UK to Force Drugmakers to Share Info

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UK to Force Drugmakers to Share Info

By MARIA CHENG - 1 hour ago

LONDON (AP) - Britain plans to force pharmaceutical companies to share more

information with regulators about clinical trials after an investigation

recently concluded that GlaxoKline 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.

" I remain concerned that GSK could and should have reported this information

earlier than they did, " MHRA chief executive Kent Woods said in a statement.

GlaxoKline rejected the suggestion that it withheld information.

" We firmly believe we acted properly and responsibly, " said Dr. Alastair Benbow,

the company's European medical director.

British legislation only obliges companies to report side effects in patients

for which drugs are officially recommended.

Because Seroxat was only recommended for adults, GlaxoKline was not

required to report on any dangerous side effects it found in adolescents.

But Seroxat can still be given to adolescents if prescribed by a doctor. About

half of psychiatric drugs are prescribed " off-label, " meaning that doctors give

them to patients for whom the drug is not strictly intended.

The MHRA said it sifted through more than 1 million pages of evidence after

requesting details of clinical trials held between 1994 and 2002.

In response, Britain's government declared that by the end of the year, it will

tighten laws forcing companies to share all their relevant safety research with

regulators.

" Companies that conduct clinical trials should not compromise people's health by

withholding information, " public health minister Dawn Primarolo said. The new

laws will require companies to disclose a drug's side effects in all patients

tested, Primarolo said.

The GlaxoKline case underlines a growing concern among many health experts

that drug companies' tendency to hide damaging data could have disastrous

consequences.

" If we make the wrong licensing decisions for whatever reasons, then patients

may be put at risk, " said Dr. Hans-Georg Eichler, senior medical officer at the

European Medicines Agency, which licenses drugs across Europe.

Others warn that without more complete information from drug companies,

consumers might see similar unpleasant surprises in the future.

" It would be unwise to assume that this particular case was anomalous, " said Dr.

Ike Iheanacho, editor of the Drug and Therapeutics Bulletin, an independent

publication of the British Medical Journal that tracks drug treatments.

" It's perfectly reasonable for people to be anxious about what other drugs on

the market might be questionable, " he said.

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.

GlaxoKline, 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.

" If we don't know what companies are doing, how do we know what's being

reported? " said Davina Ghersi, coordinator of the World Health Organization's

clinical trials registry platform.

Britain's National Institute for Clinical Excellence, the agency responsible for

deciding what the health system pays for, issued guidelines on antidepressants

in 2004. At the time, it did not have access to all the trial data.

" I shared with them the studies I had, but they did not have sufficient

information to do a complete review, " said Kirsch, then a consultant to the

agency.

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.

" If we had seen all of the data in the first place, people might have realized

that the claims being made for the drug were overblown and coy to the point of

being fraudulent, " said Dr. Healy, a professor of psychiatry at Cardiff

University in Wales.

But scapegoating of the drug companies may be too simplistic.

" A drug may turn out to be unsafe not because anyone has done anything wrong,

but because new knowledge surfaces, " Eichler said. Until a drug has been used by

millions of people, the rarest and deadliest side effects may remain unknown.

Licenses are granted for drugs based on limited testing, Eichler said.

Post-license monitoring should help sort out which drugs may be particularly

risky, he said.

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

say.

" If we had an overall picture, we might have a very different view about how

good certain drugs are, " Healy said. " There's an awful lot of people taking

drugs that we don't know everything about. "