Every drug should be labelled to tell you how well it works

WHEN buying overthe-counter drugs or being prescribed medication by your GP, what’s the one thing you want to know? The answer is obvious, of course: how well does it work? Yet, worryingly, current drug labelling fails to provide meaningful guidance on this simple point. There’s no requirement for pharmaceutical companies to offer any scale of benefit, in a manner that patients can understand.

Current labels do a poor job of telling us the degree of effectiveness of a treatment — it’s like buying a car and being told it does miles to the gallon, but without disclosing how many miles; or a food that states it provides calories, but not how many calories.

The failure to provide this information in an understandable format is disingenuous, if not dishonest, because knowing how well a drug might perform relative to an alternative — through clearly presented data — allows doctors and patients to decide whether it’s worth the cost (both financial, and personal, in terms of potential side-effects).

Adopting this approach is perfectly possible, and yet few medicines give clear, tangible guidance on how well they worked in clinical trials.

A good example of how useful labelling can be is sunscreen. Products carry information about their benefit in the form of a single number: the sun protection factor, or SPF. It’s not a perfect measure, but it provides a usable guide to how long sunscreen will protect you from the sun’s damaging ultraviolet rays, which are linked to skin cancer.

A consumer easily understands that SPF30 will give greater protection than SPF10. So why don’t we have better drug labelling?

Unfortunately it’s because, in my view, inadequate labelling which makes it difficult to compare one drug with another or with no treatment at all, benefits every party that profits from the sale of medicines.

This includes not only the drug manufacturer but all other parties in the distribution channel. The more drugs are used, the more money flows into the healthcare system.

The lack of clear labelling allows consumers to believe that products are more effective than they really are. The questions ‘will I benefit?’ and ‘how much will I benefit?’ are being wrongly conflated. They are not the same.

It’s true, there may be no guarantees in medicine, but there is data; and that data should be shared in a clear manner with patients.

There are some drugs that have large, reasonably predictable benefits, such as many antibiotics and vaccines.

But there are also categories of medicines, such as those used to treat Alzheimer’s and depression, where most drugs haven’t been shown to have more than minimal effects.

Drug labelling should clearly state the effectiveness demonstrated in trials, in a way that has real-world relevance, such as how a patient feels, functions or survives after taking it.

In 2018, colleagues and I reviewed all 31 drugs approved by the U.S. medicines regulator — the Food and Drug Administration (FDA) — that had received the coveted ‘Breakthrough Therapy’ designation (the term given to drugs offering ‘substantial’ benefit). Few deserved the name.

The low value of many new drugs often becomes clear by carefully reviewing FDA approval papers. But the documents can be hundreds of pages long and very few people (even experts in healthcare) have time to read them.

This year I identified ten published reports that examined the evidence supporting the value of thousands of newly approved drugs. These reports collectively concluded that most drugs — between about two-thirds and 98 per cent — had only modest (if any) benefit over existing treatments.

In other cases, supposedly ‘new drugs’ were merely tweaked or repackaged older drugs. Take, for example, the arthritis medicine Duexis. One wonders why any physician would prescribe it. The drug is simply a combination of the anti-inflammatory drug ibuprofen and the heartburn medicine famotidine, both cheap over-the-counter medicines.

According to GoodRx, an online drug price information service, the average price of Duexis is $1,002, yet the components can be bought for just $20 (around £15).

My passion for providing clear disclosure to patients derives not just from research, but from personal experience.

Take just one example. Long before I began investigating this subject, I injured my right foot in the 1990s while ballroom dancing.

Despite visits to numerous doctors, they concluded the pain was ‘metatarsalgia’ — which, more or less, means ‘pain in the ball of the foot’.

AFTER trying inexpensive generic options such as ibuprofen, I followed my doctor’s advice and tried a ‘miracle drug’ (his term) called celecoxib, a non-steroidal anti-inflammatory drug (NSAID) that had recently been approved.

It didn’t do anything for the pain and after three weeks, I gave up and pursued other options, including orthotics.

A decade later, as I wrote my dissertation at Harvard, addressing the regulation of pharmaceutical efficacy, I happened to investigate NSAIDs, including celecoxib.

I discovered that, despite what my doctor intimated, the manufacturer of celecoxib had made no claim that it was more effective than alternatives such as ibuprofen.

The manufacturer simply claimed that it was ‘better’, a nuanced distinction that I discovered meant only that it should be gentler on the stomach, i.e. ‘better’ meant reduced side-effects, not greater efficacy. I didn’t have stomach issues, so there was no reason for my doctor to prescribe it.

But taking it meant I wasted time and money, and suffered pain for longer than necessary. I also felt betrayed. I had trusted my doctor to apply his expertise, yet his services had provided me with no benefit I couldn’t have achieved myself by a trip to the supermarket.

Had I been able to see the benefits on some kind of scale, I’d have chosen another alternative from the start, or asked my physician right then what else he could recommend.

So how could drug labelling be improved? Regulators should adopt a similar approach to how food is labelled, with data presented in columns that show key information and allow for side-by-side comparison (for food, key information includes things such as calories).

For example, the labelling for sleeping pills could indicate the number of minutes it took those who had used them in clinical trials to fall asleep compared with a placebo.

This would enable patients to choose one drug over another — or even conclude that the level of benefit doesn’t warrant the cost, time, inconvenience or the side-effects.

The European Medicines Agency and other regulators have considered calls for labelling to present benefit information in understandable terms. But resistance to these proposals means patients often remain in the dark. They deserve more. It’s time for change.