Medical Device Daily Washington Editor

Atomic Energy of Canada (AEC; Mississauga, Canada) reported last week that it will shut down its Chalk River reactor after problems with leaks in the reactor persisted, putting further pressure on already low levels of technetium-99, a commonly used radioisotope for medical purposes. According to AEC's May 22 statement, the remaining inventory of molybdenum-99 has been removed from the reactor and will be processed into the finished product, technetium-99, immediately.

AEC said that the deuterium leak is located "at the base of the reactor vessel in a location where there is corrosion on the outside wall," and while the rate of leakage "remains stable" at about 5 kilograms an hour, the plant's management is examining its options for plugging the leak site. Technicians are said to have examined the interior of the reactor vessel this past weekend with ultrasound instrumentation, and AEC expects the facility, which was built roughly 50 years ago, to be off line for at least a month, probably longer.

The supply of molybdenum-99 has appeared to be shaky for the past two years. AEC had shut down the reactor in 2007 due to leak problems (Medical Device Daily, Dec. 20, 2007), which was followed last year by a temporary shut-down of a reactor in the Netherlands. The Nuclear Research and Consultancy Group (NRG; Petten, the Netherlands), reported the shut-down of its High Flux Reactor because of the periodic presence of "a very small trace of gas bubbles" detected in the reactor's primary cooling system.

At present, American hospitals rely entirely on imported supplies of molybdenum-99, but Covidien (Mansfield, Massachusetts) and Babcock & Wilcox Technical Services Group (B&W; Lynchburg, Virginia) recently signed a deal that would boost supplies of molybdenum-99 by employing a processing technology that allows the use of low-enriched uranium (Medical Device Daily, Jan. 27, 2009). The deal promises to cover half the U.S. need for technetium-99.

Bruce Farmer, VP for public relations at Covidien, told Medical Device Daily in an e-mailed statement that the company "will work to minimize disruption for patients and their physicians who rely on Moly-99 for diagnosis," noting that the company's principal supplier is NRG, although he said "we have arrangements in place to secure diversity of supply from the world's three other reactors in Belgium, France and South Africa."

Farmer also noted that the Chalk River shut-down "demonstrates the critical need for industry to re-invest in securing and upgrading" the number of sources around the world, noting that Covidien is "investing in current production and processing," including the agreement with Babcock and Wilcox.

FDA contacts eye docs re: LASIK

FDA published a May 22 "Dear Doctor" letter to ophthalmologists regarding LASIK (laser-assisted in situ keratomileusis), informing them of "comments and complaints" that promotions for the procedure "failed to inform consumers of the indications, limitations, and risks associated with LASIK procedures" as well as of the lasers approved for the procedure.

FDA states that promotional materials "must be truthful, properly substantiated and not misleading," and the letter, which is signed by Tim Ulatowski, director of the Office of Compliance at the Center for Devices and Radiological Health, notes that the agency reserves the right to declare an advertisement misbranding by assessing several factors, including whether "the advertisement fails to reveal facts [that are] material ... with respect to consequences which may result from the use of the device."

FDA conducted an advisory committee hearing on the subject of LASIK last year (MDD, April 29, 2008) during which a number of former patients who opted for the procedure presented on problems they subsequently had with their vision, but Glenn Heagly of the Vision Surgery Rehab Network (Rockford, Illinois) told panelists that they must "be prepared to hear the extreme sides of an argument," warning that "both sides are at times disingenuous in their arguments."

FDA had received 140 reports on the procedure during the decade prior to the hearing, a rate of less than one complaint for every 10,000 patients, but some patients were treated despite having pupils larger than is indicated for the procedure.

Hamburg, husband to divest holdings

Incoming FDA commissioner Margaret Hamburg, MD, and her husband must divest themselves of some financial assets if her tenure at FDA is to avoid the taint of conflict of interest.

According to wire service reports, Hamburg and her husband had income of roughly $10 million last year, most of which came from her husband's employment by a hedge fund. Hamburg is said to have inherited stocks in pharmaceutical firms while her husband, Peter Fitzhugh Brown, is said to have inherited stock in Abbott (Abbott Park, Illinois) and Johnson & Johnson (J&J; New Brunswick, New Jersey) from his father. However, Brown is said to have already divested his holdings in Abbott and J&J.

Hamburg also served on the board of Henry Schein (Melville, New York), a distributor of medical and dental supplies. According to the Wall Street Journal, Hamburg will have to divest holdings valued at more than $750,000.