Bitter Pills of Contraception

New Evidence of Danger Abounds, But Sales Continue

LONDON, MAY 11, 2002 ( Recent evidence points up the danger to women´s health posed by contraceptive pills, including the newest versions.

The April 13 issue of the British Medical Journal published an article reporting on how Dutch doctors are being advised by their own professional association not to prescribe a new, low-dose oral contraceptive, marketed under the trade name Yasmin, until studies have established whether it is as safe as other contraceptive pills.

The new contraceptive has been available in several European countries since 2000 and was approved by the U.S. Food and Drug Administration in May 2001.

Last year a 17-year-old Dutch girl who had been taking Yasmin died from a venous thrombosis. Although no direct link with Yasmin has been shown, 40 cases of venous thrombosis among women taking Yasmin, two of which were fatal, have been reported in Europe, noted the British Medical Journal.

Speaking on a Dutch radio station, Frits Rosendaal, professor of clinical epidemiology at Leiden University Medical Center, said of Yasmin: “I am not satisfied it is absolutely safe.” He expressed alarm that as many as 40 cases have been reported voluntarily by doctors so soon after the contraceptive was registered.

Almost simultaneously, the Times of London on April 12 published a report on how a new contraceptive pill led to the death of 15-year-old Claire Louise Stanley. The girl developed deep vein thrombosis in her legs after taking the pill and died from a massive clot in the lungs, described by one doctor as the biggest he had ever seen.

Four doctors who examined the girl did not link her deteriorating condition with the second-generation oral contraceptive, Cilest, until after her fatal collapse. Cilest, according to the Times, is popular with teens in the United States because it also helps clear skin conditions.

England also saw, earlier this year, the beginning of a legal hearing over the health dangers of contraceptives. The Guardian reported Feb. 27 that a case on behalf of 100 women has reached the High Court. The hearing is expected to last about five months.

The contraceptives under question belong to the “third-generation” contraceptive pills and involve three manufacturers — Schering Healthcare, Organon Laboratories and Wyeth. The women who are behind the case were in their teens, 20s and 30s, and were all in good health before they took the contraceptives. Seven of them died as a result of the contraceptives, while others have suffered serious damage to their health.

The Guardian explained that the third-generation pills, introduced in the 1980s, were expected to reduce health risks. But in 1995 the British government pharmaceutical watchdog, the committee on safety of medicines, after seeing the early results of three studies, issued a warning that the newer pills should be not be a first choice.

An analysis of seven studies since 1995 reported in the British Medical Journal last year concluded that the third-generation pills carry 1.7 times the risk of potentially fatal blood clots as the second generation, though the risk is higher for first-time users.

A telling piece of evidence on the dangers of the third-generation pills was published by the Sunday Times on March 3. The paper revealed that an internal study by the drug company Wyeth found that these pills, used by hundreds of thousands of women in the United Kingdom, are almost twice as likely to cause deep vein thrombosis than earlier versions of the drug.

This problem affects eight in 10,000 women using the third-generation pills, reported the Sunday Times. Wyeth conducted a seven-year study involving 3,285 women, using information from the British General Practice Research Database.

Increased cancer risks

Then on March 26, BBC reported that women who have taken contraceptive pills at any stage in their lives have an increased chance of developing breast cancer. Their risk rose by 26%, compared with women who had never used contraceptives.

Moreover, the latest research showed those who had taken the pill over longer periods increased their risk of breast cancer by 58%, compared with those who never used it. The highest increased risk, 144%, was among women over age 45 who were still using the pill.

Dr. Merethe Kumle, who carried out the research, said: “It is clear that oral contraceptives increase a woman´s risk of developing breast cancer, particularly when they are used in the later period of reproductive life.”

The study was presented at the third European Breast Cancer Conference in Barcelona, Spain, and used data collected from 103,000 women aged 30 to 49. Dr. Kumle from the Institute of Community Medicine in Tromso, Norway, collaborated with researchers in Sweden and France to assess data from the Women´s Lifestyle and Health study carried out in Norway and Sweden.

Most of the women who had taken the pill had used the more modern brands now prescribed by doctors.

The same day as the BBC report came out, the Associated Press carried a story on the risks of cervical cancer from using oral contraceptives. According to a report in the medical journal The Lancet, women infected with the common sexually transmitted human papillomavirus (HPV) have a higher risk of developing cervical cancer if they have taken birth control pills for more than five years.

The study was conducted by the International Agency for Research on Cancer, an arm of the World Health Organization. Researchers pooled data from eight earlier studies of 3,769 women from four continents. Of those, 1,853 had cervical cancer, and 1,916 did not.

The WHO researchers found that women who had taken the pill were no more likely than the others to be carriers of HPV. However, those infected with HPV who had used birth control pills for an accumulated total of five years or more were nearly three times more likely to develop cervical cancer than HPV-infected women who had never taken the pill. The increased risk persisted for up to 14 years after use of the contraceptives stopped.

Women have about a 1% chance of developing cervical cancer. Based on the new findings, taking the pill for five years or more could push that chance up to about 3% and taking it for a total of 10 years could raise it to about 4%.

Almost 360,000 women worldwide were diagnosed with cervical cancer in 1990, the latest year for which figures are available. Of those, 190,000 died of the disease. It is the second most common cancer in women.

Recent information has also come out on the dangers of the abortion pill RU-486. Danco Laboratories, which makes RU-486, has sent a letter informing doctors that six women have developed serious illnesses and two have died after taking the drug to induce abortions, the Washington Post reported April 18.

No causal relationship has been established between the drug and the illnesses in any of the cases, according to the company letter. Nevertheless, the company was sufficiently worried to send out the alert to inform the doctors who have ordered this product, and to ask them to report any serious adverse events in women receiving the drug. Women who expected contraceptives and abortifacients to bring them “liberation” may now risk getting something they didn´t bargain for.

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