doctors and consumers about newly identified concerns. Some products had more than one boxed warning added or safety communication issued over the time of the study.”

According to lead researcher Joseph Ross, an associate professor of medicine and public health at Yale University, one of the main reasons for these failures is the public’s desire for quick access to pharmaceuticals.

“We seem to have decided as a society that we want drugs reviewed faster,” he told the Post, adding that for this reason, it’s vital “that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively.”

Further, according to a 2014 study published in the British Medical Journal, the industry directly funds the FDA, and this is likely a factor in the agency’s willingness to approve pharmaceutical drugs. That study explained:

“In 1992, because of widespread concern that the US Food and Drug Administration was taking too long to approve drugs, the Prescription Drug User Fee Act (PDUFA) was enacted, authorizing the FDA to collect user fees from drug companies to expedite the approval process. Besides providing funding for an increased FDA staff, the act established performance goals during the approval process to ensure more rapid review.”

The analysis noted that “As of the current fiscal year (October 2013 to September 2014), $760m (£450m; €570m) in drug industry money is allocated to the FDA’s Center for Drug Evaluation and Research, comprising a large proportion, more than 60 percent, of the center’s drug review expenditure.”

Though it is highly questionable that pharmaceutical companies directly fund the FDA, that study concluded it could not establish a definitive causal relationship between industry funding and increased safety issues. Still, it acknowledged “that the faster post-PDUFA drug approvals were associated with a higher rate of subsequent safety withdrawals and black box warnings.”

Perhaps another reason for the FDA’s inability to prevent drugs with adverse health effects from reaching the market is its acceptance of industry-backed research. For example, the agency recently approved a new drug for multiple sclerosis, Ocrevus (the generic version is called ocrelizumab), based on two studies. One of those studies was sponsored by Roche, the company that owns ocrelizumab’s manufacturer, Genetech. That study was conducted by scientists who disclosed financial ties to Roche and countless other pharmaceutical companies. STAT News reported that this study provided the bulk of the agency’s decision to approve the new drug.

The FDA acknowledged that side effects of Ocrevus include “upper respiratory tract infection, skin infection and lower respiratory tract infection.” Another potential side effect is cancer, which the FDA failed to note in its press release touting the drug’s approval. Further, as CBS News reported, “the new drug only modestly slowed decline” in symptoms of MS but was still considered a breakthrough.

Keeping with the findings of the recent analysis published in JAMA, this study was granted fast-track approval process and priority review.

These conflicts of interest are even more glaring in light of the fact that the FDA — the very same agency that evidently approves drugs that often ultimately prove to be harmful — refuses to acknowledge that cannabis is an effective medicine.

Despite ever-growing volumes of research — usually conducted with moldy, low-quality weed provided by the government — the FDA refuses to budge.

Rather, in fact, the agency has approved synthetic cannabis produced by pharmaceutical companies — one of which spent hundreds of thousands of dollars lobbying against cannabis legalization in Arizona last year and also manufactures fentanyl, a powerful opioid painkiller.

Meanwhile, despite the lack of serious side effects cannabis causes in individuals who find relief from it, last year the FDA actually advised the DEA to keep it on the list of Schedule I drugs, which are designated to have no medicinal value.

As the failures of the FDA continue to mount — including the pharmaceutical industry’s infiltration of the department — Americans have increasing reasons to avoid trusting their government and to do their own research before consuming potentially dangerous treatments.

 

 

Better choice: class of heart burn medications called H2 blockers (Zantac)

A Northern California woman who required a kidney transplant following years of Prilosec treatment claims that she was never properly warned about its possible renal side effects. Now she’s hoping that the litigation surrounding it and other proton pump inhibitors will push drug manufacturers to provide doctors and patients with adequate notice regarding the risks allegedly associated with these popular heartburn medications.

“I think if I had any indication that it would have done damage to any of my organs, I would have done it – go off or tried to go off,” the woman, identified only as “Penny”, recently told ABC 10 in Sacramento.

