Slashdot Mirror
Patents Choking Off Medical Research
pq writes "The New Republic has an insightful article talking about the
"absence of truly innovative drugs in current drug company pipelines. And the explanation for that might well come from the supposed fount of American innovation: our patent system." Apparently they are trapped in a situation where "it's much easier to argue that `patents support innovation' than to try to explain that some patents are good for innovation while others are bad." A long read, but unlike the latest copy-protected mp3 player, this is definitely stuff that matters!"
The linked article claims that medical research is being harmed by the patent system, but then provides no concrete evidence to prove this is so. The closest it gets is an assertion that there are fewer new meds being produced -- with the laughable backup of "watch commercials on TV, you'll see!" -- without any exploration whatsoever of possible other factors.
Was there a point to posting this on Slashdot, or are we just trying to jump on an easy-to-blame bogeyman?
If it ain't broke, you need more software.
When is the last time that drug companies actually came up with a cure ?
Answer: NEVER, cures are bad for business.
The last cures that were found (Polio, etc.) were found by independant researchers not worrying about the bottom line and how the stockholders will react)
I mean how many bloody treatments do we need ? Find a damn cure....
UPS Sucks
OK, so part of this can be tossed off as a little bit of paranoia, but the patent issue is only a small part of the iceberg that is medical research. There is a dearth of substances out there that fight depression (St. Johns Wort), cancer, and other ailments that no-one is willing to put through the rigorous testing required by the AMA, and FDA because there's NO MONEY IN IT. They can't patent it, so as soon as it's approved, anyone can sell it. It's a sad but true fact that it happens all the time. If you're intersted in starting down the road of true paranoia, look at When Healing Becomes A Crime, The Harry Hoxsey Story if you can find it. try here if you're interested
Look, I'm sorry. I personally don't give a flying fuck about Michael or any others of the Slashdot crowd.
This is not a professional news organization - for that, I'll watch 60 Minutes, Dan Rather, or people who make a good buck doing nothing but finding shit out that I think is important.
Michael, Taco, Cowboy, and the rest are just guys saying "Hey, this is something I thought (or some poster) thought was interesting, and here's my $0.02 on it."
Don't like - go get your own damn web site. I don't have time for arrogant pricks like yourself who feel you have to bash somebody because you a) don't agree with them, b) don't share there interests, or c) expect them to be more/less than they are.
I'm getting off my soapbox now. I'm gonna go have some toast with peach and raspberry jam.
52 Weeks, 52 Religions with John Hummel
My sister used to work for Bristoll Myers. One of her main points was it takes an excess of 8 years to perfect a drug. Wherein a list of ten potentials you may get one that qualifies for clinicals. Now keep in mind your development team for lack of a better word concist of PhD chemist and Biologist commanding a 6 figure per anum paycheck. Now the catch is after all that R&D investment drugs that pass clinicals only have a patent lasting 5 years before generics can be made. Thus the consumers take it in the pocket with high drug prices.
For once I actually RTFA, in particular I was looking for explanations for how patents could actually harm research. These can be summarized as:
1 Companies put a lot of effort into getting patent protections extended and generalized, without really improving the product.
2 Companies are reluctant to start completely new research because there is a great risk of infringing on somebody else's patents.
I am a proponent of patent protection, but these two arguments actually made me think again. As the comment goes: it's much easier to argue that `patents support innovation' than to try to explain that some patents are good for innovation while others are bad.
That being said, I think we should stay with a few solid principles rather than laying out a complicated network of legislation to maximize some utility function. The latter is an invitation to a situation much worse than today.
Tor
As this article points out, one reason big drug companies are stepping away from AIDS drug innovation, at least, is because of AIDS activists and other anticorporate do-gooders. By forcing companies to practically give away their drugs to the third world, these misguided crusaders have removed all incentive from Big Medicine to research new AIDS drugs. Any new drug development requires an immense amount of R&D capital before a cent of profit can be made; and no intelligent CEO is going to throw billions at a product that'll wind up being either given away or copied illegally by third-world manufacturers.
--
CPAN rules. - Guido van Rossum
I think one solution would be to put a cap on the royalties that one has to pay to X percent of the product revenue. If multiple patents are involved, then the *total* still would be no more than X percent. X is simply divided up among the patent holders.
There is too much all-or-nothing problems and out-of-the-woodwork surprises right now. If you know that the total will be no more than X percent no matter what, then you are more likely to take the risk. There is too much "patent paralsys" right now.
Table-ized A.I.
Just about every major drug development in the past 15 years has come from the public sector, not the private sector. Cancer drugs? Almost 100% public sector. AIDS drugs? 100% public sector. Antibiotic research? ...Same thing.
...Or change one molecule, or change chilry slightly in the process ... Or launch patent on what the drug becomes once it enters the body to extent patent ...Lobby congress for patent extension ... etc
..That's 90%.
...And you have some real scum at work.
What is the private sector doing? "Weekly" Prozac, "Extended Release" Acyclovoir, "Controlled Release" Pain Killer/Paxil
I'm not saying that some of the controlled release drugs aren't quite useful -- but the mechanisms for making them controlled release are rarely innovative. Add Wax, or Cellulose to pill
Add in captive market pricing (drug in US $212, same drug in Peru $7, same drug in Mexico $12, same drug in Australia $117).
But drug companies have some some other shady things -- like using their influence at the FDA to keep new drugs from Europe off of the US market while they work on a one off version for release here. I'm sure some countries in Europe are doing the same thing. One of those areas that trade treaties don't really cover well.
Freedom is merely privilege extended unless enjoyed by one and all.
The cliché of the moment is that pharmaceutical companies have picked the low-hanging fruit, developing drugs that interact with the limited number of enzymes and molecules that we already understand and have thoroughly modeled.
And some luddite famously quit the Patent office in 1870-something because he determined everything that could possibly be invented had already been invented.
Corporations aren't like people. If you leave a guy alone to do his job, he generally does it and even finds a better, more eficient way to do it than you taught him. If you leave a corporation alone to fulfill its mission statement, it tends to get lazier and lazier and do less and less
Before the free-market theologians jump in and remind me that a corporation's sole purpose is to make money for its shareholders, let me quote some mission statements from phramaceutical companies:
Those were just the first three I happened to look at; the rest seem similar. So, there you have it straight from the horse's ass^H^H^H mouth: these companies' missions are not primarily to return profit (Genentech doesn't even mention that); all three have medical innovation and discovery as their primary mission. Just goes to show you can't trust a corporation to do what it sets out to do.
