The Tiny Lab Finding Poison In Your Pills

they do a pretty good job of it. But recently, an independent lab called valish Or has started doing its own testing of big brand name products, and they've turned up some concerning results. Zan Tech is a popular pill used to treat heartburg a new research that it could be linked to cancer as prompting retailers to pull it

off their shelves. Johnson and Johnson voluntarily recalled a number of popular sunscreen brands after traces of a cancer causing chemical were found inside dry shampoo, but it's safety is being questioned yet again. The concern high levels of benzinge, a cancer causing chemical, detected Elevated levels of benzinge in a number of sanitizing products on the market. My colleague Anna Ednie joins me now she's a national healthcare reporter here in Washington and Ednie, thanks so much for coming

on the show. Thanks for having me. Do you've written this really interesting story about a company that is testing some of the biggest, best known drugs a lot of us take them, uh and finding some dangerous stuff in there. Tell us about this company is called valascher Balasher is an analytical lab based in New Haven Kinnectic Hit and

they started off back in as just away. They thought there was a gap in the market that you know, there wasn't a lot of oversight of drugs once they are out there and approved by the Food and Drug Administration, and you rely on the pharmaceutical companies to hopefully be doing some of this. But what they have found is they're not always testing for maybe some certain impurities or um some of the drugs might not be dissolving like they should be, and so they wanted to take a

look at that. But their biggest findings that they've made in recent years was looking into dantach and they found a carcinogen that has abbreviated n d m A. I'm not going to try to say the full name on this podcast of that chemical, but it used to be used in rocket fuel, and so Zantac, of course, is one of the most used medications in the US. Remind people what it does. It's a heartburn medication among other things.

You know, a lot of stomach issues that it can be used for um and they even give it to babies and a liquid form who you know have had upset stomach issues. And so it was one of the first blockbuster drugs. We define that as a drug that's sold more than one billion in sales. So it was approved in nineteen eighty three by the Food and Drug Administration and it was just extremely widely used for decades until Valisher came along and did some testing and found

this n d m A in there. So vlischert tested Santech they found this d m A. What does n d m A do. It's what the World Health Organization calls a probable carcin engine. So the w h O ranks carcinogens things that can cause cancer and humans. And there are your definite carcinogens like A S. Festos and then a probable carcinogen is a chemical like n d m A, where it's shown to cause cancer in animals,

but there just hasn't been human testing. And why was this substance in zanta It's an interesting case because Zantac was actually forming n d m A on its own, as it sits on a shelf that can form n d m A, and particularly in higher room temperatures, so you can think about like a delivery truck in the summer or your bathroom, um, where a lot of people store things in their medicine cabinet, is enough to cause

the n d m A to form. It's a chemical reaction between some of the ingredients essentially and the manufacturing process that the Antach used. So this is an unforeseen consequence you by this stuff. It's completely fine to stick on the shelf, use it every now and then, and at some point some of it may develop this substance, which could potentially be pretty bad for you. That's exactly right.

And um, you know, at this point, like Santac was made by many different companies, so it was widespread because the patent on Zantech expired and so generic makers were then allowed to make their own versions of the same drug. That's right. The generic companies were able to make what we call renitodine. It's the active ingredient in zantac, so they don't use necessarily the Zantac brand name. But the

generic companies were making renitodine. But then the FDA stepped in and said, you couldn't make any of those versions with that ingredient, and so they pulled it and then reintroduced it with another ingredient that was safer. That's right. The f d A asked the companies to withdraw their zantac and renitodine, depending on which version they make, and now it is back on the market using a different ingredient from motadine, which is the same as in pepsid.

PEP said, of course, another herdburn medication. That's pretty popular, right, Um, so valish your chok it upon itself to test this drug. Why why did they bother doing that? It goes back a little bit. So there was a drug, it's a heart medication called val sartin, and back in millions of these pills were recalled by the genera companies that make them and ones like them Low Sartain, Herbis Sartain, and they were recalled because n d M A, the chemical

we've been talking about, was found in them. You know, just in the course of knowing that that happened, it was it was a huge recall, and no one had really taken it to the next step and tested the drug for it, and so they just decided to test the drug. Now, if there was all this scientific literature saying that there was a possible cercinage in in this big drug, why didn't the manufacturers tested themselves? That's a

good question. It's been an interesting journey watching Vallisher do this and kind of seeing the company's respond and sometimes even seeing how the Food and Drug Administration responds. They often can be slow and with a regulatory agency, it's bureaucracy and red tape sometimes, and you know, we don't really get great answers from the drugmakers on why they wouldn't have already been testing for Was it difficult for valich or to find this? Is it a laborious testing process? No,

