Geron?s Okarma Urges Obama to Set Up Stem Cell Panel
By Rob Waters
June 4 (Bloomberg) -- President Barack Obama should appoint a commission on stem cell research to help the therapy fulfill its promise to save lives and reduce medical costs, Geron Corp. Chief Executive Officer Tom Okarma said.
Obama?s health advisers ignored Okarma?s idea before the president took office. Okarma proposed the national commission as part of a group from the Biotechnology Industry Organization, a Washington-based industry trade association, he said yesterday in an interview. Okarma is a member of the health section of the association?s board of directors.
Geron was cleared by the U.S. Food and Drug Administration in January to start the first clinical trials using human embryonic stem cells. The company, based in Menlo Park, California, will begin treating patients paralyzed with spinal cord injuries this month or next, Okarma said.
?Embryonic stem cells are not going to be a $100,000 therapy that adds three weeks of life to the end of your lifespan,? Okarma said. ?With a single intervention, you permanently restore function to the organ or tissue that?s damaged by injury or disease.?
Obama said in March he would lift restrictions imposed by former President George W. Bush on U.S. funding for embryonic stem cell research. Okarma said guidelines governing such research that were proposed April 17 show the administration doesn?t understand the potential for treatments that may cure currently untreatable diseases and save lives and money spent on ineffective medicines.
Public Comments
The U.S. Department of Health and Human Services is reviewing more than 48,000 comments submitted by the public about the draft guidelines, Reid Cherlin, a White House spokesman, said in an e-mail yesterday.
?The final guidelines, which will be issued in early July, will establish a framework for expanding human embryonic stem cell research in a scientifically worthy and responsible manner,? Cherlin said.
Okarma said a presidential commission is needed to review U.S. stem cell policy, support government funding and encourage collaborations between companies and academic researchers. Such partnerships, common in most areas of medical study, are rare in the field of stem cells, he said.
Embryonic stem cells, derived from embryos just days after conception, are able to form any of about 210 cell types in the human body. The research has been politically and ethically charged since it began 11 years ago.
Bush Ban
Bush barred federal funding for stem cell colonies created after 2001 because the extraction of the cells leads to the destruction of human embryos,
Geron?s first trial to treat spinal cord injury with stem cells will add one new patient each month for a total of eight to 10 patients, Okarma said. Researchers will follow the patients for a year to see if the treatment is safe and if it restores any function or movement. Based on those results, the company can then ask the FDA to expand the study.
?As long as we show safety and feasibility, the fetters on this cell type are gone,? Okarma said. ?We will invest heavily in scaleable manufacturing that not only addresses the spinal cord opportunity but others in central nervous system pathology,? such as Alzheimer?s disease.
To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.
By Rob Waters
June 4 (Bloomberg) -- President Barack Obama should appoint a commission on stem cell research to help the therapy fulfill its promise to save lives and reduce medical costs, Geron Corp. Chief Executive Officer Tom Okarma said.
Obama?s health advisers ignored Okarma?s idea before the president took office. Okarma proposed the national commission as part of a group from the Biotechnology Industry Organization, a Washington-based industry trade association, he said yesterday in an interview. Okarma is a member of the health section of the association?s board of directors.
Geron was cleared by the U.S. Food and Drug Administration in January to start the first clinical trials using human embryonic stem cells. The company, based in Menlo Park, California, will begin treating patients paralyzed with spinal cord injuries this month or next, Okarma said.
?Embryonic stem cells are not going to be a $100,000 therapy that adds three weeks of life to the end of your lifespan,? Okarma said. ?With a single intervention, you permanently restore function to the organ or tissue that?s damaged by injury or disease.?
Obama said in March he would lift restrictions imposed by former President George W. Bush on U.S. funding for embryonic stem cell research. Okarma said guidelines governing such research that were proposed April 17 show the administration doesn?t understand the potential for treatments that may cure currently untreatable diseases and save lives and money spent on ineffective medicines.
Public Comments
The U.S. Department of Health and Human Services is reviewing more than 48,000 comments submitted by the public about the draft guidelines, Reid Cherlin, a White House spokesman, said in an e-mail yesterday.
?The final guidelines, which will be issued in early July, will establish a framework for expanding human embryonic stem cell research in a scientifically worthy and responsible manner,? Cherlin said.
Okarma said a presidential commission is needed to review U.S. stem cell policy, support government funding and encourage collaborations between companies and academic researchers. Such partnerships, common in most areas of medical study, are rare in the field of stem cells, he said.
Embryonic stem cells, derived from embryos just days after conception, are able to form any of about 210 cell types in the human body. The research has been politically and ethically charged since it began 11 years ago.
Bush Ban
Bush barred federal funding for stem cell colonies created after 2001 because the extraction of the cells leads to the destruction of human embryos,
Geron?s first trial to treat spinal cord injury with stem cells will add one new patient each month for a total of eight to 10 patients, Okarma said. Researchers will follow the patients for a year to see if the treatment is safe and if it restores any function or movement. Based on those results, the company can then ask the FDA to expand the study.
?As long as we show safety and feasibility, the fetters on this cell type are gone,? Okarma said. ?We will invest heavily in scaleable manufacturing that not only addresses the spinal cord opportunity but others in central nervous system pathology,? such as Alzheimer?s disease.
To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.