Finding The Facts In The Tylenol Autism Case with Ann Bauer

 

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Finding The Facts In The Tylenol Autism Case with Ann Bauer

Amidst the many studies released concerning correlation between Tylenol use in pregnant women and neurodevelopmental disorders such as autism and ADHD, it’s easy to call facts fiction. But when specialists are providing legitimate, replicable, research time after time, we should probably start listening. 

Today, it’s time to cut through the outside noise and find the facts in the Tylenol autism lawsuit. 

Learn more about the research that has led to the historic lawsuit in this episode of the David vs. Goliath podcast with elite personal injury lawyers Matt Dolman and Stan Gipe and their guest, esteemed epidemiologist Ann Bauer. Matt and Stan ask the hard questions concerning the legitimacy of the Tylenol research, why the general public is pushing back against these claims, the FDA’s caution to back the lawsuit, the animal studies that back up the human research of acetaminophen effects on the fetal brain, potential arguments to explain away the need for an added warning label for pregnant women on the Tylenol bottle, and more!

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In this episode: 

  • [01:23] Ann explains how reputable studies research to determine causality  
  • [05:29] Matt and Ann discuss various studies that show the tylenol-autism correlation including the Johns Hopkins study
  • [11:52] Stan and Ann remark on the animal studies that have already shown the effects of acetaminophen, and how these studies are being overlooked
  • [18:03] Why the FDA hasn’t stepped in and taken a stand with the plaintiffs, despite a high amount of legitimate research 
  • [24:13] Making clear that these cases are not saying that acetaminophen causes autism, but that these cases are about warning pregnant women of the potential hazards of taking Tylenol for their pain
  • [32:12] Ann speaks further on how it is anticipated that the defense will defend against the autism and ADHD claims
  • [40:22] How you can get in touch with Dolman law group with any questions, concerns, or to share your story.

Transcript

Matt Dolman:

Welcome to another episode of the David and Goliath Podcast. I'm attorney Matt Dolman from the Dolman Law Group here with my business partner, Stan Gipe and esteemed epidemiologist, Ann Bauer. So Ann, we're really happy to have you on today. Our discussion is going to be centered around the Tylenol autism, or I should call it the acetaminophen Autism ADHD lawsuit right now that is pending in the Southern District of New York in federal court. And this is part of multi-district litigation. You penned several studies on this subject, so I want to go into your breadth knowledge regarding the association between use of acetaminophen during pregnancy in utero exposure to acetaminophen, and how that ties and links into the later subsequent diagnosis of autism spectrum disorder and ADHD, and other neurodevelopmental disorders. So to start off with, just tell us about the general association, the body of science that's out there.

Ann Bauer:

I think I'd like to start with talking about how we determine causality a little bit. The gold standard of evidence is a randomized controlled trial. This is what is used in pharmaceutical clinical trials. And what is done is people are randomized to two groups, one will get the treatment, the other will get placebo, and this active randomization minimizes bias. So, that's the gold standard and that's great for a brand new pharmaceutical coming on the market when the researchers believe that that treatment will be beneficial. In this case, our hypothesis is, as researchers, is that acetaminophen may be causing harm to the developing ... When used during pregnancy may be causing harm to the developing fetus. So it's unethical for us to do a randomized control trial. You cannot put people in a group and say, "You're going to take acetaminophen, and another group we're going to give a placebo," because I believe that giving them that treatment could cause the child to have autism, or ADHD, or some neurodevelopmental complications.

So, in this case you have to rely on observational data. So, we have to watch what's actually happening out there. We cannot do an experiment like that. So, when we rank the observational type studies, what is considered the best evidence is a cohort study. And so, a cohort study, the way it's designed is we enroll pregnant women, particularly for acetaminophen, looking at acetaminophen and neuro development. Women are enrolled at the beginning of their pregnancy and we continue to follow them and then the baby that's born until the time that they develop a neurodevelopmental complication or not. And we look at the women, we just observe the people we keep track of. Most of the studies relied on maternal self-report, and most of the studies asked the women at about each visit to their OBGYN during their pregnancy, at least every three months during their pregnancy, they ask them, "Did you take any medications? What medications did you take? How much?" In many cases.

