Revocation by the U.S. Food and Drug Administration of Avastin for the treatment of breast cancer has sparked a degree of controversy in the United States that is disorienting to Europeans.
For one thing, Avastin is still endorsed by the European Union. In March, European political authorities confirmed Avastin does enable women with metastatic breast cancer to live an additional several months — or, sometimes, several years.
But it’s also hard to imagine a debate in Europe at the level of intensity and public participation as that in America. The nature of this discrepancy and whether it will persist are the most interesting questions arising from the Avastin case.
So far, American patients have preserved a remarkable degree of freedom concerning the choice of medical treatments they have. Opponents of President Barack Obama’s health care legislation have argued that compulsory social insurance would erode this freedom.
Avastin, which is expensive at $8,000 per month, is a case in point. Patients could, theoretically, receive Avastin as an “off label” drug without FDA approval (as it will retain approval for other cancers), but private and public insurers likely will not reimburse its high cost, making it a “luxury drug.”
In this respect, European institutions seem more compassionate and understanding of breast cancer patients. The fact that Avastin remains available would appear to be an indication of a more dispassionate assessment of patients’ needs. But this belief would be an illusion.
In the United States, patients and physicians have actively mobilized against the FDA decision, providing abundant anecdotal evidence of the need for Avastin.
Their efforts have been relatively successful, resulting in the addition of two more FDA hearings on whether to grant the drug permanent approval. The latest of these will be held in June.
In Europe, such a scenario is almost unthinkable. Patients’ groups find little support in the public debate and medical decisions are highly centralized.
Research by the Health Consumer Powerhouse, a think tank that specifically studies patients’ empowerment in European member states, show that access to new drugs remains limited almost everywhere in Europe.
Historically, “free” health care in Europe meant its bureaucratization, with government assuming an authoritarian role and with an ever-decreasing space for free choice at the individual level.
The state monopoly of health implies a state monopoly over health science and therefore a stifled debate. Only insofar as competition opens some breaches in this wall, as in the Netherlands, can a pluralistic discussion take off, enabling the viewpoint of patients to gather momentum.
Americans continue to be so vocal about Avastin because, for all its faults, the current institutional arrangements of U.S. health care are essentially in tune with the idea that people can have legitimate claims over treatments they are subjected to.
Culture and institutions are intertwined — we can be reasonably sure that Europe needs greater competition to foster a new culture of responsible and free patients. But we do not know whether mandates are bound to kill the American patients’ sense of liberty.
Dr. Alberto Mingardi is director general of Istituto Bruno Leoni, an Italian think tank.