By Kelly Patricia O’Meara June 15, 2015 The pharmaceutical industry wants federal legislation to relax Food and Drug Administration (FDA) restrictions on the marketing of…
High doses of the popular antidepressant Celexa (known as Cipramil in South Africa) can cause potentially fatal abnormal heart rhythms and should no longer be prescribed to patients, the US Food and Drug Administration has said.
In this corner: Dr. Marcia Angell, former editor in chief of the New England Journal of Medicine, senior lecturer in social medicine at Harvard Medical School, and frequent critic of the pharmaceutical industry. In the opposite corner: Dr. Peter Kramer, Brown University psychiatry professor and author of the mega-selling “Listening to Prozac,’’ a book that helped convince thousands of Americans to live better, chemically.
At issue: a two-part article by Angell, published in The New York Review of Books, that assails psychiatrists and their pharmaceutical helpmeets, mainly antidepressants, on several fronts.
Item: Angell, quoting, among others, Tufts University psychiatrist Dr. Daniel Carlat, attacks the widely held belief that depression and other mental disorders result from chemical imbalances in the brain. Item: Citing the research of British psychologist Irving Kirsch, Angell writes that some of the most widely used antidepressants, including Prozac, Paxil, Zoloft, Celexa, and Effexor, performed only marginally better than placeItem: Angell uses a book by journalist Robert Whitaker to suggest that newly minted antipsychotic drugs may be causing “an epidemic of brain dysfunction.’’
In 2006, The New York Review of Books reported that four-year-old Rebecca Riley died of the effects of two prescription drugs—Clonidine and Depakote.
These medications, along with Seroquel, were prescribed for Rebecca after she was diagnosed, at the age of two, with attention deficit hyperactivity disorder (ADHD) and bipolar disorder. The three drugs are not approved by the Food and Drug Administration (FDA) for treatment of ADHD or long-term treatment of bipolar disorder, nor are they approved for children as young as Rebecca.
The New York Review of Books‘ recent two-part article (1) by Marcia Angell on the treatment of mental illness with psychoactive drugs (those that affect the mental state) addresses an issue that may one day prove very important to investors in pharmaceutical stocks. (All statistics and quotations herein are drawn from Dr. Angell’s article.) It is not illegal for a doctor to prescribe a drug off-label, that is, for a non-FDA-approved use, but a drug marketer cannot lawfully encourage a doctor to do so. The profits in psychoactive drugs, however, make it tempting to flout the law. In the past four years, AstraZeneca (AZN), Pfizer (PFE), Eli Lilly (LLY), Bristol-Myers Squibb (BMY) and Forest Labs (FRX) have all settled federal charges of marketing psychoactive drugs off-label, at a cost running into hundreds of millions.
It’s getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.
The new tactic is raising the anxiety level — and risks — for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.