CreakyJoints Under Scrutiny for Ties to Drug Makers 

By Pat Anson, PNN Editor

Patient advocacy groups are coming under scrutiny again for their financial ties to drug companies. The latest is the Global Healthy Living Foundation (GHLF), a non-profit charity that created CreakyJoints, a website and social media platform that raises awareness about arthritis and other chronic illnesses. 

According to Bloomberg News reporter Ben Elgin, the foundation and CreakyJoints have long had a cozy relationship with Pfizer, Amgen, Johnson & Johnson and other corporate donors. Pfizer has donated nearly $1 million to the foundation over the past decade and one of its vice-presidents even serves on GHLF’s board of directors.

In a speech to drug makers in 2010, GHLF president Seth Ginsberg reportedly sought their donations -- while at the same time promising the companies “higher profits” and “sales rep participation in our programs.”

Ginsberg, who was diagnosed with spondyloarthritis as a teenager, co-founded GHLF in 1999 with marketing executive Louis Tharp.

In addition to CreakyJoints, GHLF has two other “grassroots” programs, Fail First Hurts and the 50-State Network, which advocate for healthcare policies that often align with the interests of its donors.  

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According to GHLF’s 2017 tax return, the foundation had over $5 million in annual revenue. Ginsberg was paid a salary of $384,000, while Tharp received $220,000 as Executive Director.  Nearly $300,000 was also paid to a for-profit marketing company established by the two men, although it’s unclear what the payment was for.

Bloomberg reported that GHLF’s tax returns “reflect errors and unexplained entries that have obscured the amounts of money flowing to its cofounders.”

“Are they operating in a way that is extremely transparent? It’s safe to say they’re not,” Brian Mittendorf, a professor of accounting at Ohio State University told Bloomberg. “From looking at their disclosures, you have no idea how closely they’re related to some of the entities it pays.”

At least one GHLF board member and several patient volunteers reportedly left the organization because they were troubled by its relationships with donors.

GHLF did not grant an interview to Bloomberg, but replied to questions in writing.

“The only time we engage in advocacy is when it helps patients. If it doesn’t help patients, we don’t do it,” the foundation said in a statement. “Our mission is to engage in patient-centered research, provide advocacy for access-to-care, and to support people living with chronic disease by providing a supportive environment and accessible education.”

In a related story, Bloomberg reported that several other recently formed non-profits – such as the U.S. Rural Health Network --  appear to be little more than front organizations for the pharmaceutical industry.

“There are a number of groups created by pharma companies that look and act like patient organizations, but they’re 100 percent funded by industry,” said Marc Boutin, chief executive officer of the National Health Council. “They sound and look like patient organizations, but they take positions that industry wants.”

Drug Companies Fined for Co-Pay Programs

Last week two drug companies agreed to pay $125 million in fines to settle allegations that they used charitable foundations as front organizations to bilk Medicare.

Amgen and Japanese drug maker Astellas Pharma paid the foundations to establish co-pay prescription drug programs for Medicare patients. Federal prosecutors say the programs were primarily designed not to help patients, but to illegally pay their co-pays for Astellas and Amgen products.

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Federal anti-kickback laws prohibit pharmaceutical companies from making any kind of payment to induce Medicare patients to purchase their drugs. The prohibition includes co-pays.

“The companies’ payments to the foundations were not ‘donations,’ but rather were kickbacks that undermined the structure of the Medicare program and illegally subsidized the high costs of the companies’ drugs at the expense of American taxpayers,” U.S. Attorney Andrew Lelling said in a statement.

“When pharmaceutical companies use foundations to create funds that are used improperly to subsidize the co-pays of only their own drugs, it violates the law and undercuts a key safeguard against rising drug costs,” said U.S. Assistant Attorney General Jody Hunt.

Last year, Pfizer paid nearly $24 million to settle allegations that it also used a co-pay program to pay Medicare for the company’s prescription drugs.

