Expediting access to pediatric HIV/AIDS drugs in Guyana; a new public-private partnership

A very interesting announcement from the U.S. Department of State.

The U.S. Government, Government of Guyana, and Pharmaceutical Companies Partner to Expedite the Registration of HIV/AIDS Drugs for Children

Office of the Spokesman
Washington, DC
September 22, 2010

Ambassador Eric Goosby, U.S. Global AIDS Coordinator, announced a new public-private partnership between the Government of Guyana and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) to make safe pediatric HIV medications available faster in Guyana by expediting the country’s drug registration process. Through the Pre-approval Access for HIV/AIDS Therapies (PaATH) mechanism, the Government of Guyana will grant provisional approval to pediatric HIV medicines approved by the U.S. Food and Drug Administration within the U.S. Department of Health and Human Services. These antiretroviral drugs will then be available for purchase and use in Guyana while they await full approval through the Government of Guyana’s drug approval process.

In most countries, drug registration can be a long process. While the U.S. Government has taken steps to “fast track” approval for antiretroviral drugs through the U.S. Food and Drug Administration, slow registration processes and limited infrastructure in partner countries can be barriers to access to antiretroviral treatment and other life-saving drugs. Variations from country to country in the drug registration process also result in delays to access. Access to pediatric antiretroviral treatment is further complicated by the fact that there are fewer formulations of antiretroviral drugs for children than there are for adults.

In Guyana, an estimated 18,000 people are living with HIV, and approximately six percent of these HIV infections are in children. Recognizing the impact of HIV/AIDS in Guyana, the Government of Guyana has embraced the PaATH to further their country’s fight against the virus. Guyana has long been regarded as an innovator and global leader addressing regulatory issues specific to the developing world, particularly in the area of HIV/AIDS. Guyana’s experience with the PaATH will provide best practices and lessons learned for other PEPFAR countries interested in expediting their drug approval process. Based on the success in Guyana, the project will expand to other PEPFAR-supported countries.

The PaATH was developed through a public-private partnership that brings together the U.S. Government, the pharmaceutical industry, and non-government organizations to promote scientific and technical discussions on solutions for pediatric HIV treatment, formulations and access. The partnership includes the U.S. Government, Bristol-Myers Squibb, Gilead Sciences, Inc., and the Partnership for Supply Chain Management.

Brazil expands access to cancer treatments

Under a massive expansion of its oncology services, Brazil’s national health care system (SUS) will offer cancer patients access to nine new treatments and expand coverage for 66 already-covered procedures, including 46 chemotherapy treatments.  (source:  PharmaTimes)

The nine treatments which are to be made available for the first time through the SUS include three for liver cancer plus five for breast cancer, leukemia and lymphoma and one new radiotherapy treatment.

Investments in the SUS oncology services, which provide treatment for around 300,000 cancer patients, will increase 25% to 412.7 million reals this year, rising to 2 billion reals in 2011. The widening of value coverage for already-provided treatments will see investments in chemotherapy services increasing from 1.25 billion reals last year to 1.5 billion in 2011, with particularly large increases in spending on treatments for conditions such as chronic lymphocytic leukemia, set to rise 765%.

Cancer is Brazil’s second-biggest killer after cardiovascular disease, and the fact that the SUS guarantees virtually all diagnosed patients have access to treatment makes it an attractive market for drugmakers. For example, last year the country’s breast cancer drug market was worth  $424 million, rivaling some major markets such as the UK and Japan and greatly exceeding the other BRIC (Russia, India and China) nations, says market research firm Decision Resources, which forecasts that breast cancer drug sales in Brazil will rise to $611 million by 2014.

The analysts forecast that the SUS oncology services will continue to give priority to the introduction of new technologies, and that the government will maintain its support for local production facilities, such as the development, in partnership with Argentina, of two reactors for the production of oncology drugs, announced in June.

Decision Resources is also forecasting good growth for Brazil’s non-small-cell lung (NSCL) cancer drug market, driven by increased uptake of higher-priced brands of chemotherapy, around 21% annual growth for targeted regimens and maintenance treatment (all in the advanced setting) and modest uptake of novel targeted agents. Drugs produced by western manufacturers will increase their share of the market from around 60% last year to 70% in 2014, when the total NSCL cancer drug market will be worth $240 million, it says.

- With annual drug sales of just over $17 billion, Brazil is the world’s 11^th-largest pharmaceutical market and is once again the biggest in Latin America. Having fallen behind Mexico in the earlier part of the decade, it has produced consistent double-digit growth in the last five years, reaching a peak of 33% in 2005 and rising 13% in 2009, reports IMS Health.

