Sales Reps Charged in Fentanyl Kickback Scheme

By Pat Anson, Editor

We’ve been reporting recently about illicit fentanyl and how drug dealers were using the potent painkiller to make counterfeit pain medication and selling it on the street, resulting in dozens of overdose deaths.

But drug dealers aren’t the only ones peddling fentanyl illegally and killing people in the process.

Federal prosecutors say two sales reps for Insys Therapeutics broke the law by paying doctors to prescribe Subsys, an oral fentanyl spray sold by the Arizona drug maker. Some doctors were wined and dined at upscale restaurants in New York City, while others were taken to private tables at a strip club, given free booze, and who knows what else.

The sordid details were revealed in a federal indictment handed down last week, which resulted in the arrests of Jonathan Roper and Fernando Serrano.

It’s not the first and probably not the last time Insys has come under scrutiny for unscrupulous marketing tactics or for putting profits ahead of patients. Another former Insys sales representative pleaded guilty to federal kickback charges in February, and the company is under federal and state investigations in Oregon, California, Massachusetts, Connecticut, Arizona and Illinois.

Subsys was approved by the FDA for breakthrough cancer pain, but Insys allegedly pressured its sales representatives to woo or bribe doctors into prescribing Subsys off-label for conditions such as joint pain and post-traumatic stress disorder.

The spray is a lucrative product for Insys and it's biggest moneymaker. According to the Healthcare Bluebook, 30 spray bottles of Subsys cost about $7,300.

“This case should be something the medical industry and the general public should pay close attention to because it’s one of the reasons we’re experiencing an epidemic of overdoses and deaths in this country,” said FBI Assistant Director Diego Rodriguez.

“Not only did the defendants in this case allegedly bully sales reps into pushing this highly addictive drug, they paid doctors to prescribe it to patients.  The more prescriptions written, the more money the doctors made.  Instead of seeing a way to help people who are dealing with extreme pain, they allegedly saw a huge payday that potentially put people’s lives in danger.”

Since Subsys was introduced in 2012, the FDA’s Adverse Events Reporting System lists over 200 deaths linked to Subsys as the probable cause of an adverse reaction.

According to prosecutors, Roper and Serrano paid two unnamed doctors hundreds of thousands of dollars to make “educational presentations” to other physicians about Subsys. Many of the presentations were nothing more than “social gatherings at high-end restaurants in Manhattan” and some of the physicians were later taken to a strip club, according to prosecutors. Sign in sheets for the presentations were frequently forged to make them appear legitimate

According to the indictment, Serrano was instructed by his sales manager to "expect and demand" that the two doctors hired as speakers prescribe "large quantities" of Subsys. The doctors apparently obliged, prescribing over $5 million worth of Subsys in 2014, much of it billed to private insurers or Medicare.

According to Open Payments, a government website that tracks industry payments to doctors, Insys paid over $7 million to doctors in 2014 for food, beverages, travel, lodging and speaker fees; over ten times what the company reported spending on research.  You can see if your doctor took money from Insys and how much by clicking here.

“Jonathan Roper and Fernando Serrano corruptly induced doctors to prescribe millions of dollars’ worth of Fentanyl through thousands of dollars in kickbacks disguised as phony educational programs.  As alleged, Roper and Serrano helped feed this devastating surge of opioid addictions by tapping into another age-old addiction, greed,” said U.S. Attorney Preet Bharara.

Roper and Serrano are each charged with one count of conspiracy to violate the federal Anti-Kickback Statute and one count of violating the Anti-Kickback Statute.  Each of the two counts carries a maximum term of five years in prison. 

Californians Busted for Selling Fake Painkillers

By Pat Anson, Editor

Three people have been arrested in San Francisco in what appears to be a widening investigation into sales of counterfeit pain medication.

Federal prosecutors say 39-year old Kia Zolfaghari and his wife, Candelaria Dagandan Vazquez, ran an illegal fentanyl pill manufacturing operation out of their San Francisco apartment. The pills were disguised to look like oxycodone.

The couple, along with King Edward Harris II of Oxnard, were arrested Friday in an undercover sting operation.

“The complaint alleges that Zolfaghari sold over 1,500 fentanyl-laced pills, over the course of six transactions, to a confidential source working with law enforcement.  The complaint further alleges that Harris, 34, of Oxnard, brokered these narcotics sales in a series of recorded calls with the confidential source and hand-delivered two of those purchases to the confidential source,” the U.S. attorney’s office said in a statement. 

“Zolfaghari also sold the fentanyl-laced pills to customers through an online marketplace.  The complaint alleges that Zolfaghari’s wife, Vazquez, 38, of San Francisco, conspired with him to carry out his drug trafficking operation, and delivered packages of pills for mailing, purchased packaging supplies, and accepted payments for narcotics via her bank account.”

Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses.

It is prescribed legally to treat severe pain, but is also being manufactured illegally and sold on the street.

Fentanyl pills disguised to look like painkillers such as oxycodone and Norco are increasingly being found in the U.S. and Canada. Fake pain pills are blamed for at least 14 deaths in California and 9 in Florida.  Some pills were purchased off the street by pain patients who were unable to get prescription medication through a doctor.

Massachusetts and Rhode Island recently reported an “alarming” rise in fentanyl overdoses. Over half the opioid overdose deaths in those states are now blamed on illicit fentanyl, not prescription pain medication.

A Minnesota medical examiner this month also blamed fentanyl for the accidental overdose of pop icon Prince. It’s not known if the fentanyl involved in Prince’s death was prescribed legally or obtained through other sources..

A Canadian couple were charged Friday with running an illegal fentanyl pill operation in British Columbia. Leslie John McCulloch and Rebekka Rae White were arrested in March after the Royal Canadian Mounted Police raided a warehouse in West Kelowna, B.C. and found pill producing equipment. The couple is currently out on bail.

Fentanyl is blamed for over 170 overdose deaths in B.C. alone so far this year.

The fentanyl scourge has become so serious that the U.S. Drug Enforcement Administration has released a training video warning law enforcement officers that they could die just by handling a small amount of the drug.

The video features two New Jersey police officers who inhaled powdered fentanyl while collecting the drug as evidence during a raid. “I thought that was it. I thought I was dying. It felt like my body was shutting down,” said one detective.

In the video, acting DEA Deputy Administrator Jack Riley warns officers to avoid testing suspect fentanyl on the scene and to even keep their police dogs away from the drug because it is just too dangerous.To watch the video, click here.

Canadian Province Adopts CDC Guidelines

By Pat Anson, Editor

Less than three months after their adoption in the United States, the CDC’s opioid prescribing guidelines are now being implemented in Canada.

The College of Physicians and Surgeons of British Columbia has released new professional standards and guidelines that are closely modeled after the CDC’s guidelines.

One key difference is that while the CDC’s guidelines are “voluntary” and intended only for primary care physicians, British Columbia’s standards of care are legally enforceable for all opioid prescribers because they set a “minimum standard of professional behaviour and ethical conduct.”

“The public health crisis of prescription drug misuse has developed in part due to the prescribing of physicians. The profession has a collective ethical responsibility to mitigate its contribution to the problem of prescription drug misuse, particularly the over-prescribing of opioids, sedatives and stimulants,” the college said.

