See American Psychiatric Association Request for Assistance
Dear Commissioner Makary,
On behalf of the American Psychiatric Association (APA), the largest medical specialty society representing more than 39,200 physicians who specialize in the treatment of mental illnesses, including substance use disorders, we appreciate the agency’s attention to maternal mental health. However, we are alarmed and concerned by the misinterpretations and unbalanced viewpoints shared by several of the panelists for the Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and Pregnancy panel on July 21st. This propagation of biased interpretations at a time when suicide is a leading cause of maternal death within the first postpartum year could seriously hinder maternal mental health care. The inaccurate interpretation of data, and the use of opinion, rather than the years of research on antidepressant medications, will exacerbate stigma and deter pregnant individuals from seeking necessary care.
Mood and anxiety disorders occur in one in five pregnancies, yet they remain largely undiagnosed, untreated, or undertreated. Suicide is a major cause of mortality for women in the perinatal period, accounting for 5–20% of maternal deaths.1 In 2023, APA released a perinatal mental health toolkit that includes a white paper and factsheets for patients and providers to ensure that informed and transparent care can be provided to individuals at this stage in life.2 The results of the literature review for the white paper show an association between unmanaged perinatal mental health problems and adverse outcomes for pregnant individuals and fetus/child, including increased morbidity and mortality.3 Research shows the risk to the mother and child from untreated mental health disorders may lead to harmful outcomes.4 This underscores the need for widespread and standardized screening practices with validated tools such as the Edinburgh Postnatal Depression Scale (EPDS), the Patient Health Questionnaire (PHQ-9), and the Generalized Anxiety Disorder-7 (GAD-7), and a greater commitment by the field to developing and implementing perinatal specific prevention and treatment initiatives.
The overall evidence suggests that individuals can and should take SSRIs prior to or during pregnancy, when they are clinically indicated for treatment. Moreover, recent meta-analyses have found no association between prenatal SSRI exposure and overall risk of birth defects.5 The analysis goes on to say that some concerns with specific SSRIs have emerged. These should be individually addressed between the patient and physician to partner in decision making ensuring the best outcomes for the patient and the fetus, as is the case for any drug. Physicians should also work closely with patients to assess the risks and benefits of psychopharmacotherapy and monitor for potential side effects, ensuring each patient receives individualized care. The American College of Obstetricians and Gynecologists (ACOG) Guidelines on Psychiatric Medication Use During Pregnancy and Lactation are widely used by physicians to treat perinatal and pregnant individuals, and it states, “Treatment with SSRIs or selective norepinephrine reuptake inhibitors during pregnancy should be individualized.”6 ACOGs guidelines also strongly recommend against withholding or discontinuing medications for mental health conditions due to pregnancy or lactation status alone.7 Psychiatric medications are safe, effective, and can be lifesaving if they are taken properly — as directed –under the care of an appropriately licensed healthcare professional.
The dissemination of inaccurate and unbalanced information by a federally sanctioned public panel has the potential to cause harm. It can undermine public confidence in mental health treatment, exacerbate stigma, and deter pregnant individuals from seeking necessary mental health care. We urge the FDA to review the composition and scientific rigor of its expert panels, particularly those influencing public health messaging. We also urge the FDA to re-evaluate the research that was presented to ensure that a true risk benefit analysis happens prior to any actions taken by the FDA.
The FDA has a duty to ensure that its public health guidance is rooted in science and transparency. As the largest organization worldwide for psychiatric physicians, we would like to partner with your agency to inform your policy decisions and to educate the public on the treatment of maternal mental health disorders. Many of our physician members have devoted their careers to exclusively taking care of women with maternal mental health conditions, often caring for thousands of patients a year, and are uniquely poised to provide you and your team accurate and balanced information. If we can be of further assistance, please contact Kristin Kroeger, Chief Advocacy, Policy, and Practice Advancement, at kkroeger@psych.org.
