Rapid development of an effective COVID vaccine has been the main focus of the pharmaceutical industry for the past year and a half, and for good reason.

But another problem in the drug industry has grown slowly over the past 20 years: Companies are dropping or dropping antibiotic development at a time when bacterial resistance is on the rise. begins to overtake the development of new, more potent antibiotics.

This is largely due to the fact that antibiotics are not as lucrative as other drugs, which has led to the big pharmaceutical companies leaving the antibiotics business, according to Maryn McKenna, journalist and senior researcher at the Center for the Study of Human Health at Emory University.

“Continuing to make antibiotics from a pharmaceutical company’s perspective has turned out to be something that just isn’t sustainable,” McKenna said in an interview with “Marketplace Morning Report” host Sabri Ben. -Achour.

The lack of large pharmaceutical companies in this space also means that the smaller biotech companies that have done the bulk of antibiotic development are often overwhelmed by the cost of development, McKenna added.

Below is an edited transcript of the conversation on the current state of the antibiotics industry and how Operation Warp Speed ​​could provide new solutions to revitalize this sector of the pharmaceutical industry.

Sabri Ben Achour: So first of all, to what extent do bacteria develop resistance to current antibiotics?

Maryn McKenna: Very widely. In fact, bacteria have developed resistance to antibiotics for as long as we have, that is, since the mid-1940s. We have always been able to stay one step ahead of their ability to develop resistance, resistance being essentially their ability – if you can call it aptitude – to repel the attack of antibiotics. But we are losing ground on this.

The economics of antibiotics

Ben-Achour: So we are in this race with a class of deadly organisms. And yet, as you pointed out, all the major players who were going to manufacture or develop new antibiotics left the company almost 20 years ago. Why?

McKenna: It sounds really counterintuitive, doesn’t it? But if you think about the economy, there are good reasons for this. If you think back to the last time you took an antibiotic or a family member took it, you probably haven’t taken this medicine for very long – a few weeks, maybe a month or two, though. you were unlucky. It probably didn’t cost that much – a few hundred dollars at most, maybe $ 1,000 or so if it was an IV drug instead of something you just swallow. And when you’re done, that infection you were taking the antibiotics for should have gone away. All of these conditions are very different from most of the other drugs that drug companies make that they want to make money for. And as a result, continuing to make antibiotics, from a pharmaceutical company’s perspective, has turned out to be something that just isn’t sustainable. Because the costs of making a drug – 10 to 15 years, at least $ 1 billion – don’t actually vary depending on what class of drug you make. But the amount of income you get down the line is much more if you make a cancer drug, an immunological drug, a cardiovascular disease drug, than if you make an antibiotic.

Ben-Achour: You also talk about what is called the “Death Valley” problem in terms of drug development, especially antibiotics. Can you explain this to us?

A portrait of Maryn McKenna.
Maryn McKenna (Courtesy)

McKenna: Yeah, that’s the tricky thing. So if you think about how a drug is developed, most of us are quite unfamiliar with this process. It starts with an idea, with a compound, you do preclinical work on a bench, then it goes into animal testing, then it goes into human testing, these phase one, phase two, phase three trials where the people probably heard about COVID vaccines last year. And then at the end, you get clearance to practice from the FDA. When the really big pharmaceutical companies of the mid-20th century – we talk about Pfizer and Eli Lilly and so on – when they were making antibiotics, they had multiple sources of revenue in their companies, so if their new research on the antibiotics weren’t making them money yet and if it cost them money, there was another place in the budget that could help them pay. With these big companies with these multiple sources of income having left the landscape, it falls to the small biotechs, who have no other sources of income except friends and family or perhaps investors in venture capital, to fund all of these testing phases, some of which can be very large. And so it is possible for them to run out of money before they reach the end of the process with the FDA and get their drug approved.

One particular problem with antibiotics, which links back to the fact that they just aren’t drugs that make a ton of money right away, is that there is a sort of second ‘Death Valley’, which is, after approval, but before a drug reaches profitability, enough to start making money to pay back all the R&D that the company has invested. In the last couple of years a number of these little biotechs that made new drugs have gone bankrupt, gone up for auction, in various ways left the industry. And many of them did so after their drug was approved. So the economic landscape is very tricky, because there are actually two sets of hurdles that a company with a necessary new drug has to overcome before it can be sure it can stay in the market for a period of time.

Encourage the production of antibiotics

Ben-Achour: So how do we solve this problem? How to encourage more production of antibiotics? And how do you make it financially possible?

McKenna: There are a few sets of proposals that have been circulating in the past, almost a decade at this point. None of this is created very quickly. Some of these are called “push incentives”. They push drugs to the point of approval. And some of them are called “pull incentives”. They shoot drugs on this second “Valley of Death”. Incentives to push did not prove too difficult to achieve. Basically, it’s other forms of funding for this difficult section of research that come from government or investments or varieties of private philanthropy that get these new drugs manufactured by these small companies, sometimes with no other sources of income, to the point. where they can get their drug approved and marketed. The really tough part that very few places, very few countries or jurisdictions have succeeded in is this push of pull: the point at which the drug should be able to go on sale, but still won’t make enough money. money for years. to keep this business afloat.

There is one working in the world right now, it’s a program that was created less than a year ago by the UK government, it’s kind of like a subscription model, a sort of zero coupon bond paid for in drugs where they donate money to promising companies while their drug progresses through research on ensuring that they, the government, along with the national health system, will have access to the drug. medication thereafter. And part of the value of such incentives is not just guaranteed income, but the fact that the guaranteed income releases the pressure on the company to sell lots and lots and lots of drugs. Because with this underlying resistance issue, the more you use a drug, the more bacteria learn about its mode of attack, the faster resistance will develop.

Ben-Achour: People have pointed out in the past that the economics of vaccine development are just as heavy. And yet we were able to get it to work and get it to work really fast for COVID. Did we learn anything from this that could be applied to antibiotics?

McKenna: You know, over the past 18 months, as COVID responses were being worked out, I have periodically spoken to the antibiotic developers. And what I kept hearing from them was an intense craving for anything being done to bring COVID vaccines and therapeutics to market. There have been changes in funding. Operation Warp Speed, the US government’s big investment, was worth $ 18 billion. He has just paved these “Valleys of death” which we have just spoken of. But there were also changes in the way clinical trials were structured, the way [Food and Drug Administration] staff were willing to talk to companies while clinical trials were in progress. There were buy-back guarantees at the end of it, there was a whole bunch of things that just smoothed out the various barriers that kept a drug from getting to market. And it was appropriate, right? Because COVID has been the worst public health challenge in over 100 years. People who develop antibiotics say, “Look, the resistance is really bad. At some point we’re going to face something like that, we should be looking at this kind of making the landscape easier for newer antibiotics as well, so that we have them on time when we need them. “



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