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Juggling on the Berlin Wall
Wikimedia / Yann |
It is rather odd how often I hear the expression paradigm
shift during contemporary scientific presentations and seminars. The expression
was popularized by Thomas Kuhn’s book "The Structure of Scientific Revolutions".
In that book, Kuhn referred to ground-breaking and revolutionary changes in
scientific thought as paradigm shifts, but the expression is so over-used today
that even minor discoveries are sometimes marketed as paradigm shifts.
However, once in a while a true paradigm shift does come
along and I believe we are currently witnessing such an emerging paradigm
shift: open science. This concept entails that research results should be
freely and openly accessible to the broad scientific colleagues as well as the
public.
The idea of open science goes beyond merely providing public
access to published scientific articles because it also includes offering
access to the original research data. This would permit fellow researchers to
help evaluate and analyze the results, so that the broader scientific community
as well as the public can weigh in on the interpretation of the scientific
findings. This aspect of open science likely does qualify for being a true
paradigm shift, because it will require that we think of ourselves as part of
research communities and usher in “networked discovery”, as has been described
in a recent book by Michael Nielsen and discussed by Bora Zivkovic.
There are still many obstacles that need to be addressed
before “open science” becomes generally accepted. Academic publishers currently
reap significant profits from selling high-priced annual subscriptions to
academic institutions, and they would lose this income if scientists started
publishing their results in open-access journals that freely provide articles
to readers without charging for subscriptions or per-article fees. Furthermore,
academic institutions and individual scientists may be concerned about how they
would apply for patents, if the discovery process is networked and involves
score sof collaborating scientists.
Nevertheless, under pressure from the public and funding
agencies that rightfully demand public access to the results of the funded
research, it is likely that our current research culture will change. We will
gradually tear down the walls that exist in our current scientific culture. It
will not happen overnight, and we will have to develop new infrastructures to
share scientific data, novel ways to assess academic success and reward
contributions of individual scientists as well as establish high quality open
access journals in a variety of scientific areas.
However, one has to keep in mind that certain areas of
research are associated with unique challenges when it comes to the
implementation of open science. The obstacles presented openly sharing original
data and results in biomedical research may be very different from those in
astrophysics.
Clinical research is often funded by the private industry
and may thus evade mandates of public funding agencies or not-for-profit foundations
to publish in open access journals and openly share results. But even publicly
funded biomedical research is characterized by some unique challenges.
One such challenge is the importance of maintaining patient
confidentiality when it comes to data sharing. Institutional Review Boards
monitor the ethics of studies involving human subjects or patients at all
academic institutions and one of their biggest concerns is how personal data of
subjects or patients is handled. Usually, the data is de-identifed for the
purpose of publication so that any kind of description of the disease state,
symptoms, mutations or other findings cannot be linked to individuals.
Only a very small group of trained professionals have access
to the names of the subjects or patients and usually only these review the
medical charts or personal questionnaires of the participants. If the data-sets
are made publicly available, it is imperative that appropriate safeguards are
put in place to assure the participants that the data will only be shared in a
de-identified format and that anybody seeing the data-set will not be able to
link the diseases to the individual identity of the participants.
There is another critical obstacle that needs to be
addressed when open science is implemented in medical research. The primary
target audience for basic research that is not related to medicine or health
consists of fellow scientists and science journalists.
I remember that I started my research career working as a
chronobiologist on the circadian rhythms of the unicellular marine algae
Gonyaulax polyedra. I doubt that anyone other than fellow scientists or science
journalists would have been interested in accessing or interpreting our
original data, even if all the data and results had been presented in an open
access format.
On the other hand, my research in recent years has shifted
to areas that have a more direct medical relevance, such as metabolism and stem
cells in vascular disease, heart failure and cancer. My research approach is
still focused on basic biological mechanisms, but due to the change in my
research topics, I have encountered much broader interest from patients as well
as healthcare providers.
Patients with severe chronic illnesses and their loved ones
scour the internet for possible new therapies, even if these therapies have not
been proven to work. The burden of disease makes them emotionally vulnerable so
that they may selectively read and interpret the scientific literature in a
manner that gives them false hopes.
For example, I remember talking to one of my heart failure
patients who wanted to pay out of his own pocket for a trip to Thailand so that
he could receive adult stem cell injections to improve his heart failure. He
had found out about this experimental therapy through the internet. Since he
did not qualify for any of the ongoing adult stem cell therapy trials in the
US, he was extremely interested in trying out this therapy that was being
offered overseas (for a substantial fee). He was not aware of the potential
side effects of invasive stem cell injections or the importance of quality
control and he assumed that it was proven that they work for heart failure. It
was only after extensive counseling that he understood there was no clear
evidence supporting the therapy and decided to avoid subjecting himself to the
questionable therapy.
Many healthcare providers such as practicing physicians do
not have a scientific background and are not necessarily trained to critically
evaluate research data. They currently rely on review articles or meta-analyses
published in respected journals, but they are also influenced by scientific
data that are presented to them by representatives or consultants for the
pharmaceutical industry.
At first glance, open access to original data sets should
increase the transparency of research. However, if we remember the adage that
“we only see what we want to see”, we have to realize that open access to
research data will also create an opportunity for pharmaceutical companies or
for-profit hospitals to promote medical therapies on the basis of limited
scientific data.
Selective reporting of the publicly available data by
special interest groups could find an excellent breeding ground among
emotionally vulnerable patients or healthcare providers who may be easily
swayed by the plight and hopes of their patients. One example of selective
reporting or selective analysis would be when negative clinical trials are
re-analyzed to identify some subgroups of patients that showed a statistically
significant improvement with the experimental therapy.
Another example could be that the clinical significance of
in vitro cell signaling studies or animal studies could be over-stated. In a
traditional academic paper, most of our scientific colleagues (voluntarily or
after peer-review) highlight the limitations of their studies. If the data is
publicly available, the data would be open to variant interpretations, even by
members of the community who are not trained to appropriately interpret the
data.
The solution to these potential issues that may arise when
we transition to an open science format is not to limit the access of the data.
Instead, it is imperative that concomitant with the creation of an open science
environment we also build independent institutions or organizations that help
interpret the available the data in a manner that non-scientists are able to
receive accurate and solid information about the nature and significance of the
results.
“Consumer Reports” in the US or “Stiftung Warentest” in
Germany routinely test consumer products for their quality and safety, and
report them in a manner that members of public can understand the results.
Consumers buy subscriptions to their websites or magazines and they enjoy
respect among consumers, who have confidence in their unbiased evaluations of
products.
One could envision similar institutions that evaluate the
biomedical research data and can give solid advice to non-specialists. Ideally,
such institutions would need to include independent expert scientists as well
as independent experts at communicating science to the broader public. The
reason for including expertise in science reporting and science communication
is simply due to the fact that many scientists are “communicatively
challenged”. It does not help the broader public if a group of scientists
charged with providing independent evaluation of publicly available datasets
produces reports that are full of technical jargon. As funding agencies and the
public push for open access to scientific research data, they also need to push
for developing and funding infrastructures that can help the public interpret
the openly accessible data.
In summary, I believe that the time for open science and
networked discovery has arrived and that it will definitely enhance the
progress of scientific research, as long as we build institutions that help us
process and understand the flood of scientific data that will be released in
the new open science world.
