Another Example Of How Patents Skew Medical Research
from the why-bother? dept
When it comes to patents, the argument for pharmaceutical patents is a lot more compelling than for many other areas. However, as you start to dig into the details, the argument for pharma patents becomes a lot more troublesome in that it creates incentives that have little to do with improving healthcare, and quite a lot to do with what can be patented. The monopoly power granted by patents pushes all research money into only things that can be patented, ignoring other possible cures, even if they can be both profitable and quite helpful. A recent GAO study found this to be a worrisome trend, noting that fewer new innovative drugs are being created -- with pharma firms instead focusing on ways to extend the patent protection on existing products by pulling a few tricks (such as "reinventing" Claritan as Clarinex just to get more patent coverage).William Stepp points us to an example of how this focus on patents has helped to hold back one doctor's promising research on a way to help heal brain injuries. The doctor in question had come across some interesting findings back in the 1960s, but one of the problems in getting support for the research was that the findings wouldn't produce a patentable pharmaceutical product. Instead, it just showed that progesterone, a natural female hormone, could help heal brain injuries. Since it's just a natural hormone, there's nothing that can be patented, and the doctor had a very difficult time finding anyone to back the research. After decades of working on it -- often completely on the side, it seems that he's finally been able to build up some support -- and it turns out that his early findings did make sense and that the results appear to work equally well in humans as in rats (his initial test subjects). This is a clearly a big discovery -- and it was delayed decades because the focus on patents obscured the bigger issue.
This is the exact same thing that is seen repeatedly in Andy Kessler's book, The End of Medicine about the healthcare system. Time and time again, it's the pharmaceutical industry and their focus on what can they patent (rather than what can be done to improve healthcare) that gets in the way of real improvements that could save lives. The focus on what can be patented, and the games played to extend patents (at great costs) means that money that should be going towards much more useful areas of healthcare get diverted into less useful, but artificially profitable, endeavors. That's what happens when you set up artificial monopolies.
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Filed Under: medical research, patents
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Hmmm
So yes, improving health care for society as a whole means that the government should play a stronger role in prevention. There have been solid track records of success for doing so on such issues as curbing smoking or HIV. However, the business crowd doesn't like hearing this. They want to hear about profitable pharmas, biotechs, and instrument makers -- not how better population brainwashing techniques reduced the need for health products.
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Patents are only part of the problem...
I'm usually against government intervention, but this may be one case where the government needs to get involved. For example, let's say the government provided funding for clinical trials of promising new medicine. In exchange for the funding, the company agrees to license the patents to other companies for a reasonable royalty after a period of 5 years. Also a percentage of the revenue stream would go towards repaying the cost of the clinical trials, hopefully enough to make the government program self-sustaining.
A program like this would allow new companies to enter the market without a huge capital investment. The new companies would be forced to innovate or lose revenue from older products to low-cost manufacturers that take a license. The big pharma companies would be forced to react to new competition.
The pharma lobby will kill such a program before it ever gets out of committee, but I can dream, can't I?
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Oh shit, They have been recalled.....
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For profit healthcare is a fundamental problem
Healthcare and biomedical research should definitely not be treated like selling commodity items.
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The pharmaceutical industry creates pharmaceuticals. Is that surprising? Where should this funding come from? That is a very good question. I have doubts about turning over research over to the govt. because of the issues the govt. has in doing anything well and cost effective. If that isn't the option, then what?
There was an interesting article in the Wall Street Journal about a VC that had a releative die from cancer. One problem with getting scientists to work together is that if their idea isn't ready for a patent, they tend not to share their ideas with others because they don't want to get scooped. Their career is based on publication. The VC set up a place where anyone can submit ideas on cancer treatement (or prevention) and the best idea gets a million bucks.
People need to realize that they are the best source for living a healthy life. The best source for health information is their pharmacist, with a close second being Google.
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How much work do you think it takes to research add on drugs? Not much. How much research do you think it takes to come up with a vaccine for cancer? Merck found out the hard way, it takes a lot.
