Tag Archives: FDA

Drug firms paid ‘independent’ experts

Doctors working in state hospitals and community mental health centers began switching patients to the atypical antipsychotics because they were deemed the best treatment by an expert panel convened by the Texas Department of Mental Health and Mental Retardation.

But a detailed examination of public records documents on file in a whistleblower lawsuit that has been joined by the Texas Attorney General’s Office allege that the experts hired to evaluate the drugs and make recommendations for their usage were also accepting hundreds of thousands of dollars in payments from the companies developing and marketing the medications.

It started in the middle 1990s when MHMR contracted with University of Texas and some of its professors to evaluate the medications and develop a set of treatment guidelines.

The program was named the Texas Medication Algorithm Project, or TMAP. The result was step-by-step guidelines for treating major depression, bipolar disorder, schizophrenia, attention-deficit hyperactivity disorder.

Are You Taking Pills You Don’t Need? Here Are Some Reasons Why

Most people blame direct-to-consumer advertising, especially on TV, for elevating everyday anxiety to depression, depression to bipolar disorder, childhood behavior problems to psychiatric illnesses, lack of sleep to excessive sleepiness, migraines to epilepsy drug deficiencies and old age to hormone deficiency

But ghostwriting also helps the national malaise of people suffering from and treating diseases that didn’t even exist before and ballooning government and private health plans costs.

Heart Warning Added to Label on Popular Antipsychotic Drug Seroquel

Today the New York Times has reported, “AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday.” And that “Seroquel is one of the top-selling drugs in the world, at $5.3 billion last year, including $3.7 billion in the United States. Introduced in 1997, it has been approved for schizophrenia, bipolar disorrder and severe depression. Seroquel has caused legal problems for AstraZeneca, including a $520 million payment in 2009 to settle government charges of illegal marketing. Thousands of lawsuits are pending over side effects like diabetes.”

While this is seemingly good news, look a little deeper in today’s article from Paul Thacker, an investigator for Project on Government Oversight…

1 out of every 7 Elderly Nursing Home Residents on Antipsychotics—Despite Risk of Death

Long-term-care (LTC) facilities are overusing antipsychotic drugs. One of every 7 elderly nursing home residents is receiving at least 1 atypical antipsychotic; in 83% of these cases, the drug is associated with a dementia diagnosis, yet the use of atypical antipsychotics in dementia increases the risk of death and is not approved by FDA, according to a report from the Office of the Inspector General (OIG).

Bad Side-Effects Ahead For Pharma?

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.