Slashdot Mirror
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."
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.
>> They're happy to sell existing antibiotics, but they're not interested in researching and developing new ones."They're happy to sell existing antibiotics, but they're not interested in researching and developing new ones."
Said a guy who hasn't been paying attention to the way drugs get developed in the US? (New drugs can be patented and sold for outrageous amounts of money.) Or maybe the professor just needs to switch to a different university that knows how to monetize his work.
Besides, isn't the market for antibiotics shrinking now that they are no longer routinely prescribed for minor ailments?
"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."
Bullshit. They just aren't telling you about what they're working on, or have already developed but left sitting in their research archives. The Patent Timer doesn't start until they file, and they aren't going to file until there's a need for them. For all this clown knows, they've already got all the ones he has 'discovered' stockpiled and ready for FDA trials.
And there's absolutely NO indication that these ones with "serious potential such as anthramycin" are at all more effective against MRSA than existing on-the-market ones. And if it's not a resistant bacteria, then there's no point in using a new antibiotic and paying a shitload more for a pill.
I get angry at Big Pharma too, but this guy is just running off at the mouth about something he obviously doesn't really understand.
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)
The dwindling effectiveness of antibiotics is a public safety issue. No big company is going to want to take the hit and invest millions of dollars into developing new antibiotics when the return is likely to be a long way off and isn't guaranteed at all. For things like this, it makes sense to use tax money to fund research and then contract companies to develop medicines (or, god forbid, just build some government facilities to develop and produce them there).
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:
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."
But we have no way to develop them. There are no companies in the United States that care.
And is the rest of the world the same? It is bigger than the United States, y'know.
systemd is Roko's Basilisk.
basic/pure research is done through government funding of some form.
Much to the chagrin of the free market zealots.
Drug companies spend more on marketing than they do on R&D.
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.
"First they came for the slanderers and i said nothing."
When patents fail to encourage innovation they need to be changed. Overly long IP rights terms on just about everything is harming American innovation in just about every way possible.
If video games influenced behavior the Pac Man generation would be eating pills and running away from their problems.
The biggest problem is: Antibiotics CURE diseases.
According to Big Pharma there is NO MONEY in CURING diseases. They only want to research TREATMENTS for the symptoms of a disease.
That way instead of selling you a CURE once, they can sell you a TREATMENT every single DAY of your Life. Forever. $$$$$.
Pure Capitalism at it's worst.
This is why we need to vote in a government that does care. Otherwise nothing will happen. The choice is ours.
“He’s not deformed, he’s just drunk!”
of course they don't spend money on R&D, because we won't let them. One company increased prices on one drug to try to fund research on newer drugs, and the news media blew a gasket. I'm not sure how they think that shit gets done or where the money is supposed to come from. Now the goverment is getting into the feeding frenzy.
They increased a cost-to-consumer by over $700. That is not okay, at least not after they have recouped development costs and a healthy profit. Supply-and-demand doesn't work right when you have a monopoly over a lifesaving drug. It's okay to defend big pharma when it comes to recouping development costs of a given drug over a patent's lifetime. It is not okay to defend them when they raise a single drug's cost by $700 overnight.
Despite the lack of press, an incompatible medical system, and dismissal by the pharmaceutical industry, phage therapy has been demonstrated as effective against MRSA.
http://www.prevention.com/health/health-concerns/cure-antibiotic-resistance
I talked to a doctor about new antibiotics. The problem is you won't make your money back from them.
This is *exactly* the problem, and is why constant government-funded work bringing new antibiotics to market should be the norm.
Eventually the market will correct the problem without government intervention, notably when the additional costs to providers from having to deal with resistant complications become too high, but we will take a long time to get there, longer for our investment strategies to catch up, and a lot of people needlessly dead in the meantime.
