Fighting Medical Misinformation or Big Pharma Dictatorship?

Is the Polish Parliament Serving the Interests of Pharmaceutical Corporations and So-Called Academic Medicine?

An exclusive interview for www.wiedzainauka.pl with Prof. Paolo Bellavite.

On 3 July, the Sejm (the lower house of the Polish Parliament) passed an amendment to the Act on Patients’ Rights and the Patient Ombudsman, commonly referred to as the „Lex Charlatan” law. According to the government and the Ministry of Health, the purpose of the new legislation is to protect patients by introducing strict measures against medical misinformation. In reality, however, many critics argue that these draconian provisions will not affect genuine charlatans or fraudsters, but rather naturopaths and physicians practicing complementary medicine. Throughout the bill, repeated reference is made to the concept of „current medical knowledge.” However, this term has never been given a legal definition under Polish law. During the Senate’s consideration of the bill, two amendments were submitted by Marek Skowroński, the journalist who conducted the interview with Prof. Paolo Bellavite. Among other things, these amendments proposed introducing a statutory definition of „current medical knowledge” and guaranteeing that every decision concerning diagnostic methods and treatment would be agreed upon jointly by the physician and the patient, while also taking into account each patient’s individual characteristics and needs. The full text of these amendments is attached below the interview.

Marek Skowroński: Poland is currently debating a bill commonly referred to in the public discourse as the „Lex Charlatan” law. Its declared purpose is to protect patients from medical misinformation and practices that may endanger their health. In reality, however, many critics argue that the law will lead to the closure of natural medicine clinics, marginalize complementary medicine in favor of conventional Rockefeller-style medicine and the interests of Big Pharma, and introduce penalties of up to EUR 250,000 for so-called „medical misinformation.” The Patient Ombudsman would also be granted legal powers which, according to critics, resemble those exercised by political commissars in the Soviet era rather than those expected in a democratic state governed by the rule of law. Have similar debates taken place in Italy? What lessons can be drawn from the Italian healthcare system?

Prof. Paolo Bellavite: In Italy, there has always been controversy over various forms of medicine, but the conflicts have not reached this legislative level. And I hope this bill doesn’t pass in Poland either! If we’re talking about fighting authentic charlatans, who could be against it? But, leaving aside the most egregious cases, who can precisely and objectively define what „disinformation” means in the medical field? What are the boundaries between information and disinformation, and, above all, who will decide what they are? Promoting COVID-19 vaccines as capable of stopping infections was a lie, yet no one stopped it, because it was promoted by the government and by major medical organizations. In medicine, different paradigms of thought and practice have always clashed; there has never been a single vision; everything evolves. What is certain is that in Italy and in most Western countries, there is strong opposition towards complementary medicine from conventional medicine organizations and big pharma, especially in universities and in programs implemented within the national health system. Complementary medicine, primarily homeopathy, is marginalized and survives in private study and teaching circles, but it’s not prohibited. Indeed, in Italy there’s an official agreement between the State and the Regions under which homeopathy, phytotherapy, and traditional Chinese medicine are recognized as medical disciplines, and doctors and dentists can practice them upon registration in a special register maintained by the provincial professional associations. Homeopathic medicines are officially recognized in Europe under Directive 2001/83/EC (and subsequent amendments), and in Italy the regulatory framework is governed by Legislative Decree 219/2006, managed through the Italian Medicines Agency.

– One of the most frequently used terms in the Polish bill is „current medical knowledge.” In your experience, is it possible to formulate a single, clear, and legally applicable definition of this concept?

– Not at all! Medical knowledge is constantly evolving, and there is no such thing as „current” medical knowledge. Or, if we consider, say, the knowledge of the last year or three years, it is not „unique.” Often, a „prevalent” consensus is created on a certain topic, but certainly there is not a single body of knowledge. Countless examples could be cited of how in many fields of medicine the so-called „current knowledge” is often surpassed by discoveries and new theories. Who could, in general, dismiss the efficacy of antibiotics? But in many clinical fields, there is no consensus on their use, due to their adverse effects and the risk of inducing resistance.  And when it comes to most vaccines, discussions are still very open, and their benefit/risk ratio is hotly debated. Finally, we cannot ignore that medical journals are subject to strong commercial pressure, and scientific publications are often tainted by authors’ conflicts of interest.

