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Justinian Lane

Still think preemption is a good idea?

The major premise of preemption is that lay juries shouldn't "second guess" the experts at the FDA.  The phrase "second guess" implies that juries are looking at the same information the FDA did.  Unfortunately, that's often not the case.  In many instances, pharmaceuticals submit incorrect or incomplete information to the FDA.  Only during product liability lawsuits does the correct & complete information get revealed. 

One scary example of a pharmaceutical hiding and obfuscating data is Paxil.  GlaxoSmithKline determined that Paxil wasn't effective at treating depression in adolescents and increased the risk of suicides among adolescents.  So they tweaked the results of the study until they claimed that the drug was both safe and effective.  Alison Bass, a reporter at the Boston Globe has written a book about GSK's antics.  Here's an excerpt of an interview with her by Pharmalot:

Pharmalot: What was the most surprising info you came across while researching the book?
Bass: What I found most surprising was they doctored the research on the Paxil study. When I looked back at memos I received from the Institutional Review Board from Brown, teenagers were withdrawn from the study and called non-complaint when they were in suicidal as a result from Paxil and should’ve been counted in the study as adverse effects. If these had been appropriately coded, there would have been an even greater risk of suicidal effects from Paxil. That was really amazing. There were many indications this Paxil study, it was called study 329, was doctored. But because it was published in a prestigious medical journal, Journal of the American Academy of Child & Adolescent Psychiatry in 2001, doctors paid attention.

Pharmalot: In reading the book, you don’t get much of Glaxo’s voice. Did the company not cooperate?
Bass: They didn’t respond to my requests. I spoke with Wick (Joseph Sollers, an attorney with King & Spalding, which represented Glaxo) on the phone a few times. I asked if I could interview some of their top officials, but they wouldn’t grant the requests. I did speak with the spokeswoman several times, as you could tell. But there were a lot of unseen documents from lawsuits. That’s how I got the smoking gun memo saying not to publish negative studies.

Source:Paxil And A Drugmaker On Trial: Alison Explains // Pharmalot

The already-overburdened FDA lacks the manpower and the willpower to fully investigate the results of pharmaceutical trials; personal injury attorneys don't.  If FDA preemption becomes the law of the land, pharmaceuticals will be emboldened to hide or misrepresent data because the odds of being caught will drastically decrease.  Unless and until we change the drug approval process so the FDA conducts studies, unethical pharmaceutical executives will always have the ability to distort test results in order to win FDA approval. 

Justinian Lane: Author Bio | Other Posts
Posted at 2:07 PM, Jun 17, 2008 in Preemption
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Comments

Hi Justinian - As you may have noticed, there has been a great deal of discussion of preemption on Pharmalot over the past few months.

For those interested, just put "preemption" in their search engine.

Posted by: Henry Greenspan | June 17, 2008 5:50 PM

Where is the evidence anti-depressants cause suicidal ideas?

Were there any serious self-injuries in the study?

This type of bogus lawyer and left wing ideologue gotcha has caused all severe and dangerous patients to get excluded from anti-depressant studies. The patients that need them the most, that respond to placebo the least, that respond to anti-depressants the best are being excluded systematically to prevent lawyer and irresponsible left wing government regulator gotcha.

If a family has lost a young person to suicide, thank the lawyer who has deterred the sole proven method of suicide prevention, adequate treatment of the underlying disorder causing suicide ideas.

This posting is misleading, irresponsible lawyer, pretextual garbage gotcha. At some point, patients who have suffered the indirect mass murder of loved ones at the hands of these cult criminals decide they have had enough, and bring accountability to the doors of the cult criminals.

Posted by: Supremacy Claus | June 17, 2008 9:27 PM


Are you serious??? The evidence of antidepressant-induced suicidal AND homicidal thoughts is everywhere - medical research for many years, package inserts for the drugs, anecdotal evidence (all the suicides - like the missing arms and legs of the babies born to the moms who took Thalidomide - the reason drugs get pulled from the market), etc. Even the head of NIMH said they work like Ketamine, a sister drug to PCP! There is research comparing antidepressant reactions to LSD as well.

How can the world be so completely oblivious to this still?!! I have spent almost 20 years doing everything I can think of to raise awareness of this issue and the ignorance continues to abound!! And no, I am NOT associated with any cult - what an absolutely ridiculous scape goat that the drug companies have been able to get incredible mileage out of rather than having to address the issue at hand!!!

The research on serotonin is simple and clear and anyone with a functioning brain could see it IF they had the opportunity to do so. The theory behind these drugs is backwards, plain and simple. But the truth would not be financially advantageous to those bringing in hundreds of millions daily on these drugs. Yes, I said hundreds of millions!

Preemption is NOT in the best interest of anyone but the drug companies and that is why Daniel Troy introduced it after leaving(or did he really leave?) Pfizer.

