AUSTRALIAN PACKAGING OF EZETIMIBETHE CASE
The drug ezetimibe is co-marketed in Australia as Ezetrol and as Zetia in the US, by Merck Sharp & Dohme and Schering-Plough. It is approved for use to treat high cholesterol. In the official product information it is described as a "cholesterol intestinal absorption inhibitor".
Ezetimibe is also marketed under the brand name Vytorin in several different combinations with the venerable lipid-lowering drug simvastatin. Vytorin became available under the Australian Pharmaceutical Benefits Scheme (PBS) on 01/02/2006. Only two months later the manufacturers became aware of a probable lack of efficacy, but neglected to publicise this information.
There was a comprehensive study of the efficacy of the various Vytorin combinations called the ENHANCE clinical trial. On 25/01/2008 the FDA issued an "Early Communication" indication that there was concern with the clinical trial results and that the FDA will be analysing the data further, before recommending any action.
This is the worst possible result for the drug company. The combination appears to be adding to the potential risk to the patient without adding any benefit.
The whole episode gets murkier. In the US the House of Representatives, Committee on Energy and Commerce is holding an investigation into why Merck Sharp & Dohme and Schering-Plough withheld the results of the ENHANCE trial even though it finished in April 2006.
The Pharmaceutical Benefits Advisory Committee (PBAC) needs to look at the listing of items containing exetimibe and restrict the benefit to patients already stabilised on this therapy - at least until the matter is clarified.
MY VERDICT
With behaviour like this it is no wonder that the general public is deeply suspicious of the pharmaceutical giants. There is a feeling that profits are more important than public health to these companies.
Lets not forget that it is only about three years since Merck Sharp & Dohme had to quickly withdraw it anti-inflammatory drug Vioxx (rofecoxib), because it was implicated in increasing heart attacks and strokes in long-term users.
If you are taking the ezetimibe either alone or in the ezetimibe /simvastatin called Vytorin, and you are concerned, please see your prescriber.
The drug ezetimibe is co-marketed in Australia as Ezetrol and as Zetia in the US, by Merck Sharp & Dohme and Schering-Plough. It is approved for use to treat high cholesterol. In the official product information it is described as a "cholesterol intestinal absorption inhibitor".
Ezetimibe is also marketed under the brand name Vytorin in several different combinations with the venerable lipid-lowering drug simvastatin. Vytorin became available under the Australian Pharmaceutical Benefits Scheme (PBS) on 01/02/2006. Only two months later the manufacturers became aware of a probable lack of efficacy, but neglected to publicise this information.
There was a comprehensive study of the efficacy of the various Vytorin combinations called the ENHANCE clinical trial. On 25/01/2008 the FDA issued an "Early Communication" indication that there was concern with the clinical trial results and that the FDA will be analysing the data further, before recommending any action.
"This communication is based on information that FDA has not yet fully evaluated. FDA is not advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available."The reasons for the concern are that there was no greater lowering of the amount of cholesterol deposited with the ezetimibe/simvastatin combination than with simvastatin alone. However the ezetimibe/simvastatin combination has a greater incidence of side effects than simvastatin alone.
This is the worst possible result for the drug company. The combination appears to be adding to the potential risk to the patient without adding any benefit.
"There are no clinical studies available that demonstrate a reduction in risk of heart attack or stroke when ezetimibe is used alone or in combination with a statin, including the fixed-dosed combination drug of ezetimibe and simvastatin"There really does not seem to be any point in taking ezetimibe with or without a "statin" such as simvastatin.
The whole episode gets murkier. In the US the House of Representatives, Committee on Energy and Commerce is holding an investigation into why Merck Sharp & Dohme and Schering-Plough withheld the results of the ENHANCE trial even though it finished in April 2006.
“In light of today’s results, which were released nearly two years after the ENHANCE trial ended, it is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data ........ It’s currently unclear whether these companies knew that adding a new expensive drug accomplished nothing more than an established, cheaper, generic."I hope that the Therapeutic Goods Administration (TGA) in Australia is awake and takes early action on this information. The TGA website does list Vytorin as a "Drug of Current Interest".
The Pharmaceutical Benefits Advisory Committee (PBAC) needs to look at the listing of items containing exetimibe and restrict the benefit to patients already stabilised on this therapy - at least until the matter is clarified.
MY VERDICT
With behaviour like this it is no wonder that the general public is deeply suspicious of the pharmaceutical giants. There is a feeling that profits are more important than public health to these companies.
Lets not forget that it is only about three years since Merck Sharp & Dohme had to quickly withdraw it anti-inflammatory drug Vioxx (rofecoxib), because it was implicated in increasing heart attacks and strokes in long-term users.
If you are taking the ezetimibe either alone or in the ezetimibe /simvastatin called Vytorin, and you are concerned, please see your prescriber.
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