“They swallowed our story, hook, line and sinker”, wrote in an e-mail the research and development director of the pharmaceutical company Pfizer after having successfully presented the new arthritis drug Celebrex, concealing the secondary effects shown in Pfizer´s own research data.
Pfizer had decided to ignore warnings from other employees and an external consultant about the dangers of “selectivly reporting” clinical trial data on this drug. The medical director of Pfizer admitted that they had given the clinical results “a data massage” because that was the only way the new medicine “could look like it was better” than existing ones. In fact, Pfizer and its partner, Pharmacia, presented the results from just the first six months of a year long study rather than the whole thing. 1
There is increasing criticism of distorted claims of new medicines that exaggerate their eficacy and minimize their secondary effects. This is especially relevant within a context of which very few new drugs are significantly more effective than existing ones. Only a small percentage of all new medical products reaching the market have a real therapeutic value over existing medicines (4 out of 97 in 2010) – La Revue Prescrire, 2011. 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 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 with regards to clinical trials as these clinical trials are the final path by which scientific discoveries become biomedical products.
Under the present model of biomedical innovation what predominates is the opaque, closed “self-regulated” processes of Big Pharma. 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 Medical Agency on the basis of clinical trial data. These are usually prepared by large pharmaceutical companies through their experiments on animals and humans. Nevertheless, most of the resulting raw data is not available for the scrutiny and research of scientists, doctors and academics. And the reasons given for this secrecy range from “commercial confidentiality”and “patent rights” to simply “the general public might misinterpret the data”.
The issue of access to medical data poses important ethical issues. Since valuable scientific data from clinical trials is not shared, they often need to be repeated, especially in the case of new medicine developments that have been abandoned due to scientific problems. This model of secrecy means that countless laboratory animals and tens of thousands of human patients of clinical trials can be exposed to totally unecessary suffering and risks. This level of confidentiality also means citizens never find out why some medicines are approved by the FDA in the US but not by the EMA, or viceversa.
Is it acceptable for essential medical research data to be shrouded in secrecy? Can the health of citizens be protected with very little or insufficient access to clinical trial data concerning the eficacy, safety and secondary effects of a drug?
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 is important for rational decision making by physicians, patients and governments then there is something fundamentally wrong with our priorities in health care“.
The mentioned European Parliament meeting organized by the TransAtlantic Consumer Dialogue and Health Action International, with the sponsorship of MEPs 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 in recent years and he blamed a conflict between the goals of protecting commercial interests and promoting rational prescribing by doctors.
“The evidence base on which prescribers are obliged to make their choice of therapy was largely determined by industry-sponsored clinical trials and misleading and inaccurate publicity at the launch of the medicine“, he said.
“We do not get the information we need for prescribers and patients“, said Ludwig, citing the case of reboxetine which, he said, had been shown to be ineffective but only in assessments that had remained unpublished.
Both Gøtzsche and Ludwig insisted that access to the raw data is essential because summaries and tables are grossly insufficient. According to Gøtzsche the generalized lack of dependable medical data often converts the “informed consent” of patients to accept treatment into a “delusion”.
Many voices at the Brussels meeting accused the European Medical Agency of obscurantism and pro-industry bias in their strict policies of confidentiality.
The EU Ombudsman representative Nicholas Catephores affirmed that “all citizens have the right of access to EU documents and that the EMA could not legally withold 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 provoke a negative impact on public health. He also expressed concern over the data protection of clinical trial patients. As well, according to Eichler, commercial interests could exploit the findings of others. Nevertheless, Eichler apologised for EMA’s “stupidity“ on occasions, in responding to data requests with material that was almost entirely blacked-out.
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 programme (an 80 billion Euro initiative). Within a few weeks the European Commission shall present a proposal for a new Directive on Clinical Trials that will center discussions of stakeholders and lawmakers over the next year.
In the consideration of this legislation the issue of transparency regarding essential medical data will be promoted by civil society actors, who recognise that openness is crucial in the defence of our health.