Experts Voice Concerns, Cautious Optimism With Kennedy Potentially Leading the HHS

President-elect Donald Trump has nominated Robert F. Kennedy Jr to be the secretary of the Department of Health and Human Services (HHS) and leader of the “Make America Healthy Again” movement. The decision has sparked considerable debate as Kennedy has taken to the media to share his plans to “gut” the FDA, as well as denouncing vaccines and emphasizing the “aggressive suppression” of treatments such as ivermectin, hydroxychloroquine, stem cells, and nutraceuticals.¹

The opinions of agency heads, experts, and the American public are divided. Some express more concern over the potential consequences of his positions on vaccines, drug regulation and approval processes, and access to therapies such as psychedelics, a historically controversial issue. Others maintain a position of uncertainty, erring on the side of cautious optimism, as Kennedy’s emphasis on healthy eating and living has garnered positive responses and brought the chronic disease epidemic in the United States to the forefront.

Stethoscope and gavel | Image Credit: © Joaquin Corbalan - stock.adobe.com

“FDA’s war on public health is about to end,” stated Kennedy in an X post prior to election day. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can't be patented by Pharma. If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags.”²

At a conference hosted by the nonprofit Friends of Cancer Research on November 12, 2024, FDA Commissioner Robert Califf, MD, addressed the future of the agency.³

“I think we just don’t know what’s going to happen,” Califf said at the conference. “The gist of this administration, from everything that’s been said, is that they want to change a lot of things, and how it gets changed depends on who gets appointed into key positions.”³

In an interview with Pharmacy Times^®, Michael Hogue, PharmD, FAPhA, FNAP, FFIP, executive vice president and chief executive officer of the American Pharmacists Association, shared his perspective on opportunities for finding alignment despite differing views.⁴

“There's probably not a single HHS secretary in the history of secretaries that the profession of pharmacy was completely and totally aligned with on every issue. But we always find areas that are common ground where we can help move the profession forward and help improve the access that consumers have to the pharmacist care services," Hogue said. “And I think there's some components of that RFK has talked about that, I think, give me some hope that there might be an open door to do some new things that could be very beneficial for the pharmacy profession. So, we're going to focus on those areas that we have common ground and try to collaborate on those areas.”⁴

As Kennedy’s potential appointment continues to provoke debate across the health care landscape, pharmacy professionals are preparing for the potential challenges and opportunities his policies may bring. While concerns over his controversial positions persist, the focus for many within the profession will remain on identifying areas of alignment and advocating for initiatives that improve patient care and access to essential therapies.

The Future of the FDA

“To say that you're going to gut an agency gets a lot of great headlines, but what does it really mean?” said Hogue. “I always take those very broad and general statements as hyperbole, because the devil is always in the details of what's going to actually transpire.”⁴

There are both potential upsides and downsides to Kennedy’s claims and plans for the FDA, creating opportunities for improvement or compromising existing regulations and processes. The proposed changes could have negative implications for health care policy, potentially interfering with science-backed regulatory decisions and undermining the FDA’s authority to regulate medical treatments available to the public.³

Department of Health and Human Services, FDA sign | Image Credit: © Grandbrothers - stock.adobe.com

Kennedy’s intent to clear out departments of the FDA and other public health agencies has raised concern amongst officials over key position dismissals and appointments. Depending on who is appointed to these positions, the efficiency of FDA operations and regulatory processes could be greatly reduced. This has raised alarms among officials, who fear that poorly chosen appointments could disrupt regulatory processes and reduce the agency’s efficiency.³

However, there are some experts who believe that Kennedy's leadership could present opportunities for positive change in certain areas of health care policy. They point to his focus on addressing the chronic disease epidemic and advocating for a more holistic approach to health care, which some view as a necessary shift in the current landscape.

"My perspective is he certainly has some ideas that are problematic, but he has seemed to have tapped into this larger concept of the decline of American health in a way that feels authentic and long overdue,” explained Colby Burns, PharmD, MBA, primary care and mental health pharmacist at CHAS Health in Seattle and a member of the Psychedelic Pharmacists Association, in a Pharmacy Times interview.⁵

“The fact is, we live shorter lives, spend more money on health care and suffer more days of productivity lost due to chronic illness than basically every single one of our peer nations. And maybe this does require a holistic approach to critically examining every element of our public health infrastructure, including the FDA, to determine how we got here."⁵

Rethinking public health priorities could create opportunities for meaningful reform, particularly in areas like preventive care and alternative therapies. However, how these ideas are implemented—and the balance between innovation and regulation—will ultimately determine their impact on the health care landscape.

