It is with regret that I inform you that the FDA has denied IVC compassionate use approval for treating Coronavirus.
After acknowledging receipt of the 18,000+ signed petition, the FDA Center for Drug Evaluation Research (CDER) notified us by e-mail that we should submit an application for an as a "investigational new drug" and that their goal is to "determine if candidate therapies are effective and safe and then make these therapies available to patients."
The way compassionate use works is that potential therapies would be made available first to patients, and then determined if they are effective and safe later! This seems ethical and logical to do if you are in a national emergency, where 110,000+ have perished within a few months, businesses have closed, people have lost their jobs, and families have been greatly affected.
When the FDA recommends "applying" for a new drug, this can only suggest that:
- A compassionate use approval has been denied. The petition goal was to obtain compassionate use approval so they obviously counter offered with a "regular" application process.
- They don't believe IVC is safe and effective treatment
A clinical trial would have to be designed, approved, and funded not at the expense of the FDA.
If we accept their offer to submit a new drug application, this would mean we would be accepting the FDA's belief that IVC is unproven and ineffective. - For this reason, we absolutely refuse to submit the "investigational new drug" application! Sorry FDA, but IVC already has sufficient evidence to warrant compassionate use approval.
So what does this mean for you or your family?
If you or one of your beloved family is hospitalized with Coronavirus, your doctor has no obligation to treat you with IVC.
If you or one of your beloved family is hospitalized with Coronavirus and develops the complications ARDS, Sepsis, or Sepsis Shock, your doctor would have no obligation to give you IV Vitamin C!
Even if you request it, they are not really required to give you it and you would have to risk conflict. They can still prescribe if they desire, but that depends on who is treating you and whether they are educated on IV Vitamin C. As this natural therapy is not mainstream yet, the majority of doctors would probably not comply with your request.
IVC and Sepsis/ARDS Clinical Studies
1986
16 ARDS patients were given 1 gram IVC every 6 hours along with selenium, NAC, and Vitamin E.
Another 16 ARDS patients received placebo or sugar water
The mortality rate in the IVC group was 37% compared to 71% in the other group.
That's a nearly 40% decrease in mortality rate!
Sawyer M.A.J., Mike J.J., Chavin K., Marino P.L. Antioxidant therapy and survival in ARDS. Crit. Care Med. 1989;17:S153.
2016
The Marik Study of 94 patients
47/94 Sepsis/Septic Shock patients received 6 grams IVC per day along with IV hydrocortisone and IV Thiamine
47/94 Sepsis/Septic Shock received the placebo
IVC Group Mortality rate: 8%
The other group: 40%
This is a 32% decrease in mortality rate!
Marik P.E., Khangoora V., Rivera R., Hooper M.H., Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017;151:1229–1238. doi: 10.1016/j.chest.2016.11.036.
2016
A group of 14 septic shock patients that received 25 mg/kg IVC every 6 hours for 3 days had a mortality rate of 14% compared to 64% in the other group of 14 septic shock patients that received no treatment.
Zabet M.H., Mohammadi M., Ramezani M., Khalili H. Effect of high-dose Ascorbic acid on vasopressor’s requirement in septic shock. J. Res. Pharm. Pract. 2016;5:94–100
2017
Cleveland Clinic CITRIS ALI Trial
30% mortality in IVC group vs 46% mortality rate in the other group
Fowler A.A., Truwit J.D., Hite R.D., Morris P.E., DeWilde C., Priday A., Fisher B., Thacker L.R., Natarajan R., Brophy D.F., et al. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019;322:1261–1270. doi: 10.1001/jama.2019.11825
Would the benefits experienced in 2017 apply again in 2020 Coronavirus?
Very likely. Sepsis in 2017 is Sepsis in 2020. ARDS in 2017 is ARDS in 2020. I would assume that sepsis or ARDS has not changed itself with the 3 years.
So lets pretend that diabetes (high blood sugar) was a complication of Coronavirus. Diabetics usually take metformin to reduce their sugar levels in real life. Would it be rational to give Coronavirus Diabetics metformin? Absolutely. But by the FDA standards, they would probably argue that metformin has to be proven to work in Coronavirus patients before approval.
Sepsis and ARDS are Coronavirus complications. So IVC definitely has great potential in treating these complications.
2019
VICTAS Trial
A combination of IVC, Thiamine, and Hydrocortisone will be given to about 500 Sepsis patients across 30 Medical Centers.
This is the Dr. Marik protocol done on a greater scale.
Coincidentally, Sepsis and ARDS are common complications seen in hospitalized Coronavirus patients. When these research studies were being done, Coronavirus did not cause the Sepsis or ARDS. But it would be fair to assume that it would still work for Sepsis and ARDS that is caused by the Coronavirus.
According to the CDC, 67-75% of ICU admitted Coronavirus patients, develop ARDS!
https:/https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html
Why shouldn't these patients deserve IVC?
Doctors live under great scrutiny and are heavily regulated by various health agencies. They don't have the true freedom to try new therapies. This is where the FDA, CDC, HHS need to give them some clearance to apply new therapies. Sadly, these health agencies are not really interested.
According to the FDA CTAP website, over 900 potential therapeutic applications for Coronavirus were submitted. Yet, only 2, have received emergency use authorization. Hydroxychloroquine and Remdesivir.
They are simply not using the emergency use approval enough!
With over 110,000 perished and 4 months into this, you have only managed to approve just 2 medicines?
Do you believe that Americans should not receive other potentially life saving treatments such as Vitamin C, plasma therapy, zinc, etc?
When Veteran American physician, Dr. Richard Cheng, reported IVC curing 50 patients in China, shouldn't that warrant approval?
When Dr. Weber noticed that Vitamin C levels in Coronavirus patients experiencing sepsis was "very low," shouldn't that warrant approval?
When you originally granted hydroxychloroquine emergency use approval without any U.S. based clinical studies that it works for Coronavirus, do you believe that this standard should not be applied towards other potential therapeutics?
Even if you approve these medicines, what do you have to lose? Cant you simply revoke the emergency use approval status if you feel that the new drug doesn't seem to work?
The Remdesivir ACTT Adaptive Covid Treatment Trial Examined Closer
This Ebola antiviral medication was granted emergency use approval after the average duration of ICU stay decreased from 15 to 11 days, or nearly 31% in a study of nearly 1100 patients.
If you review the research study closely, you will find out that this faster recovery statistic was experienced in Coronavirus patients that required "supplemental oxygen" and not to those more severe that required ventilators.
According to the NIH,
"Data from a multinational, randomized, placebo-controlled trial (the Adaptive COVID-19 Treatment Trial [ACTT]) of hospitalized patients with COVID-19 showed that patients with severe disease who were randomized to receive remdesivir had a shorter time to clinical recovery than those who received placebo. The benefit of remdesivir on reducing time to recovery was clearest in the subgroup of hospitalized patients with severe disease who were not intubated but who required supplemental oxygen. In the preliminary analysis of ACTT, there was no observed improvement in the time to recovery among those who were mechanically ventilated, but the follow-up period may have been too short to have shown a difference."
https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/
The Remdesivir ACTT researchers even concluded that remdesivir alone is not sufficient enough for treating Coronavirus stating that:
"Our findings highlight the need to identify COVID-19 cases and start antiviral treatment before the pulmonary disease progresses to require mechanical ventilation. However, given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient."
This is where IVC, IV zinc, corticosteroids, or antibody therapy could be combined with remdesivir to produce a more robust treatment.
From the Remdesivir website:
"Remdesivir is an investigational drug that has not been approved by the FDA for any use. It is not yet known if remdesivir is safe and effective for the treatment of COVID-19."
So if Remdesivir claims there is no evidence there medicine works for Coronavirus, then why does the FDA need "evidence" for IVC or the many other potential therapeutics?
The FDA's failure to grant IVC compassionate use approval or any other potentially life-saving therapeutic in spite of well established evidence is an act of negligence by definition.