The Way Forward: California’s New Opioid Guidelines

By Dr. Forest Tennant and Kristen Ogden

The Medical Board of California recently published new guidelines for prescribing opioids and other controlled substances for pain, which emphasize “individualized care” that is customized for each patient. 

The guidelines are a remarkable, positive and practical way forward in pain care. All persons concerned about chronic pain treatment with opioids, benzodiazepines and other controlled drugs need to know the basic concepts embedded in them.    

As the medical board was updating its guidelines, we had great concern that they would bury California’s Pain Patient's Bill of Rights and Intractable Pain Treatment Act. When these laws were passed in the 1990’s, they were a godsend to patients with chronic intractable pain, who were given the right to “request or reject the use of any or all modalities in order to relieve his or her pain.”

That means patients, with the support of their doctors, could get opiate medication without first having to submit to surgery, medical devices and other forms of pain treatment.  

To our great pleasure, the medical board’s new guidelines recognize, define and support these worthy laws.  Importantly, the guidelines also state that they are “not in any way intended to limit treatment” of patients in hospice or palliative care. And they allow for doctors to prescribe high dose opioids, provided they keep good medical records that document a need for them.

Defining Intractable Pain

The California guidelines provide a classic definition of intractable pain as “a state in which the cause cannot be removed or otherwise treated and no relief or cure has been found after reasonable efforts.” 

The problem with this definition is that intractable pain may be mild or intermittent and not curable, but may still be treated with non-opioid modalities. To require and receive treatment with opioids and other controlled drugs, one really needs a specific causative diagnosis of the unremitting “high impact” pain that produces physiologic complications such as hypertension, tachycardia, and endocrine deficiencies. 

Put another way, is intractable pain an incurable but treatable problem? Or is it constant and incurable with potentially life-threatening complications? 

Physicians, as a group, are often mystified, confused and unaware of how to determine which patients have an incurable, but readily treatable problem, and which patients have the constant and incurable pain that causes complications and require opioid therapy.

Physicians need help to make sound, defensible treatment decisions in the face of this quandary.  Some patients with complex intractable pain are greatly impacted and require non-standard treatment, which may include high-dose opioids, benzodiazepines and stimulant drugs. 

Here are the recommended criteria to identify such patients and support non-standard treatment plans.

1. A specific medical cause of intractable pain has been identified.

2. Constant pain has impacted some physiological and/or mental functions such as sleep, eating, hygiene, reading, concentration, and mobility.

3. Trials of standard medications and dosages with such agents as anti-depressants, muscle relaxants, anti-inflammatories, stimulants, anti-seizure medications, and low-dose opioids have not controlled pain or normalized functions.

4. There is objective physical evidence of the causative disease or complications of the pain, such as hypertension, tachycardia, neurologic deficits, or anatomic structural abnormalities.

5. There is an objective, diagnostic test result that documents an abnormality of the cause of pain or its complications, such as a magnetic resonance imaging (MRI), hormone deficiency, elevated autoimmune or inflammatory marker, or an abnormal electrodiagnostic test.

It is the lack of adequate treatment of complex intractable pain that is really the crux of the suffering and deaths that have emerged due to overzealous and misinformed opioid regulations and guidelines.  These legitimate, complex patients comprise about 3 to 5% of chronic pain patients.

The California medical board’s new guidelines provide clinicians the opportunity to implement individualized and effective treatments for these unfortunate and deserving intractable pain patients. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain. Dr. Tennant was the lead physician in crafting California’s Intractable Pain Law and Pain Patient Bill of Rights, and worked with the legislature to get them passed. 

Kristen Ogden is a patient advocate from Virginia. Kristen and her husband Louis travel regularly to California for his intractable pain treatment and prescriptions, which are not available in their home state. Kristen testified during public hearings on the California guidelines and closely followed their development. 

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Medical Cannabis Is Losing Credibility

By Roger Chriss, PNN Columnist

As more and more states legalize medical cannabis for chronic pain, anxiety, seizure disorders and other common medical conditions, the question of efficacy becomes increasingly important. Recent studies show a lack of efficacy, but so far states are not modifying their list of approved conditions for medical cannabis.

Many states approved cannabis for medical conditions without good evidence. California legalized medical marijuana in 1996, yet nearly three decades later the Medical Board of California is still advising physicians that “there is a lack of evidence for the efficacy of cannabis in treating certain medical conditions.”

We not only still lack evidence, but new research suggests that cannabis doesn’t help and may actually be harmful:

• A small randomized trial in Boston found no significant improvement in pain, anxiety or depression in people given medical marijuana cards, but a higher risk of developing cannabis use disorder.

• A matched cohort study in Hawaii on people 50 or older saw a “significantly greater risk of coronary heart disease, chronic non-cancer pain, stroke, myocardial infarction, cyclic vomiting, and injuries” in people using cannabis compared to non-users.

• An observational study in New York of 29 people with epilepsy given two formulations of cannabidiol (CBD) and tetrahydrocannabinol (THC) concluded that “we found no evidence of efficacy… in treating epilepsy, sleep, or behavior in our population.”

Recent reviews of past studies are similarly disappointing.

• A review of 16 studies of CBD for mental health disorders found that “there is currently not enough high-quality evidence to suggest the clinical use of CBD for any psychiatric disorder.”

• A systematic review of 28 studies on medical marijuana for multiple sclerosis concluded that “the magnitudes of effects on short-term neurological outcomes in MS patients are either small, limited, or moderate.”

Lack of Efficacy

The 2017 National Academies report on cannabis noted the need for more research. Since then, over 6,400 studies have appeared on PubMed on medical cannabis specifically, and a total of 12,100 studies on cannabis in general. More studies are forthcoming, including 460 clinical trials of cannabis that are active or recruiting.

The result so far is a growing body of high-quality studies and clinical trials published in major journals showing a lack of efficacy and a risk of poor outcomes for conditions that cannabis is state-approved for.

