SARS-CoV-2 (Covid-19) took the world by surprise. Many experts knew a pandemic of this magnitude would eventually hit. No thanks to our experiences with HIV (1981 to present), H1N1 swine flu (2009), or the Spanish flu (1918), another pandemic was expected. Madison Law, APC represents a company that has developed an antiviral botanical drug to treat Covid-19. All eyes are on the progress of this drug. This article discusses the process to have this drug approved through the appropriate channels.
Management of the Covid-19 pandemic fell upon the U.S. Department of Health and Human Services (“HHS”), which is the overarching department charged with protecting the health of all Americans. HHS operates divisions such as the Food and Drug Administration (“FDA”), the Centers for Disease Control and Prevention (“CDC”), and the National Institutes of Health (“NIH”). These agencies are charged with the duty to provide oversight, grants, and facilitate communication to meet the goals of the HHS. They operate domestically and beyond the U.S. borders, frequently cooperating with their European, Canadian, Australian, and Asian counterparts. Technically, if a potential for a pandemic arises anywhere in the world, HHS should be promptly alerted so it can thwart eminent dangers.
Each HHS agency provides a primary function aimed at fulfilling a particular need. The FDA’s role is limited to oversight and governance of the foods and drugs Americans use. Thus, all new drugs and devices used for treatment of humans must meet the FDA’s standards.
When Covid-19 hit, the FDA had a huge function to fulfill. In the U.S. alone, within a few months, over 1,000 applications were filed with the FDA, each having something to do with Covid-19. These included tests, vaccines, and treatments, all hoping to clear FDA. The FDA’s function is not unique. The European Community, Canada, Japan, China, and many other countries have similar organizations to protect their own citizens. They have also been inundated with similar applications. However, the FDA sets the gold standard within these regulatory organizations. The FDA has developed a process to decipher voluminous applications to protect the public. The rest of the world looks to the FDA for leadership and usually gives deference to its judgment.
- The Process
The FDA oversight process starts with a sponsor filing a new application, known as an Investigational New Drug (“IND”) application. In its application, the sponsor provides preclinical tests, scientific studies, proprietary data, and other convincing evidence to prove that its product will provide a benefit to patients. Once the FDA has reviewed and confirmed that a potentially helpful product or treatment has been offered, it issues an IND number. The issuance of that number is the start of a lengthy, detailed, and rigorous process to ensure the product is safe and efficacious. This process includes preclinical tests, multiple clinical trials, and an examination of the manufacturing and chemistry of the drug employed by the sponsor.
The sponsor must first establish the safety and efficacy of its product. This process involves in-vitro and in-vivo preclinical tests. The sponsor uses these tests to prove that its vaccine, drug, test, device, etc., is not harmful to live cells or animals. They also prove that the product provides a benefit. Thus, if a Covid-19 treatment is offered, the preclinical process requires the sponsor prove its drug can effectively neutralize Covid-19 and that it can do so without harming test animals.
- Clinical Trials
There are usually three phases involved in clinical trials. You may have heard recent comments from the FDA stating that no sponsor will be allowed to sidestep these three phases just because Covid-19 is a national emergency. These phases were designed to protect lives and ensure efficacy. In the first phase, the sponsor must prove that its product, or drug, does not pose a safety threat. Thus, if a vaccine or drug causes an illness, the product fails.
In the second phase, the sponsor must prove that its product will likely address the need for which it was designed. During this phase, a vaccine must show some evidence of efficacy, while a drug must show that a patient who takes the drug is more likely to recover, or recovers more easily, due to the drug. The second phase should involve a double-blind test where the drug or a placebo is administered to each member of a small sample of patients. If the results show that patients fare better as a result of taking the drug, phase two is satisfied.
The third phase is usually a second phase “on steroids.” The third phase involves more details and an increased number of patients. A phase two trial for Covid-19 may involve 50 to 100 patients, while phase three can involve 500 to 5,000 patients. A series of statistical formulas are used to provide reasonable certainty that the test results and sample sizes are sufficient and reliable. The third phase employs a double-blind approach, ensuring that neither the patient nor the investigator knows whether the drug/vaccine or a placebo was administered to the particular patient. Upon completion of the third phase, the double-blind code is broken and actual results are computed. If the results prove the drug or vaccine was helpful, the sponsor may proceed with other steps.
- Manufacturing and Chemistry
In its review, the FDA also pays detailed attention to the manufacturing and chemistry process used by the sponsor. The FDA employs a highly confidential process for submission and review of the sponsor’s proprietary information. During this process, the FDA ensures the process is safe, repeatable, and scientific. The FDA will also audit and thoroughly examine all manufacturing sites, systems, and documentation. Numerous unannounced site visits by FDA agents is a normal occurrence. Nothing is left to chance.
- A Cure for Covid-19 and HPV
Madison Law, APC represents a company with multiple INDs currently pending with the FDA. Some of these INDs relate to the treatment of HPV and cervical indications. One IND offers a treatment for Covid-19 with the help of a botanical drug known as N110-7. This drug is an antiviral liquid that is comprised of figs, vinegar, and colloidal silver. The protocol calls for daily oral administration of N110-7 for two weeks to infected patients. Preclinical tests have shown that N110-7 blocks the proteins of Covid-19 from binding to healthy cells at a rate of 60% to 65%. Numerous other tests have shown safety and efficacy of the N110 family of anti-viral drugs against HPV, herpes, coxsackie virus, and HPV-caused warts. We are excited to see the development of N110-7 and look forward to a safe treatment for Covid-19.