Fighting neglected diseases: anti-TB compounds offer hope

Compounds being developed against tuberculosis also show promise against deadly tropical diseases threatening millions of people.  As reported by Reuters, the Global Alliance for TB Drug Development has granted the Drugs for Neglected Diseases Initiative (DNDi) rights to develop a class of potential anti-TB compounds offering hope of treating Chagas disease, African sleeping sickness and leishmaniasis.

Chagas, a disease caused by a parasite found mainly in rural areas of Latin America, kills some 14,000 people annually and an estimated 8 million are infected. Infection is lifelong and can lead to heart disease and heart failure. Some 100 million people are deemed at risk of the disease.

Leishmaniasis and sleeping sickness, formally known as human African trypanosomiasis, each kill roughly 50,000 people a year and pose a threat to a combined total of 400 million people.

The Gates Foundation is providing a $1.5 million grant to DNDi for preclinical assessments of compounds specifically for use against visceral leishmaniasis, a deadly parasitic infection spread by the bite of a sandfly.

Though found in Europe, Asia and Africa, leishmaniasis is most concentrated in India. An estimated 350 million people worldwide are deemed at risk from infection.

UN Report: Efforts to boost maternal and child health falling short

From the UN Daily News:

An annual assessment report released today by the United Nations shows that while significant declines have been recorded by many countries in reducing maternal and child mortality, greater progress must be made to meet the global targets contained in the Millennium Development Goals (MDGs).

According to the MDG Report 2010, launched by Secretary-General Ban Ki-moon in New York, the number of deaths among children under the age of five has dropped from 12.6 million in 1990 to an estimated 8.8 million in 2008.

The greatest advances were made in Northern Africa, Eastern Asia, Western Asia, Latin America and the Caribbean, and the countries of the Confederation of Independent States (CIS).  But most striking is the progress that has been made in some of the world’s poorest countries. Bangladesh, Bolivia, Eritrea, Laos, Malawi, Mongolia and Nepal have all reduced their under-five mortality rates by 4.5 per cent annually or more.

“Despite these achievements, and the fact that most child deaths are preventable or treatable, many countries still have unacceptably high levels of child mortality and have made little or no progress in recent years,” stated the report.  The highest rates of child mortality continue to be found in sub-Saharan Africa, which accounted for half of the 8.8 million deaths in children under five worldwide in 2008.

The publication pointed out that child deaths are not falling quickly enough to reach Goal 4, namely a two-thirds reduction in childhood mortality rates between 1990 and 2015, and millions of children continue to die each year at a tragically young age.

First agreed at the UN Millennium Summit in September 2000, the eight MDGs set worldwide objectives for reducing extreme poverty and hunger, improving health and education, empowering women and ensuring environmental sustainability by 2015.

Malaria outbreak in Venezuela

Statistics published this week by Venezuela’s Health Ministry show that malaria cases have doubled so far this year, particularly in Bolivar, where officials say there is an epidemic.  21,601 cases of malaria have been reported nationwide so far this year, up from 10,758 during the same period last year.

Public health officials attribute the rise in malaria in part to a government-led operation this year in which soldiers have evicted thousands of miners from illegal strip-mines.  That has led to a movement of displaced miners to other towns, and they have carried the disease with them and helped it spread into areas that didn’t used to have much malaria.

For more details, read the report published by the Miami Herald.

Counterfeits threaten public health in Peru

The prevalence of counterfeit medicines in Peru has increased annually (since 2005) by an average of 45% – representing a significant threat to patient safety and public health.  Nearly a quarter of the counterfeit medicines found by Peru’s National Quality Control Center did not contain any active ingredient, providing no health benefit or protection to patients.

Ecuador eliminates river blindness

Ecuador has become the second country in the Americas to stop the transmission of river blindness (onchoceriasis), a disease that can cause blindness, skin rashes, lesions, intense itching and skin depigmentation. The parasitic disease is caused by the filarial worm and is spread by the bite of infected black flies.

Major progress in combating the disease was made in the late 1980s, when Merck offered to donate Mectizan, a drug used to treat and prevent river blindness. Ecuador’s ministry of health began distributing Mectizan in 1990.

In 1993, the Carter Center spearheaded the launch of the Onchocerciasis Elimination Program of the Americas, which worked with several global health groups, including the World Health Organization, to target Brazil, Colombia, Ecuador, Guatemala, Mexico and Venezuela.

Since the launch of OEPA, twice-annual doses of Mectizan have been administered to residents in at-risk communities. It’s led to 85 percent treatment coverage in each country and prompted Colombia to announce in 2008 that it had stopped transmission of the disease.