“In 2001, there had been some initial assessments among the team that we had prosecuted lots of drug dealers, pharmacists and doctors [for illicit distribution of opioids] but no one had investigated the company that was making and marketing the drug,” says Brownlee. “So we decided to look into it.”
By the early 2000s, OxyContin was a popular painkiller that generated about $1 billion in sales for its manufacturer, Purdue Pharma. OxyContin was introduced onto the market in 1995, right as the medical profession was reassessing its longtime resistance to prescribing opioids for anything other than acute pain or terminal illness.
The World Health Organization, pain specialists and patient advocates involved with the HIV/AIDS epidemic were advocating for more aggressive use of opioids to help anyone with pain. People with chronic pain, they argued, were needlessly suffering and opioids could not only relieve physical suffering, but also reduce anxiety and enable faster recovery.
The movement relied on a few small studies from the 1980s that suggested the risk of opioid addiction was low in hospital settings.
States changed their rules to allow doctors to prescribe opioids more liberally. The Joint Commission, an organization that sets hospital standards, emphasized that pain assessments should be monitored along with the vital signs of a patient’s temperature, pulse, breathing rate and blood pressure. Pain became known as the fifth vital sign. Purdue Pharma argued that its OxyContin was safe and less likely to be abused because addiction risks were low. The company also claimed it manufactured OxyContin to be abuse-resistant.
“None of that was true,” says Brownlee, now chair of Holland & Knight’s National White Collar Defense and Investigations Team in Washington, D.C.
In 2003, Brownlee and his investigators gathered millions of documents and emails, and conducted dozens of interviews, shedding light on the company’s marketing practices and its knowledge that its products were being widely abused. The investigation concluded that Purdue Pharma and its top executives knew that OxyContin could be abused and easily crushed, snorted or injected, causing a high as powerful as heroin.
“The prosecutors discovered sales call notes [from Purdue Pharma reps] and corporate training videos that established that the company was falsely communicating to doctors that there was little risk to prescribing OxyContin,” he says. “We followed the evidence, and it showed that a lot of people were being harmed by this criminal conduct.”
Brownlee’s four-year investigation led to the successful prosecution of Purdue Pharma and its top three executives for falsely claiming that OxyContin was less addictive and less subject to abuse than other pain medications. In 2007, Purdue pled guilty to misbranding its product and paid a total fine of more than $600 million. Its three top executives pled guilty to criminal misdemeanor charges, fined $34.5 million, and were suspended from participating in the industry for 12 years.
The case represented a “shot across the bow” of the industry, says Brownlee.
The company agreed to reformulate OxyContin to make it harder to abuse.
Today, the Centers for Disease Control and Prevention says opioids are appropriate for patients who are in active cancer treatment, palliative care and end-of-life care. But it doesn’t recommend them as routine therapy for chronic pain and advises that clinicians should only consider opioid therapy if the expected benefits for both pain and function outweigh the risks to the patient.
Epicenter of the Opioid Epidemic
Thirteen years after Purdue Pharma’s guilty plea, unscrupulous physicians are still overprescribing opioids and drug dealers are selling new, even more lethal opioids that are killing people.
After Purdue Pharma was forced to change the formulation of its pills, addicts turned to heroin. Not long after, deaths from illicit opioids spiked higher. Drug dealers began mixing heroin with the synthetic opioids fentanyl and carfentanil. Fentanyl is 80 to 100 times stronger than morphine, and carfentanil, an elephant tranquilizer, is 10,000 times more powerful.
Between 2007, when Purdue Pharma changed the way it made OxyContin and 2017, overdose deaths climbed 950 percent.
At the same time, the opioid epidemic was raging in Virginia.
Last March, Thomas Cullen J.D. ’04 followed the footsteps of alumnus Brownlee by becoming the U.S. Attorney for the Western District of Virginia. Cracking down on opioid drug dealers and physicians overprescribing drugs are among his top priorities.
The district is part of the Justice Department’s Criminal Division’s Appalachian Regional Prescription Opioid Strike Force (ARPO), which utilizes investigators from multiple agencies including Justice, the FBI, the Office of the Inspector General in the Department of Health and Human Services and the DEA.
