IN DEPTH INTERVIEW WITH BECKY McCLAIN

A Roach In The Kitchen-Interview With Injured Pfizer Molecular Biologist Becky McClain



http://www.councilforresponsiblegenetics.org/GeneWatch/GeneWatchPage.aspx?pageId=248

A ROACH IN THE KITCHEN

By CRG staff - interview with Becky McClain

After becoming seriously ill while working in a Pfizer laboratory and being denied workers' compensation, Becky McClain sued Pfizer for damages. In April, a judge awarded her $1.37 million, finding that Pfizer violated her right to free speech and her whistleblower rights. The judge dismissed McClain's claim that Pfizer's wanton misconduct had caused her to become infected by a genetically engineered virus in its labs, citing the lack of evidence. The Occupational Safety and Health Agency has told McClain that it cannot force Pfizer to turn over the exposure records that would provide this evidence, as they are protected trade secrets.

You went to court because of your own illness and Pfizer's conduct, but did you start seeing safety problems before you had any health problems yourself?

Yes. And I reported safety problems before I had any problems myself. That's what's so egregious about all this: it's not that there was an accident that I was exposed to, it's that they were careless, and willfully and wantonly disregarding appropriate safety precautions.

What were some of the big problems?

There were a lot of safety issues, but they to a large extent could have been solved by two things: either by giving us a break room with a door, with no scientific stuff going in there at all; or they could have given scientists offices outside the lab. That was a major problem. There are some labs where the dangers of exposure to materials are minimal. But when you're running a recombinant lab, bringing in genetically infectious viruses, you should use your common sense, and you shouldn't have scientists with administrative desks inside the laboratory where they are not afforded personal protection. That's just common sense.

It seems like an easy fix, too.

Pfizer reported that it would cost something like $1.6 million, and that's just ridiculous. I think they looked at how they could revamp the whole department for that cost, but all they had to do was get a six foot by ten foot room that we could share as a break room, with a door. That wouldn't cost $1.6 million.

So the break room was in the lab?

The break room was in the hallway. It was a working hallway, with biological refrigerators and freezers and people walking lab to lab carrying genetically engineered viruses, blood samples, monkey samples ... and that's where we were eating. We would find genetically engineered viruses where we were eating and drinking. We wouldn't find something every day, but I compare it to a roach in the kitchen: if you see a roach in the kitchen, you'd better know that there are a hundred roaches behind the wall. By the time you call OSHA to come in to kill that roach, it's gone.

One of the major issues was that when I was on the safety committee, I was told to stop formally documenting my safety concerns. Instead, the role of the safety committee was to perform in-house laboratory inspections. The laboratories were given advanced warning of the time and date of the inspection. So everybody had the opportunity to clean up the lab in preparation for the inspection. And so when we would do the safety inspection, we could check the box that everything's safe. Now Pfizer has all these wonderful safety inspections stating that everything's safe. But in actuality that was not the case.

We had evidence that people were getting sick shortly before and after a safety inspection, but if you look at the safety inspection report, the lab was completely safe. You see what they're doing? Pfizer was basically forcing the safety committee to do these half-bogus inspections that would create documentation that the labs were safe-but they wouldn't allow us to document anything else in between these inspections.

And this was a higher-up company policy that was handed down?

When the safety committee was formed, at the end of the meeting they gave instructions as to how we would start to perform these inspections using a form where you check boxes if the lab was in compliance. I didn't see anything wrong with that. But after that meeting, I started bringing up these additional safety issues regarding inadequate break facilities and scientists having administrative desks inside laboratories without adequate protection. But when I started bringing up these issues, some people on the safety committee stiffened up. So soon after I wrote a draft, a really rough draft, of a letter to the safety committee documenting some of these points ... and within two hours of submitting it, I get an email from management telling me to stop formally documenting these things. So what happened was that my role in the safety committee was not to report actual safety issues; it was just to conduct safety inspections. That's it.

When I went to OSHA I found that as scientists, we do not have legal rights to raise safety issues or to have the right to get them formally addressed. And you have to remember, we're working on state-of-the-art technologies. Even if we did have regulations, the regulations are going to be outdated because the science is constantly evolving. So safety forums for scientists are pertinent to ensure worker safety and public health and safety. There needs to be a formal way that scientists can get their safety issues addressed formally. This is dangerous-we're making genetically infectious viruses.

Even as other people started raising safety issues, Pfizer just ignored them. Their answer was, "We'll form a management team to address these." Three years later, they were never addressed. There's just no formal forum for scientists to raise safety issues and get them addressed, and we legally don't have the right to do that.