I actually got to see this testing process. I visited their lab in Connecticut and it's a really big, expensive machine. I mean, you and I couldn't do it, but any drug maker has to have this machine because they're doing all kinds of tests on it's the gold standard for how you test things. But does the f d A actually do any testing of its own or is it relying completely on what the drug makers tell them about the drugs. The FDA does not do any testing on

its own. They have to rely on what they're told about the drug. They try to their best to verify that the data is right and it's not manipulated in some way. They do very very very tiny, tiny amount of checking in on some of these products that are already on shelves. Do you think when a company like Valishort tests and finds a possible car sin gen in a very popular drug, the FDA would welcome that information,

but you're reporting found different. A lot of people would and I would assume that the FDA would welcome that information is something that's helpful to them. But Lasher has done it, not just with Santac, but personal care products like sunscreen and anti perse brant as well. And the f d A really pushes back with Zantac. They pushed back pretty hard and you know, tried to be little Lasher's data. Why do you think they had such a negative reaction to a discovery that could possibly harm users

of this drug. I think it's a really curious question. I've covered the FDA for a really long time now what I've seen with these kinds of situations, valischer Um is the biggest that it's happened to, But it has happened in the past where researchers have come forward with some disturbing findings about a drug and they've been fought most of the way, and so the reaction from the FDA just always seems to be defensive at first. I guess one question a lot of people might be thinking.

I know I'm thinking it is the FDA just in the pocket of drug makers. Is that relationship where they're reliant on drug makers to give them all the data which then they approve or disapprove of create a power imbalance here? Yeah, I think it's a phrase I've heard a lot is regulatory capture in relation to the FDA,

and what is that? What it means is is when an agency works really closely with an industry, and in this case, the they do with the drug makers um, and it's so close that it's eventually seems to turn a little bit and that the agency is working more for the industry rather than the people it's supposed to protect. And it's not necessarily nefarious or money exchanging hands or something like that, you know, behind closed doors, but just a cued outlook from being sort of isolated and dealing

with the industry so much. And Ednie, thank you for joining me today. It was great to be on. Thanks West. We'll come back to this idea of whether the f d A is too close to drug companies in just a bit, but first I talked to the CEO of Avalisher, the lab that started all of this. I'm here with David Light, the CEO of Valicher, the company we've been talking about. And David, I want to start by asking

you what made you think to even tests antech for carcinogen's. Yeah, so Valuscher actually started off commercially with its own pharmacy. So our pharmacy was our biggest client, and we would be testing every batch of every medication that we dispensed all over the United States. So Zantech was just part of our standard screening that we were doing at Valisher and back in two thousand nineteen when we owned the pharmacy,

So it batches of zantech. I mean, you get, you know, hundreds of bottles of it coming on the shelf for the phremiacy, and you would test a certain amount of it, right, So what we would test is just a sample from a large batch. So for example, if we had ten thousand tablets that we would buy it from, our wholesaler, will take a few of those tablets, analyzed those before

we dispense any further tablets from that batch. What happened actually with Zantex specifically, was we had just added our carcinogenic analysis screen where we were looking for probable human carcinogens like n d m A. And it was actually one of our co founders, his infant daughter was prescribed a syrup version of zantec or nittatin, and we put it through our system and we're chocked to find essentially what became the fundamental instability of the zantec molecule that

was forming very high levels of n d m A. Once you discovered this, obviously a big deal, you want to let people know so that it doesn't continue to happen.

What happened next? Who did you report it to? So we filed an FDA SISM petition with the FDA, and it was also picked up by a lot of press in including Bloomberg, and it was great to see that there was a lot of recognition of at least what we perceived as the problem back in September of two thousand nineteen, which was that there was a fundamental instability

in the molecule. So in September there's also an announcement by the f d A and the e m A, the Upeans Medicines Agency that came out on renting products including Zantac, saying that there was a small level of

n d m A detected as a contamination. And although that might be true and was shown to be true later on, we were much more concerned that it wasn't just a kind of batch to batch contamination manufacturing problem, but a fundamental problem with the drug itself that was not just being contaminated, it was actually forming the carcinogen and d m A. When you reported this, uh, how

did the FDA respond? So they originally responded with that statement in September, you know, saying that this was kind of a small contamination problem, and six months later they actually did agree with our petition from the standpoint of withdrawing the drug entirely. So by April of theft, he withdrew all Rendine products from the market. Valoischer's kind of

a loan in its field in doing this. If drug companies spent a whole lot of money testing their drugs for safety, and the FDA spends a lot of time scrutinizing it before they give it approval, why does your company need to exist? How is it that drugs are going out there with these flaws in them? So I think there's again a lot of misconceptions about what the f d A process is and how many facturers fit

into that. But what stince on the market and being manufactured, it's really just the manufacturers producing those lots and those batches of the medication and then occasionally testing and then self reporting that data to the FDA. So the kind of consistency of manufacturing quality is very, very different than that original drug approval billion dollar process that a lot of people are familiar with as part of the FDA process.

