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August 6th, 2016

Fishy, Fishy, Fishy, Fish!

I received this exciting offer recently:

Re:  Fish Disease — Manuscript Invitation

Dear Dr. Paul E Sax,

We gladly invite you and your colleagues to contribute the articles on the topic Fish Disease in Johnson Journal of Aquaculture and Research of Johnson Publishers.

During our past two volumes, we had an excellent and fruitful cooperation, especially with our Editorial Board members.

We hope this volume will be interesting, with the presence of articles from Eminent personalities like you.

We are looking forward to receive and review your papers. For any information needed, please feel free to contact via e-mail:

Thank you for your attention towards this letter.

We are happy to announce that this is the 2nd year for this Journal. It will be a great honor for us and an excellent opportunity for you to share your newest scientific work on the field of Johnson Journal of Aquaculture and Research related issues in our international scientific review.


Jennifer Griffin
Johnson Journal of Aquaculture and Research
Johnson Publishers
9600 Great Hills
Trail # 150 w
Austin, Texas
78759(Travis County)

What an opportunity! Here’s my response:

Dear Ms. Griffin:

Thank you so much for reaching out to me about submitting a paper to the Johnson Journal of Aquaculture Research. I have long been an admirer of your journal, and am proud to say I was one of the inaugural subscribers; I eagerly await each issue with great excitement.

Your invitation today was propitious, since, as luck would have it, my research team and I have just completed a major study on the topic of Fish Disease. It should be right in your journal’s wheelhouse, as they say.

(Since you are based in Austin, Texas — Travis County, as you note — you no doubt understand that wheelhouse expression.)

Anyway, I ramble. Let me get right to the point — we think our study is groundbreaking. If we don’t win a Nobel Prize in Fish Disease (there is one in Fish Disease, right?), we’ve been robbed.

Here’s the abstract:

Background:  Ichthyophthirius multifiliis (commonly known as freshwater white spot disease, freshwater ich, or freshwater ick) is a common disease of freshwater fish in home aquariums. It can cause white spots, clamped fins, and reclusive behavior due to severe embarrassment, poor little things. The optimal treatment is unknown. Methods:  We randomized household guppies with moderate-severe ick to standard of care treatment (whatever that is) or a chlorhexidine whole body wash. Outcomes were assessed by trained fishologists blinded to study arm, using validated ick instruments and quality of life scores (CDC HRQOL-14, SF-36, WHOQOL-BREF, and some other letters put together that sound impressive). Results:  After informed consent was obtained (at least to the extent possible from a fish), 6 guppies were enrolled, 3 in each treatment group. Baseline characteristics seemed roughly comparable, but how would we know (they’re just little guppies, after all). On a 100-point ickiness scale, the chlorhexidine washed guppies scored 22.4 International Ick Units (IIUs), vs 57.8 IIUs for the standard-of-care group (p < 0.0000001 — wow, that’s significant, isn’t it). Quality of life measures also favored the chlorhexidine-treated group (“I’m just happier,” one guppy said). Conclusion: For common aquarium guppies suffering the embarrassment of freshwater ick, chlorhexidine whole body wash is superior to usual treatment. Prevents MRSA, too.

I hope you will consider our study carefully. Eminent personalities like us ponder long and hard about the best venue for such important research. Your email was perfectly timed.

Sincerely yours,

Dr. Paul E. Sax
Henry Limpet Professor of Ichthyologic Ick
University of Travis County

(Part of an occasional series, I guess. H/T to Monty Python for the title.)

July 31st, 2016

Summertime Pre-Olympics ID Link-o-Rama

28188787890_1be3985223_oIf you’re wondering what to do between the end of the presidential conventions, the baseball trade deadline tomorrow, and the start of the Summer Olympics, here are a few ID/HIV related items to contemplate:

Hey, World Hepatitis Day was this past week (specifically, July 28). Do these “Diseases Awareness Days” (I made that term up) actually do anything? I can understand the motivation, but the cynic in me says that they are just preaching to the already aware. Maybe somebody has done a study of their usefulness?