"Every physician is professionally responsible for the prescription that they provide to a patient."

Like the CDC guidelines, the college discourages the prescribing of opioids for chronic pain, but goes even further by saying they should not be used to treat three specific health conditions: headaches, fibromyalgia and low back pain.

Opioids for acute pain should be limited to three to seven days’ supply, and when prescribed for chronic pain should be limited to only a month’s supply at a time. British Columbia physicians are also warned not to prescribe opioids concurrently with benzodiazepines and other anxiety medication.

Doctors are also cautioned to carefully document their reasons for increasing doses over 50 morphine milligram equivalents (MME) per day and to avoid increasing the dose to over 90 MME per day.

The British Columbia standards are more strict than Canada’s national guidelines, which have not been revised since 2010, “leaving them out of date with current research associated with taking painkillers,” according to The Globe and Mail.

“While Canada’s guidelines for opioid-prescription are expected to be updated in January, the death toll is mounting too quickly to wait,” said the Toronto Star in an editorial urging Ontario’s College of Physicians and Surgeons to adopt guidelines similar to British Columbia’s.

“B.C. has shown the way for other provincial regulatory bodies. Colleges across the country, including Ontario’s, should follow its example and set informed rules now. Injudicious prescriptions have already destroyed the lives of too many Canadians.”

Like the United States, Canada is one of the top opioid prescribing countries in the world and is struggling with an “epidemic” of addiction and overdoses. A growing number of deaths, however, can be attributed to illegal opioids such as fentanyl and heroin, and it remains in doubt whether restricting access to prescription opioids will lessen the problem or only make it worse by forcing legitimate patients to turn to the streets for pain relief.

As Pain News Network has reported, Canadian drug dealers are now selling counterfeit painkillers laced with fentanyl, an opioid that is more potent and dangerous than most pain medications.

The Star sees the problem differently, blaming doctors for Canada's opioid problem.

“It’s hard to believe that a large part of the blame for Canada’s latest drug-addiction crisis lies not with dealers, but with doctors. That is the conclusion of a growing number of health experts across the country who say our ballooning opioid problem can’t be solved until physicians stem the flow of prescriptions for the highly addictive painkillers,” the newspaper said in its editorial.

Pain Patients Sound Off on ‘Barbaric’ Treatment

By Pat Anson, Editor

We received a lot of feedback from this month’s PNN newsletter, which looked at the impact the CDC’s opioid prescribing guidelines are having on pain patients.

The guidelines – which discourage the use of opioids to treat chronic pain -- are voluntary and recommended only for primary care providers, yet pain patients say they are being widely implemented by physicians regardless of specialty. Many wrote to tell us they were being cutoff or weaned off opioids. Some were having trouble just finding a doctor willing to treat them.

I thought I’d share some of the comments with you, as well as some tips on what to do if your doctor drops you from their practice.

"My pain medications were reduced the very first appointment I had with my doctor after the CDC guidelines came down,” said Kathleen, who suffers from neck and shoulder pain.

“I have not had an increase in my pain medications in over 4 years and yet I was told that I may have hyperalgesia. I was told that the guidelines are going to cause insurance companies to reject payment for pain meds and that I was going to be weaned off, slowly, but weaned off.” 

“Do I believe suicide rates will increase due to these new guidelines? Absolutely.  ABSOLUTELY!”  wrote Karen, who suffers from Chronic Regional Pain Syndrome and other chronic conditions.

“For myself, I'd choose quality of life over quantity. And I think that's true for most people in chronic pain.  When the pain becomes too great, goes untreated and there's no hope in sight, I imagine death would be a welcome end.”

“All I know is they are trying to take my wife’s pain meds away because of a bunch of junkies is insane,” said one man. “They are forcing a lot of people in pain to turn to the streets. If we had an animal that we allowed to live in pain we would be fined or jailed for cruelty to an animal but according to our government it’s ok to do it to people. My wife said she won’t live like that. Wrong. So wrong.”

“I too have been told from my doctor that I'll no longer be receiving Rx narcotics from him. He said as a group they've decided not to prescribe to anyone but cancer patients,” wrote Peggy, who’s been taking opioids for almost 20 years. “There will come a time when I'm bed bound once again, not able to even cook, shower, care for myself because opioids are the only thing that work for me.”

Even some cancer patients are being weaned off opioids, as we learned from 64-year old Dan Hartsgrove, who was diagnosed with throat cancer last year.

“I suffer every day. Cannot eat or sleep due to the pain,” Dan wrote. “I have enough to deal with and no way in the world should be suffering in this manner. No one should. This whole opioid war is a failure and aimed at the wrong people.” 

Dan’s pain management doctor said he was taking “too much medication” and discharged him after Dan refused to have a pain pump installed. Even his chemotherapy doctor has lowered his dosage.

“It was fine for me to be allowed the poison of chemo and radiation, however I am allowed no relief from suffering daily,” said Dan.  “Where is the compassion? My wife had a friend who was 49 and had throat cancer, he was in so much pain he would put his head through his wall at night when he was trying to sleep. The doctors would not help control his pain and he committed suicide 2 years ago. This is barbaric.  I am slowly slipping away from this pain. I need to eat and just can't. Everybody thinks cancer patients are excluded from this war on opioids. NOT TRUE.”

A Florida woman who has been taking opioids for years for an autoimmune disease also says her doctor is trying to talk her into a pain pump.

“I currently have a kind and understanding pain management doctor who knows this is helping me but his office was raided last year by DEA agents and ever since then he has been afraid to prescribe,” she wrote.  “I feel I have been given a choice to get the pump or else. I shouldn't have to get something I don't want just to please the DEA and CDC. My doctor feels that by years end opioids will become less available at the pharmacy.”

“Now every snake oil salesman is pushing something to take the pain away. It’s all garbage. Opioids as a whole have been the gold standard for thousands of years when it comes to pain relief,” said Michael. “Take away the only thing that legitimately reduces our pain, then just kill us now, put us in jail or a psychiatric hospital. This is where we will ALL end up if this continues.”

“The last thing chronic pain patients need is to take less medication than they should because they're afraid of either being labelled addicts or even worse, having their medicine taken away without any notice,” said Doreen, who suffers from fibromyalgia and autoimmune diseases.

“My rheumatologist has told me I cannot ever stop taking the pain patches I'm on. I don't enjoy taking them, but it scares the hell out of me wondering what will happen when I get to that point! Please consider chronic pain patients when talking about cancelling the prescribing of opioids!! Where does this leave us?”

Tips for Dealing with Patient Abandonment

Patient advocate and fibromyalgia sufferer Celeste Cooper says she’s been “deluged” with complaints from patients who have been abandoned by their doctors.

“It’s important to understand what is happening. Physicians are caught in a quagmire of discontent. They are put in harm’s way by the DEA and other government agencies if they do prescribe opioids, and yet they run the risk of losing their license if they don’t treat their patient’s pain and it causes harm,” Celeste wrote on her website.

