ethics
SCANDALS
policy
in
What’s driving unethical practices?
By Victoria Parente
F
raudulent data published to substantiate the
effectiveness of Merck & Co.’s painkiller Vioxx
and stem cell line production in South Korea have
undermined the public’s trust. Are unethical cases in the
life sciences industry just a few outlying, extreme examples
giving research a bad name?
The underlying factor: money
The underlying factor leading to most data fabrication in
both the biotech industry and academia is money. Recent
studies show researchers with a financial tie to industry may
have a “conflict of interest”, and be more likely to publish
“Trust is a very important and
precious commodity, and all
these things chip away at the
public’s trust.”
positive results. Likewise, academia is funded largely by
grants, and the best grants are typically awarded to the
researchers with the most publications in the best scientific
journals.
Covering up negative data is a cause for concern. “It
probably happens more often than we realize because we
only see the cases where someone has figured this out after
the fact,” says Dr. Mildred Cho of the Bioethics Department
at Stanford University, and an associate professor of
pediatrics.
Such unethical practices, when discovered, demoralize
the public’s trust in biomedical research. “Trust is a very
important and precious commodity, and [life science
52 stanford scientific
scandals] chip away at the public’s trust,” she remarks. “You
can see this, for example, in clinical trial participations - they
have gone down over the past few years. It becomes very
difficult to get people to participate in something they don’t
trust.”
The Vioxx scandal
The Vioxx scandal is a prime example of how conflicts of
interest have damaged the public’s trust in pharmaceutical
research. In November 2000, The New England Journal of
Medicine published an article by Merck & Co. confirming the
effectiveness of Vioxx in treating arthritis and other painful
conditions. The data suggested little risk of heart problems
with Vioxx. The article omitted data from three patients who
suffered heart attacks, leaving a positive impression of the
safety of Vioxx.
In September 2004, Vioxx was pulled off the market
after scientists realized it was causing significant heart
complications. Of the two million patients who were taking
the drug, Vioxx may have led to Photo by Simon Pyle
more than 27,000 heart attacks
and sudden cardiac deaths. Only
after it was taken off the market
did editors of The New England
Journal of Medicine discover that
the authors of the Vioxx article
had omitted data that could have
illuminated potential fatalities
due to the drug. Furthermore,
it was also found that of the 32
scientists chosen by the FDA
to evaluate the drug, 10 were
affiliated with manufacturers of
the same painkiller. Professor Margaret Cho
 ethics
+
Merck & Co. has since lost its third Vioxx suit, and has same time - not just one big group where there is policy
been charged with over $21 billion in damages. one main head of it who is powerful and [whom]
people don’t challenge.”
The South Korean stem cell scandal
The Korean stem cell scandal is another glaring case of How do we prevent future unethical practices?
false data publication. Leading researcher Dr. Hwang Woo Many in the scientific research field say that there is
Suk at Seoul National University published a paper in Science nothing more we can do. They know that the independent
peer-review process
“It wasn’t a matter of him wanting screens out much of
the false data, and that
to get famous - he was famous the embarrassment
of getting caught and
already, his face was on billboards, ruining their reputation
is just not worth the risk
he had songs written about him. of cheating. They say

He was a popstar.”
that the process is not a
perfect one, but that it
is the best one possible
that claimed he had derived stem cell lines from several for preventing most
cloned human embryos. The use of these stem cell lines unethical publications.
would provide new avenues for therapeutic treatments and Others say that
basic scientific research. The scientific community and the more can be done. To
public at large celebrated Hwang’s work. He was voted one help prevent unethical
of the “People Who Mattered in 2004” by TIME Magazine. conflicts of interest,
After increasing suspicion by the end of last year, however, industry relations Photo by Tanya

it became clear that much of Hwang’s data had been falsified.
The hopes of doctors, scientists, patients and the public
at large had been dashed. Seoul National University fired
Hwang, and the Korean government stripped him of the title
of the nation’s “supreme scientist”.
Hwang’s research lab was one of the best funded in
the world, and the money did not come from a company
pressuring him for favorable results. “Hwang was in a very
unusual situation,” says Cho. “It wasn’t a matter of him
wanting to get famous; he was famous already. His face was
on billboards; he had songs written about him. He was a
popstar.”
So why did he do it?
Some say Hwang’s behavior resulted from a push for more
fame, to keep his superstar status alive. Others say Hwang
believed that his work was possible, and got impatient that
he couldn’t conclusively prove it. He wanted to be the first
to publish it, knowing that dozens of other labs around the
world would work hard to reproduce the results, until finally
someone would actually be able to do it.
How did he get away with it?
Some believe Hwang’s lapse in scientific integrity was
due to environmental factors. The hierarchical organization
of his laboratory prevented scientists from critiquing and
questioning each others results. Additionally, the laboratory
was compartmentalized in such a way that each scientist
was assigned to one job, such as obtaining stem cells from in
vitro fertilization treatments, and there was no supervision
to ensure that each job was conducted ethically.
Using Stanford as a counterexample, Cho claims “we
have lots of people doing the same types of research at the
should be disclosed in
all published articles.
Additionally, as demonstrated by the Korean stem cell
scandal, environmental factors conducive to fraudulent
experiments should be changed. Researchers should shy
Vioxx may have led to more than
27,000 heart attacks and sudden
cardiac deaths.
away from hierarchical organizations in which it becomes
impossible for younger or lower-level scientists to question
their superior’s methods or results.
Although it is believed that extreme cases of fraudulent
data manipulation do not commonly occur, the cases that
are discovered are made very visible. The public’s view of
biomedical research has been shaken, but perhaps upcoming
research findings will replace that distrust with optimism
and faith once again in science. S
Victoria Parente is a junior majoring in Biology, with an emphasis on
Neuroscience and Psychology. In her spare time she enjoys running,
swimming, and reading the New York Times.
To Learn More:
NIH Conflict of Interest
http://www.nih.gov/about/ethics_COI.htm

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