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The Pulse

New drugs ... dunno, mate

by Peter Lavelle

Just because a drug is new doesn't mean it's more effective, or safer, than older drugs used to treat the same condition.

Published 26/07/2007

New drugs 300 x150iStockphoto

Have you ever heard your doctor tell you: 'There's a new drug that's just come on the market. Let's try that!'

There's a tendency to assume that because it's the latest medicine to hit the market, it's better than older drugs. After all, the newer the drug, the more advanced the science that led to its development, surely?

Not necessarily. In fact, older drugs may be just as good or better – and possibly safer – argues Dr Ike Iheanacho, editor of the journal Drug and Therapeutics Bulletin, in an article in the latest British Medical Journal .

Yes, new drugs do go through clinical trials, initially on animals, then on groups of humans to test whether they're effective and safe.

Regulatory authorities like the Food and Drug Administration (FDA) in the US, and the Therapeutic Goods Administration (TGA) in Australia use this information to decide whether to license it.

But he says, all too often, there isn't enough good information supplied by the manufacturer, and the drug turns out be unsafe and no better than older drugs used to treat the same condition.

The drug may not be tested on enough people – the numbers of people in the trials is usually small – a few thousand at most. To pick up an uncommon, but potentially serious, side effect – say one that occurs in one person in 10,000 – it needs to be tested on at least 30,000 people. Often a serious side effect isn't seen until after it's on the market, after large numbers of the general population take it over a long period of time.

Or the evidence that it works may not be all that good. The drug may not be compared in trials to other, older drugs. It often turns out, in later studies done when the drug is actually on the market, that it's no better than the older, cheaper, generic (out-of-patent) forms. Several recent studies have shown that older hypertensive drugs, for example, are just as good as many of the new antihypertensives drugs, and cheaper. Older drugs also have the advantage that they've been on the market longer, and more is known about their side effects.

Role of the regulators

Compounding matters is the role of industry regulators, who take a 'she'll be right' attitude to the licensing of new drugs, according to Iheanacho. The regulators look at the trial results provided and funded by drug companies and 'rubber stamp' the approval process, he argues.

He says the links between regulators and industry is too close. The most extreme example of this is the FDA in the US, which is actually funded by the pharmaceutical industry (to be fair to the FDA, the situation comes about because US government funding was small, and it took too long to get important new drugs (like HIV/AIDS drugs) on the market while people were dying of HIV/AIDS. Industry funding was seen as a way around the problem). In Australia, the TGA is also funded by the pharmaceutical industry.

But the closeness of the relationships means that regulators aren't asking enough questions about the drug company data.

In 1999, both the FDA and TGA, for example, approved the anti-arthritis drug Vioxx, since shown to cause heart attacks and stroke, on the basis of drug company data, even though the company knew there were problems with the drug from the beginning.

Identifying side effects

There are mechanisms for gathering and reporting information about side effects of new drugs. In Australia, doctors, pharmacists, and patients are encouraged to report side effects to the Adverse Drug Reactions Advisory Committee, which is administered by the TGA.

If side effects do emerge, the Committee can alert doctors and pharmacists about side effects via a regular bulletin, and force drug companies to provide information about those side effects in promotional material to doctors, pharmacists and patients.

In serious cases it can order the drug off the market. Or the drug company will do this themselves (usually to limit the damage) and fight personal injury claims in the courts from people who say they've been injured, as is happening in the US, Australia and elsewhere with people who've taken Vioxx.

Drug companies aren't necessarily being wilfully negligent. They want and need a new drug to be effective and reasonably free of side effects. But they also need to keep development and clinical testing costs down, and get the drug to market as soon as possible. The problem for drug companies is that it costs billions of dollars to bring a new drug to market, and the company has a short time frame – about ten years – to recoup the cost before the patent runs out and other drug companies can manufacture it as a generic drug.

So they have to market it aggressively as effective and safe, until the facts prove otherwise. Some doctors may be swayed and prescribe it, argues Dr Iheanacho.

So what does this mean for consumers? Should you avoid new drugs altogether?

Not necessarily. All drugs start out new. The possible benefit of a drug over other drugs may outweigh the risk of side effects even if it is new. Side effects can be treated.

But new isn't necessarily better. So if your doctor says: 'Here's a new drug, let's try this', you should ask:

  • What is the claimed benefit – is there good scientific evidence that it really better than the older drug? Has it been tested in independent studies reported in journals?
  • Has it been accepted by the medical profession (by specialists and hospitals) as useful and safe?
  • Is there a generic version that is cheaper?

If the answer is: 'Dunno, mate, but the drug company reps were very keen on it' then you might want to do some independent research on the drug yourself.

There's plenty of information available to consumers about side effects and effectiveness of particular drugs. Follow the links at the end of this story.

The National Prescribing Service, for example, has an information hotline on 1300 888 763 (local call cost except for mobile phones).

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