Medical Device Daily Washington Editor

The management at Medtronic inneapolis, Minnesota) was probably happy to get the Riegel case behind it at the Supreme Court level, but as one of the largest makers of medical devices, its legal and ethical liability profiles are still huge. And one of the nation's leading electrophysiologists recently took the firm to task over the Sprint Fidelis problem.

William Maisel, MD, formerly the chairman of FDA's circulatory systems advisory committee, wrote an opinion piece in the March 8 edition of the New England Journal of Medicine, blasting the company for what he said was a tardy response to preliminary reports of breakage of the Fidelis leads. Maisel wrote that FDA approved the lead "on the basis of bench testing but no human clinical data ... no public outcry." He said that this and other recent events "underscore the urgent need for legislation that will ensure adequate [patient] protection."

Maisel, director of pacemaker services at Beth Israel Deaconess Hospital (Boston) said that the demands on ICD leads "are intense," requiring that they "withstand hundreds of millions of repetitive cardiac cycles ... in the hostile environment of the human body."

Maisel said that while Medtronic argued that the failure rate seen in Fidelis leads was in line with rates seen in other leads, he described such analyses as "notoriously inaccurate because most malfunctioning leads are not removed and returned to the manufacturer." He also characterized the study said to have followed 100 patients for two years as "grossly underpowered to detect even a moderate increase in fracture rate."

In response to statements that public disclosure of reliability information can steer individuals away from needed device therapy, Maisel asked whether that outcome is not "precisely the point," in that such disclosures are expected to deter some patients. He also said such information is essential to "informed consent."

Maisel pointed out that patients with recalled devices "are not even assured of a single visit with their healthcare provider at no cost ... to discuss the implications of the recall." And he said that placing the highest priority on patient welfare "will require congressional action," and charging that device makers with having "stronger legal obligations to their shareholders than to patients."

FDA to place full-time staff in China

The U.S. FDA reported that it has received approval from the U.S. State Department to establish eight full-time permanent agency positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.

The agency called this "an important step forward" in its plans to hire and place FDA staff in China over the next 18 months. It said it also will be hiring five Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

"In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters," said Murray Lumpkin, MD, deputy commissioner for International and Special Programs, FDA. "Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market."

The agency said that bolstering its capacity outside U.S. boundaries supports the agency's "Beyond our Borders" initiative that facilitates the building of stronger cooperative relationships with the FDA's counterpart agencies around the world and enhanced technical cooperation with foreign regulators.

It said that the permanent overseas offices in China also will allow greater access for inspections and greater interactions with manufacturers to help assure the safety and quality of products shipped to the U.S.

New NIH genomics and disparities center

The National Institutes of Health reported its establishment of the NIH Intramural Center for Genomics and Health Disparities (NICGHD), a venue for research about the way populations are impacted by diseases, including obesity, diabetes and hypertension. NICGHD will employ a genomics approach, collecting and analyzing genetic, clinical, lifestyle and socio-economic data to study a range of clinical conditions that have puzzled and troubled public health experts for decades.

The trans-NIH center will be directed by internationally renowned genetic epidemiologist Charles Rotimi, PhD. former director of the National Human Genome Center at Howard University.

"The priority of our center will be to understand how we can use the tools of genomics to address some of the issues we see with health disparities," Rotimi said.

NICGHD will be established within the NIH Office of Intramural Research and administered by the National Human Genome Research Institute. Additional support for the center will come from the NIH Office of the Director, the National Institute of Diabetes and Digestive and Kidney Diseases and the Center for Information Technology.

The research activities of NICGHD will take place on the NIH Bethesda campus.