The American Statesman, a newspaper in Austin, Texas today reported that an attorney, citing a 2005 Mayo Clinic study that documented 11 Parkinson’s patients who became compulsive gamblers while on a drug called Requip, filed suit against manufacturer GlaxcoSmithKline on behalf of a retired doctor in Austin, Texas.
What is Requip?
Ropinirole, marketed under the name Requip, is a dopamine agonist. The drug stimulates dopamine receptors and mimics the action of dopamine in the brain. In 1995, GSK sought to submitted get Requip approved to treat the symptoms of Parkinson’s disease. The FDA approved ropinirole for marketing and distribution for treating symptoms of Parkinson’s disease in 1997.
In July 2005, GSK added for the first time a small disclosure to the Requip label revealing that the drug had been associated with pathological gambling–but failed to advise physicians, pharmacists, or patients of the change through “Dear Healthcare Provider” letters, as permitted by FDA regulations, and did not send out the new label until October 2005. The label has since been revised to add a stronger warning concerning the association of ropinirole with impulse control disorders in general and, in particular, gambling.
The Complaint in This Case
Plaintiff’s Complaint alleges that after taking Requip in 2004, the plaintiff “developed an irresistible compulsion to gamble,” which lead to his losing over $13 million. The Complaint also claims that the casinos knew or should have known of his Parkinson’s and the Mayo Clinic study (conveniently ignoring that the study came out after he lost most of his money). Glaxco argues that the available scientific evidence does not establish a causal relationship between Requip and any level of gambling or impulse control disorders and there is no statistically significant association between Requip and any level of gambling, or any impulse control disorder or group of impulse control disorders.
My Take in 2006
I worked for GlaxcoSmithKline as an outside lawyer about five years ago defending their antidepressant Paxil. I cannot imagine a scenario where they would ever consider resolving a claim like this. You cannot blame Glaxco in this case. This lawsuit seems frivolous. (I use the word “seems” only because I do not have access to the same information that the attorney filing the suit may have.) A study of 11 patients is not enough for Glaxco to rely upon given the side effect is not life-threatening. I find these claims frustrating because there are many meritorious claims pending against Glaxco and the other drug companies. Pharmaceutical lawsuits like this one weaken by association those deserving pharmaceutical cases.
2017 Update: Whoops
I called these cases frivolous. I was going to delete and rewrite this post but I thought it was better to come clean. These Requip, Mirapex, and Abilify had/have real teeth.
Requip is a dopamine receptor agonists which means is activates dopamine in some way. Medical journals began to observe a possible association of dopamine agonists, like Requip, to compulsive behavior, in the late 90s. These articles continued to appear in the medical literature. In 2005, the Mayo Clinic put out a paper linking the risk of compulsive behavior, and particularly compulsive gambling, to dopamine agonists like Requip.
In 2008, a paper came out entitled “Dopaminergic Therapy and Impulse Control Disorders in Parkinson’s Disease: A Cross-Sectional Study of Over 3,000 Patients” (called “Weintraub Poster”). This study arguably found that the administration of Requip in individuals with Parkinson’s disease results in a 200-300% increase in the risk for the onset of compulsive gambling.”
2017 Abilify Cases
The Abilify cases are still going strong and lawyers are still taking these cases. Why? Because Eli Lilly was very late to give a warning. Post-marketing reports of pathological gambling have been reported in patients treated with Abilify. A warning has been given in Europe and Canada but for the very same drug Eli Lilly did not warn about the risk of compulsive gambling. The warning should have, plaintiff’s lawsuits argue, made mention of the fact that pathological gambling has been reported in patients prescribed Abilify.
In January 2016, pathological gambling was included in the Postmarketing Experience part of the label. But it should not be a fishing trip to get to the warning. There was still no reference to gamling in the patient medication guide. Finally, on May 3, 2016, the FDA issued a warning that Abilify was associated with “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.” The FDA recommended that doctors “make patients and caregivers aware of the risk of these uncontrollable urges,” “closely monitor” patients, and consider reducing or stopping Abilify if compulsivity emerges.