Those of the public who attend FDA advisory committee meetings have witnessed demonstrable indefference to the plight of children who have suffered severe, life-threatening adverse drug effects. Recent hearings involved psychostimulants and other psychotropic drugs prescribed for what is acknowledged a condition not validated by any scientific criteria–as no reliable diagnostic tools exist to ensure that healthy children are not falsely "diagnosed" and swept up into a life of drug dependency.
Child psychiatrists shamelessly lobbied against strong warnings about the validated risks of harm. FDA officials twiddle their thumbs and shrug off evidence of causal drug-induced cardiac arrest, psychosis and violent behavior leading to tragedies–as if the children were mere statistical dots on a chart.
One is never quite prepared to witness how doctors sworn to "do no harm" betray their human and professional responsibility by lobbying against full public disclosure about the life-threatening risks posed by widely prescribed drugs. The motivation is likely to be found in their financial ties to psychotropic drug manufacturers.
Betrayed by the medical profession and government oversight agencies, the public must rely on trial lawyers to stop the irresponsible marketing of toxic drugs that have triggered lethal behavior–including suicide–in young children. There is probably no greater crime than knowingly putting a child’s life in danger for financial gain.
Below a press release from the lawfirm, Baum Hedlund, announces it has filed a class action lawsuit against GlaxoSmithKline charging the company with fraud, negligence, strict liability, and breach of warranty in its marketing of Paxil (Seroxat) by concealing the risk of suicide.
Earlier the firm settled a class action lawsuit against Pfizer, the maker of Zoloft (sertraline).
Two children named in the lawsuit:
11-year-old Trevor Blain was prescribed Paxil for "separation anxiety disorder" by his pediatrician in October 2000. He immediately began having difficulty sleeping and had angry outbursts while on Paxil, but his family did not make the connection between his deteriorating behavior and the drug. He continued taking the medication as prescribed. In early November 2000, Trevor hanged himself with his dog’s leash in the family laundry room. Although he survived the suicide attempt, he remained comatose for several weeks and died on December 7, 2000.
17-year-old Tonya Brooks was a shy high school student. Her family doctor diagnosed her with "social anxiety disorder" and prescribed Paxil in 2004. She became agitated, aggressive and had difficulty sleeping while taking Paxil. She first attempted suicide by taking an overdose of Paxil and a sleeping medication, Ambien. She survived the attempt and two days later gouged a hole in her leg with a pair of scissors. She was hospitalized for several days.
"GSK has defrauded the medical profession, the Paxil patient population, and the general public."
The suit will be closely watched as it promises to widen the net to reveal a Who’s Who among those responsible for a pattern of deception and corrupt practices in the marketing of a dangerous antidepressant targeting the pediatric population.
Contact: Vera Hassner Sharav
veracare@ahrp.org
March 23, 2006
FOR IMMEDIATE RELEASE
Baum Hedlund
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA 90025
Contact: Robin McCall, Media Relations
Day: (800) 827-0087 or (310) 207-3233
Email: RMcCall@BaumHedlundLaw.com
Web: www.baumhedlundlaw.com
National Class Action Filed against Drug-maker for Paxil-induced Suicides in Youths
Los Angeles, March 23, 2006 – – The mother of an 11-year old Wichita, Kansas boy who committed suicide on Paxil and a teenager from Pflugerville, Texas (a small town outside of Austin) who attempted suicide while taking Paxil, jointly filed a national class action lawsuit today in federal court in Philadelphia, Pennsylvania, the hometown of Paxil-maker, Glaxo SmithKline. The two plaintiffs theoretically represent all individuals under the age of 18 in the United States who attempted suicide or the families of individuals who killed themselves as a result of an adverse reaction to Paxil. The complaint charges include fraud, negligence, strict liability and breach of warranty. (See attached Lawsuit Allegations.)
The FDA has required all antidepressant manufacturers to place a black box warning in their labels alerting physicians and patients to the increased risk of suicidality, which went into effect in January 2005.
The Plaintiffs
11-year-old Trevor Blain was prescribed Paxil for "separation anxiety disorder" by his pediatrician in October 2000. He immediately began having difficulty sleeping and had angry outbursts while on Paxil, but his family did not make the connection between his deteriorating behavior and the drug. He continued taking the medication as prescribed. In early November 2000, Trevor hanged himself with his dog’s leash in the family laundry room. Although he survived the suicide attempt, he remained comatose for several weeks and died on December 7, 2000.
17-year-old Tonya Brooks was a shy high school student. Her family doctor diagnosed her with "social anxiety disorder" and prescribed Paxil in 2004. She became agitated, aggressive and had difficulty sleeping while taking Paxil. She first attempted suicide by taking an overdose of Paxil and a sleeping medication, Ambien. She survived the attempt and two days later gouged a hole in her leg with a pair of scissors. She was hospitalized for several days.
Tonya is one of six youths featured in a new documentary film entitled "Prescription: Suicide?" The film will be screened at the upcoming Beverly Hills Film Festival on April 8, 2006. The documentary takes an intimate look at children and teens who have committed suicide or attempted suicide while taking antidepressants and the impact these tragic events have had on their families. Tonya’s mother, Cheryl Brooks stated: "No parent should have to go through what we did." Explaining her horror when she found her daughter sprawled on the bathroom floor after her suicide attempt, Mrs. Brooks stated: "[T]here was blood everywhere…. [The manufacturers of these drugs] should be paying for this. They gave these medicines to these kids – that’s murder…" http://www.prescriptionsuicide.com/
Baum Hedlund partner, Karen Barth Menzies, stated regarding the lawsuit: "Through our Paxil litigation, we’ve obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children. That’s about as reprehensible as you can get. Governmental regulators around the world have now analyzed the actual data from the clinical trials, not GSK’s version of it, and have found an increased risk of suicidality. Yet the drug companies and their hired mouthpieces in the medical academic community, including the pediatric arm of the APA [American Psychiatric Association], continue to downplay the Black Box Warning as an "over-reaction" by FDA. They continue to try to hide this risk from parents for the sake of profits. We wanted to make sure the rights of all of these kids are protected by filing this lawsuit."
