Sex, Shopping Addiction Lawsuits May Force Faster Drug-Safety Updates
The litigation over whether Pfizer (PFE) and Boehringer Ingelheim's drugs for Parkinson's disease turn people into sex-crazed gamblers who are addicted to shopping and food could center around the question of what the companies knew and when they knew it. Boehringer was on notice in 2005, which was when the Mayo Clinic reported finding impulse control disorders in patients taking the Parkinson's drug Mirapex, but the company didn't publish its research into the side effect until this year.
The cases signal a sea change for managers on health and safety issues. Courts are no longer finding it acceptable to simply obey the minimum federal regulations on product safety. Instead, they expect companies to follow the higher standards of the states, and for companies to actively research and update safety information on their products. Even though the Mirapex cases are the stuff of late-night show monologues, they will illustrate a dividing line between those companies that proactively manage the safety profiles of their products and those that are merely hoping to fly under the radar.
Nearly 14 percent of patients on Mirapex and dopamine-replacement therapies such as Pfizer's Cabaser develop impulse control disorders (ICDs). The BI-sponsored study published this year showed that impulsive disorders occur at up to 3.5 times the rate with the drug than normal:
This association represents a drug class relationship across ICDs.Scarily, 3.9% had two or more ICDs at the same time. The warnings on Mirapex, however, leave a lot to be desired. There is no "black box" caution for the drug, which is the kind of serious alert that doctors actually pay attention to. Instead, there's only this side effect, buried among a longer list (which includes hallucinations!):An ICD was identified in 13.6% of patients (gambling in 5.0%, compulsive sexual behavior in 3.5%, compulsive buying in 5.7%, and binge-eating disorder in 4.3%), ...
Cases of pathological gambling, hypersexuality, and compulsive eating (including binge eating), and compulsive shopping have been reported in patients treated with dopamine agonist therapy, including pramipexole therapy. As described in the literature, such behaviors are generally reversible upon dose reduction or treatment discontinuation.That warning was added in 2005, the same year that a small Mayo Clinic study found addictions among its Parkinson's patients that went away once the drug was stopped. Since then, the drug seems to have wreaked havoc on the lives of dozens if not hundreds of users. Here's one 45-year-old woman's account of how she bankrupted her family business by diverting its cash to casinos and online wagering:
"Right after Christmas holidays, was the first day we were supposed to go back to work. I had been internet gambling at work, using the company's business account. I thought that, if I hit one big slot [machine], I could win all this money back for the company... instead I just dug myself into a deeper hole." She arrived at work, then promptly turned the car around and drove to the closest casino.
[Her husband] Doug finally told his father-in-law about her addiction. They pulled the company records and found that she had spent over $60,000.
... She was also obsessed with sex.
"It was another compulsion that I couldn't control," says Deidra. "Before Mirapex, I never initiated sex and then I couldn't get enough (Doug wasn't complaining). So now that I am off it, my sexual needs may slow down."In Australia, more than 100 are suing Pfizer and Aspen Pharmacare, which marketed Permax, over their addictions. Fourteen cases (like this one) making similar allegations about Mirapex have been consolidated in Minnesota's federal district court. Those cases include a Las Vegas man who developed a sex and gambling compulsion -- arguably the worst place on earth to do so. Even the porn industry -- via its trade publication, Adult Video News -- is following the cases. BI has already lost a test case, over a man with a gambling habit, for $8.2 million.
Given that BI's own research is showing that Mirapex carries a high rate of ICDs, one might also ask what it was doing promoting the drug for Restless Legs Syndrome after it learned about Mayo's concerns.
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Hat tip to Pharmalot.