Pain Warriors Unite - (202) 792-5600
As the country grapples with the opioid epidemic, there's been a broad crackdown on opioids in general. Now, HHS is urging doctors not to go too far in cutting off prescriptions. Other news on the crisis focuses on the court challenges to Purdue Pharma and other drugmakers.
The Associated Press: US Urges Shared Decisions With Pain Patients Taking OpioidsU.S. health officials again warned doctors Thursday against abandoning chronic pain patients by abruptly stopping their opioid prescriptions. The U.S. Department of Health and Human Services instead urged doctors to share such decisions with patients. The agency published steps for doctors in a six-page guide and an editorial in the Journal of the American Medical Association. (Johnson, 10/10)
The New York Times: Health Officials Urge Caution In Reducing Opioids For Pain PatientsAfter more than 300 medical providers, pharmacists, patient advocates and others emphasized these concerns in a letter to the C.D.C. earlier this year, the agency put out a clarifying statement saying the guidelines did not “support abrupt tapering or sudden discontinuation of opioids,” and warning doctors not to misapply them. The new tapering guide goes deeper, detailing the potential harms to patients who abruptly stop taking opioids and laying out factors to consider and steps to take before starting a taper. It includes several examples of tapering protocols. (Goodnough, 10/10)
NPR: Don't Force Patients Off Opioids Abruptly, New Guidelines Say, Warning Of Severe Risks"It must be done slowly and carefully," says Adm. Brett P. Giroir, MD, assistant secretary for health for HHS. "If opioids are going to be reduced in a chronic patient it really needs to be done in a patient-centered, compassionate, guided way." This is a course correction of sorts. In 2016, the Centers for Disease Control and Prevention issued prescribing guidelines. Those highlighted the risks of addiction and overdose and encouraged providers to lower doses when possible. In response, many doctors began to limit their pain pill prescriptions, and in some cases cut patients off. (Stone and Aubrey, 10/10)
The Washington Post: New Guidelines On Opioid Tapering Tells Doctors To Go SlowMillions of people in the United States — an estimated 3 to 4 percent of the adult population — take opioids daily. About 2 million people have been diagnosed with prescription opioid use disorder, according to HHS. There is a consensus in the medical community that these painkillers have been overprescribed and that many patients would have better long-term health outcomes if they cut back on their dosages and took advantage of other types of treatment, ranging from physical therapy to nonnarcotic painkillers. (Achenbach, 10/10)
Modern Healthcare: HHS Gives Physicians Guidance On Tapering Patients Off OpioidsHHS' assistant secretary for health Dr. Brett Giroir urged clinicians to collaborate with patients on deciding how fast they reduce or stop their opioid therapies. "We know that it is critical that clinicians manage acute and chronic pain in an individualized, patient-centered way," Giroir said. (Johnson, 10/10)
Stat: With A New Guide To Tapering Opioids, Federal Health Officials Seek A Balanced Approach To PrescribingThe anxiety around prescribing built in response to the opioid crisis, which drove more than 47,000 fatal overdoses in 2017 alone. The crisis was caused in part by some clinicians overprescribing the drugs, leading to cases of addiction in patients and a source of pills that were diverted. Prescribing levels have dropped since 2012, and some advocates have warned that the fear around opioids has left some patients unable to get them. (Joseph, 10/10)
HHS' assistant secretary for health Dr. Brett Giroir urged clinicians to collaborate with patients on deciding how fast they reduce or stop their opioid therapies.
"We know that it is critical that clinicians manage acute and chronic pain in an individualized, patient-centered way," Giroir said.
There have been numerous reports of individuals being abruptly cut off their medication regimen after the Centers for Disease Control and Prevention's Guideline for Prescribing Opioids for Chronic Pain in 2016, according to Giroir.
The CDC guidelines recommended clinicians prescribe opioids only after exhausting other pain therapies, prescribe the lowest effective dosage, evaluate patients within 1 to 4 weeks of starting opioid therapy for chronic pain, and taper or discontinue opioids if the harms OUTWEIGH the benefits.
"Clearly, we believe that there has been a misinterpretation of the [CDC] guidelines, which were very clear," Giroir said. "People have inappropriately misinterpreted cautionary dosage thresholds as mandates for dose reduction."
