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| Johnson & Johnson tried to prevent report about pelvic mesh devices, court hears | Johnson & Johnson tried to prevent report about pelvic mesh devices, court hears |
| (7 months later) | |
| Hundreds of Australian women launch class action Johnson & Johnson companies alleging meshes caused chronic and debilitating pain | |
| Christopher Knaus | |
| Mon 10 Jul 2017 07.10 BST | |
| Last modified on Thu 19 Oct 2017 08.51 BST | |
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| The pharmaceutical giant Johnson & Johnson tried to stop French health authorities publishing a report warning against the use of its untested pelvic mesh devices, two years after they began giving them to Australian women, a court has heard. | The pharmaceutical giant Johnson & Johnson tried to stop French health authorities publishing a report warning against the use of its untested pelvic mesh devices, two years after they began giving them to Australian women, a court has heard. |
| Hundreds of Australian women have launched a class action against three Johnson & Johnson companies alleging the meshes – used to treat two common childbirth complications – have caused them chronic and debilitating pain, ruined their sex lives, and, in some cases, destroyed their livelihoods. | Hundreds of Australian women have launched a class action against three Johnson & Johnson companies alleging the meshes – used to treat two common childbirth complications – have caused them chronic and debilitating pain, ruined their sex lives, and, in some cases, destroyed their livelihoods. |
| Thousands of patients in the UK, Canada and the United States have launched similar cases. | Thousands of patients in the UK, Canada and the United States have launched similar cases. |
| On Wednesday, the federal court in Sydney heard Australian women were effectively used as “guinea pigs” by the Johnson & Johnson group. | On Wednesday, the federal court in Sydney heard Australian women were effectively used as “guinea pigs” by the Johnson & Johnson group. |
| Barrister Duncan Graham SC told the court the devices were not properly tested before they were approved by the Therapeutic Goods Administration and placed on the Australian market in 2005. | Barrister Duncan Graham SC told the court the devices were not properly tested before they were approved by the Therapeutic Goods Administration and placed on the Australian market in 2005. |
| Johnson & Johnson instead conducted an aggressive marketing campaign aimed at convincing surgeons the devices were inexpensive, simple to implant, and therefore a lucrative alternative to other treatment options. No randomised controlled trials were conducted, the court heard, and the scant testing that was available was insufficient or too short-term. | Johnson & Johnson instead conducted an aggressive marketing campaign aimed at convincing surgeons the devices were inexpensive, simple to implant, and therefore a lucrative alternative to other treatment options. No randomised controlled trials were conducted, the court heard, and the scant testing that was available was insufficient or too short-term. |
| Had such trials been conducted, Graham said, they would have found the devices posed an unacceptable risk to women. | Had such trials been conducted, Graham said, they would have found the devices posed an unacceptable risk to women. |
| “It was sell first, test later,” Graham said. “The women who had them implanted were part of an experiment, they were guinea pigs,” he said. | “It was sell first, test later,” Graham said. “The women who had them implanted were part of an experiment, they were guinea pigs,” he said. |
| The court has been shown internal documents from one of the Johnson & Johnson companies, Ethicon, suggesting it knew it lacked the proper trials. | The court has been shown internal documents from one of the Johnson & Johnson companies, Ethicon, suggesting it knew it lacked the proper trials. |
| In 2007, the French health authority, Haute Autorité de Santé, was preparing to release a report on the mesh devices. The report found a proper randomised controlled trial was needed before the devices could be approved. It concluded they should be used only in clinical research until such a trial was complete. At that stage, the devices had been on the Australian market for two years. | In 2007, the French health authority, Haute Autorité de Santé, was preparing to release a report on the mesh devices. The report found a proper randomised controlled trial was needed before the devices could be approved. It concluded they should be used only in clinical research until such a trial was complete. At that stage, the devices had been on the Australian market for two years. |
| The looming French report prompted concern within Ethicon. Meeting minutes described in court show the company feared the report “could have a major impact on our business if made public”. | The looming French report prompted concern within Ethicon. Meeting minutes described in court show the company feared the report “could have a major impact on our business if made public”. |
| It said work was needed to “stop the publication of the report”. | It said work was needed to “stop the publication of the report”. |
| “So there is no randomised clinical trial, the [French] commission wants one and essentially until it gets one, Prolift, which has already been on the market in Australia for two years, is considered only suitable for clinical research,” Graham told the court. | “So there is no randomised clinical trial, the [French] commission wants one and essentially until it gets one, Prolift, which has already been on the market in Australia for two years, is considered only suitable for clinical research,” Graham told the court. |
| The court also heard evidence about the origins of a journal article supportive of the safety and efficacy of the devices, which was published in the New England Journal of Medicine in 2011. | The court also heard evidence about the origins of a journal article supportive of the safety and efficacy of the devices, which was published in the New England Journal of Medicine in 2011. |
| Graham said the journal had been forced into an “embarrassing” correction two years later, after it emerged the study had failed to properly disclose the involvement of Ethicon. Ethicon had paid the authors consultant fees, and reviewed the original study protocol and a presubmission draft of the manuscript. | Graham said the journal had been forced into an “embarrassing” correction two years later, after it emerged the study had failed to properly disclose the involvement of Ethicon. Ethicon had paid the authors consultant fees, and reviewed the original study protocol and a presubmission draft of the manuscript. |
| The presubmission draft differed in several respects from the published article, the court heard. | The presubmission draft differed in several respects from the published article, the court heard. |
| Part of the device’s appeal to surgeons was the apparent ease with which it could be inserted. Johnson & Johnson marketed the mesh’s implantation as a standardised technique. That claim, Graham alleged, was a “pipe dream, and a dangerous one at that”. | Part of the device’s appeal to surgeons was the apparent ease with which it could be inserted. Johnson & Johnson marketed the mesh’s implantation as a standardised technique. That claim, Graham alleged, was a “pipe dream, and a dangerous one at that”. |
| He said there was variability in the technique, and the surgery was complex, beyond the skills of lesser-trained or inexperienced surgeons. | He said there was variability in the technique, and the surgery was complex, beyond the skills of lesser-trained or inexperienced surgeons. |
| A study published in the Lancet in December found that women who were given mesh implants were roughly three times more likely to suffer complications and twice as likely to need follow-up surgery compared with women who had the traditional version of the surgery, where stitches are used to provide support for the organs. | A study published in the Lancet in December found that women who were given mesh implants were roughly three times more likely to suffer complications and twice as likely to need follow-up surgery compared with women who had the traditional version of the surgery, where stitches are used to provide support for the organs. |
| The case continues before Justice Anna Katzmann. | The case continues before Justice Anna Katzmann. |
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