FDA Warns that Paxil Makes Depressed Adults Suicidal

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Dr. Peter Breggin

 

05.21.2006

FDA Warns that Paxil Makes Depressed Adults Suicidal

 

 

 

Getting the FDA to move forward by presenting it with scientific data

is like using a peacock feather to tickle a sleeping giant tortoise on

its shell. Many people die before the agency opens its eyes and then

it barely reacts at all.

 

Bloated with conflicts of interest, under the best of conditions the

FDA is barely able to drag itself along the ground.

Slowly, oh, so slowly, it inches its way toward the obvious conclusion

it can never quite reach: Antidepressants cause suicide; therefore,

they aren't antidepressants at all. These drugs don't cure

depression--and they frequently cause or worsen it. Regarding the most

dreadful risk of depression, suicide, so-called antidepressants put

depressed people of all ages at much greater risk of killing themselves.

 

The FDA Confirms Antidepressant-Induced Suicidality in Adults

 

So, after years of prodding by me and more lately by a handful of

other professionals, what new point in its journey has the FDA

tortoise reached? In a May 2006 release in collaboration with the

manufacturer GlaxoSmithKline (GSK), the FDA has acknowledged the

antidepressant Paxil causes a statistically significant increased rate

of suicidality in depressed adults as measured in controlled clinical

trials (1). The results are based on a re-analysis of all adult

controlled clinical trials that compared Paxil with placebo.

 

Buried in the FDA/GSK release is an astounding fact: Depressed people

are 6.4 times more likely to become suicidal while taking an

antidepressant than while taking a sugar pill (2).

 

No other antidepressants were mentioned in the FDA's warning but all

SSRI antidepressants share a common profile of adverse mental and

behavioral effects, including Paxil, Prozac, Zoloft, Celexa, Luvox,

and Lexapro. Several other relatively new antidepressants have also

been implicated in producing similar psychiatric abnormalities,

including Wellbutrin, Effexor, Serzone, and Cymbalta. All of the newer

antidepressants can produce stimulation or activation with the

potential for increased agitation, anxiety, mood instability,

disinhibition, irritability, aggression, hostility, mania, and

crashing into depression and suicide. They can also cause a flattening

of emotional responses, including a loss of caring, that can unleash

dangerous actions (3, 4).

 

It is hard to cheer the FDA when in books and scientific reports, I've

been warning about the risk of antidepressant-induced suicide (and

violence) for fifteen years, starting in1991 with Toxic Psychiatry. My

most comprehensive scientific review of the subject was published in

2003 (4). In more recent years, other professionals have also joined

the fray, especially Harvard psychiatrist Joseph Glenmullen.

Scientific reviews confirmed that antidepressants cause suicidality in

children and adults (5), but the FDA delayed acting on mounting

evidence. To this day, the agency waffles about the importance of the

antidepressant suicide risk. Thus far it has focused only on Paxil in

regard to adult suicide and it has hinted that the risk may be slight

when it is catastrophic. It also continues to avoid facing evidence

that the drugs cause violence.

 

A few weeks before the FDA and GSK published their recent admission

that Paxil can make adults more suicidal, I published a special report

in Ethical Human Psychology and Psychiatry in which I released

previously suppressed data indicating that GSK had manipulated its

research results to hide the risk of Paxil-induced suicidality (6)

(available on www.breggin.com; also see previous blog). I based my

observations on suppressed company data that I had discovered during a

three-day investigation inside the drug company's secret files,

working as a medical expert in a murder-suicide product liability case

against the company. Simultaneously, I published on my website the

original product liability report with all the scientific data that I

had unearthed during those three days. More than a year earlier, I had

informed the FDA at two of its public hearings that I possessed this

sealed smoking gun. They never responded to me directly. Perhaps they

are responding to me now.

 

The Struggle to Enlighten the Public, the Profession and the FDA

 

Beginning with the widespread use of Prozac in the early 1990s, the

struggle to gain public and professional recognition of

antidepressant-induced suicide and violence has a long and stormy

history. Drug advocates accused critics of Prozac of taking away a

" lifesaving " treatment from depressed patients. Ironically, these same

drug advocates would never be able prove that Prozac or any other

antidepressant can reduce the suicide rate; but the evidence has

mounted, ultimately proving that these drugs can increase suicide and

violence.

