U.S. war on drugs moves to pharmacy from jungle

http://www.reuters.com/article/us-dea-prescription-drugs/u-s-war-on-drugs-moves-to-pharmacy-from-jungle-idUSBRE85F09220120618

(Reuters) – Pamela Storozuk, a petite 59-year-old, spent most of her career as a sales representative, dragging heavy suitcases filled with presentation materials. When her husband developed prostate cancer, she cared for him, often helping to lift him out of the bath or into bed.

Eventually, the strain on her back caught up with her. Today she has five herniated discs and relies on painkillers to function.

Over the past six months, however, the Fort Lauderdale, Florida, resident has found it increasingly difficult to get her medications. Her regular pharmacy is often out of stock, and others refuse to dispense painkillers to new patients.

“They look at you like you’re an addict, a lowlife,” she said.

Storozuk is one of thousands of Americans caught up in the U.S. government’s latest front in the war on drugs: prescription painkillers. From 1999 to 2009, the number of deaths from narcotic pain pills nearly quadrupled to 15,597, more than those from heroin and cocaine combined, according to the latest figures from the U.S. Centers for Disease Control and Prevention.

In response, the U.S. Drug Enforcement Administration has beefed up its efforts to block the diversion of prescription drugs to the black market, using many of the techniques it employs to combat illegal drug use: wire taps, undercover operations and informants.

Such efforts have helped it dismantle hundreds of “pill mills” – sham pain clinics that write thousands of prescriptions with few questions asked – as well as dozens of rogue Internet pharmacies.

Now the agency is using the same tactics to prosecute the legitimate pharmaceutical supply chain, which is required to maintain certain record-keeping and security protocols to prevent drug diversion.

Over the past three years, the DEA has stepped up its inspections and levied millions of dollars in fines against drug wholesalers for what it said were breaches of those rules.

In February, the DEA suspended the license of drug wholesaler Cardinal Health Inc to sell narcotic painkillers and other controlled substances from its center in Lakeland, Florida, saying it had failed to detect suspicious order volume from several pharmacy customers. Under a settlement, Cardinal has agreed not to ship controlled substances from the facility for two years.

Shortly afterward, the agency raided two CVS pharmacies and issued inspection warrants at a half-dozen Walgreen Co drugstores and a Walgreen distribution center.

NOT THE MEDELLIN CARTEL

“The techniques that law enforcement uses to combat drug traffickers, whether they’re Colombian organizations or Mexican cartels or Afghan drug lords, those techniques are very, very essential in combating prescription drug abuse,” DEA Administrator Michele Leonhart said in an interview.

But critics say applying the same strategy to the legitimate supply chain as to Colombian drug lords is ineffective and is also causing supply shortages that hurt pain patients.

“Going after a pharmaceutical manufacturer is not like going after the Medellin cartel,” said Adam Fein, president of Pembroke Consulting, which advises pharmaceutical manufacturers. “I don’t believe it is appropriate for the DEA to shrink the supply of prescription drugs, because it has unanticipated effects that have nothing to do with the problem.”

Florida has long been considered the epicenter of painkiller abuse, due to the spread of pill mills. But experts say those are only a small part of the problem.

“The majority of drugs that end up in the illicit trade come from otherwise well-meaning physicians who do not understand the consequences of their prescribing habits,” said former DEA agent Robert Stutman, whose Stutman Group management consulting firm designs substance abuse prevention programs.

Between 1991 and 2010, prescriptions for narcotic painkillers rose to 209.5 million from 75.5 million, according to National Institute on Drug Abuse.

Leonhart said that physicians, however, “now understand the problem.”

PRESSURE FROM CONGRESS

As prescription drug abuse has risen, the DEA has come under increasing pressure from Congress to show it is containing the problem. A report last year from the nonpartisan Government Accountability Office said the DEA had not shown its strategy was working and called for clearer performance measures.

Leonhart said the best benchmarks were and should be “quite similar to what we use on the nondiversion side, which is the disruption and dismantlement of the organizations and the networks, and we’re going in that direction.”

That has meant some changes at the agency. For one thing, Leonhart has begun breaking down barriers between the DEA’s nearly 5,000 special agents, who have focused on the illicit drug trade for most of their careers, and about 500 diversion investigators, who enforce rules covering handlers of controlled substances.

The agency has expanded its use of tactical diversion squads, which combine special agents, diversion investigators and local law enforcement officers to track down and prosecute prescription drug dealers.

Forcing the two sides to come together was not easy at first, Leonhart said, since special agents initially were reluctant to work on “pill cases.”

But the effort has shown some results. Asset seizures on the diversion side rose to $118 million in 2011 from about $82 million in 2009, Leonhart said.

CULTURE OF FEAR

Still, sending in tactical diversion squads to break up pill mills does not address the leaks occurring from medicine cabinets at home or the drugs passed along from friends and family. That is one reason the DEA is attempting to squeeze supplies at the wholesale level.

”Going after Cardinal has sent shivers up the distributor grapevine,“ said John Coleman, a former DEA chief of operations. ”Close a CVS pharmacy in Florida, and I guarantee every pharmacy within 500 miles will be checking their records.

“You don’t have to hit a horse with a whip,” he said. “You just have to show it to them once in a while.”

