NIH Won't Let Others Supply Life Saving Drug Even Though Genzyme Can't Make Enough
from the patents-costing-lives dept
Earlier this year, we wrote about the situation with a petition to the National Institute of Health (NIH) to let other companies produce Fabrazyme, a drug that treats Fabry disease. Fabry disease is an enzyme deficiency that can create very serious problems in those who have it -- including kidney failure and heart attacks. Genzyme holds the patent on Fabrazyme, but has a problem: it can't produce enough of the drug. That means people die. A group of Fabry patients petitioned the NIH to see if other companies could be allowed to produce just a little more Fabrazyme. They didn't ask to break the patent. All they wanted was to let others make the drug, and pay Genzyme a royalty. On top of this, it's worth noting that the key research for the development for Fabrazyme wasn't actually done by Genzyme, but was done by the Mount Sinai School of Medicine and was financed with taxpayer money from the NIH.At the time, we doubted the petition would be approved -- and indeed, the NIH has rejected the petition. An opening was left for an appeal, if another petition is filed by a company that wants to make Fabrazyme, rather than the patients (you know, the folks actually suffering). As the statement of Robert Weissman from Public Citizen makes clear, this is a ridiculous situation:
Why is NIH resorting to legal gymnastics to avoid exercising its legal authority to ensure an adequate supply of an important medicine? NIH agrees Genzyme is failing to produce an adequate supply of the important medicine Fabrazyme. It is plain that removing the patent monopoly on the drug is a necessary condition to enabling other potential manufacturers to enter the market. Yet NIH chooses to deny a request to issue open licenses for the Fabrazyme patents -- a request for which it has undisputed legal authority -- on the Alice-in-Wonderland, self-justifying grounds that there are as yet no competing suppliers. Of course there are no competing suppliers -- why would any firm try to enter a market it believed closed by a patent monopoly?
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Filed Under: fabrazyme, fabry disease, nih, patents
Companies: genzyme, nih
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So...what the fuck?
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Re: So...what the fuck?
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Re: So...what the fuck?
Then they'll start whining about how they need to do all of this because of their "research" costs, despite the fact that their R&D costs are roughly 1/3 of their marketing costs.
In other words, evil isn't a new endeavor for these corporatist idiots....
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Re: Re: So...what the fuck?
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Re: So...what the fuck?
*Certain limitations apply (life, liberty, and pursuit of happiness are not included). Void where prohibited. Limit of one per customer. Patent pending. Copyrighted Frances Scott Inc. all rights reserved. Any descriptions, images, or stick-figure drawings (analog or digital) without the express written consent of the FBI, CIA, and ICE (hereto referred to as �Disney�) is prohibited.
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Re: Re: So...what the fuck?
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Re: Re: So...what the fuck?
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At some point...
But if I knew someone affected by Fabry disease, I'd sue the NIH for negligence. By passing on the petition, they acted negligently which contributed to the continued suffering and death for thousands.
I hate legal remedies like that - its not supposed to be this way - but since playing nice didn't work, its one time I hope they force others into action.
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Re: At some point...
Maybe Fabry sufferers should petition the Justice Department next to encourage Genzyme to license its drug to other manufacturers in order to stave off an anti-trust investigation.
I don't know, I think the solution is earlier in the chain, like putting publicly funded research in the public domain.
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Has that changed? Would taking away the patent have changed anything concerning the shortage? I am always wary of changes that don't actually address and solve the problem.
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That may be true, but there are two inescapable conclusions:
1. Because of Bayh-Dole, this is an instance of publically funded discoveries being licensed as a commodity to private interests, with all the exclusions that such an arrangement implies, and
2. Because of that, no other company has invested in the capability to produce this medicine.
The key issue isn't that the NIH decided this because other companies wouldn't be able to ramp up production in time, it's that, because of NIH supported legislation, a beneficial public discovery that would have once been in the public domain is now locked up by a company, and THAT is the reason other companies aren't producing the medicine, and THAT is resulting in fucking DEATH....
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Read the actual decision first...
The stated reasons for the rejection make more sense when you read them for yourself.
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Re: Read the actual decision first...
The true reason is undoubtedly that Genzyme is paying the NIH some of their profits from being the only provider of the drug, and that would be in jeopardy one way or the other if the NIH allowed other producers. Either by asking for the same profit sharing setup in exchange for permission and getting called out, or by breaking the agreement and losing the $$ from Genzyme.... They do not want to lose one of their largest sources of dirty money...
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Re: Read the actual decision first...
They promised to try real hard. Fuck that.
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Re: Read the actual decision first...
It should never have been patented in the first place. Then there would never have been a shortage.