Penny was prescribed Prilosec to treat acid reflux. It worked so well, she remained on the drug for more than a decade. A recent eye infection, however, prompted her doctor to order a urinalysis that revealed Penny’s kidney function had been reduced to 30%.  In 2015, she was forced to undergo a kidney transplant.

In February, Penny joined a growing number of plaintiffs pursuing legal action against the manufacturers of Prilosec and other proton pump inhibitors for kidney failure, chronic kidney disease and other life-threatening renal complications. According to ABC 10, she doesn’t believe the drug companies will change their warning labels unless they’re sued.

Proton Pump Inhibitors and the Kidneys

Proton pump inhibitors have been on the market for more than 30 years, and are now available in both prescription and over-the-counter versions. In addition to prescription Prilosec and Prilosec OTC, other drugs in this class include:

  • Nexium/Nexium 24 HR
  • PrevAcid/PrevAcid 24 HR
  • Dexilent, Kapidex
  • Aciphex
  • Protonix

In 2014, the U.S. Food & Drug Administration (FDA) required the manufacturers of prescription proton pump inhibitors to modify their product labels to note their potential with acute interstitial nephritis. This serious disorder is characterized by swelling in between the kidney tubules, and is often the result of a sensitivity reaction to a medication. Untreated, the acute interstitial nephritis can progress to kidney disease and kidney failure.

In April 2015, a study published in CMAJ Open linked proton pump inhibitors to a 3-fold increase in the risk for acute interstitial nephritis, as well as a 2.5 times higher risk of acute kidney injury.

Just last year, two additional studies raised new concerns about the potential for proton pump inhibitors to harm the kidneys. The first was published in the January 2016 issue of JAMA Internal Medicine , and indicated that long-term use might increase the likelihood of chronic kidney disease by as much as 50%.  The following April, a study in the Journal of the American Society of Nephrology linked the drugs to a 96% increase in the risk for kidney failure, as well as a 28% heightened risk of chronic kidney disease compared to another class of heart burn medications called H2 blockers.

WI: treating opiate addictions with dependency on Suboxone ?

Wisconsin Medicaid panel decides to keep Suboxone on its preferred list

watchdog.org/293259/wisconsin-medicaid-panel-decides-keep-suboxone-preferred-list/

WISCONSIN – Suboxone, a medication that aids in the recovery of opiate addiction, will remain a preferred Medicaid-covered drug in Wisconsin despite complaints from state jail officials that it’s too easy to smuggle into prisons because of its film form.

A state Medicaid pharmacy committee decided this week to add a pill form of the drug to its preferred medications list but also to keep the film form on the list.

Suboxone is a brand name drug made of buprenorphine, which is an opiate, and naloxone, an opiate blocker, that helps in the recovery from opiate use disorder.

Someone doesn’t know the difference between Naloxone (Narcan) used for opiate OD’s and Naltrexone (Vivitrol)… which is used to treat a addict in recovery.

The drug comes in a film form that dissolves under the tongue.

“Suboxone is used as part of an overall treatment plan,” Carolyn Baxter MD, Psychiatrist at Prevea Behavioral Care in Sheboygan, told Watchdog.org. “It is given as a daily dose so that people can stop engaging in drug-seeking behavior.”

Because of Suboxone’s effectiveness in treating opiate addiction, Medicaid has designated it as a preferred drug.

But the Badger State Sheriffs Association and Wisconsin Sheriffs and Deputy Sheriffs Organization asked the state Medicaid program to stop covering the film version of the drug.

“Our issue, I guess, is not necessarily with the drug in and of itself, it’s with the administration of it, the smuggling in of the strips is what it is because it provides a very unique opportunity for the criminals and the addicts, if you will, to hide the strip, if you will, of Suboxone, buprenorphine into the jails and correctional facilities, therefore causing issues within the walls itself,” Sheriff Kim Gaffney, president of Badger State Sheriff’s Association, said.

