FATAL FLAW Efforts to Overturn SSRI Black Box warning before it has even been implemented

Date: Mon, 24 Jan 2005

Even as the Black Box Suicidality Warning on SSRI antidepressant labels have not even been implemented, aggressive efforts are underway by a powerful consortium of medical-pharmaceuticaql self-interest groups – among them, the American Medical Association (AMA), the American Psychiatric Associaion (APA), American Academy of Child and Adolescent Psychiatry (AACAP)–to overturn the hard won ‘Black Box’ suicidality warning label on antidepressant drugs.

Based on replicated independent analyes of the the scientific evidence from controlled clinical trials, the FDA was forced to acknowledge that: “A causal role for antidepressants in inducing suicidality has been established in pediatric trials.”

Disclosure to doctors and parents that antidepressants can cause an increased suicide risk for some children threatens the financial interests of the medico-psychiatric establishment which has become totally dependent upon the financial support from the drug industry. A Black Box warning at least puts doctors on alert for the protection of children’s lives. Those who are working to undermine the safeguard – which has yet to be implemented – continue to make false claims.

Contrary to assetions made, there is no substantiating scientific evidence for the claim that antidepressants “have proven successful in the treatment of some children and adolescents.”

Contrary to assertions that no teenager committed suicide in an antidepressant trial, Traci Johnson, a 19 year old Bible school student who was a healthy control subject in a duloxetine (Cymbalta) trial testing the antidepressant drug for use as a treatment for incontinence, committed suicide at Eli Lilly’s laboratory.

A report from the Seattle News Tribune describes the human ramifications of the “Fatal Flaw” – the suicide trigger:

“Chris Reid might still be alive if the drugs’ side effects were recognized for what they were, his mother, Coralie, said. The 18-year-old Seattle resident was an outgoing person – the life of the party, even – when a doctor suggested Prozac because Chris was blue over a breakup. The boy quickly grew agitated, hostile and withdrawn on the drug. He went around like he was in a different world. All are signs that something is wrong. Then, the night his sister got married and five weeks after starting Prozac, Chris took his own life by starting his car in a closed garage. His parents found him hours later. His older brother Roy, who was brain-damaged at birth, lost his best friend and helper. ”

How shameful that the AMA, the APA and the AACAP would rather put children’s lives at risk by eliminating a warning that alerts physicians to a fatal risk for patients rather than risk their “educational” grants from industry.

Contact: Vera Hassner Sharav
212-595-8974

http://pn.psychiatryonline.org/cgi/content/short/40/1/1-b

Professional News
AMA to Study Safety of SSRIs In Youngsters
Mark Moran

The decision is a response to the recognition that parents, physicians, and the public are confused and uncertain about the use of antidepressants in children and adolescents.

The AMA will prepare an independent and comprehensive review of the scientific data pertaining to safety and efficacy of using selective serotonin reuptake inhibitor (SSRI) antidepressants in the treatment of child and adolescent psychiatric disorders.

In response to a resolution introduced by APA and the American Academy of Child and Adolescent Psychiatry (AACAP), the AMA’s Council on Scientific Affairs will be preparing a report in an attempt to mitigate some of the confusion surrounding the Food and Drug Administration’s (FDA) recent “black box warning” about the risk of suicidality in children and adolescents being treated with SSRIs (Psychiatric News, November 19, 2004).

The resolution was approved by the AMA’s House of Delegates at last month’s interim meeting in Atlanta. Testimony in reference committee hearings preceding the vote was overwhelmingly supportive.

(Prior to any action taken by the House of Delegates, all resolutions are brought before a reference committee and debated; based on testimony provided during that hearing, the reference committee then makes a recommendation to the house to approve the resolution or not, with or without amendments.)

John McIntryre, M.D., chair of the AMA Section Council on Psychiatry and chair of the reference committee that heard testimony on the issue of children and SSRIs, told Psychiatric News that the FDA action had created much confusion around the use of medications that have proven successful in the treatment of some children and adolescents.

“It was clear to the House of Delegates that the FDA black-box warning was confusing both to the public and parents with kids on antidepressants, but also to physicians who prescribe these medications,” McIntyre said. “The house approved the resolution asking for a prompt study by the AMA’s Council on Scientific Affairs.”

Child psychiatrist David Fassler, M.D., vice chair of the Section Council on Psychiatry, AACAP delegate, and author of the resolution, told the reference committee that the data on which the FDA based its action were far from conclusive. “Data on children and SSRI antidepressants are inconsistent and inconclusive,” Fassler said. “In particular, it’s important to underscore that there have been no actual suicides in any of the clinical trials, which have now included close to 5,000 subjects. Second, the public is confused by inaccurate and contradictory media reports. And finally, physicians are confused by the recent FDA decision to require black-box warnings on all antidepressants used in the treatment of children and adolescents with psychiatric disorders. We very much need an independent, authoritative scientific review of this topic.”

In October the FDA ordered drug companies to label all antidepressants distributed in the United States with strongly worded warnings that the medications “increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) or other psychiatric disorders.”

