HIV and ID Observations

An ongoing dialogue on HIV/AIDS, infectious diseases,
all matters medical, and some not so medical.

How to Make the Flu Vaccine More Popular, Warts and All

In a week that saw both our hospital’s influenza-induced bed crunch make the New York Times, and my son, mother-in-law, and me succumb to this seasonal plague despite our receiving flu shots, I have been highly attuned to all things influenza.

But the focus here will be on that perennial whipping boy of preventive Infectious Diseases, the flu vaccine. Let me get it out of the way that I unequivocally believe that it’s our best way of preventing flu, and that I would never skip it. Nonetheless, it’s far from perfect, which is why in the court of public opinion, it just can’t win.

Why do most universal flu vaccine campaigns seemed doomed from the outset? Let me list the ways, some of them the fault of the vaccine, some just human nature:

It has to be repeated yearly. Like magazine subscriptions renewals, membership dues, car inspections, and taxes, the flu vaccine comes round every year and induces the same feelings of nauseating weariness. Again? You mean I need that shot already? Didn’t I just do it? And will it even work this year? All right, go ahead. Medically savvy patients note that we’re not making them repeat any of the other shots yearly, which must imply to them a serious weakness in our vaccine.
It doesn’t always work. Estimates of flu vaccine effectiveness vary widely, so I like to cite the 70% figure from this study rather than the more discouraging CDC’s aggregate data of 60%. And then I add some motivating language such as, “but it works better in some people than others, so let’s be on the optimistic side.” Plus I mention that all doctors and nurses get the vaccine, which though a bit of a lie, is at least true about ID docs/nurses.
Many people think it works even less well than it does. Flu season just happens to coincide with the seasonal increase in all kinds of other respiratory tract infections, and it’s inevitable that patients with bad colds will blame that on the failure of the flu vaccine. Plus, approximately 32.56% of the population use the term “stomach flu” to describe various short-term gastrointestinal ailments, and regardless of what that term actually means, it’s 100% certain that the flu vaccine does nothing to prevent them. More failure! Even the above-mentioned Times article compounds this confusion by starting the piece on influenza, yet including several paragraphs on norovirus — just because, um, it’s sort of related, I guess. (It’s not.)
“It gives me the flu.” I find it truly mystifying why so many people believe that the flu vaccine gives them the flu, but regardless, it’s either the top reason cited by vaccine refuseniks or a close second to, “I never get the flu, so I don’t need it.” My hunch is that people believe the flu vaccine gives them the flu because 1) colds are common and 2) they once got a bad cold (the “flu”) shortly after getting the vaccine. QED.
It has to be matched each year with the predicted circulating influenza viruses. Sometimes the match is a good one (this year it is), sometimes less so. Unfortunately, in the absence of an all-knowing, popular Nate Silver-like projection guru — someone who updates his/her predictions on a regular basis for the public to see, and does it in plain language — the process of matching the vaccine to the circulating viruses is not for the faint of heart. (I dare you to read this all the way through.) This stuff is rough going even for most doctors, hence it’s no wonder that the public is skeptical on an annual basis. For the record, this is what’s in this year’s vaccine (in case you want to make one at home): an A/California/7/2009 (H1N1)pdm09-like virus, an A/Victoria/361/2011 (H3N2)-like virus, and a B/Wisconsin/1/2010-like virus (from the B/Yamagata lineage of viruses). Piece of cake.
Weird stuff happens. Just like no vaccine is 100% effective, none is 100% safe either. The sheer volume of flu vaccines given every single year means that bad stuff is numerically more likely to happen with the flu vaccine than with others, at least in adults. Some of these linked events will be little more than anecdotes — do you really think your golf game was worse this week is because you just got a flu shot? — but some will be real, e.g. the 1976 swine flu vaccine and Guillain-Barré syndrome. These associations are hard to shake, and not a year passes where I’m not asked about the flu vaccine and Guillain-Barré, along with much more tenuous (really nonexistent) links such as flares of multiple sclerosis, transplant rejection, arthritis, and inflammatory bowel disease.

Given the above challenges, what can we do about it?

Seems what we need is a truly trustworthy spokesperson for the flu vaccine, someone who will take on what Magic Johnson did for HIV. He or she will calmly recommend the vaccine, reassure people about its safety, acknowledge fears and misconceptions — perhaps even mention that even if the vaccine doesn’t work, it probably makes the breakthrough case of flu milder — how many people know that?

