Thousands of N.C. doctors are over-prescribing opioids despite a new state law

Thousands of North Carolina doctors appear to be breaking a new state law that limits opioid prescriptions for patients using the addictive drugs for the first time, according to preliminary data from the N.C. Department of Health and Human Services and the state’s largest health insurer, Blue Cross and Blue Shield.

The NC STOP Act, enacted June 29 and effective Jan. 1, limits opioid prescriptions to five days for first-time patients with short-term pain, or seven days if the patient had surgery. The law, which is intended to stop patients from getting more opioids than they need, is a response to a grave public health concern that leftover narcotics could be taken recreationally or sold, feeding an opioid epidemic that claimed 12,590 lives in North Carolina between 1999 and 2016.

The data from the state health department shows that in March more than 16,000 physicians across the state prescribed opioids for over a week to at least one patient who had not had a prescription in six months. But the agency noted that additional information was needed to determine if those prescriptions actually violated the law.

The agency presented its preliminary report Tuesday to the staff of the N.C. Medical Board, the state body that licenses and disciplines the 27,000 doctors working in the state. It was the first time DHHS had provided the Board with such a list. The data comes from the state’s controlled substances reporting system, a database of prescriptions doctors and pharmacists can use to see if a patient is getting opioids from multiple doctors. The challenge for DHHS and the Medical Board is that the database does not contain the medical details necessary to filter out irrelevant cases and determine if the prescription violates the STOP Act.

The Medical Board’s spokeswoman noted that thousands of the prescriptions are likely legitimate, but said that the scale of the problem is challenging the organization to find alternative ways to enforce the law.

“Investigating every prescriber on the DHHS report is simply not feasible,” said Jean Fisher Brinkley.

The Medical Board, which opened 2,500 investigations last year, lacks the staff and resources to investigate tens of thousands of doctors and does not expect to be ready to start warning or censuring doctors until this fall at the earliest.

“We have this big new law that changes how doctors prescribe for acute pain,” Brinkley said. “It turns out it’s a bear to enforce.”

N.C. DHHS declined to provide The N&O with a total number of opioid prescriptions with the same parameters for January through April, which would give a more accurate picture of the difficulty officials will have enforcing the law. But it’s clear that the total number of prescriptions is much bigger than that provided to the Medical Board. The DHHS list, while statewide, covers only one month and only physicians and excludes other medical professionals authorized to prescribe opioids.

The Blue Cross answer

A Blue Cross analysis of all medical practitioners in its commercial plans released Monday shows that about 4,500 doctors, dentists and other medical professionals have written prescriptions exceeding the law’s limits between Jan. 1 and April 13. This data is also limited because it represents just the insurer’s commercial plans, which cover 1.3 million people in North Carolina. About 9,000 Blue Cross members received the prescriptions.

“Doctors are writing them, pharmacies are filling them,” said Estay Greene, Blue Cross’s vice president of pharmacy programs. “If a prescription is written and you only end up using it for three days, and the doctor wrote it for 30 days, you have 27 days of opioids sitting in your medicine cabinet.”

In April, Blue Cross started electronically blocking prescriptions from being filled beyond seven days. The insurer says the policy blocked more than 1,100 prescriptions and prevented between 25,000 and 30,000 opioid pills from being dispensed to patients in the first two weeks of its implementation. Based on that figure, the company estimates that 225,000 to 275,000 opioid painkillers have been over-prescribed on its commercial plans between Jan. 1 and mid-April.

Under the NC STOP Act, after the initial five- and seven-day limit, the patient can receive another prescription if the pain continues and requires medication.

Questioning the data

Related stories from Raleigh News & Observer

“Large numbers of the names on that [DHHS] list we would expect to be found to have prescribed appropriately,” Brinkley said. “We need a way to generate a report that filters out the appropriate prescribers.”

Rep. Greg Murphy, a Republican and urologist from Pitt County who co-sponsored the opioid law, said he expected it would take some time for all doctors to understand the new law, but high numbers reported by Blue Cross don’t match his personal experience in talking with doctors and the medical profession’s concern about opioid abuses.

