While the USA represents the single biggest customer for the pharmaceutical industry, Europe has long been the nerve centre for R&D of the global industry, with Swiss (Novartis, Roche), French (Sanofi), UK (GlaxoSmithKline, AstraZeneca) and German (Bayer, Boehringer Ingelheim, Merck) companies dominating.
Cancer drugs have a greater share of the global market than any other drug category. Of these, chemotherapy drugs contribute more to sales than any other category. What’s more, there’s been a greater-than-predicted surge in more targeted drugs that are promoted as being more effective than the older, versions they replace.
Assuming these new drugs work, can be afforded (they are very expensive) and don’t cause more harm than good, all is well. But that’s where the fairy story falls apart, as revealed in a study by a research team headed by King’s College London scientist Dr Courtney Davis and published in the British Medical Journal on 5 October (2017).
The big take home from this study was that the majority of new cancer drugs being licensed by the European drugs regulator, the European Medicines Agency (EMA), have not been demonstrated to work. That’s when important things like cancer survival rates over 5 years and quality of life improvements are evaluated.
This discovery, in essence, drives a coach and horses through the entire edifice of drug regulation that we’re told repeatedly exists to ensure that licensed drugs are proven effective. Not so, it seems, and this issue isn’t just confined to cancer drugs. Just 11% of treatments (mostly involving drugs) have been proven effective across some 3000 treatments examined by BMJ Clinical Evidence journal.
The media reported on October’s BMJ cancer drug study, but offered little in the way of opinion, certainly none that might cause people to rethink whether or not to try the latest cancer drug on offer. The only analysis that does the BMJ study justice, in our view, is one published recently by ANH friend and British medical journalist Jerome Burne.
He makes the case (abbreviated version below), that creating a truly sustainable healthcare system, will involve rethinking the way treatments are regulated and licensed ,a process that should involve non-pharmaceutical once as well. That’s something we’re considering in our own work that includes the development of criteria for more sustainable healthcare systems.
“It is remarkable that so few cancer drugs enter the European market without any clear data on outcomes that matter to patients and their doctors: longer survival and better quality of life.” So goes the commentary by Huseyin Naci, Assistant Professor in the London School of Economic’s Department of Health Policy, co-author of the BMJ study.
These are the same medicines routinely marketed as ‘breakthrough drugs, yet the commentary describes them as giving the ‘false hope’ that they will work better than the older drugs they replace.
Ironically, giving ‘false hope’ is one of the most common charges laid against natural and non-drug ways of supporting cancer patients – yet the the recent BMJ study found that, of the 68 cancer drugs approved by the European Medicines Agency (EMA) between 2009 and 2013, 57% were released onto the market without any clear evidence that they improved the quality or length of patients’ lives. The majority of them had been approved on ‘surrogate endpoints’, such as the cancerous tumour shrinking, which, the researchers made very clear, does not reliably predict you are going to live any longer.
Will better targeting of genes cure cancer?
It's a shameful finding, which should prompt patients and doctors alike to be sceptical of the latest ‘breakthrough’ drugs being rushed through the licensing process. Perhaps it may even lead to more serious attempts to test non-drug therapies such as the simple and non-invasive ketogenic diet.
The revelation comes at a time when cancer professionals are claiming that the long-promised transformation of cancer treatment by genetics is yet again just around the bend. However, there are serious reasons for believing that the limitations of the genetic approach mean that new, rushed gene targeting drugs are not going to effectively tackle cancer on their own. And if our current licencing system continues to allow a stream of useless drugs into the clinic, they won’t provide a cure however precisely they are targeted.
Not an isolated issue
The BMJ’s findings only relate to the European regulatory system , however this is far from being a Europe-only issue. A 2015 report in the Journal of the American Medical Association (JAMA) revealed that the American drug regulator - the FDA – was approving new cancer drugs on the basis of surrogate end points just as the EU was 2 years later. The authors concluded: "most cancer drug approvals have not been shown to, or do not, improve clinically relevant end points."
Between 2008 and 2012, 38 cancer drugs were licensed, 67% on this basis. A check on survival rates four years later found that five of the drugs had improved life expectancy - but 18 had not. A deal with American companies whose drugs were nodded through relied on such efficacy trials being undertaken yet, four years later, a third of said companies had made zero effort towards running such tests.
It is clear that the interests of the supposedly most important people in this whole sorry saga – the patients – seem to have been totally ignored.
What does the future hold?
Everything points to the fact that we have a broken regulatory system. As the researchers of the BMJ so aptly stated, “when expensive drugs that lack clinically meaningful benefits are approved and reimbursed within publicly funded healthcare systems, individual patients may be harmed, important resources wasted, and the delivery of equitable and affordable care is undermined.”
With plans such as the 100,000 Genomes Project’s blindly optimistic reliance on the honour of companies running reliable clinical trials and follow-ups of new cancer drugs, it is hard not to see how the aforementioned ‘false hope’ is similarly embedded in the vision of gene-targeted treatments. To recognise that this current system is far from working is at least the first step in making treatment both safer and more effective for patients suffering from cancer. The idea that all orthodox drugs are scientifically based is a myth – and so is the idea that nothing other than gene-targeted drugs can ever be of use in treating cancer patients.