Reprint

Research reveals birth pill risk for 2m British women

The Sunday Times, September 18 1988
By Brian Deer, Social Affairs Correspondent

FAMILY doctors are to be urged to switch more than 2m British women from their current brands of contraceptive pills, after a scientific investigation which suggests that the most popular pills available carry the greatest health risks.

The pills, which all contain the synthetic hormone levonorgestrel, include leading brands Microgynon, Eugynon, Ovran, Ovranette, Trinordial and Logynon, which currently dominate the British oral contraceptive market. Worldwide, more than 15m women are believed to be taking this type of pill.

Doubts about the levonorgestrel pills have circulated among scientists and doctors for the last two years, after The Sunday Times revealed that important research publications, purporting to show the relative safety of the products, was fabricated.

Now, the gap left in the medical literature by the exposure of the fraud is to be filled by research which shows the pills to be more likely to cause heart disease and other cardiovascular problems than other brands available.

The new research was carried out in Britain on behalf of the American government’s National Institutes of Health, and is the largest investigation of its type ever undertaken independently of drug firms.

The £500,000 research project was led by Professor Victor Wynn, whose team at the Cavendish clinic in north London studied more than 1,400 healthy women taking nine different formulations of pill.

Wynn has been a leading authority on contraceptive safety for more than 20 years. His team measured complex changes in the blood, which are now regarded as key indicators of whether a person is likely to develop cardiovascular diseases. Across a range of measurements, they found that women taking levonorgestrel pills were in significantly greater danger.

The implications for women now taking the pill are likely to be far-reaching. Professor Wynn is currently recovering from illness, but his staff said that family doctors should be alerted to the increased risks which they believe are posed by the levonorgestrel pills.

“These are significant effects that we have found. Here we have the basis for a major shift in prescribing,” said Dr Ian Godsland, a senior biochemist in Wynn’s team and co-author of the research.

More women are taking levonorgestrel pills than any other type of oral contraceptive, after a marketing campaign in the medical profession by their multinational manufacturers. The firms involved are Schering AG of West Berlin and the Philadelphia-based company, Wyeth.

In recent years, the two companies have particularly encouraged doctors to prescribe their so-called “triphasic” levonorgestrel pills, which deliver a smaller quantity of the synthetic hormone. These “low-dose” pills also fared badly in the research.

It was also the triphasics that became the centre of an investigation by The Sunday Times. This revealed that Professor Michael Briggs, a British scientist and a former senior staff member of Schering, faked a series of papers which appeared to refute links between the pills and heart disease.

His work, carried out at Deakin University in Australia, was financed by Schering, which also paid for the results to be published and distributed to doctors worldwide. The company denied knowledge of the deceptions and, after our inquiries, deleted Briggs’s work from its literature.

Schering said this weekend that it did not contest Wynn’s findings at present, and that it is not currently promoting levonorgestrel pills. The company said that it is now recommending to doctors that they consider Femodene, a new oral contraceptive containing a different hormone.

Dr Peter Longthorne, medical director of Schering’s UK subsidiary, said: “We do not know what the implications of this study are in a clinical setting. It is an interesting finding and I do not think we can draw a definitive conclusion at this stage.”

Wynn’s method was to examine more than 30 aspects of blood metabolism in more than 1,400 women. They were a random sample, with an average age of 28. The most worrying sign he detected was a decline in an element in blood known as HDL2, which is believed to protect women against heart disease.

The pill which fared best in the investigation was Marvelon, which contains a hormone called desogestrel, rather than the suspect levonorgestrel. Very closely behind this were pills containing small amounts of norithisterone, such as Brevinor, Minovlar and Loestrin.

General practitioners and doctors in family planning clinics may wish to switch women to these pills, but this will not be easy. Levonorgestrel-containing contraceptives are popular because they are good at preventing “breakthrough bleeding” and because the hormonal changes can in many cases promote a sense of well-being and improved libido.