FDA: Pain Patients Dependent On Opioids Are Not Addicted

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has released new guidance to drug makers to streamline the development of buprenorphine products to treat opioid addiction. Commonly known by the brand name Suboxone, buprenorphine has long dominated the market for addiction treatment.

Of importance to pain patients is a statement about the guideline by FDA commissioner Scott Gottlieb, MD, that seeks to clarify the difference between opioid addiction and patients who need opioids for pain relief.

Gootlieb said there is still stigma and misunderstanding – even in the medical and addiction fields – about the difference between opioid addiction and dependence.

“Because of the biology of the human body, everyone who uses a meaningful dose of opioids for a modest length of time develops a physical dependence. This means that there are withdrawal symptoms after the use stops,” Gottlieb said. “A physical dependence to an opioid drug is very different than being addicted to such a medication.

“Addiction requires the continued use of opioids despite harmful consequences on someone’s life. Addiction involves a psychological preoccupation to obtain and use opioids above and beyond a physical dependence. But someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving the drugs is not addicted.”

“Someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving the drugs is not addicted.”

— Dr. Scott Gottlieb, FDA Commissioner

In recent years new and generic formulations of buprenorphine have been released in tablets, sublingual films, injections and implants, and the FDA is trying to promote the development of more of them.

The guidance released by the agency basically tells drug makers they may be able to submit new drug applications for buprenorphine products without conducting the safety and efficacy trials that are usually required for other medications.

“The guidance we’re finalizing today is one of the many steps we’re taking to help advance the development of new treatments for opioid use disorder, and promote novel formulations or delivery mechanisms of existing drugs to better tailor available medicines to individuals’ needs,” Gottlieb said. “Our goal is to advance the development of new and better ways of treating opioid use disorder to help more Americans access successful treatments.”

There are currently only three drugs approved by the FDA for medication-assisted treatment (MAT) – buprenorphine, methadone and naltrexone. Physicians wishing to prescribe buprenorphine to patients must have a special certification from the DEA and are limited in the number of patients they can treat.

Buprenorphine is an opioid that is also used to treat pain. When combined with naloxone, buprenorphine reduces cravings for opioids and lowers the risk of abuse.

Some addicts have discovered that buprenorphine can also be used to get high or to ease their withdrawal pain from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked buprenorphine as the third most diverted opioid medication in the U.S. in 2014. 

Federal Prosecutors Warn Top Opioid Prescribers in Wisconsin

By Pat Anson, PNN Editor

Wisconsin’s two U.S. Attorneys have sent letters to 180 physicians, physician assistants and nurse practitioners in the state warning them that their opioid prescribing practices could result in prosecution.

None of the prescribers have been charged with a crime and it’s not clear if any are under investigation or have been linked to overdoses. Copies of the letters were not released and the recipients were not identified.

According to a news release, the letters warn doctors that they are prescribing opioids at “relatively high levels” that could lead to addiction and that “prescribing opioids without a legitimate medical purpose could subject them to enforcement action, including criminal prosecution.”

“We know that for many, addiction began with opioids prescribed by a medical professional,” said Matthew Krueger, U.S. Attorney for the Eastern District of Wisconsin. “By sending these letters, we are asking medical professionals to join the fight against addiction and ensure they prescribe no more opioids than are necessary.”

“Opioid addiction has touched the lives of far too many families in our state,” said Scott Blader, U.S. Attorney for the Western District of Wisconsin. “Medical professionals play a pivotal role in stemming the flow of legal opioids into unlawful channels.”

According to a spokeswoman, the 180 recipients of the warning letters were selected based on a review of Medicare prescription drug claims, which found that they prescribed opioids above the CDC’s highest recommended dose of 90 MMEs (morphine milligram equivalent). 

“They were identified through Medicare data for two years,” Myra Longfield, a public information officer in the Western District of Wisconsin, told PNN. “And from that data, practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain.” 

The 2016 CDC opioid guideline is voluntary and only intended for primary care physicians. Longfield said warning letters were not sent to pain management physicians, oncologists or those working in hospice or palliative care, where higher opioid doses may be needed to control pain. 

Chilling Effect on Prescribers

Federal prosecutors in Georgia and Massachusetts have sent similar warning letters to high prescribers. While the intent is to urge caution, critics say the letters are likely to intimidate other doctors.

“This will have a totally chilling effect. The abuse of statistics is pathetic. It would only be an ignorant person that would take the top prescribers and say that they are endangering lives,” said Mark Ibsen, MD, a Montana doctor who nearly lost his medical license over allegations that he overprescribed opioids.  

“After they lop off the top prescribing doctors, guess what that leaves? More top prescribing doctors. Until there are none. Soon we will be seeing tattoos on physicians, similar to POWs.”

“This is an egregious overreach and will lead to more deaths not fewer,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine. “Using the CDC guidelines as a goal post is not what even the CDC recommended. Most opioid addictions do not begin with a legal prescription of opioids. It usually starts long before exposure to a prescription opioid. The major problem is with illegal opioids smuggled in from Mexico and China. 

“I am worried for tens of thousands of patients in Wisconsin. Many of them will be at risk of suicide or seek illegal drugs, where the real harm exists. Sad. Very Sad.”

Last year, the American Medical Association adopted resolutions opposing the “misapplication” and “inappropriate use” of the CDC guideline. The resolutions by the AMA House of Delegates warn that “no entity should use MME thresholds as anything more than guidance” and that physicians should not be disciplined or prosecuted for prescribing opioids at levels above those recommended by the CDC. The AMA said some patients “can benefit from taking opioids at greater dosages” and “such care may be medically necessary and appropriate.” 

Most opioid overdoses in the United States are now linked to illicit fentanyl and heroin, not prescription opioids. In Wisconsin, 916 people died of opioid overdoses in 2017. Most of those deaths involved either heroin or fentanyl.

Compounded Pain Creams Ineffective for Chronic Pain

By Pat Anson, PNN Editor

Compounded topical pain creams work no better than placebo creams and should not be used to treat chronic pain, according to a new study published in the Annals of Internal Medicine.

Researchers at the Walter Reed National Military Medical Center enrolled nearly 400 people with chronic neuropathic, joint or muscle pain in the study. Some received pain creams specially compounded to treat their type of pain, while others received a placebo cream.

The compounded pain creams included a blend of FDA-approved drugs such as ketamine, lidocaine and gabapentin, or a combination of muscle relaxants and non-steroidal anti-inflammatory drugs (NSAIDs). The creams were applied to the affected areas three times a day.

One month after treatment began, researchers found no significant differences in the pain scores of patients who used the real pain creams and those who used the placebo ones.

“We found that specially formulated compounded pain creams provided little benefit in our study participants,” said lead author Steven Cohen, MD, Director of Pain Research at Walter Reed.

“Overall, the response rate was lower than that afforded by stand-alone creams shown to be effective for specific conditions, such as NSAIDs and lidocaine. Considering the increased costs of using a non–FDA-approved and regulated compounded cream rather than a single agent, we caution against routine use of compounded creams for chronic pain.”

