Slashdot Mirror
Patents Choking Off Medical Research
pq writes "The New Republic has an insightful article talking about the
"absence of truly innovative drugs in current drug company pipelines. And the explanation for that might well come from the supposed fount of American innovation: our patent system." Apparently they are trapped in a situation where "it's much easier to argue that `patents support innovation' than to try to explain that some patents are good for innovation while others are bad." A long read, but unlike the latest copy-protected mp3 player, this is definitely stuff that matters!"
OK, so part of this can be tossed off as a little bit of paranoia, but the patent issue is only a small part of the iceberg that is medical research. There is a dearth of substances out there that fight depression (St. Johns Wort), cancer, and other ailments that no-one is willing to put through the rigorous testing required by the AMA, and FDA because there's NO MONEY IN IT. They can't patent it, so as soon as it's approved, anyone can sell it. It's a sad but true fact that it happens all the time. If you're intersted in starting down the road of true paranoia, look at When Healing Becomes A Crime, The Harry Hoxsey Story if you can find it. try here if you're interested
Look, I'm sorry. I personally don't give a flying fuck about Michael or any others of the Slashdot crowd.
This is not a professional news organization - for that, I'll watch 60 Minutes, Dan Rather, or people who make a good buck doing nothing but finding shit out that I think is important.
Michael, Taco, Cowboy, and the rest are just guys saying "Hey, this is something I thought (or some poster) thought was interesting, and here's my $0.02 on it."
Don't like - go get your own damn web site. I don't have time for arrogant pricks like yourself who feel you have to bash somebody because you a) don't agree with them, b) don't share there interests, or c) expect them to be more/less than they are.
I'm getting off my soapbox now. I'm gonna go have some toast with peach and raspberry jam.
52 Weeks, 52 Religions with John Hummel
My sister used to work for Bristoll Myers. One of her main points was it takes an excess of 8 years to perfect a drug. Wherein a list of ten potentials you may get one that qualifies for clinicals. Now keep in mind your development team for lack of a better word concist of PhD chemist and Biologist commanding a 6 figure per anum paycheck. Now the catch is after all that R&D investment drugs that pass clinicals only have a patent lasting 5 years before generics can be made. Thus the consumers take it in the pocket with high drug prices.
As this article points out, one reason big drug companies are stepping away from AIDS drug innovation, at least, is because of AIDS activists and other anticorporate do-gooders. By forcing companies to practically give away their drugs to the third world, these misguided crusaders have removed all incentive from Big Medicine to research new AIDS drugs. Any new drug development requires an immense amount of R&D capital before a cent of profit can be made; and no intelligent CEO is going to throw billions at a product that'll wind up being either given away or copied illegally by third-world manufacturers.
--
CPAN rules. - Guido van Rossum
No, it's right on. It's a well-known problem too.
It's not that the drug companies are sitting on the cure.
They're not LOOKING for it. The private money is funneled into drug possobilities that will pay off. Actually, I'm fine with this. Great, we get treatments. But government has to step up and pay the bill for research that benefits "the public good". Markets arn't the perfect solution for everything. In drug/health care, cooperatives that are put improving health above, investment returns are very important.
Think about it. Any companies that put the amount of money towards vaccines etc that was relative to their health care value WOULD GO OUT OF BUSINESS. Why vaccines aren't profitable. They are one time use (or so). You only get so many years of monopoly anyway. People will (rightly so) riot if you charge $10,000 for a vaccine for polio, which might make it more profitable.
So close and yet so far from the world's perfect ID number
Just about every major drug development in the past 15 years has come from the public sector, not the private sector. Cancer drugs? Almost 100% public sector. AIDS drugs? 100% public sector. Antibiotic research? ...Same thing.
...Or change one molecule, or change chilry slightly in the process ... Or launch patent on what the drug becomes once it enters the body to extent patent ...Lobby congress for patent extension ... etc
..That's 90%.
...And you have some real scum at work.
What is the private sector doing? "Weekly" Prozac, "Extended Release" Acyclovoir, "Controlled Release" Pain Killer/Paxil
I'm not saying that some of the controlled release drugs aren't quite useful -- but the mechanisms for making them controlled release are rarely innovative. Add Wax, or Cellulose to pill
Add in captive market pricing (drug in US $212, same drug in Peru $7, same drug in Mexico $12, same drug in Australia $117).
But drug companies have some some other shady things -- like using their influence at the FDA to keep new drugs from Europe off of the US market while they work on a one off version for release here. I'm sure some countries in Europe are doing the same thing. One of those areas that trade treaties don't really cover well.
Freedom is merely privilege extended unless enjoyed by one and all.
