Family Wonders if Prozac Prompted School Shootings

US: RED LAKE, Minn., March 25 - In their sleepless search for answers, the family of Jeff Weise, the teenager who killed nine people and then himself, says it is left wondering about the drugs he was prescribed for his waves of depression.

On Friday, as Tammy Lussier prepared to bury Mr. Weise, who was her nephew, and her father, who was among those he killed, she found herself looking back over the last year, she said, when Mr. Weise began taking the antidepressant Prozac after a suicide attempt that Ms. Lussier described as a "cry for help."

"They kept upping the dose for him," she said, "and by the end, he was taking three of the 20 milligram pills a day. I can't help but think it was too much, that it must have set him off."

Lee Cook, another relative of Mr. Weise, said his medication had increased a few weeks before the shootings on Monday.

"I do wonder," Mr. Cook said, "whether on top of everything else he had going on in his life, on top of all the other problems, whether the drugs could have been the final straw."

The effects of antidepressants on young people remain a topic of fierce debate among scientists and doctors.

Last year, a federal panel of drug experts said antidepressants could cause children and teenagers to become suicidal. The Food and Drug Administration has since required the makers of antidepressants to warn of that danger on their labels for the medications.

The suicide risk is particularly acute when therapy starts or a dosage changes, the drug agency has warned.

Although some studies link the drugs to an increased suicide risk, the research does not suggest such a connection to violence like Mr. Weise's rampage through Red Lake High School.

Without knowing Mr. Weise's medical history or precise diagnosis, it is virtually impossible to speculate on what factors may have affected him - the drugs, his underlying depression, a gloomy childhood wrapped in tragedy or something else entirely.

"What I can say is that his physician, I'm sure, made the appropriate recommendations based on whatever the dosages were," said Morry Smulevitz, a spokesman for Eli Lilly, which makes Prozac.

The dosage range, Mr. Smulevitz said, runs from 20 milligrams to 80 milligrams a day, so Mr. Weise's 60 milligram dose fell in that bracket. Mr. Weise, though just 16, was taller than 6 feet and weighed 250 pounds.

Ms. Lussier, who lived with Mr. Weise in her mother's house on the Red Lake Indian reservation in far northern Minnesota, said she could not understand what else, aside from drugs, had changed to explain his sudden violence.

Since his suicide attempt and 72-hour hospitalization a year ago, Mr. Weise had seemed to be improving, she said, and he was receiving mental health counseling and a doctor's care at the medical center on the reservation.

Others in Red Lake said, however, that they had seen few signs of improvement in the dour, solitary boy.

The driver of a school bus, Lorene Gurneau, said she often saw Mr. Weise standing outside the middle school, wearing his long black clothes and strange hairdos, staring off into nothing, in a daze, even as children raced by or teachers passed him.

Still, in at least one Internet posting last fall, Mr. Weise sounded determined to improve his life after his suicide attempt, and he noted that he was taking antidepressants.

"I had went through a lot of things in my life that had driven me to a darker path than most choose to take," the posting said. "I split the flesh on my wrist with a box opener, painting the floor of my bedroom with blood I shouldn't have spilt. After sitting there for what seemed like hours (which apparently was only minutes), I had the revelation that this was not the path."

"It was my decision," he went on, "to seek medical treatment, as on the other hand I could've chose to sit there until enough blood drained from my downward lacerations on my wrists to die."

On Monday, in the hours before the shooting, Mr. Weise had seemed cheerful and normal, Ms. Lussier said. His teacher, who was spending an hour a day at his house as part of a "homebound" study program that the school system had created because of his troubles, arrived to give him his homework assignments, as usual. At 12:30 p.m., less than three hours before the shootings, another aunt, Shauna, stopped in.

"He was watching a movie on TV," Ms. Lussier said. "There was nothing out of the ordinary. People keep saying he was depressed, but if you saw him, he was getting better. All we can think of is, what about the drugs?"

Though research has not linked antidepressants to acts of violence on others, several incidents have gained wide publicity.

In 1989, Joseph Wesbecker walked into a printing plant in Louisville, Ky., with a bag of guns and killed eight co-workers and himself. He was taking Prozac, which had recently been approved.

In 1999, a student involved in the Columbine High School shootings in Colorado had reportedly taken Luvox, an antidepressant similar to Prozac.

In 2001, Christopher Pittman killed his grandparents while taking Zoloft, another antidepressant similar to Prozac. His lawyers faulted the drug, but a jury in Charleston, S.C., convicted him of murder in February.

Still, Katherine S. Newman, a professor at Princeton University who has studied school killings, said just a small percentage appeared to have possibly involved psychiatric drugs. Of 27 such killings from 1974 to 2001, fewer than one-fifth of the suspects had been diagnosed with a mental health disorder before the shootings,

Professor Newman said. Dr. Frank Ochberg, a former associate director of the National Institute of Mental Health, said he once dismissed any links between antidepressants and suicides or homicidal acts. The recent research, however, has changed his mind, Dr. Ochberg said.

