- A company is paying the FDA to investigate a drug, which has zero track record for COVID-19.
- Since it is a drug, it can later be sold at a very high price by a single supplier
- Vitamin D has been observed 32 times (as of Nov 19) to greatly reduce COVID-19
- But Vitamin D is a supplement. and not a drug, so FDA/Big Pharma are not intrested it.
- A "Investigational New Drug Application" is extremely expensive - no supplement manufactor could afford the fee
- The INDA is just the first of a whole set of fees which must be paid to the FDA to get approval
- Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER) FDA March 2020
- "An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. "
- More than half of the FDA entire budget now comes from Big Pharma, not the govt. – Sept 2018
- A single RCT for a drug is sometimes sufficient
- There have been over 500 RCTs for Vitamin D, but it is not approved by the FDA
- Off topic – FDA buried evidence of fraud in 78-600 clinical trials – Feb 2015
Researchers are testing whether a probiotic called Lactobacillus rhamnosus GG can prevent COVID-19 in household contacts of COVID patients.
On the Nov. 12 episode of the Blood & Cancer podcast, Anthony D. Sung, MD, of Duke University, Durham, N.C., joined host David H. Henry, MD, of Penn Medicine in Philadelphia, to discuss the trial of LGG as well as other research. The following transcript of that discussion has been edited for length and clarity.
David Henry, MD: Here we are in COVID. We’re recording this the first week in November. Sadly, cases are spiking in the country. And I understand you’ve got some information that you might share about how manipulating ... the microbiome that we all exist with inside our gut might somehow play into doing better or worse with COVID.
Anthony Sung, MD: Absolutely. So, as associate director of the Duke Microbiome Center, I was approached by one of my colleagues, Paul Wischmeyer, who is a professor of anesthesiology and critical care medicine at Duke. Paul had previously done some very nice murine studies with the probiotic Lactobacillus rhamnosus GG, or LGG.
He showed, in a murine model of pseudomonas pneumonia, that giving LGG to mice would help modulate their microbiome and, in turn, their immune system, leading to decreased inflammation, decreased TNF-alpha, IL [interleukin]-2, and IL-6, [and] increased Treg cells Clin Nutr. 2017;366:1549-57. This also helped prevent lung injury, and it actually significantly improved survival in mice receiving LGG Shock. 2013;406:496-503.
In addition, there has been a randomized clinical trial of LGG showing that its administration would help prevent ventilator-associated pneumonia, or VAP Am J Respir Crit Care Med. 2010 Oct 15;1828:1058-64.
And a few years ago, there was another RCT [randomized, controlled trial], published in Nature, showing that another Lactobacillus product significantly decreased the combined endpoint of sepsis and mortality, primarily by reducing lower respiratory tract infection Nature. 2017 Aug 24;5487668:407-12.
Dr. Henry: And how is that working? What is the bacillus doing to help us?
Dr. Sung: We think it’s through modulating the immune system. As mentioned in Paul’s studies, we saw significantly decreased amounts of TNF-alpha, IL-2, and IL-6, which are the same cytokines that have been implicated in COVID-19 and associated with increased lung injury in patients during this pandemic.
And we believe that by giving individuals this probiotic, LGG, we may help modulate the immune system, decrease lung injury and symptoms, and maybe even prevent COVID-19.
So with support from the Duke Microbiome Center, as well as private donations and philanthropy, we are conducting a randomized clinical trial of LGG to prevent COVID-19 in household contacts who’ve been exposed to the disease. In other words, if someone in the house gets COVID-19, we want to try to prophylax everybody else living in that house and prevent them from coming down with the same infection.
Dr. Henry: And this is an oral administration?
Dr. Sung: Correct. This is an oral pill, two pills once a day.
Dr. Henry: And it’s an ongoing study, of course, in COVID right now?
Dr. Sung: Correct. So we have an IND [investigational new drug application] from the FDA [Food and Drug Administration], and we are actively recruiting subjects both at Duke University, but also due to the unique study design, we can enroll patients anywhere across the country. Because of the importance of social distancing, everything is done remotely.
So a household contact can hear about us, either through your podcast or one of our Facebook ads or through other media. They can reach out to our study website, which is https://sites.duke.edu/protectehc, or reach out to us at our study email, email@example.com.
And we can go ahead and screen them for eligibility in our trial. And if they are eligible and they consent to participate, we will mail them a package basically overnight, FedEx, containing either LGG or placebo, as well as kits so that they can self-collect their stool and nasal swabs so we can test it for SARS-CoV-2 by PCR [polymerase chain reaction] and look at the microbiome.
Dr. Sung and Dr. Henry have no relevant disclosures. Funding for the trial is provided by the Duke Microbiome Center and philanthropic giving. The LGG and placebo used in the trial are provided by DSM.