The story of the SSRI antidepressants is one of fraud, corruption and greed. It is not a unique or uncommon story; it is enormously tragic, nonetheless.
If depression is due to a 'chemical' or neurotransmitter imbalance; it is an imbalance that has yet to be identified. The claim that antidepressants are fixing an identified imbalance was developed as a marketing strategy. The strategy is based not on an identified or defined imbalance; it is a hypothesis based on what is understood about the biological mechanism of action of the SSRI antidepressant drugs. While researchers may one day discover a biological mechanism causing depression, they have not yet actually done so. This being the case, it is not honest to imply that a 'chemical imbalance' causes depression--it is unethical to use what is essentially a false claim as a marketing tool; in truth using a false claim to encourage "treatment compliance" or to convince a person that they have a disease the must be treated with psychotropic drugs it not ethical, it is criminal fraud. It is morally reprehensible for a professional or trusted patient advocacy organization to imply a hypothesis is a fact. To claim that depression is caused by an imbalance that psychiatric drugs "safely and effectively" treat without warning patients and parents of children about the well known, inherent risks of taking teratogenic drugs that can cause an episodic condition to become chronic; physical dependency; aggressive, violent behavior; and suicidal and/or homicidal behavior is unethical and morally reprehensible. How could any medical professional believe that a patient has given Informed Consent for a recommended treatment if serious inherent risks are not disclosed and understood prior to taking a prescribed SSRI antidepressant? How could any advocacy group fail to warn patients about well-documented risks and the corporate dishonesty which allowed pharmaceutical companies to bury the evidence along with the bodies of those who died due to an adverse reaction to a drug?
The Consumer Protection Act does not apply to the direct-to-consumer marketing of drugs, and the FDA is failing to protect consumers. Indeed, the FDA consistently protects the pharmaceutical industry, not the American people. It is FDA policy to consider known negative effects discovered in clinical trials before FDA approval of a drug, including death; 'trade secrets.' Prescribers are not even legally required to report adverse events for drugs they prescribe to the Adverse Event Reporting System; not even death. I have spent hours researching on this database, and what is striking is that most of the deaths are reported by someone other that a doctor, or medical professional with prescribing privileges.
Glaxo Smith Kline the makers of Seroxat, known as Paxil here in the United States, covered up the fact that their drug causes violence, aggression, suicidal and homicidal behavior. Covered up that it causes birth defects, some so severe the babies die shortly after being born. Paxil has caused people to have horrific extended withdrawal symptoms, and some people can not in fact seem to stop taking it; no matter how badly they want to. The professionals call it 'discontinuation syndrome,' instead of withdrawal; this is a ploy to disassociate the withdrawal from the fact the drug causes dependency; i.e. addiction.
In England, SSRIs have been restricted; and are rarely prescribed to people under eighteen years old due to the negative effects; the negative effects are known to be more severe for adolescents and children.
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"GSK's biggest clinical trial of Seroxat on children was held in the US in the 1990s and called Study 329.
"Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329."
"In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK."
"He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates."
"In amongst the archive of emails in Malibu, Shelley was surprised to find that her own emails to Dr Ryan from 2002 asking questions about the safety of Seroxat had been forwarded to GSK asking for advice on how to respond to her.
She also found an email from a public relations executive working for GSK which said: "Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results."
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"Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise."
"But the article was published in the Journal of the American Academy of Child and Adolescent Psychiatry which says it ranks as number one in child mental health in the world."
The claim to being number one does not mean that the Journal of the American Academy of Child and Adolescent Psychiatry retracted the fraudulent, ghost-written article. The 'professionals' involved with Study 329 were not censured, discredited, prosecuted or even experience any negative consequences for conducting unethical research or for colluding with Glaxo Smith Kline in a criminal enterprise. To this day, this article written to deceive other medical professionals, remains in the number one children's mental health medical journal. Medical Journals are supposed to be science-based medical resources. Study 329 continued to be cited by other professionals until 2008, when the following article was written.
via Accountability in Research
Industry-Sponsored Ghostwriting in Clinical Trial Reporting: A Case Study
a few excerpts:
"The initiative for Study 329 came from Martin Keller (considered a “key opinion leader” by SKB) who led a group of psychiatrists and psychologists, including seven of the first eight authors of the published article (SKB, 1992). Keller and his colleagues successfully pitched the study to SKB. SKB staff then implemented the project in consultation with some or all of Keller's co-investigators. As recruiting problems demanded more sites, so were more “principal investigators” added to the team."
