By David Hammerstein, Senior Advisor on intellectual property for the Transatlantic Consumer Dialogue in Brussels.
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.
“They swallowed our story, hook, line and sinker”, wrote the research and development director of the pharmaceutical company Pfizer in an e-mail after having successfully presented the new arthritis drug Celebrex. http://www.nytimes.com/2012/06/25/health/in-documents-on-pain-drug-celebrex-signs-of-doubt-and-deception.html?pagewanted=all
The medical director of Pfizer admitted 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.
There is increasing criticism on distorted claims about new medicines that exaggerate their efficacy and minimize their secondary, often negative effects. This is especially relevant in an environment where few new drugs are significantly more effective than existing ones. 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. http://english.prescrire.org/en/81/168/46843/0/NewsDetails.aspx. 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 (http://www.nytimes.com/2004/11/14/business/14merck.html) to Tamiflu (http://www.medpagetoday.com/InfectiousDisease/URItheFlu/30727). 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. http://circoutcomes.ahajournals.org/content/5/2/236.full
In Europe new medicines are approved by the European Medicines Agency (http://www.ema.europa.eu/ema/) 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. 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 and other laboratory studies related to the drug are 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 of pre-clinical trials and tens of thousands of human patients of clinical trials can be exposed to totally unnecessary suffering and risks.
Is it acceptable for essential medical research data to be shrouded in secrecy? Can the health of citizens be protected without adequate access to the data that are supposed to demonstrate the quality and efficacy of a drug?
At a meeting at the European Parliament in June 2012 (http://tacd-ip.org/archives/674) 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“. (http://circoutcomes.ahajournals.org/content/5/2/236.full)
The mentioned European Parliament meeting organized by the TransAtlantic Consumer Dialogue (http://www.tacd.org/) and Health Action International (http://www.haiweb.org), 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 (http://www.akdae.de/en/index.html). 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 the anti-depressant drugreboxetine (http://www.guardian.co.uk/business/2010/oct/13/reboxetine-pfizer-antidepressant-placebo-bmj) 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 we cannot rely on summaries and tables prepared by the companies, as they are often shown to misrepresent the data . 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 (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 provoke a negative impact on public health. Els Torreele, of the Open Society Institute, replied that she was surprised “about the argument of the risk of bad use since today we have exactly that: the ownership of the data is in Pharma industry hands. The issue that is not mentioned is the design of clinical trials – anyone who knows anything about clinical trial design knows that you can design your study to make sure you have certain data results or not; clinical data shouldn’t be the private property of pharmaceutical companies”.
Mr. Eichler also expressed concern over the data protection of clinical trial subjects. 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: http://ec.europa.eu/research/horizon2020/index_en.cfm). In addition, within a few weeks the European Commission shall present a proposal for a new Directive on Clinical Trials, which presents another opportunity to regulate how clinical trial data should be treated.
In the consideration of EU legislation the issue of transparency regarding essential medical data will be promoted by civil society actors who recognise that openness is a crucial factor in the defence of our health.
The Transatlantic Consumer Dialogue is a grantee of the Open Society Foundations Public Health Program and Information Program.