Isabel Gal

Last updated
Dr

Isabel Gal
Born1925
Died2017
London
NationalityHungarian
CitizenshipUnited Kingdom
EducationUniversity of Edinburgh Medical School
Alma materUniversity of Budapest
Known forPaediatrician known for establishing the link between hormonal pregnancy tests and severe birth defects.

Isabel Gal (1925 - 2017), was a Jewish Hungarian paediatrician who was responsible for highlighting the link between use of the hormonal pregnancy test Primodos and severe birth defects.

Contents

Early life and education

Born in Hungary in 1926, [1] Isabel was the daughter of Geza Gunsberger, a merchant from Papa, Hungary, and Irma Hacker, from Austria. Gunsberger worked first for a timber merchant and later founded a lingerie company. During the Holocaust, Gunsberger was deported to Auschwitz concentration camp. He later died in Buchenwald concentration camp. Isabel, along with her mother and sisters, Erica and Lia, were sent to Auschwitz concentration camp, all four survived the war. [1] After the war, Isabel returned to Hungary and studied medicine at the University of Budapest. Qualifying as a doctor, she worked as a paediatrician at Bokay children's hospital in Budapest. [2]

In 1953, she married Endre Gal, a mathematician, whose father was a timber merchant who Isabel's father had previously worked for, and in 1956 the couple's daughter Katinka was born. [1] Later in 1956, with the Hungarian Revolution underway, the family left Hungary together with Isabel's mother Irma, and fled through Austria to England where Erica had settled after the war. [1]

Career

In the UK, Gal retrained as a doctor at University of Edinburgh Medical School and her husband taught mathematics at Imperial College London. [2] After re-qualifying Gal worked as a paediatrician at Great Ormond Street Hospital in London, and Queen Mary’s Hospital for Children in Surrey, [3] and as a clinical lecturer at the Institute of Obstetrics and Genealogy, at Imperial College London. [4] Throughout her career Gal published extensively on pregnancy tests, oral contraceptives and vitamin A.

Primodos

In 1967, while working at Queen Mary's Hospital for Children, Gal published an article in the journal Nature, highlighting a potential link between the hormone-based pregnancy test Primodos, manufactured by German drug company Schering AG, and congenital birth malformations. Gal found that from a group of 100 women who had babies born with spina bifida, 19 had taken Primodos, whereas in a control group of 100 women with healthy babies, only four had used the drug. She hypothesised that the high dose of hormone in the pregnancy test, might have interfered with the foeto-placental unit. [3] In the article, Gal also noted that the pregnancy test used the same components as oral contraceptive pills which might also constitute a similar risk. [3]

Gal took her findings to the Department of Health and the Committee on Safety of Medicines however neither Schering nor the UK government acted on her research. [5] [6] It was not until 1975, when further evidence emerged supporting her findings, that the Committee on Safety of Medicines issued a warning about use of the drug, [3] and it was 1978 before Schering withdrew the Primodos, by which time it had already been banned in several other countries. [7] One reason for this inaction was that the government did not want to discourage women from taking the newly available oral contraceptive pill. [8] In a 1997 book, [9] Bill Inman who had been Senior Medical Officer at the UK Department of Health and Social Security at the time and who corresponded with Gal about her findings, wrote:

On the one hand we had Dr. Gal's suspicion of a possible danger to the foetus and, on the other hand, a very real danger that publicity might cause a woman to stop using oral contraceptives or other preparations that were important in the treatment of a variety of gynaecological disorders. I was advised not to discuss these possibilities with anybody in case the idea that the HPT problem might have much wider repercussions inadvertently slipped out, though I can hardly believe that many people would not have thought of it themselves.

in 2017, Inman was found to have destroyed documents relating to the case. [5]

Gal believed that she was discriminated against and blacklisted for voicing her concerns about hormonal pregnancy tests and their potential link to the oral contraceptive pill. Her position Queen Mary's was terminated, she was unsuccessful in securing another senior post and eventually left the medical profession. [2] [3]

An Independent Medicines and Medical Devices Safety Review, led by Baroness Cumberlege, published in 2020, vindicated Gal's original research, finding that "avoidable harm" resulted from the use of Primodos, and concluding that the drug should have been withdrawn from use in 1967. [10] [11]

Later life and death

Later in life Gal lived with her husband Endre in Teddington, south west London. She died in 2017 at the age of 92.

Media

Thames Television produced a documentary titled The Primodos Affair in 1980, [12] and in 2020, Sky News produced a documentary titled Bitter Pill: Primodos, which highlighted Gal's role in identifying the dangers of the drug.

Related Research Articles

<span class="mw-page-title-main">Emergency contraception</span> Birth control measures taken after sexual intercourse

Emergency contraception (EC) is a birth control measure, used after sexual intercourse to prevent pregnancy.

