You’re listening to Radio Health Journal, the trusted news source for medicine, science and technology. I’m Elizabeth Westfield. I’m Mayan Vastabetancourt.
And I’m Greg Johnson. This week, a test that accelerates care for patients with rheumatoid arthritis. I would have been able to maybe get a diagnosis and not wait until it was so inflamed that I had trouble walking and getting out of bed and holding a cup of coffee with one hand.
But first, a potential solution to make our food supply safe and healthy. The post-market authority and review is slow, sporadic, it’s not comprehensive and it’s definitely not rigorous and it’s not responding to the science. All that and more this week on Radio Health Journal.
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800-859-3220. The FDA has undergone some major changes recently, including the layoffs of thousands of employees and budget cuts. And as you’ve heard from our recent segment with FDA researcher Daniel Aron, the agency had already been struggling to fulfill all of its responsibilities before these most recent challenges.
In fact, the organization has a long history of searching for patchwork solutions that don’t use extra resources. One popular move is called the GRASS List, which stands for Generally Recognized as Safe. It’s a collection of substances that don’t need a formal pre-market review because qualified experts have agreed they’re safe within the context of their intended use.
While it helps reduce some burden from the FDA, Jennifer Pomerantz says it’s created a loophole where food companies can self-determine that an additive is considered GRASS without ever notifying the FDA. The food industry is required to submit a petition for the FDA to review food additives and color additives. However, they can just opt to put in ingredients that they’ve determined are generally recognized as safe or GRASS.
There is no requirement that the industry even run that by the FDA and say, hmm, should this be a food additive or should this be GRASS? The industry can just determine for itself that, oh, we’ve decided this is a GRASS ingredient. They’re supposed to engage in scientific research to confirm that it’s generally recognized as safe. But there’s no requirement that
they actually show this data to the FDA or even tell the FDA that they’re adding these ingredients to food.
Pomerantz is a public health lawyer and associate professor at the NYU School of Global Public Health. She notes that the GRASS loophole has had a giant footprint in our country. A 2022 analysis by the Environmental Working Group estimates that nearly 99 percent of new food chemicals have used this policy workaround since the year 2000.
So that’s concerning because there is no oversight or even knowledge of some of the ingredients in our food supply. And remember, if they want to submit the food additives petition, then that’s kind of their decision whether they’re going through that food additives framework or GRASS framework. There is no regulation telling them which one they have to choose.
So a lot of these decisions are being left to industry. There is a post-market review process that’s designed to catch any harmful products that may have slipped through the cracks. However, Pomerantz says that the agency doesn’t actually have the resources needed to make this system effective.
Even though they have the full authority, they don’t have the resources to engage in that post-market review. And what we see as a result is that ingredients with known evidence of harm, decades of evidence of harm, remain in our food supply where the FDA is not removing it. There are many examples.
Industrial trans fat, which was removed very recently, there were 30 years of evidence that it was harmful. BVO, which is brominated vegetable oil, was in the food supply for 53 years. And there was evidence of harm back then.
BVO is a food additive that’s been used in drinks since the 1920s to prevent the flavor oils from separating. It was added to the original GRASS list, but was removed in the late 60s due to toxicity concerns. The FDA states that there wasn’t enough data to fully remove the additive from the market, so the agency limited its use level in products.
Still, it took more than 40 years after this decision to gather enough data for the FDA to finally revoke the use of BVO in 2024. Companies now have one year to reformulate, relabel, and sell the rest of their products that contain BVO before the rule is enforced. The post-market authority and review is slow, sporadic.
It’s not comprehensive, and it’s definitely not rigorous, and it’s not responding to the science. Also, what it’s not responding to is when Europe is removing ingredients from their food supply, there should be some type of effort immediately on the U.S. to say, the default should be, maybe we should look at this ingredient as well, but we haven’t been doing that. Again, the slow action isn’t a purposeful move to keep dangerous ingredients in our food.
It’s a harmful side effect of minimal resources and funding. Experts like Pomerantz believe that many of these failings can be improved if the food industry started paying a sort of tax to the FDA, called user fees. The tobacco and pharmaceutical industries both pay user fees.
In fact, these dues account for nearly half of the FDA’s current budget. There are user fees for every type of human drug. There are user fees for animal drugs, and there’s user fees for tobacco.