The FDA decision has not been without controversy. In a joint statement, APA President Michelle Riba M.D., M.S., and President-elect Steven Sharfstein M.D., said, “The American Psychiatric Association believes antidepressants save lives…. We restate our continued deep concern that a ‘black-box’ warning on antidepressants may have a chilling effect on appropriate prescribing for patients. This would put seriously ill patients at grave risk.” Riba and Sharfstein said that APA is “working to help mitigate such an impact by collaborating with nonpsychiatric physicians – including pediatricians and general practitioners – to help them better understand their patients’ needs and properly diagnose, treat, and monitor patients” (Psychiatric News, November 5, 2004).

http://www.thenewstribune.com/soundlife/v-printer/story/4480721p-4217724c.html

THE NEWS TRIBUNE
A fatal flaw
Sometimes the drugs designed to help people battling depression do more harm than good
M. ALEXANDER OTTO; The News Tribune
January 24th, 2005 10:25 AM (PST)

If you or someone you care about takes anti-depressants, there’s something you need to know.

Although it’s very rare, drugs like Prozac, Paxil, Effexor and Zoloft can cause such horrific side effects that people have taken their own lives to escape, according to experts.

That “selective serotonin reuptake inhibitor” andi-depressants and drugs like them can trigger suicide in children and adolescents is no longer controversial, and there is little doubt it can happen to adults, too. Labels were updated last year to warn of the association, and stronger warnings are coming soon.

But what has not been widely reported is how to recognize the side effects before it’s too late. Recent Food and Drug Administration hearings were full of stories about how patients and their doctors did not realize an andi-depressant was making problems worse. Mistaking side effects for deteriorating mental health, doctors increased doses instead of stopping the drug. People already feeling bad were pushed right over the edge.

To prevent such tragedy, Morry Smulevitz, a spokesman for Eli Lilly, the company that makes Prozac and Cymbalta, said, “education is critically important.”

Chris Reid might still be alive if the drugs’ side effects were recognized for what they were, his mother, Coralie, said. The 18-year-old Seattle resident was an outgoing person – the life of the party, even – when a doctor suggested Prozac because Chris was blue over a breakup. The boy quickly grew agitated, hostile and withdrawn on the drug. He went around like he was in a different world. All are signs that something is wrong. Then, the night his sister got married and five weeks after starting Prozac, Chris took his own life by starting his car in a closed garage. His parents found him hours later. His older brother Roy, who was brain-damaged at birth, lost his best friend and helper.

The anguish is still in Coralie’s voice more than a decade later: “I gave Chris money to buy the gas.”

The Activation Syndrome

No one can say for sure, but her son might have suffered from what is probably the worst andi-depressant side effect, akathisia.

It’s an excruciating anxiety or inner agitation sometimes accompanied by outward physical restlessness. Hot-wired insanity might be a better description; it’s unlike anything most people will ever experience. The Soviets and Nazis, some say, induced it in victims as torture.

“People cannot take it and will do anything to make it stop,” said Vera Sharav, a patient safety advocate who heads the Manhattan-based Alliance for Human Research Protection.

Akathisia is at the far end of a host of side effects known as the “activation syndrome.” Mania is possible along with lesser problems like insomnia and irritability.

The key to recognizing when it’s the pill causing the problems and not underlying psychological issues is a sudden deterioration during the time when severe side effects are likely to happen: the first few weeks of treatment, the time when the dose is either increased or decreased or when the drug is stopped, said Harvard psychiatrist Dr. Joseph Glenmullen, a nationally recognized expert on andi-depressants and the author of “The Antidepressant Solution.”

The deterioration will likely show itself in restlessness or some other activation syndrome warning sign.

Jitteriness when people first start taking andi-depressants is not uncommon, but it usually passes with no problem. What Glenmullen is talking about is something more severe that doesn’t pass, but gets worse.

The deterioration often comes with a new or suddenly greater preoccupation with death and suicide.

It’s an overwhelming, impulsive, often-violent desire to escape intolerable side effects, though people will not recognize it as such.

Sometimes, victims lash out; murder-suicides have been reported. The drugs can do away with inhibitions, which is thought to play a role in such violence.

In contrast, depressed people are usually low-energy and seek to escape feelings of worthlessness and helplessness through quiet means like an overdose, Glenmullen and others explained.

“The activation syndrome is real. It causes people to act out violently,” said Dr. Stefan Kruszewski, a psychiatrist in Harrisburg, Pa., who has advised members of Congress on andi-depressant pharmacology.

Akathisia Who?

University of Washington psychiatrist Wayne Katon cautions that only a tiny fraction of people ever run into such problems.

Katon, who’s done paid work for drug companies that make andi-depressants, is worried that emphasizing side effects could turn people away from medicines that he said are – overall – so effective in adults that they have contributed to a recent drop in suicides.

Still, to be safe, he tells patients they might feel jittery, feel nauseated or get headaches. He also tells them to call him immediately if side effects become intolerable.

It’s something all doctors should do, Katon said.

However, many physicians are not fully aware of andi-depressant dangers. In fact, about 70 percent of prescriptions are written by primary care providers with no particular expertise in psychiatry.

“If you said akathisia to a group of even well-trained physicians, they might look at you with a blank stare,” said Dr. Michael Kelly, a family doctor in Lakewood and past president of the Pierce County Medical Society.

Side effects

Anti-depressant side effects that could make people suicidal:

• Akathisia (drug-induced agitation)
• Psychotic reactions (inability to tell what’s real and what isn’t)
• Mania
• Paranoia
• Disinhibition (impulsiveness, hostility, irritability)
• Panic attacks and other severe anxiety reactions
• Insomnia

M. Alexander Otto: 253-597-8616

Originally published: January 24th, 2005 12:01 AM (PST)