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Drugs and suicide: Crisis in drug control

Drugs and suicide: Crisis in drug control


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By Miguel Jara

Being overweight can lead us to suicide and / or serious psychiatric problems, if we consume certain medications for it. The European Medicines Agency (EMEA) has decided to suspend the marketing of the preparation against overweight Acomplia (whose active ingredient is rimonabant), manufactured by the Sanofi Aventis laboratory.


There are drugs that kill *. Being overweight can lead us to suicide and / or serious psychiatric problems, if we consume certain medications for it. The European Medicines Agency (EMEA) has decided to suspend the marketing of the preparation against overweight Acomplia (whose active ingredient is rimonabant), manufactured by the Sanofi Aventis laboratory. The Spanish Agency for Medicines and Health Products (AEMPS), like many state agencies in Europe and the world, has notified health professionals of the suspension of marketing of this drug that was authorized in Europe since June 2006, despite the fact that the almighty US agency - the FDA - did not allow its sale. Once again the mechanisms for controlling the safety and efficacy of drugs have failed. Why? For the simple reason that they are not independent from the pharmaceutical industry.

But let's go in parts. After its latest review, the Committee for Medicinal Products for Human Use (CHMP), dependent on the aforementioned EMEA, has concluded that, with the information currently available, the benefit-risk balance of rimonabant is unfavorable. The licensed indication for Acomplia was "adjunct to diet and exercise for the treatment of obese patients or overweight patients with associated risk factors, such as type 2 diabetes or dyslipidaemia." As the Spanish Medicines Agency recognizes in its official note: “At the time of its authorization, psychiatric disorders, particularly depressive disorders, were identified as the most relevant safety problem associated with this medicine. (…) After its commercialization, the reported cases of serious psychiatric disorders, including attempted suicide and completed suicide, have increased.

Additionally, in the field of ongoing clinical trials, there have been five cases of suicide in patients receiving Acomplia, compared to one case in patients receiving placebo, with a similar number of patients exposed in both treatment groups ”. Additionally, it was considered that the effectiveness of Acomplia in clinical practice is lower than expected based on the results of clinical trials prior to its authorization. This lower than expected efficacy is due, among other factors, to the fact that the drug has been used for a short period of time. Therefore, the CHMP has currently considered the benefit-risk balance to be unfavorable and has recommended suspension of marketing.

Regarding its situation in Spain, Acomplia began to be sold in March 2008 and, according to the AEMPS, until now the use of the drug has been very low as it is excluded from public funding. The Spanish Pharmacovigilance System has received twelve notifications of suspected psychiatric adverse reactions, of which nine were serious and two “referred to suicidal ideation”. No case of suicide has been reported in Spain. But as a pharmacist in Andalusia comments: "The control mechanisms do not work and they can work badly if the controlled ones themselves financially support the controlling bodies".

In this case there is the strange paradox that the FDA, the world's leading drug agency, did not approve it. Data to take into account as this public institution in charge of ensuring the safety and efficacy of the drugs sold in the United States, is financed 70% by the laboratories themselves, as has been published on numerous occasions. This is so because in the US, laboratories can pay the FDA a stipend to speed up the authorization procedure for their drugs. As I said, in the Acomplia case the FDA did not approve it, which is already worthy of consideration given the pro-pharmaceutical bias of it.


And what about the EMEA, the European Agency? Well, it does not carry out independent studies before granting a license to market a drug; It is limited to collecting the information sent by the laboratories and checking that it is correct. But, I insist, without contrasting it with independent works. This, to make matters worse, is perfectly legal as it is contemplated by the operating rules of this European public institution which, as if it were a never-ending story, does not depend on the Directorate-General for Health of the European Commission but on that of Commerce. The commercial focus of the organism on which the health and lives of millions of Europeans depend is obvious. It goes without saying that if the licensing process for the sale of a drug is centralized in the EMEA, all the state agencies in Europe act according to the decisions of the former.

The doubts about this drug were started by a study carried out with 4,000 patients by the Department of Nutrition at the University of Copenhagen. The results were released just a year ago. The drug potentiated psychiatric disorders. If this work is not carried out, the EMEA would have taken even longer than that year to withdraw it. Who knows if it would have taken the 22 years that passed until, in 2005, another Sanofi Aventis drug, Agreal - prescribed to "treat" hot flashes of menopause - was banned, after recognizing the terrible ailments it has caused in women. numerous women who took it. Coincidences of life or death, or not, one of the first sentences handed down in Barcelona in favor of the victims of the Sanofi Aventis preparation argued that Agreal “incited suicide”. As one of the spokespersons for the National Association of Consumers and Users of Health Services (Asusalud) comments on Acomplia: “This type of medication belongs to the group of selective serotonin reuptake inhibitors and other neurotransmitters, due to their mechanism of action. It is proven that it can produce on the nervous system: abnormal movements, such as muscle spasm, ataxia, tremor, seizures, and it can also cause hallucinations, suicidal mania, panic attacks and other niceties. There are occasions, in patients diagnosed with bipolar disorders, schizophrenia or recurrent depression, in which they should be used because it gives very good results, but what should NEVER be done is to use it à la carte. This was announced ”. So in 2005, Agreal, a potent neuroleptic from Sanofi Aventis, which caused mental and nervous system damage and incited suicide, was withdrawn from the market. And a few months later, in June 2006, the sale of another powerful drug from the same house that affects neurotransmitters and causes psychic damage and incites suicide is approved: Acomplia.

There is an urgent need to debate the lack of independence of drug regulatory agencies and to reform them thoroughly. The FDA has been widely questioned in recent years for its lack of independence, especially in the wake of the Vioxx case, Merck's osteoarthritis drug that the drugmaker knew could cause strokes and heart attacks and still withheld those studies from the FDA. This approved it and as a Spanish pharmacologist explains, extrapolating the data from the work done by Merck to the number of consumers who took it, more than 300,000 people may have died in the world until 2004, when it was withdrawn. The EMEA cannot continue to depend on Industry, it will have to depend on the Directorate General for Health. And you will have to do your independent studies to contrast the information that the laboratories send you when approving or not approving a drug. All this will not happen as long as the different health professionals are not united in a large platform that brings together all the critical groups of the health system, including patients.

At present there are numerous organizations of professionals in medicine, nursing, pharmacy and pharmacology, researchers, drug victims and patients of numerous diseases, consumers and users of health, etc., that are independent of laboratories and critics with what is happening. But its strength is lost by not reaching the union that is the germ of efficiency in any field.
www.ecoportal.net

* To be more precise, we should talk about drugs that continue to kill. It's been seven years since I started researching the most serious cases of drug-induced adverse effects resulting in death. In 2003 I published my first report on it in The Ecologist. There are so many dangerous drugs that as Medicines that Kill I titled the first of the four blocks in my book Health Traffickers.
Info about Book Traffickers of health: http://migueljara.wordpress.com/libros/traficantes-de-salud/


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Comments:

  1. Filmore

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  2. Agastya

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  3. Vishakar

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  4. Luis

    I think you are making a mistake. I propose to discuss it.

  5. Devlyn

    I apologize that I intervene, would like to propose another solution.

  6. Daunte

    Okay, very helpful thought



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