http://www.washingtonpost.com/wp-dyn/articles/A19163-2004Mar23.html

Keeping Doctors in the Dark

By Lawrence Diller
Wednesday, March 24, 2004; Page A21

The Food and Drug Administration issued an official warning this week on the increased risks of suicidal tendencies when taking antidepressants such as Prozac. The makers of Prozac and of nearly every other major antidepressant used in this country (Paxil, Zoloft, Wellbutrin, Effexor, Celexa, Lexipro) will have to include a new warning on the package label. This action is the culmination of more than 10 years of efforts to bring to light potential dangers of these medications.

The new warning alerts doctors and patients that in the first days and weeks of treatment, side effects such as agitation, panic, irritability, insomnia and severe restlessness may occur, contributing to an overall increase in the risk of suicide. More than a decade ago similar concerns over Prozac were beaten down in U.S. courts by an onslaught of "expert" testimony of industry-sponsored researchers and legal arrangements that gagged victims and their families with large monetary settlements.

In fact, it's likely we still wouldn't have the information on the antidepressants today, if it weren't for foreigners, specifically British doctors, who were more skeptical about the antidepressants' value in treating Depression in children. The Medicines and Healthcare products Regulatory Agency, Britain's FDA, first issued a warning on Paxil and Effexor last summer. In October, all the antidepressants known as SSRIs except Prozac were banned because studies from the United States did not show they were effective in treating children with depression, but did show that they were twice as likely as placebos to lead to suicide.

The British decision led to the FDA's move to hold a hearing on Feb. 2 in Washington. Until that time, of seven published studies of SSRI use for childhood
depression, only three demonstrated positive effects as compared with placebos. At the meeting, doctors and patients learned that the FDA had eight additional drug company studies in its "back files" that also showed no positive effects for the drugs but were never published. The drug companies had performed these studies under the "pediatric rule," which extended the patents of these medications for the companies by six months. But the companies were under no obligation to publish them, and so they languished in darkness until the British government's action made us aware of them.

At the meeting, even researchers and academic psychiatrists who were well-known proponents of psychiatric medication for children pleaded for transparency in research findings. How can doctors make sensible decisions when most of the studies are withheld from public scrutiny? The companies responded that the studies are proprietary company property and that publication of such data could hurt their product and stockholders.

The lack of an economic interest also precludes any systematic follow-up on drugs once they are approved by the FDA. Most studies required for FDA approval last only a few months. Once approved, these drugs can be used forever, and for whatever purpose a doctor sees fit to prescribe them. The drug companies have little incentive to check whether the medicines are still working years into a treatment. And it can take years of general use before side effects are discovered to be associated with a drug.

It seems that only the trial lawyers have a vested economic interest in following up on medications. That's a costly post-marketing surveillance system, both to the society that absorbs the legal costs and to the people hurt by a medication, before enough publicity or economic pain is felt by the manufacturer to change the label or withdraw the drug. Nearly 80 percent of respondents to a poll on my Web site said they'd pay at least a 1 percent surcharge on their medications to fund independent, systematic follow-up on pharmaceuticals.

The FDA decision to issue its warning on antidepressants is a vindication, albeit a much delayed "bitter pill" to the families that lost a child to suicide as a result of taking what might have been no better than placebo treatment. How many more children must die from other questionable drugs before our government takes the necessary actions to "heal" the sick regulation of the pharmaceutical industry?

The writer practices behavioral-developmental pediatrics in Walnut Creek, Calif., and is the author of "Should I Medicate My Child?"








From the following NEW YORK TIMES article we quote one physician:

"We're going to continue to use these drugs pretty freely until we start seeing the ads in the newspapers from lawyers saying, `Have you or your family member been prescribed these drugs? If so, you may have a case,' " said Dr. Phillip Kennedy, a family practice physician in Augusta, Ga. "When the big L word, liability, raises its ugly head, that's when things will really change."