So with the help of this nice list of the most Trustworthy Celebrities, plus some of my regional/personal biases, I ask you to help choose our Flu Vaccine Celebrity Spokesperson. I am 100% sure that after hearing of their nomination, they will quickly drop whatever project they are doing and volunteer their time for this important public health effort.

Categories: Health Care, Infectious Diseases, Patient Care, Policy
Tags: flu, flu shot, influenza, influenza vaccine

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January 9th, 2013

HIV Exceptionalism is Alive and Well — and That’s Too Bad

Email exchange with a colleague who works at one of our community health clinics:

Guy: Hi Paul, your patient 17432862 [that’s a made-up medical record number] came to our walk-in clinic with a rash on her hand. OK that I gave her a week of topical steroids? I know how inhaled steroids interact with some meds — wasn’t sure about the creams.

Me: Could be, good thought. Regardless, a short course should be fine. Tell me, who is the patient? What meds is she on?

Guy: I didn’t want to put her name or meds in the email, what with her disease state, HIPAA, etc.

At which point I entered the medical record number into our electronic medical record, figured out who the patient was, and let out a big sigh.

Hey, any sensible clinician understands the importance of patient confidentiality, but at some point these mysterious messages get kind of ridiculous. (I should emphasize that we have a secure internal email system.)

Furthermore, there are several reasons why the above brief email communication is a prime example of how HIV is still treated differently from the rest of the diseases — infectious or otherwise:

It’s a patient well known to me, yet there’s no identifying information except for the medical record number. Not a first name, not even initials! Hey, we both know her, right? This will not be a disclosure of her diagnosis!
The clinician correctly identifies a possible drug-drug interaction with HIV meds, but doesn’t actually mention any of the antiretrovirals. Too incriminating?
When I ask for the patient’s name, he cites as the reason for not including it her “disease state” — wonder if that state votes red or blue? — with no mention of HIV.
There’s a reference to “HIPAA, etc.”, as if HIPAA was created way back specifically for HIV. Wrong.

If we imagine that my patient had diabetes, or hypertension, or even HCV, then none of this covert communication would have occurred, I guarantee it. The implied message in all of this clandestine language, even though we both know the patient, is that there is something shameful about her being HIV positive, something that even health professionals need to communicate about in hush-hush terms.

Could this and related behaviors perpetuate the stigma associated with HIV? You bet.

Because privacy is one thing. But this is different, and kind of sad.

Categories: Health Care, HIV, Patient Care
Tags: HIPAA, HIV

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January 3rd, 2013

What’s a Fulyzaq? I Thought You’d Never Ask

As Physician’s First Watch noted, we sure know what the folks at the FDA were doing this holiday season — and most emphatically they weren’t visiting Aunt Selma in Boca Raton.

Nope, they were stuck in White Oak, Maryland, reviewing various new drug applications, with three of the four related to Infectious Disease. The FDA’s late 2012 actions:

Approved use of oseltamivir (Tamiflu) in children as young as 2 weeks old.
Approved the oral anticoagulant apixaban (Eliquis) to reduce risk of stroke for patients with atrial fibrillation not caused by valvular disease. (That’s the non-ID one — unless atrial fibrillation is caused by XMRV.)
Approved bedaquiline (Sirturo) as part of combination therapy to treat multi-drug resistant tuberculosis. (This is is the first new TB drug approval in at least a thousand years. I’m exaggerating slightly.)
Approved crofelemer (Fulyzaq) for diarrhea due to antiretroviral therapy.

For crofelemer, according to the FDA announcement, approval was based on the results of a phase III, double blind study comparing 125 mg of crofelemer twice daily to placebo in HIV patients with non-infectious diarrhea:

The trial was designed to measure clinical response, defined as the number of patients who had two or fewer watery bowel movements weekly. Results showed that 17.6 percent of patients taking crofelemer experienced clinical response compared with 8 percent taking placebo.

Further information on the drug — including its mechanism of action and nifty source, “the Croton lechleri plant, native to northwestern South America” — can be found on the company’s website.