I agree, it takes a lot to research new drugs. I don't buy the $1.8 billion figure, because that includes opportunity cost, which I believe is BS. Even taking that away, its not $200 million, because that doesn't include money spent on drugs that don't make it to market. At $500-800 million, that is a tough nut.
Govt? The NIH spends alot on research, and even they give up on certain things. Healthcare is difficult.
Mike, I was at Columbia University today at the medical center with a group from the HIT Lab. Check out OursMedicina. Google it. If you are interested, we can talk.
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This is the reason patents are necessary.
Let us follow the story with two medical companies, A and B. In this case it is clear at the outset that no patent can be granted on the final product. Now researching a medical drug costs more than $400 - 500 million. Imagine company A, decides to research this medicine and finally after years of effort and money is successful.
Hallelujah we have a cure. But wait, the medicine is not under a patent. So company B can also market this medicine. Most probably both companies will launch at the same time, as the composition and efficacy will be known by all. Now in the final analysis which company is the winner. We would have to say that it is company B. The company which DID NOT innovate.
If there are no patents, innovation is not rewarded, and the other person (the non-innovator if you may) is rewarded. This is the real reason that patents are required and essential.
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Too much safety?
One thing that pushes the costs up is the reluctance to take risks. There are so many regulatory barriers to new pharmaceuticals these days that, I believe it has been pointed out, if penicillin were to be submitted today, it would not get approval.
A classic example of the dilemma was the thalidomide disaster: it would be nice to avoid a repeat of the human cost of that, but there is also a human cost in discouraging the introduction of new drugs.
A more recent example was the stage II trial last year which ended up putting a bunch of people in hospital. That wasn't a botch-up: they didn't know what the effect of the drug would be, that's why they were doing the trial. Yes, there was a risk, that's why they used a small bunch of volunteers who were under observation the whole time. Shit happens; it's important not to overreact to it.
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About big drug patents
I know what you mean . There are many natural remedies,
for instance one that will cure almost any disease; but since it is not patentable none of the drug companies are interested. After all they are more interested in their own profit at the expense of the life and well being of the general public ! What would Jesus say about this ?
The Love OF MOney is the root of all evil.
Thanks !
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Re: This is the reason patents are necessary.
Huh? It's quite clear from the article that the fact that this was just a hormone, rather than a new compound, it wouldn't get the research funds.
Let us follow the story with two medical companies, A and B. In this case it is clear at the outset that no patent can be granted on the final product. Now researching a medical drug costs more than $400 - 500 million. Imagine company A, decides to research this medicine and finally after years of effort and money is successful.
Ah, I love it when people make up hypotheticals that try to simplify things, but which distort what actually happens. Your description not quite right for a variety of reasons. The cost is often mostly in testing, not in researching, so it's a different problem that you're trying to solve.
But wait, the medicine is not under a patent. So company B can also market this medicine. Most probably both companies will launch at the same time, as the composition and efficacy will be known by all. Now in the final analysis which company is the winner. We would have to say that it is company B. The company which DID NOT innovate.
That's the assumption, but it's not necessarily true. Off-patent drugs still tend to sell well and do so at a premium price -- despite identical generic competitors. So the idea that company B will be able to siphon away the profits is not true.
Second, you focus your analysis at the wrong level: which is what's the best way for pharmaceutical companies to make money. Instead, take a step back and start thinking about what's the best way to make people healthy. When you start to do the research, you'll start to realize that patents distort that question by having people overly focused on pharma rather than on health. This situation was a perfect example of that.
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Re: Re: This is the reason patents are necessary.
Testing cost is part of the cost of developing a medicine to market. It is still bourne by Company A.
That's the assumption, but it's not necessarily true. Off-patent drugs still tend to sell well and do so at a premium price -- despite identical generic competitors. So the idea that company B will be able to siphon away the profits is not true.
This argument has been made by you before, but it is in the case of medicines which have been on patent for a while and then go off patent. (tylenol, asprin etc). There the company has developed a brand name for some 15-20 years and hence has the larger marketshare.