"If your intention is shooting the place up and dying as you do it, you can put the fantasy together," he said. "Suicidal and homicidal intentions together could theoretically follow the same path."

Monica Davey reported from Red Lake for this article, and Gardiner
Harris from Washington. Jodi Wilgoren contributed reporting from New York.

By MONICA DAVEY posted 29 March 05

Illustration:

Mother's Little Helpers
Approved for adults only, Prozac is being used to medicate children as young as 8 years old. Why are we using powerful drugs to raise our daughters?

N.R.A. Aide Urges Armed Teachers

PHOENIX, March 25 (AP) - All options should be considered to prevent rampages like the Minnesota shooting, including making guns available to teachers, Sandra S. Froman, first vice president of the National Rifle Association, said.

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Drugs licensing flaws exposed

Special report: Pfizer advised on how to get antidepressant approved by member of body deciding on application.

A leading figure in the world of psychiatry gave a pharmaceutical company advice on how to get its new drug approved while he was sitting on the committee which was deciding the licence application.

An internal memorandum from Pfizer, the world's largest drug company, says Stuart Montgomery would be happy to become a paid adviser and declare an interest to the Committee on the Safety of Medicines (CSM) once the drug, an antidepressant to rival Prozac, had been through the licensing process.

The drug, sertraline, which acquired the brand name Lustral, became a billion-dollar success, but is now one of several banned from use in children in the UK because of evidence they can cause them to become suicidal. Their use in adults is under investigation.

Dr Montgomery says his ad vice to Pfizer in 1989 was permissible because he was not receiving money from the company at the time. But Kent Woods, chief executive of the drug regulatory body which grants licences on the advice of the CSM, said such conduct was "absolutely unacceptable".

"Not only does each member [of the CSM] on appointment sign a letter ensuring confidentiality but at every meeting, the chair as a matter of routine reminds everybody that proceedings are confidential," he said. If the company had questions, they should have talked to officials of the Medicines and Healthcare products Regulatory Agency (MHRA), not the independent CSM experts.

Critics say the case exposes weaknesses in the drug licensing system, run by a regulatory body which, other papers obtained reveal, it has an unquestioning relationship with drug companies.

That relationship is so close that the pharmaceutical trade body in June drew up a business plan for the regulator, concluding: "Our priorities are aligned."

In the first of a two-part investigation into the influence of the drug companies over doctors and government intimacy between the industry and the regulator.

The MHRA is responsible for licensing medicines and regulating the industry. It relies on the advice of the independent experts on the CSM when it grants a new product licence. These experts, from all fields of medicine, are supposed to declare any pharmaceutical company interests, such as consultancies, fees and shareholdings, and must leave the room when drugs from companies that have paid them are discussed.

During his time on the CSM, Dr Montgomery disclosed payments for lectures and advice from Eli Lilly, the makers of Prozac, and from Organon, Beecham, Merck, Sanofi, Glaxo, Novo, Jouveinal, Duphar, Wyeth and Almirall.

Dr Montgomery, who held a joint post with St Mary's hospital, Paddington, and Imperial College in London, was a psychiatric expert on the CSM. His opinion was crucial in 1989, when the Medicines Control Agency as it was then known was considering an application from Pfizer for a licence for sertraline.

A confidential internal memorandum from Pfizer, dated April 24 1989, which was submitted in evidence to a recent court case in the US, has together with Mind, the national association for mental health, which has been campaigning for better drug regulation. Richard Brook, its chief executive, will today call for an external inquiry. "There is clear confusion about the role that Dr Montgomery was playing in this situation," he said.

"It also makes it very difficult for outsiders to believe there was not a serious conflict of interest when one of the major experts on depression involved in the CSM is actually speaking to a drug company about how they best present their results for licencing."

Dr Montgomery became a professor of psychiatry at Imperial College in 1993. The journal he edits, International Psychopharmacology, regularly publishes company-funded studies of antidepressants, as other journals do. He authors many of the papers, often jointly with other senior figures in the field.

The memo reveals that Dr Montgomery met Pfizer officials at St Mary's. He told them the committee had accepted that the drug was effective but "the safety analyses require re-presentation" and he advised them how to go about it.

He told Pfizer they must appeal against the CSM's initial decision. The memo reveals that Dr Montgomery is not going to declare an interest in Pfizer.

"He would still like to remain a disinterested party at the CSM till the appeal was heard," says the memo. "Thereafter he would be happy to act as an adviser to Pfizer and declare an interest."

The Pfizer drug got its approval first in the UK. Other European regulators were not happy that the data from clinical trials proved it worked.