While some of the medications in pain creams may be effective when taken orally or intravenously, Cohen and his colleagues say they are not absorbed through the skin in sufficient doses to be effective. Another drawback is their cost, which can reach thousands of dollars.

A recent report from the Office of Inspector General for the Department of Health and Human Services found that over 500 pharmacies that billed Medicare for compounded topical creams had suspiciously high costs. One pharmacy in Florida billed Medicare for $1.8 million in pain creams in 2016.

Medicare spending for compounded creams, gels and ointments has skyrocketed, rising from $13 million in 2010 to $323 million in 2016. Price hikes and a growing number of prescriptions for pain creams drove the increase, the Inspector General’s report found.

Medicare paid an average of $751 per tube of compounded lidocaine and $1,506 for a tube of the NSAID diclofenac. Non-compounded tubes of those same drugs averaged $445 and $128, respectively.

Last year the FDA said it would inspect compounding facilities to assess whether drugs that are essentially copies of FDA-approved medications could be sold commercially at less cost.

Diarrhea Drug Involved in Growing Number of Overdoses

By Pat Anson, PNN Editor

A little over a year ago, the Food and Drug Administration asked Johnson & Johnson and other drug makers to limit the number of anti-diarrhea pills they sell. FDA commissioner Scott Gottlieb, MD, said the “unprecedented and novel action” was needed because Imodium and other over-the-counter formulations of loperamide were being abused by opioid addicts.  

A few of us guffawed at the news as another example of government regulation gone amuck.

But it turns out there is cause for concern.

Researchers at Rutgers University have documented that overdoses of loperamide have been steadily increasing in number and severity, and have even resulted in some deaths.

Their study, published in the journal Clinical Toxicology, found a growing number of people addicted to opioids who are using loperamide to prevent or self-treat withdrawal symptoms. Some are even taking massive doses to get a high similar to heroin, fentanyl or oxycodone.

The New Jersey Poison Control Center has reported several fatalities or near-fatalities from loperamide in the past 12 months.

“When used appropriately, loperamide is a safe and effective treatment for diarrhea – but when misused in large doses, it is more toxic to the heart than other opioids which are classified under federal policy as controlled dangerous substances,” said senior author Diane Calello, MD, executive director of New Jersey Poison Control at Rutgers New Jersey Medical School.

“Overdose deaths occur not because patients stop breathing, as with other opioids, but due to irregular heartbeat and cardiac arrest.”

The researchers reviewed toxicology cases in a national poison control center database from 2011 to 2016, and found a 91 percent increase in loperamide overdoses during that time period.  In 2015 alone, there were 916 cases and two deaths.

Patients who misused loperamide were predominantly young Caucasian men and women. The majority used extremely high doses of loperamide, the equivalent of 50 to 100 two-milligram pills per day.

“Possible ways of restricting loperamide misuse include limiting the daily or monthly amount an individual could purchase, requiring retailers to keep personal information about customers, requiring photo identification for purchase and placing medication behind the counter,” Calello said. "Most importantly, consumers need to understand the very real danger of taking this medication in excessive doses."

Misuse of loperamide is concerning because it is readily available over-the-counter, undetectable in routine drug tests, and can be bought in large quantities online or in retail stores.

In 2017, the FDA added a warning label to loperamide products cautioning consumers not to ingest high doses. Some drug makers are now selling the anti-diarrhea pills in smaller packages and in blister packs that are harder to open.

How Sackler Family Built an OxyContin Fortune

By Christine Willmsen and Martha Bebinger, WBUR

The first nine months of 2013 started off as a banner year for the Sackler family, owners of the pharmaceutical company that produces OxyContin, the addictive opioid pain medication. Purdue Pharma paid the family $400 million from its profits during that time, claims a lawsuit filed by the Massachusetts attorney general.

However, when profits dropped in the fourth quarter, the family allegedly supported the company’s intense push to increase sales representatives’ visits to doctors and other prescribers.

Purdue had hired a consulting firm to help reps target “high-prescribing” doctors, including several in Massachusetts. One physician in a town south of Boston wrote an additional 167 prescriptions for OxyContin after sales representatives increased their visits, according to the latest version of the lawsuit filed in Suffolk County Superior Court in Boston.

The lawsuit claims Purdue paid members of the Sackler family more than $4 billion between 2008 and 2016. Eight members of the family who served on the board or as executives as well as several directors and officers with Purdue are named in the lawsuit.

This is the first lawsuit among hundreds of others that were previously filed across the country to charge the Sacklers with personally profiting from the harm and death of people taking the company’s opioids.

WBUR along with several other media sued Purdue Pharma to force the release of previously redacted information that was filed in the Massachusetts Superior Court case. When a judge ordered the records to be released with few, if any, redactions, Purdue filed two appeals and lost.

The complaint filed by Massachusetts Attorney General Maura Healey says that former Purdue Pharma CEO Richard Sackler allegedly suggested the family sell the company or, if they weren’t able to find a buyer, to milk the drugmaker’s profits and “distribute more free cash flow” to themselves.

That was in 2008, one year after Purdue pleaded guilty to a felony and agreed to stop misrepresenting the addictive potential of its highly profitable painkiller, OxyContin.

At a board meeting in June 2008, the complaint says, the Sacklers voted to pay themselves $250 million. Another payment in September totaled $199 million.

The company continued to receive complaints about OxyContin similar to those that led to the 2007 guilty plea, according to unredacted documents filed in the case.

While the company settled lawsuits in 2009 totaling $2.7 million brought by family members of those who had been harmed by OxyContin throughout the country, the company amped up its marketing of the drug to physicians by spending $121.6 million on sales reps for the coming year. The Sacklers paid themselves $335 million that year.

The lawsuit claims Sackler family members directed efforts to boost sales. An attorney for the family and other board directors is challenging the authority to make that claim in Massachusetts. A motion on jurisdiction in the case hasn’t been heard. That attorney hasn’t responded to a request for comment on the most recent allegations.

Purdue Pharma, in a statement, said the complaint filed by Healey is “part of a continuing effort to single out Purdue, blame it for the entire opioid crisis, and try the case in the court of public opinion rather than the justice system.”

Purdue went on to charge Healey with attempting to “vilify” Purdue in a complaint “riddled with demonstrably inaccurate allegations.” Purdue said it has more than 65 initiatives aimed at reducing the misuse of prescription opioids. The company says Healey fails to acknowledge that most opioid overdose deaths are currently the result of fentanyl.

Purdue fought the release of many sections of the 274-page complaint. Attorneys for the company said at a hearing on Jan. 25 that they had agreed to release much more information in Massachusetts than has been cleared by a judge overseeing hundreds of cases consolidated in Ohio. Purdue filed both state and federal appeals this week to block release of the compensation figures and other information about Purdue’s plan to expand into drugs to treat opioid addiction.

The attorney general’s complaint says that in a ploy to distance themselves from the emerging statistics and studies that showed OxyContin’s addictive characteristics, the Sacklers approved public marketing plans that labeled people hurt by opioids as “junkies” and “criminals.”

