The recently published Cochrane Report caused outrage in both those countries that have augmentation therapy and those that aspire to have it. The report was written by Professor Peter Gøtzsche of Denmark and co-authored by his wife.
Their findings were, that based on two clinical trials, the effectiveness of augmentation therapy was not demonstrated. The two trials had small sample sizes and were flawed in a number of ways.
The American Alpha 1 foundation was quick to heavily criticise the report. Talecris joined the mounting criticism. In the UK Professor Stockley also pointed some of the flaws in the Cochrane analysis.
Members of the charity board were interviewed by EP Vantage (a publication which Evaluates Pharmaceuticals – mainly looking at the regulatory and financial aspects).
Apart from the apparent flaws in the report, we were concerned about the timing of the report and the fact that it seemed to be rushed to publication. The report came at an interesting time. Just days before its release the new entrant to the AAT market, Kamada’s Glassia, won US approval (Kamada wins US approval for new AAT therapy, July 9, 2010).
The Cochrane Reports are generally widely esteemed. The Cochrane Collaboration method is to look at a number of trials which in themselves have low statistical value and combine them in such a way that certain measures have statistical significance.
A reference to Cochrane is in the recent Goverment publication Government Response to the Health Select Committee on Commissioning. The full report can be downloaded here.
Paragraph 33 reads:
33. NICE has made specific efforts to identify opportunities for “disinvestment” from particular health technologies or interventions, both by encouraging topic suggestions and by actively trawling the research database held by the Cochrane Collaboration. This exercise revealed very little by way of current NHS practice that is simply ineffective. This should not obscure, however, the opportunities for more effective technologies and services. NICE can offer advice, but it will be for commissioners and providers of healthcare to lead in delivering those efficiency gains.
The meaning of disinvestment in this context is not explained. Nor is the necessity of putting the word in quotation marks.