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Has the pharmaceutical industry become the Pied Piper of Hamelin--ridding us of lethal diseases only to turn around and "take" our children?

Would a physician from the 1950s "have identified the frenzy to treat bipolar disorders in infants that developed in twenty-first-century American as a mania?"

In his latest book, Mania: A Short History of Bipolar Disorder (the John Hopkins University Press) David Healy, author of Let Them Eat Prozac, looks at the historic roots of our current "medicalized distress" in which half the population is said to suffer a mental illness at some point in life and babies are diagnosed in utero as bipolar.

Bipolar disorder, once called manic depression, has been embroiled in controversy from its first descriptions in Paris in the 1850s. The pharmaceutical companies and academics behind its current popularity as a "catch-all" disease say it dates back to the ancient Greeks.

But David Healy, professor of psychiatry and the director of the North Wales Department of Psychological Medicine at Cardiff University, is not so sure.

References to the frenzied behavior of mental patients found in Hippocrates' Epidemics books 1 and III, Plato's Phaedrus and other early writings almost certainly referred to infective states and not what we mean by bipolar disorder today he writes:

Even if the disorder existed before direct-to-consumer television advertising beamed its warning signs into living rooms, it was rare says Healy. Between 1875 and 1924 only 123 patients from North West Wales were admitted to the asylum in North Wales with what we would today call bipolar disorder from a population of a quarter of a million or 12,500,000 person years.

The discovery of lithium in 1817--so plentiful and inexpensive it was added to soft drinks and beer until 1929--and its value in treating bipolar disorder in the late 1950s, changed the course of psychopharmacology says Healy.

Lithium not only introduced the concept of a drug that could act as a mood stabilizer-- offering actual prophylaxis against a mental disease--it introduced the concept of a randomized controlled trial (RCT) in which a drug's effectiveness is tested against placebo.

RCTs, part of what is called evidence-based medicine, are designed to refute a null hypothesis, says Healy, so that a successful outcome literally means "it is not right to say a treatment has no effect."

But RCTs were developed to forestall irrational medical exuberance and "cast doubt on clinical enthusiasms about new treatments," he argues, not to demonstrate "treatment effects of dubious significance," the inverse use for which the pharmaceutical industry has "commandeered" RCTs.

Medical case reports, now dismissed as anecdotal, have been edged out by RCTs in journals and as drug evaluation tools even though chlorpromazine (Thorazine), imipramine (the first tricyclic) and even Viagra resulted from case report vignettes, says Healy.

Moreover the suicidal and akathisia side effects that blemished the antidepressant Prozac were revealed --but ignored--in case reports of the antihypertensive drug, reserpine.

Randomized controlled trials ironically amount to "a more problematic anecdotalism," writes Healy by "garlanding" the experience of one drug responder "over the ninefold larger pool of other responders or nonresponders" with the claim it will "generalize to others given the treatment in a way that was never claimed with traditional medical case reports."

The data manipulation potential of RCTs is so great, charges Healy, it allowed GlaxoSmithKline to promote Paxil for child and adolescent "depression"--it sold 900,000 prescriptions in 2002--despite conclusive data the drug did not work in children as was actually harmful.

David Healy, author of The Antidepressant Era and the Creation of Psychopharmacology, was an early critic of the pharmaceutical industry's one-size-fits-all marketing of antidepressant Prozac and its selective serotonin reuptake inhibitor (SSRI) cousins.

Now pharma is marketing atypical antipsychotics like Zyprexa, Seroquel and Ripserdal with similar abandon, says Healy and the bipolar disorder "disease mongering" is especially targeted at children.

("Just as Prozac revolutionized the treatment of depression…so, too will Zyprexa forever change the way physicians view and treat bipolar disorder," he quotes a Lilly marketing doc proclaiming.)

These former antischizophrenic drugs which "probably reduce life expectancy" have "nothing distinctive" about them except their marketing says Healy.

Atypicals are now given to children "thought to be prone to bipolar disorder early in life before their first episode," writes Healy with alarm and if they fail to work, sometimes in conjunction with four or five other drugs, their promoters will say it is because the "disorder has taken too deep a root."

In conclusion, Healy says our frenzy to treat bipolar disorder has marginalized the voice of independent physicians in a kind of "brand fascism" and altered the very language we use to describe ourselves so it now reflects the "fall of off-patent and rise of newly patented compounds."

By: Martha Rosenberg