In The Latest Recount Of My Blogpoll Data, ES&S® Corporation Tells Me 98.2% Of You Actually Wanted To Hear About Big Pharma Skullduggery

Which works out pretty well, as in this Olympic year, we may have a new gold medal winner for Pud-sucking by a pharmaceutical corporation. You'll recall our previous co-champions were Merck and Schering, who are accused of withholding scientific data that would have made their product, Zetia, look bad.

Just a shame they didn't go the extra step of actually changing the numbers, or they could have won it all.

The key to our story is this:

"High doses of estrogen are known to raise the risk for blood clots that can cause heart attacks and strokes."

We've known this for awhile now. Estrogen levels have been getting lower and lower in Oral Contraceptives for years, as drug companies push the envelope to see how far down they can go and maintain effectiveness. Good for them. Heart attacks and stokes tend to suck. Twelve years ago, Johnson & Johnson had an idea to push that envelope a little lower, at least to hear them tell it:

In 1996, the company told (The FDA) it planned to develop the Ortho Evra patch in part because it would be likely to expose women to less estrogen than pills. The company suggested that the body would not break down hormones delivered via the patch as readily as the pill, so lower doses could be used to achieve contraception.

There was, of course, the formality of actually proving that women would actually would be exposed to less estrogen, which as you'll remember, was known to raise the risk for blood clots that can cause heart attacks and strokes.

But a crucial trial completed in 1999 showed that the patch delivered 30 to 38 micrograms of estrogen into the bloodstream each day, according to company documents. Because up to half of the estrogen in pills is lost in the digestive tract before it reaches the blood, the study suggested that the patch delivered an amount of estrogen that could be as high as a pill containing 76 micrograms of estrogen. In 1988, the F.D.A. banned birth control pills with more than 50 micrograms of
estrogen.

Wait a minute! That's more estrogen! Which is known to raise the risk for blood clots that can cause heart attacks and strokes! Johnson & Johnson was wrong! Boy I bet they felt silly as they immediately scrapped plans for Ortho-Evra and went back to the drawing board. I mean, that's what any ethical company would do.

But the study’s author, Dr. Larry Abrams, who has since retired from Johnson & Johnson, decided to apply a “correction factor” to the results of the 1999 trial, according to documents. He claimed that the patch actually delivered about 40 percent less estrogen than the trial results showed — about 20 micrograms a day.

Dr. Abrams made the change, according to his deposition, to adjust for the different ways the body metabolizes hormones from pills and patches. This adjustment was never part of the study protocol, a plan filed with the F.D.A..

Johnson and Johnson was so proud of the scientific breakthrough that led to the discovery of this "correction factor" that they mentioned it one time in 435 pages filed with the FDA, buried as part of a mathematical formula. Fancy High-falutin' scientists with PhD's and paychecks signed by Big Pharma can come up with terms like "correction factors," but simple pharmacists with Bachelors degrees and roots in the hillbilly land that is Southeastern Ohio call it "pulling numbers out of your ass"

After the patch was approved, the company marketed it as releasing 20 micrograms of estrogen to the blood every 24 hours, a figure it now acknowledges was inaccurate. It also acknowledges that the patch releases more estrogen than the pill

Yeah, definitely pulling numbers out of your ass. Which makes this part not surprising at all:

Since then, an epidemiological study has shown that women on the patch can have as much as double the risk of blood clots than those taking pills.

Reached for comment in an alternate universe that doesn't actually exist, Johnson & Johnson Chairman and CEO William C. Weldon said in my mind, "but it's sticky....Ortho-Evra is sticky and you can wear it"

"Just try sticking a tablet on your skin" he added in my imagination.

Thing is, Johnson & Johnson totally got this bullshit past the FDA, whose job it is to protect the public from things like "correction factors" Which means you should take total comfort in the following:

....because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

Allow me to translate:

1) Johnson & Johnson pulls numbers out of its ass and uses those inaccurate numbers to market a product.

2) The FDA, underfunded, understaffed, and incompetent because it is run by political appointees who believe that government shouldn't do anything but start wars, looks at the numbers and says...."ddduuuhhhhh"

3) The Supreme Court, now packed with political appointees who believe government shouldn't do anything but start wars, may be about to say that if something approved by the underfunded, understaffed, and incompetent FDA injures or kills you, than tough shit. You have no choice other than die.

Enjoy your tax cut.