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Why New Antibiotics Never Come To Market (vice.com)
citadrianne writes: New antibiotics are generated naturally over time by bacteria, as weapons in their ongoing chemical warfare against other microbes. Predicting where and when they can be found relies mostly on good fortune and following a hunch. Scientist Brian Murphy's hunch is that the bacteria which live on freshwater sponges could be a hive of new chemicals. "We don’t know a huge amount about these species," he said. "But the only way to find out if there’s anything there is by actually diving down there and carving them off with a knife." But even if these sponges yield the antibiotics of the future, there are seemingly endless roadblocks that prevent us from actually using them to cure disease. "We've discovered six antibiotics in the recent past," Professor William Fenical said. "Of those, three to four have serious potential as far as we know, including anthramycin. But we have no way to develop them. There are no companies in the United States that care. They're happy to sell existing antibiotics, but they're not interested in researching and developing new ones."
I've seen plenty of new vaccines developed, the one that comes to mind at the moment is HPV - in 2000, HPV was just a nuisance that women got regular pap smears for, then cervical resurfacing when they came up positive with "precancerous lesions." We asked "What about HPV testing" when presented with a "just cut a loop around the cervix, it might mean you won't be able to carry a child to term, but it will prevent cancer" diagnosis in 2000, and were told "oh, that's all theoretical stuff, you can get tested, but at the end of the day, we need to take out the precancerous stuff to be sure..."
Fast forward to 2005 and there's a new "HPV vaccine" legally required to be administered to all Texas schoolgirls virtually on the day it was cleared for use by the FDA. Tell me there's no profit in a vaccine that state Governors push laws through to require for school attendance.
I worked in the pharma industry for a bit so let's look at some numbers:
Pharma business is split into 3 basic areas: Discovery, Development, Commercial.
Discovery: 10k molecules are examined to get to 250 that look promising and down to about 5 to get sent into development. This takes about 5 years. Costs vary wildly. Key concept (among many) here is molecules get thinned down usually because they don't work or aren't safe (Chlorox), but sometimes you just can't manufacture it even if you wanted to make it.
Development: Those 5 are then put through Development which is composed of pre-clincals (tissues and at least 2 species of animals), phase 1, 2a, 2b and 3 trials (human). The patent on the molecule is done early in this process and is good for 20 years. Development lasts about 9 years and costs around US$800m. Key concept here (again out of many) is molecules get dropped off here due to their ADME (absorption, distribution, metabolism, excretion) properties. If you can't deliver the molecule to where it needs to go, it won't work as a drug.
Commercial: Out of Development, there is only about 1 molecule that becomes a drug. You've now spent upwards of US$1b including the cost of failures. The new drug has a patent for around 12 years or so (remember you patented it early in the Development phase). If you don't make that $1b back somehow, you won't be in business very long to develop other drugs. You now have cost of manufacture. This is usually pretty small for small molecule drugs that can be put into a pill, but can be expensive for large molecule (biologic) drugs that are intravenous (think insulin). You also have to collect data and send it to regulatory bodies (phase 4).
So this guy has found a few molecules (one that is hard to get any kind of quantity of from TFA) that are part of the 10k funnel at the beginning of the process. Could be that companies have other compounds that they are exploring that are further in the process. They may be seeing if those fail before starting to look at his. Super-bugs aren't new so companies may have been looking at them already (5 yr Discovery funnel).
And before anyone goes whining about Big Phara, think what you would do if you spent a billion dollars on developing ONE item and had tens (if not hundreds) of thousands of employees that you would like to keep around. How would you decide WHAT to develop and HOW to price it?
I only whine when the Feds do all the work, on our dime, yet we end up with a drug company getting all the profits.
This is rarely the case - only 25% of new drugs originate in (presumably federally-funded) academic labs, and even those have to go through a lengthy development process mostly paid for by companies.
Actually, no. Most, or at least many, other governments around the world regulate the prices of drugs.