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Insight on the News - National
Prescription Drugs May Trigger Killing
By Kelly Patricia O'Meara
The kid spoke unsteadily: "I was sitting on a hill outside the school eating lunch with my best friend when Eric Harris came over and started shooting me. I was shot between seven and 13 times. No one really knows the exact number because there were so many bullet tracks. Most of the bullets just went right through me. After I was shot I just lay there, playing dead, and could see others being shot."
These are the recollections of 19-year-old Mark Taylor, who spent nearly two months in the hospital and has endured three years of follow-up operations for the gunshot wounds he received during the murderous 1999 rampage of Eric Harris and Dylan Klebold at Columbine High School in Littleton, Colo.
Taylor slowly is recovering from his wounds and, in an effort to bring attention to what he believes was the cause of Harris' deadly rage, has filed a lawsuit against Solvay Pharmaceuticals Inc., the manufacturer of Luvox (Fluvoxamine), the antidepressant that Harris had been prescribed and was taking at the time of the shooting spree. Despite the deadly assault against him, Taylor's perception of the young men who nearly killed him is surprising.
Taylor tells Insight, "I'm suing Solvay because I believe that Eric Harris did what he did because of this drug. I didn't personally know Eric, but I knew him as one of the 'Trench Coat Mafia.' Everybody thought Eric and Dylan were the nicest people. My cousin, who was in Eric's class, told me that Eric and Dylan used to bring her flowers and cookies. Eric was forced onto these drugs and I feel sorry for him, like so many other kids who are put on these drugs. I don't have ill feelings against him since I don't think you can hold him accountable, because he didn't know what he was doing." Taylor's lawsuit against Solvay claims that the mind-altering drug Luvox was the cause of Harris' rampage — that the drug made Harris manic and psychotic.
Luvox is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs) that interact with the serotonergic system in the brain, as do Prozac, Zoloft and Paxil. Street drugs that interact with the serotonergic system include LSD and Ecstasy. The Food and Drug Administration approved Luvox in 1997 for treatment of obsessive-compulsive disorder in children, but not for treatment of depression.
The Physicians Desk Reference (PDR) records that, during controlled clinical trials of Luvox, manic reactions developed in 4 percent of children. Mania is defined as "a form of psychosis characterized by exalted feelings, delusions of grandeur … and overproduction of ideas." Court records show that the prescription for Harris had been filled 10 times between April 1998 and March 1999, and that three-and-a-half months before the shooting the dose had been increased — a common thread many experts say they are finding prior to adverse reactions to psychotropic drugs. The autopsy on Harris revealed a "therapeutic level" of Luvox in his system.
Other school shooters on antidepressants at the time of their attacks include 15-year-old Kip Kinkel who, while on Prozac, killed his parents and then proceeded to school where he opened fire on classmates, killing two and wounding 22 others; 14-year-old Elizabeth Bush, on "antidepressants" when she wounded one student at Bishop Neumann High School in Williamsport, Pa.; and 18-year-old Jason Hoffman, on Effexor and Celexa when he wounded one teacher and three students at Granite Hills High School in El Cajon, Calif.
The medical histories of scores of "school shooters" have not been revealed, allegedly to protect the minor child. Ann Blake Tracy is a consultant in Taylor's lawsuit and director of the International Coalition for Drug Awareness. She holds a doctorate in biological psychology and is a specialist in what she believes are the adverse reactions to SSRI medications. She says Luvox caused Harris to go on the Columbine shooting spree and thinks the medical history of children who commit violent acts in school should be made public.
"Suing Solvay for the injuries Mark Taylor suffered is one of the biggest SSRI suits we'll ever see," Tracy says. "It's a pivotal case because what happened at Columbine was so big. It's really crazy when you think about it. All you have to do is read the Luvox package insert to see that Eric's actions were due to an adverse reaction to this drug. Show me a drug anywhere that has listed mania and psychosis as frequent adverse reactions. That is what the insert says for Luvox. There is no doubt in my mind that Luvox caused Eric Harris to commit these acts."
The PDR lists adverse reactions of Luvox to the nervous system as:
"FREQUENT: amnesia, apathy, hyperkinesis, hypokinesis, manic reaction, myoclonus, psychotic reaction;
"INFREQUENT: agoraphobia, akathisia, CNS depression, convulsion, delirium, delusion, depersonalization, drug dependence, emotional liability, euphoria, hallucinations, hostility, hysteria, incoordination, increased salivation, increased libido, paralysis, paranoid reaction, phobia, psychosis, sleep disorder, stupor, twitching, vertigo."
