For months and months, we heard the mantra of “Obama: the change we need; change we can believe in.” The election is finally over. The people have spoken. Now that Senator Barack Obama is president-elect, it is my hope that certain “changes” supported by the president-elect will help jump-start two areas of focus in the Boston life sciences community: embryonic stem cell research and “personalized medicine.”
Since 1996, a law has banned federal spending on research that harms human embryos. In August 2001, President George W. Bush issued an executive order that loosed this restriction slightly by allowing federal funding for embryonic stem cell research that used one of the few then-existing stem cell lines. Now, seven years later, President-elect Obama is reviewing President Bush’s order and may reverse or amend the decision made in 2001. Expectations are high for a change. In a 2007 news release supporting legislation to loosen restrictions on stem cell research, Mr. Obama said:
I am frustrated … that we are preventing the advancement of important science that could potentially impact millions of suffering Americans … My hope, and the hope of so many in this country, is to provide our researchers with the means to explore the uses of embryonic stem cells so that we can begin to turn the tide on the devastating diseases affecting our nation and our world.
Some have asked why, given the advances in stem cell research with the federal prohibitions in place, particularly the dramatic results seen in the last few years with making stem cell-like cells from skin cells (also known as reprogrammed or induced pluripointent stem cells (iPS)), any change is needed. But there are a number of reasons why removing limitations on embryonic stem cell research is “change we need.”
Research in reprogrammed cells, while dramatic, is still in its infancy. In fact, the first reprogrammed cells were reported just a few short years ago. As a result, many issues need to be worked out. iPS cells are currently produced, at least in part, through the introduction of genes associated with cancer, using a virus that could lead to cancer-causing mutations. Needless to say, more research is needed before this methodology reaches the clinic.
Another important issue is the equivalence of iPS and other types of stem cells. Are the cells the same? Do certain types of stem cells have properties that might provide clinical advantages? Some scientists believe that iPS cells will never be suitable for cell therapy. Time and research will tell. Relaxing the ban would allow scientists in the field to use equipment and facilities funded with federal research dollars, potentially accelerating research while, at the same time, reducing research costs.
Relaxing the ban could provide another important dividend. For ethical and political reasons, many pharmaceutical and biotechnology companies have stayed away from stem cell research. It is hoped that federal support of stem cell research will encourage commercial investment, resulting in what we all hope for: clinical treatments.
Will the Obama administration change the federal position on embryonic stem cell research? I’m confident this change will happen. At the September 22, 2008, HSCI Stem Cell Summit, Rep. James Cooper (D-TN), in discussing what the results of the presidential election would mean to stem cell research, stated that his part of the country has an expression: “You dance with the one that brung ya.” Representative Cooper’s position was that if Senator McCain had been elected, even though he was on the record as supporting embryonic stem cell research, he would certainly not have lifted the ban, given the conservative members of the Republican Party he was courting with the nomination of Governor Palin for vice president. Given who “brung” President-elect Obama to the “dance,” I’m certain we will see change. I’m hoping for this change in the first 100 days.
(On December 12, 2008, Dr. William Lensch, an instructor at Harvard Medical School and affiliate faculty member at the Harvard Stem Cell Institute (and an Xconomist), will address these issues at the offices of Nixon Peabody in Boston, MA. If you are interested in attending, please contact Allison McClain at email@example.com.)
What other changes can we expect in the life sciences? For years, we have been talking about using the power of genetics or other biomarkers to direct individualized or personalized treatments. With the exception of a few successes in the treatment of cancer, progress has been slow. Now the hope is that legislation originally introduced by Senator Obama in 2007 to promote personalized medicine will change that. According to the Personalized Medicine Coalition, Mr. Obama’s legislation, “among other things, aims to improve the coordination of public and private efforts to facilitate the development of safer and more effective drugs, create a biobanking initiative, expand the genomics workforce, and improve the quality of clinical genetic testing.”
Recently, Rep. Patrick Kennedy (D-RI), in the Genomics and Personalized Medicine Act of 2008 (H.R.6498), added to the language of Mr. Obama’s 2007 legislation. The new language adds tax and test credits to encourage research and commercialization.
The Obama and Kennedy bills encourage government agencies, including the NIH, FDA, and CDC, to work together to establish a national biobank for use as a resource for researchers, and provide funding and training for diagnosis, treatment, and counseling of genetic diseases.
The Kennedy bill further provides incentives that would encourage the development of companion diagnostics by drug sponsors and by device companies, including, among other things, a tax credit for research expenses incurred in the development of a companion diagnostic test.
Given President-elect Obama’s support for personalized medicine, the recent passage of the Genetic Information Nondiscrimination Act (GINA) and the hope that tailored therapies will ultimately reduce healthcare costs, this “change” should be an easy one.
While the “change” necessary to encourage personalized medicine isn’t nearly as contentious as that for promoting stem cell research, the result will ideally be the same: moving federally funded scientific research from the laboratory to the clinic.
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