THE CASE
The Australian newspaper published an excellent article by the chairman of the Consumers Health Forum of Australia (CHF), Mitch Messer, on 01/03/2008.
As I have written before the two rules of medication are:
1. Medicines should do no harm, or at the very least the benefits should outweigh the risks.
2. Medicines should be proven to be effective in treating the conditions they purport to treat.
The article clearly explains the difference between listed and regulated products.
"The main difference in the regulatory process is that the TGA evaluates data from clinical trials to determine whether or not a registered medicine has the effects that are claimed for it. Listed products, on the other hand, are simply assessed for quality and safety. While companies are supposed to be able to provide TGA with data supporting the claims made for these products, TGA does not routinely request and assess this data."
In other words registered medicines must comply with both of the above rules, while listed medicines must only comply with "rule 1". There is some sort of weak provision for the sponsors of listed medicines to indicate that they hold evidence of effectiveness, but this is largely ignored and unenforced.
In an ideal world sponsors of new medicines should have to answer to a third rule:
3. New medicines must have demonstrable advantages over medicines already on the market.
One reason for this rule is to prevent drug companies rushing "me-too" products on to the market, that subsequently prove to have disadvantages over existing products. MSD did this when they rushed the Australian marketing of Vioxx (rofecoxib) to combat the already marketed Celebrex (celecoxib). Unfortunately Vioxx was quickly shown to increase the risk of heart attack among patients using it for more than eighteen months. This may have been known even before Vioxx was marketed in Australia.
Another example is the waste of resources by each major pharmaceutical company producing a lipid-lowering "statin" (more correctly but less conveniently called HMG-CoA reductase inhibitors). These different drugs are just variations on a theme:
- Atorvastatin
- Fluvastatin
- Pravastatin
- Rosuvastatin
- Simvastatin
are all currently available in Australia, and there is more difference in the packaging than there is in the therapeutic effect (despite what the drug reps. are programmed to tell doctors). Several other "statins" have already come and gone.
MY VERDICT
The chance of "rule 3" happening in Australia is unfortunately remote. The lobby group Medicines Australia will make sure of that.
The chances that listed medicines will be forced to comply with "rule 2" are slightly brighter.
2 comments:
Although I can symphatize with someone wanting to find out more facts about medical information and so forth, I actually laughed quite well reading this blog. "My verdic" is posted on end of every topic, as if this person has all human knowledge and his verdic has a superior value above the rest of humanity! LOL!
Its a bit egotistic, frankly.
Anonymous you are right, I am opinionated, egotistical and I do appear to have a superiority complex. ...But hey that's what blogs are about.
You are attacking the messenger and not the message, and I do say "My Verdict" not "The Verdict".
If I were to attack the messenger in your case I would point out that "verdict" has a "t", the spelling is "sympathise" or "sympathize" not "symphatize". I would also question why you post anonymously, don't you believe in your ideas?
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