Experimental therapies: 50 shades of grey
Miracle cures for cancer are widely promoted on the internet: an exotic plant that is claimed to kill all cancer cells or a recipe to manipulate your own immune cells and erase cancer completely from your body. At the Anticancer Fund, we are confronted with this kind of misleading information every day. Cancer patients reach out to us with questions about pseudo-scientific products or services they’ve heard of and as we are open-minded and provide non-judgmental information, we dig into these to find more about the medical evidence, mostly hard to find. Until now, the so-called miracle cures that came to our attention remained unproven.
Things can go wrong
In an article entitled ‘Diffuse intrinsic pontine glioma: a clinic in Mexico, social media, and unpublishable data’ that appeared in the May issue of The Lancet Oncology (*), the Anticancer Fund exposes a clinic in Monterrey (Mexico) involved in a lucrative unproven cancer treatment. For years, the Institute of Interventional Oncology in Monterrey, also known as Clínica 0-19, offered a super selective intra-arterial chemotherapy to treat children diagnosed with a devastating brain tumour called DIPG (Diffuse Intrinsic Pontine Glioma). This is one of the deadliest forms of childhood cancer, with a long-term survival rate of less than 1%.
At the time of our research, a treatment cycle at the Mexican clinic costed between 20.000 and 30.000 US dollars and needed to be repeated every 4 weeks. Many parents from around the world brought their kids for treatment there, hoping for a miracle. Because the doctors of this clinic were not transparent about their treatment and their results, we could only rely on data posted online by parents, to form an opinion and to inform other parents and paediatric oncologists of the treatment in the clinic. Though we couldn’t formally publish the data as we didn’t want to infringe privacy and ethics principles – the signal we captured was important and the Lancet Oncology publication discloses our findings under the heading “Quackery”, two years after we revealed the problems.
One can argue that by definition these investigators are no quacks since they are licensed doctors providing a scientific rationale for their experimental intervention, but poor transparency, lack of official registration and unproven therapeutic claims are indicative for suspicious activities.
In the meantime the Mexican clinic became less attractive and is treating very few children from abroad with DIPG, so it seems. But we fear that after this clinic, parents of children with DIPG will be turning to another unproven treatment. It looks like these unregulated therapies come in waves and when the therapies don’t deliver what they promised, after a while, the hype fades out, making room for another one.
Ever heard of GcMAF?
This is not the first time that the Anticancer Fund warns the scientific community and patients about unregulated and unproven medicines sometimes provided by licensed doctors. Already in 2014, we informed the editors of the 'Cancer Immunology, Immunotherapy' journal about inconsistencies and questionable reliability of publications on another self-declared miracle cure called GcMAF. (**)
Since we reported issues with GcMAF, a protein that has never been proven as an effective cancer treatment, others have confirmed the scientific fraud. The money-driven business eventually got uncovered, resulting in jail sentences in the UK (2018) and France (2021) for the main protagonist.
More to come?
We may now be confronted with another example of large scale deliberate misinformation, this time regarding dendritic cell therapy offered by a company, named Immucura, located in Spain. Through its website and social media it’s soliciting cancer patients for treatment in private clinics in Spain and Germany.
Immucura describes its cell based immunotherapy as ‘the last hope for many cancer patients’, but what is this about? On its website, the clinic mentions the cultivation of monocytes (blood cells) into immune managing cells (dendritic cells) and how to teach them to fight cancer with cancer antigens. This type of medicinal product is called an ATMP (advanced therapy medicinal product) and should comply with the European ATMP regulation. The specific dendritic cells therapy of Immucura is unregulated. This was confirmed to us by the Spanish competent authorities. Moreover, the specific therapy seems unproven as we didn’t find any evidence coming from Immucura in the published literature. When we requested the company to provide their own publications or study results, it ignored our questions.
This therapy became a topic of interest recently in Belgium through Goedele Liekens, a public figure, politician and a cancer patient promoting the treatment in the media. As a response, Professor Bart Neyns (Free University of Brussels), who has been conducting research on dendritic cells for years, highlighted the danger of treating patients in a non-controlled environment in the newspaper: “Removing cells, treating them in a lab and reinserting them: all kinds of things can go wrong. If the quality of those dendritic cells is insufficient, they can even signal the body not to reject cancer cells, but on the contrary accept them.“
Although cell therapy is a promising and exciting field, these complex therapies still need to be studied more in depth before they can be administered to a larger population. Patients should not pay for experimental treatments but should be included in clinical studies, where therapy is free of charge. Moreover these studies should be approved by an ethics committee and be listed in a publicly accessible clinical trial databases, ensuring patients’ rights and safety are guaranteed.
When, exceptionally an experimental therapy is provided against payment, it should be in a regulated way following national legislation. Clinics offering non approved treatments for payment in a non-regulated way are likely to be solely driven by monetary return and are not acting in the patient’s best interest.
The grey zone
Medical quackery is clearly an issue that is lingering in a grey zone. Most oncologists will do anything within their power to help their patients. Doing so, they will never expose their patients to unacceptable risks or deprive them from standard care. If they use experimental treatments, they will try to do this in a controlled way, by including them in a clinical trial or in some cases within an hospital exemption regulated by the national authorities. We therefore always urge patients to reach out to their own oncologist and to present the information in order to discuss their treatment options.
There might be physicians that are tempted to use occasionally an experimental treatment outside the clinical trial setting, because they are faced to a situation where there just are no more other valuable treatment options to offer to their patient. Doctors, however, who contribute to organised clinics that offer expensive investigational treatments, charged to the patients, in a non-controlled setting, only motivated by an economic benefit, are a blame for the medical profession.
There’s no miracle cure
The introduction of new therapies has always been an important contributor to advances in cancer care. Therefore, new experimental therapies have to be studied in clinical studies, but even the most promising of these treatments can fail during this process. There are no miracle cures for cancer and only evidence can eventually reveal the true potential of a treatment. Nevertheless, for many patients, the participation in a clinical trial is a good option. Those patients should be offered the opportunity to consider participation in clinical trials whenever possible. However they should be conducted under solid ethical guidance, in a licensed hospital, approved by an ethical committee and with the informed consent of the patient. This means that the patient should clearly understand the risk-benefit of participating in a trial.
How to inform people about experimental treatments ranging from quackery over unregulated and/or unproven therapies to proper clinical trials? Since the answer is seldom black or white, the Anticancer Fund is convinced that providing patients with personalised, independent, evidence-based information is of crucial importance. We do so with our free personal service, My Cancer Navigator. Based on our knowledge resulting from our research activities in clinical trials, we can offer patients reliable information on cancer therapies.
At the Anticancer Fund, we will do everything we can to fight pseudo-science. We are not detectives and we don’t search the internet to find unproven health schemes, but if we are alerted through questions we receive at My Cancer Navigator from cancer patients and we are triggered about suspicious treatments, we will use our resources to dig somewhat deeper.
This was the case for GcMAF, the clinic in Monterrey (Mexico) and now the cell therapy of Immucura. When we identify a questionable practice, we believe it is our moral duty to inform cancer patients at large. That’s why we will keep publishing our findings on false-proclaimed medicines and cures.
(*) Discover the full article in The Lancet Oncology, "Diffuse intrinsic pontine glioma: a clinic in Mexico, social media, and unpublished data", here.
More about DIPG and the clinic in Monterrey, in Dutch: here and here.
(**) Read more on our reporting of GcMAF: