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Report Says Patents Prevent New Drugs
An anonymous reader writes "Current orthodoxy claims patents encourage innovation, by allowing developers to enjoy profitable monopolies on their inventions which in turn inspire them to create new inventions. A new report by the non-partisan General Accounting Office suggests that this orthodoxy is wrong — at least when drug companies are involved. According to the report, existing patent law allows drug companies to patent, and make substantial profits off of, "new" drugs which differ little from existing medicines. Given high profit margins on very minor innovations, the report argues that drug companies have little incentive to produce innovative new drugs. In other words, current patent law actually discourages drug companies from producing new medicines.
Responding to the report, Senator Dick Durbin (D-IL) released a strongly worded statement suggesting that a legislative response will be forthcoming. "The findings in this new GAO report," said Senator Durbin, "raise serious questions about the pharmaceutical industry claims that there is a connection between new drug development and the soaring price of drugs already on the market. Most troubling is the notion that pharmaceutical industry profits are coming at the expense of consumers in the form of higher prices and fewer new drugs.""
The headline draws rather a long bow. I think that what's clear from this report is that the current patent system is broken and stifling innovation. However, this does not invalidate the very concept of a patent, which the article summary suggests is the case. "Current orthodoxy claims patents encourage innovation, by allowing developers to enjoy profitable monopolies on their inventions which in turn inspire them to create new inventions" - this is still true. It's the current implementation of the "profitable monopoly" that is causing issues.
So is this why there is not yet a pill that will let me do without sleep?
New drugs? Bah, as long they quit trying to outlaw potent supplements like in Europe, Canada, Australia, NZ.
Ridiculously overeaching regulation of this specific market kill innovation. With the kind of laws regulating this industry, you wouldn't even be able to research *aspirin* today, let alone have it approved or sold.
Global warming is a cube.
Seems to me that the problems with drug patents are similar to the problems we see with software patents. The guys who are approving/disapproving the patents don't know anything about the field to which the patent applies, and so make poor judges of whether or not a new patent is sufficiently innovative to deserve approval.
If you substantially increased the fee for patent applications then you could hire real experts to review new patents, and that might help solve some of these problems. Of course, many would claim that gave large companies with big coffers an unfair advantage compared to the little guy, and they would be right.
What are some real solutions to this problem?
This game will waste your life. Don't clicky!
That the patent department is stupid and cannot judge wether a patent is "a substantial technical improvement" as required by law. Not a problem with the patent system itself.
Perhaps peer review would prevent these issues. Give everybody who requested a patent last year the chance to review current patents and accept them or not. If not, they need to explain why and an agreement needs to be found by e.g. removing some claims. Something like this might just work.
I realize that making drugs (or any other product, for that matter) requires research and testing, etc., and manufacturers need to recoup that money spent. Plus, profits from a block-buster drug go into funding expensive research on drugs that can only target a very small portion of the population. However, making tiny changes to an existing drug and calling it "new" sucks, unless the change actually has an effect on how the drug works or reduces a side-effect.
Having said all that, maybe there should be a patent peer review board (or, in government speak, the PPRB) that reviews the validity of a patent request. Maybe patents should be harder to get and you should really have to prove your stuff is unique. After some of the vague, hand-waving tech patents, I've read, it's obvious that the guys in the government reviewing these things don't have a clue.
Have you ever considered piracy? You'd make a wonderful Dread Pirate Roberts.
One example is Claritin vs. Clarinex. (Both are anti-histamines that don't cause drowsiness in most people). Claritin was a cash cow for Schering-Plough whose patent expired a few years ago. It used to be prescription-only and the cost used was around $1 a pill. Now you can buy 300-ct bottles over-the-counter at CostCo for ~ $10.00.
Enter Clarinex, which Schering claims is certified for both indoor and outdoor allergies. Once again, it's a prescription-only medication with high prices. The punch line: Clarinex is exactly the same drug as Claritin after Claritin passes through your liver once. There are tons of examples like this, where drug companies change the chemical formulation only slightly, usually in inactive places of the molecule (i.e. the "business end" that interacts with the target enzymes is unchanged). Why new formulations like this are granted patents is beyond me.
If the drug companies can get away with sticking a capital letter on the end of an existing drug while changing its dosage to get a new patent, thats certainly an issue with the patent system. But its only one element in a perfect storm in this case. If consumers weren't so brand horny, and were more cost oriented when buying their drugs then these drugs wouldn't even sell. Few of them offer any signifigant benefit, and I'd argue none have any benefits worth the extra cost. But consumers see that 'D' or some other moniker advertised and assume thats the new one with less side effects that they need to demand from their doctor while asking for antibiotics to treat their viral infections. For health care providers part though, its their job to recommend drugs to their patients...and since a lot of them seem to be getting a kickback from the drug companies, they don't always make the the correct decisions.
My company offers a generous healthcare plan for this day and age. But they ask all of us to do our best to keep costs down. I can't tell you the number of times I requested a generic from my awful dermatologist when I didn't even know one existed, only to find out that it did...and wasn't the automatic first choice! Most people aren't concerned with those costs since the insurance pays for it...but we've seen what that attitude has caused, insurance is more expensive and less people have it.
I personally don't think HSA and the like are the solution. But I can understand why they are being tried. Consumers need to be more proactive about doing their part to keep insurance costs down.
Many of these "newer drugs" are simply older drugs with some manipulation...patented manipulation.
Frankly, I avoid the use of drugs whenever and wherever possible. I find that addressing the cause rather than the symptoms is a better approach -- at least for simple stuff. I'm not a medical professional, but I (and many other slashdotters I have noticed) find that better health can be had by eliminating stuff from the body rather than by adding foreign substances.
People often have some weird ideas when it comes to medicines. TV commercials don't help much when they draw diagrams of something taken in the mouth somehow routing around the digestive tract and directly to the troubled area. The only drugs I can think of off he top of my head that behave that way are topical cremes and ointments and suppositories. Beyond that, people seem to expect often magical properties from "modern medicine." It ain't happening.
From TFA: "the ability of drug manufacturers to easily obtain patents for minor changes to products, or to receive patent exclusivity for new uses of existing products, have reduced incentives to develop new drugs."
Sounds to me like its the ability to get a patent on something that's essentially already out there in the market that is stifling innovation. This sounds a lot, to me at least, like the general distaste for 'junk patents' in the software/computer industry. Perhaps if we start requiring inventions to be unique before we allow patents on them, we'll actually start encouraging bolder, newer ideas again?
...is that profits are much lower for drug products, such as vaccines and antibiotics that are extremely effective and "cure" in a small number of doses, than for drugs products that merely help, or palliate.
The invisible hand of the marketplace skews development toward drugs that must be taken forever, such as blood pressure medication, or cholesterol lowering medication, or anti-depressives and so forth. These drugs are godsends if you need them, but the fact remains that drugs that actually save lives, with a small number of doses, are less profitable than drugs that merely improve or prolong them, and need to be taken continuously and repeatedly forever.
It is this warped incentive that needs to be fixed.
The antibiotics we have are losing effectiveness. Hospital infections are becoming more and more dangerous. My generation is probably going to be the only generation in human history to live its life mostly free of the mortal fear of dying from bacterial infection. There are virtually no new antibiotics in development.
"How to Do Nothing," kids activities, back in print!
The pharmaceutical industry is where the software industry would be if it wasn't for the existence of Open Source. That the closed source companies are pushing for a US style patent regime in Europe and elsewhere is a given. What with patented GM crops we see farmers being sued in the US for reusing GM seeds grown from their own crops. Something practiced for centuries.
It's also difficult to avoid infringing some patent as the GM crops cross-fertilise with plants in the next field. The resultant seed being also covered by the same patent. The GM companies would of course have the farmers buying their seed annually from the companies. What next, produce sterile crops and totally outlaw unlicensed seeds.
