African Experts Discuss Need for Better Regulation of Medicine

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In most African countries, pharmaceutical drugs are poorly regulated or not regulated at all, posing huge risks for those who depend on them to stay healthy. But for the first time, the topic has gotten the attention of African officials, who holding a scientific conference on the topic in South Africa.

Access to safe and effective medicine can be touch and go in Africa, where the market abounds with drugs that are fake or expired.

That can have disastrous consequences, says Margareth Ndomondo-Sigonda, a Tanzanian who oversees pharmaceutical issues for an African Union agency, the New Partnership for Africa’s Development, or NEPAD.

“The situation that you see in Africa is that most of the medicines circulating in our market, more than 30 percent, either does not meet the standards, meaning that it cannot treat the disease that it is intended to, or it is falsified, meaning that it is not a real medicine,” Ndomondo-Sigonda said. “Could be that it does not have the necessary active ingredients, and therefore it may not treat or it may even cause harm to the patient instead of actually treating the disease that is intended.”

She is one of hundreds of experts who gathered in Johannesburg this week for the first-ever scientific conference bringing together pharmacists, health workers, governments and civic organizations to discuss how to better regulate the drugs that make it to health facilities across Africa.

Ndomondo-Sigonda says that most African nations lack the capacity to effectively police medicines. Nations are considering tightening and refining their testing protocols and collaborating on testing, among other interventions.

Experts also noted the role that law enforcement authorities can play in cracking down on fake drugs. While this is sure to be a long and costly process, NEPAD’s head science advisor Aggrey Ambali says these measures may end up making drugs cheaper for consumers.

If countries cooperate to test drugs, he says, they can save money. And if local drug producers are made aware of the new guidelines, they can compete more effectively.

“Without actually having the actual numbers, but the pointers are there that if this were to succeed, I think there are opportunities of trying to find ways of cutting costs which can actually be reflected in the final price of the medicine,” said Ambali.

Ndomondo-Sigonda says consumers can protect themselves now by being selective about where they buy their drugs and sticking to trustworthy health facilities.

“The minute they go and buy medicines in the open markets, that is where the problem starts, because the products in the open markets, they are not assured because you do not know where they source them from and you have a huge potential for buying counterfeit medicines in such markets,” she said.

That fact was illustrated in 2011, when the World Health Organization reported that in Nigeria, the continent’s largest pharmaceutical market, nearly two-thirds of drugs used to fight malaria were fake.

via African Experts Discuss Need for Better Regulation of Medicine.

–Anita Powell
Source: VOA News

Non-Profit Offers Free Kits of Potential Malaria Cures for Researchers to Study

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malaria-boxA nonprofit called Medicines for Malaria Venture (MMV) is sending free kits of potential malaria cures for researchers. It’s called The Malaria Box, and it is the result of a high-throughput screen done by MMV and cooperating pharmaceutical companies. All you have to do is send your request, along with a summary of your research and how you plan to share the data. The box contain samples of 400 substances that MMV has found may be promising malaria cures. The Malaria Box is meant to be a starting point for researchers at universities or small companies.

Available free of charge, on request, the Malaria Box is a treasure trove of 400 diverse compounds with antimalarial activity. The Malaria Box has been assembled by MMV in a bid to catalyse malaria and neglected disease drug discovery and research. All of the compounds have confirmed activity against the blood-stage of P. falciparum and are commercially available. It includes:

  • 200 diverse drug-like compounds as starting points for oral drug discovery and development
  • 200 diverse probe-like compounds for use as biological tools in malaria research

The final selection, formatted as solutions at 10mM concentration in dimethyl sulfoxide, was distilled from around 20,000 hits generated from an extensive screening campaign of around four million compounds from the libraries of St. Jude Children’s Research Hospital, TN, USA, Novartis and GSK. The selection was made to provide the broadest cross-section of structural diversity and, in the case of the drug-like compounds, properties commensurate with oral absorption and the minimum presence of toxicophores.