I confess this approval took me by surprise. I was aware that crofelemer was in clinical trials, but hadn’t heard a peep about it at scientific meetings or other venues. Obviously some of this low profile is due to the fact that it’s not an antiretroviral agent, but compared with the attention given to tesamorelin, this is certainly a stealth approval.

Notably, current HIV medications are far less likely to cause diarrhea than the first generation of meds. The big offenders — ddI, full-dose ritonavir, nelfinavir, amprenavir, soft-gel saquinavir, even lopinavir/r — are today used either infrequently in the United States or not at all. (Several are not even available.) I assume that clinicians who have patients with ongoing diarrhea on any of these agents would switch antivirals first rather than starting a new medication for the side effect.

So who are the appropriate candidates for this drug? Even after switching off older HIV meds, some patients will continue to have diarrhea, either still due to the medications — most notably the PI’s with ritonavir — or from “HIV enteropathy”, which is damage the virus has done to the GI tract which in some people reverses very slowly, or not at all. For them, this approval gives them a welcome new option.

Plus, we get a sparkling new brand name to learn, and to make jokes about. This one’s a doozy — Fulyzaq!

So who came up with that? See above for an artistic rendition of a Fulyzaq in the wild.

Categories: Health Care, HIV, Patient Care
Tags: crofelemer, Fulyzaq, HIV

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January 1st, 2013

HIV Incidence: The Latest Numbers

The CDC has recently issued the latest report on HIV incidence (i.e., new infections) in the United States, and as always it’s fascinating to review the numbers.

To start, the year-by-year estimated incidence:

2007: 53,200
2008: 47,500
2009: 45,000
2010: 47,500 (38,000 men, 9,500 women)

Nope, not much change. Will data from HPTN 052 — published in the summer of 2011 — eventually have an impact? I think so, as the results strongly influenced both treatment guidelines and patients’ willingness to start therapy. A more pessimistic view is that the treatment-as-prevention message from 052 won’t have much of an effect, since data like these show that only a minority of people with HIV are actually on successful treatment. We’ll see.

This latest CDC report then highlights two important trends, one good news, one not-so-good:

The new analysis also finds two noteworthy trends among heavily affected populations: early signs of an encouraging decrease in new HIV infections among black women (21 percent decrease between 2008 and 2010), and a troubling and continuing increase in new infections among young gay and bisexual men (22 percent increase over the same time period).

In these days of fiscal cliff wrangling, I could use my taxpayer’s prerogative and show you a whole slew of figures — but these three really stand out as giving us a snapshot of who gets HIV in the United States these days:

1. Incidence in 2010 among various “risk groups” (MSM, men who have sex with men; IDUs, injection drug users):

2. Proportion of new infections by transmission category:

3. Rate of new infections by race, ethnicity, and sex:

The glass-half-full message is that HIV prevention efforts are clearly working, at least to some extent, as the prevalence of HIV — the number living with the virus — continues to increase, yet the incidence stays the same.

The half-empty view? The continued shift of the epidemic to younger MSM of color will make additional gains difficult, as this is a patient population that could be challenging to reach.

Categories: HIV, Infectious Diseases, Policy, Research
Tags: CDC, HIV

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December 22nd, 2012

Chaos in the Diagnosis of C diff, and Dogs are Amazing Creatures

If you’re confused about the best way to diagnose C diff these days, welcome to the club. There are all kinds of tests out there, and no uniform approach between labs. Our lab actually does three tests — and will do a fourth (the classic cytotoxicity assay) if you request it.

The result? Chaos, confusion, and lots of queries.

For an example, here’s an email from a colleague:

Hey Paul — my patient had diarrhea after antibiotics, so I sent a C diff. Not sure what to tell her about the result, which I’ve pasted below. (She’s better now by the way with no treatment.)
Audrey

Specimen Type: STOOL
C. DIFFICILE ANTIGEN/TOXIN ASSAY – Final
ANTIGEN:POSITIVE; TOXIN:NEGATIVE
RESULTS PENDING PCR ANALYSIS.
TOXIGENIC CLOSTRIDIUM DIFFICILE QUALITATIVE BY PCR — NEGATIVE

My response:

Audrey — the lab does two rapid tests initially — antigen and toxin assay. She had a positive antigen (indicating the presence of the organism) but a negative toxin (not all C diff produces toxin). So the PCR was done as a more sensitive and specific test for toxin, and this was negative. Strongly suggests she does not have active C diff. No treatment required. Paul

Yes, this is tricky. Some labs go right to PCR as the first step, but this is more expensive — but it sure would eliminate the confusion.