As the report says in relation to pharmaceuticals, you can see the same thing in the closed Windows monopoly, little real innovation, "new" software that is differs little from the old and a small number of companies making vast fortunes and lastly it's the consumer that suffers from no real choice.
davecb5620@gmail.com
when an industry is the 3rd most profitable, aren't you justified in charging your consumers out the ass for your product, and then say "oh, our R&D is really expensive"
wait... that doesn't sound very moral to me
The process of electrolysis/electrocoagulation and its effects on virus proteins are nothing new. The fact that they found a current level that could denature HIV's protein shell without denaturing every other protein in the blood is, but as a treatment, it's unclear how one would use this, except if one were to insert it into the heart or the aorta where all of the blood would pass through the electrodes. Then there is the question of if the blood cells are unaffected, would the HIV proteins currently being assembled in an infected T cell be affected, or would you need to continuously do this for the length of time of several generations of HIV (even assuming HIV takes longer than one blood circuit to reinfect another T cell). Also, since HIV is found in other bodily fluids, would the HIV in, say, the host's semen reinfect him?
To reject any application that can't explain in plain english and 2 sentences (120 words) or less why it is unique and deserving of a patent.
Why this criteria? Because if you have to draw comparisons with other items and state that this application improves incrementally over items 1-n, then it's not innovative and not deserving. Take the pet rock for instance (however trivial and droll):
It's a polished rock with googly eyes, marketed as a "pet". There is nothing like it in existance today.
I'm still not sure it should have a patent, but at least you can explain it in 2 sentences or less, including the all important "unlike anything else" clause. (whether that was true or not is a different issue)
As for funding the patent process:
Make patents holders pay a percentage take to the PTO, paid at least yearly, with a minimum fee of the application itself, increasing by some scale over the years. The older they get, the more expensive they get. Failure to pay on time means it becomes public domain.
I believe such an approach solves several issues, while still allowing invidividuals to profit from their work without undue hardships.
The cesspool just got a check and balance.
I can think of one example in the software industry where this easily applies.
"...the current patent system..."
"...patents as they are currently defined..."
or just simply "patents"? There is no virtual patent system available, there is only the implementation of law that we have that we call "patent".
I think you are trying to defend patents when this report is saying they don't work. What's the difference between "the patent system doesn't work" and "patents don't work" in effect? Both require that the patent system be removed. Another "patent" system could be introduced but then you'd have to show why this problem wouldn't occurr with that implementation.
Patents are broken because there are too many patents. ANY system that doesn't control the number will break this way eventually.
Isn't that kinda the whole point of getting a Patent ?
Wanna fight ? Bend over, stick your head up your ass, and fight for air.
There are other reasons, like it is a lot safer to make a trivial change to an already approved drug with known side-effects than to release something new and risk being sued or not having it pan out. We are too unwilling to let a couple people die even if it would save several hundred.
Also the incentives to cure and treat minor diseases tend not to be there. The incentives to find new uses for non-patentable drugs is also not present.
Technically the incentives to discover a cure should still be there. You just take all that income you would have gotten over the life of a patent and figure out the NPV. That is what you charge for it.
Antibiotics are losing their effectiveness because of over-prescribing, lack of compliance by patients and the agricultural industry. But the main reason is because insurance shields the customer from seeing the price. If people had to pay more for antibiotics and other drugs, they would probably take less of them and doctors would be more careful in prescribing.
If the patent office applied the 'not obvious to a person skilled in the art' test instead of ignoring it, they wouldn't get patents on minor tweaks. Again the problem is the twisting of patents by the patent office, not the original intent of them.
How dumb is it that the patent office equates number of patents issued with growth in innovation and starts thinking that if it only issues more patents then there is automatically more innovation....
No to increasing patent fees! As much money as we in the USA spend on bridges to nowhere and wars based on lies we can afford to hire and pay for patent officers who know and understand their respective fields. There is simply no excuse, given the amount of money we pay in taxes, for crap like this. It's time US citizens hold the goverment accountable. You mean to tell me with the billions that we're spending spilling blood in Iraq we couldn't shelter the homeless, provide basic health for all, vastly improve education and hire decent patent officers. If you're answer is no learn to think for yourself.
I say that we should just scrap the whole thing and go back to the days of the traveling snake-oil salesmen. God knows that was much better for consumers.
And while I understand that the urge to deteriorate into meaningless hyperbole is nearly irresistible when writing a two sentence post, let's not lose touch with reality. Every year drugs with amazing complexity are trialled and approved. Say what you want about drug companies, but advances in the pharmaceutical industry are just as--if not more--impressive than in any other industry. Maybe they could be better under different circumstances, but I'm absolutely sure that they could be worse.
The grim truth is that we still only have rudimentary understanding of our own biology. The only reliable way that we've found to test drugs (and drug interactions) is by lots and lots of human trials in graduating size and complexity. How else are you going to know what drug X does when it's mixed with drugs Y & Z on a patient that used to take drugs C, D, and F and once suffered from diseases J and K?
Even now--with this rigorous testing--we find that some drugs should never have been sold. Vioxx comes to mind. These episodes are famous because they're so rare and they shake consumer confidence in the pharma industry. Imagine what it would be like if that were a weekly or monthly occurrence.
I for one am super thankful for me-too drugs. I have been through 4 iterations of basically the "same" drug for my condition. The first one caused a lot of awful side effects, and stopped working for me after awhile. The next few variations of the same thing (5-aminosalicyclic acid (5-ASA) were more effective and had no side effects. I was diagnosed with my condition about 14 years ago, and these little innovations have made all the difference.
"I don't think it's selfish, to eat defenseless shellfish." -NOFX
GAO Junkie
blarg.
I believe the process they are suggesting would involve pumping all your blood out of your body and passing it through a machine which would electrify it and then return it to your body. This notwithstanding, the evidence of this process working is dubious at best.
All information on the process seem to be verbatim repetition of the patent application, which was taken out by doctors true, but if you look them up you'd realize that the doctors concerned are a gynecologist and psychologist from a very small school in NY. There appears to have been no peer review of the idea, and looking up the lead doctor involved indicates that his only other major achievement beside this patent is ignoring the anti-abortion protesters outside his clinic.
- A drug company gets an idea for a new drug. They do some initial tests and take out the patent. They have to patent early because it is impossible to keep things secret once the drug goes into trials.
- At first the drug is tested on animals. However, as was discovered in Great Britain, that is no insurance that it will work properly in humans.
- So the tests on humans are absolutely necessary. They also have to be performed for long enough to see if there are any side effects.
- Another problem is how to produce the drug in large quantities. Scaling up production of complex chemicals is not a trivial problem.
- All this testing etc. etc. takes somewhere between 10 and 15 years and may take longer if the tests do not give a conclusive result. Since a patent only lasts 25 years, that leaves not that much time to recap the expense let alone make a profit.
- All together this means that developing a new drug, from idea to market costs roughly $200 million. And if a drug fails late in the test cycle, the drug company can just wave goodbye to the money spent on it.
So to me it is perfectly understandable that a drug company wants to recap its expenses.My opinion? See above.
Okay, so from now on, software companies aren't allowed to patent new products unless they do something in a totally new way. And no more "me too" games like, say, Half Life, or Counterstrike--don't they know that we've already got an FPS game? Or maybe Coke--no more of this cherry coke, coke vanilla nonsense. Come back when you've got Coke Filet Mignon!
I'm not going to say that the current system of IP as it applies to pharma is ideal; certainly, if companies can get away with marketing a slightly improved version of a drug for a premium price, they're going to. I just don't trust Congress to implement intelligent regulations of such a complex issue.
Most firms are now getting into pharmacoeconomics, which uses market data to figure out (in essence) what drugs are worth producing. I'd feel much better about a market-derived, self-regulation than anything imposed by almighty goverment.
For example, in a recent press release they write:
By allowing the pharmaceutical companies to keep their prices artificially high, the patent system kills people every day, particularly in third world countries. And it's completely unnecessary.The standard argument for allowing the pharma companies to charge whatever they want for patented drugs, is that they spend the excess revenues on research for new drugs. But that is not true.
