August 14, 2019; Washington Post
The vilely overpriced realm of the pharmaceutical industry is being encroached upon by nonprofits—that is, players that are not in it primarily to extract a quick buck off of people who are ailing and increasingly impoverished by that. (Excuse the “point of view,” but the pharmaceutical field is definitely a job for the nonprofit sector.)
We have already covered the development of a drug production company owned by a collective of hospitals and nonprofit pharmacies. More recently, Steve Dubb wrote about the potential entry of nonprofits into the development of new antibiotics. Now, we see a nonprofit cleared by the FDA to bring a new TB antibiotic to market specifically to treat highly drug-resistant tuberculosis, strains of which kill around 500,000 people each year worldwide.
The drug in question, pretomanid, is developed the nonprofit TB Alliance. It’s one of a number of next-generation antibiotics that are pricy to produce but unlikely to generate much profit.
The United Nations projects that drug-resistant infections could cause 10 million deaths each year by 2050 if a pipeline for the development of these kinds of antibiotics is not established. Pretomanid is now only the third FDA-approved anti-TB drug the past 40 years.
“We can have a huge impact on the lives of people who are afflicted and also take a major step ultimately toward, really, the eradication of a disease like TB,” said Mel Spigelman, president and chief executive of TB Alliance. “One definite advantage of a not-for-profit is you don’t have to look at things like returning your profits into shareholders.”
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In the New England Journal of Medicine this month, an article entitled “Sustainable Discovery and Development of Antibiotics—Is a Nonprofit Approach the Future?” makes the case for greater reliance on nonprofits for drug development. The authors write:
Because they lack shareholders, nonprofits… face less pressure to increase drug prices and are better positioned to control post-approval antibiotic use (e.g., through the existing limited-population antibiotic drug regulatory pathway). A drug with annual sales in the tens of millions of dollars is a catastrophic failure for many for-profit companies but would be a lifeline for nonprofits, which could reinvest revenue from the drug to sustain research and development efforts. Organizations that highlight the potential of nonprofits in this area include the TB Alliance, which has participated in the development of new antibiotics for tuberculosis, and the Medicines for Malaria Venture, which developed artesunate and is actively developing other antimalarials.
The authors suggest that nonprofit organizations could easily act as a cost reducing component of a supply chain that brings antibiotics, or they could bring them to market themselves, but “for such a strategy to be effective, nonprofit development of antibiotics would have to be part of a broader framework of new ways to combat infections.”
Potential approaches could include better targeting of existing financial incentives for development of antibiotics and finding strategies for preventing or treating infections that don’t rely solely on antibiotics. Nonprofit organizations could participate in developing new vaccines to prevent infections, as well as immunotherapies, nutritional-deprivation strategies, inflammatory modulators, and other approaches to treat them.
They also suggest a number of nonprofits functioning in this image be capitalized from a proposed pool of $1 billion. Any move in this area, they warn, would be opposed by those with vested interests in the status quo, and they anticipate the argument would be a scare tactic related to the end of innovation. But, they write, even as drug resistant ailments proliferate, for-profit companies haven’t been able to reliably produce in the post-antibiotic era, and it is time to build an alternative.—Ruth McCambridge