Vaccines

Kennedy has long perpetuated medical misinformation and is well known for spreading claims regarding the dangers of vaccines. For decades, he has touted their connection to autism based on a retracted paper published in Lancet in 1998, despite numerous studies finding no causal link. Although Kennedy disputes claims he is an anti-vaxxer, his criticism and denouncement of vaccine policy has had direct consequences on public health safety.⁶

Since his nomination, various reports have resurfaced highlighting his controversial positions, as well as their direct influence on the public. This includes his visit to Samoa in 2019, which was followed by a measles outbreak resulting in least 83 deaths and 1867 hospitalizations. Top officials in Samoa directly link Kennedy’s perspective on vaccines and spread of misinformation to this outbreak.⁷

Many members of the American public have also questioned vaccine safety and expressed concerns over the number of vaccines administered to children, contributing to vaccine hesitancy. Prior to the COVID-19 pandemic, the United States had one of the best childhood immunization rates in the world, resulting in the near eradication of diseases like measles, pertussis, and mumps.⁴

Vial with MMR vaccine | Image Credit: © Leigh Prather - stock.adobe.com

“When we look at the United States Health Rankings, most all of the countries who are above us on the health rankings have vaccination rates that are at or above where our current vaccination rates are overall,” said Jerome Adams, MD, MPH, FASA, former United States surgeon general, in an interview with Pharmacy Times. “While chronic diseases do play a big role, you can't die of a heart attack or cancer when you're 60 if you've already died of measles or polio when you were 6.”⁸

Since his Trump announced Kennedy as his nominee to oversee various federal health care agencies, Kennedy has pulled back on anti-vaccine rhetoric, opting for an approach that emphasizes increased transparency and data.

“If vaccines are working for somebody, I’m not going to take them away,” he told MSBNC. “People ought to have a choice, and that choice ought to be informed by the best information.”⁹

Alternative Therapies, Nutraceuticals, and Healthy Living

Kennedy has voice desires to improve access to various alternative therapies. Stem cells, psychedelics, and nutraceuticals have been brought to the forefront as effective treatments across disease states, yet they often remain underfunded, under researched, and under regulated. The success of these alternative therapies often remain largely under researched and underfunded despite their benefits for some individuals.

"There's a huge gap between how the FDA treats pharmaceuticals versus nutraceuticals and supplements, and RFK has a different stance on that,” Kevin Lanzo, PharmD, a co-founder and board member of Psychedelic Pharmacists Association, principal consultant at Pharmaka Clinical Consulting, and executive in Residence at Lionheart VenturesIf, told Pharmacy Times in an interview. “There's value in those nutraceuticals and supplements, and I completely agree with that, because the industry's incentives are totally set up for the big money in pharmaceuticals and all the money that needs to go into the clinical trials.”¹¹

Hand holding supplements | Image Credit: © amenic181 - stock.adobe.com

Stem cells have gained clinical attention in recent years, especially following the successful reversal of type 1 diabetes in a woman from China. Studies have also indicated their potential use for Parkinson disease or heart failure. However, they remain largely unavailable in the face of controversy and the need for more study. Psychedelics are in a similar position. Although there is some encouraging evidence around the use of MDMA, ketamine, and psilocybin for various mental health disorders, more data are needed to determine the safety and efficacy of such therapies in large populations. Additionally, there are ethics concerns around psychedelic clinical trials and patient safety, as illustrated by the FDA’s rejection of MDMA as assisted psychotherapy for posttraumatic stress disorder.^12-15

The core of Kennedy’s platform is addressing the chronic disease epidemic with the “Make America Healthy Again” movement, honing in on the negative effects of ultra-processed foods and the influence of large corporations on food production. This has gained support among health experts and the American public alike as chronic illness rates soar and the quality of food gains more attention.¹⁶

There are increasing opportunities for health care professionals to play a more active role in addressing chronic disease through the promotion of better nutrition. With the growing recognition of the impact that ultra-processed foods have on public health, expanding access to nutritional guidance has become a priority. Among all health care professionals, pharmacists are uniquely positioned to make a difference due to their accessibility and active community presence.