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Many local authorities are looking at better ways to prevent easy access of the drug to inmates.

“Certainly our officers and our correctional facility staff must be more diligent, better trained and more aware of these type of issues because once the drug does get in, it can be used for its non-prescribed purpose, if you will, as well as to be abused within the facilities,” Gaffney said.

Gaffney, Baxter and others agree that the drug itself is not the issue.

“Suboxone is not evil in and of itself,” Devorah Goldman, Health Policy Consultant for Capital Policy Analytics, said. “Obviously it helps a lot of people and particularly naloxone, which basically blocks the effects of opiates, can be very valuable.”

Wisconsin Attorney General Brad Schimel has filed a lawsuit against the drugs’ manufacturers. According to the lawsuit, the drug manufacturer, Reckitt Benckiser Pharmaceutical, introduced the drug in tablet form in 2002. Before their exclusivity period ran out, they worked with MonoSol Rx to create the film version of the drug and then pulled the tablet form off the market, the lawsuit alleges. Thirty-five other states have joined the lawsuit.

In a statement made after Wisconsin’s lawsuit was filed, MonoSol Rx CEO Keith Kendall said it was frivolous.

“We believe that the allegations in the complaint are wholly without merit and the suit is both factually and legally deficient,” Kendall said in the statement.

Despite issues with the drug in its current form, Baxter said it’s too effective to take off the market.

“There are a lot of people who benefit from this drug who are on Medicaid,” Baxter said. “The public and personal health risk is significant, the money being spent on Suboxone through Medicaid and Medicare is worth it.”

Sessions: what you get when political favors are REPAID ?

Image result for graphic trump you're fired

5 Reasons Why Jeff Sessions’ Drug War Reboot Will Fail

https://www.leafly.com/news/politics/5-reasons-jeff-sessions-drug-war-reboot-will-fail

On the day he issued a two-page bid to revive the federal government’s failing war on drugs franchise, US Attorney General Jeff Sessions stepped up to a lectern in West Virginia to address a conference on America’s opioid crisis.

 
Sessions sees a nation keening with 52,000 overdose deaths and scolds us for our ‘complacency.’

“We’re on a bad trend right now,” Sessions told the audience at the University of Charleston  on Thursday. “We’ve got too much complacency about drugs. Too much talking about ‘recreational drugs.’ That’s the same thing you used to hear in the 80s. That’s what the pro-drug crowd argued then. But we realized from reality—empirical fact, neighbors, friends, crime, that this was not a legitimate thing.”

It was an extraordinary moment. Sessions spoke to West Virginians living in the heart of heroin country, where 864 people were killed by opioid overdoses last year. The conference was all about the opioid crisis. And yet he chose to bang his shoe against…cannabis? (Nobody talks about heroin as a ‘recreational drug.’) This in a state where—only three weeks ago—legislators and the governor proudly legalized medical marijuana under West Virginia law.

Protestors hold up signs as they await the arrival of Attorney General Jeff Sessions, who gave opening remarks during a Drug Enforcement Administration (DEA) 360 Heroin and Opioid Response Summit at the University of Charleston, Thursday, May 11, 2017, in Charleston, W.Va. The event, which was sponsored by the DEA, Community Anti-Drug Coalitions of America and the University of Charleston School of Pharmacy, was held to provide solutions and strategies for combating the heroin and prescription drug abuse epidemic. (AP Photo/Sam Owens)
Protestors hold up signs awaiting the arrival of Attorney General Jeff Sessions at the DEA’s 360 Heroin and Opioid Response Summit at the University of Charleston on Thursday. (AP Photo/Sam Owens)

After Sessions’ speech, federal prosecutors received fresh marching orders from the new boss. The Sessions sentencing memo, as it will surely be known, orders US attorneys and their subordinates to “charge and pursue the most serious, readily provable offense” in nearly all cases, “including mandatory minimum sentences.”