But once it's approved and on the market and that it's in manufacturing day to day, that there's a very different quality assurance world because the FDA relies on information from the drug companies and evaluating whether a medication is safe. Do you think that every drug as part of that approval process should go through an independent evaluation that that

should have become a standard practice. Absolutely, And the FDA does have independent review boards for drug approval, but again they're just reviewing the data that was submitted to them by the manufacturers. So having as part of that independent review process an independent chemical analysis, not by a quote unquote third party laboratory, but by a private laboratory, I

think is critically important. And the fact that Vlisher, a new and relatively small company, can have found so many of these problems in such a short period of time, I think it's fundamental proof that this is very much needed. And we're probably just scratching the surface. So let's sort of reception. Are you getting to your push to have independent labs evaluate the safety of drugs as part of the approval process. Do you think this is something that

the FDA will embrace them? Are they going to go for that? So we're already seeing large players going for that from the manufacturing standpoint, from the purchaser standpoint, and there is precedent for this. Even from a regulatory perspective, you know, you can't buy electronics in the United States. You can't buy a lamp or a laptop adapter without

it being independently tested. If you look at the badges that are on even your adapter, the CE mark, the U L mark, other marks that's actually required by regulation that those products need to be independently tested. If our

lamps are independently tested, why not our pharmaceuticals. Given all the testing you've done on a wide variety of medications and just products, what percentage of things that we use sort of on our bodies, like sunscreen, anti pur sprints and medications have some sort of harmful ingredients in them

that shouldn't be in there. Yeah, So it's a very broad question, and I can say that especially when we were operating our own pharmacy and we were looking very broadly in the pharmacy space, we were rejecting about ten percent of the batches of medications and consumer products that we were analyzing, and that could be for a carcinogenic contamination.

That could be the dosage wasn't with inspect where the disillusion how the tablet actually dissolves was outside of our specifications, but there's certainly areas that have much higher percentages, Like mentioned sunscreen. We we did a deep dive study and found the citizen petition, and we were finding benzene, a known human carcinogen, in about of the sunscreen products that

we analyzed. We did it also for body sprays and antipersprints, which are primarily aerosol cans, and we found about half of them were contaminated with benzine. And most recently, dry shampoo's a cosmetic product but often available in pharmacies. We found about seventy of those were contaminated with benzine. So given all that, how concerned should people be that the stuff they pick up of the pharmacy shelf is safe?

It definitely adds a layer of concern that I think is very important to understand that we do need more of this independent review. These are very serious and real problems. When you see these large recalls that often follow it underscores that this isn't just an area of general concern. You know, there are other chemicals like DP, a pair of bins, others that people hear about, especially in the consumer space, that wererant further study that are active areas

of scientists conducting research. But when we look at something like benzene is a completely different ballpark. It's practically a different planet. I mean, this is a molecule that has been studied for over a hundred years. There's dozens of epidemiological studies that have directly linked the exposure to benzene and increased risk of cancers in human beings, not just in animal studies, but in humans. So these are extremely

concerning compounds that absolutely shouldn't be there. That Day itself, specifically on benzine, says that these are unacceptably toxic, should not be used in any pharmaceutical manufacturing whatsoever. Not just the drug substance, but even the inactive ingredients that go into a product should not contain benzene. Then why is benzine in products? Well, it obviously shouldn't be. You're never gonna find it on a product label. Um, it's not

gonna say that it has benzine in there. And the reason that it's obviously there, as we've detected in multiple areas, is because independent testing doesn't exist in this world, and so it's probably assumed not to be there. It's it's been banned for decades, and it got into the supply chain, likely through the raw materials. Many companies have now pointed to the propellants through when you're spraying it, the thing that shoots it out of the can, right, what you're

actually spraying shooting out of the can. The propellants like propane and butane are petroleum discialists that come out of the ground and it is often contaminated with benzine and is supposed to be refined out, but apparently hasn't been and we were able to detect that at Valisher and I think it's actually a great example of how vulnerable the supply chain is and this problem wasn't detected anywhere

along that entire chain and likely for decades. David Light, thanks so much for taking the time to talk to me. Thanks so much for your interest in this. I really appreciate it. We asked the f d A if someone could come on the show. They declined. When I come back, more on that complicated, some say too close relationship between

