Domain: phrma.org
Stories and comments across the archive that link to phrma.org.
Comments · 12
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Re:For the patent FUDsters sure to follow....
I find patents on pharmaceutical products, specifically, to be rather legitimate, though I agree with you generally about patents on incremental steps in innovation and ideas that don't have the novelty to justify a temporary monopoly.
Drug companies use that specific form of IP law to justify spending millions of dollars on research:This is not a complicated economic and legal argument for intellectual property protection. It is a plain, pragmatic argument for results. We need new medications for the future. We will need them as much, or more, than we do today. Therefore, we must have continued innovation. We must encourage and protect that innovation...
And Aids is a disease that is always new - due to the constant evolution of the virus - and requires new solutions. Where will these come from if we hobble the patent system that drives innovation?(source)
For those that don't know, patents on drugs are necessary for the innovator(s) for motivation, and the previous quote is just one example of the industry (pro-patent) hawking it loud and proud. It costs exorbitant amounts of money in R&D to the company to put a new drug on the market. Other companies can reverse-engineer that drug and produce non-trademarked bioequivalent substances ("generic drugs") at a fraction of the cost to the innovator.
Without patent protection, a drug manufacturer is economically disadvantaged by innovating: R&D is a large fixed cost that only the innovator pays, so why do it?
Under the patent system, you receive a significant economical advantage for a time by coming up with a "killer" product (and the privileged of society that have the economic means to consume your product at your price also benefit...), and when your protection is up, society receives the advantage of being able to make use of those innovations at approximately the marginal cost of manufacturing the product.I believe that this is a prime example of a large industry that claims that "a patent is the only motivation for invention". I imagine that there are other industries out there that have similar claims.
Patents on software, on the other hand, are ridiculous. I don't think any software patent can simultaneously be specific enough that an isolated coder couldn't come up with the same idea and broad enough to afford more protection than copyright.
In perspective, I could probably (invariably?) sit around writing some code and, in the process, use some algorithms that violate some patents somewhere. You don't just come up with a complete chemical formulation, years of clinical trials, and regulatory approval for a patented drug. -
Re:I'm involved in something closely related.
Sorry, make that the PhRMA, not the FDA. Same results, implications, and effects, however.
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Re:But what comes next?
Even if a corporation was willing to spend that much money... there's no way it would happen. Almost everyone (politicians, executives, shareholders, and the general public) is pretty much incapable of long-term thinking. Hell, most companies don't even seem to think beyond this quarter, much less this year--just look at all the dumb decisions that boost quarterly profits at the expense of long-term ones.
A counter-example: Pharmaceutical companies in the US spend around $60 billion on R&D each year, and most of the drugs they test never make it to market. For those that do make it to market, the average time-to-market is 12 years. Despite the immense cost and huge amount of time before any profit is seen, the drug companies still invest in the long-term.
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Re:AIDS free worldDrug companies aside, there's no way this would be used anytime soon in 3rd world countries, so the problem will simply continue to grow there. 3rd world pharma companies have been breaking patents on AIDS/HIV drugs for quite some time now with their governments' support.
Even highly developed countries like Brazil have done so
Here is the response from The Pharmaceutical Research and Manufacturers of America -
ahh, no
"Actually, the vast majority of research - particularly in potential drug therapies - is done with public (NIH grants) and not-for-profit funds (think March of Dimes, Juvenile Diabetes, Jerry Lewis, William Gates Foundation, etc.) by universities and such."
Who starts these urban legends?
http://www.kaisernetwork.org/health_cast/uploaded_ files/Iglehart_Slides.pdf
http://www.phrma.org/publications/publications/17. 03.2005.1142.cfm
http://www.bain.com/bainweb/Consulting_Expertise/h ot_topics/detail.asp?id=22 -
Fallacies
"The majority of the expenses associated with new drug discovery are actually made in the public sector - by Universities and so forth."
Private R&D spending on pharmaceuticals exceeds public R&D spending. This is actually true for R&D in general ($132 billion federal vs. $190 billion industry), and it's true for pharmaceuticals ($30 billion federal vs. $49 billion industry). For the first 3 figures, see here:
http://www.aaas.org/spp/rd/rd06main.htm [chapters 2 & 4]
For the last figure, see here:
http://www.phrma.org/publications/publications//20 05-03-17.1145.pdf
The last is an industry organization, but r&d spending is part of companies' public SEC filings and the figures are in line with the aggregate numbers.
It's a fallacy that public and private pharmaceutical r&d are substitutes. Public r&d tends to focus on basic science while private r&d focuses on specific drug development and testing. Here it is from the horse's mouth:
http://ott.od.nih.gov/Reports/211856ottrept.pdf
The public sector would be just as good at developing drugs as it would be at making cars and televisions (see Union, Soviet).