All that is asked in return of Malaria Box users is for the resulting data to be published and placed in the public domain to help continue the virtuous cycle of research.

More information Medicines for Malaria Venture.

Show Me the Money! The Sad State of Compassion

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global-fund-aids-tb-malaria-logoJeffrey Sachs, Director of the Earth Institute at Columbia University and author of To Move the World: JFK’s Quest for Peace, recently wrote a provocative piece in the Huffington Post entitled “World to Poor: Drop Dead.”

“The spin-masters are already at work putting all of the sugar coating on it, but the reality is shocking and revealing. The world as a whole didn’t come up with a measly $5 billion a year for the Global Fund to Fight AIDS, TB, and Malaria. $5 billion was a bare minimum needed to maintain momentum in the fight against these diseases. Yet the U.S., Canada, UK, France, Germany, Italy, Spain, Portugal, Norway, Sweden, Japan, Denmark, Belgium, Austria, Switzerland, China, Singapore, Korea, Saudi Arabia, Jamie Dimon, Lloyd Blankfein, John Paulson, Barack Obama, Stephen Harper, 1,600 billionaires (with combined net worth of at least $5.5 trillion), and the rest of humanity couldn’t find the money. They came up with $4 billion instead, $1 billion short.” [Read more…]

WHO Sets Roadmap Goal for Vaccines to Reduce Malaria by 75%

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Malaria infects hundreds of millions of people every year and causes well over a half million deaths. The World Health Organization and its partners Thursday announced a new goal to license vaccines by 2030 that would sharply reduce malaria cases and eventually eliminate the disease.

The 2013 Malaria Vaccine Technology Roadmap was unveiled in Washington. It expands the scope of vaccine research, calling for vaccines that can reduce malaria cases by 75 percent and that are suitable for use in all endemic-areas. Malaria affects nearly 100 countries and territories, with a particularly heavy burden in sub-Saharan Africa.

“The most recent figures that we have from the World Health Organization are for an estimated 660,000 deaths each year. It’s hard to get your head around that number because it’s such a large figure, said Dr. Vasee Moorthy, who’s with the World Health Organization’s Department of Immunizations and Vaccines. “So another way of thinking about it is that’s about 2,000 deaths each day from malaria. Now most of those deaths are in children under five in Africa, but there are also deaths elsewhere in parts of the Americas, in the Middle East and in Asia. And in terms of the number of cases, those deaths are from about 219 million cases of malaria.”

While there are no licensed vaccines yet against malaria, progress has been made in reducing cases. That’s due to better diagnosis, drugs, insecticide-treated mosquito nets and control of mosquito populations, which carry the malaria parasites.

“We’ve seen a 26 percent reduction in global malaria death rates over the last decade. If we could successfully develop malaria vaccines, they could have an important complementary role together with these malaria control measures,” Moorthy said.

Moorthy said that the 2013 Malaria Vaccine Technology Roadmap builds upon the original roadmap unveiled in 2006.

“It’s a more ambitious target now — in that the roadmap is now being expanded to include Plasmodium vivax as well as falciparum,” he said. “So falciparum is the form of malaria that causes most of the deaths, but vivax wasn’t previously included.”

While Plasmodium vivax may not cause as many deaths, it’s the source of many new cases. This is true in many countries – especially in the Americas and Asia — where progress has been made against the falciparum form of the disease. It often strikes adults, leaving them unable to work.

“The original roadmap included a goal of having a licensed vaccine by 2015 against the most deadly form of malaria, falciparum. And this is retained in the new roadmap — and adding the new goal of having a second generation of vaccines licensed by 2030,” said Moorthy.

It’s not clear whether the 2015 goal will be met. There are 27 malaria vaccine candidates in clinical trial. The most advanced candidate, RTS,S/AS01, is in Phase III trials. The results will be available in 2015 and then undergo regulatory review.