U.S. Pain Foundation Co-Pay

The U.S. Pain Foundation is under investigation by the U.S. Senate Finance Committee for a similar co-pay program established with Insys Therapeutics, a controversial Arizona drug company. Insys makes Subsys, an expensive and potent fentanyl spray blamed for hundreds of overdose deaths.

U.S. Pain received $2.5 million from Insys to launch the “Gain Against Pain” program, which ostensibly helped Medicare patients pay for drugs prescribed for breakthrough cancer pain. Critics say the program was primarily used to increase prescriptions for Subsys, which can cost $24,000 for just a four-day supply.

Former U.S. Pain CEO Paul Gileno initially defended the co-pay program, saying the money from Insys “does not influence our values,” but later resigned over allegations that he misappropriated $2 million from his own charity.

The Gain Against Pain program was subsequently shutdown in August 2018 and U.S. Pain said it would no longer accept funding from Insys.

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Sen. Ron Wyden (D-OR), the ranking member of the Senate Finance Committee, sent a lengthy letter last December to U.S. Pain interim CEO Nicole Hemmenway asking a series of questions about the Insys co-pay program. According to the senator’s office, Wyden has still not gotten a full response.  

“The U.S. Pain Foundation has yet to provide a substantial amount of the information that Senator Wyden requested in his letter. Staff is in communication with the organization in order to get to the bottom of the organization’s financial relationship with pharmaceutical manufacturers, including Insys, and its compliance with applicable federal laws,” a Wyden spokesperson said in a statement to PNN.

A federal jury in Boston is currently in its third week of deliberations in a criminal case against Insys founder John Kapoor and four former executives of the company, who are accused of bribing doctors to boost sales of Subsys. 

U.S. Pain also remains under investigation by the Connecticut Attorney General’s office for financial irregularities that led to Gileno’s resignation.

New Safety Concerns for Osteoarthritis Drug

By Pat Anson, PNN Editor

Disappointing results from a Phase 3 clinical study are raising new safety concerns about an experimental class of pain-relieving drugs once considered a promising alternative to opioids.

Pfizer and Eli Lilly say 6.3% of osteoarthritis patients taking a 5 mg dose of tanezumab experienced rapidly progressive osteoarthritis in their joints. There was significant improvement in their pain and physical function, but the patients’ overall assessment of their condition was no better than those treated with non-steroidal anti-inflammatory drugs (NSAIDs).

Patients taking a lower 2.5 mg dose of tanezumab did not have any significant improvement in their pain, quality of life or overall condition. And 3.2% experienced rapidly progressive osteoarthritis.

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“We are analyzing these findings in the context of the recent Phase 3 results as we assess potential next steps for tanezumab,” Ken Verburg, Pfizer Global Product Development, said in a statement. “We plan to review the totality of data from our clinical development program for tanezumab with regulatory authorities.”

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases as a result of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from reaching the brain.

Tanezumab was considered so promising a therapy that it was given fast track designation from the FDA in 2017, a process that speeds up the development of new therapies to treat serious conditions.

Ironically, it was the FDA that slowed the development of NGF inhibitors in 2010 because of concerns that tanezumab made osteoarthritis worse in some patients. Most clinical studies of tanezumab did not resume until 2015.

The reappearance of the same safety issue and the marginal pain relief provided by tanezumab could be the last straw for the drug, according to one analyst.

“It is hard for us to imagine how these results could have been much worse. Pfizer indicated that they ‘plan to review the totality of data’ with regulatory authorities, which suggests to us that the co-sponsors will try to find a way to resurrect the program for some subset or sub-population of patients, but recognizes that this result puts the drug’s entire future in doubt,” SVB Leerink research analyst Geoffrey Porges said in a note to clients.

A clinical study of fasinumab, another NGF inhibitor being developed by Teva and  Regeneron Pharmaceuticals, was stopped by the FDA in 2016 after a patient showed signs of severe joint disease. Regeneron and Teva are continuing to study fasinumab in patients with chronic low back pain.