So, one of the concerns people have is that people won't remember very well. We're asking in a relatively close time period to when the exposure's occurring. So, we're asking about the exposure before the child develops autism or ADHA. A case control study, which is another type study when we take the kids who already have this disease and then go ask what exposures they had. So, when the child is five or eight years old, go ask, "What did you take while you're pregnant?" Well, they're going to have a hard time remembering. So, now there are over 30 studies that are cohort studies, the type where we followed the women during their pregnancy and then follow the children. That suggests that acetaminophen increases the risk of neurodevelopmental disorders when taken during pregnancy of the neurodevelopmental disorders of the offspring.

So, more recent studies have improved methods and they found an even stronger signal. Some of these more recent studies have measured the amount of acetaminophen in the infants cord blood, in the meconium or the mother's urine, or the mother's plasma. And so, we actually have measurements of the acetaminophen. And those, we get even a stronger signal of an association between acetaminophen and these neurodevelopmental disorders. Primarily what's been investigated and found is ADHD, but also autism has been found in a number of studies.

Matt Dolman:

So, I've seen 16 studies now that show a dose-dependent dose response relationship, meaning the greater the dose, the higher level of acetaminophen that was either measured in the cord blood or that was reported in observational study, the greater the rate of incidents of autism spectrum disorder in terms of diagnosis, or ADHD. In fact, the science looks better actually for ADHD than it is for autism. But there's an association for both. And that's some of what we're going to discuss today, Stan and I are interested in is attacking the science because we're proponents of the science. But how is this going to play out in litigation? How's it going to play out when the federal standard is Daubert and when they eventually have the Daubert hearings in this case, what does the science look like? As some of the critiques are based on the fact they're observational studies, and the inherent biases that are related to observational studies and the lack of a control group. For instance, in the Johns Hopkins study that came out in, I believe it was 2019, that was published in JAMA Psychiatry.

Ann Bauer:

Yeah, let me explain something about that study. And any study. We have a number of research studies that suggests that acetaminophen is ubiquitous within the population, meaning it apparently is in our groundwater. So, everyone is going to have a very low level in their blood. So, what you see in that Hopkins study is they were able to divide into three groups, but there is no unexposed group. I don't know that you're going to find a completely unexposed group anywhere. It's been around the world that they found that it's in the groundwater. So, I personally don't think that's a valid criticism of the Hopkins study. They divided into tertiles of exposure and compared the lowest group of exposure to the highest group of exposure in the middle group. I would still say that the very low level is a valid control group because of this situation.

Stan Gripe:

Ann, let me back up and make sure I understand the different types of studies you're talking about, because Matt's looked into this a lot more and I'm probably a little closer to a layman when it comes to some of this. When we're talking about your cohort studies, this is just people who show up to the doctors, you get them at the beginning of their pregnancy, and they're reporting along the way what kind of drug intake, acetaminophen intake, and other stuff they've got during the pregnancy. After the person has the baby, then going back and looking and saying, "All right, well did this child have any ADHD or autism?" And then you're looking retroactively at the acetaminophen consumption based on self-reporting along the way. Correct?

Ann Bauer:

That's correct. For a good portion of the studies. You stated it very nicely.

Stan Gripe:

Okay. So, that's kind of where you're talking about those 30 studies that show that there was some sort of correlation, right?

Ann Bauer:

Correct.

Stan Gripe:

Now, correlation, for the layman, doesn't necessarily mean causation. Because there could be something else in the pregnancy that's causing pregnant women to take acetaminophen, and it could be that underlying cause that the reason they're taking acetaminophen could also have been the cause of the ADHD or autism. Correct?

Ann Bauer:

Right.

Matt Dolman:

Which by the way is the greatest critique of the research out there is, could the underlying conditions cause this?

Stan Gripe:

How does that dovetail with the cord blood studies? It seems like the core blood study starts to move us out of that just, hey, it's correlation, to now we're looking at a higher concentration equals a more likelihood of the occurrence of the underlying condition.

