Posted on behalf of Alison Abbott.
A controversial decree allowing severely ill patients to continue treatment with an unproven, and possibly unsafe, stem-cell therapy may be amended, if the Italian parliament’s Chamber of Deputies has its way.
[UPDATE, 22 May 2003 — The Chamber voted in favour of the amendments on 20 May, and the amendments were accepted by the Senate on 22 May. The amended decree thus becomes law, and Stamina Foundation therapy will be available only in the context of clinical trials. Stamina head Davide Vannoni says that he will not comply with the requirement to provide the therapy for trials, according to good manufacturing practice.]
Yesterday (16 May) the Chamber’s social affairs committee unanimously passed amendments to the decree that would allow the Brescia-based Stamina Foundation, which developed the therapy, to continue administering it. However, Stamina would be required to do so within regular clinical trials, under the oversight of regulatory agencies and using cells manufactured according to Good Manufacturing Practice (GMP). A supervisory ‘observatory’ comprising experts and patient representatives would oversee clinical trial procedures.
The proposal is intended to defuse the tensions between, on one side, terminally ill patients and their families, who believe the Stamina treatment is their only hope, and on the opposite side, scientists and regulators who believe it to be dangerous and almost certainly not effective.
Stamina claims to have treated in the past six years more than 80 patients with diseases ranging from Parkinson’s disease to muscular dystrophy. Many of the patients have been young children. In the therapy, mesenchymal stem cells are extracted from the bone marrow of the patients, manipulated in the laboratory and re-infused into the patients.
According to the committee’s proposed amendments to the decree, the government would make €3 million (US$3.9 million) available for the clinical trials over the next 18 months. The plenary Chamber is expected to vote in favour of the amendments on Monday.
But that won’t be the end of the story. The upper house, the Senate, will then have to approve the Chamber’s amendments, and in the continuing emotional heat, its final decision is hard to predict. Patient groups wearing tee-shirts bearing the slogan ‘Yes to Stamina. Yes to Life’ demonstrated against the amendments in Rome yesterday. Stamina’s charismatic president Davide Vannoni was among the demonstrators. Vannoni claims that the Chamber had been influenced by the interests of the pharmaceutical industry.
If no final political decision is made by 25 May, the decree will automatically expire.