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wattWhen Emma* decided to try for a baby, she began stopping some of the medications she was relying on to survive Ehlers-Danlos syndrome. The complex condition, which affects the connective tissue, left the 35-year-old patient without his bladder and forced to feed through a tube into his small intestine. but there are some drug She couldn’t leave safely without it. That’s when Emma realized no one could tell her for sure whether the drugs would harm her baby.
“The vast majority of the information out there is, ‘Just use it if there are no other options and no research has been done’. If I didn’t take the medication, I would end up in hospital, so I had no choice but to take it,” Emma said. The lack of information left her feeling “guilty and anxious”.
More than 90% of drugs have it Never tested during pregnancyleaving behind millions of female People around the world are making the impossible choice: go without treatment, or receive treatment without a doctor’s full assurance of its safety. This year, this is the biggest change in a generation—— The Thalidomide Scandal of the 1950s and 1960s – The World Health Organization (WHO) will start working with scientists, doctors and drug developers to change this.
This tragedy is the root cause of this situation. In the 1950s, a drug that had never been tested on pregnant women was used to treat morning sickness. At the time, scientists did not know that drugs could pass from mother to fetus across the placenta. It took years to realize that it was causing severe birth defects, including shortened or missing limbs.
The thalidomide scandal led to the creation of a drug safety monitoring system in the UK that still exists today, and the passage of the Medicines Act 1968. The law sets strict rules on how drugs must be tested before they are given to patients. But pregnant women—whose experiences led to the creation of these safety nets—are systematically excluded from trials. Mariana Widmer, a maternal health scientist at the World Health Organization, explains that this is not done out of malice, but out of fear.
“Since the thalidomide tragedy, people have been afraid to treat pregnant women,” Widmer said. “Pregnant women are also afraid to receive treatment.”
“No one organization or individual can make this change. This change is huge. It will take time,” she added. “We need cooperation, we need partnerships. That’s what we at the World Health Organization want to do…bringing all these actors together and working together to make this change is the only way to achieve this”.
While the fear of lifelong disability in the baby created an attitude that it was better not to take the risk, the risks of excluding pregnant women were ignored. They will have illnesses that require treatment just like everyone else. For now, it’s often up to midwives and doctors to have the difficult conversation with them — they may need drugs to keep them and their babies healthy, but they “need to know that this drug has never been tested in pregnant women,” Widmer said, meaning we can’t know for sure how well they work.
After fatal bleeding, the second most common category of maternal death globally is chronic disease, including heart disease, diabetes and epilepsy. “Pregnant women still die from otherwise preventable diseases,” she said.
Emma is very aware of this “Catch-22.” One of her medications, Nabilone, is a synthetic version of THC, a compound found in marijuana. She was taking the drug for persistent nausea and vomiting.
“In my possession [Nabilone]I was hospitalized every few weeks and required IVs and electrolyte replacement. So I thought it would be safer to keep going because we knew what would happen if I didn’t. It could be more dangerous.”
Due to the lack of randomized trials, much of the evidence regarding THC use Pregnant Emma was told the data came from recreational cannabis users, who were also more likely to smoke and drink alcohol – known risks to the fetus – which made the data “meaningless”.
Likewise, withdrawal from opioid painkillers could make her pain worse, putting her at risk of losing consciousness. Pregnantshe was told. “It’s a constant weighing of what’s more dangerous and what’s not more dangerous, and it’s really difficult to make that call,” she said.
The WHO team plans to develop a list of essential medicines for the most common chronic diseases. They will provide information to those testing the drug on how to safely include pregnant women in it. The next step is to incentivize drug developers to prioritize this work, in part by talking to regulators about fast-tracking drugs after testing.
Widmer explains that we are in a different situation now than we were some 70 years ago when thalidomide began to be used to treat morning sickness. Scientists have a better understanding of how to test drugs safely and thoroughly, and trials are tightly regulated.
“We have ways of knowing how to do this correctly to keep women and babies safe,” she said.
This involves testing the drug first in cells in petri dishes and animals, then in healthy, non-pregnant people, and then in non-pregnant people with health problems. “It’s a step-by-step approach. We’re not directly enrolling pregnant women in clinical trials,” Widmer said.
Drug trials are conducted in particularly controlled and closely monitored environments, so any problems are more likely to be detected than in the general population.
Dr Teesta Dey worked in the NHS for ten years and now works in global health consultancy, but it was becoming a new mother herself that decided she wanted to pursue this career.
When she was 15 months old and going through a complicated pregnancy, she was surprised to find it difficult to understand which medications she could and couldn’t take. Labels are unclear or contradictory. “It puts me in a real dilemma because I don’t know can I use it? Is it safe for me? Is it safe for my baby? It puts a huge burden on me as a mother to make this decision.”
When Dr Dey was speaking at a recent Birth Trauma Association conference chaired by Women’s Health Minister Baroness Gillian Mellen, she heard countless stories from women who didn’t know whether they could have treatment for conditions ranging from severe pregnancy reactions to heart disease. “So the reality is that people are taking the drug off-label,” which “puts that blame on the woman who made the choice,” and health care providers are forced to say, “I didn’t know.”
“We extrapolate this from men [and non-pregnant] Models have shown it’s safe and effective,” she said. “But we know pregnancy status is very different. Even your circulating blood volume increases by 40%. “On the other hand, testing all people who are likely to use the drug can give us more reliable information about how to safely treat patients.
“I think sometimes we’re very focused on the risks … but we never think about what’s the benefit here,” Dr. Day added. “It’s important to shift the way we think.”
A good example of this is what happened during the Covid-19 pandemic, when 75% of vaccine studies excluded pregnant and breastfeeding women, she said.
“We also know from the data that these women have the worst outcomes, the longest hospital stays, and the greatest burden of having the disease. But they didn’t include them in the study,” Dr. Day said. Because so many people were vaccinated in a short period of time – including those who may not have known they were pregnant – it quickly became apparent that the vaccine was indeed safe. But a lack of early information led to distrust.
“Widmer stressed that it’s not that I want all pregnant women to be involved regardless of their condition, but that when someone decides to develop a drug that could benefit women during pregnancy, one should start at “ground zero” and consider the potential effects on pregnant women.
Similar sea changes have occurred before in children’s medicine. Until about 20 years ago, children were often excluded from trials, and if they needed to take a drug, they were treated like small adults when it was administered – even though they were biologically different.
In 2007, the European Union passed a regulation requiring pharmaceutical companies to test their products on children if they want their products to be approved for use in children. Now, it’s a routine thing to do when it’s safe to do so. “This is something I wanted to do during my pregnancy,” Widmer said.
A WHO information toolkit for scientists and patients will be launched in the spring.
According to Dr. Day, it’s not just a matter of safety, but a matter of choice. She criticized the “paternalistic model that has broken down, with women being actively excluded and not even given the opportunity to participate in trials”.
She said pregnant women had the ability to understand the risks and decide for themselves whether to take part in a trial – something Emma said she would consider if given the opportunity.
Instead, Dr. Dey said, “we have taken away autonomy and control.”
*Name has been changed
This article is part of The Independent Rethinking global aid project