Robert F. Kennedy Jr. had a long love story with the science of junk food, and as a secretary of health and social services, he adopted it once again, the most cheeky to justify his false affirmations that vaccines cause autism. Last week, he brought another study in a strongly designed to a different fight. During a hearing of the senatorial committee, he cited a report That few scientists would recognize as science in order to justify an examination of the FDA security of the Miffepristone drug, which is used in the majority of abortions in the United States.
President Donald Trump had previously asked HHS to study the safety of the medication, and Kennedy stressed the hearing that the drug examination would be a priority for the FDA. The unusually high rate of undesirable events identified in the report, he noted, “says that at least, the label must be modified.” In other words, the senior American health official is ready to rework – based at least in part on a poorly designed report which has not suffered a scientific journal – official government advice on a widely used drug.
The report that Kennedy cited was published at the end of last month on the website of Center for ethics and public policyA Washington -based reflection group, DC, focused on “pushing the extreme progressive program while establishing a consensus for conservatives”, according to its website. The study authors, Jamie Bryan Hall, director of EPPC data analysis, and Ryan Anderson, the organization’s president, are not health experts, and none seems to have a record for publication of scientific research through peers. Their methods deviated wildly from what is standard in the world of health research, and therefore, as you would expect dozens of trials Directed worldwide over the decades, the EPPC report has determined that mifepristone is a danger to women.
The EPPC wrote that its report “presents a meticulous and conservative evaluation of the safety of the abortion pills”. However, the study lacks basic transparency on how this evaluation was carried out. The authors relied on the data of an insurance database which, according to the report, included more than 800,000 Miffepristone abortions from 2017 to 2023. But the authors do not really say what database they used, so “there is no way to try to recreate their analysis to see if they receive the same results”, ” Sara ReddFrom the Center for Reproductive Health Research in the south-east of the Rollins School of Public Health of Emory University, told me. (In an e-mail, Hunter Estes, director of communications of EPPC, told me that the center contract with their data supplier prevents the EPPC from sharing the name of the database or even the seller. But, it added: “These insurance data is available from a dozen data brokers and are widely used by researchers and health professionals.”)
The report also took particular methodological measures to achieve its conclusions. One of its main conclusions is that more than 10% of people who take mifepristone feel what the study calls for “serious adverse events”. (A variety of studies Put the rate of significant adverse events of medical abortions involving mifepristone less than 0.3%, which makes the medication safer that Tylenol and Viagra.) But the unusually extended criteria of the EPPC study to define these events raise many questions. The researchers counted the extra-uterine pregnancy as an adverse event, arguing that doctors should have excluded it before prescribing mifepristone. (The American College of Obstetricians and Gynecologists acknowledges that mifepristone can be dangerous in the event of an extra-uterine pregnancy but said The fact that the screen of the rare state – a process that implies ultrasound – is not necessary for most women taking the medication.) The authors counted episodes in which surgical procedure was necessary to finish abortion after mifepristone – patients require additional treatment in approximately one in 20 cases, so that the FDA considers that it is a recognized result. They counted “other potentially deadly unwanted events”, including heart problems and mental health problems, which women in the study have experienced in the weeks that followed abortion – which has nothing to do with mifepristone.
They also counted “serious” events documented during emergency visits made within 45 days of a patient with mifepristone. However, the report does not fully explain how they knew that these events were linked to mifepristone, and to judge those who considered “serious”, they used a scale designed For cancer research, which has not been validated for use in abortion care studies. The wave counting of emergency visits could artificially inflate the estimate of the risk associated with obtaining an abortion, Upadhyay Upadhya, an epidemiologist and a reproductive health researcher at UC San Francisco, said to me: in a study She directed visits to emergency rooms linked to abortion from 2009 to 2013, half of the patients had such light symptoms as they needed treatment. She also said that the authors did not effectively distinguish between the results of the abortions and the false layers treated with mifepristone, or between normal quantities of post-avoort bleeding and severe hemorrhage.