Oh, and the day after was National Lasagna Day.

(Photo source: Library of Congress)

July 24th, 2016

Really Rapid Review — AIDS 2016, Durban

aids2016 logo vertThe International AIDS Conference returned this year to Durban, South Africa, where it was famously first held in 2000. At that time the HIV epidemic was exploding in South Africa; funding for HIV treatment was essentially non-existent, and there was ongoing HIV denialism quite openly from some very influential figures in the South African government (including the President). Globally, fewer than 1 million people were receiving antiretroviral therapy, hardly any of them in Africa.

Encouragingly, according to this UNAIDS report, the number being treated today is 17 million — with, incidentally, the largest number in South Africa. Yes, this 17 million is only half the number who need treatment, but this is still extraordinary progress. HIV-related deaths started steadily declining in 2005, a trend one can hope will continue.

OK, on to a Really Rapid Review™ of the conference. It’s organized by prevention, treatment, complications, and whatever else happened to have caught my eye; I welcome suggestions for what I’ve missed (undoubtedly something important) in the comments section.

A few non-scientific words about being back in Durban after 16 years:

  1. Underrated beachfront. There’s plenty of activity during the day, with the surfers out between 6-7AM and the walkers, joggers, bikers, skateboarders, rollerbladers, and general observers appearing just a bit later to experience the beautiful sunrise. All day long a walk on the beachfront promenade was an ideal way to clear the brain of “conference head.”
  2. Great, affordable food. Not surprisingly, there is a pervasive Indian influence, as Durban has one of the largest Indian populations in the world outside of India. (If you get a bunny chow, be reassured it has nothing to do with rabbits.) And don’t skip the Pinotage and Chenin Blanc (I didn’t). Unfortunately, unlike my experience 2 years ago in Melbourne, the coffee is terrible.
  3. Pride. Every person I met from Durban was both extremely kind and extraordinarily proud of their city; all knew the history of the city well, and were eager to talk about it. I sensed a bit of both envy and disapproval of both Cape Town and Johannesburg.
  4. Uber rules. Cheap, reliable, and every bit (if not more) the “disruptive innovation” it is in the USA.
  5. Safety. It did seem as if the local advice about security was even stronger than the first time I visited. It was obvious stuff: don’t walk alone to the conference center, don’t carry your computer, don’t take out your cell phone on the street, and (repeatedly) never walk alone at night. Some of this, no doubt, is that the first time we were here it was pre-9/11. It’s a different world.

An ancillary benefit about going to this conference — the noise from a certain political convention was only a faint peep, or a footnote on a distant TV that happened to be turned to CNN!

July 14th, 2016

Must-Read Item: This Year’s JAMA HIV/AIDS Issue

s_jama_276_2_coverlargeThe folks over at the Journal of the American Medical Association have been doing a periodic HIV/AIDS themed issue for years, generally around the time of the International AIDS Conference.

The latest issue is out this week, and it’s terrific. Here are some highlights:

Hey, remember when JAMA had art on the cover? (And yes, I miss that.) The 1996 cover to the HIV/AIDS issue was famously blank (see image above), the absence of artwork making a strong statement about “the toll the virus has taken among artists and other creative persons who have died prematurely because of AIDS.”

Now, 20 years later, the current HIV/AIDS JAMA issue includes content that would have been unfathomable at that time. Little did we know that 1996 would be the pivotal year, the turning point when this rapidly fatal disease — then the leading cause of death among young Americans — would become both treatable and preventable.

Amazing progress.

Even “augmented reality” can’t compete.

(I predict 2-3 months for this Pokemon Go craze, but what do I know.)

