FDA Told Analyst To Withhold Information On Antidepressants, Then Cover Up

[hatrack]

A Food and Drug Administration medical officer was told by top agency officials to delete material on the risks of antidepressant drugs from records he was submitting to Congress and then to conceal the deletions, according to documents released yesterday at a hearing on Capitol Hill.

A bipartisan House panel said the FDA also repeatedly prevented Andrew D. Mosholder from disclosing his conclusions that the medications increase the risk of suicidal thoughts and behavior among children, potentially delaying the issuance of a public warning. During the day-long hearing, legislators repeatedly accused the agency of obfuscating the risks, slowing action and subjecting Mosholder to harassment.

The disclosures added a new dimension to a year-old controversy over the use of antidepressant drugs in children, which led a government advisory panel to recommend last week that the FDA require a strongly worded "black box" warning on the medications. While depression itself is known to increase the risk of suicidal behavior, two FDA analyses, including one by Mosholder, have concluded that the drugs may double the risk of suicide among some children.

After revelations that Mosholder was asked not to present his findings at a public forum in February led to an outcry, the agency's internal investigative arm told Mosholder he might be subject to disciplinary action, the documents showed. He was asked whether he had leaked his findings to the news media and denied doing so. He then prepared a sworn statement about his findings and stated that he had been targeted by the internal inquiry. When investigators working for Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) sought a copy of his records, Donna Katz of the FDA's Office of Chief Counsel urged him to delete material from the statement and submit a cleaned-up version."

EDIT

http://www.washingtonpost.com/wp-dyn/articles/A45643-2004Sep23.html

[Warpy]

1. Psychiatrists have always know about the risk of suicide

with antidepressants, and that isn't restricted to the new class of antidepressants. That's why they were only given out under strict supervision until insurance companies got into the act and tried to Walmartize medicine for the working class, and ended the expensive supervision.

The problem is that a severely depressed patient who is not being monitored will begin to feel increased energy before the pain has lifted. With severe pain and increased energy, suicide that wasn't possible in the profoundly depressed person becomes possible and even attractive. The pills haven't relieved the pain yet, an no depressed person really believes they will, yet he's been given enough energy to do the one thing he knows will end the pain.

Handing a clinically depressed person a bottle of pills with six refills is not only unconscionably negligent, it's downright dangerous. It's high time somebody figured that out, and it's a problem with all antidepressant drugs, not just the current medical whipping boys.

[HysteryDiagnosis]

2. Look..... it's as simple as this.....

>>The disclosures added a new dimension to a year-old controversy over the use of antidepressant drugs in children, which led a government advisory panel to recommend last week that the FDA require a strongly worded "black box" warning on the medications. While depression itself is known to increase the risk of suicidal behavior, two FDA analyses, including one by Mosholder, have concluded that the drugs may double the risk of suicide among some children.<<

FDA stands for "fatal drugs allowed". This article proves that.

There is a fat... a commonly occurring fat that is key to maintaining proper brain health, function, neurotransmission etc. In the orient they get plenty of this fat due to the seafood diet... (however that is becoming someting of an issue due to heavy metals) in fact... Japanese women have on average 6 times the amount of DHA in their breastmilk than do American women.

This is the National Institutes of Health search page.... go there
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed
and enter DHA depression in the search window and these papers will come up. Enough of this crap of putting kids on psychoactive drugs. The rampant stupidity of America's healthcare system is that they try to replace nutrients that are key to maintaining nervous system health, circulatory health and the like with synthetic chemicals. Their schooling was greatly lacking...

1: Naliwaiko K, Araujo RL, da Fonseca RV, Castilho JC, Andreatini R, Bellissimo MI, Oliveira BH, Martins EF, Curi R, Fernandes LC, Ferraz AC. Related Articles, Links
Abstract Effects of fish oil on the central nervous system: a new potential antidepressant?
Nutr Neurosci. 2004 Apr;7(2):91-9.
PMID: 15279495
2: Kidd PM. Related Articles, Links
Free Full Text Bipolar disorder and cell membrane dysfunction. Progress toward integrative management.
Altern Med Rev. 2004 Jun;9(2):107-35.
PMID: 15253674
3: De Vriese SR, Christophe AB, Maes M. Related Articles, Links
Abstract In humans, the seasonal variation in poly-unsaturated fatty acids is related to the seasonal variation in violent suicide and serotonergic markers of violent suicide.
Prostaglandins Leukot Essent Fatty Acids. 2004 Jul;71(1):13-8.
PMID: 15172679
4: Frasure-Smith N, Lesperance F, Julien P. Related Articles, Links
Abstract Major depression is associated with lower omega-3 fatty acid levels in patients with recent acute coronary syndromes.
Biol Psychiatry. 2004 May 1;55(9):891-6.
PMID: 15110732
5: Covault J, Pettinati H, Moak D, Mueller T, Kranzler HR. Related Articles, Links
Abstract Association of a long-chain fatty acid-CoA ligase 4 gene polymorphism with depression and with enhanced niacin-induced dermal erythema.
Am J Med Genet. 2004 May 15;127B(1):42-7.
PMID: 15108178

