GESTIÓN EN SALUD PÚBLICA: Untested stem cell treatments in Australia

sábado, 13 de agosto de 2016

Untested stem cell treatments in Australia

Untested stem cell treatments in Australia

Bioedge

Untested stem cell treatments in Australia

by Xavier Symons | 12 Aug 2016 |

Australia has seen a sharp rise in the use of unproven stem cell treatments, with sham clinics exploiting loopholes in government regulations.

A small number of evidence-based stem cell treatments (such as bone marrow transplants) are routine around the world, but certain treatments in Australian clinics are unproven and based largely on anecdotal evidence.

A paper published in Cell Stem Cell reported that stem cell clinics “not only pre-emptively proceed to marketing [new treatments] in advance of reporting, review, and approval, they often claim broader clinical benefits than can be justified by the specific indications they purport to have tested”.

One of the lead authors of the paper, Professor John Rasko, of the University of Sydney, called on the Therapeutic Goods Administration (TGA) to close loopholes in regulations governing the provision of stem cell treatment in Australia.

“[The regulatory loopholes] allowed doctors to take cells from any parts of the body, manipulate them and reinject them into the body,” Rasko said. “It took shonky clinics years to realise they could take advantage of this but take advantage they certainly now have.”

In June, a 75 year old New South Wales woman died as a direct result of a stem cell treatment that doctors said would alleviate the effects of her dementia.

TGA regulations state that autologous treatments – treatments where stem cells are taken from the recipient's own body – are not therapeutic goods and therefore cannot be regulated.

The TGA has conducted a public consultation on whether regulations should be extended to autologous treatments, but are yet to act on the recommendations.

- See more at: http://www.bioedge.org/bioethics/untested-stem-cell-treatments-in-australia/11957#sthash.5w9ynbd1.dpuf

The death of Ivo Pitanguy in Rio this week was the intersection of bioethics and the Olympics. The world’s best-known cosmetic surgeon and a celebrity in his native Brazil, he carried the Olympic flame on the day before he died of a heart attack at the age of 93.

A member of the Brazilian Academy of Letters, Pitanguy thought deeply about his specialty. “My operations are not just for my patients’ bodies. They are for their souls,” he wrote. He regarded beauty as a human right and he made cosmetic surgery as popular among the poor as among glittering celebrities.

However, his poetic vision of his specialty clashes with the scepticism of some bioethicists. The Nuffield Council on Bioethics, in the UK, is currently conducting an inquiry into cosmetic procedures, in response to concerns that patients are being victimized and that the industry is sustained by sexist stereotypes. Its discussion paper is particularly interesting. We hope to cover this area in more depth in the future.