All's true that is mistrusted
It's a difficult thing to prove quantitatively (although the market woes and the lack of any new groundbreaker like Viagra and Prozac in the pipeline is mentioned .. did you want that in a pie chart?) .. especially since the questions of what drugs are important, which arn't, whether some drugs are actually better than the problem they cure .. these are not neccessarily quantifiable things.
The thing is, most of the people I know in the scienitific community right now agree with that main charge of this article. Yes, patents are important, but there is a crowing concensus that simply allowing anything and everything to be patented (which is increasingly the case) harms the very industry that patents were put in place to support.
We've become so engrossed in the battle for the pie that we ruined the pie for everybody in the first place. There's plenty to share, so we shouldn't focus so hard on ensuring that yoou'll get your pie. Or in another analogy, if capitalism is people in competition to the finish line, we've gotten so good at tripping each other up and not actually runny that we might as well have all walked the distance.
Yes, there is no quantitative proof, but the way the industry operates, you'd have to wait 5 or 10 years to see the effects that the current research climate has on the consumer end of the industry. So, we have to rely on people in-the-know to identify problems and solutions before we can tally them on a spread sheet.
"Old man yells at systemd"
That's total bullshit and you know it. Which drug companies are tripping the others up? Are the Merck people sending spies to Pfizer to poison their samples?
Listen to yourself, dude, you're just babbling.
If it ain't broke, you need more software.
I tend to agree. There isn't a new arguement here, and none of them hold water.
A good bit of what I read was a poke at the prices of new drugs, and a drop in investment. Well, new drugs are expensive to produce and test thoroughly. There's the expensive research to find a new treatment. Then, there's the expensive and extensive government-mandated testing to make sure the drugs won't do more harm than healing. After that, before the drug can be marketed, it has to be patented... which means telling everyone else how to make it.
And there's only a short time period for the research company to recoup its expenses before the 'generic' drug companies are allowed enter the market... to produce the same drug, without all the R&D costs. If it's an extremely useful drug, you'll hear of people lobbying the government to let the generics start early, cutting in on that short time period the patent-holder has to recoup losses and make enough money to satisfy the investors. And now, you've got more folks wanting the government to step in again and engage in more price-fixing for drugs used by retirees.
Whenever the government limits the odds of receiving return on one's investment, investment will drop. And that applies to the investments of time and effort by drug researchers as well as the financial investments from Wall Street.
Good judgment comes from experience.
Experience comes from bad judgment.
You hold a typical cynical teenager view of the world of medicine, here.
First, what's the difference between treating and curing a disease? Last time I checked the only way to "Treat" a virus is to kill it or disable it. Infections? Try antibiotics (they ALL cure infections). Bacteria? Again, can't treat without curing.
I'll cut you with my razor now, it's so simple anyone can see it:
All the companies are looking for cures, because if they're the first with a cure for a disease they'll make *billions* of dollars. There are always moer diseases coming.
Moderation: Put your hand inside the puppet head!
The fact that so many of these posts are modded up as "insightful" is insane. The biotech industry is one of the fiercest out there.
Patents hurt drug companies as much as their business model and costs do. They must constantly produce *results* and *product* at a much higher rate and much more competitive environment than most industries. Without upstream patents, anyone could horn in on development and steal it away. Recent innovations in Solid Phase Synthesis really streamline the production of analogues to various drugs. Once something is found that has the desired effect (to any degree), all related compounds can be made AND tested in a very short time. The long period is in clinical trials and FDA approval. So once a company finds something and patents the process, it can own a whole set of molecules. So if any information is leaked out, a rival company could have found a better/more active/more specific similar product in a very short time. With the short duration of downstream patents and the high cost of R&D, the biotech companies have a difficult struggle to stay afloat.
Not to mention competition from universities, whose costs are paid by the government. The lab I work in, which consists of just 5 people, easily spends $2000 A DAY on just supplies.
So, a hard question is raised: How do you allow these pharmaceutical companies to compete in such a tough environment against competitors that have no costs and deal with patents, while still promoting miraculous developments? Our current system seems do a good job of most things, though generally poorly. I really don't have an answer.
One company, however, had a good idea. They gave us several thousand dollars in new product (which needs some testing as to what it does and is good for), some more money to pay labor, and just expects us to publish some (hopefully important) papers about it. The university is getting most of the cost of the research, and the company will get good advertising for their protein complex, which they can then sell. Seems like a good bargain, on a small scale.
Quick overview.
1. Pharmaceutical companies have big ties into our government, controlling legislation.
2. Pharmaceutical companies can patent receptors which blocks other companies to interact with those receptors.
3. The FDA has limited manpower, which means less drugs tested.
4. Knowledge which researchers shared freely, is now corporate information, and locked away.
5. Pharmaceutical companies are holding licenses. Screwing the public on new drug treatments from other corporations.
And my favorite.
6. breweries-and-distilleries index are up 25 percent; shares in the pharmaceuticals index, meanwhile, are down 25 percent.
Read the article again. They explicitly mention hepatitis research, and Harvard suing over osteoporosis research. Then there's the suggestion that HGS may be able to interfere with AIDS research. And aside from screwing other people, Big Pharma is now trying to squeeze every little bit of life out of existing products for which it has patents (or can get bogus new ones) rather than doing actual innovation.
This isn't *quantitative* evidence, but it doesn't sound like the author just pulled all this out of his ass. And as a biomedical researcher, I assure you there is a huge body of evidence to support the article's assertion which did not appear there.
I'm sure Michael understands why DRM is pretty important and why the other issues matter, but what you don't understand is, his point wasn't to dismiss DRM and other technology issues, but rather highlight the apathy to these issues.
What you don't SEEM to understand is, while MP3 patents and DRM issues are very big issues that will really affect us in 5-15 years time, people don't care or understand it yet. People understand when you tell them the patent system is gridlocking medical advancements (Cancer, HIV cures).
What you also don't seem to understand is that we're a small voice of people who despirately need allies with organizations who have issues that people care about (Cancer research, HIV). First, you have to understand that a lot people won't care about DRM and MP3 patents. You're going to have to find another reason to get them to care. In this case, it's using HIV and Cancer issues to get people caring about an issue that affects us (Corrupt patent system). If we're smart, we'll would leverage the business interests of ISPs and consumer electronics on DRM issues.
