Precision medicine – promotion is an ethical challenge

Precision medicine is the carefully chosen term for what has been called ‘personalised medicine’. It is more appropriate but it still hides a range of issues affecting cancer patients which the promoters are not keen to discuss. When my eye was caught by the headline Cancer Care is Rapidly Changing — Here’s How You Can Keep Up it was no surprise to find precision medicine over promoted as usual.

The story describes the launch this week of Precision Medicine for Me which claims to take a new slant on the subject. It is a collaboration of more than a dozen patient organizations, patient advocates, startups, and industry leaders with the admirable objective to inspire and help patients understand and navigate the potential of new tumor testing, and raise awareness of the latest treatments and trials.

They discuss the challenge of getting tumours tested for genetic mutations, the fact that few centres which treat cancer have the capability yet, and the fact that it is costly. They skate around the fact that drugs may not be available to treat mutations which have been identified, drugs which might work may not be approved or funded for certain cancers, and that clinical trials of unproven treatments may be the only route open to a patient. It is a US initiative and the collaborators have a cancer background. One patient is named who has benefited from the approach.

Precision medicine is an important development, however it has a long term view even though it may benefit a select (and growing) group of patients in the meantime. Precision Medicine for Me is focussed on lung cancer, five of the collaborators are lung cancer specific. It is a matter of great regret that their story failed to focus on that specific point and made a promise to all cancer patients which cannot be met.

To illustrate the issues it may be useful to recall that one specific sarcoma benefited from one of the very first ‘precision’ drugs. Imatinib for GIST was first studied back in 2000 and was the fastest drug to achieve a licence when it was approved in the US and Europe. The rise of secondary mutations resistant to imatinib, commonly after about two years, has been followed by further drugs to treat them, or some of them. We now have strategies designed to delay resistance to imatinib. Mutation analysis has identified more than 40 secondary mutations. We have many patients alive after well over a decade of treatment, and all that is truly welcome. We also have patients who have died because the secondary mutations they faced are untreatable. Hopes we might have had for rapid development of similar treatments for other sarcomas have been dashed long ago.

This is a tough reality.

The truth is that at present more cancer mutations are being found each year than there are drugs to treat them. The FDA in 2016 licensed treatments for 11 cancer indications – 2 were extensions of an existing licensed drug, 2 were for side-effects – a total of 7 new cancer therapies (by the way one was for sarcoma). EMA’s activity was similar. This is a recipe for frustration – science can find the mutations but drug development cannot deliver the treatments anywhere near fast enough.

So beware promoting precision medicine. The danger of raising expectations in people desperate for treatment makes it unjustifiable. The ethics of unbalanced promotion are questionable, the science should be discussed but even the vaguest promises should be avoided. Ideally only specific clinical situations should be reported. The GIST story should be remembered and if it is replicated in other tumours it should be openly talked about.