Responding to an ”erosion” of public trust in drug trial data, Eli Lilly promised to post online the research results — good and bad — for every drug it sells.
Lilly said it will provide clinical data on the safety and effectiveness of each of its government-approved drugs on the internet by the end of the year.
The maker of Prozac, diabetes care products and other drugs will start by disclosing data from trials ending during the second half of 2004. Eventually, the website will include information from hundreds of trials for Lilly drugs approved since 1994, said Dr Alan Breier, chief medical officer of the Indianapolis-based
company.
”There has been an erosion of trust in medical data,” Breier said in an interview on Tuesday. ”The more openness, the more transparency on this topic, the better for everybody.”
New York’s attorney general sued GlaxoSmithKline in June for fraud for allegedly withholding critical clinical information about its anti-depressant Paxil. The American Medical Association that month passed a resolution calling for a government-run registry for all drug study results so that unfavourable results aren’t buried.
Glaxo has since said it will post drug trial results on the internet by the end of the year, but doctors criticised the company for not agreeing to disclose the start of drug trials. By not disclosing drug trial starts, a manufacturer may avoid the need to account for negative results.
Lilly said it will disclose the results of all trials of every drug it has approval to sell, even if the tests do not show the drug effective for a particular indication. It also will reveal the start of phase three and phase four trials. Phase three is the last step
before federal approval. Phase four trials test drugs that are already on the market.
The AMA said on Tuesday it was ”encouraged” by Lilly’s announcement but renewed its call for a central industry registry.
”Ultimately, the AMA believes a comprehensive clinical trials registry is necessary to reduce the impact of publication bias, prevent duplication of effort, promote collaboration, and improve evidence-based medical practice,” said a statement attributed to Dr Joseph Heyman, an AMA trustee.
Until recently, drug companies risked only bad publicity by withholding trial data from public scrutiny, but the New York lawsuit against Glaxo came as a ”wake-up call” for an industry that now risks fines and other penalties, said Hemant Shah, an independent industry analyst based in Warren, New Jersey.
”How aggressively the other companies will follow is hard to say,” Shah said.
Lilly shares closed down 33 cents to $63,22 on Tuesday on the New York Stock Exchange. – Sapa-AP