FDA obstruction: Patients die, while Trump gets the blame

T. Belman. I live in Israel.  This week I asked my doctor for a precription for this drug for propholactic purposes and he refused because Israel is not endorsing it.  He went on to say that if I get the symptoms then we will discuss it again.

by Harvey Risch, WASH EXAMINER | October 19, 2020

In a recent Washington Post op-ed, seven former FDA commissioners claimed that the agency has lost credibility with the public, and they blamed it on President Trump.

Jumping on the same bandwagon, an editorial in the once-venerable New England Journal of Medicine accused the president of “failing at every step” to stop the COVID-19 pandemic, thus enabling more than 220,000 deaths to date.

In reality, these charges are driven by craven politics and Big Pharma conflicts of interest. They divert attention from the FDA’s despicable efforts to block access to effective and inexpensive generic medications. Foremost among these is hydroxychloroquine.

Let’s take this in steps.
These days, finding a sense of community is a lot like prospecting for gold
First, who is bringing these charges? The seven commissioners include David Kessler — adviser for the Biden campaign; Scott Gottlieb — board of directors of Pfizer and consultant to many pharmaceutical companies; Mark McClellan — board of directors of Johnson & Johnson; Robert Califf — extensive ties with many of the largest pharmaceutical companies; Andrew von Eschenbach — board of directors of the biotech company BioTime and director of Viamet Pharmaceuticals; and Jane Henney — who has served on the board of directors of AstraZeneca.

Many of these companies manufacture patented COVID-19 vaccines and medications. These products are in direct competition with generic, low-cost drugs that FDA has been asked to approve for outpatient COVID-19 use, but that it has refused.

Not to be outdone, the New England Journal of Medicine editorial was led by Deputy Editor Lindsey Baden, who disclosed that he is involved in COVID-19 vaccine clinical trial work conducted in collaboration with the National Institutes of Health, COVID-19 Vaccine Prevention Network, and Crucell/Janssen, Moderna, the Gates Foundation, and the Ragon Institute.

Baden is also chair of the Antimicrobial Drug Advisory Committee of the FDA. Not only is Baden, because of his role with the FDA, motivated to deflect blame from the agency, but he appears to be incentivized financially to tilt the COVID-19 response away from inexpensive generic medications and toward patented and massively profitable vaccines.

The reality is that the FDA has undermined its own credibility, and it has done so brazenly in plain sight. No president was needed for that, as I’ll explain.

As background, one must understand that COVID-19 patients are typically hospitalized because they have developed a severe and life-threatening pneumonia, one that fills the lungs with inflammatory debris and causes abnormal blood clotting in the lungs and small blood vessels. This advanced and dangerous condition, often described as acute respiratory distress syndrome, or ARDS, is entirely different from early “outpatient” (that is, outside the hospital) manifestations of COVID-19, which typically consist of a self-limiting, flu-like illness. We are thus speaking of two very different groups of patients. This distinction between COVID-19 outpatient and inpatient, of course, is well known to the FDA.

And yet, on July 1, the FDA posted on its website a large, black-letter warning against using hydroxychloroquine, or HCQ, to treat outpatients: “FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting.” The FDA justified this warning — stated on the website, just beneath the warning itself — by referring to safety concerns among hospitalized patients.

The FDA does not mention the crucial distinction between evidence for outpatients and inpatients. It does not mention the large body of evidence that HCQ is safe when used in COVID-19 outpatients. It does not mention that HCQ is currently being used safely by millions of outpatients with lupus and other rheumatological conditions. Nor does the FDA mention that HCQ has been safely used worldwide by hundreds of millions of persons, equaling tens of billions of doses, over more than half a century.

And finally, the FDA does not mention that it has no data showing adverse events in outpatient use. In short, among relatively healthy outpatients, HCQ has amassed one of the deepest and most extensive safety records of any drug in history, and the FDA’s warning implication of general harm is an outright lie.

On Aug. 18, Republican Sens. Ron Johnson, Ted Cruz, and Mike Lee sent a letter to FDA Commissioner Stephen Hahn asking the FDA to justify its public warning. After a seven-week delay, the FDA gave a vacuous non-response that contained no data on outpatient adverse events. Yet, the black-letter warning remains on the FDA website. That warning has caused state medical and pharmacy licensing boards to block physicians and patients from obtaining HCQ, and it has caused large health systems, medical groups, individual doctors, and other care providers to shun HCQ altogether.

Why is this important? There is extensive evidence that HCQ, when used within the first five days of symptom onset, produces a sharp and statistically significant reduction in hospitalization and mortality. Seven controlled, well-conducted clinical studies show this: 636 outpatients in São Paulo, Brazil; 199 clinic patients in Marseille, France; 717 patients across a large HMO network in Brazil; 226 nursing-home patients in Marseille; 1,247 outpatients in New Jersey; 100 long-term care institution patients in Andorra (between France and Spain); and 7,892 patients across Saudi Arabia.

All of these studies pertain to the early treatment of high-risk outpatients, and all showed 50% or higher reductions in hospitalization or death. Not a single fatal cardiac arrhythmia attributable to the HCQ was reported among these thousands of patients. In addition, a new summary analysis of five randomized controlled trials has also shown a statistically significant outpatient benefit, proving the case.