– Throughout your scientific career, you have repeatedly emphasized the importance of Evidence-Based Medicine (EBM). In your opinion, how should EBM be understood in everyday clinical practice? Does it simply mean following the guidelines issued by scientific societies?

–  This is a particularly important issue. EBM was defined by proponents such as Sackett and Haynes as the integration of the best research evidence, clinical experience, and patient values. There is no doubt that the application of EBM has contributed to important advances in medicine and healthcare, primarily in the evaluation of drug efficacy. The hierarchical model, topped by meta-analyses of randomized clinical trials (RCTs), was quickly criticized for hindering new areas of knowledge and creating resistance in the medical community. Although the pyramidal hierarchy of evidence has its place in EBM, it is not the most appropriate approach when considering safety outcomes and the benefit-risk balance of therapeutic interventions in real-world clinical settings. A recent article in BMJ Open (Shakir, S., and Lane, S. From a pyramid to an amphitheater: embracing the totality of evidence for the postmarketing evaluation of the safety of therapeutic interventions. BMJ Open 15, e103538, 2025) explores the growing role of real-world data and evidence, which are increasingly contributing to therapeutic decision-making in the postmarketing context, emphasizing that RCT and real-world studies are complementary rather than competitive. The authors propose a „circular” approach, which embraces the totality of available evidence without a rigid hierarchy and emphasizes the integration of diverse data sources to address medical research and healthcare problems. By considering the totality of evidence, this model uses a more holistic approach to support clinical decision-making and public health protection. The issue was brought to the forefront during the pandemic, as rigid adherence to EBM principles often seemed to prevail over the precautionary principles of acting in the face of uncertainty and considering the human and social costs of inaction. Critics of the government guidelines complain that, in the absence of solid evidence from RCTs, other sources of evidence, such as observational studies, were ignored, thus delaying therapeutic measures or even discouraging the use of repurposed drugs for early home treatment, which later proved effective.

– In many Italian regions, the public healthcare system allows the use of selected complementary medicine therapies. What conditions had to be met to make this possible? What mechanisms are in place to ensure patient safety?

– As I mentioned above, even in Italy, the public healthcare system is very reluctant to use complementary therapies, except perhaps for a few acupuncture and homeopathy clinics, but only in a few regions. Only one hospital, in Tuscany, has a complementary medicine department. In any case, natural drugs and supplements are subject to good manufacturing practices and quality and safety measures, monitored by the Italian Medicines Agency. Clinical practice is entrusted to the freedom of the physician, who is allowed to practice complementary medicine to the best of his or her knowledge and belief. Of course, the doctor assumes responsibility, so if the patient’s condition worsens due to incorrect treatments, he or she could be held legally liable. On the other hand, such liability is usually not incurred if incorrectly prescribed conventional drugs don’t work or cause serious side effects. No physician has been criticized or subjected to disciplinary action for prescribing paracetamol to patients with COVID-19, even if it’s certain that this drug was the least suitable for that condition.

– Critics of complementary medicine often argue that its inclusion in the healthcare system may weaken scientific standards. How would you respond to this argument?

– This argument demonstrates a failure to understand the positive contribution of complementary medicine in a healthcare system. First, it’s obvious that some aspects or applications of complementary medicine are questionable and open to criticism, but so-called official medicine cannot be considered exempt from criticism, as evidenced by the fact that many people find their health problems unresolved by official, state-run medicine. But the point is another: medicine is not just „science” in the strict sense of the term; it is also “art”, that is, a practice that considers all dimensions of human health and suffering, from various perspectives. Finally, those making such criticisms demonstrate ignorance of the fact that the main complementary medicines practiced in Europe have strong scientific evidence of their efficacy and mechanisms of action. Personally, together with Lenka Tenžera, a homeopathic doctor from Belgrade, I have just finished writing a book entitled „Homeopathy: The Science of the Simile” which is 398 pages long and contains 1,167 references, most of them from PubMed, documenting recent advances. When it is published, I hope it will do justice to the malicious criticisms made by those ignorant of the subject.