Pfizer and Eli Lilly are also studying tanezumab as a treatment for low back pain, and reported promising results from a Phase 3 trial in February. Rapidly progressive osteoarthritis was also reported in a small number of patients involved in that study.

Doctors Say Guidelines Exaggerate Effectiveness of Lyrica and Neurontin

By Pat Anson, PNN Editor

There is little evidence that gabapentin (Neurontin) and pregabalin (Lyrica) should be used off-label to treat pain and prescribing guidelines often exaggerate their effectiveness, according to a new clinical review in JAMA Internal Medicine.

Gabapentin and pregabalin belong to a class of nerve medication known as gabapentinoids. The drugs were originally developed to prevent seizures, but their use has tripled over the past 15 years as more doctors prescribed them for a variety of chronic pain conditions. It is a common practice for doctors to prescribe drugs “off label” for treatments that are not FDA-approved.

“Gabapentinoids have become frequent first-line alternatives in patients with chronic pain from whom opioids are being withheld or withdrawn, as well as in patients with acute pain who traditionally received short courses of low-dose opioid,” wrote Christopher Goodman, MD, and Allan Brett, MD, of the University of South Carolina School of Medicine.

“The evidence to support off-label gabapentinoid use for most painful clinical conditions is limited. For some conditions, no well-performed controlled trials exist.”

Gabapentin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder.  Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries, but it is also widely prescribed off-label to treat other types of pain.

The drugs are sold by Pfizer under the brand names Lyrica and Neurontin. The company has paid nearly $1 billion in fines for misleading and improper marketing of the drugs for off-label use.

“Despite documentation that these drugs were promoted improperly for off-label treatment of pain, the recent rapid increase in prescribing of gabapentinoids suggests a persisting sense among clinicians that gabapentinoids are highly effective pain medications,” the doctors wrote.

“Guidelines and review articles have contributed to this perception by often uncritical extrapolation from FDA-approved indications to off-label use.”

Goodman and Brett say the wording in many medical guidelines “reinforces an inflated view of gabapentinoid effectiveness” by falsely claiming the drugs should be used to treat all types of nerve pain.

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“Another example is the 2016 guideline on opioid prescribing from the U.S. Centers for Disease Control and Prevention, which states broadly that gabapentin and pregabalin are first-line drugs for neuropathic pain, without further detail or specification,” they wrote. “Even for treatment of diabetic neuropathy (for which pregabalin is FDA approved and gabapentin is off-label), guideline conclusions tend to exaggerate effectiveness.”

Many patients who take gabapetinoids have side-effects such as dizziness or drowsiness, and there are an increasing number of reports that the drugs are being abused and sold on the street.   

Goodman and Brett have sounded the alarm before about the drugs, warning in a 2017 commentary in the The New England Journal of Medicine that “gabapentinoids are being prescribed excessively.”

They say doctors should do a better job warning patients about the side effects of gabapentinoids and the drugs should be stopped if a patient reports little or no benefit.  They also think medical guidelines should be revised to stop the promotion of gabapentinoids for any pain labeled as neuropathic.

New Non-Opioid Drug Effective in Treating Low Back Pain

By Pat Anson, PNN Editor

Pfizer and Eli Lilly have announced positive results from a large Phase 3 study evaluating an experimental non-opioid pain reliever as a treatment for chronic low back pain.

Patients receiving 10 mg injections of tanezumab showed statistically significant improvement in back pain at 16 weeks compared to placebo. A lower dose of tanezumab 5 mg was not as effective. Over 1,800 people with chronic low back pain in North America, Europe and Asia participated in the study.

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body because of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

"This study demonstrates the potential of tanezumab to treat individuals suffering from moderate-to-severe chronic low back pain who have been unable to achieve relief with currently available medicines," said Ken Verburg, Pfizer’s tanezumab development team leader.

“This is one of the longest studies conducted to date in chronic low back pain. We look forward to further analyzing these results, and believe the data from this study will support our planned future global regulatory submissions in chronic low back pain."