July 3rd, 2016

Velpatasvir/Sofosbuvir Makes HCV Treatment Simpler, Especially For Genotypes 2 and 3

One of the ways ID and hepatology hepatitis C experts like to show off is by discoursing on the nuances of cleverly named clinical trials, and how these impact treatment guidelines.

It usually goes something like this:

“In the EP-CILEON [I made that up] study of [insert HCV regimen here], treatment-experienced patients with genotype [insert non-genotype 1 patients here, usually genotype 3], compensated cirrhosis, and baseline viral loads greater than [some large number], the SVR [why can’t they say “cure”?] to the 12-week regimen was only [insert some number here that we could have only dreamed about in the interferon era, but well shy of the 95% mark we expect today — let’s say “82%”]. That’s why these patients need to be treated for [a longer duration than 12 weeks, a number also divisible by 4] weeks, with the addition of weight-based ribavirin [as opposed to fixed-dose ribavirin? when would we do that?].”

Fortunately, these obscure study results are then quickly incorporated into the excellent HCV guidelines, so we mortals can just look them up.

With the FDA approval last week of velpatasvir/sofosbuvir (VEL/SOF, “Epclusa”), however, bragging rights to these arcane details might now be irrelevant, kind of like knowing how to text with a flip-phone.

The new option makes things pretty simple, really. For patients with HCV genotypes 1-6 (that’s all of them, if you’re keeping track), here’s what to do:

  • Almost everybody:  One pill of VEL/SOF a day for 12 weeks.
  • Those with decompensated cirrhosis (Child-Pugh B or C):  Same thing, but add weight-based ribavirin.

Or if you prefer, from the package insert:


In several clinical trials (published right here in the hallowed pages of the NEJM), VEL/SOF cured 95-99% of those treated, including patients with tricky genotype 3. Side effects were infrequent, and, as we’ve come to expect with modern HCV therapies, discontinuations due to adverse events wonderfully rare (0.2%).

Of course you’re thinking — Sounds good, but what does this new treatment cost? Because that, after all, has been the major challenge in HCV therapy the past two years:  Access.

The simple answer is that the price is around $75,000 for a 12 week course.

And that is potentially good news, as demonstrated by the following (approximate) list “prices” for various treatment courses, the most relevant comparisons for the VEL/SOF option bolded:

  • Ledipasvir/sofosbuvir for 12 weeks, genotype 1:  $94,000 (8 weeks for HCV RNA < 6 million, no cirrhosis, treatment naive, is 2/3 that cost)
  • Paritaprevir/ritonavir/ombitasvir plus dasabuvir, genotype 1:  $83,000
  • Grazoprevir/elbasvir for 12 weeks, genotype 1:  $55,000
  • Sofosbuvir plus ribavirin for 12 weeks, genotype 2:  $88,000
  • Sofosbuvir plus daclatasvir for 12 weeks, genotype 3:  $147,000

I wrote “potentially” good news, since these numbers are before negotiated prices. The negotiated price is the deal made between the pharmaceutical companies and the payers, behind closed doors and opaque to patients and providers, but quite relevant when we want to prescribe something.

Hardly any insurance plan or pharmacy benefit manager pays these full prices — it’s sort of like the sticker price on the car in the showroom, a starting point for discussion. However, it differs from buying a car in that there’s no easy internet research to find out what the plans actually pay. We prescribers and patients get a relative idea when the prescription either sails through or gets blocked in favor of something else.

But a quick glance at the clinical trials data and the sticker prices shows that VEL/SOF could easily become the recommended treatment for genotype 2 (good riddance, ribavirin!) and genotype 3. For the latter, this is not only based on price; sofosbuvir plus daclatasvir needs to be given for 24 weeks, with ribavirin, in all genotype 3 patients with cirrhosis. So VEL/SOF really is an advance — this is a simple, safe, and effective 12-week treatment for all genotypes that will rarely need ribavirin, except when there is decompensated cirrhosis (Child-Pugh 2 or 3).

