When buying over-the-counter drugs or being prescribed medication by your GP, what’s the one thing you want to know?

It is easy to see the obvious answer: How well does it actually work. Sadly, the current system of drug labeling fails to give meaningful guidance. 

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.

When buying over-the-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?

When buying over-the-counter drugs or being prescribed medication by your GP, what’s the one thing you want to know? It’s obvious: How well does it work.

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).

It is possible to adopt this approach, even though few medications provide any clear guidance as to how effective they were in clinical trials.

The sunscreen example is an excellent example of how helpful labelling can prove to be. The sun protection factor (or SPF) is a number that identifies the product’s benefit. 

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.

SPF30 provides greater protection than SPF10. This is easily understood by consumers. 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.

The distribution channels include all the parties that are involved with the manufacture of drugs. More drugs mean more money for the healthcare system.

Lack of clarity in labelling can lead consumers to think that certain products are more efficient than they actually are. The questions ‘will I benefit?’ and ‘how much will I benefit?’ are being wrongly conflated. These are two different things.

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.

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

The sunscreen example is an excellent example of how helpful labelling can prove to be. The sun protection factor or SPF is the single number that identifies the product’s benefit.

Certain drugs, like many vaccines or antibiotics, have significant, predictable benefits.

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.

The effectiveness of a drug label should be clearly stated in clinical trials. It must also reflect real-world implications such as the way a patient feels or functions after they take 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). The name was not given to many.

Reviewing FDA approval documents can often reveal the low quality of new drugs. The documents can run to hundreds of pages and few, even experts in the field of healthcare, have the time or patience to go through them.

Ten reports I reviewed this year examined evidence that supported the benefits of thousands upon thousands of recently 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. For example, Duexis, an arthritis medication. You might wonder why any physician would ever prescribe this medication. This drug is simply a combination between the over-the counter anti-inflammatory drugs ibuprofen (and the heartburn medication famotidine), both of which can be purchased cheaply.

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).

Not only is my passion research-based, but also personal experience.

Let’s take just one instance. This is the first example. I was ballroom dancing in 1990s when I hurt my right foot.

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, while I was writing my Harvard doctoral dissertation on pharmaceutical efficacy regulation, I discovered that I was interested in NSAIDs (including celecoxib) and began to research them.

My doctor did not tell me that celecoxib was any more effective than other options like 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.

However, I was wasting my time and money and was enduring more pain than needed. Also, I felt like a victim. 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.

How can drug labelling be improved, then? Similar approaches should be used by regulatory agencies to label food. The data presented in columns must show the key information, and permit side-by sides comparisons (for food, this includes calories).

The labelling of sleeping pills, for example, could show how long it took to get people who used them in clinical trials and fall asleep.

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.

European Medicines Agency (or other regulatory bodies) have looked into the possibility of labelling benefits information to make it more understandable. Patients are often left in the dark because of their resistance to such proposals. They are entitled to more. It’s time for change.

Angela Epstein Interview