The Editorial Executive Committee of Australian Prescriber is concerned about the increasing difficulty of obtaining good information about new drugs. It is not unusual for a drug to be marketed in Australia despite a lack of published peer-reviewed information to support its manufacturer's claims. This is particularly the case for adverse effects and for 'head-to-head' comparisons with older drugs used to treat the same conditions as the new drug. The data (both published and unpublished) may have been evaluated by drug regulatory authorities so there is a strong argument that their evaluations should be available to health professionals and consumers.
A lot of prominence has recently been given to the need for 'transparency' in the drug regulatory system. For example, there have been calls for an international register of clinical trials so that unfavourable results are not hidden.12 Greater transparency in the process for subsidising drugs was also an important part of the free trade agreement between Australia and the USA. However, transparency means different things to different people.
The Australian pharmaceutical industry sees increased transparency as the right to scrutinise the deliberations of the Pharmaceutical Benefits Advisory Committee (PBAC). Currently, companies are informed why their drugs are not recommended for subsidy on the Pharmaceutical Benefits Scheme. Increased transparency will give them an opportunity to interact with and scrutinise the basis of the decision.
Disclosing information about the PBAC may improve understanding of its decisions, but the corollary the industry makes is that increased transparency is meaningless unless there is a process for challenging a decision. The call for increased transparency can then be confused with calls for an appeals mechanism.
There are two sides to transparency. Drug companies have been reluctant to make public the information they have submitted to the PBAC, despite the argument that the data for drugs submitted for public subsidy should be open to public scrutiny. The free trade agreement has however enabled the PBAC to release a public summary containing information about how it reaches its decisions. Time will tell how useful this will be to clinicians.
The industry may be concerned about transparency because its dealings with the PBAC include commercially sensitive information about cost-effectiveness. There therefore should be less concern about data which do not include cost information. The data submitted to the Therapeutic Goods Administration (TGA) to support the registration of a drug in Australia deal only with quality, safety and efficacy. This is important information for health professionals and patients, but it is often deemed to be commercial-in-confidence. The TGA does not release any details of its evaluations, unlike the Food and Drug Administration in the USA and the European Medicines Evaluation Agency. We would expect that similar standards of transparency would apply in Australia to help good prescribing. Instead, Australian health professionals and patients often have to rely solely on published information. As the formulations or use of drugs overseas may be different, we cannot always depend on international information.
The withdrawal of rofecoxib in 2004 is a salutary reminder of the difficulty of identifying the adverse effects of a new drug. It is also salutary that the decision to remove rofecoxib from the market was made by the manufacturer, not by the regulatory authorities. The manufacturer was in possession of important safety information that even the regulatory authorities, let alone the prescriber or the public, were not. There have even been suggestions that some companies have tried to limit the dissemination of data for commercial reasons.3
The Editorial Executive Committee supports the call of the International Committee of Medical Journal Editors for a register of clinical trials.1 The need for a register would be less urgent if the drug regulation process was as transparent as possible. Transparency should not be limited to industry's desire to scrutinise the PBAC. There is a far greater need for the clinical information supporting a new drug to be made public. To explore issues around access to information, National Prescribing Service is holding a seminar in September 2005.*
In future, when Australian Prescriber publishes its summary of a new product in the New Drugs section, it will inform readers whether or not the company involved was prepared to provide the journal with the clinical information which was evaluated by the TGA, but has not been made public (see article 'Two-way transparency'in this issue). Companies are gradually accepting the need for transparency and those that are willing to share their information should be recognised.
* Informing Judgements about Medicines. 7-8 September 2005, Sydney. http://www.nps.org.au/events
- Clinical trial registration [editorial]. A statement from the International Committee of Medical Journal Editors. Med J Aust 2004;181:293-4.
- Is this clinical trial fully registered? [editorial]. A statement from the International Committee of Medical Journal Editors. Med J Aust 2005;182:609-10.
- Dyer O. GlaxoSmithKline faces US lawsuit over concealment of trial results. Br Med J 2004;328:1395