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!"
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.
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CPAN rules. - Guido van Rossum
The fact that so many of these posts are modded up as "insightful" is insane. The biotech industry is one of the fiercest out there.
Patents hurt drug companies as much as their business model and costs do. They must constantly produce *results* and *product* at a much higher rate and much more competitive environment than most industries. Without upstream patents, anyone could horn in on development and steal it away. Recent innovations in Solid Phase Synthesis really streamline the production of analogues to various drugs. Once something is found that has the desired effect (to any degree), all related compounds can be made AND tested in a very short time. The long period is in clinical trials and FDA approval. So once a company finds something and patents the process, it can own a whole set of molecules. So if any information is leaked out, a rival company could have found a better/more active/more specific similar product in a very short time. With the short duration of downstream patents and the high cost of R&D, the biotech companies have a difficult struggle to stay afloat.
Not to mention competition from universities, whose costs are paid by the government. The lab I work in, which consists of just 5 people, easily spends $2000 A DAY on just supplies.
So, a hard question is raised: How do you allow these pharmaceutical companies to compete in such a tough environment against competitors that have no costs and deal with patents, while still promoting miraculous developments? Our current system seems do a good job of most things, though generally poorly. I really don't have an answer.
One company, however, had a good idea. They gave us several thousand dollars in new product (which needs some testing as to what it does and is good for), some more money to pay labor, and just expects us to publish some (hopefully important) papers about it. The university is getting most of the cost of the research, and the company will get good advertising for their protein complex, which they can then sell. Seems like a good bargain, on a small scale.
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
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.
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
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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
..or PBS for short is the drug subsidising program of Australias social health system. It provides government subsidised prescription drugs (often 75% of the cost or higher) to every australian as long as it is part of the extensive list of drugs that is PBS subsidised.
A drug may be approved for actual sale in australia, but until it is on the PBS list it is unlikely to be very often prescribed, especially if there is a suitable equivalent drug on the list. What does this mean, "me to" drugs from different companies that treat the same conditions or for a drug with only a marginal benefit usually are sold at a much lower overal cost (before the subsidy is included) compared to the US.
The commitee of health professionals that decides which drugs are included are able to negotiate with drug companies from a very strong position, if the companies don't get their drug on the list, they won't sell much of that drug in Australia.
Effectively it is a system for the whole of australia to bargain with drug companies as one large block. And is the reason Australia has one of the lowest (for a while was the lowest, not sure at the moment) per capita spending on drugs in the develop world. Oh and the drug companies absolutely hate it.
I think that most people in the pharma industry 1)really want to make money (who doesn't?) and 2) are tied to a specific company at any given time. One looks at the situation and sees that for me to make money, my company must make money and my company can only make money by exercising patents (excluding generics) and my company can make more money by milking the patent system as much as possible (repackaging, etc.) Also, the industry is so 'rules' bound (by the FDA, which I think is a good thing) that they look at rules as a game to be milked as much as possible: first when selling the drugs to doctors regarding labeling and second when manipulating the patent system.
It's not just the patent abuse. Don't forget that the pharma companies have zillions of high-pressure salespeople pounding on your doctor's door every day. Some are low cut top, batting eyelash, some are "Hey buddy, how's yer golf game, let's hit the strip club! Your escort will be at your room when we get back", some are "here's your check, er, honorarium, for your professional leadership speech at the luxury resort in Hawaii" and on and on. Sure, R&D is expensive, but the marketers/salespeople are paid insane amounts and have massive budgets. A big part of our health insurance premiums are being funneled to the pharma marketing/sales monster.
In the 1970's, Procter and Gamble created a promising new drug. Say the process of creating this compound ("D") was by the following method:
A -->B -->C -->D
Anyway, so P&G created compounds B,C and D and finally patented only their product D. It turns out that drug D failed FDA testing and was forgotten. Another company found out that compound C was a great drug for a totally unrelated illness. That company took the un-patented compound C, patented it, and made billions.
Because of that, drug companies now spend the extra measly few bucks (to them) to patent everything under the sky that they create. This saves their asses, but unfortunately forbids anyone else from researching their patented side-notes (because say some other company realizes that the now patented intermediate compund from P&G is a miracle cure. It would have cost millions to discover this, and P&G would be totally in-the-right legally to develop this and reap 100% of the profits).