American Pain Society Files for Bankruptcy

By Pat Anson, PNN Editor

The American Pain Society (APS) filed for bankruptcy Friday after an overwhelming vote by its members to dissolve the financially troubled medical organization. In a membership vote last month, 93% voted in favor of a recommendation by the APS board of directors to file a voluntary petition for Chapter 7 bankruptcy.

The APS is a non-profit, research-based organization that focuses on the causes and treatment of acute and chronic pain. Although many of its members are researchers and academics who are investigating non-opioid treatments for pain, the APS was targeted as a defendant by Simmons Hanly Conroy and several other law firms seeking to recover billions of dollars in damages in opioid litigation cases.

In a press release, APS said efforts to resolve the “meritless” lawsuits without lengthy and expensive litigation were unsuccessful.

“It’s the perfect storm and now pointless to continue operations just to defend against superfluous lawsuits.  Our resources are being diverted to paying staff to comply with subpoenas and other requests for information and for payment of legal fees instead of funding research grants, sponsoring pain education programs, and public policy advocacy,” APS President William Maixner, DDS, said in a statement.

“As a result, the Board of Directors no longer believes APS can continue to fulfill its mission and meet the needs of our members and the pain care community.”

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Press coverage of the APS often parroted what the opioid lawsuits alleged. The Guardian, for example, called the APS a “pawn of big pharma” and claimed the organization “pushed doctors to prescribe painkillers.”

The Guardian’s coverage was based largely on a report by Sen. Claire McKaskill (D-MO), who accepted over $400,000 in campaign donations from Simmons Hanly in her failed bid for re-election in 2018. APS is named as a defendant in several opioid lawsuits filed by Simmons Hanly, which stands to make hundreds of millions of dollars in contingency fees if the lawsuits are successful. The Guardian failed to mention any connection between Simmons Hanly and McKaskill.

The APS’ bankruptcy filing likely brings an end to its monthly publication, The Journal of Pain, which has been rated among the top five scientific journals in pain science. The current issue features research articles on diverse topics such as meditation for low back pain, diagnostic codes for fibromyalgia, whether opioids are effective for chronic noncancer pain, and the use of virtual reality to relieve arm pain.

“APS has been advocating for increased investment in research for many years, and it is particularly ironic that APS’s voice will go silent at this critical time in our history, when increased investment in pain research has finally become a reality in an effort to combat the opioid crisis,” said Roger Fillingim, PhD, an APS past president and professor of psychology at the University of Florida School of Dentistry.  

“There is a sad irony that the professional organization best poised to provide the spectrum of science to improve the prevention and treatment of pain and related substance abuse is defunct,” said APS President-elect Gary Walco, PhD, director of pain medicine at Seattle Children’s Hospital.

“Now, more than ever, our nation needs the collective efforts of leading scientists and clinicians who hold patients’ well-being at the highest premium.  The principal focus on punishing those in industry that may have contributed to the problem is shortsighted and far from sufficient.”

The APS is the second professional pain management organization to cease operations this year. In February, the Academy of Integrative Pain Management (AIPM) also shutdown. Opioid litigation has not only been costly for APS and AIPM, it has contributed to steep declines in financial support from pharmaceutical companies for other pain organizations, medical conferences and patient advocacy groups.   

American Pain Society Likely to File for Bankruptcy

By Pat Anson, PNN Editor

The board of directors of the American Pain Society (APS) is recommending to its members that the organization cease operations and file for bankruptcy, PNN has learned.

The APS is a non-profit, research-based organization that focuses on the causes and treatment of acute and chronic pain. Although many of its members are researchers and academics who are investigating non-opioid treatments for pain, the APS has been named as a defendant in numerous “spurious lawsuits” involving opioid prescriptions.

“Despite our best efforts, APS was unsuccessful in its attempts to resolve these lawsuits without the need for what will no doubt be lengthy and expensive litigation. The anticipated time-consuming and costly litigation combined with the declining membership and meeting attendance has created the perfect storm placing APS in a precarious financial position,” the board said in a letter sent to its members yesterday.