Pharmacists confirm that they are indeed fearful. Some are reluctant to take new painkiller customers. Others will only accept patients within a certain geographic area or refuse to accept cash.

“We turn away five or six people a day,” said Steven Nelson, owner of the Okeechobee Discount Drugs store in Okeechobee, Florida, and chairman of governmental affairs for the Florida Pharmacy Association.

Even large chains are leery. Walgreen spokesman Michael Polzin said that after looking into everything going on in Florida, “we’ve decided not to comment on our operations there at this time.”

CVS pharmacies across the state stopped filling prescriptions written by 22 of the top-prescribing physicians pending a review of their dispensing practices, according to court documents filed as part of the company’s dispute with the DEA.

The company declined elaborate on its actions, except to say that it will continue to monitor prescriptions for controlled substances and is “committed to supporting efforts to prevent drug abuse and keep controlled substances out of the wrong hands.”

Physicians are equally nervous. Many have stepped up patient monitoring, according to Storozuk’s physician, Dr. Martin Hale. That means more urine tests, more documentation, and more frequent “pill count” checks, where patients must go to the doctor’s office with their pill bottle to prove they have not sold or misused their medication.

“Every hour of the day I have concerns I’ll be audited, that my ability to take care of my patients and my family can be taken away, and I‘m as legitimate as you can get,” said Hale, who has a private orthopedic practice a few miles from Fort Lauderdale and is an assistant professor at Nova Southeastern University. “You’re constantly watching over your shoulder, and it takes a toll.”

CUTTING SUPPLIES

Over the past five years, Cardinal has cut supplies of controlled substances to more than 375 customers nationwide, including 180 pharmacies in Florida, it says.

Other wholesalers are similarly cautious. Rival AmerisourceBergen Corp says it now monitors orders for suspicious spikes of 20 percent to 30 percent in volume.

“All of us want to make sure that abuse is curtailed,” Chief Executive Officer Steven Collis said. But when it comes to the DEA’s requirements, he added, the rules have not always been clear.

Other wholesalers, pharmacists and physicians say they are also keen to help, but would welcome more communication from the DEA.

Leonhart rejects the notion that the DEA is uncommunicative. The agency repeatedly lays out its requirements in meetings and presentations, she said.

But John Burke, president of the nonprofit National Association of Drug Diversion Investigators, says the DEA behaves as though those it monitors are the enemy.

“The mindset is, these are folks we have to keep at arm’s length,” said Burke, whose organization tries to foster communication between law enforcement, regulators and industry.

The DEA’s strategy is also prompting new questions from Congress. Senators Chuck Grassley of Iowa and Sheldon Whitehouse of Rhode Island recently asked the GAO to study whether the agency’s actions are contributing to shortages of medications for pain patients.

Others say the DEA should not be in the business of regulating industry at all.

Scott Gottlieb, former deputy commissioner of the Food and Drug Administration, publicly fulminated against the DEA recently for tackling prescription drugs in the same way it pursues drug cartels.

“The problem is, the DEA may be the wrong enforcer here. It’s very difficult to separate appropriate use from illicit use with law-enforcement tools alone,” Gottlieb, who now sits on the board of biotechnology company CombiMatrix Corp, wrote in an opinion piece in the Wall Street Journal.

The DEA’s confrontation with wholesalers and pharmacies follows a public dispute with manufacturers over who was responsible earlier this year for shortages of certain stimulants used to treat attention deficit disorder.

The DEA strictly controls the amount of an ingredient in a potentially addictive drug that its manufacturer can obtain each year, based on projected needs of legitimate patients. Makers of the stimulants said the agency did not always authorize enough material in time for them to supply customers.

For its part, the DEA said the shortages resulted from unspecified business decisions made by the companies.

With all sides in the prescription drug fight blaming each other, nothing will be achieved without more communication and cooperation, Stutman says.

“We need to take some really bright people on each side of the issue and say: ‘Where do we start today to make this problem better?’” he said.

In the meantime, patients like Pamela Storozuk are struggling to function. She has not been able to find oxycodone for five months. Replacement drugs have made her sick and even those are now hard to come by. She has lost 20 pounds and is frequently in pain.

“It’s a horrendous problem down here for people like me who need the medication,” she said. “You can’t even imagine.”

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93 Year Old Doctor Gets 10 Years In Jail

www.doctorsofcourage.org/judge-throws-the-book-at-93-year-old-doctor-accusing-him-of-being-a-drug-dealer/

Las Vegas August 1, 2017 – A 93 year old pain management doctor was sentenced to 10 years in jail and called a drug dealer by a Las Vegas Judge. Some DOC readers believe that the real motivation for throwing this World War II veteran in jail and accusing him of drug dealing was to take his assets which the judged fined him 2.5 million dollars. Senior U.S. District Judge Kent Dawson imposed the prison term and the fine, hurtling allegations that the 93 year old Doctor Henri Wetselaar was supplying scores of drug addicts and dealers with powerful opioids.

A witness to the sentencing, Dave Stewart, said, “What in the hell in going on with these prosecutors and judges!” Apparently, the prosecutor had asked the judge to give Wetselaar 20 years in the slammer, to teach him a lesson for dealing with drug dealers and addicts. Dave said that government overreach and the prosecutors have crossed the line and he believes that the real reason for doctor Wetselaar’s lock-up and harassment, is the result of money. They need money, said Mr. Stewart, “Throwing his hands up in the air with disgust.” The government is plotting to rip-off the professional people of this country and take their hard earned savings and bank accounts. These are police outfits he said, and they are not interested in proving anybody innocent and showing evidence that would exonerate them.