“When a patient is fired, the physician has an ethical obligation to ensure a patient’s care is uninterrupted or they are subject to the repercussions of patient abandonment. If a patient is harmed because they are abandoned, there may be grounds for a lawsuit.”

Celeste says it’s important to gather factual evidence to protect your legal rights, such as getting a written letter from the doctor stating their reasons for stopping your pain care. The physician is also obligated to provide copies of all relevant medical records.

If you have been harmed due to patient abandonment or changes in pain care, you could file a complaint against your doctor under the Ensuring Patient Access and Effective Drug Enforcement Act of 2016, which was signed into law in April.

Flood Congress with Phone Calls

Connie Raterink suggests another way pain patients can get their voices heard. In 1994 she was homeschooling her children when Congress was considering legislation that would have basically made home schools illegal. When attempts to amend the bill failed, home school advocates flooded their congressional representatives with phone calls.

“We literally shut down Congress that day. They couldn't make outgoing calls, and the only ones getting through were home schoolers. They couldn't even call their own staff within Congress!” Connie said. “They got the message, and immediately amended the bill. Over the few days involved with this, there were over one million phone calls made.”

Connie, who suffers from a severe form of osteoporosis, thinks the same approach could be used by pain patients.

“So, pick a date... get the message out.... there are 600 people in my Church alone that would call just on MY behalf,” she wrote. “Congress again needs to hear from us individually, but en masse. We need to tell them to get their noses out of our medical records, and let our doctors make the decisions for their patients, not Congress.”

To learn more about the home schoolers’ campaign, click here.

To sign up for our free monthly newsletter, click here.

Belbuca Effective in Treating Pain Long Term

By Pat Anson, Editor

A new opioid film designed to be taken orally twice a day significantly reduces pain and the need for breakthrough pain medication in patients with moderate to severe pain, according to a new clinical study by Endo International (NASDAQ: ENDP). The results of the Phase III study were released this weekend at the International Conference on Opioids in Boston.

Belbuca is the only analgesic formulation of buprenorphine in a sublingual film that is dissolved in the mouth and absorbed through the inner lining of the cheek.

Buprenorphine is an opioid classified as a Schedule III controlled substance, which means it has lower abuse potential than Schedule II drugs, a category that includes opioids such as hydrocodone. Buprenorphine is also used to treat addiction when combined with naloxone.

Over 400 patients with moderate to severe pain took Belbuca for 48 weeks after being titrated to find the most effective dose. During long term treatment, the average daily pain score was about 3 on a scale of 0 (no pain) to 10 (worst pain imaginable).

The need for daily rescue medication to relieve breakthrough pain decreased from an average of 3 tablets to 1.1 tablets.

"Many patients living with chronic pain require long-term treatment to control their suffering, so it is important that patients have options to manage their pain," said Martin Hale, MD, Medical Director of Gold Coast Research, one of the study's investigators. "These new findings support the safety and tolerability of treatment with Belbuca across a broad range of dosage strengths.”

About half of the patients (54%) experienced some type of side effect, including nausea, constipation, headache, vomiting and upper respiratory tract infection.

Belbuca was approved by the U.S. Food and Drug Administration in October 2015 for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate.

Belbuca utilizes a drug delivery system developed by BioDelivery Sciences (NASDAQ: BDSI). Because the oral film delivers buprenorphine into the bloodstream faster than pills or skin patches, lower doses are needed to treat pain. The film contains one-tenth to one-twentieth the amount of buprenorphine as Suboxone and other products that are used to treat opioid addiction.

Belbuca is available in seven different dosages, allowing physicians to titrate Belbuca to a tolerable dose that provides pain relief with fewer side effects. According to the Healthcare Bluebook, a 75mcg, 60-day supply of Belbuca should cost about $265.

Fentanyl Blamed in Prince Overdose

By Pat Anson, Editor

A medical examiner has confirmed widespread speculation that opioids were involved in the accidental death of pop star Prince. The surprise was the type of opioid that was found in the singer's system.

“The decedent self-administered fentanyl,” Dr. A. Quinn Strobl, chief medical examiner for the Midwest Medical Examiner’s Office, wrote in his widely awaited report, which you can see by clicking here.

The report was released six weeks after Prince's death and only covered the manner and cause of death. All other information is considered private under Minnesota law.

The medical examiner’s report is likely to focus new attention on the so-called opioid abuse epidemic, which is routinely blamed on prescription opioids. Fentanyl is a potent opioid more powerful than morphine, and when prescribed the drug is generally only given to people in severe pain.

However, the report does not state whether the fentanyl that killed Prince was from a prescription or if it was illicit fentanyl obtained through other means.

Illicit fentanyl is an odorless white powder that is typically combined with heroin or cocaine to boost their potency. In recent months it has increasingly been found in counterfeit pain medication sold on the streets.  

Thousands of people have died from fentanyl overdoses in the U.S. and Canada, but because of the nature of the drug it’s impossible to tell whether it was prescribed legally and used for medical reasons or manufactured illegally and sold as a street drug.

“Toxicology tests used by coroners and medical examiners are unable to distinguish between prescription and illicit fentanyl. Based on reports from states and drug seizure data, however, a substantial portion of the increase in synthetic opioid deaths appears to be related to increased availability of illicit fentanyl,” said a recent report from the Centers for Disease Control and Prevention, which nevertheless still classifies all fentanyl overdoses as prescription drug deaths.

Massachusetts and Rhode Island recently reported a “significant increase” in fentanyl-related overdoses, with nearly 60% of the fatal overdoses in those states now attributed to fentanyl. Rhode Island health officials say the shift to fentanyl worsened when “more focused efforts were undertaken nationally to reduce the supply of prescription drugs.”  

Prince’s body was found in an elevator at his Paisley Park estate near Minneapolis on April 21. There was immediate speculation the singer was addicted to pain medication that he took for hip pain, but the only opioid ever mentioned was Percocet.  In the days before his death, Prince reportedly sought help from an addiction specialist in California.

The singer’s use of painkillers and how he obtained them are now the focus of a criminal investigation. No charges have been filed and a judge has sealed all records in the case.

According to search warrant that was accidentally released and obtained by the Los Angeles Times, Dr. Michael Todd Schulenberg, a family medicine practitioner, treated Prince on April 7 and 20, the day before his death.

Senators Propose Tax on Opioid Pain Meds

By Pat Anson, Editor

A group of U.S. Senators has introduced legislation that would establish a federal tax on all opioid pain medication. If approved, it would be the first federal tax on a prescription drug levied directly on consumers.

The bill, called the Budgeting for Opioid Addiction Treatment Act, would create a one cent fee on each milligram of an active opioid ingredient in pain medication. Money from this “permanent funding stream” would be used to provide and expand access to addiction treatment.  

“A major barrier that those suffering from opioid addiction face is insufficient access to substance abuse treatment,” said Sen. Joe Manchin (D) of West Virginia. “This legislation will bridge that gap and make sure that we can provide treatment to everyone who makes the decision to get help. I look forward to working with my colleagues to get this bill passed so we can take another step forward in the fight against opioid abuse.”

