HIV and ID Observations

(Inspired by various unvalidated, non-FDA approved lab tests.)

Fatigued? Achey? Having difficulty concentrating?

Don’t have quite the “zip” you used to have when you were young?

If you suffer from any of these symptoms and are frustrated by unrevealing medical work-ups and negative blood tests, you’ve come to the right place.

For at DNA-Dx, we’ll find that positive test result — we guarantee it or your money back!

Using novel antibody tests with in-house interpretive criteria, home-brew PCR assays and in situ hybridization, imaginative culture techniques, and other proprietary amplification tests, we dial up the sensitivity of our testing so that no stray molecule of infection passes by us undetected.

Not sure what test to order? No problem! Just order our special Pathogen Discovery Panel ($1299.99), which rigorously evaluates blood, urine, and stool specimens for literally thousands of microorganisms, leaving no stone unturned.

It’s available now for a special introductory price of only $999.99. And once you get that positive test result — whatever it is — you’ll agree it’s worth every penny.

Not only that, but if you order now, you get a free canvas tote bag with the DNA-Dx logo. Great for picnics, trips to the beach, or just shopping.

About Us

DNA-Dx is a company founded by Dr. Melvin Smoot, a chiropractor with over 20 years experience in spine manipulation and core alignment. Based on his patients’ histories, he was convinced that many of them with negative work-ups for fatigue and aches were in fact suffering from an undiagnosed infection. Working with Scientific Director Virginia Gleeper, Ph.D. (an honors graduate of Eastern Slovenia Polytechnic Dietary Institute), Dr. Smoot opened his first lab in the food court of an abandoned shopping mall. By redeploying some leftover equipment (in particular from Sbarro and Panda Express), they were able to offer an increasingly broad range of diagnostic studies.

Today, the company has over 100 employees, with offices and labs in most communities with high median incomes.

Frequently Asked Questions

• Q:  What do you use for negative controls?
  A:  We at DNA-Dx do not believe in negative controls. Even our negatives are positive, provided you test them the right way.
• Q:  Can you refer me to any scientific validation of your results?
  A:  The best data supporting the validity of our tests are the numerous patient and client testimonials praising our work. We have literally thousands of letters, emails, and cashed checks that endorse what we do.
• Q:  What is your most common positive test?
  A:  Our expansive stool analysis routinely returns positive for hundreds of different microbes.
• Q:  What techniques do you use for testing for tick-related infections?
  A:  At DNA-Dx, we are very concerned about the rising incidence of tick-related infections. As a result, we feel it is our responsibility to do as many different tests as possible. We won’t stop until one is positive.
• Q:  One of my tests was positive — what do I do now?
  A:  If you click here, you can book a free consultation with one of our trained providers. They will guide you through our selection of a wide range of natural therapies and supplements, each proven* to help restore you to vigorous health. (Credit card required.)
• Q:  Do you take insurance?
  A:  No.

*Disclaimer:  DNA-Dx is a registered trademark of DNA-Dx, Corp., and may not be reproduced, reprinted, or repurposed without the express written consent of DNA-Dx. Tests offered by DNA-Dx were developed and its performance characteristics determined by DNA-Dx. Tests and therapies have not been cleared or approved by the U.S. Food and Drug Administration to diagnose or treat any condition. 

Save

Once upon a time, I used being on service as a convenient excuse for not writing very much — or certainly, not writing very much of importance — on this site.

The on-service time also allowed me to poke gentle fun at my colleagues, several of whom always turn on an “out-of-office” message when they attend on the inpatient ID consultation service.

I’m talking about this thing that responds instantly when you email them:

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 me by calling xxx-xxx-xxxx, or leave a non-urgent message here and I will respond shortly.
Thank you,
Rudolph

Reminding me of this post, my friend Carlos Del Rio sent me this email earlier this year:

Going on service April 1st. Should I put my “Rudolph” message up?

I’d advised Carlos to check Emory’s Policies and Procedures — am sure it’s in there somewhere.

Now, having just completed a couple of weeks doing inpatient ID consults — and falling behind on emails — I thought it time to add a few additional observations about this practice:

1. Who is most likely to do it? Let’s call people who do this “OOODS.” (Pronounced like the first syllable of “noodle,” and standing for “out-of-office during service” types.) My anecdotal impression is that OOODS are predominantly academic physicians, people who know patient care is important but don’t do it on a day-to-day basis. Hence they want to “clear the decks” of other pressing responsibilities. A minority might be full-time outpatient clinicians who only rarely do inpatient work.
2. When not on service, they are generally very responsive to email. OOODS are often “inbox zero” types who wouldn’t think of allowing the sun to set on a critical research or administrative query. So when busy consult days happen, and the long hours on the wards make it impossible for them to keep up, they want to reassure their colleagues and friends that they haven’t suddenly decided to abandon academic medicine for more frivolous activities. Imagine the speculation!
   

