by Johan PE Karlberg, MD, PhD, BSc, Founder and Editor of Clinical Trial Magnifier; Author and Editor of Reviewing Clinical Trials: A Guide for the Ethic Committee; and Author and Editor of Study Site SOP Standardization – The 4S Project
During the past thirty-five years I have been active in clinical research; between 1998 and 2011, I acted as the director for the Clinical Trials Centre at The University of Hong Kong. During those twelve years we conducted 640 industry-sponsored clinical trials. I have seen many good clinical studies, but also a number of poorly run, unethical studies.
Unethical and fraudulent behaviour have become more and more common among academics. For instance, a recent article in Nature reported a 1,330% increase in the number of retracted publications in scientific journals, even though the total number of papers published has risen by only 44% over the past decade.
A recent study in the British Medical Journal included the responses of 2,800 clinicians and academics. The study showed that 13% had witnessed colleagues intentionally altering or fabricating research data and 6% were aware of possible research fraud at their institution that hadn’t been properly examined. If those figures are accurate then we are facing scientific fraud on a large scale. The saga goes on and on.
Fraud and manipulation of research data can also be linked to other unethical behaviour. I just came across a report about a medical professor at a university in Germany. He has been a world-leading clinical researcher in anesthesiology He is currently under criminal investigation for possible research forgery. According to the report, 89 of 102 studies published by the professor contained research that lacked proper approval from an ethics committee.
Another area of fraudulent behaviour is insider trading. Last November, US regulators were suspicious when Gilead Sciences, Inc. announced it was buying Pharmasset, Inc. for $11 billion. The stocks volume and per share premiums were unusually large, prompting US regulators to investigate the transaction. In another example, from August 2012, Robert Ramnarine, a Bristol-Myers Squibb executive, was arrested and charged with making $311,361 in illegal profit by buying stock options in three companies targeted for acquisition.
Concerns about insider trading also exist in academia. There are growing concerns about the interaction between academic researchers and the life-sciences industry, and the extent to which confidential research data are being traded improperly. For instance, a French doctor in Paris was an investigator for a trial of a hepatitis C drug. He also acted as a member of the steering committee for the trial. The doctor was accepting gifts and cash in exchange for insider information that he gave to an American hedge fund manager. The doctor recently pleaded guilty and was sentenced in the US to a total of 24 days in prison. The US hedge fund manager was sentenced to five years in prison. This example demonstrates that inappropriate exchange of early results from clinical trials has reached international proportions, further challenging efforts to detect it. It also shows that society views such crimes more and more seriously, as evidenced by the sentence of the fund manager.
Inspired by these cases, I have written a detective novel (published under the name Marjus Swan) addressing unethical and fraudulent behaviours in clinical research.
Assassin in Svanstrand is a detective story about the unethical conduct of clinical trials and insider trading based on the trial results. The story takes place in Svanstrand, a small Swedish fishing village and summer holiday paradise for people escaping from the city. A series of murders occur during a heavy Christmas snowstorm that paralyses infrastructures in Svanstrand, Österlen, and Skåne. Assassin in Svanstrand is available as an ebook at Amazon.com, and a second novel on this same topic is underway.
My objective is to expose this very challenging and disturbing development to a larger public, so that we can begin to work towards addressing and combating these issues. I welcome you to share your own experiences and what you have done to address unethical behaviours in the conduct of research by leaving a comment or emailing me at CTMagnifier@gmail.com.