So for doctors to understand how serious an issue this is they need to be herded into court? Well, that sounds like a clear call for all good attorneys to step forward now! If that is what it takes to save lives, we need attorneys taking out ads.

And I would like to know how on earth Gardner Harris let this statement make it into his article by a spokesperson for Eli Lilly without asking how carefully physicians should monitor their patients - as closely as they monitored Traci Johnson when she hung herself in their laboratory last month?

"Spokesmen for drug companies said that they would emphasize to physicians that the F.D.A.'s warning did not conclude that antidepressants cause suicide.
"My hope is that people won't make a link with the drugs," said Jennifer Yoder, a spokeswoman for Eli Lilly & Company, maker of Prozac. "I think the message will be that suicide is an inherent part of the disease of depression, and physicians should carefully monitor their patients."

Your quote was the best Tom. So, why did they save it for last? [Tom and Kathy Woodward are our PA directors for the International Coalition for Drug Awareness]






http://www.nytimes.com/2004/03/24/health/24DEPR.html?pagewanted=2&e...
en=75d76ba44cb666cc&ex=1080795600&partner=GOOGLE


Overprescribing Prompted Warning on Antidepressants

By DENISE GRADY and GARDINER HARRIS

Published: March 24, 2004

he government's warning on Monday that people newly taking antidepressants can become suicidal and must be closely monitored grew at least in part from a concern that the drugs were being handed out too freely and without enough follow-up, especially in children and teenagers.

Dr. Wayne K. Goodman, chairman of psychiatry at the University of Florida College of Medicine and a member of an expert panel that advised the Food and Drug Administration, said, "I think many physicians, and particularly nonpsychiatrists, have been lulled into the notion that these drugs are safe."

He emphasized that the drugs carried few serious physical side effects and a low risk of overdose. But, Dr. Goodman added, "I think what's been underestimated is this behavioral toxicity, which can indirectly lead to problems, including possibly suicidal behavior."

Yesterday many doctors acknowledged that the new warning was sound advice and yet said they worried it might discourage doctors and patients from treating depression.

Dr. Eva Ritvo, an associate professor of psychiatry at the University of Miami, said: "A depressed patient needs to be watched closely, particularly in the initial stages of treatment or when the dosage is raised. This is something we should be doing anyway as mental health professionals."

But, she added, "Untreated Depression is dangerous and takes a huge toll on people's lives, and we can only hope this warning doesn't discourage people from seeking treatment."

Patients had mixed reactions.

Some people who suffered Depression in the past but shunned medication said the new warnings reinforced their wariness.

Barry Owen, 51, a magazine consultant in San Francisco, refused antidepressants during an emotional crisis.

He said his doctor recommended the drugs a few years ago "because at that point I was pretty severely depressed and having panic attacks and couldn't eat and sleep." Mr. Owen added: "I decided then not to take her advice. And while I don't doubt the usefulness for a lot of people, this new information gives me one more question about them."

But patients who have done well on the drugs were not troubled by the new warnings. Paul Festa, 33, a San Francisco artist and writer, took Zoloft for about a year in 1999, and then Paxil for a year or so after the 2001 terrorist attacks. He said: "I would never hesitate to go back on these medications because I already know that I react extremely well to them. I feel like there should be a warning for people who are depressed that not taking these medications could lead to suicide. If you're depressed, you're putting yourself at risk for all sorts of self-destructive behaviors, up to and including suicide.

"When I was depressed, the thought of suicide was crossing my mind more than it ought to have, and the antidepressants got me out of that loop."

The advisory issued Monday by the drug agency asked manufacturers to put detailed warnings about a possible increased risk of suicidal behavior and the need for monitoring on the labels of 10 antidepressants: Prozac, Zoloft, Paxil, Wellbutrin, Luvox, Celexa, Lexapro, Effexor, Serzone and Remeron. The warning included both children and adults.

