The Dark Side of Medical Research

by Daniel Tippens

I graduated from New York University in 2014 and subsequently began working as a research technician in a lab at the medical school. While our lab is a part of the Department of Surgery and has only one researcher with a Ph.D. (most are M.D.s), we apply for and secure a large number of grants. So, as one might expect, the medical center has put us in a luxurious building on the East River, with a spectacular view of Queens.

If you were to try and guess the salary that researchers receive, on the basis of the building in which we work, you would think that we all take home a six-figure paycheck. But, of course, the building’s “facade” is just that – something that conceals the reality of what goes on inside. We are nickel and dimed – indeed, was underpaid by some $10,000 for the first year I was employed. I am technically on “salary,” which is supposed to mean that while I cannot earn overtime, I am paid a fixed amount,  no matter how many hours I work. However, the department of surgery requires us to submit a time-sheet each week, and if we report that we worked fewer than forty hours, it is taken out of our pay. If we report more than forty hours hours, we get nothing extra. In effect, we are paid hourly, but without reaping the benefits of hourly employment.

I didn’t know it at first, but it turns out that creating the illusion of respectability is a pervasive theme in medical research … or at least, it is where I work, and I have been given no reason to think that things are substantially different elsewhere. Every lab that works with animals and receives federal funding must submit a protocol to the University’s regulatory agency, the Institutional Animal Care and Use Committee  (IACUC). One purpose of the protocol is to inform the committee of the experiments that we will be performing, what kinds of pain the animals will endure, and what the scientific justifications for the experiments are. Performing any experiment that isn’t on this document is supposed to be strictly prohibited. Another purpose of the protocol is to notify the committee of exactly who will be performing experiments. Only those listed in the document can partake in executing the studies.

When I first started to volunteer in the lab as an undergraduate, I worked with an M.D. who was waiting to get into a residency program. He was in charge of doing revisions for a paper we had already submitted, and this involved a performing large quantity of partial hepatectomies (surgical removal of the liver) on mice. I was asked to perform about a hundred of these surgeries, having never even heard of a protocol. Of course, this means that I was never trained in the procedure, and the consequence was a significant animal-welfare disaster. I had instances where a mouse would wake up mid-surgery due to an improper dosage of anesthetic and analgesic, and it would begin gasping in pain while I was resecting its liver and suturing the site of incision.

Our lab has been caught in significant noncompliance twice. The first time was about five years ago, when there were three people approved to do experiments on our protocol. IACUC did a surprise inspection (something they almost never do), and walked in to find no less than ten unapproved people performing surgeries on mice. The result was essentially a finger wag –  several of our lab members had to attend a few hours of compliance “training sessions” and that was about it.

The second incident happened within the past few months. We were giving antibiotics-laced water to mice in order to deplete their microbiome, so that we could test the effects of microbiome changes on cancer development. The study was not something that we had cleared with IACUC. Worse, the antibiotic-water was being dispensed to the mice through special bottles, which are highly visible in the cages. For a year we had been performing these studies, out in the open, and in all that time not a single person had checked to see if it was on our protocol. One of our researchers even had a conversation with an IACUC veterinarian about the water study, asking for recommendations on how to dispense the water properly, while the two were standing just two feet away from the cages.

Just over a month ago, several mice in our antibiotic study died due to what appeared to be dehydration. The husbandry personnel (MISPRO) who perform standard upkeep tasks on our mice – cleaning the cages, adding food, etc. – found the dead animals and finally looked over our protocol. We received a lengthy email detailing the allegations against us, and IACUC began in investigation into the matter.

The task of replying to the allegations ended up in my hands, and I wrote a twenty page response letter, detailing the conditions of the lab and explaining why the mice had died. Of course, there was no way to justify the fact that we were doing an off-protocol study, so I simply pleaded guilty to that charge on behalf of the lab.

IACUC replied to us, announcing the date and time when they would inspect our lab and animal facility to ensure we were no longer doing anything off-protocol. I can’t underscore enough how, despite having concrete evidence of noncompliance against the lab, IACUC notified us of exactly when they would be inspecting us. Of course, when that date rolled around, a meeting was held where all volunteers who are not on our protocol were instructed to stay at home during IACUC’s inspection, and the research fellows were told to refrain from doing any experiments that day. We even hid some experimental materials, as well as mice, so that off-protocol work wouldn’t be found. We were trying to re-establish our veneer of respectability.

Our cover-up efforts worked, and in the end, IACUC gave us another slap on the wrist – a few mandatory training sessions and a signed statement that we wouldn’t do experiments off protocol in the future (something we had already promised not to do).

For years, our lab has been performing studies under IACUC’s radar, so one wonders how we could have gotten away with this sort of thing for so long. Why haven’t we been shut down? The explanation includes a careless attitude, as well as corruption at virtually every level of the research process.

