On Feb. 5th, a judge sentenced Los Angeles general practitioner Hsiu-Ying Tseng to 30 years to life in prison for the murder after the fatal overdose of three patients she overprescribed addictive drugs.

Tseng had been convicted by a jury in October 2015 of three counts of second-degree murder, 19 counts of unlawful controlled substance prescription and one count of obtaining a controlled substance by fraud. Her sentencing also reflected that she did nothing when informed of three previous patient deaths in 2007 and 2008.

“The defendant was repeatedly notified by law enforcement that her patients were dying on her,” L.A. County Deputy District Attorney John Niederman said during the trial.

Over the course of three years, nine of Tseng’s patients died, though she was only charged with three deaths due to mitigating factors; these included one death ruled a possible suicide and another death involved prescriptions from multiple doctors. According to the Drug Enforcement Administration (DEA), during that time she wrote more than 27,000 prescriptions, an average of 25 a day. Her office also reported $5 million in revenue for that three-year period. This factored into her sentencing—it was believed she willfully ignored the deaths for monetary gain.

The overprescribing of opioids has been labeled “epidemic” in the U.S. With opioid overdoses on the rise, doctors, patients and even the FDA struggle with countermeasures. Before the sentencing, the L.A. County Superior Court judge stated that Tseng had placed blame on patients, pharmacists and other doctors rather than accepting responsibility for her actions.

Despite being notified by DEA agents of the deaths, she failed to consider her prescribing practices. “I told myself that my patients’ conduct was beyond my control,” she stated. Tseng later admitted she had no training to prescribe addictive drugs, believing that to be the cause for the patient deaths.

While Tseng is not the first doctor to be charged with murder after prescribing painkillers for patients who subsequently died, she is the first to be convicted. Dr. Frank B. Fisher was charged with involuntary manslaughter for overprescribing OxyContin in 2002. Several more opioid cases surfaced in Florida in recent years. In 2002, Dr. James Graves was convicted of manslaughter for overprescribing OxyContin. While Dr. Denis Deonarine wasn’t convicted of murder for excessive opioid prescriptions in 2005, he was convicted and sentenced to 25 years in prison for drug trafficking. 

In the wake of Tseng’s landmark case, physicians are bracing for increased scrutiny, patients wonder if they can still have access to the painkillers they need, and the effect on clinical trials remains to be seen.

Cami Gearhart, CEO of Quorum Review IRB, said, “Even though Dr. Tseng apparently was not involved in the conduct of clinical research, this tragic situation is a reminder of the potential for misconduct whenever opiates are involved. We continue to see important study proposals involving opiates, and my hope is that the research community uses Dr. Tseng’s situation as a reminder to carefully scrutinize and monitor the conduct of such research.”

On Feb. 4th, one day before Tseng’s sentencing was announced, the FDA’s Deputy Commissioner for Medical Products and Tobacco joined other FDA top officials in calling for a far-reaching action plan to review the FDA’s opioid policies. Reacting to the opioid abuse epidemic, they will launch a large-scale action plan to attempt to reverse it.

In the media briefing, Dr. Robert Califf said, “As a doctor, I’ve had first-hand understanding of the important and legitimate need for powerful medications to help people deal with chronic or severe pain. If you’ve had a family member or a loved one touched by a serious illness or injury, you understand it too. You know how tough it can be to see them try to endure pain that can’t be touched by anything you can get over the counter. But as all of you know, more Americans now die every year from drug overdoses than they do in motor vehicle crashes.”

In Tseng’s case, the three patients ranged in age from 21 to 28 years old. They represent a much larger number of people who’ve lost their lives to opioid abuse in recent years, a statistic Dr. Califf went on to point out in the media briefing. “Opioids were involved in over 28,000 deaths in 2014 according to the CDC. The FDA is deeply concerned about this growing epidemic and I’m personally disturbed by the toll it’s taken in communities across this country.”

Among other measures, the FDA will take another look at the risk-benefit paradigm for opioids, reflecting on their larger effects on public health. They will also create an expert advisory committee before approving a new drug application for any opioid lacking abuse-deterrent properties, and increase warnings on immediate-release opioid labeling. In addition, they will expand access to abuse-deterrent formulations and foster their development. They will expand on the action plan in the coming weeks and months.  

Lisa Chontos is a freelance medical writer with 15 years of experience writing for hospitals, biotech firms, pharmaceutical companies and publications like CenterWatch. You can contact her at lisa@lisachontos.com.

This article was reprinted from Volume 20, Issue 06, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »