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.