UK government tightens rules on drug trial results

The UK government is to increase drug companies’ responsibility to pass on information about clinical trials.

The move comes after the regulators announced last week that it could not prosecute GlaxoSmithKline (GSK) for non-disclosure of trial data that showed it was unsafe for children younger than 18 to take the antidepressant paroxetine (Seroxat).

The Medicines and Healthcare Products Regulatory Agency (MHRA) issued the final report of its four year investigation into GlaxoSmithKline, during which investigators sifted through one million pages of evidence. It concluded that the drug company hadn’t broken the law but criticised it for not reporting the information earlier. GlaxoSmithKline denied it had broken any regulations.

Fears about the safety of paroxetine for children younger than 18 first surfaced in 2003 after a comprehensive review of selective serotonin reuptake inhibitors (SSRIs) by the Committee on Safety of Medicines. The review uncovered clinical trial data that show an increased rate of suicidal thoughts and behaviour in children and adolescents who take paroxetine and other SSRIs. The MHRA investigation arose from a concern that GlaxoSmithKline had held the information for some time and had failed to disclose it.

Speaking last week, the MHRA’s chief executive, Kent Wood, said that his doubts remained: “I remain concerned that GlaxoSmithKline could and should have reported this information earlier than it did. All companies have a responsibility to patients and should report any adverse data signals as soon as they discover them.” He said that the investigation had shown “important weaknesses” in drug safety legislation.

In a statement, the health minister Dawn Primarola said that the government would immediately strengthen the law so that there could be no doubt over companies’ obligation to report safety issues.

“I have taken immediate steps to secure a strengthening of the law in this area through changes to the EU directive and, in the meantime, amending the law as it applies in the United Kingdom to make it clear to all pharmaceutical companies that they should disclose any information they have that would have a bearing on the protection of health,” she said.

At the time of the events in question, the law did not require a drug company to inform the regulator of clinical trials data in groups for whom the drug was not licensed. There was insufficient evidence that GlaxoSmithKline promoted the product for “off label” use in children younger than 18.

Alastair Benbow, medical director for GlaxoSmithKline Europe said, “GSK does not promote its medicines for indications for which they are not approved and maintains that Seroxat was not promoted to UK doctors for use outside the terms of the UK marketing authorisation.”

Mental health campaigners welcomed the report, although Mind urged the government to ensure the legislation passed quickly through parliament. “This is far too important to be delayed any longer. There can be no excuses from the pharmaceutical industry,” said the chief executive, Paul Farmer. He said that the Parliamentary Health Committee’s 2005 report on the influence of the drug industry had made similar recommendations and urged the government to “revisit” them soon.