Drug company is reprimanded by UK regulator
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《英国医生杂志》
A drug company has been publicly reprimanded for trying to subvert a safety message issued by UK regulators for a drug used to treat depression and anxiety.
The Medicines and Healthcare Products Regulatory Agency, which monitors the safety of drugs, censured Wyeth last week after a health professional complained about the way that company representatives had openly questioned a safety warning on the drug venlafaxine (sold as Efexor and Efexor XL), a serotonin and noradrenaline reuptake inhibitor.
In December the Committee on Safety of Medicines warned of potential cardiac problems with the drug. Subsequent guidance from the National Institute for Clinical Excellence (NICE) on the treatment of depression states that mental health specialists using the drug to treat patients should "consider monitoring cardiac function" and "undertake regular monitoring of blood pressure, particularly for patients on higher doses."
NICE also advised that before the drug is prescribed to patients they should undergo electrocardiography and that their blood pressure should be measured. Wyeth does not accept the need for such measures and is appealing against the original ruling by the Committee on Safety of Medicines.
However, the regulatory agency is angry that in the meantime internal company documentation that cast doubt on the validity of the recommendations from the Committee on Safety on Medicines was distributed by Wyeth representatives on two separate instances in January.
One of the internal documents describes NICE抯 recommendation to monitor cardiac function as "confusing," and the advice is not given in the summary product characteristics for the drug (the summary that the manufacturer provides to the regulator).
In a separate document, described by the agency as an "information pack," the company acknowledges that although cardiac events "were reported to have occurred" during treatment with venlafaxine they "were not necessarily caused by it."
The document continues: "These events may have been related to an underlying disease, to venlafaxine, to other drugs being taken concurrently, or they may have occurred coincidentally during venlafaxine use." It acknowledges, however, that increases in heart rate can occur, particularly at high doses, and that "caution should be exercised in patients whose underlying conditions might be compromised by increases in heart rate."
Both documents are marked "internal use only—do not photocopy," even though it is known they were used outside the company.
According to the agency, Wyeth抯 material not only openly questioned the safety advice from the Committee on Safety of Medicines but also undermined the intention of the urgent safety restriction. It also misquoted guidance on the treatment of depression given by NICE so as to favour the drug.
Jeremy Mean, the agency抯 policy group manager, said the agency would not tolerate misleading advertising material when it comes to safety issues.
"In naming and shaming Wyeth, we hope this message will be clearly understood by all involved in medicines," he said.
A spokeswoman for Wyeth said the company had reviewed its procedures as a result of the case. She did not know if anyone had been disciplined for wrongly using this internal material. Wyeth has withdrawn its information pack.
"Wyeth regret that on two occasions the documents did get into the wrong hands," she said.(Lynn Eaton)
The Medicines and Healthcare Products Regulatory Agency, which monitors the safety of drugs, censured Wyeth last week after a health professional complained about the way that company representatives had openly questioned a safety warning on the drug venlafaxine (sold as Efexor and Efexor XL), a serotonin and noradrenaline reuptake inhibitor.
In December the Committee on Safety of Medicines warned of potential cardiac problems with the drug. Subsequent guidance from the National Institute for Clinical Excellence (NICE) on the treatment of depression states that mental health specialists using the drug to treat patients should "consider monitoring cardiac function" and "undertake regular monitoring of blood pressure, particularly for patients on higher doses."
NICE also advised that before the drug is prescribed to patients they should undergo electrocardiography and that their blood pressure should be measured. Wyeth does not accept the need for such measures and is appealing against the original ruling by the Committee on Safety of Medicines.
However, the regulatory agency is angry that in the meantime internal company documentation that cast doubt on the validity of the recommendations from the Committee on Safety on Medicines was distributed by Wyeth representatives on two separate instances in January.
One of the internal documents describes NICE抯 recommendation to monitor cardiac function as "confusing," and the advice is not given in the summary product characteristics for the drug (the summary that the manufacturer provides to the regulator).
In a separate document, described by the agency as an "information pack," the company acknowledges that although cardiac events "were reported to have occurred" during treatment with venlafaxine they "were not necessarily caused by it."
The document continues: "These events may have been related to an underlying disease, to venlafaxine, to other drugs being taken concurrently, or they may have occurred coincidentally during venlafaxine use." It acknowledges, however, that increases in heart rate can occur, particularly at high doses, and that "caution should be exercised in patients whose underlying conditions might be compromised by increases in heart rate."
Both documents are marked "internal use only—do not photocopy," even though it is known they were used outside the company.
According to the agency, Wyeth抯 material not only openly questioned the safety advice from the Committee on Safety of Medicines but also undermined the intention of the urgent safety restriction. It also misquoted guidance on the treatment of depression given by NICE so as to favour the drug.
Jeremy Mean, the agency抯 policy group manager, said the agency would not tolerate misleading advertising material when it comes to safety issues.
"In naming and shaming Wyeth, we hope this message will be clearly understood by all involved in medicines," he said.
A spokeswoman for Wyeth said the company had reviewed its procedures as a result of the case. She did not know if anyone had been disciplined for wrongly using this internal material. Wyeth has withdrawn its information pack.
"Wyeth regret that on two occasions the documents did get into the wrong hands," she said.(Lynn Eaton)