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Prescription: Suicide? - A Documentary Film about a 12 year old child prescribed Zoloft

Fri, 2008-06-06 16:22 - Kerry

Sat, 15 Oct 2005

Prescription: Suicide? is a documentary film about Candace Legh Downing, a 12-year old girl who was anxious about certain school tests. A child psychiatrist prescribed the antidepressant, Zolfot, and soon after she committed sucide. When she died, 1000+ people attended her service.

A recurring theme in drug related deaths of even well cared for children, is the frustrations parents--most often mothers-- encounter when they question a psychiatrist's judgement.

Mothers, whose efforts are guided by both instinct and intelligence, are dismissed forthwith or patronized when they object to "doctors orders."

When parents err, they pay the price.

When doctors err, and the patient dies, doctors don't pay the price for their miscalculation, or poor judgement, or ignorance about the adverse effects of many of the drugs they prescribe.

100,000 Americans are killed each year due to adverse drug reactions. There is no central database monitoring which drugs kill--the FDA does not even monitor the 1% (at most 10%) adverse drug effect reported to MedWatch

So, a culture change is in order: public policies that coerce parents to drug their children must be replaced with policies that respect parental rights.

It makes both good public policy and common sense for parents, not doctors to have the final say about medical decisions for their child's best interest. A major threat confronting children's well-being is an ill-advised, but commercially promising initiative that was developed by a Columbia University psychiatrist and has the government seal of approval. TeenScreen is labeling children with mental disorders on the basis of a inane questionnaire. If they answer questions such as the following, Yes, they are sent for "mental health services" which are invariably one or more psychotropic drugs:

"In the last year ... Has there been a time when you felt you couldn't do anything well or that you weren't as good-looking or as smart as other people?"

"In the last year?Has there been a time when you couldn't think as clearly or as fast as usual?"

If TeenScreen is adopted, and all school children will be screened for presumed mental problems, there will be thousands of children for whom psychotrorpic drugs--such as the one prescribed for 12-year old Candace Leigh Downing.

How many children must be sacrificed on the altar of Big Pharma--now clad in academic gowns.

Contact: Vera Hassner Sharav
212-595-8974
veracare at ahrp org

a film by Roberto Mancierorobert manciero

The Downing family   [A brief video can be found here:  http://poundpuplegacy.org/node/19497]

This is Andy, Mathy and Caroline Downing's first time ever to appear together in a film about the tragic death of their daughter and sister, Candace Leigh Downing. Having turned down media approaches in the past, they were reluctant at first, but agreed to participate in Prescription:suicide? once they had talked to and met the directors of the film and understood the overall theme of the documentary.

Mrs. Mathy Downing is a past member of the Board of Trustees for the school both girls attended, and continued to act as a room parent for Candace's eighth grade class even though Candace died during seventh grade. After a six month medical leave beginning with the death of her daughter, she returned to her job, that of teaching children. Andrew is a businessman, and Caroline is in her junior year of high school.

The first hint they had that their 12 year old daughter Candace Leigh Downing might be suicidal was when they found her hanging from the valance of her bed.

Recalls Mathy Downing, "I went to check on her upstairs and found my beautiful little girl hanging, her knees drawn up. I don't know how long she had been there. I began screaming for my husband and rushed to get her down and lay her on the floor. I called 911, praying they could get there in time. My husband tried to administer CPR, but he knew the minute that he saw her, that it was too late. She was taken by ambulence to the closest hospital where they worked on her another 45 minutes, but it was too late. "Do you know what that's like, to see your happy little girl hanging? There was no note, no warning, not for her, not for us."

Mathy and Andy Downing blame the anti-depressant drug, Zoloft. The Downings say Candace wasn't suicidal -- wasn't even depressed. Depression had never been the issue. She was prescribed Zoloft for a generalized anxiety disorder which had manifested in school anxiety.

When Candace entered middle school, she began having problems on tests and frustration over certain homework assignments. She would block on answers she knew on tests, or write so illegibly that some answers were marked incorrect, even if she had them correct. Because of her parents' concern, she saw her pediatrician, who recommended that she see a child psychiatrist. Candace was viewed as a very bright little girl, an overachiever.

