What Pharma is Reading These Days - Part 1

Last week a small, unscientific sample of people working in pharma responded to our questions about which industry stories they've been following. Their comments may reflect the pervading mood in the industry these days.

No one mentioned scientific breakthroughs apt to hit the popular press this year or next. Likewise, no comments emerged about visible signs that the industry's economic fundamentals appear poised for a substantial upswing. Instead the news trends that appear to merit attention reflect a wariness or even a general apprehension.

For example, one group of middle managers, especially those involved with the neurology-psychiatry product classes, have been paying more attention to a slowly building story concerning the rampant overuse of antipsychotic medications.

Last week the veteran journalist James Ridgeway published an insightful overview of the pattern, based on several books and articles in both the professional and popular literature. "Once upon a time," according to Ridgeway, "antipsychotics were reserved for a relatively small number of patients with hard-core psychiatric diagnoses - primarily schizophrenia and bipolar disorder - to treat such symptoms as delusions, hallucinations, or formal thought disorder. Today, it seems, everyone is taking antipsychotics." The "everyone" in Ridgeway's reference includes unruly kids, older people with signs of dementia, insomniacs and people who are either chronically depressed or frequently anxious.

The widespread use of antipsychotics is more than just an impression. As recently as 2009 total worldwide sales of antipsychotic products exceeded those of any other therapeutic category. This sales explosion didn't happen by chance or because mental illness suddenly spurted to epidemic levels. Instead, according to Dr. Marcia Angell, a Harvard professor and formerly the editor of the New England Journal of Medicine, "Psychiatrists are in the pocket of industry."

Citing ties between pharma and luminaries of the American Psychiatric Association, Angell and other researchers show that industry influence has expanded professional guidelines of mental illness to include "perfectly normal people."

The sales boom in antipsychotic medications coincided with the launch of the so-called "atypicals" drug class in the early and mid-1990s. Marketers at the time touted the atypical antipsychotics for their greater effectiveness and tolerability, properties they claimed would return mentally distressed patients to functional, more enjoyable lives. Yet recent studies in medical journals such as The Lancet have shown that the atypicals are no more effective than the older, cheaper medications for psychoses. At the same time researchers established that the atypicals tend to promote weight gain to a point where some patients develop Type 2 diabetes.

Neither modest effectiveness nor serious side effects prevented some pharma companies from promoting their atypicals for unapproved uses. At least two such companies wound up paying fines of more than $1 billion each for such infractions.

Another developing storyline under close watch by some pharma employees deals with the fact that federal government agencies feel these billion dollar fines can't make pharmas obey the law. At the same time, a third segment of pharma people have their eyes on another theme related to the potential hazards of conducting more manufacturing and clinical research in countries such as China and India. More on those next week.

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