Primodos – The Secret Drugs Scandal. Congratulations to Jason Farrell and Sky TV – Why there should be a full Public Inquiry


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Primodos – The Secret Drugs Scandal. Congratulations to Jason Farrell and Sky TV

This evening (March 21st) a brilliant Sky TV documentary, Primados The Secret Drugs Scandal, is being broadcast by Sky TV. Congratulations to Jason Farrell and the team that put this forensic examination together. Sky News state that “in January 1975 the British regulator warned manufacturers Schering of a five-to-one risk that the drug could cause malformations.”  It is alleged that collusion between the medical establishment and the drug company led to the failure to warn the public about the dangers involved.

http://news.sky.com/video/primodos-the-secret-drug-scandal-10801048

The Government now needs to tell us when they first became aware that no toxicology or testing had been undertaken before the licensing of the drug Primodos; whether they have examined the alleged collusion of the pharmaceutical company who manufactured Primodos and the regulatory bodies; why the regulator alerted the drug company to a 1 in 5 risk of abnormality occurring in an unborn child, but not the public; when they first learnt that Primodos was being used in some parts of the world as an abortafacient while being sold in the UK fir pregnancy testing. and what Government what funding is being provided to research scientists in Cambridge examining   the composition of the drug Primodos and its likely affects on the child in the womb.

I have today called for a full Public Inquiry to be established  and also tabled the following questions :

Lord Alton of Liverpool

To ask HMG, in the light of the scientific review of the regulation of the drug Primodos to be undertaken by the Medicines and Healthcare products Regulatory Agency, what progress has been made on the inquiry into the drug which was established in 2014; whether they have determined when regulators first became aware that (1) no toxicology or testing had been undertaken prior to the licensing of that drug, and (2) Primodos was being used in some parts of the world as an abortifacient whilst being sold in the UK for pregnancy testing; whether they have examined alleged collusion between the drug manufacturer and the regulatory bodies; and what assessment they have made of the decision of the regulator to alert the drug manufacturer of the risks associated with the drug but not the public.

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In 2010 I pressed the Government about this scandal – and these were their replies:

Asked by: Alton of Liverpool, Lord | Party: Crossbench

To ask Her Majesty’s Government what assessment they have made of the safety of the drug Primolut; and whether the licence for its sale has been reviewed.

Answering member: Howe, Earl | Party: Conservative Party

Primodos first became available in the United Kingdom in 1959 and was discontinued in 1978. Primodos was used as a hormonal pregnancy test and for the treatment of various gynaecological complaints. The licensed dose of Primodos as a pregnancy test was one tablet on each of two consecutive days. Each Primodos tablet contained two sex hormones, a progestogen (norethisterone acetate, 10 milligrams) and an oestrogen (ethinylestradiol, 0.02 milligrams). No licensed medicines currently available in the UK contain norethisterone acetate and ethinylestradiol at the same doses as Primodos. The Medicines and Healthcare products Regulatory Agency (MHRA) has no information on the number of children who were born with disabilities to mothers who took Primodos during pregnancy. A total of three reports of suspected adverse drug reactions (ADRs) in association with Primodos (spina bifida, cleft palate, congenital abnormality and pre-eclampsia) via the UK’s Yellow Card Scheme are on the MHRA database. None of these cases reported the dose that was administered to the patient. As of 13 October 2010 the MHRA had received a total of 32 UK spontaneous ““suspected”” ADR reports associated with the combination of the drug ingredients norethisterone and ethinylestradiol (other than Primodos) which describe a congenital abnormality. These reports were received over a period of 45 years. The former Committee on Safety of Medicines (CSM) advised on the safety of a number of hormonal preparations, including Primodos in 1975 and 1977. The CSM letters and the minutes from the CSM meeting have been placed in the Library. The advice of the CSM was that these hormonal preparations should not be indicated for, or promoted as, a pregnancy test; that a warning about a possible hazard in pregnancy should be inserted in all promotional literature; and that pregnant women should not use these products. In the absence of any significant new scientific evidence that has become available since Primodos was discontinued, a meeting such as that suggested would be unlikely to benefit any of those concerned. Local clinicians and multidisciplinary teams assess the health and care needs of people who consider that they have been adversely affected by Primodos or other hormonal pregnancy tests. The MHRA therefore has no current plans to meet members of the Association for Children Damaged by Hormone Pregnancy Tests, people suspected to have been adversely affected by the drug Primodos, or with the pharmaceutical company, Bayer. A large number of medicines currently available in the UK contain norethisterone and ethinylestradiol. These are licensed for hormone replacement therapy, contraception, various gynaecological conditions and in the treatment of some cancers. When used for oral contraception the doses of norethisterone and ethinylestradiol are lower than Primodos. Norethisterone is also currently available as progestogen-only contraception. In common with all licensed medicines, warnings relating to potential side effects of medicines that contain norethisterone and ethinylestradiol are provided in the patient information leaflet that accompanies each medicine, including information about use in pregnancy. All medicines on the UK market are continuously monitored to ensure the benefits outweigh the risks. Primolut N is one of the norethisterone-containing medicines currently available in the UK. Primolut N tablets are licensed for use in a range of gynaecological conditions and contain five milligrams of norethisterone, a progestogenic sex hormone. Advice and warnings relating to potential side effects of Primolut N are provided in the summary of product characteristics for health care professionals, and the patient information leaflet that accompanies each packet of medicine. As with all medicines used in the UK, the MHRA, together with advice from an independent advisory body, the Commission on Human Medicines keeps the safety of Primolut N under continuous review. The MHRA is not aware of any current safety issues with Primolut N.