And for those who are not very hepatically inclined, and wondering what the heck Child-Pugh is, it is a commonly used scoring system to assess the prognosis of patients with cirrhosis.

Take it from Charlie, our beloved clinic nurse, who had this email exchange recently with a pharmacy over getting HCV treatment approved for one of our patients:

child-pugh ha ha2

Such a great line, had to share.

Hey, since I started this post with a parody of sorts, here’s one on TED talks making the rounds that could not be more spot-on.

June 25th, 2016

ID Cartoon Caption Contest Closed — Time to Vote

The response to our First Ever ID Cartoon Caption Contest was gratifyingly brisk, with hundreds of entries.

Not going to lie about this — we were somewhat concerned the response would be silence … you know, as in <<crickets>> … but you readers proved very much up to the task, with numerous funny suggestions.

Our sophisticated computer algorithm has gone through the submissions, and noted several themes, specifically:

  • Pig-Pen.
  • Colistin, KPCs, and other references to resistant bacteria.
  • Fecal transplants.
  • How hard (and messy) it is to be an intern, resident, or fellow, compared to the clean faculty members standing next to him.
  • The ironic (and therefore funny!) contrast between the coat (dirty) and his hands (presumably washed) or tie (tucked in).
  • References to historic names in ID/microbiology (Lister, Petri, Semmelweis).
  • The Hygiene Hypothesis.
  • How being an ID (or GI, or Emergency Medicine) doctor, or Pediatrician, can be a squalid business.
  • Puns/word plays on medical terminology. Many funny, all groan-worthy.

Of course, some responses were just baffling, with even our sophisticated supercomputer unable to decipher the humor — or frankly the meaning — of the submission.

The good news is that after hours of number-crunching, we’ve come up with 3 possible winners.

First, as a refresher, the picture:


Now, no doubt inspired by this wacky Presidential campaign and Brexit, you get to vote.

Which is the funniest cartoon caption?

View Results

Loading ... Loading …

June 19th, 2016

ID Cartoon Caption Contest

The New Yorker magazine is justifiably famous for its fine writing, with its contributors a veritable Who’s Who of famous authors and journalists of the past century. Truman Capote, Ann Beattie, J.D. Salinger, John Cheever, John Updike, Dorothy Parker, E.B. White, Philip Roth, Alice Munro, John Hersey, Malcolm Gladwell, Roger Angell, James Thurber … you get the idea.

But for many (OK, I admit it, often for me), it’s mostly just a print vessel for the cartoons. These offer some of the most brilliant commentaries on the world you will find anywhere — witty, profound, whimsical, silly — and my web browser has this link bookmarked in case I’m feeling glum.

The magazine also has a Cartoon Caption Contest, in which readers contribute captions for a drawing that changes weekly. I’ve entered the contest dozens of times, and have won the same number of times as I’ve won Wimbledon.

Oh well. You might think this brilliant entry could have done the trick:

"I need the miles."

                                   “I need the miles.”

I share this low success rate with my sister Anne, who in my unbiased opinion should have won with this one:

"You were right -- I'm STILL not free."

                             “You were right — I’m STILL not free.”

Admittedly motivated by our failure, we hereby offer our own ID Cartoon Caption Contest. The drawing is Anne’s (I’ve featured her art before), and it was inspired by a certain white coat controversy.

Submit your caption either in the comments section, to my Twitter feed, or if you want to keep it secret, email me at

We’ll judge them on funniness using only the most highly objective and scientific criteria. In addition to widespread fame, the winner will receive a free lifelong subscription to this blog.

Here’s the drawing — have at it:


June 12th, 2016

Progress in Lyme Disease Badly Needed — Could a “Hackathon” Help?

Someone recently asked what keeps me, a specialist in Infectious Diseases, up at night.