Sincerely,
Marketa Wills, MD, MBA, FAPA
CEO and Medical Director American Psychiatric Association
1 Davis, N. L., et al. (2019a). Pregnancy-Related Deaths: Data from 14 U.S. Maternal Mortality Review Committees, 2008- 2017. Atlanta, GA, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services
2 American Psychiatric Association, Perinatal Mental Health Toolkit, 2023, https://www.psychiatry.org/psychiatrists/practice/professional-interests/women-s-mental-health/maternal-mental-health-toolkit
3 Clarke DE, De Faria L, Alpert JE, The Perinatal Mental Health Advisory Panel, The Perinatal Mental Health Research Team. Perinatal Mental and Substance Use Disorder: White Paper. Washington, DC: American Psychiatric Association; 2023 [Available from: https://www.psychiatry.org/maternal].
4 Clarke DE, De Faria L, Alpert JE, The Perinatal Mental Health Advisory Panel, The Perinatal Mental Health Research Team. Perinatal Mental and Substance Use Disorder: White Paper. Washington, DC: American Psychiatric Association; 2023, page 49 [Available from: https://www.psychiatry.org/maternal].
5 Clarke DE, De Faria L, Alpert JE, The Perinatal Mental Health Advisory Panel, The Perinatal Mental Health Research Team. Perinatal Mental and Substance Use Disorder: White Paper. Washington, DC: American Psychiatric Association; 2023, page 49 [Available from: https://www.psychiatry.org/maternal].
6 American College of Obstetricians and Gynecologists Guidelines on Psychiatric Medication Use During Pregnancy and Lactation, 2008, Am Fam Physician. 2008;78(6):772-778, found at: https://www.aafp.org/pubs/afp/issues/2008/0915/p772.html
7 American College of Obstetricians and Gynecologists Guidelines on Psychiatric Medication Use During Pregnancy and Lactation, 2008, Am Fam Physician. 2008;78(6):772-778, found at: https://www.aafp.org/pubs/afp/issues/2008/0915/p772.html
See American Psychiatric Association Request for Assistance
annie says
Lame Ducks – work with your physician, oh, and by the way, we produce the guidelines for physicians..
Moreover, recent meta-analyses have found no association between prenatal SSRI exposure and overall risk of birth defects.5 The analysis goes on to say that some concerns with specific SSRIs have emerged. These should be individually addressed between the patient and physician to partner in decision making ensuring the best outcomes for the patient and the fetus, as is the case for any drug. Physicians should also work closely with patients to assess the risks and benefits of psychopharmacotherapy and monitor for potential side effects, ensuring each patient receives individualized care. The American College of Obstetricians and Gynecologists (ACOG) Guidelines on Psychiatric Medication Use During Pregnancy and Lactation are widely used by physicians to treat perinatal and pregnant individuals, and it states, “Treatment with SSRIs or selective norepinephrine reuptake inhibitors during pregnancy should be individualized.”6 ACOGs guidelines also strongly recommend against withholding or discontinuing medications for mental health conditions due to pregnancy or lactation status alone.7 Psychiatric medications are safe, effective, and can be lifesaving if they are taken properly — as directed –under the care of an appropriately licensed healthcare professional.
My starting point was that it is in the public interest that clinical trials protocols are disclosed,’ says Dr Selley. ‘The logic of Pharma is, don’t let any information out at all in case something might cause us a problem in the future.’
The doctor who fought a quango for the truth about vaccine trials
https://www.conservativewoman.co.uk/the-doctor-who-fought-a-quango-for-the-truth-about-vaccine-trials/?utm_source=newsletter&utm_medium=email&utm_term=2025-09-18&utm_campaign=TCW+Daily+Email
DR PETER Selley, a retired general practitioner, has found a new pastime. He is taking the initiative in seeking more openness over vaccine clinical trials being run in the UK by Moderna, the company with which the Government entered into a strategic partnership in December 2022.
The object of his attention is the Health Research Authority (HRA), a Department of Health and Social Care (DHSC) quango tasked with making the UK ‘the easiest place in the world to do research that people can trust’.
Expanding the clinical trials network in the UK is a policy objective to which the Government is committed. On August 28, 2024, the Government announced it was investing up to £400million to create 18 clinical trial hubs to ‘fast-track the development of new medicines to patients’.
Health and Social Care Secretary Wes Streeting said: ‘It will enhance the UK’s global competitiveness and transform the country into the epicentre of health research, supporting an NHS fit for the future.’
HRA, which oversees the Research Ethics Service and regulates the conduct of clinical trials, is meant to promote transparency in research and protect the interests of participants by encouraging research that is safe and ethical. Twice over the last year Dr Selley has tested it over clinical trials run by Moderna and found it wanting.
