NL Times

 

Scientists Not above Cheating
By Dr Syed Amir
Bethesda, MD

Not so long ago, any scientific paper published in a reputable journal was regarded as sacrosanct, beyond any suspicion that the reported results were either manipulated or concocted by the authors. The only criticism that scientists permitted were differing interpretations of the research findings, without questioning their veracity. In the last decade, however, the implicit trust that scientists erstwhile placed in the data of their colleagues has been undermined by numerous allegations of misconduct and data fabrication. What has changed and what prompted this erosion of distrust?

Today, science has become a major enterprise and the competition for shrinking funds to support it is at an all-time high. In this country, most biomedical research is supported by the National Institutes of Health (NIH), a Federal Government body, with a budget close to $31 billion a year, larger than that of many countries. Yet, the NIH can scarcely support 10 to 15% of meritorious research proposals it receives from scientists. The situation is especially bad for young investigators in the early stages of their careers, who are struggling to establish themselves. Even the so-called Ivy Leagues universities, such as Harvard, Cornell, Johns Hopkins, and Princeton, although flushed with money, are loathe to pay salaries to their academic faculty. Instead, they pressure them to generate outside funds to support their pay and research. Consequently, for a young faculty member winning a grant becomes critical, making a difference between having a prestigious academic job and joining the unemployment line.

In academia, great premium is placed on publishing results, especially in well-recognized journals. Publications help in securing research grants and attaining tenured faculty appointments. However, the acceptance rate of manuscripts submitted to highly rated journals is low. In an effort to boost chances for acceptance, a few scientists succumb to the ignoble temptation of tampering with their results, making them look more impressive than they actually are. In extreme cases, some fabricate results outright, inventing data without conducting any experiments. Such doctoring of the data has a pernicious effect, as others attempting to replicate them can waste months and precious resources. The falsified data are ultimately exposed and the authors forced to retract their papers, essentially spelling the end of their careers.

While fraud in science has always existed to some degree, since 1975 there has been a tenfold increase in the rate of retracted papers. According to the British paper Guardian, there were only three cases of data falsification out of 309,800 publications reported during the entire year of 1976, whereas in 2007 the number climbed up to 83 retractions. Similarly, a study published in the respected scientific journal,  Proceedings of the National Academy of Sciences, noted that two-thirds of the publications withdrawn in biomedical sciences were done because of deceitful data, not some innocent, inadvertent errors.

Whereas, publication of deceptive scientific findings is unethical, the manipulation of data to make money, especially by concealing or distorting information that directly impacts human health and wellbeing, is much more serious business. Over the past decades, compelling evidence has emerged to suggest that some international pharmaceutical companies have indulged in just such immoral practices.

One of the most archetypal examples is the case of the popular diabetes drug, Rosiglitazone (trade name: Avandia), marketed by  GlaxoSmithKline  . The drug is very effective in controlling type-2 diabetes; its sale a few years ago crossed the three billion dollars mark. However, after it came into wider use, independent researchers at Cleveland Clinic, specializing in heart diseases, discovered that it raised the incidence of heart attacks by 43% and deaths 63%. Based on these findings, the use of the drug was restricted in the US in 2010, and was banned completely in Europe. There is strong evidence that the company knew about the harmful effects of the drug, as they had already been uncovered by its own scientists. Yet, apparently, it chose to suppress the information. The company was later found battling several law suits worth billions of dollars filed by patients or relatives of patients who suffered the ill-effects.

Much like Avandia, several other drugs have been implicated in heart attacks and strokes. Vioxx, prescribed for reducing the pain of Arthritis was introduced in 1999 by Merck Pharmaceuticals with great fanfare. Its sale soon reached 2.5 billion annually. Yet, within four years, it was withdrawn voluntarily by the company as convincing evidence surfaced that its long-term use was associated with increased risk of both heart attack and stroke. Nevertheless, an estimated sixty-thousand deaths have been attributed directly to its use worldwide. Avandia had been hailed as a more effective medicine than any of its competitors. Incredibly, the data on which these claims were based according to reports were not legitimate, and had been made up by scientists, some employed others not directly employed but paid for by Merck.

Two other well-known drugs, Celebrex and Bextra, also prescribed for relief of inflammation and arthritic pain, and marketed by Pfizer, saw their worldwide sale climbing to billions of dollars in 2004. However, Bextra was found to cause serious harmful effects. Pfizer, as a result, withdrew it in 2005. In 2009, the US Department of Justice fined the company $2.3 billion for wrongdoing in the promotion of Bextra and four other drugs.

Celebrex is still available in the United States and is counted among the best money-making drugs for the company. Nevertheless, its effectiveness and safety remained a subject of an ongoing controversy. It was claimed that unlike other drugs of this class, Celebrex caused no stomach problems in patients. However, independent studies failed to confirm this claim. Definitive information whether Celebrex causes a higher incidence of cardiovascular problems was awaited.

Why does it take years before the dangerous side-effects of drugs in use worldwide are recognized? There is no great mystery. In the US, the Food and Drug Agency (FDA) has the responsibility of monitoring the safety of all approved drugs and food products. It usually does an excellent job. However, it does not have the resources or wherewithal to conduct its own independent safety tests. Ultimately, it relies on the integrity and judgment of scientists engaged by pharmaceutical companies. Unfortunately, they are not always unbiased investigators. Some own company stakes, others may be paid consultants, or recipients of lucrative monetary rewards from commercial organizations whose products they are evaluating. Surprise is that under the circumstances when billions of dollars are at stake, a large majority of scientists manage to remain honest and objective.