nos-trum. pronunciation: \nos'-trum\. noun. Etymology: Latin, neuter of noster our, ours.
1. a medicine of secret composition recommended by its preparer but usually without scientific proof of its effectiveness.
2. a usually questionable remedy or scheme.
See here for more discussion.

Friday, April 16, 2010

UPDATE: New Old Drug Cost A Social Responsibility?

The now-approved gout drug, colchicine: does new research and FDA approval make it a new drug?  And who pays for its increased cost if it is?

[See my previous post on this issue.  Today I want to discuss the underlying issues of moral responsibility]

Ninety percent of the new drugs in the world come from US pharmaceutical companies.  Chances are, you've never taken a medicine developed anywhere else.  But what about an old drug, first extracted by the Greeks 3000 years ago, that has remained a staple in the treatment of gout.  Does it count as "new" because the FDA has finally gotten around to approving it, and the company that did the research that gave the FDA supporting objective evidence of its effectiveness now markets it under the name Colcrys?

This odd situation comes about because the FDA "grandfathered" drugs that existed prior to the agency receiving authority to approve medications:  it didn't "approve" them; it just said they could continue to be produced and sold.

Some of these grandfathered items have fallen by the wayside, but some, like colchicine, are still very useful.

With its heart in the right place (altho no govt agency has such an organ...even metaphorically), the FDA has been addressing these ambiguous situations by encouraging original research from which the agency can make an objective decision about approval or disappproval.

URL Pharma, a drug company, took them up on the need and invested in two studies of colchicine use, safety, and effectiveness.  Some new information was obtained on side effects, and new guidelines substantiated as to what length of treatment was best.  For their efforts the FDA granted an exclusive marketing privilege for 3 years (for this purpose).  The FDA does this--although the term length may be different--for all new approved drugs.  This gives the company the right to recoup its investment costs and to generate profit for investors.  It also funds the company's expansion into other drug development

For patients and insurers, the implications in this case are at the opposite pole:  what used to cost $0.09 a pill, now costs a little less than $5 a pill.

In an opinion piece in the New England Journal of Medicine on the issue,  the authors say,
"Although the goals underlying the development of Colcrys were sound — few would argue against the need to comply with FDA requirements and the need to ensure the safety and efficacy of all prescription drugs — and the manufacturer seems to have followed FDA guidance, the reward appears to be out of proportion to the level of investment." (Apr 14).
It's true that this is the same medicine, it works the same way, maybe it's a little more pure (?), but should the patient shoulder the cost of the manufacturer in obtaining FDA approval?  I hope it's clear that the drug company would not stay in business if they received the old cost per pill, and any other company could produce it in competition.

As the NEJM authors point out, there's "no evidence of any meaningful improvement to the public health."  They suggest that an alternative would be to fund the FDA's "catch up" program--for permitted, but not approved, drugs--through federal grants.  Of course this still puts the cost on the public through the taxpayer, but it spreads the cost around to everybody, almost all of whom will never get gout.

The New England Journal is heavily invested in concepts of social justice, so this proposal is the way they would approach it.  Reading their opinion pieces and reporting on health care reform makes it clear where they stand. 

But like most things in life, it's not black and white.  As a moral issue, do we all owe low cost care to the few, not just here, but in all of the thousands of instances where the sick and injured are not us?  By ensuring their care, do we likewise ensure that others will be there for us?  Gout is one of those diseases with a genetic component and a behavior componenet:  it runs in families, but diet can precipitate an attack or make it worse.  Still, the mutual benefit calculus seems close to straightforward.  But there are cases where there is no quid pro quo.  Consider the concern over public funding of abortions:  can individuals for whom abortion is repugnant opt out of allowing their tax dollars to be used for that purpose?  There is no return on the financial support for abortion for those who will never consider it.  Even if you argue that generosity without expectation of return should motivate the decision in the colchicine drug cost situation, in some cases, like abortion, generosity and human kindness are overridden in the minds of those who abhor abortion by a different moral concern.  And there are those who argue that any medical condition where the behavior of the individual influences whether they suffer from it (cigarette smoking, motorcycle helmets and head injury) should not be a public responsibility.

[This back and forth argument can go on longer.  I'm stopping here.  Let me know what you think.]

I don't offer any definitive answer.  But until the country decides what we owe to each other, and what we should expect from each other--not only in mutual support, but also in self responsibility--then we will continue to have conflict.


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