“I can’t expect everyone to change their prescribing pattern overnight,” Murphy said. “Those numbers look very high to me. … It may not be what it’s being portended to be.”

Blue Cross spokesman Austin Vevurka said the company is confident its data is accurate.

However, Blue Cross acknowledges its data does not present a complete picture. For example: The data, which comes from claims filed by pharmacies, includes acute pain patients, whose prescriptions are limited by the NC STOP Act, along with chronic pain patients, whose prescriptions don’t fall under the new law. Including the chronic patients inflates the total, but Blue Cross can’t filter the data without reviewing every claim.

At the same time, however, the company could be understating the problem because it excluded all newly enrolled customers from its tally, so that long-term pain patients would not automatically show up as new patients just because they’re new to Blue Cross. That precaution excluded acute pain patients whose prescriptions may be out of compliance with the law.

The state data was generated using the same algorithm as Blue Cross and contains the same potential inaccuracies, Brinkley said.

State can’t enforce the law

Once doctors, dentists and other health care practitioners are flagged in the database for potential violations of the law, DHHS does not have the authority to fine or otherwise discipline them. The law allows the agency only to notify the practitioners and their various licensing boards about opioid prescriptions that look suspicious.

The law also does not include criminal penalties for practitioners whose opioid prescriptions exceed the new limits. Criminal penalties are reserved for drug trafficking and drug diversion; questions of professional judgment are best left to medical licensing boards, said Laura Brewer, spokeswoman for N.C. Attorney General Josh Stein. Stein’s office helped draft the legislation. Stein has said over-prescribing is the main cause of the nation’s opioid crisis.

The first notices and warnings to doctors are not expected to go out from the N.C. Medical Board for months. In order to receive information from the Controlled Substances Reporting System to conduct investigations, the Medical Board has to adopt regulatory guidelines for the disclosure of confidential information, a process that needs to go through public hearings and be approved by the N.C. Rules Review Commission.

The Medical Board is discussing its options now and could vote as early as this month. If it doesn’t, it won’t have another opportunity until its meeting in July. Still, the board lacks the resources to double or triple its workload. One option might be to send alerts or warnings to doctors and to investigate only chronic offenders, who could be subject to harsher discipline, such as a suspended license.

Doctors in difficult position

Blake Fagan, a family physician in Asheville, said some doctors are still unaware of the new prescribing limits under the NC STOP Act. Fagan teaches courses on opioids and pain for the Mountain Area Health Education Center and has given about 30 presentations across the state on the NC STOP Act since Jan. 1.

At a February presentation to 500 podiatrists in Charlotte, at least several dozen said they had not heard about the new law, he said.

In more recent presentations, doctors say they know about the law but then ask questions — such as: How many pills can I write? What happens after seven days? — betraying their confusion about the details.

Fagan said that the law puts some surgeons in a difficult position, because they don’t want their patients to get just seven days of painkillers after a mastectomy, knee replacement or gall bladder removal. Getting painkillers beyond seven days requires another consultation and a new prescription.

The law defines acute pain as pain that’s expected to last less than three months. Such pain is treated by short-acting opioids like Percocet, Vicodin and Demerol.

The NC STOP Act does not apply to pharmacists who fill inappropriate prescriptions that a doctor writes in violation of the new prescription limits.  Why it’s so hard to break an opioid addiction

 

The average prescription length in Blue Cross’s electronically denied cases was 19 days of opioids, said the insurer’s spokesman Vevurka. When Blue Cross started blocking prescriptions in April, some customers challenged the move as an error, and Blue Cross reversed initial denials for 151 customers between April 1 and April 16, approving opioid prescriptions for longer than seven days for those customers.Because the law doesn’t define what a first-time patient is but limits controlled substances to patients after an “initial consultation,” Blue Cross and DHHS defined that period as 180 days since the last opioid prescription for that patient. The law’s five-day and seven-day opioid prescription limits don’t apply to hospitals, nursing homes, hospices and residential care facilities.

Pharmacists say that the law’s opioid prescription limits don’t fit the definition of every new patient. Some undergo difficult surgeries and will experience more than seven days of pain, said Penny Shelton, executive director of the N.C. Association of Pharmacists.

