Tag Archive: Purdue Pharma


 

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Prosecutors in Connecticut and New York are considering charges of fraud and racketeering against the billionaire Sackler family, whose company Purdue Pharma produces the prescription painkiller OxyContin.  Earlier this year, The New York Times reported Purdue executives knew OxyContin was highly addictive as early as 1996, the first year after the drug hit the market, but still promoted it as less addictive than other opioids.  Many feel that Purdue Pharma planted the seeds of the opioid epidemic through its aggressive marketing of OxyContin.  The pharmaceutical giant has long claimed it was unaware of the powerful opioid painkiller’s growing abuse until years after it went on the market.

A copy of a confidential Justice Department report uncovered that federal prosecutors investigating the company found that Purdue Pharma knew about “significant” abuse of OxyContin in the first years after the drug’s introduction in 1996 and concealed that information.  Company officials had received reports that the pills were being crushed and snorted; stolen from pharmacies; and that some doctors were being charged with selling prescriptions.  In 2006, 10 years after the drug was first put on the market- federal prosecutors wrote that the drug maker continued “in the face of this knowledge” to market OxyContin as less prone to abuse and addiction than other prescription opioids.

Prosecutors found that the company’s sales representatives used the words “street value,” “crush,” or “snort” in 117 internal notes recording their visits to doctors or other medical professionals from 1997 through 1999.  The investigation cited emails showing that Purdue Pharma’s owners, Richard Sackler and founders Raymond and Mortimer Sackler, were sent reports about abuse of OxyContin and another company opioid, MS Contin.  Purdue Pharma’s general counsel, Howard R. Udell, wrote in an email in early 1999 to another company official “We have in fact picked up references to abuse of our opioid products on the internet.”  That same year, company officials learned that OxyContin was being described as “the hottest thing on the street — forget Vicodin” according to emails.  Just a year after that email exchange, Udell and other company executives testified in Congress and elsewhere that the drug maker did not learn about OxyContin’s growing abuse until early 2000, when the United States attorney in Maine issued an alert. The company still maintains that position despite evidence to the contrary.  After a four-year investigation, the prosecutors recommended that three top Purdue Pharma executives be indicted on felony charges, including conspiracy to defraud the United States, which could have sent the men to prison if convicted.

Instead, top Justice Department officials in the George W. Bush administration did not support the move and the government settled the case in 2007.  Purdue Pharma pleaded guilty to a felony charge of “misbranding” OxyContin while marketing the drug by misrepresenting, among other things, its risk of addiction and potential to be abused. Three executives; Michael Friedman, Dr. Paul D. Goldenheim and Howard Udell, each pleaded guilty to a misdemeanor “misbranding” charge that solely held them liable as Purdue Pharma’s “responsible” executives and did not accuse them of wrongdoing. The company and the executives paid a combined $634.5 million in fines and the men were required to perform community service.

Over the past two decades, more than 200,000 people have died in the US from overdoses involving prescription opioids and the epidemic was declared a Public Health Emergency in 2017.  While the Justice Department may hail the settlement as a victory, many feel the decision not to bring more serious charges and air the evidence prosecutors had gathered meant that a critical chance to slow the trajectory of the opioid epidemic was lost.

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Massachusetts has filed a lawsuit against 16 top executives of Purdue Pharma, the maker of the popular drug OxyContin, claiming they misled doctors, patients and the public about the dangers posed by the opioid-based painkiller.  Attorney General Maura Healey said “Their strategy was simple: The more drugs they sold, the more money they made—and the more people died. We found that Purdue engaged in a multibillion-dollar enterprise to mislead us about their drugs. Purdue pushed prescribers to give higher doses to keep patients on drugs for longer periods of time, without regard to the very real increased risk of addiction, overdose and death.”  Texas, Florida, Nevada, North Carolina, North Dakota and Tennessee have filed similar lawsuits in state courts against the drug maker, whose headquarters are in Stamford, Connecticut.