Source: Wall Street Journal
The ruling Monday by an Oklahoma judge that Johnson & Johnson must pay $572 million for selling opioids will be cheered by everyone who wants a scapegoat for the scourge of addiction. But the ruling could have far larger, and more dangerous, consequences by opening a vast new arena for product-liability suits.
More than 2,000 states and municipalities have sued opioid makers and distributors in federal litigation in Ohio. Another 250 or so have filed lawsuits in state courts where they hope local judges and juries will provide a more sympathetic audience. Most like Oklahoma GOP Attorney General Mike Hunter have been aided by private plaintiff attorneys.
Mr. Hunter has since focused on his $17 billion claim that Johnson & Johnson “abate” the alleged public nuisance caused by opioid addiction. Public-nuisance torts usually involve damage to property, and the remedy is enjoin or correct nuisances. But state AGs and the trial bar have been stretching public-nuisance law beyond its intended purpose. New York City and Oakland, California, have tried to use public-nuisance law to sue oil companies for damages they claim they will incur in the future from climate change.Purdue Pharma, the OxyContin maker, this spring agreed to settle litigation with Oklahoma for $270 million, which included $200 million for a new National Center for Addiction Studies and Treatment at Oklahoma State University. Mr. Hunter’s son is employed by OSU’s Center for Health Sciences, where the new center will be housed.
Oklahoma’s opioid shakedown is equally dubious. J&J’s opioids, which include a fentanyl patch and crush-resistant pill, constitute less than 1% of Oklahoma’s prescription opioid market. The Food and Drug Administration approved the drugs and their black-box warnings, and they’re still legal. Patients may only obtain the drugs with prescriptions through government-licensed pharmacies.
Like most of the opioid plaintiffs, Mr. Hunter can’t draw a clear line between doctors who supposedly relied on the opioid companies’ alleged misrepresentations and the injuries suffered by victims. He doesn’t even attempt to specify the particular doctors, prescriptions, pharmacists or victims involved in the chain of addiction.
This is the general language the plaintiffs lawyers are driving through. According to state Judge Thad Balkman, J&J was acting “unlawfully” by issuing “misleading marketing” that was aimed at “influencing doctors” and a “wide range of governmental agencies” at “‘optimizing the benefits of prescription opioids for pain management [and] minimizing their risks,’ including the risk of addiction, abuse and diversion.” Yet while opioid pills were often overprescribed, J&Js products include patches that aren’t passed out by pill-mill pharmacies.But public-nuisance law is more elastic than product-liability claims because it doesn’t require evidence of direct causation. To be liable, a business must be “unlawfully doing an act, or omitting to perform a duty.
Judge Balkman also stretches the traditional public-nuisance limitation with respect to property damage by claiming that J&J is liable because its sales reps were trained in their Oklahoma homes, used company cars and sent messages to homes of thousands of Oklahomans via computers. By this standard, cell manufacturers could be liable for damages caused by distracted drivers.
The state’s $572 million “abatement” claim is brimming with pork to fund government agencies, new opioid treatment centers and licensure boards such as the Board of Dentistry and Veterinary Board. Patients won’t receive much benefit, but the plaintiff attorneys who helped Mr. Hunter will be winners, having already raked in $60 million from the Purdue settlement.
The opioid addiction problem is varied and complex, and these days it is largely a problem of illegal fentanyl and meth. It won’t be eased by bankrupting America’s pharmaceutical companies. Armed with this ruling, Mr. Hunter will pressure J&J to settle. But J&J says it will appeal, perhaps because it can see the risk this ruling poses to any law-abiding business.
More Reactions to Verdict:
Former Drug Czar Dr. William Bennett: "the problem isn't rx drugs...talk to the coroner's, I have. It's Fentanyl & meth that's the major cause of death today."