In other words, you need to give people a simple reason to care. Expecting otherwise is just stupid.
"Communism is like having one [local] phone company " - Lenny Bruce
>Which drug companies are tripping the others up?
.. there comes a time when you're spending so many resources on trying to be competative other than the actual market fitness of your product that you sacrifice the over-all quality of the product being produced. One example: My father, being a principal R&D guy at a pharmaceutical technology company, was involved in patent litigation that delayed the development of a product they were working on. You simply cannot assume that the cost of not enforcing their patent ALWAYS outweigh the costs involved in filing it, defending it, nor preventing other companies from building off of it. You can't predict the future, either, which means that theres no way to actually prove that had you not filed/enforced a patent, you wouldn't be better off for it.
.. some patents are getting in the way of the very goal (to create better drugs) they are supposed to encourage. I have never met anybody in science who doesn't recognize that you can have too much of a good thing when it comes to patents. So then its just a matter of, like I said, figuring out the point where people are spending more time/money trying to defend what they have instead of using that time and money to do what they are chartered to do.
s/tripping/patent-litgation
So, effectively, you're saying this entire article is BS. Which I assume means that you believe that the actual granting, defence, and enforcement of patents can only be good, regardless of the situation, whats be patented, whos patenting it. It can only help humanity, right? All patents. More patents! More!
No
Tripping each other up doesn't imply illigal action, it implies exactly what the article implies
"Old man yells at systemd"
but he still has HIV, the virus that causes AIDS, in his system. AIDS is just a state where your immune system have been broken down to the point where almost any virus makes you quite ill. Many people who have HIV do not even develop AIDS for years.
I am not joking - there must be loads of chemists and doctors out there who could make it work.
They could do research, and let drug companies make a small profit out of the resulting product - after all, the drug companies wouldn't have had to pay directly for the research - in return for the drug companies agreeing to do research such as clinical trials, which has to be government monitored. The governments could give large tax breaks for the drug companies supporting the successful drugs, which would urge them to take it seriously, not just sit back and think, 'ah, we can make some residual money on this'. There should be big bucks for a cure for cancer, and honors for the sponsors, and open source scientists, who lets face it, would be able to get a job just about anywhere if they were credited in that way.
For crying out loud, people are dying. The open source model could really do some good here.
1. Drug companies exist to make profit for the shareholders.
2. Drug companies seek to maximize their profit by extending patents.
3. Presumably, money cannot be spent on both legal matters and research.
So it is the extensibility of patents, and not patents themselves that is "choking off" research. This is a very different thing to say than "the patents are choking off research". To fix this problem, if it is a problem, we need to tighten the laws regarding patent extensibility. Agreed?
This whole golden goose B.S. bugs me. Can someone explain to me why someone would shell out 50 million dollars to develop a drug if, after the research is complete, my competitors can benefit equally from it?
I think the general idea is to socialize drug research. That would be great, because then results wouldn't matter. Not only that, but we would have a value judgment forced on everyone as to the value of drug research (I don't care if you think that paying your credit card bill this month is more important, we're still taking your tax dollars for drug research).
The real problem here is that people just cannot deal with the fact that there's only so much money and time and resources to go around. We wish that everything could be a priority. But it can't, so we have to use some system to ration those scarce resources. A free-market system says that resources will be rationed according to private agreement and negotiation, but there's always a few "never studied history much" folks who think that concentrating power and information is the way to Utopia. The road to hell, etc.
If your bitterest enemies are people who hack the heads off civilians, then I would say you're doing something right.
Its an article, not an indepth research study. Most people will only read bite sized articles as this, and thus get a small education on the problem.
Look at the laws being passed about drug perscription prices, the news articles on price fixing on drugs, the patents on genome. AIDs drugs waiting for FDA approval.
Use the article for what it is, a spark to make you think and ponder.
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The advertisement is the most truthful part of a newspaper. - Thomas Jefferson (1743 - 1826)
The more you tell a kid they cannot do this or that, the less they will do in their life.
The more constraints you apply in the way of "Cannot" based laws, the more constraints will constrain.
It's really all rather inherently inherent.... knowledge begets knowledge unless knowledge to constrain begets more knowledge to constrain.
What we really need to do is grab a copy of the Declairation of Independance and use it as a inspiration to write a "Freedom to Innovate and Be Creative" document that will act as a foundation for creating laws that protect innovation and creativity, rather than suppress such.
Hmmm now where is Lawrence Lessig and the EFF in supporting the proactive offence rather than being bound up in subjective defence?
Is this guy supposed to be telling us something we don't already know?
We all know damn well that no company in any industry is concerned about their consumers/users and the public good first. Companies are only concerned with the bottom line; those that aren't go out of business. A companies first goal is to make money, and the public good, consumers, users, the environment, anything, is only secondary and considered in regard to how it affects the bottom line.
This isn't something companies should necessarily be chastized for. Their first obligation by the law is to maximize profit for their shareholders while obeying the law. But some companies use illegal, immoral, or unethical means.
What this means is that you can't trust anything a company tells you. A company's position on social issues is never consistent and will always vary, depending on what will benefit that company the most. In "The Future of Ideas," Lessig noted that AT&T's position on whether or not cable lines should be open changed when from "open access" to "no way" when it became a large owner of them.
That said, some industries have engaged in reprehensable behavior (biotech, software, etc), while others have no (referring here to non-technological industries, such as clothes industry).
In particular, the biotech industry has:
(1) Biopirated (stolen) treatments and cures for diseases from indigenous peoples around the world, patented those ideas, then turned around and charged indigenous peoples for the cures they themselves created.
(2) (In conjunction with the software industry) extended patent rights and duration beyond all reasonable grounds. Companies can patent things for which they do not even know what they do. They can also receive patents on very basic and primitive things which are no-where near leading to a drug, but which will be needed to be used in the research necessary to product a drug (upstream patents). Upstream patents should be retroactively eliminated (retroactive elimination is OK in this case because the gov't had no right to create them in the first place). Only downstream patents on a specific drug should be allowed; minor modifications to the drug should not result in a new patent. The standard for obtaining a patent needs to be dramatically raised. Every minor and trivial adaptation of an existing drug does not deserve a patent. Furthermore, patents on downstream drug products should not apply to basic research. Universities, governments, and companies should be able to obtain the drug in question for research purposes at the cost of production, without licensing hindrances.