Those are the sentences that gave America the dubious honor of being the nation with the world’s highest incarceration rate, and did nothing to stanch illegal drug use or prevent the opioid death spiral so many communities are now experiencing. Sessions sees a nation keening with 52,000 overdose deaths every year and scolds us for our “complacency.” His answer? Bring back the days of D.A.R.E., “Just Say No,” and hard prison time for two joints.

This franchise reboot will fail.

  • It will fail because the American people have learned from “reality—empirical fact” that medical cannabis is not a hippie’s delusion. “Neighbors, friends” have confided to other neighbors and friends that, Well, actually, medical marijuana worked for me when I was suffering from (insert here): cancer, intractable seizures, PTSD, chronic pain. Those neighbors and friends are conservative and liberal, old and young, rich and poor, religious and agnostic. They are responsible parents, smart entrepreneurs, hard workers, and morally righteous. They are us.
  • It will fail because science and the federal government are increasingly acknowledging that cannabis offers a rational way out of the opioid crisis. Studies are showing that states with legal medical marijuana programs suffer fewer opioid addiction rates and overdose deaths than states upholding strict cannabis prohibition. We hear daily from patients who have weaned themselves from catatonic doses of prescribed opioids by using moderate, stable, and functional amounts of medical cannabis. Just last month the National Institute on Drug Abuse (NIDA), the most hardline anti-cannabis agency outside the DEA, posted an acknowledgment that “data suggests that medical marijuana treatment may reduce the opioid dose prescribed for pain patients,” and that “medical marijuana legalization might be associated with decreased prescription opioid use and overdose deaths.” That’s on a website called drugabuse.gov.
  • It will fail because Republican conservatives have turned against it. Medical marijuana and cannabis legalization are no longer liberal-Democrat issues. Data from last November’s election showed conservative voters in deep red districts in states like Florida, Arkansas, and North Dakota voting overwhelmingly in favor of medical marijuana. Rep. Dana Rohrabacher, a red-meat-loving, Trump-backing Orange County (California) conservative, has zero in common with Rep. Earl Blumenauer, a bow-tied, bicycle-riding Portland (Oregon) liberal—except cannabis. Their shared bond over legalization is so strong that the recent budget rider that protects medical marijuana patients from Jeff Sessions is named the Rohrabacher-Blumenauer amendment, forever conjoining their names in history.

AG Sessions wants to enforce all laws ?

Jeff Sessions issues tougher criminal charging policy

http://www.foxnews.com/on-air/the-fox-news-specialists/index.html

http://video.foxnews.com/v/5432283125001/?playlist_id=5411796059001#sp=show-clips

  At about 5 minutes into the piece Chris Stirewalt asks “what is the biggest drug problem in the USA ?”

Chris Stirewalt   Opiates… if course…. with two attorneys on this panel and well indoctrinated person from the media… what do you expect ?  The 550,000 deaths from the TWO DRUGS … ALCOHOL & NICOTINE… are justifiable preventable deaths ?

Is it time for those in chronic pain community to start filing violations of the Americans with Disability Act, Civil Rights Act for refusal/denial of care IN MASS ?  To see how serious that our new AG is about enforcing ALL THE LAWS ?

Is it time to file complaints against the Boards of Pharmacy… in the Controlled Substance Act 1970 there is a phrase “corresponding responsibility” which the DEA has interpreted that a Pharmacist can be held responsible for a controlled substance in the hand of a person that doesn’t have a valid medical necessity.  The DEA does not have any authority to hold a Pharmacist responsible for not getting a controlled substance into the hand of someone who has a valid medical necessity and a valid prescription.

The Boards of Pharmacy (BOP) primary charge is to protect the public’s health/well being… so it would seem only appropriate that the BOP’s would be responsible to protect the public’s health/well being by take as much action against a Pharmacist that gets the wrong drug in the wrong hand as failing to make sure that the right dose gets into the right hand.