26 Oct 2010 | Written questions | Answered | House of Lords | 2593 | 721 c264-6WA

Date answered: 26 Oct 2010

Subject: Licensing; Safety; Primolut N

show related items (1)

Asked by: Alton of Liverpool, Lord | Party: Crossbench

To ask Her Majesty’s Government whether they will meet with members of the Association for Children Damaged by Hormone Pregnancy Tests, people adversely affected by the drug Primodos, and with the pharmaceutical company, Bayer, to discuss the consequences for people adversely affected by the drug Primodos.

Answering member: Howe, Earl | Party: Conservative Party

Primodos first became available in the United Kingdom in 1959 and was discontinued in 1978. Primodos was used as a hormonal pregnancy test and for the treatment of various gynaecological complaints. The licensed dose of Primodos as a pregnancy test was one tablet on each of two consecutive days. Each Primodos tablet contained two sex hormones, a progestogen (norethisterone acetate, 10 milligrams) and an oestrogen (ethinylestradiol, 0.02 milligrams). No licensed medicines currently available in the UK contain norethisterone acetate and ethinylestradiol at the same doses as Primodos. The Medicines and Healthcare products Regulatory Agency (MHRA) has no information on the number of children who were born with disabilities to mothers who took Primodos during pregnancy. A total of three reports of suspected adverse drug reactions (ADRs) in association with Primodos (spina bifida, cleft palate, congenital abnormality and pre-eclampsia) via the UK’s Yellow Card Scheme are on the MHRA database. None of these cases reported the dose that was administered to the patient. As of 13 October 2010 the MHRA had received a total of 32 UK spontaneous ““suspected”” ADR reports associated with the combination of the drug ingredients norethisterone and ethinylestradiol (other than Primodos) which describe a congenital abnormality. These reports were received over a period of 45 years. The former Committee on Safety of Medicines (CSM) advised on the safety of a number of hormonal preparations, including Primodos in 1975 and 1977. The CSM letters and the minutes from the CSM meeting have been placed in the Library. The advice of the CSM was that these hormonal preparations should not be indicated for, or promoted as, a pregnancy test; that a warning about a possible hazard in pregnancy should be inserted in all promotional literature; and that pregnant women should not use these products. In the absence of any significant new scientific evidence that has become available since Primodos was discontinued, a meeting such as that suggested would be unlikely to benefit any of those concerned. Local clinicians and multidisciplinary teams assess the health and care needs of people who consider that they have been adversely affected by Primodos or other hormonal pregnancy tests. The MHRA therefore has no current plans to meet members of the Association for Children Damaged by Hormone Pregnancy Tests, people suspected to have been adversely affected by the drug Primodos, or with the pharmaceutical company, Bayer. A large number of medicines currently available in the UK contain norethisterone and ethinylestradiol. These are licensed for hormone replacement therapy, contraception, various gynaecological conditions and in the treatment of some cancers. When used for oral contraception the doses of norethisterone and ethinylestradiol are lower than Primodos. Norethisterone is also currently available as progestogen-only contraception. In common with all licensed medicines, warnings relating to potential side effects of medicines that contain norethisterone and ethinylestradiol are provided in the patient information leaflet that accompanies each medicine, including information about use in pregnancy. All medicines on the UK market are continuously monitored to ensure the benefits outweigh the risks. Primolut N is one of the norethisterone-containing medicines currently available in the UK. Primolut N tablets are licensed for use in a range of gynaecological conditions and contain five milligrams of norethisterone, a progestogenic sex hormone. Advice and warnings relating to potential side effects of Primolut N are provided in the summary of product characteristics for health care professionals, and the patient information leaflet that accompanies each packet of medicine. As with all medicines used in the UK, the MHRA, together with advice from an independent advisory body, the Commission on Human Medicines keeps the safety of Primolut N under continuous review. The MHRA is not aware of any current safety issues with Primolut N.

