4 ms·

The blog post seems to frame the issue as: "Should this company be allowed to make massive profits off of their investment in clinical trials?" Any reasonable

by ebbv 14y ago

The blog post seems to frame the issue as: "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.

refurb 14y ago
As an added note, Biogen has a patient assistance program with no income limit. If you don't have insurance you get help and even if you do have insurance you pay nothing more than $10 per month. I'd say that's a pretty good deal.
- marmot1101 14y ago
  So the counter side to that is basically Biogen is bilking the hell out of the insurance companies. While it is noble of them not to screw over poor MS patients, they're screwing over the rest of the healthcare system instead.
  - ctdonath 14y ago
    It took 'em a big pile of money to prove a cheap chemical is suitable treatment for a major disease. Who, by you, should make it worth their while to do so? and to do such things more than once?
nateabele 14y ago
I'll grant you the ethics issue, but the entire healthcare industry is now riddled with so many perverse incentives that ethics barely even enter the picture anymore. 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').
jerf 14y ago
Before I could formulate a reasonable answer to that question of whether this is "unreasonable" (leaving aside the complicated matter of what that exactly means), I'd be interested in a serious analysis of what the costs are; $50,000 may not be so obscene if their costs were $45,000/possible patient, for example. What's the floor here? 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....)
- bmelton 14y ago
  And to be fair, the last number I saw on clinical trials estimated the cost at between 100 million and 800 million dollars per drug candidate, which means that the sunk cost of any drug that works is going to be pretty high right out of the gate. 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.
bargl 14y ago
Agreed, I think that there is typically a balance between profit and ethics. One would hope that companies would follow a code of ethics, but many don’t. 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...
danielweber 14y ago
If you have a system where the developer isn't allowed to charge money because the people it could help are poor, you are setting up a system where the developers will only work on diseases of the rich. 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.
- ctdonath 14y ago
  "He soon became a specialist, specializing in diseases of the rich." - Tom Lehrer
belorn 14y ago
Please note that patents are not considered by the FDA as an compensation method in regard to investment in clinical trials. For clinical trials, FDA gives out a special monopole status to encourage further trials to be made. In this case, Tecfidera got exclusivity power in the market from both the FDA and the patent office.

by ebbv 14y ago

refurb 14y ago

As an added note, Biogen has a patient assistance program with no income limit. If you don't have insurance you get help and even if you do have insurance you pay nothing more than $10 per month. I'd say that's a pretty good deal.

marmot1101 14y ago
So the counter side to that is basically Biogen is bilking the hell out of the insurance companies. While it is noble of them not to screw over poor MS patients, they're screwing over the rest of the healthcare system instead.
- ctdonath 14y ago
  It took 'em a big pile of money to prove a cheap chemical is suitable treatment for a major disease. Who, by you, should make it worth their while to do so? and to do such things more than once?

nateabele 14y ago

I'll grant you the ethics issue, but the entire healthcare industry is now riddled with so many perverse incentives that ethics barely even enter the picture anymore. 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').

jerf 14y ago

Before I could formulate a reasonable answer to that question of whether this is "unreasonable" (leaving aside the complicated matter of what that exactly means), I'd be interested in a serious analysis of what the costs are; $50,000 may not be so obscene if their costs were $45,000/possible patient, for example. What's the floor here? 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....)

bmelton 14y ago
And to be fair, the last number I saw on clinical trials estimated the cost at between 100 million and 800 million dollars per drug candidate, which means that the sunk cost of any drug that works is going to be pretty high right out of the gate. 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.

bargl 14y ago

Agreed, I think that there is typically a balance between profit and ethics. One would hope that companies would follow a code of ethics, but many don’t. 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...

danielweber 14y ago

If you have a system where the developer isn't allowed to charge money because the people it could help are poor, you are setting up a system where the developers will only work on diseases of the rich. 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.

ctdonath 14y ago
"He soon became a specialist, specializing in diseases of the rich." - Tom Lehrer

belorn 14y ago

Please note that patents are not considered by the FDA as an compensation method in regard to investment in clinical trials. For clinical trials, FDA gives out a special monopole status to encourage further trials to be made. In this case, Tecfidera got exclusivity power in the market from both the FDA and the patent office.