People with rheumatoid arthritis and others have chronic pain symptoms that flare up infrequently enough to render the patient classified as a new prescription under the NC STOP Act, Shelton said. In those cases, the doctor can write a subsequent prescription, but it complicates life for people in extreme physical discomfort.

“Ninety-five percent are in legitimate pain and have a legitimate need for the medicine,” said Jonathan Harward, pharmacy manager at Josefs Pharmacy in Raleigh.

Your Government is LYING To YOU….REALLY LYING…to all of US…..

How would I prosecute a Federal prosecutor?

#KMart Pharmacist told me to take my prescriptions somewhere else

I have been a customer of Kmart pharmacy for several years, but on this past Monday April 30,2018, I was informed by the on staff pharmacist that he was short on my prescription but would order on Tuesday, and could pick up on Wed. I called back on Tuesday to confirm it would be there on Wed, and the time I should come in. At that time a different pharmacist told me to that I should ask my Dr for a different strength or to go somewhere else because he was saving what he had for Drs that ordered from him. I asked him to please fill at least one more time giving me time to find another pharmacist due to the fact that every pharmacy says they are not taking new patients. He refused. On Wed I sent my friend in to food city, but he misunderstood and went to Kmart, the clerk checked and said come back in 30 mins while they filled it, but it never happened John, the manager pharmacist yelled (I was on the phone with my friend and heard) and said I am the manager I am refusing. I have never had a problem, in fact they always were very pleasant. This pharmacist violated my hibba rights, but saying my name my medication, and saying I needed to go else where. I was terrified of the fear of how I would feel nit being able to fill this, and humiliated. My question is what, if anything can I do? I would sincerely appreciate any help in guiding me on where to go to file a complaint. Thank you so much..

 

Yet Another Podcast on Drugs…

https://radio.foxnews.com/2018/05/02/yet-another-podcast-on-drugs/

Greg’s guest today is Jacob Sullum who is a senior editor at Reason magazine and a nationally syndicated columnist. They discuss new research that finds that the banned drug, MDMA (aka Ecstasy), helps PTSD. They also discuss some facts and fictions about the opioid epidemic.

 

https://radio.foxnews.com/2018/05/02/yet-another-podcast-on-drugs/

Podcast on the link…could not copy the link down to this post

Gov Kasich: wants to PLAY DOCTOR ?

Ohio sets new requirements for chronic pain patients to get opiates

— Ohio Gov. John Kasich on Wednesday announced new prescribing rules for patients suffering pain for more than six weeks, hoping that the move will prevent opiate addiction and accidental overdoses.

Prescribers will be required to:

* talk with patients and consider non-medication treatment

* assess the function of the patient,

* look for signs of abuse,

* consult with specialists,

* offer a naloxone prescription

* take other steps when treating someone suffering from subacute or chronic pain.

The more opiates a patient is taking, the more steps will be required by prescribers.

“Here is the message: if you have chronic pain, you don’t need to worry that somehow your medication will be cut off. The message is you’re going to be treated in a very special way, not that patients aren’t being treated that way now but it’s going to force everyone in that whole world to slow down and think about the individual,” Kasich said at a press conference.

The new rules, which take effect in the fall, won’t apply to hospice or terminal cancer patients.

Related: Five steps Ohio has taken to combat the opioid crisis

Some 80 percent of Ohioans who died from an overdose in 2016 had a history of abusing prescribed controlled substances.

While the Kasich administration efforts have led to a drop in deaths attributed to prescribed drugs, fatal overdoses on illicit drugs have continued to fuel Ohio’s alarming numbers.

“Don’t do street drugs, okay? That’s what’s driving up the numbers,” Kasich said.

Related: Drug overdose deaths jump 33-percent in Ohio

Accidental drug overdoses killed 4,050 Ohioans in 2016, up 33 percent over the 3,050 fatalities in 2015. Driving the spike is the emergence of fentanyl, carfentanil and cocaine laced with fentanyl, the health department reported.

The increase came even after the state spent $1-billion into programs to combat the crisis, including expanding Ohio Medicaid, distributing naloxone to counteract overdoses, beefing up the state’s online prescription tracking database and writing stringent prescribing rules.

