Petition Asks FDA to Take NarxCare Off the Market

By Pat Anson, PNN Editor

A citizen’s petition filed with the U.S. Food and Drug Administration is asking that controversial software used by Bamboo Health to analyze health data and give patients “risk scores” be declared a misbranded medical device and taken off the market.

The petition by the Center for U.S. Policy (CUSP) says the software “has fundamentally altered the practice of medicine in the U.S. to the detriment of patients” by depriving many of them of access to opioids and other controlled drugs.

(Update: On July 21, the CUSP petition was rejected by FDA on procedural grounds because it was “not within the scope” of the agency’s petition process.)

The clinical decision support (CDS) software – known as NarxCare -- uses proprietary algorithms to gather and analyze prescription drug and other health information for millions of patients, creating risk scores for them based on their potential for misuse. The risk scores are widely used by hospitals, pharmacies, insurers and other healthcare providers to decide whether to prescribe and dispense controlled substances to patients.

Patient advocates have long said the Narxcare scores are inaccurate and being abused, depriving legitimate patients of medications to treat pain, anxiety, depression and opioid use disorder (OUD). Some also believe the scores are being used by law enforcement to identify and take action against doctors writing high-dose prescriptions.

“There are a lot of cases of people being harmed,” says Lynn Webster, MD, a pain management expert and Senior Fellow at CUSP. “What tipped the scale for me was when I was asked to look at records for a doctor who had been accused of prescribing inappropriately, totally based on a risk score. And his records did not justify being investigated or asking that his DEA license to be forfeited.

‘There is actually no validity to the scores that they provide. Too many people are being harmed from a lot of different perspectives. It’s only hurting people, not helping.”  

Having NarxCare declared a misbranded medical device is a novel approach, but Webster says the software is no different than any other device used to diagnose and treat a patient. Medical devices need prior approval from the FDA, which the agency has not given to NarxCare. Bamboo Health closely guards what data is used to create its risk scores.

“If you’re going to have a decision support tool for physicians, they have to have enough information to take a look at the content of what goes into developing that score, so they can override it and make their own judgements. But there is no information about what has really gone into it that’s publicly available that I can find,” Webster told PNN.

The petition asks the FDA to issue a warning letter to Bamboo Health, start a mandatory recall, and inform healthcare providers not to use the NarxCare risk scores.

Bamboo Health did not respond to requests for comment. In the past, the company has defended its software as an important clinical tool to help providers identify patients at risk of abusing opioids, antidepressants, sedatives and stimulants. Much of the data is collected from state-run Prescription Drug Monitoring Programs (PDMPs), which gather information on virtually every patient in the country who has been prescribed a controlled substance.

A 2021 clinical study looked at NarxCare scores for nearly 1,500 patients who were prescribed opioids in Ohio and Indiana. Researchers concluded that their risk scores were a “useful initial screening tool” for prescribers. The scores were deemed 86.5% accurate in identifying patients who are at low risk of opioid misuse.  

But prescribers are not the only gatekeepers in the process. If a physician decides to go ahead and write a prescription for a “high risk” patient, a pharmacy or insurer could still refuse to dispense or pay for the medication, based on their NarxCare score.

“When patients with pain, OUD, anxiety, or insomnia, for example, have inadequate access to controlled medications their health care providers deem necessary, the resultant harms can include relegation to the illicit drug market, exposure to substances adulterated with illegal fentanyl, prosecution and incarceration, drug poisoning, suicide, and death,” Michael Barnes, CUSP’s chairman, said in a statement.  

Public Officials Ignorant About Overdose Crisis

By Christopher Piemonte, Guest Columnist

A recent Washington Post article highlights an ongoing debate between the Drug Enforcement Administration and some public officials, who are demanding that DEA further reduce the supply of opioid medication. DEA has responded that, without more precise data, such a reduction would be ineffective and dangerous for Americans that need opioids.

At the center of the debate is the Aggregate Production Quota (APQ) for Schedule I and II opioids and other controlled substances. Every year, the DEA sets the maximum amount for each substance that can be produced. DEA began cutting the opioid supply in 2017 and has proposed further cuts in 2020.  

