The global pharmaceutical industry unveiled plans on Thursday to publish more data about trials of medicines in a bid to reassure patients following recent alarms over drug safety.
Trade groups in the United States, Europe and Japan, in collaboration with major drugmakers, agreed an industry-wide code to publish detailed information about all clinical trials, other than exploratory Phase I studies, on the Internet. The code will be voluntary, but companies are expected to be keen to take part, hoping to head off potentially more onerous legislation from governments in the wake of scandals over pain drug Vioxx and the use of antidepressants in adolescents. “By publishing not just the results of the trials that have taken place — whether positive or negative — but also those that are just starting, the industry has made a major step toward achieving greater transparency,” Richard Barker, Director General of the Association of the British Pharmaceutical Industry (ABPI), told reporters. The scheme has the backing of major pharmaceutical groups such as GlaxoSmithKline Plc, Pfizer Inc., AstraZeneca Plc, Merck & Co. Inc., Novartis AG and Sanofi-Aventis SA, the ABPI said. Under the plan, companies must register trials within 21 days of their start and give each one a unique identifier to ensure easy tracking through multiple databases. Results should be published within one year of a medicine’s approval or, for trials on drugs that have already been approved, within one year of the trial being completed. The scheme applies to new trials initiated after July 1, while trials already underway should be included from Sept. 13. COMMERCIAL SECRETS The move does not represent full disclosure, however. Early stage Phase I studies on healthy volunteers — often the first sign a company has a good hunch about a new drug approach — are exempt and there is no obligation to reveal results of studies before a drug is approved. “There are issues around commercial sensitivities at the very early stage,” ABPI medical director Richard Tiner said. Companies will also not give details on precise clinical trial design, although this might be included in a secure non-public third-party database for later disclosure. Controversy about drug firms concealing research, either to prevent rivals learning too much or because negative results would hit product sales, has been simmering for years. New York Attorney General Eliot Spitzer brought the issue to a head last June by accusing GlaxoSmithKline of fraudulently suppressing important information about the use of its antidepressant Paxil, or Seroxat, in children. GSK settled the case for $2.5 million, a trifling sum for a company with 2003 sales of 21.4 billion pounds ($40.15 billion). But it also agreed to publish results of its drug trials in a registry, setting a precedent for greater disclosure. SAFETY CONCERNS Concerns about drug safety have also come to the fore in recent months, with the worldwide withdrawal of Merck’s Vioxx pill in September after it was linked to heart attacks. And a senior official at the U.S. Food and Drug Administration raised concerns about AstraZeneca Plc’s cholesterol-lowering medicine Crestor in November. Safety concerns have led to hearings over medicines in the U.S. Senate, and British parliamentarians are investigating the influence of the pharmaceutical industry. Drugmakers, already struggling to find enough new medicines to sustain historic growth rates, need to tread a fine line when deciding how much information to disclose about their trials. While seeking to satisfy legislators, they are anxious to hold back anything that could give them a competitive advantage in an increasingly cut-throat industry. The ABPI’s Barker said the new voluntary code should satisfy the industry’s critics, including a group of 11 medical-journal editors who last September demanded much more openness. “We hope this issue will now be rather in the past than the future,” he said. (Source: Reuters Health: Ben Hirschler: January 2005.)