The drug budgets, they’re reauthorized every five years, which allows Congress to re-evaluate and also see how they’re working out. The way every single user fee is authorized is actually through Congress, so the agency can’t do that unilaterally, but Congress will implement the user fee programs, but in general, the way the numbers are determined is actually through negotiations between the FDA and the industry trade groups. It’s a system that helps both parties.
The FDA receives enough resources to effectively do its job, and the drug manufacturers get their products reviewed in an appropriate amount of time. However, a question that’s often asked is how much room does this negotiation leave for corruption to take place? It is a very common concern. The interesting thing is we did not see any indication that user fees ended up corrupting the FDA’s ultimate judgment.
User fees are only to pay for the process, so they basically pay for registration of companies, the process of reviewing applications. There is no guarantee on the outcome. However, Pomerantz says that in general, there are instances of regulatory capture.
This refers to a situation where the agency is accidentally influenced by the industries it’s policing. As a result, the agency begins to act in ways that benefit the interests of the industries. While this does happen, Pomerantz says that it’s not directly connected to the user fee system.
We see that as a problem across industries. For example, the food industry essentially polices itself, and there are really almost no user fees in the food context. So that industry capture of regulatory interests, that is happening separate from user fees.
There are a couple of food-specific user fees currently in place, but Pomerantz says they only make up about one percent of the entire foods program budget, which in 2022 was just over $1 billion. It’s for color. Color additives have a user fee.
There are also user fees from the Food Safety Modernization Act, and these are things for recall or reinspection. The FDA actually doesn’t collect those user fees, even though they’re authorized to do so. The reason is they said that they wouldn’t collect them until they issued a small business guidance, which actually helped small businesses either reduce their fees or be able to abide by the fees in an easier way.
The FDA hasn’t issued that small business guidance, so it doesn’t collect the user fees that it’s allowed to collect. Then there’s a voluntary user fee program for very small parts of the FDA’s oversight as well. So that’s where that one percent is coming in, from these voluntary programs and then the color additives.
But really, that one percent is a minor drop, and it’s not really funding the major operations of the FDA when it comes to food. Pomerantz says the user fees are needed to fund more than the review of additives. There are countless processes that require oversight but aren’t getting done in a timely manner, if at all.
For example, if a new infant formula is introduced that has major changes to existing products, the FDA is notified and has 90 days to review that petition. At least that’s what’s supposed to happen. Pomerantz says they currently don’t have the resources to meet that expectation.
They can’t review it within 90 days. They don’t have the resources to do it. So that also slows down the infant formula companies.
And as I mentioned earlier, there’s health claims that the companies want to put on their products, but because it takes a really long time for the FDA to review those, they don’t get to put them on their products for years. So there are other areas where user fees will speed up these processes, and that is actually helping industry get to market quicker. However, Pomerantz says this timeliness isn’t a big enough incentive to bring the industry to the bargaining table, especially when they can already use the grass loophole to bring many other products directly to market.
Well, it’s a grass loophole for safety reasons. And then user fees are a really natural result of closing that grass loophole because then the industry will want to make sure that they can get to market quick. And in order to do that quickly, the FDA will need user fees to fund those operations.
Pomerantz has a few ideas on how to close the loophole, one being that the FDA has to review the data establishing an additive as safe. Which is not actually the worst idea because we have so many ingredients already in the food supply. Anything new created is clearly not like something from nature.
It would be an industrially created ingredient at this point. Right. There are less rigorous ways they could just notify the FDA of their determination that something is grass and also provide the science to the FDA.
At least it would give the FDA the information that the FDA could review. But then they would still go to market after a certain period of days. At the very least, the manufacturers could add the ingredients to a public database.
This would allow nonprofit organizations to review the evidence of safety. And also it would really keep the industry from putting in ingredients in the food supply where the evidence of safety does not support that it’s safe. Right.
So if this is public data, they’re not going to put in something that clearly the evidence doesn’t support the safety. So that’s not a bad idea. And it’s also much less labor intensive, right, to put it on a public database.
Unfortunately, the FDA is in a tough spot at the moment. In order to bring the food industry to the bargaining table, they need to close the grass loophole. However, they need the resources to be able to do that, which would come from the user fees.