Or we could just start using dogs. As demonstrated in this paper, and summarized in Journal Watch ID by Stephen Baum, a trained dog does a terrific job of diagnosing people with C diff, even without a specimen:

A 2-year-old male beagle was trained to identify the odor of toxin-producing C. diff and to sit or lie down on detection of this scent. In preliminary testing involving 50 positive and 50 negative stools, the dog’s sensitivity and specificity were 100% …[In further testing done in the hospital], the dog correctly identified 25 of the 30 case-patients (sensitivity, 83%) and 265 of the 270 controls (specificity 98%).

The most amazing thing about this study is not only the performance of the poop-sniffing dog, but the fact that he most likely enjoyed doing it. He’s a dog, after all.

Don’t believe me? Just Watch these two video clips. First, one from the BMJ paper (let’s hope that the beagle took his HIPAA training class seriously):

And second, this Cat vs. Dog short, which clearly demonstrates (around 1 minute in) why a dog is eager to help us diagnose C diff:

Categories: Health Care, Infectious Diseases, Medical Education, Misc, Patient Care

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December 20th, 2012

Severe Telaprevir Rashes and Waiting (or Not Waiting) to Treat Hepatitis C

Yesterday, the FDA issued a drug safety alert about severe rashes — “some fatal” — in patients treated for HCV with interferon, ribavirin, and telaprevir.

The culprit, of course, is the telaprevir. The label already contained warning information about serious skin rashes with the drug, and this alert serves to heighten our awareness of the problem, with strong wording about the importance of stopping treatment when severe rash with systemic symptoms occurs (bolding is from the FDA):

When any of these serious skin reactions occur, it is necessary for healthcare professionals to immediately stop all three components of Incivek combination treatment and the patient should receive urgent medical care.

Anyone who has prescribed or taken this drug already knows its no picnic, and of course interferon and ribavirin are hardly a walk in the park either. (Can one mix the picnic and walking in the park metaphors? Sure, why not — a picnic in the park.)

Importantly, the FDA alert again raises the key question facing people with HCV and their providers right now: Given the rapid pace of HCV drug development, with safer and more effective regimens on the horizon, why should anyone be treated for HCV today rather than waiting a few years?

I’ve asked my ID and GI colleagues this question numerous times, and received a variety of answers, but these two are the most common responses:

Patient has advanced liver disease and can’t wait. Who knows when the new regimens will actually be available anyway?
Patient does not have advanced liver disease, but really REALLY REALLY wants treatment now.

I certainly can understand the former, and have treated patients in this category. But what about the second one? Is this a good enough reason to treat someone with a potentially toxic treatment that, in all likelihood, will be all but obsolete relatively soon?

Anecdotally, it seems that the GI doctors (at least those that manage HCV) are more prone to treat because the patient really wants it than the ID docs. It could be our experience with HIV treatment influencing us — we saw what happened with that first generation of HIV drugs (efficacy just barely justified the toxicity, and certainly not in early disease), and we rarely use any of those medidcations today. By contrast, the GI docs see and manage advanced liver disease all the time, and must be motivated to do anything possible to prevent it.

So what do you think?

Categories: Health Care, HIV, Infectious Diseases, Patient Care
Tags: HCV, hepatitis C, telaprevir

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December 17th, 2012

On Service — But Some Works in Progress

When several of my colleagues attend on the inpatient consult service, they turn on an “out of office” message that provides an automated e-mail reply that goes something like this:

I am currently attending on the inpatient consult service. During this busy time, I may not be able to respond to email in a timely fashion. If you need to reach me urgently, please page my by calling xxx-xxx-xxxx, or leave a non-urgent message here and I will respond shortly.
Thank you,
Rudolph

Of course what they really mean is:

Please leave me alone.
Thank you,
Rudolph
p.s. In other words, I’m too busy to respond to you — but when I do, you should feel grateful, because after all, I told you I was busy.
p.p.s. I wish my name were something less silly.

Now I don’t do this — though I can understand why some people choose to do so, especially researchers for whom this time is their only clinical work. (Of course those who do clinical work full time are always “on service”, but that’s a different topic.)

