“This case is over and we are very happy.” In October the head of the Italian Medicines Agency, Luca Pani, reacted to the news that the Italian health minister had halted a government trial of a controversial stem-cell therapy. He is less happy now, and his discontent should be shared by anyone who cares about the harsh use of scientific evidence and the safety of vulnerable patients.
The decision undermines an October decision by Health Minister Beatrice Lorenzin to scrap the test, which may yet be allowed to go ahead. It shouldn’t be. As Nature and Independent Experts have pointed out several times, there is no evidence that the claimed therapy works, and that it may in fact be harmful.
Lorenzin must put an end to this uncertainty. He must release the members of the committee who prepared the important report from the confidentiality agreement.
The public should be free to voice their opinion on the claims of the Brescia-based Stamina Foundation, which extracts stem cells from a patient’s bone marrow, manipulates them and then injects them back into the same patient’s blood or spinal cord. does. And Lorenzin should release the protocol for a broader investigation that the organization says it will follow to conduct the test.
Already, members of a patient group have appealed for such openness, arguing that they have waited long enough to understand whether the endurance method can help them live, and that they themselves. I want to be able to do justice to.
Lorenzin has replied that it is not in his possession. It is unusual for a government-sponsored clinical trial to be so confidential, and it is natural that many are now asking questions about why the government insisted on confidentiality, which would go beyond any trial, and when it should be Why shouldn’t it be removed? It is clear that it would be in the public interest.
He should act now as things may turn bad soon. Last week’s decision by a regional administrative court in Rome said a new committee should be appointed to take another look at the legality of the trial. To make this successor committee more balanced, the court suggested, it may invite foreign scientists to participate.
It may sound like a good idea, but it’s landing on dangerous ground. There are strong international interests that support clinics offering unproven stem-cell therapies in countries such as Mexico and Uganda.
Such countries lack the strict regulatory oversight that prevents exploitation of desperate patients in Europe and the United States – and clinics would prefer to open up a regulatory loophole in a European country. In setting up a replacement committee, Lorenzin should go to scientists who are independent of companies that lobby for looser regulation of stem-cell therapies.
Stamina had been treating critically ill patients, mostly children, on a ‘compassionate basis’ since 2007 – until Pani’s agency closed its laboratory in Brescia in August 2012 for safety reasons. Some patient groups have lobbied passionately and publicly for access to therapy that Stamina chief David Vanoni claims can treat a range of otherwise deadly diseases.
In November, when it looked like clinical trials had finally stopped, Vannoni led a demonstration in front of parliamentary buildings in Rome, where patients spilled their blood on photographs of the president and prime minister. The spirit of those whose children are mortally ill is a powerful weapon.
The decision – a decision on Stamina’s appeal – shocked scientists in Italy and should shock scientists elsewhere. This seems to have ignored why the committee was restricted to considering the clinical protocol of Stamina and what specific disorders to recommend for treatment in any clinical trial. The committee was asked only to assess whether the technical aspects of the proposed study met ethical, clinical and legal standards.
The court argued that the committee lacked balance as most of the members were opposed to the stamina approach. It also complained that the committee had failed to look into the documentation of Stamina’s claims for treatment successes (something beyond its mandate).
The uncertainty arising out of this latest decision must be eliminated. Lorenzin must find the courage to act.