Pressing to Look Closer at Blood Clots and the Pill

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From: byrd45 (Original Message) Sent: 3/30/2007 7:27 AM
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<NYT_HEADLINE type=" " version="1.0">Pressing to Look Closer at Blood Clots and the Pill </NYT_HEADLINE>
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<NYT_BYLINE type=" " version="1.0">
By MICHAEL MASON
</NYT_BYLINE>
Published: February 13, 2007
<NYT_TEXT>
At every exit sign that whizzed past, Kathleen Biggins wondered if she should turn off the Saw Mill River Parkway and call for help.

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The pain that had begun earlier that day in her left arm flowered into agony as she drove home from Manhattan to Ossining, N.Y. Suddenly she was gasping for breath.

Ms. Biggins pulled over to the shoulder of the road and dialed 911 on her cellphone. At the emergency room at Phelps Memorial Hospital Center, doctors discovered a blood clot in her left lung and put her on an anticoagulant.

She had none of the risk factors for sudden blood clots, they determined, except one. Months earlier, Ms. Biggins, a 41-year-old radio news writer, had begun taking a low-dose oral contraceptive called Cyclessa.

As her condition began to improve, doctors warned her that she should never take the drug again.

“Each breath was the worst pain I have ever experienced,” Ms. Biggins recalled. “It was very frightening.”

For more than a decade, scientists have argued whether newer oral contraceptives cause certain types of blood clots more often than their predecessors.

The long-simmering controversy boiled over last week, when a consumer advocacy group petitioned the Food and Drug Administration to ban several popular low-dose “third generation” oral contraceptives containing desogestrel, a synthetic form of the hormone progestin. Among the brands named in the petition were Ortho-Cept, Desogen, and Cyclessa.

The group cited more than a dozen studies indicating that third-generation pills containing desogestrel were linked with blood clots in women more often than older versions, which used different forms of progestin.

“Originally there was some hope that third-generation pills would be more effective,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, which filed the petition. “In fact, they turn out to have unique risks and no benefit over second-generation contraceptives.”

While acknowledging that all oral contraceptives carry some increased risk of blood clotting, the F.D.A. maintains that third-generation contraceptives are both safe and highly effective.

The group’s petition “is selective by not referring to better-controlled studies that did not confirm the differences initially observed,” said a statement from Organon, the maker of Cyclessa.

The first oral contraceptive, approved in 1960, relied on heavy doses of the hormone estrogen to prevent pregnancy. Before long, it was clear that high doses too often led to serious side effects, among them blood clots, high blood pressure and weight gain.

Subsequent formulations of the pill sought to balance reduced estrogen levels with increasing amounts of progestins — hormones that help to suppress ovulation and to regulate the cyclical development of endometrial tissue. The newer progestins in third-generation pills, like desogestrel, were intended to avoid the side effects caused by older versions, which included increased low-density lipids, weight gain and acne.

Beginning in the mid-1990s, a series of studies, mostly in Europe, suggested that compared with women taking second-generation contraceptives, those using third-generation pills suffered higher rates of venous thrombosis — blood clots in the deep veins of the legs, lungs and other parts of the body.

But other studies were less conclusive, and in any event, the absolute risk to the average woman was small.

“There may be a modest increase in clotting with third-generation progestins, but it is far, far less than occurs in pregnancy itself,” said Dr. Charles J. Lockwood, chairman of the obstetrics, gynecology and reproductive sciences department at Yale University.

Still, Dr. Lockwood, who is also acting chairman of an F.D.A. advisory panel on reproductive health drugs, said many of the original studies used to evaluate contraceptive pills drew on homogeneous groups of healthy women who were not representative of Americans as a whole.

Smokers and obese women, for example, were usually excluded from the studies. As a result, some disadvantages of low-dose oral contraceptives may have been understated.

Some researchers have also wondered whether low-dose contraceptives are as effective as advertised for women who are overweight, since they too were often excluded from evaluation.

In 2004, researchers at the University of Washington compared weight and body mass index for 248 women who became pregnant while on the pill with a group of 533 women who did not. Overweight and obese women were 60 percent more likely to become pregnant than women who weighed less, the scientists found.

“It’s yet another unpleasant surprise of the obesity epidemic,” Dr. Lockwood said.

Nonetheless, his panel refused last month to set a benchmark by which the agency could measure the efficacy of new oral contraceptives. To do so would unduly limit the choices available to women with a wide range of risks and needs, Dr. Lockwood said.

The advisory panel is urging the F.D.A. to weigh new contraceptives against available alternatives and to continue evaluating the drugs even after they are on the market.

Perhaps more important, the panel wants the F.D.A. to ensure that it gathers data on the safety and efficacy of oral contraceptives from real women — older, overweight, forgetful even — living in a real world where contraceptive choices have real consequences.

That is, from women like Ms. Biggins, who has fully recovered and is grateful to be celebrating her birthday tomorrow.

“Had I known the risk, I would have thought twice about taking it,” she said. “Most women would.”

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