In early 2020, it used to be a science fact that COVID-19 kills predominantly men, and clever therapies were invented. Female hormones are being proposed to save the men, maybe one day someone suggests chemical castration. More recently, some greedy quacks in Brazil got bored with peddling hydroxychloroquine and ivermectin and teamed up with a US hair loss company, to convince you that the anti-androgen hormone proxalutamide is the cure for the pandemic.
You might laugh, but knowing how Jair Bolsonaro’s regime works, especially regarding quack cures, this bold yet pseudoscientific nonsense is likely to become the national COVID-19 therapy in Brazil soon.
Even these shilling quacks (who always claim to have no financial conflict of interest) are aware that by today, SARS-CoV2 is not seen as a men-killer anymore. It turned out that the (alleged) initial discrepancy of ~70% male ratio COVID-19 deaths was a fluke, for example the current data from Germany (for 2020 and 2021) shows that the difference is not that big, maybe not even that significant. The coronavirus kills both sexes, it even seems its current variants might cause more severe and prolonged disease in young women.
The Feminine Side
Already back in the spring 2020, scientists proposed first cures, with female hormones. New York Times wrote in May:
“Last week, doctors on Long Island in New York started treating Covid-19 patients with estrogen in an effort to increase their immune systems, and next week, physicians in Los Angeles will start treating male patients with another hormone that is predominantly found in women, progesterone, which has anti-inflammatory properties and can potentially prevent harmful overreactions of the immune system.
“There’s a striking difference between the number of men and women in the intensive care unit, and men are clearly doing worse,” said Dr. Sara Ghandehari, a pulmonologist and intensive care physician at Cedars-Sinai in Los Angeles who is the principal investigator for the progesterone study. She said 75 percent of the hospital’s intensive care patients and those on ventilators are men.”
As it is always in science news, when the actual results do not support the headline breakthrough bombshell story, it is not newsworthy anymore. The Cedars-Sinai trial NCT04365127 recruited 40 male patients (22 controls and 18 in progesterone group), those already on ventilation were excluded. On 20 February 2021, the scientists published their results, and neither NYT nor anyone else was interested. This is their recent paper:
Sara Ghandehari, Yuri Matusov, Samuel Pepkowitz, Donald Stein, Tamana Kaderi, Divya Narayanan, Josephine Hwang, Stephanie Chang, Robert Goodman, HeliGhandehari, James Mirocha, Catherine Bresee, Victor Tapson, Michael Lewis Progesterone in Addition to Standard of Care Versus Standard of Care Alone in the Treatment of Men Hospitalized with Moderate to Severe COVID-19: A Randomized, Controlled Pilot Trial (2021) DOI:https://doi.org/10.1016/j.chest.2021.02.024
The authors conclude:
“Progesterone at a dose of 100 mg, twice daily by subcutaneous injection in addition to SOC may represent a safe and effective approach for treatment in hypoxemic men with moderate to severe COVID-19”
This does not really sound like a promised success. And this despite the declaration that “Drs. Ghandehari and Pepkowitz report patent pending on method of use of progesterone agonist for treatment of COVID-19“.
We also learn that the “Study period was shortened to 15 days from the initially 29 days“, that the control group had more patients with obesity and hypertension and that nine progesterone-treated patients were still classified as controls:
“Control patients with significant clinical deterioration (requiring higher supplemental oxygen through high flow devices or mechanical ventilation at any point during the study), or those at Day 7 without clinical improvement were permitted to cross over to receive progesterone therapy. These patients remained in their intention-to-treat group for purpose of analysis.“
In short, progesterone as COVID-19 therapy was a failure.
Another genius approach NYT celebrated in the same article from May 2020 was an oestrogen therapy:
“The genesis of the estrogen trial at the Renaissance School of Medicine at Stony Brook University on Long Island stemmed from a similar observation, said Dr. Sharon Nachman, the trial’s principal investigator, who credited a Stony Brook surgeon, Dr. Antonios Gasparis, with the idea.
The trial enrolled its first patient this past week, and preliminary results could be available in a few months, she said.
“It’s totally out of the box, which is how good ideas often start,” said Dr. Nachman, associate dean for research at the Renaissance School”
This is the clinical trial, NCT04359329, titled “Estrogen Patch for COVID-19 Symptoms” and it’s listed as “recruiting”, almost a year after it started. Dr Sharon Nachman’s institutional website never mentioned any progress on that area of research either. It is likely that the oestrogen therapy, just like the progestogen one, proved useless. Unsurprisingly.
