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GSK Response Letters to Abacavir Article in the The Independent
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Letters Editor
The Independent
Independent House
191 March Wall London E14 9RS
14th May 2008
FOR PUBLICATION
Dear Sir,
We strongly refute that warnings regarding the safety of the HIV treatment abacavir were "downplayed" (article 12th May 2008).
In August 2005, GSK was contacted by the WHO Uppsala Monitoring Centre in Sweden regarding a signal of abacavir and myocardial infarction.
Within one week upon receipt of this information, GSK conducted a review of the data supplied and that of our own internal safety database, alongside data from the US Food and Drug Administration's AERS database.
This analysis led to the conclusion, that the signal communicated to GSK, was not validated by these other internal and external safety databases.
However, in the interests of patients' safety, GSK further conducted a comprehensive evaluation using data from multiple sources, including the WHO collaborating Centre for International Drug Monitoring. This was done, not withstanding ongoing 6 monthly reviews to assess this signal, since abacavir was launched.
This evaluation, which was provided to regulatory agencies, found no convincing evidence of a causal relationship between abacavir treatment and myocardial ischaemia.
Contrary to the suggestion made in the article, the description in the current summary of product characteristics of "mild myocardial degeneration," in mice and rats given the drug for two years, refers to a small increase in incidence of a heart finding which is seen as a common background finding in untreated, aging animals. This is pathologically distinct from myocardial ischaemia or infarction.
GSK takes any indication of increased risk with any of our medicines very seriously and we will continue to monitor and investigate the safety of all our medicines, including abacavir.
Yours faithfully,
Alastair Benbow
European Medical Director
GlaxoSmithKline
cc.
Roger Alton, Editor
Steve Connor, Science Editor
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2nd Letter
Steve Connor Science Editor
The Independent
Independent House
191 March Wall
London E14 9RS
14th May 2008
Dear Steve,
Following publication of your article, I would like to take this opportunity to affirm some of the information we discussed last week.
I have also sent a letter for publication to the newspaper.
· In August 2005, GSK was contacted by the WHO Uppsala Monitoring Centre in Sweden regarding a signal of abacavir and myocardial infarction which had been included in the WHO Signal document for May 2005. Within one week, GSK conducted a review of the data supplied, which was performed along with data from both the FDA's AERS database and GSK's safety database, OCEANS. These analyses led to the conclusion that the signal was not validated by these internal and external safety databases.
· However, in the interests of patients' safety, GSK further conducted a comprehensive evaluation using data from multiple sources, including the WHO collaborating Centre for International Drug Monitoring. This was done, not withstanding ongoing 6 monthly reviews to assess this signal, since abacavir was launched.
· The results of this detailed evaluation, completed in August 2006, considered data from the following sources: literature/epidemiological studies, WHO collaborating Centre for International Drug Monitoring, GSK Safety Database, FDA AERS database and a summary of safety for abacavir prepared for regulatory response.
· This evaluation, which was provided in full to the European Medicines Agency in February 2007 as part of our ongoing safety reporting to the Agency, found no convincing evidence of a causal relationship between abacavir treatment and myocardial ischaemia was found during this evaluation. The Agency concluded that there was no evidence to support the suggestion that the association of ischaemic cardiac events or myocardial infarction in particular, with abacavir containing products was an issue requiring further action.
GSK takes any indication of increased risk with any of our medicines very seriously. GSK's ongoing pharmacovigalence activities, for abacavir, support recommendations by Regulators that these events continue to be monitored. The most recent analysis of the GSK clinical trials database did not reveal any signal for an increased risk of heart attack and use of abacavir. GSK is unaware of any confirmed increased risk of heart attack with abacavir in the published literature. However, it is important to note that data from the literature does indicate that there is an increased risk of cardiovascular disease in HIV infected patients, which is related to duration of disease and duration of Combination Antiretroviral treatment.
Contrary to the claim made in this article, there is no specific labelling in the current summary of product characteristics (SmPC) for abacavir relating to a risk for myocardial infarction or ischaemic heart disease. Furthermore, there has been no signal from non-clinical studies indicating a risk for ischaemic cardiovascular events with abacavir. The description in the SmPC of "mild myocardial degeneration" in mice and rats given the drug for two years, refers to a small increase in incidence of a heart finding which is seen as a common background finding in untreated, aging animals. However this is of unknown relevance to humans and importantly is pathologically distinct from myocardial ischaemia or infarction.
GSK believes that it is important to note that HIV infection is a potentially fatal disease. Controlling the HIV virus requires multiple medicines used in different combination as the virus continues to mutate. Abacavir has been approved for the treatment of HIV/AIDS since 1998 and is a cornerstone of HIV/AIDS treatment. As with all medicines, physicians and patients must weigh the risks of the disease against the risks and benefits of the medicines available to treat it. Certain risks seen particularly in these patients, such as underlying cardiovascular disease and lifestyle choices, may be able to be managed as part of standard HIV patient care.
I hope that this letter is helpful context and confirms GSK's commitment to ongoing investigations and better understanding within this complex area.
Yours sincerely,
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