Groundhog Day and Prozac

This morning an email from one of my former juniors alerted me to the latest Times headline on antidepressants:

“Depression drugs don’t work, finds data review.

…. Millions of people taking commonly prescribed antidepressants such as Prozac and Seroxat might as well be taking a placebo, according to the first study to include unpublished evidence….”

She remembered hearing the same from me quite a few times a number of years ago.

The paper that attracted the latest media attention is ”Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration”. It was published in PloS (Received: January 23, 2007; Accepted: January 4, 2008; Published: February 26, 2008). The authors were listed as: Irving Kirsch, Brett J. Deacon, Tania B. Huedo-Medina, Alan Scoboria, Thomas J. Moore, Blair T. Johnson.

This is how the authors described the methods and findings:

“… We obtained data on all clinical trials submitted to the US Food and Drug Administration (FDA) for the licensing of the four new-generation antidepressants for which full datasets were available. We then used meta-analytic techniques to assess linear and quadratic effects of initial severity on improvement scores for drug and placebo groups and on drug–placebo difference scores. Drug–placebo differences increased as a function of initial severity, rising from virtually no difference at moderate levels of initial depression to a relatively small difference for patients with very severe depression, reaching conventional criteria for clinical significance only for patients at the upper end of the very severely depressed category…. ”

This looks exceedingly similar to the report in USA Today on 7th July 2002:

“Study: Antidepressant barely better than placebo.

… Through a Freedom of Information Act request, two psychologists obtained 47 studies used by the FDA for approval of the six antidepressants prescribed most widely between 1987-99.

… More than half of the 47 studies found that patients on antidepressants improved no more than those on placebos… “

The drugs included in his evaluation were: Celexa, Prozac, Paxil, Zoloft, Effexor and Serzone. The findings were released in a paper titled “The emperor's new drugs: An analysis of antidepressant medication data submitted to the U.S. Food and Drug Administration” published in Prevention and Treatment, an e-journal of the American Psychological Association on 15th July 2002. The authors were listed as: Kirsch, Irving (a University of Connecticut psychologist); Moore, Thomas J.; Scoboria, Alan; Nicholls, Sarah S. (Notice that some of these names are the same as those in the new “ground breaking” paper.)

A paper titled “Another view: Talking back to Prozac” in Psychology Today, Jul/Aug 94 (Article ID: 1471) also came to mind. It was written by Peter Breggin who has been the most vocal against SSRIs and drug treatment for ADHD.

As early as on 19th March 1999, CNN reported: “Study: Prozac no better than older depression drugs”

Yet today the Guardian reported:

“Prozac, used by 40m people, does not work say scientists.

.…The review breaks new ground because Kirsch and his colleagues have obtained for the first time what they believe is a full set of trial data for four antidepressants.

… They requested the full data under freedom of information rules from the Food and Drug Administration, which licenses medicines in the US and requires all data when it makes a decision….”

Then I checked my Web Bookmarks:

14 September, 2004: Prozac raises child suicide risk

8 August, 2004: Prozac found in drinking water

8 February 2008: Britain 'is true Prozac Nation'

Groundhog Day or otherwise, raising public awareness is no bad thing. No matter, some big Pharmas must be holding emergency meetings.

What we have to consider is not only whether anti-depressants have the desired effect, but also what undesirable effect they may have.

Only a few days ago, CNN reported:

“Girlfriend: Shooter was taking cocktail of 3 drugs.

.… Steven Kazmierczak had been taking three drugs prescribed for him by his psychiatrist, the Northern Illinois University gunman's girlfriend told CNN.

…. Jessica Baty said Steven Kazmierczak was irritable but not erratic before his shooting rampage.

…. Jessica Baty said Tuesday that her boyfriend of two years had been taking Xanax, used to treat anxiety, and Ambien, a sleep agent, as well as the antidepressant Prozac…”

Just who can we trust now? An article in the Independent (27^th February) read:

“Drug giants warned: Tell the truth on medicines.

After antidepressant treatments are discredited, fears grow tht other products may be ineffective ..."

I can hear Peter, Paul and Mary sing:

“Oh, when will they ever learn? Oh, when will they ever learn?”

(From: Where have all the flowers gone - 1962 Debut Album.)

Peter, Paul and Mary saw us through medical school!