Tracking Black Market Malaria Drugs

“The theft and black market resale of anti-malaria medications is a serious problem in African countries like Angola and Tanzania, hindering the global aid effort to combat the disease. U.S. investigators are leading a probe into the widespread theft and black-market resale of malaria drugs donated to Africa by the U.S. government. Organized theft is plaguing the multibillion-dollar aid effort, according to people familiar with the investigation, raising questions about the supervision of donations in corruption-ridden nations,” according to the Wall Street Journal.
[Read more…]

Malaria Death Toll Rises in North Cameroon

YAOUNDE — The death toll from malaria in north Cameroon has risen to 2,500.  The minister of health says treated mosquito bed nets that are supposed to be distributed free are instead sold in hospitals or exported to neighboring countries.  Meanwhile, hospitals say they no longer have space for patients as the epidemic keeps growing.

Tanimou Maimouna cries in front of the Bon Secours clinic in Maroua as her 11-month old daughter dies from malarial complications.  Her family is just one among thousands who have lost loved ones since a malaria spike began in the far north in September.

Cameroon’s Minister of Health Andre Mamma Fouda said the number of cases have spiraled.

He said 657,754 patients have been treated in local hospitals with more than 180,000 diagnosed with malaria.  He said 75 percent of those had simple malaria while the rest presented with serious or deadly complications.

The Health Ministry confirmed more than 2,600 people have died – many of them pregnant women and children.  But local newspapers reported a much higher death toll.

Minister Fouda said the government was responding rapidly to the growing demands being placed on local hospitals.

He said highly specialized equipment has been brought in to quickly diagnose suspected cases, and they have increased the supply of the latest anti-malaria drugs at highly subsidized rates.

He said children under 5 years of age with uncomplicated cases of malaria were being treated for free.

The government also said it has intensified the free distribution of insecticide-treated mosquito bed nets.

But Suzan Birni, a nurse, said most facilities like the Pont Vert hospital in Maroua where she worked have not received the nets to distribute to pregnant women.

“For quite some time now there are no mosquito bed nets to distribute.  So when a woman delivers they just ask them [her] to go back without any bed net,” she said.

Newspaper reports accused some of the hospital staff of selling the bed nets in neighboring countries like Chad.

Nigerian-born Johnson Nnandi is a local market vendor who said that he bought and sold treated bed nets for about $10 to $15 each.

“At times we sell one for six thousand francs, at times seven thousand francs.  But when business is not going on well we sell for 5,000 francs,” he said.

Back at the Pont Vert hospital in Maroua, the situation is getting desperate.

Mr. and Mrs. Abdoulaye Abbo have been receiving treatment outside in the courtyard as there is not space inside.  The couple and their baby are all suffering from malaria.

Despite the substandard conditions, they sid they appreciated the hospital staff for working hard to save lives.

He said he was the first to get malaria, then his wife, and now they were back at the hospital with their daughter.  He thought the malaria was the worst ever this year.

Malaria cases constitute the highest number of consultations in Cameroon’s hospitals, and the death rate from the disease stands at 28 percent.

Health officials in Cameroon blame the epidemic on the refusal of people to use treated mosquito bed nets, the fact that many people do not respect basic hygiene standards, the failure to clear outdoor standing water, and people who do not visit health facilities when they have early signs of malaria.

The World Health Organization warns that waiting six hours for treatment can mean death to a child sick with malaria.

–Moki Edwin Kindzeka

Source: VOA News

Liberia Fights Fake Drugs

DAKAR — Liberia is cracking down on the sellers of fake or expired pharmaceutical drugs, but has met some resistance from people, especially in rural communities, who say these black market medicines are all they can get or afford. The traffic and sale of old and counterfeit medicine—a multimillion dollar industry—is widespread in West Africa.

It is not hard to find one of Liberia’s roving drug salesmen known locally as “black bag doctors.” John Harris walking down a county highway just a few kilometers outside the capital, Monrovia, where a VOA reporter met him.

He wore a backpack and carried a bucket. Both were full of unmarked plastic bags of pills that he said were painkillers and malaria drugs. Harris said this is not what he had in mind for his life when he graduated from medical school.

“How does the government expect us to survive when there is no job? So I do this, moving from villages and towns and sell these drugs to the people,” Harris explained. “At least we are helping government. Some of the places we go, there are no health facilities. So I think we are a help.”

