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Ivermectin study to take a while

DEMAND AND SUPPLY - Boo Chanco (The Philippine Star) - May 10, 2021 - 12:00am

There is a groundswell for fast approval of Ivermectin for use in COVID cases because people are frustrated and afraid. The Duterte administration has failed to make enough vaccines available early because, as Foreign Secretary Teddy Locsin complained, someone dropped the ball.

Without the vaccines, people cling to drugs that are anecdotally claimed to be effective against COVID. Ivermectin, an antiparasitic drug, is one of those.

Repurposing a drug is nothing new. But it requires extensive clinical trials to make sure it will be effective against the new disease. The right dosage must also be determined.

Ivermectin had been safely used for decades in Africa to treat parasitic diseases. But using it for COVID requires clinical studies to make sure it works and at what dosage. Toxicity at this new dosage must be determined for safety.

That’s why our scientific community, from the FDA to 41 associations of doctors and pharmacists, want a proper clinical trial. But clinical trials take time and money.

It will cost taxpayers P22 million, money well spent to get answers one way or another. They also need eight months to conduct it, but likely, more.

Here are excerpts from the report of DOST Secretary Fortunato dela Peña on Ivermectin clinical trials during last week’s televised report of Duterte to the nation:

“Ang proyekto po ay pangungunahan ni Dr. Aileen Wang, isang multi-awarded researcher na ang specialization ay pulmonary – siya po ay konektado sa Philippine General Hospital.

“Ang schedule po ng implementation ay walong buwan at magsisimula sa June 2021, kasi po itong Mayo, ang ginagawa pa nila ay ‘yong makuha ‘yong ethics approval para doon sa kanilang gagawin at makapag-recruit ng mga tao o staff na siyang mag-a-administer ng clinical trials.

“At anim na buwan po ang nakikita nilang haba ng panahon para makakuha nitong 1,200 adults na magbo-volunteer 18 years old and above, asymptomatic, and non-severe or mild to moderate. Ito po ang pinili kasi ang karamihan po ng pasyente natin talaga ay itong asymptomatic and non-severe…

“Ang DOH po ang nag-commit ng P22 million para sa Ivermectin clinical trials and ito po ay inaasahan natin na makapagpo-provide ng data sa efficacy, safety, and the effect on viral clearance of Ivermectin among asymptomatic and non-severe Filipino patients.”

There it is… The study must be properly designed. There must be no shortcuts if it is to get accepted by the medical community.

Some weeks ago, someone in one of my e-groups posted the link to a study (published by an electronic journal of the Lancet, not the regular Lancet) that was supposed to have indicated the use of Ivermectin for COVID cases. I checked it out and the researchers qualified their findings:

“This pilot points towards a potential use of Ivermectin in COVID-19, which warrants further exploration under larger trials, with clinical outcomes in patients with risk factors or more severe disease. This is of particular importance for settings with limited resources given Ivermectin´s low price, broad availability, and scalability of manufacturing processes.

“This pilot has several key limitations that warrant careful interpretation of the results.

“Firstly, it was designed to explore a potential signal for the use of Ivermectin in COVID-19, not to provide definitive evidence on the subject, hence its small sample size.

“Second this pilot was restricted to subjects with non-severe disease and no risk factors in whom the treatment was provided in the first 48 hours of fever or cough…”

A Filipino doctor in the US who reacted to the study commented that “Unfortunately, this study has major flaws, making the findings of questionable value.

“One major flaw is that there were only 12 patients in the Ivermectin and 12 patients in the placebo group, way below what they calculated (called power calculation) to be needed to assure that the findings are not due to chance. They started with 90 subjects, but through elimination, ended up with 24, 12 in each group.

“Secondly, the primary objective was to determine if the virus is still in the body after at least one week and sometime later. In both occasions, there were no differences between the two groups on days tested, where almost all subjects still carry the viral load.

“The only significant differences were in a few men whose smell and taste returned sooner in those who were taking Ivermectin compared to placebo.

“No report of any death in any group, and no report of anybody getting worse and all survived.

“So, if everybody without any control got Ivermectin, you can declare the drug to be effective, and likewise, if all got placebo, you can declare placebo to be a cure as well since all survived and no one worsened and no one died!

“Remember, for people less than 70 years old, over 99 percent will survive and for those over 70, 95+ percent will survive covid!”

The same Filipino doctor observed that “A peer reviewed paper from JAMA (Journal of the American Medical Association) reported the most recent randomized controlled trial comparing Ivermectin to placebo found Ivermectin was no better than a placebo or a placebo is as good as Ivermectin in treating early cases of covid-19.

“Without any comparison of the active drug to a placebo or another treatment, known as prospective randomized controlled trial (RCT) the outcome is of questionable value.

“One could argue that treating with something may be better than nothing, especially in the Philippines, that it seems hopelessness is getting prevalent because of the government’s slow action or inaction. Ivermectin gives hope, and I just hope it is not false hope.”

Expect our politicians and bureaucrats to provide a loophole. Last Friday, the FDA approved Ivermectin for use as a human antiparasitic treatment. This will allow local manufacturing of the drug.

Doctors can claim they wrote the prescription to get rid of a patient’s roundworm problem. A patient can use it off-label. The politicians are happy. FDA is relieved from political pressure. Politics wins over science.

People who take it know they are taking a risk. Given the state of hopelessness, it is a risk most are willing to take. Desperate enough, I might too.

And that’s where we are now. Poor us.

 

 

Boo Chanco’s e-mail address is bchanco@gmail.com. Follow him on Twitter @boochanco

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