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."

Comments

You must choose....

[JoeMerchant]

You have billions of dollars, and a business that makes billions more per year.

Do you choose to continue that business and rake in personal rewards like a G5 and an island to fly it to, or do you invest the billions on a risky venture that might pay off some time in the next 10 to 15 years?

Answer from the perspective of a 60 year old with multiple cancers.

Re:You must choose....

[ColdWetDog]

Leaving out the Strum Und Drang for a moment, lets look the TFA. You have this interesting character that runs around and looks for novel biologics. This isn't really breaking new ground - there are thousands of people out in various biomes doing exactly that. Seems like our good prospector has had some success taking a few chemicals and doing some basic research on them with potentially useful results. Kinda neat way to make a living actually.

The article gets more than a little squishy when it talks about the End of the Antibiotic World As We Know It and makes it sound like we're all going to die in a septic heap because of the transgressions of our society. While there is some validity to the 'superbug' hypothesis, it really is only an edge problem. Some people die of multidrug resistant infections, but not many. The antibiotics we have work pretty well.

So, from an economic standpoint, Big Pharma has a point. It costs one hell of a lot of money to take a random, complex molecule and try to make an economic product out of it. Remember, it's pretty easy to get a molecule to destroy a bacterium - Chlorox works great and is rather inexpensive. It's just hard to get a molecule that targets ONLY a bacterium (or cancer cell) and leaves the rest of the organism alone. So this guy has his work cut out for him and has a lot of competition in other "bioprospectors". His business plan is not in it for the long run of taking a molecule from the field to the syringe - he wants to go back out into the field and get more critters to play with. He wants somebody else to do the real grunt work.

Yep, the system could work better but it sounds like this guy needs to start writing a few NSF grants.

Re:You must choose....

[oh_my_080980980]

Reading comprehension isn't your strong point.

"...little funding is available from the public sector.

Twenty-five years ago, the urgent need to find treatments for HIV became a politically charged battleground. Faced with intense pressure to deliver results, the US National Institute of Infectious Diseases became a center entirely dedicated to virology. This remains the case today, but there are now no national programs aimed at tackling drug-resistant bacteria."

Re:You must choose....

[gtall]

Roughly 25 years ago, I did work on a system that went to a major drug company. I learned that at that time, it cost roughly $1 billion to get a new drug to market. Of the hundreds of candidates that they would start testing, only 1 or 2 would have the right properties of not killing the patient, not having horrible side effects, etc. And the documentation required by the regulators would fill several semis, because it isn't enough to prove to yourselves that you have a wonder drug, you must prove it to the regulators. This is to prevent Joe's Bait and Pharmacology Shop from putting snake oil on the market. Once on the market, your drug must compete against others. And if those others are in their generic phase, you can express pricing pressure as well.

Then the market for the drug must be assessed. In the case of antibiotics, there are many of them out there, many in generics, so bringing a new one on the market is destined to not sell well...at least as long as too many people aren't dying from super-bugs.

This is a prime area for government research and development. The conservatives and libertarians will whine about the fed. gov. getting into the drug business. However, this is what we expect our government to do, i.e., make up for the shortfalls of private industry. The way I look at it, private industry has a big tote board. When frequency of deaths due to super-bugs rise above a certain level, they'll move. Until then, the conservatives and libertarians will gladly attend your funeral...just kidding, they don't give a flying rat's ass about you.

Re:You must choose....

[khallow]

This is what happens when you allow sociopaths to run corporations.

I'm not sure why the /. crowd gets up and rallies around in defense of sociopaths. It seems to pop up in nearly every political or social converstation that is a trigger for American libertarianism

Maybe because a lot of Slashdotters are tired of clueless idiots treating business and enterprise, core parts of modern society, like an incurable mental illness that needs to be scrubbed from the Earth.

Take your two minute hate somewhere else.

They need to do things to improve the way abx work

[Anonymous Coward]

why not have antibiotics that are inactive in the gut and activate on first pass metabolism, then there will be billions of bacteria which are not exposed, thus limiting resistance, oh wait, no one will pay for the development and safety studies necessary, and concomitant use and safety/efficacy studies (why would anyone develop a drug which will loose money like that)

But Pharma said they need protection to do R&D

[Anonymous Coward]

And yet, compensating research and development costs is exactly why the pharma industry's Senators claim the US needs a TPP treaty -- just one that's more stilted in favor of US pharma than the current draft, which they claim doesn't line corporate pockets enough to pass ratification. From Reuters this morning:

[Orrin] Hatch said failing to secure 12 years' protection for next-generation biological drugs could make it hard for innovators to recoup investment in new products, drive companies out of the industry and leave American consumers subsidizing cheaper medicines in other countries.

Of course not

[khelms]

The pharmaceutical companies aren't interested in developing inexpensive drugs you take a few times and then are done with. They want to develop something you have to take for the rest of your life to treat a chronic condition and charge as much as they can get away with. That's why both new antibiotics and new vaccines are seldom developed.

Americans pay far more for their prescription drugs than the rest of the world and the excuse is that we're funding "innovation". Most of the innovation going on seems to be coming up with slight variations of existing drugs in order to extend the copyright and doing their best to delay a generic version of a drug from being marketed.

Even when a generic version of a drug appears, greed is often in play. Just a month or two again, this was in the news "The rights to Daraprim were purchased in August by a new company, Turing Pharmaceuticals, which promptly increased the price from $13.50 per tablet to $750 per tablet -- a 5,000 percent jump -- the New York Times reported."

I talked to a doctor about this one

[phantomfive]

I talked to a doctor about new antibiotics. The problem is you won't make your money back from them. A company has to go through all the trials to prove that the new antibiotic is safe, and than enough people need to buy them to make it worth it. In the case of antibiotics, there are so many already on the market that doctors won't use the new antibiotic, they'll just use existing ones.

Note this only applies to antibiotics......if there were a drug curing malaria or AIDS, it would be a different story.

Re:And the rest of the world?

[blue9steel]

And is the rest of the world the same? It is bigger than the United States, y'know.

Sure, there is plenty of other land mass but they are either over-regulated, poor, or have low quality research infrastructures. The majority of all new drugs come out of research from the United States and that trend has only increased over the last forty years. That doesn't mean everything is happy days here, excessive market consolidation has reduced the number of new substances produced by more than 60%.

Need to get rid of proving drugs are safe

[trout007]

The burden in drug companies is too high. Biology is too complex. If peanuts were a drug they wouldn't get approved because too many people have bad reactions, but they are perfectly safe for others.

All a drug company should need to do is disclose what the drug contains and be liable for fraud if it deviates from this.

I'm confused

[LunaticTippy]

I keep hearing about how there are no new antibiotics, but I never really looked into it. A quick gooble search found 36 new antibiotics currently in development. Some of them are combinations of existing antibiotics (a promising but not very innovative approach) and some of them are new molecules.