LARGO – Pinellas County School Board members on Tuesday refused to subject students to suicide screenings, quashing any hope of introducing a controversial mental health plan in two of Florida’s largest school districts.
Board members took less than 30 minutes to reject a proposal to change a policy that prohibits surveys such as TeenScreen, a test designed to spot suicidal thoughts and other mental health disorders in youngsters.
Their decision met with applause from an audience of nearly 140 people, mostly members of the Church of Scientology, whose adherents have overwhelmed the board with e-mail expressing outrage over the proposal.
Linda Lerner was the only board member to support the proposal, and she accused her colleagues of flinching before the e-mail blitz, a gesture that drew shouts and murmurs from the audience.
Lerner called teen suicide “a real issue and a real problem, [and] this board is being stopped from even discussing it.”
Board members objected to Lerner’s comments. They cited unease over a screening they said was inappropriate for students. Some said the test questions are too intrusive, and it was unclear who would help students once problems were discovered.
David Shern, dean of the Louis de la Parte Florida Mental Health Institute at the University of South Florida, had asked the school board to change its policy and allow TeenScreen.
There is too much confusion about the program, which requires consent from parents and students, Shern said.
The board received e-mail from people who tried to derail the proposal by spreading erroneous information about TeenScreen, he said. “I am very disappointed.”
TeenScreen was developed by New York’s Columbia University and is used in 41 states. Students spend about 10 minutes answering 30 questions designed to gauge their mental health.
If therapists or psychologists find problems, they interview the teen and provide options for mental health services, if appropriate.
The Hillsborough County school district in recent months also considered the program.
Administrators, however, worried that there would be no long-term help for students without health insurance, and they found the test too intrusive.
The Pinellas school board has received more than 700 e-mail messages about TeenScreen. Most of them are from Scientologists who consider psychiatry and psychology abominations. Church members said all parents should worry about exposing their children to such testing.
Before this week, Pinellas school board member Jane Gallucci sought more information about the program.
She said Tuesday that she was angry that Laurie Flynn, of Columbia University, told a U.S. Senate committee on health and education matters 10 months ago that pilot TeenScreen programs were operating in Hillsborough and Pinellas counties.
Shern said Flynn meant only that mental health specialists and the school districts were working to develop the program in one Tampa high school and in one St. Petersburg high school. Flynn has sent a letter of apology to the Pinellas County School Board, Shern said.
For more information on TeenScreen, go to www.psychsearch.net/teenscreen.html
Prozac: A class action lawsuit is filed in Montreal
MONTREAL, Jan. 14, CNW Telbec
A class action lawsuit was filed before the Superior Court in Montreal this morning. Giant drug maker Eli Lilly is alleged to have withheld vital information on the safety of Prozac, its flagship drug for years. Yesterday, the Indianapolis based drug maker completely vindicated the British Medical Journal, which it had charged earlier this week with misleading its readers, when it posted a document on its website called Annotations. Eli Lilly had been invited on numerous occasions to answer whether a document called Summary of a preliminary analysis of clusters of adverse events based on pooling data from multiple studies was authentic and whether it had been released to health authorities around the world.
Eli Lilly confirmed the authenticity of the document and implicitly admitted that it had never been released to health authorities, including the FDA, or anyone else. The document consisted of data stemming from numerous studies conducted by Eli Lilly and that showed that Prozac caused activation in 38% of its users compared with 19% with placebo and 4% for Tricyclic, a then well known drug in the treatment of depression.
When Eli Lilly representatives attended the FDA hearings on the safety of Prozac in 1991, they had known the existence of the study for years but failed to disclose it to the FDA, in the word of the lead plaintiff’s attorney, “lest it should warrant a much stringent warning on the label of the drug with regard to its safety, thereby seriously hampering Eli Lilly’s efforts to market its new drug as effective and safe.” In the words of Serge Petit of the law firm Petit Desjardins based in Montreal, Canada, that represents the lead plaintiff “such a likelihood was looming large since Eli Lilly knew that if doctors had been made aware that Prozac, back then being introduced as the new kid on the block, caused activation in 38% of its users compared with 19% of patients taking a placebo and 4% of those taking a drug then well known to doctors, Tricyclic, they would certainly have hesitated before prescribing Prozac. It was nearly a ten folds increase in activation compared with the other drug they could prescribe.”