Sens. Amy Klobuchar (D-MN), Jeanne Shaheen (D-NH), Angus King (I-ME), Heidi Heitkamp (D-ND), Tammy Baldwin (D-WI) and Bill Nelson (D-FL) are co-sponsoring the bill, which has been dubbed the “LifeBOAT” Act.

“By establishing a reliable stream of funding, this bill will bolster treatment facilities across the country, increase the amount of services available, and support people as they fight back against addiction – all while doing so in a cost-effective way,” said Sen. King.

The opioid tax would raise an estimated $1.5 billion to $2 billion per year. In an interview with the Portland Press Herald, King said the fee would range between 75 cents and $3 for a 30-day prescription, depending on the dose. He claimed many patients wouldn’t have to pay the additional cost because their insurance would cover it.

King said treatment programs need funding, and tacking the cost onto the price of the drug is a fair way to do it, much like automakers are required to install seat belts and air bags in vehicles.

“The obvious way to fund this is to build it into the price of the drug,” said King. “The cost of the drug should reflect the danger of the drug.”

Although most of the press releases and public statements from the senators avoid using the word “tax” and refer to it as a fee, the bill itself doesn’t hide behind semantics. The legislation would apply to the sale of “any taxable active opioid” and would amend the Internal Revenue (IRS) Code to make it possible.

The federal government and the vast majority of states do not levy a sales tax on prescription drugs. Only two states, Illinois and Georgia, currently have a sales tax on prescription medication.

"I don't understand how, in a world where we are getting upset about the 'tampon tax' we find it perfectly socially acceptable to tax chronic pain patients to pay for addiction treatment," said Amanda Siebe, who suffers from Chronic Regional Pain Syndrome (CRPS) and is a founder of the advocacy group #PatientsNotAddicts.

"With less than 5% of chronic pain patients becoming addicted to opiates, this leave the other 95%, who are often some of the poorest in America and have nothing to do with addiction or addiction treatment, to pick up the tab for addiction treatment. I find myself truly disappointed and ashamed of our government. This tax is discriminatory and we are going to fight it."

The LifeBOAT Act would exempt buprenorphine, an opioid used to treat addiction, from taxation, as well as all over-the-counter pain relievers such as acetaminophen. Cancer and hospice patients would be exempted from the opioid tax, although they would have to apply for a rebate to get their money back.

“The discount or rebate mechanism shall be determined by the Secretary of Health and Human Services with input from relevant stakeholders, including patient advocacy groups. The discount or rebate shall be designed to ensure that the patient or family does not face an economic burden from the tax,” a fact sheet on the bill states.

Sen. Manchin told to his colleagues that there would be little or no opposition to the bill.

“There’s not one person who will lose a vote over this. Not one person. You won’t be accused of voting for a tax,” Sen. Manchin said during a news conference announcing the bill.  He noted that no Republican senators have signed on as co-sponsors.   

“This is something that’s much needed, overdue and they all recognize it, but they’re scared to death. They’ve taken the (no tax) pledge. They’re scared to death somebody will use it against them. I’ll be standing beside my Republican colleagues if any Democrat tried to attack them and said they tried to vote for a tax,” Manchin said.

To read the full text of the bill, click here.

To watch a video of the press conference, click here.

Canada Fights Wave of Fake Pain Pills

By Pat Anson, Editor

Canada’s Healthy Ministry today added a dangerous synthetic opioid – known as W-18 -- to a list of illegal controlled substances after the drug was found in counterfeit pain medication sold on the street.

W-18 has been used recreationally in Europe and Canada over the past two years. Recently, Canadian law enforcement have found W-18 disguised to look like legitimate prescription pain medication, such as oxycodone. W-18 is believed to be manufactured in China. It is blamed for one overdose death in Calgary.

"Substances like W-18 are dangerous and have a significant negative impact on some of the most vulnerable people in our society,” said Jane Philpott, Canada’s Minister of Health.

Classifying W-18 as a Schedule I controlled substance – the same class as heroin and cocaine -- makes its production, possession, importation and trafficking illegal in Canada. W-18 was originally developed in the 1980’s as a pain reliever at the University of Alberta, but was never marketed commercially. It is 100 times stronger than fentanyl, another synthetic opioid that is also increasingly being disguised as pain medication and sold on the street.

A Health Canada analysis of counterfeit oxycodone and Percocet pills confirmed the presence of W-18 last month, according to The Globe and Mail.

“Of particular concern is a green coloured oxycodone tablet marked CDN80,” said Corporal Eric Boechler of the Royal Canadian Mounted Police. "It was discontinued as a prescription tablet in 2012, so virtually any encountered on the street today are counterfeit and will contain fentanyl and/or other potent synthetic opioids such as W-18.”

Last week police in North Bay, Ontario seized hundreds of fake fentanyl pills that were disguised to look like 30 mg oxycodone prescription pills. The pills are blue and imprinted with “A 215.”

Counterfeit fentanyl pills have previously been found in western Canada, where they are blamed for dozens of overdose deaths. This was the first time they were found in North Bay, according to BayToday.

“I don’t think these illicit pills coming in from China are aimed at pain patients," said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada.

NORTH BAY POLICE PHOTO

"They appear to be aimed at those who are willing to try ‘new’ things and the usual addiction population. I don’t know what possesses the younger groups to try this stuff from the street as they know full well what could happen.”

As Pain News Network has reported, fake fentanyl pills have also been appearing in the United States, where they are blamed for at least 14 deaths in California and 9 in Florida.  Some pills were purchased off the street by pain patients who were unable to get prescription medication through a doctor.

Massachusetts and Rhode Island have both reported an “alarming” rise in fentanyl overdoses. Over half the opioid overdose deaths in those states are now blamed on illicit fentanyl, not prescription pain medication.

Painkillers Cause Chronic Pain? Rats!!!

By Pat Anson, Editor

A provocative new study is likely to stir fresh debate about the risks associated with opioid pain medication. It’s not another study about addiction or overdose, but whether opioids actually increase chronic pain, a condition known as hyperalgesia. 

An international team of researchers found that even just a few days of morphine can make chronic pain last for several months by intensifying the release of pain signals in the spinal cord.

But there’s a catch. The research was conducted on laboratory rats.

"We are showing for the first time that even a brief exposure to opioids can have long-term negative effects on pain," said Peter Grace, PhD, an assistant research professor at the University of Colorado-Boulder's Department of Psychology and Neuroscience. "We found the treatment was contributing to the problem."

Grace and his colleagues found that damaged nerve cells in rats send a message to spinal cord immune cells known as glial cells, which normally act as "housekeepers" to clear out unwanted debris and microorganisms. The first signal of nerve pain sends glial cells into alert mode, priming them for further action.

"I look at it like turning up a dimmer switch on the spinal cord," said Grace.

Nerve pain was induced in the rats by slicing open their thighs. A fine thread was then tied around a major nerve. Over the next three months, researchers poked the rats' paws with stiff nylon hairs to see how sensitive they were to pain.

Injured rats that were not treated with morphine eventually recovered and did not show pain, but those that were treated with morphine for five days remained sensitive to pain. Researchers believe the morphine stimulated their glial cells and sent them into overdrive. They liken the effect to being slapped in the face twice.

