How Secrecy in Medical Research Harms our Health | Open Society Foundations

“Medical research data remain shrouded in secrecy.  As a result the data is distorted and misrepresented by pharmaceutical companies launching new medicines to exaggerate their efficacy, minimize their harmful side effects, and conceal the fact that these products are often no more effective than those already on the market.  Clinical trials are unnecessarily repeated and overall, health-care and patients suffer... Only a small percentage of all new medical products reaching the market (4 out of 97 in 2010) have a real therapeutic value over existing medicines. Most new products are ‘me too’ drugs, which means that they are practically the same as the existing ones. Biomedical research should strive for the truth uncontaminated by the perception of bias. The reality is that there are many examples of alleged industry bias and duplicity in the manipulation of scientific data, from Vioxx to Tamiflu. What can we do about it? One answer is transparency and openness. Under the present model of biomedical innovation, the generation, analysis, and dissemination of clinical research data is largely controlled by the pharmaceutical industry, through opaque, closed, and ‘self-regulated’ processes.  According to many experts this has provoked a long list of medical scandals, tens of thousands of lives lost, billions in wasted public investments, and new drugs that are primarily market oriented instead of health-needs oriented. In Europe new medicines are approved by the European Medicines Agency on the basis of a dossier containing all information related to the new drug, including clinical trial data, obtained by carefully assessing the positive and negative effects in patients.  However, most of these data are kept secret, analyzed internally, and not available for the scrutiny and research of independent scientists, doctors, and patients... At a meeting at the European Parliament in June 2012 the Director of the Nordic Cochrane Center, Professor Dr. Peter C. Gøtzsche, took a clear stance when he stated, ‘if commercial or academic success depends on withholding data that are important for rational decision making by physicians, patients, and governments then there is something fundamentally wrong with our priorities in health care.’ That meeting—organized by Transatlantic Consumer Dialogue and Health Action International with the sponsorship of Members of the European Parliament from three political groups—included the participation of Professor Wolf-Dieter Ludwig, chairman of the Drug Commission of the German Medical Association.  He said that the duty to provide access to clinical trial data has not been met in Europe... ‘We do not get the information we need for prescribers and patients’ he continued, citing the case of the anti-depressant drug reboxetine which, he said, had been shown to be ineffective but only in assessments that had remained unpublished... Many voices at the meeting accused the European Medical Agency (EMA) of deliberately obscuring the facts and a pro-industry bias in their strict policies of confidentiality. The European Union (EU) Ombudsman representative Nicholas Catephores affirmed that ‘all citizens have the right of access to EU documents and that the EMA could not legally withhold information on the grounds of commercial confidentiality when an issue of public health is at stake.’ The head medical officer at the EMA, Hans-Georg Eichler, admitted that transparency needed to be improved at the EMA but expressed great concern about releasing ‘the treasure trove’ of raw data from clinical trials. He stated that this data could be misused or misinterpreted and in this way lead to a negative impact on public health... In the coming months the EU will adopt legislation that will affect access to medical data. The European Parliament is presently discussing the rules on open access to publications and data for its massive Horizon 2020 Research and Innovation program (an 80 billion Euro initiative). In addition, within a few weeks the European Commission will present a proposal for a new Directive on Clinical Trials, which presents another opportunity to regulate how clinical trial data should be treated...”