An ongoing dialogue on HIV/AIDS, infectious diseases,
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 Authored by an expert panel, these updated occupational PEP guidelines replace the (woefully outdated, sorry, had to write that) previous version, which dates back to 2005.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 […]
May 8th, 2013
HIV Opportunistic Infection Guidelines Updated
Some very hard-working folks at the NIH, CDC, and IDSA have updated the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, which are available for review here. As with the previous versions (the prior iteration is from 2009), the OI Guidelines are comprehensive, exhaustively referenced (184 references for TB alone!), […]
April 20th, 2013
Postexposure Prophylaxis (PEP) After Blast Injuries
From a colleague came this query: We are being consulted by surgeons who are finding within blast victims tissues from other humans. We have been offering post-exposure prophylaxis. Have you folks developed any policies re PEP for explosion victims? Welcome your thoughts, P Needless to say, the bombing victims are currently facing far greater challenges […]
March 3rd, 2013
It’s Not Safe Sex If You’ve Just Had the Smallpox Vaccine
One of my more memorable teachers used to love warning us about the hazards of sex. No, this wasn’t in my 8th grade health class — this was during my first year of Infectious Diseases fellowship, and the teacher was one of our highly experienced attending physicians, now retired. To him, sex carried limitless infectious […]
February 24th, 2013
Solve This Problem Please — Microbiology Results in Electronic Medical Records
Our hospital and affiliated practices have had electronic medical record (EMRs) of some sort for decades, so I’ve had my chance to try my hand at multiple “platforms,” both commercial and home-brew. (Weirdly — and I kid you not on this — a version of the first iteration from the 1980s is still around, running […]
Paul E. Sax, MD
Associate Editor
NEJM Clinician
Biography | Disclosures & Summaries
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