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The publicly funded research should have been place in the public domain. Doing that with all public research is the first step to fixing situations like this.
Now with the publicly funded research in the public domain, another company can use that research to develop their own different cure for the same condition and can get their own patent on that different cure.
There. Two companies building mousetraps. If there's still a supply shortfall there's some other artificial restrictions in place mucking up natural market forces but this should take care of the big interference.
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Re: Read the actual decision first...
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Re: Re: Read the actual decision first...
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Re: Read the actual decision first...
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Re: Read the actual decision first...
Two issues remain
1) Why did NIH allow a situation to arise where we are dependent on a single supplier. The semiconductor industry always used to operate on the basis of "second sources" - and big customers (the NIH is effectively a customer here) would always insist on the availability of a second source.
2) The argument presented is a kind of circular - chicken and egg argument. Clearly we cannot get out of the situation quickly - and maybe Genzyme will be back on stream before a second source was available - but equally clearly Genzyme cannot be relied on not to mess up again - so getting a second source in place BEFORE that happens would make good sense.
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Re: Re: Read the actual decision first...
There are alternative treatments that are being produced and apparently sini is suing these competing manufacturers for patent violations and trying to block production of those competing drugs in a couple countries (big surprise there huh?).
while neither NIH nor genzyme appear to be all that innocent in not doing much to prevent this situation from coming up, dont dismiss the FDA and sini for their roles in this.
and none of that really matters to the people who have this condition who are apparently asking for someone to come along and wave a magic wand which will allow some other company to get through a 2-5 year process and start shipping tomorrow (cant blame them for wanting that, but want does not have much effect on reality).
looks like there is plenty of dookie to go around on this one.
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Re: Read the actual decision first...
No, their stated reasons are even more stupid than Mike made them out to be. Thanks for the link. Here are the relevant bits:
The problem is that there is a shortage.
You don't say?! No other company has gone through the trouble of making a competing version that they know would violate patents and thus open them up to patent lawsuits. Really? Amazing.
It's analogy time. Their house is on fire. Their cousin says he can put it out so they don't need to call the fire department. Someone comes along and says their house is going to burn down if they don't call the fire department now. And they respond with, "It's too late. More of the house will have already burned by the time they show up."
Oh, so the cousin also says there isn't a reason to call the Fire Department because he has everything under control. Even though he's the one that started the fire and let it get to this point, let's just trust him this time.
This exemption is practically worthless. It gives companies an opportunity to spend millions of dollars on creating a competing product and putting it through years of trials, so that when the FDA finally approves it, they can then NOT sell it because the exemption isn't for actually selling it to the public. This is fantastic.
In other words, they will continue to monitor the house to see if their cousin can actually stop the blaze, and if he can't then they will reconsider whether to call the Fire Department at that time. Of course, at that time, they will use the same logic, which is, by the time any one arrives, more of the house will have burnt down, so there isn't a reason to call.
In short, they've denied allowing any one to make a competing drug, simply because no one is currently making a competing drug, thus no one will be able to bring the supply up in the short term. So what about the long term? Oh it's OK, because Genzyme says they'll get supply issues under control this time. No really, they promise this time.
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Re: Re: Read the actual decision first...
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This should be an prime example
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The best there is
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It is really hard to make money and really easy (and fun!!) to make new humans... the choice is obvious!
/s
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Second, this is an orphan drug, which means it serves very small numbers of people. Getting companies to invest in anything with such a small market is difficult, which is why the drug costs $36,000 a month. Better have a good insurance package for that one.
Third, the order requires Mt. Sinai is required to notify the NIH if Genzymes progress change or if they are asked by anyone else to allow manufacturing of the drug. This gets back to the point of Genzyme being the quickest one to manufacture the drug again.
The report even states that getting rid of the patent wouldn't fix this problem, since it is an orphan drug, without a patent in the first place, would anyone be producing this drug. There is a reason for the benefits received for manufacturing orphan drugs.
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1) You do not have the right to life saving drugs. If you can afford them, you can have them. The .gov has no responsibility to step in and save your life.
2) A company has a responsibility to make money. That's what they do. It's not fair to a company that spends millions on research to have their cash cow sold at auction because someone else wants the milk.
3) This is a capitalist society. If I have something you want, you will pay me for it. It could be my time, my house or my knowledge, but nothing is free, unless I choose to give it away. The company is making as much of the drug as they can, so they are selling as much as they can. Supply and demand. If they were artificially depressing production output for profit, they should be hammered.
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I thought you said they were supposed to be making money. If depressing output would increase profit, you wouldn't support that? If not, why do you support letting people die to keep competition away from this company, but you don't support it in other profit-seeking scenarios?