Richard Sackler allegedly wrote that Purdue should “hammer” them in every way possible.

Addiction Treatment ‘Attractive Market’

While Purdue Pharma publicly denied its opioids were addictive, internally company officials were acknowledging it and devising a plan to profit off them even more, the complaint states.

Kathe Sackler, a board member, pitched “Project Tango,” a secret plan to grow Purdue beyond providing painkillers by also providing a drug, Suboxone, to treat those addicted.

“Addictive opioids and opioid addiction are ‘naturally linked,'” she allegedly wrote in September 2014.

According to the lawsuit, Purdue staff wrote: “It is an attractive market. Large unmet need for vulnerable, underserved and stigmatized patient population suffering from substance abuse, dependence and addiction.”

They predicted that 40-60 percent of the patients buying Suboxone for the first time would relapse and have to take it again, which meant more revenue.

Purdue never went through with it, but Attorney General Healey contends this and other internal documents show the family’s greed and disregard for the welfare of patients.

This story is part of a reporting partnership between WBUR, NPR and Kaiser Health News. 

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Overdose Crisis Will Worsen, But Not Due to Rx Opioids

By Pat Anson, PNN Editor

The opioid crisis will “substantially worsen” in coming years and could result in the overdose deaths of over a million Americans by 2025, according to an eye-opening new study. Because most of the deaths will involve illicit opioids, researchers say limiting the supply of prescription opioids will have only a “modest” effect in reversing the trend.      

The study, published in JAMA Network Open, is based on mathematical models developed by a team of researchers at Harvard Medical School, Boston University School of Medicine, Pennsylvania State University and other academic institutions.

“Our study also highlights the changing nature of the epidemic. The opioid crisis is expected to worsen in the next decade owing to multiple factors,” said lead author Jagpreet Chhatwal, PhD, a researcher at Massachusetts General Hospital.

“First, the number of individuals using illicit opioids is expected to increase substantially. Second, unlike historical trends where prescription opioid use has served as a path to heroin use, more people are directly initiating opioid use with illicit opioids. Third, there has been a rapid increase in illicit opioid lethality, likely mainly driven by the infiltration of the heroin supply with the highly potent synthetic opioid fentanyl.”

Under a “base-case” scenario, with the opioid crisis stabilizing by 2020, researchers project that over 700,000 Americans will die from opioid overdoses from 2016 to 2025. Nearly 80 percent of the deaths will involve fentanyl, heroin and other illicit opioids. Overdoses involving prescription opioids would decrease by about 10% during that period.

JAMA NETWORK OPEN

A “pessimistic” scenario developed by researchers is even more jaw dropping. If the opioid crisis does not stabilize until 2025, they project over 1.2 million Americans will die from overdoses. Over 88% of the deaths will involve illicit opioids.

In either scenario, efforts to reduce the misuse of opioid medication, such as limiting the dose and supply of prescription opioids, will only reduce the number of overdose deaths by 3 to 5 percent.

“State and local governments have instituted several interventions aimed at preventing individuals from exposure to prescription opioids, including a recently proposed goal to lower opioid prescriptions by one-third in the coming 3 years,” said Chhatwal.

“Our study does not devalue these efforts and it is possible that their effect could improve over time, which may ultimately yield a substantial benefit in the long term. However, given the large number of individuals who have already engaged in prescription opioid misuse or illicit opioid use, our study indicates that prevention efforts, in isolation, are unlikely to have the desired level of effect on opioid overdose deaths the near term.”

The researchers say a strong, multi-pronged approach is needed to reduce overdoses, including greater scrutiny of patients for signs of opioid use disorder (OUD).

"It could include implementation of screening for OUD in all relevant health care settings, improving access to medications for OUD such as methadone and buprenorphine, increasing OUD training programs at medical and nursing schools, improving access to harm-reduction services, and controlling the supply of illicit opioids,” they concluded.

Another recent study also predicts that reducing the supply of prescription opioids will have little effect on the overdose rate and could lead to increased use of heroin.   

Pain Management Association Shutting Down

By Pat Anson, PNN Editor

An association of pain management providers that was a leading advocate for patient access to pain care is closing its doors. The board of directors of the Academy of Integrative Pain Management (AIPM) voted unanimously this week to cease operations, largely due to financial problems.  

“This is an incredibly difficult and sad decision,” said Bob Twillman, PhD, AIPM’s Executive Director. “Our message has never been more relevant than now, amid the nation’s opioid crisis, yet we have found it increasingly difficult to maintain the resources needed to sustain our efforts.”

For over three decades, AIPM promoted an “integrative model” of pain care that utilizes a variety of different treatments, including both drug and non-drug therapies.

Although that model has become a standard of pain care, AIPM’s membership has steadily declined due to demographic and other industry trends. With doctors under increasing scrutiny for opioid prescribing, pain management is not an attractive specialty for recent medical school graduates.

“Joining associations like ours just is not a high priority for younger health care providers, and decreased interest in attending in-person educational events has contributed to significantly decreased conference revenues for AIPM,” said W. Clay Jackson, MD, President of the Board of Directors.

The demonization of opioid medication by policymakers and politicians also played a major role, causing many drug makers to limit or drop their support for medical associations and patient advocacy groups.

“My understanding is that the decreased industry support is not limited to the pain space, but it is especially acute here because for many years it was the opioid manufacturers who were the greatest source of funding,” Twillman wrote in an email to PNN. “As recently as five years ago, it would not be unusual for a company to drop nearly $100,000 at a single conference, between big exhibit hall booths, grants for continuing education programs, sponsored meal programs, and items such as bags, lanyards, key cards, etc.

“But when the lawsuits against opioid manufacturers started to ramp up, the logical response from the manufacturers was to withdraw support. After all, if they are being accused of using groups like ours as ‘front organizations,’ then it is completely logical for them to stop any behavior that might be perceived that way.”

A 2018 report by Sen. Claire McCaskill (D-MO) even accused the AIPM and other industry supported groups of playing “a significant role” in starting the opioid epidemic.

“These financial relationships were insidious, lacked transparency, and are one of the many factors that have resulted in arguably the most deadly drug epidemic in American history,” McCaskill's report alleged.

"Sen. McCaskill and the others haven’t spent the necessary time talking to us to understand how we do things and what we have to offer," Twillman said at the time. "It appears that they’ve simply looked at how much money we got from a set of pharma companies, constructed a narrative about what that means, and published it."

Over a five-year period, McCaskill’s report found that AIPM received over $1.25 million in support from opioid makers. But the report failed to mention that AIPM also accepted funding from chiropractors, yoga therapists, acupuncturists and massage therapists.

“We’re all very sad at this turn of events, but we’re also very proud of what we accomplished.”

— Dr. Bob Twillman

Among other things, those donations helped AIPM host the 2017 Integrative Pain Care Policy Congress, a meeting that united dozens of providers, insurers, patients, researchers and policymakers.

The Congress adopted a consensus definition of integrative pain management that is “person-centered and focuses on maximizing function and wellness.”