WATCH FULL CLIP: https://video.foxnews.com/v/6077905603001
WATCH Jennifer Braceras, Esq. vs Dr. Mark Siegel discuss the Opioid Trial Verdict: https://youtu.be/D4RXaW9Nmho
If Appeals court upholds Public Nuisance Law it will open pandoras box for lawsuits against just about every industry:
Jennifer C. Braceras, the director of Independent Women's Forum’s Center for Law & Liberty, issued the following statement in response to the verdict:
“Sadly, most people today know of someone who has grappled with opioid addiction. But lawsuits brought by publicity-seeking politicians won’t solve the problem. The verdict is a victory for taxation by litigation, but it is consumers who will pay the price in the form of higher prices and reduced access to pain medications for patients who need them.”
Read the IWF Legal Brief on public nuisance lawsuits against pharmaceutical companies HERE.
Blaming opioid makers for the "opioid crisis" may be emotionally satisfying, but the reality is more complicated.
Can legal sales of prescription opioids constitute a nuisance? Two decisions, based on nearly identical statutes, reach diametrically opposed conclusions.
A RAND report highlights the importance of new synthesis methods, cheap international shipping, and online distribution aided by privacy-protecting technologies.
Nonmedical use of prescription analgesics did not become more common, but it did become more dangerous.
In a recent interview with the National Pain Report, Dr. Vanila Singh, the Chairperson of the Pain Management Inter-Agency Task Force kept taking the subject back to the volume of commentary the effort received and the influence it had on the final report.
The report provides advice and recommendations for the development of best practices for pain management and prescribing pain medication.
Dr. Singh, who is an anesthesiologist who has treated pain, believes the report shows that the challenges are more than just about treating pain—that they reveal it is “a front-line health care issue.”
That is why she emphasized the importance of 200 professional organizations who commented and over 160 of them who have praised and supported report, including the American Medical Association which has strongly endorsed it.
“Many organizations came out with amazing support of the draft report with great insight,” she said. “This is very important in depicting the relevance across all health care providers and stakeholders, as well as their interest in the Task Force Report.
All told—over 9000 comments including pain patients, pain professional groups, nursing organizations and pharmacists were received.
Source: National Pain Report
This is a three-part series on the nation's struggle to address a crippling opioid crisis, and the unintended victims left in its wake.
By Elizabeth Llorente | Fox News
Dec. 10, 2018 - The national opioid crisis propelled a crackdown on prescription painkillers, causing hundreds of doctors to abruptly reduce or completely cut off their patients’ prescriptions, leaving many among the estimated 20 million Americans who suffer from daily debilitating chronic pain to consider suicide. This is the story of the overlooked victims of America's opioid epidemic.
Dec. 11, 2018 - As federal and state agencies respond to the staggering rate of drug overdose deaths -- primarily involving illegal opioids like heroin and illicit fentanyl -- doctors who maintain they are responsibly prescribing opioids are getting caught up in the crackdown. This is their side of the story to the opioid crisis and how it has impacted -- and for some -- ruined their lives.
Dec. 12, 2018 - The government has addressed the overdose epidemic with an aggressive focus on reducing prescribing practices, which has unintentionally led many doctors to cut down or cut off their patients’ pain medications altogether. This tactic has left many chronic pain sufferers undertreated, with some even contemplating taking their own life. Fox News spoke with numerous doctors, specialists and scholars to find out what the next steps should be to address these unintended consequences.
Fentanyl is now the most commonly used drug involved in drug overdoses, according to a new government report. The latest numbers from the US Centers for Disease Control and Prevention's National Center for Health Statistics say that the rate of drug overdoses involving the synthetic opioid skyrocketed by about 113% each year from 2013 through 2016.
Researchers who set the new guidelines for how doctors should prescribe opioids say the providers have wrongly implemented some of their recommendations. They find that some health care players use the guidelines to justify an “inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages." Other news on the crisis comes out of Tennessee, Texas and Louisiana.
The authors of influential federal guidelines for opioid prescriptions for chronic pain said Wednesday that doctors and others in the health care system had wrongly implemented their recommendations and cut off patients who should have received pain medication. “Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” the researchers wrote in a paper published in the New England Journal of Medicine. (Joseph and Silverman, 4/24)
The Centers for Disease Control and Prevention, in new guidance for opioid prescribing, said many physicians were guilty of a "misapplication" of 2016 guidelines that clamped down on the use of opioids. The new guidelines, published in the New England Journal of Medicine, was the latest federal acknowledgement that many physicians' responses to the opioid crisis went too far. Former Food and Drug Administration commissioner Scott Gottlieb, a physician, spoke out last July about the impact the opioid crisis response had on pain patients when he called for development of more options. (O'Donnell and Alltucker, 4/24)
April 26th report by Shepard Smith about the harms to chronic pain patients as a result of the overarching CDC Guidelines.
