When President Barack Obama vowed to “restore science to its rightful place,” he wasn’t kidding.
The federal government has approved the first-ever human trial of therapy derived from human embryonic stem cells. But before the heavens part and the chorus of angels starts jubilating, let us keep in mind that Rome was not built in a day and that America ““ at least its scientific community ““ cannot be rebuilt so soon.
Though the Food and Drug Administration’s approval of the trial comes as a rare milestone in the eyes of stem cell research advocates, its relative lateness serves as a reminder of the defective government policy that ultimately holds back scientific progress. Overturning ineffective and meaningless policies is necessary if science is to be restored to its optimum productivity.
The approval for the test did not come easily. The FDA could not find the necessary peer-reviewed research, apart from one by Geron, the biopharmaceutical company that proposed to start the trials. Valuable research time was lost due to the need to compile complicated research proposals. In fact, the proposal for the trial amounted to some 22,000 pages of data. The effort in creating these applications could be better channeled to furthering the study. To add to this, work had to be halted as Geron awaited the go-ahead from the FDA.
The procedure for approving clinical trials must be reformed to expedite the research process and to eliminate unnecessary idleness. The sooner proposals get approved, the sooner results will come.
Apart from red tape, numerous laws that prescribe tight limits to research involving stem cells are in place, further impeding progress.
“People didn’t think this would happen for another five years,” said Dr. Thomas Okarma, Geron’s chief executive, to CNN. “But it will happen soon, and it would have happened sooner if it weren’t for the ridiculous Bush policies.”
Okarma was partly referring to policies limiting the potential for the cultivation of stem cells. According to the Stem Cell Research Enhancement Act of 2008, support will only be extended to research in which the cells “were derived from human embryos donated from in vitro fertilization clinics, were created for the purposes of fertility treatment and were in excess to the needs of the individuals seeking such treatment; prior to donation, it was determined that the embryos would never be implanted in a woman and would otherwise be discarded.”
The restrictions placed on stem cell research were created mainly due to opposition against the process behind embryonic stem cell cultivation. Pro-life advocates liken the procedure to abortion, as these stem cells, isolated around four to five days after fertilization, spell the destruction of the embryo.
A duality of principles exists in the government’s policy regarding the definition and valuation of life. While the argument against the use of embryonic stem cells is rooted in the notion that life begins after fertilization, the same objection is not applied to other fields, such as in vitro fertilization.
Current methods of in vitro fertilization employ a shotgun approach: Numerous embryos are grown, the number of which depends on the carrier’s fertility diagnosis, in the hope that at least one of them survives to the point of birth. Moreover, with in vitro fertilization, embryos may be created and disposed, depending on procedural needs. In fact, as noted earlier, utilizing embryos left over from in vitro fertilization clinics is the only avenue through which embryonic stem cell research is eligible for government financing.
Limits on government funding have already significantly slowed the progress of embryonic stem cell research. Because these restrictions are based on an argument that nevertheless allows for procedures such as in vitro fertilization to thrive, the government has no real reason to keep limiting financing for this scientific field.
The controversy behind this field is both unfounded and unwarranted. In fact, considering how much this area has been held back over the past few years, increased funding for stem cell research may not be a bad idea.
“It is the private sector that has kept the technology alive so that it can see the light of day in a clinical trial,” Okarma said.
It’s the government’s turn to make sure that this persistence was not made in vain.
E-mail Ong at rong@media.ucla.edu. Send general comments to viewpoint@media.ucla.edu.