NEWS Doctors Say They Will Cut Antidepressant Use

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Doctors Say They Will Cut Antidepressant Use

By GARDINER HARRIS

Published: September 16, 2004

Psychiatrists, pediatricians and family practice doctors said in interviews

that they would restrict their use of antidepressants in the wake of a

federal advisory committee's decision that the medicines should contain

severe warnings about the risks of suicide.

Dr. Lerman, a child and adolescent psychiatrist in New York City,

said that he would no longer prescribe the medicines to some children and

that for the rest he would sit down with their parents and discuss in detail

the risks of the drugs.

The advisory committee made its recommendation after reviewing numerous

studies of antidepressants. Although no children in any study of the drugs

committed suicide, there were reports of increased suicidal thoughts and

behavior. The risks are greatest in the first weeks of therapy.

" Some parents are very uncomfortable with their kids being on medication to

begin with, " Dr. Lerman said, " and this will be enough so that some parents

will not allow their kids to be on medicines. "

Meanwhile, top officials at the Food and Drug Administration have decided to

re-evaluate whether the drugs can cause adults to become suicidal, too. Dr.

Janet Woodcock, the agency's deputy commissioner of operations, said in an

interview that for years the F.D.A. had largely evaluated the risk of

suicide in adults by analyzing the final outcomes of antidepressant trials.

That analysis has shown no link to suicide or suicidal behavior, she said.

But the agency identified the risk of suicidal thoughts and behavior in the

trials involving teenagers and children by analyzing in a new way the

adverse-event information provided with the trials. The agency is now

gearing up to do the same thing in its adult trials, a database that

includes 234 tests with more than 40,000 patients.

" I think there might be more to be learned, based on what we learned from

the pediatric studies, " Ms. Woodcock said.

In the meantime, doctors will have to struggle with how to treat depressed

children and teenagers. There are few good options. While data from 24

studies of nine drugs provided wildly different estimates of each drug's

benefits and risks, the advisory committee decided that the studies were so

small that there was no convincing evidence that any drug was safer than

another. And studies that included one-on-one talk-therapy failed to show

any benefit for that treatment.

The advisory committee decided that the suicide warning should also be

placed on the physician prescribing sheets for an older set of

antidepressants called tricyclics. These medicines have largely fallen out

of favor because of the damage they can do to patients' hearts and the risks

that result from overdoses.

The warning was extended to them in part because of the " great risk in

scaring clinicians back to the tricyclics, " said Dr. Laughren, a top

agency official.

Indeed, committee members openly worried throughout their deliberations that

their decision might lead some physicians to stop treating depression in

children and teenagers. In interviews, some clinicians said the committee's

push for a warning had done just that.

" I can tell you that my writing for antidepressants for kids has dropped off

dramatically, " said Dr. Kennedy, a family practice physician in

Augusta, Ga.

" It used to be that when I saw a kid who was 14, 15 or 16 and who was really

down, I felt very comfortable writing them an S.S.R.I. prescription, " Dr.

Kennedy said, referring to a class of antidepressants. " I don't now. "

Whether antidepressant prescriptions for children and teenagers will really

decline is unclear. In March, the F.D.A. issued a vaguely worded warning

about suicide risk, and it had no impact on prescriptions trends, agency

officials said. Nearly 11 million prescriptions for antidepressants were

given to children and teenagers in 2002, and that total has since been

growing steadily. In the first six months of this year, the number of such

prescriptions grew almost 8 percent.

Indeed, worldwide sales of antidepressants in the 12-month period ending in

March were $19.97 billion, according to IMS Health, a pharmaceutical

information and consulting company, making them among the biggest selling

drugs.

Most physicians have written scores of prescriptions for the pills with no

ill effects. And since doctors are unable to distinguish between a drug and

a placebo effect, many feel the drugs work quite well. In fact, the drugs

have by and large not proven any more effective in children and teens than

placebos, and even in adults prove better than placebos in only half of all

studies.

Still, the warning that the advisory committee is recommending, a so-called

black-box warning on the label that explicitly talks of the suicide risk, is

a serious precautionary measure, and physicians said in interviews that the

promise of such a warning has gotten their attention. The risk of suicide

from the drugs is small. If 100 children and teenagers are given the drugs,

two or three will become suicidal who would not have been suicidal if given

placebos.

Dr. Albert Melaragno, a pediatrician in Valencia Calif., said that five

years ago he never prescribed antidepressants. But, Dr. Melaragno said, the

scarcity of psychiatrists and the growing unwillingness of managed-care

plans to pay for mental-health services has thrust the task of dealing with

depressed children and teenagers onto him.

The new warning will lead him to be more cautious in using the pills and

more likely to refer patients to psychiatrists, he said. But he feared that

many patients who need the medicines will now refuse therapy.

" It's raised such a specter with patients that more of the teens who have

the need for treatment will be frightened off of using it and suffer more

because of that, " Dr. Melaragno said.

http://www.nytimes.com/2004/09/16/health/16depress.html