Processing Magazine

Britain Wants More Info From Drugmakers

March 26, 2008
The Associated Press is reporting that Britain plans to require pharmaceutical companies to share more information with regulators about clinical trials after an investigation recently concluded that GlaxoSmithKline PLC deliberately withheld information about an antidepressant.

The four-year probe by the Medicines and Healthcare products Regulatory Agency, completed earlier this month, said the British company should have revealed more quickly that Seroxat sometimes increased the suicide risk in teenagers -- by more than six times.

But without stronger legislation in place, the MHRA admitted there is no chance of prosecuting the company for what the agency perceives as an ethical lapse.

GlaxoSmithKline rejected the suggestion that it withheld information. The company said that when the trials were reviewed individually, none showed a significant increase in the suicide rate. It was only when the data were all analyzed together that the increase was noticed. GSK then alerted regulatory authorities, including those in Britain.

British authorities declared that by the end of the year, they will tighten laws forcing companies to share all their relevant safety research with regulators.

The GlaxoSmithKline case underlines a growing concern among many health experts that drug companies'' approach toward toward disclosing damaging clinical data could have disastrous consequences.

Others warn that without more complete information from drug companies, consumers might be wary about future treatments.

Patients could be taking drugs they do not need or do not work, said Irving Kirsch, a professor of psychology at Britain''s University of Hull and lead author of a study that concluded antidepressants like Prozac are mostly ineffective.

Kirsch and colleagues analyzed data about popular antidepressants after submitting a Freedom of Information Act request to the U.S. Food and Drug Administration. They found that depressed patients taking drugs did not actually do much better than those taking fake pills.

GlaxoSmithKline, makers of numerous antidepressants, responded in a statement that Kirsch''s conclusions were incorrect because they evaluated only "a small subset of the data available."

But Kirsch and colleagues looked at nearly all the research submitted to the FDA. If that was only a small subset, experts wonder what other data might be out there.

In recent years, once-blockbuster drugs, such as the painkiller Vioxx and the diabetes pill Avandia, have revealed worrying side effects, including significantly boosting the risk of a heart attack, years after being on the market.

But scapegoating of the drug companies may be too simplistic.

Without more data, people should be wary of what medications they take, experts say.