The Texas’ lawsuit accuses Purdue Pharma, the privately held manufacterer of OxyContin, of violating the Texas Deceptive Trade Practices Act by aggressively selling its products “when it knew their drugs were potentially dangerous and that its use had a high likelihood of leading to addiction,” state Attorney General Ken Paxton said.  “As Purdue got rich from sales of its opioids, Texans and others across the nation were swept up in a public health crisis that led to tens of thousands of deaths each year due to opioid overdoses,” Paxton said.

State officials in Arizona, Alabama, Delaware, Illinois, Kentucky, Louisiana, Mississippi, Missouri, Montana, New Hampshire, New Jersey, New Mexico, Ohio, Oklahoma, South Carolina and West Virginia,  — sued various pain-killer manufacturers and distributors for their roles in helping the opioid epidemic grow.  In 2007, Purdue Pharma did not admit wrongdoing when it paid $19.5 million to settle lawsuits with 26 states and the District of Columbia after being accused of aggressively marketing OxyContin to doctors while downplaying the risk of addiction.  Nevada, North Carolina, Tennessee and Texas were part of that agreement while Florida and North Dakota were not.

Opioids were the cause of nearly 42,250 deaths in 2016, according to the federal Centers for Disease Control and Prevention.   Research suggests that since heroin and opioid painkillers, (including prescription ones) act similarly in the brain.  Opioid painkillers are often referred to by some doctors as “heroin lite” and taking one (even “as directed”) can increase one’s susceptibility to becoming hooked on the other.  Drug overdoses are now the leading cause of death for Americans under the age of 50, with opioids as the number-one driver.

Deaths from opioids (including fentynals) have been rising sharply for years with an estimated 100 drug overdoses a day across the country.  Experts say the epidemic could kill nearly half a million people across America over the next decade as the crisis of addiction and overdose accelerates.

 

 

 

 

 

 

opioid epidemic.jpgNew York City Mayor Bill de Blasio has announced the city is suing major pharmaceutical manufacturers and distributors over their role in the opioid crisis.   The lawsuit filed in state Supreme Court seeks $500 million in damages for current and future costs from what the mayor described as “corporate drug pushers.”  Among the companies being sued are Purdue Pharma, which is the maker of OxyContin, Teva Pharmaceuticals USA Inc., Johnson & Johnson, and Janssen Pharmaceuticals.

The lawsuit alleges opioid manufacturers used deceptive marketing to flood the city with prescription painkillers, creating “a substantial burden on the city through increased substance use treatment services, ambulatory services, emergency department services, inpatient hospital services, medical examiner costs, criminal justice costs and law enforcement costs.”

John Puskar, director of public affairs at Purdue, issued a statement saying the company “vigorously” denies the charges leveled by the city.  “We are deeply troubled by the prescription and illicit opioid abuse crisis, and are dedicated to being part of the solution. As a company grounded in science, we must balance patient access to FDA-approved medicines, while working collaboratively to solve this public health challenge. Although our products account for approximately 2% of the total opioid prescriptions, as a company, we’ve distributed the CDC Guideline for Prescribing Opioids for Chronic Pain, developed three of the first four FDA-approved opioid medications with abuse-deterrent properties and partner with law enforcement to ensure access to naloxone. We vigorously deny these allegations and look forward to the opportunity to present our defense.”

The opioid crisis killed nearly 64,000 Americans in 2016 and provisional data for 2017 from the CDC show no signs of the epidemic abating, with an estimate of more than 66,000 overdose deaths for the year.   While overdose rates increased in all age groups, rises were most significant in those between the ages of 25 and 54.  Overdoses are now the leading cause of death of Americans under the age of 50.  “Based on what we’re seeing, it doesn’t look like it’s getting any better,” said Bob Anderson, chief of the mortality statistics branch at the National Center for Health Statistics.