Co-Pay Assistance Programs Fail to Help Uninsured Patients

By Pat Anson, PNN Editor

Co-pay assistance programs – also known as co-pay charities – are ostensibly designed to help needy patients pay for prescription drugs. But a new study by researchers at the Johns Hopkins Bloomberg School of Public Health found that nearly all co-pay programs fail to cover uninsured patients who need financial help the most.

The researchers also found that co-pay programs were more likely to cover high-cost, brand-name prescription drugs, despite the availability of lower-priced generic medications. The findings are published online in JAMA.

“Independent patient assistance programs favor higher-priced drugs, and the higher the drug price, the higher the likelihood of it being covered,” says co-author Gerard Anderson, PhD, professor in the Bloomberg School’s Department of Health Policy and Management. “Unfortunately patients with the greatest financial needs -- people without health insurance -- do not qualify for these programs.”

Anderson and his colleagues looked at the six largest charity organizations, which ran 274 different patient assistance programs in 2018.

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Most of the programs only covered drugs for cancer-related conditions or genetic and rare diseases. None offered free drugs and typically they only covered the most expensive medications.

“Only covering insured patients may help these programs cover more patients with their limited funds,” said lead author So-Yeon Kang, MPH, a research assistant in the Bloomberg School’s Department of Health Policy and Management. “But leaving out the uninsured diminishes the charitable aspects of these organizations supported by tax-exempted donations.”

Misconduct Widespread

Patient assistance programs run by independent charities are usually funded by pharmaceutical companies. Federal investigations into several co-pay assistance programs led to multimillion-dollar settlements with drug companies for allegedly steering patients to their higher-priced drugs.

Over the past year, Pfizer, Amgen, Jazz Pharmaceuticals, Astellas Pharma, Lundbeck and Alexion have all paid heavy fines to settle allegations that they used co-pay programs to defraud Medicare. Federal anti-kickback laws prohibit pharmaceutical companies from making any kind of payment to induce Medicare patients to purchase their drugs. The prohibition includes co-pays.

“We are committed to ensuring that pharmaceutical companies do not use third-party foundations to pay kickbacks masking the high prices those companies charge for their drugs,”  U.S. Attorney Andrew Lelling said in a statement. “This misconduct is widespread, and enforcement will continue until pharmaceutical companies stop circumventing the anti-kickback laws to artificially bolster high drug prices, all at the expense of American taxpayers.”

Similar allegations were made against Insys Therapeutics and the “Gain Against Pain” co-pay program run by the U.S. Pain Foundation. Insys donated over $3.1 million to U.S. Pain, with most of the money going to its co-pay program to help patients pay for Subsys, an expensive fentanyl spray made by Insys. A four-day supply of Subsys can cost nearly $24,000.

The founder of Insys and four former executives were recently found guilty of racketeering charges unrelated to the co-pay program. The company also agreed to pay $225 million in fines and penalties to settle criminal and civil investigations. U.S. Pain ended the “Gain Against Pain” program in 2018 and said it would no longer accept funding from Insys.

In an editorial, Katherine Kraschel, a lecturer at Yale Law School, and Gregory Curfman, MD, deputy editor of JAMA, called for more oversight of co-pay programs to make sure they help patients who truly need it.

“Although patient assistance programs may provide important financial relief for patients, the current patient assistance program structure largely neglects uninsured individuals,” they wrote.  “Absent other regulatory interventions, the Department of Justice needs to continue to scrutinize patient assistance program practices, and the Internal Revenue Service and state attorneys general should examine the tax-exempt status of patient assistance programs.”

Would Decriminalization Solve the Overdose Crisis?

By Pat Anson, PNN Editor

Vancouver, British Columbia was the first major North American city to be hit by the overdose crisis. In 2016, after a wave of overdose deaths involving illicit fentanyl and even more deadly synthetic opioids like carfentanil, the western Canadian province declared a public health emergency.

