Prozac: More Controlling Tactics Used By The Drug Giants

When my friend, Kelly, had a physical examination a few years ago, her doctor asked how things were going in her life. Things weren't good. Kelly's job was stressful, her marriage was on the rocks, and a family member had recently died. She admitted that she felt pretty blue most of the time. Her doctor asked her if she'd like to try Prozac.

The idea shocked her. She'd never thought of herself as someone who would take an antidepressant drug. But she was also intrigued. The idea of a mental boost to help get through the day was appealing. So her doctor gave her a free sample pack of Prozac, and wrote a prescription to start off on a low dose.

Later Kelly told me that on the drive home from her doctor's office her spirits were better than they'd been for months. She felt empowered and hopeful - like a dark cloud had lifted. In short, she didn't feel the least bit depressed. And at this point she hadn't taken her first dose of the Prozac.

What Kelly was experiencing was similar to a placebo effect. What she needed most in her life was not a drug, but the feeling that someone - or something - was in her corner, offering a helping hand. And it's people like Kelly who have been messing up the results of clinical trials for antidepressant drugs. In some cases the positive results in these trials were stronger among placebo subjects than those taking the drugs.

Well... we can't have that! So now drug companies are devising ways to weed out study subjects like Kelly - subjects known as 'placebo responders.'

Cordially uninvited
Now, you know I'm not one to put a lot of stock in headlines, but the recent headline of a Wall Street Journal (WSJ) article summed up the situation in a nutshell: 'Drug Makers Seek to Bar 'Placebo Responders' From Trials'

The WSJ article reports that Eli Lilly (maker of Prozac) and Pfizer (maker of Zoloft) are funding research on brain imaging at the University of California, Los Angeles in the US. This research is designed to identify disruptions in sleep and thought processes experienced by depressed subjects. But some depressed patients don't experience these disruptions, and it's these patients who are believed to be placebo responders.

According to WSJ, Pfizer researchers have also conducted studies indicating that placebo responders may be identified through DNA testing.

It's an efficient plan: Spot the troublemakers, keep them out of the trials, and the outcome will probably be much more in line with desired results. The key word here is 'desired.' Accurate results are secondary to desired results when medical approval of a cash cow pharmaceutical is in the balance.

Drug companies claim that the techniques designed to exclude placebo responders would only be used for early trials - not for officially approval medical trials.

Naaa! They wouldn't do that! They have too much integrity!

But think about it: That very claim indicates an awareness that - at worst - there may be something unethical about this practice, while - at best - it corrupts the basic design of clinical studies.

Going off the gold standard
Kay Dickersin, a professor at Brown University and the director for the Centre for Clinical Trials and Evidence-Based Healthcare at Brown, told WSJ that placebo responder screening encourages bias with a 'subtle manipulation' of trial results. I think Professor Dickersin is being charitable. This manipulation is not so subtle at all.

The gold standard for clinical trials calls for three elements:

• Placebo-control (one group receives an active agent while another receives a placebo)
• Double-blinding (neither the subjects nor those who administer the study are aware of which subjects receive placebo)
• Randomisation (once the group of study subjects are in place, they are randomly assigned either placebo or active agent).

So when you're studying the effects of an antidepressant on mildly depressed subjects, and you remove any subjects who qualify as mildly depressed but who will probably respond to placebo, then you're compromising the randomisation. The results of your trial will indicate how a drug works only on those subjects who are not placebo responders. The implication: The drug won't be tested on placebo responders, but it doesn't matter because, you know, ANYthing works on them!

Included out
Research that involves brain imaging and genetics doesn't come at bargain prices. So the fact that two huge drug companies are willing to underwrite such expensive research reveals to what lengths companies will go to tip the balance of clinical trials in their favour. Now, with new antidepressants in development for both Pfizer and Lilly, just think how successful upcoming trials might be if those pesky placebo responders simply get included out.

P.S.: Kelly did try the Prozac, but stopped using it after one month. She said the drug made her feel woozy. So she started taking St. John's Wort and that was enough to see her through a mild depression during a tough time.