But it is a crime to sell medicines in the street without a license. Inspectors from Liberia’s Pharmaceutical Board have been combing the countryside looking for drug peddlers like Harris this year.

Chief Pharmacist Reverend Tijli Tarty Tyee said the pills and treatments these peddlers sell are expired, damaged by sun or humidity, or just fake.

“Medicines sold in this manner will not have the basic ingredients that will bring about cures and as a result of that,” Tyee explained, “people taking the medicines, there is a potential of having microbial resistance to the medicines. When we have resistance to our imported medication, then we are in a very serious, serious situation.”

He said he understands that people need medicines and they need them cheap.

“They want to have a shortcut in getting medicines but that shortcut is dangerous to them,” Tyee said.

The crackdown has met some resistance from local communities and from the peddlers themselves. Tyee says inspectors have been injured during “raids.”

It is harder to go after the source.

The U.N. Office on Drugs and Crime says fraudulent medicines in West Africa are both imported and manufactured locally.

It’s a diffuse supply chain with limited government oversight. Flour has been discovered packaged as the antibiotic amoxicillin. Manufacturers try to raise profit margins by reducing the amount of an active ingredient. Or real medicines can make their way into a street peddler’s backpack once they are past their expiration date.

Experts say the true scope of the problem is near impossible to measure.

The UNODC says even legitimate providers in West Africa, like pharmacists and doctors, can not be 100 percent sure that what they are administering is real.

–Ann Look

Source: VOA News

Bill Gates: What’s More Important – Connectivity or Curing Disease?

The internet is not going to save the world, says the Microsoft co-founder, whatever Mark Zuckerberg and Silicon Valley’s tech billionaires believe. But eradicating disease just might. Bill Gates describes himself as a technocrat. But he does not believe that technology will save the world. Or, to be more precise, he does not believe it can solve a tangle of entrenched and interrelated problems that afflict humanity’s most vulnerable: the spread of diseases in the developing world and the poverty, lack of opportunity and despair they engender. “I certainly love the IT thing,” he says. “But when we want to improve lives, you’ve got to deal with more basic things like child survival, child nutrition.”
[Read more…]

CDC Warns of Imported Malaria – U.S. Cases Reach 40 Year High

Increase underscores importance of taking recommended medicines to prevent malaria when traveling

In 2011, 1,925 malaria cases were reported in the United States, according to data published in a supplement of the Morbidity and Mortality Weekly Report (MMWR) released today by the Centers for Disease Control and Prevention (CDC). This number is the highest since 1971, more than 40 years ago, and represents a 14% increase since 2010. Five people in the U.S. died from malaria or associated complications.

Almost all of the malaria cases reported in the U.S. were acquired overseas. More than two-thirds (69%) of the cases were imported from Africa, and nearly two-thirds (63%) of those were acquired in West Africa. For the first time, India was the country from which the most cases were imported. Cases showed seasonal peaks in January and August.

“Malaria isn’t something many doctors see frequently in the United States thanks to successful malaria elimination efforts in the 1940s,” said CDC Director Tom Frieden, M.D, M.P.H. “The increase in malaria cases reminds us that Americans remain vulnerable and must be vigilant against diseases like malaria because our world is so interconnected by travel.”

Malaria is caused by a parasite transmitted by the bite of an infective female Anopheles mosquito. In 2010, it caused an estimated 660,000 deaths and 219 million cases globally. The signs and symptoms of malaria illness are varied, but the majority of patients have fever. Other common symptoms include headache, back pain, chills, increased sweating, muscle pain, nausea, vomiting, diarrhea, and cough. Untreated infections can rapidly progress to coma, kidney failure, respiratory distress, and death.

“Malaria is preventable. In most cases, these illnesses and deaths could have been avoided by taking recommended precautions,” said Laurence Slutsker, M.D., M.P.H., director of CDC’s Division of Parasitic Diseases and Malaria. “We have made great strides in preventing and controlling malaria around the world. However, malaria persists in many areas and the use of appropriate prevention measures by travelers is still very important.”

Travelers to areas with malaria transmission can prevent the disease by taking steps such as use of antimalarial drugs, insect repellent, insecticide-treated bed nets, and protective clothing.

Travelers in the United States should consult a health-care provider prior to international travel to receive needed information, medications, and vaccines. CDC provides advice on malaria prevention recommendations on-line. If a traveler has symptoms of malaria, such as fever, headaches, and other flu-like symptoms, while abroad or on returning home, he or she should immediately seek diagnosis and treatment from a health-care provider.