In this case, both companies would launch their products at around the same time, and brand effects would not matter. Also company B, having a lower cost structure could price the medicines at a lower rate than company A, increasing B's marketshare.
Second, you focus your analysis at the wrong level: which is what's the best way for pharmaceutical companies to make money. Instead, take a step back and start thinking about what's the best way to make people healthy. When you start to do the research, you'll start to realize that patents distort that question by having people overly focused on pharma rather than on health.
Development of new cures is an important part of the medical health system and should not be deprecated.
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Re: This is the reason patents are necessary.
I fully agree that company A should be rewarded for its efforts however they should not be awarded with the ability to dangle a cure over the heads of the have-nots.
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Skeptical of drug company research
Second, I am sick and tired of hearing people say that the drug companies are stopping natural cures because they can't be patented. Aspirin was (still is) a miracle drug that was isolated from the bark of the will tree. Bayer isolated it and then proceeded to make truck loads of money off of it. If these herbs were so effective pharma would be doing everything in its power to bring the active ingredients to market.
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I don't get it
b) The reason the government needs to grant patents to drug companies in the first place is because the government (with our blessing) artificially restricts drug availability. Since the FDA forces drug companies to go through years of trials to prove safety and effectiveness, it's only right that the drug company be given a short-term monopoly -- otherwise, they wouldn't bother going through the process, they'd just wait for another company to finish a trial and then jump on. You take away the carrot (the patent), then either you get rid of the stick (the drug trials) and deal with untested medicines, or leave the stick and get fewer new medicines. (Or let another country take the lead in medicine, as many countries have let the US do.)
What I don't get is the whole concept of entitlement, that if a drug company finds a medicine, it's somehow responsible for giving it to everyone. I'm not a shill for drug companies, I just don't understand why everyone thinks they should be quasi-government agencies, run for the welfare of people. Should anyone who receives a patent on something that could improve peoples' lives be morally obligated to give their product away to anyone who wants it?
What about that Anecia Survival Capsule from the "American Inventor" show? They have to go through government testing, and they have a patent so no one else can make it for a limited time. If it's shown that it could protect babies better in car accidents than regular car seats, does that mean the company should provide one to every parent, regardless of ability to pay? Or should the government fix the price, or subsidize it?
Where do we draw the line?
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Exhibit 1
Evangelos Michealakis of University of Edmonton has found that DCA virtually erases proliferating vascular cells in rats, resulting in healthy subjects that were suffocating to death a week earlier. (see pubmed) Despite such promising results, human clinical trials remain unfunded.
Something I don't get about healthcare policy: why aren't insurance claims-payors knocking down Dr. Michealakis' door to fund his clinical trial to assure that DCA can be prescribed to human beings dying of proliferative vascular disease (heart disease, pulmonary hypertension, and perhaps cancer)? If DCA works, it can certainly displace billions of dollars in claims for patented drugs.
An insurance company pays claims for patented drugs made by Big Pharma companies. At the same time, the insurance company's portfolio invests in Big Pharma companies that maintain profitability through soaking large insurance payors. Go figure.
Policy changes are needed to overtly bond motivated parties together so that alternatives emerge to Big Pharma drug development. Insurance-provider/generics research is one such alliance that has not found its voice in the labs or in Congress. I've been wondering about how such a model might work so that rewards reach the individuals most willing to bring solutions to the clinic.
Patient care is the only thing that matters in medicine. All institutions ignoring that fact will eventually fail by means of public outrage.
Andy
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The fact is, they are not really interested in their customers long term health because they won't be long term customers. People switch insurance companies, so they don't care about 10 years out, because by then you will probably be someone elses problem.
Another issue is that sometimes people don't get early treatement and then they die. No healthcare expenses.
Want to know the healthcare system that is cheap and most effective at preventing health problems? One that would pretty much solve our "health care crisis"? People not being overweight, people not doing destructive drugs and people not smoking. If this happened, our healthcare expenditure would drop.
One other thing to remember is that health in America is getting better. People are living longer. People are living better lives.