We can look at the numbers for Novartis, Pfizer or AstraZeneca.
They all spend around 15% of their revenues on research. The number is typical for the industry. The other 85% go to other things, according to their own figures. More than half their revenues are spent on marketing an profits.
So there are clearly better ways to finance drug research than to hand out patent monopolies to the big pharma companies, and hope that they will spend the money they make on research. Because clearly, they don't.
The Swedish Pirate Party has one proposal for an alternative system. Many others have suggested other alternatives.
But at least it is time for us to start discussing the problem in earnest. Today's situation is expensive, wasteful and completely immoral. There must be a better way.
Christian Engström, Former Member of the European Parliament 2009-2014 for The Pirate Party, Sweden
Cause drugs are bad, right? Yeah for patents!
Having to become somewhat familliar with the ins and outs of many kinds of medications- their are many many problems with medical standards and practices. What's bothersome is more basic: Currently America is one of only a handfull of counteries that has "private" medical-ie medical that isn't socialised such that costs from the doctors and patients comes from taxes. Few companies have any sort of insentive to release patents any sooner than absolutely legally required, and even then fight it tooth and nail. I pine very heavly for the days when medicaition costs are in part part of ourtaxes, yeah having higher taxes will suck , on the other hand it will probably suck about as much as spending around 400 yearly for medication-but at least mabie then I also won't be also spending 100 per a session to see my cute chinese medical doctor
I work for one of those major (top 3) drug companies. It always irritates me when people like you make comments about subjects you know nothing about. I tell you what is not fair... 1) Our company spends a BILLION dollars developing a new drug and jumping through all the regulatory hoops required of us. 2) Years are spent doing extensive testing of the product to get FDA approval. 3) The drug significantly reduces the chance of DEATH for those taking it. 4) We get sued for a $300 Million dollars when a small group of people have an adverse reaction and die (as they probably would have anyway). That my friend is why DRUGS ARE EXPENSIVE! At any minute we could get tagged for a lawsuit for BILLIONS in damages when we have done everything required of us by the FDA and a dozen other regulatory agencies. You want to reduce the cost of drugs? Protect drug companies from lawsuits on FDA APPROVED drugs.
You know what the nicest thing about Japanese and German television is compared to American TV? It isn't what you see(TV is pretty dumb the world over), but more of what you don't see. No ads for prescription drugs for starters(no ads for ambulance chasers either, but that is a different story). The reason drug companies patent drugs that vary little from existing drugs is because they can still make money off of them by advertising them both to patients and to doctors. Patients go in and demand the name brand of the drug they saw on TV(which further feeds into the trend of self-diagnosis, but that is another rant) and doctors who are required to get a certain amount of education every few years enroll in drug company sponsored classes. They turn a well meaning law into profit for drug companies.
If we really want to see new drugs AND get cheaper health care, banning advertisements is a good start.
Monstar L
GAO is now the Government Accountability Office. Here's a link to the report.
http://www.gao.gov/new.items/d0749.pdf
Patents and copyright always act as a force to IMPEDE innovation. The problem is that this fact is very counterintuitive. Intellectual property exists for the sole reason of fostering innovation, and on paper it seems like it should do that. Monopoly as motive to create. Sounds logical. But communism looks good on paper too. Unfortunately both communism and IP are total and complete failures, as well as oppressive regimes which crush individual freedom. You can't publish that 30 year old email. You can have a website with a one-click purchase button. You can't market that life-saving pill. You can't cover that song. Unless you pay me a government-sanctioned extortion fee. Patents don't just hurt innovation with new drugs. They hurt innovation accross the board. But we'll never get rid of them.
Stupid people make stupid things profitable.
If we really want to measure the effect of IP on drug innovation, it might be better to compare the U.S. drug companies to those in other countries where the laws are different. Even then, it would be very difficult to draw conclusions because there are so many factors. And is it bad if more research is being done on non-NME's? Presumably that's because there is a greater expected ROI, which may mean there is a greater need for those drugs.
Prov 9:8 Do not rebuke mockers or they will hate you; rebuke the wise and they will love you.
And it is exactly like you described, only without the GM. It takes a lot of time to grow a new cultivar, and without that protection/monopoly there would be no incentive to develop new ones. There is no way one could keep their cultivar secret, as it is the very product the farmer is selling.
On the other hand, the farmers themselves still have the demand for better/different cultivars, so abolishing these breeders rights will not undermine the driving force of the breeders market, and the traditional breeders would still be the ones with the most marketable knowledge. The game would just shift from paying for products (seedstock) to services (if you cross this batch with this batch you will get a bigger harvest).
This space is intentionally staring blankly at you
There is really a main part of the patent system. Encouraging innovation is just a side effect. The idea is that without patents there are a few outcomes.
1) Companies would keep their "trade secret" forever, if the person who knew it died in an unfortunate plane accident with the plans in his briefcase there would go the life saving drug.
A Patent gives the company incentive to reveal their secret and at the same time are protected for some time it's an exchange.
2) Competition (such as in the early part of the industrial revolution) would hire employees of said company to steal the trade secret, since there is no legal protection, and it would be very hard to prove this type of theft. The patent system creates a legal system were people file their inventions and are protected from this behavior.
The vast majority of research in drugs or is done at the medical school level, where they have people paying for the privilege of doing research. Pharmaceutical companies are partnered with them to get that research (funded by governments in many countries). It wasn't until the 1990s that collages were allowed to patent research paid for by public money, so in many cases they gave their work to companies that then got the patent on this research paid for by the public.
This has changed and now many universities hold a significant patent portfolio when it comes to drugs and drug research. In addition there are huge government grants to fund research for drugs that will have limited or no ability to make a profit during the life of a patent.
The other major issue is liability, drug companies don't want to be sued, so its better for a big name to create a spin off company that can do the research on very new drugs that way if any issues come up (big lawsuit) then they can fold that company, and then reap the profits with a new warning label.
The bottom line is that its not just patents, its a whole string of problems that exist with the system, and no one who has the ability to change things is really interested in doing anything. If there were no patents, we would quickly see the only drug these companies put out would be safe ones that they are sure will sell allot of.
Pharmaceutical companies cannot afford to fund the necessary studies to evaluate the effectiveness and safety of their drugs for new and different uses as patent protection applies to the drug not the use. For example the patent on Prozak has expired, shortly before its expiration, there were very promissing studies on its effectiveness as part of a therapy on recovering stoke patients. These vital studies however will not be continued because there is no way to recover the cost of the study through the sale of the drug. I am a recovering stroke paient and I attribute a great deal of my recovery to this drug, yet further exploration of it's life restoring capability will likely never be performed and hundreds of thousands of people will suffer needlessly. We have orphan drug laws to fund research for curable but rare diseases, we need something similar for new uses of old drugs. Bruce Kusens
It is certainly believable that drug companies will patent minor changes to drugs to gain more protection, but I don't quite see how that stiffles competition. Consider a drug company that makes a genuinely new drug, labelled A, and patents it. A little while later, they also patent a slight variant on the drug, call it B.
17 years(?) later, the patent on drug A expires and anyone who wants to can create copies. The patent on the "me too" drugs are still in effect, but does that matter? As long as I only want to copy the original formulation, the patent on the original drug A would seem to be the only one of relevance.
Can someone who knows about the drug industry enlighten me?
I sued to be an analyst at a fund managemetnt company. I used to look at pharmas (although I was not a sector specialist).
A few things I noticeded.
1) Lots of patents cover minor improvements of existing drugs.
2) Lots new drugs are similar to existing drugs.
3) Patents are such a wonderfully effective mechanism that regulators (the FDA etc) have to give pharmas additional incentives (such as orphan drug deisgnation) to develop certain drugs.
4) Patents do more to boost marketing expenditure than R & D expenditure.