First, we can implicate my lab. We would falsify the records to which IACUC had access, claiming that we were performing an on-protocol experiment with mice, when in fact we were doing unapproved studies on them. So, no one knew that we were breaking the rules and no one bothered to check.  One might wonder why we conducted our business in such a shady manner, and the reason has to do with time. Getting an experimental model approved is a time-intensive process, and we either wanted to get some pilot-studies going right away or had received a “revise and resubmit” on a paper and needed to perform the relevant experiments quickly.

Second, we can blame the IACUC . They announced virtually all of their inspections ahead of time, so we were able to prepare for their visits. And of course even when we were caught, we got nothing more than a slap on the wrist, despite breaking the most serious of all regulatory rules; i.e. those having to do with animal welfare.

The IACUC, while answerable to federal agencies, is also under pressure from the university to be lenient with labs that bring in large amounts of money. Thus, the agency tries to appear as if it is regulating us strictly, so that they satisfy government regulators, while simultaneously working to keep our lab going, in spite of gross noncompliance. It is like one parent telling the babysitter that no ice cream is allowed, and the other whispering to the sitter that ice cream is fine. In the end, the babysitter brings home some soft-serve, but makes sure to take out the trash and with it, the evidence.

Third, scientific journals also bear some responsibility. Despite informing authors that they must adhere to strict regulatory rules, they would accept our manuscripts and essentially do nothing to ensure that our experiments were approved by IACUC. Their only check on this is a signature page, where we are asked to swear to them that we acted in compliance. Consequently, our lab has published papers, in the highest ranking journals, which contain experiments that were never approved. If anyone were simply to check on this they would catch us red-handed.

All of this takes place against the backdrop of gross expenditures of money in medical – and especially cancer-related – research.  It is shocking how easy it is to get a grant for hundreds of thousands of dollars.  Indeed, I’m aware of several instances where labs have flat out falsified grant data by repackaging old data and submitting it with different x and y axis labels, claiming that it is preliminary data and therefore, warrants grant money. Frequently, labs falsifying grants will never even pursue projects related to the proposal they submitted.

Any human activity that has too much money in it invites a culture of corruption.  And in some contexts, medical research has become so flush with money that it has engendered a craven, self-interested culture, one that has debased the altruistic goal that were supposed to undergird the whole endeavor, namely that of saving lives.

11 Comments »

  1. “It is shocking how easy it is to get a grant for hundreds of thousands of dollars”: not where I come from, though it might be better where you are. In 2015, NIH funded 9241 of 51073 research project grant applications (18.1%) – you might guess from this how many unsuccessful grant applications I was involved with this year, and how much time out of each year grant writing takes. For a three year grant, just one salary (plus associated costs) eats up money quickly, and in Australia NHMRC grants set the the pay rate at ~10% under the actual rates required by our universities. You sound like you are a bit cheaper though 😉 It was the case that the Ivy League paid postdocs 1/3 less than those at lesser universities.

    As to the maze of institutional review boards, don’t get me started. Just wait until you are involved in a multi-centre study where each IRB demands different changes from every other. Bliss it is when we can decide that a protocol change would be covered by the original approval. Do you think there would have been any different outcome to your example of feeding mice antibiotics if all the forms had been filled in? As to you doing procedures, I agree that sounds like laziness of your supervisors not offering adequate training. I suppose the question is whether extra layers of bureaucracy are necessarily the answer, especially when compared to equivalent events in other domains (say Facebook experiments on political belief).

    I suppose the more general point is whether the scientific (and academic) enterprise as it is currently organised is much better than other human institutions. My personal evaluation is fairly positive. One can optimistically regard the current crises of confidence (increased awareness of scientific fraud, nonreplicability, stupidity of funding areas that I think are nonsensical etc) as part of the “normal self-correcting” property of an ideal science (I find the ideal v. non-ideal in political science/philosophy a useful concept).

    Liked by 1 person

  2. I wish I could say this was shocking, but having worked in both the Academy and in the medical field (as an LPN), I can only remark a recurrent disappointment.

    I would hope such bureaucratic bumbling about at least makes real advances in research possible; but I admit misgivings….

    Liked by 1 person

  3. The more that rules, laws and regulations proliferate, the less compliance there is, it seems. Perhaps all these prescriptions decrease the moral commitments of individual members of a community.