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They do when they're using our tax money to fund the research....
"2) A company has a responsibility to make money. That's what they do. It's not fair to a company that spends millions on research to have their cash cow sold at auction because someone else wants the milk."
Try to read. The company didn't do the research. NONE of it. Sinai did....and with taxpayer money. Besides, R&D costs for pharma companies are largely bullshit. They spend vastly more on marketing and lobbying....
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Re: A few salient points
When Taxpayers fund it, there is no way in hell a private corporation should be able to lock it up.
2) A company has a responsibility to make money. That's what they do. It's not fair to a company that spends millions on research to have their cash cow sold at auction because someone else wants the milk.
Dont you mean millions of taxpayer dollars? The responsibility to make money at the expense of human life?
3) This is a capitalist society.
Exactly! and since the taxpayers funded it, where is our return? Oh thats right we dont get any. All we get is a sharp pain in the a** while being fu*ked.
"if they were artificially depressing production output for profit, they should be hammered."
They are doing exactly that.
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So I guess it's just been shortened to "liberty and the pursuit of happiness" these days, eh?
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I would hold that is exactly one of the roles of government - the protection of its citizens.
I have a genetic medical condition that I can do nothing about. The flare-ups (when uncontrolled) are frequent and debilitating and include intense pain, hospitalizations, loss of work time and a whole host of other effects I wouldn't wish on my enemies.
It is very treatable with a medication on the orphan drug list. The cost of this drug and its administration (annualized) is approximately US$40,000.
What, exactly, do you expect people like me to do if this drug became unavailable from problems in manufacture, under-estimation of usage patterns, or the patent-holder deciding to stop production?
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In the general case, I agree with you. Unfortunately, none of what you wrote applies to the case in hand.
If there were no patents involved, then we can let the government off the hook. No one, however, is asking the government to force others to make the drug. They are not even asking the government to stop limiting who can make the drug. They are asking the government to give other companies the opportunity to license the drug. This company's cash cow was created by tax payers and locked up by the government. It's not a matter of taking away the company's cash cow, it's a matter of taking back the cow we lent them.
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3) This is a capitalist society. If an enterprise cannot produce enough money to market a drug then tough shit - oops the tax-payers are capitalists too!
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How do I get in on this racket?
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Coke and Pepsi spend more on marketing than a drug company, but you don't see them getting $36K a month out of their customers. For some drugs, their cost of production is probably about the same.
Genzyme didn't do the research (maybe not all) but bringing a drug to market is still very expensive. The D costs more than the R. Getting things through the FDA is tough, we could address those issues to lower costs but would that change the somewhat safety levels we currently have?
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Yes, it does, because these pharma firms regularly include marketing costs in their R&D line items. It's an accounting trick they use to justify the high costs, and it's bullshit.
"Coke and Pepsi spend more on marketing than a drug company"
Bullshit.
"The D costs more than the R."
Citation needed.
"Getting things through the FDA is tough, we could address those issues to lower costs but would that change the somewhat safety levels we currently have?"
This part I'm more murky on knowledge wise, but are you telling me that our govt. allows Sinai to license a drug out to a company BEFORE it gets FDA approval? Is there evidence that this is the case?
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Also, if Sinai DID sell the patent prior to FDA approval, wouldn't that mean that Sinai was in breach of the Constitution somewhere?
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SG&A costs for Pepsi YE 09 were $15 billion. Pfizers same year end number was $14 billiion.
Mt. Sinai, which owns the patent, licensed it to Genzyme, they didn't sell it.
The order actually kind of made sense because if the NIH ordered the patent invalidated, Genzyme would still be the first to get the drug back on the market. You can argue that if there was no patent in the first place, other companies would be manufacturing it already so the Genzyme issue wouldn't be an issue, but that is a different argument.
If that were the argument, I would say that without orphan status, the drug wouldn't be on the market by anyone as the people who need the drug are too small a market to be concerned with.
I know, it sucks that life saving drugs are not available while companies invest in giving guys woodies because that is profitable.
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In the near future, big pharma will be nothing more than venture capitalists. Their excuses will go away but I don't see things getting any better, at least for consumers.
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Exactly why the Orphan Drug law exists. The drug in this article only treats about 1K people, it is sold for $36K a month. If there were no orphan drug law, no one would be making this drug (well, trying to make it, as Genzyme seems to have screwed up their process.)
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The NIH decision
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If you think there should be more than one company to manufacture an important drug, you could logically claim that the govt. shouldn't allow any single company to be the only manufacturer of any drug.
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