FDA to Prove A-D risks for Adults After Planning Warning for Kids.....

September 28, 2004

..

September 28, 2004"FDA to Probe Antidepressant Risks for Adults

After Planning Warning for Kids, Agency to

Re-Examine Evidence Suggesting No Danger

of Suicide"By ANNA WILDE MATHEWSStaff Reporter of THE WALL STREET JOURNALSeptember 28, 2004http://online.wsj.com/article_print/0,,SB109632629148029432,00.htmlAfter determining that antidepressants can pose a risk

to young people, the Food and Drug Administration is

turning its attention to the drugs' effects in adults.The FDA says it will do a study of risks to adults in light

of the evidence of a tie between the widely prescribed

drugs and suicidal tendencies in children and adolescents.That finding -- after an exhaustive re-examination of

clinical-trial data on young people -- led the agency to

say it will require a strong label warning about

antidepressants' risks for young people. Now FDA

officials will comb through the existing data on adult

clinical trials in the same detailed fashion."We learned from that," says Janet Woodcock, a

deputy commissioner of the FDA. "It's a different

way of analyzing the data." British regulators alsoare studying adult data for evidence of suicide risk.The FDA has examined the issue in adults before,

and found no increased risk of suicide.It's unclear why some drugs could increase suicidal

tendencies only in a small subset of young people,

and not in adults. One theory is that younger people

may have less control over their impulses, or less

ability to cope with or understand an unexpected

drug effect. "One hypothesis is that in some patients,

[these drugs] have a disinhibiting effect," says WayneGoodman, chairman of the FDA panel that examined

the issue in young people. "Children are already a bit

disinhibited" because their brains aren't fully developed.Many doctors believe "there is something different in

depression in children and adolescents versus adults,"

says John Mann, a professor of psychiatry at Columbia

University.Doctors say it's well-established that children and

adults don't always respond to medications in the

same way. For example, the antidepressants in wide

use today -- mostly selective serotonin reuptake

inhibitors, or SSRIs -- are effective in adults, but

most haven't been proven to work in young people.

Similarly, older antidepressants known as tricyclics,

which aren't widely used, are considered effective

for adults but not children. Moreover, tranquilizing

medicines such as Ambien and Valium are far morelikely to cause side effects such as hallucination and

agitation in children than adults.WEIGHING DIFFERENCESWhy risk of suicidal behavior with antidepressants

may be different in adults than young people. Young

people may have less impulse control, or less ability

to cope with an unexpected drug effect.. Depression in adolescents may be fundamentally

different from depression in adults.. Developmental differences between the pediatric

and adult brains may play a role.SSRIs, including Prozac, Paxil and Zoloft, act to

increase the amount of serotonin, a chemical in the

brain that affects mood. Children's serotonin

systems are more active than those in older people,

says Dr. Mann, though it isn't clear why or whether

this would make the SSRIs ineffective or createside effects. "There may be other developmental

differences" between adult and pediatric brains,

he says.The FDA has much more information available to

study about adults and antidepressants than it had

about young people. It has a database of 234

randomized trials for 20 drugs that it plans to use

in its new study, Dr. Woodcock says. For pediatric

patients, the FDA analyzed 23 pediatric drug-industry

trials, and one result from a National Institutes of

Health study.Dr. Woodcock says the agency had gone through the

adult database, in an analysis that still is being finalized,

for trends based on the number of actual suicides.As it did with the pediatric clinical trials, the agency

will examine closely the adult data in an effort to

find and characterize individual incidents that could

indicate suicidal tendencies. The agency is trying to

decide on its exact approach, such as whether the

data should be sent to outside researchers to examine.Concern among regulators and the public over the

possible downsides of antidepressants emerged in

1990, when Martin Teicher, chief of a laboratory at

McLean Hospital in Massachusetts, wrote a paper

describing six patients who experienced "intense,

violent suicidal thoughts" after taking Eli Lilly & Co.'s

Prozac.RATING BEHAVIORThe FDA had outside experts come up with classifications

to sort potentially suicide-related events that occurred

in antidepressant trials with young people. Here are some

of the categories, along with actual examples:Suicide attempt: A girl lit herself on fire. A 15-year-old

impulsively slit her wrists following a fight with her mother;

the wounds were superficial and weren't stitched.Preparatory actions toward imminent suicidal behavior:

A 16-year-old tried to hang herself and was prevented

by her family. An 11-year-old held a knife to his wrist

and threatened to harm himself. Self-injurious behavior

with no suicidal intent: A girl cut herself but denied that

she was suicidal and said it gave her a "good, weird"

feeling.Suicidal thoughts: A patient had thoughts for three

days of killing himself, but didn't take any action.Source: Kelly Posner of Columbia University, the

principal investigatorThe finding in young people "makes the association in

adults seem more credible," Dr. Teicher says today.

