According to O Globo, one of the most widely-read newspapers in Brazil, last February a town in the state of Amazonas, Itacoatiara, in dire straits due to the COVID-19 pandemic, received a visit from a “saviour” – the president of Samel, of a private healthcare company – bringing a miracle cure for the disease in the form of an experimental drug, originally developed for the treatment of prostate cancer, called proxalutamide. With the complicity of local politicians, the COVID-19 patients of Itacoatiara were led to sign misleading consent forms to become guinea pigs in an illegal, unsanctioned, unauthorised drug trial. Relatives of people who died there now use the word “extermination” to refer to what happened to their loved ones.
Less than a year before, in April 2020, right after Didier Raoult’s infamous paper on the miracles of hydroxychloroquine (HCQ) another private healthcare provider, called Prevent Senior, became one of the strongest advocates of HCQ.
Despite the name, the putative mission of the company seems not to be preventing people from staying alive until they become elderly, but instead taking care of senior citizens. They launched the first ethically-challenged, bumbling attempt to “prove” that medical fantasies based on shoddy science (in this case, HQC) could stop the pandemic.
This column already called attention to how several private healthcare companies pushed the use of the “covid kit”, a mixture of unproven medications for COVID-19, including different combinations of hydroxychloroquine, azithromycin, ivermectin, nitazoxanide, zinc, vitamin D, flutamide, etc.
Back in April 2020, Prevent Senior officers circulated the report of a “clinical trial” in the form a PDF file, together with a press release, stating that Prevent Senior was going to divulge “game changer” results that could save Brazil – and possibly the world – from COVID-19. The press release had an embargo date – a stern warning for journalists not to say anything before April 17th, 4 PM – and came with the promise that the PDF would soon be available in pre-print repositories and in the Public Library of Science (PLoS) journal.
The contents of the PDF revealed a sad excuse for a clinical trial of HCQ. It was full of flaws, both technical, and ethical. Despite the sky-high promises of the press release, the work has never seen publication or even “pre-publication” anywhere (not even preprint repositories accepted it). Subsequently, Prevent Senior officers have tried to rewrite history, saying that the PDF was but a collection of preliminary results, divulged in an unauthorised “leak” (maybe hoping that nobody will remember the loquacious press-release or the intense social media campaign the company’s cronies launched at the time).
The so-called study lacked authorisation from Brazil’s National Ethics Commission (Conep). It was not a randomised clinical trial. Patients were not randomised into groups, but rather asked whether they wanted to receive HCQ or not. Those who agreed (approximately 400) were placed into the “treatment group”. Those who did not (200) were placed into the control group. No one asked the control group if they agreed to be part of a trial, or even asked them to sign a consent form.
Worse still, there was no diagnosis of Covid. People were included based on flu-like symptoms, but were not tested to confirm if they even had COVID-19. One can only imagine the number of flu-like symptoms likely to appear in an all-elderly patient base, as is the case of Prevent Senior. They had no idea what illnesses they were throwing their “experimental” kits at: hundreds of flu cases, along with common cold, allergies, bacterial pneumonia and sore throat cases might have made the “Covid” list.
The study was not double-blind, as every patient knew what they were taking, and every medical doctor involved too. The primary outcome was need for hospitalisation, so if everyone – including the person who’ll decide who needs to get hospitalised, a person who is in the study sponsor’s payroll – knows which patient is taking what, the results are likely to be totally biased. Of course, there was also no placebo group to ensure a fair comparison.
These facts alone, at that time, should have been enough to completely discredit this so-called clinical trial. Even more so, once well-designed RCTs started to pile up, showing that HCQ does not work for COVID-19. The episode, which resembled much more a botched marketing campaign than a scientific trial, seemed to be over.
Last month, though, a group of medical doctors who used to work for Prevent Senior came forward, anonymously, to the Parliamentary Inquiry Committee (CPI) investigating the government’s responsibility during the pandemic, with very serious claims. They told the CPI – and the Brazilian press – that Prevent Senior never stopped using the “covid kit”. Quite the opposite, they pushed doctors to prescribe it, and even set a “goal”, like a sales target, for prescription. Doctors were reprimanded when they refused and feared losing their jobs. There was an internal guideline from the hospital, advising doctors NOT to inform patients and family about the drugs they were taking. Medical records were modified to hide deaths from Covid. That infamous PDF from April 2020? Besides being deeply methodologically flawed, it was also tampered with to exclude seven deaths in the treatment group.
Recently, even more serious accusations came to light. Pedro Batista, medical director of Prevent Senior, actually confessed to the CPI that the network’s guidelines were to change the ICD (International Classification of Disease) in patients’ records fourteen days after their first symptoms. This means that after fourteen days, even if a patient came in with Covid and eventually died, the information on their death certificate would state that they died of a complication, and not from COVID-19.
If these accusations are true, it means that Prevent Senior has been performing medical experimentation in humans without ethical clearance, any regard for human rights or, even, for the reliability of the data produced. This is too serious to ignore.
The Itacoatira case, then, is just one more entry in the log of Bolsonaro-aligned healthcare entrepreneurs playing god with the Brazilian population. Proxalutamide, at least, had some biological plausibility: it’s a hormone inhibitor. It works by down-regulating the number of cell receptors that aid in the virus entry to the cell. This has been demonstrated in prostate cells, in vitro, but never in respiratory cells. So far, our best knowledge is that the drug doesn’t work for COVID-19. And even if it does – after World War Two, the international community established rules for experimentation in humans for a reason. We shouldn’t forget the rules, nor the reason.
One of us (Natalia Pasternak) was called to depose at the CPI as an expert in science communication. When asked by one of the Senators why she had signed a Jewish manifesto for democracy and against the government, she replied that as a grandchild of the Holocaust – her grandfather, a survivor – it is our duty to never forget what authoritarian governments can do to people.
Prevent Senior is suspected of having close ties to the government – recently leaked videos show executives from the company and scientists who consulted for it sharing “preliminary results” of their “kit covid” experiments with government officers . History already showed us what can happen when authoritarian and fascist governments get too cozy with private money and society goes on as if it was business as usual.
What’s happening in Brazil right now is not business as usual. It is not just a bad government and some “unavoidable” corruption. It is not just private healthcare companies doing dubious marketing stunts. It is about ethics and human rights. And this too can’t be forgotten.
