September 21

18% decrease SSRI use in Youth – NYT / Suicide Risk Not New – Globe / Prozac no different

18% decrease SSRI use in Youth – NYT / Suicide Risk Not New – Globe / Prozac no different

Tue, 21 Sep 2004

The FDA failed to stop drug manufacturers from flooding the air waves and the scientific literature with false and scientifically invalid claims-based on partial data. “The FDA and pharmaceutical companies swept [the suicide risk] under the carpet in 1991. It was just absolutely junk science, and people have died because of that,” Dr. Joseph Glenmullen told the Boston Globe.

When parents and physicians learned that truth–that antidepressants have not demonstrated an effect greater than placebo, but have demonstrated the potential for lethal harm, they responded appropriately.

The New York Times reports: “The number of teenagers and children being prescribed antidepressants in the United States dropped 18 percent over the last year after studies found that the medicines appeared to lead some to become suicidal, according to one provider of drug benefits.”

The Times reports that Dr. Richard Malone, a Baltimore pediatrician who served on FDA’s advisory panel, and voted for black box warnings for physicians and parents, said he received two telephone calls from parents asking if it was time to take their children off the antidepressant. “I have 3,500 children in my practice, and to get two calls on the same issue on the same day is pretty unusual,” he said.

On Thursday, FDA officials will have to answer a congressional committee why they collaborated with drug companies in the concealment of vital drug safety information?

In light of the established evidence of a causal relationship between all SSRI and SNRI antidepressants and a suicidal risk, will the FDA retract the false statements senior FDA officials made in briefs submitted in court cases in which the agency falsely claimed that evidence is lacking to demonstrate causal relationship between antidepressants and a suicide risk? See: Cong. Hinchey Press Release RE: FDA chief counsel

The hearing in scheduled for Thursday, Sept 23, at 11:00 at the Rayburn Office Building Room 2123.

Contact: Vera Hassner Sharav
Tel: 212-595-8974

September 21, 2004
Study Finds Less Youth Antidepressant Use


The number of teenagers and children being prescribed antidepressants in the United States dropped 18 percent over the last year after studies found that the medicines appeared to lead some to become suicidal, according to one provider of drug benefits.

In a study done at the behest of The New York Times, Medco Health Solutions found that 43,859 of the roughly 3.5 million children and teenagers for whom the company provided drug benefits in July, or 1.26 percent, were prescribed antidepressants that month. That is down from 60,902 children and teenagers, or 1.69 percent of the total, who were prescribed the drugs a year earlier. It was the first decline in prescriptions for antidepressants among teenagers and children in years, the company found.

Some experts greeted the news with guarded optimism, saying that it meant that physicians may be using more care when prescribing the drugs to youngsters. “You would hope that the inappropriate use of these medicines has dried up a bit,” said Dr. Richard Malone, a pediatrician in Baltimore and a member of the Food and Drug Administration’s advisory committee that concluded last week that the agency should place a strong warning on the drugs about the risk of suicidal thoughts or behavior in pediatric patients.

The finding by Medco Health Solutions is at odds with information provided last week by the F.D.A. to its advisory committee. An F.D.A. official told the committee that prescriptions of antidepressants for children and teenagers continued to rise by 7 percent this year despite a growing controversy about the safety of the drugs. “We did not see any decline,” Michael Evans, a drug use specialist with the F.D.A.’s office of drug safety, told the committee.

Mr. Evans told the committee that his information came from IMS Health, a health information and consulting company. Lance Longwell, a spokesman for IMS Health, said that the company provided data to the agency, but that the agency did its own analysis.

IMS Health obtained most of its information about drug use by surveying pharmacies, but it did not collect patient information. Mr. Longwell said that he did not know how the agency distinguished between prescriptions given to adults and those given to teenagers and children.

A spokesman for the F.D.A. said the agency would not comment.

Medco provides prescription drug benefits for about 60 million Americans over the course of a year, or about a fourth of those who have health insurance in the United States. The company’s finding on antidepressants resulted from a direct analysis of its patients’ prescription drug histories, said Ann Smith, a Medco spokeswoman.