Despite efforts to decrease the supply of prescription opioids in BC, over 3,600 more people have overdosed since the emergency was declared, with fentanyl detected in 87% of the deaths last year.

So when BC’s largest healthcare system recommends some radical solutions to the overdose crisis, it’s worth noting. Vancouver Coastal Health (VCH) released a report last month recommending that illegal drugs be decriminalized and that drug users be given access to prescription opioids as an alternative to the black market.

"Legalization and regulation of all psychoactive substances would reduce people's dependence on the toxic illegal supply, criminal drug trafficking and illegal activities that people with addictions must engage in to finance their drug use," said Dr. Patricia Daly, VCH’s chief medical health officer.  

Some Canadian drug policy experts think the idea makes sense.

"The illegal market is an absolute toxic mess right now," Donald MacPherson, executive director of the Canadian Drug Policy Coalition, told the CBC. "It's really in line with consumer protection strategy ... just like we do with every other substance that we ingest, whether it be food or drugs."

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Also notable about the VCH report is that – unlike most regulators and politicians in Canada and the U.S. – prescription opioids are not singled out as the root cause of the overdose crisis. Instead, opioid medication is seen as part of the solution.

The report recommends pilot programs to see if prescription fentanyl and other opioid medications made available at supervised consumption sites could help high-risk illicit drug users “transition” to legal opioids.

“Piloting legal access to opioids is different from OAT (opioid agonist therapy) as treatment and would be low-barrier and flexible. Initial pilots would include observation of consumption, followed by pilots allowing distribution of opioids for people to take away for later consumption,” the report recommends.

The idea is controversial, but some doctors are warming up to it. A pilot program recently began at a Vancouver clinic, where hydromorphone tablets are given to about 50 patients who ingest them on site under staff supervision. In Ontario, over 400 healthcare providers and researchers recently signed an open letter asking that high dose injectable hydromorphone be made widely available to illicit drug users.

Substance Abuse and Socioeconomic Problems

The primary cause of the opioid crisis, according to the VCH report, is a “complex interaction” of socioeconomic problems, such as unemployment and homelessness, combined with substance abuse and an increasingly dangerous black market supply.

VCH analyzed the deaths of 424 overdose victims from 2017 and found that less than half (45%) even sought treatment for acute or chronic pain. They were far more likely to be unemployed (72%) and have a substance abuse problem (84%). About four out of ten overdose victims used opioids, alcohol or stimulants daily.

“Most of those who died used multiple substances including opioids, alcohol and stimulants such as cocaine and crystal meth. A significant percentage of those who died of opioid overdoses had primary alcohol use disorder and/or stimulant use disorder,” the report found.

Importantly, most of those who died were no strangers to the healthcare system. The vast majority (77%) had seen a healthcare provider in the year before they overdosed and one out of five (21%) had seen a provider a week before their death. Six out of ten (59%) had received Suboxone or methadone to treat opioid addiction, but the medications were either not effective or they dropped out of treatment.

In addition to decriminalization, the VCH report recommends improving access to addiction treatment, better substance abuse training of healthcare providers, and increased access to the overdose reversal drug naloxone.

Lessons from the Opioid Database

By Roger Chriss, PNN Columnist

Last month The Washington Post made public for the first time a DEA database of opioid prescribing that shows “the path of every single pain pill” sold in the United States from 2006 to 2012.

The Post’s analysis showed that 76 billion pills flowed through the country and nearly 100,000 fatal overdoses occurred over a seven-year period.

Biospace explained that opioid manufacturers, distributors and retailers “allowed the drugs to reach the streets of communities large and small, despite persistent red flags that those pills were being sold in apparent violation of federal law and diverted to the black market.”

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The first lesson from the database seems obvious. Too many pills were prescribed, with opioid manufacturers, distributors and retailers failing to report suspicious orders and government agencies failing to oversee the prescription opioid supply.