Tracy continues, "Beyond the adverse reactions listed about Luvox, one of the first clues I had that these boys were on antidepressants was when it was made public that Eric [Harris] and Dylan Klebold had both been in anger-management classes. Anger-management classes equal antidepressants. Unfortunately, Dylan Klebold's medical records have been sealed, so there's no way of knowing what if anything he was on, but it makes sense that if he was in anger-management classes he was prescribed some antidepressant."
The problem, Tracy concludes, "is that this is a public-safety issue. So why is everything kept so secret, under lock and key? This information should be made available to the public so that people can learn from it and maybe we can stop this kind of tragedy from happening in the future. We've got a nightmare on our hands with these drugs, an absolute nightmare. We've got kids on these drugs that are ticking time bombs in every school in America. Most of these drugs are not approved for children, but it doesn't stop doctors from prescribing them. Laws should be passed requiring that this medical information be made public. And states should demand toxicology reports for drugs of this kind in all murders and suicides."
Donald Marks specializes in internal medicine, has a doctorate in microbiology and has worked in pharmaceutical research for more than a decade in the area of drug safety and clinical research. Marks was brought into the Solvay lawsuit as an expert by Taylor and is not surprised that there may be a causal relationship between Luvox and Harris' murderous behavior. Marks also testified in a Wyoming case last year involving a murder related to the SSRI Paxil in which the defendant won an $8 million judgment against GlaxoSmithKline, maker of Paxil.
As part of the Columbine lawsuit, Taylor claims that Solvay failed to warn adequately of the risks and adverse reactions associated with Luvox, and Marks provides a preliminary expert opinion to the court stating that Solvay "acted in an unreasonable manner" by failing to provide adequate warnings of the adverse reactions to the drug. The Marks opinion continues: "In view of the evidence of a strong and likely causal relationship between SSRI medications, of which Luvox is one, and akathisia/suicide/homicide, Solvay should only have marketed this drug with prominent warnings and cautionary statements."
U.S. District Court Judge Clarence Brimmer has accepted Marks' preliminary report, allowing the case to go forward and giving the expert access to information that has been held under lock and key in a vault in Denver since the Columbine shooting. Marks tells Insight that "the preliminary report was based on what I know from past cases, because I haven't been allowed to examine information about Mr. Harris or anyone who knew him. The information has been locked in a room in Denver, and I haven't been allowed in the room until now."
According to Marks, "The real problem is that physicians, of which I am one, are not told that there is a potential for a causal relationship between these drugs and homicide and suicide. Therefore we're not educated to look for the kinds of adverse reactions that could herald this kind of event. That's why proper warnings about such drugs are so essential. I'm in the process of updating my report for the court, but my preliminary impression from looking at the material is that there very well could be a causal relationship here, that this drug could have been a factor that tipped Harris from being a troubled teen to a murderer."
Marks says, "In the report, I talk about the adverse-event profiles of other SSRI medications and how, in the context of rules of evidence, a statement of general causation could be made for all SSRI medications and how it could be applied to Luvox. The neuro-psychiatric-event profiles of the SSRI drugs are clearly associated with seizures and psychosis. Some have been associated with hypoglycemia, suicide and homicide. So it's not entirely implausible that one additional member of this class, like Luvox, would have those same effects."
The fact that the court has allowed the case to go forward is a good sign for Taylor, but there have been some very strange developments. Lincoln, Neb., attorney John DeCamp, who now represents Taylor against Solvay, tells Insight that "two days after I took the case, Solvay pulled Luvox from the market. I don't know if my coming on the case had any bearing on them pulling the drug, but it is interesting." (click here for Luvox announcement) Solvay announced that the drug was being removed temporarily from the U.S. market to revise data about how Luvox is manufactured.
Another interesting twist involves families pulling out of the lawsuit. "I am very reliably informed," DeCamp says, "and I'm satisfied that the people telling me this aren't lying, that at the settlement conference families were informed that a Colorado law that applies both in federal and state court says: 'If you lose, you pay.' These families were told that if they continued to sue and lost the case they would be sued in return and they'd lose their homes, cars and everything for the rest of their lives. So if you were one of these families what would you do?"
