Zinc – “Clinically proven”

Whether stated in an ad for conventional or alternative medicine, I typically take claims of “clinically proven” with a grain of salt. That’s because the statistical methodology used to “prove” these claims basically says “if we assume these claims aren’t true, then the results we have seen in studies would have been too bizarre.” This [...]

Other trends that affect clinical research

Lilly is “outsourcing”:http://pharmagossip.blogspot.com/2006/11/lilly-say-ta-ta-to-jobs-in-west.html jobs to India. This is nothing new; pharma companies often outsource their clinical trial operations and analysis, but what is interesting about this move (besides the fact it comes on the heels of a similar announcement by Novartis) is one of the reasons given:
bq. “The goal of our relationship with TCS has [...]

The evil twin brother of Number Needed to Treat

Some weeks ago I posted an entry on the NNT(Number Needed to Treat), which is essentially the expected/average number which you would have to give a treatment (surgery, pharmaceutical, or device) at the labeled dose/frequency to receive the labeled benefit.
When you are talking about adverse event risk, the number is NNH(Number Needed to Harm), which [...]

The New Statistics?

A group has “claimed to find a better way”:http://www.slaterfund.com/slaterfund/content_template.asp?file=newsdetail.asp&newsID=17 of doing statistics in clinical trials. It is based on a “pure likelihood”:http://64.233.161.104/search?q=cache:gmTfSWoOwSQJ:igitur-archive.library.uu.nl/dissertations/2004-0301-095707/c7.pdf+%22clinical+trials%22+%22pure+likelihood%22&hl=en&gl=us&ct=clnk&cd=4 approach, which, at first pass, seems to take the size of the p-value into account as well as whether it is below 0.05. I’ll have to investigate this a little more closely, but [...]

The price of truth with statistics: Dr. Gottlieb’s statment at the conference on adaptive design

A while back I tried to express the opinion that, as good as statistic was at describing populations, it’s bad at predicting outcomes. Looks like the deputy director of medical policy at the FDA agrees:
Another problem with the empirical approach is that it yields statistical information about how large populations with the same or [...]

When statistics can’t tell the truth, a followup application to the Vioxx controversy

I’ve avoided posting on the Vioxx controversy for a long time, but I would be amiss if I discussed drug safety without discussing the hot button issue of the day that has brought drug safety to the forefront.
My earlier thesis is
Clearly, closely adhering to the rules of statistics isn’t going to get anyone very far [...]

Return on investment for clinical trials

A paper in ??The Lancet?? (and reported here) noted that the ROI (return on investment) for 28 clinical trials done by the NINDS(National Institutes of Neurological Disease and Stroke) resulted in a calculated societal benefit of $15 billion. That’s billion with a B. And if you don’t like that measure of societal benefit, try an [...]

Lying with statistics: when statistics can’t tell the truth, or why I’m interested in the statistics of drug safety (and an application to the thimerosal-autism controversy)

Drug safety is hard to study. There are so many things that can go wrong with the human body. To statistically analyze every single possible thing that can go wrong is impossible. There are thousands of possible adverse events, a whole lot of laboratory measurements that have to be taken (so we can address, among [...]

Lying with statistics: relative risk vs. absolute risk

Apparently, the theme of the day is Mike Adams the “Health Ranger”:http://www.newstarget.com.
Pat Sullivan alerted me to “this article”:http://www.newstarget.com/019368.html by the Health Ranger which alerts people to a valid concern in the reporting of statistics. This is another case where you should really read the source before reading the rest of my comment.
My comments:

A disconnect between doctors and patients

We already know that there tends to be a disconnect between doctors and patients when it comes to communication. This makes deciding a course of treatment very hard. This study covered by “Cognitive Daily”:http://scienceblogs.com/cognitivedaily starts to untangle some of those disconnects. Part of the problem comes in with understanding probability. In fact, at least 20% [...]