Drugs: How to restore confidence
After the Levothyrox crisis, a report provides pointers for improving information on medicines.
On November 29, the Minister of Health, Agnès Buzyn, set up a mission "to improve the information of patients and health professionals about drugs". A response to the "Levothyrox case", during which health authorities had neither anticipated nor manage the crisis due to the change in formulation of the drug. The mission, chaired by Dr. Gerald Kierzek (emergency physician and journalist) and Magali Leo (Renaloo association), made his proposals Monday and wants to promote a real transparency.
The Minister of Health reacted positively to the report: "I have always considered that access to information is an essential right of the patient." On the other hand, it did not give a precise timetable for the future.
More intelligible information
The Kierzek-Leo report immediately sets foot on the plate, stressing the "technicist bias" of information in the Levothyrox crisis. The French Medicines Agency (ANSM) opted for a communication focused on "the best stability" of the new formulation, instead of analyzing and responding to adverse effects reported by patients. "The traditional system is too rigid and slow," conclude Kierzek and Leo. "The ANSM has not yet understood that communication has to be done and not just information," adds Gérard Raymond, president of the French Federation of Diabetics. It must be done because the Ministry of Health has already announced its intention to "entrust emergency communication in the event of a warning about a drug to the ANSM". The ministry is also relying on new technologies to "spot weak warning signals outside the pharmacovigilance system". The mission was also surprised that the health authorities do not have, in 2018, a rapid operational tool to alert all health professionals in case of major problems. But, beyond crisis situations, it is all the information on the drug that is to be reviewed for Kierzek and Leo. The Ministry of Health has announced its intention to "set up a single source of information on the drug based on sante.fr", but Patrick Baudru, administrator of the association Epilepsy France, is skeptical. "The RCPs (summaries of product characteristics) of each drug are huge, it often exceeds 100 pages per drug if we take the complete documentation: no doctor can know everything, even on a given class of drugs, explains he. And aggregating incomplete information on a single site would not be enough, the information must first be accurate.
Strengthen transparency
Obviously, the report stresses the need to give citizens better access to data, which requires a structure that makes it intelligible. A crucial point for Emmanuel Jammes of the League Against Cancer: "What information do we want to make transparent? he asks himself. If it is to hide once again behind the secret of negotiations and business and lead to these reports entirely deleted from the Transparency Commission of the High Authority of Health, it is useless. "Same concern with the proposal to bring a patient representative to the CEPS (the economic committee for health products, which negotiates the prices with the laboratories), which would be "in any case held like the other members to respect the secrets protected by the law". For Emmanuel Jammes, "Out of the question to participate in a system that we denounce the opacity if it is to lose his voice!
Trust associations
The main interest of the Kierzek-Leo report is not so much in the series of proposed technical measures. No, the most important thing in this report is the mentality revolution that underlies the proposed measures: to trust patients. We are far away today. Trust them when they report information, even if it seems inconsistent. Also trust them to be involved actors of the system at all levels. "We are ready to work upstream with drug companies and institutions," says Gerard Raymond. Finally, give the associations the financial means to learn about the life of the drug and to communicate, in their own way, to the population.
The right of patients to be informed generates an uninterrupted flow of information
Too much info, kill the info! This is one of the paradoxes pointed out by Dr. Gerald Kierzek and Magali Leo in their report. They underline an unforeseen effect of the strengthening of the obligation of information on the drug that has emerged over the years, in particular with the law of 4 March 2002 on the rights.
Comments
Post a Comment