FDA approves human embryonic stem cell research study

embryos_stem_cell2The US Food and Drug Administration (FDA) has approved California based Geron Corporation to carry out the world’s first human embryonic stem cell (hESC)-based clinical. Geron will test the stem cells on eight to 10 patients with severe spinal cord injuries.

The trials are set to begin at seven medical centers aims to mainly determine the safety of the cells in human subjects. Researchers will also look for any signs that the therapy restored sensation or movement.

“This is obviously an extraordinarily exciting event,” Geron chief executive Thomas B. Okarma said. “It marks the dawn of a new era in medical therapeutics. This approach is one that reaches beyond pills and scalpels to achieve a new level of healing.”

President Barack Obama is set to lift restrictions on federal funding for such research imposed by former President George W. Bush in 2001. Geron’s work had not been restricted by the Bush administration policy. The cells being used by the company were derived from leftover embryos at fertility clinics before 2001.

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Obama overturns anti-abortion funding policy

Obama signed the memorandum without coverage by the media on a day following the 36th anniversary of the 1973 landmark Supreme Court ruling in Roe v. Wade that legalized abortion.

The move by Obama to reverse the Mexico City Policy received both praise and criticism from both sides of the abortion debate.

“Women’s health has been severely impacted by the cutoff of assistance. President Obama’s actions will help reduce the number of unintended pregnancies, abortions and women dying from high-risk pregnancies because they don’t have access to family planning,” said Tod Preston, a spokesman for Population Action International.

“Yesterday, President Obama issued executive orders banning the torture of terrorists but today signed an order that exports the torture of unborn children around the world,” said Tony Perkins of the Family Research Council.

“President Obama not long ago told the American people that he would support policies to reduce abortions, but today he is effectively guaranteeing more abortions by funding groups that promote abortion as a method of population control,” said Douglas Johnson, legislative director of the National Right to Life Committee.

In a statement issued with the memorandum Obama said the limitations on funding were “excessively broad” and adding that “they have undermined efforts to promote safe and effective voluntary family programs in foreign nations.” He added that “For too long, international family planning assistance has been used as a political wedge issue, the subject of a back and forth debate that has served only to divide us.I  have no desire to continue this stale and fruitless debate.” Obama also said that he would ask his administration to initiate a “fresh conversation” on family planning and to seek common ground with abortion opponents.

In an accompanying statement, President Obama said he would also work with Congress to restore U.S. funding support for the United Nations Population Fund “to reduce poverty, improve the health of women and children, prevent HIV/AIDS and provide family planning assistance to women in 154 countries.”

According to the Washington Post, lifting the Mexico City Policy would not permit U.S. tax dollars to be used for abortions, but it would allow funding to resume to groups that provide other services, including counseling about abortions.

Bush Administration Issued Last-Minute Rule Reinforcing Protections for Health Care Workers’ Conscientious Objections

In the Bush administration’s final days in power, the Bush administration issued a federal rule reinforcing protections for doctors and other health care workers who conscientiously object and refuse to perform abortions or other procedures due to religious or moral objections. 

Under existing federal law, health institutions are not permitted to discriminate against individuals who refuse to perform abortions or refer patients to abortion providers.  According to administration officials, this new rule ensures that federal funds do not go to providers who violate those laws by requiring recipients of federal funding to certify their compliance with laws protecting conscience rights.

Despite multiple laws on the books protecting health providers, the administration argued that the rule was needed “to raise awareness of federal conscience protections and provide for their enforcement.”  Critics say the protections are so broad they limit a patient’s right to get care and accurate information; they fear the rule could make it possible for a pharmacy clerk to refuse to sell birth control pills without ramifications from an employer.

The rule will take effect on Jan. 18, two days before Obama takes office.  The Obama administration could issue new regulations that would trump these recently passed rules.