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Silversoul
Rhizome


Registered: 01/01/05
Posts: 23,576
Loc: The Barricades
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"The High Cost of Developing Drugs"
#5674649 - 05/25/06 09:01 PM (17 years, 8 months ago) |
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http://mutualist.blogspot.com/2006/05/high-cost-of-developing-drugs.html
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"The High Cost of Developing Drugs"
My last post on patents led to an interesting exchange between a couple of regular readers taking opposite views of the subject: Joshua Holmes, a frequent contributor to No Treason, and quasibill, an apparent former drug industry insider who often weighs in against Ron Bailey's (stipulation--unpaid) cheerleading for Big Pharma at Reason Hit&Run.
Josh made the point that new food recipes, with relatively low development costs, were hardly typical of product innovation. Quasibill, in response, provided some new and (for me at least) mind-blowing information on just why the cost of developing new drugs is so high. I was aware that the FDA testing regime added considerably to the cost--not only its excessively stringent safety testing requirements, but its requirement since the 1960s of testing for efficacy. And I understood that such regulatory inflation of costs served as a market entry barrier, effectively cartelizing the drug industry between a handful of highly capitalized firms. What I didn't realize was just how much of the cost comes, not from testing specific drugs, but from gaming the patent system: i.e., testing a spectrum of related drugs in order to secure patent lockdown on alternative versions of the same drug, and thus forestall competition.
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What generally gets included in the accounting for research costs are some amazing things, that I can't do justice to on a blog - I get surprised everytime I talk to my friends in the industry about how much waste is involved - but it's all invisible to them. It's just "how it needs to be for the FDA to keep track of everything." If you want, I can give you some examples, but I'd rather focus on another point for now -
Namely that what big pharma is researching is cancer meds. It's not. In the rare instances that big pharma produces and markets such medicines, it has purchased them from small start-ups that themselves are the result normally of a university laboratory's work. When big pharma cites to billions of research costs, what it is talking about is the process whereby they literally test millions of very closely related compounds to find out if they have a solid therapeutic window. This type of research is directly related to the patent system, as changing one functional group can get you around most patents, eventually. So you like to bulk up your catalogue and patent all closely related compounds, while choosing only the best among them, or, if you're second to market, one that hasn't yet been patented.
This work is incredibly data intensive, and requires many Ph.D's, assistants, and high powered computers and testing equipment to achieve. But it is hardly necessary in the absence of a patent regime. In the absence of patents, (and of course the FDA), you could just focus on finding a sufficient therapeutic window, and cut out the remaining tests. It would be an issue of marginal costs to determine whether someone would go to the effort to find a "better" therapeutic window, or related parameter.
So the "high cost of developing drugs" is really the high cost of maintaining a monopoly against potential competitors pursuing similar lines of research. Think of that the next time you see one of those smarmy, soft-lit Glaxo or Pfizer ads with the elevator music in the background, where some biochemist gets all teary about her Alzheimer's-afflicted grandma.
If anyone here is knowledgeable on this subject, I'd like to hear your thoughts on this.
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SirTripAlot
Semper Fidelis


Registered: 01/11/05
Posts: 7,459
Loc: Harmless (Mostly)
Last seen: 5 hours, 19 minutes
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Re: "The High Cost of Developing Drugs" [Re: Silversoul]
#5674740 - 05/25/06 09:28 PM (17 years, 8 months ago) |
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I am no way an expert on the subject.....but I know that cheaper generic prescriptions are not allowed because of trivial laws within the patent.....
http://www.whitehouse.gov/news/releases/2003/06/20030612-4.html
Now, one way to make prescriptions more affordable is to ensure that generic drugs are not delayed in reaching the market, are not delayed for consumers to be able to purchase. In our system, when a drug company develops a new medicine, the company is given a patent. And patents ensure that investment and innovation are rewarded, so we continue to get additional life-saving drugs as new discoveries are made. It makes sense to have a system that protects investment, for a while.
Yet, when a patent expires, other companies have the right to make a safe, lower cost generic version of the drug. However, the system a lot of time doesn't work because the original inventor of the drug uses delaying tactics to avoid competition. They delay the process of patent expiration so that consumers don't have additional choices of generic drugs.
At my direction, today, the Federal Drug Administration, the FDA, is taking action to close loopholes that slow the movement of generic drugs to the marketplace. First, we are limiting the amount of time that a drug company can delay the marketing of a generic competitor. Instead of letting them file one delay after another, the government will allow a single 30-month stay while legal complexities are sorted out. In other words, the initial manufacturer of a drug will not be allowed to use the legal process for endless delay, which hurts our consumers in America.
Secondly, we are no longer allowing drug companies to block generics because of patents on minor features, such as the color of the pill bottle, or some combination of ingredients not related to the effectiveness of the medicines. Thirdly, we are tightening the overall rules on patent applications so that false statements to get a patent result in criminal charges.
-------------------- “I must not fear. Fear is the mind-killer. Fear is the little-death that brings total obliteration. I will face my fear. I will permit it to pass over me and through me. And when it has gone past I will turn the inner eye to see its path. Where the fear has gone there will be nothing. Only I will remain.”
Edited by SirTripAlot (05/25/06 09:31 PM)
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Catalysis
EtherealEngineer