The new Malaria Vaccine Technology Roadmap is a collaborative effort led by the WHO, along with the U.S. and European governments and agencies, donors, developers and NGOs.

–Joe DeCapua

Source: VOA News

SMS for Life Uses Mobile Phones to Increase Access to Essential Antimalaria Medications

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SMS for Life harnesses everyday technology to improve access to essential malaria medicines in rural areas of developing countries. It uses a combination of mobile phones, SMS messages and electronic mapping technology to track weekly stock levels at public health facilities in order to:

  • Eliminate stock-outs
  • Increase access to essential medicines
  • Reduce the number of deaths from malaria

SMS for Life is an innovative public-private partnership led by Novartis and supported by the Tanzanian Ministry of Health and Social Welfare, IBM, Medicines for Malaria Venture (MMV), the Swiss Agency for Development and Cooperation (SDC), Vodacom and Vodafone. The project comes under the umbrella of the global Roll Back Malaria Partnership.

New Tech Savvy Peace Corps Embraces Global Teamwork to Fight Malaria

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Christopher Hedrick, Country director of the Peace Corps Senegal writes about the “New Peace Corps” — one that embraces new malaria tools and technological advances to fight malaria on a larger scale than it ever has in the past, with the dedicated efforts of a new generation of young, tech savvy volunteers with lofty goals and accustomed to working with disparate teams.
[Read more…]

Tracking Black Market Malaria Drugs

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“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

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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

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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

Mass drug administration for the control and elimination of Plasmodium vivax malaria: an ecological study from Jiangsu province, China

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Recent progress in malaria control has caused renewed interest in mass drug administration (MDA) as a potential elimination strategy but the evidence base is limited. China has extensive experience with MDA, but it is not well documented.
Methods

An ecological study was conducted to describe the use of MDA for the control and elimination of Plasmodium vivax in Jiangsu Province and explore the association between MDA and malaria incidence. Two periods were focused on: 1973 to 1983 when malaria burden was high and MDA administered to highly endemic counties province-wide, and 2000 to 2009, when malaria burden was low and a focal approach was used in two counties. All available data about the strategies implemented, MDA coverage, co-interventions, incidence, and adverse events were collected and described. Joinpoint analysis was used to describe trends in incidence and the relationship between MDA coverage and incidence was explored in negative binomial regression models.
Results

From 1973 to 1983, MDA with pyrimethamine and primaquine was used on a large scale, with up to 30 million people in target counties covered in a peak year (50% of the total population). Joinpoint analyses identified declines in annual incidence, -56.7% (95% CI -75.5 to -23.7%) from 1973–1976 and -12.4% (95% CI -24.7 to 2.0%) from 1976–1983. Population average negative binomial models identified a relationship between higher total population MDA coverage and lower monthly incidence from 1973–1976, IRR 0.98 (95% CI 0.97 to 1.00), while co-interventions, rainfall and GDP were not associated. From 2000–2009, incidence in two counties declined (annual change -43.7 to -14.0%) during a time when focal MDA using chloroquine and primaquine was targeted to villages and/or individuals residing near passively detected index cases (median 0.04% of total population). Although safety data were not collected systematically, there were rare reports of serious but non-fatal events.
Conclusions

In Jiangsu Province, China, large-scale MDA was implemented and associated with declines in high P. vivax malaria transmission; a more recent focal approach may have contributed to interruption of transmission. MDA should be considered a potential key strategy for malaria control and elimination.

AUTHORS: Michelle S Hsiang, Jimee Hwang, Amy R Tao, Yaobao Liu, Adam Bennett, George Dennis Shanks, Jun Cao, Stephen Patrick Kachur, Richard GA Feachem, Roly D Gosling and Qi Gao

Source: Malaria Journal 2013, 12:383 doi:10.1186/1475-2875-12-383
http://www.malariajournal.com/content/12/1/383/abstract
Published: 1 November 2013

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.