Doctor Wetselaar Will Die In Jail

The doctor suffers from ailments that include prostate cancer, chronic renal failure, multiple heart valve disorders and brain atrophy. Throughout the court process, Wetselaar’s failing health caused several trial delays as he was in and out of the hospital. With all this stuff on his plate, the prosecutor still asked for a 20-year prison sentence. The prosecutor stuck to his 20 year prison term because he said, “Wetselaar’s behavior was far from that of a doctor,” prosecutors wrote in a separate sentencing memorandum filed last week. “Rather he was an individual who cared little for the health and well-being of his patients.”

The jury convicted doctor Wetselaar of all 11 drug counts, money laundering and related counts contained in a 2011 indictment against him. His medical assistant and a local pharmacist also were charged in the case. According to the indictment, Wetselaar prescribed large amounts of drugs — including oxycodone, hydrocodone, Xanax and Soma — to more than 230 people who did not medically need them. This is the same MO that is seen all around the United States. How much evidence did the prosecution withhold from the Jury? What kind of exonerative evidence was not given to the jury or concealed? Did DEA / Police misconduct play a role in the investigation?

The answers to all of these questions is highly possible, since the police misconduct is intentional hidden by prosecutors and judges. Doctor Wetselaar, at the age of 93 years old, was a sitting duck for law enforcement and greedy DEA agents to come and take his nice stash of money, totaling 2.5 million. The Medical Board should be the one getting jail time for letting a 93 year old work in a clinic and the prosecutor should be put in jail for going after his money and using government confidential informants to trick this doctor into giving them pills and then arresting him. It’s a cold world out there and I guess somebody has to do the devils work.

How Can You Make A Difference?

• BECOME A MEMBER: Please support Doctors of Courage and our fight against unlawful Government abuse of doctors and healthcare providers nationwide. Your Membership helps to provide support for thousands of doctors who are being unlawfully jailed and stripped of their medical careers for treating patients with legal prescriptions.
• JOIN THE FIGHT: Please support the American Pain Institute (API) at www.americanpaininstitute.org and get involve with their PAIN ADVOCACY WEEK, April 23rd – 30th, 2018, March On Washington and donate to help this cause. Thousands of Chronic Sickle Cell patients’ lives are being drastically reduced and they are dying because doctors are afraid to follow NIH treatment guidelines due to bigotry and government wrongful persecution of doctors in this country.
• HELP MAKE CHANGE: Sign our petition requesting that Congress enact a Medical Board Civilian Police Review Committee law to deter medical board police and prosecutorial misconduct and hold these officials responsible for their actions. The most common crime against doctors made by the medical board police teams are “FALSE REPORTS” that police officers refer to as accusations. These are criminal actions by law enforcement and they are not held accountable for making false statements, perjury, and manufacturing evidence. A Civilian Police Review Committee will help stop these senseless acts against healthcare providers and restore justice and constitutional rights. It is also possible to get bail bonds so why not try these out for time being in such cases?

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Opioid crisis could keep chronic pain sufferers from getting medicine

http://www.kmov.com/story/36620554/opioids-chronic-pain

KMOV.com –

A 60 Minutes investigation may have brought to light an unintended consequence of the growing concern over the opioid epidemic. The CBS news magazine’s story concluded Congress passed legislation that crippled the DEA’s ability to fight opioid abuse.

Chronic pain sufferer Carolyn Bailey told News 4 that doctors have become reluctant to prescribe opioid painkillers recently because of concern over overdose deaths.

“This pain could not be more real and my doctors know it but they’re so terrified because it’s such a big deal in the news and the government’s all involved,” said Bailey.

Bailey said she suffers from nerve damage caused by diabetes and without an opioid painkiller she lives in constant, crippling pain. But recently her primary care physician and pain management doctor informed her that they’d no longer be prescribing oral medications and she would only get spinal injections for pain. Bailey said the injections don’t work. 

Dr. Alexander Garza, medical director for SSM Health acknowledged the natural reaction of physicians to the opioid crisis is to write fewer prescriptions for painkillers. But he said doctors have to be careful not to overreact.

“Somewhere in there has got to be the happy medium where people with legitimate chronic long-term pain do have access to things that help out their pain,” said Dr. Garza.

Bailey said without opioid painkillers she and others suffer unnecessarily. 

“There are so many people in so much pain for so many reasons and if there’s medicine available why not let them have it,” said Bailey.

News 4 reached out to Bailey’s primary care doctor to ask him about the pressure on physicians to write fewer prescriptions for painkillers, but he didn’t get back to us.

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The Terrifying New Trend in Heroin Addiction

https://www.vice.com/en_us/article/qvjgvb/the-terrifying-new-trend-in-heroin-addiction

Jeremy Lesser is one of the faces of America’s increasingly mainstream opioid crisis. Now in recovery for two years, he’s 27, white, and comes from a middle-class family in New Jersey. But he didn’t start using opioids with pills from a doctor—or even pills from a friend or the family medicine cabinet. Instead, his first opioid was heroin.