Registered: 04/23/02
Posts: 1,742
Last seen: 15 years, 6 months
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Re: "The High Cost of Developing Drugs" [Re: Silversoul]
#5675087 - 05/25/06 10:55 PM (17 years, 8 months ago) |
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Its pretty simple actually. They can make it easier for generic drugs to come on the market but they will slow down new drug development by diverting money from drug developers to drug producers at the benefit of reducing costs for the consumer.
The idea that most or even a significant part of drug development money goes towards protecting patents is patently absurd. Scientific research is incredibly expensive and it is as simple as that. Everything else is just tin-foil hat crap. The comments about FDA cost is also true. At Abbott labs, the FDA has their own 10-story complex and they literally go through every notebook of every scientist, even the technicians. This is good though. The US has the best drug regulatory agency in the world and it saves thousands of lives.
It all comes down to either having cheap, current drugs or continuing innovation. If these people think that the amazing drugs coming on the market today would still be here if we loosened patent regulations, they simply have no idea what they are talking about.
Edited by Catalysis (05/25/06 11:01 PM)
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GabbaDj
BTH


Registered: 04/08/01
Posts: 19,679
Loc: By The Lake
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Re: "The High Cost of Developing Drugs" [Re: Silversoul]
#5675140 - 05/25/06 11:11 PM (17 years, 8 months ago) |
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Quote:
What I didn't realize was just how much of the cost comes, not from testing specific drugs, but from gaming the patent system: i.e., testing a spectrum of related drugs in order to secure patent lockdown on alternative versions of the same drug, and thus forestall competition.
Sounds like Product Rollout.
Lengthy product rollouts are planed for just about all new things. From computers to cars, the when and where has been planed out to maximize profits of a single product over time. Variables change time frame and availability but the general purpose stays the same.
To make the highest dollar.
-------------------- GabbaDj FAMM.ORG
Edited by GabbaDj (05/25/06 11:11 PM)
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badchad
Mad Scientist

Registered: 03/02/05
Posts: 13,372
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Re: "The High Cost of Developing Drugs" [Re: GabbaDj]
#5676118 - 05/26/06 07:04 AM (17 years, 8 months ago) |
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People want to have their cake and eat it too.
There is so much red tape to go through with FDA regulations that it makes the process of bringing a drug to market burdensome and extremely expensive.
Then as soon as a problem arises everyone is quick to point out: "OMFG the FDA is horrible and wants to kill people, they don't care about safety".
So what do you want? More regulations and red tape to increase safety? or less FDA involvement to bring down the cost of drugs?
-------------------- ...the whole experience is (and is as) a profound piece of knowledge. It is an indellible experience; it is forever known. I have known myself in a way I doubt I would have ever occurred except as it did. Smith, P. Bull. Menninger Clinic (1959) 23:20-27; p. 27. ...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely. Osmond, H. Annals, NY Acad Science (1957) 66:418-434; p.436
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blacksabbathrulz

Registered: 05/22/02
Posts: 2,511
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Re: "These High Cost of Developing Drugs" [Re: badchad]
#5676797 - 05/26/06 11:35 AM (17 years, 8 months ago) |
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I'll weigh in on this. My father is a pharmaceutical expert and I'll leave it at that. That is a bunch of BS. Granted, they will play around with functional groups, in order to find out what has the greatest efficacy, and they may later find that that doesn't apply like they thought. But if they patented every compound remotely similar they would never get anything done, and you would never see the generic compounds that come out several years later, which are just that, the original compound with a functional group change, generally something like a chloride group changed to a bromide group.
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