Ordinarily, states follow the laws and regulations of the Food and Drug Administration, recommendations from medical societies, and research findings and other sources of major reviews. With almost any other substance with such a weak track record, there would have been a reassessment by now. But not with cannabis.

California still approves medical cannabis for glaucoma, even though the American Academy of Ophthalmology is against it due to lack of efficacy. California is not alone. So far, no state has removed any condition from its approved list for medical cannabis use.

However, the conditions of using cannabis are changing. Some states now require patients in pain management programs to have their urine tested for cannabinoids. Many medication management agreements – known as “pain contracts” – also expressly forbid cannabis use even if it has been legalized in that state. Some medical specialties tell patients to simply avoid cannabis because of risks from drug interactions and contraindications.

Although cannabis may be safer than some prescription drugs, that won’t matter if it has no demonstrable benefit. Cannabis is losing credibility as a therapeutic as studies show poor outcomes for diagnoses that states approve cannabis for.

Holding cannabis to the same standards as other therapeutics would increase confidence in cannabis where it is shown to be beneficial. It will also help improve patient outcomes. As it stands now, however, medical cannabis is starting to look more like medicinal alcohol during Prohibition than a credible therapeutic for 21st-century medicine.

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

Teen Charged with Murder in Fentanyl Death of 12-Year-Old

By Pat Anson, PNN Editor

A California teenager was arrested and charged with murder this week in the death of a 12-year-old girl who fatally overdosed after consuming a counterfeit painkiller made with illicit fentanyl. The 16-year-old suspect allegedly sold the pill to the girl in 2020, and she overdosed after crushing and snorting the tablet at a party in San Jose.

Like many other counterfeit pills involved in overdoses, the tablet was made to look like a 30 mg oxycodone pill, stamped with a “30” on one side and an “M” on the other. The girl passed out and began snoring soon after ingesting the drug, which prosecutors say is a “telltale sign of a fentanyl overdose.”

“After thousands of deaths, everyone should know that fentanyl is a deadly poison,” Santa Clara County District Attorney Jeff Rosen said in a press release. “Thanks to the San Jose Police Department, the Santa Clara County Specialized Enforcement Team, and our investigators, this child’s tragically short life may help save others.” 

The DA’s office calls the 12-year-old victim “Jane Doe” because of her age, but local media have identified her as Dalilah Guerrero of San Jose. The girl was with two other teens when she bought the “M-30” pill from the alleged dealer. The group later took a video of Dalilah lining up the crushed pill for ingestion.   

The 16-year old suspect’s name has not been released because he is a minor. Investigators looking into his online social media accounts reportedly found screen shots of public service warnings about fentanyl that predated the girl's death.

Failed Policies Made Drug Crisis Worse

The overdose of such a young victim is the latest example of how the “opioid epidemic” has morphed into an even more deadly overdose crisis fueled by illicit fentanyl and other street drugs. Efforts by law enforcement and public health officials to prevent more deaths by prosecuting doctors and restricting the supply of opioid medication have not only failed – they may have made the drug crisis worse.

In recent years, the number of opioid prescriptions has fallen dramatically nationwide and now stand at 20-year lows, while fatal overdoses rose to record levels. Last year the number of U.S. drug deaths crossed 100,000 for the first time, largely driven by illicit fentanyl.

As the charts show below, Santa Clara exemplifies both trends, with prescriptions falling dramatically in the county while fentanyl deaths spiked.

SOURCE: CALIFORNIA DEPT. OF PUBLIC HEALTH

Santa Clara County was the first local government in the nation to file a lawsuit against drug makers alleging that they caused the opioids crisis. The law firm of Motley Rice filed the initial lawsuit in 2014 on behalf of Santa Clara, and the case snowballed from there into nationwide litigation against opioid makers, distributors and pharmacies.

Last year a California judge ruled that drug makers did not use deceptive marketing to promote pain relievers and there was “no evidence” the companies were liable for the state’s opioid crisis.

The tragic death of Dalilah Guerrero is not the first time Santa Clara County has lost a young person to counterfeit pills. In 2019, county health officials announced that 9 fatal overdoses had been linked to fake oxycodone pills, including the deaths of two teenagers.  

In 2020, murder charges were filed against a San Jose man who allegedly sold over Snapchat a counterfeit pill laced with fentanyl to an 18-year-old girl and her 17-year old boyfriend. Both teens overdosed. Paramedics were able to revive the boyfriend, but the girl died.

In 2020, the last year for which full data is available, there were 143 opioid related deaths in Santa Clara County, a 139% increase from 2018.  Fentanyl was involved in most of them.

Judge Finds ‘No Evidence’ Pain Relievers Caused Opioid Crisis

By Pat Anson, PNN Editor

In a major victory for the pharmaceutical industry, a California judge has ruled that four opioid manufacturers did not use deceptive marketing to promote pain relievers and are not liable for the state’s opioid crisis.

Three California counties and the city of Oakland filed suit against Johnson & Johnson, Allergan, Endo and Teva Pharmaceuticals, claiming they used false and misleading marketing to increase sales of prescription opioids.

But in Monday’s ruling, Orange County Superior Court Judge Peter Wilson said there was no evidence that “medically appropriate prescriptions” fueled the opioid crisis.

"There is simply no evidence to show that the rise in prescriptions was not the result of the medically appropriate provision of pain medications to patients in need," Judge Wilson wrote in a 41-page ruling. "Any adverse downstream consequences flowing from medically appropriate prescriptions cannot constitute an actionable public nuisance.''

Plaintiff law firms representing local governments across the nation have filed over 3,000 lawsuits against drug companies for their role in the opioid crisis. Several cases have already been settled out of court.

Los Angeles, Orange and Santa Clara counties and the city of Oakland wanted the four drug companies to pay over $50 billion in damages. The law firm of Motley Rice filed the initial lawsuit in 2014 on behalf of Santa Clara county, and the case snowballed from there into nationwide litigation against opioid makers, distributors and pharmacies. If successful, plaintiff law firms stand to make billions of dollars in contingency fees.

