No conflict, but FDA's head drug official steps aside from an approval process
Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), has recused herself from the approval process for two competing blood-thinning drugs that mimic the anticoagulant with a troubled recent past, heparin. The FDA claimed that Woodcock did not have a conflict of interest regarding the approvals, though she enlisted the help of scientists from one of the competing drug makers, Momenta Pharmaceuticals, to investigate tainted supplies of heparin from China in 2008. According to the FDA, she stepped aside voluntarily, and the US Department of Health and Human Services has halted an investigation into allegations of a conflict lodged by Amphastar Pharmaceuticals -- the firm that's competing with Momenta for approval of their heparin generic.

Woodcock Image: FDA

Reviewers to NIH: Huh?
The US National Institutes of Health's Office of Extramural Research released more instructions for reviewers of NIH's reformatted grant proposals, but a lack of clarity on how to score the "Overall Impact" of proposals is leaving some reviewers scratching their heads. At issue is the relative emphasis reviewers are to put on the details of research proposals versus the general impact the work might have on its field, and how to quantify the latter. According to the DrugMonkey blog, the Office of Extramural Research seems to be contradicting itself, telling reviewers that "Overall Impact" is distinct from core review criteria (significance, innovation, approach, etc.) that have always been considered while stating that the "Overall Impact" score should "take into account the individual review criteria and provide an overall evaluation."

European drug agency charts course for future treatments
The European Union's version of the FDA -- the European Medicines Agency (EMEA) -- also made news recently, laying out its roadmap for the next five years. The agency's draft five-year plan, which is available for public comment, outlines a move toward regulating emerging treatment strategies such as personalized medicine, nanotechnology, synthetic biology, and regenerative medicine.

MS drug connected to dangerous brain inflammation
The FDA has found a link between deadly brain inflammation and multiple sclerosis drug Tysabri. The FDA confirmed on Friday that 31 patients receiving the drug had experienced progressive multifocal leukoencephalopathy (PML), a swelling of brain tissue that is usually fatal, since mid-2006. The drug was pulled in 2005 over concerns about PML but reentered the market in July 2006. New labeling for Tysabri, which has been used by more than 65,000 people worldwide, states that no patients taking the drug for less than 12 months have been reported to suffer from PML, and that one in 1,000 people taking the drug for 2-3 years, are expected to experience PML.

Plants make progesterone
Finally, last week, researchers reported that they've found the female sex hormone progesterone in a plant. Previously, scientists thought that progesterone could only be produced by animals, but chemists at the University of Illinois, Chicago, found the compound in the leaves of the common walnut tree. The finding pushes back the date of progesterone's arrival on the evolutionary scene and hints at a broader physiological role for the compound.


Related stories:

Conflicts brewing at the FDA
[13th August 2009]

MS drug sickens patient...again
[16th December 2008]

Clearing Estrogen's Bad Name
[November 2008]