The article complains that "Despite their best attempts, they were unable to collect enough species (Diazona angulata) to obtain sufficient amounts of the precious chemical.". However this article omits a significant detail: a biologically active analog of diazonamide A was synthesized in 2003 AND he is listed as one of the authors. http://www.ncbi.nlm.nih.gov/pu....
Or perhaps...they'll wait until we misuse the current batch of antibiotics so much that we truly and desperately need a new antibiotic. Throwing a portfolio of effective pharmaceuticals at the market when existing drugs are reasonably effective and profitable might not be in everyone's interest.
Quack, quack.
Too bad the only place in the world you can get your antibiotic developed is the US.
Oh, wait.
Somehow, in the midst of the anti-corporate hate spiels this click bait story was designed to inspire it somehow goes entirely unnoticed that the US is presumed to be the only place the R&D might occur. There is a whole planet full of capital and laboratories you might use.
Of course, you're less likely to reap a collection of beech-houses or A6's if Italy or China funds you. Maybe that has something to do with it...
Nah. Couldn't be that.
The reason it is so profitable for companies to continue to sell old antibiotics is that the research and marketing is largely done. It' s pure profit with no additional investment. And there is no competition because they are protected by long patent terms.
Patents exist (see Art. 1, Sec 8 of the US Constitution) to encourage science and the arts. Not to encourage profit. The Congress has been bought and they keep extending the length of patent and copyright protections.
So shorten the time that patents are in effect. When the old antibiotics become public domain there will be a strong incentive for the big rich pharma companies to invest in developing the new ones.
"He took a duck in the face at 250 knots." -- William Gibson, Pattern Recognition
So lots of people her complain about "Big Pharma" and then go on to claim the socialized medicine in Europe & Canada is a superior model with cheaper drugs. How are they doing developing new antibiotics (or drugs generally)? And how do they how do they finance and amortize the cost of development if selling price is so cheap?
Radiolab just did a story that talked a little about this. I'm not defending the pharmaceutical companies, but apparently one of the problems is that new antibiotics often have a very short window of effectiveness before bacteria develop resistance to them. It might take 10 years and $1B to bring a new antibiotic to market, but then bacteria will evolve resistance to it in 1-2 years. That is not enough time to recoup the R&D costs. Bacteria had already developed resistance to penicillin by the time that Fleming was heralded on a Time magazine cover, for example.
So how do you drive down the time and cost to market? That would incentivize the companies to keep searching.
It doesn't matter if a new drug is able to make 99% of the people who take it better, if it is detrimental to even 1% it never makes it to market. The lawyers pounce on the 1% who had adverse effects and sue the pants off the company who tried to sell the drug. Even if 100 patients had a disease with a 50% mortality rate and this drug dropped the rate down to 10 percent (saving 40 lives), if one or two other lives were somehow cut shorter, the jury will award many $millions.
We need to learn to stop using non-renewable medical assets to create more beef before we license them for sale.
Otherwise, we will just be putting off the coming resistant-strain disaster by months, rather than decades.
excitingthingstodo.blogspot.com
... there were a National Institute, of some sort, focused on Health, funded collectively by annual citizen contributions.
"Two years have gone by since Fenical identified anthramycin and no one has shown any interest in taking it from the research lab to the clinic."
The point of this article seems to be that HIS study on a drug that apparently is as deadly as the disease it cures, isn't a big hit with drug companies. You dont see drug companies pass over anything they might be able to sell to millions of people per year.
The rest of the world wants the US pharmaceutical companies to develop the new drugs so they can be sold in the US at a high price and dumped elsewhere.
It wouldn't be right for people in other countries to bear the actual cost of developing the drugs they use.
Because of so many logical flaws, it's mind boggling.
If it is important to bypass the gut, use an injection. ... leading to higher chance of resistance.
The gut wall is permeable. those metabolites will be in the gut anyways. But in lower concentration
Metabolism is all over the map. Trying to figure out the pharmakinetics of such a drug to achieve proper dosage would be a nightmare.