Although pleased that Candace seemed to have an easy rapport with the psychiatrist and appeared to have no problems talking to him about her frustrations, he immediately wanted to medicate her. Mathy was opposed, but he reassured her that it was safe and that he would recheck her in three weeks. After three weeks, he wanted to double that amount, from 12.5mg to 25mg of Zoloft, which Mathy opposed. She did not feel that three weeks was enough time to judge that type of medication. Because of her vehemence, the medication was not increased at that time.

Candace was tested both psychologically and educationally. The findings showed a very bright little girl who had a tendency to shut down somewhat when frustrated, but who tried hard to please. She was very bright, but not a risk taker. She exhibited no signs of depression or suicidality, but high levels of anxiety. She loved her family and her friends and considered home her "safe haven".

Right before school started following summer vacation, Mathy and Candace returned to the child psychiatrist, who once again wanted to increase Candace's dosage of Zoloft, his reasoning being that with 7th grade, came a new level of daily transitions and that it would be in Candace's best interest to be less stressed. When Mathy voiced concern, he stated, "What are you worried about? Kids take 100-200mg of Zoloft a day without any problems."

"Why was so much hidden from us? Why were we not ever informed about the contraindications or adverse reactions of Zoloft, or for that matter, antidepressants in children? Didn't we have the right to be informed?" is what Mathy asks now. Shouldn't it have been our choice to place Candace on medications that involved risk rather than the pharmaceutical companies or the FDA?

Everyone had been important to Candace. She had more friends than many other child her age. Everybody loved her. In her personal journals, she always wrote about her family first, then her friends and her animals. Her promise was to never leave her friends.

When she died, 1000+ people attended her service, which had to be held in the school gym. Three local private schools provided buses to transport people from a park opened for excess parking, to the school. Bishop John Chane, the bishop of Washington, helped officiate. Candace was everybody's little girl, i.e. this could happen to her, it could happen to anyone's child.

"Do you know what it's like to go from being a sibling to an only child? It is extremely hard to see your "parents in pain when you, yourself, are grieving," says Caroline, Candace's big sister.

In retrospect, the Downings have also become very much aware after the fact, that an abrupt withdrawal from an anti-depressant can prove fatal. The sudden withdrawal of these drugs creates psychotic states, which decrease powers of reasoning, and places them in altered states of consciousness. No one ever told them that their daughter was going in and out of psychotic states and needed to be watched closely every second.

"If we had been able to make our own choices, if we had been aware of the risks, this would never have happened, as we would never have allowed Candace to be placed on such a risky and controversial medication," says Andrew Downing.

"What happened to our daughter and so many others like her is a travesty. We have since met other families who have lost their child after Zoloft was prescribed for test anxiety. Those in a position to create positive change can go home to their children at night. We will never have that opportunity with Candace again. Our therapist referred to what happened to Candace as abduction. She was taken away from us with no warning and died in the process. What gave them that right?", Mathy stated tearfully.

Whether or not drugs like Zoloft, used to treat OCD and depression, really do cause suicides is a matter of medical debate. But another debate is running. The Downings, and other families, charge that drug makers knew from pre-marketing studies that these drugs made some children and teens suicidal, but hid the study results, and altered other studies by pooling negative studies together to show more positive results.

"This is not about money," says Mathy Downing, "This is about the right of the American people to make their own decisions. I can't sit back as an American citizen and watch children continue to die. And that is why we hope the documentary Prescription:suicide? will help to get that message out where it counts: among the American families whose biggest concern is to protect and nurture their children."

The Downings have testified at FDA hearings and are lobbying congress to make all research public. Mathy Downing has also addressed the US Drug Safety Systems Committee, which is reviewing the numerous allegations against the FDA's handling of policy regarding anti-depressants among medical controversies.

For more information contact:
David Garland
Phone: (818) 681-2105
Website: http://www.prescriptionsuicide.com/downingmedia.html
Copyright  2005 Full Vision Productions. All Rights Reserved.

