The Biotech Antibody Deception (2)

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One of the many major figures in the covid-biomedical complex who are priming the pump of the antibody pipeline is Ian Lipkin. He’s director of the Center for Infection and Immunity at Columbia University in New York. Lipkin is involved at high levels in many global organizations including the World Health Organization and the Bill & Melinda Gates Foundation, as well in pharmaceutical companies. And he is quoted in a ‘fact-check’ of a July 2020 article titled “No one has died from the coronavirus.” Lipkin states, among other aspects, in the fact-check piece that “Conspiracy theorists are not persuaded by data.”

Lipkin co-authored a Feb. 12, 2021, paper in which he and his team claimed to have identified, using a new ‘peptide-microarray’ technology they invented, 29 amino-acid sequences unique to the novel coronavirus. They assert that antibodies specific to the sequences could be created – and that these in turn could be harnessed “to facilitate diagnostics, epidemiology, and vaccinology” for covid. The only conflict Lipkin and some of his co-authors disclose in the ‘competing interests’ paragraph at the end of article is that they invented the peptide-microarray technology described in the article, no word about their involvement in the companies which actually sell tests containing these molecules or their antibodies.

Do antibodies used to treat covid fare any better?

Antibodies are also being marketed to treat covid. Some are sold singly (known as ‘monotherapy’) and others in pairs. They are deemed to confer ‘passive immunity.’

Among the most-reported-on set of antibodies for treating covid is the Regeneron monoclonal antibodies ‘casirivimab’ and ‘imdevimab’. This pair reportedly was used in October 2020 to treat then-U.S. President Donald Trump. The combo subsequently was granted an EUA by the FDA on November 21, 2020. It also is being considered for approval by Health Canada.

We’d like to focus on a somewhat lesser-known monoclonal antibody called ‘bamlanivimab’. It’s being used both singly and as one half of a pair for treatment of symptomatic covid patients early in the course of their infection. The antibody was discovered, and clinical study of it started, by the US National Institute of Allergy and Infectious Diseases (which is headed by Anthony Fauci) and a Vancouver, British Columbia-based company called AbCellera Diagnostics. The antibody is being manufactured and sold by Eli Lilly. It costs more than $1,200 a vial. AbCellera is developing a significant pipeline of other antibodies. Its capabilities for this were developed over the past two-plus years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform program.

Note: AbCellera also has received hundreds of millions of dollars from the Canadian government, including for building an antibody-manufacturing plant. And Peter Thiel, who co-founded both PayPal and Palantir, is a board member. So is John Montalbano, who’s also on the board of the Canada Pension Plan Investment Board and until 2015 was CEO of RBC [Royal Bank of Canada] Global Asset Management. This and significant positive media coverage helped propel the company to the biggest Canadian-biotech-company Initial Public Offering, on Dec. 11, 2020.

Bamlanivimab was given an EUA by the FDA on November 9, 2020, for treatment of mild to moderate covid. And Health Canada gave the monotherapy an interim authorization on November 17. It was not getting much attraction in clinical practice so far in Canada, though, perhaps because of the less-than-stellar results from clinical trials. But this hasn’t deterred the Canadian and US federal governments, which combined have purchased close to half a million of these tests. For example, on February 26, 2021, the US government bought 100,000 vials.

The only study on bamlanivimab made public prior to the November 9, 2020, FDA approval was one posted October 1, 2020, on the website of the online-only journal bioRχiv. [Note: the journal and its sister publication medRχiv contain only non-peer-reviewed articles and were created by an organization headed by Mark Zuckerberg and his wife.] The study used rhesus monkeys and provided very extensive details about how the antibody was discovered and checked for specificity to the novel coronavirus. The researchers concluded that the antibody – at that time known as LY-CovV555 – has “potent neutralizing activity” against SARS-CoV-2.

On January 14, 2021, altmedia investigator emailed the lead author of that paper, Bryan Jones. He’s a researcher in Lilly’s Biotechnology Research Program. Jones had been asked where in their paper is the proof the antibody is specific to SARS-CoV-2 (and therefore isn’t binding to something else instead of, or in addition to, the novel coronavirus). He responded promptly, as follows: “While we did determine that LY-CoV555 is specific to SARS-CoV-2 (and doesn’t bind to the spike protein of SARS-CoV), that is not specified or detailed in any of the figures or tables [in the paper].” Jones pointed to several parts of the paper and supplemental material published with it that he said show, via indirect extrapolation, that the antibody is specific for the novel coronavirus. That’s not exactly convincing.

Then on December 22, 2020, a study in the New England Journal of Medicine gave a thumbs-down to the usefulness of bamlanivimab in people hospitalized after receiving a covid diagnosis. The paper noted that in late October the study was stopped because the antibody didn’t help the patients any more than did placebo.

But this didn’t deter Lilly. On January 21, 2021, the company issued a news release about a study of bamlanivimab in residents and staff of nursing homes. They claimed their research showed that the antibody “significantly reduced the risk of contracting symptomatic covid-19.”

However, they didn’t back this up with much information. The study hasn’t been published in a journal or presented at a scientific/medical meeting. And there’s no word on when it will be.

Despite that, on the same morning the release was sent out by Lilly, glowing articles appeared in major media outlets stating that the study showed bamlanivimab appears to significantly reduce covid symptoms in the frail elderly.

For example a Bloomberg article was posted at 8 a.m. on Jan. 21 with the headline, “Eli Lilly Antibody Cuts Covid-19 Risk Up to 80% in Nursing Home Study.” The article was carried in many other media outlets such as the Globe & Mail. The article quoted Lilly’s Chief Scientific Officer Daniel Skovronsky as saying: “This is an urgent situation. Where there’s an outbreak in nursing homes and people haven’t yet received the vaccine, this could be a potential way to protect them before they get it.”

And January 21 New York Times piece by senior science journalist Gina Kolata quotes a vaccine expert at Boston Children’s Hospital, Ofer Levy, who wasn’t one of the scientists involved in the study, as saying: “I see only positives here. This is a win.” Kolata also reported that Lilly plans to ask the FDA for an EUA for bamlanivimab for prevention of covid in the frail elderly, focusing on those in nursing homes and long-term-care homes.

In parallel, Lilly is pivoting to using bamlanivimab in combination with another monoclonal antibody called ‘etesevimab’. A study on this combination in people with mild or moderate covid was published on January 21, 2021. The results indicate it doesn’t reduce symptoms, but only lowers the viral load of people.

This didn’t deter Lilly either; it’s spinning this in the media as a very positive result. And so is the FDA: on February 9, 2021, the agency issued an EUA for the combination of the two antibodies for treating mild or moderate covid.

Then the next twist in the plot occurred, on February 16: a paper published that day in bioRχiv indicated that bamlanivimab doesn’t neutralize the South African and Brazilian variants of the novel coronavirus.

Instead of conclusion – words of Scott Adams

Dilbert-cartoon creator Scott Adams makes this observation on page 13 of his book Loserthink: “One thought I can say with complete certainty is that it is a bad idea to trust the majority of experts in any domain in which both complexity and large amounts of money are involved.”

This perfectly describes the situation with antibodies for the novel coronavirus.

Buyer beware, follow the money and stay tuned.

yogaesoteric
February 2, 2022