Conflicts of Interest and Personal Bias

Ultimately a discussion on conflicts of interest and personal bias is centered around the concept of ethics. How one conducts their personal and professional business. As Dan Ariely discuses in his 2011 TED talk Beware conflicts of interest, all people have inherent bias that is shifted towards their own personal interests. It is not necessarily malicious behavior or meant to harm or take advantage of others. As Dan puts it, we’re very good at being “blinded by our own incentives.” We are always interested in what suits us best.

However, in some cases this inherent bias can lead to destructive practices. In Dan’s 2013 TAM talk The honest truth aboutdishonesty, he imagines the thought processes behind they American financial crisis of the past decade. By reducing transparency on financial decisions and having been shifted so far away from the persons that would suffer from poor decisions, the possible consequences seem less severe. Furthermore, by creating incentives to do what would be considered wrong or unethical makes the wrong action seem justifiable because the personal outcome becomes a positive one. What’s more, the further we are removed from our actions the better we feel about misbehaving. He touches lightly on the idea of cognitive dissonance, without getting into it. The idea that in some cases we convince ourselves that our actions are not wrong or unethical, but in the right and justifiable.

Ultimately, personal and professional biases have impacts on others. But these impacts are avoidable and in some cases, unnecessary. Perhaps by identifying our own personal biases we can intentionally avoid them, removing conflicts of interest and possible breaches in ethics. The result would be a society of people that treat each other appropriately and conducts themselves in a respectable manner. It sounds like a pipe-dream, but perhaps if we took the time to consider how our actions affect others, it wouldn’t take very much to see positive change. 

Seeking Integrity on the Shoulders of Giants

One of the books that has most shaped my view of the world is Mother Night by Kurt  Vonnegut. In it, the narrator describes his philosophy of how people’s minds are like clockwork, with every fact we know serving as a tooth in a cog. In many ways, though, we are missing teeth. Either we are unintentionally blinded to truth because of the environment in which we were raised, or we purposely deny truths because they do not fit nicely with our mental constructs. He says, “I… will say that I have never tampered with a single tooth in my thought machine, such as it is. There are teeth missing, God knows -- some I was born without, teeth that will never grow. And other teeth have been stripped by the clutchless shifts of history -- But never have I willfully destroyed a tooth on a gear of my thinking machine. Never have I said to myself, 'This fact I can do without.’” As a scientist, my greatest quest is to find truth and to try to fill the gaps in our understanding of the world. Yet, one of my greatest fears is that, knowingly or unknowingly, I am missing teeth in my gears.

Our first lecture with TJ Murphy struck home with me not only because it brought to light the “reproducibility crisis,” but it also reminded me of my part in it. I see that we today are standing upon the shoulders of giants. Everything that we know and believe to be truth is based upon the years of work of those before us. Though I am astounded by the brilliance, creativity, and passion of our predecessors, a part of me is also frightened. How much of what we take for granted is actually truth? In what ways do I contribute to the reproducibility crisis, and where does my own blindness come into light? How can I help promote an environment of scientific integrity? Christopher Pannucci and Edwin Wilkins cite the many different forms of biases that can distort an investigator’s ability to assess their findings, so I must confront and address my biases head-on before starting a project. As stated in The Economist, science is not necessarily self-correcting, so my fellow researchers and I must begin the movement to be more open about science as a powerful, yet fallible, tool for approaching our world’s many questions.

Considering Publishing Ethics as Research Ethics: On Recent NCATS Clinical Studies

Five years ago, Director of the National Institutes of Health (NIH) Francis Collins, was met with much criticism (mostly from big pharma execs) when he proposed a publically-funded translational medicine institute at the NIH. The National Center for Advancing Translational Sciences (NCATS) has since been up and running at the NIH, and has been under a scrutinizing eye of many in the translational research community.

A slide produced by Vtesse about VTS-270

In its short history, NCATS has had some promising breakthroughs: finding more than 50 chemical compounds that block the Ebola virus from entering cells, for instance. However, much money has been spent on VTS-270, a mixture of 2-hydroxypropyl-B-cyclodextrins, which has been shown to be a potential treatment for the deadly childhood disease Niemann-Pick Type C-1. The process in developing the compound has been sped up thanks to collaboration between NCATS and a Maryland-based company called Vtesse.

Vtesse has recently been running late-stage clinical trials of the drug by injecting the large sugars into the spinal fluid of the lumbar of patients with the disease. Prior to the lumbar puncture, the team also tried to use implanted reservoirs similar to those used to inject chemotherapeutic agents in the brain, in the brain’s ventricles. However, reservoirs in two of the three children in the study became infected.

A diagram of the reservoir system used to inject drugs into patients' brains

The mother of the twin children who had infected reservoirs is now angry that the recently published article in Current Topics in Medicinal Chemistry had no mention of the failed direct-brain administration of the compound. Although the initial research article was submitted only 9 days after the conclusion of the clinical trial in April 2013, the study was not published until 2014, almost a year later. Chris Hempel (mother of the children), brought this information to the attention of the journal’s editor. A correction has since been published, illustrating the shift from direct brain injection to the lumbar puncture technique. The clinical trial was put on hold soon after.

