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Justinian Lane

What color is this box?

Walter at Overlawyered reports that there’s no such thing as a “black box” warning:

About that FDA "black box"

Per Dr. Matthew Mintz: "There is no such thing as a 'Black Box', it is a boxed warning. The 'black' is something scary the media added". More here.

Posted by Walter Olson

Source: PointofLaw.com | PointOfLaw Forum: About that FDA "black box"

Perhaps I’m just color blind.  What color is this box?

bbox

Justinian Lane: Author Bio | Other Posts
Posted at 1:47 PM, Jul 27, 2008 in FDA
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Comments

What is the legal point of this question?

The content of the warning is wrong. It was put in after bullying of the FDA Psychopharmacology Committee by witnesses organized and brought by the Church of Scientology.

As a result of this warning, pediatricians got deterred from treating adolescent depression. That drop in anti-depressant prescriptions result in an increase of suicide in this age group by the hundreds. This warning killed hundreds of young people with a treatable illness.

As the lawyer is responsible for the high murder rate by his criminal clients, so now is he responsible for the increasing suicide rate, in furtherance of the Scientology agenda.

Posted by: Supremacy Claus | July 27, 2008 3:16 PM

After the SSRI black box warnings came out, teen suicide rates increased. Therefore, the black box warnings caused the increased suicides. Sounds like a classic post hoc fallacy to me.

Posted by: Justinian Lane | July 27, 2008 3:33 PM

Although the criminal cult enterprise makes all policy decisions, it knows nothing about the subjects it controls. This is true in all technical fields. It runs utilities, industries, technology. Yet the lawyer knows only about taking its plunder, its fee and holding on to power, not because of any competence, just at the point of a gun.

The suicide rate followed a drop in the prescribing of anti-depressant solely by general practitioners, pediatricians. Psychiatrists had no drop in prescribing anti-depressants. They ignored this bogus, irresponsible warning. If any doctor gets sued after the suicide of a patient taken off anti-depressants, the doctor should file cross-claims against the FDA, the members of the Committee, every bullying witness, and the Church of Scientology. The doctor should file a federal tort claim against every policy lawyer at FDA and at HHS. This would not be a frivolous lawsuit. It would be to pierce the unjust and unconstitutional self-dealt immunity of the criminal cult enterprise.

I have to think about whether the doctor should file a cross claim against every pro-lawyer, anti-clinical care blogger. They would have acted as self-appointed, but incompetent guideline makers, but their republication of this irresponsible warning, and by endorsing it.

Justinian, they will not teach you this in Torts. Guideline makers have an affirmative duty to do no harm, even if they had no involvement in the actual harm.

Posted by: Supremacy Claus | July 27, 2008 4:07 PM

The rise in adolescent suicides preceded the decrease in prescribing of antidepressants. However, it does track the increased use of antipsychotics and anticonvulsants/mood stabilizers for bipolar disorder in this same age group.

In fact the FDA recently had an advisory committee meeting about a doubling fo the suicide rate with anticonvulsants. However, it was conducted by the Neurology advisory committee and they felt special warnings were not needed for seizure disorders. Unfortunately this lack of warning carries over to bipolar disorder where part of the justification for treating children off-label is so as to prevent suicide.

This is a lawsuit waiting to happen.

With regards to advisory committees I have personal knowledge of FDA colluding with AC members to swing votes in order to favor drug companies.

Signed.

Clinical Researcher

Posted by: Anonymous | July 27, 2008 10:30 PM

The rise in adolescent suicides preceded the decrease in prescribing of antidepressants. However, it does track the increased use of antipsychotics and anticonvulsants/mood stabilizers for bipolar disorder in this same age group.

In fact the FDA recently had an advisory committee meeting about a doubling fo the suicide rate with anticonvulsants. However, it was conducted by the Neurology advisory committee and they felt special warnings were not needed for seizure disorders. Unfortunately this lack of warning carries over to bipolar disorder where part of the justification for treating children off-label is so as to prevent suicide.

This is a lawsuit waiting to happen.

With regards to advisory committees I have personal knowledge of FDA colluding with AC members to swing votes in order to favor drug companies.

Signed.

Clinical Researcher

Posted by: Anonymous | July 27, 2008 10:32 PM

Anonymous should have the honesty to indicate whether he is affiliated with Scientology or a plaintiff attorney, in any way.

The post is biased and misleading. The reported number of suicides on these anti-convulsants is lower than expected in any large group of epileptic patients or mood disorder patients. If millions of people are taking a medication. One expects around 1 in 10,000 to die by suicide each year. In such patients the risk is over 10 times higher than in the general population. There should be 1000's, if not 10's or 100's of 1000's, over 70 years of use, if the risk were elevated instead of suppressed.

The reported events were ridiculous. If you smacked your forehead because you could have had a V8, you got reported as injuring yourself.

The FDA repeated the mistake it made with the anti-depressant warning. More doctors will get deterred, more patients will needlessly die by suicide.

Justinian, you are really gathering flies here, with your garbage.

Posted by: Supremacy Claus | July 28, 2008 12:14 AM

MAXIDEX WARNING

I had eye surgery and in the post-op pack was MAXIDEX(dexamethasone) drops by ALCON LABS.

Two days later I was BLIND

Use Google and enter EPOCRATES MAXIDEX to verify

Posted by: WEL | August 7, 2008 5:58 PM

The box is white. It's not even 10% gray. A black box would be more visible, because it would be entirely black with reverse-white text, as in many automobile manuals. Dr. Mintz accurately describes the text as a boxed warning.

Posted by: Ted | August 7, 2008 6:34 PM