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"Reboxetine" ineffective - IQWiG calls for publication obligation for studies The antidepressant "Reboxetin" from the pharmaceutical company Pfizer "is overall an ineffective and potentially harmful antidepressant". The authors around Dirk Eyding and Beate Wieseler from the German Institute for Quality and Efficiency in Health Care come to the conclusion (IQWiG) in the current edition of the “British Medical Journal.” The worrying: Pfizer has apparently had 16 different studies for a long time that come to the above-mentioned result, but the pharmaceutical company has apparently willfully withheld a large part of the studies from the licensing authorities.
"Reboxetine" should help with depression
"Reboxetine" is used as a selective norepinephrine reuptake inhibitor (NARI) in patients with depression. In contrast to most modern antidepressants (selective serotonin reuptake inhibitors), the mechanism of action is based on the increase in norepinephrine instead of serotonin. According to the pharmaceutical company Pfizer, the active ingredient should counteract the loss of interest, energy and joie de vivre as well as the accompanying hopelessness, the concentration disorders and the helplessness in depression patients. Depressed patients are also treated in Germany with preparations such as "Edronax" and "Solvex", which contain the active ingredient "Reboxetine".
Active ingredient approved in Germany since 1997 "Reboxetine" received approval in Germany as early as 1997, the assessment
however, only six studies were made available by the regulatory authorities, all of which came to positive results in the interests of the pharmaceutical company. While many European regulatory authorities approved the active substance on the basis of the known studies, in May 2001 the US regulatory authority FDA refused to allow Pfizer to launch the product due to the lack of convincing proof of effectiveness (“lack of compelling evidence of efficacy”). At the beginning of 2002, the Federal Joint Committee (G-BA) commissioned IQWiG to carry out a corresponding benefit assessment of antidepressants in patients with depression, in the context of which the active ingredient "reboxetine" should also be examined in more detail.
Only six out of 16 studies were ahead of the regulatory authorities Beate Wieseler, deputy head of the drug evaluation department at IQWiG, and her team came across a large number of previously unpublished studies while researching “reboxetine”, which were also not available to the regulatory authorities. The authors were able to determine that the active substance had been examined in at least 16 studies with around 4,600 participants, whereas the authorities were only provided with the results from six studies with 1,600 patients. IQWiG should submit its assessment of antidepressants to the G-BA by 2009, but despite massive pressure, Pfizer was very hesitant to publish the remaining studies. The current article by Beate Wieseler and colleagues is still not based on all 16 studies. "Only under massive public pressure" were the examiners able to persuade the pharmaceutical company to publish at least 13 studies.
Data base increased by 74 percent due to subsequent studies The added data have now been examined in detail by the scientists as part of a meta-analysis, with the subsequent studies increasing the patient base from approximately 1,600 to 3,033 (by 74 percent). "Deception by concealment is not a trivial offense," said Peter Sawicki, then head of the testing institute, already very annoyed at Pfizer's approach at the end of 2009. Based on the current findings, it can be seen that the studies originally provided overestimated the effect of reboxetine by 115 percent compared to placebo and by 23 percent compared to selective serotonin reuptake inhibitors, the authors explain in the "British Medical Journal".
Clear result - "Reboxetine" does not help
The clear result of the meta-analysis by the experts from IQWiG: "Reboxetine" doesn't help against depression better than placebo preparations. However, taking the active ingredient brings with it significantly more side effects. In September 2010, the G-BA excluded all “reboxetine” antidepressants from reimbursement by the statutory health insurance companies. Since the authors of IQWiG are deliberately deceived by the pharmaceutical company's approach, they will in future demand stricter rules on the publication of all studies. Because Pfizer is not an isolated case. The selective publication of studies with a positive result is one of the most common and treacherous sources of error in the approval of medicinal products and their later medical use, the experts explained. Accordingly, the effect of therapies with certain preparations is often overestimated, as in the case of "reboxetine", which leads to deficits in treatment.
Publication requirement required - about half of all studies remain under lock and key
The scientists assume that about half of all clinical trials started will not reach the public due to unsuitable results for the client. According to the authors in the British Medical Journal, all studies in Europe should therefore also be subject to registration, as was already legally stipulated in the USA in 2007. According to the experts, the obligation to publish should not only include studies on medicinal products, but also on medical devices and non-medicinal processes. In their opinion, the publication obligation provided for in the current draft of the Medicinal Market Reorganization Act (AMNOG) only for selected studies is not sufficient. In addition, according to the IQWiG experts, the results of older studies must also be published accordingly. "We need the results of all studies," said Beate Wieseler in a current IQWiG press release. Representatives of the pharmaceutical company Pfizer, on the other hand, were rather sheepish in their current statements and declared that they should review the Edronax® rating. However, Pfizer still considers "reboxetine" to be a suitable active ingredient for the treatment of depressive disorders and major depression. (fp, 14.10.2010)