OT: FDA to require suicide studies for meds- article

[Guest guest]

This won't do much good if they don't enforce requirements for COI

disclosures or that research be generated from sources without

industry conflicts or without industry influence on academic studies

and finally, without industry influence on the very FDA officials

deeming certain studies kosher or un. It will just be the same old

number-fiddling we see with vaccines.

Also, Silverman (the article's author) mentions, without irony,

probably the most bogus and thoroughly debunked, moldy pharma-

concocted theory to explain away suicidal side-effects of certain

drugs: that people on the meds attempt suicide as the fatigue portion

of the depression " lifts " (from those wonderful drug benefits),

allowing the person the " energy " to carry out the suicide attempt

that they'd formerly been too unmotivated (from the depression) to

carry out. One among a hundred holes in this theory is, of course,

that people being treated with the drugs for non-depression related

conditions also attempt suicide on the drugs.

FDA To Require Suicide Studies

http://tinyurl.com/295hku

The new rules represent one of the most profound changes of the past

16 years to regulations governing drug development. But since the

F.D.A.'s oversight of experimental medicines is done in secret, the

agency's shift has not been announced publicly, The New York Times

reports.

The drug industry, however, is keenly aware of the change. Makers of

drugs to treat obesity, urinary incontinence, epilepsy, smoking

cessation, depression and many other conditions are being asked for

the first time by the FDA to put a comprehensive suicide assessment

into their trials, the paper writes. In recent months, the FDA sent

letters - but wouldn't say how many - to drugmakers requiring they

use such a scale. Merck, Sanofi-Aventis and Eli Lilly are all using a

detailed suicide assessment in clinical trials being conducted now.

The seeds for the new effort were planted four years ago with the

discovery that antidepressants may cause some children and teenagers

to become suicidal. Top agency officials at first discounted the

finding but commissioned researchers from Columbia University's

department of psychiatry, led by Posner, to reanalyze the

drugs' clinical trials. This work caused the drug agency and its

experts to view the risk as real.

" Clearly we were somewhat surprised when this signal emerged in the

pediatric antidepressant data, " Tom Laughren, director of the FDA's

division of psychiatry products, tells the paper. " So various groups

within FDA are now looking at suicidality more broadly as a possible

adverse event. "

The FDA later received an application for Sanofi-Aventis' Acomplia,

but as agency medical reviewers discovered hints that it could cause

psychiatric problems, too. In June, an FDA advisory committee voted

unanimously that the agency reject Acomplia because of psychiatric

effects, and Sanofi-Aventis withdrew the application although the

drug is sold in Europe.

Just this month, the results of a trial of Merck's obesity drug were

published showing similar psychiatric problems. Meanwhile, fears have

grown that drugs used to treat epilepsy, seizures and mood disorders

may have similar effects. An extensive examination of these medicines

by the drug agency should be completed this year. Suddenly, agency

officials realized that multiple classes of medicines might cause

dangerous psychiatric problems.

The FDA's concerns are consistent with a growing body of research

confirming that behavior is heavily influenced not only by genes but

also by seemingly innocuous changes in body chemistry. Drugs not

reaching the brain were once thought to be largely free of mental

effects. " One lesson from pharmacology is that you can see effects on

emotion and cognition without the drug entering the brain if a drug

leads to peripheral changes in " other chemicals that enter the brain,

Tom Insel, director of the National Institute of Mental Health, tells

the Times.

Some critics say that the agency's new-found focus on psychiatric

side effects is long overdue. " The list of drugs that causes

psychiatric problems is a very long one, " Sid Wolfe of Public Citizen

tells the paper.

There are two reasons that the FDA for years was inattentive to the

psychiatric effects of new medicines. First, distinguishing between

mental problems that spring from a disease and those that result from

its treatment is often difficult. For antidepressants, many

researchers suggested that suicidal behaviors resulted because, as

patients' depression lifted, they suddenly had the energy to carry

out previous suicidal thoughts.

Second, drug side effects are often first identified in clinical

trials when multiple doctors treating hundreds of patients record

similar problems in trial notes, the Times points out. But terms to

describe depression or suicidal thoughts can vary widely, making them

hard to discern.

Posner tells the paper that so many companies and academic research

programs were adopting the suicide questionnaire that she was having

trouble keeping up with the demand for its use. The questionnaire has

been translated into 80 languages, and she's trained scores of teams

of investigators from around the world on how to use it.

" If a drug makes people depressed but doesn't make them suicidal,

what do you conclude? " asks Colman, the FDA's deputy director of

the division of metabolic and endocrine products. " There will always

be some uncertainty. "