One of the more interesting recent medical stories to hit the mainstream media was the news that for the first time, the FDA has cleared the use of embryonic stem cells in human clinical trials. This particular trial will use a stem cell line developed by Geron, Inc. of Menlo Park, CA and will be implanted in people who have suffered acute spinal cord injury. As somebody who has actually seen the Geron-developed video of the stem cell’s affect on paralyzed mice walking and running after having been implanted with the Geron cells, the raw potential of the therapy is breathtaking. Of course, it will take many years of rigorous scientific testing in people to determine both safety and efficacy. This first small 10-patient trial however is an important first step.
What is curious and thought provoking about this news is its timing. The public debate over embryonic stem cells has been raging for many years now. Embryonic stem cells, as their name suggests, are derived from embryos. Specifically from embryos that develop from eggs that have been fertilized in vitro and then donated for research purposes, with the informed consent of the donors. The debate became a political ‘hot button’ issue when in 2001, the former Bush administration precluded public funding of additional stem cell research beyond 31 specific stem cell lines—ironically of which the Geron cell line was one. The Geron cell line was developed without public funding using instead the private capital markets. The public funding issue was largely perceived as a political gesture toward conservative supporters of President Bush as well as an extension of former President Bush’s own religious beliefs. To which of course, he is certainly entitled as are we all.
During the course of applying to the FDA for clearance of this trial, Geron submitted a 21,000 page Investigational New Drug (IND) application to the FDA, believed to be the largest and most thoroughly documented science that the FDA has reviewed in its history. The company says that the application detailed more than 24 separate animal studies of its product that established both safety and efficacy in animals. A lot of this scientific data had appeared in peer-reviewed publications over the years of development, including a study published seven years ago that showed efficacy in rats. As the FDA laboriously poured over the data during the years of the Bush Administration’s tenure, more people suffered from acute paralysis and investors bounced Geron’s stock up and down.
Then on January 21st, only ONE day after the Obama Administration took office, the FDA, suddenly and without warning, announced clearance of the Geron trial. While much of the news reporting on the clearance focused specifically on the scientific importance of the trial, a few intrepid reporters openly speculated that the change in the White House had immediate impact on FDA policy. This is a topic worthy of discussion. Was the timing simply a coincidence? Or did the Bush administration tacitly impose its own political and/or ethical views on the FDA? The job of the FDA is difficult. It must ensure that the safety of the public is held paramount and at the same time carefully guide new products and technologies through a process that allows new therapies to get to the marketplace after appropriate review. To add a layer of “politicization” to this process does not serve the public or the government. The science of medicine is after all transparent to personal belief or religious conviction—and politics.
Tags: FDA, Geron, Stem Cells
Posted by Lloyd Benson on February 5, 2009 at 11:57 AM