Katy Athersuch katy.athersuch at googlemail.com
Wed Oct 5 03:08:39 PDT 2011


Treatment Shortage Forces MSF to Halt Diagnosing Chagas Disease in Paraguay;
New Treatment Projects Suspended in Endemic Areas in Bolivia

-- 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
Chagas-endemic countries. The shortage comes as a number of countries
actively seek to treat people living with the already long neglected
disease. The international medical humanitarian organization Médecins sans
Frontières (MSF) is urging the Brazilian Ministry of Health, responsible for
the world’s only laboratory that manufactures benznidazole, to respect its
commitment to Chagas patients and to take immediate measures to make the
drug available.

Chagas treatment depends entirely on a single pharmaceutical company to
produce benznidazole tablets, the Brazilian State laboratory LAFEPE
(Laboratorio Farmaceutico do Estado de Pernambuco). Production of the drug’s
active pharmaceutical ingredient (API) used by LAFEPE was recently
transferred to a 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 demand for new treatment, and are expected to run out of
stocks of benznidazole in the next few months. No information has been
provided by the Brazilian Ministry of Health on the situation, and the World
Health Organization (WHO) and Pan American Health Organization (PAHO) have
not put a contingency plan in place to maintain stocks of the drug for acute
cases of Chagas. Future availability of the drug is not known; according to
various estimations it is unlikely to be before mid-2012.

“This situation is unacceptable,” said Dr. Henry Rodríguez, MSF head of
mission in Bolivia and Paraguay.  “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. 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,”
he said. 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 in addition to children.  Additionaly, the WHO
and 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,” said Dr. Unni Karunakara, MSF international president.

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 PAHO—for the
rational use of 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 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,” said
Dr. Karunakara. “It must now act swiftly to keep its commitment to Chagas
patients worldwide.”

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 8-10 million people have the disease. Case numbers are rising
in the US, Europe, Australia, and Japan as a result of greater international

In most Latin American countries the disease is primarily transmitted by the
“assassin bug,” although it can also be transmitted from mother to child,
through 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,
roughly 30 percent of patients develop heart lesions and 10 percent suffer
potentially fatal gastrointestinal damage.

Until recently, treatment was thought only to be effective in the acute
stage of the disease (up to three months after being infected) and in its
very early chronic stage. However, studies now show that treatment can also
be effective in the chronic stage. It has was also found in recent years
that the side effects of benznidazole, which are more common in adults, are
manageable, and that treatment is feasible under supervision in primary
healthcare settings.

Alexandra Lee
Webmaster/Online Content Editor
Médecins Sans Frontières- Campaign for Access to Essential Medicines


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