Judge Wilson’s tentative ruling – which only applies to the California case -- was the first big win for drug companies involved in opioid litigation. The plantiff law firms said they would appeal.

“The people of California will have their opportunity to pursue justice on appeal and ensure no opioid manufacturer can engage in reckless corporate practices that compromise public health in the state for their own profit,” the lawyers said in a statement.

Addiction Claims Debunked

Anti-opioid activists have long claimed that “overprescribing” of opioid medication fueled the U.S. drug abuse crisis, an argument that Wilson rejected. 

“Plaintiffs made no effort to distinguish between medically appropriate and medically inappropriate prescriptions. Mere proof of a rise in opioid prescriptions does not, without more, prove there was also a rise in medically inappropriate prescriptions,” Wilson said in his ruling.

Wilson also disputed claims made by Dr. Anna Lembke, a Stanford psychiatrist and board member of Physicians for Responsible Opioid Prescribing (PROP). As a paid expert witness testifying for the plaintiffs, Lembke said one in four patients prescribed opioids become addicted.

“As Defendants point out, the studies relied upon by Dr. Lembke for that conclusion are inadequate to support it. The more reliable data would suggest less than 5%, rather than 25%. Under either number, addiction based solely on the patient having been prescribed opioids does not occur in ‘most of these patients,’” Wilson said.

Johnson & Johnson issued a statement calling Wilson’s ruling “well-reasoned.” It said the company’s “marketing and promotion of its important prescription pain medications were appropriate and responsible and did not cause any public nuisance.”

In 2019, an Oklahoma judge ruled J&J was liable for $465 million in damages for its marketing of opioids, a case that is still under appeal. The company recently proposed a nationwide settlement of $5 billion and agreed to stop making opioid medication. It voluntarily halted sales of prescription opioids last year.

(Update: On November 10, the Oklahoma Supreme Court overturned the ruling against J&J.)

Although opioid prescribing has fallen significantly over the past decade, overdoses have risen to record highs. The vast majority of drug deaths involve illicit fentanyl and other street drugs, not prescription opioids.      

The DEA recently issued a public safety alert warning of a surge in counterfeit pills made with illicit fentanyl. The agency has also proposed further cuts in the legal supply of prescription opioids in 2022.

The High Cost of California's Death Certificate Project

By Dr. Denise Phan, Guest Columnist

Even as the Covid-19 pandemic occupies the nation’s attention, most of my work as a primary care doctor still revolves around other chronic diseases.  

Every day, people are still giving birth, still getting sick, still dying from terminal diseases, still getting hurt and still having pain. Yet more and more, physicians’ hands are tied when it comes to prescribing opiate medication to reduce their patients’ pain and suffering, especially now that surgeries, physical therapy and injections are discouraged due to social distancing guidelines.

Last year, a patient came to me with a letter from her previous doctor explaining that he is no longer able to prescribe any opiates. The local pain specialists he recommended in his letter were either not taking new patients on opiates or would not prescribe the dosage of oxycodone needed to control her pain.

Several months ago, another patient came in complaining that his pain specialist had cut his dosage down so quickly that he now resorts to street heroin to control the pain and withdrawal.

Yet another patient asked me a few months ago to stop the chemotherapy for his lung cancer and put him in hospice care so he can get adequate pain control.

And just last month, a patient told me she can no longer bear to attend her online fibromyalgia support group because five people in the group had killed themselves in the past few years.

Recently, a frustrated nurse in the oncology/orthopedic ward asked me, “What is it with you doctors? Are you all going to let people scream themselves to death from pain? "

DR. DENISE PHAN

A cardiologist friend of mine remarked, “Ten years ago you could get sued for not prescribing pain meds to patients, now you can get sued just for writing one."

Project Targets ‘Inappropriate’ Prescribing

One of the causes for this sad state of affairs in California is the state medical board’s “Death Certificate Project.” The board investigated the overdose deaths of 450 patients who may have received “inappropriate” opioid prescriptions and sent warning letters to their physicians. Disciplinary action was taken against dozens of them.

The Death Certificate Project sounds like a well-meaning idea, but in practice it has decimated the field of pain management and brought tremendous suffering to patients living with real legitimate pain.

The most egregious of the project's many faults is the decision to pull death certificates from 2012-2013, and then use the state’s prescription drug database to identify "overprescribers." The deaths occurred years before the medical board adopted tougher guidelines on the prescribing of opiates in 2015 and the CDC released its opioid guideline in 2016. 

By this irrational act, the project targeted hundreds of primary care doctors and pain management specialists who were caring for the high-risk populations of chronic pain patients, and were following previous California guidelines to treat pain aggressively and with opiate medications if necessary.  

To date, the board has filed accusations of negligent prescribing against 66 physicians. Forty-eight of them have faced discipline such as license surrender, public reprimands and probation. Some were forced into early retirement. Eighteen doctors are still awaiting hearings or trials. The vast majority of them are responsible physicians who have had no other complaints lodged against them. 

Throughout the Covid-19 pandemic, standards of care and public policies have been rapidly evolving, even flip-flopping from week to week, some causing and some preventing thousands of deaths along the way. It is incredibly irrational to retroactively penalize doctors for following the previous standards of care during a epidemic. Yet this is precisely what the Death Certificate Project is doing by focusing on overdoses in 2012-2013, when the opioid epidemic had not even been recognized or publicized by the medical board itself. 

Imagine going to work every day on the frontline of an epidemic, knowing that the state or federal government can change their policies at any time; and that they can go back and prosecute you for the deaths that resulted from their previous policies.  As we watched our colleagues in the field falling like dominoes one by one, can you blame the doctors for running scared?