Here is a link to all the BOP’s websites… where complaints can be filed  www.nabp.net/boards-of-pharmacy

If only a few people file complaints/grievances … they will probably be dismissed as some “addict” upset because they couldn’t get their next fix …  LARGE NUMBERS TALK

Who believes that all the FED/STATE legislators passed laws… believing that they would not be enforced by those within the bureaucracy responsible for doing so ?

 

 

 

LAW FIRMS: unconstitutional to possibly inflict pain on criminals/murders during execution ?

FILE - In this undated file photo released by the Georgia Department of Corrections, J.W. Ledford Jr., poses for a photo.  Lawyers for Ledford, a Georgia death row inmate argue the state's lethal injection drug will cause him unconstitutional suffering and that execution by firing squad is the only appropriate alternative. J.W. Ledford Jr. is set to be put to death Tuesday, May 16, 2017,  by injection of the barbiturate pentobarbital.

Lawsuit: Execution drug will cause unconstitutional pain

FILE – In this undated file photo released by the Georgia Department of Corrections, J.W. Ledford Jr., poses for a photo. Lawyers for Ledford, a Georgia death row inmate argue the state’s lethal injection drug will cause him unconstitutional suffering and that execution by firing squad is the only appropriate alternative. J.W. Ledford Jr. is set to be put to death Tuesday, May 16, 2017, by injection of the barbiturate pentobarbital. Georgia Department of Corrections via AP)

The firing squad is the only appropriate method of execution for a condemned Georgia prisoner — even though it’s not permitted under state law — because the state’s lethal injection drug could cause him to suffer more than the Constitution allows, his lawyers say.

J.W. Ledford Jr. is scheduled to die Tuesday. He was convicted of murder in the January 1992 stabbing death of his neighbor, 73-year-old Dr. Harry Johnston, near his home in Murray County, in northwest Georgia.

Ledford, 45, suffers from chronic nerve pain that has been treated with increasing doses of the prescription drug gabapentin for more than a decade, his lawyers said in a federal lawsuit filed Thursday. They cite experts who say long-term exposure to gabapentin alters brain chemistry, making pentobarbital unreliable to render him unconscious and devoid of sensation or feeling.

“Accordingly, there is a substantial risk that Mr. Ledford will be aware and in agony as the pentobarbital attacks his respiratory system, depriving his brain, heart, and lungs of oxygen as he drowns in his own saliva,” the lawsuit says.

That would violate the prohibition on cruel and unusual punishment in the Eighth Amendment of the U.S. Constitution, Ledford’s lawyers argue.

 

State lawyers on Friday called Ledford’s lawsuit “manipulative,” and said the experts cited by his lawyers make dubious claims based on speculation and that they have failed to show that pentobarbital is “sure or very likely” to cause him “a substantial risk of serious harm,” as required by U.S. Supreme Court precedent.

State lawyers also cite their own expert, Dr. Jacqueline Martin, chief medical examiner for the Georgia Bureau of Investigation, who said the amount of pentobarbital used by the state is “more than sufficient” to carry out the execution without causing Ledford pain, despite his use of gabapentin.

The U.S. Supreme Court has said that when claiming an execution method violates the Eighth Amendment, an inmate must propose a “known and available” method of execution.

There is no alternative method of lethal injection available to the state, since the drugs used in executions have become harder for states to obtain because manufacturers have prohibited their use for capital punishment, the lawsuit says. So Ledford’s lawyers proposed using a firing squad, which the Supreme Court has already declared constitutional. Georgia already has the skilled personnel, weapons and ammunition needed to carry out an execution by firing squad, Ledford’s lawyers argue.

Three states — Mississippi, Oklahoma and Utah — allow for a firing squad as a backup if lethal injection drugs aren’t available, said Robert Dunham, executive director of the Death Penalty Information Center, which compiles capital punishment statistics.

