Dr. Michael Bukhalo, a Rolling Meadows dermatologist and primary investigator for clinical trials, would like to give us his viewpoint on the current international search for a successful corona virus vaccine and drugs.
Dr. Bukhalo has been involved in 250 studies that have included all phases of research by statistical numbers. These studies also viewed serious biologic injections given to patients who were then observed, examined, and treated. Here is his opening statement: “Being a doctor-researcher helps me keep my mind open and allows for a better acceptance of novel options of treatment.” He adds “But it also makes me more cautious. Simply, because I know how exactly drugs and vaccines are developed, I do not jump for joy seeing what has been happening in our development market.”
Dr. Bukhalo is worried that much of the research is too rushed and non-specific to be considered scientific. The good doctor also states he believes that often research is focused on financial gains. A case illustrating these comments is the recent acknowledgment by Russia’s President Putin of his country’s “first in the world” successfully produced Covid-19 vaccine. Some health and pharmaceutical Russian and Western officials have expressed alarm at the speed with which Moscow’s scientists developed the vaccine. Using testing on their own soldiers and even Putin’s one daughter, Russia’s researchers used accelerated evaluations and brief trial times to speed through regulatory corners. Indeed, the vaccine received its government’s approval after less than 2 months of testing on humans. The trials consisted of a combined 1st and 2nd phase of only 76 people – no 3rd stage was present that would have involved thousands of people. Furthermore, as of the present time, Russia has not released any safety or immediate data from its studies. They plan to start mass vaccination in October.
Meanwhile, Dr. Bukhalo continues that only Phase 3 of the trials “allows for proper gathering of research data on a large sample of patients to assess safety and efficacy (effectiveness) of the new medication.”
He states that rushing this trial will cause the process to have cutting edges that will result in safety risks. It worries Dr. Bukhalo that the use of the word “success” can lead to the lack of actual data that should be scrutinized.
Here are Dr. Bukhalo’s questions about what he would like to have answered about all of the present on-going trials. He tells us that we need to know their answers before we can start using a new drug or vaccine:
1. How big was your sample of patients?
2. How diverse was your sample (gender, age, medical history, lifestyle, ethnicity)?
3. What was the rate of placebo versus the real drug? This answer would take into consideration the percentage of effectiveness among the placebo or non-medical group vs. the real drug or patient group.
4. What was the number of beginning patients enrolled in the study and the number that finished?
5. How many patients experienced adverse occurrences? How many actually had serious setbacks leading to hospitalization or death?
6. How was the patients’ group exposed to the actual virus to aid in the study of that vaccine?
7. What was the efficacy-positive response rate that considered a total number of patients who were enrolled in the study and not just those who finished the study?