Do you think this is part of the reason that, although you won your case on free speech and whistleblower rights, a judge would not hear your case regarding whether you were infected in Pfizer's lab?

We had very good evidence, scientific evidence regarding the link of my illness to the exposure and the willful and wanton behavior of Pfizer. But, Pfizer was denying us pertinent exposure records necessary for us to meet the high standard of proof required by law to bring this to civil court. So in the end the judge would not allow the jury to hear the evidence regarding my illness and instead remanded it to workers comp.

If the jury would have had the opportunity to hear that count and the facts surrounding my injury, I do believe they would have ruled in my favor. Pfizer's duplicity regarding virus identities and their lack of appropriate documentation were appalling. Together with these facts and their lack of response to my safety concerns, it clearly implied willful intent. We had good evidence that the exposure caused my illness. I was hoping that my case would set a precedent for other injured biotech workers.

But the burden of proof of causation and intent required by Connecticut law is so outlandishly high and in favor of business... that no one seems to have a remote chance of bringing an egregious work-related injury claim before civil court.

And unfortunately, worker's comp brings no remedy either. Without the exposure records that Pfizer denies me, worker's comp is a dead end street. The sad part is...is that I am not alone in facing this predicament of having a work-related illness. Workers compensation is full of problems, leaving many workers abandoned with no healthcare or financial remedy for serious illness they acquired from work.

Because the burden of proof was on you, not the company?

Yes-and it should be, I'm not complaining about that. But one of the problems with the proof was that Pfizer refused to give me my exposure records.

And there is no law requiring them to give you those records?

No, there is no law under OSHA for a biotech worker to obtain the necessary exposure records needed for medical care upon a biological exposure. In fact OSHA ruled in my case that trade secrets supersede a worker's right to these records. That was one of the primary reasons why I had to file a civil claim in an attempt to obtain those records for my healthcare. So finally in civil court, the judge ordered them to give me the records, but Pfizer never gave them to us after numerous requests.

Let me back up so you know the history of what happened. I was exposed two times. The first issue was a biological hood which started making people ill. Prior to that, people were bringing genetically engineered viruses in there; and after they changed out the hood, it became recontaminated. So we didn't know: was this a biological agent that was making the hood become continually contaminated? Or was it a chemical problem? It was a mystery agent that was making people ill. I did know that people were using genetically engineered viruses, but the reason I didn't bring this up to OSHA right away is that I was told these were not human infectious viruses. I thought, oh well, I can't get sick from a non-human infectious agent anyway.

One of the other major details about the hood is that they purposely mistested the hood so that we couldn't collect adequate data for exposure.

How did they go about that?

How a hood works is that air is drawn in from where you put your hands in; 70% of the air recirculates within the hood, but 30% passes through filters and goes out the top of the hood into the lab. The exhaust is what was making people ill. When we asked Pfizer to please test the hood, because we had been getting sick for a year, they didn't bother to ask us how to test the hood. It's common sense how you would do it: air comes out the top, so where would you put the probe?

You'd put it where 30% of the air is coming out, at the top.

Right! You're not a scientist, but you get this-it's common sense!

So we got a knock on the door, and in come two men in biohazard suits. They looked like astronauts-they had respirators, oxygen tanks, everything. And they ask us to step out of the lab- can you believe this? They were all dressed up in biohazard suits, and I thought they were going to test adequately-they looked like professionals. But when we got the results back, we found they had purposely mistested. They never put the probe by the exhaust. They put the probe inside the hood, not even near the exhaust. The other thing was that we knew the contaminant was bound up in the HEPA filter in the hood, and we specifically requested that the HEPA filter be tested. All they had to do was test those filters, but they wouldn't test it. So they gave us these bogus results, and that's when my boss came up to me and pointed out the sampling error and said, "Listen, we're going to get in trouble for raising safety issues again, and I'm not going to have any part of this." He was afraid he was going to get fired.

Do you think this is why you got sick?

Where I had an etiological link to my illness was another exposure. In November of 2003, my coworker Bill Blake came up to me and asked if I knew what lentiviruses were. He had been told to work on my bench with a lentivirus experiment that he was doing. Now I'm not a virologist, I don't make genetically engineered viruses. I was making genetic expression systems that could be cloned into viruses -in layman's terms, genetic missile systems that could target a specific gene and blow it up. And Blake wasn't a virologist either. He was a tissue culture specialist, and all of a sudden he's working on these genetically engineered viruses, and he said they didn't give him any background papers, they didn't give him any training, and he didn't know exactly what this virus was. He didn't know if it was a human infectious agent!

