In the aftermath of a building fire, investigators study the scene for clues to the fire’s cause. They look for burn patterns and suspicious materials while chemists search charred debris for traces of flammable liquids. But investigating fires is not as straightforward as it once was, because investigators now know more about the complexity of how fires burn. In this episode of Stereo Chemistry, host Kerri Jansen explores how scientists are working to better pinpoint specific chemicals amid the chaos a fire leaves behind and how a new understanding of the chemistry and physics of fire has revolutionized the way fire scenes are interpreted.
The following is the script for the podcast. We have edited the interviews within for length and clarity.
John Lentini: You know, my dad told me that if I went to college, I wouldn’t need to use a shovel to make a living. But it didn’t turn out that way. If you want to investigate a fire scene, you need to have a shovel in your hand.
Kerri Jansen: That’s John Lentini, an independent fire analysis consultant based in Florida. John has shoveled a lot of burned and waterlogged debris in his career. He started as a chemist in Georgia’s state forensic lab in 1974 before expanding into fire scene investigation a few years later. And he’s investigated more than 2,000 fire scenes in the last 4 decades.
Then, he says, he watched the field of fire scene investigation hit rock bottom in the 2000s.
In 2009, an investigative article in the New Yorker publicized controversy over the interpretation of fire pattern evidence in the case of Cameron Todd Willingham, who was executed in 2004 after being convicted of setting a fire that killed his three daughters in their Texas home 13 years earlier. Fire investigators at the time concluded the fire had been intentionally set. Independent investigators began to raise questions about the conviction in the weeks prior to the man’s execution and in the years after. John Lentini was part of a panel, commissioned by the Innocence Project to review the evidence, that in 2006 determined the conclusion of arson—based on physical clues like burn patterns on the floor and fracture patterns in glass—was not supported by modern science. The New Yorker article focused an uncomfortable light on a field that was already reeling from criticism of its methods. Just months earlier, a report from the National Research Council had harshly criticized almost every discipline of forensic science—including fire pattern investigation—for a lack of scientific underpinning in its practices.
John describes this as a dark time for the field of fire investigation. The events called into question the trust the public and the criminal justice system placed on fire scene investigators.
John Lentini: What we have learned in the last 10 years or so is that the ability to determine the origin of a fire, which is a fire investigator’s core competency, that ability is questionable.
Kerri: Underlying that loss in credibility was that investigators’ techniques and training were sometimes based on faulty science—or no science. And although that was a difficult realization, it became a galvanizing moment for the community, John says. Many investigators, John included, devoted themselves to establishing scientifically backed methods for fire investigation.
In this episode, we’ll dig into those efforts to strengthen fire science and promote objectivity, both at the scene of a fire and in the analytical labs that support an investigation. In particular, we’ll examine how a better understanding of a fire’s chemistry is restoring and bolstering the field’s scientific credibility.
I’m Kerri Jansen, and you’re listening to Stereo Chemistry.
Oh, and we’ll also have a new edition of the Stereo Chemistry Book Club for you at the end of the episode, featuring Lisa Jarvis and a very special guest discussing Bottle of Lies by Katherine Eban. So be sure to stick around for that.
Let’s return to John and that core responsibility of a fire investigator: determining how a fire began. To restore faith in their ability to do that, John and his colleagues first had to understand what was wrong with the conventional thinking.
And that thinking actually sounds very reasonable when you hear it. The idea was that in a fire scene, the spot that was burned the worst was where the fire began.
John Lentini: What was happening is people would rely on the lowest and deepest char to determine the origin. People used to think burning on the floor was suspicious because fire burns up and out. Because heat rises, right? So people used to look at the floor and they say, “Oh, I see burning on the floors; it must have had help, the fire must have had help.” Well, it’s not true.
Kerri: Understanding the truth requires understanding a phenomenon called flashover. This is when a fire in a room becomes a room on fire. You’ll also hear investigators call this “a fully involved fire.” Not all fires will hit flashover, but for those that do, there is an important change that was being neglected. And it all comes down to the basic chemistry of combustion.
Fire requires heat, fuel, and oxygen. Before flashover, the fuel drives the fire. After flashover, the fire shifts to being controlled by the available oxygen.
