Merck’s problems deepen as MHRA reveals investigation
pharmafile | September 8, 2005 | News story | Sales and Marketing |Â Â Â
The controversy around the withdrawal of Vioxx has taken a new twist with news its manufacturer is being investigated for potentially withholding trial data, a criminal act.
UK regulator the MHRA said the investigation has been ongoing for nearly a year, but only disclosed the fact at the end of August following renewed media interest.
The government body is investigating whether or not Merck Sharp and Dohme (Merck's UK affiliate) withheld information about the potential risks of Vioxx when it applied for its UK licence in 1999.
The MHRA made the investigation public after a US court ruling reignited interest in the story in the UK.
The ruling by a Texas court that Vioxx had caused the premature death of 59-year-old marathon runner Robert Ernst means Merck could face up to 4,000 similar lawsuits around the world.
The company has been ordered to pay $253 million (141 million) to Ernst's widow and commentators forecast Merck may be forced to pay as much as $18 billion in damages to other claimants – nearly as much as the company's total revenues for 2004.
Merck is appealing against the decision, but the case could represent a turning point for drug safety and company liability across the industry if similar claims prove successful.
A number of patients from the UK and Europe are now hoping to take legal action against the company, and any evidence that it misled regulators would strengthen their claims.
A spokesman for Merck Sharp and Dohme confirmed it was helping the MHRA with an investigation but would not divulge any further details.
If found guilty, MSD employees responsible for misleading the regulator could face two years' imprisonment while the company could be fined an unlimited amount.
The MHRA said its probe was launched in response to alleged breaches in the licensing process uncovered in the US, where a parallel criminal investigation is underway.
The inquiry is the MHRA's second recent investigation into the alleged concealment of negative clinical data by a pharmaceutical company.
Last year, it launched an investigation into GlaxoSmithKline (GSK) after concerns arose that the UK manufacturer withheld paediatric clinical data of antidepressant Seroxat.
The MHRA said when the investigation is complete it will pass its findings onto government prosecutors who will decide if legal action is necessary.
While declining to comment on specifics of the investigation, GSK said it rejected any suggestion that it attempted to hide results or misled regulators over paediatric clinical trial data for Seroxat.
"We are confident that we acted responsibly in first carrying out the clinical trials for Seroxat in children and adolescents and then sharing the information from the pooled analysis of those trials with regulatory authorities," a spokesman said.
Like the investigation into MSD, named individuals at GSK could face the possibility of a prison sentence under the 1968 Medicines Act.
Meanwhile, a study recently published in the online journal BMC Medicine made fresh accusations that GSK did not submit its detailed original clinical trial data on Seroxat to the regulator when it applied for its licence.
The absence of a detailed breakdown between suicide attempts and suicidal thinking distorted the conclusions on the dangers of the drug, the study concluded.
But GSK rebuffed the claims, arguing they only served to cause confusion and unnecessary concern for patients.
GSK said the study's sub-analysis was misleading as it selected some of the original trials used for approval and not others.
It added that post-marketing trial data had also been ignored, despite containing significantly more data which had also been reviewed by European authorities.
The pharmaceutical industry is concerned that growing concerns about drug safety will bring about stricter regulatory practices, which it fears could block patient access to new drugs and hit revenues.
In the US, industry organisation PhRMA has voiced its opposition to FDA plans to post preliminary information about drug side-effects on a public Drug Watch website.
In an interview with Reuters, PhRMA president Billy Tauzin said: "There's a deep concern that bad information gets into the system…and people stop using drugs they need."
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