Both studies were however run by female investigators, and regular readers of my site know that the biggest and the most successfull COVID-19 bullshitters and quack cure inventors are all male. Didier Raoult and Vovka Zelenko with chloroquine, David Sinclair with “anti-aging” NAD+ supplements, Nadir Arber with cell culture supernatant (EXO-CD24), Jean-Claude Tardiff with colchicine, Michael Holick with Vitamin D, Shai Efrati with hyperbaric oxygen, Jean-Pierre Changeux with nicotine, and almost all others are very virile alpha-males. Their rule is always: take your favourite medicinal product, ideally the one you happen to be selling or shilling for, and declare it to be a COVID-19 game-changer cure. Media loves such stories.
Look, here is another male genius, the French psychiatrist Nicolas Hoertel, who decided that the antidepressant fluvoxamine cures COVID-19, because of the buzzword “cytokine storm”, don’t bother trying to understand why. Hoertel based his verdict on an earlier trial NCT04342663 claiming a kind of success (Lenze et al 2020), which was led by two US psychiatrists, Angela Reiersen and Eric Lenze, to be fair the former is a female bullshitter.
Only men can successfully turn crap into hype. There is no evolutionary psychology in it, just our patriarchal society rewarding male bullshittery and business scammery. And Brazil is definitely a country where patriarchy and toxic masculinity rule supreme.
And look, this all-male team of Brazilian inventors of an anti-androgen therapy succeeded where US women failed. Their approach works, well, in a YouTube video of press conference with a Microsoft PowerPoint at least. This is how they communicated their results last week, as a five-member-strong (pun intended) manel.
A bald scam
Their magic drug is Proxalutamide, an anti-androgen non-steroid hormone patented by the Chinese company Suzhou Kintor Pharmaceuticals, marketed in cooperation by the US company Applied Biology (more on it later), and in urgent need of a medical indication. Before the pandemic, Proxalutamide was proposed by its sellers for the treatment of male hair loss or alopecia, and now, it is declared to be curing COVID-19, Kintor Pharma already received an FDA approval to run a pPhase 3 clinical trial in USA. The pseudoscientific rationale for that will be revealed below. Here is one of the team proudly tweeting the breakthrough:
So there is no paper, no press release even. Hence, some screenshots from that YouTube study:
Here a translation of the slides’ message:
- double-blind randomized controlled clinical trial with proxalutamide and placebo pills.
- 12 hospitals in Amazonas state
- N= 600 / ITT=590 Proxalutamide N=294 (56.8% male, median age 53,5yo, 97%constant O2, 69% non invasive ventilation); Placebo N=296 (57.8% male, median age 53yo, 96% constant O2, 67% non invasive ventilation.
- 3.7% deaths and 80% fully recovered in Proxalutamide arm; 47.6% deaths and <10% fully recovered in Placebo arm. 92,2% mortality reduction (p<.0001)
- Sides Effects. Severe: zero. Most common: increase appetite (25%), diarreia (15%), fatigue (8%), increase libido (7%), irritability (3%), prolonged erection (2%)
- Conclusions: Proxalutamide dramatically reduced the number of deaths and hospitalization time dramatically, inhibited COVID-19 progression, and seems to act on main COVID-19 mechanisms.
The only side effects are increased appetite, both for food and sex, combined with prolonged erection. That in case you, as a virile yet pandemic concerned man, were worried the anti-androgen therapy would affect you masculinity: no, it even increases it while protecting you from COVID-19!
And yet, isn’t it weird that 50% of patients in the control group DIED??? Did the researchers recruit the most severe cases, where hope was already lost? In the video, they do claim that almost 100% patients were on oxygen, 70% of these ventilated. But this cannot be, because the trial registration says something else.
The clinical trial NCT04728802 describes that the patients were admitted if they had a clinical status on the COVID-19 Ordinal Scale of 3 (Hospitalized, not requiring supplemental oxygen – no longer requires ongoing medical care), 4 (Hospitalized, not requiring supplemental oxygen- requiring ongoing medical care) or 5 (Hospitalized, requiring supplemental oxygen)”. Everyone on ventilation, either invasive or non-invasive, was explicitly excluded from the study, and yet now they claim almost 70% were ventilated.