Link to Video: https://youtu.be/2Jg0ZV9ftFE
Fox News' Greg Gutfeld has been reporting about our plight for several months. Watch the most recent segment about the CDC Clarification featured on "The Five"
Watch segment here:
More from Greg Gutfeld:
On Gillibrand Opioid Crackdown:
Facts and Fallacies:
Dr. Drew: https://drdrew.com/tag/greg-gutfeld/
Daniel Horowitz, Esq. - The government’s war on pain patients
CDC is raising awareness about the following issues that could put patients at risk:
The Guideline was developed to ensure that primary care clinicians work with their patients to consider all safe and effective treatment options for pain management. CDC encourages clinicians to continue to use their clinical judgment, base treatment on what they know about their patients, maximize use of safe and effective non-opioid treatments, and consider the use of opioids only if their benefits are likely to outweigh their risks.
** URGENT BULLETIN ** Please SHARE with all State& Federal Representatives and Regulatory Agencies in charge of regulating Controlled Substances/Opioid prescribing.
Re: CDC Guideline Clarification Letter & FDA Advisory Notice pertaining to Opioid Prescribing
Below is a letter from the CDC clarifying the 2016 Opioid Prescribing Guideline and an Advisory Notice issued by the FDA regarding abrupt opioid tapering.
The Guideline is not intended to deny any patients who suffer with chronic pain from receiving opioid therapy as an option for pain management. Rather, the Guideline is intended to ensure that clinicians and patients consider all safe and effective treatment options for patients.
Clinical decision-making should be based on the relationship between the clinician and patient, with an understanding of the patient’s clinical situation, functioning, and life context, as well as a careful consideration of the benefits and risk of all treatment options, including opioid therapy.
CDC encourages physicians to continue to use their clinical judgment and base treatment on what they know about their patients, includes the use of opioids if determined to be the best course of treatment. Providers should communicate frequently with their patients to discuss both the benefits and risks of opioid therapy and revisit treatment plans for pain regularly to achieve the most positive outcomes for patients.
Reports of "serious harm" in patients dependent on opioid painkillerswho suddenly stop taking the medication, or rapidly decrease the dose, have prompted a drug safety communication issued today by the US Food and Drug Administration (FDA).
Addiction starts before drug use
There is no shortage of news coverage on the opioid epidemic. I pay close attention, and not because I am a scientist, or a health care provider, or a legislator. Nor do I have a loved one seeking help for a substance abuse disorder. Not any more.
In Opioid Cases, Local Prosecutors Are Torn Between Empathy and Demands for Punishment
Judge Gregory Grimslid reeled off the drugs 27-year-old Tyson Kelly had consumed: OxyContin, fentanyl, morphine, marijuana.
Opioid Addiction Treatment Begins in the Emergency Room in a Camden, NJ, Hospital
Every day at Cooper University Hospital in Camden, N.J., emergency room doctors treat, on average, five to fifteen patients who have overdosed on opioids.
Adam Bisaga, MD, on Addiction, Chronic Pain, and Stigma
This is Part 2 of an interview with Adam Bisaga, MD, an addiction psychiatrist, clinician, researcher, and professor of psychiatry at Columbia University.
Adam Bisaga, MD: Referring Patients to Most Opioid Treatment Centers Is Now Unethical
Adam Bisaga, MD, is an addiction psychiatrist, clinician, researcher, professor of psychiatry at Columbia University, and author of Overcoming Opioid Addiction.
At its 2018 interim meeting in Maryland, the AMA House of Delegates adopted a series of resolutions that recognize the mistreatment of pain patients and call for restraint in implementing the CDC guideline – particularly as it applies to the agency’s maximum recommended dose of 90mg MME (morphine milligram equivalent units).
