meImagine having to make this decision: Your health care provider recommends that you take a specific drug for a disease or condition, but then tells you that it hasn’t been tested on people like you. Do you take the medication or refuse it?
This is the position the 3.5 million women who give birth each year in the US are in when they are counseled about taking medication.
Pregnant people have the same diseases as others, including depression, diabetes, high blood pressure, cancer and HIV. And pregnancy can cause serious conditions that require the use of medication. Up to 90% of pregnant people take one or more medications during pregnancy, or were taking some type of medication when they became pregnant.
However, the doctors who treat them almost always have to tell them that there is no information about the safety and effectiveness of these drugs for pregnant women and their fetuses. Human pregnancy data were only available for 11% of FDA-approved drugs between 2010 and 2019. Without data, a doctor cannot be sure whether to increase or decrease the dose of ‘a drug to achieve the desired results, or evaluate it. if the risk to the pregnant person and the developing baby would be greater if the mother’s condition is not treated, since pregnancy alters the body in many ways, including doubling blood volume and changing the way it metabolizes the drugs
This information gap about the risks to pregnant women and their children has frustrated doctors for years. Decades ago, medical dilemmas of this kind practically arose all women, because most clinical research at the time was limited to men. Focused attention on this problem in the 1990s led to congressional legislation and changes in Food and Drug Administration and National Institutes of Health policies that promoted women’s health through their greater participation in clinical research. But the situation of the subset of people who are pregnant remains unchanged.
A report released this month by a committee of the National Academies of Sciences, Engineering and Medicine, on which we served, offers a way forward.
Pregnant people understandably worry that the medications they take may harm their fetuses. Faced with uncertainty, many decide not to take a medicine, or stop taking it. This choice can have serious consequences for your well-being and even for the maintenance of the pregnancy. Others choose to take the drug, exposing themselves or their unborn children to uncertain risks of harm and no guarantee of benefit.
Some pregnant people experience both horns of this dilemma. Our committee heard from a woman who was advised during her first and second pregnancy to stop taking all the medicines she had been taking to control her rheumatoid arthritis. When her condition flared during her second pregnancy, her doctors told her the inflammation was more dangerous to her fetus than restarting the medication, which she did. Not surprisingly, he found that a very uncomfortable and difficult decision to make due to limited safety data.
The usual explanation for excluding pregnant people from research is that pharmaceutical companies and other sponsors of clinical trials, and the research institutions and professionals who conduct them, fear being legally liable for harming pregnant participants or their fetuses or children. Our panel found these perceptions of legal risk to be misplaced. In the past 60 years, over 1,000 legal cases related to the post-marketing use of medical products in pregnancy have been reported, but no legal cases have been reported arising from the use of investigational medical products by pregnant research participants.
Excluding pregnant women from research does not prevent harm to them and their children, and in fact increases this Instead of producing data from carefully designed studies with small numbers of consenting volunteers and closely monitored, excluding pregnant people from clinical trials creates a large experiment for the use of a product by people who are pregnant population
The use of the medication by pregnant people once it is on the market will not provide clinically useful information about the dosage, efficacy and safety of the products. In addition, data are not systematically collected on the outcomes experienced by this population who decide to take a recommended treatment or not.
Exclusion of pregnant people from research extends to pregnancy-specific illnesses. In the past two decades, the FDA has approved only one new drug for obstetric conditions that remains on the market today. The harms experienced by pregnant women and their fetuses are not often attributed, as they should be, to the near total failure to develop and test treatments for this population.
A lot of attitudinal change about clinical research will have to happen if pregnant people are to have access to the medicines they need and adequate evidence to make informed decisions with their doctors that the rest of us take for granted.
Our committee recommends that FDA expedite this process by making clear that it expects pregnant women to be included as soon as possible in studies conducted for the approval of any medical product expected to be used by these patients.
Congress should also pass legislation, similar to its 2003 legislation designed to incentivize research on pediatric drugs, to give the FDA the authority to require data on dosage, administration, safety and effectiveness of new medical products from research involving pregnant people, as well as from post-marketing studies of existing products. To overcome challenges in implementing these changes, our committee recommends that Congress authorize programs to extend the time that companies maintain a drug’s sole license or offer tax breaks when they quickly complete studies with pregnant participants and send the data to the FDA. to include them on product labels.
As others have argued for the past three decades, the time has come to stop treating pregnant people as a vulnerable group in need of protection. from investigate and, instead, protect them and their offspring Through research
Alexander M. Capron is University Professor Emeritus at the University of Southern California and was the first Director of the World Health Organization’s Department of Ethics, Trade, Human Rights and Health Law. Anna Mastroianni is Research Professor of Bioethics and Law at the Johns Hopkins Berman Institute of Bioethics and Charles I. Stone Professor Emeritus at the University of Washington School of Law. She was director of studies for the Institute of Medicine’s Committee on Legal and Ethical Issues Related to the Inclusion of Women in Clinical Research and co-editor of its Report 1994. Both are members of the National Academies of Sciences, Engineering, and Medicines Committee on the Development of a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons, which published its report on April 10, 2024.
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