According to DeCamp, "My client is basically judgment-proof. In other words, Mark doesn't have anything. The other families didn't settle, they just dropped out of the suit — they were basically told that they were going to lose and, when it was over, the pharmaceutical companies were going to own their lives. It's fair to say that my client was presented with this argument, but he doesn't have anything."
The lawyer continues, "It's also interesting in this case that there's more security to keep related evidence from surfacing than there is to get into the White House or Fort Knox. I have never, in 35 years practicing law, seen its like. There's been more evidence gathered than you can even imagine — things that I hope one day will be made public. I stated in court that if ever there was a monumental event this is it and the information that is locked in this room should be made public. History will be very unforgiving if that doesn't happen."
But the foremost question in the minds of experts on adverse reactions to SSRIs is whether history is just repeating itself. Recent court decisions, however, may be useful in Taylor's case against Solvay.
In April 2001, then 16-year-old Cory Baadsgaard took a rifle to Wahluke High School in Washington state and took 23 classmates and a teacher hostage. Baadsgaard was held in jail for 14 months. Based on expert testimony by psychiatrists about the adverse reactions to the drugs he was taking, he finally was released from jail under community supervision for five years. Baadsgaard has no memory of his violent actions toward his classmates, which took place exactly 21 days after he had been cold-turkeyed off Paxil and switched to a high dose of Effexor (an SSRI) to treat "situational depression."
Cory's father, Jay Baadsgaard, says, "The morning that Cory went to school and did what he did, my wife and I just knew that it had to be something with the drugs. That morning he had taken about 300 milligrams of Effexor, and I thought it was something about him going off one of the drugs and then the high dose of the other. One of Cory's friends told us that Cory was yelling and then he just stopped, looked down and saw the gun in his hand and woke up."
There is no doubt that Cory is lucky not to have gone further, says his father, "and I guess I could blame myself for having the gun available, but if I'd known then just what these drugs could do it would have been the drugs that would not have been in our home. They always talk about how the kids who do these things are the ones who get picked on by the jocks and stuff, but Cory was a jock. He was on the varsity basketball team, played football and golf, and was very popular in school. I pray every night that the media will get ahold of this issue. If Cory had been on PCP the media would say 'Oh, he needs drug rehabilitation,' but because these were prescribed medications they say 'Oh, it can't be that,' but now we know it can be."
Taylor hopes his lawsuit against Solvay will make people aware of the dangerous side effects of such drugs. "Someone," he says, "has to do something about these drugs, because too many people are dying."
Kelly Patricia O'Meara is an investigative reporter for Insight magazine. email the author
Solvay Pharmaceuticals Inc. Suspends Sales of LUVOX© in the United States after FDA Exclusivity Expiration
Solvay Pharmaceuticals Inc., Marietta, Georgia, has voluntarily requested the withdrawal of the U.S. Food & Drug Administration's original approval for LUVOX® (fluvoxamine maleate) Tablets, in the United States only. All other countries where fluvoxamine maleate is available for patients will remain entirely unaffected by this decision.
The turnover generated by LUVOX® in the United States has sharply declined since its U.S. FDA exclusivity expired, in June 2000. The bulk of Solvay's fluvoxamine maleate sales are now in Japan and the European Union. The interruption of LUVOX® shipments in the US does not affect the prospects of the Group's pharmaceutical sector for 2002.
Both the FDA and the company have no concerns over the safety or efficacy of LUVOX®.
This withdrawal has no relation to the immediate release forms of fluvoxamine manufactured and sold in several countries around the world, and is based solely on U.S. administrative policy concerns. Prior to withdrawal of the application, Solvay Pharmaceuticals suspended further shipments of LUVOX® in the U.S. only.
SOLVAY PHARMACEUTICALS, Inc. (www.solvaypharmaceuticals-us.com) of Marietta, Georgia, is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health. It is a member of the worldwide Solvay chemical and pharmaceutical group, headquartered in Brussels, Belgium.
SOLVAY is an international chemical and pharmaceutical group with headquarters in Brussels. It employs some 31,400 people in 50 countries. In 2001 its consolidated sales amounted to EUR 8.7 billion generated by its four sectors of activity: Chemicals, Plastics, Processing and Pharmaceuticals. Solvay is listed on the Euronext 100 index of top European companies. Details are available at www.solvay.com