<span class="mw-page-title-main">Combined oral contraceptive pill</span> Birth control method which is taken orally

The combined oral contraceptive pill (COCP), often referred to as the birth control pill or colloquially as "the pill", is a type of birth control that is designed to be taken orally by women. The pill contains two important hormones: a progestin and estrogen. When taken correctly, it alters the menstrual cycle to eliminate ovulation and prevent pregnancy.

<span class="mw-page-title-main">Levonorgestrel</span> Hormonal medication used for birth control

Levonorgestrel is a hormonal medication which is used in a number of birth control methods. It is combined with an estrogen to make combination birth control pills. As an emergency birth control, sold under the brand names Plan B One-Step and Julie, among others, it is useful within 72 hours of unprotected sex. The more time that has passed since sex, the less effective the medication becomes, and it does not work after pregnancy (implantation) has occurred. Levonorgestrel works by preventing ovulation or fertilization from occurring. It decreases the chances of pregnancy by 57 to 93%. In an intrauterine device (IUD), such as Mirena among others, it is effective for the long-term prevention of pregnancy. A levonorgestrel-releasing implant is also available in some countries.

<span class="mw-page-title-main">Contraceptive patch</span> Transdermal patch applied to prevent pregnancy

A contraceptive patch, also known as "the patch", is a transdermal patch applied to the skin that releases synthetic oestrogen and progestogen hormones to prevent pregnancy. They have been shown to be as effective as the combined oral contraceptive pill with perfect use, and the patch may be more effective in typical use.

Progestogen-only pills (POPs), colloquially known as "mini pills", are a type of oral contraceptive that contain synthetic progestogens (progestins) and do not contain estrogens. They are primarily used for the prevention of undesired pregnancy, although additional medical uses also exist.

<span class="mw-page-title-main">Drospirenone</span> Medication drug

Drospirenone is a progestin and antiandrogen medication which is used in birth control pills to prevent pregnancy and in menopausal hormone therapy, among other uses. It is available both alone under the brand name Slynd and in combination with an estrogen under the brand name Yasmin among others. The medication is an analog of the drug spironolactone. Drospirenone is taken by mouth.

<span class="mw-page-title-main">Norgestrel</span> Progestin medication used for birth control

Norgestrel is a progestin which is used in birth control pills sold under the brand name Ovral in combination with the estrogen ethinylestradiol and Opill by itself. It is also used in menopausal hormone therapy. It is taken by mouth.

<span class="mw-page-title-main">Hormonal contraception</span> Birth control methods that act on the endocrine system

Hormonal contraception refers to birth control methods that act on the endocrine system. Almost all methods are composed of steroid hormones, although in India one selective estrogen receptor modulator is marketed as a contraceptive. The original hormonal method—the combined oral contraceptive pill—was first marketed as a contraceptive in 1960. In the ensuing decades many other delivery methods have been developed, although the oral and injectable methods are by far the most popular. Hormonal contraception is highly effective: when taken on the prescribed schedule, users of steroid hormone methods experience pregnancy rates of less than 1% per year. Perfect-use pregnancy rates for most hormonal contraceptives are usually around the 0.3% rate or less. Currently available methods can only be used by women; the development of a male hormonal contraceptive is an active research area.

<span class="mw-page-title-main">Beginning of pregnancy controversy</span> Cultural-linguistic, not scientific question

Controversy over the beginning of pregnancy occurs in different contexts, particularly as it is discussed within the debate of abortion in the United States. Because an abortion is defined as ending an established pregnancy, rather than as destroying a fertilized egg, depending on when pregnancy is considered to begin, some methods of birth control as well as some methods of infertility treatment might be classified as causing abortions.

<span class="mw-page-title-main">Birth control</span> Method of preventing human pregnancy

Birth control, also known as contraception, anticonception, and fertility control, is the use of methods or devices to prevent unintended pregnancy. Birth control has been used since ancient times, but effective and safe methods of birth control only became available in the 20th century. Planning, making available, and using human birth control is called family planning. Some cultures limit or discourage access to birth control because they consider it to be morally, religiously, or politically undesirable.

<span class="mw-page-title-main">Norethisterone enanthate</span> Chemical compound

Norethisterone enanthate (NETE), also known as norethindrone enanthate, is a form of hormonal birth control which is used to prevent pregnancy in women. It is used both as a form of progestogen-only injectable birth control and in combined injectable birth control formulations. It may be used following childbirth, miscarriage, or abortion. The failure rate per year in preventing pregnancy for the progestogen-only formulation is 2 per 100 women. Each dose of this form lasts two months with only up to two doses typically recommended.

John Charles Rock was an American obstetrician and gynecologist. He is best known for the major role he played in the development of the first birth control pill.