(3) Denied people much-needed cures/treatments to further their bottom line. Companies have prevented patients from being treated so that they can get royalties on drugs. Lets save some scorn for the Universities too, which are recently becoming nothing more than corporations who also teach and train. My own University of Rochester was granted a patent to cox-2 inhibitors, which are used in Celebrex's anti-arthritis drug. The University received a patent recently (after Celebrex created the drug) and then filed lawsuite against Celebrex, potentially stopping those suffering from arthritis from getting the drug. While my respect is due to those at the UOR who researched cox-2, that research was done using public grants (which come out of the taxpayers pocket) and using the tuitions of students. It should be put in the public domain.
(4) Denying people in third world countries cures. Rather than allowing companies in third-world countries to make generic drugs and sell them cheaply (saving millions of people's lives), drug companies have tried to prevent such. Blinded by their greed, they have failed to realize that you can't squeeze water from a rock. Perhaps drug companies would be happy if people in the third world started selling them their body parts in exchange for drugs.
(5) Used propaganda to create the illusion that certain illnesses exist which in fact don't, boosting the sales of marginally useful drugs.
(6) Spent far far more money on lawyers, public relations, lobbying, and paying greedy executives than on actually doing research to find cures (not that any company is researching cures anyways).
I could go on and on.
The point is this patent non-sense has to stop. Its a problem everywhere, but most importantly in the biotech industry where its a problem that get people killed by preventing people from being treated, or preventing cures from being researched. As harmful as copyrights are given the fact that their scope is overly broad and their duration overly long, patents are an even bigger problem for the same excesses.
Initial innovation needs to be followed by subsequent innovation, sequential innovation; patents, in their current state, prevent this. I have a simple solution for this:
(1) Reduce the duration of patents. 10 years instead of 20.
(2) Force patent-owners to license patented drugs to those who wish to incorporate them into a product to be sold. A forced license of 50% of the profit from the venture going to the licenser is fine.
(3) Force patent-owners to license patent drugs to anyone for research purposes under a minimally restrictive license. The drug should be provided (for research purposes) at the cost of production, and the only limitation to the license to use it is that the drug itself cannot be sold.
(4) Prevent drug companies from strategic licensing. A company sitting on a patent while research is done based off of that patent and mentioning nothing, then when a product is made, suing for royalties, should be prohibited. (I'm referring here to the same thing happening in the drug industry [i.e., with cox-2] that happened with MP3's).
(5) Retain a much stricter patent-granting scheme. Patents should not be granted for things which aren't really innovative. Currently, patents are granted on every minor modification of an existing drug.
(6) Hold a strong stance on patent nullification of patents ill-gotten. Patents should not be granted for drugs obtained via the results of biopiracy. Those which are discovered to have been obtained from that should in invalidated. Similarly, patents should not be granted on things which were previously invented by others. Should such happen, the patent should be invalidated.
(7) Punish companies for inappropriate patent behavior. If a compoany inappropriately attempts to use its patents to halt, or obtain patents by biopiracy, etc, it should lose all of its patent rights.
(8) Prevent universities for filing for patents, or if they do, require them license the patents under a "patent-left" license. Universities obtain their money for research from the public -- from government grants, funded by the taxpayers, or from students tuitions (also basically the public). Thus, their discoveries and/or inventions should either be in the public domain or patent lefted; i.e., a license corresponding to that of the GPL -- any discoveries/inventions using this patent must either be put in the public domain or licensed under this license, which allows unabridged access.
It is ever-important that we put these kind of restrictions on drug companies (and any technology companies). They will not govern themselves and act morally; indeed, it would be double standard to expect them to do so, since our laws require that they use any and all legal means to maximize profit for their shareholders. Thus, we need to make laws which prevent this kind of nonsense.
social sciences can never use experience to verify their statemen
http://www.despair.com/consulting.html
"if you're not a part of the solution, there's good money to be made in prolonging the problem."
when religion is no longer the opiate of the masses, governments will resort to real opiates.
AFAIK, Ciprofloxacin is one of the first totally synthetic antibiotics - it acts by preventing DNA replication and hence cell division. Most antibiotics previously came from fungus and mold.
Isn't Ciprofloxacin patented by a major drug company?
The drug has to be patented very early in the process, because all of the research that proves it's effective has to be peer-reviewed. That means that a huge fraction of the R and D cycle is actually eating up patent years. It also means that you end up patenting a lot of things the FDA will never let you sell.
Thanks for the clarification. I don't actually work in the industry, I just have a friend who has a family member that does. I knew all of these steps had to be taken, but not their order off the top of my head. It sounds like yet another chokehold on the industry.
Good judgment comes from experience.
Experience comes from bad judgment.
Celbrities, Pharmaceutical Researchers Urge House to Reject Patent Legislation that Would Harm Patients
Drug companies have 20 years from the filing of patent to have exclusive rights to the drug. After going through NDA and FDA approvals the average drug gets 7 years on the market. Meanwhile, hundreds of millions of dollars are needed to be recovered in 7 years.
If we combine the effects of foreign governments not allowing US based companies to charge for "R&D costs" (they allow a small amount of profit), US citizens usually get a bum deal in terms of name brand drugs. US residents are accustomed to paying high prices. That is why the main R&D center of the largest British pharmaceutical company is located near Philly.
Luckily this summer, the Senate passed the Schumer-McCain bill that helps boost access to generics and boosts competition. The traditionally self-competing and bickering major generic manufacturers also have formed a pharmaceutical association in a similar vein as the major pharma companies.
I am a med student who is concurrently getting an MBA in health administration. The current health care costs are 14% of our GDP (~$1.4 trillion) and drugs are the fastest increasing component of the cost.
Please, if we are all to help force down drug prices, ask your pharmacist for generics
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I'm just an ordinary man with nothing to lose.
I work in an industry that supports the very early stages of drug discovery at all the large pharmaceutical companies, so I can give you a different perspective than the author, who is apparently not a chemist.