Georgia’s lawyers noted that the 11th U.S. Circuit Court of Appeals ruled this week in an Alabama case that the state must be able to implement the proposed alternative “relatively easily and reasonably quickly.” State courts and the Georgia Department of Corrections cannot change Georgia law, which only allows execution by lethal injection, so Ledford has failed to meet that standard, the state argues.

If Ledford “really thought the firing squad was a reasonable alternative he could have alerted the State years, instead of 5 days, before his execution,” state lawyers said in a court filing.

Ledford’s lawyers argue that because Georgia law only allows for lethal injection, they are effectively prevented from meeting the burden imposed by the Supreme Court when challenging an execution protocol on the grounds that it is cruel and unusual.

For that reason, they acknowledge that their lawsuit will certainly be dismissed, and say a quick dismissal would allow them enough time to request a hearing before the full 11th Circuit.

State lawyers agree that the lawsuit should be dismissed, calling it “just another manipulative attempt by another death row inmate to invalidate the Supreme Court’s method of execution standard.”

Ledford’s attorneys also have asked the State Board of Pardons and Paroles to spare his life, citing a rough childhood, substance abuse from an early age and his intellectual disability.

The board, which is the only authority in Georgia with power to commute a death sentence, plans to meet Monday to hear arguments for and against clemency.

Former teacher sues CVS, alleging privacy violations

Former teacher sues CVS, alleging privacy violations

https://www.bostonglobe.com/business/2017/05/12/former-teacher-sues-cvs-alleging-privacy-violations-that-led-drug-charges/ldwUVI3hn9iaISqnYy1tyJ/story.html

A former teacher who was accused — and later exonerated — of providing prescription drugs to a student sued CVS in Essex Superior Court on Friday, arguing that the pharmacy chain violated her privacy rights by releasing her prescription history to police without a warrant.

In 2015, prosecutors in Essex County alleged that while Elizabeth Backler was a teacher and coach at North Andover High school, she provided oxycodone and other drugs to a student athlete who was experiencing shoulder pain.

The high-profile case touched on issues of opioid abuse and student-teacher relationships. But it was dropped late last year after a judge ruled that a key piece of evidence — Backler’s CVS prescription history, showing she had been prescribed oxycodone and diazepam in July 2013 — could not be presented in court, because police obtained the records from pharmacists at a local CVS without a warrant.

The state eventually agreed to dismiss the case, in part because of the barred evidence, according to Carrie Kimball Monahan, a spokeswoman for the Essex County District Attorney’s Office.

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Now Backler, 29, is suing CVS and the pharmacists, who have not been named, accusing them of violating privacy laws and pharmacy regulations by providing the information to police. She says the pharmacists’ decision to provide the records resulted in her arrest — effectively ending her career as a teacher, putting a “severe detrimental impact on her earning capacity,” and causing “extreme situational depression and anxiety.”

Rhode Island-based CVS said it was not aware of the lawsuit and declined to comment further because “this matter may be subject to pending litigation.”

By the time Backler was charged, she had left North Andover High and was working at a school in Amesbury. She was forced to resign from that position and has been unable to obtain teaching work since, according to the suit. Backler’s attorney, David H. Rich, said Backler is currently working “odd jobs,” including teaching spin classes.

“But for CVS’s conduct, we do not think we’d be where we are today,” Rich said in an interview. “There would have been no charges.”

Rich wrote to CVS chief executive Larry Merlo in February, outlining the case and demanding $2.5 million in relief for Backler.

CVS responded to Rich in March, in a letter from outside counsel Ellen Epstein Cohen.

Cohen wrote in the letter that CVS did not believe it had violated privacy laws because Massachusetts rules provide some exceptions from pharmacy regulations. Cohen also said that if CVS had not given officials the prescription history, “law enforcement almost certainly would have obtained this information through some other means” that would have been admissable in court.

The charges against Backler stemmed from a broader investigation into a potential “inappropriate” relationship between Backler and the student, which allegedly involved text messaging and gift exchanges, according to Cohen’s letter and to statements from prosecutors at the time.