   “Hey, I emailed Dr. Smith 12 hours ago, and he hasn’t  gotten back to me yet — that’s weird, he’s usually so quick to respond. Plus, no out-office-message.”

   “Yes, that’s weird. But he’s a pretty big Phish Phan — maybe seeing all their summer concerts?”

3. They’re generally pretty important. Many exceptions to this rule, but the academic rank and productivity of OOODS is impressive. One study found that the number of citations for papers published by OOODS was significantly higher than non-OOODS, even when controlling for total RVUs generated on the consult service. NIH grant dollars and the impact factor of their published papers were also significantly higher. If you don’t believe me, the published paper can be found here.
4. One person who inspired the original post identified herself almost immediately. Shortly after I wrote it, I received this email:
   

   Hey, I’m Rudolph aren’t I??? Is that a bad thing?

First, let the record show that this OOODS person who emailed me was only one of several people who sent me a similar query, as I adapted the sample out-of-office message from a bunch of different ones used by friends and colleagues.

Second, it is by no means a bad thing — it’s just a thing some people choose to do; others don’t (I don’t) — as evidenced by the fact that this particular OOODS person was most deservedly just appointed an extremely important leadership position.

Congratulations, Rochelle!

Rabbit or duck?

Two new HCV regimens gained FDA approval recently, bringing us closer to the end of this extraordinary phase of drug development.

Think about it — has there ever been a more spectacularly rapid improvement in treatment of anything? If so, please let me know what that is. Remember, as recently as early 2013, highly toxic interferon-based therapy (with ribavirin and telaprevir or boceprevir) was still standard-of-care.

The recent approvals:  Sofosbuvir-velpatasvir-voxilaprevir (Vosevi) on July 18, indicated for patients who have failed prior treatment with either sofosbuvir or an NS5A inhibitor. Twelve weeks of treatment (one pill daily) will cure 95–96% of patients, and pretreatment presence of NS5A, NS3, or NS5B resistance mutations does not reduce response. A month of sof-vel-vox — which will only be used as a salvage therapy — is priced at $24,900.

Then, glecaprevir-pibrentasvir (Mavyret) was approved on August 3rd. A pan-genotypic regimen that includes both an HCV protease inhibitor and an NS5A inhibitor, “G/P” is 3 pills daily, requiring only 8 weeks of therapy in treatment-naive individuals without cirrhosis. Clinical trial results show cure rates in the high 90s, with a low incidence of treatment-related adverse events requiring drug cessation.

Glecaprevir-pibrentasvir can also be used in patients with renal impairment (including dialysis), prior treatment failure of genotype 1 with either an NS5A inhibitor or PI (but not both), and in compensated cirrhosis. Treatment duration should be increased to 12 weeks in those with prior treatment or cirrhosis.

So where does that leave us in terms of “unmet needs” in HCV therapy?

Let’s review what we currently have:

• Nearly 100% of those who get treated are cured.
• Most regimens are one pill daily.
• Ribavirin is rarely required for treatment-naive patients.
• Side effects leading to drug discontinuation are exceedingly uncommon.
• Treatment duration is only 8–12 weeks.
• Drug interactions are mostly manageable; if not, HCV treatment is so short that temporary discontinuation of the conflicting drug is usually fine.
• Several pan-genotypic options are available.
• Certain therapies are also effective for treatment-experienced patients with resistance.
• Some regimens are safe and effective for those with moderate-severe renal disease — even hemodialysis.

From a medical perspective, this doesn’t leave out a whole lot, does it? Treatment of HCV is so easy there’s a strong push in some circles to move it to front-line providers in primary care — and of course outcomes in their hands are as good as with hepatologists and ID specialists.

Yes, cost of and access to HCV therapy remains an issue, especially in certain regions.

But things have vastly improved in this area too. With prices way down from the crazy days of early 2014 (when the non-FDA approved “sim-sof” regimen was > $100,000/cure), we should anticipate that more payers will stop medically unjustified policies such as fibrosis criteria, negative toxicology screens, and limiting prescribing of HCV therapy to specialists.

And market forces are doing something — note that the wholesale price of G/P is $13,200 per month, very close to the negotiated discounted price for LDV/SOF with the VA and certain state Medicaid programs.

Which brings me back to the title of this post — Have We Reached the End of HCV Drug Development?

If we’re not there yet, we’re certainly close.

Here’s a poll about where we should go with HCV research — please vote!

Save