The Medco data suggest that the controversy about the safety of antidepressants has made an impression on physicians, young patients and their parents. Last summer, GlaxoSmithKline, the manufacturer of Paxil, and Wyeth, the maker of Effexor, both warned that studies of their drugs in youngsters indicated that some had become suicidal. For GlaxoSmithKline, the warning came from an analysis requested by the F.D.A. that looked at studies that the company had kept largely secret. None of the children in the trials committed suicide, but some thought about or attempted suicide, researchers found.

After these findings, the F.D.A. asked manufacturers of seven other antidepressants to study the effects of their drugs on children and teenagers. Taken together, the studies found that children and teenagers given antidepressants are twice as likely to become suicidal as those given placebos. In February, the F.D.A.’s advisory committee suggested that the agency provide a general warning about the risks of suicide among antidepressants users, which the agency did in March.

Last week, the advisory committee voted that the drugs’ warnings should be strengthened. The agency is still studying the committee’s recommendation and promised to act within months.

Dr. Lauren Marangell, an associate professor of psychiatry at Baylor College of Medicine in Houston and another member of the advisory committee, said at last week’s hearing that despite the growing evidence of the risks of the drugs she was not hoping for a decline in antidepressant use among the young.

“I don’t want to see prescriptions drop because these people need to be treated,” Dr. Marangell said at the hearing. “They need to be warned about the risks.”

In an interview yesterday, Dr. Marangell said it was impossible to tell whether the decline found by Medco was real and, if so, whether it was beneficial.

“It’s bad news if kids that need treatment don’t get it, and it’s good news if people who don’t need the drugs aren’t getting them,” Dr. Marangell said. Others said that the Medco data were consistent with their experience.

Dr. Malone, the Baltimore pediatrician, said he received two telephone calls from parents of patients he had put on antidepressants asking if it was time to end the therapy.

“I have 3,500 children in my practice, and to get two calls on the same issue on the same day is pretty unusual,” he said.

Both parents said that they were concerned about the newfound risks of the drugs, Dr. Malone said.

James McGough, a professor of clinical psychiatry at the University of California, Los Angeles, and another member of the advisory committee, said that antidepressants were often given to the wrong young patients for the wrong reasons. On the other hand, he said he saw a depressed young girl yesterday who needed antidepressant therapy. “But her parent is so afraid of the medicines that it’s getting in the way of what this girl truly needs.”

Copyright 2004 The New York Times Company

The Boston Globe
Drugs, suicide link is not new
By Carolyn Y. Johnson | September 21, 2004

Although suicide was linked officially to antidepressant use in children only last week, the connection is not new and the risks may not stop at puberty. Suspicions first raised in the late 1980s never were scientifically established because company data were kept private and because it is tricky to prove why a depressed person committed suicide.

The Food and Drug Administration is considering reexamining whether the antidepressants are linked to suicide in adults. While studies in children show slim or no benefit from the drugs, there is more evidence in adults that the antidepressants can have a positive effect as well.

The link with suicide was first identified in the late 1980s among adults who used Prozac. Germany’s FDA equivalent refused to approve the drug because of a 1987 study that showed nonsuicidal patients who took the drug attempted suicide or succeeded at three times the rate of those taking placebos.

A group of Harvard researchers then found in 1990 that violent, suicidal thoughts developed in 3.5 percent of depressed patients.

“The antidepressants worsen, in a small population of people, every single symptom of depression,” said Dr. Martin Teicher, chief of the laboratory of developmental psychopharmacology at McLean Hospital and author of the 1990 study. Teicher said the antidepressants have a role, but are not for everyone. “What’s happened with children that made this so much clearer is there was more access to unpublished data” than with adults.

At last week’s FDA hearing, experts had access to clinical trials performed by pharmaceutical companies that were previously confidential. At a 1991 hearing on the safety of Prozac in adults, doctors had reviewed only the limited number of studies that the drug companies had chosen to publish. That panel voted, 6 to 3, that Prozac and similar drugs were not connected to suicidal behavior.

A spate of news stories and lawsuits in the 1990s described people who killed others or themselves and were thought to be taking Prozac, although the FDA continued to deem the drug safe for use. Last March, however, the agency warned that the antidepressants were possibly linked to an increased risk of suicidal behavior in adults as well as children.

The British version of the FDA, which has already banned pediatric prescriptions of antidepressants other than Prozac, is now reviewing a possible link between antidepressants and suicide in adults, according to Dr. Joseph Glenmullen, a Harvard psychiatrist and author of the critical book, “Prozac Backlash.”

