Crisis Levothyrox : the Agency of the drug, destabilized communicates

ALLILI MOURAD/SIPA

Published the 08.12.2017 at 23.31

A A

Keywords :

LévothyroxcriseANSMAgence of the drug

Since the change, at the end of march, the formula of Levothyrox by Merck, thousands of patients have reported adverse effects, painful, or unbearable, on the 3 million who partake of it. To memory, this format change only relates to the ” excipients “, the products are inert tablet, and aimed to respond to a request for the Drug Agency who wanted to ensure the stability of the drug.

Reported sick from July

From the month of July, social networks and patients ‘ associations, showed that the first reports of adverse effects. It was not until mid-August that the press made echo of a petition of the sick under Levothyrox denouncing the adverse effects caused by the new formula and which were already 20 000 first signatories. In the following days, the petition asking for the return to the old form is signed by 312 000 persons and the notifications of adverse effects are multiplying at the portal of pharmacovigilance of the MAN to reach more than 20 000.

Self-destabilization of the MSNA

One catch : the agency is destabilized by improving its own pharmacovigilance system which does not concern only doctors but also patients. Even if it’s only less than 1% of the patients, the crisis is launched, and never to stop.
However, the Agency was thought to have done well since she had sent out a newsletter to 400 000 health professionals before march to announce this change. A information that has not been for nothing since it does not raise the hypothesis of adverse effects as strong… as it was not anticipated !

A lack of anticipation

Yet, there was material to suggest that it would be something since in 2009, in France, a generic Levothyrox had already been proposed. The reactions of some of the sick had already been so strong that the drug Agency recommended that doctors monitor the “risk patients” and that the doctors quickly stopped prescribing the generic. They had even put “non-substitutable” on prescriptions of Levothyrox, so that the pharmacists could not substitute the generic.
The Agency could also turn to the foreign country where the change to the new formula has already been achieved (Denmark, New Zealand…), to see how it went.

The agency is at the foot of the wall

Today, after it asked Merck to import 2 opportunities 200 000 boxes of the old formula, there will be more because the production lines have been stopped, and it takes at least 4 months if one wants to raise and even if 4 other drugs now exist, they are not strictly identical to the old formula.
The Agency is at the foot of the wall, and it is to try to take back the hand that she launched in a press conference on December 8, a series of runs to improve the management of this type of crisis : in 2 words, it is a matter of expanding the “risk analysis” monitoring best social networks, and develop new information tools and risk management.

Information, monitoring and data management

The information doctors by mail may not be the alpha and the omega of the information of the MAN who reflects on the development of an application that would be directed as much to doctors as to patients. With regard to the monitoring of social networks, many scientific studies have reported the monitoring of tweets, for example, to detect the onset of a flu epidemic. This is not more effective than a good experience, but this quickly gives other information. The portal of pharmacovigilance of the MAN, however, has played its role in this area : as soon as patients have learned through the press that they can report their adverse reactions, the number of reporting has soared : it has been multiplied by 80 in a few days and the reports by the patients increased from 5% in normal times to over 90%. However, these data have not been exploited quickly enough.

Respect the voice of patients

In fact, you may want to develop all the systems of the world, it doesn’t do anything if the doctors and the Agency of the drug do not take proper account of the complaints of the patients. As the change of formula could not be, pharmacologically, be liable for any toxicity, while the world puts those reporting adverse events to the best on the other disease associated, at worst, a “hypersensitivity” of the sick. The MSNA recalls as well that approximately 15% of patients complained already of adverse effects at a time of the year when they were on therapy with the old formula of Levothyrox.

The MSNA and the doctors have not wanted to consider that patients are able to suffer and this is where the shoe pinches. It is also for this reason that the trial is coming, with various possibilities of attack and the courts : lack of information, deception, or incompetence of the agency. This is several opportunities to win.