And finally, it's tough enough finding a drug. Finding a drug that can be created by a metabolic pathway is tough squared.
Yeah, you're going to lose money.
The world is made by those who show up for the job.
"promising chemical" + no investment = bad expected return on investment. How come? That's the central issue, but it's not even mentioned as a question. The reader will project whatever his emotions like as a reason for this outrage, adding to the confusion.
"promising chemical are being discovered, but they're not invested in, so they aren't converted to drugs", we don't even have that fact, since "promising" is not defined, e.g. in terms of a point reached on an ideal drug development route.
On the bright side, ifever promising chemicals are really being left out, it may prove to be for the best for the majority of mankind, since they may be developed only _after_ mankind has been pushed to better strategize its use of antibiotics.
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 love Jesus, except for his foreign policy.
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.
Man, you really need that seminar!
This is *exactly* the problem, and is why constant government-funded work bringing new antibiotics to market should be the norm.
If that were true then why does this problem exist? There are all sorts of governments all over the planet that fund their medical services and R&D through the government. Yet somehow, the only viable place one might find the necessary resources is the US......... and since that isn't working to your satisfaction, your solution is to make the US just like all the places that aren't even considered by those seeking to do R&D......... Brilliant!
You stupid haters are going to crush the last place in the world where there might be some hope of finding funding.
Not at all--I think there is amazing innovation in US healthcare and a massive amount of interest in further innovation. But that innovation follows the money and has to run the gauntlet. When there is something that we clearly need that the current innovation engine will not steer us toward for a long time, it can make sense to tweak that innovation engine a bit--and that can mean throwing public dollars at private industry to incentivize them to actually develop the thing that we need. Part of government's value is to take a longer-term view.
Thanks to over regulation by the FDA it now costs hundreds of millions of dollars in research and in years of testing to bring new drugs of any kind, including antibiotics to market. And those companies which choose to risk spending those millions have only a few years to recoup those millions before the drug becomes generic and the price drops to marginal cost. So companies are less eager to pursue research for which they may never be financially reimbursed and for which they will be publicly vilified for charging a high enough price to recoup their expenses plus a profit for their investors. It is politically and culturally easier to vilify drug companies than to reform an entrenched bureaucracy such as the FDA.
This is one person's opinion that 'they don't care'. Wow. Misleading title as well. They haven't found any of these but they know if others would 'care' that they would be found. Therefore, Like a monkey in the White House the antibiotics DO exist then.
If the US constitution requires the federal government to be responsible for national defense, why wouldn't some of our defense money be spent on antibiotics and vaccines? If the free market is dropping the ball, it needs to get picked up in some way.
Greed is the root of all evil.
Apparently, there are no companies anywhere that care. In fact, of all the countries in the world, the US is by far the most active in terms of new drug development, and the US market has been the primary driver for new drug development. However, with increasing regulation and cost controls in the US health care market, and the potential for a single payer market, the motivation to develop new drugs will likely dwindle here as well.
It works equally well for every situation!!!
Simply require the drug companies to do the needed work to develop the new antibiotics and inform them if they do not make a serious and timely effort that their business permits will be denied and their patents will become public property. In essence by executive action make such actions in the very best financial interests of drug companies.
New radiolap is about this
http://www.radiolab.org/story/...
last antibiotics that got into market developed resistance in 2 years, so commercial companies don't want to deal with this
otoh at least this podcast gives hope (similar to article) that we just have to rotate the antibiotics we have :)
Hmmm, so it looks like patent protection is not serving as a motivation to develop these drugs.
Yet another demonstration of how patents are not actually effective at what they are supposedly "good" for.
I wonder why new antibiotic development does not happen in Cuba. They have the skills, and by design they do not have the big pharma.
If these substances are that promising how come no company from any country is picking this up? Of course the US pharma industry only cares about profit, but surely if this was so promising some other, less greedy company somewhere should surely have taken this opportunity to diversify the antibiotics available. This is especially the case given the concerns about antibiotic resistance.