26 Oct 2010 | Written questions | Answered | House of Lords | 2592 | 721 c264-6WA

Date answered: 26 Oct 2010

Subject: Congenital abnormalities; Side effects; Primodos

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Asked by: Alton of Liverpool, Lord | Party: Crossbench

To ask Her Majesty’s Government which drugs currently available in the United Kingdom contain Norethisterone and Ethinylostradiol; what are the known disabilities which have occurred in the children of users of drugs containing these constituents; and whether any warnings are given to those who take them.

Answering member: Howe, Earl | Party: Conservative Party

Primodos first became available in the United Kingdom in 1959 and was discontinued in 1978. Primodos was used as a hormonal pregnancy test and for the treatment of various gynaecological complaints. The licensed dose of Primodos as a pregnancy test was one tablet on each of two consecutive days. Each Primodos tablet contained two sex hormones, a progestogen (norethisterone acetate, 10 milligrams) and an oestrogen (ethinylestradiol, 0.02 milligrams). No licensed medicines currently available in the UK contain norethisterone acetate and ethinylestradiol at the same doses as Primodos. The Medicines and Healthcare products Regulatory Agency (MHRA) has no information on the number of children who were born with disabilities to mothers who took Primodos during pregnancy. A total of three reports of suspected adverse drug reactions (ADRs) in association with Primodos (spina bifida, cleft palate, congenital abnormality and pre-eclampsia) via the UK’s Yellow Card Scheme are on the MHRA database. None of these cases reported the dose that was administered to the patient. As of 13 October 2010 the MHRA had received a total of 32 UK spontaneous ““suspected”” ADR reports associated with the combination of the drug ingredients norethisterone and ethinylestradiol (other than Primodos) which describe a congenital abnormality. These reports were received over a period of 45 years. The former Committee on Safety of Medicines (CSM) advised on the safety of a number of hormonal preparations, including Primodos in 1975 and 1977. The CSM letters and the minutes from the CSM meeting have been placed in the Library. The advice of the CSM was that these hormonal preparations should not be indicated for, or promoted as, a pregnancy test; that a warning about a possible hazard in pregnancy should be inserted in all promotional literature; and that pregnant women should not use these products. In the absence of any significant new scientific evidence that has become available since Primodos was discontinued, a meeting such as that suggested would be unlikely to benefit any of those concerned. Local clinicians and multidisciplinary teams assess the health and care needs of people who consider that they have been adversely affected by Primodos or other hormonal pregnancy tests. The MHRA therefore has no current plans to meet members of the Association for Children Damaged by Hormone Pregnancy Tests, people suspected to have been adversely affected by the drug Primodos, or with the pharmaceutical company, Bayer. A large number of medicines currently available in the UK contain norethisterone and ethinylestradiol. These are licensed for hormone replacement therapy, contraception, various gynaecological conditions and in the treatment of some cancers. When used for oral contraception the doses of norethisterone and ethinylestradiol are lower than Primodos. Norethisterone is also currently available as progestogen-only contraception. In common with all licensed medicines, warnings relating to potential side effects of medicines that contain norethisterone and ethinylestradiol are provided in the patient information leaflet that accompanies each medicine, including information about use in pregnancy. All medicines on the UK market are continuously monitored to ensure the benefits outweigh the risks. Primolut N is one of the norethisterone-containing medicines currently available in the UK. Primolut N tablets are licensed for use in a range of gynaecological conditions and contain five milligrams of norethisterone, a progestogenic sex hormone. Advice and warnings relating to potential side effects of Primolut N are provided in the summary of product characteristics for health care professionals, and the patient information leaflet that accompanies each packet of medicine. As with all medicines used in the UK, the MHRA, together with advice from an independent advisory body, the Commission on Human Medicines keeps the safety of Primolut N under continuous review. The MHRA is not aware of any current safety issues with Primolut N.