The following is my presentation to the FDA Advisory committee to encourage the black box warnings:

September 13, 2004: I am Ann Blake Tracy, PhD, head of the International Coalition for Drug Awareness. I am the author of Prozac: Panacea or Pandora? - Our Serotonin Nightmare and have testified in court cases involving antidepressants for 12 1/2 years. The last 15 years of my life have been devoted full time to researching and writing about SSRI antidepressants.

Research on serotonin has been clear from the very beginning that the most damaging thing that could be done to the serotonin system would be to impair one?s ability to metabolize serotonin. Yet that is exactly how SSRI antidepressants exert their effects.

For decades research has shown that impairing serotonin metabolism will produce migraines, hot flashes, pains around the heart, difficulty breathing, a worsening of bronchial complaints, tension and anxiety which appear from out of nowhere, depression, suicide - especially very violent suicide, hostility, violent crime, arson, substance abuse, psychosis, mania, organic brain disease, autism, anorexia, reckless driving, Alzheimer?s, impulsive behavior with no concern for punishment, and argumentative behavior.

How anyone ever thought it would be "therapeutic" to chemically induce these reactions is beyond me. Yet, these reactions are exactly what we have witnessed in our society over the past decade and a half as a result of the widespread use of these drugs.

In fact we even have a whole new vocabulary as a result with terms such as "road rage," "suicide by cop," "murder/suicide," "going postal," "false memory syndrome," "school shooting," "bi-polar" - every third person you meet anymore - along with the skyrocketing rates of antidepressant-induced diabetes and hypoglycemia.

Can you remember two decades ago when depressed people used to slip away quietly to kill themselves rather than killing everyone around them and then themselves as they do while taking SSRI antidepressants?

A study out of the University of Southern California in 1996 looked at a group of mutant mice in an experiment that had gone terribly wrong. These genetically engineered mice were the most violent creatures they had ever witnessed. They were born lacking the MAO-A enzyme which metabolizes serotonin. As a result their brains were awash in serotonin. This excess serotonin is what the researchers determined was the cause for this extreme violence. Antidepressants produce the same end result as they inhibit the metabolism of serotonin.

These are extremely dangerous drugs that should be banned as similar drugs have been banned in the past.

As a society we once thought LSD and PCP to be miracle medications with large margins of safety in humans. We have never seen drugs so similar to LSD and PCP as these SSRI antidepressants. All of these drugs produce dreaming during periods of wakefulness. It is believed that the high serotonin levels over stimulate the brain stem leading to a lack of muscle paralysis during sleep thus allowing the patient to act out the dreams or nightmares they are having. The world witnessed that clearly in the Zoloft-induced murder-suicide of comedian Phil Hartman and his wife, Brynn.

Connecticut witnessed the Prozac-induced case of Kelly Silk several years ago. This young mother attacked her family with a knife, then set the house on fire killing all but her 8 year old daughter who ran to the neighbors. As she stood bleeding and screaming for help she explained, "Help! My mommy is having a nightmare!"

Out of the mouths of babes we will understand these nightmares for what they are. She understood that this was something her mother would do ONLY in a nightmare, never in reality.

This is known as a REM Sleep Behavior Disorder. In the past it was known mainly as a drug withdrawal state, but the largest sleep facility in the country has reported that 86% of the cases they are diagnosing are patients on antidepressants.

Because this was known in the past as a condition manifesting mainly in drug withdrawal you should see how dangerous the withdrawal state from these drugs will prove to be. That is why it is so critical to make sure patients are weaned EXTREMELY slowly so as to avoid ANY chance of going into a withdrawal state.

_________________

Posted by: Ann Blake-Tracy, PhD | June 18, 2008 12:48 AM

Ann: The package inserts were based on lawyer caused over-cautiousness and intimidation of the inexperienced academics on the Psychopharmacology Committee. These folks do not see many patients and are junior to clinicians in every way, including IQ.

There were no suicides in the marketing studies. If you slapped your head because you could have had a V8, it got reported as a self-injury. These were really either trivial or non-suicidal forms of self abuse. The rates were clinically trivial. After using a required correction learned in 11th grade statistics, the statistical significance evaporated. It had stemmed from the large sample sizes that inflate significance of differences in proportions that are not clinically meaningful.

The black box warning was not resisted by the drug company. Why not? Because it shifts the liability for any self-injury to the doctor, once the warning is put on.

Your testimony is unfair, and uninformed opinion. The anecdotes of violence represent the failure of anti-depressants to improve previously violent people and criminals. No one has claimed they could.

The mass murders predated the invention of anti-depressants. No one has matched the biggest school killing in history, in Michigan from the 1920's.

http://en.wikipedia.org/wiki/Bath_School_disaster

Not on anti-depressants. Driven to rage by lawyers.

Posted by: Supremacy Claus | June 18, 2008 9:50 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 22, 2008 5:05 PM