Twillman says AIPM — formerly known as the American Academy of Pain Management — had less of a financial cushion than other pain organizations and was not able to adjust to changing times or the backlash against pain management.

“I fear for the future of those organizations, because I'm not sure this set of problems is going to get better, and I don't see the other organizations adapting as quickly as perhaps they should,” said Twillman, who has long stood up for patient rights and been a reliable source of common sense for PNN.

“I very much want to remain in a pain policy position if possible, because that is my real passion,” he said. “We're all very sad at this turn of events, but we're also very proud of what we accomplished, and can only hope that others will pick up the baton and continue the race while we look for ways to keep pursuing our passion.”

Civil Rights Case Gives Hope to Pain Patients

By Richard Dobson, MD, Guest Columnist

People with chronic disabling pain frequently complain that doctors discharge them from their practice because of the medications they take. Sometimes doctors refuse to accept patients who are taking opioid pain medications, even though the medications treat a legitimate medical condition.

There may be hope that such actions will be considered violations of the civil rights of patients.

This week the Civil Rights Division of the Department of Justice (DOJ) signed a formal agreement with Selma Medical Associates, a large primary care practice in Virginia, that may open the door for people with chronic pain to regain their full access to medical care.

Selma Medical refused to schedule a new patient appointment for a man who was taking the addiction treatment drug Suboxone. He filed a civil rights complaint asserting that his rights were violated because has a disability.

According to the complaint, Selma Medical “regularly turns away prospective new patients who are treated with narcotic controlled substances such as Suboxone.”

The DOJ and Selma Medical settled the complaint out-of-court. The full agreement can be read here.

In essence, Selma Medical agreed to stop discriminating on the basis of disability, including opioid use disorder (OUD). The settlement identifies several specific ways that Selma Medical was violating the civil rights of people with disabilities.

“By refusing to accept the Complainant for a new family practice appointment solely because he takes Suboxone, Selma Medical discriminated against him by denying him the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of Selma Medical.

By turning away the Complainant and other prospective patients who are treated with narcotic controlled substances, including Suboxone, Selma Medical imposed eligibility criteria that screen out or tend to screen out individuals with OUD.

Further, Selma Medical failed to make reasonable modifications to policies, practices, or procedures, when such modifications are necessary to afford such goods, services, facilities, privileges, advantages, or accommodations to individuals with disabilities.”

In the agreement, Selma Medical agreed to stop discriminating now and in the future. The staff and administration are also required to undergo intensive training on the implementation of the Americans With Disabilities Act (ADA).

Importantly for pain patients, the agreement applies to people taking “narcotic medications” for any reason and is not limited to people who are taking Suboxone for OUD. The agreement does seem to imply that people taking opioid medications also have their civil rights violated if they are refused medical care on the basis of their diagnosis and their use of opioids.

A former staff attorney in the DOJ’s Civil Rights Division agrees.  

“This formal settlement agreement from DOJ affirms that discrimination in access to medical treatment based solely on an individual’s use of a particular medication — in this case, a narcotic controlled substance — may violate the law,” says Kate Nicholson, a pain patient and civil rights attorney who helped draft federal regulations under the ADA.

Anyone who has chronic pain and who is discharged from a practice or refused admission to a medical practice should let the medical staff know that this is a violation of the ADA. Show them the agreement between Selma Medical and the DOJ. Then if the medical practice still refuses care, file a formal complaint with the Office of Civil Rights. Instructions on filing can be found here.

As part of the settlement agreement, Selma Medical had to pay $30,000 to the complainant for “the discrimination and the harm he has endured, including, but not limited to, emotional distress and pain and suffering.” Selma Medical also had to pay a civil penalty of $10,000.

It seems to me that the substance of this agreement gives real hope to the chronic pain community that discrimination based on disability, even if the disability is based on pain, is illegal and violates their civil rights.

Richard Dobson, MD, worked as a physician in the Rochester, New York area for over 30 years, treating and rehabilitating people suffering from chronic pain, mostly as the result of work or motor vehicle accidents.  He is now retired.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

What Should You ‘Tell Your Children’ About Marijuana?

By Roger Chriss, PNN Columnist

Depending on your point of view, the new book “Tell Your Children: The Truth About Marijuana, Mental Illness, and Violence” is either a welcome cautionary tale about cannabis or a reincarnation of the infamous movie Reefer Madness.

Author Alex Berenson, a novelist and former reporter for The New York Times, is clearly no fan of cannabis legalization and the growing hype over its medical use.  

“Marijuana is not medicine. Marijuana and THC-extract products — whether eaten or smoked — are intoxicants and mild pain relievers, like alcohol,” he writes. “Marijuana in the United States has become increasingly dangerous to mental health in the last fifteen years, as millions more people consume higher-potency cannabis more frequently.”

Berenson argues that cannabis causes paranoia and psychosis, with more use leading to greater mental health issues and even violence.

He uses a combination of history and statistics as evidence, often with lurid reporting about cannabis and violent crime in the U.S. and Britain from over a century ago. Berenson describes incidents of psychotic breaks, murderous episodes, and heinous acts of violence that read a bit too much like true crime stories.

“Marijuana causes paranoia and psychosis. Psychosis causes violence. The obvious implication is that marijuana causes violence,” he writes, without offering any evidence linking the two.

Berenson then gives a brief history on the promotion of cannabis in the modern era by groups such as NORML, the Drug Policy Alliance and the magazine High Times. He emphasizes that the cannabis of the 1960s and ‘70s was “near beer” compared to the cannabis of today.

Berenson builds his case on the work of Swedish physician Sven Andréasson, who in the 1980s used data from the Swedish military draft to investigate the connection between cannabis and schizophrenia. Andréasson found that the use of cannabis was strongly correlated with schizophrenia and that the risk was dose-related.

To bolster his argument, Berenson draws on the work of Phil Silva in the Dunedin Multidisciplinary Health and Development Study; Robin Murray at the Institute of Psychiatry in London; and the 2017 National Academies report on cannabis.

The cannabis-schizophrenia connection has been overlooked, in part because of limited data. In Washington state, for example, where recreational cannabis was legalized in 2014, the state health department doesn’t even keep track of schizophrenia cases.

Berenson says legalizing cannabis for medical use is a cagey strategy to protect recreational users and gain public support for full legalization, because it “encourages voters to think of marijuana as something other than an intoxicant.”

“Medical marijuana is a way of protecting a subset of society from arrest,” he wrote, adding that “marijuana simply wasn’t a strong enough painkiller to be effective for most people who truly needed opiates.”

He even suggests cannabis legalization may be exacerbating the opioid crisis.

“What’s gone unnoticed in the discussion over state-by-state changes is the striking correlation between the opiate epidemic and cannabis use at the national level,” he said. “The direct economic benefits of legalization also appear to be vastly overrated.”

Berenson concludes with an ironic argument for more research: “The government should drop its barriers to researching cannabis for medical purposes. The reason is not that marijuana is likely to prove a miracle cure for cancer — or anything else. It’s precisely the opposite. Let’s put unfounded claims to rest, permanently.”

