NEWS OF THE WEEK
for $750 million reflects U.S. crackdown on adulterated products
E
NDING A MAJOR CASE in a spate of U.S. gov-
ernment actions against drug manufacturers, GlaxoSmithKline will plead guilty and pay $750 million to settle civil and criminal complaints that it knowingly marketed adulterated products made at a plant in Cidra, P.R., between 2001 and 2005. The drugs involved include Kytril, a nausea treatment; Paxil CR, an antidepressant; Bactroban, an antiinfective ointment; and Avandamet, a diabetes drug. The plant closed in 2009. The company will pay a $150 million criminal fine that covers violations of FDA’s current Good Manufacturing Practices (cGMP). Among the violations were the packaging of drugs of different types and strengths in the same bottle and failure to ensure that finished products were free of contamination. A $600 million civil settlement resolves claims that GSK sold drugs at variance with FDA standards for
CARBON CAPTURE BY SOLIDS POROUS CRYSTALS: Study uncovers
details of CO2-binding sites in framework compounds
B
Y COMBINING experimental and computational
methods to examine an amine-functionalized metal-organic-framework (MOF) compound, researchers in Canada have identified the chemical nature of carbon dioxide-binding sites in that porous crystalline material (Science 2010, 330, 650). The study reveals molecular-level details of nitrogen-CO2 interactions, which are central to commercial CO2scrubbing systems. The findings could lead to advances in carbon-capture technology. Carbon cleanup in industrial settings today is often carried out by flowing flue gases through a column containing an aqueous solution of amine compounds such as monoethanolamine to selectively extract CO2 from the exhaust stream. The CO2-enriched solution is then typically heated to above 100 °C to remove the CO2 and regenerate the amine solution. Technology based on those processes is well established. Nevertheless, various shortcomings, such as the corrosive nature of the solutions and the high energy
GSK’s headquarters, in Brentford, England.
input required to regenerate them, leave room for improvement. Solid adsorbents might offer viable alternatives, especially because some MOF compounds exhibit the capacity to take up exceptionally high quantities of CO2. That feature has motivated researchers to synthesize large numbers of these compounds, including ones with amine moieties, in hopes of pushing CO2 uptake even higher. In the new work, a team led by chemists Ramanathan Vaidhyanathan and George K. H. Shimizu of the University of Calgary and IN PLACE AngstromTom K. Woo of the University of Ottawa used level details of CO2 crystallography and computational techniques binding (dotted pink to sort out subtle details of CO2 binding in line) in an aminean amine-functionalized zinc-based triazole functionalized MOF oxalate compound. Among other findings, the compound, including group determined the geometry of the amineformation of T-shaped CO2-binding site in the MOF. The researchers dimers (dotted yellow found that cooperative binding of CO2 in the line), have been form of dimers and suitable pore size are coluncovered. Zn is light lectively responsible for the material’s high blue, N is dark blue, O is uptake of the gas. red, and C is gray. “This study reveals for the first time the specific interactions that hold CO2 in the pores of amine-functionalized MOFs,” says Omar M. Yaghi of the University of California, Los Angeles. “This is a significant step toward understanding what makes for a good CO2-capture material.”—MITCH JACOBY
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SCIENCE
PHARMACEUTICALS: Settlement
purity and strength and caused false documents to be filed with government health care programs. The civil settlement also resolves a lawsuit brought by Cheryl Eckard, a former GSK quality manager, under the whistle-blower provision of the Justice Department’s False Claims Act. Eckard will receive $96 million. “We regret that we operated the Cidra facility in a manner that was inconsistent with cGMP requirements,” says Elpidio (PD) Villarreal, GSK’s head of global litigation. The company notes that it has not received an FDA warning since the one at the Cidra plant in 2002. Denise Smart, a regulatory compliance expert and cofounder of Smart Consulting Group, says she has noticed a distinct increase in the number of FDA warning letters issued in recent months. “And I have not seen anything like the GSK settlement, where the government is bringing both criminal fines and civil penalties for cGMP violations,” she says. “They are taking cGMP enforcement to a new level.” Earlier this year, Genzyme signed a consent decree with the U.S. to correct quality problems uncovered in its Allston, Mass., plant. More recently, Bristol-Myers Squibb received a warning from FDA for cGMP noncompliance at its Manati, P.R., site.—RICK MULLIN GL AXOSM IT HK L IN E
GSK PAYS BIG
