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colombine revisited

captain wardrobe | 28.06.2004 00:43

code: sinister

Company: Solvay Pharmaceuticals, Pharmacia & Upjohn
Approval Status: Approved April 1997
Treatment for: obsessive compulsive disorder

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two roles for one drug ocd & depression?


LUVOX® is used in major depression, a disabling mood disorder that can interfere with people's functioning in jobs, relationships and as parents. The degree of inability to carry on caring for themselves or others is actually greater than it is for people with illnesses such as diabetes or high blood pressure, and it is a problem which can last long after the episode of depression has subsided. Depression is also a very common disease: one in twenty people suffers from it at any given time.

In the United States LUVOX® is exclusively registered for Obsessive Compulsive Disorder, and in many other countries it carries this indication as well.
 http://www.solvaypharmaceuticals.com/html/products/Psychiatry/luvox.html
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what if you only have OCD and are not depressed...or visa versa?





Luvox(R) (fluvoxamine maleate) Tablets is the first SSRI to gain clearance from the U.S. Food and Drug Administration (FDA) to treat Obsessive Compulsive Disorder (OCD) in children and adolescents.

As the first selective serotonin reuptake inhibitor (SSRI) for this indication, Luvox Tablets offers new hope for the estimated one million children and adolescents who have OCD. The product is jointly marketed by Solvay Pharmaceuticals Inc. and Pharmacia & Upjohn Inc.
 http://www.pslgroup.com/dg/2261a.htm
 http://www.rxlist.com/cgi/generic/fluvox.htm
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Typical Side Effects: The usual for SSRIs - headache, nausea, dry mouth, sweating, sleepiness or insomnia, and diarrhea or constipation, weight gain, loss of libido. Most everything but the weight gain and loss of libido usually goes away within a couple of weeks.

Not So Common Side Effects: Worsening of symptoms, be it anxiety, depression or OCD. Even if you're taking Luvox for one thing you might get the symptoms of something else.

Freaky Rare Side Effects: Agoraphobia, fecal incontinence, priapism.

How Luvox Works In Your Brain: Like all SSRIs Luvox doesn't make you produce more serotonin, rather it makes your neurons soak for a longer period of time in the serotonin you already produce. Serotonin is one of the big three neurotransmitters responsible for depression, along with norepinephrine and dopamine. My wild-ass guess / rule of thumb is that imbalances of one or more of the three are responsible for 80% of the depression issues. It's all just a matter of figuring out exactly the extent of the tweaking and what neurotransmitters you exactly need to tweak.
 http://www.crazymeds.org/luvox.html
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Clinical Results
A 10-week, randomized, double-blind, placebo-controlled, multi-center study of LUVOX Tablets involving 120 children ranging in age from 8 to 17 years showed that fluvoxamine is more effective than placebo for the treatment of OCD. LUVOX Tablets was also well-tolerated; only three children taking fluvoxamine dropped out of the study due to adverse effects, none of which were considered serious.

Side Effects
Most commonly observed side effects included agitation, hyperkinesia, depression, dysmenorrhea, flatulence and rash.
 http://www.centerwatch.com/patient/drugs/dru254.html
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Columbine
The Columbine High School massacre occurred on April 20, 1999 at Columbine High School in Littleton, Colorado, United States, when two teenage students, Eric Harris (born April 9, 1981) and Dylan Klebold (born September 9, 1981), executed a planned shooting rampage, killing 12 other students and a teacher before committing suicide. Some argue that one of the shooters killed the other and then himself.

[snip]

It's been publicly revealed that Harris had been prescribed and was taking Luvox® (Fluvoxamine maleate), a powerful antidepressant, at the time of the shooting spree. Although Klebold's medical records have been sealed, there is strong reason to believe that he too had been prescribed one of several popular drugs for depression. Throughout the 1990s these drugs arguably became the standard response to a wide variety of behavioral problems in schools, especially for boys. An alleged side-effect of these drugs is a loss of empathy for other human beings. Of the various USA "school shooters" whose medical history has been made public, all were either currently taking or had recently gone off one of these powerful mind-altering prescription drugs given to them to treat various serious behavioral problems.
 http://www.brainyencyclopedia.com/encyclopedia/c/co/columbine_high_school_massacre_1.html


Eric Harris was taking Luvox (a Prozac-like drug) at the time of the Littleton murders
by Peter R. Breggin, M.D.