“Constrained by these unfortunate circumstances, we do not believe APS can continue to fulfill its mission and meet the needs and expectations of our members and community.”   

In order to proceed with a Chapter 7 bankruptcy filing, only 10% of the organization’s 1,173 active members need to approve the board’s recommendation. Assuming there are sufficient votes, an independent third party trustee would then be appointed by a bankruptcy judge and all lawsuits pending against APS will be subject to an automatic stay.

“This will allow APS to minimize legal expenses and maximize recoveries for its creditors, as opposed to future dissipation of assets in defending the lawsuits which have no end in sight,” the board wrote.

The APS membership vote will be tallied May 29th.

Sad day for U.S. pain research, education, advocacy and patient care,” APS member and Stanford University psychologist Beth Darnall, PhD, tweeted to her followers.

In recent years, thousands of lawsuits have been filed by states, cities and counties seeking to recover billions of dollars in damages caused by the “overprescribing” of opioid pain medication. The lawsuits initially focused on Purdue Pharma and other opioid manufacturers, but have recently expanded to include opioid distributors, wholesalers, pharmacies and professional medical organizations like the APS as defendants.

If the APS files for bankruptcy, it would be the second pain management organization to cease operations in recent months. In February, the Academy of Integrative Pain Management (AIPM) shutdown, largely due to financial problems.  

“It's really sad that pain organizations are failing,” said Bob Twillman, PhD, the former Executive Director of AIPM. “I'm not clear about the extent to which this was an anticipated or desired outcome of the lawsuits against opioid manufacturers, but it strikes me that an effort to say that we've been harming people by treating pain the wrong way has now eliminated two organizations focused on treating pain the way every guideline now says it should be treated, and on discovering new treatments that might obviate the need for opioids.”

Twillman says the shutdown of APS and AIPM will cause “significant gaps in the field” of pain management.

“The unintended consequences here may end up being quite ironic," he added.

Guilt by Association 

Like other professional medical organizations, APS relied on corporate donors to help pay for its annual meetings and widely respected publication, The Journal of Pain. That meant accepting nearly $1 million in donations from Purdue Pharma, Janssen, Depomed and other opioid manufacturers.

It also meant being targeted by lawyers and politicians in a campaign of guilt by association.

In 2018, APS was one of the medical societies and patient advocacy groups singled out by Missouri Sen. Claire McCaskill (D) in a Senate report that accused the organizations of being mouthpieces for opioid manufacturers. 

“Initiatives from the groups in this report often echoed and amplified messages favorable to increased opioid use — and ultimately, the financial interests of opioid manufacturers,” the report found.

McCaskill’s report failed to mention that she accepted nearly $500,000 in campaign donations since 2005 from the national law firm of Simmons Hanly Conroy, which represents many of the plaintiffs involved in opioid litigation. It has named the APS as a defendant in several of those lawsuits, along with American Academy of Pain Medicine and American Geriatric Society “for working with the manufacturing defendants in promoting opioids to doctors and patients.”

Simmons Hanly Conroy was the third largest contributor to McKaskill during her losing bid for re-election last year, donating over $400,000, an amount seven times larger than it gave to another candidate in 2018, according to OpenSecrets.org.

According to its website, Simmons Hanly Conroy currently represents governmental entities in Illinois, Louisiana, Texas, and eight New York counties in opioid lawsuits. The law firm reportedly stands to collect one-third of the proceeds from opioid settlements, which could potentially reach $50 billion, according to a Bloomberg analyst.

‘Corrupting Influence’

APS is also mentioned in a congressional report released this week by Reps. Katherine Clark (D-MA) and Hal Rogers (R-KY). The “Corrupting Influence: Purdue and the WHO” report accuses the World Health Organization of being unduly influenced by Purdue Pharma and other opioid makers when it developed guidelines in 2011 and 2012 to treat pain in adults and children.

“The web of influence we uncovered, combined with the WHO’s recommendations, paints a picture of a public health organization that has been manipulated by the opioid industry,” the report said. “The investigation revealed that multiple organizations that claimed to be independent patient advocacy groups, including the American Pain Society, received significant payments from opioid manufacturers.”

