Pubdate: Wed, 03 Sep 2003 Source: Anderson Valley Advertiser (CA) Column: Cannabinotes Copyright: 2003 Anderson Valley Advertiser Contact: http://www.mapinc.org/media/2667 Author: Fred Gardner Bookmark: http://www.mapinc.org/mmj.htm (Cannabis - Medicinal) PFIZER-FUNDED FABRICATION "Antidepressant Use for Kids Gains Support," read a three-column headline in the Wall St. Journal Aug. 27. The subhead said, "New research shows Zoloft eases debilitating symptoms." And it does so, according to the lead paragraph, "while showing no increase in suicide attempts." What we have here is a case study in how pharmaceutical companies respond to warnings that their products cause harm. Earlier this summer British health authorities advised against treating children and teenagers with Paxil because it triggers suicidal thinking and actual suicide attempts. Zoloft (which is Pfizer's name for a chemical called "sertraline") affects the same receptor system, and is evidently just as dangerous. The WSJ story referred to a Pfizer-funded study in the Aug. 27 Journal of the American Medical Association, conducted by Karen Dineen Wagner, MD, PhD, and colleagues at the University of Texas Medical Branch in Galveston. It involved 376 subjects, ages six to 17. From the headline and lead of the WSJ story (which is all most readers take in), you'd think the results were dramatic and unambiguous. But it turns out that 59% of the kids given a placebo showed improvement, compared to 69% of the kids taking Zoloft. In other words, the little bit of attention received along with the sugar pill had almost the same emotional impact as the powerful drug. The WSJ story ignores the following key fact from the study as published in JAMA: "Seventeen sertraline-treated patients and five placebo patients prematurely discontinued the study because of adverse events." Factoring in the drop-outs, the number of subjects helped by Zoloft (beyond the placebo effect) goes down from 20 to eight, and the supposed improvement rate slips below 4%. Another nine Zoloft-using patients dropped out because their parents withdrew consent. No effort was made to find out why; these kids, too, may have been suffering adverse effects. Nor did the Journal reporters -Thomas Burton and Patricia Callahan- quote this line from the study concerning subjects who stuck it out: "Adverse events that occurred in at least 5% of sertraline-treated patients and with an incidence of at least twice that in placebo patients included diarrhea, vomiting, anorexia, and agitation." Note the "at least"s. Zoloft caused severe problems at more than double the rate of the placebo -and, for all we know, at three or four times the rate. If the kids who endured Zoloft-induced vomiting, etc., had not been counted as "improved," the study actually would have yielded results displeasing to Pfizer. (Improvement was measured by the Children's Depression Rating Scale, which the authors call "a validated 17-item, clinician-rated instrument," plus the Multidimensional Anxiety Scale for Children, the Children's Global Assessment Scale, and the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire, "a validated instrument that assesses quality of life.") The pro-Zoloft spin that Wagner et al put on their study is made possible by the following finding, which comes with a misleading disclaimer: "The number of suicide attempts was the same in each treatment group (2 for sertraline and 2 for placebo). Our trials showed a lack of significant difference in suicidal ideation between sertraline-treated and placebo-patients as measured by the CDRS-R." Notice that no numbers are given in parens for suicidal ideation. But in another section of the JAMA paper we learn that Zoloft induced three such fantasies, plus one case of "aggressive reaction;" the sugar pill induced zero suicidal plans and zero "aggressive reactions." Instead of grouping suicide attempts, suicidal ideation, and "aggression reaction" -which would have led to the conclusion that Zoloft is three times more dangerous than placebo-the authors simply define the dangerous fantasies as not "significant." The Wall St. Journal reporters tart this sophistry up with an impressive adverb: " There wasn't any ITAL statistically END ITAL significant difference in suicidal thinking between the groups." There is no conveying, dear reader, how much gibberish "scientific" papers can contain. The statistical sections of the paper by Wagner et al go on for paragraphs like this: "Categorical variables (proportions of CDRS-R responders and CGI-I responders at study end point) were compared between treatment groups using Cochran-Mantel-Haenszel methods with centers as strata..." The jargon serves to create an aura of must-be-trueness around whatever lie the so-called "investigators" have been paid to promote. According to the fine print in JAMA: "Dr Wagner has received research support from Abbott, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Organon, Pfizer, and Wyeth-Ayerst; has served as a National Institute of Mental Health consultant to Abbott, Bristol-Myers