Tag Archives: FDA

The business of ADHD

As the DSM-V looms closer to becoming a reality, I can’t help but think of words from the man who chaired the committee for the DSM-IV. Allen Frances, M.D., wrote in the in the LA Times:

As chairman of the task force that created the current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), which came out in 1994, I learned from painful experience how small changes in the definition of mental disorders can create huge, unintended consequences.

Our panel tried hard to be conservative and careful but inadvertently contributed to three false ‘epidemics’ – attention deficit disorder, autism and childhood bipolar disorder. Clearly, our net was cast too wide and captured many ‘patients’ who might have been far better off never entering the mental health system.

Antipsychotic Drugs Deadly for Elderly Patients, Prescribed Anyway

Antipsychotic drugs prescribed to as many as one in seven patients with dementia at nursing homes increase the risk of death and are not approved for such uses, a government audit has found.

Drugs such as Risperdal, Zyprexa, Seroquel, Abilify and Geodon are “potentially lethal” to many of the patients getting them and in many cases, completely unnecessary and unneeded.

Wellbutrin – To Promote or Not Promote… That is the Question

Lauren Stevens, the Glaxo associate general counsel, who is charged with one count of obstructing an official proceeding, one count of falsifying documents before a federal agency and four counts of making false statements to the FDA, has heard evidence given to a jury by James Millar, GSK vice president of strategic pricing, contracting and marketing. Millar had originally refused to testify but prosecutors persuaded the US District Judge [Roger W. Titus] to order him to give his testimony.

FDA approved Big Pharma drugs without effectiveness data

Consumers constantly are told how complicated it is to get a new drug on the market. After all, researchers have to jump through all sorts of hoops to assure safety before new therapies are approved for the public, right? It turns out they may be missing some of those hoops or not jumping through some of the most important ones.

In fact, huge red flags are being raised about how drugs are tested and approved in two new studies, including one just published in the May 4th issue of the Journal of the American Medical Association (JAMA).

A case in point: it turns out that only about half of the new prescription medications pushed onto the market over the last decade had the proper data together for the U.S. Food and Drug Administration – yet the FDA approved them anyhow.