Ann Bauer:

It's a better exposure assessment. And so, it's better to have an actual biomarker than to be asking the mother. Although, you're not getting the full complement of exposure, you're only getting exposure for a short period of time by measuring cord blood because the half-life is fairly short for acetaminophen. You're only capturing four hours to eight hours worth of exposure with that. The best design study may be capturing both biomarkers as well as maternal report, but like a daily diary. But I do want to say all of those studies that were done, the researchers did try their best to control for potential confounders that they were aware of. So, almost all of them control for the reason the woman used the acetaminophen. They controlled for things like age, and they controlled for socioeconomic indicators. Many tried to control for genetic confounding by using various methods.

Not all of them, but some of them. But I think the key is that all these studies from around the world pretty darn consistently come up with there's a signal suggesting there's increased risk. And I think that the ones with biomarkers are important. It's harder to argue with the biomarker studies. But again, they can still potentially have some of these confounders. And there's always concern about confounders that the researchers didn't even think about or don't know about. So, the associations are modest. So, it is possible that other factors can explain these correlations. I would argue though that it's important to look at the animal studies because they also consistently find an increased risk of autism-like behaviors that are altered behaviors, and they've dissected the brains and found alterations in the areas of the brain that we think are associated with these disorders.

So, I think that's really important because an animal study is not subject to genetic confounding. The two groups, they do a control group and a treatment group, and they're randomized. The animal studies, so genetics aren't really a factor with those. And the reason that indication for use can't really be confounding those findings. So, I think it's important to look at the totality of the research.

Stan Gripe:

All right. I want to ask you a little more about that, because that's something that to me, it looks like we're able to do certain things with animal research that might not be necessarily ethical or possible to do with human research obviously.

Ann Bauer:

Absolutely.

Stan Gripe:

So, this animal research, we can get the control group and the group that we're actually feeding the acetaminophen to at known, rates at known times, and known exposures. Correct?

Ann Bauer:

Exactly. You can control everything. And then afterwards you can look at the brain, you can look at the placenta. You can't really do this and look at the fetus. You can't do these things with human studies, obviously.

Stan Gripe:

So, what is it the animal studies have found in general?

Ann Bauer:

They seem to point to a specific time window that we're exposed ... The human studies and the animal studies suggest that risk exists all through the pregnancy. However, they seem to have pinpointed a period of greatest risk right around the time of birth. And that may be why these cord blood studies from John's Hopkins found such strong associations. So, that may be the time of greatest risk or it may be just the better measurement of exposure. So, they're finding changes to the hippocampus that are reflective of ADHD and autism. They're finding behavioral changes in these animals. Similar repetitive behaviors, changes in their sociability, they're finding different type behaviors that look somewhat like what we're seeing in the humans. I mean, it's not exactly translatable. We can't say we gave a mouse autism exactly, but we can say, "Oh, these behaviors look very similar. They're having different behavior when they're doing these." They have all these different tests.

Matt Dolman:

Can we say it impacts the fetal brain development of an animal?

Ann Bauer:

Absolutely. In the animal studies, we're seeing behavior and neurodevelopmental changes.

Matt Dolman:

So, we know that acetaminophen has a very short shelf life, or half-life, I should say. Apologize. My question is, and it's like the greatest critique of the cohort study, at least the Johns Hopkins study is, does the acetaminophen level in the umbilical cord blood sample, does that represent acetaminophen use during pregnancy though? I mean, because it's again at a very instant time at the time of birth. So, how do we actually translate or extrapolate that data to show what a pregnant woman used, and what the real exposure was in utero to that baby throughout the tenure of pregnancy? And is it just during that exact time? Because women would obviously use painkillers more preceding birth.

Ann Bauer:

It's certainly possible. There's some studies that suggest there's some accumulation, but majority of it is reflecting the exposure right before that baby was born, in that day or so before. I was reading an animal study yesterday that says from prolonged use it's accumulating more in the fetal brain than in the maternal brain. I don't know exactly if that's translatable to humans, but it appears that prolonged use is what we should be most concerned about. I think the risks are relatively low if you look at taking it one time during pregnancy. We're talking about the people who are taking it for days, who are experiencing a situation where they have to take the acetaminophen for days on end.