Dr Montgomery said he had no conflict of interest over Pfizer. "My comments to Pfizer in 1989 were the usual clarification of the objections of the CSM to their application. At that time I had no conflict of interest with Pfizer, I was not a paid consultant, I was not in receipt of research grants from Pfizer, and I did not own shares in Pfizer," he said.

"The extracts from the memorandum make it clear that I was a disinterested party and was not prepared to consider a relationship with Pfizer while an application was under review."

By Sarah Boseley posted 6 October 04

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UK bans SSRIs for kids

Modern antidepressant drugs which have made billions for the pharmaceutical industry will be banned from use in children today because of evidence, suppressed for years, that they can cause young patients to become suicidal.

The Medicines and Healthcare Products Regulatory Agency (MHRA) told doctors last night not to prescribe all but one of the antidepressants known as selective serotonin reuptake inhibitors (SSRIs). The exception is Prozac, which is licensed for use in depressed children in the US. But the MHRA will warn that, at best, it helps only one child in 10.

The decision has big implications for drug regulation.

The agency - which is the government's watchdog body on drug safety has reached this point only after intense pressure from patients and campaigners. They were concerned about patients - at first mainly adults - who appeared to have become suicidal on the drugs, and others who had got hooked and suffered distressing symptoms when they tried to stop taking them.

Public unease about these potential side-effects prompted the agency to investigate last year. It has looked at the details of clinical trials of depressed children that were in the hands of the drug companies in the late 1990s.

These studies revealed the problem of suicidal behaviour in children, but the companies did not draw it to the attention of the regulators in the US or the UK. It has become clear from the investigation that the regulators generally see only a summary of the data resulting from trials. It is prepared for them by the drug company only when it is seeking a licence.

The agency became aware of a problem with Seroxat in children this year only when the manufacturer, GlaxoSmithKline, submitted data from trials which finished in 1996. Pressure for a change in the regulatory system will inevitably grow.

Two of the SSRI class of drugs have already been banned - or, technically, contra-indicated in children - by the agency. The first, in June, was Seroxat, which goes by the generic name paroxetine; the second, in September, was Efexor (venlafaxine); joining them now will be Lustral (sertraline), Cipramil (citalopram), Cipralex (escitalopram) and Faverin (fluvoxamine).

Trials on children have not been carried out in all the drugs, but the completed studies show a worrying increase in suicidal behaviour among those on SSRIs compared with those given a placebo (sugar pill). None of the drugs has a licence for use in children with depression in the UK, but GPs have prescribed more and more SSRIs for children.

It is estimated that as many as 50,000 children on antidepressants in Britain.

The agency will warn that patients should not stop their medication suddenly to avoid withdrawal symptoms.

The ban will cause problems for doctors because insufficient counsellors and psychotherapists are available to offer the alternative treatment of therapy, and the bill to the NHS for such treatment would be much higher than the cost of the drug prescriptions.

Drug companies began clinical trials on the safety and efficacy of the SSRIs in children only after prompting by the US food and drug administration in the early 90s. David Healy, the director of the North Wales department of psychological medicine, said: "It was standard practice for the FDA approving drugs like Seroxat (Paxil in the US) for adults in 1991 to write to the company and say this drug will also be used in children - it would be helpful if you could run trials in children so we can see what the safety profile is."

But trials that did not produce favourable results were neither published nor sent to the FDA or the MHRA.

The first major Seroxat trial in children was finished by 1996, but the results were not published until 2001. Data was also gathered in 1996 after a trial of Lustral, manufactured by Pfizer, showing that 9% of depressed children on the drug became suicidal.

Dr Healy, whose own researches led to the establishment of the SSRI review, said yesterday: "They should have known by 1996 that there was a problem. GSK and Pfizer were asked to do this by the regulators so that we knew what the safety issues were." The drug companies dispute that a problem exists.

Only a tiny minority of children taking the drug become suicidal and their depression could be the real cause, they claim. GSK says several trials, not just one, were needed to establish whether its drug caused problems.

The SSRI review group, which has advised the Committee on the Safety of Medicines of the agency to ban the drugs from use in children, will now look at the safety and efficacy of the drugs in adults.

Sarah Boseley, health editor Posted 11 December 03

THE DOG: Seems Britain has finally bitten the bullet and banned SSRI prescriptions for kids - with a similar review of their use by adults now underway. The exception is Prozac, which considering the strong evidence that it is no better than the other SSRIs seems to be more a reflection of the PR muscle of Eli Lilly than an evidence based medical decision.

The Aus psychiatric establishment is firmly in the pocket of these companies - a situation that only continues to get worse as they tighten their grip on the Royal Australian & NZ College of Psychiatry, Beyond Blue, individual practitioners and 'consumer groups' like the Schizophrenia. So don't expect to see a similar ban here until the bodies have piled up too high to be ignored.

Drugs for depressed children banned

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