Legacy of OxyContin tainted by controversy History of controversy

Stamford’s largest biotech company is mostly known by government officials and the general public because of one drug.

As the maker of OxyContin, Purdue Pharma has been pummeled by controversy since the opioid hit the market in 1996. The company has poured many millions of dollars into promoting Oxy, and made billions in return. But an increasing number of public officials and medical professionals see the revenues as tainted because they say Purdue has knowingly stoked the escalating epidemic of opioid abuse by consistently making false claims about a drug linked to thousands of deaths.

“This was the perfect storm — a push to ask for painkillers, higher dosing, more powerful medications and erroneous studies that said that these drugs were not addicting,” said Dr. Arun Nandi, chairman of emergency medicine at Stamford Hospital.

As deaths from opioid abuse continue to soar, the “perfect storm” has brought a deluge of lawsuits from individuals, cities and states — including Connecticut. Purdue has paid millions of dollars in settlements. Still, the lawsuits keep coming.

Changing view of pain

The perception and treatment of pain in the U.S. underwent fundamental changes in the 1990s, as a number of medical groups responded to what they saw as an epidemic of ignored and untreated pain.

In 1996, the American Pain Society introduced the phrase “pain as the fifth vital sign,” which aimed to elevate pain assessment to the same level of importance as the standard four vital signs.

Amid the rising focus on pain management, the U.S. Food and Drug Administration approved OxyContin in 1995. The new drug would consist of a controlled-release, semisynthetic opioid painkiller to treat moderate to severe pain lasting more than a few days.

Purdue’s annual spending for OxyContin advertising jumped from about $700,000 in 1996 to approximately $4.6 million in 2001, according to a 2003 federal Government Accountability Office report. Powered by its marketing, OxyContin’s annual sales surpassed $1 billion by 2001, making it the most-prescribed brandname narcotic of its kind in the U.S., according to the GAO.

Long litigation

Purdue has been dogged for years by opioid-related litigation. By some counts, more than a dozen states and approximately 100 counties and cities have already sued Purdue and other opioid makers and drug distributors.

The filing of lawsuits has accelerated this year as officials from states around the country, including Connecticut, have laid much of the blame on Purdue for the opioid abuse ravaging their constituencies. U.S. Department of Justice officials also are investigating.

“I filed the lawsuit simply because I felt something needed to be done to address the opioid crisis in Sullivan County,” said Barry Staubus, the Sullivan County, Tenn., district attorney general, of a lawsuit he filed in June. “I saw babies who are born addicted to drugs. Many of those drugs are OxyContin.”

Purdue officials have issued statements in response to the lawsuits, in which they deny the allegations, but say they share concerns about the opioid crisis and express a commitment to “working collaboratively to find solutions.”

The company’s CEO, Craig Landau, was not available for an interview for this article.

In 2007, Purdue pleaded guilty in federal court to illegally misbranding OxyContin to mislead and defraud physicians and patients. The company agreed to pay some $600 million in criminal and civil penalties and other payments. Purdue Pharma has played a controversial role in the U.S. opioid crisis since its top-selling painkiller OxyContin went on the market in the mid-1990s.

1995: U.S. Food and Drug Administration approves OxyContin

1996: OxyContin goes on market

2001: OxyContin annual sales surpass $1 billion

2003: U.S. Government Accountability Office details OxyContin’s role in escalating opioid crisis and outlines dubious Purdue marketing practices

2003: Company receives warning letter from FDA about its marketing practices

2007: Company and three top executives plead guilty to fraudulent marketing and agree to combined $635 million penalty to federal and state authorities, in largest financial sanction to date against Purdue

Despite the perception that settlements represent at least some admission of guilt, companies see agreements with plaintiffs as preferable to the risks associated with a case going to trial.

“Jury decisions are very unpredictable,” said John Goldberg, a professor at Harvard Law School. 2010: FDA approves reformulated version of OxyContin

2015: Purdue reaches $24 million settlement with state of Kentucky related to lawsuit tied to false marketing claims

2017: Lawsuits mount against company. State officials from Alaska, Louisiana, Missouri, New Jersey, New Hampshire, Ohio, Oklahoma, South Carolina and Washington file complaints; many local and county governments also file litigation

2017: Mark Timney resigns as CEO; Craig Landau, former head of Purdue Canada, becomes new CEO

2017: Purdue joins new initiatives with National Sheriffs Association and National Prescription Drug Safety Network to combat opioid crisis

2017: Department of Justice launches investigation of Purdue SOURCE: U.S. Food and Drug Administration; U.S. Government Accountability Office; various offices of local and state attorneys general; Purdue Pharma “It’s very possible that they’d lose their shirts if they went to trial. There could be some catastrophic punitive damages awarded. They want the closure. What businesses tend to hate the most is uncertainty.”