Merck head 'misled jury in Vioxx court cases'
THE head of clinical trials at Merck faces claims that she misled jurors, after the publication of evidence allegedly showing that Merck failed to release data on the risk of heart problems in patients who took the painkiller Vioxx.
The allegations about Alise Reicin came as the latest trial involving a patient who died of a heart attack after taking the drug was declared a mistrial in federal court in Houston — the jury failed to reach a unanimous verdict following more than 18 hours of deliberation.
In the case, Ms Reicin gave evidence that Merck had never tried to withhold relevant findings from clinical trials.
However, last week, as the jurors were deliberating a verdict, the New England Journal of Medicine claimed that Merck had excluded data relating to three patients who had suffered heart attacks after taking the drug.
Lawyers acting for those now suing Merck have seized on the Journal’s findings. Mark Lanier, the lawyer who represented the first winning plaintiff to sue Merck over Vioxx, is in the process of filing a complaint against Ms Reicin.
Merck has in the past repeated that it never withheld any evidence. It said yesterday that there was a “misperception” about the data that was not included in the trial results, adding that the heart attacks happened after a “cut-off date” for clinical evidence to be included in the study.
Phil Beck, the chief external counsel for Merck, said: “The information in question came to light after a pre-specified cut-off date. Additional information about the studies was given to the FDA (US Food and Drug Administration). Alise Reicin testified to this effect in this case and has never lied in court.”
The mistrial verdict in Houston, which was the first Vioxx case to be heard in a federal court, was greeted by the plaintiffs as a huge failure for Merck and as a “big disappointment” by the company.
Roche, the pharmaceuticals company, has finally signed a subcontractor to bolster supplies of its antiviral drug, Tamiflu, which could help to stop a pandemic flu outbreak (Richard Irving writes).
Roche said that it had agreed a deal with Shanghai Pharmaceutical Group. It is in talks with a further 12 potential partners to sign sub-licensing deals that would alleviate any supply shortages of the drug.
The allegations about Alise Reicin came as the latest trial involving a patient who died of a heart attack after taking the drug was declared a mistrial in federal court in Houston — the jury failed to reach a unanimous verdict following more than 18 hours of deliberation.
In the case, Ms Reicin gave evidence that Merck had never tried to withhold relevant findings from clinical trials.
However, last week, as the jurors were deliberating a verdict, the New England Journal of Medicine claimed that Merck had excluded data relating to three patients who had suffered heart attacks after taking the drug.
Lawyers acting for those now suing Merck have seized on the Journal’s findings. Mark Lanier, the lawyer who represented the first winning plaintiff to sue Merck over Vioxx, is in the process of filing a complaint against Ms Reicin.
Merck has in the past repeated that it never withheld any evidence. It said yesterday that there was a “misperception” about the data that was not included in the trial results, adding that the heart attacks happened after a “cut-off date” for clinical evidence to be included in the study.
Phil Beck, the chief external counsel for Merck, said: “The information in question came to light after a pre-specified cut-off date. Additional information about the studies was given to the FDA (US Food and Drug Administration). Alise Reicin testified to this effect in this case and has never lied in court.”
The mistrial verdict in Houston, which was the first Vioxx case to be heard in a federal court, was greeted by the plaintiffs as a huge failure for Merck and as a “big disappointment” by the company.
Roche, the pharmaceuticals company, has finally signed a subcontractor to bolster supplies of its antiviral drug, Tamiflu, which could help to stop a pandemic flu outbreak (Richard Irving writes).
Roche said that it had agreed a deal with Shanghai Pharmaceutical Group. It is in talks with a further 12 potential partners to sign sub-licensing deals that would alleviate any supply shortages of the drug.
posted by Chris Placitella at 6:23 AM
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