PAHO’s vaccine system hampers African efforts

Efforts to make newer and more costly vaccines widely available to the poorest in Africa are being hampered by a long-standing system that makes vaccines affordable to middle-income Latin American countries, reports the Financial Times.

The Pan American Health Organization’s (PAHO) revolving fund, which began in 1979, negotiates substantial discounts with manufacturers on prices in richer countries, offering in exchange significant volumes, predictable demand and funding.

At issue is a clause demanding that the vaccines purchased for these middle-income countries are made available at the “lowest possible price” charged anywhere in the world, making it impossible to negotiate even lower prices to poorer countries.

Disagreement between PAHO and the Global Alliance on Vaccines and Immunisations (GAVI), has already delayed wider use of certain vaccines amongst the poorest of countries.

GAVI uses mechanisms such as advance market commitments and IFFIm’s (long-term, guaranteed aid funding from donor countries) to overcome historic limitations to development funding for immunisation.

GAVI also relies on the principle of tiered pricing to provide vaccines to the poorest of countries.  Countries are grouped using a range of indicators of ability to pay, with poorer countries paying less per vaccine.

Companies have been increasingly willing to offer discounts on western prices to poorer countries, but they want richer countries to pay more in line with income levels to help support access to the poorest as well as research for future products.

Tension emerged last year over Wyeth’s vaccine against pneumonia and meningitis, which was offered to the revolving fund at $26 a dose, less than a third of its price in richer countries.  However, the fund’s demand for the lowest possible price clashes with negotiations at $7 a dose for countries served by Gavi – with gross national income less than $1,000 a head.

EU: Seizures of counterfeit imports double in 2008

The European Union said seizures of fake branded goods more than doubled last year from 2007.  Customs authorities seized some 178 million counterfeit goods last year, compared with 79 million a year earlier.

Some 20 million of these items were potentially dangerous to health and safety, officials said, because fake toys, medicines and electronics don’t meet EU standards.

While China was the main source of fake goods overall, Indonesia was the main supplier for fake food and drinks, the United Arab Emirates for counterfeit cigarettes and India for medicines.

New drug being tested in Africa for river blindness

The World Health Organization reports that a clinical trial is being launched in three African countries of a drug that could eliminate onchocerciasis, or river blindness, one of the leading infectious causes of blindness across Africa. The drug, moxidectin, is being investigated for its potential to kill or sterilize the adult worms of Onchocerca volvulus, which cause onchocerciasis.

Currently, the disease is controlled by ivermectin, which has been donated for more than 20 years by the pharmaceutical company Merck & Co. for use in onchocerciasis endemic countries. Treatment with ivermectin has enabled significant progress in the control of onchocerciasis, and currently reaches more than 60 million people in Africa annually. However, ivermectin kills the O. volvulus larvae but not the adult worms, so annual treatments for an extended period of time (at least 11-14 years) are required to ensure disease control.

If moxidectin kills not only the larvae but also sterilizes or kills the adult worms, it has the potential to interrupt the disease transmission cycle within around 6 annual rounds of treatment. The drug could be distributed through the community-directed mechanisms set up in collaboration among APOC, African control programmes, and NGOs for the distribution of ivermectin.

“This is a devastating illness that has plagued 30 African countries for centuries, in particular the populations in the most remote areas ‘beyond the end of the road’,” says Dr Uche Amazigo, Director of the African Programme for Onchocerciasis Control (APOC). “Over 100 million people are at risk of infection with onchocerciasis in Africa and a few small areas in the Americas and Yemen.”

The development of moxidectin for onchocerciasis is being conducted through a collaboration of the Special Programme for Research and Training in Tropical Diseases (TDR), which is administered by WHO, with Wyeth Pharmaceuticals. The work ranges from the development of a formulation for human use and initial studies in healthy volunteers, to clinical studies and community studies in Africa.

TDR is building the capacity and managing the clinical trials in Africa. If the development is successful and results in a positive scientific opinion from the European Medicines Evaluation Agency, Wyeth with the assistance of WHO will request approval by regulatory authorities in the countries where onchocerciasis is endemic.

The trial will take place over the next two and a half years.

UN launches trial Mobile Health campaign in Uganda

The UN launched a ten-day initiative on July 1, 2009 intended to reach out to 10,000 people in Uganda through mobile phones to demonstrate the reach and potential use of mobile phones in health information and promotion.