So my understanding of lentiviruses at that time was that they were species-specific. HIV is a lentivirus, and we also were working on feline immunodeficiency viruses. Blake was working on lentiviruses with mouse embryonic stem cells, so I said, "I don't believe you could possibly be working with an HIV virus because you're working with mouse embryonic stem cells. It's got to be a mouse specific virus." But I asked him, "Could you please go check?" He had been working with this lentivirus without biocontainment on my bench for an entire month, and that was my private bench. I would at times work on that bench with my papers, doing lab reports, and I wasn't wearing gloves, so I could easily get exposed.

He came back the next day, and he did look a little bit nervous; but he said, "It's safe, but I'm supposed to decontaminate."

And did you get sick soon after he started using your bench?

I got sick exactly around the time he started using the lentivirus on my bench in October 2003, but it didn't click yet because I assumed he was telling the truth about the virus being safe and implying it was a non-human infectious agent.

As I started getting sicker and sicker, I thought, what's going on here? One doctor wrote in my report that I had some post-viral syndrome. By this time I was already on medical leave. That's when I started writing Pfizer, telling them I want the identity of these viruses that were used in my lab. I was coordinating this through OSHA now-they were advising me about how to go about doing this-but Pfizer told me to go take a hike, that no viruses were used in that lab. Well, I knew that was untrue.

Wait - they said no viruses were used in your lab?

Yes. They said that Bill Blake had never used a virus in that lab. So basically, I went to OSHA and told them Pfizer wasn't giving me the information. OSHA sent Pfizer a letter, and by law they had to tell me the identity of the biological agent. Pfizer immediately sent me the results of what Bill Blake was using. They said it was an HIV-derived lentivirus pseudotyped with VSVG. Let me explain what that is. HIV-derived lentivirus-you know what that is. It's a genetically engineered virus derived from the HIV virus. They take the HIV virus and they manipulate it-pseudotyped with VSVG, which is a virus in the rabies family which subsequently makes the HIV-derived lentivirus broadly and highly infectious.

If you are exposed to an HIV virus, you can only get it blood-to-blood. But the rabies family-you know how horribly infectious that is. It can infect through your eyes, if you breathe it in, if it gets in your mouth. So what they're doing now when they make genetically engineered viruses-and this is a BL2 lab-they can basically put a rabies-like coat on the HIV virus. Now you have an HIV-derived virus that can infect you like a rabies virus. You can imagine, as I'm working on this bench without gloves, doing paperwork ... all I have to do is touch it, put my finger in my mouth, and I'm infected.

Do you know if Bill Blake ever got sick from it?

He was all gloved up, and then he never worked on the bench again. I was the only one that I know of who was exposed to that virus.

So when I found all this out, I was just aghast. I could not believe it. And then I found out that the virus they were using in the hoods had been human infectious agents also-and they had told me they weren't! They had told me it was a mouse leukemia virus. They were bringing human infectious agents into the lab, and I was never notified.

And the people working on it, do you think they knew these were human infectious agents?

Bill Blake didn't know. He had never worked with viruses-I was really surprised that they had allowed him to do this. My boss should have known it was a human infectious agent.

At this point I'm hospitalized, and I'm getting sicker and sicker. They diagnose me with something called transient periodic paralysis, but they don't understand why I have this. Periodic paralysis is usually a genetically inherited disease. What was weird is that I don't have any of this in my family. Also, if you inherit this condition, you present at an early age -not at middle age.

I knew I had been exposed to genetically engineered viruses that were human infectious agents. They had given me the name of it, but that doesn't tell us anything. I went back to OSHA and told them that the name of a virus is not the identity of a virus. With a genetically engineered virus, each one is custom-made, and you can name it whatever you want to name it. So I went to OSHA and Pfizer and told them they needed to give me the genetic code so we could see what was in the virus and figure out why I was falling into paralysis. It took OSHA around a year to make a ruling-it went from Hartford to Boston to Washington D.C.-and they ruled that protection of trade secrets supersedes my right to get any genetic information on this virus.

That's an OSHA rule?

That was their interpretation. The OSHA law was really made for chemicals, but they're trying to apply it to biological agents, which is a little bit ridiculous.

