This question I have asked myself for over 10 years as we try to provide an immunotherapy treatment against glioblastoma.
In 2005, my team and I, proved that immunotherapy is active against cancer in an animal model (rats). At that time, the best scientists in Belgium, France and the USA were very sceptical, not that they disputed the data, but that they seemed unable to admit the evidence of effectiveness. I was told that I was wasting my time
Most terrifying is that these people (scientific) have said that it was totally conservative and must strictly follow evidence-based medicine. They say, the majority of them, that they are progressive and not conservative and that they are open-minded but for a new evidence, they are totally opposed.
How to explain, in the context of relapsing glioblastoma, with a survival prognosis of a few months, that an (academic) Ethics Committee refuses a clinical trial project studying the vaccine, arguing it is not clear why the vaccine would work? whereas the animal model was demonstrative and encouraging and this situation is, in the opinion of all, a therapeutic impasse. These investigators touted themselves as the most progressive in the field, yet they embraced the safety of the status quo. Human results in clinical trials and compassionate use over the last 10 years using our immunotherapeutic glioblastoma vaccine have extended the lives of many patients who otherwise would have succumbed much earlier to glioblastoma. Immunotherapy in general is now regarded as offering the best hope to combat other cancers. There are many new immunotherapeutic drugs on the market including Keytruda and Opdivo that have improved the lives of countless victims of cancer. The "progressive" experts who had claimed immunotherapy was a dead end have been proven wrong.
Several potential treatments for COVID-19 (the disease caused by the SARS-COV-2 coronavirus) have emerged over the past few months. These include hydroxychloroquine (Plaquenil), Azithromycin (Zithromax), certain anti-hypertensive drugs (ACE inhibitors and ARBs), and the use of convalescent serum. The current SARS-COV-2 pandemic has unfortunately demonstrated that the world’s scientific "experts" have not learned their lesson. These experts cower in fear of this diabolical virus, refusing to think and act outside the box to save lives. This scepticism that I have to face in the development of the vaccine against glioblastoma, I find it in the attitude of academic authorities towards Hydroxychloroquine in the COVID-19 pandemic.
Here is this drug now recommended to be included in the next version of the Guidelines for the Prevention, Diagnosis and Treatment of Pneumonia caused by COVID - 19 , issued by the National Health Commission of the People' s Republic of China for treatment of COVID-19 infection on larger populations in the future. Recall that the potential therapeutic benefits of chloroquine have been studied in vitro and reported for SARS-CoV-1 (which caused the 2003 epidemic).
Dr. Didier Raoult from France is one of the leading infectious disease experts in the world. He recently published a pilot study using hydroxychloroquine and azithromycin in patients with SAR-COV-2 infection. The results were stunning, demonstrating strong statistical significance in eliminating the virus from the treated patients versus the untreated control patients. His work has been downplayed and ridiculed by other experts who reject Dr Raoult’s findings as anecdotal. These so-called experts clamour for large randomized controlled trials before such therapy should be utilized. Professor Didier Raoult quickly confirmed the Chinese studies in Marseille on the basis of a prospective but not randomized study, showing a significant benefit with a P value of 0.01
Need I remind you that the toxicity of Hydroxychloroquine is very well known ! It is even given to pregnant women and millions of people have already taken it. Azithromycin is a commonly used antibiotic So how is it possible not to already be administered to all patients critical of this disease regarding the fact that the drugs already exists and that it is available at low cost ?
Many scientists have got the same question as I and we have . This isn't science any more, this is a negation of the evidence and these scientific Academics need to be excluded from the International Community. The salient point here is that all of these therapies share several very attractive commonalities. They are all relatively safe, carrying few side effects. They are all readily available approved agents currently being used by a multitude of patients around the world. The risk for using them is therefore low. Logic seems to dictate that patients suffering from life threatening complications of SARS-COV-2 infection should be offered one or all of these potential therapies. The scientists representing establishment thinking will cry foul, claiming that it is not ethical to administer a therapy that is not yet proven by a large randomized clinical trial. We resolutely disagree. Large scale randomized trials will take years to complete. How many patients must die in the interim while we wait for the results? The medical community and the world's regulatory agencies must unite in order to give at least temporary approval for these potentially life saving therapies. This would allow physicians on the front line to utilize the therapies enumerated above in their armamentarium against SARS-COV-2. We know that the potential morbidities of these therapies is low, and the failure to act in the face of aggressive COVID-19 disease is catastrophic.
The regulatory agencies should not make the same mistake with SARS-COV-2 that they have been making for decades with potential therapies for cancer. The time for large scale clinical trials will come in the future when the pandemic has abated. Now is the time for action, not more pontificating by medical academics living in an ivory tower.
If Dr. Raoult is right , that we strongly believe that he is because of the evidence, then all the scientists and Physicians that don't give especially an approved drug to the critical patients , need to resign not only from their current job but also from being doctors and scientists for the rest of their lives and they need to do another job. In my point of view these ''scientists'' are the enemy of the people because they don't try the best for their patients and that is the reason why they need to be judged. It is not logical to have recommendation by a Medical agency like China and clinical studies in vitro and in vivo with a P value and significance and you still need more data when at the same time patients are dying without any treatment.
I strongly recommend that in the future we need to change the vision of making science. If a scientific team in the planet can prove even with the use of anecdotical data , that a treatment works against a deadly disease, then without any other possibility this should be approved by all the agencies. Patients could thus have access to it, which does not exclude at the same time the realization of confirmation studies and the withdrawal of accreditation if the results were not confirmed
Does the Academic community kill the patients? Imagine that we have only one picture from a satellite that the earth is a sphere...do we need more evidence and more pictures?
Apostolos Stathopoulos
CEO of ERC , MD PhD
Neurosurgeon and Tumeur Immunologist
