Jay Lawrence, an energetic truck driver in his late 30s, was driving a semitrailer across a bridge when the brakes failed. To avoid ploughing into the car in front of him, he swerved sideways and slammed the truck into a wall, fracturing his back. The Huffington Post's Art Levine reports that for more than 25 years, he struggled with the resulting pain. But for most of that time, he managed to avoid opioid painkillers.
In 2006, his legs suddenly collapsed beneath him, due to a complex web of neurological factors related to his spinal cord injury. He underwent multiple surgeries and tried many medications to alleviate his pain. The next year, he began to experience some semblance of relief when his doctor prescribed morphine, one of a class of opioid drugs. By 2012, he was taking 120 milligrams per day.
But, the report says, this isn’t a story about opioid addiction. Lawrence managed a relatively productive, happy life on the medication for the better part of 10 years. “This isn’t the life I thought I’d have,” he told his wife, Meredith Lawrence, in December 2016. “But I’m all right.”
Living on disability payments, he could still walk around their two-bedroom trailer home using his cane, take a shower on his own and, on his good days, even help his wife make breakfast. Then, the report says, in early 2017, the pain clinic where he was a patient adopted a strict new policy, part of a wide-ranging national effort to respond to the increase in opioid overdose deaths.
Citing 2016 guidelines from the US Centres for Disease Control and Prevention, her husband’s doctor abruptly cut his daily dose by roughly 25% to 90 mg, Meredith Lawrence said. That was the maximum dose the CDC recommends, though does not mandate, for first-time opioid patients.
The doctor also told Lawrence that the plan was to lower his dose to 45 mg over the next two months, a cutback of more than 60% from what he had been taking. At the end of that traumatic visit, his wife said, Lawrence’s doctor dismissed their concerns and shared his own fear about losing his license if he continued to prescribe high doses of opioids. (When HuffPost followed up, the doctor declined to comment on the case, citing patient privacy.)
The report says for a month, Lawrence suffered on the 90 mg dose. At times, his pain was so bad that he needed help to get out of the recliner, and when his wife looked over, she sometimes saw tears streaming down his face. He dreaded his next appointment when his dose would be slashed to 60 mg. In the weeks before that scheduled visit on 2 March, 2017, Lawrence came up with a plan.
On the day of his appointment, on the same bench in the Hendersonville, Tennessee park where the Lawrences had recently renewed their wedding vows, the 58-year-old man gripped his wife’s hand and killed himself with a gun.
The report says there are at least 9m chronic pain patients in the US who take opioid painkillers on a long-term basis. As law enforcement and medical regulatory bodies try to curb the explosion in opioid deaths and the rise in illegal opioid use, they have focused on reducing the overall opioid supply, whether or not the drugs are provided by prescription.
The report says there’s mounting evidence this won’t work – that curbing patient access to legal prescription opioids does not stem the rate of overdoses caused primarily by illegal drugs – and that patients are being denied desperately needed relief. There are also troubling indicators that cutting back on opioids increases the risk of suicide among those with chronic pain.
Some chronic pain patients and advocates have even begun compiling lists of individuals they know who have died by suicide after they were no longer able to treat their pain with opioid medication. “There is no doubt in my mind that forcibly stopping opioids can destabilize some of the most vulnerable people in America,” said Dr Stefan Kertesz, a professor of medicine and an addiction researcher at the University of Alabama at Birmingham. “And the outcomes for those folks include suicide, overdose and falling apart medically.”
For a decade or so, the report says, government officials in the US have sought to drive down the opioid supply through a range of tactics – from increased seizures of diverted opioid medications to state crackdowns on “pill mills.” The Trump administration has embraced the hard-line approach. In late January, attorney general Jeff Sessions announced a “surge” in Drug Enforcement Administration activity targeting pharmacies and physicians that, in the agency’s view, oversupply opioids.
In February, the Justice Department doubled down with the announcement of a new task force that would focus on manufacturers and distributors of opioids. In March, President Donald Trump unveiled a plan to lower opioid prescriptions by a third within three years. And in late June, the federal government arrested 600 people, including 165 medical professionals, for allegedly participating in $2bn worth of fraud schemes involving opioids.
