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Drug firms face dilemma on trials disclosure

Drug companies, already struggling to find enough new medicines to sustain historic growth rates for their businesses, face a dilemma as demands increase for them to reveal results of all clinical trials.
/ Source: Reuters

Drug companies, already struggling to find enough new medicines to sustain historic growth rates for their businesses, face a dilemma as demands increase for them to reveal results of all clinical trials.

Firms don’t want to share scientific secrets with rivals but cannot afford to alienate doctors and politicians who argue their failure to publish all data is harming patients.

One way or another, greater openness looks inevitable, industry experts say. But it is the level of detail and timeliness of publication that will determine the impact on corporate profits.

“From a PR (public relations) point of view, it is important that the industry is seen to be doing something. But it is not going to over-disclose,” said Stuart Bowman, vice president for life sciences at consultancy Wood Mackenzie in Edinburgh.

Forcing firms to show trials data too early could undermine the incentive to find new medicines, push up costs and increase the drug development risks, he said.

“Any putative disclosure that destroys competitive advantage is bad news for innovative companies.”

Controversy about firms concealing research, either to prevent rivals learning too much or because negative results would hit product sales, has been simmering for years.

But New York Attorney General Eliot Spitzer brought the issue to a head in June by accusing GlaxoSmithKline Plc of fraudulently suppressing important information about the use of its antidepressant Paxil in children.

GSK settled the case last month for $2.5 million -- a trifling sum for a company with annual sales of $38 billion. The long-term fallout could be much greater, however.

Calls for more openness growing
As part of the settlement, GSK agreed to publish results of its drug trials in a registry and the wider industry has also moved quickly to play ball, with the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group announcing plans last week for an online database starting Oct. 1.

PhRMA says its voluntary scheme will provide the information that is of most use to doctors using its products.

But editors of 11 major medical journals argue the industry-sponsored scheme is inadequate, since many early-stage or unfinished trials will not be included.

Instead, they want all trials registered at the outset in an independent database as a pre-condition of subsequent publication, so that unflattering findings cannot be covered up.

Calls for more openness are growing not only in the United States -- where some members of Congress are considering ways to force companies to show their hands -- but also in Europe.

British cancer researchers complained earlier this month that results of many valuable clinical trials never see the light of day.

Still scarred by past public relations disasters --including a court case against the South African government over AIDS medicines -- drug makers are treading carefully.

“They have to weigh the cost-benefit (ratio) of keeping these things under wraps,” said David Webster, president of Webster Consulting Group, a pharmaceutical and biotechnology consulting firm based in Bethlehem, Pennsylvania.

But corporations are not going to roll over and reveal all.

“If you think a lot of money has been spent fighting against things like reimportation, it would pale in comparison to what they would spend to fight this. There’s too much at stake,” he said.

Faster imitation
The reason is simple: competition in drug research is cut-throat and the time between introduction of an innovative new drug and arrival of the first imitator has narrowed sharply.

Back in 1977 SmithKline’s ulcer pill Tagamet enjoyed six clear years before Glaxo’s Zantac hit the market. By 1999, Searle’s painkiller Celebrex had a lead of just four months over Merck & Co Inc’s Vioxx.

For society full transparency and the rapid transfer of know-how on new ways to fight disease clearly offers benefits.

“In the long run, if everybody publishes negative clinical trial information then the industry will stop reinventing wheels that don’t work,” said Martyn Postle, director of British-based advisory group Cambridge Healthcare & Biotech.

But for individual companies it makes sense to keep research that offers a competitive advantage under the radar.