On April 29 the Washington Post confirmed that Eric Harris, the leader in the Littleton tragedy, was taking the psychiatric drug Luvox at the time of the murders. On April 30 the same newspaper published a story quoting expert claims that Luvox is safe and has no association with causing violence. In fact, Luvox and closely related drugs commonly produce manic psychoses, aggression, and other behavioral abnormalities in children and young people.
Luvox is a Selective Serotonin Reuptake Inhibitor (SSRI) that is approved for children and youth (up to age 17) for use in the treatment of obsessive compulsive disorder. However, doctors often give it for depression, since it is in the same SSRI class as Prozac, Zoloft, and Paxil.
According to the manufacturer, Solvay, 4% of children and youth taking Luvox developed mania during short-term controlled clinical trials. Mania is a psychosis which can produce bizarre, grandiose, highly elaborated destructive plans, including mass murder. Interestingly, in a recent controlled clinical trial, Prozac produced mania in the same age group at a rate of 6%. These are very high rates for drug-induced mania--much higher than those produced in adults. Yet the risk will be even higher during long-term clinical use where medical supervision, as in the case of Harris, is much more lax than in controlled clinical trials. These drugs also produce irritability, aggression or hostility, alienation, agitation, and loss of empathy.
Reports suggest that Eric Harris may have had a relatively good family life. If so, it adds to the probability that he was suffering from a drug-induced manic reaction caused by Luvox. The phenomenon of drug-induced manic reactions caused by antidepressants is so widely recognized that it is discussed several times in the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association and many times in The Physicians' Desk Reference.
I have lectured widely and written extensively about violence in association with taking SSRI antidepressants in Talking Back to Prozac (St. Martin's Press, 1994) and Brain-Disabling Treatments in Psychiatry (Springer Publishing Company, 1997).
I have testified as a medical expert in three teenage cases of murder in which SSRIs were implicated in playing a role. In one case, a sixteen year old committed murder and tried to set off multiple bombs and incendiary devices at the same time. I have also testified in cases of adult murderers who were under the influence of SSRIs, including one mass murder of twelve people followed by suicide. The comparisons to Littleton are obvious.
Psychiatric drugs including Ritalin and Prozac have also been taken by at least one other school murderer (Kip Kinkle). Psychiatric drug use is only one of the contributing factors to the episodes of school violence. However, it is one of the most easily prevented factors. There is strong scientific evidence to support the view that SSRIs should not be given to children and teenagers.
 http://www.angelfire.com/mn2/illstandbyyou/luvlittle.html

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Families of five Columbine High School shooting victims are suing the maker of an anti-depressant that one of the student gunmen was taking when he opened fire.

A therapeutic amount of the drug Luvox was found in Eric Harris' system after he died, the Jefferson County coroner's office has said.

Solvay Pharmaceuticals Inc. makes the drug to treat obsessive-compulsive disorder and depression. The lawsuit filed Friday in U.S. District Court claims Solvay failed to warn Harris' doctor about side effects.

"Such drugs caused Eric Harris to become manic and psychotic," the lawsuit states.
 http://www.cbsnews.com/stories/2001/10/22/national/main315368.shtml
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The legal filings all revolve around two civil lawsuits in federal court. In one, injured Columbine student Mark Taylor sued Solvay Pharmaceuticals, the maker of a drug Harris was taking when he and Klebold killed a dozen classmates and a teacher and wounded more than 20 others on April 20, 1999, at the school.

The second lawsuit was filed against the killers' parents by the families of five students who died at Columbine - Danny Rohrbough, Kelly Fleming, Matt Kechter, Lauren Townsend and Kyle Velasquez.
 http://www.rockymountainnews.com/drmn/columbine/article/0,1299,DRMN_106_2351576,00.html

Insight Magazine reporter, Kelly Patricia O'Meara, reports in (below) that 19- year old Mark Taylor, a victim of the shooting spree at Columbine high school in 1999, spent nearly two months in the hospital plus 3 years of follow-up operations. Taylor is suing the drug company, Solvay Pharmaceuticals, manufacturers of Luvox, an antidepressant drug whose adverse side-effects include manic and psychotic reactions. See:  http://www.drugawareness.org

The suit claims that Eric Harris had been taking Luvox at the time of the shooting and that the drug triggered his violent outburst. Taylor's lawyer, Nebraska attorney, John DeCamp, is quoted saying: "two days after I took the case, Solvay pulled Luvox from the market. I don't know if my coming on the case had any bearing on them pulling the drug, but it is interesting." Solvay removed Luvox temporarily from the U.S. market to revise data about how Luvox is manufactured.

