Archive for March, 2011

Five Great Healthcare and MedTech Info Resources

March 28th, 2011
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With the abundance of information available online today, sometimes it’s hard to sort through the SPAM to find quality sources of news and opinions, particularly if you want to stay current on trends and policies in healthcare and medical technology.  I’m here to help with some of my favorite sites for great info on these topics.  Add your picks to the comments, and together we can create a resource to sort through the junk.
The Healthcare Blog: WebMd dubs this blog “a free-wheeling discussion of the latest healthcare developments.” I enjoyed last week’s post on “The Incredible and Wasteful Complexity of the U.S. Healthcare System,” which provided a brief and twistedly entertaining look at the mishmash of laws, regulations, and other pieces that combine to create complexity and inefficiency in the U.S. healthcare system. The “internet journal of emerging medical technologies” has something for anyone interested in gadgets and medicine. A recent article spoke of new medical scrubs featuring fabric patterns based on micrographs of pathogens. What an opportune way for every nurse, medical student and hospital staffer to stand out from the crowd.
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Benlysta: Long & Winding Road to Genomics’ Payoff

March 16th, 2011
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On March 9, 2011, the U.S. Food & Drug Administration approved Benlysta® (benlimumab) for the treatment of systemic lupus erythematosus. Benlysta is the first new drug approved for the treatment of lupus in more than 50 years: a triumph of genomic medicine. The drug was born of a partnership, dating back some 18 years, between biotech Human Genome Sciences and multinational pharma GSK. The Benlysta story is an interesting example of how molecular biology and genomic technologies can be applied to create new treatments for challenging diseases, even though the timeline extended well beyond what was anticipated by the lofty projections made in the earliest days of genomic medicine some 20 years ago.
Benlysta is a monoclonal antibody that was developed by HGS and GSK from antibodies that were provided by Cambridge Antibody Technology (which was acquired by AstraZeneca and is now part of AZ’s biologics arm, MedImmune). It acts against B-lymphocyte stimulator (BLyS), which is believed to increase the production of white cells that attack healthy tissue in lupus patients.
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Point/Counterpoint: On FDA Regulation of DTC Genetic Tests

March 10th, 2011
Posted by reporter Emma Hitt wrote yesterday, “A U.S. Food and Drug Administration advisory committee has agreed that direct-to-consumer (DTC) clinical genetic tests should have more oversight from the U.S. Food and Drug Administration (FDA).”
The recommendation came after the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee met for two days in Washington, DC. The Panel discussed several issues – from potential risks of incorrect results for DTC testing performed without medical counseling to claims associated with various DTC genetic tests.
We’ve long been interested in this subject area and we followed some of the live coverage of the panel via Twitter posts from the likes of @RDGene @aliciaault @likesky3 @genomicslawyer and @dgmacarthur using the hashtag #FDADTC. Subsequently, we read perspectives surrounding the Panel’s deliberations via blog posts by @dnalawyer and @dgmacarthur, which you may want to check out.
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“Supplementing” Conversation About Nutraceuticals/Cosmeceuticals

March 8th, 2011
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“Relieves, helps, aids, protects, reduces, may help to slow…”
Fill in the blank for many products (particularly those labeled nutraceuticals or cosmeceuticals) whose marketers some times “claim” that they can do all or some of the above.
These claims can be dangerous, as shown by a recent report in FDA’s Medwatch. The report provided public notification of an “undeclared drug ingredient” in Fruta Planta, a dietary supplement imported from outside the United States.  The FDA had received multiple reports of adverse events associated with the use of the product, which included cardiac events and, in one case, death.
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After the Conference Ends: Thoughts Following Tri-Con 2011

March 3rd, 2011
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Now that the Molecular Med Tri-Con 2011 has ended and attendees are back at their offices, labs, practices, and/or hospitals – or perhaps have landed at their next business meeting or conference destination – it’s a good time to reflect on some of my general observations from the event.
The conference covered so much information that it would be impossible to review every topic. Following are a few areas that captured my attention and remain in my thoughts:


  • STEM CELLS – There was a lot of focus on induced pluripotent stem cells (iPSC), in particular how to better characterize and understand those cells. Pluripotent stem cells can differentiate, or change, to become any one of the many types of cells that make up an organism. These cells are already being used for applications such as drug testing and drug screening. Once they are induced to re-differentiate, iPSC can provide good models for disease: what some conference speakers referred to as a “disease in a dish.” Some discussion among presenters focused on the idea of isolating cells from patients, producing iPSC, and then reintroducing the produced cells into the patient to replace cells that have been damaged or lost as a result of disease – an elegant form of cell-based therapy. Although widespread use of this approach is likely a ways off, I’m both optimistic of the therapeutic potential and somewhat cautious because of regulatory hurdles and potential safety issues (including some data showing tumor production in animals). Read the rest of this entry »

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