The public’s hope for stem cell cures remain high, but scientists warn that many basic problems with this approach remain to be solved – and that investors demand profits far faster than research can be finished.
“We’ve created a system that is unrealistic and short sighted,” said Dr. Darrell Kotton, director of Center for Regenerative Medicine at Boston University’s Boston Medical Center.
Few of the 38 publicly traded stem cell companies will survive, said Philip Reilly, a physician, attorney and venture partner with Third Rock Ventures.
It is very difficult to produce returns in “venture time,” defined as less than five years, said Reilly. “There is tremendous disconnect,” between investors and biologists’ timelines, he said.
The best strategy, he believes, is for a small company to show data with enough promise – what he called “an inflection point” – that it wins the interest of a larger company, with the resources to carry the research across the finish line.
“Few will make it,” he said, of existing companies. At almost all, the cost per share has fallen below the opening price. “They were launched too soon.” Continue reading
On Forbes.com, Gergana Koleva digs deep into the ongoing court battle between Regenerative Sciences and the FDA over the question of whether stem cells “should be federally regulated as drugs.” While the treatment at issue isn’t generally a matter of life or death, the courts’ decisions in this case will have implications for other headline-grabbing stem cell treatments.
(Photo: National Institutes of Health)
At the heart of the debate is a therapy that uses stem cells derived from bone marrow to repair damaged joints. It was developed in 2005 by the Colorado-based company, which began offering it to patients around 2007, and has since gathered a raft of clinical evidence and testimony about its safety and efficacy. The FDA is questioning its legality, alleging that the stem cells it uses are more than minimally manipulated drugs and should be regulated and subject to approval as drugs. In 2008, the agency accused Regenerative of practicing medicine without a license required for the introduction of a new drug, and in 2010 sued to stop it from performing the procedure.
Regenerative and its allies argue that, because the therapy re-injects a patient’s own cells, it creates, as Koleva writes, “fewer and less severe complications than the more invasive and costlier surgical procedures it helps many patients avoid.” For its part, the FDA calls the therapy unproven and not guaranteed to be safe. In the end, the FDA indicates, it boils down to semantics.
Regulators have argued that the Regenexx procedure is equivalent to the administration of a drug because the stem cells that are re-injected into patients constitute an “‘article’ that is intended to treat, cure, and mitigate diseases and to affect the structure and function of the patient’s body,” therefore fitting within the definition of “drug.”
Peggy Peck of MedPage Today found that research presented as new at the European Society of Cardiology’s annual meeting this weekend was actually published in July, despite the society’s requirement that information submitted for presentation must be new, unpublished data.
When asked by MedPage Today to point out the “news” in the Hot Line presentation, STAR lead investigator Bodo-Eckehard Strauer, MD, of the Heinrich Heine University of Düsseldorf, Germany, said the news was that bone marrow cell therapy significantly improved survival in patients with chronic cardiomyopathy, which he illustrated with a slide showing a Kaplan-Meier curve – the same graph that was published in the July issue of the European Journal of Heart Failure. Moreover, every data slide in Strauer’s presentation matched the tables in the published paper.
Following questions from MedPage Today, the organization acknowledged its error and has announced the researcher will not be allowed to present at its meetings for two years. Roberto Ferrari, M.D., president of the society, said the research had been accepted for presentation because they thought it had new data but that “We were snookered.”