Dietary Guidelines Lawsuit; Expensive NIH Policy; Pediatrician Running for Office

The following is a transcript of the podcast episode:

Rachael Robertson: Hey everybody! Welcome to MedPod Today, podcast series where MedPage Today reporters share deeper insight into the week’s biggest healthcare stories. I’m your host Rachael Robertson.

I’ll kick off today’s episode with details on why a physician group is suing the U.S. government over the most recent dietary guidelines. Then Cheryl Clark will break down how a new NIH policy may impact article processing charges. Lastly, Joyce Frieden will share key takeaways from her interview with a pediatrician running in the race to succeed the late South Carolina Senator Lindsey Graham.

Cheryl will take the host seat for this first segment.

Cheryl Clark: A physician group has filed a lawsuit against the government over the most recent dietary guidelines. The suit alleges that HHS and the U.S. Department of Agriculture (USDA) botched the process. Rachael Robertson is here to tell us more about it.

So, Rachael, who are the parties involved in this lawsuit?

Robertson: The group is called Physicians Committee for Responsible Medicine, or PCRM. They’re a D.C.-based nonprofit that’s been around since 1985. They advocate for plant-based diets and alternatives to animal-based research, and they have a long history of using legal pressure to further their goals.

They’re suing both HHS and USDA, which together are in charge of the Dietary Guidelines for Americans. You’ll remember the most recent update caused a stir, particularly the now infamous upside-down food pyramid that quite literally flipped conventional dietary advice on its head.

And those guidelines were criticized for containing errors and cherry-picked evidence. In the legal complaint, PCRM argues that these agencies assembled a secret panel that was rife with conflicts of interest and didn’t follow the long-established process for updating the guidelines.

“The government allowed the meat and dairy industries to ghostwrite the dietary guidelines.” That’s a quote from the PCRM president Neal Barnard, MD, and he said that in a press release. He continued: “They put money in the industry’s pocket and cholesterol in Americans’ arteries.”

PCRM is ultimately asking that the court withdraw the current dietary guidelines and issue new ones that follow a process that’s compliant with the Federal Advisory Committee Act, or FACA, which they say the most recent guidelines violated.

Clark: Well, how are the guidelines supposed to be named?

Robertson: The dietary guidelines are usually based on the work of the volunteer Dietary Guidelines Advisory Committee, or DGAC. Every 5 years, 20 nutrition and obesity experts comb through the evolving evidence over the course of 2 years, and they write up a report on how they advise the government to update national guidelines. After they submit that report, DGAC’s role is over, and they really don’t have a say in what actually changes — though the government usually heavily considers their recommendations. The most recent DGAC submitted their report right as the second Trump administration took over, meaning HHS Secretary Robert F. Kennedy Jr. oversaw the dietary guidelines update.

PCRM’s lawsuit further alleges that HHS and USDA violated FACA when they handpicked nine members for a second panel to review the evidence and update the guidelines without notifying the public or adequately vetting conflicts of interest. Several of those panelists are known to have strong ties to the beef, dairy, and egg industries.

Clark: What are the experts saying?

Robertson: Former DGAC members told me that they’re glad that someone is standing up to the administration. Christopher Gardner, PhD, who’s a nutrition expert at Stanford University, said that “standard scientific and political procedures are not being followed, and you can’t let that lie. Somebody has to show outrage. … People have spent decades setting that process up so that it’s as transparent as possible, and they’re bypassing all of it.”

Fatima Cody Stanford, MD, MPH, an obesity medicine physician at Harvard Medical School, told me, “this is the first time in history since 1980, when the Dietary Guidelines Advisory Committee began informing the guidelines, that we saw this lack of transparency.” She also noted that this situation “really speaks volumes to what we’re seeing under this current administration.”

Gardner also pointed out that it’s strange that Kennedy formed the second so-called secret panel by passing standard processes and violating laws, since the government already is not required to follow DGAC’s recommendations. We’ll be following how this lawsuit unfolds.

Clark: Very interesting. Thanks, Rachael.

Robertson: Thank you, Cheryl.

A new NIH policy regarding access to NIH-funded journal manuscripts could cost researchers a lot more money and publication fees. Cheryl Clark is here to tell us more.

Cheryl, what’s the impact of this new policy?

Clark: So, up until this policy took effect a bit over a year ago, many of the most prominent academic journals declined public access to articles on PubMed, sometimes as long as a year after publication, because under existing journal practices, if the authors or their institutions wanted non-subscribers to be able to access that article as soon as it was published, they had to pay journal fees. Now these are called article processing charges or APCs. The journals argue that they lose money in subscriptions when their research papers are immediately open to the public.

Now, the new NIH policy requires that if a researcher’s work is supported by the NIH, then all such manuscripts must be available immediately on PubMed upon publication, not just available to subscribers. So the journals apparently hope to reap a lot of money that otherwise wouldn’t have to be paid.

Robertson: How much money are we talking?

Well, many would say much too much money. Earlier this year, researchers at the University of New Mexico at Albuquerque figured that out, and they just published their findings in JAMA Internal Medicine.

