Health authorities unanimously declare that from a public health point of view, the benefits of vaccinations against Covid-19 are far greater than possible side effects. With incentives, they invite populations to get vaccinated with one of the approved vaccines.
Some who express skepticism feel too quickly placed in the corner of religious fundamentalists or conspiracy fantasists. But the skepticism is partly based on experience with the pharmaceutical industry. With full transparency, the pharmaceutical companies could eliminate many doubts and Fears.
On 25 January, it was also reported that Pfizer/Biontech has not yet published the raw data of its approval study for the corona vaccine Comirnaty nor made it available to independent researchers. Nor have other vaccine manufacturers such as Moderna done so. However, access to this data is important.
It attracts billion dollar sales
The mere prospect of regulatory authorities in the USA and Europe approving a drug with a high sales potential increases the share prices of the pharmaceutical companies concerned. Rising prices promise CEOs even higher bonuses. News of unexpected side effects, on the other hand, have a negative impact on the share price. Reports about side effects and expected approvals can therefore usually be read first on the stock exchange pages.
Almost all studies on the benefits and possible side effects of drugs and vaccines are carried out and financed by the manufacturers themselves. Their economic interest is to design the studies in such a way that the benefits appear as great as possible and at the same time rare but serious side effects are statistically lost. Two cases of serious data falsification and trickery have now been dealt with by involved experts in a book after the conclusion of many years of court proceedings.
The main problem: despite the obvious conflict of interest, the authorities do not require pharmaceutical companies to publish all raw data from the studies they conduct in order to obtain approval. As the past has shown several times, transparency would be extremely important for the benefit of the public and researchers: it could at least prevent gross abuses. Without transparency, authorities should not actually recognize these studies as scientific, because they cannot be verified by other researchers without knowledge of the detailed data. The authorities themselves do not commission any studies. The law that requires scientific studies, i.e. reproducible ones, remains a dead letter.
$ 3 Billion fine for misleading Information about trial
After several years of proceedings, the US Department of Justice fined the pharmaceutical company GSK three billion dollars. In addition, various damages were paid. Reason: The pharmaceutical company spread false information about its approval study called “Study 329”, and promoted the sale of the antidepressant paroxetine to adolescents, although this was prohibited in the USA.
The “Study 329” was published in 2001 with allegedly positive results. As a result, paroxetine was then widely used by young people in many countries (in the trade under the names Paroxetine, Paxil and Deroxat). Only after several years and millions of prescriptions did it come to light that paroxetine had practically no benefit, but that it resulted in suicides, suicide attempts and increased depression.
Only after years of conflict did GSK publish the raw data of “Study 329”. It was then an Australian team of researchers with paediatrics and psychology professor Jon Jureidini who, based on a review of these raw data in the British Medical Journal in 2015, discovered that paroxetine did not actually work better than a placebo, but had the severe side effects mentioned above.
The manipulations with the study
Together with emeritus Professor Leemon McHenry from California State University, Jureidini now exposed the following tricks of the pharmaceutical company GSK:
GSK compared paroxetine with a comparable drug, but it was given to the test participants in too high a dosage, which led to more side effects. Thus, the new agent Paroxetine made a good figure in comparison.
Already the GSK study showed that in the case of paroxetine as a serious side-effect of a suicidal behavior. However, this was not mentioned by name, but reduced to the term “emotional lability”.
Severe side effects were simply divided into different side effects, so that the individual could be classified as “rare” or not mentioned at all.
At the beginning of the study, one of the endpoints to be examined was the reduction of depressive symptoms in the paroxetine group compared to the placebo group. Because the study found no difference, other endpoints that happened to favor paroxetine were simply compared at the end of the study.
The researchers found another trick in a second study: when comparing the test groups, a group of participants should have been excluded from the evaluation for scientific reasons, but this did not happen.
The two researchers and authors are convinced that these manipulations were “not unusual”. It was only because GSK had to extract crucial documents in court that otherwise remained secret that it became public how pharmaceutical companies deal with their studies “regularly”. Professor Peter Gøtzsche in his book “Deadly Medicine and Organized Crime” has impressively shown that this is indeed true. Gøtzsche was director of the Nordic Cochrane Center. Nothing has ever been known of counter-representations, corrections or complaints by the pharmaceutical companies concerned against the serious allegations.
Jureidini and McHenry draw attention to the problem that pharmaceutical companies have a great economic interest in ensuring that their studies come to a positive conclusion. Already with the test facility and the experimental setup, you could use many possibilities to influence the results in your sense.
Above all, however, manufacturers would have exclusive access to the data, which would allow them to perform many statistical tricks during the evaluation. Without access to the raw data, independent researchers would not be able to detect the manipulations. It should not be allowed that"only those have access to the primary data who have a self-interest in the evaluation".
“Information laundering” instead of control at the trade journals
Even the" renowned " journals could check the studies very inadequately without access to the original data. But they would also have no incentive to look closer. Because they are financially dependent on the pharmaceutical industry in two ways: first, the companies run profitable advertising, and second, the pharmaceutical companies buy off-the-shelf prints of the articles about their medicines-sometimes for very high amounts.
It is significant that the journal of the American Academy of Child and Adolescent Psychiatry has not withdrawn “Study 329” until today, so that it continues to be cited with its manipulated results. The book authors label scientific journals as" information launderers " of dubious studies.
Pharmaceutical companies could contribute to trust
Full transparency could remove some mistrust, especially with regard to the vaccines developed at a rapid pace. However, even if the regulatory authority were to request the raw data of the vaccination studies, it would not be able to pass this data on to independent researchers. The manufacturers forbid themselves and the parliaments wave this through, of course.
Parliament could repeal this protection and even require that all raw data from the studies be available to the public for approval. But this is wishful thinking. Because politicians cannot do anything against the power of the international pharmaceutical companies. If the regulatory authorities would not comply with this, there would be no more access to important drugs. With regard to vaccines and, more recently, also with regard to several expensive drugs, the authorities are no longer even allowed to inform the public about the negotiated prices. A market economy without transparent prices? No matter!
Pharmaceutical companies could make a significant contribution to confidence in vaccines (and medicines) by disclosing all the raw data from their studies right from the start. You could continue to benefit from long-term patent protection.