The lead plaintiff contends that the reason why Eli Lilly failed to disclose the document to Health authorities was that it would have placed another study, that consisted of a pooling of what is called spontaneous reports and showed alarming increases in suicide attempts and other violent acts in patient using Prozac as compared with four other drugs, in a totally new perspective and prevent it from being dismissed by FDA and Eli Lilly as inconclusive. To Serge Petit “had the study on activation and the one on spontaneous reports been put side by side before the FDA, Eli Lilly would have faced an uphill battle as to the safety of its drug”.
The class action contends that Eli Lilly misled health authorities around the world and therefore the millions of users of its drug Prozac around the world as to the safety of its drug by failing to disclose the said document. To Serge Petit, “the passage of time cannot condone Eli Lilly’s behavior and it must be held accountable for circumventing the safeguards that have been put in place to protect the public health.” The lead plaintiff is seeking $10,000 in punitive damages and $5 000 for herself and each member of the group from Eli Lilly for misrepresenting the safety of its drug.
Papers indicate firm knew possible Prozac suicide risk
By Tom Watkins, CNN, Monday, January 3, 2005
(CNN) — An internal document purportedly from Eli Lilly and Co. made public Monday appears to show that the drug maker had data more than 15 years ago showing that patients on its antidepressant Prozac were far more likely to attempt suicide and show hostility than were patients on other antidepressants and that the company attempted to minimize public awareness of the side effects.
The document was provided to CNN by the office of Rep. Maurice Hinchey, D-New York, who has called for tightening FDA regulations on drug safety.
“The case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks,” he said.
The 1988 document indicated that 3.7 percent of patients attempted suicide while on the blockbuster drug, a rate more than 12 times that cited for any of four other commonly used antidepressants.
The document, which cited clinical trials of 14,198 patients on fluoxetine — the generic name for Prozac — also stated that 2.3 percent of users suffered psychotic depression while on the drug, more than double the next-highest rate of patients using another antidepressant.
In addition, the paper said that 1.6 percent of patients reported incidents of hostility — more than double the rate reported by patients on any of four other commonly used antidepressants.
The trials reviewed in the document said that 0.8 percent of users of Prozac reported causing an intentional injury — eight times the rate associated with any of the other antidepressants.
In the paper, titled “Activation and sedation in fluoxetine clinical trials,” the authors said that the drug may produce nervousness, anxiety, agitation or insomnia in 19 percent of patients, and sedation in 13 percent of patients.
The paper, apparently produced by the drug company’s marketing department, said “several suggestions may be helpful in presenting this information to physicians,” including emphasizing that more patients on another class of antidepressants stopped taking their drugs than did those on Prozac.
The existence of the document obtained by CNN and other documents was reported last week by the British Medical Journal. Its editors said the documents had been reported missing from a 10-year-old murder case, and that they had sent them to the U.S. Food and Drug Administration for review.
A spokesman for Lilly said his company was expecting the release of the purported internal documents, but that he could not comment on them until he had seen them.
The journal said the documents disappeared in 1994, during the case of Joseph Wesbecker, a printing press operator who had killed eight people at his Louisville, Kentucky, workplace five years before, while taking fluoxetine. He then shot and killed himself.
Each of the four pages of the paper obtained by CNN is stamped “Confidential” and “Fentress,” the name of one of Wesbecker’s victims.
In a civil suit against Eli Lilly, victims’ relatives contended the company had long known about the side effects of fluoxetine, including its alleged role in increasing a user’s propensity to violence.
Lilly initially won the case, but was later forced to admit that it had made a secret settlement with the plaintiffs during the trial, which meant that the verdict was invalid, the journal said.
The FDA has recently warned that antidepressants can cause side effects such as agitation, panic attacks, insomnia and aggressiveness.
FDA spokeswoman Susan Cruzan said last week that the agency had no comment on the documents.
US drug company knew that ‘Prozac could lead to violence’
Rhiannon Edward, The Scotsman, Fri 31 Dec 2004
CONFIDENTIAL drug company documents appearing to suggest a link between a popular anti-depressant and suicide and violence have been handed to authorities in the United States, it emerged today.