"You might get away with the first slap, but not the second," said co-author Linda Watkins, a Distinguished Professor at CU Boulder. "This one-two hit causes the glial cells to explode into action, making pain neurons go wild."

"The implications for people taking opioids like morphine, oxycodone and methadone are great, since we show the short-term decision to take such opioids can have devastating consequences of making pain worse and longer lasting," said Watkins. "This is a very ugly side to opioids that had not been recognized before."

Patient advocates had a mixed reaction to the study.

“Linda Watkins is doing some awesome work. We know that glial cells are the key to pain generation. Exactly how is still poorly understood,” said Terri Lewis, PhD, a rehabilitation specialist who teaches in the field of Allied Health.  “We know that 'something' triggers inflammation and maintains it. When that trigger is turned up high, glial cells are activated."

“Generalizing from rats to humans is not okay. But if the same results are found in pigs, there is probably something to talk about,” added Lewis.

“There is enough evidence in humans that opioids work and do not make pain worse,” said Janice Reynolds, a retired nurse and patient advocate.  “Even the work in hyperalgesia has not, contrary to claims by opiophobics, translated well from rats to humans. The write up is extremely negative and tends to lead one to believe the results may be slanted or even poorly interpreted. The fact they are singling ‘chronic pain’ out is a warning sign.”

The CU-Boulder study, which is published online in the Proceedings of the National Academy of Sciences, does have an impressive pedigree, including researchers at the University of Adelaide in Australia, the University of North Carolina, the Chinese Academy of Sciences, the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and Tsinghua University in Beijing.

The study was funded in part by the American Pain Society, Australia's National Health and Medical Research Council, the National Natural Science Foundation in China, the National Institute on Drug Abuse, the National Institute of Dental and Craniofacial Research and the National Institute of Alcohol Abuse and Alcoholism.

Most Patients Don’t Think Opioids Are Risky

By Pat Anson, Editor

A small survey of chronic pain sufferers may give physicians a better understanding  of why many patients are reluctant to reduce or discontinue their use of opioids. Most patients simply don’t see themselves at risk of abuse and addiction, and think they can manage their opioid use safely.

Researchers at the University of Colorado School of Medicine and the VA Eastern Colorado Health Care System conducted in-depth interviews with 24 patients who were on long-term opioid therapy for chronic non-cancer pain. Six of the patients were still taking their regular opioid dose, 12 were tapering, and 6 had discontinued the use of opioids.

“When asked about specific concerns related to opioid medications, patients were generally aware of opioid overdose as a potential complication but did not perceive themselves to be at risk,” said lead author Joseph Frank, MD, assistant professor of medicine and a primary care physician at the VA Medical Center in Denver.

“The majority of patients described a long history of opioid medication use without prior overdose and cited this as evidence of their ability to safely take opioid medications. Patients attributed overdoses to others using opioids in risky ways or overdosing intentionally rather than accidentally.”

The survey findings, published in the journal Pain Medicine, include comments from some of the patients.

“Overdose? No. I’m very mature, very conscious, very intelligent as far as adhering,” said a 52-year old man who was still taking his regular opioid dose.

“The concern is that if they increase my opioid dosage, I could stop breathing. It’s ridiculous,” said another patient who was also taking his normal dose.

Even patients who were tapering or had discontinued opioids said that overdose risk was not their primary motive for cutting back. Others said they were so focused on pain relief they were willing to overlook the side effects of opioids.

“I like to research everything, but the pain was so severe I didn’t care about anything else... I don’t think that people actually consider the side effects and what not when it comes to something like that. I think that they just want the pain to go away,” said a 46-year old woman who was tapering.

“I don’t think people in chronic pain think about long term. We are basically, how do I get through today? I just gotta get through today,” said another woman who was still taking her regular dose.

Many patients said they had extensive experience with non-opioid therapies and found they weren’t effective. That led to pessimism about their ability to manage pain without opioids.

“I needed help desperately by the time [hydrocodone] was prescribed for me... I had taken ibuprofen, Aleve, everything over the counter, and it did nothing to help me at all. So I knew I needed more help, stronger help,” said a 73-year old woman who was tapering.

"Throughout my life, the doctors have done everything, trying to get me to exercise, to stretch, things that shocked my muscles,” said a 58-year old man. “In the ‘70s, they put some kind of body cast on me that I wore for months... Gosh, I’ve had everything. I’ve went through all the minor ones like Tylenols and aspirins and stuff, you know... I’ve went through a few years on Morphine. I’ve went to a time on Oxycodone and OxyContin, Vicodin, Tramadol. Now I’m on Fentanyl patches.”

Several patients said they eventually decided to taper when they realized that opioids weren’t helping as much or reduced their quality of life.

“The pills turned out horribly for me... I wasn’t caring for myself. I wasn’t bathing. I was sleeping all the time... Everything in my life was such a mess, and my husband was, you know, really worried about me... My husband [told me] that this is bad. This is really bad. You’re not doing well,” said a woman who was tapering.

“I didn’t stop under doctor’s orders or discussion or anything. I just got up one day and I’m done,” said a 60-year old male patient. “Instead of taking four, I took three and I did that for a couple of weeks and then I took two and then I took one. I never felt any discomfort or anxiety or anything so... it worked for me.”

Patients who tapered successfully emphasized the support they received from family, friends and healthcare providers in helping them make the transition.

“My doctor is very conscientious, and I respect her very much... It wasn’t her idea to take me off OxyContin,” said a 73-year old woman. “I just quit cold turkey, which was difficult... She was overjoyed. She thought it was just great that I didn’t need it anymore."

“It’s not much worse without the medication as it is with it. After you’ve taken it for a while, it doesn’t do any good. That’s what I’ve found,” said a 61-year old woman. “But that’s hard to convince people of it. They look at me like I’m nuts, but it’s true... I mean my pain is not any more severe than it was when I was taking all that stuff.”

“I am more alert since I stopped taking [OxyContin], and I need less sleep, which is a blessing. So I’m able to do more things with my life,” said a 72-year-old female patient.

The researchers admit their study was small and may not be representative of the pain community. But they think there are important lessons to learn from it, because tapering “may become an increasingly common patient experience.”

"To achieve goals of improving quality of life and preventing opioid-related harms, we need better evidence and more resources to support patients both during and after this challenging transition," Frank said.  “It will be important to ensure that patients' voices are heard in the national conversation about these medications."

Are CDC Opioid Guidelines Causing More Suicides?

By Pat Anson, Editor

A recent report by the Centers for Disease Control and Prevention documented a disturbing trend in suicides in the United States. Suicides increased by 24 percent from 1999 to 2014, and are now the 10th leading cause of death in the country.   

In 2014, nearly 43,000 Americans committed suicide, over twice the number of deaths that have been linked to opioid overdoses. Most often suicides are blamed on depression, mental illness, financial problems, or drug and alcohol abuse. Untreated chronic pain is rarely even mentioned.

But in recent months there have been a growing number of anecdotal reports of pain patients killing themselves because they can no longer get pain medication or find doctors willing to treat them.

Donald Alan Beyer of Bovill, Idaho was one of them.

After years of suffering from chronic back pain, the disabled logger went into his backyard on May 8 – his 47th birthday --- and shot himself in the head.

