HANDS OFF!

There's a new bill in The House! It is HR 3156. Well, actually, it is an old bill from the last session of Congress that never even came to a vote.

The "new" bill has the same name as the old one -- The Dietary Supplements Access and Awareness Act. Don't let the name fool you. This bill is designed to remove access to dietary supplements.

The grave robbers that dug up this corpse from its congressional grave have added a portion to their Frankenstein creation that gives heightened power to the FDA for removal of a dietary supplement. The exact wording of the bill permits removal "without the need to prove that the substance has actually caused harm".

Meanwhile the FDA is slow to action or takes no action at all on deaths due to prescription drug use. The FDA doesn't need more authority to remove dietary supplements that might possibly do some harm. The FDA needs to use the authority it has to protect people from actual prescription drug deaths!

HANDS ON!

The FDA needs a HANDS ON approach to drug regulation and a HANDS OFF approach to dietary supplements.

This week it was reported that the deaths of a dozen young women from blood clots last year were related to the new birth control patch. Dozens of others on the patch suffered strokes.

Yet the FDA director in charge of the division that licenses these types of drugs noted that these deaths were within expected levels and that there was no reason for any follow up.

Deaths due to normal usage of a non-life essential drug are expected and acceptable? How long do you think any dietary supplement would remain on the market if dozens of deaths and serious injuries related to it occurred in one year?

Stirring the pot

Prior to approval of the birth control patch the manufacturer downplayed the blood clot risk. An FDA reviewer strongly disagreed in his report with capital letters and underlining to emphasize his point.

The reviewer urged a strong label warning that was subsequently not utilized when the drug was approved.

The pot thickens like a blood clot

The director of women's health care for the manufacturer of the hormonal birth control patch is a Dr. Andrew Friedman.

The duties of Dr. Friedman involve design and review of clinical trials for hormonal birth control, and writing package insert labels.

Last week Friedman was the central focus of an article about fake research reaching an all-time high last year. Just prior to his work on the birth control patch he previously faked and even made up study figures for many studies -- including a study involving gynecological hormonal studies.

Yet a spokesman for the manufacturer noted Dr. Friedman as an asset to the company.

The FDA has plenty to do tending to drug deaths and side effects that it is not doing.

The scant few deaths allegedly related for the entire history of dietary supplement use pales in comparison to prescription drug deaths in just one year.

The FDA can just keep their drug death soaked hands off of dietary supplements.

HR 3156 again

The "new" old bill specifically exempts dietary supplements that contain only vitamins and/or minerals. It targets every other dietary supplement.

Meanwhile the CODEX treaty that will be empowered if CAFTA passes the house specifically targets only vitamins and minerals.

HR 3156 in combination with CODEX by way of CAFTA addresses control and restrictions of every single dietary supplement.

Is that an odd coincidence?