Part One: At the root of an epidemic in Maine: a prescription pad

At every step of her education as a doctor, Candice McElroy was warned about the dangers of overprescribing opioid painkillers.

Her residency training in Massachusetts taught the family medicine practitioner to prescribe pain medications, like Vicodin and OxyContin, “extremely judiciously,” she said. McElroy moved to Maine in 2011 and, even without the current regulations to control opioid prescribing, her practice at York Hospital was “very, very judicious in the use of opioid pain medications.”

“I had always felt very defensive when people said the opioid crisis was started by doctors, because I didn’t start it if I could count on my hand the number of times I prescribed an opioid in a year,” she said.

It was a shock to her, then, when in 2019 she was hired as the new medical director for Sacopee Valley Health Center, a federally qualified rural health center serving about 6,000 patients in Porter and surrounding communities on the southwestern edge of Oxford County.

It was immediately apparent to her that the physician she was hired to replace left behind more than 200 patients on high daily doses of opioid pain medications.

“That, for me, was really eye opening,” McElroy said. “I walked in here and said, ‘Oh my goodness, (the opioid crisis) really was in some cases really fueled by doctors who were being pushed by pharmaceutical companies.”

Last year, an estimated 632 Maine people died from fatal drug overdoses, the deadliest year on record, representing a 23% jump in deaths over 2020. University of Maine researchers say there are multiple reasons for the growth in the number of deaths, including the fact that people aren’t aware illicit drugs can be laced with the highly lethal synthetic opioid fentanyl. Additionally, under pandemic conditions, people are often using drugs while they are alone and no one is around to call for help or administer naloxone.

Most drug deaths involve more than one type of drug and very often include alcohol. And cheap, illicit drugs — like methamphetamine — are being increasingly combined with fentanyl.

But even as law changes in the early 2000s and again in 2016 stemmed the flow of prescription opioids in Maine, the data obtained by the Sun Journal is clear: Opioids continue to fuel the drug epidemic in Maine, whether obtained through prescription or purchased on the street.

FROM PRESCRIPTIONS TO ILLICIT DRUGS

For the better part of 20 years, drug-induced deaths where pharmaceuticals were a factor far outweighed deaths in which nonpharmaceutical, illicit drugs were involved, according to data collected by the Margaret Chase Smith Policy Center.

Then, in 2016, as a booming drug trade began creeping into New England in part fueled by a clampdown on prescription opioids, more people died from methamphetamine, fentanyl and other nonpharmaceutical-related overdoses than from pharmaceuticals for the first time since 1997, when the Margaret Chase Smith Policy Center began collecting data.

Maine Department of Health and Human Services data obtained by the Sun Journal on opioid pill distribution in Maine is revealing, showing a steady increase in the prescribing of opioids in the early 2000s.

In 2019, when McElroy started work in Porter, DHHS data tracking shows there were 20 opioid pills prescribed per Oxford County resident per year. Those 20 pills were down from a high of 42 pills prescribed per person in 2011 and 2012.

Between 2006 and 2011, according to U.S. Drug Enforcement Administration data, prescription rates climbed in every county but Lincoln.

The highest increase was in Androscoggin County, where the rate rose 80% in five years, climbing to a prescription rate of 59 pills per person in 2011. Last year, the per person rate was 19 pills, a third of what it was a decade earlier.

DHHS data reflects a tremendous drop in prescriptions across all Maine counties between 2006 and 2021. The largest was a 70% reduction in Piscataquis County, from a high of 53 pills per person in 2011 down to 13 pills last year.

Penobscot County had the highest per person prescription rate in 2006 and again from 2008 to 2012 — with a high of 62 pills per person in 2012 — but prescriptions dropped dramatically in 2016, with 18 pills prescribed per person, a drop of some 66% over 16 years.

Like other counties, rates in Kennebec County dropped dramatically between 2006 and 2021, some 45%, but data indicates it had the highest prescription pill rate per person anywhere in Maine from 2013 through 2020, and matched Somerset County at a rate of 24 pills per person last year. (See accompanying chart.)

In 2016, as Maine adopted strict new reporting requirements and caps were set on new and existing prescriptions, Maine pharmacies dispensed more than 41 million oxycodone and hydrocodone pills, enough for 31 pills for every Mainer. In contrast, by 2021 opioid prescriptions statewide amounted to 18 pills per person, a 40% decrease.

But as those prescription rates have dropped, death rates from opioid overdoses have climbed as people turned to illicit drugs, hitting a record number of deaths last year.

A GENERATION LOST

In 2019, less than a year into Aaron Frey’s tenure as Maine attorney general, the state filed suit against Purdue Pharma, the maker of OxyContin, and its owners, members of the Sackler family, alleging that the state, “like most of the country, is experiencing an opioid epidemic that stems directly from the defendants’ unlawful business practices.”

Speaking from his office at the State House last month, Frey said his experiences as attorney general and in private practice as a defense lawyer in Bangor have “exposed the ravages of, you know, really what was kicked off by the opioid crisis.”