Comments

Fri, 2008-06-06 17:47 — Kerry

A year earlier... "Prescription For Suicide?"

By MICHAEL D. LEMONICK, Monday, Feb. 09, 2004

Kara Jaye-Anne Otter, 12, had been on the antidepressant Paxil for seven months when she committed suicide. "I was told the worst side effects would be flulike symptoms," recalls her mother, Shannon Baker. "But after three weeks she had begun to cop an attitude. Her grades started falling. Then she didn't care what she looked like, and she was fighting with everybody." Baker says her daughter developed rashes and dark circles under her eyes and had trouble sleeping. Then, on June 7, 2001, Kara pinned a note to her chest reading, "By the time you find me I'll be dead. I love you with all my heart. Don't worry, Jesus is with me." She hooked a bungee cord onto a plate hanger on the wall, wrapped the cord around her neck and pulled against it until she passed out. Within minutes she was dead.

Baker is convinced Paxil is what killed her daughter, and that's what she'll tell a U.S. Food and Drug Administration panel meeting this week in Bethesda, Md. For years a small but vocal group of patients and doctors have insisted that certain antidepressants, including Paxil, Zoloft, Prozac and other medications known as selective serotonin reuptake inhibitors (SSRIs), carry an unacceptable risk of antisocial behavior and suicide in kids who take them. Many clinicians and most pharmaceutical companies disagree. Major depression is a dangerous illness that in itself can lead to suicide, and they insist that the benefits of these drugs outweigh the risks. But drug firms also refuse to release all their research--some of which tends to undercut their claims. "It's a real shell game here," says Vera Sharav, president of the Alliance for Human Research Protection, an advocacy group.

The issue is coming to a head. By last December, the British Medicines and Healthcare Products Regulatory Agency, the equivalent of the FDA, had declared Celexa, Effexor, Lexapro, Luvox, Paxil and Zoloft (but not Prozac) too risky for kids under 18. Two weeks ago, a task force of the American College of Neuropsychopharmacology fired back, saying that despite the risk of potentially serious side effects, it's riskier to withhold the drugs.

Now comes the FDA probe, which began with an investigation of Paxil launched in the fall of 2002. Last June the FDA cautioned doctors against prescribing the drug to young people because of a possible increase in suicidal thinking. In October the FDA issued a broader public-health advisory alerting physicians that in clinical trials, Paxil, along with about half a dozen other antidepressants, wasn't any more effective than a placebo at treating depression in kids. Indeed, no antidepressant other than Prozac has been formally approved for young people. But that's not the same as a ban. Once a drug is legal, doctors can prescribe it at will.

The British, on the other hand, actually banned the use of Paxil (under the drug's British trade name, Seroxat) for kids last June, and went on to ban the others in the following six months. Why the difference, when British authorities were looking at the same data as the FDA? One reason is that most studies on effectiveness aren't really definitive. They don't prove one way or the other whether the drugs work significantly better than placebos--and the Brits went with the more conservative interpretation. That, argues Dr. Graham Emslie, co-chair of the American panel and the author of several studies on SSRIs, is shortsighted. "A failure to show effectiveness is not the same as proving ineffectiveness."

Moreover, he argues, the evidence linking SSRIs to suicide is very weak. Autopsies on people who have taken their lives show that most victims hadn't taken an antidepressant, or had taken an overdose, in the hours before their death. The British cited "suicide-related events," not actual suicide, as the reason for the ban--and there's obviously a big difference. "About 2 million teens in the U.S. have clinical depression," says Dr. Harold Koplewicz, a psychiatrist and director of the NYU Child Study Center. "But 3 million kids have suicidal thoughts. They seem to be part and parcel of the adolescent experience." And, he points out, only a fraction of either group actually attempts suicide.

Finally, say critics, the British medical authorities looked at the evidence in an unsophisticated way. Many of the unpublished studies they reviewed came from the drug companies themselves, and at least some of those had been carried out for a very specific purpose. Under FDA rules, any company that tests its medications on young people at the FDA's request wins an extra six months' worth of patent protection, whether or not the results are positive. Since these studies were done for financial gain and weren't reviewed by independent scientists, they probably shouldn't be given full weight. Making them public, as activists demand, might muddy the waters rather than help families make informed decisions.

