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AIDS Drug Patent Revoked In US
Posted by
kdawson
on Wed Jan 30, 2008 02:29 AM
from the who-says dept.
from the who-says dept.
eldavojohn writes "Doctors Without Borders is reporting that four patents for tenofovir disoproxil fumarate, a key AIDS/HIV drug, have been revoked on grounds of prior art. This is potentially good news for India & Brazil who need this drug to be cheap; if the US action leads to the patent being rejected in these countries, competition could drastically lower prices. But the ruling bad news for Gilead Sciences. The company has vowed to appeal. We discussed this drug before."
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Science: Drugs May Offer AIDS Prevention 230 comments
FlipFlopSnowMan writes "There is an interesting article on MSNBC about the possibility of preventing AIDS using the same pills that are currently used to fight the virus in affected individuals." From the article: "The drugs are tenofovir (Viread) and emtricitabine, or FTC (Emtriva), sold in combination as Truvada by Gilead Sciences Inc., a California company best known for inventing Tamiflu, a drug showing promise against bird flu. Unlike vaccines, which work through the immune system -- the very thing HIV destroys -- AIDS drugs simply keep the virus from reproducing. They already are used to prevent infection in health care workers accidentally exposed to HIV, and in babies whose pregnant mothers receive them."
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that's no cure (Score:4, Funny)
And here I was, thinking that they were trying to patent an obscure Russian playwright.
Cool... (Score:5, Insightful)
The chemical and pharmaceutical industry happily grew to become one of the biggest contributors to developed nations GDP using only this kind of protection. It does not really need anything more. Anything more is just protectionism and racketeering.
Re:Cool... (Score:5, Insightful)
Ummm, no. A sensible person might believe this, but since the beginning of the nineties it has been common practice to patent the discovery of genes. As in "I have identified a gene that (allegedly) determines who will be fat and I am patenting it". Things such as this so-called "fat gene" are naturally occurring but nevertheless companies are falling over themselves to patent (the discovery of) their existence. This is happening now, there is no invention at all, just a discovery of a naturally occurring substance.
Do a google search for "gene patents" or read Michael Crichtons "Next" novel for more details.
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Re: (Score:3, Interesting)
That is new wave Biotech, not Pharmaceutical or Chemical industry company.
I agree, most of the Biotech companies out there are overinflated and underdelivering piles of fraud. Before I turned to the dark side of IT I did an MSc in chemistry and nearly finished a second degree in Molecular Biology and Biotech. While my knowledge is a bit fossilised by todays standards, it is still enoug
Remind me again... (Score:5, Insightful)
Re:Remind me again... (Score:5, Insightful)
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So you're a conspiracy nut.
Re:Remind me again... (Score:5, Insightful)
The real problem in the US is that the government doesn't want to impose a price for drugs that everyone in the country can afford. And so, because the pharmaceuticals aren't put on a leash, they charge as much as they can, which maximizes profit instead of maximizing numbers of patients who can benefit.
When two people can afford $10 and $100 respectively, the price is $100, which maximizes profit, instead of $10, which maximizes the number of people being helped.
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Your taxes do pay for the research (Score:5, Insightful)
From Physicians for a National Health Program's website: "15. Taxpayers pay for most research costs, and many clinical trials as well. In 2000, for example, industry spent 18% of its $13 billion for R&D on basic research, or $2.3 billion in gross costs (National Science Foundation 2003). All of that money was subsidized by taxpayers through deductions and tax credits. Taxpayers also paid for all $18 billion in NIH funds, as well as for R&D funds in the Department of Defense and other public budgets. Most of that money went for basic research to discover breakthrough drugs, and public money also supports more than 5000 clinical trials (Bassand, Martin, Ryden et al. 2002). Taxpayer contributions are similar in more recent years, only larger." http://www.pnhp.org/news/2004/february/will_lower_drug_pric.php [pnhp.org]
So they paid 2.3 billion (tax subsidized), and we kicked in 18 billion. Then they get to charge us for access to the drugs for which we paid 95% of the basic research costs.
