You know my repeated reflections on the perverse effects of our excessively "mediatized" society.
I put this reflection, copy on the website of the Journal LE MONDE, today:
Furosemide Teva, or administrative negligence
Health crises follow one another at an accelerated pace but are not alike, except on a worrying point: the administration's inability to prioritize and manage the alerts before effective decision-making.
Lack of reaction and loss of time concerning the prohibition of the pick as well as the removal of PIP breast prostheses; precipitation and hypermediatization vis-à-vis the Diane 35 pill that the European Medicines Agency has confirmed in its indications; relentlessly with the Ceraver hip prostheses whose lack of CE marking was at zero risk according to the authority that publicly blasted the firm and finally, indescribable national panic for a tablet of sleeping pills out of which we do not know or ! (probably the bag of the patient) and found in a box of Furosemide Teva. Enough is enough ! The National Agency for the Safety of Drugs and its guardianship, the Ministry of Health, display in each of these "cases" their inability to respond appropriately to the question of the supposed risk. Incompetence and panic combine for the worse, which, taking the place of course to the authorities, engulfed them in the deadly fear of being on the dock. To know the complexity of our health system, I do not want to set myself up as a lesson giver, but just to recall some common sense elements.
A National Health Agency can only find credibility under four conditions:
1 ° Acquire a status independent of the governmental tutelage,
A director who is revocable at the discretion of the power can not have the freedom of decision befitting such responsibilities. The pressure of politics is always very strong in that it favors most of the time its image and the media effect that will serve it in relation to the resolution of the substantive issue. Independence of decision and action is therefore essential. Clearly, an agency director must be able to hang up his phone by saying no to a minister too insistent without risking his wrath. It is at the price of this freedom that he will gain in credit and respect.
2 ° Act on reliable databases and refuse to decide without a sufficiently substantiated investigation.
In wanting to protect oneself by virtue of a precautionary principle that freezes any initiative other than repressive, one accumulates distressing decisions which seriously taint the confidence that one can have in institutions guided by the only fear. In a pragmatic way, and in all areas of human action, a decision can be considered valid when there is 75% chance that it is the right one in view of the collected information and the diligent investigations. Health organizations, either act too quickly without collecting the minimum of proof that can lead to prohibition, or on the contrary and equally detestable, seek the methodological perfection that leads them to postpone their decisions to the indefinite until 100% of evidence are not brought. So we oscillate between two deleterious extremes that do not make it easy for decision makers to make the right choice at the right time. This is so, a responsible political action must assume the uncertainty of its choices, but the tactics in place is to squarely discard this responsibility on the pretext of protecting the population in the name of this fuzzy notion that no longer rests on the precaution but only on the fear of fear alone. Precipitation then becomes the driving force of action, a perverse drift that will quickly turn against its promoters whose speeches and announcements will be less and less raw.
3 ° Keep quiet and disseminate information only when it is justified by a major risk.
It would have been so much simpler to warn the Ceraver firm to comply with the minimum modification of its orthopedic prostheses, knowing that the health risk had been declared as null at the outset. Same attitude towards Furosemide. Why not have the boxes analyzed without this infernal hype that causes patients to stop their treatment to bring back, trembling, to their pharmacist those pills that "kill"? An even bigger danger that does not seem to worry the authorities too much!
The alert system developed and financed by the pharmacists themselves under the aegis of their Council of the Order is remarkable efficiency since in less than three hours more than 95% of the pharmacies were notified of the Teva case. Once the alert was given to the professionals, there was no reason for the Agency to shout loudly to the health drama without any further proof. But in the current atmosphere of suspicion vis-à-vis the pharmaceutical industry, public authorities want to be seen as protective, transparent and virtuous. They have, in fact, deeply tarnished their image of responsible decision makers by playing with fire. Remember this order of the seventh art: SILENCE, ON!
4 ° Recognize his mistakes and publish his excuses as widely as his erroneous decisions were. Rehabilitating those who have suffered from disproportionate media action is a moral requirement. A public body may be wrong, but it must know how to make amends, an attitude that is not the forte of the senior civil service.
Let us hope that these multiple mistakes teach us how to better manage our health protection system, crisis after crisis. Ensuring alerts, verifying them, then acting, calls for short decision circuits. In times of war, the army knows how to reduce its hierarchical levels to fight better. The policy of administrative simplification desired by the President of the Republic should attack the mille-feuille of our health institutions by concentrating them. The dispersion of places of power is one of the main sources of efficiency loss. Finally, it would be up to the Haute Autorité de Santé, because of its real independence, to cover the entire field of medicine and medical devices.
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Forusemide / TEVA: what lessons ???
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