Nonsense, say scientists who favor sharing such data. The reason some studies remain unpublished is that the drug companies don't like to admit negative results. According to Dr. Martin Teicher, a researcher at McLean Hospital outside Boston who has published case reports linking suicide and Prozac use, an internal Eli Lilly study of adults taking the drug showed "a substantially greater incidence of suicide attempts in people in the study receiving Prozac than in people receiving placebo or other antidepressants."

But that study wasn't published, he says, while research showing no increase in suicide attempts was. Says Dr. Richard Harrington, an expert in child and adolescent psychiatry at England's University of Manchester: "It's very important that things get peer reviewed. There is no question about that. But if you have to make decisions about giving drugs to children, you might sometimes have to go on unpublished reports."

Starting this week, the FDA will try to make sense of it all: the studies, published and unpublished; expert testimony from both sides; and the personal stories of ordinary people like Mark Taylor, 19, wounded in the Columbine school shootings by Eric Harris, 18, who was taking the antidepressant Luvox at the time.

The agency could come to a decision by next summer, but it might not be as well informed as some would like. The truth, suspect many psychiatrists, is complicated: SSRIs help some people and hurt others. Says Teicher: "To figure out what impact [SSRIs] have on a side effect like suicidal thoughts that might only affect a couple of percent--or even less than 1%--of people in a study, you need a much, much larger study." And, says Teicher, nobody is doing those studies yet. Besides, argues Koplewicz, SSRIs are most often prescribed for kids by pediatricians or family practitioners, not by experts in child psychiatry. "We need to train these physicians properly," he says, "not ban drugs that are clearly effective." --Reported by Melissa August/Washington, Helen Gibson/London, Hilary Hylton/Austin and Sora Song/New York

With reporting by Melissa August/Washington, Helen Gibson/ London, Hilary Hylton/Austin and Sora Song/New York

Find this article at:  http://www.time.com/time/magazine/article/0,9171,993276,00.html

Fri, 2008-06-06 18:39 — Kerry

Here's my favorite part....

Dr. Graham Emslie, co-chair of the American panel and the author of several studies on SSRIs,  argues the British studies and reaction to their findings.  "Shortsighted" .   [Yes to err on the side of caution when it comes to children, is indeed narrow and short-minded, isn't it?]

"A failure to show effectiveness is not the same as proving ineffectiveness."

Moreover, he argues, the evidence linking SSRIs to suicide is very weak. Autopsies on people who have taken their lives show that most victims hadn't taken an antidepressant, or had taken an overdose, in the hours before their death. The British cited "suicide-related events," not actual suicide, as the reason for the ban--and there's obviously a big difference. "About 2 million teens in the U.S. have clinical depression," says Dr. Harold Koplewicz, a psychiatrist and director of the NYU Child Study Center. "But 3 million kids have suicidal thoughts. They seem to be part and parcel of the adolescent experience." And, he points out, only a fraction of either group actually attempts suicide.

Finally, say critics, the British medical authorities looked at the evidence in an unsophisticated way.

"Unsophisticated" are the Brits because profit made through pharmacies is not a priority?  OK.. I can see how selling drugs to those who don't need it can seem like a sophisticated sales-ploy.  [Two-points for American Business!]

Medically speaking, I can't understand how an autopsy report can be taken seriously when it states, "most victims hadn't taken an antidepressant, or had taken an overdose, in the hours before their death."

Anyone who has taken prescription medication knows certain pills require certain doses for a certain duration before that pill can be deemed "beneficial".  For anti-depressants, for instance, it's written within the instructions that it may take 4-6 weeks for symptoms to improve.

It's at this point physican and parent need to discuss "risks and benefits" to the CHILD, (not "risks and benefits" to the drug-companies that pay representatives to distribute their goods to doctor's offices, complete with misleading study-information!)

