Pharma - Pregnant in spite of the pill

Pregnant despite the pill

Women's protest in Santiago: Abortion is forbidden, contraception is all the more important

Photo: Marcelo Hernandez / Getty Images

Belén * was 22 years old when she felt severe pain in the area of ​​the uterus in November, she thought it was the onset of menstruation. After a visit to the doctor, she knows: She is seven weeks pregnant. Even though she has been taking the pill for five years. At this point, Belén has plans. She already has one child and would like to emigrate with her boyfriend after completing their training to be a nurse. "For me, the diagnosis was terrible," she says.

Belén is one of at least 300 Chilean women who accidentally became pregnant because of the faulty pill “Anulette CD” from the German Grünenthal group. The preparations are manufactured by their Chilean production facilities Andrómaco SA and Silesia SA and distributed free of charge in public health centers. Having children is expensive in Chile, and the pandemic is making things all the more difficult. Since the 90s, the Chilean state has been using birth control pills as part of the national health program for family planning. Above all women from poor backgrounds take advantage of the opportunity. In 2020, at least 276.000 packs were distributed through this program. Including those with pills that didn't work. "I have been deprived of the right to choose my body freely," says Belén.

Abortion is prohibited in Chile. Only since 2017 has there been a law that allows termination in certain cases: in the event of rape, danger to the mother's life and fatal diseases of the fetus. Belén has regular contact with other victims: “There are many, even minors, who do not want to be mothers but are not allowed to have an abortion.” She has come to terms with the pregnancy.

The case of Belén and the other victims would not have been known without the feminist organization Miles Chile. The association became aware of the fact that certain production series of the "Anulette CD" were recalled on the website of the Institute for Public Health (ISP). The lawyer Laura Dragnic then went to look for those affected with colleagues. So far, they have been able to track down more than 300 women via Facebook and Instagram who accidentally became pregnant due to the production error. Young girls, students or women with high-risk pregnancies. "But there should be a lot more," says Dragnic. Not everyone has access to the internet.

“The 'Anulette CD' are birth control pills that have to be taken every day and throughout the menstrual cycle,” explains Ana Victoria Nieto, President of the Chilean Association of Biochemists and Pharmacists. “The women only take placebos for the last seven days. Precisely these were mixed up in the packaging. ”Individual pharmacists: inside noticed the error and reported it to the ISP as the responsible control body. This initially imposed a quarantine on all "Anulette CD" in the public sector. A week later, the ISP lifted this measure and only had the production series in question withdrawn from circulation. It was said that the manufacturing defect was visible from the outside to health workers.

Packaging error

"We were already overburdened by the corona pandemic, it is inexplicable why responsibility is given to the staff," said Nieto, criticizing this decision. "Since it was an error in the packaging that went unnoticed by the company, it was to be assumed that other production series also had similar errors," she adds.

"Production problems can occur," says Nieto, "but what is relevant is that the companies have to be aware of them and ensure that the users do not suffer any damage from ingestion." The company should have distributed notices and the products should have been recalled. That didn't happen. The company rejects responsibility. The source of the error was noticed and measures were taken. "Due to the fact that twelve defective packs were found, the deficiency was visible through the transparent blister film, the packs are handed out by medical specialists and oral contraceptives do not offer XNUMX% protection, it seems unlikely that unwanted pregnancies can be attributed to the production error" , said the press spokesman Florian Dieckmann. Dragnic criticizes that with such statements the risk falls back on women. “What I see here is a denial of a defect in one's own product. An error that has already been recognized and confirmed by the ISP. "

In February the ISP pronounced the maximum administrative fine against the pharmaceutical companies. They have to pay the equivalent of around 75.000 euros to the tax authorities. The state has not yet taken any further steps against the companies. "The punishment is ridiculous and does not help the victims," ​​says Dragnic. She represents the unwanted pregnant women and wants to fight for compensation. In their view, both the state and the company have failed to take responsibility for women and have deeply violated their reproductive rights and physical integrity. Miles Chile has also appealed to the UN and the Inter-American Commission on Human Rights (IAKMR) to have the Chilean state act. Laura Dragnic tells of a woman who developed psychological problems as a result of pregnancy and is at risk of suicide. Only a court ruling made it possible for the health service to investigate whether an abortion is possible in this case. “The fetus has now grown to such an extent that the woman refrains from performing the abortion,” says the lawyer. She emphasizes that even the court has confirmed the inefficiency of the public health service in its judgment.

How does Grünenthal react?

Just like Belén, the women now have to look after another child; some of them live in the deepest poverty. The pill was seen as a guarantee not to have a child at such a time. "The state and the company must make themselves responsible for this human fate," says Dragnic. In doing so, she is addressing appropriate financial compensation. “However, it is almost impossible to measure the extent of the individual damage in monetary terms.” Ana Nieto, from the biochemist and pharmacist association, sees Grünenthal's silence as an affront. "Why can't a transnational company take care of the victims of a production error?" Since, according to Nieto, the number of those affected is limited, it would not be a financial problem. “For centuries, we women were seen only as birthing machines. Today we have to fight to be recognized as human beings. This also means that in the event of mistakes - which can occur - everything humanly possible is done to help the victims ”.

In the meantime, the Chilean consumer association has sued the company in Chile for damages with the aim of paying for the financial costs of catering for the children. However, the association has not made any direct contact with those affected. Dragnic criticizes this approach. “It's about the recognition of the breach of sexual and reproductive human rights, not about consumer protection.” The association Miles Chile tries to clarify the real dimension of the case through arbitration procedures with the state and to ensure that such errors do not occur again.

Laura Dragnic also says: "Transnational companies use weaker regulations in countries in the global south to reduce production costs." For her, there is therefore no question that low fines and weak regulation are also used to save on the quality control of their products . “That is why we need international legislation that makes it possible to take legal action against such scandals.” Belén turns her gaze to Germany. For them it is incomprehensible that such a large company should make such a mistake. If she doesn't find her right in Chile, “the German state should put pressure on the company to take its responsibility and care for the victims,” she says.

Grünenthal is not a blank slate. The pharmaceutical company triggered one of the largest drug scandals in Germany. In October 1957 she brought the sleeping pill and sedative "Contergan" with the active ingredient thalidomide onto the market. When taken in the early stages of pregnancy, it could damage the growth development of the fetuses, and at the end of November 1961 it was withdrawn from the market. “Contergan” caused severe deformities in the arms and legs of around 10.000 children worldwide, around 5.000 of them in Germany alone. It was not until 2012 that Grünenthal apologized to those affected - for the long silence. In the same year the Grünenthal Foundation was established to support those affected by thalidomide. The company is still criticized today by those affected because they do not recognize "their own fault in the incident". Ana Nieto from the biochemist: internal and pharmacist: internal association sees a connection in the scandals. It is about a massive encroachment on the integrity of women, "whereby the company first ignores the dimension of the problem and belittles it". These are "lifelong consequences". The company seems to have learned little.

* The surname is known to the editors

Samina Stämpfli and Malte Seiwerth live and work as freelance journalists in Chile. Your text on the birth control pill scandal first appeared in the Swiss magazine The Lamb