Studies in children taking the antidepressants have not found an increase in suicide. But studies of some drugs have suggested that they might increase the risk of suicidal thoughts and behaviors. Research has also failed to provide convincing evidence that the drugs are effective in children, making the potential risks even less acceptable. There is no solid data linking use of the drugs to suicide in adults.

Dr. Goodman of Florida said that panelists who met last month were troubled by reports that some doctors were giving patients samples of antidepressants and saying casually "Tell me how you do," rather than scheduling frequent follow-up appointments to make sure patients were tolerating the drugs.

"That is problematic," Dr. Goodman said, "and probably reflects people becoming a little lackadaisical about the downside of these medications in children."

Most antidepressants are now prescribed by primary care physicians, whose patients may never see a psychiatrist, because of concerns about cost or the perception of stigma attached to mental illness. Prozac, Paxil and other modern antidepressants became hugely popular in part because drug companies convinced family physicians that they were safe enough to use without a psychiatrist's intervention. Antidepressants are the third biggest selling category of drugs in the world behind cholesterol and heartburn pills.

Some psychiatrists speculated yesterday that their family-care colleagues might lose confidence in the drugs and become reluctant to prescribe them.

"We're hoping that doesn't happen, because primary care physicians have a major role to play in combating depression," said Dr. James H. Scully Jr., medical director of the American Psychiatric Association. "We hope they won't be scared off."

Dr. Robert Lee, a San Francisco physician of holistic medicine who sometimes prescribes antidepressants, said: "I don't think people already taking them will be concerned. But a lot of people who I think would benefit from these meds already won't take them because of various stigma reasons, so I'm a little concerned that this will raise that barrier even higher."

Dr. Lee said the new warning would not make him hesitate to prescribe the antidepressants.

He said, "People can get agitated from them, but I've never seen somebody get suicidal from them."

Dr. Joseph Gonzalez-Heydrich, chief of psychopharmacology at Children's Hospital Boston, said: "I've heard anecdotally that a lot of antidepressants were being prescribed by pediatricians without a lot of training or experience. I think the warning is appropriate. If it makes prescribers more vigilant or parents more vigilant, that's a good thing."

Dr. Gonzalez-Heydrich said that a sizable minority of children became more agitated and irritable on the antidepressants in question. "If we see it, we take them off it or reduce the dose," he said. "Doing it that way there are a lot of kids we feel do benefit from these medications, especially long term. But they're not for everybody."

Dr. Harold Koplewicz, director of New York University's Child Study Center, said, "The fear I have about this warning is that many teenagers will not get the medicine because it will build resistance among their parents, and that's really a tragic outcome." He noted that suicide rates in teenagers had gone down in the United States and Sweden as use of the drugs increased.

Several primary care doctors said that they had prescribed antidepressants with success for so many years that it was unlikely the F.D.A.'s new warnings would lead them to stop. Still, the warnings have given them pause, they said. They may think a bit harder before prescribing them to patients who are simply stressed, they said. And they will watch how the warnings play in the
legal field, some said.

"We're going to continue to use these drugs pretty freely until we start seeing the ads in the newspapers from lawyers saying, `Have you or your family member been prescribed these drugs? If so, you may have a case,' " said Dr. Phillip Kennedy, a family practice physician in Augusta, Ga. "When the big L word, liability, raises its ugly head, that's when things will really change."

Spokesmen for drug companies said that they would emphasize to physicians that the F.D.A.'s warning did not conclude that antidepressants cause suicide.
"My hope is that people won't make a link with the drugs," said Jennifer Yoder, a spokeswoman for Eli Lilly & Company, maker of Prozac. "I think the message will be that suicide is an inherent part of the disease of depression, and physicians should carefully monitor their patients."

Critics of the medicines said the F.D.A.'s warning was long overdue.

"These warnings are not as strong as I would like, but they're an important first step," said Tom Woodward of North Wales, Pa. Mr. Woodward's teenage daughter, Julie, hanged herself six days after starting therapy with Zoloft.

David Tuller and Terry Aguayo contributed reporting for this article