Think about the implications for the public if workers can't get their exposure records to get medical care. You need the genetic code for medical care. Basically what you need are the cloning, sequencing and production records. The cloning records show how you make the vector, whether you're putting in a toxin, a genetic missile, or just a green fluorescent protein. This should include the sequencing records so you know that the sequence is correct. Then you need the production records. This is the part of the experiment where they take the vector that they've just cloned and they make it infectious. That's important for two reasons: first, how did they make it infectious; and second, did they test for the possibility of recombination so the virus can replicate.

You need all of these things, and I call my case the perfect storm because they couldn't snowball me. OSHA doesn't have the expertise, but I knew you needed all of these things.

OSHA called me up and told me that by law they could not assist me in obtaining the appropriate exposure records that I had requested. They said that I had to work with Pfizer and that Pfizer had agreed to give me the sequence of the viruses if I would get an attorney [to draw up a confidentiality agreement]. One of the problems that injured biotech workers have is that it's difficult to find an attorney. These are new laws, and no attorney wants to pick up a high-risk case like biotech workers. You're establishing precedent in the field, and the technology is very advanced, so the cost of litigation is very high. There are a lot of people in my same situation - not necessarily only in biotech, but there are people getting injured at work who can't find attorneys. They lose their jobs, they lose their homes ... it's really a serious issue.

It was for me too. I couldn't find an attorney. I had one, but he told me it was too complex and he couldn't help me anymore. Finally I found Bruce Newman, in my little hometown of Deep River, and he helped me for a long time.

We were able to draw up a confidentiality agreement, and I got a sequence - but it's not even a complete version of the virus. They give me this chopped up virus, and it looks like it contains errors, so I know it's a rough draft. It's still good enough that I can decode it and try to learn the function of the virus, but it's not appropriate for medical testing because it's not a finalized sequence. It's like the early rough draft of a book-you can read through and see what it's going to be about, but you can't publish it because it's full of misspellings and errors.

And listen to what I found: the virus contained a genetic missile that destroys three potassium channels and two neurotransmitters. And I've been diagnosed with a potassium-sensitive paralysis. There's the etiological link.

Still, this was from a rough draft sequence-it wasn't enough for medical testing. When biologists get exposed, they should have the right to get not just medical care, but also full disclosure of their records.

Do you feel hopeful at all that these rules could actually change, that workers could be allowed their exposure records?

There's an act in Congress called the Protecting America's Workers Act, and there's no provision in it to give employees the right to adequate exposure records for their medical care. So no, I have no hope at this point that it's going to change, since it's not in that act.

One of the problems is that there are other people this has happened to and they can't get any legal remedy. What agency is collecting data on injured biotech workers? What I'm seeing is that any incident in biotechnology is being hushed up. I think it's the biotech industry, the pharmaceutical industry, and really the scientific academic industry that do not want these things to come out. They think the public will be terrified.

Though I'm not sure it's "We don't want the public to be terrified" so much as "We don't want the public to be terrified of us."

Sure, there's self protection involved. What I saw at Pfizer, how out of control it was - there is grand potential for agents to be released into the environment.

When I went to worker's comp-because you have to go to worker's comp, they force you into it-I asked for my exposure records, and worker's comp said they don't have jurisdiction. That was it. What am I going to do without exposure records?

Then while in Worker's Comp we disclosed that I had been diagnosed with transient periodic paralysis and that we could show a causal etiological link between my condition and the Pfizer lentivirus involved in my exposure. Right after that disclosure, Pfizer wrote us a letter saying, "We're sorry, we accidentally sent you the wrong virus," and they sent sequencing for a different virus without that etiologicial link. When I asked them to send the cloning and production records to show this was the right virus, they said they didn't have those records anymore.

In your experience there, would it have been the case that those records would just disappear?

No, no, no. Can you imagine if they didn't have records of how they made human infectious agents? It's a public safety issue. This type of record keeping is standard practice in scientific research.

It doesn't seem like it would be any better for them to have the records and claim they don't than to not have the records at all.

They're both bad. There's no way out of this: it looks bad for Pfizer both ways. It shows disregard for public health and safety and for worker's healthcare rights not to have or produce those records. But it was in their best interest to play that card since it shelters them from any further legal claims as it did in my case.

This is a public health and safety issue. It's great that I won my case on freedom of speech, but this other claim, trying to get my exposure records, is very serious too, and there's no avenue available to pursue it.

Biotech workers had better watch out. The best thing is to take safety very seriously and prevent these things from happening. The problem is, at Pfizer we were trying to prevent them from happening-and we were told to shut up. If it happens at the wealthiest pharmaceutical company in the world, it can happen elsewhere.