The FDA stands passively by while women are dying

No Angels

Years ago, on a rainy Saturday afternoon, I happened to catch “We’re No Angels” – the 1955 comedy that starred Humphrey Bogart, Peter Ustinov, and Aldo Ray as three convicts, escaped from Devil’s Island. If you’ve never seen it, I highly recommend it.

Aldo Ray’s character owns a deadly pet viper that he keeps in a small box. At one point, the movie’s villain (an arrogant, overbearing, upper class bully played by Basil Rathbone) picks up the viper box and gives it a shake, asking, “What’s this?” The three men reach out to stop him, but then let him go on investigating. He can’t open the box so takes it with him to his room as he turns in for the night.

Left alone, the three brilliant actors milk the scene for all it’s worth by doing almost nothing. After a long pause their conversation goes something like this: Bogart: “You know, someone really should rush in there and warn him.” After another pause, Ray: “You’re right. It would be dangerous if he opened the box.” After a couple of minutes of this, Bogart slowly makes his way to the door, knocks lightly, and lets himself in. In a moment he comes back out, goes to his chair, sits, and finally says, “Too late.”

Hysterical.

What’s far less hysterical: That scene parallels the way FDA officials seem to approach drug safety concerns. You can just imagine them sitting in a conference room, slowly mulling over multiple reports about a drug that’s clearly very dangerous, while one of them calmly says, “You know, someone really should rush out there and warn people.”

Hidden evidence

The latest news about drug safety gone horribly wrong features Ortho Evra, a birth control patch made by Johnson & Johnson.

Earlier this year, the New York Times reported that J&J representatives delayed disclosure or altered evidence that Ortho Evra delivered much more estrogen than birth control pills. Higher estrogen levels are known to raise risk of blood clots and strokes.

That was in April. Six months later, a Bloomberg report revealed court records that show J&J has quietly paid out nearly $70 million to settle hundreds of complaints against the company.

Most of the lawsuits claim Ortho Evra triggered heart attacks or strokes caused by pulmonary embolisms (blood clots in the lungs), or deep-vein thrombosis (blood clots in the legs). Twenty women who died while using Ortho Evra are represented in these complaints.

Sidney Wolfe, director of Public Citizen’s Health Research Group, went straight to the most heartbreaking detail of this mess: There’s really no good reason why women should be using this form of birth control.

In an interview with Bloomberg, Wolfe noted that, compared to other forms of birth control, Ortho Evra has unique risks, but no unique benefits.

Actually, Ortho Evra does have one unique benefit: convenience. And this is the primary selling point that’s prominently featured on the Ortho Evra website (orthoevra.com): “The Patch is birth control that I don’t have to think about every day.”

But in a way, this unique benefit makes the consequences even more heartbreaking. Women may have died for the sake of a little convenience, while many others experienced heart attacks and debilitating strokes that have changed their lives forever.

Changing the label, but not the drug

Mr. Wolfe put this question to Bloomberg: “What is the purpose of the FDA if not to regulate products like that?”

Great question.

Independent of the FDA, J&J tweaked the Ortho Evra prescribing information in 2005, 2006, and 2008. Today the label carries a warning that the drug exposes women to 60 percent more estrogen than the standard birth-control pill – a potentially deadly exposure.

Public Citizen’s Health Research Group has called on the FDA to outright ban Ortho Evra. But FDA officials seem to be clueless.

Last January, after the FDA approved the latest label change, this note appeared in the FDA News: “The FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.”

Safe and effective? This drug appears to be killing women, but the FDA would have us believe that it’s JUST FINE as long as you follow label directions.

Someone really should rush in there and warn the FDA that they’re becoming completely useless.

Sources:
“J&J Pain $68 Million to Settle Birth-Control Cases” David Voreacos, Bloomberg, 10/10/08, bloomberg.com
“FDA Approves Update to Label on Birth Control Patch” FDA News, 1/18/08, fda.gov