The report says the Trump administration’s efforts are dramatic even within the context of the CDC’s opioid dose guidelines. The guidelines were originally intended to advise primary care physicians treating chronic pain patients and other pain sufferers. They were urged to exercise caution in prescribing opioids, to use alternatives whenever possible and to prescribe daily doses of no more than 90 morphine milligram equivalents (MME) for new opioid users.
For pain patients like Jay Lawrence who had already been on opioids for years, however, the guidelines simply recommended regularly assessing the harms and benefits of the dosage. They didn’t advise either mandatory cut-offs or any set limits. (The Tennessee Department of Health’s guidelines would also have allowed Lawrence to stay at 120 mg of morphine when prescribed by a pain specialist.)
But “the CDC guidelines have been weaponised,” said Kertesz in the report. The ramped-up enforcement by the DEA and state regulators has led some doctors to choose caution and to overcorrect in their prescribing, lest they lose their ability to practice medicine at all. Kertesz decried these policies as “simplistic” in a definitive new article published last week in the journal Addiction.
In February, Sessions struck a particularly harsh tone by suggesting that the fate of chronic pain patients was not high on his list of concerns. “I am operating on the assumption that this country prescribes too many opioids,” the attorney general said. “I mean, people need to take some aspirin sometimes and tough it out a little.”
Attitudes like that are based on a series of mistaken assumptions about pain, according to Dr Thomas Kline, a North Carolina-based family practitioner and former Harvard Medical School programme administrator. Kline regularly updates a list of pain patients, published on Medium, who’ve killed themselves in the wake of draconian restrictions on pain medication.
“I ask people to imagine the very worst pain they’ve ever experienced in their lives,” Kline said. “And then that they’re denied relief by a doctor with the one medicine proven effective for pain control for 50 centuries.” (Historical records show that people in ancient Mesopotamia cultivated the poppy plant for medical use.)
The report says the government’s aggressive focus on doctors and patients is unlikely to address the very real menace of opioid-use disorders and sharply escalating overdose deaths. Fraud – driven by pharmaceutical company policies – and diversion – the phenomenon of prescription medications being sold as street drugs – initially spurred a wave of opioid abuse in the late 1990s, as some doctors turned their practices into pill mills.
But new reports by the CDC and a drug data firm, the IQVIA Institute for Human Data Science, suggest that prescription drugs play a much smaller role in today’s crisis. The reports show that total opioid prescriptions dropped 10% in 2017 – the sharpest annual decline in such prescribing in 25 years. While opioid prescriptions peaked back in 2010, the studies found that growth rates in opioid-linked deaths, overwhelmingly due to illegal fentanyl and heroin, have skyrocketed in the last seven years.
Indeed, the report says, although two-thirds of the 64,000 overall drug overdose fatalities were linked to opioids in 2016 – the most recent year for which there is data – more than 80% came from illegal street drugs such as heroin and fentanyl. Prescription opioid drug deaths alone – excluding methadone – amounted to less than 15% of all drug overdose deaths, or about 9,500 fatalities.
Still, the report says, the CDC’s guidelines have triggered restrictive laws in at least 23 states that mandate ceilings on opioid dosage. (Oregon, in fact, is moving to taper dosages down to zero for all Medicaid chronic patients over a year.) That makes relief less attainable for pain patients and threatens the practices of doctors who treat them. These laws have been augmented by the growth of state prescription monitoring programmes that use the software NarxCare, which is designed to flag addiction but can also rope in pain patients based on their prescription history and use of multiple doctors.
And in June, the House of Representatives passed over 50 bills that would establish dramatic new restrictions on opioid prescribing, eliciting alarm among patients and some disability rights groups.
The report says the side effects of the current enforcement efforts are disturbing enough, from patients denied relief to drug shortages to suicides.
No health agency has kept track of all pain-related suicides that may be linked to doctors cutting back on prescriptions. But some preliminary findings from Department of Veterans Affairs researchers indicate that VA pain patients deprived of opioids were two to four times more likely to die by suicide in the first three months after they were cut off, compared to those who remained on their pain medications.