In the early stages of a fire, a fuel like gasoline or wood feeds a fire. The room begins to fill up with smoke and hot gases rich in unburned and partially burned hydrocarbons from these sources, which continues to fuel the fire, John points out. The fire continues sucking up oxygen and throwing out heat as long as it has fuel to burn. But then a shift happens.
John Lentini: When flashover occurs—that is when that hot gas layer gets to 500 or 600 °C, 1,100–1,200 °F—all of the oxygen in the room is consumed. And the only place in the room where you can have fire is where there’s oxygen. So if there is an opening, say, a window or a door, what’s going to happen is the products of combustion are going to go out the top of the door, so the bottom of the door is going to be an inlet for cool, fresh air.
Kerri: That can cause burning on the floor. It also means that the patterns a fire leaves behind post-flashover will be different from the patterns from a fire that did not reach flashover. And if investigators are considering only one scenario when looking at those patterns, they may draw the wrong conclusion about the origin of the fire.
John Lentini: If you can extinguish the fire before that flashover event occurs or before the room becomes fully involved, then it’s really straightforward. You could walk in there and say, “Oh yeah, it started over there.” But once you get full room involvement, everything is on fire, and the only place you have any fire is where there is some air.
Kerri: The effects of flashover only started to come to light in the 1990s, and change was slow in the fire investigation community, John says. This may be in part because a lot of the conventional wisdom was laid down decades ago when home furnishings and construction materials were quite different from what is typical today.
John Lentini: When we had what’s called “legacy” furniture made out of wood and cotton and wool, it didn’t burn all that well and it might take 15 or 20 minutes for a room to get fully involved. These days, furniture is made out of polyurethane. It’s like solid gasoline, and if you light a sofa on fire, you’ve got maybe 3 minutes to get out of the room before it becomes fully involved. Flashover was just not a very common thing in the ’50s and ’60s. And now it’s really common.
Kerri: So now we know that burns on the floor don’t necessarily mean a fire had chemical help. But that wasn’t the only arson indicator to come under question. Distinctive damage patterns in materials like glass and concrete and large, shiny blisters called “alligator char” were historically believed to be signs of an exceptionally hot fire—a fire likely started with an accelerant—and used as evidence to convict people of arson. But John and other fire scientists have shown these patterns can appear even in accidental fires. Their value as proof of arson has been dismantled, one by one.
John Lentini: Where we are now is, don’t be so sure that you know where in a particular room the fire started. You can have many different burn patterns, and the one we’re looking for as fire investigators is the first one. We don’t care about a pattern that is laid down on a floor or a wall 20 minutes after the fire started. We just don’t care. For the most part, if you have a room that has burned in a fully involved condition for more than a minute or two, the best you can do in terms of defining the origin is to say it happened somewhere in that room. And then you’re obligated to examine every potential ignition source and first fuel in that particular room. It just makes it harder, doesn’t make it impossible.
Kerri: And investigators have help in this hard but not impossible task. The safety science company Underwriters Laboratories, or UL, is currently working to document how access to fresh air affects the range of behaviors fires exhibit after flashover. It’s a pretty big project. Here’s Dan Madrzykowski, one of the research engineers with UL’s Firefighter Safety Research Institute:
Daniel Madrzykowski: Basically we built a 1,200-square-foot ranch house and a 3,200-square-foot open-plan, two-story, colonial-type structure, and we lit fires in there over and over and over. And we’re looking to see how the fire burns based on whether a door’s open or a window’s open, seeing where the oxygen is and where it isn’t.
Kerri: Dan says he hopes the data will help fire investigators interpret their observations of physical evidence in terms of changing oxygen and heat levels rather than assigning one meaning, and one meaning only, to a particular burn pattern.
Daniel Madrzykowski: So the plan or the movement is really not to have a pattern-matching type of situation but to try to provide the fire investigators with enough information so they can better understand how a fire may have moved through the structure.
Kerri: Once investigators have an idea of where the fire likely started and what caused it, they may collect samples of material to send to a lab for further analysis. There, chemists work to identify the molecular clues to the cause of the fire—clues that are normally invisible to investigators. After a short break, we’ll go inside one of those labs to learn how chemists there are also working to bolster the science behind their work. And why sometimes being scientific means saying you don’t know.
Arminda Downey-Mavromatis: Hey there, this is Arminda Downey-Mavromatis, C&EN’s social media intern! It’s that time of year again. We’re looking for companies to feature in our annual 10 Start-Ups to Watch cover story this fall, and we need your help!
We highlight innovative new companies using chemistry to solve the world’s most pressing problems. Like Checkerspot, which was just a fledgling when it was selected last year, and has since raised $13 million from investors to advance its process for getting specialty chemicals from algae. And Solugen, another member of the class of 2018, which went on to raise $46 million to advance its enzyme-reactor system for producing hydrogen peroxide and other chemicals from sugar.
Do you know a groundbreaking start-up that should make our list? Nominate them at cenm.ag/startupnom.
We’re looking for firms that demonstrate both innovative chemistry and the vision to use discoveries to answer today’s questions.
Again, the link to the nomination form is cenm.ag/startupnom. We’ll post that link in this episode’s description.
Now, back to the show.
Michelle Evans: I know when I first started, my supervisor, my training officer, told me that as I got older and did more cases I would be less cavalier and more conservative in my identifications. And he’s absolutely correct.
Kerri: That’s Michelle Evans, a forensic chemist at the US Bureau of Alcohol, Tobacco, Firearms, and Explosives, a federal law enforcement agency. Michelle works in the ATF’s fire debris analysis lab.
In addition to trying to determine where and how fires began, fire investigators like John Lentini also collect evidence from fire scenes that they send to labs for further analysis. Labs like the one Michelle works in at the ATF. The ATF handles a wide variety of fire-related cases, including fires at commercial properties and churches. They also support state and local investigations.
Forensic chemists like Michelle are looking for traces of certain ignitable liquids, like gasoline. The presence of an ignitable liquid—basically, any liquid that will catch fire—can help an investigator determine the cause of a fire: Was it accidental or arson?
Michelle told me that the ATF has a peer review process in place to make sure that any identification of an ignitable liquid is defensible before any action is taken. Nonetheless, she said that the longer she’s done the job, the more cautious she has become about making a positive identification.
Michelle Evans: Looking back now, maybe I might not have said that yes this was positive. I might have been more conservative and said it was negative.
Kerri: Michelle told me she was in the process of finishing a case where she thought gasoline was there but didn’t feel she had enough support in the data to make a positive identification.
Michelle Evans: I think it’s there, but I don’t think I have enough to call it. Maybe when I was starting out I might have actually identified gasoline. But I in looking at the data, I don’t feel comfortable having to testify to that. That doesn’t mean that gasoline isn’t there, and it doesn’t mean that somebody else wouldn’t feel comfortable identifying it.
Kerri: Even when there’s a pattern that looks like it could be gasoline or another ignitable liquid, there’s a gray area where those determinations are subjective—it could go either way. But scientists like Michelle are hoping to shrink that gray area. And that’s what brought me to the ATF lab just outside Washington, DC. I talked with Michelle about how fire debris labs analyze evidence and how researchers are working to better understand their findings.
You might be wondering what qualifies as evidence after a fire. Fires are, after all, notorious for destroying everything in their path. Well, evidence the lab receives can be in the form of a liquid, a variety of charred materials from the scene, or even clothing from a victim or suspect. At the ATF and most labs in the US, that evidence arrives in airtight steel cans that are lined with epoxy to resist rust. The cans are airtight because what analysts are really interested in is the vapors coming off the collected evidence. Here’s Michelle again:
Michelle Evans: So what makes an ignitable liquid burn, it’s the vapors that are actually burning and not the actual liquid itself. At any scene where there might be an ignitable liquid, what happens is that ignitable liquid soaks into the material—anything that’s porous like carpet, wood, even dirt—and so the vapors are burning off, but there’s still liquid that’s there.
Kerri: Michelle collects those vapors on a small strip of activated charcoal, which she suspends in the headspace of the can with a highly technical apparatus involving a magnet and a paperclip. One end of the unbent paperclip goes through the charcoal strip . . .
Michelle Evans: And then we stick the paperclip to the magnet to the top of the can lid, and that’s how, I mean it’s . . .
