$10 billion commitment to vaccine research and delivery – Gates Foundation

The Bill & Melinda Gates Foundation announced today that they will commit $10 billion over the next 10 years to help research, develop and deliver vaccines for the world’s poorest countries (read more).  The Foundation estimates that increased vaccination could save more than 8 million children by 2020.

“We must make this the decade of vaccines,” said Bill Gates. “Vaccines already save and improve millions of lives in developing countries. Innovation will make it possible to save more children than ever before.”

Bill and Melinda Gates said their pledge was inspired by the remarkable progress made on vaccines in recent years. For example:

• Record-breaking vaccine access: New WHO data show that global vaccination rates have reached all-time highs.
• Improved routine immunization: Partnerships focused on reducing diseases like polio and measles are also helping build a stronger foundation for the delivery of both new and existing vaccines.
• New vaccine introduction: Important new vaccines for the two leading causes of global child deaths—severe diarrhea and pneumonia—are becoming available.
• R&D momentum: The vaccine research and development pipeline is more robust than ever.

Many of the recent advances in vaccine development and delivery have been driven by public-private partnerships such as the GAVI Alliance and the Rotavirus Vaccine Program at PATH, which coordinate the resources and expertise of vaccine companies, donors, UNICEF, WHO, the World Bank, and developing countries.

This commitment by the Gates Foundation follows the recent release of two studies in the New England Journal of Medicine which estimated that vaccines against rotavirus could save 2 million children over the next decade.  The studies showed that vaccinating babies against rotavirus significantly cut deaths from diarrhea — by 61 percent in Africa and by 35 percent in Mexico.

2010 global counterfeit medicine sales predicted to reach $75 billion

The global sale of online counterfeit drugs is likely reach $75 billion in 2010, according to research by UK, Swedish and American academics.

The research, which covers more than 50 studies published 1995-2009, provides an overview of the scale of counterfeit internet drugs and shows a 92% increase over the last five years. It also estimates that 90% of fake medicines are sold online.

Increase in innovation, access to orphan drugs

The number of orphan drug designations in the US more than doubled in the last decade, growing from 208 during 2000-02 to 425 in 2006-08, says a new study.

Since the US Orphan Drug Act of 1983 was signed into law, more than 2,000 products in development have been designated as orphan drugs, while the Food and Drug Administration (FDA) has granted market approval to 350 drugs and biologics, according to the study, which was conducted by the Tufts Center for the Study of Drug Development (CSDD).

Orphan drugs are products developed for a rare disease or condition affecting fewer than 200,000 people in the US, while in the European Union (EU) they are defined as treatments for diseases or conditions affecting five people out of every 10,000, or fewer.

The National Institutes of Health (NIH) estimates that 25 million Americans have a rare disease.

Bill and Melinda Gates Foundation Annual Letter: Focus on Innovation

Bill Gates recently published his 2010 Annual Letter on behalf of the Bill and Melinda Gates Foundation.  The focus of this year’s letter is innovation and how it can make the difference between a bleak future and a bright one.  Global health innovations discussed in the letter highlight the significant impact of medicine and vaccine development on global public health.

Some highlights from his 2010 Annual Letter include:

The improved health of children in poor countries is a great example of the power of innovation. In 2008, for the first time fewer than 9 million children under age 5 died. In 2005, the last time the number was measured carefully, it was just below 10 million. This is huge progress, and it is due to improvements like increased vaccinations and better malaria treatment and prevention.

Vaccines are one of the most effective health interventions ever developed.

Vaccines are a miracle because with three doses, mostly given in the first two years of life, you can prevent deadly diseases for an entire lifetime. Because the impact is so incredible, vaccines are the foundation’s biggest area of investment—more than $800 million every year—and the return is substantial.

