A Medical Device Daily

Harmonization is one of the keys to make global commerce work, and the Securities and Exchange Commission has signed on to a protocol that will allow the agency to share information on the use of International Financial Reporting Standards (IFRS) with its counterparts in four European nations.

According to a May 23 statement at the SEC web site, regulators in Belgium, Bulgaria, Norway and Portugal will now share such data with other signatories as part of a work plan previously agreed to by SEC and the pan-European agency known as the Committee of European Securities Regulators (CESR). The agreement follows a similar arrangement with authorities in the UK.

Christopher Cox, chairman of the SEC, said in the statement that "arrangements of this kind are quickly becoming a cornerstone of U.S. securities regulation in today's global marketplace." He also noted that the German Federal Financial Authority is on board with the IFRS agreement.

SEC said that investors in the U.S. "increasingly demand seamless cross-border access to information and capital" and that these agreements "represent an important step in our pursuit of that goal." Additionally, foreign investment in the U.S. also is rising, adding a further sense of urgency to the effort.

Clopidogrel little help for dialysis access

Keeping a dialysis patient healthy over the long term depends on keeping their blood vessels fit for dialysis, but blood clots have plagued these patients incessantly. Some doctors have thought that keeping the rate of blood clots down in fistulas the juncture of artery and vein that serves as the conduit for dialyzed blood would help ensure the long-term patency of these vessels, but a preliminary study sponsored by the National Institutes of Health suggests otherwise.

A May 22 announcement at the NIH web site states that a study conducted by the Dialysis Access Consortium, which was published in the Journal of the American Medical Association (JAMA), concluded "only 12% of patients developed blood clots when treated with clopidogrel," known as Plavix, "compared to nearly 20% treated with placebo." Despite the improved rates of thrombosis, however, "about 60% of new fistulas in each group could not be used for long-term dialysis treatment."

The Dialysis Access Consortium (DAC) is a group of academic centers and NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) that have banded together to focus on the fistula problem. The study's supply of Plavix was provided gratis by what NIH described as "Sanofi Aventis/Bristol-Myers Squibb" (Paris and New York).

The initial DAC effort tracked almost 900 patients at nine U.S. medical centers for six weeks to see if clopidogrel use would help maintain vascular patency, but the results have prompted the consortium to take another crack at it.

Catherine Meyers, MD, a kidney specialist in charge of the consortium at NIDDK, and a co-author of the study, said in the statement "[b]ecause vascular access is critical for delivering lifesaving care, we are already organizing another multi-center study to look for other ways to improve fistulas."

NIH Director Elias Zerhouni, MD, said in the statement that the outcome of the first study "tell[s] us we need to keep looking for solutions."

NIH scans gene-cell behavior

Seeing small is the key to much of modern medical science, and thanks to an NIH study, scientists now can visually track the interaction between genes and their host cells as they happen, thanks to a technique called live-cell fluorescent microscopy.

Fluorescence microscopes are not exactly new, but were limited to two-dimensional images in previous years. Thanks to improvements in the field of visualization and the addition of image processing computer software, scientists can capture images in real time and observe how genes transmit their codes into living proteins.

According to the May 22 announcement at the NIH web site, researchers at NIH's National Cancer Institute have seen enough from live-cell fluorescent microscopy to establish that a version of ribosomal ribonucleic acid (rRNA) known to scientists as RNA pol 1 functions in a more complex manner than previously understood. The new information may shed light on the processes behind the various forms of cancer.

The NIH statement said that RNA pol I "is not a single protein but rather a complex of subunits that assemble into the full polymerase when needed." The researchers concluded that some of the pol 1 sub-units "associate more stably with the gene and assemble active and complete RNA pol I complexes more efficiently.

To test the idea further, the scientists then interfered in the interactions between the RNA pol I subunits and another transcription factor, which was said to mimic "the conditions of a cell that was able to produce rRNA at a high rate," the NIH statement said, which the cell reacted to by drastically cutting the efficiency of rRNA output.

This outcome hints that the "efficiency with which the RNA pol I complex assembles all its subunits ... plays a significant role in determining when a given gene is turned on." If the results of this study generalize to other transcription factors "the observed may represent a general mechanism for regulating gene transcription," the statement said.