The primary result of the Death Certificate Project has been the effective removal of dozens of frontline doctors amid a decades-long shortage of primary care physicians and on the eve of a pandemic. The secondary result of this program is the refusal of terrorized remaining physicians to prescribe any pain medications at all or to drastically reduced the dosages. This has caused a marked increase in pain, suffering and suicide rates in the legitimate pain and addiction patient populations, as well as the subsequent rise in the use of street opioids and thus opioid deaths overall.

The data on California and national overdose deaths shows that prescription opioid overdoses have declined since 2014. Overall drug deaths spiked up sharply in 2017-2018 – but this was mainly due to street heroin and illicit fentanyl. This shows how sadly unnecessary and harmful the project is.

Beside the human and societal costs listed above, this project is costing California millions of dollars annually in funding for administrative, consulting and legal fees. This is not counting the immeasurable cost to the medical system from the loss of physician resources during the biggest pandemic of our time. 

When a medication or treatment does not work as intended and causes many harmful side effects, we need to stop it. If you are a resident of California, please join me in a letter writing campaign to end this irrational, unnecessary, harmful and costly Death Certificate Project at the Action Network website

Dr. Denise Phan is an Internal Medicine physician in Los Angeles. She works in private practice in the San Fernando Valley and is on staff at Valley Presbyterian Hospital. Dr. Phan is active in the annual missions of the mobile health units of the Social Assistance Program for Vietnam and the International Humanitarian Mission. 

Patient Who Can’t Find Doctor in Texas Flies to California for Pain Care

By Lori Ravellli, Guest Columnist

I am writing to ask for a change in attitudes toward people in pain who need improved access to treatment. I want my voice to be heard when actions are taken to curb the opioid abuse problem.

I need help. I suffer and have suffered for years from severe chronic lower back and coccyx pain that is unbearable. Some of the conditions I have been diagnosed with are chronic pain disorder, lumbar spondylosis, hypertrophic set arthropathy, degenerative disc disease, lumbar nerve root disorder and scoliosis. I honestly do not know what all of this means but I know how bad it hurts.

I also had a gastric procedure which limits the kinds of medications I can take, such as ibuprofen, muscle relaxers, naproxen and NSAIDs.

I have had multiple appointments with neurosurgeons and other doctors, who say I have too much wrong with my lower back to have any surgical procedure. I have stacks of reports and test results justifying my issues. I have had multiple injections with different medications and locations to drain my bank account, gain weight and still suffer in agony.

My only option is pain management through medication. I cannot sit down for any length of time and lying down hurts. I can only stand for so long without my legs giving out. In addition to that, I have shooting pain down my leg when I do sit.

Sadly, as much as a body needs rest, I can no longer rest comfortably. My quality of life is almost nonexistent due to the debilitating pain. Without relief, I really contemplate ending my life. I can no longer deal with the agony.

LORI RAVELLI

I do not want my friends and family to grieve because I took my life due to pain and lack of treatment. Chronic pain patients visit their doctors often, are subject to drug tests, and are not the reason there is a crisis in this country. Doctors being too scared to treat patients is not fair to us.

The problem is so bad here in Texas that doctors do not want to care for pain patients. I moved to Texas two years ago and have struggled to find care and treatment. I have been forced to fly back to my old doctor in California to get medication. My doctor I saw for many years knows me, knows I do not over-medicate, and has never needed to raise the dose of my medication.

I cannot believe that I am not able to find a doctor to treat me here in Texas. Sitting is so painful and it is a struggle to fly 3 hours for a doctor’s appointment. I have to sit in the car an hour, sit in the airport for 2 hours, and then the flight for 3 hours. Sitting is so painful because of my back and pain shooting down my leg.

By the time I arrive, I am in such horrific pain it takes days to recover. I am so tired of living in agony. This is so wrong and it is my human right to have some pain relief because it is available. 

The real problem seems be addicts that purchase medication from the streets and not knowing what they are purchasing. When people are not able to get their medication from the proper channels, they will seek options from the street with hope of finding some relief.

Pain relief is a human right and without relief people will take their lives. Living with debilitating pain you have no quality of life and no reason to wake up in the morning.

I am tired of being treated like a drug addict. I am suffering severely and need medication to be a functioning adult. I know I will never be pain free, but any relief is welcomed. Please, please for the love of God stop punishing the patients and the medical professionals trying to help them!

Lori Ravelli lives in Galveston, Texas.

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

This column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Doctor Accused of Overprescribing Opioids Fights to Keep Her License

By Pat Anson, PNN Editor

A northern California doctor who is beloved by many of her patients could lose her medical license because of allegations by the state medical board that she overprescribed opioid medication and other drugs. Dr. Corrine (Connie) Basch runs a solo primary care practice in Arcata, a small city in rural Humboldt county.

“They were looking to put a head on a spike so they could claim they were doing something about the opioid crisis,” Basch told PNN. “I am not considered a negligent doctor in town, nor am I a pill mill. And it would have taken them all of ten minutes to figure that out if they had asked anyone in my community if there was a problem here.”

A formal complaint against Basch by the Medical Board of California, first reported by the Lost Coast Outpost, centers on her treatment of five pain patients on relatively high doses of opioids and benzodiazepines, an anti-anxiety medication. Although Basch had tapered them to lower doses, the complaint alleges the amounts are still excessive and the combination of drugs places the patients at risk of overdose and death.

Board Executive Director Kimberly Kirchmeyer is seeking the revocation or suspension of Basch’s license for excessive prescribing, gross negligence and failure to maintain adequate medical records.

At no point in the 25-page complaint is it alleged that any of Basch’s patients have overdosed or been harmed while under her care.  The board began its investigation of Basch in early 2018 but didn’t file the accusation until last month – suggesting it didn’t think there was any imminent threat to her patients.

