Megan discusses clinical trials:

But clinical trials for a single successful drug cost $500 million, and not because the labs have outrageous administrative overhead. Even if the government were in charge of running them, they would still be on the hook for that $500 million,

What? I hear you cry.  There’s no way they can cost that much.

Having written software to help reduce the costs of drug testing, I can assure you that they can.  Here’s why:

• Safety is of paramount concern here, and there are layers and layers of checks, balances, rechecks, spot checks, ethics boards, etc involved in making sure these tests are proper and well-structured.  That takes a lot of time, and a lot of people to make it happen.
• There are 3 or 4 phases of drug testing.   The first two are fairly small groups, typically to test that the drug doesn’t have  violent side effects, and that it actually fixes the problem in some meaningful way
• The 3rd phase is big - involving typically hundreds if not thousands of patients, dozens if not hundreds of doctors, ethics boards, referees, extensive evaluation periods and so forth.  And the Drug Company has to pay for all of this out of their own pocket.
• • Phase III is where the “statistically significant” analysis comes from.  Which means you have to have a statistically significant number of people from each population that can benefit from the drug.
  • Once Phase III is done, typically the drug can begin to be sold
• Phase IV is not always mandated by the FDA, but if it is required, it will usually be bigger than Phase III, and linearly more expensive.     Because, again, it has to be a rigorously controlled statistically significant analysis.

Clinical trials are significant projects, like putting a building together.  You have to recruit doctors, you have to interview them, you have to get them trained up on your drug and side effects and so forth.  You have to establish protocols and procedures for them to follow.  You have to hire people to watch over the doctors, make sure they have their paperwork done in a timely manner, make sure they’re following the protocol, etc.  You have to hire labs to do blood tests and so forth on every patient the doctor recruits.

Many doctors don’t find many patients, and you have to go through the effort of finding more doctors and more patients in order to get a sufficiently large sample.   Then, of course, you have to watch these trials proceed for a year or more in order to gauge short and long-term side effects, efficacy, interactions with other drugs, etc.   Often you have to do this in multiple countries,  which adds significant cost to the process as well.  Many of these trials can take multiple years to complete, and you have to pay salaries along the way.

And usually, you have to do more than one Phase III trial, and show effectiveness in each before you can move on to the approval stage.   This is assuming you actually do, in fact, show effectiveness, and can gain FDA approval for your drug.  Because if you don’t… well then you can’t sell it, can you, and all the money you spent on the trial just went down the drain.

Resources:

• The Tufts University study on Clinical Trial costs.
• The Wikipedia page on Clinical Trials
• Costs/Subject (Patient) for Clinical Trials

1968, meet 2008

http://imgs.xkcd.com/comics/pod_bay_doors.png

If you haven’t played Portal, you’re missing out on a major piece of the geek-culture zeitgeist of 2007.

This is a great quote:

“Adultery always begins with the adulterer(s) claiming to themselves and to others that the relationship is “harmless” because it hasn’t crossed a certain line. The line where it becomes wrong is the line where you start having to rationalize like that.”

Seems about right to me.

Yo, what’s up? It’s been a while since I wrapped atcha.

This caught my eye - the chairman of the GMU economics department discusses the questionable benefits of stimulus packages.

In general, I think he’s right - if you take money from X and give it to Y, it doesn’t mean that there is more money sloshing around. Even if you borrow money from X to give to Y, the situation is the same.

However, what if you borrow money from X, who is not an American. Especially if X is a foreign government. In that situation, there’s more money in the US economy than there would be otherwise. (Unless you assume that all of that money would have come through the US anyways).  Foreign Country X may be a little lighter in the wallet, but then they were the ones who decided to buy treasuries at the agreed-upon rate of interest.

And the people who pay back the debt are our future selves, which, if the past is any indication, will be living far richer and more prosperous lives than we are.

Every technology needs a good slap in the face once in a while.   While most of this rant from Zed Shaw is insipid, there are some very good points.   Especially regarding the people and ideas that are worthy of respect, and some commentary on the potential issues with large-scale agile consulting shops.

Anyways, one doesn’t have to admire someone to admit they make some good points.

20% they said it would go up.   Well, my daily commute just went from $9.05 ($2.65 + $2.65 + $3.75) to $13.20 ($4.35 + $4.35 + $4.50) - a 45% increase.

Grrrrrrrrrr.

I love it when random happenstance leads me to fascinating stories like this one. Mary Wise, head coach of women’s volleyball at the University of Florida, is arguably the best college coach in the world, ever.

Historic Pleo Video Conference