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From TB to Treatment (Part 2): Health Over Profit

Breaking down the microbiology world one bite at a time

From TB to Treatment (Part 2): Health Over Profit

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georgiadittemore

PART 2

As a quick overview of part 1 of this article, bedaquiline has emerged as a novel antimicrobial drug effective against multi-drug resistant (MDR) tuberculosis (TB) with decreased toxicity and treatment regimen length. Bedaquiline was protected by a patent that granted Johnson & Johnson (J&J) exclusive marketing rights until 2023. While there are numerous issues contributing to the perpetuation of communicable diseases across low- and middle-income countries, including access to clean water and food, proper sanitation, and affordable and effective healthcare, a major factor is the price of life-saving treatments. With J&J charging $272 for a six-month course, bedaquiline was not readily available or affordable to those who needed it the most. 

A Proposed Solution: Global Accessibility Through Dismantling Profit-Driven Healthcare

Bedaquiline’s primary patent expired on July 18th, 2023. J&J called for implementation of secondary patents, which would limit its availability until 2027. This practice of making minor alterations to patented drugs to extend their lifetime, such that the company continues to profit and maintain market control, is known as patent evergreening. In this case, the only difference to J&J’s “new” bedaquiline lies in the addition of a negatively-charged ion called fumarate to the drug formulation, which can affect the stability and absorption properties of the molecule. 

The first beacon of hope in the fight for bedaquiline availability came in July of 2023: J&J provided licenses to Stop TB Partnership’s Global Drug Facility (GDF) to obtain and supply bedaquiline to 44 low- and middle-income countries for $130 for a six-month course, a 55% reduction in price. However, this deal excluded countries with a high TB burden that did not purchase drugs through GDF, such as Russia and South Africa, leaving many vulnerable to MDR-TB.

The first step in thwarting J&J’s push for secondary patents came from India’s Patent Office. They rejected the extension, effectively ending J&J’s monopoly. The decision to reject the secondary patent was applauded by many, including Doctors Without Borders (MSF), but still presented significant challenges in at least 34 more countries with high TB burden. Increased pressure from MSF and other TB activists, including Partners in Health, and publicity from YouTuber and novelist John Green culminated in a large online campaign to stop J&J’s patent evergreening. The Twitter hashtag #PatientsNotPatents amassed over 10,000 tweets and 117,000 people signed a petition by MSF demanding J&J drop the price of bedaquiline. In mid-July of 2023, J&J decided to not enforce secondary patents, paving the way for the production of generic bedaquiline that could cost as little as $48 for a six-month course. 

While significant progress has been made in combating MDR-TB and providing accessible treatment, many TB activists assert that there is still a long way to go in the battle to eliminate for-profit healthcare. Still, there is hope that competition between generic bedaquiline manufacturers will continue to drive down prices, greatly aiding this struggle in low- and middle-income countries. Such a magnitude of change arising solely from public activism portends future campaign successes. 

Broader Outlooks on the Future of Antimicrobial Resistance (AMR)

From a scientific standpoint, the phrase “no one is safe until everyone is safe” rings true in the context of infectious diseases. Profit-driven healthcare that solely focuses on high-income countries will continue to breed drug-resistant bacterial pathogens across the globe. While these pathogens will initially plague low- and middle-income countries, eventually these MDR infections will become global pandemics. Fighting AMR starts with antibiotic development, which must be done with the intent of worldwide distribution to reach true efficacy.

Currently, the field of antibiotic research is not considered profitable to large pharmaceutical companies for several reasons; antibiotics are typically purchased for short dosage periods compared to lifetime drugs, such as blood pressure medications or anti-depressants. Additionally, as soon as a novel antibiotic is introduced to the market, it is only a matter of time until resistance emerges, nullifying its clinical effects. 

Timeline depicting the introduction of an antibiotic into the clinic and the subsequent emergence of resistance. 

Timeline depicting the introduction of an antibiotic into the clinic and the subsequent emergence of resistance. 

Increased AMR and decreased drug efficacy highlight the necessity for novel chemical scaffolds, a space where academic research groups have historically excelled. Additionally, expanded funding for labs studying antibiotic discovery and development would incentivize increased engagement in the field, preventing a global AMR crisis before it could even develop. Prioritizing efforts that already exist in academic labs, such as open-access publication and not-for-profit research, will help elevate this issue on a global scale. 

While J&J’s contribution will make universal impacts, it is only a small example that many companies should follow to make significant change. Resolving the problem of differential healthcare outcomes requires constant vigilance. Just as bacterial pathogens constantly reproduce and evolve to evade state-of-the-art treatments, so must we grow to meet the demands of global public health.

For More Information:

To read more about the beginnings of MSF’s campaign, click here.

To read the original press release from Stop TB Partnership, click here.

To read MSF’s take on patent evergreening, click here and here.

To check out John Green’s YouTube channel, click here, and for his video to J&J, click here. 

Featured image: Generated using AI