Mobile health, or mHealth, takes advantage of the broad adoption of mobile telephones to reach the public with health messages for promotion and prevention. The objective of this short campaign is to create awareness and interest in mHealth by demonstrating the possibilities to collect information in real time and showing the ease of outreach to citizens with mobile phones.

The campaign will engage Ugandans in a SMS quiz on health prevention and promotion (questions provided by the WHO); phone users will be able to “opt in” the campaign at no cost.  Participating individuals will then receive confirmation of their responses.

The initiative is sponsored by UN’s Department of Economic and Social Affairs (UN-DESA) and the Uganda Ministry of Health.  The results of the Texting4Health demonstration will be shared with Ministers of UN Member States at the Annual Ministerial Review (AMR) session of the UN Economic and Social Council (ECOSOC) in Geneva in July 2009.

This program builds on other innovative programs such as mPedigree’s use of mobile phones to authenticate prescription drugs and combat counterfeiting.

HIV vaccine close to human trial

Researchers at the University of Western Ontario say they’re confident their HIV vaccine is only months away from being approved for human trials.

According to a report by the National Post, lead researcher Dr. Chil-Yong Kang said the approval from the U.S. Food and Drug Administration can come as soon as two or three months.

The vaccine was submitted recently to the U.S. for approval because that country already has established systems in place to check out vaccines, Dr. Kang said. If approved there, he added, worldwide acceptance of the drug will quickly follow.

There are also more HIV-positive patients in the U.S. than in Canada, which will make it easier to do a human trial comparing how the vaccine attacks the virus in volunteers.

Dr. Kang, 65, admits that it will still “take years” before results from human trials can be completed.

Drug development for TB: an innovative collaboration

A landmark collaboration could see the development of the first new-action tuberculosis drug in 40 years.  Global Alliance for TB Drug Development (TB Alliance), a not-for-profit, product development partnership, and Tibotec, a Johnson & Johnson company, have joined forces to focus on the development of the new experimental drug TMC207.

Forbes reports that if the drug is approved, it could be the first of its kind on the market and the first tuberculosis drug in more than four decades to take a new approach to treating the condition. A cocktail of antibiotics is the mainstay of treatment and there has been no major advancements since the antibiotic Rifampicin hit the market in the 1960s.

The drug candidate, now in midstage clinical trials, works by inhibiting an enzyme responsible for fueling tuberculosis cells, thereby cutting off the cell’s energy supply. Midstage study results have so far shown the drug is effective as part of a combination treatment when compared with a placebo. Results from a second stage of the midstage program are expected in 2010.

If it were approved, the parties involved will establish an access program for developing countries. The TB Alliance will have a royalty-free license on the drug for drug-susceptible forms of tuberculosis.

Tuberculosis remains one of the world’s deadliest diseases and has harshly impacted developing countries as the drug-resistant form of the condition gains ground. The World Health Organization estimates approximately one-third of the world’s population is infected with bacillus that causes tuberculosis and the disease is responsible for nearly 5,000 deaths each day worldwide.

Online pharmacies and patient safety

A recent article by the San Diego Union-Tribune raises concerns over online pharmacies.  According to the piece, a vast majority of online pharmacies may not be compliant with US Federal standards.   Carmen Catizone, executive director of the National Association of Boards of Pharmacy (NABP), was quoted as saying, “We have found that 92 percent of Web-site pharmacies are illegal or in violation of FDA regulations.”  In order for online pharmacies to be considered legitimate by the FDA they must be located within the US, licensed within its home state, and not fill orders without a written doctor’s prescription.

Moreover, the article warns that the quality and efficacy of drugs purchased at illegitimate online pharmacies can be questionable at best.  Common issues include counterfeit, expired, mislabeled, adulterated, or contaminated drugs.   The majority of such online pharmacies are located outside of the US, and though they claim to be importing mostly Canadian drugs, this is likely not the case.  An FDA investigation in 2005 revealed that nearly half of the imported drugs used to fill online pharmacy orders originated from India, Israel, Costa Rica, and Vanuatu —not Canada. Additionally, 85% of the imported drugs claiming to be Canadian actually came from 27 separate countries.

