Lois Rogers

The Sunday Times 23 February 2014

VICTIMS of a “forgotten thalidomide-style drug scandal” have begun a fresh attempt for compensation for serious birth defects linked to a pregnancy-test pill taken by 1.5m women.

Some women given Primodos, a drug based on a super-strength version of hormones later used in the “morning-after” contraceptive pill, suffered instant miscarriages in the 1960s and 1970s. Thousands more gave birth to babies with missing limbs, abnormalities of internal organs, or other handicaps.

The recent discovery of documents at the National Archives in London has prompted victims to demand a government investigation and a review of a legal action that failed more than 30 years ago. It has now emerged that 26 studies from 1960 onwards suggested the drug caused miscarriages and birth defects, yet it remained on the market.

The documents include studies suggesting Primodos caused abortions in pregnant rats, as well as evidence pointing to its manufacturer, Schering, offering incentives to GPs to give the unprescribed drug to women.

The AGM in Birmingham yesterday of the Association for Children Damaged by Hormone Pregnancy Testing heard more than 40 MPs support calls for a public inquiry. Dan Poulter, the health minister and a gynaecologist, met the group last month and agreed to investigate.

Primodos, which predated modern urine pregnancy test kits, contained a combination of 10mg of norethisterone and 0.2mg of ethinylestradiol, 13 times the strength of the “morning after” pill. Women were told to take two tablets 12 hours apart, and if they did not bleed afterwards they were told to assume they were pregnant.

The Sunday Times raised concerns about Primodos in 1975. The drug was withdrawn in 1978 without explanation. In 1986 this newspaper reported an admission by Michael Briggs, Schering’s medical director, that he had fabricated evidence relating to its contraceptive pill.

Many of the affected children are believed to have died in early adulthood from heart or organ defects or from cancer. Of those still alive, many have missing limbs, fingers or toes, or defects such as cleft lips. Others have been left deaf or blind. A survivors’ group is also campaigning for compensation for thousands of affected children in Germany.

Marie Lyon, 67, a retired building society manager from Wigan, Lancashire, whose daughter Sarah, 43, was born without her left forearm, leads the British campaigners. “Many of the parents are concerned about what will happen to their badly disabled adult children after they die, and they want funds made available to care for them,” she said.

Nicola Williams, 42, who has had more than 20 operations to correct digestive and spinal abnormalities, said she had found documents at the National Archives in which doctors likened defects associated with Primodos to those caused by thalidomide. “I couldn’t believe how much the government and senior doctors knew about this at the time,” she said.

A spokesman for Bayer, the drug company that took over Schering in 2006, said: “Bayer denies that Primodos was responsible for causing any deformities in children. [We] are not aware of any contention that evidence of alleged harmful effects from Primodos was suppressed. We have no knowledge of any payments made by Schering to doctors in respect of their use of Primodos.”

Yasmin Qureshi, the Labour MP leading the parliamentary campaign, said: “The fact is Schering knew the drug dose could cause miscarriage, they knew it affected development of the early embryo, and they knew there was a correlation with increased risk of birth defects, yet it stayed on the market.”