Related: Ohio to start new limits on painkiller prescriptions

Related: Ohio Lt. Gov. Mary Taylor opens up about her sons’ opioid addiction

Unintentional fatal drug overdoses in Ohio have been on a steady, stunning climb from 904 in 2004 to 4,050 in 2016. Since 2007, unintentional drug overdoses have been the leading cause of injury death in Ohio — ahead of motor vehicle accidents. As Ohio puts more controls on prescribed opiates, people with addictions turn to illicit drugs such as heroin.

State Sen. Matt Dolan, R-Chagrin Falls, said he supports reducing addiction but “I do not think just legislating the practice of medicine achieves this goal.”

Kasich said the additional rules aren’t intended to interfere with the doctor-patient relationship. “You don’t want to ever put the government or silly rules in between a patient and the ability of the physician to be able to practice their great, great gift,” he said.

What Happened to the Untreated Chronic Pain Crisis?

https://www.painmedicinenews.com/Commentary/Article/03-18/What-Happened-to-the-Untreated-Chronic-Pain-Crisis-/47058

Simply stated, nothing has happened to the untreated chronic pain crisis. The same percentage of patients from the population still suffer from chronic, unrelenting pain. The only difference is this: We now know that one treatment option, when taken to the extreme, is not the simplistic solution that we had hoped for and were led to believe.

In retrospect, simplistic is a nice adjective along with delusional, foolish or academically corrupt to describe the belief that any human condition can be alleviated with a known addictive substance. How the pain management experts were able to dissociate from the accumulated knowledge of both medical experts and laypersons of the dangerous nature of opioids is beyond understanding.

During the 1920s, several laws were passed in the United States to deal with widespread addiction related to over-the-counter opioid availability. In the late 1960s, laws were once again passed to curb the overuse of various mind-altering drugs with the formation of a new drug enforcement agency. It appears that 50 years later, we made the same mistake again.

Addiction has been part of the human condition as long as recorded history. Addiction has even been used as a tool of war, for example, the use of opium by the British against the Chinese in the Opium Wars of the mid-1800s. There is growing consensus that the same percentage of the population has been addicted to some agents for at least several centuries. The overreliance on opioids for the treatment of chronic pain just substituted one psychoactive medication for others. It is interesting that as the opioid crisis has become more pronounced, there is less awareness of cocaine or methamphetamine addiction.

One new part of this equation is the development of a physician, pharmaceutical and insurance complex, with each achieving a different goal with opioid use but toward the same end. Now there is a massive rebound against the use of prescription opioids for chronic pain. In the process of righting the wrongs, a number of chronic pain patients who had regained function with the appropriate treatment of their disease state with opioids are now caught in the tidal wave and losing either their opioids or their function.

This loss of function has restored, in at least some of these patients, turning to street drugs, which have become ever more potent and dangerous. This is one unintended consequence of the appropriate reduction in the amount of prescription opioids written. All interested parties should now agree that the opioid genie is out of the bottle and can’t be eliminated from society. Well-intended prescribing guidelines and laws restricting the use of prescription opioids are inflicting real harm to patients everywhere.

The groups trying to alleviate this problem include lawmakers, who generally are poorly informed and trying to satisfy the needs of their constituents. There is a very loud constituency advocating for the reduction in addiction and overdose deaths. Lawmakers will attempt to pass laws that alleviate these problems, but inevitably, any law is so broadly written that it will cause harm to a patient whose chronic pain is being appropriately treated.

Pharmaceutical companies also have a very strong interest in the use of these opioid medications. Many new tamper-resistant opioids have been produced. Although many of these medications are more abuse deterrent, they are brand-name medications and generally poorly covered by insurance companies. The least expensive way to treat pain is with immediate-release opioids. These are also believed to be the most addictive medications. Because they can easily be either injected or vaporized and snorted, these medications have limited use in higher dosage forms. Insurance companies have also been reluctant to cover alternative treatments, such as physical and psychological therapies, for prolonged periods of time, which these patients need. Also, interventional techniques can help alleviate pain for at least a moderate amount of time.