– During your professional career, have you encountered situations in which new therapeutic methods were initially met with skepticism by the scientific community but were later accepted as part of modern medicine? What do such experiences teach us about the development of science?

– This is almost a rule in the history of medicine! Classic examples of doctors criticized, ridiculed, and then rehabilitated include Ignatius Semmelweis, along with pioneers such as Barry Marshall and William J. O’Rourke. If I think only of what I’ve seen over the course of my career, I could cite three important occasions: the first in the 1980s, when acupuncture was recognized as an important medical discipline in the USA, following Nixon’s trip to China and the discovery of endorphins as a mechanism of action; the second, when 25 years ago, the journal Homeopathy was included in the list of peer-reviewed journals by PubMed, an official recognition of the scientific nature of its content; the third, when polyphenol-based dietary supplements, explicitly rejected by Italian government guidelines, were recognized as valid in the treatment of COVID-19 in numerous publications, including two meta-analyses.

– What role should physicians play when the available scientific evidence is inconclusive and the patient expects an individualized approach to treatment?

– There is no hard and fast rule, except one: focus not on the disease, but on the patient as a person. Even if the disease has no definitive cure, you can always treat the individual or some aspects of his/her health problem! Furthermore, you can rely on your own personal experience in similar cases, or on scientific rationale. For example, in treating patients with cancer, homeopathy can’t have a direct role as a “therapy” but can help to improve the quality of life. In patients with COVID-19, even in the absence of a definitively effective antiviral, it was possible (and necessary) to address their general health, metabolism, lifestyle, healthiness of their home, and nutrition. In 2020, I published a review article on the benefits of citrus fruits as antivirals, which is now among the most cited. The psychological aspects of treatment are also crucial: many patients have died in hospital because they were abandoned and terrified by the news that was being spread about the alleged severity of the epidemic; we know that fear increases adrenaline, which in turn causes blood clotting. It goes without saying that the medicine most methodologically focused on individualizing treatment is homeopathy.

– Do you believe that legislation should precisely define the limits of acceptable therapeutic methods, or should physicians be given greater professional discretion while remaining accountable for acting in the best interests of their patients?

– I would like to answer by quoting the well-known Christoph Wilhelm Hufeland (1762-1836), widely regarded as one of Germany’s most eminent physicians during Hahnemann’s era. In 1803 he wrote in his book “System der Praktischen Heilkunde”: “Test everything and retain what is good: this is and remains the first commandment of science… Medicine is the science of experience, it is practice, it is continuous experimentation… and the experiment is never concluded.” And then: “Freedom of thought, freedom of science, this is our highest bulwark and must remain so if we are to progress. No kind of despotism, no single rule, no suppression of thought. Even government should refrain from invading the field of science or from favoring or damaging a certain opinion; this has always harmed, as experience teaches, the search for truth. Only experiment, discussion and counter-discussion, continuous and free study, and time can separate the true from the false, the useful from the useless.”

– Based on the Italian experience, what legal solutions best protect patients against genuine abuses while at the same time avoiding unnecessary restrictions on scientific progress and innovative medical treatments?

– I believe it is essential that no restrictions of any kind be placed on the scientific and educational development of complementary medicine. To protect patients, the law should guarantee two basic requirements: a) healthcare professionals of all kinds must be regularly graduated from universities according to scientifically based curricula; b) the curricula of all healthcare professions must include basic notions of complementary medicine, taught by professionals qualified in their respective disciplines. Unfortunately, this second requirement is far from being guaranteed by the Italian university system.

Public debate often reveals a tension between the need to protect patients and the patient’s right to make informed choices about treatment. In your opinion, how should these two values be properly balanced?

