{"id":20841,"date":"2012-03-10T15:18:25","date_gmt":"2012-03-10T20:18:25","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=20841"},"modified":"2012-03-10T21:15:11","modified_gmt":"2012-03-11T03:15:11","slug":"more-clearly","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2012\/03\/10\/more-clearly\/","title":{"rendered":"more clearly I…"},"content":{"rendered":"
Lest it’s not already apparent, the two articles by Dr. Gibbons et al hit a nerve with me, the infuriata<\/em> nerve it seems. There’s plenty else to write about – Dr. Bor’s article on neuroimaging [The dilemma of weak neuroimaging papers<\/font><\/strong><\/u><\/a>, SEAL OF DISAPPROVAL<\/font><\/strong><\/u><\/a>]; the DOJ’s rejection of J&J’s $1 B offer to settle the Risperdal suits [J&J’s Drug Settlement for $1 Billion Is Rejected<\/font><\/strong><\/u><\/a>, Feds Reject Deal With J&J Over Risperdal Marketing<\/font><\/a><\/strong><\/u>]; Dr. Schatzberg’s recent conversion experience [Journal disavows study touted by U.S. abortion foes<\/font><\/strong><\/u><\/a>]; the exciting report of a non-pharmacologic approach to prevent or postpone the onset of Schizophrenia [Preventing progression to first-episode psychosis in early initial prodromal states<\/font><\/strong><\/u><\/a>] – but I’m unable to escape the gravity beam of Drs. Gibbons’ and Mann’s articles about the use of SSRI’s in kids. In the last several days, I’ve tried to write about other things, but I’m distracted and find myself nosing around about this topic, almost involuntarily. So I thought that I’d just give in to the pull and add a few posts about why I think I find it so magnetic. These are some of the public statements following those articles:<\/div>\n

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1.<\/font><\/strong> Suicidal Thoughts and Behavior With Antidepressant Treatment<\/font><\/strong><\/u><\/a>
      Reanalysis of the Randomized Placebo-Controlled Studies of Fluoxetine and Venlafaxine<\/strong>
      by Robert D. Gibbons, Hendricks Brown, Kwan Hur, John M. Davis, and J. John Mann
      Archives of General Psychiatry. Online February 6, 2012<\/font><\/strong>.<\/sup><\/div>\n

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Study questions antidepressant link to suicide in kids<\/font><\/strong><\/u><\/a>
Los Angeles Times<\/font><\/strong>
By Shari Roan
February 06, 2012<\/font><\/strong><\/div>\n

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In 2004, the Food and Drug Administration announced that antidepressant packages should carry a "black box" warning describing an increased risk of suicide and suicidal thoughts in children and youths up to age 25. The FDA action triggered a significant decline in antidepressant use among children and teens. Now, however, an analysis suggests there is no reason to believe that antidepressants influence suicidal thinking in kids.<\/p>\n

The paper, published online Monday in the Archives of General Psychiatry<\/a><\/font><\/u>, analyzed data from 41 clinical trials involving more than 9,000 adults and children. The adults were taking either the antidepressant fluoxetine or venlafaxine. The children were taking fluoxetine (Prozac). The study showed that adults had a decreased risk of suicidal thoughts and behaviors while taking an antidepressant. Among children, medications neither increased nor decreased suicidal thoughts or behavior.<\/p>\n

The new study draws from a larger database than the research performed in 2004 that led to the "black box" warning. However, the data on children are limited to the one medication – fluoxetine. Several important points can be drawn from the new study, said the lead author of the paper, Robert Gibbons, a professor of medicine, health studies and psychiatry at the University of Chicago. It suggests that antidepressants reduce suicide rates by treating the underlying depression. If the treatment does not work, suicide risk remains the same or rises.<\/p>\n

Moreover, antidepressants appear to affect children differently than adults with regard to suicide. "Maybe children think about suicide in part because of depression, but also maybe due to other reasons not related to depression that are not affected by antidepressants," Gibbons said in a news release. The impact of the "black box" warning, he said, was to reduce antidepressant prescriptions to kids – which was correlated with an increase in suicide rates in subsequent years.<\/p>\n