the FDA and the drug companies it overseas. I'm here with Dr Diana Zuckerman, the president of the National Center for Health Research and Washington d C. Dr Zuckerman, thanks for being here, my pleasure. Can you tell us first just what is the National Center for Health Research? What do you do? We're a nonprofit think tank. We focus on the safety and effectiveness of medical products and consumer products, and we don't take funding from any of the companies

that make the products that we have valuate. Well, that is exactly what we're talking about here today. This testing lab vallisur has found harmful substances and potentially harmful substances in medications and other products that people use. In your own research, how common is that? Well, we don't know. I mean, that's the truth. I mean what we look at at our center is what data are available, what research is available, and sometimes there's no research available. So

what values SHURE is doing is very important. And let me say, I don't know them. I've never talked to people there, we have no relationship. But it seems that what they're doing is analyzing the safety of products in a way that nobody else is doing and that the

FDA is not doing so. Specifically with regard to the f d A, can you talk about why it is that the FDA that pharmaceutical manufacturers are not catching these ingredients when Valisher's lab has been able to detect them with sophisticated but not really very difficult or uncommon means. What we're seeing with some of these products, whether it's benzene or or other chemicals, what we're seeing is that in some cases these chemicals are part of the process

of manufacturing. It's not noticeable. And of course, a carcinogen doesn't cause cancer tomorrow, you know, it takes years. Even if a carcinogen becomes present as part of the manufacturing process, there would not be a way for the FDA to know if it was at a level that was dangerous except years later, and that's it's too late by that. How did it come to be that the agency overseeing the safety of these products rely on the reporting of

the manufacturer instead of doing independent testing themselves. The law that created the FDA is about a hundred years old. It's changed a little bit, not that much. You know, the FDA was a small, underfunded agency. They didn't have the money to do the studies. So the companies did the studies, and the FDA does vet the studies. They look at the research results. Sometimes they disagree completely with what the company says about the implications of the research results.

But there is an honor system, and the honor system is that the FDA believes that the data that the company is providing, the raw data, are accurate, and they don't check those, and there are certain other things that they don't check. And of course there's so many products that it would be enormously expensive for the federal government to pay for all of it. Do you think that that is going to change now that we're starting to see an increase in the discovery of harmful substances in products.

It sounds like the f d A hasn't been very enthusiastic about the value SURE analyzes, which I think is disappointing, and I'd like to know why that is. Why do you think that is As somebody who spends a lot of time looking at the f d A, why do

you think that would be. There's always going to be a certain amount of resistance to change at the f d A, And really they don't want more work to do now you would think therefore they would welcome somebody else doing the work if they can't do it, but they'll still have to check it, you know, So it's not like it's completely done by somebody else. So what you're describing isn't necessarily a situation where the FDA has

fallen down on the job. It's just that the resources they have and the rules that they work under don't actually allow for this kind of comprehensive testing. That's a great question, and I'm not sure that the law doesn't

allow for it, but the law doesn't require it. And what happens that the f d A is if the law doesn't require it, there are a lot of things they're not going to do because they don't have enough staff and they don't have enough for sources, but also because that's not the way it's been done in the past. The FDA has always been the gold standard in certification for the safety of products. I think most Americans probably see that the FDA proved it, they feel pretty good

about that. Should that be the case, should people have the kind of trust in the f d A that a lot of people do. The f d A has been the gold standard in many ways. It still is the gold standard, but there has been so much pressure from Congress and from industry to rush approvals that I know, for myself, i'd like to see a product that's been on the market for a while before I think it's really proven to be safe, because too many products are

getting approved so quickly on the basis of short term studies. So, for example, if you study how safe is a product over three months, but most people take it for ten years or twenty years, you have no idea what that impact is going to be on those patients. Has the amount of time the FDA now takes to approve drugs and other products gotten shorter over the years. Absolutely, FDA used to be criticized for taking longer to get products on the market than most European countries. Now they're at

least as fast getting it on the market. But you know, there's a difference because when a product gets on the market in the UK, for example, the National Health Plan won't pay for it until the evidence is clear, whereas in the United States, the FDA approves it, Medicare will pay for it, Medicaid will pay for it, insurance companies will pay for it, and there's not that gatekeeper to make sure that this really is a product that's better

than other products. So to some all this up for us, how should people understand the relationship between the f d A and Farmer. Is it that it's too cozy or is it that the f d A is too understaffed, has too much work to do the testing that we need. I'd have to say all of the above, but the

relationship is too cozy. And part of the reason why it's too cozy is because there are what are called user fees, where the companies are giving so much money to the f d A and having so many meetings with FDA staff that it becomes a much cozier relationship, much more difficult to have that tougher regulatory overview of a product and of what a company is doing. Dr Diana Zuckerman, thanks so much for joining me today. Thank you. You can read Anna Edmy's story on Valisher at Bloomberg

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