“He was in so much pain he could barely get out of bed to go to the bathroom. I guess he felt suicide was his only chance for relief,” says Beyer’s son, Garrett.

“I have witnessed my Dad in more pain than any one person should deal with every day of his adult life due to degenerative disc disease that was made so much worse by an accident on the job that broke his back. This and the eventual hole in the healthcare system focused on ignoring people with chronic pain led to his suicide this month.”

That hole in the healthcare system turned into an abyss when Beyer’s doctor retired last year. Beyer searched frantically for a new doctor, according to his son, but was unable to find anyone willing to take a new patient with chronic pain.

After months without pain medication, Beyer reached his breaking point.

DONALD BEYER

“My dad was a great man and worked through the pain every day as a logger to support his family,” says his son. “Even in his suicide all he thought about was his family. He worked up the strength to go outside before he shot himself in the head specifically so he could leave his house to my little brother. If that isn't the model of what we should all be then I don't know what is.”

Garrett Beyer is sharing the painful memory of his father’s death because he wants government officials, politicians and anti-opioid activists to recognize that efforts to discourage opioid prescribing are having devastating consequences for pain patients and their families across the country. 

“I use such painfully vivid expressions in hopes that the people in the CDC and DEA and everywhere can maybe experience for a second what a person with chronic pain and their families live with every day,” said Garrett, who suffers from many of the same back problems his father did.

“I have inherited his genetic spine problems, and after a car accident when I was 19 crushed 2 of my already flawed lumbar discs leading to my first spine surgery, I suddenly plummeted quite literally into my Dad's painful shoes. I am now terrified that I will also follow in his devastating footsteps.”

Garrett is 27, married and has two children, but says he is “constantly plagued” by the feeling that his wife and kids deserve better.

“I have now had 2 spine surgeries in the past 5 years, which included 3 discectomies and laminectomies, leaving me completely disabled and preparing for yet more surgeries in hopes that one day I can be normal,” Garrett said. “But until the day that medical technology can simply cure chronic pain, we could use all the compassion we can get, rather than the exact opposite that we are getting now.”

Impact of CDC Guidelines

In mid-March, the CDC released controversial guidelines that discourage doctors from prescribing opioids for chronic pain. The guidelines are voluntary and were only meant for primary care physicians, but many other doctors appear to be adopting them, even pain management specialists. Two pain clinics in Tennessee recently said they would stop prescribing opioids to patients “in response to changing regulations.”

Pain News Network has been contacted by dozens of pain patients in recent months who say their physicians are weaning them off opioids or abruptly cutting them off completely.

Others say they are being dismissed by their longtime doctors – often with the excuse of a failed urine drug test. Still others say they are contemplating suicide, rather than face a life of intractable pain.

A 67-year old Florida woman who has suffered from migraines since the age of five wrote to us, saying she was having trouble finding a doctor.

“I finally have an appointment with a doctor in two months who will then refer me to a pain clinic which no doubt will take another two months. At this point I have to live in pain. I may become one of the suicide statistics,” said Lana.

“I was told by several people including a cousin that I should just check into a nursing home. All I need is medicine for pain. I'm not ready to be written off. A cab driver told me that a lot of retirees with pain issues are resorting to buying heroin on the street because it's easier to get and cheaper! Is that what we want for people who led productive lives and are now in pain?”

Another woman, who suffers from chronic back and abdominal pain, is worried that her physician will stop prescribing pain medication.

“My pain management doctor constantly makes comments that he's going to stop all meds. No reason or plan.  If this happens I will be forced to go on disability, I will lose my job, insurance benefits, and means of caring for myself and family,” she wrote. “I rarely speak to avoid upsetting him. This doctor has full control of my life with a swipe of his pen.”

“I’ve been on Percocet and Vicodin for 15 years passed every test,” said a 51- year old Massachusetts woman with chronic back pain who failed a drug test last month and was dismissed by her doctor.

“I was discharged. Told me I was positive for morphine, methadone, cocaine, Klonopin and no Percocet in my system. I have never ever done those drugs ever. I told doctors wouldn't all that kill me? Oh and positive too for Suboxone. I'm in shock. What went wrong?”

What went wrong is that her doctor is not following the CDC’s guidelines, which urge physicians not to dismiss patients for a failed drug test because it “could constitute patient abandonment and could have adverse consequences for patient safety.”

Unintended Consequences

“I'm a chronic pain sufferer affected by the new law to curb addiction,” Jeannette Poulson wrote to us. “I suffer severe pain disorders and no longer have access to my previously working medications. I've never had a history of abusing my medications, and the quality of my life has been greatly diminished.”

Poulson has a question for CDC director Tom Frieden, who said the guidelines couldn’t wait because “so many people are dying” from overdoses.

“Then I ask you, are you willing to deal with a new epidemic of increased suicide rates, as many are dying of a result of unintended suffering?” said Poulson.

We'll never know just how many patients kill themselves because their pain was untreated or under-treated. Experts believe many suicides go unreported or are misclassified as accidental, often covered up by grieving family members or accommodating medical examiners.

In some cases, as we learned with Sherri Little (see “Sherri’s Story: A Final Plea for Help”), it takes months or even years for someone to acknowledge that a loved one died at their own hands.

The fallout from the CDC’s guidelines – which were released a little over two months ago – was in many ways predictable. In our survey of over 2,200 pain patients last fall, many predicted there would be unintended consequences if the guidelines were adopted.

• 90% thought more people will suffer than be helped by the guidelines
• 78% thought there would be more suicides
• 76% thought doctors would prescribe opioids less often or not at all
• 60% thought pain patients would get opioids through other sources or off the street
• 70% thought use of heroin and other illegal drugs would increase

It didn’t take long for drug dealers to begin targeting pain patients as potential customers. Counterfeit pain medication made with illicit fentanyl -- disguised as Norco, oxycodone and other medications -- have recently appeared in several states. The so-called “death pills” are blamed for at least 14 deaths in California and 9 in Florida.

Rhode Island has reported a “significant increase” in fentanyl-related overdoses since March, with a whopping 60% of the fatal overdoses in that state now attributed to fentanyl. Rhode Island health officials say the shift began when “more focused efforts were undertaken nationally to reduce the supply of prescription drugs.”  

We’re still in just the early stages. How have the CDC guidelines affected you and your family?

Leave a comment below or send me an email at editor@painnewsnetwork.org.

FDA Approves New Drug Implant

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved the use of a new drug implant for the treatment of opioid addiction.  Probuphine is the first implant of its kind approved by the agency and could potentially be a game changer for other medical conditions such as chronic pain that require steady doses of medication around-the-clock.

Probuphine is designed to be inserted into the arm beneath the skin, where it delivers a low dose of burprenorphine directly into the bloodstream for up to six months.  

Buprenorphine is an opioid itself, but when combined with naloxone, the medication reduces cravings for opioids. Until now the drug has only been available as a pill or film strips placed under the tongue.