But there’s no doubt that regardless of who you are and what you do, if you’re in an academic medical center and on service, you will now have several additional hours of clinical work and teaching added to your day. This not surprisingly takes time away time from other activities.

Like this site.

So since I’ve been on service recently, my writing here has been relatively less frequent. In compensation, I’ll take a page from one my favorite writers, and provide a list of works in progress. Helps organize my thoughts, too.

Here’s what I’ve been working on, and what I hope will be coming out soon:

Why HIV social workers are the greatest
The microbiome is hot
Another “Brush with Greatness” (it’s part of a series)
Missing the diagnosis at case conference
Things ID fellow applicants say, and why
The top papers in HIV — the early years
Clinical diversity in ID, and why we love it
An incredibly disgusting source of infection (not sure I can even mention it on this family-oriented site)

Hey, service ends Tuesday!

Categories: Health Care, Infectious Diseases, Misc

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December 5th, 2012

A Complicated Curbside Consult I Won’t be Doing — But One Day Might Have To

From a local primary care provider comes this email:

Any chance you can look at my notes and scanned outside records from 6/22/2010 till today (including Nov 6 notation that details extensive past evaluation, including two previous ID consults) and labs? Briefly: 72 yr old woman with 6 episodes over the last 4 years of prolonged fever, malaise, normochromocytic, normochromic anemia, very high sed rate, negative cultures and scans. She has an upcoming rheum appt; I’m going to set up heme appt for consideration of bone marrow biopsy. Am I missing something?
Thanks in advance.
Nelson

(For the record, one stylistic part of this email to highlight — “Thanks in advance”. For some reason, I find “Thanks in advance” nettlesome, while a simple “Thanks” or “Thank you” or even “Tx” all strike me as polite — and I like it. Why? What’s wrong with me? My wife thinks I’m way too sensitive, and should get a life.)

Ok, we’ve all been there. You get a curbside that is staggeringly complex, with a truckload of data already accumulated, and you, the ID doctor, are asked to review the chart and render an opinion without seeing the patient.

It’s obviously not that this is a stupid question — on the contrary, it’s completely understandable and quite appropriate that this PCP is asking for help on this challenging case.

It’s just that there are multiple reasons why this patient should actually be seen, interviewed, examined — you know, a “formal” consultation.

Why? Let me count the ways:

History. If there’s one thing ID doctors pride ourselves on, it’s getting the history right. For more on this, read here. If you don’t want to click the link, it’s a lengthy but I hope entertaining brag about how ID doctors take the best histories. Look, we have to boast about something.
Other specialist appointments. The patient has appointments set up with a rheumatologist and hematologist. What, are the ID doctors chopped liver? Given the duration and waxing/waning nature of the symptoms, the negative cultures, and the negative scans, the PCP is correct that a non-infectious diagnosis is more likely than an infection — but then why not schedule the ID appointment to take place after these two other brilliant specialists weigh in? (This is what I recommended, by the way.)
Medicolegal risk. Chart reviews of patients you have never seen or will never see are frowned upon by malpractice lawyers, who view this as establishing a doctor-patient relationship, increasing medicolegal risk. For more on this dicey subject, read here. Hey, I don’t make the rules.
Time and dollars. All that chart review takes time. And time is money, especially in our current payment structure. ID doctor’s RVUs per visit may pale in comparison to replacing someone’s knee or removing a mole or screening for colon cancer with a long scope with a light on its end, but what else can we do?

And it’s this last financial issue that could, and probably will, end up changing how ID (and other) doctors balance formal and curbside consultations.

Under Accountable Care Organizations (ACOs), groups of clinicians receive a lump sum to work together to provide the best care for their patients — and with the greatest efficiency. (Read: “Lowest cost.”) No more payment by RVU, and medical utilization is discouraged. My gut feeling is that I’d still want to see this patient, but perhaps instead I’d be encouraged to be part of a practice group panel to review all the outside records before she gets her specialty appointments.

So if ACOs don’t end up increasing the volume and complexity of curbside consults, I’d be shocked. Capitation in the 1990s, which had a similar (but not identical) structure to ACOs, triggered an increase in curbside consults, for obvious reasons.