The report says that study isn’t without flaws. Veterans die by suicide at higher rates than average – currently accounting for 20 suicide deaths a day – so they are not a nationally representative sample. And the VA study, which was released at a national opioid summit in early April, has not yet been submitted for peer review.
But another study, published in 2017 looked at nearly 600 veterans who in 2012 were cut off from dosages after long-term opioid use and found similar results – 12% of the vets showed suicidal ideation or took violent action to harm themselves – a rate nearly 300% higher than the overall veterans community.
“To protect people, you have to take care of the patient, not the pill count,” said Kertesz, who worked on the VA’s April 2017 study but spoke only as an independent researcher. “The findings suggest that the discontinuation of opioids doesn’t necessarily assure a safer patient.”
The report says even terminally ill cancer patients are increasingly getting less relief, and there are growing shortages of injectable opioids at local hospitals and hospices, spurred in part by DEA-ordered reductions in opioid manufacturing quotas.
Leah Ilten, a 53-year-old physical therapist who lives in Kennewick, Washington, is quoted in the report as saying that as her 86-year-old father lay dying of pancreatic cancer in a hospice, the medical staff ignored her pleas to provide appropriate opioid pain relief, even cutting his dosage in half on the last day of his life. A few days earlier, when he was in the hospital, one nurse explained to her that opioids could lead to an overdose or could potentially cause the man, who lay moaning in pain, to “get addicted.” “I was horrified,” Ilten said.
In mid-April, the DEA responded to the injectable opioid shortage by lifting production quotas. According to the report, an agency spokesperson said that it was “a manufacturers’ problem, not the quotas,” while asserting that progress is being made.
There have been production issues, including Pfizer’s foul-ups with a plant in Kansas. But, the report says, the DEA’s delay in taking action – shortfalls were flagged in February in a letter from the American Society of Anesthesiologists and other health groups – definitely contributed to the shortage, according to Dr James Grant, president of the ASA. He said that quotas were among the factors creating the crisis.
Faced with the hard-line national crackdown on opioid prescriptions, people with chronic pain are trying to raise awareness of the suffering caused by the loss of medications. The report says some are gathering the names of those patients who ended up taking their own lives, both as a memorial to those who died and as a protest against the health establishment that has seemingly abandoned them. Others are seeking comfort from each other on social media.
Lelena Peacock, who declined to name her south-eastern city of residence for fear of retaliation from doctors, is struggling with how to treat the pain associated with fibromyalgia. The 45-year-old found that her social media posts drew other pain patients who turned to her for help. By her own count, Peacock has thus far convinced more than 70 chronic pain patients to call 911 or suicide prevention hotlines instead of killing themselves.
For Anne Fuqua, a 37-year-old former nurse from Birmingham, Alabama, the motivation for compiling a list of chronic pain-related suicides is to track the damage done by what she sees as policies that have left people like her behind. “There’s so many people who have died,” she said. “We have to remember them.”
The report says Fuqua has an incurable neurological illness known as primary generalised dystonia that causes Parkinson’s-like involuntary movements and painful muscle spasms. She started taking about 60 mg of Oxycontin a day in 2000. Her doctor began to limit her access to high doses of opioids in 2014, the same year she started chronicling those friends who had killed themselves or otherwise died after being denied pain medications. Her informal list is now up to roughly 150 people, augmented by lists that other pain patient advocates have compiled.
On 9 July, Fuqua joined other chronic pain patients at a meeting at the US Food and Drug Administration campus in Maryland to express their fears and outrage at the cutbacks. Sitting in the front row in her wheelchair, she told FDA officials about that list and declared, “I’m not willing to go back to the state I was in before I started treatment.”
The report says Fuqua’s own difficulties are compounded by the fact that her body does not respond to even large doses of opioids the way others do – she suffers from severe malabsorption that hampers her ability to benefit from everything from opioids to vitamin D. Since 2012, she has relied on a strikingly high daily regimen of 1,000 MME of opioids, including fentanyl patches, to manage her pain.