Cohen argued those allegations are the real reason for Backler’s trouble, because they prompted the investigation that resulted in drug charges. Backler’s financial and emotional struggles “are all the direct result of Ms. Backler’s own actions and the response by education and law enforcement authorities to her actions,” Cohen wrote.

In an interview, Rich said that argument is irrelevant because the only charges to come from the investigation were related to the drugs. Backler maintains that she did not provide pills to the student, and disputes the characterization of the relationship with the student as inappropriate, Rich said.

Adam Vaccaro can be reached at adam.vaccaro@globe.com. Follow him on Twitter at @adamtvaccaro.

JAMA: Analgesic options for patients with chronic pain have steadily declined

Management of Chronic Pain in the Aftermath of the Opioid Backlash

http://jamanetwork.com/journals/jama/fullarticle/2627567

Chronic pain is a prevalent, disabling, and costly condition.1 In the United States alone, an estimated 126 million adults reported some pain in the previous 3 months, with 25.3 million adults (11.2%) reporting daily (chronic) pain and 23.4 million (10.3%) a lot of pain.2 Three musculoskeletal pain disorders—low back pain, neck pain, osteoarthritis—are among the leading 9 causes of disability and together with migraine headache and other musculoskeletal disorders account for 9.7 million years lived with disability compared with only 8.8 million years lived with disability produced by the 12 leading causes of medical disability combined.3 Low back pain is the leading cause of years lived with disability both in the United States and globally and accounts for one-third of all work loss. Chronic pain costs the United States an estimated $560 to $635 billion annually.1 Regrettably, National Institutes of Health (NIH) funding for pain research declined sharply from 2003 to 2007 by an average of 9% per year, and the federal response to a 2011 Institute of Medicine report1 on pain in the United States has been limited and disproportionally focused on reducing opioid use rather than increasing pain relief.

Analgesic options for patients with chronic pain have steadily declined. Acetaminophen has been found to have minimal efficacy for low back pain and only small benefit for osteoarthritis.4 Similarly, the analgesic effects of nonsteroidal anti-inflammatory drugs (NSAIDs) for low back pain are very small.5 Moreover, the US Food and Drug Administration has strengthened its warning about the cardiovascular risks associated with NSAIDs, noting that there may be some risk even with short-term use among healthy individuals, although the risk appears greater among those with cardiovascular disease, with cardiovascular risk factors, and with longer-term use. Several classes of drugs, such as gabapentinoids (gabapentin, pregabalin) and serotonin-norepinephrine reuptake inhibitors (duloxetine, milnacipram) are FDA-approved for neuropathic pain and fibromyalgia, but it is unclear if they are effective for the broader group of patients with low back pain, osteoarthritis, and other musculoskeletal pain disorders. Tricyclic antidepressants and muscle relaxants are often used as adjunctive pain treatments but have a relatively weak evidence base for chronic pain.

Opioid analgesics have generated an enormous amount of concern. Several decades ago, advocates for better pain management encouraged greater use of opioids for treatment of patients with non–cancer chronic pain. Consequently, the number of opioid prescriptions, deaths related to opioid overdose, and opioid misuse escalated.6 Nevertheless, the movement to virtually eliminate opioids as an option for chronic pain refractory to other treatments is an overreaction. First, an estimated 5 million to 8 million people in the United States use opioids for long-term management.6 While the advocacy for more liberal use of opioids in chronic pain began in the early 1990s, consensus guidelines in the past 5 years still included opioids as a later step in the analgesic ladder. Many patients currently receiving long-term opioids were started when opioids were still considered a viable treatment option and if satisfied with their pain control and using their medications appropriately should not be unilaterally compelled to wean off opioids. Second, recent NIH6 and Centers for Disease Control and Prevention7 guidelines recognize that judicious prescribing and monitoring of opioids is a viable option for selected patients. Third, placebo-controlled trials have shown a modest analgesic effect of opioids,8 whereas the paucity of evidence for long-term effectiveness is true of pain treatments in general. Fourth, many patients respond better to one analgesic than another, just as patients with other medical conditions have differential medication responses. Given the small analgesic effect on average of most pain drugs, the few classes of analgesic options, and the frequent need for combination therapy, eliminating any class of analgesics from the current menu is undesirable.