There are reasons to be skeptical of Berenson’s conclusions. He points to a lack of data on trends in serious mental illness as hiding the impact of cannabis on schizophrenia rates. But the lack of data means we don’t really know what is happening. Trends are further obscured by changes in diagnostic criteria, reporting requirements and treatment availability. All of this needs to be carefully teased out in regard to cannabis as a factor in schizophrenia.

Similarly, Berenson recognizes that no research proves cannabis causes psychosis and violence. He points out that such research is not ethically acceptable. But there are other ways to establish causation, including prospective longitudinal studies and natural social experiments such as Canadian legalization. In other words, Berenson may be able to claim he is right some day, but not yet.

Lastly, Berenson ignores the issue of scale. Even if the psychotic breaks and criminal acts he describes are attributable to cannabis, they are still very rare compared to the scale of cannabis use. He needs to establish a base rate and then show that increasing levels of cannabis use are associated with rising rates of psychosis and violent crime. That work remains to be done.

“Tell Your Children” is useful but could have been better. Berenson overreaches in his conclusions and omits important considerations. But he raises relevant questions about the potential mental health risks and social implications of cannabis. “Tell Your Children” may not be essential reading, but for people who are interested in the possible risks of cannabis, it is certainly worth reading.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Hormones & Pain Care: What Every Patient Should Know

By Forest Tennant, MD, Guest Columnist

As we start the year 2019, every chronic pain patient needs to know the status of hormones and pain care. Unfortunately, the recent hysteria over opioids has obscured the positive advances in the understanding and application of hormonal care to the relief and recovery of pain patients.

In fact, research and clinical experience is starting to revolutionize the way I personally think about pain care. Hormones are showing us the natural, biologic way the body deals with pain and injury. They are clearly the way forward.

Why the Excitement Over Hormones?

Hormones have recently been discovered to be made in the brain and spinal cord (central nervous system – CNS). Some hormones are made that have the specific job and function to protect (“neuroprotection”) CNS tissue from injury and to regrow the injured tissue (“neuroregeneration”). These hormones are collectively called “neurohormones.”

Intractable, chronic pain is actually a type of poisonous, electromagnetic energy that causes injury by producing inflammation (“neuroinflammation”) in the CNS and implanting the pain (e.g. “centralization”) so as to make it constantly (“24/7”) present.

The process is similar to dropping acid on your skin which burns and causes inflammation to be followed by tissue destruction and scar formation. Fortunately, some neurohormones are made in the CNS to stop the pain, inflammation, tissue destruction and scarring process and rebuild the nerve cell network in the CNS.

Until recently, we physicians didn’t have a clue on how to enhance the natural, biologic hormonal system to help pain patients.

Excitement over neurohormones has really been enhanced by research in rats that had their spinal cords cut so that they walked around their cages dragging their hind legs. They were given some neurohormones which healed their spinal cords to the point that they could normally walk.

Other animal research studies using different test models with CNS tissue have also shown the power of specific hormones to heal and regrow brain and spinal cord nerve cells. This author can’t speak for others, but, in my opinion, these research studies are so compelling that hormone use in pain care has got to be fully investigated.

Are We Making Headway?

Absolutely, yes! First, eight specific hormones made in the CNS have been identified that produce healing effects in animals and show benefit in early clinical trials with chronic pain patients. These early trials indicate that some neurohormones can reduce pain and produce healing and curative neuroregeneration effects.

Six of these hormones are collectively known as “neurosteroids.” Don’t let the term “steroid” raise your eyebrows as it refers only to the chemical structure and not the complications of cortisone-type drugs. Some of the neurosteroids are known to the lay person such as estradiol, progesterone, and testosterone.

Two of the hormones produced in the CNS that control pain but are not classified as a “neurosteroid” are human chorionic gonadotropin (HCG) and oxytocin.

CENTRAL NERVOUS SYSTEM HORMONES

• ALLOPREGNANOLONE
• ESTRADIOL
• DEHYDROEPIANDROSTERONE (DHEA)
• HUMAN CHORIONIC GONADOTROPIN (HCG)
• OXYTOCIN
• PREGNENOLONE
• PROGESTERONE
• TESTOSTERONE

Due to all the controversies surrounding opioids and pain treatment, one would never know we have, in the past couple of years, made serious headway with hormones and pain care. Medical science has discovered which hormones reduce chronic pain and how the hormones can be prescribed. The overall hormone advance in pain care can, however, be generally summarized in that one or more of the neurohormones can be administered to provide some curative and regenerative benefit in essentially every chronic pain patient.

Replenishment of Deficient Hormones

The production of hormones made in the CNS can be assessed by blood tests which are available in every commercial, community laboratory. The amount of hormone in your blood stream is a pooled amount of hormone made in the CNS and in the glands; adrenals, ovary, and gonads (ovary and testicles).

I recommend a hormone blood test panel of these 6 hormones: cortisol, DHEA, estradiol, pregnenolone, progesterone, and testosterone. If any are low, they should be replenished. Why? Severe chronic pain may overwhelm the production of one or more of these hormones.

If you take opioids and other symptomatic pain medications such as antidepressants and muscle relaxants, you may actually suppress the production of some hormones, particularly testosterone, DHEA, and pregnenolone.

“I highly recommend that every chronic pain patient have a hormone blood panel test at least twice a year and replenish any hormone that is low in the blood stream.”

— Dr. Forest Tennant

The reason you must replace any deficient hormone is because all 6 of them activate pain centers (“receptors”) in the CNS to reduce pain and produce a healing and curative effect. These hormones act as sort of a co-factor or “booster” of symptomatic pain relievers such as opioids and muscle relaxants. I highly recommend that every chronic pain patient have a hormone blood panel test at least twice a year and replenish any hormone that is low in the blood stream.

The Pregnancy Connection

A couple of years ago I was presenting a scientific poster at a medical meeting on some of my hormone research. An old friend came up and asked, “What took you so long?”

I initially thought he was insulting me. He wasn’t. He was lamenting, along with me, a sad fact. We should have long ago been studying the pregnancy hormones, HCG and oxytocin, for everyday pain care.

Why? HCG in pregnancy is the hormone that grows the CNS in the embryo and fetus. Oxytocin is the natural pain reliever in pregnancy that allows a big “tumor” to grow in the abdomen without death-dealing pain. Also, oxytocin surges at the time of delivery to make sure that pain doesn’t kill the expectant mother.

With such obvious knowledge about natural pain relief in pregnancy, we should have tested these hormones for severe, chronic pain problems before now. Do they work? Yes. Long-term HCG use (over 60 days) is proving most effective in reducing pain and restoring function in some patients with adhesive arachnoiditis and other severe pain problems. Oxytocin is an effective short-term pain reliever that can be taken for pain flares. It can even be taken with symptomatic pain relievers like aspirin, acetaminophen, or a stimulant to help a patient avoid opioids.