But in 1991, an FDA advisory committee -- after

examining the Teicher paper as well as evidence from

Eli Lilly -- concluded there was "no credible evidence"

that Prozac caused suicides.Why medications that are supposed to alleviate

depression could, in rare cases, actually have the

opposite effect remains a mystery. Dr. Teicher

wrote a summary that included several theories.

One was that the drugs could give patients more

energy before lifting their depression, enabling

them to act on a suicidal impulse. Another was

that the drugs could somehow worsen depression

in a small subset of patients. A third theory was

that the antidepressants could cause a state of

agitation and restlessness.The questions about the adult risk of Prozac and

similar drugs never completely disappeared, in

part because of litigation against the medicines'

makers brought by people charging that they or

their relatives were hurt by the drugs. David Healy,

a professor at the University of Wales in the United

Kingdom and a controversial critic of the drugs,

argued in a paper in 2003 that, analyzed in a certain

way, clinical-trial results could show a greater risk

of suicidal acts tied to antidepressants.Drug makers have questioned Dr. Healy's methodology

and said repeated studies of their clinical trials show

no evidence to back his point. Lilly's analysis of Prozac

clinical-trial results found no statistically significantconnection between the drug and suicide. Rather, it

showed a correlation between use of the drug and

fewer suicidal thoughts, when compared with placebo

pills. Separately, a 1995 paper in the Journal of

European Neuropsychopharmacology reported

"significantly fewer" new suicidal thoughts, and

fewer suicides, among patients taking Paxil compared

with those on placebos."Each time it has been looked at, there is no suggestion

of an association" with suicidal tendencies in adults,

with relation to SSRIs, says Alan Metz, North American

medical director for GlaxoSmithKline PLC, Paxil's maker.Further support for that camp came from researchers

who authored an April 2003 report in the American

Journal of Psychiatry based on their analysis of FDA

clinical-trial data. They found there was no statistical

difference in the suicide rate between patients taking

antidepressants and those taking placebo pills.Still, the FDA's findings about young people and

antidepressants puts a new spotlight on the old

questions. The agency's analysis of a series ofpediatric clinical trials -- endorsed by its committee

of outside advisers -- found that in perhaps 2% to 3%

of the time, the antidepressants appeared to raise

the risk of suicidal thoughts or actions. None of thepatients actually committed suicide.Write to Anna Wilde Mathews at

anna.mathews

URL for this article:http://online.wsj.com/article/0,,SB109632629148029432,00.htmlHyperlinks in this Article:(1) anna.mathews

This copy is for your personal, non-commercial use only.

Distribution and use of this material are governed by

our Subscriber Agreement and by copyright law. For

non-personal use or to order multiple copies, pleasecontact Dow Jones Reprints at 1-800-843-0008 or

visit www.djreprints.com

(si-r)

==========

..

September 28, 2004

Here's the problem:

Although the PRD has a form in the back for physicians to report back to the manufacturers the effectiveness of medications after they are released for the public use,

doctors aren't going to do that to protect themselves from malpractice. When I reported many side effects and withdrawal symptoms I observed in my Mother, Alma Virginia SAnders, before her suicide, the passive agressive avoidance behaiovr I exhibited was extensive. They care more about their own bank accounts than the lives of their patients. The evidence that will be examined by the FDA will not include the statistic of my Mother commiting suicide on the antidepressants because it hasn't been collected and documented. The FDA failed to protect the public in the first place and wouldn't want to admit their intentional or unintentional enabling antidepressant manufacturers to commit gegnocide against the public. Anyone that is, please excuse my language, stupid enough to believe that a drug that will cause one segment of the population, the children, to commit suicide and won't cause another segment, non-pediatric, to commit suicide needs to have their mind examined. Notice there is no talk about another more sensitive segment of the population: geriatric. When I read the PRD's test studies for the drugs that were tested before distribution that were being prescribed to my Mother before her suicide the percentage that were included in the test studies of the geriatric population were less than the % of geriatrics in the population as a whole. This is obviously to conceal the negative effects that could be caused in this sensitive population. Take into consideration that the drugs that are being tested are singularly while after ther drugs are released for the public they are prescribed in a never ending experimental combinations based on subjective observation of behavior with no objective tests to support their use in combinations not tested and approved by the FDA. Some of the drugs that my Mother was prescribed were tested for people with seizures which my Mother never had. After they were put on the market the psychiatrists decided they'd use that drug for "bipolar" when that drug was never tested by the FDA for that alleged malady. Mother was never told she was bipolar. She mentioned to me that she didn't know she'd been diagnosed as bipolar until she realized she'd been prescribed the same drug, Depakote, that had been prescribed to my sister whose behavior on the drugs is what got her so worried that she'd gone to the mental health center for counseling in dealing with her and that is how they got her onto their drugs. Depakote is especially profitable because a blood test has to be done every 3 months to evaluate them for liver failure that can still happen in 3 days without notice.