They assessed data from NIH Reporter, OpenAlex, and OpenAPC, and they were able to count all the articles published in 2024 that did not pay an APC fee, but now would have to if the same journals published them and kept the same pricing. They then calculated that if those journals required fees for authors to comply with the NIH policy — some were calling it a pay-to-comply policy — researchers or their institutions would have to pay an additional $104 million per year in APC fees to those journals. They figured out that the average APC for these articles would be around $2,900 or $4,600, depending on the type of article or the type of journal. Some journals charge as much as $12,000, I was told.

Robertson: Does the NIH realize this?

Clark: Apparently, it does, and it has said that journal fees aren’t required. But I’m told that some of the journals are sort of regarding this as a suggestion. And there’s another problem: the NIH wants to put limits on how much of those federal grants can be used to pay these APC fees.

And not to double or triple down, although I guess that’s what I’m doing, there’s another issue that looms: a proposed new rule from the Office of Management and Budget would prohibit any NIH funds from being used for publication costs, including those APCs. That could mean fees would have to come out of the institution’s coffers, or if those are empty, the researcher’s own pockets.

I know, I know, I’m such a Debbie Downer, but there’s one more thing. The new NIH policy also requires investigators or their institutions to upload accepted manuscripts to PubMed Central. This is way before changes and corrections journal editors make to those pieces, so on the day that everything gets published, readers will have access to the unedited version and the edited version at the same time. It’s all kind of mind-boggling and definitely an issue that we plan to continue pursuing.

Robertson: Thank you so much, Cheryl.

Clark: Well, thank you, Rachael.

Robertson: With only a few weeks left before people start voting in the midterms, MedPage Today has been looking at healthcare professionals who are running for federal and statewide offices. Today, Washington editor Joyce Frieden tells us about her interview with Annie Andrews, MD, a pediatric hospitalist who is the Democratic candidate in the race to succeed the late South Carolina Senator Lindsey Graham.

Joyce, tell us more about Annie Andrews and your interview with her. So, who is she?

Joyce Frieden: Well Rachael, Andrews says she decided to be a doctor when she was 4 years old. She went to medical school at the University of Cincinnati and did her third-year pediatrics rotation at Cincinnati Children’s. And says she really fell in love with hospital-based pediatrics.

After completing her residency, she moved to Charleston, South Carolina, where she did an academic generalist fellowship at the Medical University of South Carolina, and got a master’s degree in clinical research. She’s board certified in both pediatric and pediatric hospital medicine.

This is not her first try at elected office. In 2022, she ran unsuccessfully for a House seat, losing to Nancy Mace. She will now face Lindsey’s sister Darline Graham in the Senate race.

Robertson: What are Andrews’ top priorities if she’s elected?

Frieden: Well, one of her stated top priorities is to get HHS Secretary Robert F. Kennedy Jr. out of his job. She told me that his comments expressing skepticism about some routine childhood immunizations are “deeply destructive,” and that what HHS is doing is “injecting distrust and disinformation into the American public health infrastructure and our healthcare system.”

She said that South Carolina saw the ramifications of this disinformation campaign firsthand when it had a measles outbreak with nearly 1,000 documented cases of the measles. “I have seen over my 20-year career, slowly but surely, rates of vaccine refusal and vaccine hesitancy creep up and up and up.”

Andrews said that many parents don’t feel that they can trust the vaccine recommendations coming from HHS. She urges them to turn to the American Academy of Pediatrics as well as their own pediatrician for advice.

Robertson: What issues does she want to work on related to healthcare providers?

Frieden: Reducing administrative burden is one. She says that as her career progressed, she spent more and more time dealing with administrative issues and less time at the bedsides of her patients.

“That frustration is almost universal, whether you’re a pediatrician like me working in a children’s hospital; a pediatrician working in an outpatient clinic; or a subspecialist who has a waitlist of 9 to 12 months long because we have a workforce shortage here in South Carolina.”

She added that providers are recognizing that the system is not working for them, and it’s not working for their patients. She said providers want people to have serious conversations about changing from a profit-motivated healthcare system to a patient-centered one. Andrews said she believes healthcare is a human right, and that while current political reality might not allow for the passage of something like Medicare for All, Congress should instead pass a public option so people can see how well it would work.

Robertson: Well, we’ll see how her campaign progresses. Thanks so much, Joyce.

Frieden: Thanks, Rachael.

Robertson: Things continue to heat up on the measles front. There were 197 cases last week and 132 the week before that. Pennsylvania is still the hot spot with the bulk of those cases, and sadly just reported two measles-related deaths. Ohio, Wisconsin, Kentucky, and Iowa are all also having significant upticks in cases. We’ll continue mapping the spread of measles at the top of each week. You can take a detailed look at our interactive measles tracker linked here.

And that is it for today. If you like what you heard, leave us a review wherever you listen to podcasts, and hit subscribe if you haven’t already. We’ll see you again soon.

This episode was hosted by me, Rachael Robertson. Sound engineering by Greg Laub. Theme music by Palomar. Our guests were MedPage Today reporters Rachael Robertson, Cheryl Clark, and Joyce Frieden. Links to their stories are in the show notes.

MedPod Today is a production of MedPage Today. For more information about the show, check out MedPageToday.com/podcasts.