The case of NCATS and translational medicine brings up an interesting perspective on intent versus perception in research, as well as the ethics of research and how they parallel publication ethics. When asked about the correction, Chris Austin, the director of NCATS said, “The theme of the particular issue of the journal in which the article was published was collaborative science, and therefore the article was focused on the process and collaborative environment contributing to the development of the drug. The information regarding the clinical trial is currently being written for submission to a research journal.” It shows that this particular group of scientists believe there is a clear correlation between intent, theme, and release of certain information. However, this correlation seems to have caught the scientists in a conundrum.

One can only assume that because the scientists felt that they were publishing an article with a specific theme, they believed it was OK to omit certain information. However, the scientists completely ignore the fact that they fall under the NIH’s Ethical Guidelines for Clinical Research – specifically respect for enrolled participants by informing them of “new information…that might change the assessment of the risks and benefits of participating.” In addition, by not immediately releasing the results of the infected reservoirs to the public, they put potential participants at risk. What if another company has a similar idea and further patients become infected because they hadn’t heard of previous studies? Making both other researchers and participants ignorant of infection risk is not justifiable for thematic harmony of one article submission.

In addition, it appears that the authors specifically violated certain publishing ethics set out by both European and American societies on publishing and the scientific community, as well. In publishing, there is a documented “Seven Sins” of ethical breaches in publishing: carelessness, redundant publishing, unfair authorship, undeclared conflict of interest, human/animal subjects violation, plagiarism, and other fraud. And it’s that tricky last category, other fraud, that gets these authors. “Cooking” is defined as the selective reporting of one’s data. Let’s take a step back and think about this problem as a philosophical – even economical – one. Certain taxpayers made the grants and funding possible for this research to be done; under a tacit social contract and the not-so-tacit oath of the scientists, they agree to serve the public and not involve themselves in “evasion.” Sure, it seems nit-picky, but responsibility, integrity, and honor play an important part in institutional trust and, macroscopically, public trust of science.

BIG brother regulating BIG data

http://www.sciencebusiness.net/news/79758/UK-government-plans-ethics-council-to-guide-big-data-researchers

The government in the UK recently passed legislature to regulate what they are calling ‘big data’. This is an umbrella term to describe all of the major meta data being collected recently such as the data that might be collected from Facebook and Microsoft concerning usage of their products by the public. To provide ethics and regulations for this type of data, a new committee will be put into place at the Alan Turing Institute.

I thought this story was an interesting take on ethics. We always talk about ethics in terms of potential (physical) harm to the individual. With the advances in technology and the ability to quickly access and analyze large sets of personal data it makes sense that different countries are attempting to put regulations in place to try and curb misuse. I think it is great that they are trying to put rules in place now before things get out of control. This would be in contrast to the type of bioethics committees in the US that were largely formed due to the public exposure of unethical experimentation such as the Tuskegee experiments. One aspect that I am not sure about is how long these different regulations can last before reform is needed to keep up with the times. Technology is always changing and surely new ways of mining personal data will be developed. It will be interesting how these different committees interpret these new technologies and how the rules are adjusted to protect the public. 

Why not? Nobody said we couldn't do it this way

http://www.cdc.gov/tuskegee/timeline.htm

The study originally started out as the Tuskegee Study of Untreated Syphilis in the Negro Male. The purpose of the study was to bring enough evidence forward to justify treating African Americans with syphilis infections. I think that is kind of strange. Why would you not treat people that have an infection that you know is bad for their health. Unless you are assuming that people of different races have different outcomes from disease because the races are so far apart from a genetic level? 

The study began in 1932 and originally involved 600 subjects. About 400 with disease and 200 without the disease. The men in this study never received informed consent and were given promises of free meals, free medical exams (yeah, I bet) and burial services would be paid for. These people were also lied to about the status of their disease. They were never told that they had syphilis. They were only told that they had ‘bad blood’. This is a phrase used to describe a number of ailments. In 1947, with Penicillin becoming the drug of choice for syphilis, the subjects were still not offered treatment. The study was to be conducted for 6 months but ended up lasting for 40 years.

I think that this case illustrates a number of ethical issues involving medical research. First, is the issue of do no harm. In clinical studies today it is common to give drug to an untreated or alternative treated group the drug under study if the data on the new drug is sufficient to prove that the treatment is significantly better at treating the disease. It is hard to understand why the participants would not be given the drug of choice in 1947. What is also bizarre is that the study in general makes absolutely no sense to me. It was already understood that syphilis was a bad disease so what was the point of the study? I think it is a great example of something that happens in science all too often, but certainly not to the degree of this study, which is basically putting a study together because you can. The lack of regulation in this study is staggering and makes me wonder what things would be like know if science was not heavily regulated. With the advancement of science over the last 50 years there are certainly experiments on certain researcher’s minds that would most likely put the Tuskegee study to shame.

The final outcome for the Tuskegee study was a settlement with the victims’ families. Also, study regulations were extremely modified and set the standards that we currently carry for medical research today. It should also be noted that the Tuskegee experiment did not become public knowledge until the media picked up on the issue. Could this study have continued for another 20 or 30 years without this coverage? Maybe. Overall the Tuskegee study is a primary example of why bioethics are so important for scientific investigation. It is important for keeping study participants safe but it is also good for science itself. What I mean is that it is important for science to be trusted by the general public. Otherwise you end up with stupid people not wanting to vaccinate their children.