To Your Health
June, 2014 (Vol. 08, Issue 06)
Opioids: Big Bucks, Little Regard for Truth
By Editorial Staff
It's becoming more common to see drug manufacturers negotiate "false claims" settlements for millions and billions of dollars. Most of these settlements have to do with violations in the marketing of the drugs they produce and sell. Wikipedia lists the top 20 settlements involving "false claims" by drug manufacturers, which total more than $17 billion in criminal and civil penalties between 2001–2012. Add in the significant Johnson & Johnson settlement from last year and the number is closer to $20 billion or about $1.5 billion a year.
Looking at the violations and the insidious nature of the drug companies' marketing tactics, one can't help assume that these penalties are accepted as a cost of doing business. With annual sales well over $330 billion and estimated marketing budgets
of $72 billion, a few billion in annual fines is not likely to make much of an impact, regardless of their PR rhetoric.
But a new lawsuit brought forth by the California counties of Orange and Santa Clara may begin to make a difference. The suit is directed at nine manufacturers of opioids, drugs that have been over-marketed to the point that "in 2009, there were more than twice as many deaths from prescription opioid overdoses (15,597) than from cocaine (4,350) and heroin (3,278) put together."
One of the attributes that makes this lawsuit so interesting is the detail regarding the well-crafted facade allegedly designed by the defendants. This facade was created over two decades in a concerted effort that "(1) misrepresented the efficacy of opioids, (2) trivialized or obscured their serious risks and adverse outcomes, and (3) overstated their superiority, compared with other treatments."
The goal was to expand the market for opioids from the FDA approved use for cancer and other end-of-life pain to chronic pain patients, a much larger market of over 100 million Americans. As noted in the lawsuit "Defendants' marketing efforts were ubiquitous and highly persuasive. Their deceptive messages tainted virtually every source doctors could rely on for information and prevented them from making informed treatment decisions. Directly and through public relations firms they hire and advocacy groups and professional societies they finance and influence, Defendants have funded, drafted, edited, approved, published, and distributed websites, books, patient education brochures, videos, and other materials that carry their misrepresentations to targeted groups of doctors (such as family doctors), and patients – particularly veterans and the elderly."
According to the allegations, the drug manufacturers worked through professional organizations, researchers, authors, spokespersons, key opinion leaders, patient advocacy groups and various PR firms in their effort to paint the picture that opioids were safer, more effective and not likely to be addictive. And apparently, it worked: According to the lawsuit, "In 2010, 254 million prescriptions for opioids were filled in the U.S. – enough to medicate every adult in America around the clock for a month. Twenty percent of all doctors' visits result in the prescription of an opioid (nearly double the rate in 2000). Opioids – once a niche drug – are now the most prescribed class of drugs – more than blood pressure, cholesterol, or anxiety drugs."