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Drug maker Cephalon sued for patient's death in opioid overdose


Big Pharma

(NaturalNews) Once again, Big Pharma may have claimed another victim while nutritional health supplements have not.

Family members of a Philadelphia man who died of an overdose two years ago have filed a lawsuit against Cephalon Inc. in recent days, claiming that the pharmaceutical company's aggressive marketing of an extremely powerful painkiller, Actiq – closely related to fentanyl – for conditions it wasn't approved to treat, caused him to become addicted.

As reported by the Philadelphia Inquirer, the suit against Cephalon and Teva Pharmaceuticals, which bought the former in 2011, targets the makers for their alleged role in the opioid epidemic, which has been responsible for more than 165,000 deaths since 1999, according to the Centers for Disease Control and Prevention.

Government agencies have enacted regulations in a bid to thwart Big Pharma's misguided marketing strategies, but legal experts say that it is uncommon for a civil suit to be brought by the estate of the deceased. Experts contacted by the Inquirer said that they could not remember a similar case that had succeeded.

Big Pharma shares part of the blame

That said, however, there is a culture of abuse and death surrounding the opioid epidemic – drugs which often cause addiction and which have very often led to overdose death, as in this case.

According to the National Institutes of Health, one in four families has been touched personally by the prescription opioid epidemic. In addition, the Inquirer said, surveys of Americans have found that an overwhelming majority believe that Big Pharma shares at least part of the blame.

In the past, government investigators have found evidence of illicit, profit-driven behavior by drug makers, and indeed, Cephalon pleaded guilty in 2008 to a criminal charge involving Actiq. Investigators have discovered that some drug makers have launched campaigns to convince primary care providers that their products are not risky and are more effective than the evidence suggests.

There have been other industry actions, such as the dramatic ratcheting up of prices for common medications like the EpiPen that have been around for decades, which have only fueled more public angst.

"The pharmaceutical companies act like they aren't doing anything," said Donna Shaffer, who lost her son Joey Caltagirone, 39, to an overdose after he was on multiple prescription painkillers for years, ranging from OxyContin to Percocet and the Actiq variant of fentanyl.

"They are making legal prescription junkies — that's what I call them — out of innocent people who are injured," she told the paper.

In case you've forgotten, singer-songwriting genius Prince was killed by fentanyl, which is 50 to 100 times stronger than morphine. Its illegal form, which is usually manufactured overseas by drug cartels and mixed with heroin, has been tied to a recent spike in deadly overdoses all around the country.

The Big Pharma form of fentanyl is used during surgery and for acute pain. Actiq is a fast-acting version that is absorbed into the bloodstream via a lozenge-on-a-stick that is swirled around in the mouth. It was approved by the Food and Drug Administration in 1998.

Largest settlement ever in Philly

The FDA was obviously very concerned about the potency of Actiq, because it added a boxed warning to the package insert stating that the drug "is indicated only for the management of breakthrough cancer pain", expanding it a number of times. The regulator did add a contraindication specifically directed at migraines in 2009, the Inquirer reported.

In addition, the FDA required Cephalon to send quarterly reports that alerted the regulatory agency if large numbers of primary care providers other than those specializing in oncology and pain management were handing out prescriptions.

The company promoted the drug to family practitioners and a host of other care specialists for a variety of other conditions such as headaches and wound dressing changes (for pain management), according to a federal memo accompanying Cephalon's 2008 guilty plea involving Actiq and a pair of other drugs.

The company was ordered to pay $425 million in criminal and civil fines, in what was the biggest ever health-related settlement by the U.S. attorney's office in Philly.

Sources:

AccessData.FDA.gov[PDF]

Justice.gov

Philly.com

PharmaDeathClock.com

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