“They went after me for no good reason, conducted an ‘investigation’ that was so obviously flawed, published a defamatory accusation on the Internet prior to giving me a chance to defend myself or even correct the factual errors, revealed private details of my patients’ cases on the Internet when those people live in a small town where people already know each other’s business, and would force a small town doc who treats poor people  to come up with several years’ income to defend herself and her license,” Basch said.   

DR. CONNIE BASCH

All five of the patients in the medical board complaint were already on high doses of opioids and benzodiazepines before Basch started treating them. She tapered these “legacy” patients to lower doses, but some remained on opioid doses as high as 664 MME (morphine milligram equivalent) – well above the CDC guideline’s recommended ceiling of 90 MME.   

The CDC and FDA recently acknowledged that patients should not be forcibly tapered to lower doses and that doctors should “work with patients” before tapering or discontinuing opioids. Basch was already using that approach in her own practice. She says patients who’ve become tolerant to opioids should be weaned slowly and it could take 6-12 months just to get them off benzodiazepines.

“I’ve helped a lot of people get off pain meds,” she said. “Some of my patients stay on meds. I have a patient who is super functional on 145 MME. She’s comfortable, she can sleep through the night, and she works. I don’t see a need to lower her, except that she’s afraid. They’re all feeling insecure. They want to get off (pain meds) because there will be literally no one left to prescribe.”

Afraid to Prescribe

In recent years, California’s medical board has aggressively gone after doctors who prescribe opioids at high doses. The state’s controversial “Death Certificate Project” has resulted in threats of disciplinary action against hundreds of physicians, often years after they wrote an opioid prescription for a patient who fatally overdosed. Some doctors received warning letters even though the cause of death was suicide or involved multiple drugs – both legal and illegal.

These and other enforcement actions have had a chilling effect on doctors statewide.

“What we’re finding is that more and more primary care doctors are afraid to prescribe and more of those patients are showing up on our doorsteps,” Dr. Robert Wailes, a pain specialist and chair of the California Medical Association’s Board of Trustees, told Kaiser Health News.

Should Basch lose her license or stop practicing, all 1,500 of her patients would have to find new doctors, not a simple task in a remote community where healthcare choices are already limited, especially for pain patients.

“There are now two docs I know of in our area who have retired early because of similar accusations, and another older doc who lives in a small coastal community south of us who is going through a similar thing right now,” said Basch. “There’s nowhere even to get primary care up here. And if you call and say you want to be a new patient and chronic pain is anywhere on your problem list, you are denied. So these people are literally going to be left with no one.” 

‘Medical Board Malpractice’

Basch has received over 300 letters of support from patients and several from colleagues in the medical community. Her attorney plans to present them as evidence to the medical board.

“Dr. Corrine Basch is my beloved primary care physician,” one patient wrote. “Taking away her right to assess her individual patients for risk vs benefit, forcing a bureaucratic, possibly ill-conceived set of ‘guidelines’ is what I consider Medical Board Malpractice.

“FEAR caused by actions such as yours are keeping legitimately suffering human beings from having a quality of life they deserve. THIS IS SHAMEFUL.”

“I have had my share of doctors over the years but I never had a doctor like Connie. She has ultimately saved my life and I am not just saying that,” wrote another patient who credits Basch for his sobriety after years of addiction to pills and alcohol.

“You don’t punish someone for doing the right thing and helping people get off of drugs. That is not how you fix the opiate problem plaguing America you do it by employing more people like Dr. Connie who knows the right way to get a person clean.”

Basch, who is 55, continues to practice and is gathering evidence to support her case. A hearing date has not been set on the medical board’s complaint.

“They went after the wrong person this time,” she says. “Shaming and humiliating doctors who have lived lives of service, and placing them in a position where they have to give up their calling because the cost of defense is too great late in their careers, is shameful.”   

Doctors Call Probe of Opioid Deaths a ‘Witch Hunt’

By Cheryl Clark, Kaiser Health News

The Medical Board of California has launched investigations into doctors who prescribed opioids to patients who, perhaps months or years later, fatally overdosed.

The effort, dubbed “the Death Certificate Project,” has sparked a conflict with physicians in California and beyond, in part because the doctors being investigated did not necessarily write the prescriptions leading to a death. The project is one of a kind nationally, although a much more limited program is operated by North Carolina’s board.

So far, the board has launched investigations into the practices of about 450 physicians and referred the names of 72 nurse practitioners, physician assistants and osteopathic physicians to their respective licensing boards.

To date, the regulators have formally accused at least 23 doctors of negligent prescribing, and more accusations are expected. Some of the accusations, like one 63-page document filed against Dr. Frank Gilman, a San Diego internist, detail hundreds of prescriptions for one patient over four years, most of them by him. Gilman did not respond to a request for comment.

The project, first reported by MedPage Today, has struck a nerve among medical associations. Dr. Barbara McAneny, the American Medical Association president and an Albuquerque, N.M., oncologist whose cancer patients sometimes need treatment for acute pain, called the project “terrifying.” She said “it will only discourage doctors from taking care of patients with pain.”

Using terms such as “witch hunt” and “inquisition,” many doctors said the project is leading them or their peers to refuse patients’ requests for painkiller prescriptions — no matter how well documented the need — out of fear their practices will come under disciplinary review.

The influential California Health Care Foundation also has pushed back against the project, saying it could harm patients.

Unusually aggressive for the board, the program is a reaction to the by now well-known phenomenon of physicians overprescribing opioids. Nationally, a host of policy changes and educational efforts have driven down the rate of opioid prescriptions in recent years.

The goal of California’s program, quietly launched four years ago, is not necessarily to link a doctor’s specific prescription to a specific patient’s death — although many of the cases do — but to find doctors whose patterns of prescribing are so dangerous they may lead to patients’ ultimately fatal addictions.

Sometimes a doctor was earmarked for investigation even though the cause of death included multiple drugs prescribed by many physicians, or suicide by overdose, board documents indicate.

Kimberly Kirchmeyer, executive director of the Medical Board of California, defended the project. She said the effort has found patterns of “gross negligence,” incompetence and excessive prescribing.