Kerri (in interview): Brilliant.
Michelle Evans: Right. It’s very simple, it’s very easy, but it works.
Kerri (voice-over): She puts the evidence cans in an oven overnight to help drive off the vapors. Then, in the morning, she rinses the charcoal strip in a solvent to produce a sample for the GC/MS—that’s gas chromatograph/mass spectrometer, an instrument that detects charged molecular fragments by their mass. If a sample contains as little as 0.1 μl of an ignitable liquid, the GC/MS should be able to detect it using this method.
The instrument spits out a chromatogram, which is a pattern that looks kind of like a mountain range, with peaks of different heights and valleys in between. Those peaks—their heights and their positions within the range—reflect the identity of a particular component and the amount of it in the mixture. And this is where things get tricky.
If you’re like me, and you’ve watched your fair share of crime investigation shows, you might imagine a chemist injecting a sample into the instrument and immediately getting a clear result: yes, there is gasoline here; let’s go arrest the suspect. But it’s not that simple. Because that mountain range doesn’t just contain the signature peaks of any ignitable liquid that may be present. It will also contain peaks from all the other stuff that burned during the fire—furniture, carpet, all of that. And many of those chemicals—a polyurethane coating on a hardwood floor, for example—can look suspiciously similar to common ignitable liquids. On top of that, the profile of the ignitable liquid itself can change during the course of the fire as it begins to evaporate.
It’s the chemists’ job to interpret that mess of data and identify an ignitable liquid among all the other stuff that gets lumped in with a sample.
Michelle Evans: And that’s where we have a lot of our issues is trying to interpret the data and figure out if there’s something there, do we identify it, do we not? It’s easy when you’re dealing with a single compound; you have one peak in your instrument. Unfortunately, what we’re dealing with is patterns that have potentially hundreds of compounds. Where do you draw that line?
Kerri: To help isolate ignitable liquids from all the other tricksy chemicals, she compares the results to an extensive reference library of known materials.
Michelle Evans: This is a whole binder full of all these different materials, just materials that we’ve burned.
Kerri: Michelle’s reference library includes examples of the background chemicals that might show up in her results, along with references for the ignitable liquids themselves, which are classified by category. Kerosene and diesel fuel, for example, are considered heavy petroleum distillates. A product sold as paint thinner might be considered a medium petroleum distillate or an isoparaffinic product, depending on the particular compounds it contains.
Michelle has a binder for each of the ignitable liquid classes, filled with chromatograms for chemicals that fall within that category, many including different evaporation levels, because a chemical’s GC/MS profile will shift as it evaporates, with the lightest components disappearing from the chromatogram first.
Michelle Evans: If we don’t have a suitable reference, we can’t identify it.
Kerri: It’s still a difficult task because those chromatograms rarely line up perfectly. You might get peaks that correspond to the compounds in unevaporated gasoline, for example, which is dominated by tall peaks of aromatic compounds and mostly contains compounds lighter than a 13-carbon chain. But that pattern might be distorted by other compounds in the sample.
Michelle Evans: Then you’re trying to pick out . . . I mean, this is a mess. But there might also be gasoline in here.
Kerri: The standards organization ASTM International has published some guidance on how to avoid pitfalls in interpreting complex samples. And Michelle has some nifty computer programs that can help remove the noise from the results by focusing on certain ions, kind of like a cereal-box decoder ring. But ultimately, she must make a visual comparison between two chemical patterns and determine if an ignitable liquid is present in the sample. It’s not always a clear call. And this is where the work leaves well-established analytical chemistry territory and becomes more subjective, Michelle says.
Michelle Evans: We have this saying that I was taught a long time ago in training: the easy ones are easy; the hard ones are hard; the really hard ones are negative. So if we go through our data analysis and we are beating our heads against the wall, we just can’t figure it out, then it’s going to be a negative. Because that’s what we do—it’s either positive or negative; there’s no in-between.
Kerri: When the results are uncertain, the lab won’t identify anything. Because remember: potential arson convictions can be at stake here.
Michelle Evans: One of the biggest consequences would be identifying something on a suspect’s clothing that potentially could be evidence that could convict him. And, you know, you go to the gas station and you get gas on your shoes, on your clothes, just by filling up your car. Our methods are very sensitive.