“We are squarely within the epicenter of the opioid epidemic,” says Cullen.
ARPO, which is constantly monitoring prescribing data and looking for anomalies, unearthed an unscrupulous physician, Dr. Joel Smithers, from Martinsville, Virginia. Smithers prescribed more than 500,000 opioid pills between 2015 and 2017 to patients who sometimes drove in from hundreds of miles away to get prescription pills. In May 2019, Cullen successfully convicted Smithers on 861 counts of drug distribution. The doctor was sentenced to 40 years in prison in October 2019.
But just enforcing drug laws isn’t going end the epidemic, says Cullen. Communities must also pursue a combination of prevention and treatment measures too.
Toward that end, he created a program to encourage local families impacted by the epidemic to share their stories with schools and community groups. He also partnered with the district’s federal public defender’s office to create a federal drug treatment court. Drug treatment courts allow for nonviolent offenders with pending federal drug charges to enter a medicated-assisted treatment program, under the supervision of a probation officer, as an alternative to prison.
“We need to do a better job treating people, instead of having them cycling in and out of jail,” he says.
That is why
Next Generation Interventions
The threat of opioid addiction isn’t new. In the 1800s, opium derivatives like laudanum and heroin were widely used by physicians to help patients with various ailments. By the early 1900s, there were hundreds of thousands of people addicted to heroin, prompting the U.S. federal government to make it illegal.
Researchers have come to understand that opioids work because they connect to brain receptors processing the body’s own euphoric painkillers — endorphins. Opioids boost the body’s natural abilities to block pain, slow breathing and promote calmness. People become addicted to opioids because the drug changes the wiring of the brain.
The body becomes accustomed to the opioid’s ability to create calmness and reduce pain, and thus craves more and more of it. Without the drug, some people’s brains can no longer function normally. It often takes other prescription drugs and counseling to rewire the brain to resume life without opioids.
In 2018, there were an estimated 20.3 million Americans with a substance use disorder, and 8.1 million of them said they had an illicit drug use disorder, according to the August 2019 National Survey on Drug Use and Health.
There are not enough people trained in addiction counseling to help them all.
For example, there are just 2,416 physicians in the U.S. that are credentialed as addiction psychiatrists, and 1,928 primary physicians certified in addiction medicine, according to the American Board of Medical Specialties. Another 7,500 doctors specializing in addiction will be needed to keep up with the need of patients.
That’s why the work of Sara Wang ’18 and Dr. Charles “Rick” Gressard, chancellor professor at W&M’s Counselor Education Program, matters.
Wang plans to become a primary care physician and to emphasize behavioral health as part of her care.
She is currently an evaluation coordinator at Massachusetts General Hospital’s Center for Community Health Improvement, where her team supports community health programs, including local coalitions focused on substance use disorder awareness and prevention.
Wang graduated with a B.S. in kinesiology and health sciences concentrating in public health. She credits W&M’s emphasis on public service and interdisciplinary learning for contributing to her understanding of the importance of the social determinants of health, such as housing, food, education, employment and behavioral health, when it comes to patient care.
“Medicine doesn’t exist in a vacuum, and it isn’t just about what goes on in the clinic,” says Wang, who grew up in Newton, Massachusetts. “If you are choosing to go into medicine today, you really don’t have a choice but to focus on behavioral health. The opioid epidemic touches so many people.”
Wang is in the process of applying to medical schools. She has spent her past year and a half supporting the Center for Community Health Improvement, which collaborates with community partners on health initiatives in many of Boston’s underserved communities.
The center staffs support groups for those struggling with substance use disorders and helps people navigate resources from housing support to treatment. Wang tracks data around services and outcomes connected to the center’s efforts, so that Massachusetts General can improve services and expand programs.
“We conducted a recent assessment of the community’s health needs, and alcohol and substance use remain among the region’s top concern,” says Wang.
As she has been working in public health, Wang has also noticed a promising trend with regard to the approach of responding to addiction.