Clinicians should consult the CDC Guidelines for Treatment of Malaria and contact CDC’s Malaria Hotline for case management advice, as needed. Malaria treatment recommendations can be obtained online or by calling the Malaria Hotline (770-488-7788 or toll-free at 855-856-4713).

Source: Centers for Disease Control (CDC)

World Health Organization Seeks Funding for Emergency Response to Drug-resistant Malaria

BANGKOK — The World Health Organization is warning that about $450 million is needed over the next three years to stop a strain of drug-resistant malaria from spreading beyond Southeast Asia to the rest of the world.

Researchers say the artemisinin-resistant strain has spread to Burma and Vietnam since it was first detected along the Cambodian-Thai border in 2008. In addition to sounding the alarm about drug-resistant malaria, the World Health Organization is rolling out an emergency response to what it terms a potentially serious global health threat. [Read more…]

Upsurge of Malaria in Cameroon Town

AOUNDE — A malaria upsurge in the town of Maroua, in the far north of Cameroon, has led to the death of hundreds of people. More than 10,000 people have been treated for the disease in the last month, straining the capacity of area hospitals and clinics.

Cameroon state radio said the number of people suffering from malaria in the north has made an unprecedented surge in the past three weeks.

The news broadcast said that hospitals in the far north of Cameroon are having problems handling the great number of malaria cases. “More than 10,000 cases have been reported in the Town of Maroua alone. Women and pregnant women are the highest hit,” it said.

According to statistics from the Maroua Urban health district, the ten hospitals in the area have treated more than 10,000 malaria patients in the past 21 days. Data on how many have been treated at private and mission hospitals is not available.

Palai Monique, a pediatric nurse at the Maroua Regional Hospital, told VOA that the situation has been alarming.

“All our halls have been occupied by people suffering from malaria, especially children between the ages of zero to 15 years,” she said. “There have been moments we did not have space even for serious cases, and we recorded situations in which children just died as early as they came here.”

Local newspapers have reported that at least a thousand people have died, while state radio puts the figure at about 600.

Dr. Etienne Fonjo, the secretary of Cameroon’s anti-malaria program, acknowledged that child mortality has increased as a result of the upsurge.

“Malaria remains a public health concern here,” he said. “Today morbidity has risen to 27 percent.

The doctor added that they have been struggling to assist the patients with the limited means they have.

“We can cite, for example, the free treatment given to children of less than five years, free treatment administered to pregnant women, and recently the free distribution of treated mosquito bed nets to 80 percent of households,” said Dr. Fonjo.

Health officials in Cameroon blame the upsurge on the refusal of people to use treated mosquito bed nets, the fact that many people do not respect basic hygiene standards, failure to clear outdoor standing water, and people who do not visit health facilities when they have early signs of malaria.

The World Health Organization warns that waiting six hours for treatment can mean death to a child sick with malaria. The first weeks after the dry season in Maroua are also periods when cases of malaria increase.
Moki Edwin Kindzeka
Source: VOA

Math Prof’s Mosquito Control Models Inform Malaria Research

Genetics may provide humankind its most comprehensive answers in controlling the age-old scourges of malaria, dengue fever and West Nile virus by eliminating the ability of vector mosquitoes to host the diseases.

But the new genetic solutions that involve introducing engineered malaria-resistant mosquitoes or mosquitoes replete with engineered resistant gut bacteria raise questions of their own. How large of a population with the genetic trait will be needed to be viable? Will the population survive, persist and mate with wild mosquitoes? Is it possible to completely overtake the susceptible wild population with resistant mosquitoes? Among the large number of biological factors involved in such a process, what are the most sensitive and important ones to make the genetic solutions work? As far as the release of genetically altered mosquitoes into the field is concerned, what are the better strategies for that biologically as well as economically?

Theoretical mathematical models developed by Department of Mathematical Sciences Chair Dr. Jia Li at The University of Alabama in Huntsville (UAH) can help in answering those questions. Following 20 years of disease modeling research that includes influenza and sexually transmitted diseases such as AIDS/human immunodeficiency virus (HIV), Dr. Li began working on mosquito population models in 2004, when scientists discovered they could genetically alter mosquitoes to be resistant to the malaria parasite with a process called transgenesis.

His work has been funded through a series of National Science Foundation grants since then. Recent papers are “Discrete-time models with mosquitoes carrying genetically-modified bacteria,” Mathematical Bioscience, 240.1; November, 2012: pp 35-44, and “Simple discrete-time malarial models,” Jia Li; Journal of Difference Equations and Applications; 19.4; April, 2013: pp 649-666.