Goodbye Symptomatic Treatments

Until the hormones came our way, you never heard much about “symptomatic” versus “curative” care. Why? Up until the discovery that hormones are made inside the CNS and produce curative effects, about all we could do was prescribe symptomatic pain relievers such as opioids, muscle relaxants, and anti-seizure (“neuropathic”) agents. There was no need or hope that we can permanently reduce severe chronic pain, much less hold out a hope for cure or near cure.

Chronic pain patients are beginning to use DHEA, pregnenolone, testosterone, estradiol, progesterone, and HCG on a long-term basis. Dosages are beginning to be determined. For example, DHEA requires a dosage of 200 mg or more each day. Pregnenolone requires 100 mg or more. Patients report reduced levels of pain, fatigue, and depression.

Although few controlled studies have yet been done, the open-label clinical trials are impressive and clearly call for chronic pain patients to get started with the neurohormones that are being found to be beneficial. Neurohormones have changed our thinking and old-hat beliefs.

Every severe chronic pain patient needs to know they can probably do a lot of mending with hormonal care. Be, however, clearly advised. Hormones can mend a lot of damaged nerve tissue, but they can’t fix scar tissue once it sets in.

“So far at my clinic site, we have around 60 to 70 people on oxytocin. Early results look good so far. Many are also on DHEA and pregnenolone as well. The treatment seems to be working.”

— Nurse practitioner

Unfortunately, millions of severe, chronic pain patients have had no option in the past couple of decades except to take symptomatic medication and use such devices as electrical stimulators.

Even long-standing severe chronic pain patients who are on opioids, however, can almost always benefit from one or more hormones. Most important, I am finding that hormone administration is the best way in most chronic pain patients to reduce opioid dosages but still get good pain relief.

Therapeutic Trials

One of my major purposes in writing this report is to encourage all chronic pain patients to embark upon a search for one or more hormonal treatments that will reduce their pain, need for opioids, and yield a better life. Don’t wait for your medical practitioner to offer hormone testing or treatment. To many overworked medical practitioners, such a request may be considered a real nuisance or even a threat.

Be prepared. Check with other patients in your social media group. Know what you need. Make it easy on your medic. Please share with your social media group this report and any materials you have about hormones and pain care. Most MD’s, NP’s, and PA’s will appreciate your preparation and desire to try something new on a short-term, trial basis.

Every chronic pain patient needs to know that all the hormonal agents described here can be safely tried for one month. This is known as a “therapeutic trial.” Specifically ask your medical practitioner for a one-month, therapeutic trial. In this manner you can find out if the hormone is right for you and whether you should continue with it past one month.

Forest Tennant, MD, MPH, DrPH, recently retired from clinical practice but continues his groundbreaking research on the treatment of intractable pain and arachnoiditis. To download a complete copy of Dr. Tennant’s report on hormones and pain care, click here.

This report is provided as a public service by the Arachnoiditis Research and Education Project of the Tennant Foundation and is republished with permission. Correspondence should be sent to veractinc@msn.com

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Why a Bad Night’s Sleep Causes More Pain

By Pat Anson, PNN Editor

It’s no secret that chronic pain makes sleeping difficult. And lack of sleep often makes pain worse.  But how exactly does poor sleep cause more pain?

For the first time, scientists at the University of California, Berkeley, have identified neural glitches in the sleep-deprived brain that can intensify and prolong pain. Their findings, published in the Journal of Neuroscience, help explain the self-perpetuating cycles that contribute to pain and sleep loss.

“Anyone who has had persistent back pain knows that they don’t sleep well when they are in pain. They also know that when they don’t sleep well, it hurts more the next day,” said senior author Matthew Walker, PhD, a UC Berkeley professor of neuroscience and psychology.

"If poor sleep intensifies our sensitivity to pain, as this study demonstrates, then sleep must be placed much closer to the center of patient care, especially in hospital wards.”

In a small study involving 25 healthy young adults, Walker and his colleagues found that nerves that process pain signals and activate the body’s pain relief hormones are disrupted by insufficient sleep. Study participants were given MRI brain scans twice – once after a good night’s sleep and once after a night of no sleep – and then subjected to a thermal pain test in the laboratory  

“We found some surprising changes. The sleep-deprived brain seems to let more pain in,” Walker said.

Brain imaging showed increased activity in the brain's somatosensory cortex, but there was less activity in the nucleus accumbens, a region of the brain's reward circuitry that increases dopamine levels. Dopamine is a neurotransmitter that’s been called the “feel-good hormone” because it is associated with feelings of euphoria and happiness.

Another key brain region found to slow down in the sleep-deprived brain was the insula, which evaluates pain signals and prepares the body to respond.

"This is a critical neural system that assesses and categorizes the pain signals and allows the body's own natural painkillers to come to the rescue," said Adam Krause, lead author of the study and a doctoral student in Walker's Center for Human Sleep Science lab at UC Berkeley.

To further test the sleep-pain connection, researchers surveyed more than 230 adults of all ages nationwide. Respondents were asked to report their nightly hours of sleep, as well as their day-to-day pain levels. The results showed that even minor shifts in sleep patterns were correlated with changes in pain sensitivity.

"The results clearly show that even very subtle changes in nightly sleep -- reductions that many of us think little of in terms of consequences -- have a clear impact on your next-day pain burden," Krause said.

"The optimistic takeaway here is that sleep is a natural analgesic that can help manage and lower pain," said Walker. "Yet ironically, one environment where people are in the most pain is the worst place for sleep -- the noisy hospital ward."

Walker's goal is to work with hospitals to create more sleep-friendly patient facilities.

"Our findings suggest that patient care would be markedly improved, and hospital beds cleared sooner, if uninterrupted sleep were embraced as an integral component of healthcare management," he said.

Several previous studies have found that getting a good night’s sleep helps reduce sensitivity to pain. Researchers in Norway measured pain sensitivity in more than 10,000 adults and found a strong link between pain and insomnia.

Another study in Norway found that women who have trouble sleeping are at greater risk of developing fibromyalgia – although it’s not clear if there’s a cause and effect relationship between the two symptoms.

Memories, Medications and Hospital Horrors

By Tom Parker, Guest Columnist

Some things you never forget. Your mother’s love, your favorite teacher, your first home run (oh, that’s right, I’m 61 and that still hasn’t happened yet), your first date, your first kiss and your wedding.

Christmas to the Parker family is also memorable for many reasons. My delightful wife and I have always sought to make Christmas a precious time for our family. We listen to Christmas music off and on throughout the year, but nonstop in the fall and winter. Bing Crosby and Karen Carpenter mellifluously bless our home with the glorious sounds of Christmastime.

So why do I not remember a season of joy that just ended a month ago?

For several weeks, I had been experiencing pain and an inability to fully empty my bladder. I have quite a few health problems, so I just chalked this up as just another one and pretty much ignored it as it continued to get progressively worse.

My wife and son were on a long trip to take my youngest daughter back to college. I was home alone and finally felt the need to call my doctor about the urinary retention. My doctor’s sagacious nurse urged me to immediately go to the ER, so I called for an ambulance.

I was in St. Peter’s Hospital in Albany for almost a week while an interminable number of tests were conducted to determine what was wrong. I was not allowed any of my normal medications, pain or otherwise, or food or liquids while the initial tests were conducted. Nothing whatsoever passed my lips.