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Clinical Policy and Research
My opinion about the healthcare debate? It's too complex. When people discuss "insurance companies" or "the healthcare system" the conversation quickly outruns the facts.
My suggestion is that debate be compartmentalized into clinically relevant zones. Debating about "healthcare" goes nowhere. Debating about treatment and prevention alternatives for breast cancer, or peripheral artery disease, or sinus infections...these debates immediately bring to mind specific data and hard facts where science and research can provide meaningful contributions.
For example, it's in everyone's interest (not just women in a higher risk group) that breast cancer receive comprehensive preventative programs because the total cost of the current disease incidence affects the actuarial pool that includes us all (a new concept). However, the prevention of sinus infections, while an important goal, is certainly an entirely different task for many obvious reasons than the mission to prevent breast cancer. No policy should be created to cover both, as it will distort management of one or the other. That's what I mean when I say debate needs to be "compartmentalized".
Diseases need varying degrees of government intervention and guidance to lower incidence or reduce costs. People need to think that way, and support legislation that moves us to a greater degree of differentiation. That's a long process.
Insurance companies set an example that looks interesting. Clinical Policy Bulletins(CPB) are managed care playbooks or standard operating procedures for insurance claims related to particular disease classes. Currently CPBs are thought of as loss prevention measures within the insurance industry.
However, in my fantasy league of the future, they become public documents of profound importance to the national healthcare system - debated by the greatest minds, and decided with a healthy dose of dignity and good will. Once established, a CPB for breast cancer would be the yardstick against all insurance plans would be measured. Employees, for example, would know just how much insurance they are getting when being offered a plan when compared to a public standard. Insurance companies would be shamed into offering only the public standard or better, and nothing else. Advertising claims to the contrary would be possibly illegal. Government intervention into population groups would be conditioned on CPB guidelines. Etc.
So, research efforts, whether they are paid for by pharmaceutical companies or government, would fit into a CPB policy, or not, and would compensated accordingly. The random blockbusters delivered and defended by drug companies for large disease populations, would be replaced by a well defined role in advancing a clear and well planned CPB that puts pharmaceutical development in a proper context.
Today, patented drugs are the only ones that make money because we have no overall (or even compartmentalized) plan for healthcare. If we did, if we had a roadmap, then the gaps needing research and new products would be obvious, and the public benefit clearly served for the new technology that fills a void. Arguing for a new technology from the context of a well accepted and nationally known CPB, will result in better marshalling of investment dollars towards a common goal that should be funded by available resources, both public and private.
If Pfizer, for example, finds just as much money in developing preventional programs and products as they do now for clinical products, then they may very well become more effective at helping to cure illness and promoting healing than they are right now.
Anyway, those are my thoughts right now.
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DCA is not unpatentable. It is only unpatentable as a compound. A patent has actually been filed for its use in cancer treatment ( http://www.wipo.int/pctdb/en/ia.jsp?IA=CA2006%2F000548&DISPLAY=STATUS ).
Similarly, through the miracle of process patenting even the use of progesterone in brain damage can be patented. This is definitely NOT an example of the lopsided effect of patenting/drug development costs on research. For that you should look at things like decreased research on preventive medicines, vaccines and antibiotics compared to drugs for chronic conditions such as cholesterol treatment or restless leg syndrome.
This just shows that the research body can block/delay research when it goes against their favorite model. In other words, scientists are also human. Though, there is one point I should give them a benefit of doubt. I have written research proposals which have been rejected and while I am devastated, I appreciate that the reviewers have a limited to time to look at my proposal and have to choose from ten other proposals that they have to review at the same time, so it is not surprising that they get it wrong sometimes (especially when they reject my proposals :-).
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First, not sure, but blood pressure, cholesterol drugs and others are preventative medicines. You take BP drugs to not have a stroke. You take cholesterol drugs to avoid a heart attack.
Those chronic conditions take up so much research because they kill the most people.
As for vaccines, price controls in the US is mostly responsible for little investment in vaccines. Merck was working on a cancer vaccine, but it didn't work out.
