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+--- Thread: Rise of open-label placebos + Lab-grown blood supply produced? + FDA faster than ... (/thread-3706.html)
Rise of open-label placebos + Lab-grown blood supply produced? + FDA faster than ... - C C - May 24, 2017
The rise of open-label placebos
https://www.theguardian.com/lifeandstyle/2017/may/22/knew-they-were-sugar-pills-felt-fantastic-rise-open-label-placebos
EXCERPT: Linda Buonanno had suffered 15 years of intense cramps, bloating, diarrhoea and pain she describes as “worse than labour”. She was willing to try anything to get relief from her irritable bowel syndrome (IBS) and leapt at the chance to take part in a trial of an experimental new therapy. Her hope turned to disappointment, however, when the researcher handed her a bottle of capsules he described as placebos containing no active ingredients.
Nonetheless, she took the pills twice daily. Four days later, her symptoms all but vanished. “I know it sounds crazy,” says Buonanno, of Methuen, Massachusetts. “I felt fantastic. I knew they were just sugar pills, but I was able to go out dancing and see my friends again.”
Placebos have a reputation problem. It is widely believed they are only effective when those taking them are deceived into thinking they are taking real drugs. As such, prescribing dummy or fake treatments is unethical. Yet in Buonanno’s case there was no deception. And she is not alone. A review of five studies, involving 260 patients, published last month found that “open-label” placebos – those that patients know contain no active medication – can improve symptoms in a range of conditions. This growing body of evidence raises a number of important questions. How do open-label placebos work? Which conditions do they work for? And should doctors prescribe them?
MORE: https://www.theguardian.com/lifeandstyle/2017/may/22/knew-they-were-sugar-pills-felt-fantastic-rise-open-label-placebos
Lab-grown blood stem cells produced at last
http://www.nature.com/news/lab-grown-blood-stem-cells-produced-at-last-1.22000
EXCERPT: Researchers made these blood stem cells and progenitor cells from human induced pluripotent stem cells. After 20 years of trying, scientists have transformed mature cells into primordial blood cells that regenerate themselves and the components of blood. The work, described today in Nature1, 2, offers hope to people with leukaemia and other blood disorders who need bone-marrow transplants but can’t find a compatible donor. If the findings translate into the clinic, these patients could receive lab-grown versions of their own healthy cells....
Speed up drug approvals at FDA? It's already faster than Europe's drug agency
http://www.latimes.com/science/sciencenow/la-sci-sn-fda-european-medicine-20170405-story.html
EXCERPT: Dr. Scott Gottlieb, President’s Trump’s nominee to head the Food & Drug Administration, has said the FDA displays an “unreasonable hunger for statistical certainty” and a “profound lack of confidence in the ability of doctors to make careful judgments.” In a bid to speed reviews and “change the FDA review culture itself,” Gottlieb proposed in a 2012 article that the FDA should follow the lead of its European Union counterpart, and let “a body of politically appointed (and therefore politically accountable) officials … ultimately [decide] on whether a new drug should be approved.”
[...] a study published in New England Journal of Medicine suggests that, when it comes to approving drugs, the agency he would lead outpaces others’. In an analysis of the process by which 170 new drugs were approved [...] researchers found that the FDA has taken a median of 306 days to review applications for “new therapeutic agents.” During the period studied — 2011 to 2015 — the FDA’s European Union counterpart approved 144 new drugs as safe and effective [...] and took a median of 383 days to review those applications. [...In comparison...] the FDA approved more “orphan” drugs — those proposed to treat rare disorders or diseases for which other effective therapies do not exist....