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Pizer and Eli Lilly have also reported positive findings in evaluating tanezumab for the treatment of osteoarthritis. The Food and Drug Administration granted “fast track” designation to tanezumab in 2017 to help speed its development.

Tanezumab has a history of safety concerns. Clinical studies were halted in 2010 after Pfizer reported some osteoarthritis patients receiving the drug had worse symptoms and needed joint replacement surgery. Another safety issue arose in 2012 when tanezumab caused adverse changes in the nervous system of animals.  Most clinical studies of tanezumab did not resume until 2015.

In the current study, rapidly progressive osteoarthritis (RPOA) was observed in 1.4 percent of patients receiving tanezumab and 0.1 percent of patients in the other treatment groups. Joint fractures and total joint replacements were experienced in 0.4 percent and 0.7 percent of tanezumab-treated patients, respectively, while none were observed in the other treatment groups.

In addition to back pain, the ongoing Phase 3 program for tanezumab includes studies in osteoarthritis pain and cancer pain due to bone metastases.

Can Gabapentin Improve Your Sex Life?

By Pat Anson, PNN Editor

Over the years the nerve drug gabapentin (Neurontin) has been used to treat a cornucopia of chronic pain conditions, from fibromyalgia and diabetic neuropathy to hot flashes and shingles.

Gabapentin is so widely prescribed that a Pfizer executive once called the drug “the snake oil of the twentieth century” because researchers found it successful in treating just about everything they studied.

Add sexual function to the list.

In a small study, researchers at Rutgers University found that gabapentin improved sexual desire, arousal and satisfaction in 89 women with provoked vulvodynia, a chronic condition characterized by stinging, burning and itching at the entry to the vagina. Vulvar pain often occurs during intercourse, which leads to loss of interest in sex.

The improvements in desire, arousal and sexual satisfaction were small, but considered “statistically significant” in research parlance. Gabapentin did not improve lubrication or orgasm.

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"Our theory was that reducing pelvic floor muscle pain might reduce vulvodynia pain overall and thus improve sexual function," said Gloria Bachmann, MD, director of the Women's Health Institute at Rutgers and lead author of the study published in the Journal of Obstetrics and Gynecology.

"We found that women with greater muscle pain responded better in terms of pain and improved arousal than those with less pain, which suggests that Gabapentin be considered for treatment in women who have significant muscle tightness and spasm in the pelvic region.”

Does this mean gabapentin is a female version of Viagra? Not necessarily, says Bachmann, who stressed that the study only focused on women with vulvodynia.

“We didn't research the question of gabapentin enhancing sexual function in all women,” Bachmann wrote in an email to PNN. “The decision to give gabapentin to a woman who reports chronic vulvar pain and sexual dysfunction would have to be made on an individual basis, depending on her medical history and the results of her physical and pelvic examination.

“From the data, it appears that women with increased muscle tenderness of the pelvic floor may be the group who benefit most from gabapentin.”

Sales of gabapentin have soared in recent years — not because it improves sexual satisfaction — but because it is seen as a safer pain reliever than opioid medication.

Patients prescribed gabapentin often complain of side effects such as mood swings, depression, dizziness, fatigue and drowsiness.  Drug abusers have also discovered that gabapentin can heighten the effects of heroin, cocaine and other illicit substances, and it is increasingly being abused.

Lyrica Not Effective for Treating Traumatic Nerve Pain

By Pat Anson, Editor

Pregabalin is not effective in relieving chronic pain caused by traumatic nerve injury, but it may be useful as an analgesic in treating pain after surgery, according to a new study published in the Journal of Neurology.

The placebo-controlled study followed 539 patients in North America, Europe, Africa and Asia for three months. About half had nerve pain after surgery, while the rest had nerve pain after an accident or trauma.

Researchers found that pregabalin was not an effective pain reliever for the patients with traumatic nerve injuries, but the drug did provide better pain relief than placebo for the surgery patients.