The plus side of ACOs could be greater efficiency and more collaborative care. Let’s just hope that with greater demand for this sort of clinical work — informal, curbside consultation — there’s greater recognition of its value, both for patients and providers.

Categories: Health Care, Infectious Diseases, Patient Care, Policy
Tags: accountable care organizations, ACOs, curbside consults

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November 22nd, 2012

The U.S. Preventive Services Task Force Recommends HIV Screening — And Why is This News?

A flurry of coverage recently appeared about the U.S. Preventive Services Task Force’s recommendation for one-time HIV screening for all Americans, ages 15-64.

Some might wonder why this is news — um, hasn’t this been recommended now for years? — and I think I’ve figured it out.

Let me start by relaying that every ID/HIV specialists can tell some version of the following sad story, which is still repeated on a regular basis (including just the other day, in our very own hospital):

Person sees several clinicians over months-years for various medical issues (some combination of fatigue, swollen glands, anemia, thrombocytopenia, skin rashes — especially zoster).
Many tests (blood tests, X-rays, sometimes even biopsies) are done, but because the person is not identified as being “at risk”, no HIV test is sent; or, ironically, he/she is “known” to be HIV negative based on a test done several years ago.
Person eventually shows up in the hospital with some serious complication that all but screams “AIDS” — PCP, toxoplasmosis, cryptococcal meningitis, or even worse, PML or lymphoma — and the HIV test is finally done, of course returning positive.

Because the above sequence of events is all but 100% preventable with early identification of HIV — and because people who are unaware they are infected continue to spread the virus — in 2006 (yes, it was that long ago) the CDC made a big splash by recommending one-time HIV screening for adolescent and adult patients in all health care settings.

(They also said that high risk patients should be screened annually — unfortunately this is all too rarely done, but that’s an issue for a different day.)

To say that the ID/HIV provider community (docs, nurses, PAs, social workers) supported the CDC recommendations is like saying dermatologists support wearing sunscreen and a hat in the tropical sun.

“Support” just isn’t strong enough — we were strongly, unanimously, and vociferously behind them, so much so that virtually every lecture on HIV for the next several years mentioned the guidelines. To us, this was a total no-brainer — how could anyone oppose screening?

Indeed, the American College of Physicians, the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics all came out with guidelines that said pretty much the same thing.

But not everyone did agree — namely, on the books already were guidelines from the U.S. Preventive Services Task Force, who had come out with their recommendation in 2005 for risk-based testing only.

For the unaware, the USPSTF is “an independent group of national experts in prevention and evidence-based medicine that works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services such as screenings, counseling services, or preventive medications.”

I picture these USPSTF folks with hats, T-shirts, and coffee mugs emblazoned with “Evidenced-Based Only, Please.” Nothing speaks more clearly about their mission than these slide presentations entitled “Too Much Prevention” and “What Not to Do in Primary Care“. In plain English, the presenters make the excellent case that many well-intentioned screening strategies don’t help patients — and actually hurt them by uncovering clinically silent conditions that lead inexorably to procedures and medical treatments that are harmful and expensive.

Most cancer screening (infamously PSA) falls into this category. Cardiac CT. EKGs. Regular physical exams. Spirometry as a screen for COPD. Routine urinalysis. RPR. Hepatitis C testing (ahem).

And I generally agree with them. But HIV testing? That cheap, accurate test that identifies a clinically silent, eventually deadly infection that is both treatable and can be spread to others? Don’t they realize that the “risk based” testing they favored has been a failure?

Well now they do. In the plain language so characteristic of this committee, they write:

Previous studies have shown that HIV screening is accurate, targeted screening misses a substantial proportion of cases, and treatments are effective in patients with advanced immunodeficiency. New [well, “new” since 2005!] evidence indicates that ART reduces risk for AIDS-defining events and death in persons with less advanced immunodeficiency and reduces sexual transmission of HIV.

The bottom line is if this group recommends screening, it must be the right thing to do. Because these guys are tough.

Welcome to the club, USPSTF.

Categories: Health Care, Patient Care, Policy
Tags: HIV, HIV testing, USPSTF

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HIV and ID Observations

An ongoing dialogue on HIV/AIDS, infectious diseases,
all matters medical, and some not so medical.

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January 11th, 2013

How to Make the Flu Vaccine More Popular, Warts and All