The US Food and Drug Administration is often criticized for taking a plodding approach to drug regulation. But when it comes to approving novel therapeutics, the agency is actually much speedier than its European and Canadian counterparts. Read more
The press conference last Friday held by two New York state assemblymen was no doubt timed to coincide with observance of the 4/20 celebratory day in cannabis counterculture: On 20 April the duo announced a bill that would make New York the 41st state to deem possession or sale of the active ingredients in so-called ‘synthetic marijuana’ drugs a crime punishable by jail time. The drugs in question—known to the mostly teenagers who like to smoke them as K2, Spice, Killer Buzzz, Blaze and Mr. Nice Guy— are mixtures of herbs such as oregano laced with laboratory-produced cannabinoids, a class of chemicals that also includes marijuana’s psychoactive component, tetrahydrocannabinol (THC). Read more
At a panel discussion on Monday organized by the national research advocacy group Research!America and hosted at the New York Academy of Sciences, speakers aired their concerns about the proposed 2013 US federal budget, which they say threatens to cut both grants for primary research and spending on foreign aid. “Under Paul Ryan’s (R-WI) plan, the number grants available for global health research would be reduced dramatically over the next decade,” Nita Lowey Democratic congresswoman of New York said at the conference. The plan of Wisconsin Republican Paul Ryan budget would keep the 2013 budget for the US National Institutes of Health (NIH) flat, and could decrease funding for basic research grants and for foreign aid between 2014 and 2024 by an unknown amount determined by a “review of the long-term budget outlook every 5 years”, as part of a larger goal to reduce federal spending by $261 billion. Read more
With an eye to advancing ‘personalized medicine’, clinicians have tried to predict who will respond to certain therapies using biomarkers gleaned from tests that probe genomics, proteomics and other branches of biomedicine. But according to a report from the US Institute of Medicine (IOM), such ‘omics-based’ tests require greater regulatory oversight and more transparent data-sharing before they should be allowed to move from the lab to the clinic. Read more
A report published today by the Institute of Medicine (IOM) calls for an overhaul of the way public health departments conduct surveillance and treatment of chronic diseases ranging from arthritis to depression. The report, co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Arthritis Foundation, warns that chronic disease, which accounts for three quarters of healthcare spending in the United States, is an overlooked crisis. The authors argue that the CDC can use funds more efficiently by expanding surveillance systems, integrating community health systems in schools and workplaces, and prioritizing patient education. Read more
The current controversy over the publishing of H5N1 research is good news for one unlikely group: bioethicists. Controversy in medicine breeds conversation about ethical questions, and the more people are talking, the more likely researchers are to go looking for ethical guidance as they design studies. Some bioethicists think the best way to address such questions is via ethics consultation services that act independently of institutional review boards (IRBs) so that formal regulatory and informal consulting functions are kept separate. Read more
Two-and-a-half years after a virus struck Genzyme’s main production plant—triggering worldwide shortages of Fabrazyme, an enzyme replacement therapy for Fabry’s disease, an illness that afflicts fewer than 10,000 people worldwide—regulators in the US and EU have approved a new manufacturing facility. With the opening of the new plant, Genzyme announced today that all Americans currently taking Fabrazyme (agalsidase beta) and the most severely affected European patients should be up to full dosing by the end of March. Read more
What a difference a few inches can make. On 1 January, the US National Institutes of Health (NIH) adopted the recommendations set forth in the latest version of the Guide for the Care and Use of Laboratory Animals, and already the usually soporific document is raising hackles. Read more
In a ruling that may bring relief to cancer patients across the US, a federal appeals court said that a decades-old law banning the sale of human organs does not apply to bone marrow donations. The US National Organ Transplant Act of 1984 prohibits financial compensation for human organ donations, including bone marrow, but allows people to be paid for blood and plasma donations. At the time, lawmakers made that distinction because the method used to extract marrow was dangerous, and monetary kickbacks could have encouraged desperate people to take unnecessary risks. As a disincentive to sell organs, the crime … Read more
Crossposted from Nature’s news blog The Global Fund to Fight AIDS, Tuberculosis and Malaria has cancelled its 11th funding round because of the current economic crisis. “Substantial budget challenges in some donor countries, compounded by low interest rates have significantly affected the resources available for new grant funding,” the fund said in a statement on 23 November. It will still provide some funding to existing projects to keep them going over the next couple of years, but will award no new grants before 2014. The fund, a public-private partnership supported by around 150 donor countries, also announced that it would … Read more
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