    Liked by 1 person

  4. My own personal experiences with animal models and the nature of funding’s influence on ethical conduct in research are very different from yours, it appears. As a graduate student, I came into animal work dealing with a potential therapeutic target for ovarian cancer treatment very early in my tenure in the lab and though I had zero experience with anything we were doing, aside from dissection, I was immediately added to the IACUC application and received a number of trainings for the purpose of certifying my understanding of the requirements, my role in the lab and approved procedures, and agreement to uphold standards outlined therein. The work was conducted without incident when it was finally approved, other than some members of the team finding themselves too uncomfortable to execute their responsibilities when the time came and other knowledgeable individuals filling in. The difference in our stories hinges on the role of personal responsibility. Your lab has consistently failed to uphold requirements, the university and the IACUC are more than negligent when it comes to enforcement of standards, and the constant pressure of the ultracompetitive biomedical research culture does little to afford researchers a fighting chance at maintaining both compliance and a career. However, your professional career didn’t hinge on a job as a lab technician (I’m sure your talents are better suited elsewhere). A big part of the problem in academic research, and indeed in every walk of life, is that we are rarely opposed to being complicit in wrongdoing if making a moral decision requires some effort or risk on our part. I am pretty sure of what the response would have been if you questioned the lab’s practices outwardly, but getting additional guidance on procedures and training in techniques and best practices from fellow lab members certainly could save those mice from severe distress, even though it doesn’t address regulations. If all else fails, we can make the choice not to be part of the problem by getting out of the situation altogether. Nothing will ever change if all those involved continue to accept misconduct and reform will only succeed when everyone claims responsibility for their role, no matter the outcome.

    Liked by 1 person

  5. This is something I wanted to write about in the near future, as my PhD comes to a close.

    I have worked in science from the government oversight side, and I have now worked for significant time in science from the academic side (in medical research). Both have left me so disillusioned and upset, and I certainly know stories along the lines you describe (though I can’t speak about them yet).

    The one point of disagreement I have with your essay is the implication this is due to science (or medical research as a whole) being flush with money. Greed is certainly there as a motive, but as pockets of funders have tightened, or numbers of labs have outstripped the total available funding, or money funnels into a few labs at the expense of others (all three issues are active in any given field) then corners get cut… more so than if everyone was feeling so loaded they could do what they wanted.

    I mean maybe I am a bit of an optimist but I think that most people if able to do what they wanted, would not be cutting corners and risking problems.

    You are lucky if you have found 100K grants easy to get. I know some labs or specific areas of research (for a time) are like that. Mine got absorbed by a group where it seems every funder wanted to throw money at it (while ours did not attract so much funding despite being on the cutting edge). Of course I’ve met profs complaining once it all went away (shifting to another focus or a lab that had some flashy results {maybe not real}).

    In the end I blame this phenomena on the commercialization of education, science, and medicine. And by commercialization I mean both the imperative of making profits, as well as making headlines. It is a recipe for graft and corruption.

    To me the era of science as an intellectual discipline is basically over. For the most part science is just a tool used by those who work in a science-based industry (medical or other), which means being a science researcher is simply an occupation in the service of money (and fame) and so open to the same forces that pressure bankers to put out bad loans, doctors to make wrong diagnoses, and journalists to deliver false information.

    Liked by 1 person

  6. Thanks you for all the comments, they are very interesting and insightful.

    It looks like my experience may not be as pervasive (at least with regard to grant acquisition and financially-motivated corruption), and that has been illuminating to see.

    Hi Imsupar,

    “However, your professional career didn’t hinge on a job as a lab technician (I’m sure your talents are better suited elsewhere). A big part of the problem in academic research, and indeed in every walk of life, is that we are rarely opposed to being complicit in wrongdoing if making a moral decision requires some effort or risk on our part. I am pretty sure of what the response would have been if you questioned the lab’s practices outwardly, but getting additional guidance on procedures and training in techniques and best practices from fellow lab members certainly could save those mice from severe distress, even though it doesn’t address regulations. If all else fails, we can make the choice not to be part of the problem by getting out of the situation altogether. Nothing will ever change if all those involved continue to accept misconduct and reform will only succeed when everyone claims responsibility for their role, no matter the outcome.”

    Thanks for the comment. Just for clarity, I did seek more professional training, independently, and did my own research in order to improve the animal welfare of the mice that I operated on. With regard to challenging the moral direction of the lab, yes, the response would not be a good one. In my case, I am confident it would have led to a push to get me out of the lab. With this knowledge in the background, it is difficult to deviate from being “complicit,” as you say, since the choice is either the be complicit or to lose the salary that keeps one afloat. Additionally, getting out of the situation isn’t an easy move either, when one doesn’t know what they could turn to for financial support, or when one is dependent on the job for some other important reasons. To relate this more directly to your comment, I think many people (myself included) *do* take responsibility for their role, but they find it difficult to leave for all sorts of pragmatic reasons. I find it hard to blame individuals who remain complicit, in these circumstances. We are not all moral saints who would leave, for moral reasons, regardless of the harmful outcome to one’s self.