The report does not mention that Rep. Clark has also accepted significant payments from drug makers. According to OpenSecrets.com, Clark has received over $522,000 in campaign donations from the healthcare industry since 2013, including donations from Pfizer, Celgene, Takeda, Biogen, Vertex, AstraZeneca and Sanofi.

Rep. Rogers has received over $581,000 in campaign donations from the healthcare industry during his 30 years in Congress.

Post-Surgical Pain Guidelines Reduce Use of Opioids

By Pat Anson, Editor

The American Pain Society (APS) has released new guidelines for post-surgical pain management that encourage physicians to limit the use of opioids and offer “multimodal therapies” to patients suffering from postoperative pain.

According to studies, more than half of patients who undergo surgery receive inadequate pain relief, which can heighten the risk of developing chronic pain, mood disorders and disability.

The 32 recommendations were developed by a panel of nearly two dozen experts that reviewed over 6,500 scientific studies. Most of the recommendations were adopted unanimously.

“The intent of the guideline is to provide evidence-based recommendations for better management of postoperative pain, and the target audience is all clinicians who manage pain resulting from surgery,” said lead author Roger Chou, MD, a prominent researcher who also co-authored the proposed opioid prescribing guidelines developed by Centers for Disease Control and Prevention.

Like the CDC guidelines, the APS guidelines encourage the use of non-pharmacological therapies and non-opioid medications, such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentin (Neurotin) and pregabalin (Lyrica). Those treatments would be used along with opioids for post-operative pain.

“Because of the availability of effective non-opioid analgesics and non-pharmacologic therapies for postoperative pain management, the panel suggests that clinicians routinely incorporate around the clock non-opioid analgesics and non-pharmacologic therapies into multimodal analgesia regimens,” the guideline states.

“Systemic opioids might not be required in all patients. One study suggests that it should be avoided when not needed, because limited evidence suggests that perioperative opioid therapy might be associated with increased likelihood of long-term opioid use, with its attendant risks.”

Chou says using multiple approaches to pain management provides better pain relief than a single analgesic.

“Randomized trials have shown that multimodal anesthesia involving simultaneous use of combinations of several medications -- acting on different pain receptors or administered through different techniques -- are associated with superior pain relief and decreased opioid consumption compared with use of a single medication administered by one technique,” Chou said.

The APS panel also recommends that non-pharmacological therapies, such as cognitive behavioral therapy and transcutaneous elective nerve stimulation (TENS), can be used as effective adjuncts to pain medication.

Other recommendations in the APS guidelines include:

  • Adults and children can be given acetaminophen and/or NSAIDs for postoperative pain management
  • Oral administration of opioids is preferred over intravenous (IV) administration
  • Spinal analgesia (epidurals) is appropriate for major thoracic and abdominal procedures
  • Use of benzodiazepines, tramadol and ketamine is not recommended for postoperative pain.
  • Clinicians should consider giving preoperative doses of celecoxib (Celebrex) to adult patients
  • Gabapentin (Neurotin) and pregabalin (Lyrica) can be considered for postoperative pain relief.  The drugs are associated with lower opioid requirements after surgery.

The guidelines recommend the physicians consult with a pain management specialist when a patient has a tolerance for opioids, or a history of substance abuse or addiction.

“Adequate pain treatment should not be withheld from patients with active or previous opioid addiction because of fears of worsening addiction or precipitation of relapse. In addition to the ethical requirement to address postoperative pain, poorly treated pain can be a trigger for relapse,” the guidelines say. “An interdisciplinary approach using pharmacologic and nonpharmacologic interventions might be required to achieve successful postoperative outcomes and should be considered as part of the perioperative management plan in these patients.”

The APS post-operative pain guidelines, which are being published in the Journal of Pain, was endorsed by the American Society for Regional Anesthesia. A link to the guidelines can be found here.

Why Doctors Are Slow to Embrace Medical Marijuana

By Pat Anson, Editor

Public attitudes toward marijuana have changed considerably in recent years. Voters and legislators in 23 states and the District of Columbia have legalized medical marijuana, and nationwide polls show that most Americans now support legalization.