“The ‘Make America Healthy Again’ initiative is an area where I think the pharmacy profession can work with the administration on positive change,” explained Hogue. “Pharmacists are located in just about every community in America. We're the most accessible health care professional; 90% of the population lives within 5 miles of a pharmacy.”⁴

Pharmacist handing prescription to patient | Image Credit: © joyfotoliakid - stock.adobe.com

Although Kennedy is bound to face obstacles and opposition from agencies and officials with differing positions, there are also important opportunities for improvement in health policy and public education. Pharmacists, with their deep connection to communities and accessibility, are uniquely positioned to advise the public on the importance of nutrition and lifestyle in managing chronic disease. As experts in medication management and health education, pharmacists can work with the administration to promote effective strategies that reduce misinformation and improve public health outcomes.

“I'm hopeful that out of the box thinking will at least cause that agency to contemplate finding solutions, rather than putting up barriers to improving access to patient care,” Hogue concluded. “We have a primary care crisis in this country. I think pharmacists are a solution to that primary care crisis.”⁴

Despite the challenges that may arise from potential shifts in regulatory policy, the pharmacy profession’s focus on patient care and public education provides a foundation for contributing positively to the United States health care system.

REFERENCES

1. Trump picks Robert F. Kennedy Jr. to be his Department of Health and Human Services secretary. CNN. November 14, 2024. Accessed December 6, 2024.

2. @RobertKennedyJr. FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can't be patented by Pharma. If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags. October 25, 2024. Accessed November 13, 2024. https://x.com/RobertKennedyJr/status/1849925311586238737?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1849925311586238737%7Ctwgr%5E7adb3ef3b034be0324a1999b01644dceb410484c%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Fwww.nytimes.com%2F2024%2F11%2F12%2Fhealth%2Frobert-kennedy-jr-fda.html&prefetchTimestamp=1731515044617

3. FDA commissioner suggests Kennedy Jr. and Trump might compromise an agency ‘at peak performance.’ STAT. November 12, 2024. Accessed December 6, 2024. https://www.statnews.com/2024/11/12/fda-commissioner-califf-trump-election-Kennedy-jr-public-health-food-nutrition/

4. Michael Hogue, oral communication, December 4, 2024.

5. Colby Burns, PharmD, MBA, oral communication, November 14, 2024.

6. Fact-checking RFK Jr's views on health policy. BBC. November 24, 2024. Accessed December 6, 2024. https://www.bbc.com/news/articles/c0mzk2y41zvo

7. ‘We learned the hard way’: Samoa remembers a deadly measles outbreak and a visit from RFK Jr. The Guardian. November 25, 2024. Accessed December 6, 2024. https://www.theguardian.com/world/2024/nov/26/rfk-jr-samoa-visit-measles-outbreak-vaccines

8. Make vaccination easy: Jerome Adams' call to health care workers this flu, COVID-19 season. Pharmacy Times. December 6, 2024. https://www.pharmacytimes.com/view/-make-the-healthy-choice-the-easy-choice-jerome-adams-advocates-for-flu-covid-19-vaccinations-among-health-care-providers

9. RFK Jr. talks health care agenda following Trump win: ‘I’m not going to take away vaccines.’ MSNBC. November 6, 2024. Accessed November 13, 2024. https://www.msnbc.com/msnbc/watch/Kennedy-jr-talks-health-care-agenda-following-trump-win-223720005709

10. Kennedy’s F.D.A. wish list: raw milk, stem cells, heavy metals. The New York Times. November 12, 2024. Accessed December 6, 2024. https://www.nytimes.com/2024/11/12/health/robert-kennedy-jr-fda.html

11. Kevin Lanzo, PharmD, oral communication, November 14, 2024.

12. Stem cells reverse woman’s diabetes — a world first. Nature. September 26, 2024. https://www.nature.com/articles/d41586-024-03129-3

13. Stem cells. what they are and what they do. Mayo Clinic. March 23, 2024. Accessed December 6, 2024. https://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117

14. Stringer, H. The emergence of psychedelics as medicine. Monitor on Psychology. June 1, 2024. https://www.apa.org/monitor/2024/06/psychedelics-as-medicine

15. FDA declines to approve MDMA for PTSD. Pharmacy Times. August 9, 2024. Accessed December 6, 2024. https://www.pharmacytimes.com/view/fda-declines-to-approve-mdma-for-ptsd

16. The power RFK Jr. would have over food. Time. December 6, 2024. Accessed December 6, 2024. https://time.com/7200323/rfk-jr-hhs-food-nutrition-health/