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New drugs: transparency

(Aust Prescr 2007;30:26-7)

Access to information about drugs is essential for the quality use of medicines. Since 2003 Australian Prescriber has therefore recorded details about the willingness of pharmaceutical companies to disclose the information that supported the Australian approval of their new products.1 These details are published as the T(ransparency)-score at the end of each new drug comment in Australian Prescriber.

Table 1 shows the responses to requests for evaluation data between August 2005 and December 2006. The Editorial Executive Committee of Australian Prescriber is pleased to report that there has been an improvement since the previous report was published.1 Most manufacturers now provide some information to assist in the preparation of the new drug comments. The Editorial Executive Committee hopes this trend to increased transparency continues.

Reference

1. Two-way transparency. Aust Prescr 2005;28:103.

Table1 Pharmaceutical company responses to requests for clinical evaluation data Company Drug Manufacturer provided all requested information AstraZeneca rosuvastatin Ferring quinagolide Pfizer eplerenone Pfizer sunitinib malate Roche bevacizumab Roche erlotinib Roche epoetin beta Wyeth tigecycline   Manufacturer provided some data Alcon anecortave acetate Arrow Pharmaceuticals butoconazole nitrate Arrow Pharmaceuticals solifenacin succinate Bayer sorafenib tosylate Bristol-Myers Squibb entecavir CSL rabies vaccine EpiPharm tazarotene Epitan eflornithine hydrochloride GlaxoSmithKline rotavirus vaccine Merck Sharp & Dohme rotavirus vaccine Merck Sharp & Dohme human papillomavirus vaccine Novartis deferasirox Orphan lanthanum carbonate hydrate Schering-Plough posaconazole Servier strontium ranelate Company Drug Manufacturer had no objection to providing data but did not actually provide it Novartis lumiracoxib   Manufacturer declined to supply data Amgen palifermin Genzyme sevelamer hydrochloride Novo Nordisk insulin detemir Schering disodium gadoxetate   Manufacturer did not respond to request Alphapharm cetuximab Altana Pharma ciclesonide Janssen-Cilag bortezomib Novartis darifenacin hydrobromide Schering alemtuzumab Solvay moxonidine

Fine-tuning the T-score in 2007

Manufacturers who provide all the information Australian Prescriber requests when assessing a new drug receive the highest score . Some companies only provide the approved product information. Although this is helpful, the product information is a public document so does not represent greater transparency. In these cases the T-score from now on will be . Manufacturers who say they have no objection to providing information, but then do not deliver it, will be considered to have declined to supply data . The revised T-scores are as follows:

manufacturer provided clinical evaluation

manufacturer provided additional useful information

manufacturer provided only the product information

manufacturer declined to supply data

manufacturer did not respond to request for data

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