International drug giant GlaxoSmithKline (NYSE: GSK) has taken plenty of criticism in the U.S. for its diabetes drug Avandia, and now GSK is under increased scrutiny in the U.K. for its anti-depressant Seroxat.
Labeled a “happy pill” and “joy pill,” Seroxat is the most widely prescribed such drug in the U.K., according to media reports. It also is available in the U.S. under the name Paxil.
However, the drug – similar to Prozac – has been under media fire for its potential suicidal side effects on teenagers. The BBC’s “Panorama” program raised public concern several years ago, and the British government launched an investigation lasting several years.
The Medicines and Healthcare products Regulatory Agency, or MHRA, announced last week that it would not bring criminal charges against the company.
In an editorial Sunday, the prestigious Financial Times criticized GSK as well as regulatory requirements.
"GSK avoided prosecution because of an absurd distinction: the rules were focused on reporting side-effects of drugs when tested in line with their authorised use, rather than in studies of new or alternative ‘off label’ uses – where doctors (sometimes justifiably) prescribe at their own discretion, despite lack of formal regulatory approval," the newspaper said.
Earlier, the BBC noted that the MHRA concluded it could not bring legal action.
“After reviewing more than one million pages of evidence the MHRA said no criminal proceedings could be brought against GSK because legislation on disclosure at the time was not strong enough,” the BBC reported.
“But they ‘remain concerned’ that GSK could and should have reported the information earlier than they did,” the BBC added.
The MHRA announcement did not quiet other GSK critics.
"There can be no excuses from the pharmaceutical industry,” said Paul Farmer, chief executive of Mind, a health charity in England and Wales, in a statement. “The public must be able to have trust and confidence in the medicines they are taking. We need to be sure that the tragedies associated with Seroxat can never happen again. The best way to achieve this is for drug companies to publish all clinical trials data, making it available for scrutiny and review, and to inform prescribing decisions.”
Members of Parliament quickly issued calls for reforms in drug-related legislation. Farmer, whose group said it had raised concerns about Seroxat in the 1990s, embraced a growing government call for changes.
"Mind welcomes news that the Government is to increase drug companies’ responsibility to pass on clinical trials information,” he said. “We look forward to discussions with ministers to ensure that patients’ interests are best served. We hope that the legislation will pass quickly through Parliament; this is far too important to be delayed any longer.”
In a statement, GSK, which employs some 6,000 people in the Triangle area and operates one of its two U.S. headquarters in RTP, denied any wrong doing.
“The company rejects any suggestion that it withheld drug trial information as results from its paediatrics studies were documented and submitted to regulators in accordance with regulatory requirements,” GSK said. “Results were also presented publicly, published in scientific journals and have been made available on GSK’s website.”
GSK has also been pummeled recently about links between Avandia – its popular diabetes drug – and links to heart attacks.
The story has received scant notice in the United States other than in the Wall Street Journal and an Associated Press dispatch.
Here is a sampling of British coverage:
London Times Online: ‘No prosecution on suicide-risk drug’
“A drugs manufacturer has been criticised, but not prosecuted, over claims that it withheld information about the increased risk of suicide for children taking Seroxat, the bestselling antidepressant drug.”
The Guardian: ‘Watchdog voices dismay at failure to police industry’
“The head of Britain’s drug regulatory body appealed to pharmaceutical companies yesterday to recognise they have an ethical duty to alert consumers to the dangers of their products.”
Financial Times: ‘Call for new rules on drugs makers’
“The chief medicines regulator yesterday demanded tough new rules to force drug companies to report the side-effects of all medicines swiftly, after its four-year investigation into GlaxoSmithKline’s antidepressant Seroxat failed to bring a criminal case.”
GSK responded with a statement from Dr. Alastai Benbow, medical director for GSK Europe:
GlaxoSmithKline (GSK) notes the conclusions announced today by the Medicines and Healthcare products Regulatory Agency (MHRA) regarding its investigation into disclosure of paediatric trial data for the anti-depressant medicine Seroxat (paroxetine).
“The safe use of our medicines is paramount to everyone who works for GSK and the company is committed to ensuring that all appropriate information is made available to regulators, doctors and patients. We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18,” said Dr Alastair Benbow, Medical Director for GSK Europe.
“Whilst there are substantive and rigorous requirements in place regarding disclosure of clinical trial data, it is clear that there is a need and benefit to strengthen the confidence of decision-makers and the general public that all pharmaceutical industry clinical trial data are disclosed promptly and transparently. GSK is committed to working with the Government, appropriate regulatory authorities and other pharmaceutical companies to take whatever action is necessary to improve legislation and policy in this area,” he added.