Achieving full coverage is hard in poor countries, where cost and delivery are big barriers.  Various innovations can simplify the delivery. Sometimes it’s possible to combine different vaccines into one. Since the trivalent vaccine was introduced in developing countries, tetanus deaths are down nearly 88 percent and pertussis deaths are down 70 percent. Almost all deaths from the three diseases (diphtheria, tetanus, and pertussis) would be stopped altogether if vaccine coverage were improved to 95 percent everywhere.

Even when a vaccine can’t be combined with others, you can still improve distribution by making it free for poor countries, or cheap enough that they can afford to buy it. This has been a key focus for the GAVI Alliance, which we helped create almost 10 years ago. GAVI gives grants to poor countries to improve vaccine coverage and to help pay for new vaccines.

This year the foundation helped launch a new approach to encourage a high-volume, low-cost supply of a pneumococcus vaccine that meets the needs of poor countries. This approach is called an Advance Market Commitment, and it involves a group of donors pledging $1.5 billion to help pay for the vaccine for poor countries. We expect that manufacturers will commit to building factories much earlier than they would otherwise in order to compete for this money.

If we project what the world will be like 10 years from now without innovation in health, education, energy, or food, the picture is quite bleak.

Malaria drugs may help fight lupus

Drugs used to treat malaria may be useful for patients with lupus, a chronic debilitating “autoimmune” disease, according to according to a new report published in the journal Arthritis and Rheumatism.

“The data presented, taken in conjunction with the data from the published literature, suggest that antimalarials should be used in all lupus patients regardless of their disease manifestation or disease duration,” the authors concluded.

Pons-Estel and his team studied nearly 1,500 patients with lupus from 9 countries.  About 12 percent of the patients who did not use the drugs died during the follow-up period, compared to about 4 percent of those who did.  The difference was even higher for patients who used the drugs for more than two years.  After the team accounted for various factors, using antimalarial drugs appeared to reduce the risk of death during the study by almost 40 percent.

Lupus is a chronic disease in which the immune system confuses its own healthy tissues with foreign tissues and sometimes attacks both. The condition can manifest as a skin rash or arthritis and may lead to damage to the kidneys, heart, lungs and brain to varying degrees. The disorder disproportionately affects women.

Pharmaceutical company opens access to malaria research and compounds

Pharmaceutical company GlaxoSmithKline has outlined a series of initiatives aimed at attacking neglected diseases and says that its experimental malaria vaccine is just a couple of years away from being approved.

GlaxoSmithKline (GSK) is to reveal previously confidential data on thousands of potential anti-malaria compounds. The company has 13,500 molecules which have been tested against the parasite which causes malaria.

In addition to this, the company is to pump millions into an ‘Open Lab’ for independent research teams.  One expert said more sharing of data could trigger advances like those that came from the human genome project.

Dr Timothy Wells, Chief Scientific Officer of the Medicines for Malaria Venture, which has worked with GSK on the project, said it had the potential to “dramatically alter” the way the world approached malaria research.

GSK also outlined what it calls a “sustainable approach” it has developed to price RTS,S, the world’s most advanced malaria candidate vaccine, which is currently in late-stage trials across seven African countries.  The pricing model “will cover the cost of the vaccine together with a small return” which will be “fully reinvested into R&D for second-generation malaria vaccines, or vaccines for other neglected tropical diseases”.

Global health fraud – $260 billion

180 billion euros ($260 bln) is lost globally every year to fraud and error in healthcare — enough to quadruple the World Health Organisation’s and UNICEF’s budgets and control malaria in Africa, experts said on Monday.

A study by the European Healthcare Fraud and Corruption Network (EHFCN) and the Center for Counter Fraud Services (CCFS) at Britain’s Portsmouth University found that 5.59 percent of annual global health spending is lost to mistakes or corruption.

The report found evidence for many different types of fraud, from pharmacists dividing prescriptions into small packages to claim extra fees to patients making fraudulent insurance claims.

The World Health Organization’s latest estimate of global healthcare expenditure was $4.7 trillion (3.3 trillion euros). The fraud report’s 260 billion loss figure is based on an average of 5.59 percent of spending being lost to fraud.