He, like many patients, scientists, and lawyers, questions why the FDA ignored the risk of suicide for so long in people of all ages.

“The FDA and pharmaceutical companies swept this under the carpet in 1991,” he said. “It was just absolutely junk science, and people have died because of that.”

The New York Times
September 21, 2004
Is Prozac Better? Is It Even Different?

Last week, a federal advisory panel urged regulators to warn parents that antidepressant drugs not only increase the risk of suicide in some children, but that most have a poor track record in curing their disease.

The recommendation came after a yearlong debate over whether the drugs are as safe and effective as advertised. It was based on evidence that a small minority of children show increased signs of suicidal behavior when taking the drugs.

Through it all, one of the drugs seemed somehow above the fray: Prozac.

Although the warning is recommended for Prozac as well as other drugs, Prozac is still the only one approved by the Food and Drug Administration for the treatment of depression in children and adolescents. A large government-financed trial recently found that it worked better than talk therapy in helping teenagers overcome depression. And when British health officials announced a sweeping ban of antidepressant use in children, which touched off the debate last year, they specifically exempted Prozac.

But is it really that different?

The short answer is no, experts say. Although chemically distinct from other drugs in the same class, Prozac works on precisely the same principle, they say, and there’s no evidence that it is significantly safer or more effective than the others in treating childhood depression. Prozac has shown in several trials that it can relieve depression in youngsters and adolescents significantly better than dummy pills. Such convincing evidence is not available for the other drugs. But, research psychiatrists say, that does not mean the other drugs in the same family do not work in young people, only that they have not been properly tested.

“It makes no scientific sense that you would find any significant difference in the effects” of these drugs, said Dr. Steven Hyman, a Harvard psychiatrist and former director of the National Institute of Mental Health, who is not a consultant for antidepressant makers. “All target and bind to the same molecule in the brain.”

Dr. John M. Plewes, a medical adviser at Eli Lilly, which makes Prozac, disagreed that the differences were minimal. “We’ve got very good data that the drug is safe and effective in children, and no other drug has this kind of data,” he said.

The molecule these drugs bind to is the one the body uses to dampen the activity of a mood-altering brain chemical called serotonin, Dr. Hyman said. When this molecule is tied up by a drug, serotonin surges lasts longer and, over time, improve mood in some people who are depressed. Prozac was the first antidepressant drug on the market to work primarily on serotonin, and the others that came later – including Paxil, from GlaxoSmithKline; Zoloft, from Pfizer; and Celexa, from Forest Laboratories – are what some researchers consider copycat or me-too drugs.

Prozac does linger in the body longer than the others do, once people stop taking it, psychiatrists say. This makes withdrawal more gradual than from other antidepressants, and keeps levels of the drug steady if people miss doses. Teenagers in particular often forget or skip doses, child psychiatrists say, and many of these psychiatrists believe that the potential for suicide is highest in people being treated when their dosage is changing, up or down.

One recent analysis of records of patients who had taken antidepressants, including some 160,000 adults and children, found that the suicide risk was highest in the first three to four weeks of treatment. But no one has shown convincingly that there are significant differences among the drugs, or determined exactly what the withdrawal risks are.

“You really need to watch young patients on these drugs closely at all times,” said Dr. John March, chief of the division of child and adolescent psychiatry at Duke University Medical School, the lead author of the recent study comparing Prozac to talk therapy. Dr. March has been a consultant to Pfizer and other drug makers but currently receives almost all his research financing from the government, he said.

More so than effects and chemistry, experts say, what distinguishes Prozac is the methodology of the studies that have been done to test it. Depression is a subjective experience for which doctors have no blood test, no hard and fast measure. Especially in children and teenagers, depression is fleeting.

This is one reason that in antidepressant trials the placebo effect is so large and unpredictable. In a study lasting six or eight weeks, many participants get better on their own, drug or no drug. In childhood depression studies the placebo effect can range from 30 percent up to 59 percent, which is difficult for any antidepressant to beat.

“The wonderful thing about the F.D.A. panel’s findings is that it’s going to force people to talk about these things and look at the studies very carefully,” said Dr. Jane Garland, chief of the Mood and Anxiety Clinic at British Columbia Children’s Hospital in Vancouver, who has argued that company-sponsored trials have presented data to make the drugs look more effective than they are.

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Copyright 2004 The New York Times Company

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