Adcock Ingram sold the popular painkillers Synap Forte‚ Lentogesic and Doxyfene until the end of 2011. At their peak these products were generating about R220m a year for the company and contributing between 18% and 20% of its profits‚ according to group medical executive Abofele Khoele.
The decision by the Medicines Control Council (MCC) to halt the sale of painkillers containing DPP in SA is one of the factors contributing to Adcock Ingram's poor financial performance which has made it the target of a hostile takeover bid by Bidvest.
Earlier this month the Administrative Appeals Tribunal of the Australian Therapeutic Goods Association decided that Aspen's painkillers containing DPP could continue to be prescribed. The fact that Aspen had used data from a clinical trial conducted by Adcock Ingram‚ which found no evidence that DPP products caused irregular heart rhythms‚ could strengthen Adcock Ingram's hand in its appeal against the MCC's decision‚ said Khoele.
Health Minister Aaron Motsoaledi appointed a committee last year to hear an appeal lodged by Adcock Ingram against the MCC's decision‚ but a date has yet to be set for a hearing.
Aspen Pharmacare's head of strategic trade Stavros Nicolaou declined to comment‚ saying colleagues in Australia were in a better position to do so. No Australian representatives were available.
MCC registrar Mandisa Hela said she could not comment as the DPP matter was subject to an appeal process.
Painkillers containing DPP have been taken off the market in the US and most European countries over a variety of safety concerns: they were withdrawn in the US in November 2010 following research that showed they raised the risk of irregular heart rhythms‚ which in turn raise the risk of heart attacks. The European Medicines Agency recommended the gradual withdrawal of these products in 2009‚ and the UK's Medicines and Health Regulatory Agency stopped sales several years before over concerns about the risks of accidental fatal overdoses.
Khoele said the US study used by the Federal Drug Administration as the basis of its decision to restrict the use of DPP to a "named patient basis" had used much higher doses than were prescribed in SA‚ and its conclusions were therefore questionable.
After the MCC's decision on DPP-containing painkillers‚ Adcock Ingram conducted its own clinical trial assessing the safety of these products in India. The trial concluded in October 2011‚ and while its conclusions were publicised by Adcock Ingram‚ it has yet to make the full data publicly available. Khoele said Adcock Ingram had submitted the material to two peer review journals in March 2012‚ but no articles had yet been published. The full data had been provided to the MCC‚ he said.
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