A consultant in Taylor's lawsuit, Dr. Ann Blake Tracy, heads the International Coalition for Drug Awareness, she says: "Suing Solvay for the injuries Mark Taylor suffered is one of the biggest SSRI suits we'll ever see," Tracy says. "It's a pivotal case because what happened at Columbine was so big. It's really crazy when you think about it. All you have to do is read the Luvox package insert to see that Eric's actions were due to an adverse reaction to this drug. Show me a drug anywhere that has listed mania and psychosis as frequent adverse reactions. That is what the insert says for Luvox. There is no doubt in my mind that Luvox caused Eric Harris to commit these acts."
 http://www.solvaypharmaceuticals-us.com/Products/Mental_Heal th/LUVOX/default.asp
 http://www.ahrp.org/infomail/0902/03.html
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$10 000 dollars to charity? how nice!


 http://www.solvaypharmaceuticals-us.com/newsroom/pressreleases/0,,13893-2-0,00.htm



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destroyed testimony?


A special room under strict lock-and-key, filled with evidence from two settled Columbine cases, is being shut down and a federal magistrate has ordered some of the materials - including depositions of the killers' parents - destroyed.
The room, in the federal courthouse in downtown Denver, was set aside in 2002 to "house particular documents and materials deemed to be worthy of special handling and security," according to court documents.
 http://newsmine.org/archive/deceptions/columbine-files-to-be-destroyed.txt

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Luvox withdrawn - recalled
 http://www.copd-international.com/Library/Luvox_recall.htm
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not for safety reasons? why then?
re branding?

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of the new drug applications (NDAs) for ROWASA (mesalamine) Rectal
Suppositories, 500 milligrams (mg), and LUVOX (fluvoxamine maleate) 25-
mg, 50-mg, 100-mg, and 150-mg tablets, held by Solvay Pharmaceuticals,
Inc., 901 Sawyer Rd., Marietta, GA 30062. Solvay has voluntarily
withdrawn these NDAs in response to audit findings indicating possible
inaccuracies noted in the chemistry, manufacturing, and controls (CMC)
section of the applications. Solvay has agreed to permit FDA to
withdraw approval of the applications, thereby waiving its opportunity
for a hearing. In addition, FDA has determined that LUVOX (fluvoxamine
maleate) 25-mg, 50-mg, 100-mg, and 150-mg tablets was not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to continue to approve abbreviated new drug applications
(ANDAs) for fluvoxamine maleate 25-mg, 50-mg, 100-mg, and 150-mg
tablets.

DATES: Effective September 3, 2003.

In the course of an audit, FDA discovered inaccuracies in the CMC section of the LUVOX
(fluvoxamine maleate) application.

Although these findings raised concerns about the drug product as manufactured by Solvay, they do not
affect the safety or efficacy of fluvoxamine maleate in treating obsessive compulsive disorder.
 http://www.fda.gov/OHRMS/DOCKETS/98fr/03-22359.htm
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finally they come clean...

May 2004

Subject: Stronger WARNING for SSRIs and other newer anti-depressants regarding the potential for behavioural and emotional changes, including risk of self-harm

Solvay Pharma Inc, following discussions with Health Canada, would like to inform you of important safety information regarding the possibility that SSRIs (selective serotonin reuptake inhibitors) and other newer anti-depressants may be associated with behavioural and emotional changes, including risk of self-harm

POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF BEHAVIOURAL AND
EMOTIONAL CHANGES, INCLUDING SELF-HARM.

Pediatrics: Placebo-Controlled Clinical Trial Data

Recent analyses of placebo-controlled clinical trial safety databases from SSRIs and other newer anti-depressants suggest that use of these drugs in patients under the age of 18 may be associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour over that of placebo.


The small denominators in the clinical trial database, as well as the variability in placebo rates, preclude reliable conclusions on the relative safety profiles among these drugs.
Adult and Pediatrics: Additional data

There are clinical trial and post-marketing reports with SSRIs and other newer anti-depressants, in both pediatrics and adults, of severe agitation-type adverse events coupled with self-harm or harm to others. The agitation-type events include: akathisia, agitation, disinhibition, emotional lability, hostility, aggression, depersonalization. In some cases, the events occurred within several weeks of starting treatment.
Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages. This includes monitoring for agitation-type emotional and behavioural changes.

Discontinuation Symptoms

Patients currently taking fluvoxamine should NOT be discontinued abruptly, due to risk of discontinuation symptoms. At the time that a medical decision is made to discontinue an SSRI or other newer anti-depressant drug, a gradual reduction in the dose rather than an abrupt cessation is recommended.
 http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/luvox_hpc_e.html
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Michigan Makes More Mental Health Drugs Available Without the Need for Prior Authorization[!!]