It is important to keep in mind that not only is it illegal for US citizens to import prescription drugs, despite indications from some online pharmacies, but many of these imports stem from developing nations with more lax prescription drug regulations and enforcement, leading to an increased probability that what you receive may not be what you ordered.  In addition to these concerns, FDA spokesman Christopher Kelly was quoted as saying, “The FDA will detain or refuse entry (into the U.S.) of illegal, unapproved products that it finds.”

The moral of the story is do not play with your health; avoid illegitimate online pharmacies with prices too good to be true.    For a list of NABP accredited online pharmacies or to report online pharmacies you suspect could be unlawful please visit their website at: http://www.nabp.net/.

GAVI announces innovative approach to developing vaccines for developing nations

At the end of last week, the GAVI Alliance partners (the World Bank, WHO and UNICEF), five national governments and the Bill & Melinda Gates Foundation formally announced the first-ever Advance Market Commitment (AMC) designed to accelerate access to vaccines against pneumococcal disease.

The Wall Street Journal reports that the $1.5 billion program marks a departure from previous charitable efforts to increase poor countries’ access to vaccines. Instead of buying existing drugs and giving them away, the donors will guarantee pharmaceutical companies a future market big enough to justify developing and manufacturing new vaccines needed in nations too impoverished to afford them on their own.

This innovative new model will mean faster access to vaccines for millions of children in poor countries. It’s a great example of how innovation and technology together can produce life-saving advances and make them available to people who need them around the world.

— Bill Gates, co-chair of the Bill & Melinda Gates Foundation

This innovative financing mechanism will ensure that children in the world’s poorest countries receive life-saving vaccines 15-20 years before they might otherwise have been available and at prices their governments can afford.

“It’s a great step for global health,” said Orin Levine, associate professor of international health at Johns Hopkins University and a longtime backer of the so-called advance-market commitment concept. He projects the funding mechanism could prevent between five million and eight million child deaths by 2030.

Although a pneumococcal vaccine has existed since 2000 and is part of regular immunisation programmes in developed countries, there is not a suitable and affordable vaccine for developing countries.

This pilot AMC aims to address this challenge by stimulating the late stage development and manufacture of suitable vaccines at affordable prices.

Through an AMC, donors commit money to guarantee the price of vaccines once they have been developed, thus creating the potential for a viable future market. These commitments provide vaccine makers with the incentive to invest the considerable sums required to conduct research and development and build manufacturing capacity.

The currently existing pneumococcal vaccine is sold at over US$70 per dose in industrialised countries. But thanks to the AMC, the long term price for developing countries will be US$ 3.50.

WHO set to declare flu pandemic

The BBC reports that UN health officials are expected to declare the first global flu pandemic in 40 years, after holding emergency talks on the swine flu crisis.

WHO poised to declare first flu pandemic in 40 years

Flu experts expected to recommend move to phase 6

Expected to urge finishing seasonal flu vaccine production

Spread of virus in Australia triggering declaration

The last global flu pandemic came in 1968 over the Hong Kong flu.  That pandemic killed about one million people.  A disease is classed as a pandemic when transmission between humans becomes widespread in at least two regions of the world.

The latest virus emerged in Mexico in April and since then thousands of cases have been confirmed throughout North and South America.

The H1N1 strain has spread to 74 countries but the WHO has so far resisted labelling the outbreak a full-blown pandemic.

WHO chief Margaret Chan talked to officials from eight countries with large flu outbreaks on Wednesday in an attempt to confirm the spread of the disease.

The WHO’s move follows Australia’s confirmation of more than 1,200 cases – a four-fold increase in a week.

Although most sufferers experience normal flu symptoms and make a full recovery, the WHO has confirmed 141 deaths from 27,737 cases.

The BBC’s health correspondent, Jane Dreaper, says classifying the virus as a pandemic does not mean that the virus has suddenly become more deadly.

But it does send a clear signal to health officials and businesses to continue planning for the possibility of large numbers of people catching the virus, she says.

Japan, China Start Group on Intellectual Property Rights

Bloomberg reported that Economic ministers from Japan and China will start a working group on protecting intellectual property rights as part of an effort to tighten economic ties during the global recession.

Asia’s two largest economies agreed to set up a working group to discuss intellectual property, implement economic measures pledged at the Group of 20 meeting in April and cooperate on development in Africa and other poorer regions.