By now, many Americans have heard sad stories that begin with a white teen innocently ingesting a prescription obtained from a pharma-influenced doctor. Often, these tales end with the degradation of heroin—a good kid accidentally addicted, driven to crime, and maybe even dead.

But if legitimate prescriptions were ever the chief pathway to heroin—and strong evidence has long existed that they might not be—new research and stories like Lesser’s suggest the pathway for people who get addicted to opioids is changing. Just like I did in the 1980s, heroin users in America appear to be increasingly going straight to the street drug, skipping the flirtation with pharmaceuticals.

Not that the people making drug policy seems to be noticing.

Although a Washington Post-60 Minutes exposé finally derailed the troubling nomination of Tom Marino as drug czar on Tuesday, its key finding—that pharma lobbying helped curtail the DEA’s power to cut the prescription drug supply—fails to account for the fact that doing so without offering medication treatment might have just sped up the heroin and fentanyl crisis.

This tunnel vision focus on prescription drugs as the key factor in America’s opioid crisis is shared widely throughout the government. At a recent congressional hearing on the issue, FDA commissioner Scott Gottlieb testified that “most people become addicted after receiving the drugs for a medical condition,” according to USA Today. The CDC, even before Donald Trump became president, has long highlighted the fact that the vast majority of today’s heroin users previously took prescription opioids. And a bipartisan group of state attorney generals earlier this month released a letter claiming that people “often develop opioid addiction through prescribed medical usage, with no intent by the patient to engage in abusive behavior, simply because of the addictive properties of opioid drugs.”

Except this is an overly simplified picture. The fact is that the government’s own statistics show most people start misusing prescription pills that are not prescribed to them. And the myth of innocent white addiction has led to policy that relentlessly focuses on reducing medical access, regardless of harm to pain patients. With President Trump set to finally declare the opioid crisis an official national emergency next week, now is as good a time as any to take stock of what America’s prescription crackdown gets wrong—and how we can do better.

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New research is increasingly finding that cutting the supply of prescription opioids isn’t even stopping opioid initiation—just changing which drug people try first. A study released this year of nearly 6,000 people treated for opioid-use disorder across the US over a ten-year period found that in 2005, only 9 percent of new users reported losing their opioid virginity to heroin. By 2015, however, this number had more than tripled, to just more than a third. Although most users still get their first taste from one of several prescription pills, heroin is now the single most common individual opioid taken by people first trying this class of drugs, the study found.

“Supply-side efforts are beginning to show their effectiveness in bending the curve of prescription opioid use, which is both commendable and necessary,” study co-author Matthew Ellis, an epidemiologist at Washington University in St. Louis, told me. “However, using the balloon analogy, when you squeeze one side, another side expands.”

“It makes complete sense that in a context of suppressed prescription drug supplies, people are starting on alternative sources of opioids,” added Leo Beletsky, associate professor of law and health sciences at Northeastern University in Boston, who noted that without addressing factors that really drive demand like inequality, unemployment, mental illness and despair, substitution is hardly surprising.

In other words, cracking down on prescription drugs has not stopped people from starting opioid use. In fact, it may just be sending more first-time experimenters to the most dangerous stuff on the black market.

Another recent study published in Health Affairs found that while the number of hospital admissions related to prescription overdose fell by around 5 percent annually between 2010 and 2014, the number of admissions for heroin increased by 31 percent each year between 2008 and 2014. Similarly, CDC statistics show that while opioid prescribing rates peaked in 2010 and fell about 5 percent per year between 2012 and 2016, heroin overdose rates have quadrupled since 2010 and overdoses linked to synthetic opioids like fentanyl increased 72 percent between 2014 and 2015 alone.

The vast majority of opioid misusers don’t simply jump into the drug pool at the deep end: by the time they get to opioids, even those who do start by misusing a legitimate prescription have typically more than just experimented with recreational use of alcohol, cigarettes, weed, and often psychedelics and cocaine. Going hard or exclusively after prescription drugs is not going to disrupt that.

In another recently published paper, Ellis and his colleagues found that even among those whose opioid addiction apparently began with medical exposure, 95 percent had previously taken other drugs recreationally. “Even when discounting alcohol, tobacco and marijuana, 70.1 percent still had prior experience with other substances,” he told me—a rate far higher than that seen in the general population. In 2016, for example, just 21 percent of high school seniors and 36 percent of young adults had ever even tried an illicit drug other than pot.

Lesser, who is now studying for a degree in counseling psychology, recalled being anti-drug until he was around 17, having simply accepted that “drugs are bad,” as his parents and teachers claimed. In college, however, he began to question his hardline stance. “I had friends going to Ivy League schools, and all these smart, cool kids were doing these drugs,” he told me.

He smoked weed for several months without any disaster, and likewise enjoyed MDMA, cocaine, and mushrooms. “None of the bad stuff society told me would happen, happened,” Lesser said. And so, in 2009, when a kid he texted said he didn’t have weed, but did have heroin, he was game to try it.

Chloe*, also 27 and who preferred to remain anonymous to discuss her addiction, came to heroin via a similar route: What her parents and the government said about drugs like weed didn’t seem to square with reality. She had begun smoking regularly during her sophomore year of college and later learned that some of her friends were using heroin, too. “At the time, it sounded a little crazy, but so did smoking pot [at first],” she said. “My reasoning was, ‘Oh, they were lying to me about weed, why not?'”