"While these finding show that pregabalin is not effective in controlling the long-term pain for traumatic injury, it may provide relief for patients (that) experience post-surgical pain," said lead author John Markman, MD, director of the Translational Pain Research Program in the University of Rochester Department of Neurosurgery.

"The possibility that there was pain relief for those patients who had a hernia repair, or breast surgery for cancer, or a joint replacement lays the groundwork for future studies in these post-surgical syndromes where there is so much need for non-opioid treatments."

Pregabalin, which is sold by Pfizer under the brand name Lyrica, is FDA-approved for the treatment of chronic pain associated with shingles, spinal cord injury, fibromyalgia, and diabetic peripheral neuropathy.

It is also commonly prescribed as an "off label" treatment for other types of chronic pain and as an alternative to opioid medication.

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A major challenge for doctors is that biological changes in nerves and other tissues while healing from surgery or trauma vary from one patient to the next. There is also no diagnostic method that allows doctors to identify which patients will respond to a particular type of pain treatment.

"Given the rising rates of surgery and shrinking reliance on opioids, it is critical that we understand how to study new drugs that work differently in patients like the ones included in this study," Markman added.

While critics often say there is little or no evidence to support the long-term use of opioids, the same is true for other types of pain medication, including pregabalin. Nevertheless, in its guideline for opioids, the Centers for Disease Control and Prevention recommends pregabalin and its chemical cousin gabapentin as alternatives for treating chronic pain – without even mentioning their side effects or potential for abuse.

Pregabalin and gabapentin belong to a class of nerve medication called gabapentinoids, which were originally developed to treat epilepsy, not pain. In recent, deaths involving gabapentinoids have increased in the UK, Australia and Canada, where some addicts have learned the drugs can heighten the euphoric effect of heroin and other opioids.

The use of pregabalin and gabapentin has tripled in the U.S. over the past decade, but health officials have only recently started looking into their misuse and abuse. While gabapentin has a warning label cautioning users who take the drug with opioids, there is no similar warning for pregabalin.

Studies Warn of Pregabalin Deaths

By Pat Anson, Editor

Two new studies – one in Canada and one in Australia – should give pause to patients who use opioids and pregabalin (Lyrica), an anticonvulsant medication increasingly prescribed for fibromyalgia, neuropathy and other chronic pain conditions. Both studies found a number of overdose deaths that involve – but were not necessarily caused -- by pregabalin.

The Canadian study, published in the Annals of Internal Medicine, looked at over 1,400 patients in Ontario on opioid medication from 1997 to 2016 who died from opioid-related causes. Another group of over 5,000 surviving opioid patients was used as a control group.

Researchers found that patients who were co-prescribed opioids and pregabalin had a significantly higher risk of an overdose.

The risk of death was over two times higher for patients receiving opioids and a high dose of pregabalin (over 300mg) compared to those who took opioids alone.

Patients on a low or moderate dose of pregabalin also had a heightened risk, although not as large.

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Researchers say pregabalin has a sedative effect and may interact with opioids in ways that increase respiratory depression. Few doctors and patients are aware of the risk, even though over half of Ontario residents who begin pregabalin therapy are also prescribed an opioid.

"There is an important drug interaction between opioids and pregabalin that can lead to increased risk of fatal overdose, particularly at high doses of pregabalin," lead author Tara Gomes, PhD, of the Institute for Clinical Evaluative Sciences (ICES) and St. Michael's Hospital in Toronto, told MedPage Today.

"Clinicians should consider carefully whether to prescribe opioids and pregabalin together. If they decide that both medications are clinically appropriate, they should start with low doses and monitor their patients closely."

Lyrica (pregabalin) and Neurontin (gabapentin) are both made by Pfizer and belong to a class of anticonvulsant nerve medication called gabapentinoids. Sales of gabapentinoids have tripled in recent years, in part because of CDC prescribing guidelines that recommend the drugs as alternatives to opioid medication.  