– Public debate itself must be free from commercial interference and, above all, from the direct or indirect influence of pharmaceutical companies. Looking at Italy’s experience, the major television networks treat complementary medicines as if they were witchcraft and often dwell on cases of malpractice to smear even serious professionals. Family doctors and pediatricians could play a key role in providing adequate information to patients, but they too are heavily conditioned by State protocols and pressure. For example, doctors (or pediatricians) who administer numerous vaccines are financially rewarded, while those who advise against them or fail to achieve a sufficiently high vaccination rate are penalized. How can we talk about freedom of information if such conflicts of interest exist?

– If you could offer one piece of advice to Polish lawmakers working on legislation concerning patient protection and complementary medicine, what would it be?

– As I said before, the State should refrain from imposing excessive „obligations” or „prohibitions” on medical doctors. That is, it should avoid forcing medical decisions, which should be left to the knowledge and conscience of the physician and to the organizations of the various specialties and disciplines. Science and medicine require freedom of thought. Conscientious objection must also always be protected. According to the principle of subsidiarity, also recalled in the Pope’s latest encyclical, the State should not intervene where intermediate bodies can organize services to meet society’s needs, but should encourage them in their freedom by providing support, coordination, and, perhaps, oversight against personal interests and abuse. In fact, allowing the practice of complementary medicine, strengthening scientific research, and supporting its qualified teaching are appropriate measures to protect patients.

– Do you believe that a democratic state governed by the rule of law may impose legal sanctions for actions deemed contrary to „current medical knowledge” if the law itself does not clearly define what that term means? From the perspective of the philosophy of science and clinical practice, how should this problem be addressed?

– I repeat: Except in blatant cases of malpractice (for which special laws aren’t even necessary), it’s impossible to establish by law what „contrary to current medical knowledge” means! Some examples? Vaccines are part of current medical knowledge, but in many cases they’re useless or harmful; antibiotics work for bacterial diseases, but in many cases prescribing antibiotics isn’t necessary or even useful; statins lower cholesterol, everyone knows that, but current medical knowledge shows that their effect on all-cause mortality is not significant; chemotherapy was once the standard of care for cancer and is now gradually being replaced by effective and less toxic drugs, but there’s no one „rule” that applies to all patients; neurodegenerative diseases are on the rise, but what’s the „current knowledge” about treatment? In surgical specialties and dentistry, precise rules don’t matter, but the surgeon’s decision-making and skill are what count. And then finally, the discussion could also be reversed in favor of complementary medicines, which, according to current medical knowledge, should be the first choice, especially in paediatrics and primary care.

– Finally, is there anything you would like to say to the people of Poland and to the readers of our website?

– Poland is a great nation that I love dearly. I witnessed and participated in its liberation from Soviet Communism and entry into the European Community. In this regard, we cannot forget that Europe, as a continent but also in terms of culture and traditions, stretches from the Atlantic to the Urals! Let us not be influenced by those who, for their own interests, have always sought to divide it. I would like to make a recommendation, which I also make to Italians and to myself: we must respect our traditions and not forget our Christian roots, because they are fundamental to everyday life but also a fundamental heritage to turn to in times of confusion and crisis. Especially in the field of medicine, the concept of health (in Latin „salus” means both health and salvation) cannot be separated from the judgment of what is authentically human, from what is truly worth living for, from the ultimate meaning of life and even of suffering.

– Thank you, Professor, for taking the time to speak with us.

Interview conducted by Marek Skowroński.

EDITORIAL COMMENTARY

At the session of the Senate of the Republic of Poland held on 22 July 2026, two amendments were submitted at our initiative by Senator Krzysztof Bieńkowski. Unfortunately, both amendments were rejected during the vote. They proposed the addition of the following two new provisions:

Article 67zo

1. Current medical knowledge’ shall mean the dynamic body of verified scientific knowledge and clinical experience, subject to continuous verification and development in light of new scientific discoveries, research findings, and clinical observations. Current medical knowledge shall not be regarded as dogma but shall evolve in accordance with scientific progress and medical practice.
2. The determination of whether a particular diagnostic or therapeutic method constitutes an element of current medical knowledge shall be based on the quality and reproducibility of scientific research, the possibility of its independent verification, and confirmation of its effectiveness and safety in clinical practice.
3. The process of establishing current medical knowledge shall remain free from undue political, ideological, and economic influence, in particular from conflicts of interest involving entities that may benefit from promoting or restricting specific diagnostic or therapeutic methods.
4. The scientific character of current medical knowledge is founded on the principles of falsifiability, openness to criticism, and the possibility of independent confirmation or refutation of research findings. No hypothesis, theory, guideline, or medical recommendation may be regarded as unquestionable solely on the basis of the authority of the institution or individual that issued it.