WHO strikes back at critics — H1N1 pandemic

The World Health Organization has struck back at criticism about the agency’s handling of the H1N1 pandemic, saying claims that the outbreak was a false alarm are scientifically wrong and irresponsible.

“The world is going through a real pandemic. The description of it as a fake is both wrong and irresponsible,” said Dr. Keiji Fukuda, special adviser to the WHO director-general on pandemic influenza.

Fukuda also said dismissing the pandemic as a dud is “somewhat disrespectful” to the people who died or were severely sickened by the virus, as well as to those who have worked long hours on pandemic responses around the world. Those responses, he said, are the most concerted in the history of influenza and have averted infections and deaths.

“We don’t know how much these efforts have helped to mitigate the overall effect of the pandemic, but we firmly believe that these efforts should not be discounted.”

Definition of a pandemic

According to the World Health Organization, a pandemic can start when three conditions have been met:

• emergence of a disease new to a population;
• agents infect humans, causing serious illness; and
• agents spread easily and sustainably among humans.

A disease or condition is not a pandemic merely because it is widespread or kills many people; it must also be infectious.

Gene map may help boost production of malaria treatments

The first genetic map of a medicinal herb used in the best malaria treatments is being published to help scientists develop the species into a high-yielding crop and battle the killer mosquito-borne disease (Reuters).

Artemisinin, derived from the sweet wormwood, or Artemisia annua plant, is the best drug available against malaria, especially when used in artemisinin combination therapy (ACT) medicines made by firms such as Novartis AG and Sanofi-Aventis.

Around 40 percent of the world’s population is at risk of malaria, a potentially deadly disease transmitted via mosquito bites. It kills more than 1 million people worldwide each year and children account for about 90 percent of the deaths in the worst affected areas of sub-Saharan Africa and parts of Asia.

Around 6,500 hectares of land – mostly in China, Vietnam, Africa and India — was devoted to sweet wormwood crops in 2009, producing 30 metric tonnes of artemisinin a year — enough for around 60 million treatments.

Low artemisinin yields in the usual growing areas in Africa and Asia have made production expensive and planting areas have shrunk, raising fears of shortages and contributing to a slow roll-out of ACT treatments across the world.

Patients and Patents: year in review

Many important global public health issues were discussed on the Patients and Patents blog in ’09, including:  access to treatments, medical innovation, counterfeit medicines, neglected tropical diseases and chronic conditions.  With the start of the New Year, it seemed appropriate to recap some of the most popular posts from the past year.

Cancer, cardiovascular and other Type 1 diseases will cause over three quarters of all deaths by 2030
The global burden of disease is shifting from infectious diseases to non-communicable diseases, according to a recent report from the World Health Organization [1].  As populations age in middle- and low-income countries over the next 25 years, the proportion of deaths due to non-communicable diseases will rise significantly.  This trend will be accompanied by large declines in mortality from the main infectious diseases, including HIV, diarrhea, tuberculosis and malaria…

Malaria parasite’s resistance to top drug grows
The World Health Organisation last week warned that the parasite which causes malaria is increasingly resistant to artemisinin, the best drug around, and failure to contain this trend would bring serious consequences…

NAFDAC blacklists 22 Indian pharmaceutical firms
According to the World Health Organization, counterfeit and sub-standard medicines represent an enormous public health challenge.  These products can range from random mixtures of harmful toxic substances to inactive, useless preparations.  Counterfeiting is greatest in those regions where the regulatory and legal oversight is weakest.  Many countries in Africa and parts of Asia and Latin America have areas where more that 30% of the medicines on sale can be counterfeit…

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…

Tiered Pricing Enables Health for All
The issue of affordable access to vaccines in less developed countries was recently raised by Financial Times reporter Andrew Jack.  Specifically, Mr. Jacks’ article highlighted the contentious issue of differential pricing between rich, poor and middle-income countries — and how PAHO’s vaccine system is undermining efforts to provide vaccines to the least developed countries in Latin America, Africa and elsewhere around the world…