Matt Dolman:

So, because we know the underlying factors such as the reason why women take Tylenol or acetaminophen while pregnant is fevers, pain. And fever especially, that is a cause in and of itself of neurodevelopmental disorders such as autism, ADHD.

Ann Bauer:

That is true. And so, that's where the caution comes in that we do not want women to hear this information and then decide not to treat a fever. They need to speak to their physician in the case of a fever. However, that's not the major reason that women use acetaminophen during pregnancy. Fever and infection represents about 35% of use. The rest of it is headaches, back aches, girdle pain, just discomfort and nuisance pain, some of it nuisance pain that they experience during pregnancy. So, I think at this point we don't have a great alternative, and doctors may still need to recommend that women take acetaminophen for fever. However, I think there needs to be a serious discussion about do you really need to be taking this for these other indications? Are there other ways to try and minimize your headache? I think we need to seek alternatives for that.

Matt Dolman:

So, it's not the occasional exposure, it's the prolonged exposure, the use of it over and over again, especially in the later trimester. Is that correct? Where you believe the association's strongest?

Ann Bauer:

That's where what the research seems to suggest. Yes.

Stan Gripe:

All right, it seems to be like a more judicious use of the product would probably be recommended. Hey, did we need the lower dosage? Do we use the minimum amount possible? Don't take four pills just because it hurts. Realize that there may be a risk faster associated each time you take this drug. So, take it as little as possible during pregnancy.

Ann Bauer:

Right. It's practical to say at this point, because there isn't another alternative. I'd like to see a better, safer alternative developed, but we're not there yet. And so, that we could say avoid this. But at this point I think we know enough to say people should be cautious. And I'm really thrilled that these lawsuits are happening just because it's going to get the word to women. Whether they believe it or not, they're going to think twice when they pick up that pill the next time. These pregnant women are going to say, "I remember hearing this. " So, I mean I'm very happy that you're helping educate.

Matt Dolman:

Yeah. My only worry is though, at the same point we're championing the cause. I mean, we are representing a number of clients ourselves, or a number of women who subsequently had children that were born with a neurodevelopmental disorder that had that used acetaminophen during pregnancy. My worry is if the lawsuits fail, does that embolden the critics, the individuals who think this is nonsense? And further, what's the latest science? I mean, is there studies that are being done right now? And then when can we expect at the, and can we expect, that the FDA is going to eventually take action? And when will the American College of Obstetricians and Gynecologists heed the warning and actually take a look at what ... I think it was a 2021 when you were one of 90 scientists, I think it was. Was it 90 or 91 scientist?

Ann Bauer:

91.

Matt Dolman:

Okay. That penned that consensus statement. Why is that not being heeded by the American College of Obstetricians and Gynecologists? I know I asked a bunch of questions there.

Ann Bauer:

Yeah. The ACOG, the American College of Obstetricians and Gynecologists, did take a look at the research and they were not ready to take a stand. They felt more research was required. The FDA reviewed all the evidence in 2015 and put out a statement. But at that point, there were like three studies there. I hope that they will look at it more thoroughly again. I heard rumors that they looked at it, but they have not published anything to say that they've looked at it. Again they would like more research is what they're saying. I know my colleague, David Christensen, he was writing to me about something else today. He said he has a number of studies along these lines supporting this hypothesis that are going to be published soon. His work is not cohort study, he's in the realm of the animal models.

Matt Dolman:

As in published over the next year?

Ann Bauer:

Yes. Since our consensus statement came out, a meta-analysis came out from six European cohorts, combined their data, and they found the association both to a prenatal exposure to acetaminophen, and ADHD, and autism.

Matt Dolman:

I looked at those. That covered 70,000 pairs, right? Am I correct in that?