First of all, the complaint that "Nexium... is essentially AstraZeneca's old heartburn drug Prilosec with a minor chemical twist that allowed the company to extend its patent." is shallow. Prilosec was a racemic mixture - a mixture of two mirror-image molecules with the same atomic connections. This is the old way that bioactive molecules with one or more chiral centers were patented and sold, because it was too expensive or impossible to separate the mixture into its chirally-pure components. Unfortunately, the mechanisms of the body are chiral, and often it is only one of the mirror-images which is the active ingredient. The other enantiomer is at best inactive and at worst toxic, mutagenic, teratogenic, etc. It is only with the chiral preparative and analytical methods and tools available in the last 15 or so years that it has become economically feasible to either prepare only the active enantiomer or to purify away the undesired enantiomer from the mixture. This is what AstraZeneca has done. From Prilosec to Nexium is not a minor chemical twist - it is a profound biochemical change. In the meantime, anyone else could have separated Prilosec into its components and patented only the active enantiomer, which is what a company called Sepracor has been doing. Sepracor is a company specializing in chiral separations. They have been taking patented compounds and isolating and patenting the active ingredient. Sometimes they license the compound back to the original manufacturer, but if the holder of the patent on the racemic mixture doesn't want to pay, Sepracor sells it themselves or in partnership with another firm.
Second, my customers are under constant pressure to shorten the discovery pipeline so that successful drugs can be sold under patent protection for as many years as possible. That means more work for me, luckily. To argue that the patent process is wrong or flawed is to ignore the full shelves in the pharmacy. If it weren't for the patent process, those bottles would be full of roots and bark. (Not that there is anything wrong with roots and bark, just that they may also contain toxic compounds.)
Which reminds me of: third, the author confuses small-molecule patents with biochemical patents. The old school (classical small-molecule therapies) patent system works pretty well. You get some years to make money to fund R&D on new drugs. It is the silly biochemistry and genomic patents which are insane, and the patent office has let them get away with it. From PCR to broad gene therapy claims based only on sequence - that process is as flawed as the software/business model patent crap that is every fifth story on slashdot. This is the area the author should have concentrated on.
Last, the author gives the impression that there are no new areas for drug therapies out there. This is just a lack of effort on his part. Most drugs initiate change in the body by interacting with receptor proteins on the outside of cells. And each type of receptor - the calcium channel, for example - comes in subtypes which may be expressed in different amounts dependint on tissue type or even on different areas of the same organ. Many of the drugs currently in use do not differentiate very well between the receptor subtypes to which it binds or interacts. There is a huge opportunity for development of drugs which are more and more specific to a specific receptor and so demonstrates fewer and fewer side effects - which are manifestations of interactions with other receptors than the family targeted. The combination of high-throughput screening and combinatorial synthesis, both of which are still in their early stages, promise to supply us with many times more drug candidates than classical one-pot organic preparations and one-rat-at-a-time testing of those compounds.
If Slashdot were chemistry it would look like this:Cadaverine
It doesn't just live in the blood; it lives throughout the body, in any cell, just like any other virus. It's easily transmissible by blood, but it'd also be easily transmissible through, say, liver chunks.
--grendel drago
Laws do not persuade just because they threaten. --Seneca
Just about every major drug development in the past 15 years has come from the public sector, not the private sector.
Simply not true.
Antibiotics are mostly private sector. You might be implying that drugs that are life preserving don't usually come from the private sectors. There are plenty of good examples of life preserving drugs (antibiotics). There are also plenty of good examples of life-enhancing drugs (omeprezol - Prilosec). Or the combination of the both (silfenildil - Viagra was originally indicated to reduce heart attacks, but it had an interesting side effect).
IT IS NOT CAPTIVE MARKETING!!! Blame foreign governments for the high prices here. They don't allow drug companies to charge for R&D costs.
But there are two sides of the argument here too. Here's an analogy The US may be seen as flying first class. They get from point A to point B but pay a much larger price than those in coach (foreign citizens buying drugs). But if airline companies started charging less for first class and distributing the cost to coach, then fewer people are inclined to pay for coach. There are much fewer people on the plane. The plane never leaves the ground.
---
I'm just an ordinary man with nothing to lose.
The article also seems to avoid discussing:
1. the rigorous standards and testing imposed by the FDA (which are a GOOD thing, but make truly innnovative drugs much more difficult for companies to gain clearance to manufacture), and
2. frivolous lawsuits like the current drug-dilution suit being brought against a major manufacturer. A pharmacist is accused of diluting the company's medications and thereby lining his own pockets. The company accused of compliance has no reason for it; they actually LOST profits through the pharmacist's actions. The legal eagles are going for where the big money is, but such situations waste time and resources that could be better spent on research.
You know, that may be the best idea I've heard for this in a long, long time. There exists plenty of science which is good for people but bad for business---cheap launch technology, vaccines, that sort of thing. A bounty system would make it good for business.
Of course, you'd run into nightmarish problems with fraud and deception---with that much money on the line, it not only becomes profitable to research, it becomes profitable to cheat. You'd need an honorable, impartial judge (or panel thereof) to test the supposed cures.
All it takes is one crazy millionaire to get the ball rolling and set up this foundation. Any takers?
--grendel drago
Laws do not persuade just because they threaten. --Seneca
Isn't this the definition of an abuse of monopoly power? Where a select few giant companies conspire to keep the market from functioning at full efficiency in order to squeak out a few more billion bucks?
I wonder if there are any smoking gun memos, like the ones from the cigarette companies describing their plans to market smoking to kids. Only this time, the smoking-gun memos would actually surprise some people.
Shit, now that I think about it, it would solve nothing and just create a gargantuan windfall for a select few elites in the lawyer class. This is depressing---is there any way we the people can win?
--grendel drago
Laws do not persuade just because they threaten. --Seneca
I have a genetic indicator for hereditary hemochromatosis, or iron overload. Basically, this means I'm at a higher risk to develop HH, which can cause iron to build up my body. The excess iron, over time, kills off your liver, gives you heart disease, and basically makes your life hell.
However, there has been very little research on the illness, even though it is one of the most common genetic disorders found in Americans. Why? Because Bristol Myers Squibb owns the patent on the genetic test to find that gene sequence, and charges labs to use the test, or do anything at all with that genetic sequence. Most labs can't afford the fee, nor can they afford the legal battle if they ignore BM.
