Sound familiar? Drug company executives knew dangers and kept quiet

Sleeping with One Eye Open

How do you sleep at night knowing your company is making millions of dollars on a drug that may harm and possibly kill some who use the drug?

When a couple of Johnson & Johnson vice presidents asked themselves that question, they each made a gutsy move–one bailed and one confronted.

According to a recent NBC News report, one VP wrote a resignation letter stating that J&J executives ignored “compelling evidence” that the Ortho Evra birth control patch prompted a high rate of fatalities.

Another J&J VP filed a lawsuit, claiming he was fired for expressing concerns about Ortho Evra’s very high estrogenic levels.

How high? Sixty percent higher than a birth control pill.

With a pill, the estrogen is quickly absorbed by the body. But with the patch, the body receives a continuously high dose of estrogen over several days. And because estrogen makes the pill dangerous, you can imagine how dangerous it makes the Ortho Evra patch.

So dangerous that even some drug executives throw in the towel.

And yet, it appears there were some J&J execs who were not bothered at all. In fact, according to the NBC report, they may have known about Ortho Evra’s dangers before the patch ever went on the market.

You’ve got to wonder: How do they sleep at night? (Hmmm…if I had to guess, I’d say Ambien…)

The quiet alarm

Two years ago I told you how J&J execs were accused of delaying disclosure and altering evidence that their patch delivered much more estrogen than the pill. But you know how it is–these reports hit the news and then they’re gone. So Ortho Evra has continued to sell very well.

When the NBC report broke, I went to the Ortho Evra website (orthoevra.com) and found the prescribing information that’s included with the product. Do you think there’s a black box to warn women about the potentially fatal risks of high estrogen?

Well…there is a black box. But it’s on the third page. And it’s just a standard warning we’re all familiar with: Cigarette smoking increases risk of serious cardiovascular side effects from hormonal contraceptive use.

Then the general warnings…

“The pharmacokinetic (PK) profile for the ORTHO EVRA® patch is different from the PK profile for oral contraceptives in that it has higher steady state concentrations and lower peak concentrations.”

Toward the end of that beautifully vague piece of writing is where most women probably stop reading. But if they continue, they’ll get to the good stuff–the deeply vague…

“AUC [area under the curve] and average concentration at steady state for ethinyl estradiol (EE) are approximately 60% higher in women using ORTHO EVRA® compared with women using an oral contraceptive containing EE 35 mcg.”

There it is–the smoking gun! You’ll be getting 60 percent more estrogen. But how many women reading that will understand that they’ve been given a grave warning?

The technical language goes on and on like this for four more sentences, and then finally: “Increased estrogen exposure may increase the risk of adverse events, including venous thromboembolism.”

Buried on page three: venous thromboembolism. In other words, the source of the blood clot that’s believed to be responsible for at least 20 deaths in Ortho Evra users.

Nice “warning.” It’s like they sent up an emergency flare that soars two feet high.

More than 3,000 women and their families have filed suits against J&J, claiming the drug prompted heart attacks, strokes, and death. So far, it’s estimated that J&J executives have paid out nearly $70 million to make these legal problems go away.

So that’s how they sleep at night…on piles of money.

To Your Good Health,

Jenny Thompson

Sources:
“Did drugmaker hide birth control patch risks?” Jeff Rossen and Robert Powell, NBC News, 9/22/10, today.msnbc.msn.com
“J&J Paid $68 Million to Settle Birth-Control Cases” David Voreacos, Bloomberg, 10/10/08, bloomberg.com