Kerri: But that can be a double-edged sword, as Michelle pointed out. It’s great to have instruments that can detect tiny traces of suspicious chemicals, but people are surrounded by ignitable liquids that can also have perfectly innocent uses. So Michelle also needs to consider how strong a chemical’s signature is and at what point it becomes significant enough to be identified by the data.
Michelle Evans: How much are we identifying? If it’s a really small amount, could that have been there from a transfer from something, or is that there because this person potentially committed a crime? And I think that—I would hope that more people would err on the side of caution. But that is one of our biggest challenges that we have in fire debris is we do not have a limit of detection yet. We don’t have a threshold for identification.
Kerri: Members of the fire debris analysis community are working to take some of the subjectivity out of the process of interpreting results. Michelle is a member of the Organization of Scientific Area Committees for Forensic Science—OSAC, for short—which was created by the US Department of Justice and the National Institute of Standards and Technology to develop standards for various forensic science disciplines. One of the group’s projects is to identify the threshold for identification that Michelle mentioned so all fire debris analysts are on the same page when it comes to identifying an ignitable liquid or not.
Michelle Evans: We’re trying to be more standardized so that everybody goes through the exact same process and it’s less subjective and more objective in our identification. That’s where we really need the research, and we’re working on it. It’s just going to take time.
Kerri: Brenda Christy and her team at the Virginia Department of Forensic Science are also working to make fire forensics more objective. Brenda serves on OSAC, and along with collaborators at other forensics labs, her team is taking a close look at gasoline, one of the most common ignitable liquids used in arson. The chemists are working to understand what makes gasoline unique compared to anything else you might find in the background of a sample. They’re studying multiple samples to see what changes and doesn’t change with various evaporation levels and background materials, then they’ll apply point values to each of those distinctive traits so they can produce a plot. Brenda envisions that plot as a way to provide an objective overview of how much data is available to draw a conclusion about the presence of gasoline. And it would allow forensic chemists to set a threshold for identification, the level at which they have enough information to say, yes, there is an ignitable liquid here.
Brenda Christy: There’s going to be three regions where above this it’s definitely an identification, below this there should definitely not be an identification, and then there’s going to be a gray area in the middle. And that gray area in the middle is where it could be an identification or not an identification, but there’s going to need to be some enhanced documentation to justify either conclusion.
Kerri: Another part of the process that forensic scientists are targeting is ensuring their instruments are producing the cleanest and most meaningful data. There are more than a dozen settings to tune on a GC/MS, and how you tune them is influenced by what you’re looking at or looking for. At the National Institute of Standards and Technology, or NIST, researchers are working on optimizing the settings of the GC/MS instruments used to do fire debris analysis. Forensic chemists I spoke with view this as an essential first step to standardizing other parts of the process. NIST’s Marcela Najarro is one of the scientists working on the project.
Marcela Najarro: One of the things that we want to answer is, out of all of the different settings that you’re able to optimize or to tune the instrument, which ones have the most impact on whatever quality metric you decide that you want to go after? We hope that by doing this research we will be able to say something like, “Your injector temperature is going to affect the reproducibility of your analysis the most.”
Kerri: And whatever that setting is can vary sample to sample, lab to lab. At the ATF lab, Michelle Evans told me that one of the obstacles to establishing more objective standards for all fire investigations in the US is coordinating with multiple regional and federal forensic labs—basically, getting everyone on the same page. And while the subjectivity of fire debris analysis is not unique to the United States, she admires the progress some countries have made with fewer cats to herd.
In the Netherlands, for example, most forensic investigation and research is run by a single organization, the Netherlands Forensic Institute. I talked with Michiel Grutters, a fire debris expert at the institute, and while he avoided making a call on which country’s system for fire debris analysis he thinks is better, he did highlight one significant advance in the Netherlands: in 2015, the institute published a book on interpreting fire debris analysis results, in collaboration with Germany’s Federal Criminal Police Office. That book goes above and beyond the other available international guidelines with many examples of ignitable liquids and their components. It emphasizes combinations of components that show up together, which can help chemists distinguish them from background contributions.
