Our investigations into delocalised clinical trials

© Mark Henley/Panos
Public Eye has investigated in six countries among favoured destinations for clinical trials: Russia, Ukraine, Argentina and India in 2013, Poland since 2015 and Egypt in 2016. Our research shows that Swiss and foreign pharmaceuticals multinationals take advantage of the weaknesses of the system to accelerate drug testing and increase profits, with little regard for international ethical standards or human beings.

In the past, Swiss pharmaceutical companies have already been accused of performing non-ethical clinical trials. In 2010, Public Eye denounced tests that Roche was conducting in China on its anti-rejection drug CellCept, in a country where 90% of transplanted organs come from prisoners who have been condemned to death. The Basel-based company even received two Public Eye Awards for these scandalous trials.

Swiss pharmas also made headlines in 2013. Hundreds of non-ethical clinical trials conducted in the (then) East Germany during the 1970s and 1980s by a number of companies, among which Roche, Ciba-Geigy and Sandoz (later to become Novartis). Constrained by a centralised and highly hierarchic system – and sometimes influenced by gifts from promoters – doctors enrolled several thousand people in a “trade in human guinea-pigs” marked by serious irregularities. With problems of consent, and dangerous use of placebos, this unscrupulous delocalisation lasted until the fall of the Berlin Wall.

The pharmas then turned towards other countries.

Investigations in troubled waters

Between July 2012 and June 2013, Public Eye commissioned investigations in four countries among the preferred destinations of the Swiss companies Roche and Novartis for clinical trials: Russia, Ukraine, Argentina et India. This proved to be a tedious task, performed in the climate of non-transparency that characterises drugs testing. Information is hard to come by, and the research teams – subject to confidentiality clauses – are threatened by legal proceedings if they decide to disclose information. As for the people taking part in the trials, identifying and approaching them is very difficult. However, on the basis of testimonies of key people, confidential documents and cross-checking, we were able to confirm the existence of ethical violations in all these countries. The most frequent ones were: problems in obtaining informed consent; controversial tests using placebos; discontinuation of treatment at the end of the trial; and an absence of willingness to offer compensation in case of damage to health.

These investigations have not (and probably will not) be followed up or updated. The results published on this web site are those obtained during our research in 2013.

In Europe

Also in Europe, vulnerable individuals are used in clinical trials, as in Poland where Novartis tested a vaccine against avian ’flu on homeless people without obtaining their consent and while violating the rules of good clinical practice. Public Eye conducted an investigation and gathered testimonies. One participant in the clinical trial intends to file a complaint against the Basel-based company – a procedure that could represent a landmark in this area.

This investigation will be regularly updated in line with the developments in the legal process, in which Public Eye is not formally involved.

© Roger Anis

In the land of the pharaohs, the Swiss pharmas are king

In 2016, Public Eye continued its research by conducting a new investigation in Egypt. Since the “Arab Spring” of 2011, this country has suffered from severe political instability. With the ousting of the president Mohamed Morsi in a military coup d’état in 2013, the situation has worsened for those representing civil society. Freedom of the press is severely restricted, and this state of affairs is particularly worrying with regard to human rights.

This political context could have discouraged pharmaceuticals multinationals from delocalising to this country such risky and complex practices as drugs testing. However, our investigation in Egypt shows to the contrary that the pharmaceuticals industry takes advantage of loopholes in the public health system to perform clinical trials on a vulnerable population at a much lower cost. The practices are similar: gaps in the legislation; skewed consent due to lack of choice; and no guarantees as to the continuity of the treatment after the end of the trial

This research will be regularly updated in line with developments in Egypt, in particular concerning a new law on regulating clinical trials in this country (currently being discussed in the Egyptian parliament). In April 2018, the DW Arabia channel devoted a one-hour programme to this subject, with the participation of Public Eye.