Treatment ends for chagas disease patients
October 5, 2011
Barcelona, Asunción, La Paz, Rio de Janeiro, Thousands of people with Chagas disease will go untreated in coming months due to a shortage of benznidazole, the first-line drug used in most endemic countries. As a number of countries are actively seeking to reverse the long neglect of Chagas disease, the supply of this treatment threatens to run out. Therefore, the medical-humanitarian organisation Médecins sans Frontières (MSF) is urging the Brazilian Ministry of Health, which is responsible for the only laboratory in the world manufacturing benznidazole, to respect its commitment to Chagas patients and take immediate measures to make the drug available.
Chagas treatment currently depends wholly on a single pharmaceutical company to produce benznidazole tablets, the Brazilian State laboratory LAFEPE (Laboratorio Farmaceutico do Estado de Pernambuco). Responsibility for producing the active pharmaceutical ingredient (API) used by this laboratory was recently transferred to one sole private company, Nortec Química. There is not enough API at present to produce the tablets needed, and Nortec has yet to validate production. In addition, LAFEPE has breached its promise to publish and fulfil a manufacturing schedule that would ensure availability of the drug.
As a result, various national Chagas programmes in Latin America are already struggling to meet the demand for new treatment and are expected to run out of stock in the next few months. No information has been provided by the Brazilian Ministry of Health on what is happening, and the World Health Organization (WHO) and the Pan American Health Organization (PAHO) have not put a contingency plan in place to maintain stocks of this drug for acute cases of Chagas. Future availability of the drug is not currently known, although according to various estimations it is unlikely to be before mid-2012.
“This situation is unacceptable. In Boquerón, an area with one of the highest rates of Chagas in Paraguay, we are forced to stop diagnosing patients because we simply don’t have the drugs to treat them,” explains Dr Henry Rodríguez, MSF’s head of mission in Bolivia and Paraguay. “For decades Chagas was a completely neglected disease and just when diagnosis and treatment were finally being made a priority, we’ve run out of medication. We must not allow this to continue; an urgent solution must be found for our patients.”
In recent years, demand for treatment has increased significantly because adults are now being treated as well as children. Besides, the WHO and the PAHO have strongly endorsed diagnosis and treatment at the primary healthcare level. However, all progress made to date is now jeopardised by the shortage of benznidazole. “Although we know that current treatment is more effective and more likely to prevent complications the sooner a patient is treated, we will be forced to delay it,” says Dr Unni Karunakara, MSF's international president.
In view of this critical problem, MSF has called upon the Brazilian Ministry of Health to commit to speeding up the current benznidazole manufacturing process by streamlining its validation with the API produced by Nortec. Given that the production, distribution and sales process will last for several months, Brazil must spearhead a regional contingency plan – with the support of the PAHO – for the rational use of the benznidazole stocks among the most vulnerable groups in endemic countries. MSF is also urging the Ministries of Health of endemic countries to demand this contingency plan to be put in place as soon as possible, while finding a definitive solution for the long term.
“The Brazilian government has been pioneering in the production of generic drugs, showing its commitment to people who need access to treatment. It must now act swiftly to keep its commitment to Chagas patients worldwide,” concludes Dr Karunakara.
About Chagas disease
Chagas disease, also known as Human American Trypanosomiasis, is an infectious disease caused by the parasite Trypanosoma cruzi. Endemic in several Latin American countries, it causes 12,500 deaths per year and it is estimated that 8 to 10 million people have the disease. Case numbers are rising in the US, Europe, Australia and Japan as a result of greater international travel.
In most Latin American countries the disease is primarily transmitted by the assassin bug although it can also be transmitted from mother to child, in blood transfusions, organ transplants, contaminated food and laboratory accidents. Because the infection is usually asymptomatic, most patients are unaware that they have it. However, as the disease progresses, around 30 per cent will develop heart lesions and 10 per cent gastrointestinal damage that may be fatal.
Until recently treatment was thought only to be effective in the acute stage (for up to three months after being infected) and very early chronic stage. However, studies have now shown that it can also be effective in the chronic stage. It has also been found in recent years that the side effects of the drug, which are more common in adults, are manageable and that under supervision, treatment is even feasible in primary healthcare.