It's a difficult thing to prove quantitatively (although the market woes and the lack of any new groundbreaker like Viagra and Prozac in the pipeline is mentioned .. did you want that in a pie chart?) .. especially since the questions of what drugs are important, which arn't, whether some drugs are actually better than the problem they cure .. these are not neccessarily quantifiable things.
The thing is, most of the people I know in the scienitific community right now agree with that main charge of this article. Yes, patents are important, but there is a crowing concensus that simply allowing anything and everything to be patented (which is increasingly the case) harms the very industry that patents were put in place to support.
We've become so engrossed in the battle for the pie that we ruined the pie for everybody in the first place. There's plenty to share, so we shouldn't focus so hard on ensuring that yoou'll get your pie. Or in another analogy, if capitalism is people in competition to the finish line, we've gotten so good at tripping each other up and not actually runny that we might as well have all walked the distance.
Yes, there is no quantitative proof, but the way the industry operates, you'd have to wait 5 or 10 years to see the effects that the current research climate has on the consumer end of the industry. So, we have to rely on people in-the-know to identify problems and solutions before we can tally them on a spread sheet.
"Old man yells at systemd"
I tend to agree. There isn't a new arguement here, and none of them hold water.
A good bit of what I read was a poke at the prices of new drugs, and a drop in investment. Well, new drugs are expensive to produce and test thoroughly. There's the expensive research to find a new treatment. Then, there's the expensive and extensive government-mandated testing to make sure the drugs won't do more harm than healing. After that, before the drug can be marketed, it has to be patented... which means telling everyone else how to make it.
And there's only a short time period for the research company to recoup its expenses before the 'generic' drug companies are allowed enter the market... to produce the same drug, without all the R&D costs. If it's an extremely useful drug, you'll hear of people lobbying the government to let the generics start early, cutting in on that short time period the patent-holder has to recoup losses and make enough money to satisfy the investors. And now, you've got more folks wanting the government to step in again and engage in more price-fixing for drugs used by retirees.
Whenever the government limits the odds of receiving return on one's investment, investment will drop. And that applies to the investments of time and effort by drug researchers as well as the financial investments from Wall Street.
Good judgment comes from experience.
Experience comes from bad judgment.
Actually, almost every drug company has gotten out of the vaccine business. The government is by far the largest buyer of vaccines and their budget would dictate how much they could pay. Companies couldn't make a profit selling for what the government was paying, so they just stopped doing it. Due to Wyeth-Ayerst dropping out of the tetanus vaccine market, there is almost none available in the country. Tetanus is a horrible disease that virtually nobody gets. Nobody gets it because up until now, the vaccine against it has been highly effective and rather inexpensive. That may be changing in the near future.
r e/2001/03/08/t etanus/index.html - take the space out after you paste
I love free markets, but for certain things "the market" isn't the answer. People's health and safety need to take precedence.
reference:
http://archive.salon.com/tech/featu
-B
Read the article again. They explicitly mention hepatitis research, and Harvard suing over osteoporosis research. Then there's the suggestion that HGS may be able to interfere with AIDS research. And aside from screwing other people, Big Pharma is now trying to squeeze every little bit of life out of existing products for which it has patents (or can get bogus new ones) rather than doing actual innovation.
This isn't *quantitative* evidence, but it doesn't sound like the author just pulled all this out of his ass. And as a biomedical researcher, I assure you there is a huge body of evidence to support the article's assertion which did not appear there.
>Which drug companies are tripping the others up?
.. there comes a time when you're spending so many resources on trying to be competative other than the actual market fitness of your product that you sacrifice the over-all quality of the product being produced. One example: My father, being a principal R&D guy at a pharmaceutical technology company, was involved in patent litigation that delayed the development of a product they were working on. You simply cannot assume that the cost of not enforcing their patent ALWAYS outweigh the costs involved in filing it, defending it, nor preventing other companies from building off of it. You can't predict the future, either, which means that theres no way to actually prove that had you not filed/enforced a patent, you wouldn't be better off for it.
.. some patents are getting in the way of the very goal (to create better drugs) they are supposed to encourage. I have never met anybody in science who doesn't recognize that you can have too much of a good thing when it comes to patents. So then its just a matter of, like I said, figuring out the point where people are spending more time/money trying to defend what they have instead of using that time and money to do what they are chartered to do.
s/tripping/patent-litgation
So, effectively, you're saying this entire article is BS. Which I assume means that you believe that the actual granting, defence, and enforcement of patents can only be good, regardless of the situation, whats be patented, whos patenting it. It can only help humanity, right? All patents. More patents! More!
No
Tripping each other up doesn't imply illigal action, it implies exactly what the article implies
"Old man yells at systemd"
1. Pharmaceutical companies have big ties into our government, controlling legislation.
50% of every dollar spent on medicine in the US comes from the Federal Government. No big suprise it is politicized. With prescription drug coverage for Medicare coming, the percentage will rise.
