Accurate, balanced evidence-based information about medicines
New medicines — are they always better? New medicines — are they always better?
The Australian Government approves many new prescription medicines each year. It is easy to presume that each new medicine is better than the existing one, but that is not always true. There are three points to think about:
- the government approval process
- the individual response to medicines
- the knowledge gained aftera medicine is approved.
Government approves safety
The government approves prescription medicines through two stages.The Therapeutic Goods Administration approves a medicine if the manufacturer shows it to be safe and effective. It can then be sold in Australia. Visit www.tga.gov.au for more information.
A medicine is approved for government subsidy under the Pharmaceutical Benefits Scheme (PBS) if it is shown to be at least as effective as existing medicines at an acceptable price. Visit www.pbs.gov.au for more information.
A new prescription medicine does not have to be more effective. It has to be safe, and it has to be at least as effective as existing medicines at an acceptable price.
Individual responses differ
Everybody responds differently to medicines. A medicine that improves one person’s health might do little for someone else. A medicine that causes serious problems for one person might cause no problems for someone else.
Research using clinical trials shows what happens if a large group of people take a medicine. For example, the research might show that most people will feel better, or that some will have a minor adverse effect or a serious adverse effect. The research can not show what will happen to each individual person.
Knowledge gained after approval
When a new medicine is approved, it has been through a number of clinical trials involving thousands of people. By the time these trials are finished, it is clear what the main potential benefits and harms of the medicine are. If the harms are too serious, the medicine will not be approved.
Often, once a medicine has been taken for a few years by people who are not taking part in clinical trials, more is learnt. That could mean more benefits or it could mean more harms are identified.
For example, the medicine rofecoxib (brand name Vioxx) came on to the market in 1999 as a treatment for pain in arthritis. At first, it seemed that it was similar to other arthritis medicines used for pain relief, but with a lower chance of causing stomach ulcers and stomach bleeding. However, after five years, it became apparent that rofecoxib increased the risk of heart attack and stroke for some people taking it, and it was withdrawn from sale.
So while a new medicine has been passed as safe, not everything is known about it. It may cause problems that nobody could have anticipated.
What does this mean for me?
You should think about new medicines before automatically assuming they are better. Many new medicines are described as ‘breakthroughs’, but few are. Most add to the range of medicines, but do not drastically change the way health problems are treated.
If you are taking a medicine and it does not agree with you, or you think you should be feeling better than you are, or it is just not giving you the result you were looking for, talk to your doctor or pharmacist. You could talk about adjusting your medicine or trying a different medicine. Keep in mind that all medicines have side effects as well as benefits. If you wish, you could ask what the research on the different medicines show. If you are taking a medicine that does agree with you, your health is good and the medicine gives you the result you were after, then you should think carefully before changing to something different.
For more information
Contact the Medicines Line on 1300 888 763, or the National Prescribing Service at www.nps.org.au, or the Consumers’ Health Forum of Australia at www.chf.org.au.
NPS is an independent,
non-profit organisation for the quality
use of medicines funded by the Australian Government Department of
Health and Ageing. |
