Bioroundup: Stem-cell science and money, genetic tests go political, clinical-trial data woes, and more

(NOTE: Apologies — especially to RSS readers — if you’ve seen this post before, but an apparent server error ate it late yesterday and I was only able to recover it this morning. Enjoy, or ignore, as seems most fit.)

roundup-buffalo-250px.jpgFeatured stories:

  • Stem-cell science, money and death
  • Gene tests: Out of control?
  • Clinical-trial data wants to be free
  • Drug, biotech industries face uncertainty
  • Short takes

Clones, regrown hearts, money and death — Last week, the San Diego biotech http://www.stemagen.com/ announced that it had cloned human embryos by transplanting the nuclei of adult skin cells into oocytes, or human egg cells. The cloned embryos reportedly into blastocysts, the five-day-old clumps of roughly 100 cells from which researchers can, if all goes well, extract stem cells. (The research isn’t aimed at creating cloned babies.) Although not of immediate practical use, the ability to use embryo cloning to make genetically matched stem cells would be a big step forward for the field, since the technique could be used to produce stem-cell lines specifically for the study of particular genetic disease. The Stemagen embryos, however, didn’t actually yield any stem cells, leaving some researchers skeptical that the company had actually achieved what it claimed. The NYT has more.

Another team of researchers at the University of Minnesota recently created a beating rat heart in the laboratory, although the work didn’t grow the heart from scratch and didn’t specifically use stem cells. The team used detergents to clear living cells from a dead rat heart, leaving the outer structure and valves as a scaffold that cold be “repopulated” by injected cells from newborn rats, which eventually developed into working heart muscle that pumped blood and conducted electrical signals. Eventually it may be possible to do the same with hearts taken from human cadavers and stem cells extracted from a patient’s bone marrow, potentially yielding a newly transplantable heart.

Meanwhile, stem-cell pioneer James Thomson, a University of Wisconsin biologist, argued for a major boost in state stem-cell funding, saying that Wisconsin needs to hand out $50 million a year in order to compete with California’s $3 billion program. And in sad news, a 9-year-old girl with a fatal genetic condition called Batten disease died after being treated in a clinical trial with neural stem cells intended to correct a brain-enzyme deficiency in Batten patients. Preliminary results suggested the death was a result of her disease and not the stem-cell therapy, developed by the Palo Alto, Calif., biotech Stemcells.

Test, genes and politics — A federal advisory panel raised concerns over the proliferation of genetic tests, complaining of misleading or false marketing as well as the possibility that patients could be harmed by basing medical decisions on inaccurate tests. Unsurprisingly, many tests fall through loopholes in federal regulation, partly as the result of divided responsibilities between Medicare and the FDA. No agency even knows how many such tests are currently on the market. New tests — or the prospect of them — are popping up all the time, such as a recent finding that five specific DNA variations may help predict a man’s risk of prostate cancer, a test that, predictably enough, will be commercialized within the next few months by a startup called Proactive Genomics. The panel doesn’t appear to have addressed personal-genomics services like 23andMe or deCODEme, but chances seem good that Washington will want to weigh in sooner or later.

Making the most of clinical data — Reported results of drug trials and other medical interventions tend to be heavily skewed toward “positive” trials that appear to demonstrate the effectiveness of whatever therapy is being studied. Efforts to encourage reporting of “negative” results — that is, those that show no effect, which can also yield useful information — have faced an uphill battle. Over at Fierce Biotech, the founder of Raven Biotechnologies — a company best known around here for its attempt to swallow the corpse of VaxGen — cites her personal experience to argue that neither drug companies nor scientific journals are inclined to publish negative results. “The publishing industry and pharma reinforce each other’s biases” toward positive news, Jennie Mather writes. Meanwhile, in the NYT, Memorial Sloan-Kettering Cancer Center biostatistician Andrew Vickers bemoans the culture of secrecy that discourages even academic cancer researchers from sharing their data from clinical trial more openly. Allowing others access to the data could not only improve clinical trial designs, but potentially point the way to new diagnostic tests and treatments.

Pharma, biotech under fire — Politicians are turning up the heat on the drug industry, the WSJ notes, listing efforts to allow reimportation of cheap Canadian drugs, force Medicare to negotiate drug-price discounts, permit generic forms of biotech drugs and enact healthcare reform as among the major threats to Big Pharma and Big Biotech. In California, a recent report from the California Healthcare Institute raises similar concerns about the biotech industry, arguing that increased government oversight could crimp drug development. New drug approvals are already at a 24 year low, the In Vivo blog noted recently, although research productivity at drug companies seems to be the major culprit.

Short takes:

  • Pfizer last year won approval for the first drug to treat fibromyalgia, a chronic pain condition whose existence still isn’t well accepted by doctors — including the one who first defined it in 1990, but has since changed his mind. (NYT)
  • California’s plan to become the first state to require electronic tracking of prescription drugs — a measure designed to thwart drug counterfeiting — may be delayed another two years, to 2011, as the drug industry upgrades its computer systems. (SF Chronicle)
  • Northstar Neuroscience brain-stimulation device fails in stroke-rehabilitation trial, highlighting the hit-or-miss efforts to treat brain and nerve disorders with neuromodulation. (NYT)