Though you may say that PNHP is a bunch of hippies, so if you prefer a more grandfatherly source the AARP do a decent job too: http://www.aarp.org/bulletin/prescription/double_taxation.html [aarp.org]
Of course that is the reason that while you may not trust the government, they could be a much better steward of medical research than market forces. Market based R&D is inherently morally corrupt. It can't be otherwise. If its not obvious because of the fact that more R&D is spent developing drugs to give octogenarians a hard-on and a full head of hair than to offer effective treatment for malaria that kills millions each year in the developing world, MSF gives a great summary of the reasons that market based R&D is wrong: http://www.accessmed-msf.org/main/medical-innovation/introduction-to-medical-innovation/what-is-wrong-with-r-d-today/ [accessmed-msf.org]
Though I do agree with you that at present I don't trust the government. Not that they do bad research... the NIH and the researchers they fund are amazing. But I don't trust the corrupt system that gives the breakthrough drugs that the government develops into the hands of private industry so that they can extort millions of Americans for the price that the 'market will bear' for drugs they may need to survive.
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Doesn't matter (Score:3, Interesting)
Good for US (Score:3, Insightful)
It's also good news for the US which needs this drug to be cheap. AIDS patients aren't earning a lot of money while on this therapy, and their other medical care costs a lot of money. Either them directly, or their insurance corps which mark up the payout and charge the rest of us who haven't (yet) needed the drugs.
Re:I can feel the kindness (Score:4, Insightful)
Not that I'm against making life saving drugs available to anyone who needs them, but if that's what you want to do then everybody should bear the cost (through taxes), not just shareholders of pharmaceutical companies.
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Re:I can feel the kindness (Score:5, Informative)
Don't get me started on how much of the "research" money comes from the government.
I'll willing to accept that there might be a perfectly rational, moral reason the drugs are priced the way they are... but I haven't heard it yet.
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Re:I can feel the kindness (Score:5, Informative)
I'm not defending big pharma or any company in particular.
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Re:I can feel the kindness (Score:5, Insightful)
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One thing, though... (Score:5, Insightful)
And you can't tell me that all those people who are now surviving the various types of cancer that would have died just 20 years ago is proof that people are being denied healthcare and drugs. People that would have died 20 years ago are now living full, happy lives. Well, not happy, that that's another story about how people were lied to 50 years ago about having flying cars now. On second thought, where are the flying cars...
But I digress. Seriously, for all of Big Pharma's flaws, they do help people. Medicines do cost a ton of money to research, develop, test, retest, go through FDA testing, test one more time for good measure, and finally release. Plus, after releasing the drug, more testing is done through the doctors prescribing it, as well as the company having to spend money to get the word out. Yes, advertising. It is part of it. The best wonder drug in the world won't work if nobody knows about it.
Plus, part of those high costs are for all the research on drugs that didn't work. Just because a drug is researched and millions spent on it doesn't mean it will ever get to market. One hiccup along the way can be enough to send the companies back to the drawing board. On the topic of this, costs are also raised when the company has to basically protect itself financially from when a drug reacts poorly with someone, they die, and the company is sued. Sure, it may have worked on 99,999 other people, but one wrongful death lawsuit can set a company back millions of dollars.
Last, but not least, when a drug doesn't work, it is not a complete loss. The company then knows what won't work. They can still salvage research from the drug, how it affected the virus/bacteria, and move on from there. Storage of these maybe-medicines can't be cheap, what with regulating everything from temperature and humidity to making sure that the computer backups of the backups are always up and running, because if these people lose files, it isn't just the courts they have to worry about, it is also the fact that people can die from lack of information. So their systems have to be top notch at all times. That isn't cheap.
Oh, and one last thing. As much as everyone demonizes Bill Gates, the Bill and Melinda Gates foundation does do a lot to help people. Just because his business practices weren't always on the up and up doesn't mean he's a total loss in the way of morality.
I know that I just lost half the support of Slashdot when I wrote that last comment. Oh well. Can't win them all.