And treat like a real war: the US has the best military in the world through a public sector dominated partnership with the private sector.
s p
While free market evangelists will defend the pharm industry with their dying breath, it's obvious to the rational that there are inherant conflicts between finding the best cure and making the most money.
So we should treat the fight agains disease as the war that it is: it's a war America is losing, millons of our people fall to this enemy every year.
The main difference from the Iraqis or wild lions doing this is that the enemy is microscopic, but why should that stop us from realizing we are in a WAR with disease, not a market?
The new front is regenerative medicine, and it may well not be very profitable. But it has the potential to lead to real cures...
More:
http://www.liebertpub.com/reg/default1.a
Why is holding a legal monopoly over bodily functions fostering medical improvements? Medical costs are going way way way up. This is an honest question: has anyone shown that patenting bodily functions has improved medical care in the US?
What happened with being first to market? If one company discovers WonderDrug A cures all that ills, going to market first assures some profit right? As market forces settle in, it then becomes who can make the better quanties at a lower price.
The problem with current medical patents, as with many patents, is they are too far reaching. *Anything* that has to process BadGene B can be patented even if the resulting medical conditions are seperate. Are companies even sure what BadGene B is linked to when they patent or is it just "patent squatting"?
I don't know...I seem to remember Salk saying he wanted to make the vacination for polio because he got tired of seeing people suffer. The fact he got money and glory for it after seemed like a nice bonus. Where did that kind of thinking go?
Me: Why would drug companies make a treatment when they can make a cure?
Me: Simple. If you charged people $100,000 apiece to get a cure for AIDS, they would riot in the streets and burn you in effigy.
Me: If people would riot for being charged $100,000 for a cure, then why aren't they rioting for being charged $5,000 a month for a treatment?
On a different note:
I agree with most people above. The bottom line of $5,000 a month for 20 years is more appealing than $100,000 a head, and it's just that simple. Especially when that disease is communicable, such as AIDS or HepC. Cure it, and it goes away, treat the symptoms, and everyone gets it.
And, on another different note:
Am I the only one absolutely disgusted that research into a cure for AIDS or Alzheimers is being shut down because somebody put a patent on an enzyme? And, more to the point, am I the only one disgusted that drug companies are allowed to make massive profits? Sure, a resonable return on investment should be expected for investors, but to put the future of the species into the hands of Wall Street? I find it humourous that congress can pass legislation encouraging drug companies to test drugs on children, but it can't put strong federal backing behind a cure for AIDS or cancer. Cure those, after all, and thousands become unemployed. Treat them, and everyone gets a nice, cushy job taking care of the sick.
My grandmother died of a disease that had a cure "in the pipeline". Clinical human trials started just a few months after she went. I found out years later that the drug could have been available almost 10 years earlier, but a copyright lawsuit held everything up as it was appealed to higher and higher courts.
What scares me is not that this happened.... it's that it might happen to me.
If I knew the wedgies I gave you back in 6th grade would have resulted in this . . . I might have taken a moments pause.
..or PBS for short is the drug subsidising program of Australias social health system. It provides government subsidised prescription drugs (often 75% of the cost or higher) to every australian as long as it is part of the extensive list of drugs that is PBS subsidised.
A drug may be approved for actual sale in australia, but until it is on the PBS list it is unlikely to be very often prescribed, especially if there is a suitable equivalent drug on the list. What does this mean, "me to" drugs from different companies that treat the same conditions or for a drug with only a marginal benefit usually are sold at a much lower overal cost (before the subsidy is included) compared to the US.
The commitee of health professionals that decides which drugs are included are able to negotiate with drug companies from a very strong position, if the companies don't get their drug on the list, they won't sell much of that drug in Australia.
Effectively it is a system for the whole of australia to bargain with drug companies as one large block. And is the reason Australia has one of the lowest (for a while was the lowest, not sure at the moment) per capita spending on drugs in the develop world. Oh and the drug companies absolutely hate it.
Sorry, but I work in a related industry and must disagree with your theory that a cure must be less profitable than a mere treatment.
Firstly, it is a FACT that quite a few medication plans cost more than 10k a year. 10k up front is chump change actually. I can name quite a few medical devices that cost this much and they're all up front. So to say that people would necessarily not accept a one time treatment payment plan following a similar payment schedule would be to ignore the evidence.
Secondly, the insurance companies who generally cover almost ALL of these kinds of treatments would look at this fact a lot more rationally. Although the the insurers may far prefer dragging payments out from a cash flow perspective, a perfect cure greater than the sum of the cost of the treatments up front could easily be highly desirable to them. (and if it's too burdensome a mutually agreeable payment plan could be arranged). For one, the costs associated with side effects (in terms of cost to them), imperfect treatments, costs of repeated approval of medical expenditures, and so on can easily outweigh the cost of the "cure." In other words, it could be a lot cheaper. Diabetes comes to mind.
Thirdly, a good cure for any given ailment would almost surely represent 100% market penetration which would be a large increase for the drug company in almost every case. Remember: each successive treatment (even if only an incremental improvement) for the same problem costs a lot of money to develop, each problem has a number of different competing solutions (none the same, patents have limited lifes (especially once you finally clear all the regulatory hurdles), establish the brand, etc...but a cure would presumably take them all) The drug company would be far better off with 5x as many sales, even if they only sell it at half the price of their previous treatments.
Fourthly, a cure would allow the drug companies to cut out the middlemen a lot more easily, thereby improving profitability.
Fifthly, a cure would drastically reduce the marketing costs (because it would sell itself to a much greater degree), which would increase profitability in a major way.
Sixthly, it is possible to practice discriminative pricing. In fact it is done all the time today. In other words, medicare patients will often pay a fraction of what someone with a good PPO will pay. To the extent that someone is unable to pay, the drug company can tailor its prices reasonably well and the government can also step in and help subsidize costs.
Sixthly, make up your mind. You guys want to say that corporations are driven entirely by the short term, yet you contradict yourself by saying that they wouldn't do this for the long term. To the extent that they care about the short term, they would certainly go for the cure because their revenues would surely be much larger in the first 2-3 years.
Seventhly, it is a highly competetive market and in any given market, there are a lot of companies that have almost NO market share. You can be sure that if they were sitting on a cure that they would exploit it. This is especially true for those companies that are desperate for growth today.
