Ensuring integrity of
The recent revelation in a paper published by Prof. Stanton Glantz, Professor of Medicine at University of California San Francisco USA in JAMA Internal Medicine that Sugar Industry bribed the Harvard scientists in 60s to play down the link between sugar and heart diseases has once again highlighted the importance of ensuring integrity of research. This paper has relied on thousands of pages of correspondence and other related documents which Cristin E. Kearns, a postdoctoral fellow at USCF discovered in archives at Harvard, the University of Illinois and other libraries.
Sugar industry according to the report had got a Review published authored by the Harvard Scientists in New England Journal of Medicine and the studies used in this Review were handpicked by the Sugar Group. This Review minimized the link between Sugar and heart diseases and cast aspersions on the role of saturated fat. Hence for many years the health officials encouraged Americans to reduce their fat intake, which lead many people to consume low fat, high-sugar foods which some experts now believe was directly responsible for the obesity crisis.1
Last year a story published in New York Times had also revealed that Coca Cola the world’s largest producer of sugary beverages had provided millions of dollars in funding to researches who sought to play down the link between sugary drinks and obesity. It has also been reported that some candy makers are funding studies which claimed that children who eat candy tend to weigh less than those who do not.
Yet another report coming from China has revealed fraudulent practices on a massive scale in clinical trials being conducted there. One year review of clinical trials shows that more than 80% of the clinical data is “fabricated”. The report appearing in Economic Information Daily newspaper says that the Review looked at data from 1,622 clinical trials programmes of new pharmaceutical drugs awaiting regulatory approval for mass production. It was noted that data collection during the clinical trials was incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects and tampering with data which did not meet the expectations. It is also alleged that Contract Research Organizations (CROs) have become e “accomplices in data fabrication due to cutthroat competition and economic motivation”. The government authorities are now reported to have rejected almost 80% of these applications in view of these findings. It is said that there are standards for clinical trials in China but problem lies in its effective implementation while academic ethics is also not yet fully established in China.2
It is not uncommon for the Pharma Industry too to sponsor Experts Groups to formulate Guidelines or fund research. In fact Pharma industry spends billions of dollars in Research & Development and has successfully marketed many new research molecules which are more potent, effective or have much less adverse effects as compared to the earlier preparations. But it is extremely important to look at all these Guidelines and analyze them critically and ensure proper ethical approval of new research protocols. Pharma industry and the medical profession both needs to be cautious, more careful not to bring into disrepute the research activity, ensure its integrity. Mandatory registration of all clinical trials, ensuring publication of their results irrespective of outcome positive or negative findings can help ensure integrity of these research findings. Medical Editors also have a duty to uphold professional ethics, make sure that before publication of any research manuscript including RCTs, Clinical Trials, it is approved by the Ethics Committees/Institutional Review Boards, goes through Peer Review and funding source is disclosed. Even Peer Review does not ensure 100% detection of fraud, fabrication of data but these are some of the measures which if taken and implemented in its letter and spirit, will go a long way in protecting the integrity of research and reputation of research scientists which is being polluted when such scandals are unearthed.
Tail Piece: Intellectual capital is far more valuable than material capital. A leader must master the art of being resilient and reacting to unforeseen challenges with grace, agility and speed.
- http://mobile.nytimes.com/2016/09/13/well/eat/how-the-sugar-industry-shifted-blame-to-fat.html (Accessed on October 6, 2016)
- http://www.rfa.org/english/news/china/clinical-fakes-09272016141438.html (Accessed on October 7, 2016).