Ann Bauer:

That's correct. I was just reading it the other day and I didn't realize that they found about a 20% increased risk of ADHD and 30% of autism. I might have that switched. Because the nuance needed to be able to combine data from six different collection methods, and they only looked at did you take acetaminophen during pregnancy or did you not? It was a yes, no, which is a very weak exposure assessment yet they still found a signal. I just don't think that's a very accurate measurement to say ... Because what we're seeing is if you took it just once, it's a big difference from taking it 30 times in your risk. So, I thought it was really interesting that they still were able to find the association. So, and meta-analysis ranks at the top of the scientific evidence pyramid. So, it's important that they found it, that they found risk. I guess the concern however is that it's still minimal risk. It's not a strong enough signal that it isn't possible that it can be explained by other factors that they were unable to measure.

Matt Dolman:

What's the threshold of when you get to a significant risk?

Ann Bauer:

Obviously, depends on who you ask. 20 or 30%. I would gander closer to 50% increased risk would be more that you could buy. Oh, when I had a meeting with the Mother to Baby organization about four years ago, they told me they wanted to see a relative risk of six before they would take any action on a medication. A relative risk of six. The only thing I think that's ever reached that threshold, very few things, cigarettes and lung cancer has reached that threshold. The recent Harvard study on MS, and it's linked to a virus, that reached that threshold. But it's a very difficult threshold. We do not see that often in research.

Stan Gripe:

Not to interrupt you. What does that mean? Relative risk of six?

Ann Bauer:

Took acetaminophen are six times more likely to have autism or ADHD than someone who did not take acetaminophen.

Stan Gripe:

Okay. So, when you say relative risk of six, that means it's multiplying your normal risk of acquiring this problem by six times if you associate it. So, a doubling of the risk, a tripling of the risk, a quadrupling of the risk isn't going to hit that threshold for the organization you're talking about.

Ann Bauer:

That is what they told me at that meeting.

Matt Dolman:

That's troubling. Yeah. I mean, for instance, and not to change the subject here and another gear, and I don't know if you follow this at all. So, another area that we're handling right now or another lawsuit print that's forthcoming, is the risk of uterine cancer and ovarian cancer from hair straightening products for Black women and Brown women. So, it's Hispanic and B;ack women are having ... Forever, they wondered why do they have a disproportionately high rate as compared to white women of ovarian cancer and uterine cancer? Well, as explained by the fact that they use the chemicals that are in the ... And it's endocrine disrupting chemicals that create a two to one, it doubles the risk. Doubling the risk, wouldn't you think that's troubling?

Ann Bauer:

Yes. And I think to me the threshold has to be that it's high enough risk that it can't easily be explained by other factors. So, doubling the risk, it's very difficult to say that they didn't control for something and that caused it to appear to be double the risk. And that's the importance of the Baker study on ADHD, which looked at meconium. And the beauty of the G-studies from Hopkins is that they found twofold, and what was it? 3.6 for autism in the G-study? In the cord blood? Those relative risks, or odds ratios, I forget what they used, but it's a measure of risk, are high enough that it's unlikely that association can be explained by other factors, by confounding factors.

Stan Gripe:

And I want to get something else to you. Well, when you're bringing this up you're not saying that this is so dangerous it needs to be pulled off the market, women shouldn't be able to use it. We're simply saying, "Look, if these risks are increased, let people know. Put a warning on there. Let women know that this may contribute to causing ADHD or autism so they can make an informed decision when deciding, 'Hey, do I want to take a little more pain and a little less acetaminophen or not?'"

Matt Dolman:

And Stan, you hit it on the head. I mean, that's the whole essence of this lawsuit is a failure to warn. The generic manufacturers of ... I'm sorry, the manufacturers of generic acetaminophen and the manufacturers of Tylenol, which is a subsidiary of Johnson & Johnson should have warned pregnant women. It never had that warning there.

Stan Gripe:

Now, I want to address something else, and this is probably a little selfish for Matt and I. But Matt, we do a lot of stuff on social media. And continually on social media we're getting attacked as this is something that attorney throws up-

Matt Dolman:

Oh, Ann's aware. Ann is very much aware. She's come to my defense several times.

Stan Gripe:

Listen, you see this. So, you see what's happening is people are attacking this as though we created this, or somehow we created these studies and are now going after this. When did you start first noticing these studies coming out?

