Ethical Concerns and CRISPR Potential

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The U.S. Senate Committee on Health, Education, Labor and Pensions gathered in November to discuss the potential and implications of pursuing further use of the genome editing technology CRISPR.

The U.S. Senate Committee on Health, Education, Labor and Pensions met on Tuesday, November 14 to discuss gene editing technology — in particular, the innovations and impacts of CRISPR and the implications that could arise from it. Senators from both parties gathered to question witnesses from Stanford University, Editas Medicine, and Johns Hopkins Berman Institute of Bioethics about the ethical concerns and the possible regulations that accompany the scientific breakthroughs of CRISPR.

Leading the discussion was Lamar Alexander, the Republican senator from Tennessee. In his opening statement, Alexander presented the history of CRISPR and the potential behind it, including the potential to treat devastating diseases.

CRISPR was developed in 1993, but it only recently became useful to treat humans in 2013. Alexander notes that CRISPR has been widely used in agriculture to modify tomatoes and soybeans with higher yields or have the potential to live through droughts. He continues by diving into the ethical issues of CRISPR, such as the possibility of creating “designer babies,” by editing out the unwanted and undesirable genes.

“CRISPR is just one of the amazing discoveries that has come from basic research funded in part by the federal government,” Alexander says. “Today’s hearing is truly a hearing. I intend to do more listening than talking.”

Following Sen. Alexander’s opening statement, Sen. Patty Murray, the Democratic representative from Washington, opened by asserting that gene editing technology has the potential to tackle serious gene-based diseases, such as Sickle Cell and Huntington’s Disease, as well as potentially prevent viruses such as the Zika virus. “I’m sure there are ways CRISPR technologies can help patients and families that we haven’t even begun to think of yet,” she says. “I am glad that bipartisan work on this committee has enabled us to enact policies and 21st century cures and the FDA user fee authorization that will help spur innovation.”

The hearing had three witnesses: Matthew Porteus, an associate professor of pediatrics from Stanford University; Katrine Bosley, chief executive officer and president of Editas Medicine; and Jeffrey Kahn, director of Johns Hopkins Berman Institute of Bioethics. In their opening statements, the three explained the general science behind CRISPR, as well as how the FDA

overseas clinical trials for CRISPR breakthroughs and the ethical concerns that the international community has expressed.

After the witnesses presented their testimonies about their work with CRISPR technologies, senators were allowed to begin their questioning of the witnesses. The first question came from Republican Sen. Susan Collins from Maine, which addressed the ethical issue of using gene editing to advance a person’s intelligence or athleticism – how could policy makers ensure that all countries and scientists make sure that the technologies are used for the correct reasons?

Kahn asserted that there was an international dialogue already happening around the world, with a summit previously held in 2015, and a second summit to be held in China in 2018.

“It is the case in our history that prohibitions and bans have led not to control, but quite the opposite,” says Kahn. “When technologies are banned in this country, scientists find places where there are either lax or no oversight to go perform them. A much smarter approach is a strict control to allow careful, responsible science to go forward in ways that are controlled and within our borders.”

Democrat Sen. Maggie Hassan from New Hampshire, questioned the differences between editing RNA and DNA, and Republican Sen. Tim Scott from South Carolina, asked for clarification on how CRISPR technologies could cure a person with sickle-cell disease.

Sen. Alexander asked how the FDA would be involved in approving clinical trials and treatments based on CRISPR technologies, and whether or not there would be a challenge in getting a prompt approval from the FDA.

“The FDA has the appropriate authority and they’re exercising it well and thoughtfully, so I don’t see any need for any change in legislation,” Bosley says.

Virginia Democratic Sen. Tim Kaine questioned the amount of regulation necessary to keep safety and stopping researchers from fleeing to another country to practice. Kahn defended this idea by presenting the idea of the UK’s approach to regulation. In Kahn’s written testimony, he presented the UK’s regulatory example, “where scientists are taking the lead internationally in research involving potential human applications of these technologies. This owes not to lax oversight but rather the contrary— strict oversight with clear pathways for licensure by the responsible regulatory agency, allowing careful and controlled progress with clear reporting and evaluation of results before proceeding, creating a clear path forward.”

Sen. Scott echoed this sentiment in his final remarks, saying: “I will say, Mr. Chairman, that someone, somewhere, some nation will set the ethical boundaries for this conversation going forward and it certainly would be helpful for the United States of America to establish those boundaries to a large extent.”

While CRISPR technologies seem to pose an impending ethical problem, it seems that with the correct regulation approach, gene-editing can help people and agriculture alike by editing out gene-based diseases.

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