But the nation’s medical organizations – while intrigued about the potential for marijuana to treat conditions like chronic pain – have been slow to embrace cannabis. And most doctors still refuse to prescribe it, even in states where marijuana is legal.

Those conflicting attitudes were on display last week at the annual meeting of the American Pain Society (APS) in Palm Springs, California – a conference focused on pain research. Although the APS has no stated policy on marijuana, the organization chose as its keynote speaker one of the most prominent medical marijuana researchers in the world, Dr. Mark Ware.

“I’ve done presentations and sessions, and it always surprises people how much interest there is,” said Ware, who is a family physician and associate professor in Family Medicine and Anesthesia at McGill University in Montreal.

“Cannabis gives people a window to come and learn, and while they’re learning about medical cannabis they can be learning about pain management and other things. It’s a very useful magnet to get people interested in a topic that’s obviously of enormous public importance.”

DR. MARK WARE SPEAKING AT THE APS CONFERENCE

DR. MARK WARE SPEAKING AT THE APS CONFERENCE

Ware’s two presentations at the APS conference were well-attended, but it was mostly researchers – not practicing physicians – who were listening.

“A lot of doctors are afraid to authorize it (marijuana) because they’re afraid of losing their licenses and their practices. So there’s a lot of fear and a lot of stigma,” Ware told Pain News Network.

“I think the researchers themselves are seeing opportunities, with changing state laws and increasing evidence of efficacy, that suddenly this is becoming a drug that can be taken a bit more seriously. And I think that’s giving rise to the opportunity that maybe there’s some work we can be doing here.”

Federal laws making marijuana illegal – which are still in effect – have stymied serious research into its medical benefits. Most of the evidence so far is anecdotal or the result of small academic studies – not the in-depth and expensive clinical research that pharmaceutical companies have to conduct to get FDA approval for their drugs.

“There’s still work to be done on the safety and efficacy of these cannabinoid compounds,” says Gregory Terman, MD, an anesthesiologist who is president of the APS.  “They’re very interesting molecules. But they’re not approved for people and we don’t want to pretend they’re anywhere near ready for prime time.”

The APS currently has a committee working on a policy statement about medical marijuana.

“I think people are opening their eyes to the possibility,” said Terman. “Marijuana’s already out there, and that’s why we felt like it was important to work on a policy statement.”

The American Academy of Pain Management (AAPM) also doesn’t have a formal position on marijuana – although some members are urging the organization to take one.

“I think there’s no doubt there are substances in there that can be beneficial to some people with pain. It’s just a question of figuring out what they are and how do you get them extracted in a way so that we know what we’re giving people,” said Bob Twillman, PhD, executive director of the AAPM. “We haven’t settled on a policy because there are so many different variables and so much is up in the air that coming up with a good policy is hard to do.”

Twillman says he is being lobbied by some AAPM members to advocate for the rescheduling of marijuana from an illegal Schedule I controlled substance – the same classification the DEA has for heroin and LSD – to a Schedule II medication that can be prescribed to patients.

“I don’t think you can do that with a product like this because every batch is different. How do you standardize the dose that a patient is given? I think in a regulatory scheme of things it’s more like an herbal supplement than it is a drug,” Twillman told Pain News Network.

The American Medical Association, the nation’s largest medical group, has moderated its position on marijuana – from one of strict opposition to a grudging call for more research.

Our AMA calls for further adequate and well-controlled studies of marijuana and related cannabinoids in patients who have serious conditions for which preclinical, anecdotal, or controlled evidence suggests possible efficacy,” the AMA says in a policy statement.

“This should not be viewed as an endorsement of state-based medical cannabis programs, the legalization of marijuana, or that scientific evidence on the therapeutic use of cannabis meets the current standards for a prescription drug product.”

Until that research is done and federal laws change – which could take years – many practicing physicians are unlikely to endorse or prescribe a drug that is still technically illegal.

“I think there’s still this stigma and the lack of data and concerns about safety that will always plague that discussion as long as we don’t have it,” says Mark Ware.  “So I think there will be clinicians who will be early adopters who take this a bit more seriously and there will be others who will be almost religiously opposed to the idea. And I hope that starts to breakdown.”