Lack of transparency about study results

A lack of regulations, controls and sanctions means that the results of many clinical trials are never published, which makes independent scientific and public evaluation impossible. This poses a danger to both trial participants and public health. In contrast to the EU, Switzerland is still very lagging behind.

Although the results of clinical trials are of public interest and should therefore be available to the public, pharmaceutical companies insist that this data is a trade secret and that patients can be identified. However, these are just excuses to protect their business model. In spite of these excuses, the publication of the reports does not involve disclosure of confidential information about the composition and production of the drug. The report results are also anonymized and their publication does not allow trial subjects to be identified. However, the lack of regulation and its poor enforcement means that the results of half of all clinical trials conducted worldwide are never published. Worse still, negative results are falsified or glossed over. This selective publication leads to the sale or the continued sale of drugs that are either not useful or even dangerous for patients. 

More infos

  • Tamiflu or the profit virus

    On the basis of individual studies, governments around the world – including Switzerland’s – have decided to store the Roche Group’s flu drug Tamiflu as a precautionary measure in the event of a flu epidemic. However, eight of the ten studies that contributed to this decision were never published and made available to the public. Other clinical trial results were also kept under lock and key by the Basel-based pharmaceutical company. It took four years and a public campaign by the British Medical Journal for independent researchers from the Cochrane network to finally gain access to all the data from Roche’s 74 clinical trials involving Tamiflu in 2013.

    For the first time, researchers were able to evaluate the real efficacy and toxicity of Roche Group’s flu drug on the basis of complete documentation. The results of this evaluation, published in April 2014, are clear. Contrary to Roche’s assurances, taking Tamiflu does not reduce the number of hospital treatments or the risk of serious complications in the event of flu. At best, according to observations, flu symptoms are shortened by a few hours, but Tamiflu does not prevent transmission of the virus either.

    However, these were precisely the arguments that led the World Health Organization (WHO) during the successive crises involving bird flu H5N1 (since 2004) and swine flu (in 2009) to recommend to states and large companies to stockpile large quantities of the drug. These false promises have filled the coffers of the Basel-based company well. The drug has generated huge profits for Roche, largely at the expense of taxpayers.

Fearing a flu epidemic, several countries stockpiled the drug Tamiflu. However, it was only later that published studies showed that its efficacy was much lower than assumed.

The EU is leading the way – Switzerland is lagging behind

According to the WHO, recording all clinical trials is a scientific, ethical and moral duty. It requires all clinical trial results, whether positive or negative, to be published and made available within 12 months of the trial’s conclusion. The European Medicines Agency (EMA) has implemented a new policy requiring publication of full clinical study reports for the studies submitted for marketing authorization. Switzerland, on the other hand, only requires the marketing authorization holder to publish a summary of the results of clinical trials carried out with a view to the development of an approved medicinal product on a pro forma basis and does not review them (Therapeutic Products Act, TPA Art. 67b; Therapeutic Products Ordinance, TPO Art. 71). In the database of clinical trials conducted in Switzerland, only a summary of the results must be published (Clinical Trials Ordinance, ClinO, Art. 65a), whereas the EU provides for the publication of the complete reports of trials conducted in EU countries. In addition to the possibility of obtaining a scientifically independent second opinion, the complete publication of trial reports allows doctors to prescribe the right treatment on a sound, reliable basis.

© Mark Henley/Panos
Only around half of all clinical trials conducted worldwide are published. This leads to a distortion of the results.

Commercial secret or public data? The pharmaceutical industry fights transparency

Pharmaceutical companies had taken legal action against the EMA’s transparency regulation, arguing that the publication of clinical trials would reveal commercially confidential information. Clinical trial reports must allow for an independent assessment of the efficacy or safety of the product being tested. In spite of the excuses made by the pharmaceutical industry, there are no confidential data or trade secrets involved. The report results are also anonymized and their publication does not allow trial subjects to be identified. 

Public Eye, together with other civil society organizations, had campaigned for the transparency of clinical trials. The Court of Justice of the European Union had confirmed the transparency regulation of the European Medicines Agency as legally valid and legitimate.