The anticorruption organisation Transparency International Germany supports Cochrane Collaboration’s call on Tamiflu manufacturer Roche to provide open access to unpublished clinical trial reports for an independent scientific evaluation of its clinical effectiveness and safety. In September 2009, at the beginning of the swine-flu pandemic, which turned out to be a false alarm, the anti-corruption NGO Transparency International Germany criticised the opaque manoeuvres and interest driven decisions of international and national expert committees at the World Health Organisation (WHO), the German vaccination commission (Ständige Impfkommission, STIKO) and the national public health authorities directed by the Robert Koch Institut (RKI). To date noneof these have reacted or begun to address their expert committees‘ conflicts of interest.
Cochrane Collaboration recently published results of clinical trials of the neuraminidase inhibitor oseltamivir known as Tamiflu, stirring massive doubts over clinical benefit that had been previously attributed to the drug, especially during a time of pandemic. The group of researchers led by Dr. Tom Jefferson received 25,453 pages of clinical study reports from the European Medicines Agency, which had granted access to the documents in response to their freedom of information request. Of the 5 modules contained within each study report, only module 1 and 2 (about 60 % of the actual volume) had been given to the EMA for drug licensing purposes. Although the Cochrane Groups researchers repeated their request for unpublished data, it had been declined by the Tamiflu’s manufacturer Roche. Nevertheless, the analyses of the accessible study data contradict published reports and official information which have assigned Tamiflu a very high effectiveness in reducing severe complications during influenza infections and stopping their spread. The only signs of the drug’s effectiveness found by researchers was evidence of a 21-hour reduction of the flu’s duration. The researchers found no data to suggest impact on complications and no evidence that the drug could prevent transmission of the virus. In addition, disturbing discrepancies were found between the original clinical study data and the data as presented in medical journals.
”For obtaining independent and unbiased evaluations of the effectiveness of a drug before licensing, open access to all clinical study data is necessary. Tamiflu is a drug purchased, stockpiled and because of its short durability frequently replaced in large quantities at high costs by national institutions and public health authorities for protection against pandemic threats,” said Wolfgang Wodarg, chair of Transparency International Germany’s working group on health. “Scientific evidence of benefits and harms must be absolutely trustworthy. Otherwise, licensing not to mention stockpiling at national level, is not justifiable. Withholding data fuels the devastating impression that medical research and drug licensing follows not scientific evidence but rather financial interests. Roche must immediately and decisively counteract this impression.”
Transparency International Germany calls on the EMA, which in 2002 licensed Tamiflu for the European drug market, and all national institutions involved in the decision, scientific medical societies and expert committees to support the request for open access to all Tamiflu clinical study reports granted by Roche. The renewal of the Tamiflu license, which is due in 2012, should only be granted if all such data are accessible. All Tamiflu purchases by governments or state authorities should be suspended until open data access allows for unbiased and credible evaluation of effectiveness.
“If Roche does not change its position, the Tamiflu case would indicate the selling out of the principle of integrity in scientific conduct for the sake of marketing interests. The resulting loss of public trust in science, pharmaceutical industry, but also health authorities and public institutions would be immense. A broad alliance of manufacturers, health authorities and scientists must live up to their responsibilities to prevent this from happening,” said Ulrich Keil, professor of epidemiology and member of the working group.
For any press enquiries please contact
Dr. med. Wolfgang Wodarg, Leader of the working group on health
Prof. Dr. med. Ulrich Keil, PhD, FRCP, member of the working group on health
Dr. Christian Humborg, managing director
Transparency International Deutschland e.V.
T: + 49 30/ 54 98 98 0