"I hope that the warnings will not prevent depressed children and adults from getting treatment for depression," he said. "The greatest cause of suicide is untreated or undiagnosed depression. It’s very important that this condition be recognized and appropriately treated and not discarded because doctors are afraid to be sued."<\/strong><\/sup><\/div>\n

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A Fresh Look At Antidepressants Finds Low Risk Of Youth Suicide<\/font><\/strong><\/u><\/a>
National Public Radio<\/font><\/strong>
by Alix Spiegel
February 7, 2012<\/font><\/strong><\/div>\n

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In 2004, after an extensive review, the Food and Drug Administration issued a strong warning to doctors who prescribed antidepressants to teens and children. Antidepressants, the FDA said, appeared to increase suicide among kids and teens. Doctors needed to be careful. The FDA even mandated that a "black-box warning," the strongest type, be placed on antidepressant packaging. This warning and worries that giving antidepressants to children might cause them to kill themselves was front-page news for weeks and appeared to changed the prescribing behavior of doctors. Fewer doctors used antidepressant medications with their young patients and, according to at least one study, the number of suicides among kids and teens began to rise.<\/p>\n

This week the Archives of General Psychiatry<\/em> published an analysis that finds no increase in suicide among young people taking Prozac. The findings put a new wrinkle in the long-running debate over the safety of the medicines when used to treat depressed young people. The study reviewed detailed data from over 9,000 patients — including 700 youths — who took the antidepressant Prozac and found that the drug didn’t increase suicidality in children at all. It also looked at data for adults taking Effexor.<\/p>\n

Now, the main author of the study is Robert Gibbons, a statistician at the University of Chicago’s medical school. Gibbons sat on the panel of experts that advised FDA to issue the warnings, but he always felt ambivalent about the panel’s decision. "I worried that what we might end up with was a real epidemic of suicide," Gibbons told Shots. "And the data suggests that that is exactly what happened. Rather than the black-box warning leading to decreases in child suicide rates, they were followed by some of the largest increases in child suicide rates both here in America and around the world." So why did the new study come to such a different conclusion about the risks of suicide in kids?<\/p>\n

According to Gibbons, the FDA’s findings and his findings are similar in some respects. Both found that when doctors asked their patients about suicidal thoughts and behavior in the context of regularly scheduled checkups there was no difference between the medications and placebos. But when it came to what are called adverse event reports, there was a difference between his study and the review done by the FDA. Adverse event reports occur when patients spontaneously contact their doctors with problems associated with taking a medication. When the FDA looked at these patient reports, they found that patients on antidepressant medications reported 80 percent more suicidal thoughts and behavior than patients on placebos.<\/p>\n

Gibbons didn’t look at these spontaneous reports in the same way. He only considered them when patients acted on their suicidal thoughts with a suicide attempt. He found that the small number of people who acted on their suicidal thoughts did not affect the overall risk of suicide. The original FDA study also included all antidepressants — not just Prozac. That might account for some of the differences found. Gibbons, who has become a vocal opponent of the black-box warnings since his stint on the committee that advised FDA, says that he hopes this study will reassure clinicians about the safety of the drugs. It’s not clear whether other researchers will agree with him that the new study’s findings present a fundamental challenge to the FDA’s previous conclusions.<\/strong><\/sup><\/div>\n<\/td>\n<\/tr>\n<\/table>\n

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These commentaries in very prominent media outlets came within a day of on an online article in a medical journal [published with full-text available until it mysteriously became abstract only a month later]. I can only conclude that these press appearances were pre-arranged, a "roll out" for the articles [smell a campaign…<\/font><\/a><\/strong><\/u>]. The public comments by a Ph.D. statistician reach bold conclusions about what physicians should do with his analysis including suggesting they ignore an FDA Warning added after much study, and he presuppose motives in practicing physicians that are anything but flattering:<\/div>\n