Gotta go.

Sandra Lance, D.C.

Daughter of Suicide Victim, Alma Virginia Sanders

Who Would Probably Still Be Alive Today if She'd Never been Prescribed AntiDepressants

Listen to the first two hours of my broadcasts on

Highway2Health.net for more details of how the psychiatrists

resfused to inform me of her medication changes so I'd not be alerted to the increased incidence of suicide while she was going to them every month commiting suicide not taking her cancer medication for the cancer that may have ben caused by the antidepressants after she decided not to jump off the Tennessee River Bridge.

-- Original Message -----

creativesources

Monday, September 27, 2004 11:37 PM

"FDA to Prove A-D risks for Adults After Planning Warning for Kids".....

..

September 28, 2004"FDA to Probe Antidepressant Risks for Adults

After Planning Warning for Kids, Agency to

Re-Examine Evidence Suggesting No Danger

of Suicide"By ANNA WILDE MATHEWSStaff Reporter of THE WALL STREET JOURNALSeptember 28, 2004http://online.wsj.com/article_print/0,,SB109632629148029432,00.htmlAfter determining that antidepressants can pose a risk

to young people, the Food and Drug Administration is

turning its attention to the drugs' effects in adults.The FDA says it will do a study of risks to adults in light

of the evidence of a tie between the widely prescribed

drugs and suicidal tendencies in children and adolescents.That finding -- after an exhaustive re-examination of

clinical-trial data on young people -- led the agency to

say it will require a strong label warning about

antidepressants' risks for young people. Now FDA

officials will comb through the existing data on adult

clinical trials in the same detailed fashion."We learned from that," says Janet Woodcock, a

deputy commissioner of the FDA. "It's a different

way of analyzing the data." British regulators alsoare studying adult data for evidence of suicide risk.The FDA has examined the issue in adults before,

and found no increased risk of suicide.It's unclear why some drugs could increase suicidal

tendencies only in a small subset of young people,

and not in adults. One theory is that younger people

may have less control over their impulses, or less

ability to cope with or understand an unexpected

drug effect. "One hypothesis is that in some patients,

[these drugs] have a disinhibiting effect," says WayneGoodman, chairman of the FDA panel that examined

the issue in young people. "Children are already a bit

disinhibited" because their brains aren't fully developed.Many doctors believe "there is something different in

depression in children and adolescents versus adults,"

says John Mann, a professor of psychiatry at Columbia

University.Doctors say it's well-established that children and

adults don't always respond to medications in the

same way. For example, the antidepressants in wide

use today -- mostly selective serotonin reuptake

inhibitors, or SSRIs -- are effective in adults, but

most haven't been proven to work in young people.

Similarly, older antidepressants known as tricyclics,

which aren't widely used, are considered effective

for adults but not children. Moreover, tranquilizing

medicines such as Ambien and Valium are far morelikely to cause side effects such as hallucination and

agitation in children than adults.WEIGHING DIFFERENCESWhy risk of suicidal behavior with antidepressants

may be different in adults than young people. Young

people may have less impulse control, or less ability

to cope with an unexpected drug effect.. Depression in adolescents may be fundamentally

different from depression in adults.. Developmental differences between the pediatric

and adult brains may play a role.SSRIs, including Prozac, Paxil and Zoloft, act to

increase the amount of serotonin, a chemical in the

brain that affects mood. Children's serotonin

systems are more active than those in older people,

says Dr. Mann, though it isn't clear why or whether

this would make the SSRIs ineffective or createside effects. "There may be other developmental