She added of heroin, “It was just this calm rushing over you and feeling peaceful and less anxious and able to turn everything off.”

Lesser, who had always struggled with social anxiety, said that in his case, the first time using heroin was “underwhelming”—and definitely didn’t live up to the hype he’d seen in films like Trainspotting. But that gave him a false sense of security, and when he did it a few more times, he began to understand what the fuss was about.

“I felt like I never really had a handle on my emotions,” he told me. “I let them dominate me.” But with heroin, he added, “I really liked that feeling of social and emotional control. The euphoria was cool, but it was definitely not the hooking point for me.”

Lesser’s experience of medicating symptoms like anxiety and poor emotional control seems to be the rule, rather than the exception among people who develop opioid problems. “Psychiatric issues are very common,” Ellis explained. “Roughly two-thirds of our sample indicate they have been diagnosed and treated for a psychiatric disorder, primarily depression and anxiety.” In yet another study with the same sample, Ellis’s group found that a similar proportion “indicated they used prescription opioids to self-treat psychological issues, and 80 percent indicated they did so to ‘escape’ from daily stressors, past trauma, [or other] issues going in their lives,” he recalled.

It’s not just Ellis’s work, either. Fellow researchers’ data has long suggested that early life stress, trauma, and mental illness—not the first drug someone happens to try—are the real gateways to addiction. And overhyping the dangers of certain substances clearly also runs the risk of doing more harm than good.

Whether the sequence of use goes “alcohol, marijuana, cocaine, then heroin” or “alcohol, marijuana, methamphetamine, prescription opioids, then heroin,” or some other way, the result is the same. If America doesn’t address why people find opioid escape so compelling right now, cutting the supply of medical drugs with known strength and purity may just push users to more dangerous and unpredictable street substitutes like fentanyl.

Humans have always used chemicals as ways to change their moods. To prevent overdose death and help people avoid damaging addiction, we need to offer alternatives—and to be creative when addressing supply so that the inevitable substitution leads to less harm, not more.

 

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United Nations Says Untreated Pain Is “Inhumane and Cruel”

https://www.practicalpainmanagement.com/treatments/pharmacological/opioids/united-nations-says-untreated-pain-inhumane-cruel

The national debate on the proper use of opioids continues to build as the high prevalence of addiction and overdoses fuel the continuing attention to this “public health crisis.”¹

Much of the anti-opioid rhetoric regarding the “opioid epidemic” implies that pain is a nuisance that really doesn’t require treatment. Instead of making the focus one of achieving good pain relief, far too much attention has been directed solely at the risks of opioid prescribing and how we must provide naloxone on every street corner where an opioid might be sold.

If Ever There Was a Need for a Call to Action, It Is Now

According to the Institute of Medicine (IOM), an estimated 100 million Americans suffer from pain—more than diabetes, heart disease, and cancer combined.²

What we need now is a proper discussion about the immense risks of untreated pain. Simply put, untreated severe and chronic pain are not only forms of torture but put patients on the road to death.³ We have known for ages that untreated moderate to severe pain, whether slowly or rapidly, may lead to hyperlipidemia, hypertension, tachycardia, adrenal exhaustion, cardiovascular collapse, and at times to suicide.³

All of the finger-pointing, blaming, and hand-wringing has escalated to a feverish pitch along with a lot of head-scratching. How about an earnest effort to come up with a viable solution? Clearly, a better approach is needed.

In the search for answers, I’d like to call immediate attention to the General Assembly of the United Nations (UN), which is on record as having declared that “untreated pain is tantamount to torture or cruel, inhuman or degrading treatment or punishment”.⁴ If only our legislators and government agency leaders would read the “Report of the Special Rapporteur on Torture and Other Cruel Degrading Treatment or Punishment”⁴ before acting to diminish patients’ access to needed pain medicines.

Following the UN report, Human Rights Watch weighed in, stating that “the poor availability of pain treatment is both perplexing and inexcusable”.⁵

Given the urgent need for a reasonable and responsible approach to pain care, every pain practitioner and all pain patients should become familiar with these reports, which make a case for profound governmental failures; but that’s not enough.

The time has come to demand that every pain treatment critic in the United States government, the insurance industry, members of the press, religious leaders, and anyone else for that matter who is addressing this subject seek solutions that do more than tie the hands of credentialed medical professionals who are treating patients with chronic pain. As well, there is a need to distinguish between addiction, abuse, and a medically confirmed need for opioid treatment in forming future programs.

Know the Facts Before Withholding Pain  Care

The UN report laid out the reality of suffering with pain and presented recommendations that need more widespread dissemination.⁴ In particular, people who use drugs are not necessarily addicts or substances abusers, as many are simply patients who developed a medical condition that has left them unable to function without adequate treatment for severe, chronic, or intractable pain.^2,6

In addressing marginalized groups, the UN report offered the following:⁴

• “People who use drugs are a highly stigmatized and criminalized population whose experience of healthcare is often one of humiliation, punishment, and cruelty.”
• “Actions by healthcare workers and police often deprive individuals of their civil rights and access to medical care.”
• “By denying effective drug treatment, State drug policies intentionally subject a large group of people to severe physical pain, suffering, and humiliation.”
• “Persons with disabilities are particularly affected by forced medical interventions and continue to be exposed to non-consensual medical practices” (A/63/175, para 40).