Bah. I won't bother any more, I've got stuff to do. Bye
Drug companies have 20 years from the filing of patent to have exclusive rights to the drug. After going through NDA and FDA approvals the average drug gets 7 years on the market
A question for you, which you may not know - why so long? Yes, you have to do both animal and human testing during that period, but why is it taking (on average) 13 years to do all of this? As I understand it, the standard human testing period is 1 year. I don't know about animal testing, but I'd guess it's about a year as well. Even giving an additional year to do analysis on those tests, that's only 3 years. Does all the governmental approval really eat up another decade?
I have done research in the private and public sectors (see my homepage for my publications), and I think that both sectors are valuable, but it is simply nonsense to say that drugs come out of the public sector. Please give a list of drugs that according to you came out the public sector.
The public sector does basic research, and the private sector does use this information to create products by applied research, sometimes generating more basic research as well. No university lab has the funding to conduct the sort of research and clinical trials required to bring a drug to market -- it is simple economics.
I think that most people in the pharma industry 1)really want to make money (who doesn't?) and 2) are tied to a specific company at any given time. One looks at the situation and sees that for me to make money, my company must make money and my company can only make money by exercising patents (excluding generics) and my company can make more money by milking the patent system as much as possible (repackaging, etc.) Also, the industry is so 'rules' bound (by the FDA, which I think is a good thing) that they look at rules as a game to be milked as much as possible: first when selling the drugs to doctors regarding labeling and second when manipulating the patent system.
It's not just the patent abuse. Don't forget that the pharma companies have zillions of high-pressure salespeople pounding on your doctor's door every day. Some are low cut top, batting eyelash, some are "Hey buddy, how's yer golf game, let's hit the strip club! Your escort will be at your room when we get back", some are "here's your check, er, honorarium, for your professional leadership speech at the luxury resort in Hawaii" and on and on. Sure, R&D is expensive, but the marketers/salespeople are paid insane amounts and have massive budgets. A big part of our health insurance premiums are being funneled to the pharma marketing/sales monster.
However, now that it's not a technology company, but Grandma and Grandpa, and little cousin Joey--not to mention people like yourself and myself--who suffer, we're not supposed to bitch about patents? I think a lot of people on slashdot are intentionally misinterpreting the argument in this article. He is not defending the drug companies, or the few wealthy researchers--in fact, he takes a very anti-Drug company stance--but we act like he is some schill for the drug companies. It's pretty ironic that someone who is basically spouting the slashdot party line is getting crap like this said about him.
Lets try to not construct a straw man to wail against--instead, lets think about the real problem: it's getting to be impossible for a small university or small company to do any biological research.
Was there a point to posting this on Slashdot
If you prick a geek, would they not bleed? I'm human, you're human, therefore, methinks medical technology would be of some sort of importance to us. That aside, a lot of geeks are doing research or study in these areas, (obviously not yourself), so I think this is News For Nerds.
Maybe you just have something against "The New Republic."
Yes, I'm still a junky. Are you still a bitch?
In the 1970's, Procter and Gamble created a promising new drug. Say the process of creating this compound ("D") was by the following method:
A -->B -->C -->D
Anyway, so P&G created compounds B,C and D and finally patented only their product D. It turns out that drug D failed FDA testing and was forgotten. Another company found out that compound C was a great drug for a totally unrelated illness. That company took the un-patented compound C, patented it, and made billions.
Because of that, drug companies now spend the extra measly few bucks (to them) to patent everything under the sky that they create. This saves their asses, but unfortunately forbids anyone else from researching their patented side-notes (because say some other company realizes that the now patented intermediate compund from P&G is a miracle cure. It would have cost millions to discover this, and P&G would be totally in-the-right legally to develop this and reap 100% of the profits).
You first have to do a study with a small number of people to demonstrate that the drug isn't going to make their noses grow 6" long and turn their cerebellum into an eleventh toe. Then you have to do a small study that demonstrates that the drug is effective at treating whatever it is you want to treat. Then you have to do a third, much bigger trial so that the effectiveness can be compared with existing treatments.
Throw in several years of figuring out how to make bulk quantities of whatever this drug is, testing it in animals, etc. etc., and there's obviously going to be a quite a few years of development happening.
Any sufficiently advanced technology is indistinguishable from a rigged demo
--Andy Finkel (J. Klass?)
I have written about this many times.
.Net from Microsoft? This is innovation? It certainly is Microsoft tells you because if you invest in .Net you get to buy more Microsoft products that everyone can break into and we can make you pay for software that is crap over and over and over again on a monthly basis....
Patents as they are defined in the US, are specifically designed to feed the collusion of business and government in this country to enforce monopolies, not innovation.
Innovation is the last thing on a patent lawyers mind, when filing a patent. The first thing on his mind is how to lock up the market and sue everyone who doesn't comply for the next 20-50 years.
One has to wonder, in this case when human lives are at stake, how many will have to die because a drug, being worked on by some company by a bunch of dolts, owns the patent and nobody else can work on the same research because it is simply to costly to feed the lawyers.
If you honestly think that a company that owns a patent on a drug or diagnostic process that could possibly improve the human condition, has the best brains in the world working on a solution for that drug, Mr. I got land in Florida real cheap I would like to sell ya.
Basically it comes down to this, millions will die. Why? Because the patent process has been bought by big drug companies and they also have our congress in thier pockets. No one else except in these companies can research be done on whatever the patent claims...(usually everything under the sun.)
So instead of world wide disemination of the information to some of the brightest Universities in the world....(all of them in Europe I am afraid..) we have a handful of dolts in a lab somewhere scratching thier heads over problems they will probably never solve in this DECADE because of the lack of synaptic activity between thier ears.
Meanwhile, our best and brightest in the US Universities are declining research in increasing numbers, simply because they cannot afford the risk of doing the research in the first place where said research could overlap with a commerical venture SOMEWHERE OUT THERE.
Millions are dieing from human conditions that could easily be solved much more quickly, dare I say much more cheaply if only the patent system and lawyers and our goverment got out of the way.
The artificial heart is a good example. An incredibly complex problem, being worked on by a very few PhD dolt heads because they own the patents on artificial hearts.
So I guess we will wait another 100 years before we can get a artificial heart that doesn't turn someone into a science experiment, all for the glory of the patent holder, instead of providing a solution to a person so they can live a normal life as everyone else does with healthy hearts.