TOM PARKER

When my normal medication regimen finally resumed, I found out very quickly that I had to specifically request an oxycodone tablet when meds were dispensed or I wouldn’t get one.

Which leads me to very distinct memories of my roommate for the rest of my stay. A very brawny young man of 30 or so, a massively-muscled professional bodybuilder, was wheeled into the room and into the next bed. He was just out of elective bilateral double knee replacement surgery. Forgive me for listening as his mother and wife conversed waiting for him to come out of anesthesia.

PNN readers are all too acutely aware of how pain medications are no longer properly given for serious conditions -- which would seemingly include bilateral double knee replacement. As my compatriot emerged from anesthesia, it was very audibly obvious that he was quite understandably in unimaginable agony. Multiple nurses and techs rushed in and out, and at one point a resident was summoned as the young man was having difficulty breathing.

There was serious conversation about rushing him back into surgery when I heard a loud thump. My roommate had hit his head against the headboard, knocking himself out. His relatives argued with the nurses and resident about what pain medicines should be administered during his recovery.

We live in an ungodly, strange and insidiously cruel perverse world!  When medical professionals seriously consider Tramadol as the most viable and appropriate medicine at such a time, we have reached a new low standard of medical barbarity in these United States of America.

Paging Dr. Sessions, paging Dr. Sessions….

Yes, Tramadol is a somewhat effective pain reliever for some people. But for an operation as critically complex as bilateral double knee replacement surgery?   It never was effective for me and it engendered extreme vomiting for several days.

The agonized screams of that young man over three days still haunt my sleep today -- hopefully, not again tonight.

All of us are familiar with the 1 to 10 pain scale and how it often seems wholly inadequate for describing the pain that many of us feel every day. When the young fellow awoke from his self-induced head to the headboard knockout, he was asked what his pain level was at that moment. Three numbers unmistakably rang out, loud, clear and true: “555! What the blank do you think?”

His anguish was finally lessened by multiple doses of Dilaudid, both orally and intravenously. He was also administered Celebrex for inflammation, and oxycodone. I was a very personally-interested witness to this for several days.

He and I left the hospital at almost the same time, me to go home with my beloved, and he to a rehabilitation facility nearby. His last pain attestation before leaving was “10 or 12.” I was utterly appalled to hear him say that “I will do it all over again” if he were unable to resume his bodybuilding career after rehabilitation.

Well, I have had my follow-up visit with my GP now. He renewed my oxycodone prescription without even asking me about it. For that, I am eternally grateful to God and to my kindhearted physician. He explained to me that he was very glad that I had listened to his nurse’s urging to go to the ER.

I asked him, “Why are my memories of Christmas just a month ago so very foggy?”

It was then my physician made it very clear to me, for the first time, that I had almost died from blood poisoning and kidney failure.

Tom Parker was born in beautiful Charleston, South Carolina. He currently lives in the Albany region of frozen upstate New York with his wonderful Vermont wife of 30 years, Kelly Sue. They have four adult children. Tom has multiple spine problems, including severe cervical spinal stenosis, osteoarthritis, and was born with just one kidney.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

How Government Shutdowns Worsen the Opioid Crisis

By Lynn Webster, MD, Guest Columnist

On October 26, 2017— a little bit more than a year ago — President Donald Trump declared that the opioid crisis was a national Public Health Emergency. Most Americans seemed to back his initiative to stop opioid abuse, and to reduce drug supply and demand.

However, it seems the recent 35-day government shutdown and Trump's desire to build a border wall have been at cross-purposes with his concern about addressing the opioid crisis.

Two key aspects of Trump’s opioid plan were prevention and treatment of opioid use disorder. Prevention, in part, means reducing the supply. However, everything in the supply is not equally problematic.

Opioids fall into two major categories: those that are prescribed and those that are smuggled into the United States. The number of overdoses associated with prescription opioids has remained essentially unchanged since 2011, while the number of opioid overdoses due to illicit fentanyl and other synthetic opioids surged from 3,000 in 2013 to more than 29,000 in 2017. Most of these drugs originate in China.

One of Trump's major arguments for building a wall is that most drugs that kill Americans are coming over the southern border from Mexico. However, that conflicts with the final report of his opioid commission, which found that "we are losing this fight predominately through China."

Mexican cartels do smuggle illicit opioids across the southern border in passenger vehicles and tractor trailers, often at legal points of entry. Heroin and fentanyl are also smuggled into the U.S. by sea and air or through the mail. A physical barrier doesn’t block any of these types of entry.

The U.S. Food and Drug Administration (FDA) is tasked with inspecting mail to prevent drug smuggling. Before the government shutdown, FDA Commissioner Scott Gottlieb was calling for more postal inspectors to intercept shipments of opioids. He wanted the government to be able to inspect 100,000 suspicious packages per year, but that would have required double the number of personnel that he had.

Government shutdowns handicap those efforts because it is difficult to hire during shutdowns. It can be challenging just to retain the employees you already have.

The Department of Homeland Security works with the U.S. Coast Guard and the U.S. Customs and Border Protection to patrol the South Pacific Ocean and the Caribbean Sea to stop drug smuggling. These efforts may have been impeded during the shutdown, because some of these "essential" employees had to decide whether to work without pay or call in sick. We can assume that some of them chose the latter course of action. Some government employees may be looking for other jobs because they want a reliable paycheck.

Ironically, due to increased scrutiny at the border, drug smugglers have gotten more creative, increasing their use of tunnels, boats, air and even catapults. These efforts may have been more successful due to the lack of personnel guarding trouble spots because of the shutdown.

Addiction Treatment Impacted

Government shutdowns increase the likelihood that opioids could find their way past our borders. And our ability to treat people with opioid addiction may also be compromised.

Providing treatment for addiction was the other important part of Trump's plan for addressing the opioid crisis. An estimated 2.1 million people had an opioid use disorder in 2016, yet only about 20% had access to treatment. One of the reasons so few people are treated is that not enough clinicians are trained and certified to treat opioid addiction. The president's initiative requires increasing the number of clinicians certified to treat addiction.

Buprenorphine (Subxone) is one of the tools physicians use to treat opioid use disorder. Doctors require special training and certification to prescribe the drug, as well as a waiver from the Drug Enforcement Agency. During the government shutdown, the DEA was still able to review doctors’ applications, but there were about 30% fewer certifications than there were before the shutdown. It is unclear if that was due to the shutdown or not.

Regardless of whether there will be a physical wall on our border with Mexico, we can see the potential damage that the recent government shutdown can have on curbing the opioid crisis. Congress will now discuss the merits of various options to secure the border, and President Trump is threatening another shutdown if a border wall isn’t funded.

But one thing we should take away from the recent experience is that there isn't much point in saving ourselves from illegal immigrants if we can't protect ourselves from the dangers posed by a government shutdown.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine. Webster is the author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.”