"Study 329 was one of three clinical trials (along with studies 377 and 701) conducted by SKB aimed at gaining a new indication with the FDA for paroxetine (Paxil, Seroxat) use in pediatric depression. Paroxetine failed to demonstrate superiority over placebo on primary outcome measures in all three studies, and SKB abandoned the effort to gain regulatory approval. But there was concern that failure to demonstrate efficacy in the pediatric population would undermine the profile of paroxetine more generally. SKB's Central Medical Affairs Team (CMAT) set the following as a target in a 1998 position article: “To effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.” As part of this strategy, “Positive data from Study 329 will be published in abstract form at the ECNP (Paris, November 1998) and a full manuscript of the 329 data will be progressed” (SKB, 1998a)."
"Role of the Journal
"The publication of misleading articles constitutes a failure of the editorial process (see Jureidini and Tonkin, 2003). Who should take responsibility for the journal publishing an incompetent report? JAACAP had no way of knowing the full extent of manipulation in the reporting of Study 329, but in our view the draft submitted to them contained sufficient information to show that its conclusions were misleading. At least one of the reviewers noted inconsistencies between the data and the strong claims for efficacy, but these concerns were not acted on (SKB, 2000d). When questioned about publishing Study 329 in a 2007 BBC Panorama Programme, “The Secrets of the Drug Trials,” the editor of JAACAP, Mina Dulcan, replied that she had no regrets about publishing the study, and that it served its purpose of generating all sorts of useful discussion on the issue of pediatric SSRI use (BBC, 2007). When McHenry inquired via email about whether JAACAP was aware of having been infiltrated by SKB's marketing efforts, the editors replied: “The types of papers that we publish are never written by PR firms, and since our Instructions for Authors cover the issue of authorship criteria anyway, there is no need for a specific prohibition.” And, “[u]nless there is a specific accusation of research fraud, it is not the role of scientific journals to police authorship” (Available on request). Yet the International Committee of Medical Journal Editors (ICMJE) statement on which JAACAP bases its own authorship policy clearly places responsibility with the journal: “Editors should ask authors to disclose whether they had writing assistance and to identify the entity that paid for this assistance” (ICMJE, 2001)."
via PLoS ONE:
Prescription Drugs Associated with Reports of Violence Towards Others
Results
We identified 1527 cases of violence disproportionally reported for 31 drugs. Primary suspect drugs included varenicline (an aid to smoking cessation), 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The evidence of an association was weaker and mixed for antipsychotic drugs and absent for all but 1 anticonvulsant/mood stabilizer. Two or fewer violence cases were reported for 435/484 (84.7%) of all evaluable drugs suggesting that an association with this adverse event is unlikely for these drugs.
Conclusions
Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs. Prospective studies to evaluate systematically this side effect are needed to establish the incidence, confirm differences among drugs and identify additional common features.
read here
via The National Institutes of Health Office of Human Subjects Research:
The Belmont Report
Ethical Principles and Guidelines for the protection of human subjects of research
Part A: Boundaries Between Practice & Research
A. Boundaries Between Practice and Research
It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects of research. The distinction between research and practice is blurred partly because both often occur together (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often called ”experimental” when the terms ”experimental” and ”research” are not carefully defined.For the most part, the term ”practice” refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. (2) By contrast, the term ”research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective. (emphasis mine)
The Belmont Report
It is obvious from the above paragraph that many mental health professionals do not understand what constitutes a valid medical "practice" as defined above. It is not only 'good' intent, that a particular professional has, in treating an individual patient using accepted Standard Practices, treatment protocols, and 'Practice Parameters' that is the determining factor. Some of the "interventions" used by psychiatry are based on marketing strategies, and are not "designed solely to enhance the well-being of an individual patient;" but are developed solely for the purpose of expanding the market for a particular drug.
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