The inability of COVID-19 outpatients to obtain prescriptions for HCQ — a medication that along with zinc, vitamin D, antibiotics, and likely steroids will almost certainly prevent them from hospitalization and death — stems entirely from FDA’s refusal to remove its fictional website warning, and its refusal to grant HCQ emergency use authorization in spite of the major evidence of benefit. That evidence is much stronger than that involved in the FDA’s approval of convalescent plasma, and especially of its approval of remdesivir, which has now been proven ineffective.

Many or most of the 220,000 deaths in the United States to date could have been prevented by widespread HCQ use that the FDA blocked. It is the FDA that is responsible for these deaths, not the president. It is sheer corrupt hypocrisy, and completely shameful, for past FDA commissioners and for a New England Journal of Medicine editor with ties to the FDA to accuse the president of what the FDA itself has done.

It is time to clean up this mess once and for all. The FDA must remove its black-box warning, approve the emergency use authorization for outpatient HCQ use, and let doctors get on with the work of saving lives.

October 20, 2020 | 3 Comments »

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  1. A repeat of the Bactrim story and pneumocystis carinii pneumonia revealed by the author. 17,000 died for being denied the Bactrim while waiting for AZT!!!

  2. From today’s Breitbart: “50,000 Children’s Surgeries Postponed, Deaths on Transplant Waiting List Near-Doubled Due to Lockdown: Report
    Victoria Friedman20 Oct 2020
    Girl having bandage put around catheter – stock photo
    Getty Images

    The UK’s coronavirus lockdown has impacted every area of healthcare, including cancer treatment, paediatrics, and cardiovascular care, resulting in excess deaths and delays to treatment, according to analysis.

    Office for National Statistics (ONS) figures had already revealed on Monday that there were 25,000 excess deaths at private homes since the beginning of the year — with only nine per cent being as a result of coronavirus. Another piece of analysis predicted excess deaths would rise directly as a result of the government’s “Protect the NHS” message which deterred people from making medical appointments.

    But it was the audit of several dozens of reports by health professionals, charities, and medical journals by the Daily Mail that revealed in full the staggering effect that the lockdown has had on non-COVID-19 patients.

    The report noted a Lancet paper stating that during the three months of lockdown, organ transplants fell by two-thirds, resulting in the numbers of people dying on transplant waiting lists to nearly double.

    Hospital chemotherapy attendance fell by 66 per cent in April, per a University College London study for the British Medical Journal analysed by the newspaper. Urgent referrals for early cancer diagnosis dropped by up to 89 per cent, according to the same study. Delays to treatments are unlikely to be caught up to for years, the Daily Mail says, revealing that delays could cause a 20 per cent rise on deaths of new cancer patients in England alone.

    The Royal College of Paediatrics and Child Health said that hospitals postponed some 50,000 surgeries for children from March to May in England alone.

    Rates of depression and anxiety also doubled, according to analysis from the ONS. While the British Medical Journal of Psychiatry found that nearly one-in-five people had suicidal thoughts in the first month of lockdown.

    University of Buckingham cancer specialist Professor Karol Sikora called the newspaper’s analysis a “stunning demonstration of lockdowns’ harmful effects across society”.

    “If lockdown were a drug, you’d need to consider the side effects, and yet we’re not – even though we seem to be diving headlong into another one.

    “People sometimes claim it’s a question of health versus the economy, but it’s not – it’s health versus health,” Prof Sikora told the Daily Mail.

    London GP Dr Renee Hoenderkamp wrote for the Daily Mail that in “bitter irony”, the government’s “heavy-handed” approach to coronavirus “supposedly designed to save lives appears to have achieved the exact opposite”.

    “When the coronavirus outbreak began, and the Government talked of lockdown, I felt that tens of thousands of people could ultimately die, not from the disease itself, but the misguided response to it. That is exactly what seems to be happening,” she said.

    The doctor explained that in one instance because face-to-face GP appointments have been all but cancelled in favour of telephone or video calls, parents were directed to look on YouTube to teach themselves how to administer an adrenalin shot with an EpiPen to their severely allergic child because they could not get an in-person appointment with a specialist.

    “Effectively, thanks to the Government’s edict, the system was all but closed to cases that did not involve Covid-19. In practice, the National Health Service had been temporarily replaced by a National Covid Service,” Dr Hoenderkamp wrote.

    British health and social care services are currently under scrutiny for its treatment of the vulnerable and elderly during the height of the pandemic. Last week, the Care Quality Commission (CQC) announced an investigation into allegations that NHS GPs and care homes were ordering care managers to put blanket do not resuscitate orders on senior citizens. Other reports earlier in the year revealed GPs pressuring parents of ill children and even a group that supports autistic people to put DNRs on their charges.

    The NHS also remains in a multi-year investigation into over a thousand cases of the avoidable deaths and injuries of mothers and babies at a hospital trust in England, with incidents dating back to the 1970s.” The Daily Mail article from which some of this report is taken says that about 30,000 excess deaths during the pandemic were caused by the failure to conduct necessary procedures to treat other illnesses, such as cancer. The Mail interviewed a woman who described how her daughter, still a young woman in her early forties, died of cancer while waiting for a postponed operation.