“I understand their frustrations,” she said of the complaining doctors, “but we do have to continue our role with consumer protection.”

She noted that part of the point of the project is to educate doctors and, through probation requirements, change the behavior of those who prescribe excessively.

“That’s education that could potentially save patients in the future,” said Kirchmeyer, whose agency licenses some 141,000 doctors.

Some consumer groups consider the board’s bold effort to find overprescribing doctors not aggressive enough.

“It’s long overdue,” said Carmen Balber, executive director of the nonprofit Consumer Watchdog. The board should investigate opioid-related deaths that occurred more recently, she said: “They need to get their act together and speed things up.”

The agency thus far has looked at deaths only in 2012 and 2013 in which opioids were confirmed as a cause or contributing cause. It matched the names of the dead with the prescription drugs they filled, which are listed in the state’s prescription database. The database also shows the names of the doctors who prescribed to them. Physician experts reviewed those doctors’ prescribing history and selected those who appeared to prescribe drugs heavily.

Some doctors said they were especially angered that the letters they received concerned prescriptions they wrote as long as nine years ago.

McAneny, of the AMA, noted that prescribing practices now deemed unacceptable came out of public policies years ago that “compelled doctors to treat pain more aggressively for the comfort of our patients.” Also, payers have measured quality of care by whether their patients answered surveys about whether their pain was well-controlled.

“We’re [already] doing a lot of education to undo the damage” from those policies, she said.

Similarly, Dr. David Aizuss, a Los Angeles ophthalmologist who is president of the California Medical Association, said state and federal guidelines that took effect in 2014 and 2016 impose much more stringent prescribing precautions than “what was going on six or seven years ago.”

Many insurance plans and pharmacies in recent years have restricted dosages and durations of certain painkillers a physician may prescribe at one time.

Afraid to Prescribe

The crackdown on doctors has created fear, said Dr. Robert Wailes, a pain medicine specialist in Encinitas and chair of the California Medical Association’s Board of Trustees.

“What we’re finding is that more and more primary care doctors are afraid to prescribe and more of those patients are showing up on our doorsteps,” he said.

Officially, the CMA stops short of saying the medical board should stop the project, perhaps to avoid any perception that the association condones overprescribing. But it has asked the board to hire an independent reviewer to assess the criteria the board is using to decide which physicians to investigate, and whether physicians in certain specialties or regions of the state are being targeted more than others.

Dr. Ako Jacintho, a San Francisco addiction medicine specialist, was notified by the board that he was in trouble over a year ago. A patient for whom he had prescribed methadone fatally overdosed in 2012. The letter said “a complaint” had been filed against him, and asked him to respond to the allegations or, if he delayed, face a citation or fine of $1,000 per day. (The medical board can file its own complaints against a doctor.)

The letter said the patient had died of “acute combined methadone and diphenhydramine intoxication.” Jacintho had refilled the patient’s prescription for methadone the day before but said a 10-milligram pill was not a toxic dose. And he said he never prescribed diphenhydramine, the antihistamine sold as Benadryl.

“The only way he would have died was if he had not taken it as directed, or had mixed it with a medication that was not prescribed,” Jacintho said.

As of Dec. 21, Jacintho was still waiting to hear if he would face a formal accusation.

Last year, the board rewrote those letters in a less accusatory tone — describing the “review” as routine — although it still threatens doctors with $1,000 fines.

In a much smaller subset of cases, it finds problems that result in formal accusations that can result in discipline, such as public reprimands or restrictions on a physician’s ability to practice.

“You can’t even begin to understand how disrupting and upsetting this is. It’s not just a threat on your license; it’s a threat that you’ve not been a good physician.”

— Dr. Paul Speckart

Despite its designation as a “Death Certificate Project,” the California effort has not focused only on doctors whose patients died. In an unknown number of overdose cases, the board has sent letters to living patients asking them to authorize their doctors to relinquish their medical records to the board, adding that those documents would otherwise be subpoenaed.

Dr. Paul Speckart, a San Diego internist, said three of his patients last year received board letters that seemed to question his quality of care when all he did was try to relieve their well-documented pain. The board has not filed any accusations against him.

“You can’t even begin to understand how disrupting and upsetting this is,” Speckart said. “It’s not just a threat on your license; it’s a threat that you’ve not been a good physician.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

Some California Pain Patients Forced to Buy Naloxone

By Pat Anson, PNN Editor

A new state law that mandates new prescription pads isn’t the only headache faced by doctors and pain patients in California.

Over a dozen bills passed by the state legislature and signed into law by former Gov. Jerry Brown are aimed at addressing the opioid crisis. One of them -- AB 2760 -- requires doctors to “offer” a prescription for naloxone to any patient deemed at high risk of an opioid overdose.  Naloxone (Narcan) rapidly reverses the effects of an opioid overdose and has been credited with saving thousands of lives.

The naloxone law does not require patients to fill the prescription, but some pain sufferers are being forced by pharmacists to buy naloxone if they want to get their opioid medications filled. For one patient, it was a choice between pain relief and putting food on the table.

“A medication I don't want, don't need, and didn't ask for, is being forced on me. As in holding my other medication hostage. And each dose of Narcan is $75 for the uninsured. Which I am, because my insurance company won't pay for it,” one reader wrote on PNN’s Facebook page.

“I had to go without groceries to purchase a medication I didn't want, need or ask for. Nine years of never ever breaking a rule, having any adverse effects EVER, and never failing all those ‘gotcha’ tests they inflict on pain patients. So now, in addition to being in pain, I'm hungry. This cannot be.”

Another pain sufferer said she felt treated like a drug addict when a pharmacist forced her to buy Narcan, a nasal spray that contain naloxone.

“Blackmailed by Kaiser to pay $50 for Narcan before they would give me my pain meds. I am retired, disabled, and on fixed income,” wrote a woman who lives with severe arthritis. “I was an RN who worked holidays, weekends, nights, etc. Now this ‘greatest’ country treats me like some scum addict who shoots up illegal drugs.”