U.S. health officials have only recently started looking into the misuse and abuse of gabapentinoids, which are increasingly used by addicts to enhance the euphoric effects of heroin and other illicit opioids. While gabapentin  has a warning label cautioning users who take the drug with opioids, there is no similar warning for pregabalin.

“Although current product monographs for gabapentin contain warnings about serious adverse events when this agent is combined with opioids, those for pregabalin do not. The importance of our finding warrants a revision of the pregabalin product monographs,” wrote Gomes.

Pregabalin Abuse in Australia

Health officials in Australia are also concerned about the growing use of pregabalin.  Researchers at the NSW Poisons Information Centre say poisoning cases involving pregabalin rose from zero in 2005 to 376 cases in 2016.

“Our study shows a clear correlation between the rapid and continuous rise of pregabalin dispensing and an increase in intentional poisonings and deaths associated with pregabalin,” said lead author Dr. Rose Cairns, a specialist at the NSW Poisons Information Centre.

According to the Australian Journal of Pharmacy (AJP), there have been 88 recorded deaths associated with pregabalin in recent years. Most of the deaths involved young, unemployed males who had a history of substance abuse, particularly with opioids, benzodiazepines, alcohol and illicit drugs.

“We believe that Australian doctors may not be aware of the abuse potential of pregabalin,” Cairns said. “Most patients who are prescribed this medication are in the older population but the group who are at high risk of overdosing are much younger. These people are likely to have been prescribed pregabalin despite having a history of substance abuse.”

According to researchers, up to two-thirds of people who intentionally misused pregabalin had a prior documented substance abuse history. “Prescribers need to consider this growing body of evidence that pregabalin has abuse potential before prescribing, especially to patients with substance abuse history,” said Cairns.

Pfizer did not respond to a request for comment on the Canadian and Australian studies.

Positive Findings for New Osteoarthritis Drug

By Pat Anson, Editor

Pfizer and Eli Lilly have announced positive findings in treating osteoarthritis pain with an experimental non-opioid drug that has a history of safety concerns.  

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body because of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

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In the 16-week clinical study, osteoarthritis patients who were given two injections of tanezumab had significant improvement in their pain, physical function and assessment of their symptoms compared to a placebo. Osteoarthritis is a joint disorder that leads to thinning of cartilage and progressive joint damage.

“There is a substantial need for innovative new treatment options for osteoarthritis, as many patients are unable to find relief with currently available medicines and continue to suffer,” Ken Verburg of Pfizer Global Product Development said in a statement.

“We are encouraged by these results, which speak to the potential of tanezumab as a non-opioid treatment option for pain reduction and improvement in physical function.”

Preliminary safety data showed that tanezumab was generally well tolerated, with about 1% of patients discontinuing treatment due to adverse events. Rapidly progressive osteoarthritis was observed in about 1.5% tanezumab-treated patients, but none in the placebo arm.

The U.S. Food and Drug Administration granted “fast track” designation to tanezumab last year to help speed its development as a new treatment for osteoarthritis and chronic low back pain.

Ironically, it was the FDA that slowed the development of NGF inhibitors in 2010 after Pfizer reported some osteoarthritis patients receiving tanezumab experienced worsening of their disease and needed joint replacements. Another safety issue arose in 2012 because the drug caused “adverse changes in the sympathetic nervous system of mature animals.”  Most clinical studies of tanezumab did not resume until 2015.

“We look forward to continuing to advance tanezumab in our ongoing global Phase 3 development program, which includes six studies in approximately 7,000 patients with osteoarthritis, chronic low back pain and cancer pain,” said Christi Shaw, senior vice president of Eli Lilly. In studies to date, tanezumab has not demonstrated a risk of addiction, misuse or dependence.

Regeneron recently halted high-dose trials of fasinumab, another NGF inhibitor, because the risk of harm outweighed the benefits of the drug. There is some concern that NGF antibodies work too well and encourage osteoarthritis patients to become more active, which accelerates joint deterioration.