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Eitherways, cholesterol medicines get disproportionately more money for research because they need to be given for a long time (therefore more revenue) as opposed to antibiotics. Infectious diseases do kill more people than cardiovascular disease. Of course, it might be argued that most infectious disease-related deaths occurs in poorer countries and therefore there is less money to be paid off the patients anyway.
Also, I would politely disagree on your argument on vaccines. I feel the lack of research on them is because they require more time to test as opposed to cholesterol medicines that you can give to a person and check whether the cholesterol levels come down. In the case of vaccines you need to wait a long time for the disease to hit enough people in your control group. Therefore, the process becomes economically unsustainable.
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Vaccines (for kids) is a touchy subject and now autism and other side effects are being looked at. Fact is, to accept the price restrictions, the govt. won't let you sue a vaccine manufacturer in the event that there are side effects.
Antibiotic research is in full swing, everyone in the industry knows that the ones on the market today are not good enough for the future. Pfizer got in trouble in Africa administering a drug to kids during some kind of outbreak. Doctors without borders was pretty ticked off about that. Antibiotic research is another hard thing to tackle.
I believe the key issue in terms of healthcare in America is this. We need to decide what is the bottom line, standard level of healthcare each and every citizen is entitled to. We don't have that right now. We do need to determine what everyone has a right to. Without that, all the political talk is just that. Talk.
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Here, Here
When people say "universal healthcare coverage", many are probably thinking about your bottom line approach - inexpensive prevention and simple fixes at low or no cost. Support for vaccines and antibiotics. Catastrophic care for a small minority of us who are struck with a rare condition in the prime of life. I think such an approach would have broad political support.
A universal coverage policy has so many details to it that legislation would be almost impossible to negotiate without all manner of perversion. As interest groups pressure the corners of a massive plan, it gets monstrous, loses momentum and fails. It's a problem. The impossibility of universally just healthcare legislation is a reflection of the human body and its fabulous complexity. Only a complex approach will counter the problem.
I'm interested in the corners, the details. What happens when each little corner of the plan receives a broad degree of social support by a wide cross section of population? We have these incredible tools for communication in every home. People have a strong interest in healthcare (which tends to be lop-sided to personal needs) and would be willing participants in a large plan for the future.
If planned with a huge group of participants, all who can voice sound judgment about their corner of the plan, then idealogically or profit incentive driven manipulation can be minimized. That is one thing Congress pays attention to - well informed and motivated crowds of people with a reasonable agenda.
Well, maybe some day. This has been an enjoyable blog. Thank you for maintaining it.
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I'm fairly confident that the quality of writing, music, and films wouldn't suffer much if we put the copyright system out of our misery. Yet for all the abuses of the patent system, I wonder what the results would be if it didn't exist.
Granted, the U.S. patent system is far from optimal. In anecdotal situations, it clearly doesn't work. But over all, would we necessarily be better without it?
The average person can practically pull stories and songs and videos out of his ass without much investment. But what about a new method for creating electronic circuitry or a new cancer drug? Technological developments require huge amounts of time, money, and expertise, and must be judged by objective rather than esthetic effectiveness.
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What would likely happen w/o patents
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Re: Re: This is the reason patents are necessary.
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hi
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Re: Exhibit 1
You have to get FDA approval to conduct clinical trials and that's the most cumbersome aspect of the whole process, especially with a pharmaceutical controlled FDA.
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Re: Re: Exhibit 1
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Re: Re: Exhibit 1
http://www.uncommondescent.com/off-topic/dca-update-big-pharmaglacial-rate-of-progress/
Uncommondescent has many more articles documenting the history of DCA and the difficulty in getting clinical trial approvals. You can search their forum for more details.
Also, read the comments on those threads as well.
http://www.uncommondescent.com/education/the-american-cancer-society-finally-notices-dca/
http://www.uncommondescent.com/biology/dca-update/
http://www.uncommondescent.com/biology/dca-u pdate-ii/
http://www.uncommondescent.com/off-topic/dca-the-plot-sickens/
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Patent War Hurting Patients
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