The free market is failing us on antibiotics

Harvard Medical School researchers recorded a now-famous demonstration in 2016 of the E. coli bacterium — a species often thought to be behind contaminated food.

“What we ended up building was basically a petri dish, except it’s two feet by four feet,” Michael Baym of Harvard Medical School explains in a video about the experiment.

The large petri dish contained different compartments with different levels of antibiotics. One part of it was no antibiotics, then lethal levels, then 10 times the lethal dose, 100 times, 1000 times. When the researchers dropped the bacteria into the dish, they grew like a white cloud until they were exposed to the antibiotic. Then, they stopped cold.

“Then, a mutant appears on the right,” Baym continues. “It’s antibiotic resistant, it’s spreading … when these mutants hit the next threshold, they have to stop and develop new mutations to make it 10 times more antibiotic resistant.”

This repeats itself as bacteria evolve to survive more antibiotics. After 11 days, the bacteria have grown to 1000 times the lethal level and the black petri dish has turned white. The video is simply the evolution of one of humanity’s greatest enemies, captured on film.

35,000 people die each year in the United States from antibiotic-resistant infections; that number is 1.3 million in the world.

“Bugs always win,” is a refrain that Dr. Evan Loh likes to repeat. “If you keep using the old antibiotics, they get stronger and stronger and stronger.”

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This is happening. Existing antibiotics become less effective as bacteria evolve, but the market that must develop new antibacterial drugs is failing.

And the World Health Organization says the pipeline for antibacterial treatment is insufficient. According to the Antimicrobial Resistance Industry Alliance, there are only eight antibiotics in late stages of development and only three are considered innovative. A third of the new antibiotics given in pre-clinical trials are cut off each year.

“You really need a buffet table of new antibiotics to be able to really stay ahead of the curve of innovation that’s needed because bacteria are evolving and developing resistance,” Loh said.

In addition to being a physician, Loh is the CEO of Paratek Pharma, the manufacturer of an FDA-approved antibiotic called Nuzyra for pneumonia and skin infections.

“Unfortunately we are the exception but we should be the norm,” he said.

Paratek benefits from government programs, and its antibiotics meet a specific critical need. It also comes at a price, though the company has offered the antibiotic for free to people without insurance or another way to get it.

Paratek has also been working on developing and commercializing its new antibiotic since the 1990s – and has spent $1 billion on it. It is one of several biotechnologies developing new antibiotics.

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“The big pharmaceutical companies, which have traditionally developed these antibiotics, have largely moved out of both the research and commercial arenas,” Loh said.

Some have filed for bankruptcy, the shares of others have fallen. “Investors have avoided this sector,” he added.

They have moved away because the current economy often doesn’t work.

“What’s different about antibiotics is that once you develop a really good antibiotic, it shouldn’t be overused,” said James Anderson, president of the AMR Industry Alliance. Antibiotics, especially new ones, should not be placed in every medicine cabinet, but should be used only when absolutely necessary.

“Sales are low and, in fact, when you look at the average sales of all antibiotics launched in the last 10 years, it’s less than $50 million a year—not enough to sustain sustainable operations in many companies. . . , give up on investment returns,” Anderson said.

In many cases, it costs hundreds of millions of dollars more to develop an antibiotic than it will earn.

“It takes 10 to 20 years and $560 [million] $700 million to develop an antibiotic, according to some estimates, “said Jocelyn Ulrich, vice president of medical innovation policy at PHRMA, a pharmaceutical industry trade group. Other estimates are much higher – $1.5 billion.

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“The return is in the hundreds of millions, at most,” she said, and often not enough to make it worth the cost. And all costs do not guarantee approval by the FDA.

In addition, pharmaceutical companies do not need to focus on having a global market, because bacteria develop and spread in different ways around the world.

Dr. Vance Fowler, professor of medicine at Duke University, Dr. “The particular pathogen I have to deal with may be different than the pathogens a colleague in Greece, Lebanon or Korea might have to deal with,” explained Vance Fowler.

Market failure is accelerating, Ulrich said. “Twenty years ago, around 18 of the largest biopharmaceutical companies were involved in AMR product research and development, and now we’re down to around five major players. Most are small biotechs.”

It is the invisible hand against Darwinian evolution. And now, evolution is successful.

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