A Medical Device Daily

The National Institutes of Health reported this week that it will begin implementing President Bush’s executive order to explore methods to expand the number of approved pluripotent stem cell lines “without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus.”

The order calls on Michael Leavitt, secretary of Health and Human Services, to support research that takes advantage of emerging potential alternative methods for generating stem cells that are pluripotent – that is, capable of producing all or almost all of the cell types in the developing body.

“The NIH has developed a sound, ambitious strategy to advance pluripotent stem cell research and generate more opportunities in this critical area,” Secretary Leavitt said. “I sincerely hope that these steps will accelerate the discovery of new cures and treatments.”

“NIH has been pursuing the potential of stem cells on all fronts, whether they are human embryonic, adult, or cord blood — since they were discovered. It is one of the central scientific challenges of our time,” said Elias Zerhouni, MD, director of NIH Director. “NIH will continue to consult widely with the scientific community to determine the best approaches.”

“The executive order recognizes the recent developments in adult mouse cells that can be reprogrammed to behave like embryonic stem cells, and we’ve laid out a strategy to explore their possible applications to human cells,” said Story Landis, PhD, Director of the National Institute of Neurological Disorders and Stroke. She also serves as the chair of the NIH Stem Cell Task Force.

The NIH plan includes a number of new or accelerated activities.

For example, the NIH Stem Cell Task Force will develop several funding opportunity announcements, including a Program Announcement (PA). The PA will ask for grant applications proposing research on human pluripotent stem cells derived from non-embryonic sources, such as somatic cells or cells found in amniotic fluid. In addition, the Stem Cell Task Force will create two supplement programs that will stimulate research in specific areas rapidly. They would be awarded to researchers already working in stem cell research to augment certain areas of their work that are of particular interest to NIH.

NIH also will hold a symposium to explore what avenues of stem cell research eligible for funding under federal law and policy offer the greatest potential for clinical benefit.

Under the plan, NIH will rename its Human Embryonic Stem Cell Registry as the “Human Pluripotent Stem Cell Registry” and will consider the addition of new human pluripotent stem cell lines to the registry that are deemed eligible.

Bill pushes prostate cancer diagnostics

U.S. Representatives Elijah Cummings (D-Maryland) and Albert Wynn (D-Maryland) reported that they will co-sponsor legislation that would fund the development of advances for improving the diagnosis of prostate cancer.

“Current diagnostic tools for prostate cancer are grossly inadequate,” said Angelo De Marzo, MD, PhD, associate professor of pathology, oncology and urology at Johns Hopkins University (Baltimore), who joined Cummings and Wynn at a press conference on Capitol Hill, hosted by the AdMeTech Foundation, an organization pursuing advanced technologies for diagnosing this disease. “They often produce inconclusive or misleading results, leading to widespread unnecessary treatment that can cause complications and ratchet up our nation’s ever-growing health care costs,” De Marzo said.

The bill would authorize $650 million to the National Institutes of Health and the U.S. Department of Health and Human Services for prostate cancer imaging research and education. A Senate version of the bill, known as the Prostate Research Imaging and Men’s Education Act (PRIME Act. S. 1734), was introduced by Sen. Barbara Boxer (D-California) in June.

NADL seeks dental restoration regulation

The National Association of Dental Laboratories (NADL; Tallahassee, Florida) said it has asked the FDA to implement more stringent regulations governing dental restorations.

Dental-restoration products – the crowns, provisionals, dentures and bridges permanently seated in mouths – are under-regulated, with few legal requirements for technicians to be certified and no mandates for dentists to document the source of dental work, the association said in a letter to the Presidential Interagency Working Group on Import Safety.

The products are manufactured by dental technicians employed by a dental laboratory anywhere in the world, so much of the dental work used in the U.S. is imported from China, Pakistan, the Philippines and India. These products are not tested or inspected for sterilization or for the precision of the fit, according to the NADL. Even for products manufactured within the U.S., most domestic dental laboratories are exempt from registering with the FDA, and most typically employ less than four people.

The association asserts that the FDA must act to protect Americans, recommending the following:

• Promote certification of dental technicians employed at both domestic and foreign labs.

• Require that dentists label and disclose to patients the source of dental devices, so all dental-restoration products can be traced back to the laboratory that made them.

• Step up inspections of the content and quality of imported dental-restoration products.

• Mandate that dental labs register with the FDA or with state health departments.

• Require that dentists include the registration number of their contracting dental laboratory on a prescription that is kept in patients’ dental records; so that dental devices can be traced even long after they have been implanted in patients’ mouths.

Group says provision threatens wheelchair access

The ALS Association has issued a statement urging Congress to reject a provision in the CHAMP Act that it says would threaten the ability of people with Lou Gehrig’s Disease to access power wheelchairs through Medicare.

It says that the provision would eliminate the “first-month purchase option” for power wheelchairs and “may limit what type of chair they can obtain, particularly the highly complex power wheelchairs that people with ALS rely on throughout the course of their disease.”

Steve Gibson, VP of government relations, said the association “is deeply concerned about this provision and changes in Medicare coverage and reimbursement policies that may limit the ability of people with ALS to access needed equipment,” especially the powered wheelchairs.

The group said that most people with ALS choose to purchase a power wheelchair, enabling them to obtain a highly complex power wheelchair that will meet their medical needs as the disease continues to progress. “Under a rental-only policy, people with ALS may not be able to obtain these complex chairs, including accessories like custom backs, seats, and tilt-recline systems that are so critical to people with ALS. That is because power wheelchair providers simply cannot cover the up-front costs that are required to deliver complex, customized chairs and needed services to people with ALS.”

The association said that it was pleased that the House Committee Report which accompanied the CHAMP Act included language indicating that the provision may not be appropriate for people with ALS and other complex conditions.

“We hope that Congress will remove this provision from the CHAMP bill and reject any other attempts to pursue such a policy for ALS,” Gibson said.