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Articles matching the ‘Policy’ Category

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April 12th, 2014

Unwittingly, HCV “News” Brackets Our Current Treatment Era on Successive Days

I’ve already told you what a fan I am of Physician’s First Watch, the daily email summary of hot medical news provided by my colleagues here at the Massachusetts Medical Society. If you haven’t signed up, you must do so — let’s play a short tune (always a favorite, even if out of season) for [...]


November 27th, 2013

Gynecologists May Treat Men After All

Good news here for gynecologists who screen men for anal cancer: A professional group that certifies obstetrician-gynecologists reversed an earlier directive and said on Tuesday that its members were permitted to treat male patients for sexually transmitted infections and to screen men for anal cancer… It’s always impressive when a group swiftly reverses what is [...]


October 30th, 2013

HIV Treatment of Serodiscordant Couples: The Home Run, Slam Dunk, and Open Goal in Clinical Research

Just in time for Game 6 of the World Series, my colleague Rochelle Walensky has published a paper in theNew England Journal of Medicine (covered here in NEJM Journal Watch). evaluating the cost-effectiveness of treating HIV-infected individuals in serodiscordant couples. The results: In South Africa, early ART was cost-saving over a 5-year period. In both South Africa and [...]


September 27th, 2013

Yes! An Economic Justification for ID Specialists

We’re currently in the middle of fellowship interview season, and I overheard the following conversation between two of my colleagues as they contemplated their upcoming interviewees: ID Doctor #1:  He seems like a great candidate — wants to study hospital and community epidemiology of highly drug-resistant bacterial infections, and has already made major contributions to [...]


August 28th, 2013

Poll: At $14,105/year, Is Dolutegravir Fairly Priced?

The recently approved once-daily integrase inhibitor dolutegravir is now in pharmacies and, like every new HIV drug, the price — around $14k/year — has generated some controversy. For the record, here are the per-year wholesale acquisition costs of the three FDA-approved integrase inhibitors. Raltegravir:  $12,976 Elvitegravir:  $13,428 (once disentangled from the price of TDF/FTC) Dolutegravir: [...]


August 7th, 2013

Occupational Post-Exposure Prophylaxis (PEP) Guidelines Updated — And They Are Clear and Sensible

Good news here — the United States Public Health Service has issued new national guidelines for management of occupational exposure to HIV. Authored by an expert panel, these updated occupational PEP guidelines replace the (woefully outdated, sorry, had to write that) previous version, which dates back to 2005. On a quick read-through, despite the density of [...]


June 19th, 2013

FDA, IND, FMT: Nine Letters, Some Common Sense, and a Real Video Link

Good news here — the FDA has reconsidered their requirement for an IND for fecal microbiota transplantation (FMT) for C diff: Some health care providers have stated that applying IND requirements will make FMT unavailable and have suggested that an alternative regulatory approach is needed to ensure the widespread availability of FMT for individuals with [...]


May 31st, 2013

Fecal Microbiota Transplantation — Try This At Home?

As noted before, the FDA says that an investigational new drug (IND) application is required for therapeutic use of fecal microbiota transplantation. The practical effect of this decision, at least at our institution, is to stop providing this service — it’s on hold pending those “internal discussions” planned by the FDA on the regulatory issues surrounding the [...]


May 29th, 2013

The New SARS-Like Coronavirus (MERS-CoV), and What To Do When You Don’t Know Anything About The Latest Outbreak

From one of my close friends — a non-MD — comes this alarming video (sorry, can’t remove the preceding ad). And here’s his email: Concerned? Terrified? I bet your department is buzzing about this. Um, not quite — especially since, among the 49 cases in the world (apparently there are 5 more than the WHO reported), [...]


May 12th, 2013

FDA: Fecal Transplants Need Investigational New Drug Application

Gastroenterologists, ID doctors, C diff-sufferers, and microbiome-obsessed humanoids everywhere were treated to this surprising news recently — a decision by the FDA about fecal microbiota transplantation (FMT). From an email sent by the IDSA: Because fecal microbiota transplantation (FMT) is not approved for any therapeutic purposes, an investigational new drug (IND) application is needed for [...]


HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Editor-in-Chief

NEJM Journal Watch HIV/Aids Clinical Care

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