Brazil - BRAZZIL - The scandal of fake medicine and fake labs - Brazilian Health - August 1998


Brazzil
Health
August 1998

Flower
Power

Even after having been contacted by the women who found themselves pregnant while taking fake Microvlar pill, German laboratory Schering didn't take any action to alert the public.

The disclosure that Brazilian women were taking birth-control pills made of flour instead of active ingredients has provoked the Health Ministry's intervention, which in turn has led to the discovery of a rampant use of fake medicine across the country. At least a dozen women came forward to say that they became pregnant while taking Microvlar, a contraceptive made by German laboratory Schering, one of the ten largest in Brazil.

The lab's explanation? The fake capsules that reached the market had been produced as a test for a new machine and the flour-filled pills had been sent for incineration and stolen during this process. Not very convincing, though, since the laboratory didn't tell the authorities or go public before the case had already become a scandal. Even after having been contacted by the women who found themselves pregnant while taking the medicine the company didn't take any action to alert the public.

In some instances, the medicine snafu resulted in tragedy. It was reported that ten men died across the country while taking an innocuous Androcur, a drug that was supposed to treat their prostate cancer. In the state of Amazonas, 120 AIDS patients being given a triple medicine cocktail by the government found out that their medication was adultered. All of these reports provoked panic with people being medicated, wondering if they were taking the real thing, a placebo, or something toxic and dangerous.

After being just installed in the office of the Health Ministry, José Serra closed Schering laboratory for five days while government inspectors probed their facilities. At the same time the Receita Federal (the Brazilian IRS) started to audit the company in search of possible fiscal fraud. The Justice Ministry ended up intervening. It created a special police force to fight counterfeit drugs and started a special hot line for people to report fake medicines.

Brazilian police started a national crackdown, arresting bogus drug sellers and shutting down pharmacies selling fakes. Hundreds of boxes containing phony medicines and prescription drugs stolen from hospitals were confiscated in São Paulo and Rio, Brazil's two largest cities. More than 60 counterfeit brands of pharmaceuticals were discovered by early August, ranging form antibiotics to cancer and AIDS medicines. Schering was fighting in the Justice a close to $3 million fine and eight women who said they became pregnant while using Microvlar were suing the laboratory.

Maria Seila Meireles Gonçalves, 32, one of the first women to openly speak about discovering that the birth-control pill she was taking did not work, was using the product for eight years. Gonçalves, who lives in Mauá in greater São Paulo, is one of the women suing the laboratory. "I was shocked," she explained, "I was taking the contraceptive because I'm in no condition to have more children."

Leni Aparecida, another plaintiff, says that for 10 years she had opted to use Microvlar due to the low price of the product (around $3 for a 21-pill carton against an average price of $15 charged by other contraceptives) and never had any problems.

Addicted to
Prescription

In Brazil there are 55,000 pharmacies for a population of 161 million. The country is the world's fourth largest consumer of pharmaceuticals. Experts from the World Health Organization (WHO) believe that 25,000 would be more than enough to attend to the population. Brazilians are known for selfmedication and overmedication. It is believed that half of all prescription medicines dispensed in the country is unnecessary. To complicate matters, the federal government has only 1,400 inspectors in charge of monitoring not only the pharmacies and some 7,000 distributors and 400 laboratories, but also 600 ports and airports.

If the Health Ministry has its way, (it has presented a bill in Congress to moralize the commercialization of medicaments), Brazil's drug counterfeiters and distributors of fake products might get up to 30 years in prison, the maximum allowed jail term in the country, instead of the four years contemplated by the current law.

The president of Abifarma (Associação Brasileira da Indústria Farmacêutica-Brazilian Pharmaceutical Industry Association), José Eduardo Bandeira de Mello, estimates that pharmacies across the country might hold 135 million boxes and bottles of phony medication. Inspired by the American Food and Drug Administration, Brazil is creating its own agency to control the manufacturing and commercialization of medicine to be tentatively called Agevisa (Agência de Vigilância Sanitária-Sanitary Vigilance Agency). Serra traveled at the end of July to the U.S. to meet with directors of the World Bank and the president of the Inter-American Bank of Development, Enrique Iglesias, to see how the FDA works.

The precariousness of the Brazilian health system was again exposed when only two Rio laboratories from a total of 14 were able to detect that a yellowish sample presented to them for analysis was not urine, but the popular soft drink guaraná-made from the guaraná, an Amazonian berry-mixed with water. They even detected substances that couldn't possibly be present and, at least in one instance, the result indicated a disease. The ruse was played by Rio's daily O Globo, which sent its Amazonian berry concoction to 14 labs.

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