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Humira - 700 deaths Humira – Risk of life in treatment of Rheumatoid Arthritis – this is what you should know about it! Humira is a medicine used in the treatment of Rheumatoid Arthritis considered as a high risk medicine in USA since 2002. In the European Union its risks have been hidden, which contributes to an increase in the number of deaths. The officials records say, and I quote: “A total of 22 Humira-treated patients and 2 placebo – treated patients died as a result of AEs during the development program. In Addition, two patients died of cardiovascular disorders 33 and 36 days after their final doses of study drug in study DE020. Five deaths were deemed related to infections, including three cases of sepsis, one case of aspergillosis, and one case of super-infected herpes zoster. Six deaths were related to malignancies and four others were due to cardiovascular disease”. The document Scientific Discussions of EMEA indicates 24 deaths in 2575 patients, that is 0, 93% and only 2 deaths in patients with rheumatoid arthritis that took placebo (2/ 850 = 0,24%) within the scope of the clinical research with Humira. That means that the risk of death in this population exposed to treatments with Humira or other Anti-Tnf, according to the conclusions of the European Commission itself rises approximately 4 times. In other words, from the deaths occurred, within the scope of the clinical research, 75% derived from the medicine Humira and 25% derived from the increased risks that the patients with rheumatoid arthritis are exposed to. Admitting the officially recognised rate of 0,93 % of deaths and taking into consideration the statements from Abbot in Portuguese Court that 100.000 patients had taken this medicine, we must conclude for an estimated number of 930 deaths (100.000* 0,93 %) within a period of two years, of which 75% or that is 698 deaths were directly provoked by Humira. New studies for evaluating the safety and efficacy of Humira under new conditions and for other diseases were done with smaller groups of participants (the conclusions are not so statistically relevant) and the reports are now available. Basically, the conclusions of the three studies published now are in line with the previous and most important study, and I quote; “The CHMP concluded that the adverse event profile was similar to the one previously seen in the currently approved indication. However, a tendency towards more infections in the combination therapy group was found, which was not considered surprising”. To get more information on the conclusion of these studies, please click here; Is this kind of clinical trials acceptable and legal? because these patients were not life-threaten by their disease – arthritis. They will be most probably alive today if they did not accept to participate in Abbott clinical trial with Humira. Abbott refuses to change the patient information leaflet in Europe declaring that it just does no more than to accomplish the demands of the European Commission/ EMEA and still adds that it is common practice among the American pharmaceutical companies to include a different type of information in the European Union. After several appeals and lawsuits, the European Commission/EMEA accepted to make a request to Abbott in order to revise the warning of risks in the patient information leaflet in Europe. Unfortunately this is not an isolated case; on the contrary, it has been a generalized practice, not to communicate the occurrence of deaths and serious risks to citizens. Do you accept that the risks of your medicines be hidden from you? Quoting a similar case, it is estimated that Vioxx (another medicine) was the cause of heart attack and subsequent death of about 30 thousand people in USA. How many might have died in Europe? What has been done to hold those companies responsible for the false information given and for the deaths of European citizens, who merely died to increase the profits of those pharmaceutical industries? Vioxx killed as many Americans as the war in Vietnam – New York Times It is imperative that we act, demanding a new kind of practice from both the European Commission/EMEA and the laboratories – please read the text that follows and in case you agree with it, do please subscribe our letter to the presidents of European Commission-EMEA and Abbott. (See the letter (PT) to EU comission and Aboot) Who decides on the risks you run when you take medicines? Is it you, yourself? Is it your doctor? Is it your laboratory? If you think it is your own decision that should count, do please subscribe our letters. In case you know about any occurrence of serious adverse side effects, including death, provoked by Humira or any other anti-tnf – Enbrel or Remicade – do please contact and give us any details about the case in order that a case court can be raised, against the pharmaceutical company in question. |