FDA Waffles Over Antidepressants Causing Suicides

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Health Supreme Update: FDA Waffles Over Antidepressants Causing

Suicides

 

September 15, 2004

 

 

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According to an article in the New York Times, officials of the

FDA are now acknowledging that antidepressants do cause

children and teenagers to become suicidal, but the FDA is not

taking the steps it should - ban the drugs for use in children,

as the UK has already done. The major preoccupation seems to be

that if antidepressants are removed or carry strong warnings,

there is nothing left to do. The article states that

" ...several speakers noted that clinicians would have almost

nothing to offer depressed teenagers and children if

antidepressants were banned. " This shows how locked in we are

on an exclusively pharmaceutical paradigm for health and

that we are on an exclusively pharmaceutical paradigm for health and

that it might be time to open up to a new view of the problem.

Nutritional approaches are not even considered, although they seem to

be eminently successful. In Canada, such an approach is being

pioneered by Truehope Nutritional Support, a group that proposes to

help sufferers with a specifically formulated nutritional supplement.

 

So foreign is this thought to health authorities that the Truehope was

raided at gunpoint and told that they may not sell their product

saying it might help sufferers of mental illness.

 

Another example of nutritional intervention on " mental illness " , in

this case ADHD, dates back to the discovery of kryptopyroles in urin.

In his book " Nutrition and Mental Illness: An Orthomolecular Approach

to Balancing Body Chemistry " , Carl C. Pfeiffer describes the symptoms

of patients with elevated urinary kryptopyroles as: " progressive loss

of ambition, decreased school grades, poor concentration, poor memory,

fatigue, hyperactivity, anxiety, depression, psychosis, migraine

headaches, diminished sexual potency, personality changes,

irritability, rages, moodiness, convulsions and uncontrolled excitement " .

 

According to a recent article in the German magazine raum & zeit,

kryptopyrroluria was documented more than a century ago. Irvine and

O'Reilly improved the methods of analysis and they found in the early

60's that kryptopyroles could be found in 11% of healthy people. The

percentage for mentally retarded children was 24%, but it increased in

psychiatric patients to 42% and in schizophrenics to 52%.

 

Apparently, the substance is harmless in itself; however, it tends to

attach itself to both B6 and zinc and to pull these substances out of

the body through the urine, causing deficiencies of both. The remedy:

supplementation with these nutrients in higher doses than generally

considered necessary.

 

One might wonder whether health authorities are so beholden to pharma

interests that they are blind to the fact that biochemical balance and

good nutrition are necessary preconditions for good health. While

these officials normally do pay lip service to nutrition, when it

comes to effectively doing something about bad health by nutritional

intervention, something kicks in that does not allow them to see the

potentially life saving effects of supplements. Could it be money or

is it just that health education has been under pharmaceutical

monopolistic control for almost a century now? I would say it might be

a combination of both.

 

Read the recent NYT article here:

 

 

September 14, 2004

F.D.A. Links Drugs to Being Suicidal

By GARDINER HARRIS

 

 

 

BETHESDA, Md., Sept. 13 - Top officials of the Food and Drug

Administration acknowledged for the first time on Monday that

antidepressants appeared to lead some children and teenagers to become

suicidal.

 

Dr. Robert Temple, director of the F.D.A.'s office of medical

policy, said after an emotional public hearing here that analyses of

15 clinical trials, some of which were hidden for years from the

public by the drug companies that sponsored them, showed a consistent

link with suicidal behavior.

 

" I think that we now all believe that there is an increase in

suicidal thinking and action that is consistent across all the

drugs,'' Dr. Temple said, summarizing the agency's presentation to a

special advisory committee. " This looks like it's a true bill.''

 

The acknowledgement, made after the hearing, comes a year after

the agency suppressed the conclusions of its own drug-safety analyst,

Dr. Andrew Mosholder, who first found a link between the drugs and

suicide in teenagers and children. Agency officials wrote in internal

memorandums that Dr. Mosholder's analysis was unreliable, and they

hired researchers at Columbia University to re-analyze the same data.

That study recently reached conclusions nearly identical to Dr.

Mosholder's.

 

The testimony came before an advisory committee of 31 independent

experts that the F.D.A. has charged with making a recommendation about

the labeling and use of antidepressants in children and teenagers.

 

Family members of suicide victims at the hearing angrily

denounced agency officials for the delay in admitting the risk of

antidepressants in children. The British health authorities decided in

December to ban the use of most antidepressants in children and teenagers.

 

Mathy Milling Downing of Laytonsville, Md., whose 12-year-old

daughter hanged herself in January, said: " Candace's death was

entirely avoidable had we been given the appropriate warnings. " The

blood of these children is on your hands.''

 

Agency officials said that they had no regrets about the months

of study. " I don't think the data were at that time reliable,'' Dr.

Temple said. " Scaring people needlessly " or overdoing a warning is

worrisome, he added.

 

The most popular pills are Zoloft, made by Pfizer; Paxil, made by

GlaxoSmithKline; and Prozac, made by Eli Lilly & Company. In 2002,

nearly 11 million children and teenagers were prescribed antidepressants.

