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Posted On: 05/21/2021 10:18:21 AM
Post# of 148900
Message to Rep. Katie Porter
BugEater asked me to post this. Of course it can be adapted for any congressperson or any other person. I think it's too long, but here it is:
Dear Katie (if I may) - you've always taken the side of the downtrodden and bluntly and beautifully demonstrated the misuses of power. One reason you should read this note is because the victims of Covid19 have disproportionately been poor people. But another reason is an astonishing abuse of power from the FDA. This abuse may or may not have been pushed by Big Pharma companies, but it definitely has benefited those companies.
A tiny company called Cytodyn, with under 20 employees, has recently done Covid trials with a drug called Leronlimab or Vyrologix. It’s not a vaccine, but a treatment for people already sick.
The drug has a perfect safety record: over 1200 patients, many very ill, have taken Leronlimab in clinical trials without negative effects. Very, very safe. (Note contrast to Gilead’s Remdesivir -- in one trial, about 25% of the patients given Remdesivir had Severe Adverse Events.)
What about efficacy? In a Phase II/III clinical trial, Leronlimab had some excellent results. For critically ill patients, the drug improved mortality over the placebo/Standard-of-Care arm by 78% after 7 days, and 82% after 14 days.
The trial did NOT hit its primary endpoint, which was 28 day mortality. (More on this later.) As a result, the FDA did not approve the drug. This happened some months ago. But this week the FDA issue a remarkable broadside, blandly claiming that Leronlimab had no clinically significant effect on the disease in two trials.
It was remarkable for two reasons. First, the FDA does not usually issue such statements about drugs. Secondly, there were factual errors in the statement, as if it had been rushed off.
One factual mistake in the FDA statement: in one trial, called CD10, the FDA wrote: “there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints.” In fact, the drug demonstrated "Clinical Significance" for its Primary Endpoint, and "Statistical Significance" for the Secondary Endpoint called NEWS2.
Another mistake in the FDA statement: another trial, called CD12, “also failed to find any effect of the drug on the primary study endpoint… or on any of the secondary endpoints.” Again, this is literally not true. Mortality at 14 days of treatment for the critically ill was a secondary endpoint. Leronlimab’s mortality figures for the critically ill at 14 days were an 82% improvement over the Standard-of-Care arm of the study. Big effect, not no effect.
The FDA DID NOT MENTION a critical aspect in the failure of Leronlimab to hit “statistical significance” for its primary endpoint (mortality at 28 days of treatment). Here’s why it happened. The company suggested using 4 weekly doses of 700 miligrams each. This was nixed by the FDA, who told the company only to use 2 doses, at Day 0 and Day 7.
The drug essentially leaves the body after 10 days. Sure enough, at 7 days there was 78% less mortality among the critically ill with Leronlimab (vs. Standard of Care); at 14 days, an 82% improvement. But at 21 days, which was two weeks after the last dose of the drug, the benefit was down to 50%; at 28 days, by which point the drug was essentially no longer present, the number was down to a 31% improvement – not enough to be statistically significant in a small study.
By the way, the company had ALSO initially proposed 14-day mortality as the primary endpoint – again nixed by the FDA.
In other words, the FDA altered the design of the trial in a way that affected the result. Then they entirely minimized the benefits of the drug in a public statement. This may affect the willingness of nations like India and the Philippines and Brazil to buy the drug. It may well affect the number of people who die from Covid 19 in the US as well.
There are two aspects of this that are particularly rotten. The FDA in their statement referred to the trial design as faulty. As I’ve shown, those faults were the fault of the FDA. But there’s something particularly obnoxious about these high-handed remarks re: trial design. Hydroxy-chloroquine was given EUA based on a very poorly designed study; convalescent plasma was not studied in any randomized controlled trial prior to its EUA; and bamlanivimab was approved based on a phase 2 trial -- and ultimately none of the phase 3 endpoints were met.
The true beneficiary of the FDA actions has been Gilead, who have made billions of dollars on Remdesivir. Remdesivir never showed a mortality benefit in its trials, and it does have marked side effects. The drug has just been pulled from approval in both India and the Philippines.
(As you probably know, nine of the nineteen members of the CDC/NIH Panel -- that provides Covid-19 treatment guidance to the government -- declared connections to Gilead in financial disclosures, and two others have had former connections to Gilead.)
Gilead has spent more on lobbying Congress and the administration in the first quarter of 2020 than it ever has before, according to federal filings.
Meanwhile, the FDA has said that only two conditions need to be met in an emergency for EUA: safety, and possible benefit. Leronlimab has demonstrated both of those without doubt. Yet all the FDA wants to do is discredit it in public. Why?
