HIV and ID Observations

Early penicillin apparatus (National Library of Medicine)

At the start of our weekly case conference, we get announcements from one of our ID pharmacists. New drug approvals, hospital policies, updated guidelines — that kind of thing. But over the last decade or so, the most common topic they’ll comment on is the latest important antibiotic shortage.

For those not in medicine, you might think these shortages would involve cutting-edge compounds that have complex manufacturing or distribution challenges. On the contrary! These are rarely fancy, high-tech drugs. They’re much more commonly generics that have been available for literally decades — isoniazid, amoxicillin, intravenous acyclovir, and injectable benzathine penicillin. All have important recent drug shortage in the United States that impacted patient care.

If you’ve ever wondered why these shortages exist, an authoritative review has just appeared in Clinical Infectious Diseases outlining the problems clearly. In essence, drug production internationally is much cheaper, and these lower priced versions make it all but impossible for US manufacturers to turn a profit on generic drugs. In addition, the FDA lacks the resources to provide sufficient quality oversight of the drugs made overseas. The result?

This combination of fierce price competition from Asian markets and irregular quality oversight by the FDA in these regions has resulted in a high prevalence of chronic shortages of generic drugs, with US drug shortages at a ten-year high and antimicrobials being 42% more likely to experience a drug shortage than other drug classes. As of May 31, 2024, 37 antimicrobials were listed in shortage with shortages of antimicrobial agents ranking second among all pharmaceutical classes.

Drug shortages can also lead to substantial price increases, especially when a single company remains the sole manufacturer of an essential drug. The recommended treatment of syphilis, benzathine penicillin (shortage first reported last summer), is one striking example. As a long-acting injectable drug, benzathine penicillin requires rigorous and sterile manufacturing facilities and careful oversight. Given the inexpensive price worldwide and low profit margins, there is little incentive for any company to take on making and licensing this critical drug. The number of US manufactures of benzathine penicillin can now be counted on one finger.

What remains is the perfect formula for a price increase:

1. One US manufacturer — no price competition
2. Barriers and few incentives for other companies to enter the market
3. An increased demand due to increased incidence of syphilis
4. Lack of proven alternatives, especially in certain clinical settings, most notably pregnancy

The result? A price increase! No advanced degree in economics needed! The price of a single dose of benzathine penicillin is now over $600! I’ve heard some pharmacies charge nearly $1000. Wow.

Even worse, many of the people diagnosed with syphilis have inadequate insurance coverage, in particular pregnant women. If untreated, they can pass the infection to their babies in a disastrous scenario that is 100% preventable with adequate treatment. As demonstrated in this recent review of cases of congenital syphilis in Missouri, the incidence of these cases is strongly associated with adverse social determinants of health, including absent prenatal care, substance use disorder, and housing instability.

Enter Dr. Eamonn Vitt, solo practitioner in lower Manhattan, and former punk rocker and Médecins Sans Frontières (Doctors Without Borders) veteran. He eagerly admits he was inspired by the business practices of the legendary band Fugazi, who refused to sign to or work with corporate record labels so they could maintain total control over their music. So when I say he’s a solo practitioner, I really mean it. You know those primary care practices now owned by giant insurance companies, healthcare systems, or private equity? The opposite of that. From his practice web site:

We work for you – not the shareholders of the health insurance corporations. We are out-of-network with them. We do not take money from drug companies. We are liberated from the perverse incentives plaguing the healthcare industry. Our practice serves people from all walks of life. The fees are fair and affordable.

He runs an extremely low overhead operation — just him, one assistant, an office, and a refrigerator full of vaccines he has on hand for his patient clientele, which consists of a large number of gay men who have sought him out for HIV care or for pre-exposure prophylaxis (PrEP).

Not surprisingly given his patient panel, Eamonn has to treat STIs frequently, and this means prescribing benzathine penicillin for syphilis. As he told me in a recent IDSA podcast, his patients take his prescription for penicillin down to the pharmacy, and have been increasingly met with a big price shock.

I have amazing patients, super smart people, and they have very well developed BS detectors and they all are unhappy with this. I have an economically diverse practice. I have patients who work in fast food, and I have doctors and lawyers. No one wants to pay $500 … We learn when we’re 11, that monopolies are bad for the consumer, and it’s probably one of the few bipartisan things in the country that both the red team and the blue team agree on, that monopolies are bad.

So how did he solve the problem for his patients? In a fascinating, tangled tale that involved the perfect mix of his activism, painstaking research, and energetic sleuthing, along with important supporting roles played by the FDA, Doctors without Borders, and the on-line pharmacy CostPlus Drugs, Eamonn now gets the drug for $30 a dose.

(TL/DR for those not interested in listening to podcasts: he found out the drug could be imported under an FDA emergency action, researched the cost paid by his MSF former colleagues, and cold emailed Mark Cuban — who, amazingly, responded to his email!)

Eamonn office refrigerator is a bit more crowded, now with doses of benzathine penicillin, but I’m sure his patients are incredibly grateful.

I’d wrap up by posting a video of Fugazi, but they’re a bit too hardcore for me. Instead, here’s a favorite of mine from an earlier punk era.

(h/t Dr. Katerina Christopoulos for connecting me to Eamonn, and to him for sharing this story.)