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This is a huge part of it. There are a number of drugs that are used by both humans and animals, such as anti-biotics. It's literally happened that my mom and the dog have been on the same drug - the pills are identical, the generic name the same, etc... It was a common anti-biotic.
The cost(before insurance) for Mom: $70
For
Re: (Score:3, Insightful)
I'll agree about speeding up the process in some respects, but we're deathly afraid of more Vioxx type disasters. And Vioxx is only the latest of drugs withdrawn - remember thalidomide and birth defects?
We need to find a balance, maybe not where we are, but there has to be a balance.
Big Profits for Pharma is Great news! (Score:4, Insightful)
Go ahead, take away their patents or institute price controls, and watch the money dry up. That will help everyone...not! You can't force investors to invest, no matter how much compulsion or Robin Hood economics you want to institute.
I just wish someone would make a list of the top 50 drugs in the last 50 years and who made them and how they were financed. I'm guessing it wasn't from a communist country.
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Re:Big Profits for Pharma is Great news! (Score:5, Insightful)
I think the USPS does a fantastic job. How far can you send something for $0.41 via UPS or FedEx? With USPS I can send a letter all the way to Alaska or Hawaii for the change under my couch cushions. If you compare time & cost for a 1 pound package shipped domestically, USPS comes out ahead there too.
I'm not saying the government does eveything well, but the Postal Service is one place where it excels. Many years ago, the USPS received taxpayer subsidies; but today the USPS is funded entirely by revenues from postage. If medical insurance or drug research was run half as efficiently as the USPS, we'd all be better off.
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Re:Big Profits for Pharma is Great news! (Score:4, Interesting)
Your analogy is in error. The US Postal Service does not receive any taxpayer money to operate. This link explains how the USPS operates.> [usps.com]
Otherwise, I agree with you that any form of socialized medicine is undesirable. A solution to the high cost of providing medical care must be found though.
One change I'd like to see is for drug companies to stop shipping to countries that artificially keep drug prices low. Canada is a good example of that. US citizens pay, in many cases, double the price for name medications, while our friends in Canada get great discounts. Example: Diovan, a widely used medication for hypertension, is available from Canadian online pharmacies at, in some cases, less than half the price in the US. Are US citizens being gouged? Or are we subsidizing the socialist Canadian medical system, which many Canadians don't like.
I have no problem with making good medications available to those who need them. I'm just tired of foreign governments imposing their decisions on the US consumer and taxpayer.
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Re:Big Profits for Pharma is Great news! (Score:4, Insightful)
Have you not considered the possibility that the fact that the prices in Canada are lower is because they have socialized medicine? I am quite sure you'll find the same phenomenon in other countries with similar medicine systems. Yet, against the available experimental data, you insist with the purely idiological `any form of socialized medicine is undesirable'.
You seriously think that pharmaceutical companies operate at a loss in places like Canada?
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Re: (Score:3, Insightful)
Drug company A develops drug X.
Drug X cost $1 Billion to develop and gain FDA* approval. It also, in massive quantities, costs $10/dose to manufacture and distribute for the typical treatment course.
Now, if we sell X for $100/treatment, we'll have to sell ~12 million courses in order to start making money.
However Canada, having socialized medicine, acts a lot like Walmart. It knows that it costs $10/dose to make, so they offer $12/course.
As a business, I have to
Re:Big Profits for Pharma is Great news! (Score:5, Informative)
Sorry, US citizens are being gouged.
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Re: (Score:3, Interesting)
Yes, I know you can't start a drug company but that's beside the point. Somebody would.
Re:I can feel the kindness (Score:5, Informative)
The barrier to entry is also extremely high (though this might be necessary to ensure there aren't fakes). As a patient, you have little choice. Do you honestly shop around for the cheapest doctors when it comes time for surgery? You don't have much say in what the doctor will order for you, and you have essentially no say in who your anesthesiologist will be.
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Re: (Score:3, Insightful)
Being commercial businesses that need to make profit for their shareholders, it is far more profitable to sell someone a cocktail of drugs that only alleviate some of the symptoms, such that the patient has to keep using them indefinitely, rather than providing a cure...
