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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.
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
Try the japanese system - you get two years to exploit an idea with protection from so that no one else can use your idea in that time.
At the end of those two years, if you are actively exploiting the idea in a business you can get another 1 year of protection and thats it
The principal is that if a 3 year head start on your own idea isnt enough to get you established in the market then you should probably let someone else do it anyway rather than stifle future innovation
(companies also have to keep their R&D far more secure under this system and they only usually patent just prior to launching to market - this in turns requires a much faster and streamlined patent application system)
$_="Slashdotter";$syn="OTT";s;..;;;sub _{print shift||$_};s!ash!Perl !;s=$syn=ack=i;tr+LLEd+BLAH+;_"Just Another ";_
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 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.
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
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
"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.
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.
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
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.
I think you really miss a lot of important points with this idea.
First, everything is a balancing act. The maximum extension of your logic is to legalize any substance that has shown any promise in saving lives without any testing at all. After all, we can't "kill people" by not giving them the drug, can we? But that is simply moronic. People--especially those with a proverbial gun to their head in the form of an illness--simply do not have enough information to make a decision about what non-regulated chemical to take. And without testing and regulation, doctors don't have enough information either.
Second, how many people would be "killed" if they couldn't trust the drugs that are prescribed for them? Horror stories and dead bodies would stack up and people would doubt the safety of all medications. After all, in an unregulated market just because a drug says it's Vicodin or Valium or Vioxx, it doesn't mean that it actually is.
Third, the crux of your point is just a guess. How would you possibly know what the "total sum" of "deaths from snake oil" are compared to the deaths that *MAY* have been prevented if a drug was approved quicker?
Fourth, if you have a serious illness that may be treatable with a drug in the pipeline you can (with your doctors help) get in on the late-stage trials. Many people are on experimental pipeline drugs.
Fifth, the idea that regulation "kills" people by not giving them a treatment fast enough is akin to saying that a paramedic kills the gunshot victim because he couldn't get him to the hospital in time. In reality, it's the gun shot that kills him. And maybe the paramedic could have saved him if he'd gone 110 MPH and blew thru every intersection but there's no way of knowing how many other people that would've killed.
And finally, you need to look no further than the hippocratic oath. "First, Do no harm." Your "regulation kills people" idea is the literal contradiction of that.
And really, comparing marijuana, which is literally ripped out of the ground with no further processing, to todays prescription drugs is a little overboard. The pharmacology and pharmacodynamics of the average drug are insanely complex.
Doctors & researchers were racing to find a cure for polio for the prominence of "discovering the cure." It has been postulated that the rush to find a cure for polio resulted in careless mixing of blood between test animals that brought the simian form of HIV to humans.
The same interest in curing HIV exists today, its just a harder problem to solve.
It's also easy to blame big evil drug companies for providing treatments rather than cures, but what about the big evil HMOs, who want to minimize costs? Certainly Kaiser Perminente and other HMOs are interested in cheap prevention measures, rather than expensive ongoing treatments.
Another issue preventing drug use is the lack of any mechanism similar to patent protection to induce finding new uses for existing drugs.
Consider Welbutrin: it was found to work better than other anti-depressants for many people, but after a media panic stunt that associated the drug with seizures, doctors were afraid to prescribe it. It was later found that the drug was also effective in helping people stop smoking. The Welbutrin name was tainted that its company rebadged it under a different name: Zyban. It was then proven that Welbutrin had no real danger for most people, and the seizure side effects associated with it only really affected people who already had seizure problems, and even then had less risk than alternative treatments.
Then Welbutrin (busparin) went generic and the profit motive for finding and proving new uses for the drug ended. Sales went to generics manufacturers.
Meanwhile, studies where already showing that welbutrin worked for many people as an aphrodisiac and could help them rebound from problems involving low libido, among other things. Unfortunately, not only was such a drug considered too racy (this was before Viagra), but since the drug maker would have to spend millions in clinical trials proving its efficacy, it made no sense to do so because there was little patent protection still available on the drug.
How many other drugs have known uses, but can't be formally proven because the costs are prohibitive? It's obvious that patent protection DOES create a strong profit motive for finding new uses for new drugs, but it does nothing for drugs we already have and know a lot about - drugs we know are fairly safe, and which have promising new uses.
A non-patent system, where new drugs are discovered and new uses are developed by non-profit 'open source' volunteers wouldn't have the money to do extensive formal clinical trials, which take years and can deliver huge disappointments. How far would Linux or any other FOSS project go in a software world where every program had to prove itself flawless over a long and expensive qualification testing period? Software is wholly unregulated, and anyone can dump out junk and sell it. Drugs aren't like that at all.
The only system that works at all is the huge profit potentials offered by patents, and it has serious shortcomings. As long as the FDA restricts new developments very conservatively, and as long as people can sue drug companies and win huge damages for any risk involved in taking a drug, we simply won't have full access to the drugs we already have.
Apple's Billion Dollar Patent Bluster