 

The struggle peaked in 1994 when I testified against Eli Lilly in a

case of Prozac-induced suicide and mass murder. My testimony, in

effect, was that the perpetrator, Joseph Wesbecker, hadn't gone

" postal, " he'd gone " Prozacal. " After the drug company won a split

jury decision, the judge realized that the trial had been fixed. The

plaintiffs had been paid off by the drug company to conduct a fake

trial that was rigged to end in favor of the drug company. The

outraged judge voided the verdict. I have documented these events,

including the judge's conclusions, in numerous sources including

Brain-Disabling Treatments in Psychiatry (Springer, 1997).

 

The Prozac-soaked media simply ignored this bombshell. There were no

headlines, " Drug Company Fakes Trial; Data Reveals that Prozac Causes

Suicide and Violence. " If either the media or the FDA had examined the

data I generated for that legal case, followed by the fixing of the

trial, it might not have taken twelve more years for the government

and GSK to acknowledge that Paxil causes suicidality in children and

adults. Meanwhile, the FDA and the antidepressant manufacturers

continue to deny that the drugs also cause violence. Because of this

delay, many lives continue to come to tragic ends because of this delay.

 

Continued Obfuscation

 

The FDA and GSK continue to obfuscate the true risk in their May 2006

announcement concerning Paxil-induced suicidality in depressed adults.

They emphasize the supposedly slight increase in suicidality among

young adults (through age thirty) who take Paxil for a variety of

conditions, including for depression, panic attacks, anxiety and

obsessive-compulsive disorder. Far more important is the statistically

significant increase in suicidality in all ages of depressed adults.

It's worth restating that depressed people getting Paxil were 6.4

times more likely to display suicidal thoughts and behavior than

depressed people taking a sugar pill. In regard to suicide--the most

devastating risk associated with antidepressants--it is safer for

depressed persons to stay off the drug!

 

The FDA allowed the Paxil manufacturer to soft pedal the results by

claiming, for example, that the results could be compounded by the

fact that suicide is an aspect of " psychiatric illnesses. " This is

nonsense--and every scientist knows it. Since both groups were

depressed, and since they differed only in the substances they were

given to take, Paxil and not depression was the cause of this

astronomical increase in suicidality.

 

If depression had caused the increased suicidality, then the placebo

patients--who lacked the supposed benefit of an antidepressant

effect--would have suffered a much higher rate of suicidality than the

Paxil patients. Instead, they had a much lower rate. In other words,

because the antidepressants were supposed to be helping the depressed

patients, the relative ineffectiveness of the sugar pill should led to

more suicidality than the drug, not less. The FDA, the drug company,

and the media ignored this important fact. Conventional assumptions

would have predicted increased suicidality on placebo instead of

increased suicidality on Paxil. It's a complete reversal of the

expected outcome, underscoring the seriousness of finding increased

suicidality on the drug.

 

The Real-Life Risk Is Much Greater than Describe

 

It's nothing short of a miracle that GSK-sponsored clinical trials

have demonstrated the increased risk of suicidality from

antidepressants. If not a miracle, it's a confirmation that the risk

is enormous--far more so than indicated by the studies. Keep in mind

that controlled clinical trials are planned by the drug companies,

supervised by the drug companies, and carried out by paid lackeys of

the drug companies. Keep in mind that all the data analysis is done at

drug company headquarters by drug company execs. Keep in mind that the

trials are constructed in order to prove the usefulness of the drug

and to minimize its adverse effects such as suicidality. Keep in mind

that the controlled clinical trials are very short, usually 4-6 weeks

long, and that prescreening excludes suicidal and psychotic patients

from participating in the studies.

 

In real-life medical practice, the rate of drug-induced suicidality

will be much higher than in the research-oriented controlled clinical

trials. In actual practice, many patients are already suicidal when

they are started on the drug, increasingly the likelihood that the

drug will push them over into self-injurious behavior. In actual

practice, compared to controlled clinical trials used for research,

busy doctors provide much less supervision or monitoring, the patients

are almost never tested or evaluated for suicidality, multiple drugs

are often given at once, and the doctors know little about looking for

adverse effects on the mind.

