Challenging “Flintstone facts”: Why healthcare should follow the science, not gut feelings

Basic scientific ideas can be quite counter-intuitive. The earth doesn’t “seem” round and it doesn’t “look” as though it orbits round the sun. And it’s weird to think that we are further away from the sun in summer (in the northern hemisphere).

To quote developmental psychologist Andrew Shtulman: “Humans are born to create theories about the world; unfortunately, we're usually wrong and bad theories keep us from understanding science.”

Sometimes this can be just plain funny. According to a YouGov survey , 41% of those polled were prepared to believe that people and dinosaurs co-existed at the same time. (Blame the Flintstones!)

My personal favorite is the comment on the NASA Facebook page, underneath a marvelous photo of a sunset viewed from Mars: “I didn’t know Mars had a sun!”

Joking aside...

But there’s a serious side to all this, particularly when it comes to healthcare and patient well-being.

I’m particularly concerned by the resilient myth that biosimilar medicines, which introduce competition in the field of critical biologic therapies, are fundamentally “different” to their reference medicines.

Of course, the name doesn’t help; calling them “biosimilars” already implies that there is something different, that they are somehow “not quite the real McCoy”.

The point is not that we should try to change the name, it is simply that we should be aware of the potential confusion.

But this misunderstanding is actively encouraged by a minority with a strong interest in keeping it alive and well – and a good understanding of how to make their arguments sound like sound science.

Surprise, surprise...

I touched in an earlier article on what one peer-reviewed paper calls the “double standards” applied to biosimilars and their reference medicines.

Manufacturing process changes for reference medicines are regularly approved without additional clinical trials, and even different batches of reference biologics can show measurable differences to each other.

However, it is a regulatory requirement for biosimilars to produce extensive data sets, although the same scientific concept (comparability) underlies both processes – and although this approach can unduly limit patient access without any positive impact on quality, safety or efficacy.

And even some healthcare professionals are still cautious about the relatively new practice of inter-biosimilar switching (switching patients between approved biosimilars of the same medicine).

So I’m delighted to report that three Sandoz scientists, working closely with several well-respected external experts, have just published the first systematic review of such switching studies.

And guess what, the findings support the science, indicating no reduction in effectiveness or increase in adverse events in any of the studies conducted to date. No surprise then, but some much-needed clarity.

Follow the science

Health authorities tend to be cautious before changing regulations, so I’m sure that more data will be required before biosimilar-to-biosimilar switching becomes a routine and accepted practice – regardless of whether it is really needed. But I’m equally sure that it’s just a matter of time.

When this does happen, by the way, it will mean more – not less – competition for companies like the one I work for.

But I have two guiding principles regarding the future of biosimilars, not to mention healthcare in general.

The first is that we should always follow the science, as a matter of principle.

The second is that competition, provided it is both fair and fairly regulated, is always a good thing, because it leads ultimately to improved quality, increased patient access and better patient outcomes.

It’s up to individual companies to find their source of long-term competitive advantage – and, at least in healthcare, trusting in basic science is never a bad place to start.