The ten-year £1billion strategic partnership between the Government and Moderna was brokered by the Vaccine Taskforce before it was disbanded.
Since the partnership started at the end of 2022, Moderna initiated 13 clinical trials in the UK including trials for mRNA-1283, Moderna’s covid vaccine booster and mRNA-1345, its RSV (respiratory syncytial virus) vaccine.
The latter was the proxy used by the US National Institutes of Health under the prototype pathogen project to develop coronavirus vaccines during the gain-of-function moratorium when the FDA put a clinical hold on their development because of concerns that the vaccines caused damage to delicate lung tissues.
‘My starting point was that it is in the public interest that clinical trials protocols are disclosed,’ says Dr Selley. ‘The logic of Pharma is, don’t let any information out at all in case something might cause us a problem in the future.’
In principle Dr Selley has no concerns about trials of therapeutic products intended for cancer patients or other people who are ill. Vaccines, which are given to healthy people and carry the risk of making them less well, are another matter. Transparency over the trials enables closer independent scrutiny. One reason for this, he says, is that it is difficult to know who at the HRA has actual medical expertise.
On May 4, 2023, Moderna received Research Ethics Committee approval for the Next COVE trial of its covid booster vaccine, Spikevax mRNA-1283.
In December Dr Selley submitted a Freedom of Information request asking when the HRA received the request for approval of the trial, whether the Research Ethics Committee (REC) asked for any changes to the protocol and for the release of regulatory documents Moderna submitted including the investigator’s brochure, the clinical trial protocol and the animal safety studies.
The HRA partially answered the request, telling him that the submission was made on March 31, 2023, and that the REC requested no changes to the protocol. However citing commercial confidentiality, which HRA’s spokesman says it is obliged under the Freedom of Information Act to consider, it refused to release the documents.
The HRA said the investigator’s brochure contained unspecified trade secrets, and the clinical trial protocol contained ‘unpublished elements of the study design and regulatory strategy that are not publicly available and have significant commercial value’.
Dr Selley says: ‘My concern was that the HRA’s position would encourage pharmaceutical companies to intentionally and unnecessarily include commercially confidential information in these documents in order to prevent them being publicly released.’
He asked for an internal review and, dissatisfied with the response, escalated the matter to the Information Commissioner who asked HRA to identify to it the specific information that was commercially sensitive and explain how it would hurt either the interests of the HRA or the company. The HRA failed to respond.
Not wanting the gratuitous inclusion of commercially sensitive information to become routine practice in order to avoid public scrutiny of clinical trials, Dr Selley decided to take the matter to tribunal.
‘Moderna distributed the trial protocol to 200 different trial sites around the world. It would make no sense for them to include commercially sensitive information in a document that widely distributed because they wouldn’t want to risk their commercial interest in the trial,’ says Dr Selley.
In May 2025, a first tier information rights tribunal found in favour of Dr Selley in his case against the Information Commissioner acting on behalf of the HRA. The tribunal decision is a non-binding precedent, but it’s an important one. The tribunal found the HRA had failed to cite any specifics in defence of its argument.
A spokesperson for the HRA said: ‘As an organisation we champion transparency in health and social care research through our Make it Public campaign. We respect the outcome of the tribunal and will shortly be releasing the study protocol and investigator’s brochure for this study.’
Moderna was approached for comment on the precedent but offered none, saying that it wasn’t a party to the proceedings.
Plucky Duck..
David T Healy says
It’s good to see Peter S being recognized as a folk hero – what he has done is really quite extraordinary.
The SSRI and pregnancy matters have also brought Adam Urato more clearly into the frame as someone who has done extraordinary things.
Whether the efforts of one or two people can turn things around remains to be seen.
Are as Adam hopes the public starting to understand how all of this works? SSRIs, Tylenol, etc. They do alter fetal brain development but they are profitable. Is the public beginning to understand that the medical establishment will deny any problems and the corporate media will do the same?
If we keep bringing attention to these points will these meds eventually go the way of valproic acid in terms of the general acceptance that they cause harm.?
It took nearly 50 years for the harms of valproic acid to be accepted and comments on the Epidemiology of Autism Spectrum Disorder post brings home, we still have groups linked to pharma busily minimizing the effects of even valproic acid.
David