First there was the pain. Then the will to understand. The anger came next. Anger at “a system” that failed to protect him. Neither he nor the other patients who are victims of fluoroquinolones, a family of antibiotics causing rare but very serious side effects. The system ? French health administration. An administration that Philippe Coville has not stopped shaking up for 18 months, so that what happened to him “no longer happens to others”. If today he is beginning to make himself heard, “to be taken seriously”, it is because this engineer and company manager has put all his professional skills into this battle.
“In my career, I have been a major account salesperson, an organizational consultant, I have also done litigation. I know how to push doors, carry out audits, suggest improvements, build a network…”, he says . All of this was needed. Through his fight, it is once again the inertia of the drug regulatory bodies that emerges. Their twists and turns. Their good and bad reasons for delaying action. Their difficulty in taking into account the words of patients and field alerts. And, worst of all, their inability to make themselves heard by doctors – especially when it comes to improving the use of medicines in general, and antibiotics in particular.
Because the most infuriating thing about this story is that it should never have happened. The adverse effects of fluoroquinolones have been known for a long time (tendon ruptures, heart rhythm disorders, aortic aneurysms and dissection, neuropathy, neuropsychiatric conditions). As early as 2019, the European Medicines Agency (EMA) decided, for this reason, to restrict their use, limiting it to cases where there are no alternatives. “Unfortunately, the message has not been heard enough by doctors, who have been prescribing them for 30 years. If the State had played its role better by alerting them, then by ensuring that practices had changed, I would not wouldn’t be there”, regrets Philippe Coville.
Hundreds of emails
His life changed in July 2021, after a trivial urinary tract infection. His GP put him on ciprofloxacin for 15 days. The germs disappear quickly, but calf pain appears almost immediately. They extend to the knees, feet, hips, wrists… The 50-year-old will spend his month of August “in an armchair, eating doliprane”. The return to school marks the beginning of a long medical wandering. “My GP tells me it’s not related to the drug, and several specialists assure me that these pains are in my head,” he gets angry.
Philippe Coville inquires. Search the Internet. Falls on the documents relating to the 2019 decision of the EMA, then on the letter sent to doctors by its French counterpart, the National Agency for the Safety of Medicines (ANSM), to inform them of it. “That’s the scandal, they thought a simple letter would be enough to change 30 years of prescription habits,” he continues. September 9, 2021, he sends a first email to representatives of urologists and infectiologists, to the Director General of ANSM and to the Ministry of Health. The first of “several hundred” who, little by little, will push the health authorities to take action. “Initially, I just wanted to know why I could have been prescribed such a risky drug for cystitis. But when you are a simple patient, these people do not respond,” he notes.
Never mind. Completely ignorant of the mysteries of the world of health, but stubborn, Philippe Coville ends up finding the contact of the vice-president of the board of directors of the ANSM. A pharmacist, whom he calls into his pharmacy. She suggests that he ask his question via a page on the ANSM site reserved for users – the only way to hope for an answer. Nothing comes. Reminders. An email finally arrives: “Basically, I’m told move around, there’s nothing to see”. Except that in the meantime, Philippe has approached other victims via social networks. A young woman, Ateka Tahif, “intoxicated” ten years ago, had already set up a Facebook group bringing together a hundred patients, who until then had been struggling to be heard. Some become friends – Paul Hellinckx in particular, a Belgian engineer who lives in Switzerland. Together, they send the ANSM a new argument to demonstrate that there is indeed a problem and demand a meeting.
One refuses to answer him? He asks for another
Over the months, Philippe Coville will seize all possible organizations. Pharmacovigilance centers, the High Authority for Health, the national council of the order of doctors, that of pharmacists. One refuses to answer him? He asks for another. At the ministry, he knocks on all doors, directly solicits the officials concerned. Call contacts contacts. Weaves its web. Gets annoyed when he is sent back and forth, from ANSM to Avenue de Ségur and vice versa. He ends up getting meetings, “in video, never more than an hour”. In the summer of 2022, his first victory: an ANSM official told him that an information file on fluoroquinolones was going to be posted on the agency’s website. “This publication is very important, because it confirms that there is a problem”, underlines Philippe Coville. But he wants more. An alert sent directly to doctors. Support for victims. Research to find out how to cure them.
In the fall of 2022, he set up an association, with Ateka Tahif and another patient: “Several interlocutors had advised me. In the French public health system, recognition goes through that”. Here he is, president of the association for help and information on the deleterious effects of fluoroquinolones. He continues to send emails, to search for other victims. He is also filing a criminal complaint, always with a view to shedding light on the dysfunctions he is discovering little by little: “If I had just wanted compensation, I would have gone to civil proceedings,” he says. The case now occupies him almost full time.
He also discovers victims’ associations all over Europe. Together, they will seize the European Medicines Agency (EMA). The latter indeed published during the summer of 2022 an impact study on the application of its 2019 decision, which points to the lack of modification of practices in the field. They speak directly to Emer Cooke, the director general of the EMA. “We are told once again that everything is fine. But in the signature, there is Mrs. Cooke’s phone, so I call her directly”, recalls Philippe Coville. She agrees to organize a meeting, which takes place at the beginning of January.
Holes in the racket
At the same time, he reminds all those responsible for the file in France, with the EMA study attached. An ANSM official informs him that the High Authority for Health (HAS) is going to put an alert message in the prescription (for doctors) and dispensing (in pharmacies) software. Finally ? Delighted, Philippe Coville inquires with several pharmacies. He wants to see “his” message displayed… and discovers that it hasn’t passed. New burst of emails. Another member of the HAS replied by confirming the existence of holes in the racket. HAS can write alerts, but only a small part of the software installed in healthcare professionals is configured to receive them! “The ANSM sold it to me as the solution to our requests, do you realize?” recalls Philippe Coville. New reminders: this time, the ANSM is asking the Order of Pharmacists to send pharmacies a health alert.
At the same time, the French Society of Pharmacology and Therapeutics publishes an article on fluoroquinolones, recalling that they should be avoided in everyday practice. Obviously, Philippe Coville immediately contacted its author via twitter – Professor Molimard, pharmacologist at the University of Bordeaux. The same evening, they call each other. “I was able to explain to him that reasonable communication was needed, because these drugs remain essential in certain cases”, recalls Professor Molimard. Thus drawing in hollow one of the reasons why the health authorities had long been reluctant to communicate more widely on this question: the fear of scaring. Between the fear of worrying patients, at the risk that some refuse treatment, and the need to inform about the toxicity of certain products, the crest line is sometimes difficult to maintain. Recently, the High Authority for Health also modified its recommendations: an update dated March 13 indicates that fluoroquinolones should not be prescribed as first-line treatment in the event of cystitis.
A victory for Philippe Coville. He now pleads for doctors to be obliged to complete a so-called “care agreement” form to prescribe a fluoroquinolone, in addition to a classic prescription. The idea is gaining ground. After 18 months of uninterrupted efforts, a “simple patient” will therefore have succeeded in influencing health organizations. And what does it matter if the recent media coverage of the affair has angered him with the ministry. Because Philippe Coville no longer intends to stop there. He is already collecting complaints from victims. Its new objective: to push justice to seize this file.