"these additional resources are a *fraction* of the total increase in drug prices that result from the patents they are awarded"
If patents over-compensate drug companies, then we'd see a lot more entry into the (apparently very lucrative) drug business by new firms until these extra-ordinary returns are competed away. Even with patent protection, lucrative business models attract entry by competitors until excess profits are competed away. -
Good thing!The National Institutes of Health is already proposing mandated Open Access to all NIH-funded research
This is a very good thing. If my tax dollars are going to support the research, I hope it benefits as many people as possible (instead of just the big PHaRMA ).
I had heard that the Pharma people have a way around this. They will co-sponsor research with NIH, and when it comes time to publish, claim that all of the good stuff came from their share of the funding (and hence claim it as their IP). I don't know how true this is, but that's what I've heard.
I have been on the lookout for quality (human) Microarray data for doing predictive data mining with some exciting new techniques, but can't find too many such sets around. Looking at the revenues of Affymetrix (for instance), one would think there would be oodles of data out there; but this is not the case. Yes, I am aware of the SMD, etc.
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Re:Some other examples
On your first point, I'll point you to this article that attempted to examine the effects of US-imposed drug price controls on overall global drug R&D spending. Note that the 15 largest pharmaceutical companies he studied were Pfizer, Merck & Co., AstraZeneca, Aventis, Bristol-Meyers Squibb, GlaxoWellcome, Pharmacia, Roche, Johnson & Johnson, American Home Products, Eli Lilly, SmithKline Beecham, Abbott Laboratories, Bayer, and Amgen. As is obvious from looking at the list and checking company websites, the pharmaceutical business is a global one. You can also note from the article (on page 23) that many European countries, including where a number of the top pharmaceutical companies are based, have drug price controls of one kind or another. It might be more accurate to say that U.S. consumers are the target market for the lion's share of new drugs.
The conclusion of the modeling study is that U.S. adoption of price controls equal to the average of industrialized European countries would result in lowered R&D spending overall, but that the decline could range in intensity from "a very small decline to a near complete cessation of R&D activity; the latter is, of course, an absurd conclusion". In other words, we probably shouldn't place much faith in any results from his model. The question of whether U.S. price controls would significantly cut R&D expenditures, or simply shift more of the burden for R&D to other global customers is beyond his model to answer.
On your second point, you gave the URL for the Pharmaceutical Researchers and Manufacturers of America site which contained a number of links. Not knowing exactly which article you wished to refer to, I'll simply choose the rebuttal article to this report by the Attorney General of the state of Minnesota, as they seem to clearly summarize the viewpoints of the pharmacy trade group and the opposing camp. Anyone interested in the subject should read both, hopefully with an open mind. If you would like to discuss any particular point, just let me know.
On the third point, I think your characterization of scientists is more of a caricature than a true picture. Scientists, whether publicly or privately funded, are people, who have normal human concerns and awareness of things around them. One thing basic research does is provide knowledge that makes the drug discovery phase more efficient. Discovery in finding the right compositions to pursue for new drugs is essential for making sure only the most promising approaches are followed up with more expensive development efforts and clinical trials. The pharmaceutical companies are often better suited for carrying on the later processes, but they heavily benefit from public research efforts that point them in the right direction. It's not just about total dollars spent, but also how much is saved by developing a proper scientific foundation for the search.
This also brings up the point that while the industry likes to brag about how much it costs to bring a new drug to market and how risky the prospects are for success, the truth is that the greatest development costs occur during the latest stages of product development (such as holding large clinical trials involving thousands of subjects). By the time decisions are made to hold such trials, the company must have already experienced enough success from earlier work to have a high degree of confidence in success. Most unsuccessful drugs are thus weeded out early, before huge expenditures are incurred in development. The better the basic science that is available, the more efficient this filtering process can be.
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PHRMA on Intellectual Property(My wife is still alive because of a recent drug discovery, so I suppose that perhaps my view is pro-drug-manufacturer...)
Celbrities, Pharmaceutical Researchers Urge House to Reject Patent Legislation that Would Harm Patients
Tell legislators that changes to patent law would slow development of new drugs
October 01, 2002
Washington, D.C. - A group of celebrities and pharmaceutical researchers, including television talk-show host Montel Williams and actress Kate Jackson, urged the U.S. House of Representatives to reject pending patent legislation that would harm patients by slowing the development of new life-saving, cost-effective medicines.
Along with Williams, who has multiple sclerosis, and Jackson, a breast-cancer survivor, the celebrities included television personality Leeza Gibbons, whose mother suffers from Alzheimer's disease; Peter Samuelson, a movie producer who has diabetes; and Nancy Davis, founder of Race to Erase MS, who also has MS. The group held a press conference on Capitol Hill before visiting Members' offices.
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if you are really interested.
http://www.phrma.org/pu bli cations/publications/annual2000/
warning its 17 megs. page 21~23 talks about rnd expenses.
john -
Re:Illegal?I don't think it's illegal yet. There have been quite a few attempts to get it to that stage, though. I've managed to track down some of the relevent legislation. This was shamelessly grabbed off of the PhRMA website. You can follow the links to read the full text of each. The top one is probably the most relevant to your question.