There is also no real evidence of what effect patents have. We know from academic studies that they have little positive impact on semiconductors or software, as for eveything else, we have no idea.
Just visit your local street pharmacist and ask for speed. You can stay awake for weeks with that.
There are a lot of scientists who have noted that finding new, safe effective drugs is becoming a lot harder - as the small molecule combinations are becoming exhausted and the large molecule drugs have not achieved success like people had hoped. Increasingly the new drugs that are introduced are relatively small improvements even when they are based on new chemistries.
Drug patents have existed for over a century, during this period of time there have been great waves of introduction of useful medicines, all driven by advances in sciences. The patent system didn't seem to inhibit the introduction of these drugs.
This report tries to draw a conclusion based on the correlation between drug patents and an apparent drying up of the new drug pipeline, and then state that it is cause and effect. Correlation of course does not prove causality, and in fact I wonder if you take a longer term view of what has happened in the drug industry if the correlation actually exists.
...more patents.
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it's unclear how one would use this, except if one were to insert it into the heart or the aorta where all of the blood would pass through the electrodes
what about using something like a kidney dialysis machine ? after all doesn't that filter all the blood and pump it back in again treated ? surely zapping it along its path would be trivial
See the difference?
They milk more out of insurance/consumers by perpetuating the disease.
It is universally acknowledged that the primary cause for the rise of medical costs is drug patents and the high cost of drugs. While efforts have been attempted to correct this, the pharmaceuticals are firmly infiltrated in government and lobbying such that little progress has been made.
Once a drug patent expires, generic versions usually surface. But insurance companies cannot require their doctors to prescribe generic drugs, and the pharmaceuticals have stated in print that they like it this way. It is up to the patient to request generic drugs, and with the prevalent advertising of brand name drugs few recognize that such a cheaper option exists.
After becoming aware of all this, I decided to hit the pharmaceuticals where they hurt. I no longer accept brand name drugs and I ask for the generic drug or an herbal remedy. If the government is powerless to correct this, then it is up to the consumer.
Eternity: will that be smoking, or non-smoking? I Corinthians 6:9-10
Senator Durbin's biggest campaign contributor will be the healthcare industry and his interest in this issue has mysteriously gone away.
In Soviet Russia, I ruled you
I'm surprised the GAO has just now caught up with reality. That me-too drugs are the main ingredient of big pharma's money machine was described a few years ago. The problem can be traced back to the Bayh-Dole law. Like it is said about health care more generally --that private care is a profit maximizer, not cost minimizer-- the patent systems seems to have been perverted into a profit maximizer as opposed to a maximizer of innovation.
I can't find a link for it, but I believe that the patent office has already changed it's policies of drug patents to prevent minor changes being repatented as brand new drugs. That still means that the original formula of the drug is no longer under patent.
Drug patents prevent inexpensive generic copies.
why not make the real stuff inexpensive?
If I were president, I would seize the pharmaceutical companies and regulate them out the wazoo.
and regulate them from closing up shop. and regulate them from beauracracy
They're using their grammar skills there.
"a private industry would be faster, better and cheaper."
Well, that's a nice guess but that's about it.
I'm no fan of bureaucracy, but the FDA isn't your average government agency. It's completely independent. And the idea that a "private industry" could constrain time and cost and still produce "better" results is amusing to me.
What, exactly, would you expect to be different? The drug companies run the trials. It's always been that way. All the FDA does is provide oversight, review and approval.
And not to be a prick but it's a little obvious that you under-thought this. How would a "faster" trial period possibly produce "better" results? If you're producing a drug that would be taken for extended periods of time, how would you possibly know what to expect if you don't run long-term trials?
A private enterprise has only one constituency: its shareholders. Sometimes the best interests of shareholders and the public at large align, but not always, and I wouldn't feel comfortable even saying "often." I don't care if your liberal or conservative, there are some things that a government just does better. And this is one.
Those that believe in the magical powers of the free-market to regulate itself need only look at all of human history prior to the last 75 years.
What we should do is make sure that donation and grant money for nonprofit research is plentiful, and rely on them to solve our health problems.
Money can't do much when you have these same greed-driven monopolies controlling the means that *could* lead to cures. If they have a patent on a drug and some minor modifications could change it from a treatment to a cure, it's still not something the market will ever see, regardless of the source of funding or who is doing the research.
Another part of the problem is patent extensions- for some reason, the Big Pharma, Inc. is continually being allowed to work the system by extending patent on existing drugs- the whole system is broken. What we cannot do is expect the non-profit R&D sector to re-invent the wheel each time, which due to existing patents, is pretty much what they'd have to do. The question facing us is this: Do we care more about the health of our population, or do we care more about the profits of Big Pharma, Inc.?
Could someone provide more information on these grants? If they exist and are substantial then this fact alone counters many of the arguments above that say the current system discourages research on drugs that would primarily help only a small group of people or people too poor to afford expensive medicines.
Much Madness is divinest Sense --
To a discerning Eye --
Much Sense -- the starkest Madness
The insurance companies should pool some cash and offer bounties for cures. Not treatments-cures. Sort of medical x-prizes. The developers get the loot, the insurance companies get to own the process and then license it for generic and universal production at the lowest cost. The smart guys get paid and have an inducement to be smart, the consumers get the best for the least, the insurance companies reduce risk.
http://pipeline.corante.com/archives/me_too_drugs/
"Every clinical trial that has ever been run demonstrates that the same drugs have different effects in different people - it's hardly a surprise that different drugs have different effects. And me-toos are different - different enough not to violate the patent on the innovator drug almost certainly means different enough to have different effects in some people. My local supermarket carries at least a dozen different styles of peanut butter, a fact of which I approve, but Angell thinks two angiotensin-converting-enzyme (ACE) inhibitors may be one too many (p.90). Give me a break.
Finally, it's important to recognize that small changes can actually make for important improvements. What could be more me-too than a once-a-day pill replacing a twice-a-day pill? Yet, to dismiss this change is to overlook the people factor. A once-a-day regime that people stick to is much better than a twice-a-day regime that people fail to follow. Forget the chemical structure the economics says a drug that people actually take is a better drug."
----------------
"If all drugs in each therapeutic class were identical, Celebrex would now be off the market along with Vioxx. In fact, one pill can turn out to be safer than another. Indeed, without going into details about Levitra and Viagra, their effects can also vary. .
The bigger issue is that patents and regulatory incentives can either align or disconnect. In the classic model, we think of an inventor as patenting and then having enough time to get through an expensive regulatory process to make money on the other side. But, many long published compounds, we're probably talking thousands in chemical abstracts over the last hundred years, don't get a second look by big pharma because patent protection is unknown or lost on them. Given the lack of appropriability of these compounds (Levin et al 1987 on pharma/chem vs. other industries), nobody will invest in clinical trials becuase the risks and expenses are too high to start. A patent grant based on regulatory investment (i.e. exclusivity given initiation and sucessful trials) would work fine for these. You pay you play.
Minor improvement patents. They would grant some protections but wouldn't qualify for full patent protection. Ideally the standard is slightly lower than the existing patent standards while patents for "new" devices would be raised significantly in their requirements.
This should be coupled with government-set rates for minor improvement patents, just like we have for song royalties. It would completely eliminate the whole patent litigation aspect and remove the threat of complete shutdown of a company or product just because someone patented sending email over a wireless link.
So a drug company makes a minor modification to an existing drug? Fine, they get some protection and can make money off it, but not nearly as much as for a true innovation.
Natural != (nontoxic || beneficial)
Then why are teeth different? It's common for United States residents to have their teeth cleaned by a professional hygienist and looked at by a dentist (doctor of dental surgery) twice per year.