With the admission that I do all my clinical work here in the USA — a person working in the tropics would undoubtedly have a different list — several challenging patient care and public health issues came to mind. Multidrug-resistant bacteria. Endovascular infections in patients with opiate addiction. Surgical infections with poor “source control”, especially in the abdomen. Non-tuberculous mycobacteria. Recurrent C diff and MRSA. Patients who, despite having access to lifesaving HIV therapy, don’t take their meds. An aggressive, transmissible flu strain arising from our close contact with birds or pigs. Aedes albopictus starts transmitting dengue, chikungunya, and Zika. Drug prior approvals that defy medical common sense. Electronic medical records that force docs to become overeducated clerks.

And, of course, Lyme Disease.

I’m far from alone about this concern, by the way. In an effort to make some progress against this challenging infection, a “healthcare hackathon” on Lyme will be held in Cambridge June 17-20, led by the Dean Center for Tick Borne Illness. And if you’re wondering what a healthcare hackathon is, one of the Dean Center’s doctors kindly shared this review — it’s essentially it’s a way of bringing together experts from multiple fields to work together and tackle a problem.

This approach makes abundant sense, as solutions to complex problems rarely come from a single discipline.

And boy, is Lyme the very definition of a complex problem, a keep-you-up-at-night topic — allow me to list why:

  • Lyme has become way more common. When I became an Screen Shot 2016-06-12 at 2.22.57 PMID specialist in the early 1990s, most of the people we saw with with Lyme lived on or near the coast, or had visited Cape Cod, Nantucket, or Martha’s Vineyard; now we see Lyme acquired throughout New England, and even in urban areas. It is spreading from the Northeast and Midwest into the South, and it no longer disappears completely in the winter — all it takes is a prolonged warm spell, and a few cases pop up. Here are the numbers per CDC — there are 300,000 cases/year in the USA, a substantial increase over the last 3 decades, and no doubt an underestimate since many cases are not reported.
  • Severe Lyme Disease is a bad problem. Yes, most cases of Screen Shot 2016-06-12 at 2.24.51 PMerythema migrans respond promptly to therapy; there are even people with positive tests who have never been treated and feel totally fine. That’s the good news, the mild end of the spectrum. But rarely, especially (in my anecdotal opinion) for those who get sick and delay diagnosis and treatment, Lyme can be very serious — high fevers, cardiac disease, hepatitis, arthritis, encephalitis, meningitis, neuropathies, radiculitis, myelitis. And these severe cases are those most likely to have residual symptoms after treatment.
  • There is no proven optimal treatment for patients with ongoing symptoms after Lyme. Some people think it’s best to try more antibiotics, targeting residual active bacteria. Others (read: most ID doctors) think that’s not a good idea, for four main reasons: 1) The scientific data on residual living spirochetes after treatment are far from definitive; 2) Several controlled clinical trials — most recently this one — show no benefit long-term antibiotic therapy; 3) Post-infectious symptoms may occur after many severe infections (bad influenza, sepsis, endocarditis, pneumonia, toxic shock syndrome), and we don’t give long term antimicrobial therapy for these conditions; 4) Antibiotics can be harmful — a colleague of mine notably had a patient who required a colectomy after developing C diff on a prolonged course of ceftriaxone prescribed by a Lyme specialist. Still — if we’re not giving antibiotics, what are we offering? To quote this excellent editorial that accompanied the above cited clinical trial — “Though prolonged antibiotic therapy is not the answer, we do not know what is truly helpful.” (Emphasis mine.) No wonder our patients are unhappy!
  • Testing for Lyme is confusing, sometimes inaccurate, and slow. Think how accurate HIV testing has become — sensitivity and specificity are way north of 99%, false-positives and false negatives extremely rare, and generally quite easy to sort out with supplemental tests. HIV test results are back quickly, either right away with a point-of-care test, or at most a few days. Lyme testing is the opposite — early in disease, antibody testing lacks sensitivity; later on, the two-step procedure of screening ELISA followed by Western blot is fraught with false positives (especially IgM immunoblots) and, according to some, false negatives. Delays in receiving definitive results are common, and labs do not all have the same criteria for positivity. Molecular testing with PCR is of limited accuracy (even in acute disease), and follow-up Lyme antibody tests after treatment don’t provide proof of cure. The problems with standard Lyme testing have spawned a variety of “home brew” alternatives — here’s a terrific brief review — and note that none of them is FDA-approved, many require that desperate patients pay out of pocket, and all add to the confusion about who does and who does not have the disease. Thank you very much. (That was sarcasm.)
  • Instead of cooperation, there is pervasive rancor in much of the discourse on Lyme. For whatever reason, the difficulty in prevention, diagnosis, and treatment of Lyme has created conflicts between patients, providers, and public health officials — a conflict far different from other challenging diseases. For example, the documentary Under Our Skin repeatedly attacks the medical community for ignoring the disease, and promotes numerous unproven diagnostic tests and treatments. There are several unfortunate results of this conflict, but one of the most discouraging from my perspective is the very speciality that should be front-and-center in trying to solve the problem — Infectious Disease — is repeatedly attacked; under that attack, ID doctors sometimes dig in their their heels on these controversial issues, or ignore them entirely, and the discourse stops. One can read opposing views on this from activists and IDSA here and here, respectively.

