Mom’s Soap Box

In January, Eli Lilly pled guilty to promoting its anti-psychotic Zyprexa for unapproved and dangerous uses in a $1.4 billion settlement.

In February the Justice Department charged Forest Laboratories with illegally marketing antidepressants Celexa and Lexapro to younger patients and burying a study that showed suicidal side effects in children.

In March the Justice Department charged AstraZeneca with knowing and hiding the diabetes side effects of Seroquel. The FDA approved Lilly’s Zyprexa/Prozac combo, Symbyax for treatment resistant depression (TRD). The FDA also approved Lexapro for depression in adolescents 12 to 17, despite the previous month’s Justice Department charge against Lexapro involving the suicidal side effects on children.

This month the FDA considers expanding AstraZeneca’s approvals to depression and anxiety.

Treatment Resistant Depression or “TRD” will soon join the prescription-swollen ranks of GAD (general anxiety disorder), MDD (major depressive disorder) ADD (attention deficit disorder) RLS (restless legs syndrome) GERD (gastroesophageal reflux disease) and PMDD (Premenstrual dysphoric disorder)–and for the same reasons.

The problem is that FDA drug approvals are only as good as the studies used to “prove” their efficacy. And recently, those studies have become highly suspect.

Forest paid Massachusetts General Hospital’s Jeffrey Bostic, MD $750,000 to chat up Celexa and Lexapro according to US District Court in Boston filings. AstraZeneca paid University of Minnesota Charles Schulz, MD $112,000 to push Seroquel according to US District Court in Orlando filings. And a decade of pain “studies” conducted by Baystate Medical Center’s Scott S. Reuben, MD on Vioxx, Lyrica, Celebrex and Effexor were completely fabricated. According to published reports, not even the “patients” in the study were real.

And let’s not forget Joseph “your-child-is-bipolar” Biederman, MD at Harvard who assured benefactor Johnson & Johnson his studies would have pro Risperdal results in advance of doing them. And Charles “Paxil” Nemeroff, MD who was forced to step down in December as psychiatry chairman at Emory University thanks to unreported GlaxoSmithKline income of up to $800,000.

Seroquel is linked to high blood sugar, weight gain, diabetes, cholesterol and triglycerides abnormalities, sudden cardiac death, suicide, Iraq war veteran deaths and the tardive dyskinesia it is supposed to prevent.

But its “safety” was established by a different kind of chemistry.

Research director for Seroquel, Wayne MacFadden, was having affairs with two women responsible for Seroquel studies say court documents: a researcher at the Institute of Psychiatry in London and a ghostwriter at Waltham, MA-based medical communications firm Parexel. And seated on the FDA’s Psychopharmacologic Drugs Advisory Committee at the time was Jorge Armenteros, MD, who has been a paid AstraZeneca speaker for five years according to the Philadelphia Inquirer. He now heads the committee as the FDA considers expanding Seroquel approvals to include depression and anxiety this month–and to children in June.