Läkemedel och regleringar

Regleringar kring läkemedel är ett återkommande ämne i Johan Norbergs böcker, och det med god anledning - sällan blir paternalismens, byråkratins och försiktighetsprincipens björntjänster så tydliga som när människor helt utan anledning dör och plågas för att någon pappersvändare någonstans vill utvärdera produkten ytterligare något decennium.

Riskbloggen skrev nyligen - med hänvisning till Darshak Sanghavis Slateartikel på temat - om ämnet, utifrån en teoretiskt riskneutral bedömning:

Under testningen av medicinen var de barn som hade fått det verksamma preparatet friskare, men efter något år var det mycket svårare att hitta några intressanta skillnader. Hade man förlängt testet något år hade man inte kunnat märka de tydliga skillnader som fanns under den gamla testperioden. Flera mediciner kan ha biverkningar som syns först efter lång tid, eller så kan effekten avta hos patienterna.

Men å andra sidan kan man inte kräva att medicinska preparat ska testas hur länge som helst. Dels skulle det bli för dyrt för läkemedelsföretagen, dels skulle vi gå miste om mediciner som faktiskt gör nytta - personer skulle dö i onödan.

Även Constant på The Distributed Republic filosoferar kring läkemedelsregleringar, angående att aktiekursen för Vanda Pharmaceuticals, som fått ett läkemedel godkänt av FDA, närapå tiofaldigades på ett dygn:

If the FDA's decisionmaking process is

a) not arbitrary, and
b) based on the available results,

then the FDA's decision should be highly replicable, and therefore highly predictable, by any independent entity with access to the same results. And yet the FDA's decision is, apparently, hard to predict. Two possible alternative explanations are:

1) The results that the FDA bases its decision on are extremely well-guarded right up until the very moment that the FDA makes its decision. I doubt this is possible.
2) The FDA's decisionmaking process is highly arbitrary. This is my tentative conclusion.

A few anticipated objections and responses.

Objection: Vanda's case is not typical.

Answer: Could be. However, this seems not all that atypical. When I read the story it didn't really stand out as atypical.

Objection: The typical investor doesn't know how to interpret the data, doesn't know what the data is, etc.

Answer: This is true of most investors in most publicly traded companies. If it were a significant problem the efficient market hypothesis (EMH) would be not only wrong, but wildly wrong, all the time, and Vanda's case would provide a model for disproving the EMH.

Objection: Pharmaceutical companies really keep a tight lid on their results.

Answer: I have a hard time believing that. A tremendous number of people are involved in any study that gets to this stage. Even partial information should give a sense of how well a drug is working and what its side-effects are.

Objection: The cause of the unpredictability isn't that the FDA is arbitrary, but that the drug is borderline useful, and even the most predictable decisionmaking process will be unpredictable when it comes to borderline cases.

Answer: But surely the typical drug is not borderline.

Objection: The FDA can hardly be blamed because it is fundamentally hard to judge whether a drug is useful or not. It is unclear and/or subjective whether a given drug is useful or not.

Answer: Then why is the FDA making a decision for all of us?

Det kan dock noteras att det går betydligt enklare att få igenom andra förändringar på läkemedelsfronten - från Megan McArdle:

My asthma is terrible, and I'm stuck with one of the new inhalers, which is about as effective as waving one of those magnetic copper bracelets you buy off late night tv in front of my chest. Long time readers know I like environmentalism, but this is completely moronic. Asthmatics did not cause ozone holes, and engineering the CFCs out of our inhalers has not done a thing except make politicians feel good, and make me wheeze.