But her physician, Dr Forrest Tennant, was driven to retire this year after a DEA raid and investigation. The Los Angeles-area physician mailed her a final series of prescriptions, which will run out at the end of July. “It’s terrifying,” she said looking at her future. “If these were people who had asthma or diabetes and weren’t stigmatized because of opioids, this wouldn’t be allowed to happen.”
Another doctor has quietly stepped forward to continue treatment for Tennant’s remaining patients, Fuqua said, although there’s no assurance that this physician won’t also be investigated in the future.
The report says the raid on Tennant’s home and office last November illustrates the hard-line regulatory and enforcement approach that critics say doesn’t distinguish between pill-mill doctors who deserve to be shut down and legitimate pain doctors who use high-dosage opioids. The wide-ranging search warrant served to Tennant essentially accused him of drug trafficking even though he’d earned a national reputation for deft treatment of – and research about – pain patients.
“He’s highly respected and prominent in pain management,” said Jeffrey Fudin, a clinical pharmacy specialist who heads the pain pharmacy programme at the Albany Stratton VA Medical Centre in Albany, New York, and serves as an associate professor at the Albany College of Pharmacy and Health Sciences. “Most of his patients had no other options, and they came from around the country to see him.”
The report says Tennant was known for taking on difficult-to-treat patients, including those suffering from pain as a result of botched surgeries and other forms of malpractice. His research included innovations in the use of hormones to alleviate pain and lower opioid use up to 40%, as well as work on genetic testing for enzyme system defects that lead to opioid malabsorption.
“The DEA can trigger an investigation every time they misapply the CDC guidelines without paying attention to the population the physician treats or issues of medical necessity,” said Terri Lewis, a patient advocate and a PhD clinical rehabilitation specialist with Southern Illinois University who trains clinicians on how to manage seriously ill patients with incurable pain.
The report says Special Agent Timothy Massino, a spokesperson for the DEA’s Los Angeles division, declined to comment on the agency’s approach to Tennant. “It’s an ongoing investigation,” he noted.
Tennant’s isn’t alone. Physicians must now balance their prescribing obligations to their patients with legitimate fear for their livelihoods.
DEA enforcement actions against doctors have risen some 500% in recent years – from 88 in 2011 to 449 last year, according to an analysis of the comprehensive National Practitioners Data Bank by Tony Yang, a professor of health policy at George Washington University. The report says even though that’s a relatively small number of arrests compared to the roughly 1m physicians in the country, such arrests can have an outsized impact. “They make big news, and they serve as a deterrent for physicians whose specialties require them to use a lot of pain medications,” Yang said. “It makes them think twice before prescribing opioids.”
Dr Mark Ibsen of Helena, Montana, found himself in a five-year battle against the state licensing board that’s still not over – even though a judge last month reversed the board’s decision to suspend his license because of due process violations. The court has remanded the case back to the licensing board for potential further investigation of his opioid prescriptions, but Ibsen has decided he won’t resume his medical practice.
The report says that’s bad news for Montana, which has the highest rate of suicide in the country, according to the CDC. What’s more, chronic pain-related illnesses account for 35% of all the state’s suicides, as a recent state health department study found.
In the course of his fight with the medical board, the 63-year-old doctor said three of his former chronic pain patients have killed themselves after he and other doctors stopped prescribing opioids. The first of those patients died shortly after attending a hearing to show his support for Ibsen.
The report says the deaths of pain patients haunt those who treated them and loved them. Meredith Lawrence, who sat with her husband to the very end, said, “It was as horrifying as anything you can imagine.” “But I had the choice to help him or find him dead someday when I came home,” she added.
The report says Lawrence was arrested and sentenced to a year’s probation for assisting a suicide. Now her goal is to fight restrictions on opioid prescriptions. “If we don’t stand up, more people will die like my husband.”
[link url="https://www.huffingtonpost.com/entry/government-crackdown-opioid-prescriptions-pain-patients_us_5b51ec57e4b0fd5c73c4a42e"]The Huffington Post report[/link]