For many years buprenorphine was sold exclusively under the brand name Suboxone, but several pharmaceutical companies have entered the lucrative addiction treatment market and now make versions of their own. As many as 2.3 million people who are dependent on opioid pain medication or heroin could benefit from buprenorphine treatment,

FDA approval was a major win Braeburn Pharmaceuticals and its partner, Titan Pharmaceuticals (OTC: TTNP), which holds the rights to the implant technology. Titan and Braeburn were stunned in 2013 when the FDA denied approval of the implant and asked for new clinical studies proving Probuphine’s effectiveness.  

Results from a recent Phase III study showed that over 85% of the patients who had the implant abstained from using illicit opioids for six months, compared to about 72% of patients who used buprenorphine film strips that were taken daily.

"Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA Commissioner Robert Califf, MD. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Expanding the availability of addiction treatment is a major goal of the Obama administration. The White House has asked Congress for an additional $1.1 billion to fight opioid abuse, with much of the money earmarked for addiction treatment. The administration has also proposed doubling the number of patients that doctors can treat with buprenorphine from 100 to 200.

Buprenorphine can be abused and is a popular street drug that is used to get high or to ease withdrawal pains from illegal opioids such as heroin. An implant will be much more difficult to abuse, since it can’t be crushed or liquefied for snorting or injecting. It’s also less likely to be diverted.

Probuphine is expected to cost about $1,000 a month. It consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm. Administering Probuphine will require special training because it must be surgically inserted and removed.

The most common side effects are pain at the implant site, as well as itching, redness, headache, depression, constipation, nausea, vomiting, back pain, toothache and oral pain. The FDA is requiring post-marketing studies to establish the safety and effectiveness of the implants.

Probuphine was developed using a patented implant technology called ProNeura, which is designed to provide continuous levels of medication in the blood. Titan is also developing implants to treat Parkinson’s disease and hypothyroidism, and its CEO told Pain News Network that ProNeura could also potentially be used to deliver pain medication.

“Clinical studies will need to be done to establish the ability, but the drug levels can certainly be delivered that are going to be beneficial for treating chronic pain,” said Titan CEO and President Sunil Bhonsle. “There are many applications for this technology and I think the medical community is now more in tune with looking at long-term delivery technology in the chronic disease setting.”

“It is part of our plan to move into pain because pain and opioid addiction are so interconnected and we think there are ways, by treating patients with a less abuse-able formulation, you could actually help alleviate the addiction problem,” Behshad Sheldon, President and CEO of Braeburn, told PNN in an earlier interview.

Opioids Provide Only ‘Modest’ Relief for Low Back Pain

By Pat Anson, Editor

Lower back pain may be the world’s leading cause of disability, but there is surprisingly little evidence about the best ways to treat it – including the use of opioid pain medication.

A new study published in JAMA Internal Medicine adds a little clarity to the issue.

In a systematic review of 20 clinical studies involving nearly 7,300 patients, researchers found evidence that opioid medications provide only “modest” short-term relief from lower back pain.

“In people with chronic low back pain, opioid analgesics provide short and/or intermediate pain relief, though the effect is small and not clinically important even at higher doses,” said lead author Andrew McLachlan, PhD, a professor of pharmacy at the University of Sydney in Australia.

Opioids were found to be no more effective than non-steroidal anti-inflammatory drugs (NSAIDs). About half of the patients involved in the studies dropped out because they didn’t like the side-effects of opioids or because they found them to be ineffective.

“Our review challenges the prevailing view that opioid medicines are powerful analgesics for low back pain. Opioid analgesics had minimal effects on pain, and even at high doses the magnitude of the effect is less than the accepted thresholds for a clinically important treatment effect on pain,” McLachlan wrote.

Although nearly a quarter of the opioid prescriptions written in the U.S. are for low back pain,  medical guidelines often recommend against it.

“Whereas there is evidence for significant short-term pain relief, there is no substantial evidence for maintenance of pain relief or improved function over long periods of time without incurring serious risk of overdose, dependence, or addiction,” wrote Gary Franklin, MD, in a position paper  adopted by the  American Academy of Neurology.

Franklin, who is vice-president of Physicians for Responsible Opioid Prescribing (PROP), also helped draft the recent opioid guidelines adopted by the Centers for Disease Control and Prevention.

“Evidence is limited or insufficient for improved pain or function with long-term use of opioids for several chronic pain conditions for which opioids are commonly prescribed, such as low back pain,” the CDC guidelines state. “Several non-opioid pharmacologic therapies (including acetaminophen, NSAIDs, and selected antidepressants and anticonvulsants) are effective for chronic pain. In particular, acetaminophen and NSAIDs can be useful for arthritis and low back pain.”

A large study recently published in the British Medical Journal reached a different conclusion than CDC – finding that there was little evidence that acetaminophen – also known as paracetamol – was effective in treating low back pain. Another study published in The Lancet reached a similar conclusion.

Who should patients believe with all this conflicting advice?

Perhaps the best therapy can’t be found in a pharmacy or drug store.

A recent study published in JAMA Internal Medicine found that regular exercise and education about its benefits reduce the risk of developing lower back pain by as much as 45 percent.

“If a medication or injection were available that reduced LBP (low back pain) recurrence by such an amount, we would be reading the marketing materials in our journals and viewing them on television. However, formal exercise instruction after an episode of LBP is uncommonly prescribed by physicians,” wrote Timothy Carey, MD, and Janet Freburger, PhD, of the University of North Carolina at Chapel Hill.

Over 80 percent of us suffer acute low back pain at least once in our lives, and about half will experience a recurrence within one year. 

Lyrica Linked to Birth Defects

By Pat Anson, Editor

A drug widely prescribed to treat fibromyalgia, neuropathy and other chronic pain conditions increases the risk of major birth defects, according to a new study published in Neurology, the medical journal of the American Academy of Neurology.

Women taking pregabalin were six times more likely to have a pregnancy with a major defect than women who were not taking the drug, the study found. The birth defects included heart defects and structural problems with the central nervous system (CNS) or other organs. Birth defects due to chromosomal abnormalities were not included in the results.

Pregabalin is the generic name of Lyrica, which is approved by the FDA to treat diabetic nerve pain, fibromyalgia, epilepsy, post-herpetic neuralgia caused by shingles and spinal cord injury. It is also prescribed “off label” to treat a variety of other conditions. Lyrica is Pfizer’s top selling drug, generates over $5 billion in annual sales, and is currently approved for use in over 130 countries.

The international study involved nearly 700 pregnant women in seven different countries. Four of the 125 women who took pregabalin during pregnancy had children with central nervous system defects, or 3.2 percent. That compares to a birth defect rate of just 0.5% in the 570 women who did not take pregabalin.

Of the women taking pregabalin, 115 were taking it to treat neuropathic pain, 39 were taking it for psychiatric disorders, including depression and anxiety, five were taking it for epilepsy, and one for restless leg syndrome.

Most of the women started taking pregabalin before they became pregnant. All of them stopped taking the drug at an average of six weeks into their pregnancies.

A small number of women also took another anti-seizure drug during their pregnancy. Women in that group had a 6 percent chance of a major birth defect, compared to 2 percent of the women who did not take another anti-seizure medication.

