In recent months, curious medical affairs have made the news, arousing strong concerns in patients. It must be said that the reported accounts are out of the ordinary. Overnight, a patient rushed to the games of money, until he stole thousands of euros in his son. Another patient, rather Puritan, has suddenly became addicted to sex, insisting with his partner several times a day. A third started, without more reasons than that, to torture cats. Like that, for fun.
All accuse the Requip, a medication prescribed against Parkinson, of having sparked these impulses for them, of having seized their free will. Two complaints were filed. These cases, revealed by the Chained duck And Radio Francehave not yet been educated. But they ask a thorny question: how to demonstrate that we are the victim of a drug? How to prove that it is the substance, and only it, which causes the effect that one denounces, when it is as subtle as a change in behavior?
The complaint on the TEMP is reminiscent of other things, as also amazing. Like that of the Paroxetinestill topical too. In 2021, two relatives of patients triggered legal proceedings, again against GSK. They accuse the laboratory of not having sufficiently alerted to the undesirable effects of this medication, an antidepressant. The complainants believe that the molecule has worsened the mental state of their already depressed child. He threw himself under a train in September 2021.
These disputes are particularly complex. Patients who received these drugs already had risks of knowing the effects they denounce. Parkinson’s disease, as is depression, affects the production of dopamine, the hormone responsible for motivation circuits. It is precisely because patients already find it difficult to control their thoughts, impulsive or suicidal, that these treatments be given to them. Impossible, therefore, as it stands, to know who of the disease or the substance, is to be blamed.
“Before, people rushed to the hospital …”
Contrary to what one might think, these “dead ends” are not uncommon. They are even more and more frequent. “Bringing formal evidence is increasingly difficult as pharmacology is advancing,” said Bernard Bégaud. When a medication derails, it is his phone who begins to ring: the academic, director of research at the National Institute of Health and Medical Research (Inserm), and professor emeritus at the University of Bordeaux, is one of the major French drug experts.
The scientist is even one of the founding fathers of “pharmacovigilance”, the science that monitors pharmaceutical products. Trained by the very first thinkers in the field, in the 1950s, Bernard Bégaud participated in structuring the discipline, essential for detecting the toxic remedies that could circulate on the market. He is now at the head of the Epi-Phare Scientific Council, the cell that centralizes efforts nationwide.
In his early days, in the 1970s, things were simpler, “he said:” People rushed to the hospital, flap skin, convulsion, or lightning cirrhoses, things that we couldn’t see Not like that. And to quote the Mediator affair, in which he was heard as an expert. “A heart does not degenerate on its own, not like that. While impulses, everyone has it, anyone can decide to give in.”
For demonstrations like “impulses”, no test, no medical snapshot, makes it possible to establish a direct link. Statistics are not more useful. If suddenly, among consumers of a drug, the occurrence of a certain pathology explodes, it is, usually, the sign of a problem. If in addition, what is known about the drug, on which organ, which functions it acts, if there are precedents or molecules of the same family which present a similar risk, the beam of indices is exploitable. But for the cases of which Professor Bégaud speaks, none of this is enough.
Possible is not certain
What is true for the requip is also true for paroxetine: apart from flagrant medical errors, people who receive antidepressants are precisely subject to suicidal desires. And as suicides are infrequent, the figures are not precise enough to be eloquent. Each time, complaints are theoretically founded, the substance can be involved in the behaviors denounced. But “possible” is not “certain”.
Specialists must then rely on a method. The “Bégaud” method, again. “She bears my name but it was actually my mentors who invented her,” he said. It is a very worked questionnaire, allowing to obtain a score. “Depending on the result, we can say if a case is excluded, doubtful, likely, or likely. This does not solve everything, but it makes it possible to make the most objective analysis possible”, abounds Professor François Montastruc, at the head From the Toulouse pharmacovigilance center, which also sees the complexity of the business intensifying.
The Bégaud method, developed in 1978, begins by eliminating false tracks. “There is in the elements of the file things that may have been forgotten, an old psychiatric hospitalization before treatment for example”. Then she ensures that the cause precedes the effect, that the suspicious manifestations occurred after having ingested the medication, and that it is well taken for the first time. It then resumes any statistical and theoretical elements of the file, before entering more subtle verifications.
When justice must decide alone
“If patients who take large doses have greater disorders, it is an element. But the more the patient is in a degraded state, the more he may take treatment. Here again, we cannot say if the manager is the substance or the disease, “continues the specialist. Again, the pitfalls are numerous. It is sometimes not possible to carry out all the analyzes: “Stoping and reintroducing the treatment can be a good indicator. But in the case of suicidal people, we cannot take this risk,” says Bernard Bégaud.
The specialist has in mind a particularly recalcitrant file, which has haunted it for years: that of benzodiazepines. This family of powerful calming, very often prescribed for the elderly, is suspected of causing, or accelerating dementia. “This is the typical example of a scenario where at the individual level, we cannot conclude anything. We are on audiences over 80 years old, which in any case will become more or more senile at one time or a Another, “said the specialist.
When science cannot decide, it is up to justice to decide. His logic is not there. 1998. Another case, same problem. Hepatitis B vaccines are suspected of causing multiple sclerosis. 249 cases are reported. Some of the trials are still underway. “In this case, in the absence of formal evidence, the judges still made the choice to compensate the victims, because this vaccine was compulsory. In a way, it is a recognition of a form of injustice “, analyzes the expert.
This theoretical framework does not presume the outcome of complaints against GSK, which did not wish to answer our questions. Most of the time, disputes relate to what the industrialist knew, and what he has done to ensure patient safety. But it allows you to approach reality, an “objective” response. The fact remains that, in the opinion of the experts, these gray areas of science often benefit industrialists, who can support persistent doubts to convince the judges. Until new elements tip the scales, or medical technologies evolve.
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