Squibb, Cyberonics, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Novartis, Otsuka, Janssen, Pfizer, and UCB Pharma; and has participated in speaker's bureaus for Abbott, Eli Lilly, GlaxoSmithKline, Forest Laboratories, Pfizer, and Novartis. Dr Ambrosini has received honoraria and funds for clinical trials from Pfizer. Dr Rynn has been a consultant to Pfizer, PharmaStar, and Eli Lilly. Drs Wohlberg and Yang, as employees of Pfizer, hold stock options in the company. Dr Donnelly has been a consultant and speaker for Pfizer and has participated in speaker's bureaus for Eli Lilly and GlaxoSmithKline." The corruption of the Wall St. Journal piece lies not in its simple reworking of the Pfizer press release (there's no evidence that the authors waded through the study itself), but in creating the impression that a wave of scientific opinion is now washing away the concerns raised by the British government regulators. Recall the hed: "Antidepressant Use for Kids Gains Support." This is more than an account of a new study in JAMA, this is an attempt to create a bandwagon effect, to mislead the thousands of physicians who rely on the Wall St. Journal for their continuing education. "New research on Zoloft may buttress the views of psychiatrists who say the risks of taking the drugs are smaller than the risks of not taking them," write Burton and Callahan. They quote David Shaffer, chief of child and Adolescent Psychiatry at Columbia University, who "believes that a drop in the suicide rate among U.S. adolescents likely stems from the advent just over a decade ago of SSRI medicines." They also quote a professor from Harvard Med School, Joseph Biederman, who dismisses the British report as "severe," and says, "I would be very reassuring to parents who are considering the use of medication." One of the medical conditions for which Zoloft and the other SSRIs are being pushed is called "social anxiety disorder." You might think of it as "shyness," but you haven't been to medical school, have you? This is how the Pfizer web page describes the problem: "Social anxiety disorder affects over 16 million Americans. If you have social anxiety disorder, you often get very nervous around other people. It feels like everyone is watching you and judging you. You're afraid of making a mistake, or looking like a fool. You will do all you can to keep that from happening. You may even avoid certain people, places or social events. "Social anxiety disorder is a serious illness. It can cause real problems in your life. Like any health condition, it needs to be treated. "Social anxiety disorder can make you fear or avoid Meeting new people Talking to your boss-or anyone in charge Speaking in front of groups Drawing any attention to yourself If you have to do these kinds of things, you may Blush Sweat Tremble Have a fast heartbeat "Social anxiety disorder can happen to anyone. It often starts in the mid-teen years. But Zoloft can help many people with this health condition to feel better. If you have social anxiety disorder, Zoloft may help you, too. Talk to your doctor. Only a doctor can tell if you have social anxiety disorder." When Dennis Peron observed, in 1996, that "all marijuana use is medical in a country where they prescribe Prozac for shy teenagers," many self-styled activists were appalled. They tried to disassociate themselves from him and/or shut him up. They marginalized him and undermined his morale (clearing the way for themselves to take over the leadership). But Dennis had done the real work involved in reaching such a conclusion -he had listened to the stories of thousands of members of the San Francisco Cannabis Buyers Club- and he knew what he was talking about... The goody-goodies also shook their heads in disapproval when Dennis ran against Dan Lungren in the 1998 Republican gubernatorial primary. Little did they know that within a few years the leading Republican candidates for governor would be coming out for medical marijuana. Some people are ahead of the curve; Dennis was ahead of the zeitgeist. John Kerry John Kerry stood at the white house wall With his medals in his hand Him and some other young veterans Who'd fought in Vietnam There were bronze stars, purple hearts A distinguished service cross And they threw 'em over the white house wall With a double sense of loss Take em back, take em back No medal's worth the death and hurt That's a fact. Take 'em back John Kerry knows the truth about 'Nam For the reason that he was there Lieutenant on a gunboat He did more than his share And when he got his discharge He did not forget his friends Vietnam Vets Against the War Helped bring it to an end Take em back, take em back No medal's worth the death and hurt That's a fact. Take 'em back John Kerry's running for President He's asking for my vote Lieutenant, sir, you got it On the day you made that throw To end that war in Vietnam STILL seems like a fight You can say I'm stuck in the '60s I'd have to say you're right Take em back, take em back America's worth those who died and got hurt Time to counterattack. Take it back. - -Lindy B. - --- MAP posted-by: Jay Bergstrom