 

The risk of suicide among patients given the pills is very small.

If 100 children and teenagers are given antidepressants, 2 or 3 will

become suicidal who otherwise would not have had they been given

placebos, agency officials said. None of the children in the trials

committed suicide, but some thought about or attempted suicide,

researchers found.

 

In March, the agency required antidepressant manufacturers to

include on labels a warning that therapy with antidepressants could

lead some patients, both adults and children, to become suicidal. The

committee must decide whether this warning is strong enough or whether

the drugs should be banned for children. The advisory committee is

expected to make a decision on Tuesday. The F.D.A. normally follows

recommendations of its advisory committees.

 

It is a complex task. Most studies of the drugs have failed to

show that they have any effect on depression in children and

teenagers. But the drugs have proven effective in adults, and studies

suggest that teenage suicide rates have dropped in countries where use

of antidepressants is widespread. A large study of depressed teenagers

conducted by the National Institute of Mental Health recently found

that Prozac was far more effective in treating depression in children

and teenagers than was talk therapy.

 

Several speakers noted that clinicians would have almost nothing

to offer depressed teenagers and children if antidepressants were

banned. Suicide is the third leading cause of death among teenagers,

trailing only homicide and accidents. Without treatment, many more

teenagers will die, several experts said. If the committee suggests an

even stronger warning, some patients will resist therapy and could

perhaps die, some speakers said.

 

The issue has roiled the agency and is likely to transform the

way the drug industry markets its products. Committees in both the

House and Senate have begun investigations following disclosures that

Dr. Mosholder's analysis had been suppressed.

 

The New York State attorney general Eliot Spitzer, filed suit

against GlaxoSmithKline, charging the drug maker with fraud for

failing to disclose the results of clinical trials of Paxil that found

no benefit while promoting the drug to physicians. The company settled

the suit this summer by promising to disclose the results of all of

its clinical trials of its marketed products dating back to 2000.

 

Editors of the nation's top medical journals have said they will

not to accept for publication trials that have not been publicly

registered, and legislation is expected to be offered in both the

House and the Senate requiring the disclosure of the results of all

major drug tests on humans.

 

For some bereaved parents, Monday's hearing was a chance to take

drug makers and the F.D.A. to task.

 

Mark and Cheryl Miller of Overland Park, Kan.,, told the

committee that their 13-year-old son, Matthew, had committed suicide

seven months ago while taking Zoloft.

 

" Why haven't parents like Cheryl and myself and countless others

been told the truth?'' Mr. Miller asked.

 

But others said that antidepressants had helped millions. Dr.

Suzanne Vogel-Sibilia of Beaver, Pa., said that she had brought her

15-year-old son, Tony, to the hearing to represent what she said were

the vast majority of patients who had been helped by the drugs.

 

" Please help me preserve my future, " Tony told the committee.

" Don't take away my medication. "

 

Claims that antidepressants cause patients to become acutely

suicidal have been made since 1991, just three years after Prozac was

introduced. But drug makers and regulators long dismissed these

claims, saying they were anecdotal reports without any basis in

rigorous clinical trials.

 

Then last year, GlaxoSmithKline announced that tests of Paxil had

found that teenagers and children who took the pill were more likely

to become suicidal than those given placebos. The announcement was

quickly followed by a similar one from Wyeth, the maker of Effexor,

another antidepressant. Suddenly, the anecdotal reports were being

confirmed by clinical trials.

 

Still, just how the drugs may lead some people to become suicidal

remains the subject of fierce debate. Many of those at the hearing

said that the pills had brought a change in the personalities of their

friends and relatives. Alice Erber said that Paxil caused her

21-year-old son, Jake Steinberg, to throw himself in June from the

24th floor of a Manhattan office building.

 

" If he had not taken Paxil, he would be alive today,'' Ms. Erber

said.

 

But Dr. Temple speculated that some people taking the pills

become suicidal because they are actually getting better. As their

depression improves, he said, they gain the energy to act on suicidal

thoughts that their illness had suppressed.

 

" I think the work is cut out for us tomorrow,'' Dr. Wayne

Goodman, chairman of the advisory committee, said at the end of

Monday's hearing.

 

See also related articles:

 

Paxil, Zoloft, Xantax - Drug Induced Violence

 

FDA Covers Up Report - Mosholder: 'Antidepressants Double Suicides in

Children'

 

Kruszewski: Fired 'For Digging Up Dirt' Psychiatrist Sues Employers,

Pharma Companies

 

Pharma Promotion Dishonest - Slanted Reporting of Paxil, Prozac Studies

 

Bush To Impose Psychiatric Drug Regime

 

Investigator Exposes Pharma Corruption - Loses Job

 

US: Bankrupt Health System Persecutes Alternatives

 

Health Canada: Causing Deaths by Withholding Information on Drug Dangers

 

Pharma makers withhold suicide data in drug studies

 

Drugs do not work - in most cases

 

Drugs and Doctors May be the Leading Cause of Death in U.S.

 

Report Says 195,000 Deaths Due to Hospital Error