You go to bed healthy and wake up sick and, therefore, in need of medication. It may happen because, on the other side of the world, in the United States, it has been decided – while in Italy it is night – to further lower the risk threshold of cholesterolthe value considered ideal, the target to be achieved. And since the most immediate way to reduce it is to resort to statins (drugs in use since the 1980s, which act by interfering with a key liver enzyme responsible for the synthesis of cholesterol), that’s it: the guidelines are changed and the number of candidates for treatment increases.
This is what happened (once again) a few weeks ago, when the directives ofAmerican college of cardiology and of theAmerican Heart Association have expanded the indications for treatment. The effect is that millions of healthy people have already become potential patients from a young age, further blurring the boundary between protection of public health and market dynamics: if until yesterday it was suggested to evaluate the introduction of statins when the risk of cardiovascular events in ten years reached the average value of 7.5%, now it is necessary to recommend their use starting from a (low) risk of 3%.
The Prevent-ASCVD algorithm and the new patient market
A downward revision suggested by a new algorithm called Prevent-ASCVDwhich evaluates individuals starting from the age of 30 and which in the States, where around 40 million people are already being treated with these drugs, could lead to adding at least another 25-26 million. And since US reviews are often followed by a similar trend in Europe, it is foreseeable that soon here too, more and more young people will be told that their cholesterol levels are no longer adequate.
In our country, right now around 15% of the population receives at least one prescription statins per year, while between the ages of 75 and 84 more than half of Italians take them. Their large-scale use significantly affects state budgets: the Peninsula spends almost a million on these remedies billion and a half euros per year. «The paradoxical effect of going to sleep perfectly healthy and waking up “patient” the next day, simply because the parameters have been revised, generally makes an impression, but it is a great classic of medicine», explains the professor to Panorama Nicola Montanodirector of the Internal Medicine department of the Irccs Policlinico Hospital of Milan. «This is what happened, for example, also with hypertension, when in the USA the “maximum” blood pressure threshold was lowered from 140 to 130 mmHg. A technical change, of course, but with an enormous impact on people’s lives and on the very definition of normality, as well as on state budgets.”
The boundaries of normality according to Silvio Garattini
For years, in Italy itself, an authoritative voice has been drawing attention to these mechanisms: it is that of Silvio Garattini. During a lectio magistralis held in Padua a few months ago, the president and founder ofMario Negri Pharmacological Research Institute of Milan underlined how any redefinition of the boundaries of “normality” produces an immediate advantage for the market. If for years total cholesterol values of up to 240 mg/dL were considered acceptable and, over time, the thresholds were progressively reduced – first to 220, then to 200, up to the idea that “lower is better” – the mechanism becomes clear: when risk factors are automatically transformed into diseases, the scope of healthcare intervention expands, with the risk that, sooner or later, everyone ends up being a candidate for therapy.
All this translates into a great favor to Big Pharma. And since medicine is now moving forward with algorithms and equations, it is worth remembering another “calculation” aspect. «When primary prevention is carried out in large quantities, i.e. by prescribing statins to healthy people who only have too high a cholesterol level, it is calculated that to “save” one individual from a cardiovascular problem it is necessary to treat 100 of them» he explains Antonio Clavennaclinical pharmacologist at IRCCS Mario Negri. «Translated: out of 100 people who take statins, only one will avoid a heart attack or stroke thanks to the drug, while the others will not benefit from it or would have avoided it anyway. This, however, also means that there will be many patients who will not receive any real benefit from statins, but will still be exposed to their potential side effects.”
Side effects and the myth of the natural
A kind of lottery, in short: also because these effects are no joke and also weigh on the health service. The most reported is the myalgiathat is, muscle pain. Additionally, an increase in liver enzymes and a small increase in the risk of developing diabetes may occur. The most delicate chapter, however, concerns a very rare but potentially serious complication: rhabdomyolysisthat is, the massive destruction of muscle fibers, with the release of substances such as myoglobin into the blood that can damage the kidneys.
Rhabdomyolysis has an estimated incidence of a few cases out of hundreds of thousands of patients treated, but represents the main reason for clinical attention. Symptoms include intense muscle weakness, widespread pain, and dark urine, and require prompt medical intervention. Obviously, far be it from us to engage in health terrorism, or to devalue the importance of drugs that have saved millions of people globally from heart attacks and strokes, but transparency is needed: and above all, GPs need a lot of time to dedicate to patients, who are called upon to accurately inform citizens, and not just hastily fill out a prescription when faced with that LDL cholesterol value that does not satisfy them. «There is no debate about statins in secondary prevention: if someone has already had a heart attack and has high cholesterol, taking the drug reduces the risk of a new cardiovascular event by about 35%», he continues Mountain. «The most discussed point remains the primary prevention. Here the discussion is open, and it is obvious that the patient must be examined in a “holistic” way, first of all by his family doctor: if he only has high cholesterol but is thin, does not smoke, perhaps does sports and does not have carotid plaques, rather than being started on therapy he must be adequately informed, so as to be able to participate in an informed choice”.
Faced with the need to lower cholesterol, but also with doubts about taking statins, many patients turn to supplements. This, however, is not always a good idea. “A powerful, but often misleading, narrative has been built around supplements,” says the professor Francesco Cipollonedirector of general medicine at the Chieti hospital. «Many prefer them because they perceive them as “natural” and therefore safer, but the reality is different: monacolin K from fermented red rice, for example, is chemically a statin. In the past these supplements worked for this very reason. Today, for safety reasons, the content of the products has been reduced and the effectiveness is comparable to that of one good Mediterranean diet. Marketing has played a huge role in creating this distorted perception.”
The solution is therefore to personalize treatments, moving towards extreme tailoring of therapies: also because in recent years new therapeutic options have emerged in addition to statins, such as PCSK9molecules that prevent the degradation of hepatic LDL receptors, promoting the removal of cholesterol from the blood. The fact that medicine has learned to anticipate undoubtedly helps us prevent heart attacks and other cardiovascular accidents: but it is equally true that, by lowering the bar a little more each time, the risk is of transforming “normal life” into an ever shorter interlude. Today it is cholesterol, yesterday it is blood pressure, tomorrow who knows what other parameter rewritten by an algorithm. And so, silently, without a symptom and without a truly conscious choice, the line that separates the healthy from the sick shifts: but not in the body, but on paper. Chasing risk in a space-time loop. With the final paradox: we will live longer, perhaps, but it will be a continuous passage from illness to illness. Whether real or imaginary, a spreadsheet will tell us.