One of the major problems with pain management, however, is that no technique has been shown to provide long-term pain control. Opioid medications; neuroadjunctive medications, such as gabapentin and dual-action antidepressants; traditional physical therapy, the above-mentioned procedures; and alternative treatments have not been proven to provide long-term pain control. The only techniques that have been shown to be helpful are some psychological techniques, such as cognitive-behavioral therapy. Therefore, it is difficult to advocate for any type of pain management treatment when, dependent on your point of view, nothing works. Further complicating the treatment of chronic pain are the comorbid conditions, such as psychological diagnoses, obesity, smoking, and social and societal problems.

This problem is in a state of great fluctuation. We’re at a point at which prescription drugs are being replaced by illegal drugs. This is further complicated by the fact that sophisticated pill presses can produce illegal pills that look like brand-name medications but can actually contain any number of psychoactive medications. The analogs of fentanyl are most dangerous; they can be up to 100,000 times as potent as opioids, milligram to milligram. The statistics are now likely to be corrupted because law enforcement members do not know what medications they are finding on overdosed patients, and only expensive toxicology reports can tell for sure.

The number of prescription medications actually peaked in 2012. However, the number of overdoses, overdose deaths and neonatal abstinence syndrome cases continues to grow. Emergency medical responders are actually becoming acquainted with addicts by name, as overdoses are becoming a recurrent emergency because of the prevalence of naloxone (Narcan, Adapt Pharma). Addicts can take themselves to the edge of death to achieve the most intense high, knowing that there is a good chance that they will be saved before they are not recoverable.

Because of the current fluctuation of the situation, the statistics that are being used are likely to be irrelevant to the current situation. One statistic that is assumed as fact is that more than a three-day prescription for pain medication will cause patients to become addicts. That is highly unlikely. A vast number of patients have been given post-op medications without becoming addicted. The treatment of chronic pain will require well-trained providers who are versed in a multidisciplinary approach, and a little bit of everything will be helpful.

DOJ/AG SESSION: another RAID on an addiction treatment center

DEA agents raid Watauga Recovery Centers in TN, VA, and NC

http://www.wjhl.com/local/dea-agents-raid-watauga-recovery-centers-in-tn-va-and-nc/1156361147

JOHNSON CITY, TN (WJHL) – Federal agents raided a Tri-Cities region addiction treatment organization Wednesday.

A spokesman with the Federal Drug Enforcement Administration said agents issued a Federal Search Warrant at the Watauga Recovery Centers clinic in Johnson City.

DEA Agent Jim Scott said search warrants were issued at multiple Watauga Recovery Center locations. News Channel 11 learned 9 clinics were searched Wednesday in Tennessee, Virginia, and North Carolina. The centers were closed after the raid but plan to re-open Thursday according to Dr. Tom Reach, clinic founder and president.

Watauga Recovery Center treats around 2500 patients.

Dr. Reach said they’ve done nothing wrong, and this raid sends the wrong message in the opioid crisis time that the country is in.

He said the agents also raised his home, they were looking for medical and financial records throughout the day.

“We have nothing to hide, we have never done anything remotely illegal, immoral, unethical, and we stand behind our practice. And we know we will be completely exonerated in this issue,” Dr. Reach said.

Agents were also looking for records of controlled substances, Dr. Reach said.

“Watauga Recovery Center has never had controlled substances in the facilities. We don’t sell, we don’t dispense,” Dr. Reach said.

Agents also confiscated cell phones and took hard drives from computers, which he said could keep them from seeing patients.

“My real concern is for the patients, if they’re unable to get care, the chances of them going back out and using street drugs, and using heroin and fentanyl, they could die from this,” Dr. Reach said.

No one from the practice was arrested or charged with a crime, Dr. Reach said.

We’re told the nine clinics that closed Wednesday will re-open Thursday.

AG SESSION/DOJ: now going after addiction clinics – not the addicts – follow the money trail ?

Five area doctors charged in pill mill case at addiction clinic

http://www.post-gazette.com/local/region/2018/05/03/Five-doctors-W-Pa-W-V-charged-narcotic-distribution-scheme/stories/201805030122

Five Pittsburgh-area doctors doled out Suboxone to addicts for cash at addiction clinics in Washington County and West Virginia where they worked as contract employees, according to federal investigators.

