Just days ago Dr. Lester Crawford, Commissioner of the Food & Drug Administration (FDA) resigned without warning or any prior indications.
Dr. Crawford reportedly cited in his resignation as his accomplishments at the FDA, 1) improved drug safety, 2) speeding up drug development, and 3) bringing more funding to the agency from manufacturers.
There is little if any evidence of the first item. The second item contributes to problems with the first. The third looks like an admission of payola.
Dr. Andrew C. von Eschenbach has already been named to head up the FDA in place of Crawford. Dr. von Eschenbach currently heads up the National Cancer Institute (NCI). He has already stated his intent to fill both positions.
The union of von Eschenbach as head of both the FDA and NCI brings to mind the "for better or for worse" portion of the traditional marital vows.
Marriage made in hell?
We need to look no further back than last week's column ('Celebrex or selenium to fight cancer?' 9/21/05) to address the issue of "for better or for worse".
The FDA recommended studying Celebrex as a cancer preventative. The NCI under von Eschenbach's leadership went along full speed ahead. Currently there are at least eight NCI studies investigating Celebrex as a cancer preventative.
One Celebrex study at M.D. Anderson Cancer Center in Houston, Texas is testing smokers against lung cancer. Smokers are a high-risk group for heart disease. Celebrex carries a mandatory warning that it increases heart disease risks.
Does testing a drug that increases heart disease risks on a high-risk group for heart disease as to possible benefits sound like an idea that is for better or for worse?
"The first concern is to do no harm," said Dr. Bernard Levin, vice president of cancer prevention at M.D. Anderson. Simply saying the words do not make it so.
In his newly added appointment to also head the FDA, NCI's chief von Eschenbach said, "under any circumstances, do no harm." Again, simply saying the words do not make it so.
Another interesting item about von Eschenbach is that prior to heading up the NCI he was a chief official at M. D. Anderson. Is that for better or for worse?
The mineral selenium has been noted in a previous clinical trial to dramatically reduce lung cancer incidence. Selenium is also noted for its benefit to the heart in direct contradistinction to Celebrex that increases heart risk.
Selenium or Celebrex -- for better or for worse?
While there are at least eight Celebrex studies as a cancer preventative under the leadership of von Eschenbach there is only one selenium study as a cancer preventative under his leadership. A closer examination of that one selenium study notes the disparity to be even greater than it already appears.
The previous selenium study completed almost 10 years ago used a whole food, grown dietary selenium supplement. That study indicated dramatic success. The current study uses a pharmaceutical grade, man-made, selenium supplement. Is that for better or for worse?
Whole food, grown selenium dietary supplements have been tested from 60 to more than 120 times as active in the blood than common pharmaceutical grade selenium supplements.
Additionally, more than 25 years ago I learned that the effectiveness of selenium was reduced when more units of vitamin E were used than micrograms of selenium. Micrograms of selenium should always exceed units of vitamin E for maximum effectiveness.
The one and only, single selenium study as a cancer preventative at the NCI under von Eschenbach's leadership utilizes twice as many units of vitamin E to only half as many micrograms of selenium.
Only one selenium study with an inferior selenium that is poorly matched with an excessive amount of a contrary nutrient to further weaken its effectiveness as opposed to eight Celebrex studies is a profound indictment of the leadership of von Eschenbach.
A quick annulment is in order before this union of von Eschenbach as head of the FDA and of the NCI births more defective fruits of his laborious loins.