If a new drug comes out that offers no additional benefit, but has patent protection, WHY DOESN'T THE CONSUMER BUY THE GENERIC?Because as I understand it, new drugs rarely offer "no additional benefit". For instance, Allegra (fexofenadine hydrochloride) is less toxic to the heart than Seldane (terfenadine), and Cialis (tadalafil) lasts longer in the body than Viagra (sildenafil citrate). The ADD medication Strattera (atomoxetine), a norepinephrine reuptake inhibitor, has the advantage over the previous standby Ritalin (methylphenidate) that reuptake inhibitors are an indirect stimulant and thus take longer (two weeks) to start working. This may sound like a disadvantage, but unlike amphetamine style stimulants, reuptake inhibitors does not lend themselves to abuse and are not scheduled as controlled substances. But you may be right about Nexium (esomeprazole magnesium) vs. Prilosec (racemic omeprazole magnesium), as it appears that the biggest difference is the dosage: Nexium is prescribed at higher doses than Prilosec was.
What I`m missing here is some clarity to the solution. It seems what they are doing is extending their patents, by adding a few claims to something which has already been covered by a patent. Like added a Gel Capsule to a pill, and then patent that. Clearly, this is not something "novel", and therefore not patentable. This practice of patents, which is happening in every industry infested by patents clearly needs to stop. Why should I be able to have a government granted monopoly for 20 years, and then be able to extend that by merely adding a Gel Capsule? That`s 20+20 years for basically the same pill!
More common sense into law. Law was never meant to be a ruleset that would split people, but it has always been misused in such manners. That`s what we need to fight tooth and nail!
Another suggestion is to have different patent-laws according to industry. Clearly pharmaseuticals need more protection than software, which is already protected through copyright. This means that the period of the patents can differ, say, like 15 years for medicals and max 5 years for software, if ever for software. (RSA comes to mind as one of the few ones in the software field)
You also need to define what is really a novel invention worth protecting, for every industry.
A patent should never be allowed to exist if there is impossible to construct an alternative, ie. the patent is protecting the _idea_, and not the implementation. If such patents, they should be voided on that reason.
The Patent Office should stop being an income source for the Government, and should get _more_ money from dismissing patents than from granting them.
These are just suggestions, but something very drastic needs to be done. How can we live with such a medieval system that spurs greed and hinders inventions? Something must be done now!
http://www.debunkingskeptics.com/
TFA mischaracterized the actual report. The only place where the report uses the word "reduces" is on page 33 where it simply points out that "[s]ome experts and analysts who are critical of the pharmaceutical industry often state that the emphasis on 'me too' drugs reduces innovation" (emphasis added). Reporting on a position is not the same as endorsing it. Critics of the pharmaceutical industry can't use a report on their own criticism as evidence that their criticism is sound.
The big question is who cares whether a minor variant on a drug that produces minimal gains is patentable? When the patent on the original version expires, doctors can still prescribe the medicine and consumers can still get the original benefits. And if there is some substantial gain due to the supposedly minor change, then why shouldn't the inventor get a patent? Also, if someone finds a new way of using an existing drug, something that was non-obvious, why shouldn't patent protection exist for that new use? If it is truly new and non-obvious, no one was using it for the alternative purpose nor would others have thought to use it for the alternative purpose.
Going through the actual report would show that the GAO report goes in a different direction from saying "patents are worthless." On page 36 the report suggests linking the length of patent protection to the therapeutic value (it suggest maybe 10 years protection for drugs offering less innovative benefits and up to 30 years for drugs considered innovative).
The article, the Slashdot headline, and the article summary all got it wrong when it comes to what the GAO report really said.Here in Wales, we have something called the Technium Project. The idea is to have a set of buildings each dedicated to a particular technological field. They are filled with business incubator units (which are expensive, but quite easy to get subsidy for). The idea is that putting all of these businesses close to each other leads to sharing of ideas.
One of the buildings in the project is called the BioTechnium, and is intended for biotech start-ups. Since the building came online, only one person has been employed in it; the building manager. In spite of the fact that it was designed with biotech in mind (decontamination and isolation facilities, etc), there is not a single biotech start-up moving in. Why not? Because no one will fund a biotech company that doesn't have a large patent portfolio. You can't get into the industry without a cross-licensing agreement with all of the major players, and you can't get that without a load of your own patents to offer. The result? A barrier to entry so high no one can get over it.
I am TheRaven on Soylent News
Thought some might find this interesting: Proposal For Open Source Drug Development.
"I don't think it's selfish, to eat defenseless shellfish." -NOFX
I am so ridiculously tired of hearing this absolute BULLSHIT. I'm a researcher at a pharmaceutical company. Most of the conditions we're trying to make drugs to already have a cure: Put down the cheeseburger, put down the mountain dew, get your fat lazy ass off of the couch and get the fuck outside and walk around a little. There is no cure for a retard eating 4000 calories per day with 15g of saturated fat-- you are going to get type II diabetes and atherosclerosis. That's how your body works. And the way the biochemistry works, THERE IS NO CURE. The systems are working exactly the way they're supposed to. Problem is, they've evolved to store fat during the rare times of plenty, and then dole that out during lean times.
If I could come up w/ a cure, you can bet we would make it. See, we have competitors. Who make a lot of money. If we could make a quick & easy cure, we'd make it, make a ton of cash, and move on. As an example in the last couple of years, Merck made their HPV vaccine to PREVENT cervical cancer. One time, cheap shot, and they've lost a potential cancer patient. Of course, it took forever to get to market because the Republicans think that preventing HPV infection will cause teenage girls to become whores. If you want to look for the reasons our health care system is so fucked up, I suggest that you follow not only the money, but the ideaology.
1984 was supposed to be a warning, not an instruction manual.
Yes it is.
1. The US Government is fighting a War on Drugs(tm).
2. Patents prevent drugs.
Therefore:
3. Patents are a powerful weapon in the War on Drugs.
4. The government wants to preserve the patent system.
The Polio vaccine was not invented by the (patent-powered) medical industry, but by a doctor on a childrens hospital. The HIV drugs are from the medical industry, and something you have to take for the rest of your life.
Any board etc is open to manipulation. Imagine, for example, MS getting onto -- or lobbying -- the board that reviews software patents. Imagine how well that would work.
Two things that would fix this mess: (a) reduce patent life to, say, 5 years. That is enough time to hold a monoploy. (b) do away with incremental patents. Every patent should stand on its own merits.
Engineering is the art of compromise.
Responding to the report, Senator Dick Durbin (D-IL) released a strongly worded statement suggesting that a legislative response will be forthcoming.
Friday, Dec 22nd
Dick Durbin Announces Cost Savings Plan to Eliminate the GAO and use Savings for Medicare Spending.
When information is power, privacy is freedom.
Tobacco is a good tool when you're stuck, (that is, when the leaf is organic and un-mixed with a bunch of corporate kill-you chemicals and you burn it in a pipe and not with paper). It makes it much easier to choose against negative emotions like jealousy and such. --I really understand now why Natives Americans used it whenever they sat down to meet in talks with other tribes. It's an amazing drug; raises intelligence, brain speed, memory functions, and it pretty much turns off anger and jealousy if you ask it to.
Strangest of all, I found anyway, it's not addictive. --I know that chemically it's supposed to be, I've read the science behind it and don't dis-believe it, but I spent a couple of months in the Summer smoking every day and then stopped because it suddenly felt unnecessary for me. Cravings? None at all. It's nearly Christmas now and I've used it maybe six times since August. The Summer of Smoke was an interesting experience which I felt like exploring after I learned that Tobacco had all these un-officially recognized health, mental and spiritual benefits, and that it was not even toxic if you used uncorrputed tobacco and worked hard enough to ignore the mountains of social programming we've undergone as a culture. (Burning things = Cancer). --I never even coughed or felt fleghmy, (though I certainly did when I tried a corporate cigarette as a contrasting experiment! Man, what a difference! The corporate stuff made me feel really sick and crazy and made my heart race and I sweated like a pig. What a difference 500+ extra additive chemicals make. Yuck!).
I began to wonder about tobacco when I started thinking about governments and how they lie pretty much about everything, and especially when I learned which government it happened to be that first began an anti-smoking propaganda campaign. (It was the freekin' Nazis! Not really a big surprise, but I was still taken aback.)