Even a quick wikipedia reference can inform a parent more than the physician who is too lazy to study his most updated PDR. [In fact, I wonder just how many drug companies are praying physicians aren't doing their homework by reading-up on their drug-reference pages like Paxil has to offer:  http://www.pdrhealth.com/search/search-results.aspx?searchTerm=paxil] 

Is it any wonder why parents need to be the educated consumer in health-care these days?

So here's the big-double-whammie-question:  How many parents would agree to give their children with test-taking / school / social-anxiety a medication that reads as the following information provides, (and how many parents are willing to "go against medical advice"... especially if Child Protection Services are involved?):

General side effects are mostly present during the first 1-4 weeks while the body adapts to the drug. Almost all SSRIs are known to cause either one or more of these symptoms. A person receiving paroxetine treatment may experience a few, all, or none of the following side-effects, and most side-effects will disappear or lessen with continued treatment, though some may last throughout the duration. Side effects are also often dose-dependent, with fewer and/or less severe symptoms being reported at lower dosages, and/or more severe symptoms being reported at higher dosages. Increases or changes in dosage may also cause symptoms to reappear or worsen. [6]

9 December 2004 European Medicines Agency (EMEA), i.e. the Committee for Medicinal Products for Human Use (CHMP), informed patients, prescribers and parents that paroxetine should not be prescribed to children. CHMP gave a warning to prescribers recommending close monitoring of adult patients at high risk of suicidal behaviour and/or suicidal thoughts. In other words, CHMP does not prohibit use of paroxetine with adults but stresses extreme caution in actual usage. Also withdrawal reactions upon stopping treatment is mentioned and therefore it is recommended to gradually reduce the dose over several weeks or months if decision of withdrawal is made.

Most common

Less common

Check with your doctor if these continue or are bothersome.

 Rare

See your doctor if you have any of these symptoms.

 Very rare but serious

 Other

  • Teratogenicity: Pregnant women are advised not to take the drug due to possible fetal heart defects.[19]

Paroxetine and other SSRIs have been shown to cause sexual side effects in most patients, both males and females[20].

Schmitt et al. (2001) suggested that paroxetine negatively affects cognition (i.e., IQ). In their study, healthy participants given paroxetine for 14 days (20mg for days 1-7 and 40mg days 8-14) showed poorer recall of words on day 14 compared to those receiving a placebo. Schmitt and co-workers, however, did not account for significant differences in verbal recall at baseline between those receiving paroxetine and those receiving a placebo, differences which produced the significant finding. Furthermore, participants receiving paroxetine recalled as many words at baseline as they recalled on day 14. Accordingly, the conclusion that paroxetine affects verbal recall was unwarranted.

Paroxetine, however, is known to worsen dementia in patients with cognitive impairment. The permanency of these impairments is unknown. (Modrego et al. 2007; ...)[citation needed][clarify]

 Withdrawal syndrome

Main article: SSRI discontinuation syndrome

Many psychoactive medications can cause withdrawal symptoms upon discontinuation from administration. Evidence has shown that paroxetine has among the highest incidence rates and severity of SSRI discontinuation syndrome of any medication of its class.[21][22] Common paroxetine withdrawal symptoms include repeated electrical shock sensations of the brain and body (see "brain zaps"), vertigo and hot flashes.[23] Suicidal ideation is a frequently reported experience in those withdrawing from SSRIs.[24] For those experiencing extreme and unusual difficulty discontinuing paroxetine, it is recommended that an SSRI with a longer half-life, such as fluoxetine, be administered for approximately two weeks, then discontinued, to lessen symptoms.[25][26]

For 10 years, GlaxoSmithKline's marketing of the drug stated falsely that it was "not habit forming".[27][28] In 2002, the U.S. FDA published a new product warning about the drug, and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) declared GSK guilty of misleading the public about paroxetine on US television.[21] The British Medical Journal quoted Charles Medawar, head of Social Audit: "This drug has been promoted for years as safe and easy to discontinue.... The fact that it can cause intolerable withdrawal symptoms of the kind that could lead to dependence is enormously important to patients, doctors, investors, and the company. GlaxoSmithKline has evaded the issue since it was granted a licence for paroxetine over 10 years ago, and the drug has become a blockbuster for them, generating about a tenth of their entire revenue. The company has been promoting paroxetine directly to consumers as 'non-habit forming' for far too long."[21] As of 2007, GlaxoSmithKline's prescribing information acknowledges the symptoms but eschews the term "withdrawal" in favor of the phrases "serious discontinuation symptoms" and "discontinuation syndrome."[29]

Patients considering paroxetine should be warned in advance of these risks, and withdrawal from any SSRI should be closely medically supervised by the prescribing provider.

