Semi Prozac*
New study raises hard questions about drug certification
procedures in the US
[warning: contains spoilers]
© Bryan Zepp Jamieson
2/26/08
http://www.zeppscommentaries.com/S&E/prozac.htm
A few years ago, I saw a movie starring Christina Ricci called
“Prozac Nation.” It was a good movie, with a searing performance by Ricci, about
a young woman’s struggle with depression.
But it left me dissatisfied. The ending seemed pat. The girl starts taking
prozac, and wow! She’s all better. The sun is shining, birds are frolicking,
puppies are in the trees chirping.
Or so memory informed me. I rented the movie today and watched the ending again.
It wasn’t pat; they just simply wrapped it up abruptly. The Ricci character, as
narrator, explained that it was a long hard road from depression, and what the
prozac did was give her “breathing room.” The inference was that prozac was, at
the beginning, the only thing that stood between her and suicide, and in the
climatic scene, she smashes a glass in the bathroom at her psychiatrist’s office
and stands at the sink, poised to slit her wrists, and just can’t do it. From
there to fade-to-credits is about ninety seconds, which doesn’t leave much time
to detail what probably really was a long and arduous recovery from depression.
Thus the feeling of a pat ending.
If the movie didn’t actually disintegrate into an ad for prozac, it made clear
the writer’s opinion that prozac saved her life. I have no doubt that she
utterly believes that it did.
But there was a significant study reported in today’s London Guardian, bannered:
“Prozac, used by 40m people, does not work say scientists.” Eli Lilly claims
it’s used by 54 million people, and of course has made the company a lot of
money over the years.
The Public Library of Science (PLoS) paper, entitled “Initial Severity and
Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug
Administration” was authored by Irving Kirsch (Department of Psychology,
University of Hull, Hull, United Kingdom), Brett J. Deacon (University of
Wyoming, Laramie), Tania B. Huedo-Medina and Blair T. Johnson, (both Center for
Health, Intervention, and Prevention, University of Connecticut, Storrs), Alan
Scoboria (Department of Psychology, University of Windsor, Ontario), and Thomas
J. Moore (Institute for Safe Medication Practices, Huntingdon Valley,
Pennsylvania). It is available here http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050045
The study analyzed several dozen studies, all done under FDA standards, for
Prozac and five other leading antidepressants. It also included those
non-standard studies done by the drug companies themselves, of which about a
third were not-available because the companies did not see fit to share them.
The authors of the study gained access to these results by using the Freedom of
Information act.
What the studies found was that while a lot of patients reported dramatic
improvement in the first few weeks that they were taking Prozac and other drugs,
the patients who were unwittingly taking a placebo ALSO reported dramatic
improvement. In fact, there was no significant difference between those taking
Prozac, and those taking little sugar pills. (In fact, if the pills really were
coated in sugar, and the study didn’t say, then patients might have been helped
by the sugar rush).
Only very severely depressed patients had any improvement from Prozac over the
placebo, and the improvement consisted only of the elevation of mood diminishing
less rapidly. Placebos work through hope as much of anything, and severely
depressed people aren’t noted for a strong sense of hope.
So what this study is saying is that prozac and the other drugs really aren’t
worth their weight in sugar, much less the exorbitant sums the pharmaceuticals
have been charging for them since they began hitting the markets in 1987.
The pharmaceuticals immediately complained that the study was faulty, based on
incomplete data. But the fact is the data was far more wide-ranging and
comprehensive than the data the companies presented during the certification
process! They can hardly complain about lack of data when they are the cause for
that lack.
The really big problem – and it’s gotten far worse since 1995, when Newt cowed
Congress into letting Big Pharm do the funding and quality control for the
studies – is that the government is, in effect, telling Big Pharm, “Yes, we know
you expect to make billions off this drug, but that’s no reason why you can’t
buy the fairest and most rigorous tests possible.” Big Pharm pays putatively
independent labs to do the tests, and oversees the labs for quality control.
I first became aware of how bad the problem had been when complaints starting
making the rounds in pet owner and breeder circles of diet-related problems that
were causing dogs to have dental and other physical problems, and that puppies
were being born with higher stillbirth and “fading puppy syndrome” rates, higher
rates of cataracts, immune system malfunctions, dysplasia, and a host of other
problems.
The problem was traced back to a pesticide and anti-oxidant used in dry dog food
to inhibit staleness and rancidity, a substitute for vitamin E called ethoxyquin,
made by Monsanto. Dr. Susan Thorpe-Vargas wrote a strong critique of the testing
process that brought ethoxyquin to dog food, noting that FDA regulations, weak
to begin with, were effectively nonexistent in pet trials. Long-term health
effects were gauged in six-WEEK studies, and in one notorious episode, the
clinicians managed to lose track of the genders and numbers of the animals they
were testing.
There was an uproar among dog fanciers and other pet owners, and one by one, the
pet food companies quietly removed ethoxyquin from their products and replaced
it with either real vitamin E, or BHA/BHT, which have their own problems. About
five years later the government, even more quietly, halved the amount of
ethoxyquin that was permissible in dog food.
That, combined with the gutting of the FDA by Republicans on the grounds that
“the free market can see to its own best interest” (which presumably includes
honest tests, no matter how much loss of profits those entail), is why I’m
deeply skeptical of drug trials in the United States, and not particularly
surprised by this report.
The drug companies will fight and stonewall this for years, but I can make a
pretty solid guess: along about 2015, the government will finally decide that
yes, prozac was, at best, inefficacious and at worst an utter fraud all along,
and it will be quietly pulled from the market.
Of course, I’m guessing that Eli Lilly and the rest won’t be offering refunds,
which would be in the billions of dollars. Too much of that went to buying
elections and politicians devoted to safeguarding their profits, you see.
* Title compliments of Jonathon, whose puns can be even more excruciating than mine.