It struck me that it is definitely to the benefit of a government which likes to sell war to its people to remove from the populace an inexpensive drug which calms negative emotions and makes people smarter and more perceptive; a drug to which people are subconsciously drawn, which I think might account for some of the 'addictive' properties. But that's just my opinion.
Anyway. . .
As for Corporate pharmaceuticals. . . Geez. . . I guess the last thing I used was an anti-biotic maybe ten years ago. So who uses drugs?
I lead a clean life, both mentally and physically, I avoid toxic foods and I drink clean well-water with no fluoridation and the benefits show. I'm super-healthy and feel great. I think most of the problems treated by drugs these days wouldn't be there in the first place if people lived smart. Who buys all these drugs anyway, and how did they get so sick? Start dealing with your internal stuff and the whole question of the drug market falls away into unimportance.
-FL
What if patents only allowed the bearer to hold the patent as long as it took to cover their R&D costs? So if I come up with a clever idea which I can implement overnight (like one click shopping) I get basically no protection. But if I spend a million dollars working out a flying car or a new cancer drug, I am covered by the patent until I recoup my losses, then it's fair game. It could be "recoup losses + 10% too" or something.
:)
Just thinking out loud
Please read the damn GAO publication before parroting crap about how bad the drug industry is. This was not the conclusion reached by the GAO. All the GAO did was publish select comments made by "consumer-advocates" (as well as comments by other parties which contradicted these statements). There was no real analysis presented on the patent/line-extension issue. What's more, the focus was on all the various factors that are believed to be contributing to the decline in drug approvals. In other words, this is definitely not a detailed study by the GAO concluding that patents (or even patents on line-extensions) hurt innovation.
Here are the most relevant quotes for those too lazy to read the actual document:
No where did the GAO state that any of these comments were even based on actual detailed analysis. You should also note that only "some" of these advocates concluded that these line-extensions play some role in redirecting resources away from other more innovative drugs.
You should also note the next paragraph:
Please read the article for yourself. It is hardly the damning indictment of patents in the drug industry that the poster or the Democrats imply. The article identifies many other problems (e.g., flawed scientific understanding, inability of academia to transition, etc), most of which I'd be willing to bet the average slashdot reader is ignorant of. If anything, a careful reading of this document suggests that patents are very critical to innovation in the drug industry and that, at most, some tweaking might be in order.
Another example is esomeprazole (Nexium), the S-isomer of racemic omeprazole (Prilosec), hence the name. (The R-isomer is inactive.) So, basically Prilosec is a 2:1 dilution of Nexium (stomach medicine marketed as "The Purple Pill").
... isn't 40mg of Nexium the same as 80mg of Prilosec? So wouldn't you expect that more Nexium works better than less Prilosec?" The schmuck had no good answer for that. She knew as well as we that the "new improved" Nexium was just smoke and mirrors.
...) who was about to bring out a cheaper form of generic Prilosec. The lawsuit halted the generic company's development of the generic drug for something like two years. In that time, AstraZeneca was able to make Prilosec a non-prescription drug, thus pulling the carpet out from under the generic manufacturer.
I remember when Astra-Zeneca sent some poor inexperienced sales schmuck, some biochem major, to promote Nexium, setting up a nice dinner for my colleagues and me at our clinic. They gave a PowerPoint(tm) presentation on how Nexium was found to be much more effective than Prilosec, complete with nice colour graphs and stuff. The kicker was, they were comparing 40mg of Nexium with 20mg of Prilosec.
Our ophthalmologist (the eye specialist, for crying out loud!) raised his hand for a question: "I'm an ophthalmologist and I don't prescribe stomach medicine," he apologized in advance, "but
Not so incidentally, prior to Prilosec becoming non-prescription, AstraZeneca also sued some manufacturer of generic drugs (was it Andrax? Not sure
To this day, I really resist prescribing Nexium, just because I can't stand AstraZeneca for what they did. There are lots of alternatives like pantoprazole (Protonix), lansoprazole (Prevacid) or rabeprazole (AcipHex).
Even the medical school community poked holes in the Nexium hype, as shown in this article from the spoof newsletter Q Fever, which is sort of like The Onion for medical students.
So, yes, please topple some big pharma companies so that smaller companies can get some real work done.
404555974007725459910684486621289147856453481154 in hex is "You sank my Battleship?"
[GPG key in journal]
Emphasis is mine... but this is the GAO's summary.
This is definitely contrary to the original poster's assertion that patent's are having a net negative effect on the drug industry right now.
Please read GAO Report for yourselves.
Novartis is suing the Indian government for rejecting the Novartis patent.
From TFA:
the articleNovartis had sought a patent for a new use for its cancer drug Gleevec, which was rejected by the Indian patents office in January, on the ground that the drug was a new form of an old drug, and therefore, not patentable under Indian law.
Falline is CORRECT. The slashdot article is an outright lie!
I'd like to try and offer a bit explanation about patents so that this thread can begin to read like an intelligent discourse, rather than the venting of uniformed partisans. Much of what appears here is simply nonsense. It is not surprising, because intellectual property is not particularly well understood by most people, but the US economy benefits from a well developed system that protects the rights of artisans working in a wide range of skills by providing them with limited (this is a key point) protection for their creations.
... promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."
I am currently on the faculty of a major mid-western university, spent 15 years in R&D in a major pharmaceutical company, hold >25 US and international patents and spent about half my time in industry supporting a large number of highly qualified patent attorneys prosecute and litigate patents on new products and processes.
First, in the US patents are covered constitution (Article 1, section 1 Clause 8), which reads "Congress shall have the power to
Patent law is further refined under statutory law (Title 35 of the Code of Federal Regulations) and case law. All litigation regarding patents is in the federal courts. Attorneys and patent examiners must be licensed to practice before the US Patent Bar and virtually contemporary patent attorneys hold one or more advanced degrees in engineering (MS or PhD) or one of the sciences (PhD) before receiving their law degree.
The concept of patents is deeply rooted in western cultures. It has been long recognized that economies thrive when the rights of individuals to their work are protected. The first of the patent systems, as we know it, came into force circa 1470 in Venice, which granted artisans limited monopolies (10 yrs.) in return for disclosing who they manufactured their products. In English law (which is what US law is based on) patents were first described in 1670 under the Letters of Patent in the Statute of Monopolies. In return for a limited right to a commercial monopoly for an invention, the inventor had to publicly disclose what the invention was, how it was produced, and to teach others how to replicate the invention. This remains a fundamental requirement of all exiting patent law today. Keep in mind that the definition of the word patent is OBVIOUS, in contrast to the word latent, which is hidden. A patent must fully disclose the invention in return for the right to exclude others from practicing the art for a limited time. Failure to fully disclose results in forfeiture of patent rights.
While a patent publication must make the invention obvious, to be patentable it must be non-obvious to those skilled in the art at the time of the invention. It must also be novel (it cannot have existed before), must have some practical utility, and must be reduced to practice. The inventor(s) must also fully disclose the invention so that others who are skilled in the art can reproduce and improve upon the invention, when the patent expires. These basic tests are non-trivial, and anyone who has ever dealt with a patent examiner will tell you that each and every claim is subject to challenge during the examination process, which can take 2-5 yrs (out of a 20 yr patent life, which begins on the date of filing).
What is equally important to understand is what cannot be patented. One cannot patent laws of nature, physical phenomena, or abstract ideas. There must be a tangible product. Also, once that product is conceived, the inventor(s) must continue working to reduce the idea to practice or risk forfeiting their rights. If they disclose the idea publicly before they file for a patent, (there is a one-year time limit in the US, while some other countries do not have such a grace period) they also risk forfeiting their rights.
One of the other respondents to these threads commented on how patents dif
Amazing...and yet it still continues. It's ironic how all this "innovation" has been allowed to plateau just so that entrenched interests can keep their spot as king of the hill.