26 Oct 2010 | Written questions | Answered | House of Lords | 2591 | 721 c264-6WA

Date answered: 26 Oct 2010

Subject: Congenital abnormalities; Drugs; Warnings; Side effects; Ethinylestradiol; Norethisterone

show related items (1)

Asked by: Alton of Liverpool, Lord | Party: Crossbench

To ask Her Majesty’s Government whether they have produced any data concerning the dosage of Norethisterone and Ethinylostradiol contained in the drug Primodos compared with the dosage given to patients.

Answering member: Howe, Earl | Party: Conservative Party

Primodos first became available in the United Kingdom in 1959 and was discontinued in 1978. Primodos was used as a hormonal pregnancy test and for the treatment of various gynaecological complaints. The licensed dose of Primodos as a pregnancy test was one tablet on each of two consecutive days. Each Primodos tablet contained two sex hormones, a progestogen (norethisterone acetate, 10 milligrams) and an oestrogen (ethinylestradiol, 0.02 milligrams). No licensed medicines currently available in the UK contain norethisterone acetate and ethinylestradiol at the same doses as Primodos. The Medicines and Healthcare products Regulatory Agency (MHRA) has no information on the number of children who were born with disabilities to mothers who took Primodos during pregnancy. A total of three reports of suspected adverse drug reactions (ADRs) in association with Primodos (spina bifida, cleft palate, congenital abnormality and pre-eclampsia) via the UK’s Yellow Card Scheme are on the MHRA database. None of these cases reported the dose that was administered to the patient. As of 13 October 2010 the MHRA had received a total of 32 UK spontaneous ““suspected”” ADR reports associated with the combination of the drug ingredients norethisterone and ethinylestradiol (other than Primodos) which describe a congenital abnormality. These reports were received over a period of 45 years. The former Committee on Safety of Medicines (CSM) advised on the safety of a number of hormonal preparations, including Primodos in 1975 and 1977. The CSM letters and the minutes from the CSM meeting have been placed in the Library. The advice of the CSM was that these hormonal preparations should not be indicated for, or promoted as, a pregnancy test; that a warning about a possible hazard in pregnancy should be inserted in all promotional literature; and that pregnant women should not use these products. In the absence of any significant new scientific evidence that has become available since Primodos was discontinued, a meeting such as that suggested would be unlikely to benefit any of those concerned. Local clinicians and multidisciplinary teams assess the health and care needs of people who consider that they have been adversely affected by Primodos or other hormonal pregnancy tests. The MHRA therefore has no current plans to meet members of the Association for Children Damaged by Hormone Pregnancy Tests, people suspected to have been adversely affected by the drug Primodos, or with the pharmaceutical company, Bayer. A large number of medicines currently available in the UK contain norethisterone and ethinylestradiol. These are licensed for hormone replacement therapy, contraception, various gynaecological conditions and in the treatment of some cancers. When used for oral contraception the doses of norethisterone and ethinylestradiol are lower than Primodos. Norethisterone is also currently available as progestogen-only contraception. In common with all licensed medicines, warnings relating to potential side effects of medicines that contain norethisterone and ethinylestradiol are provided in the patient information leaflet that accompanies each medicine, including information about use in pregnancy. All medicines on the UK market are continuously monitored to ensure the benefits outweigh the risks. Primolut N is one of the norethisterone-containing medicines currently available in the UK. Primolut N tablets are licensed for use in a range of gynaecological conditions and contain five milligrams of norethisterone, a progestogenic sex hormone. Advice and warnings relating to potential side effects of Primolut N are provided in the summary of product characteristics for health care professionals, and the patient information leaflet that accompanies each packet of medicine. As with all medicines used in the UK, the MHRA, together with advice from an independent advisory body, the Commission on Human Medicines keeps the safety of Primolut N under continuous review. The MHRA is not aware of any current safety issues with Primolut N.

26 Oct 2010 | Written questions | Answered | House of Lords | 2589 | 721 c264-6WA

The only way to establish why public safety was compromised and why there was a total failure of the regulatory framework is to establish a Public Inquiry under the chairmanship of a senior judicial figure.

 Also see

And

Medicines and Healthcare Products Regulatory Agency Consultation:

 The Medicines and Healthcare Products Regulatory Agency launched a consultation, ‘Hormonal Pregnancy Tests: Call for Evidence’ on Hormonal pregnancy tests on 25 March 2015 which closed on 30 June 2015. The consultation website states “we are analysing your feedback” and “visit this page again soon to download the outcome to this public feedback”. The press release, ‘Medicines Regulator Launches Call for Evidence on Previously Licensed Oral Hormonal Pregnancy Tests’ 25 March 2015 provides further information.