While the YouTube release claims the patients were almost dying, according to trial’s actual records, all treated patients treated had mild to moderate COVID-19. A death rate of almost 50% in the control group makes no sense at all, unless someone is lying. I jokingly asked one of the trialists, Carlos Wambier, a Brazilian-born dermatologist at Brown University in USA, if they recruited Ebola patients by mistake, but received no reply.
Another key character of the proxaglutamide event is Flavio Cadegiani, whose “superlative achievements include amongst the fastest PhD obtained in the history of Federal University of São Paulo (7 months) and concurrent gold medals in Mathematics, Chemistry and Physics Brazilian Olympics in his adolescence.” Basically, Cadegiani is a genius:
“Dr. Cadegiani is the only author of the sole book in Overtraining Syndrome, the prevailing sport-related disease among amateur and professional athletes. He is also responsible for approximately 70% of the articles published in the field in the world in the last 05 years, and reviewer for more than 90% of the manuscripts in the field.”
The quotes are from the website of Applied Biology (getting there in a moment), of which Cadegiani is clinical director. At the YouTube event, Cadegiani said:
“As a researcher, I’ve never seen something like that. […] “I’m one of the editors of one of the Nature journals.“
Surely Nature journals are currently fighting to publish that garbage. No, I am not being ironic. The Seven-Months-PhD-Genius also added:
“Recently FDA has approved our phase 3 Proxa study in the USA and we are going to start Proxa phase 3 in Brazil and ask for ANVISA [Brazilian authorities] for an emergency approval of Proxalutamide. We expect no bureaucracy from them.“
That I definitely believe unconditionally. I can even imagine Bolsonaro and his (soon former) Health Minister, the army general Eduardo Pazuello, already massaging proxalutamide onto their scrotums.
Now meet the most illustrious proxalutamide team member from the YouTUbe event: Ricardo Zimmermann, infectologist at the Hospital da Brigada Militar de Porto Alegre. Zimmerman previously protested in the media against lockdown measures (here and here), while peddling hydroxychloroquine, ivermectin, Vitamin D and zinc as COVID-19 prophylactics. he also made sure that the COVID-19 kit containing those magic drugs became official therapy, distributed to public in the governmental district of Porto Alegre (read here, here) and also watch here:
You cannot be a bigger quack than Zimmerman, and yet look, he now tells everyone to take proxalutamide to survive COVID-19. Now, in the YouTube study, Zimmermann proclaims:
“We are seeing a new chapter in medicine, infectious disease, and anti-androgenic therapy“
No wonder that chloroquine and ivermectin peddlers in US (AAPS) loved this announcement:
Zimmermann is not yet officially on the Applied Biology’s payroll, but who knows. So let’s see who this official sponsor of the proxalutamide clinical trial is.
No conflict of interest
It’s the small US start-up Applied Biology, whose commercial focus before the pandemic was hair loss therapy, hence the anti-androgen hormone proxalutamide this company sells for its Chinese manufacturer Kintor Pharma. It is perfectly clear that the money for the clinical trials comes from China, the Californian company is just a facade. Applied Biology’s official business seat is a mailbox at 17780 Fitch, Suite 192 in Irvine, California, the exact address many other unrelated tiny businesses use. Recall that Cadegiani is employed as Clinical Director there (even though in all of his papers he claims to be solely academically affiliated with Federal University of São Paulo), while Wambier is listed on Applied Biology’s medical board, meaning he is also paid by this company.
If you are still hopeful that this business might be serious and not a scam: one of Applied Biology’s medical board members is the Italian mega-quack and all-kind grifter Torello Lotti, who was even arrested and charged with embezzlement in his home country Italy. Please read for yourself what kind of character Lotti is, here and also here. His speciality is of course hair loss quackery, but no scam is too stupid for him, especially homeopathy, and his grift for gift authorship regularly places him as last author on demented papers about like
- “A Black Hole at the Center of Earth Plays the Role of the Biggest System of Telecommunication for Connecting DNAs, Dark DNAs and Molecules of Water on 4+N- Dimensional Manifold“
- “Recovery of Brain in Chick Embryos by Growing Second Heart and Brain” or
- “5G Technology and induction of coronavirus in skin cells“.
Smut Clyde has prophesied what was coming when he mentioned this paper with Lotti as last author:
“a March-June “Dermatologic Therapy COVID-19” Special Issue at Dermatologic Therapy features Lotti’s name on 21 of the contributions. Notably, Goren et al pursued the idea that testosterone is a risk factor for COVID-19 (as it is for so much else) because mumble mumble angiotensin‐converting enzyme 2 (ACE2) mumble mumble mumble.”