Congressional lawmakers and state attorneys general argue that the APQ for opioid medication is still too high, and the excess supply leads to overdose deaths. In a recent letter to the Acting Administrator of DEA, six attorneys general claim that the APQ does not account for opioids diverted to the black market, which “factor in a substantial percentage of opioid deaths.”

Citing data from the CDC, they assert that in 2016 “opioids obtained through a prescription were a factor in over 66% of all drug overdose deaths.”

There’s a problem with these claims: They’re wrong.

When asked about the accuracy of the letter, a spokesperson for CDC said prescription opioids were a factor in “approximately 27% of all drug overdose deaths,” a figure nearly 40% lower than that presented in the letter.

It would be one thing if this error were simply a typo or miscalculation. But these state officials, as well as many lawmakers, are insisting on a specific policy response without having made the effort to dig into the data and understand the nature of the problem itself. Specifically, they cite inaccurate data to support the incorrect notion that “prescription opioids have been a dominant driver in the growing crisis.” What’s worse, that false notion is the basis for their intransigent insistence on a blanket reduction in the supply of all prescription opioids.

Experts in law enforcement, medicine and policy agree that the attorneys general made an erroneous factual conclusion, and that an arbitrary opioid quota reduction would be both ill-informed and dangerous.

“There is no question that the DEA, or any agency, attempting to come up with valid quotas for controlled substances will find it difficult if not impossible. One of the problems with interpreting overdose death information is that illicit fentanyl and heroin deaths are frequently lumped together with oxycodone- and hydrocodone-related deaths,” said John Burke, President of the International Health Facility Diversion Association and a former drug investigator for the Cincinnati Police Department.

“The vast majority of people prescribed controlled substances take them as directed. Proposed cuts in quotas will negatively impact Americans who have a legitimate medical need for opioids, causing them even more discomfort and distress. These patients are routinely overlooked when considering the prescribing and dispensing of controlled substances, and it is a tragedy.”

Increased Demand for Street Drugs

Other experts warn that further reducing the supply of opioid medication will lead to drug shortages and increase demand for illicit drugs.   

“On the surface, it appears that limiting the quotas…could, in fact, provide a means to address the overdose crisis,” said Marsha Stanton, a pain management nurse, clinical educator and patient advocate. “That, however, will do nothing more than to minimize or eliminate access to those medications for individuals with legitimate prescriptions. We have already seen the effects of back-ordered medications, which create significant barriers to appropriate patient care.”

“Patients who lose access to prescriptions for opioids, have, in some cases, turned to street drugs as an alternative. This has led to increased morbidity and mortality since street drugs have uncertain content and are often used in a comparatively uncontrolled manner,” said Stuart Gitlow, MD, an addiction psychiatrist and past president of the American Society of Addiction Medicine.

“We, therefore, cannot afford to use a crude blunt instrument such as a quota change to address the drug abuse problem. Rather, we must focus on each patient individually and, through education of clinical professionals, ensure that each patient receives medically reasonable treatment.”

By continually insisting on cuts in opioid production, public officials demonstrate a lack of understanding of America’s overdose crisis. Put simply, they’ve failed to do their homework.

“For more than a decade, experts have urged government officials to focus on much more than reducing the opioid-medication supply. Yet, they remain fixated in intellectual laziness,” said Michael Barnes, Chairman of the Center for U.S. Policy and a former presidential appointee in the Office of National Drug Control Policy.

“Policy makers must reduce demand by prioritizing drug abuse prevention, interventions, and treatment. Prevention is the biggest challenge because it will require public officials to realize and respond to the socioeconomic underpinnings of drug abuse. The time is long overdue for politicians to get serious and do the work necessary to save lives and solve this crisis.”   

The disturbing reality is this: Despite rising death tolls and the shortcomings of recent responses, many officials involved in overdose-response policy misunderstand the complexity of America’s overdose crisis.

Until those individuals are educated about the nuances of the issue, they will continue to demand policy that does not adequately address the problem, and the crisis will carry on. Continued ignorance on the part of government officials would truly be, as Mr. Burke put it, a national tragedy.

Christopher Piemonte is a policy manager for the Center for U.S. Policy (CUSP), a non-profit dedicated to enhancing the health, safety and economic opportunity of all Americans. CUSP is currently focused on identifying and advancing solutions to the nation’s substance abuse, mental health and incarceration crises.