In the weeks following the publication of the report, EPPC published two follow up documents With more details on the study methodology, which told me that experts are still not convincing. As the documents explain, the authors relied on diagnostic codes to separate false layers, which are often also treated with mifepristone, abortions – a practice that can yield imprecise results. The report only included suicidal and homicide ideas among the mental health diagnoses classified as serious adverse events, but that still does not prove that these diagnoses were linked to an abortion, said Redd. He used “only codes linked to hemorrhage or serious bleeding (according to the definition of the FDA)” – which would still not be enough to distinguish the normal quantity of post -imfepristone bleeding and something more serious, said Upadhyay.
According to the EPPC, the peer review of the report was not possible due to “an extensive pro-avoort bias in the peer review process”, but a group of scientists of data, analysts and engineers “carried out” the project, with the help of doctors. None of their names appear in the report. When I asked questions about this decision, the EPPC representative wrote: “It is routine for people with controversial opinions to be subject to a range of personal and professional attacks, including threats of violence at home.”
Until now, the most widespread attacks against the study concerned its substance. Alice MarkAn OB-GYN and the medical director of the National Abortion Federation, told me that “calling him a study worth it”. Some anti-abortion defenders also warned against the overestimation of the rigor of the study: earlier this month, Politico reported that Christina Francis, CEO of the American Association of Pro-Life Obgyns, said On a private zoom with anti-abortion leaders that, although the report contains credible data and should inspire additional research, it is “not a study in the traditional sense” and “an uncompromising proof of anything”.
Anti-abortion activists have long considered mifepristone as a problem. In the years following the decision of the Supreme Court in 2022 to overthrow the national right to abortion, the abortions increased in part due to a Decision of the FDA 2021 that allowed Miffepristone and misoprostol (a drug often used in parallel for abortion) are prescribed by Télésanté and posted. Depending on the reports of PoliticoQuestioning the safety of Mifepristone is part of a larger strategy Called “Rolling Thunder” which aims to cut this access. High quality data did not validate these questions, so second -rate searches have often been used to plead in the event of mifepristone. In 2023, for example, a federal judge judge that mifepristone should be withdrawn from the market by citing low -quality studies that have reported harmful effects of mifepristone. (The Supreme Court later Thrown On procedural reasons.) Because of their “lack of scientific rigor”, two of the studies cited were ultimately retracted by the newspaper that had published them.
When, in the past, the FDA has evaluated the security of Mifepristone – which it has done several times since the initial approval of Mifepristone, in 2000 – extended Access to mifepristone rather than reducing it. If the agency once again assesses mifepristone and its staff is authorized to assess science independently, the FDA could further loosen its rules for mifepristone, Elizabeth RaymondAn OB-GYN and a researcher specializing in the security of mifepristone, told me. Many data support using mifepristone later in pregnancy than what is currently approved, for example.
But Upadhyay told me that she worries that the chief of the FDA Marty Makary – who previously claimed That the fetus can “resist” the tools of abortion by 20 weeks of gestation – or Kennedy could put his thumb on the scale to restrict access to mifepristone, regardless of what FDA staff recommends. “I don’t want them to examine, because I don’t trust them to base the decisions they make on science,” said Upadhyay. (HHS and the FDA did not answer my questions on the FDA plans to examine the security of the Mifepristone on the basis of the EPPC report. In an email, an HHS spokesperson told me of the FDA, “the agency rigorously evaluates the latest scientific data, taking advantage of the Golden Standards Sciences to make informed decisions.”)
Although Kennedy said he reads scientific articles in a critical way To earn a living, his approach to medical literature is most like “an extreme version of what lawyers do to defend a client: create a story and then find supporting evidence”, ” Robert CaliffWho directed the FDA under the presidents Joe Biden and Barack Obama, told me an email. The scientific method implies the opposite: Building a hypothesis and trying to refute it with an open mind. When different people carrying out the same experience come to the same conclusion, it is not a sign of a shared ideology; It is a sign of a shared reality.