Ironically, slowed research means fewer products.
What people are finding out, if you want to patent everything under the sun and sue, you maintain market share with steadily decreasing innovation and new products. Which directly translates into low or non existent profits or returns on research. Which translates into a sick economy and bad markets. Sort of sounds like the US telecommunications, computer, and now drug markets which are fairly mature, monolithic, sick, and produce high cost services for low value.
Anyone have a loved one here with lung cancer? I HAD one, but my Dad just died 4 weeks ago.
TAXOL, a key drug used to treat lung cancer, is patented. Imagine that. Ironically it comes from a tree, produced in nature!! They (the drug company) didn't even invent an original product! Nature made it yet the company that manufactures refines TAXOL owns the patent on it (TAXOL the Molecule) and no other company can sell it or do research on it without a license or they could risk getting sued!!!
Absolutely outrageous!
Whats even more outrageous, is the incredibly slow pace that this company who owns the patent on TAXOL is innovating it. Obviously a handful of PhD dolts are turning out improvements to TAXOL's effectiveness, in such small increments it could take decades to make it totally effective.
Whats its cost? Well, you can probably imagine, if only one company can produce it, and only a few idiots, chosen by a board of directors (many of them bankers not medical experts), can work on it...
What is the cost these jokers are charging people? TAXOL, a small bag, for one chemo treatment can go for as much as $3K-5K.
I point the fault of this directly at the patent system and congress who are greased nicely in thier leather chairs while people by the millions will die under these sorts of research conditions.
I personally believe that given the human suffering, that I personally experienced with my Dad, we as a society should make medical research an exception. An exception to ANY restrictions to information or access to information or research, and that it should be a society endeavor, not a motivation for profit.
Congress, could appropriate a budget much like defense, to do medical research and provide people with health care. I just can't see personally, any form of capitalism that is humanitarian, in the context of providing health care.
It is probably the only exception I can think of that makes Capitalism, even applied honestly look bad.
----
I won't even get into the broad band market place issues, why our industry can't move forward because the products that could use broadband are a direct threat to the entertainment industry in this country and therefore you have broadband prices that are high with few services that make use of them..beyond games.
I have pointed out many times that the US is headed for hard times when the Chinese and Russians wake up and decide not to play our little game and start producing technology under a much better system that values more rapid innovation and product time to market instead of a patent system that attempts to lock out markets and decrease innovation.
Linux is a good example. Not created in the USA, thank God because all of our home grown OS's created here
S U C K!
When these eastern asian countries wake up and begin to build thier own infrastructures without our products because they don't want to play or little game that keeps us at an unfair advatage, we are going to be in BIG TROUBLE BOYS AND GIRLS.
Congress is going to find out that it takes lots of dough to foot the bill for our navies, armies and military infrastructure. We defeated USSR, through economic means. Do you honestly think a society like the Chinese will NOT out GNP us eventually if they don't play by our game rules?
3 Billion of them?
They will economically crush the European Union and United States combined like a grape both in GNP, technological progress and innovation and, dare I say quality of life that comes with such a healthy economy!!
What do we do then when we start sending out children to China to learn in thier Universities, and start relying on China to police the world, because congress destroyed our economy with legalized monopolized with these patent systems and complete disregard of the law on Anti Trust issues such as Microsoft, and cannot afford a big navy or army?
Sound outrageous?
Look at the enourmous fraud, bad business climate and technology in our (US) country right now and tell me I am nuts! Turn on the news for example, and listen to the kind of business and political system "lock-in" business practices (Microsoft, PATENTS, Anti Trust laws with huge mergers that destroyed our economy etc.) that are being enforced legally in our country, simply because GREED drives our economy. Not hard work or innovation, why? Why do you need innovation if you can simply patent and freeze markets for 20 or so plus years at a time?
Look at
just as soon as we enact a DMCA law that makes it illegal to produce free software and get rid of Linux once and for all by making it CRIMINAL to use it in the US to make software of ANY kind with it!!!
Think I am nuts? We shall see...WON'T WE. But I would buy some land in China or India just in case if you want to be able to produce software or a script to read your Email without being sent to prison.
Whats the point in even considering a new cancer drug using the information from the Human Genome project for example if you could be sued in the next 20 years for making a drug that cures cancer from that information, only to loose in court because some idiotic company says they patented the entire genome because they sequenced it first???
Why even do cancer research for the next 20-50 years? Whats the point?
Which is what a lot of investors are feeling right now. Whats the point in investing in a market that has nothing but GREED driving the CEO's in this country instead of people with bright ideas?
After all its all about lawyers and market lock out and who owns the patent right?
Hack
Got Geometrodynamics? Awe, too hard to figure out? Too bad.
Gov't approval processes can eat up a well-proven drug entirely.
Realworld example: Pen-Strep (Penicillin and Streptomycin combo) had been in general farm use for several decades, and was well-proven safe and effective thru extensive use in the field. The FDA got a wild hair up its ass and decided that since Pen-Strep had never been *formally* tested, it would have to be. For whatever reason (I never got the details) this landed on Pfizer's doorstep -- maybe it was their original patent or something, I dunno. (The patent had long since run out, tho.)
Anyway, Pfizer ran the numbers and decided no way in hell could they reasonably recoup the cost of testing to FDA specs (the expected cost was in the multiple millions of dollars), and said to hell with it. The upshot was that EVERYONE ceased manufacturing pen-strep combo antibiotics.
This left farmers scrambling to find replacements that are as safe and effective -- and, well, no sufficiently broad replacement exists. So their costs (thus consumer costs) went up, with no benefit to anyone; if anything the result was increased risk of both animals lost to sickness and side effects to the public from using other drugs (which were "properly" tested but aren't as safe or effective as pen-strep).
This is equivalent to the FDA suddenly deciding that aspirin must meet FDA test specs even tho it's been in wide use for a century and the potential downsides are already well known.
Anyway... yeah, it wouldn't surprise me if gov't approval ate up a good chunk of a drug's patented lifespan.
But in my observation, the overall effect of drug patents is destructive. It gives drug companies every incentive to over-recommend patented drugs, because that's where the profits are -- since the patent helps keep prices artificially high for its duration. Generic drugs (ie. those on which the patent has already run out) have competition in the open market. Patent-protected drugs don't.
~REZ~ #43301. Who'd fake being me anyway?