'˜Bitter disappointment' over birth defect pregnancy drug ruling

The Commission on Human Medicines’ (CHM) expert working group on Hormone Pregnancy Tests (HPT) said the scientific evidence it reviewed does “not support a causal association” between the Primodos test and birth defects.

It recommended that families who took a HPT and experienced an “adverse pregnancy outcome” should be offered genetic testing to see whether another underlying cause could be determined.

Chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, Marie Lyon, whose daughter Sarah, now 47, was born with a severe limb deformity after she took the drug in pregnancy, said: “We are bitterly disappointed that the Government has once again let people down who have relied on them to be open and transparent.

“It is similar to the previous inquiries which seemed more inclined to protect the reputation of government agencies and the drug companies rather than looking after the health of the populations of the UK.”

The Association represents 236 families who believe they were affected by taking the drugs in early pregnancy. It estimates that 1.5 million took the drugs and thousands of families have been affected, though some may be unaware.

In the past Ms Lyon has argued there is “incontrovertible evidence” that the Committee on Safety of Medicines - an independent advisory committee to the UK medicines licensing authority - was “negligent in protecting the health of unborn babies”.

Ms Lyon said the drugs she was instructed to take in 1970 were “40 times the strength of an oral contraceptive”.

She said: “I didn’t ask because I assumed that was the way that you found out you were pregnant.

“But I wasn’t given a choice, I was just given these two tablets, told to take them and then if nothing happened I was pregnant. When Sarah was born she was born with her arm missing from just below the elbow but there was a tiny little palm with five little tiny fingers which they had to amputate when she was 13 months old so she could have an artificial limb fitted.

“But she was extremely lucky - some of our members have got young adults in wheelchairs, they are incontinent, some are blind, brain damaged, it is dreadful. She is exceptionally lucky and so am I, in comparative terms.”

Ms Lyons said the review had not looked at all the evidence.

She added: “Initially we had high hopes, we felt that at last someone was looking at finding justice for our members and I now feel extremely angry. It has been such a waste of money, such a waste of time, and it has raised the expectation of our members only to have them dashed again by the same organisation that actually covered up all the failings in the first place.”

The CHM said the independent review “thoroughly examined all of the evidence”, and concluded that the use of HPTs, including Primodos, in early pregnancy was not responsible for serious birth defects “experienced by some people”.

It said clinical practice has moved on since the 1970s and there have been “far-reaching” advances in medical regulation but it made a series of recommendations to “further strengthen” systems for detecting, evaluating and communicating safety concerns for use of medicines in pregnancy.

Chairman of the CHM, Professor Stuart Ralston, said: “This was a comprehensive and wide-ranging scientific review of all the available evidence on the possible association between HPTs and birth defects by internationally leading experts across a broad range of specialisms.”

Dr Ailsa Gebbie, chairwoman of the expert working group, said: “Our recommendations will strengthen further the systems in place for detecting, evaluating and communicating risk with use of medicines in pregnancy and help safeguard future generations.

“Many women use these same hormones on a daily basis for contraception and heavy periods who may experience an unintended pregnancy. So our findings are also very reassuring for them.”

A LABOUR MP has called for a judicial review or a separate inquiry to examine allegations of a cover-up by medical regulators at the time.

Yasmin Qureshi, MP for Bolton South East, became involved with the campaign when a constituent contacted her with a vast number of documents relating to a link.

She said: “They clearly have not looked at the evidence that was presented to them. If they had looked at the evidence presented to them they could never have arrived at the conclusion they have now. This report is a complete whitewash. It is not worth the paper it has been printed on.”