Michiel noted that the institute considers standardizing the interpretation of results just as important as standardizing the extraction and analytical process, which has already been standardized for some time.
Michiel Grutters: I think for the analytical part everybody sees the benefits of standardization. Because with the community you have consensus about certain methods and you can exchange your knowledge and then the whole process becomes better. And in our opinion the same goes for the interpretation, because also there you have all kinds of approaches. And if you can have a consensus, then I think the quality of the whole community gets better.
Kerri: And Michiel acknowledges his country’s centralized forensic system has likely helped this effort.
Michiel Grutters: I think it’s beneficial if you have one institute for one country. On the other hand, you know some countries are bigger than others, and then it’s quite difficult to have, for example in the United States, one institute. But for the Netherlands I think it works very nice.
Kerri: Back in the US, ATF’s Michelle highlighted one last challenge in the effort to standardize fire debris analysis. Many practicing forensic chemists lack the time to pursue research projects; most of their time is taken up by casework. She said she would love to see more independent researchers collaborating with the forensic science community.
Michelle Evans: We don’t necessarily have the time to do the research, but we would love to work with researchers and talk to them about our needs. Because if they have the time, and they have the money, we have real ideas and real goals that need to be met.
We have people who are very invested in this. They believe in it and I know that in our lifetime we’re going to see improvements. It’s just not going to be nearly as quick as I think some people would like. It’s a process.
Kerri: And now, I’ll turn the mic over to C&EN reporter and Stereo Chemistry Book Club founding member Lisa Jarvis.
Lisa Jarvis (in studio): For the last part of this episode, we have another installment of the Stereo Chemistry Book Club for you. Avid listeners might recall that previous segments have covered Bad Blood, the saga of the secrets and lies at the now-defunct blood-testing firm Theranos, and The Poison Squad, which was all about one chemist’s crusade for food and drug safety.
Today, we’re talking about Katherine Eban’s Bottle of Lies, another book rife with stunning cover-ups and one strong-willed whistle-blower named Dinesh Thakur. Bottle of Lies is an exhaustively reported look at the rapid rise of generic drugs in the US and the corners that were cut to get to cheap medicines. The bulk of the book focuses on the story of the Indian generic-drug firm Ranbaxy, which was operating under a culture of deceit that ultimately led to a record-setting $500 million fine to settle criminal charges related to drug safety.
So the central story line is how a whistle-blower, Thakur, discovers widespread fraud at Ranbaxy, where he worked from 2003 to 2005, and spent the next 8 years helping regulators piece together a case against the company—a period in which FDA, knowing about this fraud, continued to allow Ranbaxy to make and distribute its drugs in the US.
What you’re about to hear is an abridged discussion of that book between me and a very special guest.
Lisa (at the Stereo Chemistry Book Club): Joining me is everyone’s favorite blogger, Twitter connector, and C&EN contributor, Chemjobber. Hi CJ.
Chemjobber: Hi Lisa.
Lisa: As many of you know, CJ is trained as a process chemist. So I thought he’d be the perfect person to talk through the scandal that unfolds in this book, Bottle of Lies, around generic-drug manufacturing. So CJ, let’s just start by establishing that this book is full of chemists and maybe not always in a good way. Did you expect that?
Chemjobber: No, I really didn’t expect that. There are a lot of chemists. It’s like you read it and they introduce a new person and that person is inevitably trained as a chemist. And it’s cool to see how many chemists there are in the generic-drug-manufacturing industry.
Lisa: I was . . . I felt like there was a pretty even divide between, sort of, chemists doing good and chemists maybe not doing good.
Let’s talk a little bit about some of the stuff that was going on in the manufacturing facility. Because basically companies had these sort of subterranean manufacturing lines where FDA was seeing one thing and another thing was actually going on. They were disposing of data. This was primarily at Ranbaxy, but I think as the book unfolds you see that it’s happening in other companies as well. Both in the US and in India, though it’s primarily focused on India. And I mean, were you surprised by any of that? Can you imagine that happening?
Chemjobber: It was surprising to me how blatant the dishonesty was. So something that they would do was that they would run many tests and call them, like, test samples or research samples, and the ones that didn’t work out, they would throw them away. And the ones that did show that the material that they were testing was in specification, they would keep. It’s really surprising to me and pretty disconcerting. Ultimately, at the end of the day, the industry relies on this data to say that drugs are safe and that you can take them and that they will have the intended effect. And in a lot of those cases it was clear that they were not.