The FDA has a way to push development of otherwise unprofitable-to-develop drugs, you develop a drug that treats one of the named diseases and you get a voucher that can be applied so your next blockbuster drug gets reviewed and into the market faster. That means you can sell more before the patents expire and it goes generic.
https://en.wikipedia.org/wiki/...
Big Pharma...
1. Buries studies showing dangerous side effects or negative efficacy
2. Refuses to use active placebos or otherwise allows the blind to be broken and improve results for their drug
3. Pays ghostwriters to hide their own authorship of papers
4. Spends a fortune on brainwashing doctors including getting them to prescribe drugs for uses even the FDA won't approve
5. Encourages massive overprescription
6. Crowds out non-pharmaceutical treatment eg in mental health.
What else... the pharmaceutical industry is built around monopolies on drugs which sometimes mean the difference between life and death.
I'm no socialist but if ever there was a case for a state-run industry, it's pharmaceuticals.
I think your response seems to lean a little more towards "Faith-based" than "Fact-based".
Let's consider what the article has to say about the reason antibiotics are fast loosing their effectiveness, shall we?
Unless you want to take issue with the majority of medical practitioners and microbiological researchers, I think we can agree to take the waning effectiveness of existing antibiotics as a given. Simply because microbes evolve, and resistance to antibiotics is a strong survival trait. And why is it a survival trait? Because use in livestock industry (continuous sub-lethal doses of antibiotics in order to increase meat yield) produces the perfect environment for bacteria to develop resistance to antibiotics.
As many of the posts remark, we're seeing the emergence of bacteria that are resistant to many antibiotics, some that are resistant to most of our antibiotics, and a very few that are resistant to every single one of our antibiotics. Way to go, especially since bacteria swap pieces of their DNA on a continuous basis.
The mere fact that "Some people die of multidrug resistant infections, but not many." doesn't mean it's a big problem. That's like someone dropping out of a 40 story building and saying, as they pass the 30th story, "Well, nothing happened so far. The risks must be over-hyped. So lets talk 'economics' about deploying our parachute".
The most effective way to avoid finding ourselves without effective antibiotics is to stop the production of antibiotics-resistant bacterias. As in stop antibiotics use in livestock immediately, barring perhaps genuine veternarian use to treat infection. Also infection rates in livestock production can be reduced fairly sharply by avoiding overcrowded pens. That costs money of course, but in the end it's *our* money and *our* health problem.
The next thing to do is to enforce existing limitations on antibiotics (make sure that loud ("concerned and assertive") patients cannot pressure doctors into prescribing them antibiotics where they aren't medically necessary) prescription and to ensure that people actually finish their antibiotics treatment.
Last but not least we might have a look at how we can ensure development of new antibiotics. E.g. by issuing a fresh 20-year patent if and when an antibiotic actually makes it to market within the first 20-year patent period. If it doesn't make it to market within 20 years, it's not eligible for patent extension.
That ought to ensure profitability. In addition, why not fund additional (university) research into developing new antibiotics, and seek international cooperation to spread the cost? The current road from compound to medicine is a very long one: why not focus more research on shortening that a bit?
It looks like money well spent to me.
Drug companies are in 'health' for the money rather than benefits to humanity.
More news after the break.
Requiem for the American Dream
You should study "compulsory licensing" - warm-and-fuzzy-sounding, but VERY destructive to middle-class Americans scheme.