“If you don’t start millions of opioid-naive people on opioids they don’t need, it translates … in the longer term into fewer overdoses,” Stanford psychiatry professor Keith Humphreys told the Post.

But this misses a key lesson. Although no drug should ever be used when it is not needed, this leaves open the obvious and essential question: How do we reduce risks in people who do need opioids?

We cannot ban opioids completely without returning to pre-Civil War medicine. But each year we have millions of car crashes, severe battlefield and workplace injuries, new cases of cancer, major surgeries and devastating long-term illness.

In the many commentaries on the opioid database, little has been said about improving prescribing safety. We need better ways to use opioids safely because sometimes we just don’t have any other option.

If it is true, as Julie Croft, an Oklahoma addiction treatment provider wrote, “We are all just one accident away from becoming addicted to painkillers” -- then we had better rapidly improve how we use opioids or come up with better alternatives since we have millions of accidents annually.

To this end, Yale and the Mayo Clinic were recently awarded a $5.3 million FDA grant to study patients with acute pain and their use of opioids.

Reduced Prescribing May Not Be Enough

The next lesson in the database is vulnerability to substance abuse. Dennis Scanlon, PhD, and Christopher S. Hollenbeak, PhD, note in the American Journal of Managed Care, that “although using government or regulatory mechanisms to prevent or significantly curb the supply of addictive narcotics is certainly valuable, there is also value in preventing or reducing addiction at its core.”

In other words, policies that reduce opioid prescribing may be helpful, but they may also not be enough. We need better tools and greater understanding of opioid prescribing. The National Institute of Drug Abuse currently estimates that 8% of people on long-term opioid therapy develop some form of opioid use disorder, while The BMJ estimates that less than 1% of surgical patients receiving opioids face a similar fate. These numbers may seem low, but every effort should be made to reduce them.

As bioethicist Travis Reider states in his book “In Pain” about his personal struggle with opioids: “The bottom line is that we are not, by and large, acting decisively in an evidence-based way to tackle the myriad problems raised by opioids. Although we don’t know everything about how to turn the corner on this crisis, we know a lot, and we’re simply not doing it.”

The last essential lesson from the opioid database is that opioid abuse and addiction came long before the crisis. The clichéd response that we “cannot arrest our way” out of the crisis needs to be extended to we “cannot simply restrict our way out” either. We need better prevention and early intervention for opioid use disorder, and improved management of the opioid supply chain so as to prevent theft and diversion.

The crisis is a fast-moving target, with prescription opioid levels having dropped significantly since 2012. Overdoses involving prescription opioids have also fallen, while deaths linked to illicit opioids like fentanyl, cocaine and methamphetamine are rising sharply. We will need far more than a prescribing database to guide policy moving forward.

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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.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Marijuana Use May Affect Patient Anesthesia

By Kata Ruder, Kaiser Health News

When Colorado legalized marijuana, it became a pioneer in creating new policies to deal with the drug.

Now the state’s surgeons, nurses and anesthesiologists are becoming pioneers of a different sort in understanding what weed may do to patients who go under the knife.

Their observations and initial research show that marijuana use may affect patients’ responses to anesthesia on the operating table — and, depending on the patient’s history of using the drug, either help or hinder their symptoms afterward in the recovery room.

Colorado makes for an interesting laboratory. Since the state legalized marijuana for medicine in 2000 and allowed for its recreational sale in 2014, more Coloradans are using it — and they may also be more willing to tell their doctors about it.

Roughly 17% of Coloradans said they used marijuana in the previous 30 days in 2017, according to the National Survey on Drug Use and Health, more than double the 8% who reported doing so in 2006. By comparison, just 9% of U.S. residents said they used marijuana in 2017.

“It has been destigmatized here in Colorado,” said Dr. Andrew Monte, an associate professor of emergency medicine and medical toxicology at the University of Colorado School of Medicine and UCHealth. “We’re ahead of the game in terms of our ability to talk to patients about it. We’re also ahead of the game in identifying complications associated with use.”

