A recent report by the Cochrane Collaboration, an independent research network, found no evidence that Roche’s costly Tamiflu antiviral medicine reduced risk of hospitalisation or death from influenza. Tom Jefferson, clinical epidemiologist and co-author of the Cochrane review, said “only the tip of the iceberg” of the evidence was made available to regulators when the drug was approved.
Stocks of antiviral treatment Tamiflu housed in a UK warehouse (picture from French website)
Fiona Godlee, editor-in-chief of the BMJ, which published the report, says the case highlights the “irredeemable conflict of interest” between the need for impartial trial data and the industry’s commercial interests. “We have evidence time and time again that they overestimate the benefits [of new drugs] and underestimate the harm.”
Andrew Ward, in the Financial Times, reports that Roche had long resisted demands from scientists to open its trial data to scrutiny but relented last year. Disputed clinical data was at the heart of controversy over Tamiflu, disclosing questionable efficacy rather than health risks.
In response to such criticism, drugmakers, including Roche, GSK and Johnson & Johnson, have announced steps over the past year to open their clinical trial data to independent scrutiny. Others cite the need to protect intellectual property and patient confidentiality. However, the European parliament has already passed draft legislation requiring detailed summaries of all trial data to be made public.Other fairly recent cases: .
- $250m verdict against Merck & Co on behalf of a widow who blamed her husband’s fatal heart attack on its Vioxx painkiller;
- $3bn US fine paid by GlaxoSmithKline for marketing abuses in 2012;
- a bribery probe against GSK in Iraq;
- and a French competition inquiry into whether Roche and Novartis colluded to block a cheaper alternative to their blockbuster Lucentis eye treatment.
Ward concludes: “All of them, in one way or another, support the claims of industry critics who say big pharma puts profits before public health – from cherry-picking clinical trial data to conceal health risks to bribing doctors and blocking cheaper medicines”