Five pharmaceutical companies, including three based in the Philadelphia region, used deceptive marketing that caused opioid painkiller use to explode, resulting in the current resurgence of heroin use, according to a lawsuit filed on behalf of the State of California.
“They were actually lying to people, saying the drugs were rarely addictive,” said Tony Rackauckas, the Orange County District Attorney who filed the case this week.
It was marketing and not any medical breakthrough that opened the floodgates, Rackauckus said in a phone interview. “The result has been catastrophic.”
Rackauckas said the companies told doctors that they were only imagining that their patients were becoming addicted to the painkillers. The companies called it “pseudo-addiction” and recommended that doctors prescribe more of the drugs.
In 2010, opioid painkillers killed 16,651 users, twice the number of deaths from cocaine and heroin combined, the suit states, citing data from the federal Centers for Disease Control and Prevention. Prescription drug overdoses are now the leading cause of accidental death in the United States, surpassing the number caused by auto accidents.
The wide use of opioid painkillers “triggered a resurgence in the use of heroin,” the suit states, as users began seeking out heroin, which is often cheaper and offers a similar high. According to the CDC, seven of 10 heroin addicts have a previous history of opioid abuse.
Named as defendants in the suit are: Cephalon, Inc., of Frazer, Pa., (fentanyl “lollipop” Actiq and opioid lozenge Fentora); Endo Health Solutions, with U.S. headquarters in Malvern, Pa. (Percocet, Percodan and Opana); Janssen Pharmaceuticals of Titusville, N.J., owned by Johnson & Johnson, (Duragesic, Nucynta, Ultracet and Ultram); Purdue Pharm of Hartford Conn., (Oxycontin); and, Actavis of Parsippany, N.J., (Kadian and generic versions of Duragesic and Opana).
Multiple pharmaceutical companies named in the suit did not immediately respond to requests today for comment. However, Robyn Reed Frenze, a spokeswoman for Janssen Pharmaceuticals told the Los Angeles Times that her company was reviewing the case and is, “committed to responsible promotion, prescribing and use of all our medications."
The suit filed in California Superior Court seeks unspecified damages and restitution of profits generated by the misleading advertising.
Rackauckas said the suit is not about extracting cash from the companies and a fine, adding that a fine of hundreds of millions of dollars would not be enough.
“That’s just a small tax on the sale of billions of dollars worth of dangerous drugs. We’re going to push forward to a trial, not just take some money,” Rackauckas said. “We want them to be required to tell the truth.”
The suit states that, beginning in 1994, the pharmaceutical companies embarked on an aggressive campaign to change public perception of the drugs. The companies marketed directly to the public, targeting well-insured veterans and the elderly, encouraging them to ask doctors for opioids to relieve chronic pain. Additionally, the companies downplayed concerns that the painkillers could be dangerous and addictive, the suit states.
The companies funded front groups - such as the American Pain Foundation - to promote the use of opioid painkillers for ailments that had never been treated with opioids before: arthritis, back pain, headaches and fibromyalgia, according to the suit.
They published unbranded brochures, books, websites, and online talk shows that “dramatically” understated or denied the risk of addiction, according to the suit. By not specifically mentioning a brand, the materials were not subject to approval by the FDA.
Doctors funded by the painkiller manufacturers made appearances on morning TV news shows, pushing the painkillers, the suit states. On "Good Morning America" in 2010, one pharma-allied doctor claimed addiction was “distinctly uncommon.”
Those claims were rarely, if ever, based on scientific evidence, the suit states.
The campaign was wildly effective. Prescriptions more than doubled in 20 years from 76 million to 207 million, according to the suit. In 2007, Americans consumed 51.6 tons of the generic form of Oxycontin, oxycodone, or 82 percent of the world’s supply. Opioids generated $8 billion in revenue in 2010.
Experts reached separately by Philly.com agreed that opioid painkillers once were rarely prescribed by doctors. Only cancer patients and those dying in agonizing pain were granted the relief they could provide. Doctors were concerned about the serious side effects and risk of addiction posed by the drugs.
Now, according to the CDC, opioid painkillers are the most prescribed type of drug in America - more often prescribed than drugs for blood pressure, cholesterol or anxiety.
Dr. Kyle Kampman, medical director and professor of psychiatry at the Hospital of the University of Pennsylvania, said he believes there is a connection between the growth of opioid use and heroin use.
“Most of the heroin users I treat started with prescriptions and then moved to heroin,” said Kampman “Heroin is available, it’s cheap and not hard to find.”
Dr. Andrew Kolodny, the chief medical officer of Phoenix House, a chain of 150 nonprofit drug and alcohol rehabilitation centers, has seen the use and abuse of painkillers skyrocket to become the nation’s No. 1 drug problem.
“The opioid problem today is far more severe than anything we’ve seen before,” Kolodny said. “It’s the worst epidemic the country has ever faced.”
According to Kolodny, nearly 5 million Americans are addicted to painkillers.
“We are essentially talking about heroin pills,” Kolodny said.
California’s suit lays the blame squarely at the foot of the pharmaceutical companies.
“These deceptive messages gave doctors and patients a false sense of security that as long as patients are only taking opioids a doctor gives them - regardless of the dose of frequency ingested - and not manipulating them, snorting or injecting them, they are not addicted,” the suit states. “That is false.”
The California suit is not the first to target drug manufacturers for making dubious claims about their opioid painkillers. In 2007, Purdue paid a $635 million fine after pleading guilty to misleading the public about Oxycontin’s risks. In 2008, Cephalon paid a $425 million fine to settle suits charging the company with improperly marketing their fentynyl "lollipop" Actiq and two other drugs for “off-label” uses.
But the fines that settled those cases, Kolodny said, were insufficient punishment.
“They paid the fine and nothing changed,” Kolodny said.