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Published on 11/19/2015
Government Believes Brazilians Are Being Used As "Guinea Pigs" by Foreign Laboratory
08/11/2017 - 11h57
FROM SÃO PAULO
Forced to provide an expensive drug without registration in Brazil, the federal government claims a foreign laboratory is using Brazilians as "guinea pigs" for scientific research. The patients, however, say the treatment saves lives.
The impasse, at a cost of R$ 4 million (US$ 1.2 million) per year, per person, could amount to expenses of R$1.8 billion (US$ 566 million) in five years, according to the Attorney General's Office (known by its Portuguese acronym as AGU), in the event other patients with the same condition go to court – which is, in fact, expected by the patients' association.
Aegerion, a laboratory based in Canada, is at the center of the controversy. The laboratory is the target of police investigations and fines imposed by the pharmaceutical industry in Brazil, due to ethical violations.
The company manufactures two drugs, both not registered in Brazil: juxtapid, used to treat a rare condition that causes high cholesterol, and myalept, prescribed for patients with generalized lipodystrophy (irregular distribution of body fat).
The Ministry of Health spent R$ 50 million (US$ 15 million) on myalept since last year, as a result of lawsuits filed by 20 patients. Such patients have been diagnosed with the Berardinelli-Seip Syndrome, a rare disease that, due to consanguinity, is most often found in the region of Rio Grande do Norte.
Those afflicted have a genetic mutation that affects how fat is processed. As a result, fat circulates through the blood or accumulates in the liver, leading to problems such as diabetes and liver failure.
Translated by ANA BEATRIZ DEMARIA