Adcock still awaiting response from DoH on DPP issue

Louw reiterated that the group believed that this appeal process remained the most competent channel in resolving any arguments for, or against, the continued availability of products containing DPP and that an expedited process is in the best interests of all parties involved.

Last week, the court re-instated a notice by the Medicines Control Council (MCC) on 28 September 2011, withdrawing DPP-containing products from the market in South Africa.

In response, Adcock Ingram immediately suspended the sale of products containing DPP pending the outcome of the appeal process.

'Killer drugs' claims rejected

Louw said that critical to the group's request to expedite the appeal process was an understanding that no scientific evidence existed to substantiate potential risks surrounding the continued sale and use of these products.

"Adcock has rejected in the strongest possible terms any arguments that DPP-containing products are so called 'killer drugs' and fervently maintains that an accelerated MCC appeal process will correctly position the available scientific data in support of these objections.

"Adcock Ingram maintains that the study used by the MCC as the basis for its actions is not credible enough to substantiate its actions in respect of DPP-containing products as this study made use of a single non-representative sample of six patients.

"We replicated the study conducted by the FDA through an independent CRO, but with increased patient numbers, in order to fully outline the suspected risks with Synap Forte, the results of which did not detect any negative medical signals, and were comparable to placebo," Louw asserted.

'No evidence of cardiotoxicity in SA safety data'

He pointed out that DPP products remained in use in both the UK and Europe with tighter controls on scheduling and availability.

"In addition to this, the company has clinical and epidemiological data that supports the safety of its DPP-containing products.

"These products have been used safely for over 30 years, are still used in 39 countries and DPP use in South Africa represents less than 1% of global use by value, according to IMS.

It is important to note that DPP containing drugs tested overseas are not the same formulation as those used in South Africa.

"Critically, there is no evidence of cardiotoxicity in SA safety data," Louw stated.

"We place the health of patients at the centre of our business. At no stage would we ever compromise on this ethic," he added.