Comments on: Prior Authorization: The Bane of Doctors http://psychcentral.com/blog/archives/2008/04/03/prior-authorization-the-bane-of-doctors/ Dr. John Grohol's daily update on all things in psychology and mental health. Since 1999. Mon, 13 Feb 2012 22:26:24 +0000 hourly 1 By: regular reader http://psychcentral.com/blog/archives/2008/04/03/prior-authorization-the-bane-of-doctors/comment-page-1/#comment-454485 regular reader Thu, 03 Apr 2008 15:37:44 +0000 http://psychcentral.com/blog/?p=2025#comment-454485 From the article: " ... Medication discontinuation, as the authors note, is an important measure. But presented in a vacuum (as health policy journals sometimes do), one cannot really put these findings into any sort of proper context. ..." Eli Lilly underwrote the "study." How could we expect a white-paper report that addresses all sides of the issue? No input from insurance carriers or doctors? For a study in cherry picking, check the results of Lilly's "clinical trials" for Strattera that were submitted to the FDA during the fast-tracked application for approval. They were measured in weeks and ended just before the thresholds for the emergence of dangerous side effects that had erupted in much earlier trials. That was during clinical trials of the drug as an anti-depressant, Tomoxatin. (It was also tested as a weight-loss drug and treatment for binge eating before it wound up as Strattera.) They stopped studies before reaching the points when participants in the early trials had begun to show aggression, hostility, suicidal thoughts (European reports claim scores of suicides), never mind subsequent liver damage. When that failed, they recycled the drug under a different name (Strattera) and marketed it as a "safe, effective, non-stimulant alternative" drug to treat ADD/HD. Strattera later earned a black box warning after the drug had been an explosive sales success for three years and amid reports that Lilly had deliberately and knowingly withheld information from the FDA. Will we ever be free of: -- the FDA's acceptance of "trials" that have been funded and ¬ reported by the companies that are pushing to have a drug approved? -- Company-issued press releases touting benefits with not a sentence about the risks/side effects? -- "Research" reports like this one, incomplete, manipulated and put in the best, pro-company light? -- Non-disclosure of the quiet "funding" (aka huge cash infusions) of the universities, and so-called research service providers, who conduct the studies FOR the companies? -- The unreported salaries/stipends paid to the researchers? -- The practice of having the drug companies' in-house writers filter and file edited results? -- The routine of not investigating that the signatures of the researchers asserting the veracity of results aren’t from ones who had virtually no part in of the study (some never having heard of it until it was sent for their imprimatur? We deserve better. Thank you for this article. rr From the article: ” … Medication discontinuation, as the authors note, is an important measure. But presented in a vacuum (as health policy journals sometimes do), one cannot really put these findings into any sort of proper context. …”

Eli Lilly underwrote the “study.” How could we expect a white-paper report that addresses all sides of the issue? No input from insurance carriers or doctors?

For a study in cherry picking, check the results of Lilly’s “clinical trials” for Strattera that were submitted to the FDA during the fast-tracked application for approval. They were measured in weeks and ended just before the thresholds for the emergence of dangerous side effects that had erupted in much earlier trials.

That was during clinical trials of the drug as an anti-depressant, Tomoxatin. (It was also tested as a weight-loss drug and treatment for binge eating before it wound up as Strattera.)

They stopped studies before reaching the points when participants in the early trials had begun to show aggression, hostility, suicidal thoughts (European reports claim scores of suicides), never mind subsequent liver damage.

When that failed, they recycled the drug under a different name (Strattera) and marketed it as a “safe, effective, non-stimulant alternative” drug to treat ADD/HD.

Strattera later earned a black box warning after the drug had been an explosive sales success for three years and amid reports that Lilly had deliberately and knowingly withheld information from the FDA.

Will we ever be free of:

– the FDA’s acceptance of “trials” that have been funded and ¬ reported by the companies that are pushing to have a drug approved?

– Company-issued press releases touting benefits with not a sentence about the risks/side effects?

– “Research” reports like this one, incomplete, manipulated and put in the best, pro-company light?

– Non-disclosure of the quiet “funding” (aka huge cash infusions) of the universities, and so-called research service providers, who conduct the studies FOR the companies?

– The unreported salaries/stipends paid to the researchers?

– The practice of having the drug companies’ in-house writers filter and file edited results?

– The routine of not investigating that the signatures of the researchers asserting the veracity of results aren’t from ones who had virtually no part in of the study (some never having heard of it until it was sent for their imprimatur?

We deserve better.

Thank you for this article.

rr

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