This, in itself, is not a new occurrence, as it joins a long list of US state lawsuits against drug companies. With rumours that a similar 26 state joint lawsuit is about to begin, this is an indication that the corporate drug world is about to be shaken up on a grand scale.
Most of the lawsuits are over allegations that drug companies hid or massaged evidence to show that their new generation (‘atypical‘) antipsychotic drugs were more effective or less harmful than is now thought, or that they illegally promoted their drugs for conditions for which they weren’t licensed.
Most of the most popular atypical antipsychotics were introduced in the 1990s and were marketed as having less side-effects than the older generation drugs.
One of the most unpleasant are extrapyramidal side-effects. Caused by changes the dopamine system they can include involuntary movements and muscle stiffness that can resemble Parkinson’s disease in some respects.
However, recent reviews have challenged the idea that the newer drugs have less of these side-effects and other evidence has suggested that they have a higher risk of inducing problems with weight-gain and diabetes.
The marketing was remarkably successful though and the idea that the newer drugs ’cause less side-effects’ still persists. Only this week, a letter published in New Scientist stated that the newer drugs benefited patients because they have fewer side-effects.
Later, marketing shifted to suggesting atypicals were better for the ‘negative symptoms’ of schizophrenia (impaired emotion and motivation), and later still to suggest that they improved cognitive function, largely based on industry funded clinical trials.
Two ongoing independent studies have been key in challenging some of these ideas. The UK’s CUtLASS project and the US’s CATIE project are not funded by drug companies and have found, contrary to industry research, that, for example, newer antipsychotics are no better than the older drugs in improving cognitive function and that they have no advantage in improving quality of life.
Antipsychotics are genuinely useful and probably one of the most significant medical advances of the 20th century. Before then, no effective treatment for psychosis existed.
However, when side-effects appear (which is not always the case), they can range from the unpleasant to the medically serious, so doctors and patients need to be fully informed about the risks.
The most recent lawsuit from the state of Arkansas [pdf] alleges that, among other things, the drug company deliberately rigged their clinical trials to show less side-effects, failed to warn clinicians about the dangers and promoted their drug illegally.
While people like psychiatrist David Healy have been making these allegations for years, the fact that a large number of US states are willing to take the allegations to court signals that we are about to see a huge battle, and hopefully a period of significant reform, in how drug companies develop, test and market their products.
Reform is sorely needed. As well as scientific manipulation, personal drug marketing to psychiatrists is largely based on ensuring a regular supply of lavish gifts and selective information – as detailed by an article in today’s New York Times.
As an aside, if you’re in London this Tuesday, a debate is being held at the Institute of Psychiatry and the Maudsley Hospital on exactly this topic.
It’s entitled “Swallowing it Whole: This house believes that psychiatrists are unable to resist the seductive messages on the pharmaceutical industry” and is likely to be a lively event.