One small study of Colorado patients published in May found marijuana users required more than triple the amount of one common sedation medicine, propofol, as did nonusers.

Those findings and anecdotal reports are prompting additional questions from the study’s author, Dr. Mark Twardowski, and others in the state’s medical field: If pot users indeed need more anesthesia, are there increased risks for breathing problems during minor procedures?

Are there higher costs with the use of more medication, if a second or third bottle of anesthesia must be routinely opened? And what does regular cannabis use mean for recovery post-surgery?

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But much is still unknown about marijuana’s impact on patients because it remains illegal on the federal level, making studies difficult to fund or undertake.

It’s even difficult to quantify how many of the estimated 800,000 to 1 million anesthesia procedures that are performed in Colorado each year involve marijuana users, according to Dr. Joy Hawkins, a professor of anesthesiology at the University of Colorado School of Medicine and president of the Colorado Society of Anesthesiologists. The Colorado Hospital Association said it doesn’t track anesthesia needs or costs specific to marijuana users.

As more states legalize cannabis to varying degrees, discussions about the drug are happening elsewhere, too. On a national level, the American Association of Nurse Anesthetists recently updated its clinical guidelines to highlight potential risks for and needs of marijuana users. American Society of Anesthesiologists spokeswoman Theresa Hill said that the use of marijuana in managing pain is a topic under discussion but that more research is needed. This year, it endorsed a federal bill calling for fewer regulatory barriers on marijuana research.

Should Patients Disclose Marijuana Use? 

No matter where patients live, though, many nurses and doctors from around the country agree: Patients should disclose marijuana use before any surgery or procedure. Linda Stone, a certified registered nurse anesthetist in Raleigh, N.C., acknowledged that patients in states where marijuana is illegal might be more hesitant.

“We really don’t want patients to feel like there’s stigma. They really do need to divulge that information,” Stone said. “We are just trying to make sure that we provide the safest care.”

In Colorado, Hawkins said, anesthesiologists have noticed that patients who use marijuana are more tolerant of some common anesthesia drugs, such as propofol, which helps people fall asleep during general anesthesia or stay relaxed during conscious “twilight” sedation. But higher doses can increase potentially serious side effects such as low blood pressure and depressed heart function.

Limited airway flow is another issue for people who smoke marijuana. “It acts very much like cigarettes, so it makes your airway irritated,” she said.

To be sure, anesthesia must be adjusted to accommodate patients of all sorts, apart from cannabis use. Anesthesiologists are prepared to adapt and make procedures safe for all patients, Hawkins said. And in some emergency surgeries, patients might not be in a position to disclose their cannabis use ahead of time.

Even when they do, a big challenge for medical professionals is gauging the amounts of marijuana consumed, as the potency varies widely from one joint to the next or when ingested through marijuana edibles. And levels of THC, the chemical with psychoactive effects in marijuana, have been increasing in the past few decades.

“For marijuana, it’s a bit of the Wild West,” Hawkins said. “We just don’t know what’s in these products that they’re using.”

Marijuana’s Effects On Pain After Surgery

Colorado health providers are also observing how marijuana changes patients’ symptoms after they leave the operating suite — particularly relevant amid the ongoing opioid epidemic.

“We’ve been hearing reports about patients using cannabis, instead of opioids, to treat their postoperative pain,” said Dr. Mark Steven Wallace, chair of the pain medicine division in the anesthesiology department at the University of California-San Diego, in a state that also has legalized marijuana. “I have a lot of patients who say they prefer it.”

Matthew Sheahan, 25, of Denver, said he used marijuana to relieve pain after the removal of his wisdom teeth four years ago. After surgery, he smoked marijuana rather than using the ibuprofen prescribed but didn’t disclose this to his doctor because pot was illegal in Ohio, where he had the procedure. He said his doctor told him his swelling was greatly reduced. “I didn’t experience the pain that I thought I would,” Sheahan said.