The requirement that doctors offer a naloxone prescription applies to so-called “high-risk” patients taking over 90 MME (morphine milligram equivalents) of opioids a day or those who are co-prescribed benzodiazepines, an anti-anxiety medication. Patients who have previously overdosed or have a history of substance abuse are also considered high risk.

But whether high-risk or low-risk, nothing in the law requires a patient to buy naloxone or empowers a pharmacist to withhold medications.

“The law does not make it mandatory for the patient to accept a prescription for naloxone or to fill it but only for the patient and physician to have a thoughtful conversation about whether it would be in the best interest of the patient,” Assemblyman Jim Wood, the bill’s sponsor, said in a statement to PNN.

“The law does not make it mandatory for the patient to accept a prescription for naloxone or to fill it.”

— CA Assemblyman Jim Wood

“We are beginning to hear circumstances where patients are being required to fill the naloxone prescription, and will investigate the circumstances where this is happening because that is not what the law states.”

Naloxone costs only pennies to make and syringes containing generic versions of the drug typically cost about $15 each. Branded and formulated versions such as Narcan are more expensive.

Evzio, a kit that contains two auto-injectors of naloxone, retails for about $3,700 and its manufacturer has been accused of price gouging.  The company reportedly raised Evzio’s price by over 600% to “capitalize on the opportunity” of a “well established public health crisis.”

Whether it comes in a spray, injector or syringe, its impractical to expect anyone to give themselves a dose of naloxone.

“What the state and others fail to realize is many pain patients live alone. Even if one were to accidentally overdose and lose consciousness how are they supposed to administer the Narcan?” asks PNN columnist Rochelle Odell, who lives in California. “No one clearly thinks these grandiose ideas through.”

Law enforcement groups, pharmacists and the Medical Board of California supported passage of AB 2760, but the bill was opposed by the Academy of Family Physicians, American College of Emergency Physicians and the California Medical Association (CMA).

“Mandating that a specific medication be prescribed in a variety of situations, regardless of the individual patient characteristics, is inappropriate and places the government between a patient and his or her physician,” the CMA said.

Despite that warning, AB 2760 was passed unanimously by the state Assembly and Senate, signed by the governor, and became law on January 1st.

Prescription Pad Chaos

As PNN has reported, the law of unintended consequences also applies to AB 1753, which requires California doctors to use customized prescription pads for opioids that have uniquely serialized identification numbers.

The idea was to prevent counterfeiting and get more prescriptions filed electronically, but instead the early weeks of the law’s implementation have been marked by chaos. Many doctors were unaware of the new law or unable to get new prescription pads ordered before January 1st. As a result, pharmacists have refused to fill prescriptions written on old pads and patients have been sent away empty-handed.

“I just got my new prescription pads (Monday) at a cost of several hundred dollars, and the change is trivial,” Dr. Richard Buss, a family practice physician in Jackson, told the Sacramento Bee. “At the hospital here, I was next to a doctor who was trying to send a patient home after knee surgery, and the pharmacy wouldn’t honor his prescription because they were old forms.” 

Buss said this is the second year in a row that California doctors were not given proper notification of changes in their prescription pads. 

“They’re just changing prescription requirements, and then the doctors have to jump through the hoops suddenly, and I’m left with thousands of prescription blanks that are unusable, and that’s probably true for a lot of other doctors,” he said. 

Assemblyman Evan Low, who sponsored AB 1753, was unavailable to comment to PNN. In a January 7 letter to California’s Attorney General, Low blamed state regulators for the “unanticipated” confusion caused by his legislation. 

“I have been informed that numerous pharmacies have already turned away individuals holding prescriptions written on unserialized forms that are otherwise valid; in the face of possible discipline, dispensers are forced to decide between denying care to their patients and risking action against their license,” Low wrote. 

The California Medical Association is drafting new legislation to ensure a smoother transition to the new prescription pads, a process that usually takes weeks or months.

Senator’s Letter Ignores Constituent’s Chronic Pain

By Pat Anson, Editor

Pain News Network received hundreds of comments and emails from readers responding to the open letter we published from Charles Malinowski, a 59-year old California man who suffers from Reflex Sympathetic Dystrophy (RSD) and other chronic pain conditions.

Malinowski is no longer able to obtain opioid medication and blames the CDC opioid guidelines for his “unspeakable and crippling pain.”

CHARLES MALINOWSKI

“Within 60 days I expect that the CDC will have effectively killed me. I honestly don't see myself being able to tolerate the pain any longer than that,” Malinowski wrote in his letter. “Congress, in going along with this blindly, will be explicitly complicit in this negligent homicide - or homicide by depraved indifference, take your pick.”

Malinowski’s letter to Senator Kamala Harris (D-CA) hit home with many readers, who say they’ve been abandoned by doctors who are fearful of prescribing opioid medication.  

“You are correct in saying the CDC is in effect murdering us. I too suffer from chronic pain and am unable to obtain pain meds from a doctor due to CDC guidelines,” wrote one reader.

“I just read your letter and cried all the way through it. My son in law will turn 50 this month and has been living with RSD for over 8 years. His story is a carbon copy of yours. Since the change in his meds about a month ago, (he) is now showing signs of heart trouble,” wrote Jo Ellen.

“Charles you are not alone and this attack on pain patients is affecting every pain patient nationwide,” wrote Pam. “This is terrorism at its finest folks. How many more pain patients will die due to a fictitious opioid epidemic?”

“I’m stuck in bed suffering inhuman pain 24-7 days a week. I’m lucky I have sanity now to write this. For 17 years I was under the watchful eye of a very educated doctor. Now abandoned by all in the medical field,” wrote Christine.

“This exact thing happened to my husband. He unfortunately passed away from a heart attack 6 months later,” wrote Sharon. “I pray your letter falls into the correct place to save your life and many others that are now in the same situation.”