The British Medical Journal (BMJ) received the documents concerning the drug fluoxetine (Prozac) from an anonymous source and has now turned them over to the US Food and Drug Administration (FDA).
The papers reportedly went missing during a lawsuit filed on behalf of victims of a workplace shooting carried out by Joseph Wesbecker in Louisville, Kentucky, in 1989.
Wesbecker, who had a long history of depression and had been put on Prozac a month before the shootings, killed eight people and injured 12 others before killing himself.
In 1994, some of the relatives of the victims brought a civil suit against Eli Lilly, the makers of Prozac, alleging the company had for years known about the side-effects – including the fact Prozac might increase violence.
Although the company won the case, it was later forced to admit it had made a secret settlement with the plaintiffs, making the verdict invalid.
The documents sent to the BMJ include reviews and memos indicating that Eli Lilly officials were aware in the 1980s that Prozac had troubling side-effects and sought to minimise their likely negative effect on prescribing, according to Jeanne Lenzer, writing in the journal. One of the documents, dated November 1988, reported that in clinical trials, Prozac could cause behavioural disturbances.
The FDA has recently issued a warning that anti-depressants can cause stimulatory side-effects such as agitation, panic attacks and aggressiveness.
Dr Richard Kapit, the administration’s clinical reviewer who approved Prozac, told the BMJ that he was not given the Lilly data. “These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it,” he said.
The administration has agreed to review the documents passed on by the BMJ. The documents are now being reviewed by the office of Congressman Maurice Hinchey to determine whether Lilly withheld data.
“This is an alarming study,” Mr Hinchey said. “This case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs so patients and their doctors, not drug companies, decide if the benefits of taking a certain medicine outweigh the risks.”
December 9th, 2004
ABC’s Primetime Live featured a 20 minute segment on a 2 year investigation that reveals evidence that drug makers suppressed information about how antidepressants can affect children and adolescents. Includes testimony by parents who testified to the FDA about the loss of their children to SSRI-induced suicide.
December 3rd 2004
President Bush signs into law the Prohibition on Mandatory Medication Amendment.
President Bush has now signed into law the reauthorization of the Individuals with Disabilities in Education Act which includes the Prohibition on Mandatory MedicationAmendment. This amendment requires schools to implement policies that prohibit schoolchildren being forced onto psychiatric drugs as a requisite for their education.
Parents and teachers were not usually informed about documented side effects of many of these drugs, including suicide, violence, mania and psychosis and the new law bans school personnel from forcing parents to drug their children for classroom or behavioral problems.
October 15th 2004
US Orders New Warnings on Antidepressants for Kids
WASHINGTON (Reuters) – All antidepressants must come with tough warnings (Black Box labels) explaining that the drugs increase the chances of suicidal behavior in some children and teens, U.S. health officials said on Friday.
In an order to drug makers, the Food and Drug Administration said the information to be highlighted in a black box must also state whether the drug has, or has not been, cleared for use by children.
June 3rd 2004
OTTAWA – People of all ages who take newer antidepressant drugs may experience behavioural and emotional changes that may increase the risk of harming themselves or others, Health Canada warned Thursday.
The department strengthened its warning about Selective Serotonin Re-uptake Inhibitors (SSRIs) or Serotonin Noradrenalin Re-uptake Inhibitors (SNRIs).
The advisory applies to:
Bupropion (Wellbutrin and Zyban)
A small number of patients taking the drugs may feel worse instead of better, the advisory said.
Doctors, patients, families and other caregivers should be on the lookout for signs of suicidal thoughts or worsening depression, such as hostility, anxiety or insomnia, especially when a patient begins the drug therapy or whenever the dose is changed.
If someone feels worse, they should consult a doctor immediately. It is very important that patients do not stop taking their medication without first consulting a doctor, the advisory stressed.
In February, Health Canada advised patients under the age of 18 who were being treated with the SSRIs to consult a doctor.
Thursday’s stronger advisory is similar to a U.S. warning issued earlier this spring. Drug regulators in the U.K. have banned the use of most SSRIs in children.
Written by CBC News Online
June 2, 2004
New York Sues Maker of Antidepressant Drug Paxil
By THE ASSOCIATED PRESS, NEW YORK TIMES
Filed at 12:59 p.m. ET
NEW YORK (AP) — GlaxoSmithKline PLC committed fraud by withholding negative information and misrepresenting data on prescribing its antidepressant Paxil to children, according to a lawsuit filed Wednesday by New York Attorney General Eliot Spitzer.