This last item (the controversy) is the reason why, for the last several weeks, a green flyer promoting the Lyme Hackathon has been posted in our clinic, and I’ve kept a copy on my desk. Notably absent from the pre-meeting materials are attacks on either side of the debate — a refreshing change from the usual harrangues.

I wish them the best of luck — we are all hoping for some progress!

May 30th, 2016

The Sanford Guide — 46 Editions Later, Still Going Strong

sanford guideI recently had a chance to visit Portland, Oregon, which for many will conjure up images of bicycles, hipsters, Mount Hood, roses, organic everything, and craft beers.

It’s also the lifelong home of Dr. David Gilbert, the lead editor of The Sanford Guide to Antimicrobial Therapy, an invaluable resource well-known to almost every clinician. Dave was kind enough to act as my host one afternoon last week, and he shared with me some interesting facts about this remarkable handbook; I’ll add some of my personal experiences with the guide as well:

  • Dr. Jay Sanford provided the inspiration for the guide with a Medical Grand Rounds on newer antibiotics. The demand for the typed handout accompanying the talk was so strong that Drs. Sanford and Gilbert (who authored some of the original tables) realized they might be able to distribute it more widely. Oh, and this was in 1969 — the year of the Apollo 11 moon landing, Nixon’s first term, Woodstock, and the Miracle Mets, just to orient you to the time.
  • There was never really a publisher of the guide, at least not in the traditional sense. The very definition of a home-grown enterprise:  Sanford happened upon a small family-owned print house in New Jersey; they agreed to take on the project at a good price, and printed the guide for 10 years until the job became too large. It’s now printed by a large national printing company, and the publisher is “Antimicrobial, Inc” — essentially the Sanford family. Not aware of any other medical text with this arrangement.
  • From 1989 through 2015, 24 million print versions of the Sanford Guide were sold. Sales peaked at 1.6 million copies/year. As with essentially every published work, print sales have declined due increasing use of the electronic version.
  • The biggest challenge for the Sanford Guide was creating an electronic version. The complete process took 5 years, with the first electronic version released in 2010; the guide is now the top selling medical app in the Apple App Store. Says Gilbert: “The electronic version is frankly better in many ways… it’s much easier to express recommendations in the digital format.” Progress.
  • The guide is strictly independent from industry. Before regulations on pharmaceutical gifts to physicians, we ID doctors (and I imagine others) would frequently receive a Sanford Guide gratis from various companies — often in a protective plastic cover, emblazoned with that company’s logo (only to be quickly covered with strategically placed masking or duct tape). Source of these guides notwithstanding, the content is solely created by the editors, using established guidelines and best judgment. Per Gilbert, industry might contact the editors regarding decisions on individual products, generating “spirited discussions” — but that’s it.
  • The guide is published in 12 languages. Chinese, Japanese, Polish, Italian, Spanish, Portuguese, Russian, Georgian, Croatian, Turkish, Korean, and Vietnamese. (In case you were wondering.)
  • I got my first Sanford Guide right before doing my “core” clerkship in medicine. A friend of mine, already an intern, offered this sage advice to me, a very nervous med student: “Get a copy of the Washington Manual and that little antibiotic book with Chinese letters on the front — that’s all you’ll need.”