In a study underway, Wallace is working with patients who’ve recently had surgery for joint replacement to see whether marijuana can be used to treat pain and reduce the need for opioids.

But this may be a Catch-22 for regular marijuana users. They reported feeling greater pain and consumed more opioids in the hospital after vehicle crash injuries compared with nonusers, according to a study published last year in the journal Patient Safety in Surgery.

“The hypothesis is that chronic marijuana users develop a tolerance to pain medications, and since they do not receive marijuana while in the hospital, they require a higher replacement dose of opioids,” said Dr. David Bar-Or, who directs trauma research at Swedish Medical Center in Englewood, Colo., and several other hospitals in Colorado, Texas, Missouri and Kansas. He is studying a synthetic form of THC called dronabinol as a potential substitute for opioids in the hospital.

Again, much more research is needed.

“We know very little about marijuana because we’ve not been allowed to study it in the way we study any other drug,” Hawkins said. “We’re all wishing we had a little more data to rely on.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Feds Warn of Counterfeit Oxycodone Deaths

By Pat Anson, PNN Editor

In the wake of four fentanyl overdoses in southern California, federal authorities have issued a public safety alert warning drug users about a lethal strain of counterfeit medication designed to look like 30mg oxycodone tablets.

The blue bills have the letter “M” in a box on one side and the number “30” with a line down the center on the other. On the street they are referred to as blues, M-30s or Mexican Oxy.

The pills were found at the scene of four fatal overdoses in San Diego County last week. The deaths in Poway, Santee, Lakeside and Valley Center were all reported within 24 hours.

Although tests on the pills are ongoing, authorities suspect they are laced with illicit fentanyl or carfentanil, which can be fatal in tiny doses.

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“That heroin, that meth, that coke, that oxy you think you are taking? Well, it just might have fentanyl in it, and it just might be the last thing you ever do,” U.S. Attorney Robert Brewer said in a statement. “I cannot be more clear than this: Fentanyl may be the costliest drug you ever do, because you may pay with your life, and you won’t even know you took it.”

Brewer said border seizures, prosecutions and overdoses are on pace to hit all-time highs in San Diego County by the end of 2019. The Medical Examiner’s Office has confirmed 50 fentanyl-related overdose deaths so far this year, plus another 28 suspected but yet-to-be confirmed cases.

If the trend continues, the death toll could potentially reach 130, which would amount to a 47 percent increase over last year’s total of 90 deaths. The victims are overwhelmingly male, with the average age about 36.

“Just when we think it can’t get any worse, the latest numbers prove us wrong,” Brewer said.  “I am alarmed by the dramatic surge in trafficking activity and deaths, particularly of young people. San Diego is the fentanyl gateway to the rest of the country, and we are working hard to close that gate with interdiction, prosecution and education.”

Federal authorities have confiscated 1,175 pounds of illicit fentanyl – more than half a ton -- at or near the international border so far this year. In addition, there has been a record number of seizures involving counterfeit blue pills labeled M-30 that contain fentanyl. The pills sell on the street for $9 to $30 each and are appearing around the country.

Ports of entry near San Diego are major transit points for illicit fentanyl smuggled in from Mexico. The fentanyl is usually transported in vehicles, often by legal U.S. residents acting as couriers.

A recent report from the Wilson Center found that Mexican cartels are playing an increased role in the fentanyl trade.

San Diego is the fentanyl gateway to the rest of the country.
— U.S. Attorney Robert Brewer

“Chinese companies produce the vast majority of fentanyl, fentanyl analogues, and fentanyl precursors, but Mexico is becoming a major transit and production point for the drug and its analogues as well, and Mexican traffickers appear to be playing a role in its distribution in the United States,” the report found.

