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KEYCODE BAYER 609

25 March 2015, Regulatory Affairs Professionals Society (RAPS)

UK Regulators Prepare for Review of 'Forgotten Thalidomide'

Regulators in the UK are asking the public to report “suspected adverse effects” of hormonal pregnancy tests (HPTs), which have been off the market in the UK since the late 1970s after being associated with serious birth defects and miscarriages.
The information will be used as part of an independent review to determine whether there is a causal relationship between HPT use and reported side effects. MHRA is asking for submissions by 30 June 2015, and says the report is expected to be completed in early 2016.

Background
HPTs such as Primodos and Duogynon were marketed in the UK and Germany beginning in the 1950s. The pregnancy-testing products work by giving women a strong dose of hormones which induce menstruation if the woman is not pregnant.
In the 1960s, scientists began raising concerns that HPTs may be associated with miscarriages and serious birth defects. In 1967, Dr. Isobel Gal conducted a study that associated spinal bifida in children with HPT use in pregnant mothers. At the time, the Committee on the Safety of Medicines (CSM) took these reports into consideration, but did not recommend taking action against these products until 1975.
Advocates have drawn parallels between HPTs and Thalidomide, calling Primodos the “ forgotten Thalidomide.” Thalidomide, a morning sickness drug marketed in the 1950s and 1960s in Europe and Canada, caused thousands of deaths and serious birth defects before its use was banned. Now, more than 50 years after the Thalidomide disaster, victims are still fighting for compensation in some countries, and have complained that the compensation they have received is inadequate.

Recent Actions
In 2013, Labour MP Yasmin Qureshi called on the government to conduct an independent review of Primodos, which prompted the Medicines and Healthcare Products Regulatory Agency (MHRA) to conduct an assessment of the effects of Primodos.
The assessment looked at 36 studies and other sources to determine whether HPTs could have caused the reported defects and miscarriages. After reviewing the available literature, MHRA concluded that the evidence was not “sufficient to conclude that an association exists” between congenital anomalies and HPT use.
MHRA notes that there were difficulties using the historical studies to draw conclusions, citing issues with data quality and technological limitations. Thus, the agency says it cannot “rule out such an association.”

Controversy
There is considerable controversy surrounding the events before Primodos was taken off the market in 1978.
In a statement to Sky News, Bayer, which merged with Schering in 2006, said that Primodos was not labeled for use as a pregnancy test after 1970.
Advocates also claim that the government and Schering may have tried to cover up reports of adverse reactions. In a parliamentary debate in 2014, Qureshi cites minutes from a meeting of the General Medical Services Committee in the 1960s that allegedly state that “doctors should stop recording adverse reactions, and, even more significantly, that those who have recorded any such evidence should have it destroyed.”
Bayer denies that Primodos caused the birth defects and miscarriages being claimed. However, in 2011, Karl Murphy, who attributes his numerous birth defects to Primodos, reportedly uncovered documents which allegedly show that Schering employees were aware of a link between Primodos and the severe side effects being reported. Murphy says the documents were left by journalists after they interviewed his mother in the 1980s. By Michael Mezher

Primodos victims demand apology and compensation