While I work on winging my way back to the East Coast, I thought I’d leave you with a couple of links that I became aware of but didn’t get the chance to post.
First up is the older piece by that tireless debunker of dubious medicine and quackery and fellow skeptic, Prometheus. In a piece entitled Mercurial Laboratories, he dissects in detail why the laboratories that purport to show parents that their autistic children have elevated mercury levels almost certainly do not do any such thing. Indeed, what he has written can apply to almost any set of lab tests, particularly this part:
One of the conundrums in clinical laboratory medicine is this 5% of the “normal” population that – by definition – is outside of the reference range. This is particularly problematic when you are running a battery or “panel” of tests, since each one of them has a reference range that excludes 5% of the “healthy, normal” population. It is a relatively simple exercise in probability to find how many tests you have to do to reach the point where there is a greater than 50% chance that one of the results will be “abnormal” (i.e. outside the reference range) in a person who is “healthy” and “normal” [Answer: 14].
To this, I would add that, if there are 20 or more tests, the probability of at least one abnormal value approaches 100%. This principle can be applied to research as well, and perhaps I’ll expound on this in a future post.
The second post is by Kathleen Seidel and is entitled Strategic Disregard. One thing that I and others bring up about Mark and David Geier is how they had their IRB approval to do a study based on the Vaccine Safety Datalink data suspended in 2003 because of inproprieties in which they renamed files and tried to rename datasets in ways that aren’t permitted and in such a way that patient confidentiality might be compromised.
What I hadn’t been aware of is the Geiers’ response to this criticism. Kathleen deconstructs the Geiers’s explanation of what happened and demonstrates pretty convincingly that, for all the verbiage designed to distract and produce sympathy, the Geiers in essence admitted that they did what the CDC accused them of doing. She boils it down thusly:
The same sort of political pressure that enabled this legal consulting team to initially gain access to millions of private patient records was brought to bear in the spring and summer of 2004. Vaccine litigant groups and their political allies trivialized concerns about the privacy of patient records, characterizing these concerns as a “false pretext” for the denial of the Geiers’ access to VSD data. To my knowledge, no determination was ever made that the technical monitors’ allegations of misconduct were “baseless.” However, Mark Geier and David Geier’s IRB approval was reinstated that August. This reinstatement occurred in spite of their own admissions that they:
- initiated analyses not authorized in their research protocol;
- attempted unauthorized merging of datasets; and
- acquired unauthorized data files, which were named in a manner that, if undetected, could have enabled the removal from the Research Data Center of private information about millions of U.S. citizens.
Sadly, those nefarious forces aligned against the poor Geiers ultimately reinstated their IRB approval. If I violated my IRB protocol that way, I doubt I’d get the same favorable treatment.