“Both large and small organizations appear to be taking advantage of the surge in popularity of the drug, which is increasingly laced into other substances such as cocaine, methamphetamine, and marijuana—very often without the end-user knowing it. To be sure, rising seizures of counterfeit oxycodone pills laced with fentanyl illustrate that the market is maturing in other ways as well.”

Last week a former Mexican police officer was indicted for fentanyl trafficking by a federal grand jury in Texas. Assmir Contreras-Martinez, 30, was pulled over by a Texas trooper on Interstate 40 in Amarillo in May. About 73 pounds of illicit fentanyl powder was found inside his 2007 Ford Explorer, enough to kill 10 million people, according to DEA experts. 

Contreras-Martinez admitted he was paid $6,000 to transport the fentanyl from California to Florida and that it was his second such trip. Before his unlawful immigration to the United States nine months ago, Contreras-Martinez had been employed for eight years as a municipal police officer in Cananea, Sonora, Mexico.

‘Opioid of the Future’ Postponed

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is tapping the brakes on NKTR-181, an experimental opioid pain medication that has less abuse potential than traditional opioids like oxycodone or hydrocodone.

In an SEC filing, Nektar Therapeutics said it received a letter from the FDA on July 23 saying the agency was postponing all advisory committee meetings for opioid analgesics, including one scheduled for August 21 to discus Nektar’s new drug application for NKTR-181.

The FDA was due to make a final decision on NKTR-181 eight days later, but that too is apparently being postponed while the agency considers “a number of scientific and policy issues relating to this class of drugs.”

Nektar called NKTR-181 the “opioid of the future” because it is the first full mu-opioid agonist that can provide pain relief without the euphoria or “high” that can lead to abuse and addiction.

The molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier, which slows its rate of entry into the brain.

In a Phase III clinical study, patients with chronic back pain reported that their pain scores dropped an average of 65% when taking NKTR-181 twice daily. Safety studies also found that recreational drug users had significantly less “drug liking” of NKTR-181 when compared to oxycodone.

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NEKTAR IMAGE

The research was so promising the FDA gave NKTR-181 “fast track” designation to speed its development. Nektar executives told PNN two years ago they were hopeful the drug would be approved in late 2018, with a commercial launch early this year.

Obviously that didn’t happen. And the FDA’s fast track has turned into a slow walk.

Two FDA advisory committees met last month and decided “much better-quality data” was needed before approving any new opioids — even ones with low risk of abuse.  

The agency has been under growing public and political pressure to tighten its regulation of opioids. In February, a 60 Minutes report claimed the FDA “opened the floodgates” to the opioid epidemic by approving the use of OxyContin for chronic pain. The following month, the agency received a petition from Public Citizen calling for a moratorium on new opioid approvals because the agency “can no longer be trusted” due to its “poor record” of regulating opioids.

On July 25, Howard Robin, Nektar’s President and CEO, sold 100,000 shares of Nektar for $3.1 million. A spokesman said the sale was previously scheduled due to expiring options. The company’s chief financial officer and a director also sold shares this month. Nektar shares (NASDAQ: NKTR) lost about 10% of their value after the SEC filing was made public.

Lawyer Calls for DOJ to End ‘Indiscriminate Raids’ on Doctors

By Pat Anson, PNN Editor

In recent years, hundreds of physicians, pharmacists and addiction treatment doctors have had their offices raided and searched by DEA agents.

Many of the raids were orchestrated by the Justice Department’s Opioid Fraud and Abuse Detection Unit, a special team of investigators created in 2017 to mine opioid prescribing data to identify suspicious orders and practices. The investigations have resulted in the high-profile arrests of healthcare providers for fraud and risky opioid prescribing.

"If you're a doctor and you want to act like a drug dealer, we're going to treat you like one. And sometimes the only difference between a doctor and a drug dealer is a white coat," U.S. Attorney Jay Town said about a federal takedown in April that resulted in charges against 60 practitioners in seven states.