Excessive use of phrases like opioid epidemic should be avoided (a literature search revealed more than 100 articles with the words opioid and epidemic in the title). An epidemic generally suggests a disease that is widespread and usually highly contagious rather than limited to a minority of those exposed. Analysis of a large national pharmacy database found that among more than 10 million incident opioid recipients, the probability of transitioning to long-term opioids was only 1.3% by 1.5 years after the first prescription, 2.1% by 3 years, 3.7% by 6 years, and 5.3% by 9 years.9 Thus, only a small fraction of patients prescribed opioids progress to long-term use. Admittedly, the absolute number of patients taking long-term opioids is substantial given the large number who receive an opioid prescription. The reality, however, is that most patients receiving an initial opioid prescription do not proceed to chronic use and among the subset that do use long-term opioids, the majority neither misuse nor experience an overdose. An unintended consequence of excessive concerns raised about opioids could be an increasing reluctance among clinicians to prescribe even small amounts of opioids for a limited time for acute pain, including for patients discharged from the emergency department, those who are recuperating from surgical procedures, or persons with severe dental pain. No clinician wants to be accused of contributing to the opioid “epidemic.” Meanwhile, some patients may be embarrassed about asking for effective pain relief.

There is an emerging advocacy movement for greater use of marijuana for chronic pain that parallels changing statutes regarding medical use and, in some states, legalization for any use. However, the small number of trials evaluating marijuana for chronic pain have typically used synthetic cannabinoids rather than more complex marijuana products, showed modest benefits, had limited follow-up of 2 to 15 weeks, and focused on neuropathic pain more often than musculoskeletal pain. Thus, clinicians must be careful of replacing the opioid epidemic with a marijuana epidemic.

Nonpharmacological pain therapies provide a promising alternative. Cognitive behavioral therapy (CBT) has the strongest evidence. Pain self-management programs and regular exercise are also beneficial.1 Emerging, although less conclusive, evidence exists for yoga, mindfulness or meditation-based therapies, acupuncture, chiropractic, and massage. However, these therapies are neither a panacea nor a universal replacement for analgesics. First, there is a paucity of head-to-head trials of analgesic vs nonpharmacological therapies. Second, placebo controls can only be fully masked in drug trials, making it more difficult to distinguish the specific vs nonspecific effects of nonpharmacological therapies. Third, evidence of long-term effectiveness is weak for nonpharmacological and analgesic treatments alike. Fourth, CBT, exercise, and other behavioral treatments require sustained practice and lifestyle changes, reducing their effectiveness in many individuals unable to sustain such activities over many years. Fifth, there is an inadequate workforce trained in pain-focused CBT, and reimbursement strategies often favor non–evidence-based procedural or surgical pain treatments. Similar to depression, which can be treated with medications or psychotherapy, the management of chronic pain should integrate patient preferences, response to previous treatments, adverse effects, costs, and treatment availability.

Whereas skeptics tend to focus on the rather modest separation from placebo of all treatments for chronic pain, placebo effects should not be entirely dismissed. Pain responses to placebo range from 30% to 50% and have a biological underpinning: Effective placebo manipulations trigger the release of endogenous opioid peptides that act on the same receptors as synthetic opioid drugs such as morphine. Because current medical practice does not ethically condone the administration of pure placebos, leveraging the specific placebo effects of evidence-based pain treatments is compassionate rather than disingenuous care.

Imperfect treatments do not justify therapeutic nihilism. A broad menu of partially effective treatment options maximizes the chances of achieving at least partial amelioration of chronic pain.