And what about Sen. Harris, who Malinowski wrote his letter to?

She sent him a form letter that completely ignored his severe pain and life-threatening situation. It focused instead on combating opioid abuse and treating addiction.

“Thank you for reaching out to me to express your concern about the opioid crisis,” Sen. Harris wrote. “This administration and Congress must treat opioid abuse as a public health crisis. We need more funding to combat the opioid epidemic that is threatening millions.”

Malinowski replied to Sen. Harris with a second letter.

“I was very disappointed to discover that your response to me was an apparent boilerplate letter about continuing the already out-of-control hysteria over the so-called opioid epidemic,” Malinowski wrote. “My letter had nothing to do with controlling the illicit dispersal of opioids.

SEN. KAMALA HARRIS (D-CA)

"My letter was about the new CDC opioids guidelines being a literal death sentence for people like me. This is a literal death sentence because medication we depend upon is being withheld from us in a grossly and medically irresponsible manner. How you could have completely missed the blatantly obvious topic of my letter and responded so completely off-topic is simply beyond me. I think your response was shamefully ignorant and completely irresponsible.”

Unfortunately, this is not the first time we’ve heard from patients who wrote to their senator or congressman about the poor state of their pain care and gotten a form letter in response about the “opioid epidemic.” Which is no reason to stop trying or holding politicians accountable.  

“I want to hear from you. Contact me,” Sen. Harris says on her homepage. 

PNN tried to contact you, Sen. Harris. We emailed, called and left messages at your offices in Washington and Los Angeles several times in the last two weeks. Not only were we unable to speak to anyone on your staff, we couldn't even get someone to answer your phone. And we have yet to get a reply.

Neither has Charles Malinowski.  

(Update: On January 26, I finally received a reply from Sen. Harris.  But her emailed letter was yet another misdirected form letter. It thanked me for reaching out "to share your views opposing abortion."   

Fake Norco Nearly Killed California Woman

By Pat Anson, Editor

An article published online in the Annals of Emergency Medicine shows just how easy it is for someone to be fooled – and nearly killed – by counterfeit pain medication.

It tells the story of an unnamed 41-year old California woman who treats her chronic back pain with regular doses of Norco, a prescription medication that combines acetaminophen and hydrocodone.

She was one of dozens of people who died or were hospitalized in northern California after ingesting counterfeit Norco bought on the street that was laced with illicit fentanyl – a synthetic opioid that is 50 to 100 stronger than morphine.

"Street Norco is almost indistinguishable from brand-name Norco in appearance but can be lethal," said lead author Patil Armenian, MD, of the University of California San Francisco-Fresno.

"This new street drug's toxicity led to an unexpected cluster of fentanyl deaths in California this spring. These deaths in our area combined with an emergency patient who was concerned about pill appearance and exceedingly sleepy after her usual dose of medication led to our investigation."

The woman in question suffers chronic pain from a herniated disc and normally buys the Norco illicitly, 2 to 3 tablets at a time. The article does not explain why she buys them off the street.

The woman felt sleepy and became unconscious within 30 minutes of taking three of the counterfeit tablets. She next remembered waking up in a hospital emergency room. She told hospital staff the pills had the markings of Norco, but were beige in color instead of the usual white.

A blood serum analysis revealed the woman had significant amounts of fentanyl and U-47700, another type of synthetic opioid. Neither drug is an ingredient in brand-name Norco.

“Toxic effects of these compounds are similar to those of other opioids, namely, miosis, respiratory depression, coma, and possible death. To our knowledge, this is the first reported opioid toxidrome case with confirmed serum concentration of U-47700,” said Armenian, adding that the woman was discharged from the hospital and has completely recovered.

“This case highlights that fentanyl-laced Norco is spreading to other regions and may contain psychoactive ingredients other than fentanyl, such as U-47700, prompting emergency providers to remain vigilant in their care.”

As Pain News Network has reported, the Drug Enforcement Administration is warning the U.S. faces an unprecedented “fentanyl crisis” that is growing worse as drug dealers ramp up production of counterfeit medication. Dozens of Americans have died this year after ingesting counterfeit versions of oxycodone, Norco and Xanax that are virtually indistinguishable from the real medications. Even a few milligrams of fentanyl can be fatal.

Fentanyl is legally prescribed in patches and lozenges to treat severe chronic pain, but the DEA said “hundreds of thousands of counterfeit prescription drugs” laced with illicit fentanyl are on the black market. The agency predicts more fake pills will be manufactured because of heavy demand and the “enormous profit potential” of fake medication.

Canada’s Fentanyl Crisis

Canada – which has been dealing with its own fentanyl crisis – may provide a preview of what’s in store for the U.S. Overdose deaths from fentanyl have reached such an urgent level that British Columbia Premier Christy Clark asked the federal government last week to restrict access to pill presses and to start screening “all small packages” entering the province for fentanyl. 

Earlier this year British Columbia declared a public health emergency and adopted new opioid prescribing guidelines that are even more stringent than those released by the Centers for Disease Control and Prevention.  

While the CDC’s guidelines are voluntary and intended only for primary care physicians, British Columbia’s guidelines are legally enforceable for all opioid prescribers because they set a “minimum standard of professional behaviour and ethical conduct.” The guidelines state that opioids should not be prescribed to treat headaches, fibromyalgia and low back pain.

In Ontario, the backlash against opioids has reached a point that palliative care doctors are worried they will no longer be able to give high doses to their patients – many of whom are dying from cancer and other chronic illnesses. Ontario’s Ministry of Health said public health plans next year would stop paying for high doses of hydromorphone, morphine and fentanyl patches.

“Our patients under palliative care deserve better than this,” Stephen Singh, MD, director of the Canadian Society of Palliative Care Physicians, told The Globe and Mail, adding that he was “appalled” by the government’s decision.