This is the paper, published on 1 April 2020:
Andy Goren, John McCoy, Carlos G. Wambier, Sergio Vano‐Galvan, Jerry Shapiro, Rachita Dhurat, Kenneth Washenik, Torello Lotti What does androgenetic alopecia have to do with COVID‐19? An insight into a potential new therapy (2020) doi: 10.1111/dth.13365
The authors of this genius proposal to treat COVID-19 with anti-androgen hormones “declare no potential conflict of interest”. Andy Goren is Applied Biology’s founder and apparently sole owner, John McCoy is Vice-President, Wambier and Lotti are on the Applied Biology’s medical board, while Jerry Shapiro is another medical board member and dermatologist with exclusive focus on hair loss who runs a private practice in New York and a Hair Transplant Centre in Vancouver, which he himself describes as “One of the busiest, if not the busiest, hair clinic in the world“.
Trials and errors
My heart breaks that Lotti was not included on the follow-up clinical data, a kind of precursor study to what was recently announced on YouTube. This preprint namely:
Flavio A. Cadegiani, John McCoy, Carlos Gustavo Wambier, Sergio Vaño-Galván, Jerry Shapiro, Antonella Tosti, Ricardo A. Zimerman, Andy Goren Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial. Cureus (2021) doi: 10.7759/cureus.13492
That clinical study featured 236 patients (108 female, 128 male, with 65 of patients in the control arm) and nobody died there, not even in the usually so deadly control group (remember the recent 50% death rate?) Maybe it was the Brazilian standard of care, which we learn consists of the anti-parasite drug nitazoxanide and Raoult’s antibiotic azithromycin?
But then the data integrity sleuth Nick Brown noticed that there were apparently even more proxalutamide trials going on, done by the same team. Like this clinical trial NCT04446429 where 262 males were treated, with 134 in the treatment group. Only 2 patients in the control group of 128 died there, and unlike in the YouTube study where 50% died in the control arm, even ventilated patients were recruited. What is going on? How many clinical trials did these people run?
Brown found that similar trial data was described by same authors elsewhere, he even noted that “the same percentage of people in both groups were hospitalised in both studies“, referencing this preprint:
Flavio Adsuara Cadegiani, John McCoy, Carlos Gustavo Wambier, Maja Kovacevic, Jerry Shapiro, Rodney Sinclair, Andy Goren Proxalutamide (GT0918) Reduces the Rate of Hospitalization and Death in COVID-19 Male Patients: A Randomized Double-Blinded Placebo-Controlled Trial. Research Square (2020) DOI: 10.21203/rs.3.rs-135303/v1
There, it was not 236 patients, but 214 (100 in placebo and 114 in treatment group), again only 2 in the placebo group died. Oh and of course:
“the Authors declare no conflict of interest with any of the pharmacological interventions proposed by the present study“.
Even although ALL of them, every single co-author on that preprint, owns or works for the Californian hair loss company Applied Biology and directly profits financially from repurposing their drug. Shameless buggers.
Afterwards Brown, with some help from the Brazilian clinical researcher Jose Galucci-Neto, tried to make sense of all these strangely similar yet different trials. He found out that the same ethics approval referred to even more different clinical trials with proxalutamide, with varying and not really compatible numbers of patients, sometimes in combination with another anti-androgen drug, Dutasteride.
The clinical trial NCT04446429 was in July 2020 announced and funded by the Chinese mothership Kintor Pharma, where we learn that
“The experimental arm (50% of the participants) will be treated with Dutasteride + Standard Care (Ivermectin+ azithromycin) and the control arm (50% of the participants) will be treated with Placebo + Standard Care.”
What an interesting drug combination. There is also this:
“Pursuant to the Research Agreement, Applied Biology will study Proxalutamide (GT0918) as an additional arm to the Existing Clinical Trial with around 120 male participants to be enrolled, and is expected to complete the proposed research study in six to nine months of the signing of the Research Agreement.“
The first ever trial participant was enrolled on 20 August 2020, as Kintor Pharma proudly announced. But the numbers still don’t match. By January 2021, final results for the male patients were announced by Kintor, and there were merely “134 male patients in the Proxalutamide arm and 128 male patients in the Control arm“, for women all they had to show were “60 patients in Proxalutamide arm and 35 patients in the Control arm.”