In 1969, Canada told American drug companies that they could only sell their drugs there for some percentage profit over manufacturing costs, OR Canada would ignore the patents and allow Canadian firms to make and sell the drugs. Faced with the loss of all revenue from all sales outside the US (where sales would compete with the patent-violating and unencumbered-by-R&D-costs versions of their drugs) the US firms caved-in and started selling their drugs to Canada this way (shifting all the R&D costs to the non-Canadian customers). As our "friends" in Europe followed Canada (thus making their socialized health systems more affordable) the prices for drugs in the US went way up with Americans bearing all the R&D costs and then being insulted by Canadians and Europeans bragging about their access to cheap drugs. The American government attempted to protect the companies AND keep diplomatic relations calm by making it illegal for Americans to buy their drugs outside the US (Americans therefore HAD to buy the drugs that included the R&D costs in their prices).
As the AIDS crisis arose in the 80's and Africa looked like it might be wiped-out, a celebrity-driven political movement started to provide the poor masses in Africa with pills they could afford (a laudable cause, no doubt) and the UN and other outfits put the "compulsory licensing" argument into overdrive. Then as seniors in the US started violating the laws and sneaking into Canada to buy the exact same pills (that were cheaper because they lacked the R&D costs in their prices) the US government found itself in the politically-untenable spot of prosecuting poor grannies who could not afford their pills.
Nobody seemed to care about this as all the people outside the US got their cheap drugs. The average American did not notice because most were not paying directly for their drugs (their insurers where paying and the insurance costs were being paid largely by their employers). Third-party payment hid all this from the American voter/taxpayer. In the post-NAFTA era of "free trade" however, American employers have discovered that their biggest expenses (employees with super-high health insurance costs driven in-part by subsidizing the world's drug research) can be eliminated. Now with many American jobs that used to provide great health insurance "outsourced" many Americans are more exposed to the actual costs the US economy have borne for 50 years. As healthcare in the US becomes more unreachable for the middle class, Democrats keep pushing for "universal single-payer" healthcare in the US. The rest of the world had better pray this never happens - because if the US goes single-payer, the US government will have to end all this cost-shifting as a matter of financial survival; it was able to largely ignore the problem when it was a private sector matter but will not be able to when it becomes part of the Federal budget.
There's no conspiracy here, at every point people involved have tried to do "the right thing" for the people they serve. What we are dealing with is a clash between a tidal wave of decades of good intentions crashing on to the rocky shores of TANSTAAFL. The basic laws of economics are every bit as inviolable as the basic laws of physics.
By your argument, people would not make new cars or houses because the average person might only buy one house and a couple cars in a lifetime. The fact that a person might only take a couple doses of a drug and then stop when cured is no deterrent when there are BILLIONS of people on Earth.
The big problem is that drugs face several costs that impact no other product as severely:
1. Very expensive R&D. Development of new drugs costs more than almost any other product.
2. Very risky R&D. Most drug research ends in nothing. Unlike R&D for a car or a plane, which can mutate into a different model that does get produced, the research into a drug can span years and lead to only one drug, which then can be blocked from sale by a single government ruling.
3. Very expensive liability insurance. A single drug can be deemed "safe", be sold to the public for years, and then be found liable for some injury in a court case opening the floodgates to millions of claims in countless lawsuits in which sympathetic juries see a poor victim facing a massive rich company thereby wiping-out decades of profits.
The recent hyper-inflation of a pill price you cited was an extreme outlier, which was why it got so much news coverage; i.e. it was a very unusual event as-in "man bites dog" - the news does not generally run "dog bites man" stories. Let me guess: you think Obama's assertions during the push for "Obamacare" that doctors neglect diabetes patients because they make more money amputating limbs than from curing diabetes.
they are at their most dangerous.
It's really quite simple. Like everything else for USA, you have to rely on technologies and sciences developed outside the US. You don't make most of the thing you depend on to live anyway. Why should medicines be any different. This is what you get for allowing your country to become an R-selected piece of shit.
The profit margins in TREATING a person's disease are higher than those in CURING someone's disease. So you don't even attempt to cure people, just treat their symptoms.
Birds are not dinosaur descendants;birds are dinosaurs, for all useful meanings of "birds", "are" and "dinosaurs"
Antibiotics only work for like 3 years on average, and you can't make your money back.