The lawsuit, filed in New York State Supreme Court, said Glaxo suppressed four studies that failed to demonstrate the drug was effective in treating children and adolescents and suggested a possible increase of suicidal thinking and acts.
It also said an internal 1999 Glaxo document showed that the company intended to “manage the dissemination of data in order to minimize any potential negative commercial impact.”
Glaxo spokeswoman Mary Anne Rhyne said the company “has acted responsibly in conducting the studies in pediatric patients and disseminating results. All of our studies have been made available to the (U.S. Food and Drug Administration) and regulators worldwide.”
Rhyne also said the studies referred to in the suit have been made public in medical meetings, journals and letters to doctors. She said the internal document referenced in the suit “is inaccurate and inconsistent with the facts, and doesn’t express the overall company position.”
The lawsuit touches on two pharmaceutical and medical controversies: whether antidepressants increase suicidal tendencies in children, and if drug companies should be required to disclose all studies they conduct on their medicines.
Paxil is not approved for use in children, but doctors can prescribe drugs as they see fit and routinely recommend antidepressants for children suffering from depression and other psychological disorders.
Only Prozac, which is made by Eli Lilly & Co., has been approved for use in children. According to Spitzer, Glaxo’s revenues for Paxil prescriptions in children and adolescents totaled $55 million in 2002.
The lawsuit seeks the return of all profits obtained by Glaxo as a result of conduct alleged in the suit.
Glaxo’s U.S. shares fell 94 cents, or 2.2 percent, to $41.83 in midday trading on the New York Stock Exchange.
Over 4,000 doctors face charges in Italian drugs scandal
John Hooper in Rome and Heather Stewart
Thursday May 27, 2004
One of the biggest inquiries into marketing practices in the drugs industry ended yesterday with Italian police asking for almost 5,000 people to be put on trial, including more than 4,000 doctors and at least 273 employees of the British pharmaceuticals giant, GlaxoSmithKline. Some face up to five years in jail if tried and convicted.
Italy’s revenue guard, the Guardia di Finanza, said in a statement that GlaxoSmith- Kline and its predecessor firm had spent €228m (£152m) on “sweeteners” for doctors, chemists and others over four years. The alleged bribes ranged from cameras, computers and holidays to outright cash payments.
The Guardia di Finanza said GlaxoSmithKline “should be held responsible for corporate crime as its managers and other employees acted in the company’s interest”.
A spokesman for GSK said last night it had been “cooperating closely with the authorities to facilitate their investigations. GSK is committed to ensuring that all its business practices are of the highest standards and any breach of that is unacceptable”, the spokesman added.
But a British-based pharmaceuticals analyst said yesterday the type of activity the Italian authorities allege to have uncovered is common practice among global drug companies.
“In parts of Europe, these things are absolutely rife,” he said. “For example, doctors may be given ‘research grants’ – but there are no limits on how they can spend them.” He cited cases in which doctors had been offered cars or holidays as inducements to prescribe a particular brand.
Italy’s Adnkronos news agency reproduced what it said was a letter written by a GlaxoSmithKline district manager contained in the 10,000 pages of evidence assembled by the Guardia di Finanza.
The letter urged sales representatives to approach specialists directly to get them to prescribe a cancer drug produced by the company. “The initiative can work well with oncologists who have congresses, invest ments from us … and who have not given us anything in return,” the district manager was quoted as writing. Illicit incentives were said to have been disguised in the firm’s accounts under the headings of “field selling”, “other promotion” and “medical phase IV”.
Of the 4,713 people from all parts of Italy facing charges, 4,440 are doctors. They include more than 2,500 GPs and some 1,700 specialists.
The most serious accusations have been levelled at doctors, pharmacists and sales representatives alleged to have been involved in a programme intended to promote Hycamtin, a drug mainly used in the treatment of lung and ovarian cancers. In some cases, it is claimed, specialists received a pro rata cash payment based on the number of patients treated with the drug.
At a press conference yesterday, a senior revenue guard officer, Giovanni Mainolfi, estimated the investigation was costing GlaxoSmithKline’s Italian subsidiary €400m a year in lost sales