<span class="mw-page-title-main">Drospirenone/ethinylestradiol/levomefolic acid</span> Pharmaceutical combination

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<span class="mw-page-title-main">Primodos</span> Hormone-based pregnancy test

Primodos was a hormone-based pregnancy test used in the 1960s and 1970s that consisted of two pills that contained norethisterone and ethinylestradiol. It detected pregnancy by inducing menstruation in women who were not pregnant. The presence or absence of menstrual bleeding was then used to determine whether the user was pregnant. In South Korea it was also used, "perhaps as a double dose" to induce abortions.

<span class="mw-page-title-main">Nomegestrol acetate/estradiol</span> Combination drug

Nomegestrol acetate/estradiol (NOMAC-E2), sold under the brand names Naemis and Zoely among others, is a fixed-dose combination medication of nomegestrol acetate, a progestogen, and estradiol, an estrogen, which is used in menopausal hormone therapy and as a birth control pill to prevent pregnancy in women. It is taken by mouth.

<span class="mw-page-title-main">Ethinylestradiol/etonogestrel</span> Pharmaceutical birth control combination

Ethinylestradiol/etonogestrel, sold under the brand names NuvaRing among others, is a hormonal vaginal ring used for birth control and to improve menstrual symptoms. It contains ethinylestradiol, an estrogen, and etonogestrel, a progestin. It is used by insertion into the vagina. Pregnancy occurs in about 0.3% of women with perfect use and 9% of women with typical use.

Drospirenone/estetrol, sold under the brand name Nextstellis, Drovelis, and Lydisilka, among others, is a fixed-dose combination medication containing drospirenone, a progestin, and estetrol, an estrogen, which is used as a combined birth control pill for the prevention of pregnancy in women. It is taken by mouth.

<span class="mw-page-title-main">Combined hormonal contraception</span> Form of hormonal contraception combining both an estrogen and a progestogen

Combined hormonal contraception (CHC), or combined birth control, is a form of hormonal contraception which combines both an estrogen and a progestogen in varying formulations.

The activated protein C resistance (APCR) test is a coagulation test used in the evaluation and diagnosis of activated protein C (APC) resistance, a form of hypercoagulability. Hereditary APC resistance is usually caused by the factor V Leiden mutation, whereas acquired APC resistance has been linked to antiphospholipid antibodies, pregnancy, and estrogen therapy. APC resistance can be measured using either an activated partial thromboplastin time (aPTT)-based test or an endogenous thrombin potential (ETP)-based test.

References

  1. 1 2 3 4 Montuschi, Mike (2018-03-13). "Isabel Gal obituary". The Guardian. ISSN   0261-3077 . Retrieved 2020-10-13.
  2. 1 2 3 Judah, Jacob (20 August 2020). "The Holocaust survivor 'blacklisted' for warning about 'birth defect' pill". The Jewish Chronicle. Retrieved 13 October 2020.
  3. 1 2 3 4 5 "Is this the forgotten thalidomide?". The Telegraph. 12 May 2014. Retrieved 2020-10-13.
  4. ↑ Doyle, C (1977-10-03). "Babies scare denied". The Observer.
  5. 1 2 "Primodos: Sky News exposes pregnancy drug cover-up". Sky News. Retrieved 2020-10-14.
  6. ↑ Connor, Laura (2020-08-23). "Heartbreaking tragedy of brave medic who discovered Primodos birth defect link". mirror. Retrieved 2020-10-14.
  7. ↑ "Primodos was a revolutionary oral pregnancy test. But was it safe? | Jesse Olszynko-Gryn". the Guardian. 2016-10-13. Retrieved 2020-10-14.
  8. ↑ Olszynko-Gryn, Jesse; Bjørvik, Eira; Weßel, Merle; Jülich, Solveig; Jean, Cyrille (2018-10-23). "A historical argument for regulatory failure in the case of Primodos and other hormone pregnancy tests". Reproductive Biomedicine & Society Online. 6: 34–44. doi:10.1016/j.rbms.2018.09.003. ISSN   2405-6618. PMC   6234516 . PMID   30456319.
  9. ↑ Inman, W. H. W. (William Howard Wallace), 1929- (1999). Don't tell the patient : behind the drug safety net (1st ed.). Los Angeles, Calif.: Highland Park Productions. ISBN   0-9675812-0-6. OCLC   43822542.{{cite book}}: CS1 maint: multiple names: authors list (link) CS1 maint: numeric names: authors list (link)
  10. ↑ "First Do No Harm: Independent Medicines and Medical Devices Safety Review" (PDF). 2020.
  11. ↑ "Government should consider 'redress' for victims of Primodos pregnancy test drug, Theresa May says". The Independent. 2020-08-23. Retrieved 2020-10-14.
  12. ↑ "The Primodos Affair (1980)". BFI. Archived from the original on December 25, 2017. Retrieved 2020-10-14.
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