Pubdate: Thu, 22 May 2014
Source: Los Angeles Times (CA)
Copyright: 2014 Los Angeles Times
Contact:  http://www.latimes.com/
Details: http://www.mapinc.org/media/248
Authors: Scott Glover and Lisa Girion

2 COUNTIES SAY FIRMS FUELING DRUG EPIDEMIC

O.C. and Santa Clara County Sue Makers of Painkillers, Accusing Them 
of a 'Campaign of Deception.'

Two California counties sued five of the world's largest narcotics 
manufacturers on Wednesday, accusing the companies of causing the 
nation's prescription drug epidemic by waging a "campaign of 
deception" aimed at boosting sales of potent painkillers such as OxyContin.

Officials from Orange and Santa Clara counties - both hit hard by 
overdose deaths, emergency room visits and escalating medical costs 
associated with prescription narcotics - contend the drug makers 
violated California laws against false advertising, unfair business 
practices and creating a public nuisance.

In sweeping language reminiscent of the legal attack against the 
tobacco industry, the lawsuit alleges the drug companies have reaped 
blockbuster profits by manipulating doctors into believing the 
benefits of narcotic painkillers outweighed the risks, despite "a 
wealth of scientific evidence to the contrary." The effort "opened 
the floodgates" for such drugs and "the result has been 
catastrophic," the lawsuit contends.

The complaint accuses the companies of encouraging patients, 
including well-insured veterans and the elderly, to ask their doctors 
for the painkillers to treat common conditions such as headaches, 
arthritis and back pain.

The widespread prescribing of narcotics has created "a population of 
addicts" and triggered a resurgence in the use of heroin, which 
produces a similar high to opiate-based painkillers, but is cheaper, 
the suit says.

In Orange County, where the lawsuit alleges there is a 
painkiller-related death every other day, Dist. Atty. Tony Rackauckas 
said he decided to pursue the case "as a matter of public protection."

The primary goal, Rackauckas said in an interview, is "to stop the 
lies about what these drugs do."

The 100-page lawsuit brought on behalf of the entire state seeks 
compensation for the damages allegedly caused by the drugs, as well 
as a court order forcing the companies to forfeit revenue based on 
the contested marketing campaign.

Named in the suit are: Actavis, Endo Health Solutions Inc., Johnson & 
Johnson's Janssen Pharmaceuticals, Purdue Pharma, and Teva 
Pharmaceutical Industries' Cephalon Inc.

"We're committed to responsible promotion, prescribing and use of all 
our medications," said Robyn Reed Frenze, a spokeswoman for Janssen 
Pharmaceuticals. She said her company was reviewing the case and had 
no further comment at this time.

Representatives for the other drug makers either declined to comment 
or were not immediately available Wednesday afternoon.

Robert Fellmeth, a University of San Diego School of Law professor 
and former deputy district attorney, says he expects the 
manufacturers to challenge the counties' authority over federally 
regulated drugs.

But Fellmeth, who served as an expert witness in the tobacco 
litigation and helped write the unfair business practices law, says 
the case is precisely what the statute was designed for.

"California is suffering disproportionately from this problem, so it 
is appropriate for this state to take up this hammer," he said.

Twenty years ago, the narcotics industry was hemmed in by a small 
market because the long-held fear of addiction stopped doctors from 
prescribing powerful painkillers for anything but cancer pain and 
end-of-life suffering. To expand their market, the drug companies 
engaged in a dishonest campaign that "reeducated" doctors and 
revolutionized the treatment of pain associated with a wider array of 
aliments, the suit alleges.

All of the painkillers were approved by the U.S. Food and Drug 
Administration. Those approvals tightly control what the companies 
can say about the drugs they sell, and require that individual 
product labels carry warnings about addiction and other serious side effects.

The counties allege in the lawsuit that the drug manufacturers 
broadly promoted the entire class of narcotic painkillers as safer 
than they are. The marketing campaign promised unproven benefits - 
such as improved sleep and quality of life - that went beyond the 
claims the FDA allowed the companies to make in marketing specific 
drugs, the suit says.

The companies employed tactics similar to those used by the tobacco 
industry to "conceal their deceptive marketing and conspiratorial 
behavior," the suit states.

One such tactic involved the use of leading physicians - known within 
the companies as "key opinion leaders" - to spread the message to 
their peers, it says. The drug makers allegedly recruited and paid 
those physicians to give speeches and write policy papers.

Another marketing ploy was to create and co-opt patient advocacy 
organizations and medical specialty societies, the suit says. The 
companies used these front groups to promote narcotic painkillers and 
to write treatment guidelines that expanded the market, it says.

It was the drug makers' "marketing - and not any medical breakthrough 
- - that rationalized prescribing opioids for chronic pain and opened 
the floodgates of opioid use and abuse," the suit says.

The companies have continued to promote the use of narcotics for 
chronic pain even though doing so is "unsupported by competent 
scientific evidence," the suit contends.

Painkillers are involved in more than 16,000 deaths each year and are 
responsible for pushing fatal overdoses ahead of traffic accidents as 
a leading cause of death in the U.S.

This is not the first time drug makers have been accused of 
fraudulently promoting narcotic painkillers. In 2007, Purdue agreed 
to pay $635 million to settle criminal and civil charges by the 
federal government and several states that it had underplayed 
OxyContin's addiction risk to persuade doctors to prescribe it.

The counties' suit alleges Purdue, the maker of OxyContin, continued 
its deceptive marketing even after it pleaded guilty and pledged to 
stop. The suit cited a 2013 Times' article that revealed Purdue kept 
a database of doctors it suspected of recklessly prescribing its drug 
to addicts and dealers. That program, the suit alleged, was evidence 
that the company "was aware of, and profited from," the misuse of its 
popular painkiller.

The manufacturers' deceptive marketing campaign, carried out over 20 
years, "deprived California patients and their doctors of the ability 
to make informed medical decisions and, instead, caused important, 
sometimes life-or-death decisions to be made based not on science, 
but on hype," the complaint states.

Over the same period, narcotic prescriptions have soared as doctors 
often turn to them first - rather than as a last resort - for all 
types of pain, and keep many patients on them indefinitely. The 
consequences of this revolution in medical practice have been dire.

A Times investigation published in 2012 found that nearly half of the 
prescription-drug-involved deaths in Southern California from 2006 
through 2011 involved at least one drug prescribed by a doctor.

The Times' identified 71 Southern California doctors, including 
several from Orange County, who prescribed drugs to three or more 
patients who fatally overdosed.

Rackauckas said he was well aware of the toll prescription narcotic 
abuse has had in his county, based in part on consultation with the 
coroner's office. He said the problem stems from the pharmaceutical 
companies who put profit before patient care.

"In order to put money in their pockets," he said, "they've done 
serious harm to many thousands of people."
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MAP posted-by: Jay Bergstrom