Healthcare, EMA clinical studies: this is how patients’ health is sacrificed in Europe

Healthcare, EMA clinical studies: this is how patients’ health is sacrificed in Europe
Healthcare, EMA clinical studies: this is how patients’ health is sacrificed in Europe

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“If the European Medicines Agency (EMA) had not authorized Pradaxa, I’m sure my mother would still be alive,” says Nathalie, an emergency nurse I met in Valence, near Lyon, France. His story is atrocious: “It all happened in an hour, the hell in the emergency room, the nurses taking turns to empty the basins full of blood, the panic in the eyes of the doctors who had no way to stop the haemorrhage of an eighty-year-old patient”. Before she expired, her last words: “I’m bleeding to death.” It was 2012, the beginning of Nathalie’s battle against Pradaxa, an anticoagulant placed on the European market since 2009, without any antidote. Then it was discovered that over 400 deaths, in Europe and the USA, were attributable to the same drug. In the US the manufacturing company paid 650 million dollars to the victims. Investigate Europe read the letter of intent sent by the German company Boehringer Ingelheim at the EMA, where they asked to simplify the “double-blind” clinical study (in which to test a new drug two groups of patients are taken: one gets the new one, the other an existing drug or a placebo. Nobody knows which one receives) “single arm” (all participants receive only the experimental treatment). Ema accepted together with the speakers of the experiment, chosen by the company itself.

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Today we know that one of the experts selected was a French cardiologist who, after expressing a positive opinion, became a consultant for Boehringer herself. Seven years passed before the German company put an antidote on the market. Meanwhile, Pradaxa continued to be used by European patients. It is not the only story of “dangerous” drugs or those not yet ready to be marketed, which EMA has given authorization to enter the European market. The Amsterdam-based agency – which Italy had tried to bring to Milan after Brexit – has the task of approving the scientific evaluation of new drugs or updating those already on the market. An enormous power that Investigate Europe he discovered it was full of weaknesses, holes, conflicts of interest.

The first is Ema’s total dependence on industry: in 2022, 86% of Ema’s revenue came from pharmaceutical companies. In the USA 65%. Pharmaceutical companies pay for both clinical trials and licensing procedures. It wasn’t like that before. When the EMA was founded in 1995, only 20% of its budget came from industry, the rest was paid by the EU budget. This year, more than 90% is expected to be paid by industry. The company pays around 450 thousand euros for a new application and is responsible for carrying out the clinical studies. EMA evaluates whether the effectiveness outweighs the side effects. The analysis of Investigate Europe and the testimonies of experts prove that procedures are increasingly accelerated in a race against time which is to the detriment of the safety of drugs. In the last five years, 51 drugs have been approved through “conditional approval” (the company is required to produce the missing evidence of efficacy during the post-authorization phase), more than half of the total since the procedure was introduced in 2006. A total of 198 drugs were approved under other fast-track procedures. Of these 173 are still on the market.

Ema defends herself underlining that these procedures allow the treatment of fatal diseases for patients who “have neither choice nor time” and – he adds – a drug is approved only if the benefits outweigh the risks. A theory strongly supported by the former executive director of EMA, Guido Rasi: “Conditional approval is the way forward, with a rigorous plan post-marketing (has the purpose of evaluating the added value of a drug, ed) which must be implemented by the national bodies, with EMA”. But in practice, once a drug is placed on the market, it takes a long time to provide further evidence. If these arrive. The researcher proved it Courtney Davis, of King’s College London: after 7 years (2013 to 2019) the additional research evidence required in half of the accelerated procedures had not been provided. “For 30 years we have been told that studies post-marketing they would have filled the gaps – says a IE – but is not so. We don’t get this evidence.” She confirms it Beate Wieseler, of the German agency responsible for evaluating the safety and effectiveness of drugs (Iqwig): “The EMA approves drugs more and more rapidly and with less and less clinical data available, it is becoming very complicated for us to evaluate their real benefit compared to an existing drug.” And when the German agency asks the industry to provide more evidence, the door closes. The hearings of pharmaceutical companies bear witness to this. The answer is always the same. On November 6, 2023, for example, during an audit for Riociguat, a treatment for pulmonary hypertension, the representative of the multinational MSD responded to the German authorities who questioned her about the poor quality of the clinical study on the drug: “The limited study was accepted by Ema and there will be no further ones.” “It’s a scandal!”, she comments Pierre Chiracdirector of the French magazine Prescribe. “It amounts to putting patients at risk, because there is insufficient evidence that the benefit/risk ratio is favourable.” Every year Prescire publishes a list of drugs “to avoid”, because the risks outweigh the benefits, in the presence of better alternatives. In ’23 they counted 105.

One of these is Ocaliva, a treatment for primary biliary cirrhosis, an autoimmune liver disease. It was conditionally approved in 2016. Four years later, the US company Intercept Pharmaceuticals presented the clinical trial with negative results, serious side effects, some of them fatal. The EMA began examining the results in October 2023 and has not yet expressed its opinion, but the drug continues to circulate in the EU. “It’s a game. Drug manufacturers see that they can get away with it if they present a little less solid scientific evidence,” he explains Lourens Bloem of Utrecht University. Several studies on anticancer drugs show that about half of those admitted to the European market do not lead to an increase in longevity or a better quality of life. “In an emergency situation, one can understand that there are patients who are ready for anything because they are at the end of their lives, but it is not acceptable that for decades it is not known whether a drug is effective or not,” thunders Courtney Davis.

*Investigate Europe

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