  • The Chinese characters on the front mean “hot disease.” Sanford was a consultant to the US Army, including the Medical Corp in Korea. That’s where he first saw these Mandarin Chinese characters, and confirmed with Korean physicians that this was a way of expressing “fever”.
  • Screen Shot 2016-05-30 at 9.38.57 AMThe Guide is the first of the “Handy ID Resources” I list in a talk on curbside consults. In a lecture entitled “Can I Ask You a Quick Question?” (all ID doctors will recognize that phrase), I show the slide on the right. Allows me to make a joke about the challenges of presbyopia — aren’t we doctors funny? — and to mention that the Sanford Guide comes in large print versions since the original text size became unreadable for many of us years ago.
  • A friend and co-resident belittled my specialty choice of ID by citing the Sanford Guide. “How could you choose a field,” the future cardiologist asked, “where everything you need to know is in a little book small enough to fit in your pocket?” Wish I had a clever response at the time — something like, “How could you go into a field that is just an electronic pump and some tubes?” But when you think about it, there is a ton of information in each little Sanford Guide; any person who knows all its content is pretty smart indeed. (For the record, that co-resident has done quite well for himself, thank you — and I doubt he reads this blog.)
  • Some ID doctors only pull out their Sanford Guide when no one is looking. I’ve had more than one ID attending — usually in his or her first year on the faculty — say they were too embarrassed to admit needing to look stuff up. The implication is that everyone should be able to remember the dose of IV ciprofloxacin with an estimated GFR of 30, or whether meropenem covers Stenotrophomonas. (It doesn’t.) But think about it — would you want your airline pilot to just try and remember the route from Chicago to Istanbul, or prefer that they consult a guide of some sort? If you need Sanford — or the Hopkins Guide, or UpToDate — no need to worry. I promise you will not be reported as deficient to IDSA, or have your board certification rescinded.
  • The guide has given me numerous “teachable moments” when answering ID questions. For many years, a colleague and I answered the ID questions of a large multi-site group practice in the Boston area. Not surprisingly, the answer to many of these queries was clearly listed in the Sanford Guide. When confronted with a question on endocarditis prophylaxis, or when to give rabies shots, or whether antibiotic X covered bacteria Y, or whatever, I’d sometimes start this dialogue:
    Me:  Do you have one of those little antibiotic books, a Sanford Guide?
    Curbsider:  Yes.
    Me:  Now go to the index, and look up, “rabies”… you’ll find a table that tells you exactly what to do.
    Curbsider:  Hey, so it does! What a cool little book.

One last thing — please note that it’s the “Sanford Guide,” not the “Stanford Guide”, as newbies to medicine will sometimes wrongly say.

Those of us at the “Stanford of the East” are sensitive about this kind of mistake.

May 22nd, 2016

Drug Prior Authorizations Are a Very Blunt Tool for Cost Containment — And They’re Annoying

2001-apeInsurance prior authorizations, or prior approvals (PAs) — those dreaded forms clinicians have to fill out, usually triggered by prescribing a non-formulary drug — are much on my mind these days. And most of it has to do with three letters, specifically “TAF.”

As readers of this site probably know, there are now three tenofovir alafenamide (TAF)-based coformulations approved for HIV treatment, all theoretically available for prescription alongside the older tenofovir disoproxil fumarate (TDF)-forms. In comparative clinical trials, TAF has consistently had a more favorable effect on bone and renal health than TDF — a benefit of considerable importance to older patients with HIV.

