Minister in storm over Pill warning

LIZ HUNT,

PATRICIA WYNN DAVIES and JOHN SHEPHERD

The Department of Health last night faced mounting criticism at home and abroad over its controversial advice to 1.5 million women taking seven of the most popular brands of the Pill to change to another brand because of blood-clot fears.

Stephen Dorrell, Secretary of State for Health, came under increasing pressure to make a full statement to the House of Commons, as European lawyers warned the Government it faced the threat of legal action from Pill manufacturers whose share prices have fallen sharply.

Dr Ian Bogle, leader of 30,000 GPs in England and Wales, protested strongly to the Committee on Safety of Medicines (CSM), Gerald Malone, the Health Minister, and Dr Kenneth Calman, Chief Medical Officer, demanding to know why the profession did not receive more warning. Surgeries and clinics have been inundated with women seeking advice.

Leading the attack on the international front was Professor Walter Spitzer, a Canadian scientist, who accused government doctors of breaking the Hippocratic oath to create an "epidemic of anxiety" for women everywhere.

Professor Spitzer said the Committee on Safety of Medicines, the Government's drug watchdog, broke established scientific rules by issuing the Pill warning on the basis of unpublished and unreviewed data. He said this had wrecked vital research into "third-generation" oral contraceptives which, until now, were believed to have been the safest. "I have never been as outraged as I am now about the misuse of five years of my life's work," said Professor Spitzer, who is principal investigator of one of three studies that prompted the CSM to issue new advice. He flew in from Canada for just three hours to hold a press conference at Heathrow Airport.

He added: "The core of the Hippocratic oath is, above all, do no harm. I believe the Government has done harm."

The findings of the Spitzer study, and two others, show that for Pills containing the progestogens (female hormones) desogestrel and gestodene, the risk of potentially fatal blood clots is twice that of the "second- generation" variety.

Women taking the brands Femodene, Femodene ED, Minulet, Triadene, Tri- Minulet, Marvelon and Mercilon are being advised to continue with the Pills, but to see their GP before finishing the pack.

Professor William Rawlins, chairman of the CSM, last night said the committee stood by its decision. "We do not believe that the advice is premature, nor do we have any plans to revise it ... We have acted as quickly as we could to warn women and doctors to minimise the risks."

He dismissed suggestions that the decision to publicise the risks of the newer and most expensive brands was influenced by a desire to save money.

Harriet Harman, the shadow Health Secretary, last night tabled a parliamentary question asking when the decision to issue the warning had been made, and when doctors were notified.

Letters to GPs from the Department were dated 18 October, but some appeared not to have received them by last night. A notification was faxed to local directors of public health with the GP letter attached, but they were not posted until 19 October, Ms Harman said. "Doctors are right to be very concerned they had no time to draw up proper procedures to advise patients or, indeed, make any arrangements to deal with the numerous calls from patients."

Dr Peter Holden, a member of the British Medical Association's GPs' committee, said: "We are furious. We are fed up with professors lighting blue touch papers and then returning to ivory towers, leaving GPs to pick up the pieces."

Frightened women, page 2