In conclusion, the report states that: “The right to an adequate standard of health care (‘right to health’) determines the States’ obligations towards persons suffering from illness…In that fashion, attention to the torture framework ensures that system inadequacies, lack of resources or services will not justify ill-treatment.

Although resource constraints may justify only partial fulfillment of some aspects of the right to health, a State cannot justify its non-compliance with core obligations, such as the absolute prohibition of torture, under any circumstances. (Committee on Economic, Social and Cultural Rights, general comment No. 14).”

Aiming to protect people with pain conditions, UN Special Rapporteur Juan E. Mendez recommended the following:⁴

“Safeguard free and informed consent on an equal basis for all individuals without any exception, through a legal framework and judicial and administrative mechanisms, including through policies and practices to protect against abuses.

Adopt policies and protocols that uphold autonomy, self-determination and human dignity. Ensure that information on health is fully available, acceptable, accessible and of good quality; and that it is imparted and comprehended by means of supportive and protective measures such as a wide range of community-based services and supports (A/64/272, para 93).”

To work against denial of pain relief, Juan E. Mendez recommended that all states:⁴

• “Adopt a human rights-based approach to drug control as a matter of priority to prevent the continuing violations of rights stemming from the current approaches to curtailing supply and demand (A/65/255, para. 48). Ensure that national drug control laws recognize the indispensable nature of narcotic and psychotropic drugs for the relief of pain and suffering; review national legislation and administrative procedures to guarantee adequate availability of those medicines for legitimate medical uses;
• Ensure full access to palliative care and overcome current regulatory, educational and attitudinal obstacles that restrict availability to essential palliative care medications, especially oral morphine. States should devise and implement policies that promote widespread understanding about the therapeutic usefulness of controlled substances and their rational use;
• Develop and integrate palliative care into the public health system by including it in all national health plans and policies, curricula and training programmes and developing the necessary standards, guidelines, and clinical protocols.”

Inadequate Pain Care Is a Worldwide Concern

In 2012, the World Health Organization (WHO) estimated that 5.5 billion people were living in countries with low or no access to controlled medicines and had no or insufficient access to treatment for moderate to severe pain.⁷ Since 2004, the WHO has supported efforts to recognize pain as a real issue, deserving of attention.

Eighty-three percent of the world population has either no or inadequate access to treatment for moderate to severe pain. Tens of millions of people, including those with terminal cancer and end-stage, acquired immune deficiency syndrome (AIDS), suffer from moderate to severe pain each year without sufficient treatment for their chronic, unrelenting pain.⁷

Many countries fail when it comes to assuring an adequate supply of pain medications for their citizens. In particular, low- and middle-income countries account for 6% of morphine use worldwide despite accounting for half of all cancer patients and 95% of all patients with newly diagnosed human immunodeficiency virus infection.^8,9

Thirty-two countries in Africa alone, for example, have almost no morphine available. In France, a study found that doctors underestimated pain in over half of their AIDS patients.¹⁰ In India, more than half of the country’s regional cancer centers do not have morphine or doctors trained in using it. This is despite the fact that 70% or more of their patients have advanced cancer and are likely to require pain treatment.

While relatively inexpensive, highly effective medications such as morphine and other opioids have proven essential for the relief of pain and suffering, these types of medications are virtually unavailable in more than 150 countries.

The issue remains equally compelling closer to home. Surprisingly, the UN report states that over a third of patients in the United States are not adequately treated.⁴

A Better Approach to Pain Is a US Imperative

It’s time that we openly acknowledge that we are in a most profound and serious battle over the most basic of human rights—the relief of pain and suffering. Let’s call it what it is. Many entities want to deprive patients who are suffering from moderate to severe pain their human right to adequate pain treatment.

These same opioid epidemic-defenders would not admit publicly or to themselves that by withholding access to all available pharmacotherapies, they are in effect promoting torture, cruelty, or degrading treatment.  

In my opinion, the problem with our failed approach to pain care stems from a narrow view of pain that misses the point. Withholding all means of pain treatment goes against the view advocated by the UN, WHO, and Human Rights Watch.

It is past due for each and every one of us, including our pain patients and their families, to use our voices to tell all concerned parties that we support the UN view that untreated pain is tantamount to torture, and is cruel, inhuman, or degrading punishment. We need a more medically informed approach to treating people with severe, chronic, intractable pain.  

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Whaley proposes charging opioid distributors ‘nickel per dose’

http://fox45now.com/news/local/whaley-proposes-charging-opioid-distributors-nickel-per-dose

DAYTON, Ohio (WKEF/WRGT) – Dayton Mayor Nan Whaley says she has a plan she believes would help Ohio fight back against the state’s opioid crisis.

Whaley, who is also a gubernatorial candidate, says opioid manufacturers are to blame for the crisis and says they are the ones who will pay. Whaley is proposing that opioid distributors will pay a nickel per dose that is given out. Whaley says she would implement the plan if she’s elected governor. “With the dollars we’ll collect with the nickel per dose surcharge, we can begin to restore vital public safety services to the communities on the front lines fighting this epidemic,” Whaley said as she announced the plan Wednesday morning, October 18.

