Friday, August 29, 2008

Again, Via a Tip From PM: DoD to Share Data with FDA -- Investigating Possible Vytorin-Cancer Links

PM (once again!) alerted us to a salient article -- more follow-up on the SEAS Vytorin-cancer data. While the full-version requires registration -- Therapeutics Daily offers a summary, for free, telling us all we really need to know:

The US FDA is aggressively tracking down all possible leads. Quoth the summary:

. . . .The Department of Defense is searching its medical database at FDA's request to investigate a potential link between cancer and the cholesterol-lowering drug Vytorin. The investigation is an example of FDA and DoD sharing more medical information and expertise in recent months, a DoD official says.

DoD is researching TRICARE for cancer diagnosis codes and the medications prescribed, says Rear Adm. Thomas McGinnis, a former FDA official who is responsible for TRICARE'S pharmacy operations. The investigation is intended to last nine months. . . .

[Emphasis supplied.]

This is the sort of diligence -- and active inter-agency cooperation -- our tax-dollars should garner, when public health and welfare might be at stake.


Anonymous said...

This may be misleading.

The link was shown in individuals with aortic stenosis, whereas the DoD database likely has all comers. In addition the DoD's database's servicemen and women are likely skewed to a younger population that even if they are at risk of developing AS eventually much fewer are likely to have developed it already.

The only valid way to validate the results of the first study is to look at a similar population. Anything else will likely dilute out the relationship and is probably why when studies have been combined so far the association disappears.

As for mechanism it may have to do with the effect of statins on isoprenoid metabolism. Do a google search on isoprenoid or isoprenoid metabolism and it will become apparent why.


Condor said...

Salmon -- I think you are right that the DoD/TRICARE data may skew to the healthier side of the table -- but what IF a cancer link appears in THAT population?

That would be a significant nail in Vytorin's coffin, no?