AstraZeneca has been named, along with a handful of others, in a lawsuit filed by the state of Pennsylvania in February 2007, in an effort to recover monies paid through state health plans for the inappropriate use of drugs such as Seroquel.
A class action lawsuit has also been filed in the state of Florida, citing the makers of Seroquel over the risk for diabetes and off-label use of the drug.
There seems to be two issues at play: the emergence of serious, and sometimes life-threatening side effects that are downplayed in the product literature, and the practise of prescribing the medication for conditions it was not designed to treat.
Seroquel is essentially an anti-psychotic drug developed and approved by the FDA for the treatment of schizophrenia and manic episodes associated with Bipolar I disorder.
And yet, Seroquel is being prescribed for everything from anxiety, to children with attention-deficit disorder. Atypical drugs, which is the new battalion of anti-psychotic drugs touted as more effective than older medications, are not approved to treat children for any condition. And yet, researchers from Vanderbilt University found in a review of HMO records that well over 5.5 million outpatient visits involving children between 1995 and 2002 resulted in a prescription for anti-psychotic, atypical drugs for behavioural issues.
It is this practice of off-label marketing that serves as a huge boost to sales. Bloomberg.com reports sales of Seroquel increased 24 per cent in 2006 to $3.4 billion, while nearly half of Seroquel sales in the year, according to Datamonitor PLC, were off-label.
Drug companies are prohibited from directly advertising a product for use beyond that which has been approved by the FDA. But there is a loophole: doctors and qualifying health-care professionals have the capacity to make subjective decisions based on a perceived, or assumed benefit. As a result, the drug manufacturing industry has allegedly turned their attention to the medical community. Sales reps are suspected of undertaking product lobbies to doctors on behalf of their employers, and while the prescribing doctor always has the final say, increased sales combine to suggest that the strategy seems to be working.
Prescribing medication off-label to otherwise healthy people represents the largest market for drug companies.
There are currently lawsuits in the pipeline surrounding the misuse of drugs like Seroquel, and pill-pushing doctors are being investigated. One physician in California, identified as the largest prescriber of Seroquel in the state, was seen to prescribe the drug to an undercover FDA agent, without a proper diagnosis.
The widespread use of Seroquel is equally alarming when incidence of diabetes and high blood pressure are factored in. Patients currently treated with Seroquel have been shown to have a diabetes incidence rate 3.34 times higher than those patients having experience with older, anti-psychotic medications.
One such patient is Gaye Young from Bay City Texas. She was prescribed Seroquel by her psychiatrist for post-traumatic stress syndrome, after an incident on the job. Side effects were minimal for the first few years, but after a time her levels of glucose and blood sugar were found to be dangerously high. With no prior incidence of diabetes or high blood pressure in her family, it was assumed that Seroquel was the culprit, and both Gaye's psychiatrist and family doctor advised her to stop taking Seroquel, which she did.
But it was too late. Gaye Young has gone from robust health, to surviving on a disability pension at the age of 41.