A group of South African doctors has taken on South African drug regulator known as SAHPRA to make ivermectin more accessible for the treatment of COVID-19. Forming what’s called the “I Can Make a Difference” organization, recently, South African media E-News Channel South Africa (eNCA) interviewed one of the physician-activists involved about a looming Feb. 22 court date. Dr. Naseeba Kathrada reports the group has sent within their “founding affidavit” (E.g., court application) and has shared this action with the President of South Africa because he is in charge of the “National Command Council.” This affidavit was also submitted to the chairperson of SAPHRA, the regulatory authority itself and others. Dr. Kathrada reports that SAHPRA opposes the affidavit, meaning they will go to court to thwart the physician-based activist groups’ effort to make ivermectin freely available now as a therapy to treat COVID-19. Interestingly, the other parties responded they would abide by whatever a court declares; hence the only entity challenging “I Can Make a Difference” is SAPHRA.
The Fundamental Problem
The physicians are not demanding that ivermectin be placed on the SAHPRA COVID-19 protocol, acknowledging that more research is necessary. Moreover, they aren’t “anti-vax,” but the doctor noted, “However, because of the issue with the registration lapsing, etc. and SAHPRA banned the drug on the 22nd of December, it is now illegal for a doctor to have possession of tablets to give to their patients, without a Section 21 application.”
Dr. Naseeba Kathrada reports that “We have done due process like SAHPRA asked and we’re saying it’s a cumbersome procedure and it takes longer and a doctor cannot be filling in a form that takes an hour when you are seeing 40 to 60 patients a day.”
The Feb. 22 Court Hearing
Apparently, not only will Dr. Kathrada’s case be heard on Feb. 22, but actually, all ivermectin cases in South Africa have been consolidated by the judge on this date.
What do the doctors in “I Can Make a Difference” Seek?
According to Dr. Kathrada, the physicians are “seeking relief for the use of ivermectin on a prescript basis as opposed to filling in a Section 21 application because it takes so long.” TrialSite reported that although SAHPRA has pivoted from a far more draconian stance regarding ivermectin, the Section 21 exception is rife with bureaucratic stages, gates and hurdles hence why the doctors formed the activist group to take on the regulator in court.
Why would a drug, already approved by the FDA, for example, not be available for off-label prescription between consenting physician and patient? After all, in the United States, although the National Institutes of Health (NIH) haven’t budged much from their position, that is, they do not recommend for or against ivermectin, they also don’t call out for the arrest of physicians that treat patients off-label with the drug.
The right of health care workers to take as Prophylaxis
Interestingly, the South African physician also commented to the media interviewer that as part of their request “I Can Make a Difference” seeks to ensure that health care workers, who are on the front lines and face grave risk, should have the right to secure a prescription from a licensed doctor to take the drug on a prophylaxis basis.
Regulators Delay—Patients Suffer
Although SAHPRA appeared to soften their stance, changing ivermectin status completely banned except for research to compassionate use under Article 21, the regulator is apparently playing games with people’s life. How are they doing this? Well, according to Dr. Kathrada, lives are first and foremost at stake. Given the pandemic condition, doctors should be able to fill a prescription immediately.
Well, according to Kathrada, this isn’t the case. The Article 21 process takes an hour to fill out a form, and out of the five requests she has made, she isn’t impressed with the turnaround time. Out of five Article 21 applications she has made on behalf of patients thus far, she hasn’t received confirmation on three (3), and she is in a “pending” status on the first two Article 21 requests she made four (4) weeks ago.
What this means in all reality is that SAHPRA is playing a dangerous game with people’s lives. Physicians are making legitimate requests and whether due to unintentional bureaucratic malaise or intentional delays, the result is the same—patients suffer.
A Political Problem?
The theme is similar in many nations around the world. Governments resist a well-known drug with an overall safe profile that appears to be able to help treat COVID-19 in democratic societies. The ostensible rationale is that the drug isn’t yet proven, and regulators have asked for randomized, controlled trials. Yet there have been dozens of these studies, some even funded by groups affiliated with the World Health Organization, and regulators still seem unimpressed. In this case in South Africa, the group of physicians merely don’t want to be labeled criminals when they are treating their patients off-label. That’s because the bureaucratic stage gates associated with Article 21 don’t make sense during a pandemic.
TrialSite suggests that it would appear that this looks increasingly not like a scientific or even business problem, but actually, a political and legal one as is becoming apparent in South Africa. Perhaps those involved with political organizing start mobilizing. Those elected representatives in democratic societies are ultimately accountable to the voters.
Call to Action: The Feb. 22 court case results should be monitored.