[The Wall Street Journal] The procedure starts with a surgeon drilling two holes in the patient’s skull. “Every bone and tooth in my head was rattling,” says Lisa Battiloro, who was awake, but not in pain, during the eight-hour operation.
Neurologists asked her questions and issued commands as they pinpointed the exact spot in her brain for [...]

[Washington Post /AP]  The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical companies to help speed up the review of generic drugs, under an agreement with industry released by the agency on Friday.
The user fee proposal is one of three such agreements that the agency is submitting [...]

[NYTimes] ChemGenex Pharmaceuticals found out the hard way how important it is to have a trustworthy companion.

 The Food and Drug Administration last year rejected the company’s drug to treat a subset of leukemia patients whose tumors had a particular genetic mutation. The main problem was not the drug itself, the agency said. Rather, ChemGenex had [...]

WASHINGTON, D.C. – The Presidential Commission for the Study of Bioethical Issues today issued its report concerning federally-sponsored research involving human volunteers, concluding that current rules and regulations provide adequate safeguards to mitigate risk.  In its report, “Moral Science: Protecting Participants in Human Subjects Research,” the Commission also recommended 14 changes to current practices to [...]

[The Atlantic] The global health community has been abuzz with news that the new malaria vaccine, which has been in the development phase for over two decades, appears to greatly reduce the risk of malaria in children in Africa. Yet this exciting success story is just one of nearly 90 promising new [...]

[New York Times] The randomized clinical trial, long the gold standard of medical research, supposedly provides the most reliable data regarding which drugs, devices and procedures prove effective on real patients and which don’t. But when the people enrolled in the trial are quite different from those who will actually use the drug or device [...]

How ’sham’ brain surgery could be killing off valuable therapies for Parkinson’s disease.
[Nature] Peggy Willocks was 44 when she was diagnosed with Parkinson’s disease. It progressed quickly, forcing her to retire four years later from her job as a primary-school principal in Elizabethton, Tennessee. Soon, her condition had deteriorated so much that she was often [...]

[MinnPost]- In July, the federal government proposed new rules governing the protection of human participants in medical studies.
But as University of Minnesota bioethics professor Carl Elliott notes in a commentary published Friday in the New York Times, those rules will do nothing to protect people who volunteer for medical studies from an unethical marketing ploy [...]

[Blog.Bioethics.gov]- The question was simple, the answers not.
At the Presidential Commission for the Study of Bioethical Issues today, Commission Chair Dr. Amy Gutmann, president of the University of Pennsylvania, asked a panel of international experts on bioethics whether the so-called Guatemala incident could happen again. In Guatemala, from 1946 to 1948, a U.S.-funded research experiment [...]

[WSJ]- Pfizer Inc. said four patients died in a clinical trial of an experimental treatment for rheumatoid arthritis, but only one was determined by the investigators to be drug-related.
The New York company added that the death rate associated with the drug, across several studies, “is within the range of rates reported for biologic therapies” for [...]