By Johan PE Karlberg, MD, PhD, BSc
Founder, Editor, Clinical Trial Magnifier
Author, Editor (2010): Reviewing Clinical Trials: A Guide for the Ethic Committee (free access).
Author, Editor (2011): Study Site SOP Standardization – The 4S Project (free access).
During the past thirty-five years I have been active in clinical research; I have been co-author of 200+ publications and several books. 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 contracted 640 industry-sponsored clinical trials. I have seen many good clinical studies, but also a number of poor including 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 by the British Medical Journal including the response of 2,800 clinicians and academics 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 were true then we were facing scientific fraud on a large scale. There have also been many reports on pharmaceutical companies that have falsified publications simply to boost sales. The saga goes on and on.
Fraud and manipulating 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 anaesthesiology and is currently under criminal investigation for possible research forgery. The article said that 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 year in November the US regulators were suspicious when Gilead Sciences Inc. announcement it was buying Pharmasset Inc. for $11 billion. The stocks volume was large and the premium was also large underlying the US regulators looked into the trading. In August 2013 Robert Ramnarine, a Bristol-Myers Squibb Co. executive was arrested. He was charged with making $311,361 in illegal profit by buying stock options in three companies targeted for acquisition. This type of insider trading isn't any different from insider trading in any business area.
There is however 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 taking 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 USA to a total of twenty-four days in prison. The US hedge fund manager was sentenced to five years in prison. It shows that the interest in early information on the results from clinical trials has reached the international arena thus making it even more challenging to detect. It also shows that society views such crimes more and more seriously as evidenced by the sentence of the fund manager.
Another example is represented by a US-based hedge fund management company paid a significant fee to an intermediate consultant firm in exchange for contact with experts who had access to useful and important insider information for two specific life-sciences companies. Among the experts were doctors and clinical investigators. Interestingly, the hedge fund management company didn't do well initially and lost money. However, after appointing the consultant company that identified over 100 clinical investigators the business became profitable. As far as I recall, the hedge fund management company made about US$1.5 million on the stocks for one of the two life-sciences companies.
With this as a background I have just published (September 27, 2012) my first fiction detective book under the author name Markus Swan. I have started to write on a second book based on the same persons and the same setting. The two books and maybe other books later on are addressing the increasing concerns about unethical fraudulent behaviour in clinical research. My objective is to expose this very challenging and disturbing development to a larger public.
‘Assassin in Svanstrand’ is a fictional 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, a summer holiday paradise for people escaping from the city. A murder occurs in October and subsequent killings during a heavy Christmas snowstorm that paralyses infrastructures in Svanstrand, Österlen and Skåne.
The book is available at Amazon.com and is at present only available as an eBook.
You can reach met at CTMagnifier@gmail.com.