Scandals In Biomedical Research

ethics + policy

SCANDALS in

What’s driving unethical practices? By Victoria Parente

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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?

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 underlying factor: money

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 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 Professor Margaret Cho the same painkiller.

“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

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Photo by Simon Pyle

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

The Vioxx scandal

Merck & Co. has since lost its third Vioxx suit, and has been charged with over $21 billion in damages.

The South Korean stem cell scandal The Korean stem cell scandal is another glaring case of false data publication. Leading researcher Dr. Hwang Woo Suk at Seoul National University published a paper in Science

“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.” that claimed he had derived stem cell lines from several cloned human embryos. The use of these stem cell lines would provide new avenues for therapeutic treatments and basic scientific research. The scientific community and the public at large celebrated Hwang’s work. He was voted one of the “People Who Mattered in 2004” by TIME Magazine. After increasing suspicion by the end of last year, however, 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

layout design: Stephanie Le

same time - not just one big group where there is one main head of it who is powerful and [whom] people don’t challenge.”

ethics + policy

How do we prevent future unethical practices? Many in the scientific research field say that there is nothing more we can do. They know that the independent peer-review process screens out much of the false data, and that the embarrassment of getting caught and ruining their reputation is just not worth the risk of cheating. They say that the process is not a perfect one, but that it is the best one possible for preventing most unethical publications. Others say that more can be done. To help prevent unethical conflicts of interest, Photo by Tanya industry relations 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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