Why do I bring up these older patients? If you’ve been doing HIV clinical care for a while, your patient population is probably a lot like mine:

  • Of a certain vintage — note I didn’t say “old”, though this apt definition isn’t far off the mark. In one of my patient sessions last week, the average age was 57 (range 45 – 71); for the record, the oldest patient with HIV seen in our practice last week was 88.
  • On HIV treatment for a long time — often more than a decade.
  • Virologically suppressed — they are great at taking their antivirals.

These characteristics mean that AIDS-related complications are very unlikely to happen. If I found out that one of my stable HIV patients were hospitalized after being struck by a meteorite or falling satellite, this would surprise me only a little more than if one were admitted with Pneumocystis pneumonia. If we consider the health concerns of these individuals, non-AIDS diseases are far more likely to occur than those related to HIV.

And while we clinicians can’t control the random showering of space debris, we can try to minimize drug toxicity — which brings me back to the TAF-based HIV treatments, and whether we should be using them, and in whom.

I’d argue that these older HIV patients are ideal candidates for TAF (as opposed to TDF) -based drugs, and I’ve found myself wanting to switch them from TDF to TAF multiple times each week. Aging intrinsically leads to declines in renal function and bone density, and increases the likelihood that there will be comorbid conditions further impacting the kidneys and bones (hypertension, diabetes, menopause for women). Furthermore, a patient’s lengthy HIV treatment often means that they have been on TDF for a long time — probably the most important risk factor for clinically important TDF-induced toxicity.

This clinical reasoning, however, is currently lost on most of the payers, who have set up their favorite tool — the “PA” (cue scary music here) — to discourage use of these new drugs.

As far as I can tell, it’s not that they have critically reviewed the data comparing TAF with TDF, and concluded that they disagree, or find it scientifically inaccurate. It’s simply that the TAF treatments are new, and new means you have to jump through hoops to get it.

Or, even worse, you can’t get it at all. Here’s an email I received from a pharmacist trying to help me on one of these cases, this for a 70-year-old man with osteopenia currently on TDF/FTC in whom I thought TAF/FTC would be a safer choice:

The medication is not covered and is excluded from coverage because it is a new drug to market. [Insert payer or pharmacy management company here] said that a review for coverage is not possible and that an appeal would be denied outright.  They also said that a letter of medical necessity would not help to obtain coverage, either.
Thank you! Have a nice day!

Glad he can be so cheerful!

Look, I get it — drug costs are high, and PAs theoretically are a way of avoiding inappropriate use of new, more costly agents when older drugs would do the job just as well.

And though all three of the TAF formulations are cost-neutral to the older TDF treatments based on Average Wholesale Price, one has to assume there have been negotiations on price between the payers and manufacturers with TDF, deals that haven’t yet been made with TAF. (Or made public to us or our patients — “transparent” is never the word used to describe these deals.)

In addition, payers may well be looking forward to generic TDF, which is scheduled to become available next year and presumably would cost even less. It presumably will be easier to switch patients to generic TDF from branded TDF than from TAF, as a TAF to TDF switch could be viewed as switching to a potentially more toxic drug. Who would do that?

But are these mandatory PAs really the right way to decide whether a treatment is indicated — based solely on whether it’s new, and whether the clinician and his/her team have the endurance to fill them all out? Colleagues of mine delve deeper into the TAF vs TDF cost issues here, a welcome review of the relative values of these two drugs.

Meanwhile, over on an insurance company’s web page, they list the reasons behind PAs as follows:

Screen Shot 2016-05-22 at 2.10.05 PM

As far as I can tell, bullet #5 is by far the most common reason for a PA — especially if the drug is new.

HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Contributing Editor

NEJM Journal Watch
Infectious Diseases

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