Pomerantz says that instead of using regulation to force the industry’s hand, Congress needs to step in to create change. It’s time for Congress to come in and close the grass loophole and then simultaneously require user fees. Or, you know, frankly, Congress can increase appropriations to the FDA.
It would have a similar impact of giving them resources. The problem is that every year the FDA will have to implore Congress to keep that appropriations up. So user fees are a little bit more of a stable funding stream.
There are like dozens of user fees that the FDA gets and they can model it after most of them. I can imagine more, you know, review the petition review fees. It makes the most sense.
You could have facility registration fees. There’s a lot of fees they could put on. I mean, my goal here is to make our food supply safe and healthy ultimately, but safe here initially.
So we don’t need to nickel and dime the food industry. I want the fees should really just go to the FDA, ensuring the safety of our food supply. You can find more information about Jennifer Pomerantz and all of our guests on our website, RadioHealthJournal.org. For more behind the scenes, follow Radio Health Journal on Facebook, Instagram and X. Our writer producer is Kristen Farrah.
Our executive producer is Amara Zaveri. I’m Elizabeth Westfield. Coming up, the blood test that can put an end to trial and error medicine.
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It’s funny how certain old wives tales have been passed down so many times, people just accept them as fact. In Emma Larson’s family, cracking your knuckles would most definitely lead to arthritis. She was constantly scolded as a kid by her mother and grandma, who both had rheumatoid arthritis.
However, they didn’t get it by popping their joints. The condition is an autoimmune disease where a person’s immune system attacks its own tissue, causing inflamed and painful joints. Larson remembers watching her own mom suffer through the illness.
When she first started to work full time again, she would come home and just like would be exhausted and have to sit down the second she got home. And I just never understood. But it was because her joints were in so much pain.
So I never really thought that it would happen to me. Larson grew up an athlete and committed to play volleyball in college. But going into her freshman year, pain had already begun settling into her hands.
I was getting ready for like preseason for volleyball and I couldn’t set a ball without almost crying because my knuckles hurt so bad. And so I went to doctors, different doctors, different specialists. Larson was tested for various conditions such as lupus, but nothing showed up.
They said her pain was probably from changes in the weather. So Larson continued with life as normal. But then Larson began her senior volleyball season in pain, thinking it was just a lack of endurance.
She’d hit the gym every night after practice. Unfortunately, the extra training didn’t help and things only got worse after graduation. I took a trip to Puerto Rico with a few friends from college.
And I feel like it was on that trip that I was like, oh, no, something seriously wrong, because I remember just like not being able to walk in the morning, limping pretty much until like I could get my bones moving and like get used to like the movement or even like laying out on the beach, then getting up and having to like walk again and move like it took a while for me to like feel like I could move without it hurting. But then I talked to my family and they were like, oh, it’s the weather was so different. There must be the weather again.
But as she settled into life back at home, the pain persisted. And at my bartending job, like even bending down to get a beer from the cooler and then having to get back up, it was like a struggle. Like I didn’t want to bend down to get a beer because it hurt too much to get back up.
That was the last straw. Larson saw a rheumatologist that confirmed she was in the beginning stages of rheumatoid arthritis. However, it was too early to diagnose the exact disease.
So Larson’s illness was officially identified as a general autoimmune condition. And though she was prescribed medication right away, there’s no guarantee it’s the right treatment. I have to go every two or three months to get blood tests just to make sure the medicine’s working and it’s not progressing anymore because then they would have to adjust the medicine because they really just kind of guessed with this medicine.
They weren’t sure it was going to work because they didn’t know if I actually had rheumatoid arthritis. That was just their educated guess because these are my symptoms
and my family history and my joints were inflamed in the tests. So I just have to keep going back to monitor it and make sure it’s not changing or getting worse.
Which Dr. Sam Asgharian says is a common issue with rheumatoid arthritis patients. Asgharian is the vice president of clinical development at Gardened Health. He says at first, doctors can have trouble figuring out exactly where the problem is within a patient’s body.
This isn’t arthritis that’s caused by the wear and tear of the joints, which is what the person will initially think, which is also what their doctor may initially think. This is arthritis that’s caused by cells in the immune system attacking the same joints in that person’s body. And that leads to a lot of different signs and symptoms that at first aren’t easy to read.
