“The real problem is that the EMA decides, when they authorize a drug, they do it based on European law which only provides three criteria: quality, efficacy and safety. Of course these elements are important, but not enough. They don’t tell us what the relationship is between a new drug and an existing drug. If you don’t compare it, every industry is just doing its “best” to bring new products to the market. And that’s what the industry is always fighting for. So we are constantly discovering new drugs, but often they are no better than the previous drugs.” This merciless analysis is very useful Silvio Garattinifounder and president of the Mario Negri Pharmacological Research Institute. EMA, on the other hand, is the European Medicines Agency, the European Union body that evaluates, approves and controls medicines. The mechanism triggered by current legislation and the strong position of the pharmaceutical industry is that more and more new drugs are being marketed because of the need to increase profits, not to improve treatment.
Professor, the Aifa report tells us that many drugs are consumed in Italy.
“In essence, in addition to quality, efficacy and safety, it is also necessary to evaluate the therapeutic added value of a drug. If a drug is less active than existing drugs, then it should not be approved. AIFA, which participates in the activities of the EMA, has two obligations: the first is to market all drugs approved by the EMA; the second is to select those who will receive reimbursement from the National Health Service. They do this, but without real priority criteria. So how can a doctor orient himself? He organizes what he finds on the market, what he considers “new” or “useful”, but it does not have the tools to independently discriminate. Nowadays it is easier to do research on certain types of drugs: just change the chemical structure of a molecule a little and you can get a new drug. The industry of course does research, but this is done mainly to ensure profits, they have an interest in continuing to market new drugs, but we don’t know whether they are better than existing drugs. Countries that are part of the EMA have to change the rules.”
What does it produce?
«Example: we have 2 million people who suffer from 7 thousand rare diseases, none of which is used for research because there is profit. But the Constitution says that the State protects the health of all citizens. That’s not true: it protects the health of citizens suffering from profit-making diseases. Legislation needs to be changed. Not only that: we have 120 active ingredients against hypertension, makes sense? Public tenders can be called for national health services and we will only take a certain amount.”
How to solve the very serious problem of antibiotic resistance.
“With education. We need independent information. Those who prescribe only prescribe based on the advertisements of those who sell. There are even those who take antibiotics before getting the vaccine. Or there are mothers who give antibiotics to their children even though the child has a viral disease. And we never adjust the packaging of the antibiotics. Usually two tablets are given a day for six days. Yes, the Italian packaging always contains ten tablets so I have to buy two packs. So, maybe when a mother sees that there are still some tablets, in good faith she gives them to her child if he shows signs of fever.”
What scenario are we facing?
«In Italy, we are a country that prescribes more antibiotics than the European average. There are 10,000 deaths a year due to antibiotic resistance: that’s a third of the entire European population. Let’s remember: if I abuse antibiotics when I don’t need them, even though I really need them, the antibiotics may no longer work. But I repeat: the problem is that all the information comes from the seller. Do doctors go to conferences? The pharmaceutical industry pays for it. Who does the scientific community support? From those who sell drugs. And there are also other facts. The pharmaceutical market, like all markets, wants to grow. And then the level of “normality” is reduced to expand the audience of potential consumers. For many years, “normal” cholesterol was 240 mg/dl; now below 180. Normal pressure is 140/90, today 120/60. It is clear that the number of people considered sick is increasing, and therefore the market for medicines is also increasing”.8
Why is there an increase in the use of psychotropic drugs among minors?
“A lot depends on the damage caused by Covid and the fact that they were out of school and for some time deprived of normal relationships. But we know almost nothing about the long-term effects of many chemicals on young people’s brains. There are no adequate studies. And even if we did, the results would only be visible for 30 or 40 years. The same goes for marijuana: today we are seeing more cases of psychosis, schizophrenia and depression. The damage is only becoming apparent now, after years of use.”
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