 

If Paxil increased the rate of suicidality by more than six times in

the drug company's controlled clinical trials, it may be doing so by

sixty times in actual practice. We can't determine exactly how much

greater the risk will be in clinical practice but it will be

astronomically greater.

 

And the Antidepressants Don't Even Work

 

Meanwhile, a comprehensive review of all studies of antidepressant

drugs submitted for approval to the FDA showed that when the studies

are taken as a whole, antidepressants don't work (7). A drug company

may perform twenty studies in an attempt to show efficacy. Exemplified

by the case of Prozac, as I described in Talking Back to Prozac

(1994), as long as two studies show a positive effective, the FDA will

approve the drug. If a drug company cannot massage their

self-generated data sufficiently to obtain a positive result in two

out of twenty clinical trials, the company's paid consultants and

employees don't deserve to stay employed. And of course, they won't

stay employed if they fail to meet the company's needs to promote new

products.

 

Of course, many people feel helped by antidepressants, as well as many

other psychiatric and even recreational drugs. The placebo effect is

enormous. In addition, the artificial euphoria or emotional flattening

produced at times by antidepressants may provide temporary relief at

the cost of rationality and effective dealing with life.

 

It's time to say again what I've been saying for too many years on

end. The antidepressants aren't antidepressants. They are more likely

to make a person worse than better. More tragically, these toxic

agents push may people over the brink into suicide and violence.

 

It's astonishing as I approach my 70th birthday that the FDA is

beginning to catch up with what I've been saying for decades in regard

to the limits of drugging children and adults to control their

emotions and behavior. It's gratifying but also a little frustrating.

No, I don't have a biochemical imbalance, I am outraged that my

profession has consistently tried to foist off self-serving mythology

as science and that so many people have been damaged or killed by the

effects of the false biochemical diagnoses and toxic medications.

 

Meanwhile, the antidepressants are very difficult to stop taking.

Withdrawal from antidepressants can lead to " crashing, " with

agitation, violence and suicide. Withdrawal from these noxious drugs

should be done slowly with experienced clinical supervision. These

drugs are not only unsafe to start--they are dangerous to stop.

 

The best approach to antidepressants: Don't start taking them.

 

Endnotes:

 

1. Dear Healthcare Professional: Important Prescribing Information

[for Paxil]. By John E. Kraus, M.D., GlaxoSmithKline, Philadelphia,

Pennsylvania, May 2006. Available on www.fda.gov.

 

2. Among depressed adults taking Paxil, 0.32% displayed suicidal

thoughts or behaviors compared to 0.05% among depressed adults taking

placebo.

 

3. Breggin, P. (2006). Recent regulatory changes in antidepressant

labels: Implications for activation (stimulation) in clinical

practice. Primary Psychiatry, 13, 57-60. Available on www.breggin.com.

 

4. Breggin, P. (2003). Suicidality, violence and mania caused by

selective serotonin reuptake inhibitors (SSRIs): A review and

analysis. " Ethical Human Sciences and Services 5:225-246.

Simultaneously published in the International Journal of Risk and

Safety in Medicine, 16, 31-49, 2003/2004. Available on www.breggin.com.

 

5. For a review of increased suicidality in adults taking Paxil, see:

Aursnes, I., Tvete, I., Gassemyr, J., and Natvig, B. (2005). Suicide

attempts in clinical trials with paroxetine randomised against

placebo. BMC Medicine, 3:14. For suicidality in children, see: Jick,

S., Dean, A., and Jick. H. (1995). Antidepressants and suicide.

British Medical Journal, 310, 215-218.

 

6. . Breggin, P. (2006). Court filing makes public my previously

suppressed analysis of Paxil's effects. Ethical Human Psychology and

Psychiatry, 8, 77-84. Available on www.breggin.com.

 

7. For the review demonstrating lack of efficacy in antidepressant

studies conducted for FDA approval, see: Antonuccio, D., Burns, D.,

and Danton, W. (2002). Antidepressants: A triumph of marketing over

science? Prevention & Treatment, 5, Article 25, 1-17. For a study of

the lack of efficacy demonstrated by Prozac studies submitted to the

FDA, see Breggin, P. and Breggin, G., Talking Back to Prozac, New

York: St. Martin's Press, 1994.