Ann Bauer:

So, I'll tell you a little bit about my journey. So, I was studying epidemiology and we happened to have a conversation early at lunch one day. And one woman was pregnant and worried about her child having autism. And I spent the afternoon looking in PubMed. I had just learned how to use it. And I found these studies by Steven Schultz. His first study came out in 2008. His second study that's important is in 2011. And both of these are not high quality research, but they were suggesting that acetaminophen might be a causal factor. And I thought his arguments were compelling enough that I kept digging. And every time I kept digging, I kept finding more supportive information. This didn't make sense. So, I did an ecological study in 2013, and soon after that the first good cohort study came out of Norway in 2013.

So, this has been around for a while, but it somehow hasn't gotten much traction. I've tried, I've been out there on social media trying to inform people. My mentor went to me after I published my study, more of a hypothesis study. He said, "You got to let the women know. Go down on social media." And I've been trying. So, I think the problem you're having is that people think that you came up with this, that this is new information. People don't know. And people, when I see things on Twitter and such, they talk about one study. There isn't one, there are 33, 34 human studies.

Matt Dolman:

The biggest problem is, and I hate to say this, but the anti-vaxxers. And you see it all the time and anytime I have a Twitter feed and I discuss this, they want to hijack the conversation. And I'm not saying vaccines are perfect. I am a proponent of them and I was vaccinated for COVID, and got the boosters. I'm not saying that they're perfect. But at the same point though, there's never been any peer reviewed medical research out there, there's no literature out there that suggests that there is any causal link between any of the vaccinations and autism. And that's been debunked, that's been discredited. Wakefield was ... I mean, he's an embarrassment to the profession. We all know this. But I believe that created a stigma, if you will, of those who are trying to come out with any other explanations for autism besides genetic.

Ann Bauer:

Absolutely. And it's impacted the funding, I believe. It's been very difficult to get funding to research in any environmental factors. And there are a lot of studies that do say it's highly genetic. These disorders are highly genetic. However, we know there are environmental triggers such as Valproate, which is an anti-epileptic drug. We've known that for a long time that that's a trigger for autism. If you believe that any of this prevalence increase is real and not just better diagnosis and more awareness, there has to be some environmental factors involved. Genetics don't change that fast.

Stan Gripe:

Can you explain maybe the concept of a trigger there when you were saying, "Hey, this is genetic and that may be a trigger"? What's that whole concept there?

Ann Bauer:

I'm not an expert in this area, but I think people may have a genetic predisposition. You may have had family members that tended to be have similar type behaviors. So, you have a predisposition and then all you need is an increased level of oxidative stress that's brought on by acetaminophen to trigger it in a particular individual. I don't know the exact mechanisms. There are other ones that people are proposing. And we know acetaminophen is an endocrine disruptor. So, we know it's doing things to hormones. But we know it's quite obvious that not every person who takes acetaminophen during pregnancy is having a child with autism or ADHD. It's just like smoking and lung cancer. Not everybody who gets exposed gets the disease. So, there's got to be some other pieces, other factors at play.

So, I think perhaps it's genetics, most likely that's a piece of the puzzle, and maybe timing of exposure, and maybe the length of exposure. But there are a lot of factors. So, we are learning more and more about epigenetics, which is the interaction of genes and the environment. And most diseases we're finding really have an environmental component.

Matt Dolman:

And that's why I try to explain it when we get calls from women or even their husbands asking about this lawsuit, they're asking me, "Did I cause my child's autism?" I'm trying to explain to them this is not the cause. The most likely cause genetics, but it is a possible ... We believe it is a cause. It's a possible cause. But it's a factor to be considered in the totality of circumstances. But it's not the cause. And I think some individuals have trouble grasping that concept.

Stan Gripe:

I kind of think it increases the risk of it, and it may be the cause in certain people. But to say that it is a cause in all people, I think is where you get the long. But I think it definitely shows that in some people the acetaminophen is the cause.