Indictments unsealed Thursday in U.S. District Court in Pittsburgh and in West Virginia named Krishan Aggarwal, 73, and his wife, Mudha Aggarwal, 68, of Moon; Cherian John, 65, of Coraopolis; Parth Bharill, 69, of Pittsburgh; and Michael Bummer, 38, of Sewickley.

All were connected with Redirections Treatment Advocates, a treatment center based in Washington, Pa., with locations in Bridgeville and the West Virginia cities of Morgantown, Moundsville and Weirton.

The investigation became public in January, when the FBI, U.S. Drug Enforcement Administration and the Department of Health and Human Services raided the clinics.

Christopher Handa, 47, director of operations, was later indicted on counts of conspiracy to distribute Suboxone, which is used to treat addicts, and submitting bills to Medicaid and Medicare for payments to cover the costs of the drugs.

Suboxone, a brand name, is a combination of buprenorphine, a relatively mild opioid, and naltrexone, which blocks other opioids from acting on the brain’s receptors. Experienced opioid users don’t experience a high from Suboxone, but it prevents them from going into withdrawal. So some users buy Suboxone to keep from going into withdrawal during periods in which they can’t find heroin. And some try to manage their own recoveries by purchasing Suboxone on the streets.

The doctors, who were under contract at Redirections, are charged with similar crimes at the facilities where they worked.

Dr. Krishan Aggarwal and Dr. John, for example, are accused of authorizing Mr. Handa and others to fax prescriptions for Suboxone for patients who had no medical need for it and then billing insurance for the costs.

In the case of Dr. Bharill, who worked at the Morgantown office, the grand jury said he provided pre-signed blank prescriptions to Mr. Handa, who then completed the dosage information without the doctor being in the office.

Dr. Bummer is accused of the same at the Washington office and Dr. Mudhu Aggarwal at the Bridgeville office.

Dr. Krishan Aggarwal, Dr. Bharill and Dr. John are all charged in the northern district of West Virginia because they worked at the clinics there; their cases will be heard in Clarksburg, W.Va. The other two are indicted in Pittsburgh because they worked at clinics in Washington County.

U.S. marshals hauled them all into federal court Thursday in handcuffs. U.S. Magistrate Judge Robert Mitchell released them on $50,000 bonds and let them return to work.

All had just been appointed lawyers or said they would retain their own lawyers. Mr. Handa’s lawyer, Ralph Karsh, has refused comment on the investigation.

Dr. Bummer’s lawyer, Efrem Grail, said his client and his family are “deeply concerned by the grand jury’s charges. We look forward to reviewing the evidence.”

The case is being brought as part of a Justice Department program called the Opioid Fraud and Abuse Detection Unit, announced last summer to track and prosecute health care professionals who illegally deal drugs and contribute to the nation’s opioid crisis.

Several other unrelated cases are also being prosecuted in this district under the initiative, which relies on data analysis and other tools to track doctors who over-prescribe.

U.S. Attorney General Jeff Sessions also assigned a dozen prosecutors in each of 12 “hot spot” districts around the country where the opioid crisis was most acute. Pittsburgh was one of them; the special prosecutor here is Assistant U.S. Attorney Robert Cessar.

The first case in the nation since the creation of the national unit was a local doctor, Andrzej Zielke, 62, of Hampton, who operated Medical Frontiers in the Richland Mall. He is under indictment here on charges of running a pill mill.

Federal agents, who had been investigating Dr. Zielke since 2014, said he was doling out prescriptions to addicts for cash, including at least one who died of an overdose.

The DEA estimates that eight of 10 heroin addicts in the U.S. started out as prescription painkiller abusers.

Mr. Cessar and his boss, U.S. Attorney Scott Brady, said the administration’s efforts are geared towards finding the “outliers” among doctors and other healthcare professionals who are fueling addiction for their own benefit.

“We want to attack this epidemic with all of the tools in our arsenal,” said Mr. Brady.

Study Finds Opioid Medication Effective for Chronic Pain

www.painnewsnetwork.org/stories/2018/5/3/study-finds-opioid-medication-effective-for-chronic-pain

Opioids have been used for thousands of years to provide relief from pain. But are they an effective treatment? Are they worth the risk of addiction? And do they improve quality of life?