Warning for pregnant women

Pregnant women and those who might become pregnant should avoid taking the antidepressant Paxil because of a high risk of birth defects, according to a committee of obstetricians who published their opinion in the December 2006 issue of the journal Obstetrics & Gynecology.[30]

The obstetric practice committee of the American College of Obstetricians and Gynecologists said pregnant women should not take Paxil because two previous studies found that the drug posed up to double the risk of heart defects in fetuses.

Nearly a year ago, the U.S. Food and Drug Administration (FDA) and GlaxoSmithKline -- which makes Paxil -- changed the warnings on the drug to include the results of the studies. The FDA then advised pregnant women to merely switch from Paxil to another SSRI drug, such as Prozac or Zoloft.

The FDA's enhanced warning on Paxil followed the results of a review of Sweden's birth registry that found pregnant women who took Paxil were 1.5 to 2 times more likely to give birth to a baby with heart defects than women who took other SSRIs or who did not take antidepressants at all.

Neonatal withdrawal symptoms from Paxil have also been documented from mothers taking Paxil during pregnancy.[31]

Controversy

In May 2007 a US court approved a settlement in a class action lawsuit brought on behalf of everyone in the United States who purchased Paxil or Paxil CR prescribed for a minor. The lawsuit alleged that GlaxoSmithKline promoted Paxil or Paxil CR for prescription to children and adolescents while withholding and concealing material information about the medication's safety and effectiveness for minors. GSK denied all claims. The settlement terms entitled everyone, who previously purchased Paxil or Paxil CR for the child or ward, to recover up to 100% of the documented out-of-pocket expenses or $100, if the documentation was not available.[32] [33]

In the UK since 2001 lawsuits have been filed representing people who have been prescribed Seroxat. They allege that the drug has serious side effects, which GlaxoSmithKline downplayed in patient information.[34][35]

In March 2004 the FDA ordered a black box warning placed on SSRI and other antidepressants, warning of the risk for potential suicidal thinking in children and adolescents.[36][37] ABC News reported that the prescribing of these medications to children subsequently dropped by 20 percent. [38] According to the Center for Disease Control and Prevention's Annual Summary of Vital Statistics, the suicide rate rose more than 18 percent in those 1 to 19 years old, from 2.2 per 100,000 in 2003 to 2.6 per 100,000 in 2004. In those 15 to 19 years old, the figures reflected a more than 12 percent rise in suicide, from 7.3 per 100,000 in 2003 to 8.2 per 100,000 in 2004.[38] This led many experts to conclude that the warning, and subsequent reduction in the use of antidepressants, led to an increased suicide rate in this age group.[39] The finding is consistent with an earlier finding, reported to the 2003 FDA Advisory Committee by Dr David Shaffer, that suicide rates in the United States fell during the 1990s, in line with the introduction of SSRIs.[40]

Since the FDA approved paroxetine in 1992, approximately 5,000 U.S. citizens have sued GSK. Most of these people feel they were not sufficiently warned in advance of the drug's side effects - including particularly the withdrawal syndrome discussed above, after GSK had specifically advertised the drug as "not habit forming."[27]

On January 29 2007, the BBC in the UK broadcast a fourth documentary in its 'Panorama' series about the drug Seroxat.[41] This programme, entitled Secrets of the Drug Trials, focused on three GSK paediatric clinical trials on depressed children and adolescents. Data from the trials show that Seroxat could not be proven to work for teenagers. Also, one clinical trial indicated that adolescents were six times more likely to become suicidal after taking it.