Friday, January 23, 2009

Science Is Back

The health research community is waiting to see what steps President Obama will take to enable stem cell research. The previous occupier of the White House had issued an edict preventing scientists from working in laboratories, and will facilities, funded by the U.S. in stem cell research.

In some laboratories there were labels on pieces of equipment that could be traced to some funding by the U.S. government, to the effect that they were banned to stem cell research. In other examples of the idiocy, stem cell research required duplicating existing facilities, at the expected expense.

President Obama could sign an order vacating the ex-cretin in chief's ideological absurdity, or could wait for Congress to pass legislation putting it behind us.

Embryonic stem cells can develop into any cell of the body, and scientists have long hoped to harness them for therapies to treat a variety of diseases. But research has been contentious because embryos must be destroyed to obtain them. And many people believe that embryos, even in their earliest stages, are human lives that should be protected.

The dispute has prevented the passage of a detailed federal policy governing the research.

There is not a federal law against human cloning for reproductive purposes. Instead, scientists have been governed by a patchwork of state legislation, ethical recommendations from scientific organizations and the policies of their own research institutes.

Bush's executive order said that federal funds could not be used for research on embryonic stem cells created after Aug. 9, 2001, the day he signed his edict.

As a result, most scientists working with human embryonic stem cells could not work on equipment or in labs that were paid in part by federal funding, even if it was just the light bill. Universities and research institutes that receive federal funding were forced to pay for duplicate equipment and research space.

That could change immediately, prompting huge efficiencies. In Goldstein's labs, researchers could remove the red and green stickers on each piece of equipment indicating what was bought with federal funds and what wasn't.

“At a time of scarce resources, this country doesn't need to pay twice for critical and expensive equipment to advance medical research,” Klein said. “Now hundreds of millions of dollars, if not billions of dollars, worth of tools and equipment would immediately become accessible to all researchers.”

Bush twice vetoed legislation that would have lightened his restriction by allowing federal funding to be used for research using surplus embryos from fertility clinics. And he pressured high-ranking members of the National Institutes of Health not to testify about the need for more human embryonic stem cell research, Klein said.

Scientists and stem cell advocates now foresee the science being on equal footing with all other forms of basic research that are funded largely by the taxpayer-supported NIH. But there's more than Bush's executive order that needs to be changed, they said.

Legislation known as the Dickey-Wicker Amendment, first passed in 1995 and attached every year to Health and Human Services funding bills, prohibits the use of federal dollars on research that creates or destroys a human embryo.

When the amendment was first drafted, scientists were not yet able to remove stem cells from human embryos. The amendment continues to stifle a research area known as therapeutic cloning, which scientists believe is one way to make patient-specific stem cell lines, said Dr. Samuel Wood, chief executive of San Diego-based Stemagen.

Promise of relief from suffering has been held up for these past years, and many programs are poised to take off toward that relief. Spinal injuries have shown some potential for the research, and those suffering nerve and spinal damage are among the most enthusiastic for a return to enlightened outlook.

Wednesday the FDA cleared a study which involves stem cells that were not banned by the previous White House occupier, and which will work toward regenerating spinal cells.

The study will focus on the safety of the treatment. At an FDA hearing in April, several firms' executives and researchers complained that they were at a loss about what the FDA wanted in terms of clinical trials involving stem cells because the FDA itself wasn't sure.

Embryonic stem cells are the building-block cells that help drive prenatal development. Geron has developed banks of embryonic stem cells and found a way to coax them into differentiating as they do in nature into progenitors of specific cells that make spinal-cord tissue, heart muscle, cartilage and other organs and tissues.

Spinal-cord injury is one of medicine's most debilitating conditions, typically causing paralysis and other issues for which there are few, if any, effective treatments. The Geron study will enroll paralyzed patients who can be treated within 14 days of their injury. Patients will be evaluated for at least one year, after which, if the treatment proves safe, the company hopes to increase the dose and expand the potential candidates for the therapy.

The freedom to explore solutions to causes of disease and disability is very welcome. Grandstanding on ideology above the interests of the public is well banned from our government.

Ignorance is a quality this government suffers at all our peril.

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