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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
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
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"
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.
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"
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.
No, it's people like you who would kill off the poor in third-world countries to satisfy your own notions of social justice. No government in history has ever equalled the kind of productivity that our competitive market creates - and you would take that productivity away from the search for lifesaving drugs.
--
CPAN rules. - Guido van Rossum
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.
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I'm just an ordinary man with nothing to lose.
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
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
Uh - you're missing one point. Most of the money on drug development is spent AFTER a lead is found. The NIH does not do clinical trials of drugs.
What companies buy from the NIH are good ideas - most of them turn out to be duds. Sure, many compounds on the market were originally thought up by the NIH, but if you took the average NIH lead and injected it in people at random, you wouldn't cure AIDS - you would kill people.
The big pharma companies add value by formulating the lead into a drug, and then testing it and killing the development cycle most of the time when it doesn't work.
The public is reimbursed from publicly developed lead molecules - they are usually auctioned off. They don't fetch much - but that is because they aren't worth much individually - most don't actually work. If you demanded huge royalties they just wouldn't sell at all.
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.
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?