In those control arms, only 2% died. So where did they suddenly get 600 severely ill COVID-19 patients for the YouTube study, where 50% died in the control group? This Kintor Pharma press release from October 2020 admitted that the participants recruited so far were not really ill. And all male. And no way their median age was around 53. But everyone had to be bald:
“For the purpose of exploring the role of anti-androgens in COVID-19 infections, non-hospitalized male participants with mild-to-moderate COVID-19 disease, aged 50 years old or above with androgenetic alopecia, were enrolled in this clinical trial, which is double-blinded and placebo controlled. There are three arms with the first experimental arm treated with Dutasteride + Standard Care (Ivermectin+ azithromycin), the second experimental arm treated with Proxalutamide + Standard Care, and the control arm treated with Placebo + Standard Care. Ivermectin+ azithromycin are used as standard care…”
All of this, if you recall the YouTube presentation and the previous papers, means that someone is lying.
As you see, none of the data has been published in a “peer reviewed” journal yet. I’m sure Torello Lotti will recommend some reliable outlets, unless Nature grabs it first, as Cadegiani hinted.
Oh, and if you follow me on Twitter you might have seen me joking that COVID-19 mortality was associated with baldness, hence my clinical advice to wear a wig. Well, you saw Lotti’s paper with Goren et al. There is more!
Wear a wig
Have you heard of that insane journal-shaped puke-funnel for all possible idiocies, operated by Elsevier and called Medical Hypotheses?
Andy Goren , Flavio Adsuara Cadegiani , Carlos Gustavo Wambier , Sergio Vano-Galvan , Antonella Tosti, Jerry Shapiro, Natasha Atanaskova Mesinkovska, Paulo Müller Ramos, Rodney Sinclair, Omar Lupi, Jana Hercogova, John McCoy Androgenetic alopecia may be associated with weaker COVID-19 T-cell immune response: An insight into a potential COVID-19 vaccine booster Medical Hypotheses (2021) doi: 10.1016/j.mehy.2020.110439
“Our recent work has explored the influence of the androgen receptor (AR) on COVID-19 disease severity . We have elucidated that androgen sensitive phenotypes, e.g., androgenetic alopecia (AGA), are associated with increased disease severity . Here we propose that the dependence of SARS-CoV-2 on the AR may extend to the immune response and might be an important consideration for vaccine development. [..] Taken together, these data suggest that anti-androgen therapy when combined with a vaccine for COVID-19 may improve specific T-cell mediated immune response…”
And again, all these owners and employees of Applied Biology (Rodney Sinclair and Jana Hercogová are medical board members, the latter is top-ranking dermatologist in the Czech Republic) lie without getting red:
“The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.”
The disgusting part is that these greedy scammers use the late Frank Gabrin, the first US physician to die from COVID-19, as their defenceless mascot in order to sell Applied Biology’s anti-androgen hormones as a phony COVID-19 medicine. In the paper Wambier et al 2020 (“Conflicts of interest: None disclosed“) Goren, McCoy, Shapiro and others proposed:
“Dr Frank Gabrin was the first American physician to die of severe acute respiratory syndrome coronavirus (SARS-CoV)-2 infection. Dr Gabrin suffered from androgenetic alopecia and was a long-term survivor of bilateral testicular cancer […] we propose the use of the eponym the “Gabrin sign” to visually identify patients at higher risk for severe symptoms after COVID-19 infection.”
My little joke about hair loss causing COVID-19 deaths became “peer reviewed” insanity and since January 2021 official COVID-19 policy in Brazil:
“The Brazilian government announced on January 6, 2021 that it would adopt the AndroCoV protocol pioneered by Applied Biology in partnership with Brazilian scientists as part of the emergency response to the COVID-19 crisis (https://www.gov.br/saude/pt-br/assuntos/noticias/ministerio-da-saude-prepara-acoes-para-reforco-do-sus-em-manaus).”
It reads as if government announced to deploy a phone app to check if you are bald, so you get treated with proxalutamide as COVID-19 therapy.
And just look at this, as tweeted by Ana Carolina Peçanha:
The article has been updated since it was first published.
If you are interested to support my work, you can leave here a small tip of $5. Or several of small tips, just increase the amount as you like (2x=€10; 5x=€25). Those hair loss drugs are not cheap!