Families torn apart. Grandparents who suddenly became parents again, as their child struggled with opioid use disorder. Children, interrupted by the death of a parent or their absence, were forced to prematurely concern themselves with adult responsibilities like remembering doctor appointments or caring for a parent.

“A lot of what we continue to experience today, in terms of how people were addicted, how families were impacted, the generation — almost a generation of people we may have lost because of their addiction to these very addictive drugs — it has the roots in the behavior, misbehavior, of folks like Purdue and Johnson & Johnson as manufacturers and distributors who just were not paying attention to the amount of these pharmaceutical opioids that were going out,” Frey said.

They acted with impunity in their desire to make more and more money, Frey said, “without asking any questions about why in the world, you know, does a small Maine town, a small Maine pharmacy, need this much (opioid medication) coming up?”

Maine had the highest rate of prescriptions per capita for extended-release opioid pain medications, like OxyContin, out of all 50 states and the District of Columbia in 2012, according to a U.S. Centers for Disease Control & Prevention report.

HOW DID THIS HAPPEN?

Purdue released OxyContin, its extended-release formulation of the synthetic opioid oxycodone, in 1996. A highly addictive substance, oxycodone is one-and-a-half times more powerful than morphine or hydrocodone. By their own admission, the U.S. Food and Drug Administration believed that despite the high doses of oxycodone in each pill — from 10 to 160 milligrams — OxyContin’s extended-release mechanism lowered the potential for misuse, and the drug was approved.

Purdue also launched a massive, yearslong marketing campaign aimed at doctors, oftentimes primary care physicians who did not have much formal training in pain medicine.

Purdue’s drug representatives showered doctors with branded gifts, free lunches and speaking slots at medical conferences. Drug marketing campaigns were not a new phenomenon by the time OxyContin came out, however.

“The drug companies are not idiots. They know how to get a providers’ attention,” said Sen. Ned Claxton, D-Auburn, a retired family physician.

Claxton and his partners opened Family Healthcare Associates in Auburn in 1978. He said that over the years, in a single day five or six drug representatives from various companies might show up.

“They would show up and want some of your time,” he said. “It just got to be a distraction. Patients came first.”

While he and his partners decided not to pay attention to them, Claxton said there was one practice in town that “literally had every meal at lunch catered by a different drug company.”

Different from some other drug campaigns, however, were the dangerous and misleading claims Purdue pushed. It told its drug representatives to sell doctors on the idea that the risk of addiction among patients treated for pain with OxyContin was “less than 1%,” which was an out-of-context statistic taken from a one-paragraph “Letter to the Editor” in the 1980 edition of The New England Journal of Medicine.

In a 1998 promotional video that, according to The Washington Post, Purdue sent to 15,000 doctors — but did not submit to the U.S. Federal Drug Administration for review, as was legally required — a North Carolina doctor named Alan Spanos repeated the less-than-1% claim.

“And so these drugs, which I repeat, are our best, strongest pain medications, should be used much more than they are for patients in pain,” Spanos said in the video, referring to OxyContin’s time-release formula.

Critically, there was an easy way around the extended-release mechanism, and it was printed right on the bottle: The label warned users to not crush the pills, which would release “a potentially toxic amount of the drug.” The crushed pills could be snorted or dissolved in water and injected intravenously.

Purdue reformulated OxyContin in 2010 to make the pills more difficult to crush or dissolve, and called the new version “abuse deterrent.”

But, as the FDA later said, “although abuse-deterrent technologies are expected to make manipulation of opioids more difficult or less rewarding, they do not prevent opioid abuse through oral intake, the most common route of opioid abuse, and can still be abused by non-oral routes.”

CHEAP, ADDICTIVE DRUGS

In 1997, a year after Purdue introduced OxyContin, 16 Mainers died from pharmaceutical opioid-related overdoses, according to data from the Office of the Maine Attorney General and the University of Maine’s Rural Drug and Alcohol Research Program.

Fewer than 10 people died from opioid-related overdoses every year during the decade prior, per the U.S. Centers for Disease Control.

Between 1997, the first year data from the Office of the Attorney General and UMaine is available, and September of last year, 2,359 Mainers have died from a pharmaceutical opioid-related overdose.

Nationwide, nearly 250,000 people have died related to pharmaceutical opioids from 1999 to 2019, according to the CDC.

“We continue to see what was kicked off or was the conflagration, really, that was sparked by all these cheap, addictive pharmaceutical drugs coming in with the manufacturer saying, ‘Look, these are safe, they’re not addictive, don’t worry about it,’” said Frey, who is in his second term as attorney general.

“What that kicked off we are still dealing with today, even though it’s not just pills.”

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A bottle of Purdue Pharma OxyContin 15 mg pills. Andree Kehn/Sun Journal

CRACKING DOWN ON SCRIPTS

In 2003, Maine became one of the first states in the nation to implement a prescription monitoring program.

Starting in July 2004, all licensed pharmacies in Maine were required to submit data to the state on prescriptions for all controlled substances within 24 hours of filling them.