“Our work builds a theoretical framework that provides guidance to biologists, public health workers and policy makers,” Dr. Li said. “We can apply our models to malaria, dengue fever and West Nile virus. It is an interesting application of mathematics, and it shows people that mathematics is not just purely theoretic or only in the classroom.”

GLOBAL MENACES

Transmitted back and forth between humans and mosquitoes, malaria and dengue fever have no vaccine protections available and are global health menaces. Malaria is caused by parasitic protozoans. Dengue fever is viral. Both can be fatal. In 2010, the World Health Organization estimated there were 50-100 million cases of dengue fever and over 2.5 billion people – 40 percent of the world’s population – are at risk from dengue. The WHO estimated 219 million cases of malaria in 2010 worldwide, causing 660,000 deaths. It is a major problem in Asia, Central America and regions of Africa.

“If you want to control malaria, the most effective way is to control the mosquito,” said Dr. Li. Besides the use of pesticides and release of sterile mosquitoes to reduce vector populations, scientists have developed newer methodologies to control malaria’s spread that include the transgenic parasite-resistant mosquitoes and also paratransgenic mosquitoes, which are colonized by a gut bacteria that has been altered to be resistant.

“These biological control measures have shown great success and are promising in laboratories, but what happens if you release them into the field?” Dr. Li asked. His theoretical models may be helpful by indicating potential outcomes of various approaches and expenditures on future vector populations.

“For the transgenic mosquitoes, there are some ecological concerns, because they change the gene of the mosquito, and then these mosquitoes bite people,” Dr. Li said. “It is also very expensive to alter the genes of each mosquito one by one in the lab.”

The bacteria colonization approach doesn’t have the same environmental concerns because the bacteria don’t change the genetic makeup of the mosquito, he said, and bacterial innoculation of mosquitoes in the lab is much less expensive than transgenesis.

SURVIVAL FIRST

In either case, success lies first in survival. The introduced mosquitoes must be able to successfully compete with native wild mosquitoes to establish viable populations after release. Transgenic mosquitoes must be able to successfully reproduce with wild mosquitoes and pass along the genetic trait modification that resists disease transmission to their progeny. Paratransgenic mosquitoes also need to reproduce, after which their eggs are infected by the bacteria they carry and pass some bacteria through the water they are laid in to wild eggs that are present.

The mathematical models can provide researchers with “some idea about whether their approach is working,” Dr. Li said, through quantitative or qualitative analysis and asymptotic analysis. Quantitative analysis is used to model near-term numerical results of a vector control action. Qualitative and asymptotic analyses are used to model the much longer-term results and the limiting behavior of the model dynamics.

“We want to determine key biological, vital parameters, like the birth rate and the death rate, for the transgenic and paratransgenic mosquitoes,” Dr Li said. “What are the key parameters to ensure the survival of the mosquitoes released and the transgenes inherited?”

Also of concern to researchers is the threshold release value. At what population level should lab-treated mosquitoes be released to cross the threshold of viability? What are optimal release levels for given disease control goals? What will be the effects of various release quantities on a disease control goal?

Then there is the question of how persistent a dominant or recessive trait malaria resistance transgene in a lab-produced mosquito would be when interbred into a wild population.

“Our model is showing that it is not the dominance that is most important,” said Dr. Li. “The fitness – that is, the ability to both survive and reproduce – is more important than the dominance. We must make the mosquitoes so they live longer and reproduce more” than the wild populations.

In the models, longevity success can lead to a state of equilibrium between native and introduced mosquitoes. Dr. Li’s models are either of discrete time, based on difference equations, or of continuous time, based on differential equations, to help predict qualitative outcomes over a very long period of time. Difference equations compute an output at a certain times based on past and present input samples in the discrete time domain. Differential equations relate the value of an unknown function and its derivatives of various orders in a continuous time setting.

“With the difference equations, the advantage is that it is more intuitive, but its theory and development have a short history and the analysis is relatively more difficult,” said Dr. Li. “The theory of differential equations, on the other hand, has a very long history and is well developed so that it provides more tools that we can use.”

Through mathematical analysis, the models show that in theory over a very long period of time, the wild malaria-susceptible mosquitoes succumb to the introduced bugs under certain conditions, or coexist with the introduced bugs under other conditions.