BugEater asked me to post this. Of course it can be adapted for any congressperson or any other person. I think it's too long, but here it is:
Dear Katie (if I may) - you've always taken the side of the downtrodden and bluntly and beautifully demonstrated the misuses of power. One reason you should read this note is because the victims of Covid19 have disproportionately been poor people. But another reason is an astonishing abuse of power from the FDA. This abuse may or may not have been pushed by Big Pharma companies, but it definitely has benefited those companies.
A tiny company called Cytodyn, with under 20 employees, has recently done Covid trials with a drug called Leronlimab or Vyrologix. It’s not a vaccine, but a treatment for people already sick.
The drug has a perfect safety record: over 1200 patients, many very ill, have taken Leronlimab in clinical trials without negative effects. Very, very safe. (Note contrast to Gilead’s Remdesivir -- in one trial, about 25% of the patients given Remdesivir had Severe Adverse Events.)
What about efficacy? In a Phase II/III clinical trial, Leronlimab had some excellent results. For critically ill patients, the drug improved mortality over the placebo/Standard-of-Care arm by 78% after 7 days, and 82% after 14 days.
The trial did NOT hit its primary endpoint, which was 28 day mortality. (More on this later.) As a result, the FDA did not approve the drug. This happened some months ago. But this week the FDA issue a remarkable broadside, blandly claiming that Leronlimab had no clinically significant effect on the disease in two trials.
It was remarkable for two reasons. First, the FDA does not usually issue such statements about drugs. Secondly, there were factual errors in the statement, as if it had been rushed off.
One factual mistake in the FDA statement: in one trial, called CD10, the FDA wrote: “there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints.” In fact, the drug demonstrated "Clinical Significance" for its Primary Endpoint, and "Statistical Significance" for the Secondary Endpoint called NEWS2.
Another mistake in the FDA statement: another trial, called CD12, “also failed to find any effect of the drug on the primary study endpoint… or on any of the secondary endpoints.” Again, this is literally not true. Mortality at 14 days of treatment for the critically ill was a secondary endpoint. Leronlimab’s mortality figures for the critically ill at 14 days were an 82% improvement over the Standard-of-Care arm of the study. Big effect, not no effect.
The FDA DID NOT MENTION a critical aspect in the failure of Leronlimab to hit “statistical significance” for its primary endpoint (mortality at 28 days of treatment). Here’s why it happened. The company suggested using 4 weekly doses of 700 miligrams each. This was nixed by the FDA, who told the company only to use 2 doses, at Day 0 and Day 7.
The drug essentially leaves the body after 10 days. Sure enough, at 7 days there was 78% less mortality among the critically ill with Leronlimab (vs. Standard of Care); at 14 days, an 82% improvement. But at 21 days, which was two weeks after the last dose of the drug, the benefit was down to 50%; at 28 days, by which point the drug was essentially no longer present, the number was down to a 31% improvement – not enough to be statistically significant in a small study.
By the way, the company had ALSO initially proposed 14-day mortality as the primary endpoint – again nixed by the FDA.
In other words, the FDA altered the design of the trial in a way that affected the result. Then they entirely minimized the benefits of the drug in a public statement. This may affect the willingness of nations like India and the Philippines and Brazil to buy the drug. It may well affect the number of people who die from Covid 19 in the US as well.
There are two aspects of this that are particularly rotten. The FDA in their statement referred to the trial design as faulty. As I’ve shown, those faults were the fault of the FDA. But there’s something particularly obnoxious about these high-handed remarks re: trial design. Hydroxy-chloroquine was given EUA based on a very poorly designed study; convalescent plasma was not studied in any randomized controlled trial prior to its EUA; and bamlanivimab was approved based on a phase 2 trial -- and ultimately none of the phase 3 endpoints were met.
The true beneficiary of the FDA actions has been Gilead, who have made billions of dollars on Remdesivir. Remdesivir never showed a mortality benefit in its trials, and it does have marked side effects. The drug has just been pulled from approval in both India and the Philippines.
(As you probably know, nine of the nineteen members of the CDC/NIH Panel -- that provides Covid-19 treatment guidance to the government -- declared connections to Gilead in financial disclosures, and two others have had former connections to Gilead.)
Gilead has spent more on lobbying Congress and the administration in the first quarter of 2020 than it ever has before, according to federal filings.
Meanwhile, the FDA has said that only two conditions need to be met in an emergency for EUA: safety, and possible benefit. Leronlimab has demonstrated both of those without doubt. Yet all the FDA wants to do is discredit it in public. Why?
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