A cured patient will buy the cure once, and then not need any more drugs...
A patient still suffering will c
Re:I can feel the kindness (Score:5, Interesting)
It allowed me an interesting perspective, (imagine the many British period pieces you see where the nobility is carrying on their conversations in front of "The help" completely unaffected by their presence.) The tech fixing their laptop invisible to them in every way. Even if they are 1 foot away from them working on their laptop or wiring them up with a lav its like you aren't even in the room. (How you can ignore the person rummaging through your shirt and pockets is a mystery to me)
(This was the second favorite conversation I overheard there, it was carried on between two executives, right in front of me, while I was working on the microphones.)
"Everyone always thinks the scientists lead the way discovering cures and shit, but thats B.S., really we have marketing research what people are the most insecure of, what we can make the most money in treating, and then we tell the scientists to work on fixing it" (the conversation continued about what marketing looks for, wealthy and expanding demographics with certain ailments, tracking what well insured baby boomers are the most insecure of, and all the trivial things you can make a pill for, and the naivety and lack of business smarts of their scientists.) This isn't revolutionary I'm sure, but this kind of candor shocked me, These people really are as evil as people say.
(My favorite conversation were two executives talking about how they were "pumping and dumping" their own companies, firing and outsourcing as many people as they can to get short term profits up, get better bargaining power with "results" on their side, with no investments for even a few years in the future, and how great their parachute packages are. (It was a conference of executives on why CEOs are the unsung underpaid employees at a company, and about the wonders of outsourcing everything.)
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Re:I can feel the kindness (Score:5, Insightful)
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Re:I can feel the kindness (Score:5, Insightful)
If you have trouble seeing that, then I doubt anyone can successfully explain it to you.
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Why does this make them evil? Is is because they tell scientists to research the most profitable diseases? ... How dare people try and make what others want instead of what you consider best for society.
It is evil because the big pharma corporations call themselves "ethical companies" to distinguish themselves from generic pharmaceutical companies, who are presumably "unethical" by bringing low cost generic drugs onto the market, to give people affordable alternatives. If they proclaim themselves to be "ethical" the should behave ethically and try to produce drugs that are urgently needed. Instead of searching for the next big lifestyle drug that reduces your long term chance of getting a disease by
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Because it's damned expensive and takes a long time to prove to the FDA and society-leeching lawyers that a product is (relatively) safe.
Besides, most (all?) of the low-hanging fruit have been picked. It takes a lot of effort to climb to the top of the tree and hunt for edible fruit.
Re:I can feel the kindness (Score:5, Interesting)
Most drugs are stumbled upon by hitting some relatively similar molecule in a vast database of molecules the company has laying around from various sources.
If they don't stumble on it, they can't even begin. Then, if they do, they have to modify it to get it to work better than the simple one they stumbled upon. These modifications are mainly guesswork based on all of the possible modifications their chemists can think to try within certain limits. Then, if it does bind really well, it has to bind in the presence of everything else it would normally have to go through: other cellular components, plasma components, whole blood, liver enzymes, the works. If it sticks to any of those things or gets destroyed by the body's machinery before it can reach a concentration necessary to do whatever you want it to do from when you saw it work in the test tube...then you go back to square one or maybe two.
Then, if all of that is working, you can try some animals. If they don't die, you can try some humans. If they don't die, you can try to prove your case to the FDA. If they don't cry, you can finally sell your drug.
So, all of that has to be accomplished before you get a new chemical...and that's if you can find anything at the beginning in your vast library of options (which isn't as vast as you ever wish it would be). Otherwise, you wait for someone else to accomplish all of these things to at least somewhere around the mice...and then you buy them out. Of course, if you wait around for someone to get that far on a brand new target, you'll wait for quite a while, since most new, little guys won't have the library, manpower, capital, intelligence, or best target to even get as far as mice before going under...so there's always that problem too.