“We are trying to satisfy those certain conditions under which the wild mosquitoes will be wiped out,” Dr. Li said. “If it is necessary to have the other conditions satisfied and then the two types of mosquitoes coexist, we can still manage to bring the number of the wild mosquitoes down via controlling some parameters.”

Source: University of Alabama Huntsville

Ranbaxy Drug Synriam Receives Indian Government Approval to Treat Plasmodium Vivax

Single treatment for both Plasmodium vivax and Plasmodium falciparum malaria Permission received to conduct Phase III clinical trials for pediatric formulation

Gurgaon, India,: Ranbaxy Laboratories Limited (Ranbaxy) today announced that the company has received approval from the Central Drugs Standard Control Organisation (CDSCO), Government of India to manufacture and market Synriam (arterolane maleate and piperaquine phosphate tablet 150+750 mg) in India for the treatment of uncomplicated malaria in adults caused by Plasmodium vivax parasite.

Phase III clinical trials for the drug conducted in India, successfully demonstrated the efficacy and tolerability of Synriam as comparable to chloroquine.

Last year on World Malaria Day, April 25, Ranbaxy had launched India’s first new drug, Synriam for the treatment of uncomplicated Plasmodium falciparum malaria in India. Since its launch, Synriam has successfully treated around one million patients.

The company has also received permission to conduct Phase III clinical trials for the pediatric formulation in pediatric patients of uncomplicated Plasmodium falciparum malaria.

Commenting on the approval, Arun Sawhney, CEO & Managing Director, Ranbaxy, said, “Synriam is a new age cure for malaria and is fast emerging as the preferred option in the hands of doctors. This approval makes Synriam one of the few therapies in the world that successfully treats both, Plasmodium vivax and Plasmodium falciparum malaria. Ranbaxy remains committed in its fight against malaria and we are making all efforts to make this new therapy accessible to patients around the world.”

Ranbaxy is working to make this new treatment available in African, Asian and South American markets where malaria is rampant. The company has filed New Drug Applications (NDAs) for marketing Synriam in some African countries and will be filing more applications during the year. Once approved, the product will be launched in these markets.

Synriam provides quick relief from most malaria-related symptoms, including fever, and has a high cure rate of over 95%. It conforms to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria.

As the dosage regimen for Synriam is simple, it leads to better compliance. A patient is required to take just one tablet per day, for three days, compared to other medicines where two to four tablets are required to be taken, twice daily, for three or more days. The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies. Since Synriam has a synthetic source, unlike artemisinin-based drugs, production can be scaled up whenever required and a consistent supply can be maintained at a low cost.

According to the World Malaria Report 2012 published by WHO, India sees about 1.3 million confirmed cases of malaria each year, about 50% of which are caused by Plasmodium vivax, the second most important species after Plasmodium falciparum. Worldwide, 40% of total malaria burden globally is due to Plasmodium vivax , which shows the vast potential of Synriam in India and globally.

Traditional drugs are proving ineffective against the deadly malarial parasite because it has progressively acquired marked resistance to available drugs. Availability of plant based Artemesinin, a primary ingredient in established anti-malarial therapies is finite and unreliable. This leads to price fluctuations and supply constraints, which is not the case with a synthetic drug like Synriam.

Source: Ranbaxy

GlaxoSmithKline Seeks to Market RTS,S Malaria Vaccine

British drugmaker GlaxoSmithKline is seeking approval to market the world’s first malaria vaccine, after trials showed that it significantly cut cases of the disease in children.

Results from latest clinical trial of the RTS,S vaccine were unveiled at a conference in Durban, South Africa on Tuesday.

It showed that after 18 months of follow-up, the vaccine halved the number of malaria cases in young children and reduced the number of cases in infants by about 25 percent.

The trials were conducted on 15,000 infants and young children in seven African countries.

The drugmaker said in a statement that it plans to submit an application for the vaccine to the European Medicines Agency (EMA). It said that the World Health Organization may recommend use of the vaccine starting in 2015, if the EMA gives the vaccine a positive scientific opinion.

The RTS,S vaccine is being developed along with the non-profit PATH Malaria Vaccine Initiative, with grant funding from the Bill & Melinda Gates Foundation.

GSK says that once approved the vaccine will be priced at the manufacturing cost plus a margin of five percent that would be reinvested for research into future malaria vaccines.

The World Health Organization reports that malaria kills up to 800,000 people a year, with most deaths occurring among children in Africa.

Source: VOA