Is governance by health authorities sufficient?

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    The scam broke out in mid-2021: respirators from the giant Philips, which are used by patients suffering from sleep apnea, are being withdrawn from the American market. In question: the polyurethane foam they contain is suspected of being carcinogenic. Our colleague, journalist Anne Jouan, has agreed to provide us with an anonymous testimony from the director of ANSM on this topic.

    Philips respirators have been in the news for almost a year and a half. The devices are suspected of being dangerous to health because of the foam that soundproofs the interior of the machines. The substance can break down into chemical microparticles that users inhale and poses a cancer risk.

    A business that grows…slowly

    Since then, progress has been slow, with at least 128,000 French patients still using the devices, while a year ago the Dutch giant promised to replace all existing devices. By now, more than half of the respirators would have been replaced, and Philips guarantees that the replacement rate will reach 97% by the end of the year.

    The Agency for the Safety of Health Products is handling the case

    In France, the National Agency for the Safety of Medicines and Medical Products (ANSM) took up this case. In early 2022, the agency wanted to force Philips to quickly replace the faulty devices »on a fixed schedule“.

    In June, she organized a meeting with a committee of experts consisting of representatives of health care user associations and other medical professionals. To date, no reliable epidemiological study can rule out any risk to patients, as highlighted by epidemiologists contacted by ANSM, and no scientific study can establish a proven link between the use of the recalled machines and cancer.

    Mismanagement by health care authorities?

    Answering questions about the topic, Anne Jouan, journalist and co-author, with Professor Christian Richet, of the investigative book “Organized gang health,” published by whistleblower Robert Laffont, “The Mediator,” agrees to provide us with a conversation she had with the director of ANSM on Oct. 5 on condition of anonymity.

    A question from Anne Jouane: “Do you think the agency has been misbehaving recently?”

    Reply : “When I look at the management of Philips ventilators, the Agency’s slowness has exposed patients. There was no need for all this showmanship with this discussion on Youtube and all this repetitive communication that made it seem like the Agency was working on this subject while it stalled.

    The particles were identified and analyzed by the FDA, and a carcinogenic risk was determined. There were two things for the Agency: to replace the devices as soon as possible (as soon as possible, ed.) and to inform patients about the potential risks. Would a CEO agree to his partner using a Philips device to treat sleep apnea? Would she tell him that the particles could give him a crab?

    Cancer risk not proven? No, but that’s like saying Mediator has cardiotoxic potential, but given the evidence, cardiotoxic risk is not proven. There is a risk that the particles are carcinogenic, but we are waiting for this to be proven!

    We don’t tell patients what are inhaled particles, what are the thresholds?

    ANSM is providing no information, can’t they do measurements to identify these particles instead of trusting Philips? Estimate the fractions, quantify the amount of inhalable substances and also the risk: there are CNRS laboratories, engineering schools that are quite capable of doing this. ANSM is waiting for the FDA to do this“.

    A pre-trial investigation has been opened

    Last February, Maitre Lèguevacques launched a collective action at the request of many patients and with the support of the French Federation of Associations and Friends of Patients with Respiratory Failure (FFAAIR).

    Two months later, in April 2022, Philips refused to inform FFAAIR of the exact composition of its polyurethane foam, the identity of its manufacturer, and studies that showed no cancer risk.

    On June 20, 2022, the Paris prosecutor’s office opened a preliminary investigation into the fact “creating a threat to the life of other persons, deception under aggravating circumstances and introduction of harmful substances“And for its part, the federation decided to summon Phillips to appear on November 16 at the Nanterre court to compel him to produce his documents.

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