You can find him on Twitter: @LynnRWebsterMD. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

A History Lesson of the War on Drugs

By Iris Erlingsdottir, Guest Columnist

One hundred years ago this month, the 18th Amendment to the U.S. Constitution was ratified, prohibiting the production, transport and sale of "intoxicating liquors.” It cleared the way for the Volstead Act, which declared that liquor, wine and beer all qualified as intoxicating liquors.

Prohibition – the first War on Drugs -- was on.

The U.S. government has never been above abusing its citizens in the name of fighting drug wars. Then, like now, government efforts to legislate the human condition were a losing, deadly battle. In today’s war against opioid addiction, it is patients on the receiving end. A century ago it was drinkers.

Alcohol deaths only increased during Prohibition, as Deborah Blum recounts in her 2010 book, “The Poisoner’s Handbook.”

Policymakers believed poisoning the alcohol supply was an acceptable way to stop people from drinking. Methanol was added to industrial alcohol to make it unfit for human consumption, but bootleggers found ways to distill the poisoned alcohol to make it drinkable.

The government responded by adding even more toxic chemicals, like gasoline and kerosene. And bootleggers kept stealing the increasingly dangerous alcohol and turning it into liquor.

At the start of Prohibition, New York City’s Bellevue Hospital treated about twelve annual cases of moonshine and wood alcohol poisoning. About a fourth of those were fatal. By 1926, the hospital treated 716 people for blindness and paralysis due to poisoned alcohol. The holiday season that year was especially deadly. On Christmas Day alone, 60 people were treated at Bellevue for alcohol poisoning and eight died from it. By New Year’s Day 1927, 41 people were dead.

Prohibition-era statistics are notoriously unreliable, but according to some estimates over 10,000 Americans died during Prohibition from the effects of drinking poisoned liquor, courtesy of both government and organized crime chemists. Many more were blinded. Prohibition’s attempt to foster temperance instead fostered intemperance, along with violence and crime. The solution the government had concocted to address alcohol abuse had made the problem worse.

Act of Betrayal

“There is no Prohibition,” New York City medical examiner Charles Norris said in an angry report about the alcohol deaths. “All the people who drank before Prohibition are drinking now — provided they’re still alive.”

Norris and his staff considered the government’s deliberate poisoning of alcohol an “act of betrayal.” They weren’t accustomed to having their national government adopt a policy known to kill people.

Policymakers in the 21st century have few such qualms about the opioid crisis. Nor does the media, which continues to parrot the government’s blatantly misleading propaganda, blaming illicit fentanyl and heroin deaths on prescription opioids.  Just as thousands died from alcohol poisoning during Prohibition, opioid hysteria has had horrible consequences for millions of patients doomed to suffer torturous pain because of irresponsible journalism and the policy blunders it enables.

Many of the nation’s largest Prohibition-era newspapers, however, didn’t hesitate to condemn a government policy “gone haywire.”

“Prohibition in this area is a complete failure,” the New York Herald Tribune’s editorial page declared, “enforcement a travesty, the public a victim of poisonous liquor.”  The Evening World said no administration had been more successful in “undermining the health of its own people,” while The St. Paul Pioneer Press called the government an “accessory to murder.”

Perhaps the Chicago Tribune stated it best: “It is only in the curious fanaticism of Prohibition that any means, however barbarous, are considered justified.”

It’s a sentiment that applies just as aptly to today’s epidemic of opioid hysteria.

Íris Erlingsdóttir is an Icelandic journalist and writer who lives in Minnesota. Iris has a rare, untreatable arthritic condition that causes severe pain and progressive destruction of the joints. She became an advocate for pain patients’ rights after being denied continued opioid pain medication.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Spinal Fusions Ineffective for Osteoporosis Patients

By Pat Anson, PNN Editor

There is little evidence that two surgical procedures commonly used to treat spinal fractures caused by osteoporosis reduce pain for patients better than pharmaceutical drugs, according to a new report by an international task force of bone health experts published in the Journal of Bone and Mineral Research..

More than 10 million Americans suffer from osteoporosis, a loss of calcium and bone density that worsens over time and significantly raises the risk of bone fractures, especially among the elderly. About 750,000 spinal fractures occur each year in the United States alone.

The task force looked at two types of spinal fusions: vertebroplasty, where medical grade cement is injected into the broken vertebrae to fuse bone fragments together; and balloon kyphoplasty, where a balloon is inserted into the compressed area of the spine to lift it and allow the cement to be inserted. Metal plates, screws and rods can also be used in spinal fusions, but were not the focus of the study.

The researchers found little to no evidence that vertebroplasty or kyphoplasty relieve pain effectively. In five clinical studies, vertebroplasty provided no significant benefit in pain control over placebo or sham procedures. There were no placebo-controlled trials for balloon kyphoplasty, leaving doctors to rely on anecdotal, low-quality evidence.

"The message for doctors and their patients suffering from painful spinal fractures is that procedures to stabilize spinal fractures should not be a first choice for treatment," said lead author Peter Ebeling, MD, Head of the Department of Medicine in the School of Clinical Sciences at Monash University in Australia.

"While patients who had these surgeries may have had a short-term reduction in pain, we found that there was no significant benefit over the long-term in improving pain, back-related disability, and quality of life when compared with those who did not have the procedures."

The task force report comes as spine surgeons increasingly market vertebroplasty and kyphoplasty as “minimally invasive" procedures that offer immediate relief from back pain without the risks of opioid medication. But there are still risks of infection, cement leakage and complications associated with elderly patients undergoing anesthesia.

Some 300,000 Medicare patients underwent vertebral augmentation between 2006-2014, with most getting the more expensive balloon kyphoplasty. The procedures have become so common they are recognized as a standard of care. The video below calls them "the most effective pain relieving treatments for elderly patients.”

"These procedures are not a magic bullet," says Bart Clarke, MD, President of the American Society for Bone and Mineral Health and a Professor of Medicine at the Mayo Clinic. “Until now, doctors have been left to sift through the data on their own to determine whether these procedures can benefit their patients. This report coalesces all that information concisely and provides recommendations to guide them."

Clarke said Mayo Clinic doctors do not typically perform vertebral augmentation procedures unless a patient's pain is unmanageable for more than 4-6 weeks. "We've seen that with analgesics and other pain relief, our patients often get better within about 6 weeks," he said.

The task force also focused on the need for osteoporosis prevention. About 25% of older men and women who have a hip fracture will have a second fracture within one year, as will around 20% of older patients who have a spinal fracture. Breaking a bone in your spine or hip may be so traumatic – especially for the elderly -- that it often leads to disability and chronic widespread body pain.

Recent studies have shown that many patients at high risk of fractures are not being diagnosed or treated for osteoporosis, even though hormones and bisphosphonate drugs can help strengthen their bones. Bisphosphonates such as Fosamax have been found to be effective at slowing the loss of bone mass and reducing fractures, but concerns about side effects made some patients reluctant to take bisphosphonates and doctors less likely to prescribe them.  

"Overall, prevention is critical. and we need to get these high-risk patients on anti-osteoporosis drugs that have proven to reduce future fractures by as much as 70 percent," Clarke said.