I think that it’s really difficult and the book kind of—I don’t want to say it glosses over this because I’m not sure that it does—but from a historical perspective, it seems like this very ambitious project that they had to basically, how do I put it?
It’s not as if . . . It is as if they were trying to fool regulators to make money. It feels like it’s also the story of an industry striving for a bigger goal of being able to manufacture lifesaving pharmaceutical drugs at world-class standards and just utterly failing. Right. But initially the intention is, like, we’re going to do this great thing and we’re going to make a buck at it while we’re at it. And they didn’t get there. And Thakur has to do this really brave thing of saying within the company, like, “Hey guys, when we say that we’re doing this correctly, we’re not. And we’re actually lying about it a lot.”
Lisa: I mean at some point I wondered, the effort that went into creating the lie seems like if you had just put that effort into doing it the right way, things could have been fine.
So I guess I knew that there had been this scandal that unfolded, but I found myself as flabbergasted at what was going on inside FDA as what was going on at the drug company, Ranbaxy. And so I’m curious, tell me which part of this surprised you, if any, CJ. What was your reaction to kind of the FDA side of things?
Chemjobber: It was surprising to me. So I work in the contract manufacturing space. We make molecules; we do not make API. We do not . . . we don’t make finished drug product or pills, basically.
Lisa: So you’re making kind of the beginning ingredients?
Chemjobber: Yes. So, pharmaceutical intermediates. And what we are told, just broadly speaking, is that pharma companies that come in and audit us on a regular basis, and we are reminded that pharma company auditors, they more or less, they want to work with you. If they find out that you’re not doing something correct with their company’s standard operating procedures or if there’s a problem, for the most part their goal is to work with you because it’s a two-way street. If they say, “We’re never taking in your product again,” then they have to go find a new supplier. So it is, it is a working relationship.
We are told broadly speaking, by contrast, that the FDA doesn’t care. That they’re just going to come in and if they find something wrong, they will, you know, they will see that there is something wrong; they will, you know, shut you down. Which is actually something that they have the power to do. As you probably can tell, I haven’t interacted with a lot of FDA inspectors in a professional capacity, so it was really interesting to read that it was basically, no, it’s more of a two-way street than I had anticipated.
And then that Congress, in its oversight role, they want specific results from FDA, too, which is, you know, something that I did not necessarily expect. I guess that Congress can say both, you know, we want safe drugs and also you need to make sure that there are enough safe drugs. And that tension comes through in the book.
Lisa: Yeah, I think I hadn’t fully appreciated that tension, to be honest with you, in the sense that when there was such obvious wrongdoing, they tended to fall on the side of approving a drug or a facility in order to get that onto the market for consumers.
So one thing that I wanted to ask you about is the scope of this scandal and how it played publicly. Because we’ve obviously had podcasts, books, documentaries about Theranos, and Elizabeth Holmes has been this big villain. And I think it’s fair to say that there are probably a handful of people who are affected by her totally sham blood tests. But in terms of the impact on the American consumer, I mean, this Ranbaxy thing was a much bigger deal to me. I think that my friends and neighbors probably know who Elizabeth Holmes is. I don’t think probably Ranbaxy would ring a bell for them. Should it?
Chemjobber: I think it’s . . . So the answer is yes, but I think that it’s difficult for people to think about the source of generic drugs. And kind of the fact that they’re significantly cheaper is sufficient for what they’re thinking about, which is basically, “I don’t really want to take this, but I have to. It’s awfully nice that it’s low cost. Gee, I wonder how they do that.” When you go to the pizza place that sells slices for like a dollar apiece, you kind of don’t really want to, like, look back into the kitchen to see what’s there.
And then it’s happening in a continent in a country that Americans don’t probably tend to pay a ton of attention to. Most of the story is in India. And I think that between those two things, for some reason it doesn’t really grab hold of the pop culture and media machine that makes scandals.