In the 106th Congress, we have:
- H.R.571 , Human Cloning Prevention Act of 1999, SPONSOR: Rep Paul, Ron (introduced 02/04/99) A bill to prohibit Federal payments to any business, institution, or organization that engages in human cloning or human cloning techniques.
- H.R. 448 , Patient Protection Act of 1999, SPONSOR: Rep Bilirakis, Michael (introduced 02/02/99) A bill to provide new patient protections under group health plans.
- H.R.398
, Plant Genetic Conservation Appropriations Act for Fiscal Year 2000 , SPONSOR: Rep Mink, Patsy T. (introduced 01/19/99) A bill to make appropriations for fiscal year 2000 for a plant genetic conservation program.
- H.R.358
, Patients' Bill of Rights Act of 1999, SPONSOR: Rep Dingell, John D. (introduced 01/19/99) A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to protect consumers in managed care plans and other health coverage.
- H.R.306
, Genetic Information Nondiscrimination in Health Insurance Act of 1999, SPONSOR: Rep Slaughter, Louise McIntosh (introduced 01/06/99) A bill to prohibit discrimination against individuals and their family members on the basis of genetic information or a request for genetic services.
- H.R.293 , Genetic Information Health Insurance Nondiscrimination Act of 1999, SPONSOR: Rep Sweeney, John E. (introduced 01/06/99) A bill to amend the Public Health Service Act and the Employee Retirement Income Security Act of 1974 to prohibit health issuers and group health plans from discriminating against individuals on the basis of genetic information.
- S.374 , Promoting Responsible Managed Care Act of 1999, SPONSOR: Sen Chafee, John H. (introduced 02/04/99) A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 ro protect consumers in managed care plans and other health coverage.
- S.326 , Patients' Bill of Rights Act, SPONSOR: Sen Jeffords, James M. (introduced 01/28/99) A bill to improve the access and choice of patients to quality, affordable health care.
- S. 300 Patients' Bill of Rights Plus Act, SPONSOR: Sen Lott, Trent (introduced 01/22/99) A bill to improve access and choice of patients to quality, affordable health care.
- S.240 , Patients' Bill of Rights Act of 1999, SPONSOR: Sen Daschle, Thomas A. (introduced 01/19/99) A bill to amend the Public Health Service Act and the Employee Retirement Income Security Act to protect consumers in managed care plans and other health coverage.
- S.6 , Patients' Bill of Rights Act of 1999, SPONSOR: Sen Daschle, Thomas A. (introduced 01/19/99) A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to protect consumers in managed care plans and other health coverage.
Whew. That wasn't that bad, now was it. :) Cloning is certainly a controversial (and gray) area. I get the feeling the site in the story isn't real serious as a business (do they even have the facilities necessary to clone humans?). One attempted cloning, by these people or others, would certainly speed up the debates on the issue, and probably get us a test case in the Supreme Court on human cloning. - H.R.571 , Human Cloning Prevention Act of 1999, SPONSOR: Rep Paul, Ron (introduced 02/04/99) A bill to prohibit Federal payments to any business, institution, or organization that engages in human cloning or human cloning techniques.
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It's just WORDS!As usual the hot discussion is just a matter of definitions. So to clear things up here they are taken from http://www.phrma.org/genomics/lexicon/:
clone: A term which is applied to genes, cells, or entire organisms which are derived from - and are genetically identical to - a single common ancestor gene, cell, or organism, respectively. Cloning of genes and cells to create many copies in the laboratory is a common procedure essential for biomedical research. Note that several processes which are commonly described as cell "cloning" give rise to cells which are almost but not completely genetically identical to the ancestor cell. "Cloning" of organisms from embryonic cells occurs naturally in nature (e.g. with the occurrence of identical twins). The laboratory cloning of a sheep using the genetic material from a cell of an adult animal has recently been reported.
cloning: the process of producing a genetically identical copy - or clone.
twinning: Two offspring developing with the same maternal parent and born at the same time. Twins can develop from the same zygote (monozygotic or "identical twins") or from separate zygotes (dizygotic or "fraternal twins"). Identical twins share the same genetic heritage whereas fraternal twins are no more or less related than are siblings born at different times.
identical twin: Twins which have been produced by the division of a single zygote (monozygotic). Each twin has an identical genotype. While each twin begins with the same set of genetic information, the effect of the environment within which each individual grows up can cause differences in how their genetic make-up is expressed.
No wonder people disagree so much on so many subjects when they don't agree on their terminology and don't tolerate the views of others! Twins from more than one eggcell is certainly not clones, while identical twins are usually called "clones" in the media when coming from laboratories. Wether they are truly clones or whatever they are is up to whoever judges them. Whatever reason they have for judging their neighbours. Also, wether a technical cloning has actually been perfomed remains a technical issue in each case. For the rest of us it's just words. I prefer to call them humans, or by their name if I get to know them.
Human Identical Twins are still human.
Human clones are still human.
No Less.
Not bad from someone from Microsoft though. I guess you're human too *sigh*.
- Steeltoe