There are medicines that manta. The overweight can lead to us to the suicide and/or serious psychiatric problems, if we consumed for it certain medicines. The European Agency of Medicament (EMMA) has decided to suspend the commercialization of the preparation against the Complain overweight (whose active principle is rimonabant), made by the laboratory Sarnoff Adventism. The Spanish Agency of Medicines and Products Sanitariums (AMPS), like so many state agencies of Europe and of the world, has communicated to the sanitary professionals the suspension of commercialization of this drug that was authorized in Europe from June of 2006, although the all-powerful American agency – the FDA- did not allow their sale. Once again the control mechanisms of the security and effectiveness of medicines have failed. Why? For the simple reason that they are not independent of the pharmaceutical industry.
But we go by parts. After its last revision, the Medicine Committee of Use Humane (CHIMP), employee of the mentioned EMMA, has concluded that, with the information at the moment available, the balance benefit-risk of rimonabant is unfavorable. The authorized indication of Complain was “adjuvant of the diet and the exercise for the treatment of obese or patient patients with overweight with associated factors of risk, like the diabetes 2 type or dislipemia”. As the Spanish Medicine Agency recognizes in its official note: “At the time of their authorization, the psychiatric alterations, in particular the depressive upheavals, were identified like the associated problem of more excellent security to this medicine. (…) Later to his commercialization they have been increasing the cases notified of serious psychiatric upheavals, including suicidal attempt of and completed suicide.
Additionally, in the scope of clinical tests in march five cases of suicide in patients who received Complain, against a case in patients have appeared receiving placebo, with a similar number of patients exhibited in both groups of treatment”. Additionally, it was considered that the effectiveness of actually clinical Complain is inferior to the hoped one according to the results of previous the clinical tests to its authorization. This effectiveness inferior to the hoped one obeys, among others factors, to that the medicine has been used during a short period of time. Therefore, the CHIMP has considered that at the moment the balance benefit-risk is unfavorable and has recommended the commercialization suspension.
As far as its situation in Spain, Complain began to be sold in March of 2008 and, according to the AMPS, until now the use of the medicine very has been reduced when being excluded from the public financing. The Spanish System of Pharmacovigilance has received twelve notifications of suspicions of adverse reactions of psychiatric type, of which nine were serious and two “referred suicidal ideation”. Any case of suicide in Spain has not been notified. But as a pharmacist of Andalusia comments: “The control mechanisms do not work and badly they can work if the own ones controlled economically maintain to the organisms controller”.
In this case the paradoxical stranger occurs of which the medicine FDA, agency of reference in the world, did not approve it. Data to consider then this public institution in charge to guard by the security and effectiveness of medicines that are sold in the United States, is financed to 70% by the own laboratories, since it has been published in numerous occasions. This is thus because in EX. the laboratories can pay to the FDA stipendium so that it accelerates the procedure of authorization of his drugs. As I say, in the Complain case the FDA did not approve it, which already is worthy of propharmaceutical given consideration the slant of the same.
And what happens with the EMMA, the European Agency? Since it does not realize independent studies before granting a license of commercialization of a medicine; it is limited to collect that to him the laboratories send and to verify that she is correct. But, I insist, without resisting it with independent works. This, for more indri, is perfectly legal then therefore they contemplate the norms to it of operation of this European public institution that, as if it was the story never to finish, does not depend on the Main directorate of Health of the European Commission but of the one of Commerce. It is obvious because the commercial approach that del has the organism that depends the health and the life on million of European. Needless to say that if the process of concession of license for the sale of a drug is centralized in the EMMA, all the state agencies of Europe act according to the decisions of first.
The doubts on this medicine began by a study realized with 4,000 patients by the department of Nutrition of the University of Copenhagen. The results occurred to know right a year ago. The medicine harnessed the psychiatric disorders. If east work does not get to be realized the EMMA it had still taken more of that mentioned year in retiring it. Who knows if it had taken the 22 years that happened until, in 2005, another drug of Sarnoff Adventism, the Arial – prescribed for “dealing with” the siroccos the menopause it would be prohibited, after being clear the terrible sufferings that have caused in the numerous women took who it. Coincidences of the life or the death, or no, one of the first sentences dictated in Barcelona in favor of the victims of the preparation of Sarnoff Adventism argued that the Arial “urged the suicide”. As it comments on Complain one of the spokesmen of the National Association of Consumers and Users of Services of Health (Assault): “This type of medicines pertaining to the group of selective inhibitors of the recantation of serotonin and other neurotransmitters, by its mechanism of action are verified that can produce on the nervous system: abnormal movements, like for example, muscular spasm, ataxia, tremor, convulsions, and also can produce suicidal hallucinations, odd habits, attacks of panic and other sarcastic comments. There are occasions, in patients diagnosed with bipolar upheavals, schizophrenia or depression appellant, in which they must be used because it gives very good results, but what it does not have NEVER to be made it is to use it to the letter. This was announced”. So that in 2005 a powerful narcoleptic of Sarnoff Adventism retires of the market, Arial, that caused psychic damages, in the nervous system and urged the suicide. And few months later, in June of 2006, the sale of another powerful medicine of the same house is approved that affects the neurotransmitters and causes psychic damages and urges the suicide: Complain.
It is urgent to debate on the lack of independence of the regulating drug agencies and to reform them thoroughly. The FDA very has in the last been questioned years by their lack of independence, mainly as a result of the Vex case, the medicine of Merck for the arthritis that the pharmaceutics knew that it could produce cerebral infarcts and of heart and even so it hid those studies to the FDA. It approved this one it and as a Spanish pharmacologist explains, extrapolating the data of the works that Merck to the number of consumers did took who it can have died in the world more than 300,000 people until 2004 which he retired. The EMMA cannot continue following Industry, will have to depend on the Main directorate of Health. And it will have to make his studies independent to resist the information that send the laboratories to him at the time of approving or not a drug. All this will not happen while the different sanitary professionals are not united in a great platform that agglutinates all the groups critics of the sanitary system, including those of patients.
At present numerous organizations of professionals of the medicine exist, the drug infirmary, pharmacy and pharmacology, investigators, victims and patients of numerous diseases, consumers and users of the health, etc, that are independent of the laboratories and critics and so it is happening. But its force is lost when not reaching the union that is the germ of effectiveness in any scope.
