Since it seems to be a big deal to the New York Times (two articles in
two days), I thought I’d comment on this. An FDA advisory
panel recently voted to expand the warnings in the product labeling for
Just to put this in perspective, the FDA makes many
such changes. The most recent href="http://www.fda.gov/medwatch/safety/2006/oct06_quickview.htm">summary
page is from October of this year, and it lists changes to
the labeling for Avastin, Chloraprep, Coumadin, Remicade, Seroquel,
Allegra, Opana, Sodium Chloride Irrigation solution, Vicoprofen,
DepaKote, Heparin, Strattera, Taxotere, Vytorin, Abilify, Avandaryl,
Byetta, Cubicin, Factive, Ferrlecit, Flovent, Gleevec, Namenda,
Neulasta, Neupogen, Nexium, Prinival, Risperdal, Viagra, Aricept,
Cialis, Hepsera, Rapamune, Yaz, Humatrope, Intron A, and Topamax.
That is just for one month.
Generally, product labeling changes are not news.
So why is the antidepressant labeling change newsworthy? It
is not because of the science; rather, it is because it is such an
emotional topic for so many people.
The Times had two articles. On 12/13/06:
to Debate Antidepressant Warnings; and on 12/14/06:
Wants Broader Antidepressant Labeling.
To give you an idea of how emotional the topic is, here is the first
paragraph of the first article:
Public health officials, psychiatrists, grieving
parents and outraged former patients will fill a hotel ballroom in
Silver Spring, Md., this morning to argue the most bitterly divisive
question in psychiatry: do the drugs that doctors prescribe to relieve
depression make some people more likely to attempt suicide?
The reason this is a clue, is that is shows that even the guy who wrote
the article, Benedict Carey, is emotional about the topic. In
point of fact, the panel was not debating the question of whether
antidepressants make some people more likely to attempt suicide.
They’ve already debated that, and I’ve blogged about it
several times. (No point in repeating it here, now.)
Plus, he refers to this as “the most bitterly divisive
question in psychiatry.”
No, the most bitterly divisive question in psychiatry is this: Should
HMO managers be shot, or should they be hanged? Or, perhaps: Is
psychoanalysis still relevant? Seriously, there are many
bitterly divisive questions, but that is not one of them.
Can you tell that it bugs me when supposed news articles, such as Mr.
Carey’s, interleave the actual news with the misguided opinions of the
Carey and I do agree on some points. For example:
The meeting marks the latest chapter in a controversy
that began in the late 1980s, soon after Prozac was introduced as the
first in a new generation of antidepressants. Over the last 15 years,
the debate has come to transcend questions about side effects and
labeling. It is now a clash of cultures.
is fair. It is essentially the same point that I was making.
It is not about the science. It is about cultural
issues. There’s more to it, of course. Much of the href="http://en.wikipedia.org/wiki/Scientology_and_psychiatry">antipsychiatry
stuff allegedly has been spread by href="http://en.wikipedia.org/wiki/Scientology">Scientologists.
So if you consider Scientology to be a culture, then Benedict
is on to something.
There is a serious side to this that I do not want to gloss over.
There are people who’ve committed suicide while taking
antidepressants. Some of the people who testified at the
panel hearings were survivors of these tragedies. These
people are genuinely upset, and they think something should be done.
That makes sense. And from a humanistic medicine
perspective, it does make sense for patients to get adequate warnings
about treatments that are recommended for them.
So, when the panel finally voted to expand the warnings, it was a
reasonable thing for them to do. Yes, there are
counterarguments, as noted in the second article:
Some psychiatrists said expanded warnings could lead
to more suicides. Dr. Carolyn B. Robinowitz, president-elect of the
American Psychiatric Association, said the labels might cause a
“We’re talking about a devastating, chronic and
recurrent disorder, and a black-box warning may serve as another
barrier to care that people need,” Dr. Robinowitz said.
For one thing, I doubt that the black box waring will have much effect.
Studies of other drugs have shown that these warnings have too
little effect. For example, Accutane — a known href="http://en.wikipedia.org/wiki/Teratogen">teratogen
– is href="http://pediatrics.about.com/cs/pharmacology/a/accutane_2.htm">still
given to people who might get pregnant, despite an elaborate
system to prevent the practice.
It probably is true that some people will choose to avoid
antidepressant medication as a result of this. But it will be
the hype, not the warning itself, that poses the problem.
Even so, people are free to make up heir own minds.
If they do so by using a faulty analysis of the available
information, it is still their choice. The only way to
prevent that is by denying access to the information, and in my view,
that would be a greater evil.
The nettlesome thing about this issue, is that persons who are severely
depressed may also have a kind of cognitive distortion that causes them
to magnify their perceptions of risk. I suppose that some
could argue that such persons simply should not have the information,
because they will not be able to analyze it properly.
The solution is not to withhold information. The solution is
for those who have to power to shape culture, to use that power to
assist in destigmatizing mental illness; and for educators to help make
sure that people in this country have the basic ability to analyze
risk-benefit problems. Another part of the solution is for
doctors and their patients to allow enough time for an adequate
discussion of important risk-benefit issues.
The latter one is hard, especially in the area of child and adolescent
psychiatry. In part, that’s because there simply are not
enough child/adolescent psychiatrists. Another factor is the
perverse tendency of managed care organizations to impose strict limits
on the number of visits a person can get reimbursement for.
Typically, in Michigan, a person will get coverage for 20
visits a year. Those twenty visits have to be split between
the psychiatrist and the therapist. Some states have policies
that are less medieval, but the point is that benefit limits can
influence doctors and patients to cut corners with time-consuming
things. A good discussion of risks and benefits can take a
lot of time. The labeling changes may have increased the time
it will take, but that is the price of good medical practice.