Tecfidera's Price
pipeline.corante.com
pipeline.corante.com
You do not need to be a chemist to appreciate it.
[1] http://pipeline.corante.com/archives/2011/11/11/things_i_won...
http://pipeline.corante.com/archives/2010/02/23/things_i_won...
The heater was warmed to approximately 700C. The heater block glowed a dull red color, observable with room lights turned off. The ballast tank was filled to 300 torr with oxygen, and fluorine was added until the total pressure was 901 torr. . . And suddenly O2F2 aka FOOF.
Which as you might guess is just all kinds of nasty. Explosive reaction with water at 100 Kelvin etc.
http://pipeline.corante.com/archives/2008/02/26/sand_wont_sa...
The compound also a stronger oxidizing agent than oxygen itself, which also puts it into rare territory. That means that it can potentially go on to “burn” things that you would normally consider already burnt to hell and gone, and a practical consequence of that is that it’ll start roaring reactions with things like bricks and asbestos tile.
I'm not a chemist, but his tellings of not just how things could go terribly wrong once you have the substance, but the myriad ways it can wrong merely trying to make the substance had me in stitches for the better part of an afternoon.
Then again, I was always the one setting stuff on fire, breaking glassware, or trying the reaction with more reagents in high school chem lab, so maybe it only appeals to me...
[1] http://pipeline.corante.com/archives/things_i_wont_work_with...
Yep, [the stable-to-explosion sensitivity was] below the detection limits of a lab that specializes in the nastiest, most energetic stuff they can think up. When you read through both papers, you find that the group was lucky to get whatever data they could - the X-ray crystal structure, for example, must have come as a huge relief, because it meant that they didn't have to ever see a crystal again
Hitting engine with hammer - $1
Knowing where to hit engine with hammer - $9999
Here the only reason why the company is able to charge a large amount of money is because they've gone through the whole process of tests and clinical trials to get the drug available for consumption. That's an entirely different kettle of fish than the expert knowledge $9999 you mention above.
The gist of the article isn't about expert knowledge, it's that a fairly simple chemical compound (the name itself gives the simplicity away - dimethyl fumerate is too short to be anything horrendously complicated) is jacked up in price, and that someone suffering from the disease could presumably get the drug made themselves for much less than $50,000 per annum.
But if the law is as described in the ref'd comment, I wonder why there aren't sites or books that walk you up to the point where you can provide the invention for your personal use.
http://www.bpmlegal.com/patqa.html#1 http://www.iusmentis.com/patents/crashcourse/rights/ http://www.law.cornell.edu/uscode/text/35/271
my understanding is that none of these (existing and new MS drugs) is a 100% applicable fix. they all are effective on only a subset of patients, and they all have different side-effects (which is still good news as it improves the chance that any one patient will find something that works (the subset of affected patients changes with the drug) and is not harmful).
also, fwiw, the govt here in chile pays 80% of the cost. i don't know if that means it can also negotiate a lower price, but i would suspect so.
and does this also suggest help for other auto-immune diseases (lupus etc)?
[update:] also, talking more about the economics - the market is probably very inflexible. existing patients with a drug that "works" (and these only work in some statistical sense - they reduce the chance of outbreaks) is not going to want to switch, because (1) there's a large chance that you'll start having outbreaks again and (2) often they take months to become effective.
so the main pressure in lowering prices has to come from either large purchasers (national health systems, insurers) or from new patients. for new patients i guess that oral delivery (i think?) is a big win over injections. that is something people will pay for.
"Should this company be allowed to make massive profits off of their investment in clinical trials?"
Any reasonable person would say "Sure they are allowed to make a profit off of that." I don't think there's going to be much objection to that question.
But that's not the real issue, and I think if the author is honest he knows that. The real issue is:
"Should MS patients, many of whom are poor, be forced to pay $50k/year for medication to help with their condition."
The answer to that is obviously no. Now you can say that the insurance company will take care of it, but that's presuming people have insurance and that the insurance company isn't going to dump them, they're not going to have a deductible they can't afford, etc.
When it comes to medicine, ethics have a larger role to play than say, home decor.
Anyone who doesn't acknowledge that is being disingenuous.
I'd say that's a pretty good deal.
However, consider your question in the abstract: is a buyer entitled to the products or services of a seller on terms the buyer deems fair? (Solve for any values of 'buyer', 'seller', and 'fair').
If the costs are $10,000s of dollars/patient even before the drug company needs to take profit (and have money to invest in their next drug, after all), then a full investigation of the "blame" for this very expensive very cheap drug must also be pointed at the processes that cost that much in the first place. If it's so bad that MS patients are paying $50,000/year, then perhaps the real problem (or at least a nontrivial part of it) is that the costs of certification have greatly exceeded the benefits.
(But people don't like to think in terms of costs/benefits when it comes to medicine and appear to be willing to incur enormous costs if it allows them to continue pretending they don't have to think about it....)
On top of that, you have a VC-like model where the successes must also pay for the cost of failures as well as the funding of new R&D so that they can keep making new drugs.
As for insurance paying for the drug, that is a reasonable expectation in our current system here in the states. That system is broken on many levels. One example of where bad ethics in another company could potentially overlap with the costs of this drug, Wal-Mart. They do quite the opposite of what this company is doing. Sure they pass the savings onto the consumer, but at what cost. They pay their employee’s so little that many live below the poverty line, a situation that forces them to forgo health insurance. Then those employees without health insurance are forced to pay for drugs, such as this one, on their own. Where as other companies will subsidize health insurance (Whole Foods) and charge their consumers more.
The issue here is that it makes a really good headline and seems atrocious to us as readers. But this is just part of a bigger problem. So when we decide to regulate, we need to attempt to look at the system holistically, not just at this one very outrageous situation.
Also, some people may not be disingenuous, just greedy and immoral...
You could say "well, they should have just done this one for free," but there's no more reason for them to it than for you. In fact, there are charities which go through all the funding of researching drugs for the poor. The Bill And Melinda Gates Foundation has paid for drug companies to get drugs approved, with the contract saying that they will be available at low cost once everything is done.
To be honest because the DEA will drive such printers underground, which with 54,000 reasons to go underground is an amazingly bad idea
If you are interested in recreational drug legalisation this is the industry to support - something will change
There's a team at the University of Glasgow working on this. They published in Nature Chemistry last year [0] and garnered a lot of attention in the popular science media.
0. http://www.nature.com/nchem/journal/v4/n5/full/nchem.1313.ht...
Further, the reagents and catalysts involved in drug synthesis vary wildly, so it will take a substantial amount of shopping to even get the raw materials you would need to setup a viable reaction.
While this is a cool setup, it's best not to overstate it's capabilities.
I am making some assumptions: That pharma-drugs are manufactured almost entirely by machines, that there are several classes of process that use the same intermediate steps (keep at this temperature, grind evenly to ensure stable emulsion etc etc) and that those steps could or perhaps even are, amenable to being joined - ie you could pass product into one shiny metal machine, out into anohter and another till presto you have the final product.
And that these modularised mini manufactureing machines will be useful for commerical purposes - and subsequently for pro/amateur use - and I could concievably brew up my own MS cocktail at home for less than the price tag of a yearly supply.
Amateur drug synthesis does occur (particularly for recreational drugs), but it's neither safe, nor efficient, nor flexible.
It will take a new platform technology to allow for distributed drug synthesis, and a likely a better understanding of those drugs to get there.