The program’s database includes patient and prescriber information; drug type, dosage and quantity; date the prescriber wrote the prescription; and the date it was filled at a pharmacy.

For the first 13 years of the prescription monitoring program’s existence, however, participation in the program was mostly voluntary. Licensed pharmacies were required to submit prescriptions within 24 hours of filling a prescription, but they were not required to look up the patient in the database beforehand. Looking up a patient in the database beforehand would allow a pharmacist to confirm that a patient was not filling multiple prescriptions at multiple pharmacies in a short period of time.

And, until 2017, two decades after OxyContin first came to market, prescribers were not required to look up a patient in the database before writing a prescription for a controlled substance.

That year, a state law took effect mandating prescribers and dispensers electronically submit all prescriptions for controlled substances, like opioid pain medications, to the prescription monitoring program. It also mandated that prescribers check the prescription monitoring program database before writing every new opioid prescription and every 90 days after.

“By tracking all controlled substances dispensed at retail pharmacies across the state of Maine and exchanging this data with other states, the PMP has substantially reduced inappropriate opioid prescribing, virtually eliminated ‘doctor-shopping’ and pill mills, and built the capacity to allow clinicians access to critically important patient prescription history at the point of care,” read the 2021 annual report from the Maine Department of Health and Human Services’ Office of Behavioral Health, the program’s administrators.

On April 16, 2016, when Maine Gov. Paul LePage signed into law “An Act to Prevent Opiate Abuse by Strengthening the Controlled Substances Prescription Monitoring Program,” it was the first time Maine put significant restrictions on how physicians could prescribe opioids. It also required continuing education for opioid prescribers and added veterinarians as prescribers.

Under that law, new prescriptions for an opioid pain medication were capped at 100 morphine milligram equivalents per day and existing ones were limited to 300 morphine milligram equivalents per day for the first year, after which they were capped at 100 morphine milligram equivalents per day. The only way around the rules were exemptions for palliative, hospice or cancer care, medication-assisted treatment and a few other loosely defined diagnoses.

The Sun Journal was granted access to certain records within the database through a Freedom of Access Act request after several months of back-and-forth with the Maine DHHS, including a requirement to sign an agreement for the data use. (See accompany explanation on methodology.)

The line-level data describes point-of-sale transactions at retail and chain pharmacies in Maine from 2016 to 2021 for oxycodone and hydrocodone prescriptions. It identifies the name and location of pharmacies but not the identity of patients or prescribers.

Because of an amendment that passed with the original law in 2003 requiring that all data older than six years be destroyed, Maine only has prescription monitory program records dating back to 2016.

The Sun Journal has similar line-level data for 2006 to 2014 from the U.S. Drug Enforcement Administration’s Automation of Reports and Consolidated Orders System, which tracks the flow of controlled substances from the point of manufacture to the point of distribution. The Washington Post and the publisher of the Charleston Gazette-Mail in West Virginia gained access to the database in 2019 through a court order on a successful appeal following a yearlong legal battle. The Washington Post made the raw data public the same year.

“Certainly there has been significant effort to dial back, provide greater accountability and transparency when it comes to pharmaceutical opioids,” Frey said.

But, as McElroy, the medical director for Saco Valley Health Center found, there were holes in the system.

Among the 211 patients who were on opioid pain medications when she arrived in 2019, the average daily morphine milligram equivalent was 89.

A 2016 report from the U.S. CDC advised prescribers to use caution when prescribing any kind of opioid for chronic pain. The authors recommended that prescribers should “carefully reassess evidence of individual benefits and risks” when increasing the daily morphine milligram equivalent to 50 and should avoid dosages at or above 90 morphine milligram equivalents per day, writing that they should “carefully justify” that decision.

The former medical director’s prescribing practices at McElroy’s health center in Porter were not outside of Maine law, but they felt “unethical” to McElroy. These patients were not receiving end-of-life care, she said.

“Again, they were people who had chronic back pain and yet were actually actively working in construction and things like that,” she said. “And my understanding and my view is somebody with a palliative care exemption is, you know, a step probably before hospice, not somebody who’s taking a large amount of medications and yet still out there, functioning and working, in some cases, (but) not all.”

The Sun Journal reached out to the former director, who is employed by another health care organization, for comment. Voicemail and email messages were not returned.

In July last year, as a result of the multistate lawsuit against the Sackler family and Purdue Pharma, the two agreed to pay more than $4.3 billion for prevention, treatment and recovery efforts across the country. Maine is slated to receive as much as $130 million over 18 years from that settlement, with distribution scheduled to start this month.

In addition, thousands of Americans are expected to receive compensation for Purdue’s misconduct through the bankruptcy process. Purdue sought bankruptcy protection in 2019 as a means to settle lawsuits filed by state and local governments, and by individuals.

Next week: We look at how a booming drug trade ushered in a new era of the opioid epidemic and at the generational hold addiction can have on families, and one woman’s journey toward recovery.

The project was produced in partnership with the USC Annenberg Center for Health Journalism through its 2021 Data Fellowship program.

[This article was originally published by Sun Journal.]

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