Playing Fight for Kids: Prescriptions and Suicide

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According to the parent-website, Prescription:  Suicide?, the Downings share the tragic story of their 12 year old daughter who was found hanging from a valence of her bed.  [The film, which features 6 families was produced in 2005]

"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.

 The Candace Downing Story, (not to be confused with the Candace Newmaker [Candace Tiara Elmore] story), is a must-read and see for ALL parents, as it relates to the risks and benefits of treatement (in this case, prescription drug use on children), and informed consent.

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

One year before the film was produced, an article found in Time.com made headlines:  Medicine: Prescription For Suicide? 

Bold/highlighted text is my own edit.

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

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 a person reads an autopsy report and concludes, "most victims hadn't taken an antidepressant, or had taken an overdose, in the hours before their death."  Um, wouldn't common sense dictate - if the drug was present in the system, the drug would have an effect on behavior?  In other words, what was the level of the drug/hormones in the bloodstream at the time of death, and would that level cause harmful effects?

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 physician 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 Physician Desk Reference, the bible-like drug reference book found on virtually every hospital floor I have ever worked on.  [In fact, I wonder just how many drug companies are praying physicians are NOT doing their homework, like a good responsible physcian with a prescription pad, should?

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 new odd behaviors (like anxiety related to test-taking, school, social situations) a medication that can cause the following:

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

  • Weight loss or gain (most often gain)
  • Headache
  • Nausea
  • Dry mouth
  • Increased sweating
  • Drowsiness/Somnolence or Insomnia
  • Increased or decreased appetite
  • Constipation or diarrhea
  • Inability to achieve orgasm
  • Partial or complete loss of libido (sexual desire)
  • Erectile dysfunction
  • Tremor
  • Vertigo/Dizziness/Motion sickness

Less common

Check with your doctor if these continue or are bothersome.

  • Increased feelings of depression and anxiety (initially)
  • Apathy
  • Loss of empathy
  • Flattening of emotional response
  • Nocturnal salivation
  • Nocturnal bruxism (teeth grinding)
  • Pupil dilation
  • Asthenia or muscle weakness
  • Muscle ache
  • Pruritis
  • Rash
  • Nightmares or change in dreams
  • Change in sense of taste

 Rare

See your doctor if you have any of these symptoms.

  • Myoclonus (involuntary muscle twitching)
  • Sodium depletion
  • Severe restlessness or akathisia
  • Uncharacteristic levels of aggression (especially in children)
  • Uncharacteristic risk taking

 Very rare but serious

  • Suicidal ideation and Suicide
  • Serotonin syndrome
  • Bipolar mania or hypomania
  • Schizophrenia (unverified)
  • Jaw, neck, and back muscle spasms
  • Fever, chills, sore throat, or flu-like symptoms
  • Yellowing of the skin or eyes (Jaundice)
  • Black, tarry stools (this can indicate upper GI bleeding)

 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

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.

And more compelling, how many parents would be willing to "go against medical advice", if the doctor reported back to social services, "Parents refuse medical tratment for the child exhibiting x,y,z, behaviors"?

There are many many shades of gray in this country that wants to say NO to street drugs, but YES to the doctor/ pharamacy relationship.  Parents of all types, (biologic, foster, adoptive, step)  need to know what they are giving their children, and why informed consent is so critical in the doctor/patient relationship.  

Pound Pup Legacy