For up to date warnings on the effects of various medications especially psychoactive ones.... visit

www.drugawareness.org www.drugawareness.org www.drugawareness.org www.drugawareness.org www.drugawareness.org www.drugawareness.org www.drugawareness.org www.drugawareness.org

Excellent excellent excellent resource for protecting you and your family.

[Heyo]

3. I am wondering...

... why are they putting so many young children on SSRI's? Why were most kids just fine before these drugs came along? Now that we have the drugs, we have the diseases to go with them. Shouldn't that happen the other way around?

I think parents are doping up their kids just for being kids. Maybe they are too lazy to do some real actual parenting.

I would not knock someone with a serious disorder. But.. bipolar?.. okay.. you're happy some of the time, and sad some of the time. That sounds like NORMAL LIFE to me. It's just a continuum how for people go on each end of the spectrum. Maybe if you go to the extremes you are a true bipolar. But the notion of what is considered a candidtate for it keeps getting pushed more and more towards what normal people are SUPPOSED to experience. (Can't be happy ALL the time folks.)

I would bet that of all the people taking psychotropic drugs, about 5% actually need them.

The drug companies just try to convinve people that aspects of what is just real LIFE is a disease that needs to be cured, and they are destroying untold numbers of human minds in the process. SSRI's are heavier drugs than people realize, they may cure some depression and maybe a little anxiety, but they do a lot of other things, too, many of which are not good. They are the "bull in a china shop" in your brain. They are not very polite in there.

Heyo

[Warpy]

4. Kids can be clinically depressed

They've seen it in children as young as five. Just because you think they're just being a different type of kid is no reason to leave them in pain.

However, drugging them up with no followup is dangerously negligent. These kids need frequent talking therapy, if not hospitalization, and this is what the insurance industry is simply not willing to pay for.

Mental health is the most neglected branch of insurance driven medicine. The insurance companies do a great job on anything that can be cut out or cured with two weeks of antibiotics. When it comes to any chronic problem, they fail miserably, and depression is generally a chronic and recurrent problem.

[Heyo]

6. "Kids can be clinically depressed"

Sure they can.

But I am not at all optimistic with regard to the percent of the kids on drugs that ARE actually depressed.

Heyo

[Maeve]

5. Most kids were fine (still are) BUT....

Lots of them weren't (aren't). Too many times serious problems were glossed over with "It's just a phase" --the last phase the kid would go thru, unfortunately. Serious depression, suicidal tendencies, extreme mood swings due to chemical imbalances are all far too real even in the young.

Not to disagree entirely, however. Too many kids are getting treated for the wrong reasons.And some parents want a magic bullet that will make a kid we used to call "rambunctious" docile. We expect active kids to shut up and sit down, take away recess time that might have burned up that excess energy, push them to achieve faster, sooner, more...

[NNadir]

7. It is outrageous to conceal data in all circumstances. That said...

...some people have told me that SSRI's and other drugs helped them.

I tend to be highly suspicious of mind altering drugs, legal and otherwise. Still, as someone who once lived with a person who committed suicide (schizophrenia), I wish that there was some medical intervention that might have helped.

I can say that drugs are often used inappropriately and without much thought on the part of both doctors and patients. I was under huge pressure from the school and others to put my kid on Ritalin, pressure I sucessfully resisted. Fortunately I am educated enough in medicinal chemistry to understand that this was not an appropriate course of action. (My boy's problem is that he's dyslexic, but New Jersey doesn't recognize dyslexia as a syndrome.)

But let's face it, we live in a culture than favors quick band aid solutions rather than difficult, but possibly much better in the long term, solutions. This is not someone else's fault. We all bear responsibility.