The Government of Mexico City distributed ivermectin to thousands of covid-19 patients, despite the fact that its use is not approved for the treatment of coronavirus by the country’s regulatory authorities. Public policy and a study signed by officials has unleashed a scandal led by the Claudia Sheinbaum Administration, which invested more than 29 million pesos (around 1.4 million dollars) to include the drug in medical kits that were distributed to the population at the end of 2020. The Government defends, before the voices that ask for the resignation of those involved, that the decision was made with the information that was available two years ago and defended that there is scientific evidence that supports the treatment of covid with ivermectin. The authorities have been indicated by ethical problems by assessing public policy without obtaining an informed consent of the participants, not to declare conflicts of previous interest to publicize and methodological biases to justify the distribution of the drug.
The distribution of ivermectin, authorized for veterinary use and in humans as a dewormer and the treatment of some infections, surfaced after an investigation published last week by journalist Dalila Sarabia on the portal Political Animal. The text documented the use of public resources: the 29 million pesos were used to buy 293,000 boxes of ivermectin, 100,000 of acetylsalicylic acid (the compound in aspirin) and 93,000 of azithromycin, an antibiotic that has also been discouraged for treatment of covid. From that information it is clear that at least about 200,000 people participated in the study. The delivery of the medical kits, according to the report, began in December 2020 and pretended to demonstrate that those patients who received the drug were less likely to worsen and hospitalize that those who did not receive it. It is not clear if the kits were delivered without indications on the use of medications they included.
The controversy over the use of ivermectin in covid patients has a long history. Since June 2020, just a few months after the pandemic was declared, the World Health Organization (WHO) has advised against ivermectin treatments for those infected with coronavirus, after a study published in Australia suggested that it was effective in inhibiting the virus replication in vitro. At that time of the epidemic, no vaccine had yet been authorized and pharmaceutical companies and authorities around the world were looking for accessible drugs that were already in circulation and that could help in the treatment of covid-19.
The WHO said there was not enough evidence to prove that it was effective and accused biases in the information collected. The Food and Drug Administration (FDA), the US regulatory agency, has said that its intake in large quantities is dangerous and has indicated that the risks outweigh the supposed benefits. The Centers for Disease Control and Prevention, the country’s epidemiological authority, have also warned about its use, as has the European Medicines Agency. In Mexico, Hugo López-Gatell, the government official of Andrés Manuel López Obrador in charge of the response to the pandemic, has also been emphatic against the use of ivermectin for covid cases. “Ivermectin is used incorrectly for the treatment of the COVID-19, without any scientific evidence of its effectiveness and safety for the treatment of this disease,” said a message from the Pan American Health Organization that shared López-Gatell in September of 2020.
Despite this evidence, the digital public innovation agency, the local health secretariat and the Mexican Social Security Institute sought to prove the effectiveness of ivermectin, which was not originally contemplated in the medical kits distributed by the authorities, and follow the Steps of cities in Brazil and India, among other countries, which also bought the medication and distributed it. They also supported statements by the Nobel Winner of Medicine in 2018, Tasuku Honjo, who encouraged to continue investigating the effectiveness of the drug. They called it a “quasi experimental” analysis. “What is really important here is to validate that the public policy that Mexico City implemented massively, (…) the medical kit, was an important factor in reducing hospital admissions and, of course, possible deaths,” said José Merino, head of the ADIP, in statements made last May quoted by Political Animal.
Merino, with a long career as an academic before joining the SheInbaum government, is one of the authors of the study published more than a year ago, which also appears the Secretary of Health, Oliva López and Eduardo Clark, General Director of Government Digital of the ADIP. The SOCARXIV portal, which lodged the publication, decided to withdraw it last week, alleging that it contained “wrong information” and that was collected in an “unethical” way. Merino repudiated the decision and described it as “colonialist” and “authoritarian”. The owner of the ADIP added that the scrutiny that has undergone the publication is proof that there is nothing to hide and described as “hysteria” and “false scandal” the criticisms made to the investigation of him. “It was a bad politics and little ethical,” said Sociologist Philip N. Cohen, Director of Socarxiv. Cohen explained that a deeper study of the ivermectin was encouraged, which is not equivalent to his mass distribution: “There was never a good reason for the massive distribution of this medication, and many reasons to be skeptical or opposed.”
Saul Caballero, one of the co-authors of the study, did retracted the results and the consequences of the investigation. “Applaud and support the decision of Cohen and Socarxiv to withdraw the scientifically false article,” wrote Gentleman, who served as director of data analysis in the ADIP until mid-year, in the Twitter account. The other six co-authorities have signed a letter where they ratify the analysis and deny that it is “poor quality”.
The academic discussion has become a political scandal. Opponents Party National Action and Citizen Movement (MC) announced that they were going to sue Merino and Shienbaum for the distribution of ivermectin and their payment with public resources. “They decided to use citizens as laboratory mice,” said Royfid Torres, Coordinator of MC at the Local Congress, and regretted that this was given in the most serious peak of the pandemic in Mexico. As an express question of this newspaper, a spokesman for the City Prosecutor’s Office said that he was going to confirm if an investigation had been opened or not after journalistic revelations about the use of ivermectin.
“It was not an experiment as painfully has been handled in some media,” said the health secretariat of Mexico City in a statement. The health authorities said that it is no longer included in the medical kits since last September and rejected that there were considerable risks for mild and moderate patients of Covid for the use of ivermectin. They said that he could not speak of ivermectin as an “experimental treatment” because it had been approved 30 years ago for other treatments and did not recognize any error or criticism of the study they performed. Since its perspective, the evaluation of a public policy has been taken out of context.
The crossing of accusations on both sides by “lies” and “paranoias” leaves different edges in the air. If it was treated in effect of a scientific study, if all ethical protocols were followed and the necessary methodological considerations were taken and, whether to reconsider the permanence of the officials involved or political reading has exceeded ethical concerns. The criticisms go through several issues in the political arena: from the management of the pandemic until the lack of congruence in policies against the Covid in the different government orders. Also in the spotlight is the justification given by the authorities of the capital – which has led the application of tests, the tracing of infections and one of the best vaccination strategies in the country – to use ivermectin, despite the fact that it was not Recommended by reference institutions in Mexico and abroad. Doubts and debate about the answers will continue in the coming days.
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