Wrong. The Democrats simply distorted this GAO report. The Dems just pulled comments that the GAO merely cited (those of "consumer-advocates"). What's more those assertions were just based on the beliefs of the "advocates" and were not cited as being in any way more authoritive that comments to the contrary. Just because the GAO quotes a Democratic activist does not mean that they're supporting their beliefs or backing them up in any shape, way, or form.
Please read my response here
As for the big pharmas themselves, they loose billions of dollars a year on drugs that don't pan out. For instance, Pfizer alone lost an estimated 1 billion dollars this year with the failure of torcetrapib. Please read: http://www.pharmaceutical-business-review.com/art
You may also want to look at how investors have faired in these supposedly highly lucrative businesses. Between 2000 and today Pfizer has lost almost 50% of its market value. Too lucrative? Hardly.
http://finance.yahoo.com/q/bc?s=PFE&t=5y&l=on&z=l
In any event, the big pharma companies do their best to diversify their risks so that one or even several losses are offset by their gains in other areas (usually with the handful of hit drugs). Arguing that pharma companies should go bankrupt more often is like arguing that insurance companies should go bankrupt more often or that consumers shouldn't be obligated to pay their premiums... It's just plain idiotic.
And this is based on your experience
Also, you might want to compare, say, Pfizer's current margins of 24% (volatile and likely to plummet soon) against, say, Redhat's margins of 22%... Yeah, you might argue it's because they're spending it a lot of money on marketing, but these companies are spending to maximize their profits (because they can't generate enough sales to recoup their losses otherwise)....not because they all like to throw that kind money out the window continuously.
FDA regulations mean it costs $500M to develop a new drug.
...
The first thing they tell you in a drug development course is that every new drug must have 4X that number yearly sales, now $2B.
Very few diseases are that prevalent: cancer is multiple diseases,
So, drug companies recycle drugs: as the patent on one expires, they have a minor change for a new drug, and all their marketing efforts go to that drug. MDs comply, as the studies 'prove' the new drug is superior to the old.
Consequently, the FDA kills 100s of 1000s of people around the world every year: not because of dangerous drugs (public databases and liability laws could handle that just fine), but because drugs do not get developed for most of the world's diseases.
Don't blame drug companies: they are responding to the incentives they are given.
Patents are NOT the issue here.
Like what? I can think of only a few examples of conditions/medicines which might actually be necessary.
Asthma is one. I can see a need for pain killers and maybe hormone treatments to ease things like menopause, and for use in birth control, (though a woman can choose to exercise her will power over whether or not her body accepts fertilization, though few people realize this again thanks to centuries of programming. What a mind-job on humanity!). I can think of allergy medicines and snake-bite and poison antidotes. . . Also vaccines, but only when they are responsibly used by agencies which don't want to experiment on/poison the population with secondary additives, as they generally do. Beyond that. . , I start coming up short.
Most other conditions I can think of are typically the result of ignorance, body mis-management or internal emotional baggage and can be solved through knowledge rather than drugs. Good genetics don't have much to do with it.
Also, tobacco is bad for you when smoked, even if you don't see the effects right now. I smoked for eight years and never had a cough, but that means nothing.
Well, we certainly keep on being told this, don't we?
And I'd believe it too, given that the stuff being tested is corporate tobacco which is full of known poisons, as well as radium (from phosphate based fertilizers), and if you were smoking filtered cigarettes, then your lungs will also have a number of 3 micron-large fibers from the filters, (covered with toxic tar) lodged in your lungs. Sure, that stuff has the potential to make you sick. But pure tobacco? Sorry. I don't see any good reason to believe the negative hype, and I've looked at all of it. --And I researched it all before I tried, mind-you. If I thought there was a real danger, I certainly wouldn't have bothered.
-FL
O RLY? What about Antabuse? Or antipsychotic meds?
Additionally, if you're allergic or resistant to a drug you should be thankful that some evil pharma company decided to come up with a redundant molecule...Unless you're allergic to that too. Ask the people who are allergic to Benadryl.
The fact of the matter is that the GAO report did NOT draw the claimed conclusions at all. What the GAO report says is:
They then, however, go on to note that others disagree with this viewpoint. At least to me, it appears very much as if the "American Constitutional Society" (i.e. the blog referred to in the /. summary) is mostly reading its own viewpoint into the GAO report. If you read the report itself you'll find that it expresses no such position at all, and in its actual "concluding remarks", its only mention of patents is: "The extent to which scientific, business, regulatory and intellectual property issues related to drug development can be addressed will largely determine if and how quickly these trends can be reversed."
The fact is that the report itself takes basically no stance on patents in either direction, basically stating the near tautology that if issues with patents affect innovation, then addressing those issues will affect innovation as well.
To give my summary: don't trust the summaries. Read the paper itself, and draw your own conclusions -- at least IMO, the ACS blog entry simply isn't very accurate.
The universe is a figment of its own imagination.
First, let's start with a link to the report itself, rather than a blog entry about the report:
http://www.gao.gov/new.items/d0749.pdf
Second, you'll find the blog entry to be mostly 'spin' of the GAO report. The GAO report pretty much restricts itself to reporting what a 'panel of experts' they convened said about declining research productivity in pharmaceuticals - the usual industry criticisms are there together with the standard rebuttals, with the report presenting almost no consensus conclusions beyond the basic numbers/graphs on drug approvals. In fact, I tried multiple substring searches of the one quote in the blog entry claimed to be from the report and I couldn't find it. Maybe the blog writer too got confused about what someone said about the report and what the report itself says!
Sorry for the factual interruption. We now return you to the highly-moderated pharma-bashing party.
Disclaimer: I work for a pharma company
Imposing Libertarian views on everyone online since 1992.
Depends. Is a "unit" a milligram or a dollar? If generic racemic omeprazole 40 mg is significantly cheaper than the price of Nexium 20 mg, then why prescribe the more expensive Nexium instead of twice as much generic?
I imagine they thought of it, just can't do it from legal reasons, their lawyers might think it might be construed as price fixing for example. In some areas where it has been legal, when they get no direct money from their efforts, insurance companies have lobbied together for political change in both their economic favor and their customers, seatbelt laws for a huge example. I can easily remember when zero cars came with seatbelts, and it sure wasn't the car companies pushing for them, same as they hates CAFE standards and so on..
My idea for medical cure bounties is just a variation on that and as applied to medicine. Another reason "why not?" so far is the entire concept of bounties is still relatively rare in our economy. The closest on any large scale that we have is the contracted bid system, but that is still arranged up-front before any work is started, then the work proceeds knowing the bid winner will get paid so it isn't exactly the same. A bounty system means only the very best as in intelligence and skills would get paid, and they would get paid handsomely. That gives an incredible inducement to do a very good job, which would lead to the best possible solutions, and also eliminates a lot of the busywork wannabes who know they don't have a clue so won't even try. A bounty system rewards true productivity and innovation, and not just time clock punching and half assed work and relying on these small patent variations and near vendor lockin for max profits.
Anyway, this is probably maybe the sixth or seventh time I have thrown this thought-meme out to the world at large on various forums going back numerous years. It ain't much but I hope eventually it might gain some traction as someone might see it is a viable alternative to how things are being done now. You never know, on slashdot we have billionaires to paupers, politicians to CEOs to office drones to grunt workers and everyone in between. The whole idea of commenting on an issue on webforums is to share thoughts-so I just did. That's me thoughts on how to make a part of the system better.