Lisa: Yeah. No, that makes sense. That makes sense. I mean speaking of manufacturing is being this process that happens that people don’t like to think about. I did think that the point of the book was to focus on the generic-drug industry. It felt to me a little reverent towards big pharma almost in a way that was surprising. And, you know, there’s just this sort of reverence around the attitude about quality and science and research. Do you think it was fair to sort of put all of this on the generic-drug industry?
Chemjobber: I think it’s fair in the sense that the US pharmaceutical industry or the pharmaceutical industry of the developed world is more advanced or in general has a better quality culture than that of, say, the Indian pharmaceutical industry in the 1990s or the 2000s. At the same time, the pharmaceutical industry of the developed world is—maybe I’m wrong—50 or 100 years older. And so it’s not as if pharma in the United States or in western Europe hasn’t had those scandals. Those scandals just happened probably in the 1930s to the 1940s and the 1950s.
Maybe a writer that had more space or a writer who was more historically oriented would have gone back and said, “Well, gee, why did we have the FDA in the first place?” You know?
Lisa: Right. Right.
Chemjobber: Because, well, the answer is not because Americans love regulation. It’s because Americans love snake oil or Americans of the 1910s and the 1920s love snake oil and love making it, love selling it to people.
Lisa: No, it makes sense. I was thinking about maybe the difference being branded-drug companies coming forward when there is an issue versus a generic-drug company in this instance hiding the issue. I mean I guess I thought the underlying gloss was like manufacturing if done right is easy almost. Does that make sense?
Lisa: And I don’t think that’s true, right. Like we saw in, say, 2009, Genzyme had an issue at one, at their Allston, Massachusetts, manufacturing site that lingered for quite some time and caused a shortage of important drug again. I don’t know if you remember in GlaxoSmithKline had this issue with, I think it was Paxil, an antidepressant where all of the active ingredient was on one side of the pill. So we’ve seen these things happen and maybe the difference is just that those companies knew they had to fess up.
Chemjobber: Yeah, and something that is a really big difference is that FDA inspectors, or actually inspectors across the US and Europe basically have the right to show up to a manufacturing facility at any time and stay as long as they want. So FDA, I think it’s Health Canada . . .
Lisa: The EMA.
Chemjobber: Yeah. EMA. European Medicines Agency. It’s basically they walk in, they slap their business card down on the table at the receptionist, and say, “I’m here to inspect your facility.” And all of these companies they live under, I don’t want to say the threat, but they live under the watchful eye or at least we all hope they do—We know that they do and then we also hope that they do. They live under the watchful eye of these organizations. They kind of know inevitably errors and malfeasance will be found out. So you may as well do the right thing.
Lisa: Maybe before reading the book and then after reading the book can you give me your thoughts on, you know, would you give your family generic drugs? Do you worry at all about the quality and safety?
Chemjobber: Yeah. I think that overall . . . I am going to hem and haw here. I have confidence in well-known branded generic drugs. Right. The Tevas and the Mylans of the world are probably doing the right thing. Who knows for the other companies? I probably thought that before reading this book and now after.
Lisa: OK. So we’re running out of time. I will ask if overall you think this is a book that is worth the time of C&EN readers to pick up. Would you recommend it?
Chemjobber: Hmm. Yes, I would recommend it. It’s shocking and it’s quite the long narrative of really one whistle-blower’s kind of journey and also one whistle-blower’s fight against a company and all almost like a whole culture.
Lisa: Well thank you so much CJ for joining us today. I’m so glad to get your perspective on this book.
Chemjobber: You’re welcome.
Lisa: And we’ll have to come up with another book for you to come back with us on. So thank you.
Chemjobber: That would be great.
Kerri: Do you have a recommendation for a book to cover in the Stereo Chemistry Book Club? Let us know! You can email us at firstname.lastname@example.org. We also accept recommendations for crime investigation TV shows at that address.
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Stereo Chemistry is a production of C&EN, the newsmagazine of the American Chemical Society. This episode was written and produced by me, Kerri Jansen. It was edited by Matt Davenport, Lauren Wolf, and Bibiana Campos Seijo. Sabrina Ashwell is our copyeditor. The music you’re listening to now is “Blonde” by Nctrnm. The ad music was “Plain Loafer” by Kevin MacLeod. Thanks for listening.