After Researchers Take Shortcuts: Why Recent Medical Scandals Might Boost Research

RIO DE JANEIRO, BRAZIL – The retraction of two medical studies in high-profile journals is a major scandal. It points not only to the tremendous pressure to which the scientific community is exposed in coronavirus times, but also to well-known minefields. These must be defused.

The novel coronavirus has changed many things — even the everyday life of scientists. Epidemiologists, virologists, and doctors have seldom been in such great demand as in recent weeks and months. We all hung on their lips when they spoke about the state of the nation. What they said influenced authorities and politics, but also our lives.

In record time, researchers identified the new pathogen and decoded its genetic make-up. Diagnostic tests were quickly available. Using their mutable genetic fingerprint, scientists were also able to trace how the microbe spread from China to the rest of the world. In the absence of effective drugs and a protective vaccine, scientists were able to fulfill all the demands made on them.

The scandal surrounding two retracted medical studies from the Harvard Medical School in Boston, USA, now proves that such top-level research conducted under the greatest pressure also entails risks. One of the publications examined the influence of common antihypertensive drugs on Covid-19.

The other, with Zurich involvement, investigated whether critically ill Covid-19 patients would benefit from old antimalarial drugs. President Trump had recommended the idea months ago as a “game-changer” in the fight against the pandemic. He did so in his typical salesman spiel,  more interested in grand emotions than petty facts.

Embellished or even fabricated database

The gloating must have therefore been great for many when the Harvard study disproved the President. But soon strong suspicions emerged that both studies were based on embellished, if not fabricated, data. These data came from a small, unknown company called Surgisphere in Chicago.

The company claims to have collected and analyzed patient data from hundreds of hospitals worldwide. What struck independent researchers immediately: the records were too perfect to be true. There were also many inconsistencies. For instance, the data for Australia showed more Covid-19 deaths than the country had recorded.

The whole world is now asking itself: Why didn’t the study’s authors, and those responsible for the journals, notice the problems that stink to high heaven? Ultimately, the papers were published in The Lancet and the New England Journal of Medicine. These are two of the oldest and most prestigious medical journals in the world. As long as the problems have been discovered, one could turn around and forget the matter.

The quick retraction of the studies shows that the research system works – even in times when the number of publications in specialist journals and on so-called preprint servers has massively increased.

However, anyone arguing along these lines is missing the opportunity to learn from the debacle and improve the system. This is because the most recent misconduct, which now needs to be dealt with in detail, casts its shadow on well-known problem areas in medical research. First and foremost, the study data must be identified. They are the center of many fraud cases.

This is not surprising, as every study starts with raw data collected from patients. Whoever holds this data has the power to interpret the research. This is also because, with enough data and the “right” statistical analysis, a wide variety of results can be obtained.

Data can also be manipulated. But generally, the case is more subtle: the data is kept under lock and key, instead of being shared with other researchers and the interested public. This is what happened in the scandal surrounding Roche’s influenza drug Tamiflu. The company only published data used in studies supporting its commercial interests.

For years it was able to claim that Tamiflu reduced the rate of complications and hospitalization in influenza patients. That this was wrong was only proven by an independent study, using a broader database, and only occured after years of legal battles.

Public access to patient data

As a result of such scandals, renowned scientists have long been calling for clinical patient data to be made publicly available in an anonymous form. This way, they can be independently reviewed by researchers if required. Despite progress on this issue in recent years, the request is still far from being implemented.

Not only commercial companies are required to share their patient data with others: so are many academic researchers. The situation could potentially be improved if sponsors such as the Swiss National Science Foundation would condition their financial support on complete data transparency. Professional journals could also exert greater pressure in this regard.

The Lancet and New England Journal of Medicine’s publishing of the retracted studies has also discredited the so-called peer-review process. This is the term used to describe the review of the submitted work by proven expert scientists. Only if these experts give the green light will the study be published. This quality control procedure has become standard practice in reputable journals since the mid-last century.

Discontinuing it now because of individual misconduct, as some voices are demanding, would mean throwing the baby out with the bath water. It is preferable to adjust the process to new developments in research. For instance, recent issues with renowned scientific journals show that clinical trials increasingly require the involvement of experts in handling large amounts of data (big data), study design, and statistical analyses for review.

In the case of particularly complex studies, it would also be useful to upload the work to a preprint server for public review prior to publication.

A further problem area concerns the sanctions that researchers face in the event of misconduct. These are insufficiently clear and not uniformly regulated in Switzerland. It is therefore the responsibility of universities and institutions to punish their fallible staff.

This can lead to the same “offense” resulting in a reprimand at one university and dismissal at another. This injustice could be prevented if the penalty were imposed by a supra-regional committee.

An argument in favor of such a structure is that the guidelines on scientific integrity are also based on a national level. The Swiss Academy of Medical Sciences (SAMS) established this in 2002. Since then, the rules of the game have been relatively clear – “relatively”, because there is always considerable scope for interpretation, particularly in the case of minor offenses.

This is the case with questions such as: Have the authors of an erroneous study sufficiently fulfilled their responsibility to review the work? Or have their passive or negligent behavior enabled the misconduct of others in the first place? No less sensitive is the question of whether someone has invested enough of their own work in a research project to be included as an author on the publication.

Science and sports have many parallels

As in sports, science also depends on its members playing fair. However, in both disciplines, there will always be people who try to take a shortcut, be it with doping or with unfair research methods. As the Bernese anatomist and former SAMS president Ewald Weibel once said: “Research fraud is as old as the research itself”.

“For research is a human activity and therefore subject to all human virtues and vices.” In order to keep the proportion of sloppy researchers as small as possible, one must “educate them to truthfulness”. For such an education, in addition to clear rules and binding consequences in case of transgression, credible role models are needed.

Scientific misconduct is usually driven by two factors: money, and the ego of individual researchers. Both are directly opposed to the goals of science. The aim is to gain knowledge for the benefit of the general public. The damage that research fraud can cause is exemplified by the Wakefield study, which falsely demonstrated an alleged link between measles vaccination and autism.

Although the Lancet study was pulled out of circulation in 2010, the implications of this false connection have not been erased to this day. Scientific misconduct thus not only damages the reputation and credibility of science, but it also adds credibility to anti-science circles and the promoters of conspiracy theories.

However, the media and society also play an important role in the topic of “Research fraud and how to prevent it”. For instance, the eternal rhetoric about the individual “star surgeon” or “top virologist” – even the “top terrorists” exist – may corrupt poor and narcissistic personalities and cause them to lose their grip on reality.

The double play that some press titles display in their reporting was shown by the verbal skirmish of the German “Bild” newspaper against the “star virologist” Christian Drosten. Apparently, the tabloids prefer fallen stars to heroes.

Rather than making stars out of exceptional individuals and rolling out the red carpet for them, the team approach should be more strongly emphasized in medicine and research. This is the only way to ensure safety and trust in these areas. Aviation has shown that this is possible through its impressive safety record. It is also fitting that one flies with Swiss or Lufthansa airlines and not with the “star pilot” X or Y.