Millions of chronic pain patients who use prescription opioids so that they can work, sleep, bathe and do simple household chores would quickly answer “Yes” to those questions.

But that’s a radical concept in an age of anti-opioid hysteria and propaganda. Prominent anti-opioid activists insist that “opioids are ineffective or can worsen both the pain and the long-term outcome.” And the CDC’s opioid prescribing guideline tells us there is “insufficient evidence to determine long-term benefits of opioid therapy for chronic pain.”  

Except now there’s a review that says opioids are effective and the evidence was there all along.

Researchers at Brown University and Tufts University School of Medicine analyzed 15 clinical studies performed for the Food and Drug Administration that looked at the effectiveness of opioids in treating chronic non-cancer pain. Their findings were just published in the Journal of Pain Research.

“The recent claims that opioids lack efficacy for chronic pain have created controversy among physicians, prescribers, regulators, scientists, and the general public,” wrote lead author Nathaniel Katz, MD, president of Analgesic Solutions and a professor of anesthesia at Tufts University.

bigstock-Chronic-Pain--Medical-Concept-89339426.jpg

“This review was, therefore, performed in order to gather together the key evidence to facilitate understanding opioid efficacy within the paradigm of FDA studies required for approval, and to perform a meta-analysis in order to quantify opioid efficacy for chronic pain.”

‘Ample Evidence’ Opioids Work

The authors are careful to note that they did not try to study or minimize the risks of opioids but were simply trying to reach “an accurate assessment of their benefits.” The 15 placebo controlled studies they reviewed evaluated the effectiveness of hydrocodone, oxycodone, tramadol and other opioids for up to 3 months.

What did they find?

“There is an ample evidence base supporting the efficacy of opioid analgesics for at least 3 months’ duration,” Katz wrote. “This evidence base is at least as large as that for any other class of analgesics, and analysis of responders demonstrates clinically meaningful improvements.”

Nearly two-thirds of the patients (63%) who participated in the 15 studies demonstrated “a clinically meaningful response” to opioids as a treatment for chronic pain. Their physical function only improved marginally, and researchers say there was no positive or negative effect on the patients’ mood. Interestingly, adverse effects were similar in the patients who took opioids and those who were given placebos.  

In short, the authors found no reason to abandon opioids as a treatment for chronic pain.

“While the effectiveness of existing treatments for chronic pain leaves plenty of room for improvement, and considering that only a small minority of patients do not experience clinically meaningful treatment response, discarding all analgesics approved for chronic pain contradicts numerous treatment guidelines, international treatment guidelines, widespread patients experience, and the FDA approval process,” they wrote.   

Critics will no doubt question why the authors only reviewed studies that lasted 3 months or less. The answer is that high quality, placebo controlled studies longer than that simply don’t exist. Long term safety and efficacy studies are not required for a drug to get FDA approval — which is why many anti-opioid activists and the CDC claim there is “no evidence” or “insufficient evidence” that opioids work long-term. It’s also a misleading statement, because non-opioid pain medications and alternative treatments are not studied for long periods either.   

“The reason for the 3 months isn’t because there aren’t good studies that go beyond 3 months but that 3 months is the period of time the FDA requires for efficacy studies.  It is the regulatory standard for assessing long-term efficacy of placebo-controlled studies in chronic pain conditions,” explains pain management expert Lynn Webster, MD, who is vice president of Scientific Affairs at PRA Health Sciences. 

Webster says there are technical and ethical reasons researchers do not conduct longer studies of analgesics.

“It is very difficult to conduct longer studies that are placebo controlled because of the number of dropouts in the placebo arm and the ethical concerns of denying patients access to treatment,” he told PNN. “It is true there aren’t placebo-controlled studies longer than 3 months but there are extended open label studies that are 12 months.  As the article states, these extension studies show the efficacy (of opioids) is maintained.”  

Katz and his colleagues have worked as consultants to Endo, Pfizer, Purdue Pharma and other opioid makers, which they disclose in their article. Funding for the study was provided by Analgesic Solutions and several pharmaceutical companies.