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Re: (Score:3, Interesting)
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Re:I can feel the kindness (Score:4, Interesting)
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Re:I can feel the kindness (Score:5, Interesting)
Yet, if some company hold so called "intellectual property", say for a HIV-drug, and millions of people in your country are HIV positive and will DIE if not given the drug, then there is NO similar set of laws that allow the government to forcibly buy the rights to manufacture the drug ?
Notice that with eminent domain the government still has to PAY for the property. But you are forced to sell, even if you would prefer not to, is my point.
I think it would be very sensible to have a similar system for patents: let the government buy them out if they are sufficiently important for society. By all means, make the price such that the company comes out ahead, significantly more than it cost to develop the patent in questions.
It's very strange, I think, that "We want to build a road here" is reason enough to overrule real property while "25% of our population will die if they don't get this treatment" is not reason enough to overrule so-called "intellectual" property.
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Re:I can feel the kindness (Score:4, Interesting)
Its a different problem if the government wants the drugs but doesn't like paying the market price. I guess then it can seize the drugs anyway, problem solved. Just remember that if you start a business some day and make a product that the government likes, it might decide to seize it from you as well.
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Re:I can feel the kindness & I can feel the fr (Score:3, Interesting)
Having achieved these patents with no more innovation than a few simple blood plasma level tests, and a few grand for a better pill press. The drug companies
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Re:I can feel the kindness (Score:4, Insightful)
And to answer your question, there were ~46k new diagnosed AIDS cases and ~38k new diagnosed HIV cases in 2005. High mortality rate, but the percent of infected are still low enough to prevent the average person from knowing many, if any of them, making it "someone else's problem" in their minds. The old adage "out of sight, out of mind" is still true.
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Re:I can feel the kindness (Score:5, Informative)
This is why they struggle so hard, quote [nybooks.com]: " In 2001, the ten American drug companies in the Fortune 500 list (not quite the same as the top ten worldwide, but their profit margins are much the same) ranked far above all other American industries in average net return, whether as a percentage of sales (18.5 percent), of assets (16.3 percent), or of shareholders' equity (33.2 percent). These are astonishing margins. For comparison, the median net return for all other industries in the Fortune 500 was only 3.3 percent of sales. Commercial banking, itself no slouch as an aggressive industry with many friends in high places, was a distant second, at 13.5 percent of sales." (emphasis mine)
CC.
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Re: (Score:3, Interesting)
2001 was obviously a bad year for certain industries (airlines, tech companies) so maybe that had an effect as well.
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Hell, more gross profit than the bankers?
Either the pharmaceutical companies are all run by geniuses, or there's a serious imbalance that should be corrected by the government - I'd be inclined to levy a windfall tax just to see the bastards squirm.
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Yet another Pharma Myth you've bought (Score:5, Interesting)
The $800 million figure is based on the small unrepresentative subsample of all new drugs. It excludes the majority of "new" drugs that are extensions or new administrations of existing drugs, as well as all drugs developed by NIH, universities, foundations, foreign teams, or others that have been licensed in or bought. Variations on existing drugs probably cost much less because so much of the work has already been done and trials are simpler.
About half of the $800 million figure consists of "opportunity costs", the money that would have been made if the R&D funds had been invested in equities, in effect a presumed profit built in and compounded every year and then called a "cost." Drug companies then expect to make a profit on this compounded profit, as well as on their actual costs. Minus the built-in profits, R&D costs would average about $108 million 93% of the time and $400 million 7% of the time.
The $800 million estimate also does not include taxpayers' subsidies via deductions and credits and untaxed profits (DiMasi, Hansen, and Grabowski 2003; DiMasi, Hansen, Grabowski et al. 1991). Net R&D costs are then still lower.
Contrary to some press reports from the industry, screening for new compounds is becoming faster and more efficient and the time from initial testing to approval has shortened substantially (Kaitin and Healy 2000). The large size of trials seems more due to signing up specialists to lock in substantial market share. Advertising firms are now running clinical trials (Bassand, Martin, Ryden et al. 2002; Peterson 2002; Moyers 2002).
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As long as they haven't had kids yet, I'm all for that. Darwin and all.