1. RESOLVED that our AMA affirms that some patients with acute or chronic pain can benefit from taking opioids at greater dosages than recommended by the CDC Guidelines for Prescribing Opioids for chronic pain and that such care may be medically necessary and appropriate.
2. RESOLVED that AMA advocate against the misapplication of the CDC Guidelines for Prescribing Opioids by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit access to opioid analgesia
3. RESOLVED that our AMA advocate that no entity should use MME (morphine milligram equivalents) thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guidelines for Prescribing Opioids.
Links To Articles:
Despite the opioid epidemic, health insurers are still failing to reimburse chronic pain patients for effective non-opioid treatments, including psychological counseling and acupuncture. Even coverage for physical and occupational therapy varies widely in terms of the number of visits allowed, and whether prior authorization is required.
Last week more than 100 healthcare professionals and pain advocates signed a letter urging the Department of Health and Human Services to “prohibit or minimize rapid, forced opioid tapering in outpatients.” The letter was drafted by Beth Darnall, PhD, a pain psychologist at Stanford Medical School. It addresses the plight of chronic pain patients who were prescribed very high doses of opioids in the past, but who—whipsawed by rapid changes in medical consensus about the risks and benefits of such medication—are suddenly finding that they can no longer obtain their medications at such dosages. An estimated 18 million Americans are now on long-term prescription opioid therapies.
FOR IMMEDIATE RELEASE:
Washington, DC (April 16, 2019) — In 2016, the Centers for Disease Control and Prevention (CDC) issued prescribing guidelines to reduce the risks associated with long-term opioid therapy for chronic pain. What followed, however, was widespread misapplication by physicians, as well as insurers, government agencies, pharmacy chains, and health employers, which invoked the guideline as grounds to involuntarily reduce — and in some cases cease — opioid treatment for many chronic pain patients.
AEI Resident Scholar Sally Satel, M.D., in conjunction with other physicians and members of Health Professionals for Patients in Pain (HP3), explained in an open letter to the CDC: “Patients with chronic pain, who are stable and, arguably, benefiting from long-term opioids, face draconian and often rapid involuntary dose reductions.
Often, alternative pain care options are not offered, not covered by insurers, or not accessible. Others are pushed to undergo addiction treatment or invasive procedures (such as spinal injections), regardless of whether clinically appropriate.” Consequences have included intensification of pain, relapse into a disabled state, and even suicide.
Last week, Dr. Satel and her HP3 coauthors were delighted to receive a letter from the CDC in response to their open letter. In his reply, CDC Director Robert R. Redfield assured Dr. Satel and her coauthors — and, by extension, all prescribers, pharmacists, administrators, and regulators — that “the Guideline does not endorse mandated or abrupt dose reduction or discontinuation as these actions can result in patient harm.”
“We are so grateful to the CDC for its essential clarification,” said Dr. Satel. “Now it’s time for the federal, state, and nongovernmental institutions that have invoked the CDC’s authority to push [for] . . . traumatic changes . . . to reverse course.”
The full open letter from HP3 to the CDC is available here.
The full response from the CDC is available here.
Dr. Satel’s Wall Street Journal article on the CDC’s guideline reassessment is available here.
Practical Pain Management:
April 24, 2019
Andrew Kolodny, MD, told an Rx Drug Abuse & Heroin Summit audience that it is time to close the cash pipeline that helped feed the opioid epidemic.
April 23, 2019
The federally supported Healing Communities Study could dramatically reshape the effort to address the harms caused by the opioid crisis, attendees of the Rx Drug Abuse & Heroin Summit heard on Tuesday.
April 23, 2019
Ed Thompson, president of Pharmaceutical Manufacturing Research Services, explained to attendees at the Rx Drug Abuse & Heroin Summit why he wants the FDA to start requiring substantial scientific evidence of efficacy for the intended use of new…
April 16, 2019
President Donald J. Trump and First Lady Melania Trump will address participants of the eighth annual Rx Drug Abuse & Heroin Summit on April 24 in Atlanta.
April 12, 2019
Researchers who developed a tracking system to better understand the evolution of insurance coverage for opioid use disorder will share their findings at the Rx Summit.