differences" between adult and pediatric brains,

he says.The FDA has much more information available to

study about adults and antidepressants than it had

about young people. It has a database of 234

randomized trials for 20 drugs that it plans to use

in its new study, Dr. Woodcock says. For pediatric

patients, the FDA analyzed 23 pediatric drug-industry

trials, and one result from a National Institutes of

Health study.Dr. Woodcock says the agency had gone through the

adult database, in an analysis that still is being finalized,

for trends based on the number of actual suicides.As it did with the pediatric clinical trials, the agency

will examine closely the adult data in an effort to

find and characterize individual incidents that could

indicate suicidal tendencies. The agency is trying to

decide on its exact approach, such as whether the

data should be sent to outside researchers to examine.Concern among regulators and the public over the

possible downsides of antidepressants emerged in

1990, when Martin Teicher, chief of a laboratory at

McLean Hospital in Massachusetts, wrote a paper

describing six patients who experienced "intense,

violent suicidal thoughts" after taking Eli Lilly & Co.'s

Prozac.RATING BEHAVIORThe FDA had outside experts come up with classifications

to sort potentially suicide-related events that occurred

in antidepressant trials with young people. Here are some

of the categories, along with actual examples:Suicide attempt: A girl lit herself on fire. A 15-year-old

impulsively slit her wrists following a fight with her mother;

the wounds were superficial and weren't stitched.Preparatory actions toward imminent suicidal behavior:

A 16-year-old tried to hang herself and was prevented

by her family. An 11-year-old held a knife to his wrist

and threatened to harm himself. Self-injurious behavior

with no suicidal intent: A girl cut herself but denied that

she was suicidal and said it gave her a "good, weird"

feeling.Suicidal thoughts: A patient had thoughts for three

days of killing himself, but didn't take any action.Source: Kelly Posner of Columbia University, the

principal investigatorThe finding in young people "makes the association in

adults seem more credible," Dr. Teicher says today.

But in 1991, an FDA advisory committee -- after

examining the Teicher paper as well as evidence from

Eli Lilly -- concluded there was "no credible evidence"

that Prozac caused suicides.Why medications that are supposed to alleviate

depression could, in rare cases, actually have the

opposite effect remains a mystery. Dr. Teicher

wrote a summary that included several theories.

One was that the drugs could give patients more

energy before lifting their depression, enabling

them to act on a suicidal impulse. Another was

that the drugs could somehow worsen depression

in a small subset of patients. A third theory was

that the antidepressants could cause a state of

agitation and restlessness.The questions about the adult risk of Prozac and

similar drugs never completely disappeared, in

part because of litigation against the medicines'

makers brought by people charging that they or

their relatives were hurt by the drugs. David Healy,

a professor at the University of Wales in the United

Kingdom and a controversial critic of the drugs,

argued in a paper in 2003 that, analyzed in a certain

way, clinical-trial results could show a greater risk

of suicidal acts tied to antidepressants.Drug makers have questioned Dr. Healy's methodology

and said repeated studies of their clinical trials show

no evidence to back his point. Lilly's analysis of Prozac

clinical-trial results found no statistically significantconnection between the drug and suicide. Rather, it

showed a correlation between use of the drug and

fewer suicidal thoughts, when compared with placebo

pills. Separately, a 1995 paper in the Journal of

European Neuropsychopharmacology reported

"significantly fewer" new suicidal thoughts, and

fewer suicides, among patients taking Paxil compared

with those on placebos."Each time it has been looked at, there is no suggestion

of an association" with suicidal tendencies in adults,

with relation to SSRIs, says Alan Metz, North American

medical director for GlaxoSmithKline PLC, Paxil's maker.Further support for that camp came from researchers

who authored an April 2003 report in the American

Journal of Psychiatry based on their analysis of FDA

clinical-trial data. They found there was no statistical

difference in the suicide rate between patients taking

antidepressants and those taking placebo pills.Still, the FDA's findings about young people and

antidepressants puts a new spotlight on the old

questions. The agency's analysis of a series ofpediatric clinical trials -- endorsed by its committee

of outside advisers -- found that in perhaps 2% to 3%

of the time, the antidepressants appeared to raise

the risk of suicidal thoughts or actions. None of thepatients actually committed suicide.Write to Anna Wilde Mathews at

anna.mathews

URL for this article:http://online.wsj.com/article/0,,SB109632629148029432,00.htmlHyperlinks in this Article:(1) anna.mathews

This copy is for your personal, non-commercial use only.

Distribution and use of this material are governed by

our Subscriber Agreement and by copyright law. For

non-personal use or to order multiple copies, pleasecontact Dow Jones Reprints at 1-800-843-0008 or

visit www.djreprints.com

(si-r)

==========

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