Our Research Was Funded By Sponsors

Tempo ()

THE Covid-19 combination drug produced by researchers from Airlangga University (Unair), Surabaya, East Java, with the support of the State Intelligence Agency (BIN) and the Army was officially submitted to the National Food and Drug Agency (BPOM) on Wednesday, August 19. “If in the evaluation it turns out something was amiss, we will rectify it,” said Unair Rector Mohammad Nasih in a telephone interview with Abdul Manan from Tempo, on Thursday, August 20. He explained the initial idea for conducting the drug combining, the BIN and military’s involvement in the initiative, and the subsequent controversy that erupted.

How did the idea come about to do this drug combining?

Initially we were aiming at producing a new medication. The proposal for the idea was sent to several parties in early March. Upon receiving the proposal, some persons in BIN showed interest. But a new medication would need to go through lengthy procedures, meanwhile the country needed something quickly. A new drug would only be ready by 2021 and it could well be the Covid-19 would have dissipated by then. Then it came the idea to seek something quicker. For this, we conducted research on drugs already being used by doctors, and which ones were the most effective. And so emerged the notion, what if we combined them? When we go see a doctor, they usually prescribe a combination of four to five drugs. This was the basic idea.

What was the initial target?

Honestly speaking, the original target was conducting in vitro (lab tests) to (seek out) the most effective drugs. The output would be a recommendation for the end-user. If someone was seeking for a combination of medications, they would be these. It was as simple as that. But then a question arose in the public, has this gone through clinical trials? So we conducted clinical trials. After the trials, things heated up once again. So, fine, we went back and perfected our methodology.

How did BIN come to also fund the research?

When Unair has had five compounds, which we named the Unair 1 to 5, we had no money to fund the research. In a discussion (with BIN), a schedule was drawn up. At that stage we were still conducting lab tests on rodents. The results would only be able to be announced in September in stages. From there, we would have to conduct clinical trials on humans for three to eight months. And, God willing, by February 2021 we’d be ready. But that would have been a long waiting period. Then we came up this short-term solution, testing out a combination of drugs.

Why did you accept the offer to work in cooperation with BIN and the military?

This is an open joint-venture. It could be that from the beginning, it was BIN which showed concern, understood the situation, and made predictions. They were encouraging, and showed a real desire to handle the matter. We at Unair had taken part in the WHO (World Health Organization) solidarity trials, Oxford research, and also several other similar research drives. But for this particular initiative, our colleagues, BIN and the Indonesian Army, were willing to get involved. When there’s money, things could continue moving ahead, because researchers don’t have money.

Were many of the research subject students from the Army Officer Cadet School (Secapa) who had contracted Covid-19?

This too was a law of nature. Initially we were prepared to seek out subjects from many locations, when fate decided there would be an incident at the Secapa. We were asked to handle Secapa. So the tests in other places continued, but not as rapidly as at Secapa. This was not engineered.

Is it true that asymptomatic persons from Secapa became the subjects for the clinical trials?

We separated the asymptomatic people from the rest. We had thousands of subjects. Of the some 1,100 subjects, we only met up with 784 in the hospital. Of that, some 400 persons were asymptomatic and did not fulfil our requirements.

The medication’s efficacy was questioned because your researchers were using drugs which had been discontinued in Covid-19 trials...

Hold on, it was not as if they had been banned, you know. It was only that their use had been stopped in the solidarity trials. In our findings, when combined with other drugs, it turned out they supported each other’s efficacy. We had no subjects suffering heart problems. Chloroquine has a side effect for heart disease patients. None of our patients had heart issues.

Was this why demographically, the clinical trial subjects were considered insufficient?

We could seek them out later (if it became necessary). We were given a time frame. We had to act quickly. The BPOM gave us a minimum target of 600 subjects. Once we achieved the targets, we reported the findings. If in the course of the evaluation there are certain things amiss, we would rectify them. These are medications used by doctors. Even without this research, doctors were already using them. God willing, we can guarantee their safety.

The efficacy of the combination of these drugs to cure Covid-19 patients came under question. What were the findings?

From what we can reveal, it’s positive-negative. What initially was positive became negative. We can show those findings. If with that, the public found the results to be unsatisfactory, we need to show more data that we already have from clinical trials, data related to lab findings. If we only looked at the end results, though, indeed the results are outstanding.

Why not publish the details of these findings?

Currently there are too many curious spying eyes. Obviously we cannot provide too much detailed data. Once you become very detailed, there are too many parties ready to go into production, executing the remaining phases. So initially, we only furnished detailed reports to the organizations that hired us, namely BIN and the military. If we had published the findings from the outset, not in journals, it has that potential issue, aside from a lay community that would find very detailed data incomprehensible. But in principle, the data is available. We have submitted them to our sponsors.

Did the polemic surrounding the research emerge because no detailed data was published?

That was one of the issues. But, again, this was not the aim of the research. It was research paid for by sponsors, with very specific aims. If you are given a project to design a bridge, really, would you go ahead and publish your draft drawings? But obviously, we will eventually do this. Even though that was not the main goal of the research.

Are you hoping the BPOM will issue a permit to produce the drug?

We asked our colleagues at the BPOM to look at the issue as objectively as possible. If some of the items still need perfecting, and there are further steps that need to be executed, we will carry them out willingly. Because if there was even the slightest risk, the onus would also be on us. Caution is of utmost necessity. With objectivity and real caution, we are really optimistic a production permit will be issued. If there are no outstanding side effects, they do not cause death, moreover considering these medications are what many doctors already use, why then should there be further lengthy waiting. But production is no longer a matter concerning Unair.