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„More Americans Died Than In The Vietnam War“
Peter Sawicki; © IQWIG
MEDICA.de spoke to Peter Sawicki, head of the Institute for Quality and Efficiency in Health Care about researching industry, mistakes in drug evaluation and Goethe.
MEDICA.de: Mister Sawicki, did you ever sweep negative study results under the carpet?
Peter Sawicki: No, I have always published completed studies, no matter whether they had a positive or negative result.
MEDICA.de: You are rather an exception then. Studies reveal that scientists publish negative results of their projects less frequently than positive ones. Why is that?
Sawicki: For example, many studies are initiated by the pharmaceutical industry that seeks to bring products to the market. In the contracts between scientists and industry, there is often a passage included: publication by mutual agreement only. That means if a drug shows no effect or has strong side effects the pharmaceutical company may refuse the publication. After all, around 80 to 90 percent of the studies financially depend on the pharmaceutical industry in the field of pharmacology.
Furthermore, negative studies are disappointing. The physicians themselves hope to contribute to the progress and to find something that helps the patients. And in the end all investors, no matter whether industry, scientific or political institutions, aim to attract attention with the financed research project. The media, however, usually only print the positive study results - that is when a new mechanism of action was found. Negative results mostly meet with no response, except for scandals. Scientists, therefore, are under pressure to deliver positive results.
MEDICA.de: Do study proposals have better chances to be financed if a positive outcome can be expected?
Sawicki: Yes, absolutely. Sceptical research is less promoted. I do not agree: in my mind, negative studies are also positive studies. They help just the same by showing that a new drug is not better than a well-tried one or that surgeries such as the removal of the tonsils or the uterus are often unnecessary.
MEDICA.de: Since many negative results are never published, surely the same research objectives are financed repeatedly. This sounds like plenty of wasted money in science.
Sawicki: Exactly. Yet much worse is that it puts humans at risk.
Sawicki: Negative studies are important to prevent medical errors. When they are not published physicians commit faults systematically. If ten studies are conducted on one drug of which six show a harmful effect and four produce positive outcomes, and then only the four positive results are published – then the physicians use drugs that do not help or even are dangerous. Ignorance impedes healthy scepticism towards new developments. Already Goethe knew that doubt increases parallel to the knowledge. According to him, the worst form of lying is not to tell the full truth since it lulls us in a false sense of security.
The best example is the antiarrhythmic agents, drugs to suppress fast rhythms of the heart. Already in the 70s, the pharmaceutical industry has carried out trials to test these drugs. One result was that the additional heartbeats were in fact reduced by this medication. Another one was that patients died earlier due to this drug. This last part of the trials, however, was not published. Only through a large-scale study in 1991 the harmful effect of the drug was revealed. A journalist at that time has calculated that more Americans died because of the wrong evaluation of the medication than in the Vietnam War.
MEDICA.de: Central registers for clinical trials in which started studies are listed are to give a better overview over published and unpublished studies. Has this already shown any impact?
Sawicki: No, so far not. To date, researchers as well as industry are not obliged to anything. We need binding laws that make the registration of trials as well as their publication a duty. Statutory rules could be that all trials have to be registered and that everyone has to justify to public authorities if he or she does not want to publish a result. Countries leading in science could team up and define a painful penalty for unpublished study results. In the case that studies are not even started because negative results are expected, public funds have to be provided.
The interview was conducted by Anke Barth.