they created chaos; now they want to fix it

The drug shortage in public hospitals is, by far, one of the most serious problems generated by this government due to its wrong decisions on suspicion of corruption that they never documented or accused. The dismantling of the purchasing system that worked in previous six-year terms and the lack of knowledge and of an alternative plan to buy and distribute the thousands of medicines that the federal health sector demands to treat the diseases of Mexicans, was the main cause that in the last three years, millions of patients from all the states of the Republic, the same children with cancer, diabetics, hypertensive, people with HIV AIDS or patients with kidney diseases, had their treatments, therapies and procedures interrupted, with a serious deterioration of their health and in some cases even death.

Without undermining the possible corruption or the monopolies that operated in the distribution of medicines throughout the country, which otherwise did not end in any complaint or investigation, much less in any individual or company accused of that corruption, the government of Lopez Obrador made capricious and unsupported decisions, to the detriment of the production and supply of substances and medicines necessary to treat chronic diseases, causing one of the worst crises in memory in the public health system due to the shortage of medicines and treatments; that combined with the disappearance of the Popular insurance and its Fund for Catastrophic Expenses and the creation of an Insabi in the hands of improvised health workers, were the perfect cocktail to undermine the health of millions of Mexicans of all ages, especially those with the fewest resources who totally depend on the public health system.

A case that documents the serious mistakes made by the Ministry of Health and the irrational whims of officials, such as the undersecretary Hugo Lopez Gatell, supported and defended to the point of ignominy by the president, is the production of Methotrexate in Mexican laboratory plants that supplied public hospitals with this substance, which is essential for chemotherapy for people suffering from cancer. It was precisely methotrexate together with vincristine, the first substances that began to be scarce in the health system, causing the crisis of children with cancer and the protests of these and their parents before the suspension of chemotherapies and the death of up to 3 thousand minors for this reason, as documented by the associations of parents of children with cancer in several states of the Republic.

On April 21, 2021, according to documents in the possession of this column, Cofepris notified Pisa Laboratories of the closure of its Methotrexate production plant, located at Av. Miguel Ángel de Quevedo 555 in Colonia Romero de Terreros, in the mayor of Coyoacan. In a diligence carried out that day, the Sanitary Authorization Commissioner of CofeprisAmérica Azucena Orellana, personally went to the plant to order the closure of production, just when the methotrexate shortage crisis was causing the suspension of chemotherapies for children and adults in public hospitals.

With Official Letter No. CAS/7022/2021, Cofepris, from the Ministry of Health, ordered Pisa to suspend “the manufacture of oncological sterile products (lyophilisates and solutions)” by revoking the authorization they had from the same commission with the number 203300EL531533. It also ordered the Mexican laboratory to stop the operation of its “physiochemical and microbiology analysis areas of the Quality Control Laboratory, as well as the use of sampling and weighing of the warehouse.” Both suspensions were based on alleged quality failures in the production processes in Pisa that Cofepris never documented, but which did serve to stop the production of methotrexate and other oncology solutions demanded by public hospitals.

The verification act of Cofepris, with which this closure was decided, argues violations of the General Health Law, and articles 224 and 225 of the Regulation of Inputs for Health and NOM 059-SSA-2015 of Good Practices in the drug manufacturing. And from that, without allowing the company to demonstrate that there were no such violations, the seals were placed and it was ordered: “the suspension of work of the product methotrexate, injectable solution, placing the suspension seal 069 on the main door of access to the manufacturing area and filling of the injectable oncology area”.

Since this suspension was effected, the aforementioned laboratory has presented information and studies that document the reliability of its processes and compliance with all sanitary regulations in the production of injectable oncological drugs such as methotrexate; but to date Cofepris has refused to reopen the Pisa plants not only in the Mexico City but a new plant built in Guadalajara that has state-of-the-art technology for the manufacture of methotrexate and other oncological substances.

But given the delay in the purchase of medicines by the UNOPSwhich has not yet managed to bring to Mexico more than 40% of the key medicines demanded by the health sector, including oncological substances that are needed for chemotherapy for children and adults with cancer, from the Ministry of Health there are those who seek to reactivate the suspended production in national laboratories and the purchase of medicines and substances from the national pharmaceutical industry, although according to high-level sources from Cofepris, the main obstacle to lifting the suspensions of production in Mexican laboratories and being able to re-establish government purchases from them, his name is Hugo López Gatell.

The paradox of this whole story is that the same undersecretary who refuses to grant the Covid vaccine to Mexican children, arguing that “they have a lower risk of death”; the same one who told us at the beginning of the pandemic that this was “a minor illness that will pass soon”; the one in which I estimate the most catastrophic scenario of deaths from Covid at 60,000 Mexicans, when today more than 315,000 have died according to the official figure and even more than 500,000 according to the surplus mortality figures from the Ministry of Health; The one who described children with cancer and their parents who demand medication and protest as “coup plotters”, is the same one who now has stopped the production of oncological substances in national laboratories. Why? Because he feels like it and because his boss and defender, the president, allows it.

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