The following new provision was also proposed:

Article 9a

When selecting a diagnostic and/or therapeutic method, the physician shall take into account the patient’s individual biological, physiological, genetic, and psychophysical characteristics, as well as the patient’s overall health condition, so that the chosen course of action is tailored to the individual rather than based exclusively on general recommendations or statistical findings derived from population studies.

The amendment under discussion repeatedly refers to the concept of „current medical knowledge”, yet it fails to provide a statutory definition of this term. However, the interpretation of this concept may determine the scope of the rights and obligations of participants in the healthcare system, as well as the application of legal provisions carrying significant legal consequences.

The proposed amendment did not alter the standards governing scientific research or the practice of the medical professions. Its purpose was merely to clarify one of the key concepts of the Act in a manner consistent with the true nature of medical science as a discipline that is continuously developing and subject to constant verification.

The proposed definition makes it clear that current medical knowledge is based on verified scientific evidence, clinical experience, and the possibility of independent evaluation of research findings. At the same time, it emphasizes that medical progress requires openness to new scientific discoveries and the preservation of the scientific process free from non-scientific influences, including conflicts of interest.

Introducing a statutory definition would strengthen legal certainty, facilitate the consistent application of the law, and reduce the risk of divergent interpretations by administrative authorities and the courts.

The Act should also explicitly recognize that applying current medical knowledge requires taking into account the individual characteristics of every patient. No two human beings are identical. Age, coexisting diseases, genetic predispositions, previous therapies, contraindications, the risk of adverse effects, and the patient’s informed wishes all mean that treatment must always be individualized.

A physician does not treat statistics. A physician treats a human being.

Guidelines and recommendations issued by scientific societies should not be equated with current medical knowledge. They constitute valuable reference material, but they should themselves be evaluated in terms of the quality of the supporting scientific evidence, the transparency of their methodology, and the disclosure of potential conflicts of interest.

The history of medicine clearly demonstrates that scientific progress has repeatedly been achieved by challenging views that had previously been regarded as established truths.

The law should guarantee that the process of determining current medical knowledge remains free from undue political, ideological, and economic influence. Public confidence in the healthcare system requires complete transparency and the independence of the process by which scientific evidence is evaluated.

Unfortunately, on 31 July, the Sejm ultimately adopted only cosmetic amendments proposed by the Senate, while rejecting those addressing the most fundamental issues. Consequently, should the President sign the Act into law, it may mark the end of complementary medicine, naturopathy, and natural methods of treatment in Poland.

Instead, what will be established, in the author’s opinion, is a system in which medical professors with conflicts of interest—arising from their financial relationships with pharmaceutical corporations—will effectively determine what constitutes acceptable medical practice.

Who stands to benefit? Large pharmaceutical companies, professors and physicians who have been financially influenced, and incompetent government officials. Who stands to lose? Above all, the ordinary patient. Once all official medical procedures and guidelines promoted by Big Pharma prove ineffective, patients will no longer have the opportunity to seek treatment through other therapeutic methods that are recognized internationally and supported by scientific research. Instead, Polish citizens are being offered vaccinations whose effectiveness, according to the author, has not been adequately demonstrated and whose potential risks are not properly weighed against their expected benefits. Alongside an increasing number of vaccinations being introduced as mandatory in Poland, surgery and anesthesiology will dominate medical practice. When treatment based on official guidelines ultimately fails, physicians will, without hesitation, sign a futile treatment protocol, effectively leaving the patient without further therapeutic options. There remains transplantation medicine, which is often directly connected with decisions concerning futile treatment. However, this is a subject deserving a separate article and a separate discussion.

Marek Skowroński