3. The FDA has limited manpower, which means less drugs tested.
This is wrong. Every drug is tested by its maker, on its maker's dime. The FDA only requires testing and examines results. The average cost of testing is near $100 million, and the drug may then not work (most don't make it through testing). Backups due to the FDA do not lead to untested drugs being released, it leads to fewer drugs being released.
Celbrities, Pharmaceutical Researchers Urge House to Reject Patent Legislation that Would Harm Patients
Drug companies have 20 years from the filing of patent to have exclusive rights to the drug. After going through NDA and FDA approvals the average drug gets 7 years on the market. Meanwhile, hundreds of millions of dollars are needed to be recovered in 7 years.
If we combine the effects of foreign governments not allowing US based companies to charge for "R&D costs" (they allow a small amount of profit), US citizens usually get a bum deal in terms of name brand drugs. US residents are accustomed to paying high prices. That is why the main R&D center of the largest British pharmaceutical company is located near Philly.
Luckily this summer, the Senate passed the Schumer-McCain bill that helps boost access to generics and boosts competition. The traditionally self-competing and bickering major generic manufacturers also have formed a pharmaceutical association in a similar vein as the major pharma companies.
I am a med student who is concurrently getting an MBA in health administration. The current health care costs are 14% of our GDP (~$1.4 trillion) and drugs are the fastest increasing component of the cost.
Please, if we are all to help force down drug prices, ask your pharmacist for generics
---
I'm just an ordinary man with nothing to lose.
I work in an industry that supports the very early stages of drug discovery at all the large pharmaceutical companies, so I can give you a different perspective than the author, who is apparently not a chemist.
First of all, the complaint that "Nexium... is essentially AstraZeneca's old heartburn drug Prilosec with a minor chemical twist that allowed the company to extend its patent." is shallow. Prilosec was a racemic mixture - a mixture of two mirror-image molecules with the same atomic connections. This is the old way that bioactive molecules with one or more chiral centers were patented and sold, because it was too expensive or impossible to separate the mixture into its chirally-pure components. Unfortunately, the mechanisms of the body are chiral, and often it is only one of the mirror-images which is the active ingredient. The other enantiomer is at best inactive and at worst toxic, mutagenic, teratogenic, etc. It is only with the chiral preparative and analytical methods and tools available in the last 15 or so years that it has become economically feasible to either prepare only the active enantiomer or to purify away the undesired enantiomer from the mixture. This is what AstraZeneca has done. From Prilosec to Nexium is not a minor chemical twist - it is a profound biochemical change. In the meantime, anyone else could have separated Prilosec into its components and patented only the active enantiomer, which is what a company called Sepracor has been doing. Sepracor is a company specializing in chiral separations. They have been taking patented compounds and isolating and patenting the active ingredient. Sometimes they license the compound back to the original manufacturer, but if the holder of the patent on the racemic mixture doesn't want to pay, Sepracor sells it themselves or in partnership with another firm.
Second, my customers are under constant pressure to shorten the discovery pipeline so that successful drugs can be sold under patent protection for as many years as possible. That means more work for me, luckily. To argue that the patent process is wrong or flawed is to ignore the full shelves in the pharmacy. If it weren't for the patent process, those bottles would be full of roots and bark. (Not that there is anything wrong with roots and bark, just that they may also contain toxic compounds.)
Which reminds me of: third, the author confuses small-molecule patents with biochemical patents. The old school (classical small-molecule therapies) patent system works pretty well. You get some years to make money to fund R&D on new drugs. It is the silly biochemistry and genomic patents which are insane, and the patent office has let them get away with it. From PCR to broad gene therapy claims based only on sequence - that process is as flawed as the software/business model patent crap that is every fifth story on slashdot. This is the area the author should have concentrated on.
Last, the author gives the impression that there are no new areas for drug therapies out there. This is just a lack of effort on his part. Most drugs initiate change in the body by interacting with receptor proteins on the outside of cells. And each type of receptor - the calcium channel, for example - comes in subtypes which may be expressed in different amounts dependint on tissue type or even on different areas of the same organ. Many of the drugs currently in use do not differentiate very well between the receptor subtypes to which it binds or interacts. There is a huge opportunity for development of drugs which are more and more specific to a specific receptor and so demonstrates fewer and fewer side effects - which are manifestations of interactions with other receptors than the family targeted. The combination of high-throughput screening and combinatorial synthesis, both of which are still in their early stages, promise to supply us with many times more drug candidates than classical one-pot organic preparations and one-rat-at-a-time testing of those compounds.
If Slashdot were chemistry it would look like this:Cadaverine