Lyrica and Neurontin Ineffective for Low Back Pain

By Pat Anson, Editor

Lyrica, Neurontin and other anti-convulsant drugs are ineffective for treating low back pain and may even be harmful to patients, according to a new study published in the Canadian Medical Association Journal.

Prescriptions for anti-convulsant drugs have soared in recent years, as doctors seek “safer” alternatives to opioid pain medication.  Lyrica (pregabalin) and Neurontin (gabapentin) belong to a class of anti-convulsant nerve medications known as gabapentinoids. They are primarily used for treating nerve pain and fibromyalgia, but are increasingly being prescribed off-label to treat lower back and neck pain.

Australian researchers reviewed 9 placebo-controlled randomized trials and found high quality evidence that gabapentinoids did not reduce back pain or disability and often had side effects such as drowsiness, dizziness and nausea.

“The take-home message is that anti-convulsants are not effective and can lead to adverse effects in people with low back pain and radiating leg pain (eg, sciatica), so they should not be recommended to this patient population,” lead author Oliver Enke, MD, a researcher at the University of Sydney Medical School, told Helio Family Medicine.

Low back pain is the world’s leading cause of disability. Guidelines for treating low back pain usually recommend physical therapy, exercise and non-opioid pain relievers rather than stronger analgesics such as opioids or anti-convulsants.

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A 2017 study published in PLOS Medicine also warned that pregabalin and gabapentin were ineffective for low back pain and have a “significant risk of adverse effects.” 

PNN readers often complain about side effects from Lyrica and Neurontin.

“I have used both medicines and neither help with lower back pain for me,” said Sheri. “I will say the mental confusion and memory loss on Lyrica is very real, but it takes a slight edge of pain away in my body as a whole from the fibromyalgia.”

“I can vouch that Lyrica does not help with back pain,” said Debra. “It helped with the nerve pain but I thought I was literally losing my mind. I couldn't remember simple words or synonyms for words.”

“I've been taking gabapentin for almost six months; it has helped my peripheral neuropathy, but I still suffer every day from arthritis in every joint of my body, including my lower back,” another reader wrote.

Lyrica and Neurontin are both made by Pfizer and are two of the company’s top selling drugs, generating billions of dollars in sales annually. Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles, and spinal cord injuries.

Neurontin is approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but is also widely prescribed off-label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses. About 68 million prescriptions were written for gabapentin in the U.S. last year, compared to 44 million in in 2013.

There have been increasing reports of gabapentinoids being abused by drug addicts, who have learned they can use the medications to heighten the high from heroin, marijuana, cocaine and other substances. Gabapentin is not currently scheduled as a controlled substance by the DEA, while pregabalin is classified as a Schedule V controlled substance, meaning it has a low potential for addiction and abuse.  

Growing Abuse of Gabapentin

By Christine Vestal, Stateline

Doctors who are cutting back on prescribing opioids increasingly are opting for gabapentin, a safer, non-narcotic drug recommended by the Centers for Disease Control and Prevention.

By doing so, they may be putting their opioid-using patients at even greater risk.

Recently, gabapentin has started showing up in a substantial number of overdose deaths in hard-hit Appalachian states. The neuropathic (nerve-related) pain reliever was involved in more than a third of Kentucky overdose deaths last year.

Drug users say gabapentin pills, known as “johnnies” or “gabbies,” which often sell for less than a dollar each, enhance the euphoric effects of heroin and when taken alone in high doses can produce a marijuana-like high.

Medical researchers stress that more study is needed to determine the role gabapentin may have played in recent overdose deaths. However, a study of heroin users in England and Wales published last fall concluded that combining opioids and gabapentin “potentially increases the risk of acute overdose death” by hampering breathing and reversing users’ tolerance to heroin and other powerful opioids.

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Kentucky last year classified gabapentin as a controlled substance, making it harder for doctors to prescribe it in copious quantities and for long durations. The new classification also allows police to arrest anyone who illicitly sells the drug, although the state’s drug control chief, Van Ingram, said that was not the intent of the new law.

