TV ads often tell you why one brand is better than the others. Whether it is cheaper, better looking, longer-lasting or simply more effective. Even adverts for painkillers and other OTC drugs will talk about how they compare with other treatments – albeit usually stopping short at naming names. Clearly people respond well to comparisons like this.
Why then isn’t the same true of branded medicines?
You could be forgiven for thinking that modern clinical trials are all about safety. Certainly, GCP guidelines make it clear that patient safety is priority number one but of course, effectiveness of the test drug is vitally important too. However, those unfamiliar with the sector would be surprised to learn that trials very rarely compare new “brands” with popular competitors.
Of course, all trials need a control group, but this is normally in the form of a placebo or previous generation treatment administered via a double blind rather than any product the new drug may be directly competing against. Comparative trials of new and existing treatments are relatively rare.
In most countries, the legislation underpinning clinical trials is very clear. One of the key aims is to prove that the new drug does what it is supposed to do, whilst minimising unwanted effects – a risk:benefit calculation. Whether or not the drug does the job better than the competition rarely enters into it.
Of course, where the condition being treated requires regular treatment, it would be inhuman to randomly withdraw it from those who drew the short straw and were given the placebo! As a result trials examining efficacy of diabetes and cancer treatments, for instance, tend to be comparative. To an extent.
However, even these trials often fail to examine the most effective competition. According to an article in the New England Journal of Medicine last month, the cost of buying alternative treatments is an important barrier to research – especially in oncology trials. In a sector where the average cost of a year’s course of treatment exceeds $100,000 it is easy to see why researchers just don’t have the funds.
The article lists five different tumour types where the authors consider comparative trials would be useful. However, they calculate that the drugs require for the trials would cost up to $68 million!
Unless regulators were to force companies to provide drugs for comparative studies at cost (or at least a very heavy discount), it’s hard to see research like this ever happening.
Comparative trials could certainly help cash-strapped healthcare providers by arming them for the first time with information they need to be really wise shoppers. However, research costs aside, I can imagine them opening several rather nasty cans of worms, and possibly leading to an escalation in trials purely to refute another company’s claims about a best-selling drug.
If the aim of drug development is to carry out only those trials that are necessary to develop new, safe and innovative treatments, maybe this isn’t such a good idea…
|
|
 |
|
|
Share on LinkedIn |
Share via Email |