Rarely publicized are the cases where criminal charges are never filed because the evidence against doctors is weak or non-existent.

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“It’s quite frustrating to see how their careers were ruined even though they never faced criminal charges. That’s because the government was incapable of bringing credible charges against them,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers. “When I read a criminal complaint, what I would see as ‘best practices’ is construed as criminal exploitative behavior on the part of the prosecutors.

“There’s a heavy bias against medications to treat pain and opioid use disorder that is driving some of the aggressive enforcement actions. Also, an overzealousness combined with a lack of understanding of the practice of medicine.”

Barnes recently wrote an op/ed, published online by American University’s Washington College of Law, calling for an end to the DOJ’s “indiscriminate raids” on doctors.

“DOJ raids and searches of professionals’ homes and medical clinics interrupt the delivery of health care, put patients’ lives at risk, and unjustly destroy careers and livelihoods. They also create confusion and fear,” wrote Barnes. “Not all health care professionals subject to the DOJ’s searches and seizures are ‘dirty docs.’ In fact, some of them are nationally recognized leaders not just in pain management, but also in addiction medicine.” 

Barnes cites the case of Dr. Stuart Gitlow, an addiction psychiatrist whose Rhode Island home and office were raided by FBI agents in March 2018. Sixteen months later, the reasons for the raid remain unclear and Gitlow, the former president of the American Society of Addiction Medicine, has not been charged with a crime.  

MICHAEL BARNES

MICHAEL BARNES

Neither has Dr. Forest Tennant. In November 2017, DEA agents raided the office and home of Tennant, a prominent California pain physician who was flagged for “very suspicious prescribing patterns.” In a search warrant, the 76-year old Tennant was depicted as the kingpin of a drug trafficking organization that spanned several states.

“I know based on my training and experience that patients traveling long distances to obtain controlled substance prescriptions is another ‘red flag’ of drug abuse and addiction,” wrote DEA investigator Stephanie Kolb, who led a two-year investigation of Tennant.

But Kolb, who was self-employed as a dog walker and pet groomer before she started working for the DEA in 2012, failed to note that Tennant only treated intractable pain patients, many from out-of-state, and often prescribed high doses of opioids because of their chronically poor health. Some patients were in palliative care and near death, and one committed suicide after learning of the raid, fearing she would lose access to opioid medication.

Tennant denies any wrongdoing and was never formally charged, but retired from clinical practice a few months after the raid.

“It’s hard to continue operating when they never closed my case, and so I’m going to retire and move on,” Tennant told PNN at the time. “That’s on the advice of both my lawyers and my doctors."

(Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.)  

Biased Investigations

Barnes says the biases of some prosecutors extends to the expert witnesses they hire to help build their cases. The role of these witnesses is important because they help DOJ persuade judges to sign off on search warrants that are key to gathering evidence. It’s a lucrative sideline for some paid witnesses, who charge the government hundreds of dollars an hour for their time and expertise.

“Expert witnesses are eager to give DOJ business to get the expert witness fees, and they of course will help to spin the facts in a way that is prejudicial to the defendant,” Barnes said. “What we’re seeing here is people who are really not qualified to be making assessments of other practices serving as experts for the government.” 

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Dr. Timothy Munzing, a Kaiser Permanente family practice physician in California, has worked as a medical consultant for the DEA, FBI and DOJ on over 100 investigations, most of which involve prescriptions for opioids and other controlled substances.

According to GovTribe.com, which tracks payments to federal contractors, Munzing has been awarded nearly $1 million in DOJ contracts since 2017 and is currently working on nearly two dozen DEA investigations, mostly reviewing patient files and data from prescription drug monitoring programs.

It would be unusual for a family practice physician to treat an intractable pain patient without making a referral to a pain or palliative care specialist. But Munzing was one of the expert witnesses hired by the DEA to analyze Tennant’s prescribing.