SSRIs appear to be safer especially in patients with heart disease, and for patients on multiple medications who cannot tolerate some of the anticholinergic effects of the tricyclic antidepressants, or who would be more at risk of drug interactions with their other medications. SSRIs available without the need for prior authorization include: Celexa, Fluoxetine, Fluvoxamine Maleate, Lexapro, Luvox, Paroxetine, Prozac Weekly and Zoloft.
 http://www.michigan.gov/emi/0,1303,7-102-112-70488--,00.html

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Doping Kids
Title: "Doping Kids"
By: Helen Cordes
Source: Mother Jones, Vol. 28, No.5, Sept.-Oct
Researched by Adam Stutz

Adult pharmaceutical companies have been endangering children. Between 1997 and 2000 the FDA reported 7,000 cases of adverse reactions in children and out of these 7,000 reported incidents there were 769 reported deaths due to allergic reactions attributed to prescription drugs. There have been a large number of children who are often receiving these prescriptions in combination with other medications. The effects can be devastating. Nearly a quarter of a million children took Prilosec in 2000, according to the U.S. Food and Drug Administration, and nearly 100,000 children were prescribed similar "proton pump inhibitors"(PPI) heart burn drugs such as Prevacid, Nexium, Protonix, and Aciphex. None of these PPI’s were approved for pediatric use at the time (Prevacid was in 2002).

The FDA had warned that children taking Prilosec could face the risk of developing pancreatis and liver problems. Three out of four children’s prescriptions are "off label." Drug salesmen are prohibited from this practice but it still occurs quite commonly. The pharmaceutical companies look at children as a very lucrative demographic. This can be made apparent in the amount of advertising
undertaken by pharmaceutical companies at various children related activities such as sporting events.
 http://www.projectcensored.org/newsflash/newsflash.html#dopekids


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Breeding psychopaths?
unfeeling unempathetic robots?


Bush plans to screen whole US population for mental illness

A sweeping mental health initiative will be unveiled by President George W Bush in July. The plan promises to integrate mentally ill patients fully into the community by providing "services in the community, rather than institutions," according to a March 2004 progress report entitled New Freedom Initiative (www.whitehouse.gov/infocus/newfreedom/toc-2004.html). While some praise the plan's goals, others say it protects the profits of drug companies at the expense of the public.

[snip]

The president's commission found that "despite their prevalence, mental disorders often go undiagnosed" and recommended comprehensive mental health screening for "consumers of all ages," including preschool children. According to the commission, "Each year, young children are expelled from preschools and childcare facilities for severely disruptive behaviours and emotional disorders." Schools, wrote the commission, are in a "key position" to screen the 52 million students and 6 million adults who work at the schools.

The commission also recommended "Linkage [of screening] with treatment and supports" including "state-of-the-art treatments" using "specific medications for specific conditions." The commission commended the Texas Medication Algorithm Project (TMAP) as a "model" medication treatment plan that "illustrates an evidence-based practice that results in better consumer outcomes."

 http://bmj.bmjjournals.com/cgi/content/full/328/7454/1458

for Bushes Army?

Coming Soon
The Return of the Draft, a Bipartisan Production
By JACOB LEVICH

Barring a sudden reversal in the direction of US foreign policy, a strong bipartisan push to reinstate the draft can be expected soon after the November elections. Whether or not Bush wins is irrelevant. The logic of empire requires more boots on the ground, and conscription looks like the only way to get them.

In fact the campaign for the draft is already under way, though election-year politics have dictated a nuanced approach. Long-dormant draft boards have been quietly reactivated and restaffed -- even as the Bush administration continues to claim, in the face of mounting evidence to the contrary, that current troop levels are sufficient.

Meanwhile, a consensus behind conscription is building on Capitol Hill. Senators Chuck Hagel (R-Neb) and Joseph Biden (D-Del), chairman of the Senate Foreign Relations Committee, are among many prominent politicians suddenly calling for a "national debate" on the draft. Open supporters of the draft include Sen. Ernest Hollings (D-SC) and Reps. Nydia Velazsquez (D-NY), Pete Stark (D-Cal), and Charles Rangel (D-NY). HR 163 and S 89, Democrat-sponsored bills to restore conscription, are quietly working their way through committee. According to The Hill, Republicans are ready to sign on as soon as they get the nod from the Bush administration.
 http://www.counterpunch.org/levich06012004.html


captain wardrobe

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