Ann Bauer:

I think that's correct. I like to bring people back to smoking and lung cancer, because people understand that. Not everyone who gets lung cancer was a smoker. And not every smoker gets lung cancer. It's the same kind of thing. There are other causes of autism and we know some of them, we have some clues. We know some things, like pesticides can could be a factor. Air pollution has been repeatedly found as a factor. So, there are other causes out there. But I think acetaminophen is an important cause because so many women use it. 65% of American women will take acetaminophen during their pregnancies. 50% in the rest of the world. So, it's an exposure, directly ingested exposure. And the other thing to remember is it's easy to take too much of this drug.

It's in 600 different medications. So, if you're taking a cold medicine and you decide to take acetaminophen, you're getting too much. The therapeutic index is fairly narrow. It's the number one cause of acute liver failure because of its toxicity. So, it's not a benign substance, but it has a reputation that it is. And I think that's part of the education is this is not a benign substance.

Matt Dolman:

Understood. How do you think the science is going to be attacked by the defense?

Ann Bauer:

I think on genetics, and I think on indication for use. They're going to go and say that it was really the fever, the reason the woman took the acetaminophen that's the cause. I think those are the two major reasons it's being attacked. And also the other issue with autism and ADHD is it isn't like you can get a blood test and diagnose it. It's reliant on we have scales to measure behavior. We have doctors diagnoses, but it's not a hard and fast diagnosis. So, they can attack you on exposure. We didn't measure that well. They can attack you on the outcome, isn't measured as well as in some other studies. And then the confounding factors and the biases, those are the things. I think the animal studies are particularly important. And that's been totally ignored by the American College of Obstetricians and Gynecologists, and the FDA. The fact that they're all saying the same thing, to me it's a strong indicator that the epidemiology is correct.

Matt Dolman:

Understood. Because again, the confounding factors don't relate to animals.

Stan Gripe:

Yeah. I want to ask you about something you said in the beginning that some people who are listening may either find incredible or something that they just didn't really have the concept, because I looked into this years ago. We get a lot of stuff in our groundwater in really small measurable concentrations. So, you mentioned something like everyone gets exposure to acetaminophen because it's in the groundwater. Explain that a little bit. We're not talking like high concentration, we're talking like parts per billions or something like this, aren't we?

Ann Bauer:

Yeah, I'm not an expert on this either. But I know that David Christensen did a study and they were shocked when they first found that everybody in his Danish cohort was exposed. It is very low concentrations. But Matt said specifically that the Johns Hopkins study on cord blood didn't have a control group. And I think that's one of the criticisms, but it's not exactly because I just don't think that the people who lodge that criticism understand that everybody has this low level. You've seen the studies that newborn babies have 200 chemicals in their blood when they're born. People are exposed to low levels, very low levels of chemicals, and it can be detected when you're doing these type studies.

Stan Gripe:

And when you've got sensitive measuring devices, I've looked into this, it's amazing the different stuff they found in groundwater, tap water in different places, including narcotic drugs, things like that, that you'll find at these ultra, ultra low levels. And I was shocked. So, it's just a concept I wanted you to get into a little bit more because some people may listen to this in the beginning and go, "Wait, acetaminophen's in the groundwater? This lady's crazy. How does that happen?"

Matt Dolman:

Well, we're learning more about forever chemicals, and then PFAS and PFOS, and those are just from firefighting foam, fire retardant chemicals that are now getting into the aquifer and the water base. You can't get rid of the chemicals, one, and it's getting into the aquifer and we're drinking it.

Ann Bauer:

I mean, the good news about acetaminophen is that it has a short half life. It's not like PFAS, it's going to be around forever. But because-

Matt Dolman:

Bad analogy, I apologize.

Ann Bauer:

No, no, it's fine. But we're constantly using it. The fire foam, they pretty much stopped using and it's still a problem. About 150 million Americans will take a pain reliever each week. And so, some of it's absorbed into their bodies, but some of it is excreted through their urine, goes into our sewer systems. Some places treat and can manage to remove it from the groundwater, but there's still low levels in the groundwater. That's why you're seeing it. Even in people who say they're not exposed in that Hopkins study, they still had a very low level in the cord blood.