The State Board of Pharmacy reported 631 million doses of opioids were distributed in 2016 across Ohio. Whaley says under her plan, this would translate into $31.5 million for the state. Whaley, a Democrat, says the nickel per dose would give the state sustainable funding to “start repairing the damage across Ohio.”

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Patient with neck pain 8/10!

https://www.facebook.com/markmusheribsen/videos/10213636886091842/

 

CLICK ON LINK TO SEE VIDEO

 

If physicians are suppose to be HEALERS…  allowing a pt to ATTEMPT to live – have quality of life – in a pain level >5… which some consider a torturous level of pain..  Are they committing insurance fraud ? For billing for CARE that they are not providing ?

 

 

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Misdiagnosing Causes and Casualties in the Opioid War

http://reason.com/blog/2017/10/18/misdiagnosing-causes-and-casualties-in-t

“The opioid crisis is an emergency,” declared President Donald Trump in August. “And I am saying officially right now that it is an emergency, a national emergency. We are going to spend a lot of time, a lot of effort, and a lot of money on the opioid crisis.”

As of this week, President and his advisors have not yet completed the paperwork for an official national emergency declaration. So how much of a crisis is the “opioid epidemic”?

In 2015 some 33,000 Americans died from overdosing on various synthetic opioids. Some researchers forecast that as many as 500,000 Americans could die of opioid overdoses in the next decade. The drugs most associated with overdose deaths are prescription pain pills like oxycodone, along with black market heroin and fentanyl.

Lots of media reports have made pharmaceutical manufacturers, distributors, and “pill mill” physicians the chief villains in the rise of overdose deaths. “The Drug Industry’s Triumph Over the DEA,” published earlier this week by The Washington Post and CBS’ 60 Minutes, is one such “exposé.”

While it is true that some unscrupulous phyisicians and pharmacies have overprescribed opioid medications, Josh Bloom, director of Chemical and Pharmaceutical Sciences for the American Council of Science and Health provides a helpful guide to some of the deceptive claims being peddled by drug warriors. Specifically, Bloom decodes Andrew Kolodny’s “The opioid epidemic in 6 charts,” over at The Conversation.

Kolodny, executive director for Physicians for Responsible Opioid Prescribing, cites data from the National Institute on Drug Abuse showing that more 60,000 Americans died of drug overdoses in 2016. Bloom suggests that that assertion misleads readers into thinking that those deaths are mostly the result of taking prescription opioids.

The actual number of deaths associated with overdosing on prescription opioids was around 17,000 last year. And as Bloom points out, most of those overdose deaths occurred in conjunction with benzodiazepines (like Valium and Xanax) and black market heroin and fentanyl.

A recent Center for Disease Control Morbidity and Mortality Weekly Report focusing on drug overdose deaths in Ohio found that 90 percent of the decedents tested positive for fentanyl, 31 percent for cocaine, 27 percent for benzodiazepines, 23 percent for prescription opioids, and 6 percent for heroin. Once these are taken into account, Bloom estimates that “the number of deaths from opioid pills alone will be much lower, perhaps in the neighborhood of 5,000.”

Bloom also objects to Kolodny’s observation that the “effects of hydrocodone and oxycodone on the brain are indistinguishable from the effects produced by heroin.” Both prescription opioids and heroin operate on the same receptors in the brain, but hydrocodone and oxycodone are four and two times less powerful, respectively, than heroin. And they are 200 and 100 times less powerful than fentanyl.

Long-term use of prescription “opioids are more likely to harm patients than help them because the risks of long-term use, such as addiction, outweigh potential benefit,” Kolodny says. Bloom counters that the “absence of evidence is not evidence of absence.” His main argument is that Kolodny cannot make his claim for the simple reason that no long term studies on the effects of opioids to manage chronic pain have been conducted.

In any case, Bloom cites 2010 research that the risk of addiction is below one percent for patients who use prescription opioids for short term pain control. A 2013 review similarly reports the risk of addiction is below one percent and concludes, “The available evidence suggests that opioid analgesics for chronic pain conditions are not associated with a major risk for developing dependence.”

A 2015 review article in the Annals of Internal Medicine reported that “reliable conclusions about the effectiveness of long-term opioid therapy for chronic pain are not possible due to the paucity of research to date.” However, the Annals reviewers were less sanguine than Bloom about prescribing opioids to treat pain. “Accumulating evidence supports the increased risk for serious harms associated with long-term opioid therapy, including overdose, opioid abuse, fractures, myocardial infarction, and markers of sexual dysfunction.” The Annals review also notes that various studies found the prevalence of prescription opioid addiction ranging from 2 to 14 percent.

Some pharmaceutical companies, Bloom acknowledges, helped fuel the opioid problem by falsely claiming their medicines were less addictive and less subject to abuse than other pain medications. For example, Purdue Pharma, the manufacturer of Oxycontin, admitted it had misled physicians and paid in a fine of $653 million in 2007.

But given that most of the opioid deaths now result from consuming illicit drugs, Bloom argues Kolodny’s effort to blame the problem on drug companies is now irrelevant.

Kolodny rejects the claim that the reformulation of prescription opioids after 2010 to make them more difficult to snort or inject pushed many users to black market heroin and even more dangerous substances in search of highs. Bloom points out that after 2010 the number of deaths attributed to prescription opioids flattened while those from heroin and fentanyl increased almost five-fold.

