BWhen she was pregnant with her second child, Busisiwe Beko was HIV positive, but that didn’t worry her. She had been taking antiretroviral drugs for years and, as an experienced AIDS activist in South Africa, she knew that if she continued to take her daily pills, her second baby would be just as free from infection.

But another disease was lurking in Beko’s lungs: tuberculosis (TB) was hiding behind the usual pregnancy symptoms. The disease turned her pregnancy into a nightmare.

At the clinic she attended in the township of Khayelitsha in the Western Cape, she was given medication when nurses discovered she had tuberculosis. But it didn’t help. Then, in the fifth month of her pregnancy, she was diagnosed with drug-resistant tuberculosis (DR-TB).

Beko became increasingly ill. “I wasn’t sure if I would make it,” she says.

She was finally hospitalized after seven months of pregnancy. But because there are few treatments that are safe for pregnant women, she only started taking medication after giving birth – a brutal 24-month course of drugs. Her son was born with DR-TB.

Worldwide, approximately 500,000 people are diagnosed with DR-TB each year, which is already difficult to treat without the additional complication of pregnancy. In fact, there is still no recommended treatment for DR-TB in pregnant women.

Pregnant women have been excluded from drug trials, meaning doctors cannot rely on high-quality data from clinical trials. Instead, they must rely on less convincing evidence, such as anecdotal reports, analyses of patient records and data from animal studies, or studies in which women were allowed to continue participating after an unplanned pregnancy.

The result is that pregnant women do not benefit from the shorter, gentler and more effective tuberculosis treatments that have been developed over the years.

In some countries, women also often face discrimination and inadequate care from cautious health professionals. Some have been called “stupid” for becoming pregnant or even pressured to have an abortion because “we don’t know what you are going to give birth to,” according to a 2019 study in South Africa’s KwaZulu-Natal province.

This is not only the case with tuberculosis drugs. Less than 1.5 percent of drug trials conducted between 1960 and 2013 included pregnant women. A major reason for this is fears of potential risks to the fetus. The Contergan scandal of the 1960s – in which a drug used to treat morning sickness resulted in more than 10,000 children being born with severe birth defects – contributed to researchers’ reluctance.

Since her experience, 49-year-old Beko has been fighting for change and there are signs that this attempt is working.

In May, the World Health Organization’s first working group on tuberculosis during pregnancy held its inaugural meeting. The group is made up of scientists, researchers and activists, including Beko, whose son Othandwayo is now a healthy 18-year-old.

“Being pregnant does not mean that you cannot make good choices for yourself,” says Beko, who works for the South African organisation TB Proof. “Pregnant and breastfeeding women deserve quality health care just as much as anyone else.”

The results of the first tuberculosis studies, which included pregnant women from the outset, are now being evaluated. This is the Beat TB study in South Africa, which, according to the WHO, is one of the 30 countries with the highest burden of the disease.

Pregnant women will also participate in two studies by the Smart4TB consortium that will examine the effectiveness of shorter treatment regimens. Smart4TB is a USAID-funded project led by the Johns Hopkins University TB Research Center, along with groups such as the Elizabeth Glaser Pediatric Aids Foundation and the Treatment Action Group.

The Prism-TB trial will begin in December or January, and the Breach-TB trials will begin later in 2025.

“It’s time for researchers to stop saying, ‘We don’t have data.’ The data is there in the communities, they need to start collecting it,” says Beko.

“Pregnant and breastfeeding women have clear options for HIV, a disease that only emerged in the 1980s,” she says. “Why is this not the case for tuberculosis, which has been around for much longer?”

Nicole Salazar-Austin, an assistant professor of pediatrics at Johns Hopkins University, says the world of tuberculosis has yet to catch up with advances in HIV. Early in the HIV epidemic, it was clear that doctors needed to give pregnant women drugs because more than half of babies born with the virus would die by age two.

“Babies are affected by TB, but they are not always infected,” she says. “The consequences are not particularly good; the children could be born prematurely or too small, and TB can also increase the risk of miscarriage.”

Including pregnant women in trials requires some adjustments, Salazar-Austin says. They need to pay special attention to changes in the mother or baby’s health, and dosing needs to be carefully determined.

Clinical trials are never completely free of risks, but Salazar-Austin believes that strictly controlled studies are the right place to examine the risks.

“These risks exist in any case. But without good information, the responsibility clearly lies with the pregnant women and their doctors.”