Deep excavation of a betrayal where victims blamed themselves

A pharmaceutical scandal over birth defects in Britain has been unravelling and stalling for half a century. Can a documentary bring new evidence to light?

On November 30th, 1970, at exactly 1.30pm, Lynda Ramsay smoked her first cigarette. She can be precise about the moment, because no one would ever forget such awful circumstances. Her new-born baby, Gary Lee, had died, having come into the world with such serious malformations that his mother could neither hold him nor take a photograph – even the flash would cause him pain –   and a doctor was attempting to console her. “I still smoke,” she says, quietly.

Ramsay is one of hundreds of British women who had been prescribed Primodos, a hormonal pregnancy test drug introduced in the late 1950s and finally removed in 1978, which has been associated with birth defects. If you wonder why anyone would take a prescription pill to determine pregnancy, it says a lot about how primitive the previous methods had been – the most reliable test in the 1950s was to inject female frogs with the patient’s urine to see if it produced eggs.

Primodos, which contained similar components to the contraceptive pill but in much stronger doses, was intended to induce menstruation in the absence of pregnancy. Ramsay had her own doubts. “Them days, if the doctor said the moon was made of green cheese, you’d believe the doctor. These days I wouldn’t, but in them days I did.”

The Sky News documentary Primodos: The Secret Drug Scandal (Sky Atlantic, Tuesday, 8pm) works like a deep excavation of betrayal, made more emotive because without other explanation, the victims were inclined to blame themselves. Prompted by an unusual number of spina bifada cases, in 1967 the London paediatrician Dr Isabel Gal researched hormonal pregnancy tests and published dire findings. But Primodos was not withdrawn until 1978, and a legal case against the drug's manufacturer, the German pharmaceutical Schering, stalled in 1982.

READ MORE

Robin Hayes, whose son was born with a heart defect from which he died in childhood, tries to rein in his cynicism as he describes how medical experts dropped out of the case, one by one, when research grants posed conflicts of interest. As the case grew shaky, legal aid was removed, and the claimants could no longer afford to maintain it. The evidence against Primodos was inconclusive.

Jason Farrell’s documentary is not inclined to harbour doubts. Unearthing documents from Britain and Germany, some of them prepared for the legal battle that never happened, the evidence presented is damning. Nothing is quite as galling as communication between the UK regulator, Dr William Inman, and the pharmaceutical company in 1975, in which Inman determined a “five-to-one risk” of birth defects, and sent the company a letter that resembled a tip-off more than a charge. (Inman destroyed the material on which his investigation was based “to prevent individual claims” that could be based on it.)

The patterns are depressingly familiar. Whistle blowers, such as Dr Gal or Schering employee Dr Ulrich Moebius, are either undermined or discredited. Internal reports about the drug’s lack of testing issue dark warnings – “We’re defenceless”; “likely guilty of a breach in duty”; “dynamite in the hands of the claimants” – and still there is little culpability. Farrell never talks to a representative of the pharmaceutical company, owned since 2006 by Bayer, which declines an interview but issues a defensive letter that could have been drafted in the 1970s.

Farrell lays out his findings: that the drug was never tested; that the company was told it was negligent; that the regulator warned of risks; and a similar case in the US resulted in a huge settlement. This scandal, now more than half a century old, may still be unravelling: the UK drugs regulator is reviewing the new evidence on Primodos and is expected to report back later this year. It’s not hard to feel for the claimants, still waiting for answers, and in Lynda Ramsay’s case, still smoking.

Peter Crawley

Peter Crawley

Peter Crawley, a contributor to The Irish Times, writes about theatre, television and other aspects of culture