And even after doctors are able to diagnose a condition as rheumatoid arthritis, they still have to guess at which medication will work without causing more harm. It’s hard to then figure out which part of their immune system is overreacting. And as a physician, you can’t turn off someone’s immune system, right? Because now they’re susceptible to all kinds of viruses, bacteria and other illnesses and diseases.
So they have to figure out a way to only fix the part that’s overreacting while keeping the rest of the patient’s immune system intact. That makes it really difficult. That ultimately is why in the world of autoimmune, you see physicians practicing trial and error medicine.
That’s not ideal, right? That means I want to try this. If it works, great. If not, well, we’ll have to try something else.
And the best way to solve that is by really practicing precision medicine or personalized medicine, finding out the molecular root cause of someone’s disease, and then prescribing a treatment that really focuses on just that root cause to give them that right outcome. In an effort to give patients this option, a first of its kind blood test has been created called PRISM-RA. It can detect which specific molecules are overreacting in a person’s immune system.
So what our test PRISM-RA does is it looks for markers of inflammation at the gene level and basically says if those areas are what we see in the blood, that that means that it’s that part of the immune system that’s overreacting. The test is important because as Geryon says, rheumatoid arthritis, like other autoimmune diseases, isn’t the same in every patient. There’s slight variances person to person because everyone’s immune system is different.
There’s all these different components of the immune system and the goal biologically is sometimes one branch overreacts and it’s different in each person, right? So that’s why it’s called personalized or precision medicine because you’re not treating based on their diagnosis, which has a lot of variety. You’re treating based on their individual biology and therefore you have the ability to be more targeted in your treatment because you know that particular part of their biology is what’s overreacting and your treatment is targeted to that area. And that’s the hardest part to figure out without a blood test and without molecular information.
Which is exactly the type of information PRISM-RA is able to give to physicians. It gives the doctor insight into something they can’t see with their naked eye. The doctor will be able to
see this months from now when those cells ultimately reach their joints that they’re interested in attacking and that leads to that person’s issue.
But our goal is to give them enough predictive information ahead of time through a simple lab test to where they can with confidence prescribe the right drug earlier than those symptoms actually present or progress. A test Larson could have used when the pain was first in her hands. Even with her current medication, Larson’s condition has slowly spread.
Asgerian says Larson’s issues are common in the autoimmune disease world. He explains that we’ve gotten really good at solving simple chronic problems but that hasn’t carried over into autoimmune research. These diseases that are complex and they are chronic sometimes they don’t end up in death but they do end up in disability or a lot of debilitation and the quality of life comes down.
The other issue that we see is a lot of wasted pharmaceutical spend effort and energy. People take drugs and they’re taking them the way that their doctor prescribed them but they’re not working. They’re not effective and they know that they feel like they’re still getting sicker and that is the burden that we’re trying to relieve.
And with PRISM-RA, Asgerian believes we’re one step closer to closing that gap. You can find more information about Emma Larson, Dr. Sam Asgerian and all of our guests on our website, RadioHealthJournal.org. This segment originally aired in September of 2022. Our writer producer is Kristen Farah.
Our production manager is Jason Dickey. I’m Greg Johnson. Radio Health Journal returns in just a moment.
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Is there a new brain region for our senses? Scientists have identified a little-known part of the brain that could be the key to how we sense the world around us. New research published in Cell Reports reveals that this region helps combine touch, sight and sound into one unified experience. Scientists hope that learning more about this area could improve our understanding of neurological conditions that disrupt sensory processing, like autism.
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Loneliness can raise the risk of heart disease, stroke and early death. And finally, can fish oil really slow down aging? A daily dose of omega-3 fatty acid could help delay the biological aging process. A study in the Journal of the American College of Cardiology has found that people with higher omega-3 levels showed slower marks of cellular aging.
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Call Big Lew at 800-859-3220. 800-859-3220. Thank you for joining us this week and every week as we break down the science stories you need to know.
You can find all of our past segments and guests on our website, RadioHealthJournal.org or wherever you listen to podcasts. Follow us on Instagram, Facebook and X for daily content and tune in next week for another edition of Radio Health Journal.
