Alzheimer: The Health Authority confirms the lack of interest of current medications

The four currently available drugs have been reassessed by the Transparency Commission, which is part of the Health Authority. Front of their very low therapeutic value and their risk of significant side effects, their Actual benefit was lowered and new conditions of use have been decided. Back on the context and the announcements of the HAS that could lead to a significant reduction in the use of these products in France.

At least 800,000 people with Alzheimer's disease

There are about 850 000 people in France of an Alzheimer's disease or related. Of these patients, "550 000 followed medically (assessment end of 2009) 350 000 which benefit from support under the condition long term", said the health authorities at the balance sheet of the plan AD 2008 to 2012.

This disease is the result of a degeneration of neurons that are poorly understood causes: the role of cardiovascular problems? Head injuries? Neurotoxic substances such as solvents or mercury? Role of pesticides, fine particles emitted by diesel engines, aluminum? Others? Early identification of disease is also not yet ready (current research on biological signs, radiological and neuro-psychological).

This misunderstanding is coupled with an inability to prevent or slow down significantly, for the moment, neuronal degradation. Currently available drugs are in fact not effective enough.
4 drugs available but disputed

Donepezil (Aricept ®, Eisai Laboratory), galantamine (Reminyl ®, Janssen Cilag), rivastigmine (Exelon ®, Novartis) and memantine (Ebixa ®, Lundbeck) is available in France for a dozen years.

The first 3 are cholinesterase inhibitors: their role is to prevent the breakdown of acetylcholine, which is involved in nervous system function. As for memantine, it is supposed to block certain receptors in the synapses of neurons, which could improve their operation.


Problem: studies have shown that a very modest efficacy, only in some patients, and transitional. Moreover, these drugs have many side effects. Their administration is not effective enough to change the prognosis of the disease, unlike, for example, the combination therapy in HIV, as noted by the President of the Jean-Luc Harousseau HAS.

That's why many doctors, including those of the journal Prescribing, denounce their uselessness for many years almost complete in practice. But despite these warnings, these drugs have been widely prescribed in France: more than 250 million euros per year and repayment of several million boxes sold every year!

It must be said that these drugs were considered by the HAS to have a medical benefit (SMR) important. The explanation? Plan before Alzheimer care was not organized, resulting in estimated value of drug prescriptions (including neurologists) as a structure (it might have been better "structure" support with a harmless placebo and cheap instead of expensive drugs, virtually ineffective and risky ...).

But since the situation has evolved: the role of caregivers is emphasized, the fight against prescription drugs unnecessary and even dangerous as neuroleptics, developed, and so on. (Alzheimer Plan 2008-2012). Hence the decision to re-evaluation in January 2011, said Gilles Bouvenot, Chairman of the Transparency Committee and Professor of therapy.
Reassessment under the sign of independence and transparency


After the case Mediator ®, which showed a probable deleterious influence of Servier laboratory of the French system of medicine (health agencies, doctors, politicians) for 40 years, transparency and the implementation of measures to ensure the independence of decision circuit were a priority.

Without waiting for the reform of the drug, recently passed by Parliament, the Health Authority and the Transparency Commission, therefore evolved their working methods so as not to expose himself to suspicion: the experts to reassess the medical made of four drugs had nothing to dispute of interest with the 4 laboratories. Mr. Harousseau said that everyone could express themselves, "pluralism of expression is a prerequisite for the objectivity of decisions." Besides the discussion of the Commission are available in full on video on the site of HAS since this morning.
Decrease in actual benefit

Between July and October 2011, the Transparency Commission (TC), composed of 26 health professionals in office, has reviewed all existing studies, analyzed the practices in France, Europe and the United States, interviewed experts from different backgrounds and independent (general practitioners, neurologists, geriatricians, doctors working in retirement homes ....) and then listened to the arguments of the four laboratories.


Decisions, voted unanimously after intensive discussions have taken "solely on scientific data," recalled repeatedly Prof. Gilles Bouvenot.

It appears from this work together in an evaluation report is being finalized and as a notice for each product (downloadable at the bottom of this page), that these drugs "have only a very small" regretted Prof. Bouvenot with "best slowdown or stabilization of cognitive decline for a few months, no effect on mood, behavior. In addition their use does not delay entry into the institution." Additional concern: that these drugs have minimal effect in some patients. Now modern science can not predict the responders, or even what percentage of patients may derive little benefit from these drugs.

This reassessment has confirmed against the risk of drug interactions (the elderly are often full of other drugs) and possible side effects: gastrointestinal (nausea, vomiting, diarrhea ..), neuropsychological (difficult to distinguish from dementia) and especially cardiovascular disease (cholinesterase inhibitors: risks of slowing of the heart, syncope, need for installation of a pacemaker ...).

The CT has decided to lower the drug for each medical service rendered important "low" and not "insufficient" because they "can still do something for some patients", said Prof. Bouvenot. Repayment from 65 to 15%, but in practice this might not be too costly for the patient and his family. Indeed, if the doctors still want to prescribe these drugs despite the negative signal that is the demotion, it is likely they will ask a first support 100% for their patient (ALD).
New terms of use and new recommendations for good practice

The CT also noted the rapid depletion of the possible positive effect of these drugs. That is why she recommends, when prescribing, to reassess the patient at 6 months and 1 year.

This reassessment at 1 year should be "systematic, comprehensive, multidisciplinary," stressed Prof. Bouvenot. The attending physician, the neurologist and / or psychiatrist will have to assess the impact of treatment in a collegial manner (which in practice will perhaps not be obvious ...) and stop in the absence of profit objective.

These changes low-SMR, reassessment of the duration and risk / benefit ratio of treatment-and the challenge to the independence of the previous recommendations (Expert bound by conflicts of interest), will lead the HAS to be made public by the end of November new recommendations for the therapeutic management of Alzheimer's disease.

Let us hope that these new recommendations, also transparent and independence displayed, will heavily loaded with non-drug ... in the meantime, hopefully, the next development of truly effective drugs or strategies to block or roll back, this devastating disease that affects more and more families ...