The Lawsuit’s Allegations
Paxil was introduced into the U.S. market on December 29, 1992, and is a well known antidepressant medication in the same class as Prozac, Zoloft, Effexor, Celexa and Lexapro (selective serotonin reuptake inhibitors or "SSRI’s"). Paxil is approved for marketing in the United States for conditions such as depression, obsessive compulsive disorder, panic disorder, and "social anxiety disorder." It is not approved for pediatric use.
Although a number of clinical trials have been conducted in the pediatric population, Paxil has never been approved by the FDA for use in children/adolescents because the studies show that the drug doesn’t work. (¶ 18.)
The studies show a more than doubling of the risk and in one study, there was a nearly 6 times increase of suicidal thoughts and behavior compared to placebo. (¶ 19.)
Not until 2002 was it recognized that GSK had been coding suicidal behavior as "emotional lability," thus hiding the risk. (¶ 19.)
Notwithstanding the clinical trials which showed Paxil to be ineffective for pediatric patients and associated with an increased risk of serious, and possibly deadly, side effects, GSK engaged in a campaign to promote the use of Paxil for use with pediatric patients. (¶ 20.)
GSK, faced with the negative results from the pediatric studies, began a campaign to reduce the negative impact of this bad study data. GSK prepared a medical journal article regarding Study 329 that was not only "ghost written," but falsely stated that Paxil was superior to placebo among "four of the parameters," including one which was identified as a "primary outcome measure." In fact, GSK knew that Paxil was not found to be superior to placebo amongst any of the "primary outcome measures." Further, the article stated that "most adverse effects were not serious," and failed to list suicide-related events as "serious." (¶ 20.)
In a document directed to "all sales representatives selling Paxil," a GSK manager stated that, according to the "Keller" article, "Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression." (emphasis in original). The document states that "the findings of this study provide evidence of the efficacy and safety of Paxil in the treatment of adolescent depression." As GSK well knew, study 329 found Paxil to be neither effective nor safe. (¶ 20.)
GSK also hired doctors to go around the world and promote the use of Paxil for pediatric patients by way of "posters" and lectures at medical conferences. These "posters" and their presenters claimed that Paxil was effective for treating adolescent depression and free from serious side effects. In fact, GSK knew that to be false. (¶ 21.)
In internal, unpublished documents, which have been kept from public and regulatory scrutiny via the stratagem of over-broad "confidentiality" designations, GSK has made numerous admissions about Paxil’s associated harmful side effects and lack of effectiveness in children and adolescents. Notwithstanding these admissions, in flagrant and conscious disregard and indifference, GSK has denied publicly that such nexus exists, and has failed utterly to take any measures whatsoever to alert the public, the prescribing physicians, and the patients who take it, of the incipient dangers associated with Paxil. (¶ 72.)
GSK has defrauded the medical profession, the Paxil patient population, and the general public in that it, among other acts:
(a) Hired a firm to "ghostwrite" an article that was widely publicized which claimed, falsely, that Paxil was effective and safe for the treatment of depression with children and adolescents;
(b) Hired doctors to present "posters" around the world at medical conferences which claimed, falsely, that Paxil was effective and safe for the treatment of depression with children and adolescents;
(c) Fraudulently mischaracterized and miscoded adverse events involving self-harm with the term "emotional lability" so as to reduce the number of occurrences and hide their existence from the public and regulators;
(d) Failed to inform the medical and research communities that a significant number of pediatric patients taking Paxil during clinical trials attempted acts of self-harm at a rate that was at least twice that for pediatric patients who took placebo;
(e) Fraudulently claimed that Paxil’s characteristic side effects of insomnia, agitation and anxiety were of little or no concern when in fact these effects are known to be among the most critical and deadly of the short-term risk factors for self-harm;
(f) Fraudulently denied Paxil’s association with serious or deadly thoughts or acts of self-harm when its own investigators informed GSK (and GSK determined itself) that Paxil was associated with such conditions;
(g) Allowing the use of concomitant medications in clinical trials to lessen side
effects in order to avoid the reporting of treatment-emergent adverse events, such as akathisia;
(h) Aggressively promoted Paxil to doctors for use with pediatric patients even though Paxil was not, and is not, approved for use with children and adolescents.
In early 2005, GSK updated Paxil’s label to include a "black-box" warning, which is the strongest warning allowed for by FDA regulations. That warning states:
Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of PAXIL or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PAXIL is not approved for use in pediatric patients. (See WARNINGS and PRECAUTIONS — Pediatric Use)
Pooled analysis of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4,400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.
About Baum Hedlund and Karen Barth Menzies
Baum Hedlund is one of the leading national law firms representing antidepressant suicide and suicide attempt victims across the country. The firm represents approximately 50 victims, over one third of those are children and adolescents.
Since 1990, Baum Hedlund has been handling SSRI (selective serotonin reuptake inhibitors) suicide/violence cases and served on the Plaintiffs’ Steering Committee in the first SSRI-suicide litigation involving Prozac (the first SSRI approved by the FDA for marketing in the U.S.).