Bloom decries what he calls the “opioid pain refugee crisis,” in which new federal rules restrict patient access to effective drugs to control severe pain. In 2012, the Institute of Medicine at the National Academy of Sciences issued a study, Relieving Pain in America, that reported: “Chronic pain affects about 100 million American adults—more than the total affected by heart disease, cancer, and diabetes combined. Pain also costs the nation up to $635 billion each year in medical treatment and lost productivity.”

“We do not question that opioid misuse is a serious and growing public health problem,” writes Arthur Lipman, editor of the Journal of Pain & Palliative Care Pharmacotherapy. “We do not, however, accept the simplistic solution of limiting opioid use that is advocated by many commentators as being rational. Although opioid overprescribing and access undoubtedly contribute to the problem, opioids are still seriously underprescribed for and unavailable to many legitimate patients with moderate to severe pain who need these medications to function adequately.”

While Kolodny argues for substantially increasing restrictions on patient access to prescription opioids, he also urges federal and state governments to “ensure that millions of Americans now suffering from opioid addiction can access effective addiction treatment.”

Instead of pursuing the failed Drug War policies of restriction and prohibition, one good way for President Trump to “spend a lot of money” to help those opioid users who do become addicted is to increase access to medication-assisted therapy programs as recently suggested by my Reason colleague Mike Riggs.

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Minnesota struggles to rein in prescription opioids

http://www.bradenton.com/news/local/health-care/article178112216.html

ST. PAUL, Minn.

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As Eliquis Lawsuits Fall, New Study Heightens Bleeding Risk in Eliquis Class

https://www.lawyersandsettlements.com/articles/eliquis/eliquis-lawsuit-side-effects-blood-9-22651.html

Manhattan, NYA new study released earlier this month suggests that blood thinners in the non-vitamin K oral anticoagulant class, or NOACs, could see heightened risk of bleeding when the blood thinners are taken in combination with certain drugs. Amongst the drugs in the so-called NOAC class is Eliquis, a new-age blood thinner that has been the subject of many an Eliquis lawsuit alleging unnecessary bleeding risk.

The non-vitamin K oral anticoagulants reference a heritage blood thinner – warfarin, which is marketed as Coumadin – which has been on the market for over half a century. Requiring strict monitoring of diet and blood levels, warfarin is nonetheless proven effective as an anticoagulant with the added benefit of an antidote in the event of an unexpected bleeding event. To that end, an infusion of vitamin K succeeds in reversing the anticoagulant properties of warfarin, helping to stem an event that might otherwise place a patient in potential jeopardy.

Newer blood thinners such as Eliquis (apixaban) do not respond to vitamin K in the same fashion as warfarin. Plaintiffs considering Eliquis injury lawsuits allege the manufacturer was irresponsible in putting apixaban on the market without an antidote in place.

The study, published online in the Journal of the American Medical Association (JAMA) October 3, suggests a greater risk of bleeding events when NOACs are taken with drugs such as Rifadin, Diflucan and Dilantin.

Researchers in Taiwan studied data from more than 91,000 patients using the new crop of blood thinners, including Eliquis anticoagulant. The study authors found that the risk for a major bleeding event increased when patients on a NOAC anticoagulant for blood thinning were also prescribed amiodarone, or Rifadin (rifampin), Diflucan (fluconazole), and Dilantin (phenytoin).

“Among patients taking NOACs for nonvalvular atrial fibrillation, concurrent use of amiodarone, fluconazole, rifampin, and phenytoin compared with the use of NOACs alone, was associated with increased risk of major bleeding,” the researchers concluded. “Physicians prescribing NOAC medications should consider the potential risks associated with concomitant use of other drugs.”

Meanwhile there has been significant movement of late with regard to Eliquis lawsuits housed in multidistrict litigation.Law360 (10/13/17) reports that no fewer than 24 lawsuits against Pfizer Inc. and Bristol-Meyers Squibb Co. have been recently dismissed with prejudice resulting from a decision back in May by US District Judge Denise Cote with regard to an Eliquis lawsuit filed by plaintiffs Charlie and Clara Utts.

The plaintiffs in the Utts lawsuit argued that Eliquis labels lacked warnings with regard to the risk for internal bleeding. The Utts also argued that dosages should be tailored to the patient, with patients monitored after taking Eliquis in order to minimize risk.

However, Judge Cote ruled in May that pharmaceutical manufacturers can only alter labels given the availability of new information. That wasn’t relevant to the Utts action, which was filed in state court. The Judge Cote noted that claims stemming from more strict state laws would have been preempted by federal law, under which the US Food and Drug Administration (FDA) operates.

On October 12, Judge Cote dismissed four Eliquis lawsuits – including Utts et al v. Bristol-Myers Squibb Company et al. “Although permitted to file amended complaints in response to the guidance given in Utts, none of the plaintiffs in these four actions opted to do so,” the judge said in her order, released Thursday October 12, 2017. Judge Cote dismissed a further 20 lawsuits the following day, on Friday October 13.

According to Law360 the 24 lawsuits were originally filed in state court and quickly removed to federal court before the defendants had been properly served. Plaintiffs argued those circumstances created grounds for returning the litigation to state court. However the judge disagreed.

 

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