As to why insurance companies don't do this or that with crime, etc, they DO. I was an insurance agent for a year before and saw a lot of what goes on, and just being a normal american am aware of a lot of issues. Insurance companies will cut you financial slack for living in safer neighborhoods, following sane home protection practices, making sure your property is kept in good repair, making sure your ride is in good repai and that you drive responsibily, etc, etc. the financial carrot is there, really, they wouldn't care if their gross went down, as long as they could keep dropping their outlay from claims, because that increases their bottom line *net* which is where it is at.Here's another example, many insurance companies are now either dropping hurricane coveage or vastly increasing rates as much as possible, because governments have failed to mandate better construction techniques or better infrastructure protection, nor have individuals done enough to protect what they have, so from their POV, why should they, unless you want to pay a premium equal to the worth of the object in question or what your debt load is compared to income yearly, sure, they'll cover that because it's a sucker bet and they lose nothing, worst case break even. They offer guidelines, but it is up to local governments to implement them. They don't,the big wind comes by, stuff that should not be destroyed if it was built better gets destroyed, too bad on having coverage again, blame your local government and your mortgage lender for *not thinking* hard enough on what they "approve". Fire the mayor and inspectors, get new ones who can think and act, switch to a bank that is prepared to tell you no if your home is built like crap. Sure, they play the odds and do studies and believe me, it is never in their interest to have to pay a claim, so to try and make that as much reality as possible, they lobby pretty hard for things of the safety nature.
There are influential people in medicinal chemistry, like Christopher Lipinsky, who argue that making small variations on existing drugs will be an important avenue for new research.
Their reasoning is based on a few simple observations. On the one hand, many drugs are known to have multiple effects. For example, the impressive list of potential uses of aspirin and its derivatives goes well beyond the suppression of small aches. On the other hand, they believe that the number of chemical structures that are potentially useful drugs is much more limited than chemists like to think. As evidence for this they point out that efforts to find new drugs by creating lots of new molecules have been rather unsuccessful.
So, they argue, the sensible thing to do is to look at the handful of drugs that we already have, and find new applications for them. This is likely to be a cost-effective approach, because these are compounds of which the properties are well documented, and clinical studies have already been done. Several companies are exploring this strategy and they are reporting promising results.
Of course the derived drugs would carry a lot of patent baggage. But that does not really need to be worry, for what you can actually patent is not the drug but its use, so if you find a really novel use you can still move forward with it.
As for your suggestion of limiting the time period of a patent: Think of the economic consequences for the patients. This is a matter of simple mathematics. Suppose a firm spends $1bn on the development of a new drug, and it needs to sell at least $2.5bn of it to sink its costs and generate a profit. If it has five years to sell the drug, then it will need to earn $500m a year, and it will set the cost of the drug accordingly. If it has only one year --- then it will simply set the cost of the drug five times as high. And if patients and governments cannot afford that cost, then they will not develop the new drugs. There is not that much choice, for a commercial entity with an obligation to its shareholders.
What we really need to do is make the length of patents more flexible, and adapt it to the social and human dimensions of a disease problem. For example, grant short-term patents (say 5 years) for lifestyle drugs for rich Americans, and long-term patents (say 25 years) for drugs against the life-threatening diseases of poor people in the third world. That would give companies a better incentive to work on the latter, in the expectation that over a longer period they can still make a profit.
I find that alcohol is a great drug also and I hate to disappoint you but it's even better than tobacco. When I used to drink 2/3 bottle of corporate produced vodka per night I had terrible headaches in the morning. However, now I drink only pure liquor distilled from organic corn mash by a neighbor. It comes from a copper still with pure lead solder, not the corporate lead that has so many heavy metals in it. Natural liquor is much purer than the stuff from Big Liquor and its unique characteristics have really helped me. My liver and kidneys have adjusted away from the water-dominated diet I used to have, and of course 60% ethanol is absolutely sterile. My driving is much better and I get places a lot faster with fewer worries than I used to, especially at night. I find that few things if any trouble me. When I wake up I have a cup of it slightly warmed and there are no headaches either. My life is great! (I think.)
We need patents to recoup our investment in new drug research. Researching new drugs is expensive, ya know. Why the patent license fees for other drugs we need for the research alone comprise a big chunk of those costs!
"USA, however, [having your teeth cleaned] is a status symbol"
It's no more a status symbol than frequent bathing.
"('does it have dental?' seems to be a common question Americans ask when deciding whether to take a job)"
Well, inquiring about benefits is a normal thing, but a teeth cleaning costs about $50. Not exactly a big-ticket item.
Spin should refer to interpretation of the facts in the best light for one's position. It should not refer to anything the dems have said over the last 8 years which is nothing but bald faced lies and a political immitation of worthless sports trash talk.
The patent system may be broken - but only in the arena of expense and difficulty in obtaining patents. It's premise is quite sound. In fact, the problems are in the enforcement of patents and in the cost of obtaining them. The alternative to patents is trade secrets which provide protection but never offer a benefit to society by going into the public domain. Occaisionally, trade secret disappear and never resurface. Famous examples appear to include Stradivarius violins, damascus steel, that astronomy clock found in the 2000+ year old shipwreck and Babylonian batteries from over 2 millenia ago.
The real reasons for lack of competition in the pharmeceuticals industry and for pills costing so much are substantially the very people pushing this crap about patents. Between the trial lawyers and the FDA, it's no wonder the cost of medicine is sky high. Also, due to the hundreds of millions of dollars in costs and the years of research and testing required by the FDA guarantees that many drugs cannot be created because the market is insufficient to cover the expenses. The risks of billion dollar lawsuits from greedy corrupt shyster lawyers like john edwards means that the risk of extreme expenses in coming up with a new product only begins when it is released. Note that this lawsuit threat raises the cost of everything associated with medical practice to be far more expensive than it would otherwise.
Who does this help? Follow the money! Big pharmeceuticals get to charge outrageous amounts of money for their mediocre offerings and get to enjoy a lack of competition, especially new competitors where real innovation tends to occur. It's too expensive for them to enter the market or do much. It benefits these socialist dems who want more power and control for themselves. Besides, at least some of them think they world will be far better off when you're dead because you're polluting the planet and taking up space on their freeways. Insurance companies are another pet industry of this cabal because they get to make some nominal profit on the payments they receive and the more expensive medical treatment is - the higher the rate they get to charge and as an added bonus, there are far more people who have to have medical insurance rather than paying for coverage out of their pocket. Hospitals get to be sloppy and inept and charge outrageous rates on which they can make a percentage profit.
The libertarians have air'ed a clever ad over the years of some FDA announcement of a new cure for some deadly disease that was 10 years in the making. And then, they ask the question about how many people died awaiting the cure that took so long to get thru the bureaucratic tape. Unfortunately, while that can be comprehended so easily by anyone who views it, the real damage done is far more serious than that yet it is not nearly as easy to comprehend. It's not only the delays, it's the treatments and cures that never were created which makes our society and world so much worse off than it needed to be.
Until the root problem is successfully dealt with, the problems with costs and availability of drugs and medical care in general will continue to get worse. What's more, the cure offered by these socialist dems will only appear to fix the problem until they get total control over it. At that point, they can decide who lives and dies, who is treated and who is left to suffer. That's the holy grail of their dreams - and it's the beginning of the real nightmare for the rest of us because according to some of them - there's over 5 billion too many of us out here and in the name of clean dirt, they've gotta save the planet.
IMO:
> Patents bad for innovation?
No kidding.
Patents are government granted monopolies. Monopolies are illegal. For a reason. Then why legalize them? (Special interests.)
Patents are like IP land mines. They lay in wait for unsuspecting (or these days, even suspecting) victims. Beneficiaries of the patent system are IP predators --- who flog their ideas to the USPTO for monopoly privileges, and then flog other companies with lawsuits.
IMO, it's government granted extortion.
These are IP landmines. On ideas. By idea predators. There isn't even a guarantee that the innovator invented the idea. Patents are monopoly grabs, not innovation.
Purge _all_ patents, not just software patents (patently absurd), drug patents (usually the poster child of patents "working"), and all business and any other patent. In other words, illegalize monopolies --- as usual. Let the current patents expire at an exponentially increasing rate (max three years for existing companies to recover from the changing legal landscape).
USPTO becomes USTO (take out patents).
No brainer.
Would anyone care to explain what the hell this has to do with my rights online?
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