“I find to a high level of certainty that after review of the medical records… that Dr. Tennant failed to meet the requirements in prescribing these dangerous medications,” Munzing wrote in an affidavit. “These prescribing patterns are highly suspicious for medication abuse/and or diversion. If the patients are actually using all the medications prescribed, they are at high risk for addiction, overdose, and death.”  

Munzing’s affidavit and the DEA search warrant identified no patients who were actually harmed while under Tennant’s care. As PNN reported, some patients found the allegation that they were selling their medication and funneling the profits back to Tennant laughable.      

“It’s like everything else they do. They don’t talk to any patients. They don’t talk to any doctors. They just go and throw all this stuff out there and making all these incriminations against people. They don’t have any evidence that I’ve sold anything. It’s just ludicrous,” said Ryle Holder, a Tennant patient who lives in Georgia.  

Barnes says the bias against opioid prescribing “is inherent in the work of many of the investigators and prosecutors.”

“Then there is the incompetence as it relates to many of the law enforcement officers not having the medical expertise to make judgements of a medical nature. And then, when they do consult with the experts, those experts are typically trying to please their clients and getting repeat business as a result,” he told PNN. 

State Medical Boards

To bring more expertise into investigations of healthcare providers, Barnes is proposing that state medical boards play a more prominent role. He wants Congress to amend federal law to require DOJ investigators and prosecutors to get a referral from a state licensing board before investigating a practitioner for misconduct. Similar laws at the state level would also need to be changed to require state and local law enforcement to get a referral from a medical licensing board.

To make sure complaints are handled in a timely manner, Barnes says federal funds should be used to bolster the budgets of state licensing boards so they can investigate allegations of misconduct.  

“There are some detractors who say medical boards didn’t do an adequate job leading up to the overdose crisis. But the reality is neither did law enforcement,” Barnes says. “The medical boards could get up to speed and make these assessments on medical needs and patient care to make sure that healthcare providers can be assessed with medical expertise, rather than law enforcement trying to guess about standard of care and best practices.”

“Making it more difficult for law enforcement to investigate potential diversion of dangerous and addictive controlled substances, including powerful painkillers, is probably not going to happen right now,” says DEA spokesman Rusty Payne.

This idea that people need to worry about the DEA hiding in the bushes if they write an oxycodone prescription is ridiculous.
— Rusty Payne, DEA spokesman

Payne points out the DEA is both a law enforcement and regulatory agency, one that oversees 1.3 million practitioners licensed to prescribe controlled substances. He says enforcement actions are relatively rare and not “indiscriminate” as Barnes suggests.

“The numbers are incredibly low. It is a very, very, very small number.  So this idea that people need to worry about the DEA hiding in the bushes if they write an oxycodone prescription is ridiculous,” he told PNN. “We don’t have the resources. We don’t track individual prescriptions. We look for patterns and large-scale significant diversion.”  

Getting state medical boards involved, according to Payne, is not a good idea.

“I don’t think making it harder for us to scrutinize those that are acting outside the law is in anyone’s best interest,” he said.

But Barnes’ proposal makes sense, according to Dr. Lynn Webster, a PNN columnist and former president of the American Academy of Pain Medicine. 

“Barnes makes a sensible recommendation. If the law enforcement suspects a provider is not complying with the law, then the first step should be a referral to the medical board where the provider can be evaluated by their peers,” Webster said. “If a doctor goes to trial, they will not be evaluated by their peers. That is not the way the justice system is supposed to work.” 

Webster was once the target of a federal investigation of his opioid prescribing practices and DEA agents raided his Utah pain clinic in 2010. Four years later, the DOJ said it would not prosecute Webster, who said his “reputation was tarnished forever.”  

“DEA investigations are often designed to entrap a provider on technicalities.  Even if an investigation never leads to any charges the doctor's reputation is damaged.  In the court of public opinion an investigation must mean something was wrong,” Webster said.