Save the Children Norway trialed anti-malaria drug Lariam in Mozambique—1993–1994

By Moeen Raoof, 

Roche AG, a Swiss multinational health-care company, needed to trial a new anti-malaria drug, Mefloquine, also known under the brand name Lariam, in malaria-prone areas of Africa. This was despite known serious side effects, including long-term health problems such as depression, hallucinations, anxiety and neurological effects such as poor balance, depression and impaired mental health.
The Norwegian Chapter of Save the Children, also known as Redd Barna, operated in Mozambique under a Dutch national. Redd Barna began to distribute Lariam in Mozambique between 1993 to 1994. This drug was given to men, women and children, including pregnant women.
The Lariam trials were conducted by distributing the drug based on the criteria of prevention and treatment of malaria and without due regard to age, medical status, or state of pregnancy. Recipients of the drug were not told of the side-effects but were actively monitored during the period of treatment, which lasted approximately 18 months, after the commencement of distribution. These trials were conducted without the consent of the Mozambican government or the Ministry of Health.
Children as young as 3-years old were given whole pills to take during either the prevention or treatment phases, without regard to the side effects of the pills on very young children. Pregnant women and women with babies were also given the drug, but only if they had contracted malaria, not preventatively.
The trials were more common among Mozambican men and women between the ages of 18 and 60 years, divided into prevention and treatment risk groups. They were provided a course of treatment, accordingly. One assumes that these persons were closely monitored for symptoms and side effects during and after the treatment period.
Many young Mozambicans during and after the treatment period began showing signs of unusual behaviour, including bouts of violence after the testing of the drug ended in 1994. There was an increase in violent crime as well as murders in Mozambique. This, despite there being a very low crime and murder rate among civilians prior to 1993, including during the civil war that had ended 1990.
Media in Mozambique explained away this increase in crime and murder post-1993 as drug-related, linking the violence to the use of the Methaqualone/Mandrax drug that was allegedly smuggled in from South Africa. However, this drug could not justify the rising cases of mental illness among all age groups, in users and non-users alike. Mandrax was the prime and only suspect drug blamed for all ills in Mozambique during the 1990s. As to why the wide use of Lariam was not considered as a possible cause relating to increase in violence, mental illness, crime, including murders remains a mystery.
The Mozambican Civil War began in 1977, two years after the end of the war of independence. It resembled the Angolan Civil War in that both were proxy battles of the Cold War that started soon after the countries gained independence from Portugal. The ruling party, Front for Liberation of Mozambique (FRELIMO), and the national armed forces (FAM), were violently opposed from 1977 by the Mozambique Resistance Movement (RENAMO), which received funding from white-ruled Rhodesia and later, apartheid South Africa. About one million people died in fighting and from starvation; five million civilians were displaced, and many were made amputees by landmines, a legacy from the war that plagued Mozambique for more than two decades afterward. Fighting ended in 1992 and the country’s first multi-party elections were held in 1994.
Roche admitted that Lariam had worse side effects than other common antimalarials. The head of drug safety and quality at Roche admitted that a study had shown there was an “increased risk” of neuropsychiatric problems compared to other drugs available. Roche further stated that anyone with pre-existing conditions such as depression should not be given the drug, stating that, “There is an increased risk but the balance of risk to the balance of benefit is still believed to be important in this global endemic, if it is prescribed to the right people.”
Roche further stated, “The patient should be informed of these increased risks with Lariam and should they become aware of any of those features, a change in mood, a change in personality—then they are advised to immediately contact a doctor and stop taking it.”
Medical advice regarding Lariam recommends the following, do not take Lariam if patients have or have previously experienced:
  • an allergy to Mefloquine or any of the other ingredients of this medicine or to similar medicines such as quinine or quinidine
  • depression, thoughts about suicide and self-endangering behaviour
  • any other mental problem, including anxiety disorder, schizophrenia or psychosis (losing touch with reality)
  • fits (seizures or convulsions)
  • severe liver problems
  • Blackwater fever (a complication of malaria that affects the blood and kidneys)
Warnings and precautions—Lariam may cause serious mental problems in some people. Tell your doctor immediately if you experience any of the following while taking Lariam:
  • suicidal thoughts
  • self-endangering behaviour
  • severe anxiety
  • feelings of mistrust towards others (paranoia)
  • seeing or hearing things that are not there (hallucinations)
  • nightmares/abnormal dreams
  • depression
  • feeling restless
  • unusual behaviour
  • feeling confused
  • epilepsy
  • fits (seizures or convulsions)
  • heart problems, especially changes in heart rhythm
  • liver or kidney problems
  • eye problems (e.g. loss of fine detail, colours seem faded, sudden loss of vision, poor vision at night)
  • blood or lymphatic disorder (abnormal blood test showing a decrease or an increase in white blood cells, a decrease in red blood cells or platelets)
  • neuropathy with signs of pins and needles, weakness, numbness, new or worsening clumsiness or unsteadiness on your feet, or shaking of the hands and fingers
  • Inflammation of the lungs, also known as pneumonitis. This is a serious, potentially life-threatening allergic reaction in the lungs which may cause fever, chills, cough, and shortness of breath or chest pain.
  • previously contracted malaria even though you were taking Lariam tablets for malaria prevention
  • experienced a mild to serious potential life threatening allergic reaction to Lariam or any of its ingredients
  • low blood glucose due to a pre-existing condition called congenital hyperinsulinemia hypoglycaemia.
How widespread the use of Mefloquine, also known as Lariam, in Africa is not known for certain. Yet Roche, the manufacturer, and aid agencies operating in Africa and elsewhere around the globe are failing to warn users and doctors of the risks involved.

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