In the last two years, Illinois, Ohio, Massachusetts, Minnesota, Tennessee, Virginia and Wyoming also have moved to control the flow of gabapentin by requiring doctors and pharmacists to check a prescription drug database before prescribing it to patients to make sure they aren’t already receiving gabapentin, or some other medication that interacts with it, from another physician.

In a statement to Stateline, Pfizer communications director Steven Danehy said, “Reports of misuse and abuse with this class of medicines are limited and typically involve patients with a prior history of substance abuse, including opioids.”

The drugmaker also pledged to “continue working with regulatory authorities and health officials to evaluate and monitor the safety of these medicines.”

Prescribed for Many Conditions

Approved by the FDA in 1993 for the treatment of epilepsy and the nerve pain associated with shingles, gabapentin is sold by Pfizer under the brand name Neurontin. A generic form of the drug has been available since 2004 and is now sold by several other companies as well.

Gabapentin is now one of the most popular prescription drugs in the United States, according to the New England Journal of Medicine. It was the 10th-most-prescribed medication in 2016. Its more expensive cousin, pregabalin, sold as Lyrica and also made by Pfizer, was the eighth best-selling.

Many doctors recommend gabapentin to patients for a long list of disorders, including hot flashes, migraines, restless leg syndrome, fibromyalgia, and neuropathic pain associated with diabetes and spinal injuries. Some doctors also prescribe it for anxiety and insomnia.

Now, research is underway to determine whether gabapentin may be effective as a treatment for alcoholism.

Already, it is widely used to ease the symptoms of drug and alcohol detoxification. And addiction specialists routinely use gabapentin to manage pain in people who are either addicted or at risk of addiction to opioids and other substances.

Alone, high doses of gabapentin have not been found to affect breathing. The vast majority of gabapentin deaths, about 4 in 5, also involved opioids, according to the journal Addiction.

People who stop taking the medication abruptly, however, can suffer withdrawal symptoms such as trembling, sweats and agitation.

In February, Food and Drug Administration director Scott Gottlieb said the agency was reviewing the misuse of gabapentin and, for now, had determined no action was necessary. Similarly, the CDC has not issued a warning about gabapentin, nor has the Drug Enforcement Administration.

(Editor's note: the CDC opioid guidelines recommend gabapentin without any mention of the risk of abuse or overdose associated with the drug, or of possible side effects such as weight gain, anxiety and mood disorders.)

Early Signs of Abuse

In Kentucky, Ingram said it has been clear to police and pharmacists for the last three or four years that gabapentin was becoming an increasingly popular street drug. “People were seeking early refills, claiming they lost their prescriptions and openly conducting transactions in parking lots outside of drug stores,” he said.

But since it wasn’t a controlled substance, nothing was done about it. That’s likely to start changing with the new law, he said.

“Misuse of gabapentin is just one more collateral effect of the opioid epidemic,” said Caleb Alexander, an epidemiologist at Johns Hopkins University who has been studying the heroin and prescription drug epidemic. When one drug becomes less available, drug users historically seek out alternatives, he said. “What is most surprising is the sheer magnitude of its use.”

The share of Appalachian drug users who reported using gabapentin to get high increased nearly 30-fold from 2008 to 2014, according to a 2015 study in the American Journal of Psychiatry.

Paul Earley, an addiction doctor practicing in Georgia and a board member of the American Society of Addiction Medicine, said, “We knew that a small subset of our addiction patients would abuse gabapentin.” But he said it wasn’t until 2016, when Ohio sounded an alarm about the drug’s association with overdose deaths, that addiction doctors started taking the problem more seriously.

“For years, we considered gabapentin to be ‘good for what ails you,’” Earley said. “But I’m much more cautious than I used to be. If there’s anything we’ve learned from the opioid epidemic, it’s that we need to rethink how we prescribe drugs we once assumed were safe.”

This is story is republished with permission by Stateline, an initiative of The Pew Charitable Trusts.