Stan Gripe:

That's a controversial program we've got here in our area. The people who are against it call it toilet to tap. Because they don't like it. But it is, there's a way that people can go re-treat and dilute excrement, waste water, so kind of the gray waste water, and put it back into use in areas where you've got limited fresh water resources. It's an accepted method of getting water back to use. And sometimes it may be reclaimed, sometimes it may be re-treated, but all these things eventually make it back down into our groundwater in some minuscule, minuscule amounts.

Ann Bauer:

But then again, we don't know. We don't know. Are these exposures all additive? I mean, do they interact? We have a lot to learn. We don't know. So, endocrine disrupting chemicals or interesting in that low levels have effects, which was a real challenge to conventional toxicology was that low levels can have adverse effects. So, we don't know. We have a lot to learn.

Matt Dolman:

I mean, we're going to wrap up in a second but I wanted to ask you about, you mentioned David Christensen, the researcher who's your colleague and friend. Are any of his studies speaking to these topics on these confounding factors? Or what is his latest research about specifically regarding any link between acetaminophen and autism?

Ann Bauer:

His research is using animals. So, confounding is not the issue with his work. I think he's going to try and replicate some of the prior studies. He may be looking at some interaction with other chemicals. I haven't seen exactly what he's doing. But his work has primarily focused on the reproductive issues involved with taking acetaminophen. And that research has actually been going on longer. There's male congenital malformations that are associated with using acetaminophen during pregnancy. And he has done a lot of the animal models and worked on the mechanisms, which seem to be depletion of testosterone, which also my other colleague, Shauna Swan, has done a lot of work on testosterone reduction, and has pub published a book on sperm count decline across the world. Which these are all seem to be related to endocrine disrupting chemicals. So, David is just shifting over to looking at the neurodevelopmental side because that seems to be where most people are focused at the moment.

Matt Dolman:

Okay. Well, we greatly appreciate your time. You're a wealth of knowledge, and I know that this is a body of science that continues to evolve. It's fluid. And we're probably going to have you on as a guest in the future as this lawsuit continues to develop and move forward. And I look forward to reading David Christensen's new studies when they're published and seeing if you know of any other studies that are coming out, or anything that comes to light, just obviously let me know.

Ann Bauer:

Will certainly do that.

Matt Dolman:

I appreciate you, Ann.

Stan Gripe:

Yeah. We really appreciate you taking time to be on here. It's been very informative.

Ann Bauer:

Well, I hope I gave you some insight, and I appreciate you listening. This has been a passion of mine for a long time, and I'm so glad that we're finally getting ... We're informing pregnant women so they know at least, so they can make informed decisions and choose wisely with their use of medications during pregnancy.

Matt Dolman:

And hopefully over time that the American College of Obstetricians and Gynecologist heeds the warning. Or there's enough of a body of science that will change their opinion to at least realize that this is a potential cause, and they should at least warn pregnant woman about regular use of acetaminophen.

Ann Bauer:

Yes. From your lips to their ears. Yes.

Stan Gripe:

Absolutely. We really appreciate it.

Matt Dolman:

Well, that wraps up another episode of David V. Goliath. Stan, anything else you want to add?

Stan Gripe:

No, no, I think we got everything here.

Matt Dolman:

Well, appreciate your time and have a great day.

Ann Bauer:

You too. Thank you so much.

💡 Meet Your Hosts 💡

Name: Matthew A. Dolman, Esq.

Title: Partner at Dolman Law Group Accident Injury Lawyers, PA

Specialty: Matt is a nationally recognized insurance and personal injury attorney and focuses much of his practice on the litigation of catastrophic injury and wrongful death cases throughout Florida. 

Connect: LinkedIn | Twitter | Instagram 

Name: Stanley Gipe, Esq.

Title: Partner and Head of Litigation at Dolman Law Group Accident Injury Lawyers, PA

Specialty: Stan is a Florida Board Certified Civil Trial Lawyer. This distinction connotes expertise in the discipline of trial practice. He has served as lead counsel on over 1,000 Florida personal injury lawsuits.

Name: Ann Bauer

Title: Epidemiologist & Researcher at University of Massachusetts, Lowell

Specialty: Epidemiology and Research

Connect: Twitter

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