“We can’t draw any definitive conclusions from this study, since many of the women were taking other drugs that could have played a role in the birth defects and because the study was small and the results need to be confirmed with larger studies, but these results do signal that there may be an increased risk for major birth defects after taking pregabalin during the first trimester of pregnancy,” said study author Ursula Winterfeld, PhD, of the Swiss Teratogen Information Service and Lausanne University Hospital in Lausanne, Switzerland.

“Pregabalin should be prescribed for women of child-bearing age only after making sure that the benefits of the drug outweigh the risks and after counseling them about using effective birth control. In cases where women have taken pregabalin during pregnancy, extra fetal monitoring may be warranted.”

A spokesman for Pfizer said the study was small and the findings could have been influenced by other factors.

"As the authors agree, the study has significant limitations and cannot be used to draw definitive conclusions," Steven Danehy said in an email to Pain News Network. "The study was small, did not account for other medical conditions or medications, and the women taking Lyrica had higher rates of smoking and diabetes, all of which can negatively affect pregnancy outcomes."  

Because women are more likely than men to have a chronic pain condition such as fibromyalgia, they are the biggest consumers of Lyrica.

The FDA warning label for Lyrica does not specifically warn pregnant women not to take the drug. But it does caution them to consult with a doctor if they are pregnant or plan to become pregnant.

“It is not known if Lyrica will harm your unborn baby. You and your healthcare provider will have to decide if you should take Lyrica while you are pregnant. If you become pregnant while taking Lyrica, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry,” the label says.

The label also cautions men to see a doctor if they plan to father a child while taking Lyrica. 

“Animal studies have shown that pregabalin, the active ingredient in Lyrica, made male animals less fertile and caused sperm to change. Also, in animal studies, birth defects were seen in the offspring (babies) of male animals treated with pregabalin. It is not known if these problems can happen in people who take Lyrica,” the warning label states.

The Hidden Dangers of Self-Medicating with OTC Drugs

By James Campbell, MD, Guest Columnist

The Centers for Disease Control and Prevention (CDC) recently unveiled guidelines for primary care physicians on the use of opioids for chronic pain. Not surprisingly, the guidelines urge physicians to first try non-pharmacologic and non-opioid treatments before resorting to opioid therapy.

If you’re one of the millions of Americans living with pain on a daily basis, it’s likely you’re not a stranger to over-the-counter (OTC), non-prescription pain medications such as naproxen (brand name Aleve), ibuprofen (Advil and Motrin), aspirin and acetaminophen (Tylenol).

In fact, most of my patients with chronic pain began their quest for relief with a cocktail of OTC pain relievers, muscle relaxants and even alcohol, before seeking professional help and eventually graduating to prescription treatments such as opioids, anti-depressants and anticonvulsants.

While OTC pain medications are generally safe when taken at their recommended doses, it’s all too common for patients to unknowingly put themselves at risk of a fatal accidental overdose or serious drug-drug interactions by mixing OTC pain medications or taking them in combination with prescription treatments for pain or other common health conditions.

Given the sheer magnitude of serious adverse events and fatalities associated with opioids, the hidden, yet preventable dangers of the pain medications on your pharmacy shelves are not often discussed.

Let’s take one of the most common OTC pain relievers: acetaminophen. When used as directed within the advised dosing guidelines, acetaminophen is safe and effective. However, if a person takes more than one medication that contains acetaminophen and exceeds the maximum recommended dose, they may be at risk of serious liver damage.

This happens so often that acetaminophen overdose is the leading cause of calls to poison control centers in the United States -- more than 100,000 instances per year – and are responsible for more than 56,000 emergency room visits.

In fact, in 2011, in an effort to reduce the risk of severe liver injury from acetaminophen overdose, the Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription medications, including combination acetaminophen and opioid products, to no more than 325 mg per tablet, capsule or other dosage unit.

Then in 2014, the FDA recommended that health care professionals discontinue prescribing and dispensing prescription combination products that contain more than 325 mg of acetaminophen.

While the FDA’s efforts may help curb accidental overdose related to prescription medications that contain acetaminophen (Tylenol with codeine, for example), it does little to address the risks of OTC acetaminophen or other OTC pain medications such as ibuprofen, a type of non-steroidal anti-inflammatory drug (NSAID), which can cause gastrointestinal bleeding and injury, and cardiovascular side effects when taken on a chronic basis.

Drug Interactions

In addition to the risk of overdose, people taking multiple OTC and prescription medications for pain and other conditions are also at risk of serious drug-drug interactions. Simply put, any “drug” – whether it be a medicine, vitamin, supplement or even alcohol – that enters your body and alters your natural internal chemistry has the potential to interact or alter the intended effect or unintended side effect of other medications.

Even though most medications are accompanied by warnings about combining them with other drugs, most vitamins and supplements are not -- so, unless you’re a licensed medical professional, it’s virtually impossible to recognize the potential for drug-drug interactions.

If you’re using OTC medications, whether alone or with prescription medications, to cope with pain on a daily basis, here are three precautionary steps you can take to safeguard yourself against the risk of accidental overdose or drug-drug interactions.

1) Recognize that ALL medications, whether OTC or prescription, can cause harm if used improperly, and the fact that some medications are available without a prescription does not mean they are inherently safe. Read the labels that come with your medications. Tylenol, Advil and Vicodin are household names, so it can be easy to overlook their “generic” names (or the active ingredient in each).

For example, the generic name for Tylenol is acetaminophen, while that of Vicodin is acetaminophen hydrocodone. Without close examination of either label, a person taking Vicodin and Tylenol together could be inadvertently exceeding the recommended dosage of acetaminophen.

2) Consult a medical professional before you take more than one medication on a daily basis. If your chronic pain is being treated by a physician, be sure to tell them (even if it’s on your medical history) about any OTC or prescription medications you are currently taking. This includes vitamins and other supplements that may seem harmless, but could interact with your pain medications.

3) If you are independently treating your chronic pain, make a list of all the medications, vitamins and supplements you take on a regular basis and share them with your local pharmacist. Pharmacists can identify potential drug-drug interactions like taking acetaminophen and ibuprofen on a long-term basis, which can result in an increased risk of developing kidney problems.

The American Chronic Pain Association also recommends using the same pharmacy for all your prescriptions, so that the pharmacist can screen health information and current medications to avoid the pitfalls of overdose and drug interactions.

As a neurosurgeon with a special interest in pain for over 30 years, I’m empathetic to the daily struggle that patients face and their desperate quest for relief, seeking anything and everything that can simply make the pain stop.

For the patients who are fighting this seemingly endless battle with pain without the help of a medical professional, I hope I’ve provided some useful information and practical advice to help avoid serious risks associated with self-medicating. However, people living with moderate to severe chronic pain may benefit from a consultation with a licensed pain management specialist, who can help guide you toward steps that will help reduce your pain. 

James Campbell, MD, has spent the last 30 years pioneering efforts to improve the diagnosis and treatment of patients with chronic pain. 

Dr. Campbell is professor emeritus of Neurosurgery at Johns Hopkins University School of Medicine and is the founder of the Johns Hopkins Blaustein Pain Treatment Center - one of the largest pain research centers in the U.S. He is also a former president of the American Pain Society. 

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.