    DB and David Duffy,

    I’d love to hear more about your lab experiences, and more broadly about your diagnoses for some of the problems we agree are occurring.

    Liam,

    I think you raise an interesting suggestion about how perhaps, when rules are being ubiquitously broken, it might mean that they are rules that we should do away with, instead of trying to get people to follow them.

    EJ,

    I’d love to hear about the similar ethical dilemmas you faced in your time in the medical industry.

    Like

  7. David Duffy,

    Do you think that almost 20% is a low rate at which to be awarding grants? If my chances of being awarded a grant for tens of thousands — perhaps hundreds of thousands — of dollars I would say those are pretty good odds, especially if you happen to be quite capable at streamlining grant-writing (something my lab is remarkably good at).

    Also, I think it is harder to get one’s foot in the door with grants, but once one does — in that one gets a grant — it becomes easier in the future, since you are able to acquire better preliminary data with the first grant-money you were awarded and what not.

    Like

  8. DantT asks “Is 20% a low rate?” I have sat on the Australian equivalent of an NIH Study Section on multiple occasions. We see heaps of really good science miss out on funding every year (we have a 14% success rate, with more applications each year for the same total budget). I have been a co-investigator on several NIH RO1 grants, which you might know are open to non-US applicants where the work couldn’t have been done by anyone else – that became pretty impossible after 2008 for obvious reasons. So I think the work we do is internationally competitive, but we were not too successful in this year’s round. And not everyone is in an area where grant applications can be churned out quickly with a good probability of success. Let’s say I want to follow a cohort of people with a particular condition for 20 years. What are the chances my project will be continuously funded over multiple funding rounds? Each paper in epidemiology takes longer and costs 2-3 times as much as a wet lab paper (the numbers I have seen are $50K v. $20K), so if each discipline gets the same size pot, fewer proposals are funded in the former case. But there is still a big difference between the money available in medical research as opposed to other fields, and more so for that closer to the clinic (more charitable money too).

    Like

  9. Hi Dan T, rather than discuss something I encountered myself (of which there were plenty at all levels), I will discuss a case I know of that shows much better why recommendations like Imsapur’s are not entirely realistic.

    A lab submitted an article based on a student’s work (with that student’s name on it). The student had not known this was going to be done, until receiving a copy of the submission. The way the data was represented was incomplete and inaccurate. It was wrong. The student tried to get this corrected through normal channels in the lab and was ignored. Tried to go above the lab, talking to others in school administration, and only got in trouble for doing so. The student then contacted the journal with the errors, who came back on the lab rather hard and it was rejected. Who was in trouble and “punished” for this? The student.

    The system wants publications and its profs all inerrant scientists. They will protect that process and that illusion as much as they can. In this case they silenced a student, making the student essentially persona non grata to that institution, then corrected the data (slightly) and resubmitted. The prof and school came out on top. The student’s career put in jeopardy. Not easy to just get a job somewhere else when you were black-balled by the place you left, especially for not being a team player. The student certainly learned their lesson as did anyone else in the lab, or knew the student and the story.

    Unfortunately, as the tail end of my first comment suggests, this is a widespread systemic problem. It is not just the sciences. And it is not just about the presence of money.

    While I like free markets, I think people have become fixated on that model and measurable/quantitative ends as if something “real” and of intrinsic value. The way all things are supposed to be treated. This has led to a corruption of critical institutions by adding pressures that are not needed, and in fact counter productive.

    I don’t want to say a revolution is necessary (as people like Chris Hedges or Cornell West might argue) but I do think a paradigm shift is called for. We have to recognize (as we once did with fire and police departments) that there are certain services that function better outside a market model, without profit incentive and the current “advertisement” model we’ve adopted as part of that.

    A science lab, even in medical research, is not an assembly line for routine production of technology or papers. Yet that is exactly how they are treated, including for funding. Until it is treated as an ongoing service, a public good, where papers and technology emerge as warranted rather than as expected (to produce spectacle and so cash flow) it is only going to get worse.

    And within the free market model, people at educational facilities should be getting smarter about how many scientists are needed and restricting “production” of them. That is to say limiting programs and labs and students to those that make sense for available funding. Then again that involves treating educational facilities outside a market model, with concern for what is useful (the service provided) rather than how much “product” they can produce to drive in revenue.

    On top of this I might add that we need to develop a culture where people reporting problems are not viewed as “rats” that need to be punished, as if they did something wrong, but as providing a valuable service to the community (including the one they are a part of). A recognition that this is loyalty, more than conforming to silence about something that has gone wrong.

    But, as people might tell me, good luck with all that.

    Liked by 2 people