GSK malaria vaccine could save millions of lives

The following report published in The Guardian today provides encouraging global health news — GSK’s new vaccine against malaria has been shown to halve the risk of malaria.

Malaria vaccine could save millions of children’s lives

Millions of small children’s lives could be saved by a new vaccine that has been shown to halve the risk of malaria in the first large-scale trials across seven African countries.

The long-awaited results of the largest-ever malaria vaccine study, involving 15,460 babies and small children, show that it could massively reduce the impact of the much-feared killer disease. Malaria takes nearly 800,000 lives every year – most of them children under five. It damages many more.

The vaccine has been in development for two decades – the brainchild of scientists at the UK drug company GlaxoSmithKline, which has promised to sell it at no more than a fraction over cost-price, with the excess being ploughed back into further tropical disease research.

Lupus drug approved – first in last 50 years

As reported by Scientific American, the autoimmune disease lupus has confounded drug developers for more than 50 years. But a new therapy finally broke through that barrier yesterday when the US Food and Drug Administration (FDA) announced the approval of Benlysta (belimumab) for the treatment of systemic lupus erythematosus.

This breakthrough has been a long time coming — though not for lack of effort.  At least seven possible medicines have been turned back at the clinical trial stage in the last several years (Source:  PhRMA).

For those with Lupus, this approval is not the only good news.  Other similar drugs are in the pipeline and could be available in the near future.

Joint venture aims to develop new rotavirus vaccine for poor

A joint venture between U.S. drugmaker Merck and Britain’s Wellcome Trust charity is working on an oral rotavirus vaccine designed to be cheaper and easier to use than current shots, as reported by Reuters.

The vaccine will aim to protect against diarrhoea-causing rotavirus infections and will be based on thin strips or granules that dissolve in the mouth and can be easily transported, stored and administered.  Currently available rotavirus shots, made by Merck & Co. and GlaxoSmithKline, need to be kept in cold storage — making their transportation and delivery complex and costly.

Diarrhoea is one of the top two killers of children under five worldwide, and rotavirus is the leading cause of severe diarrhoeal disease in children. Each year, rotavirus-related diarrhoea kills more than 500,000 children and is the cause of many millions more needing hospital treatment.

Vaccines are often the best hope for tackling many diseases in poor countries.

New malaria vaccine shows long-lasting protection

(From Reuters) An experimental malaria vaccine from GlaxoSmithKline provides African children with long-lasting protection, though its effectiveness declines slightly over time, according to recently published trial data.  Scientists conducting the mid-stage trial at the Kenya Medical Research Institute said results showing the shot offered 46 percent protection for 15 months meant it had “promise as a potential public health intervention against childhood malaria in malaria endemic countries.”

Malaria is an infectious disease spread by mosquitoes that threatens up to half the world’s population. Most of its victims are children under five in poor countries in sub-Saharan Africa.

Late-stage trials of the GSK vaccine, known as RTS,S or Mosquirix, in 16,000 children in seven countries across Africa are ongoing, with immunizations due to end next month.  If data show the vaccine was effective, it could be licensed and rolled out as soon as 2015.

GSK chief executive Andrew Witty has said that if RTS,S proved effective in final-stage trials it would be sold at a price that those who need it most can afford. The company has said it was planning for a profit margin of 5 percent over the cost of making the vaccine, and that would be reinvested in new vaccines for malaria and other neglected diseases.

The Promise of American Medical Innovation

Ahead of its symposium Wednesday (Medical Innovation at the Crossroads:  Choosing the Path Ahead), the Council for American Medical Innovation released a Web video on the impact of medical innovation on American life and its potential (as reported by POLITICO Pulse).  The symposium includes U.S. Chief Technology Officer Aneesh Chopra, former House Majority Leader Dick Gephardt, former HHS Secretary Mike Leavitt, PhRMA’s John Castellani and Cleveland Clinic’s Chris Coburn, among others.

PULSE caught up with Aneesh Chopra, Obama’s chief technology officer, who headlines the event, to give us a preview of his Wednesday remarks: “I’m going to make the case that this is the best time and opportunity to work on health care innovation. Between health reform and the recovery act, the conditions, I believe, are ripe for innovation and improvement.”

Pharmaceutical innovation and data protection – WTO forum discussion

An interesting discussion was recently started in the World Trade Organization’s community forum on a complex topic — data protection and pharmaceutical innovation.

Posted by KMLybecker

Generating the data necessary to secure regulatory approval has become more extensive and more expensive. Clinical testing has become more difficult and laborious. These regulations and associated costs play an increasingly important role in the pharmaceuticals and agricultural chemical industries, sectors in which product safety and efficacy are of utmost importance. As such, it is necessary to incentivize data generation by providing protection for the investment in data generation. Regulatory data protection serves to protect originator firms against free riding, and safeguards the substantial financial investment involved in drug discovery and regulatory approval.

WHO report on NTDs highlights ongoing commitment of pharmaceutical industry

An interesting article on neglected tropical diseases — and a recent report from the WHO — sourced from World Health Advocacy.

First WHO report on NTDs highlights ongoing commitment of innovative drug companies

The World Health Organization today released their first report on neglected tropical diseases – diseases that affect mainly poor people and cost billions of dollars in lost productivity annually.

“Good medicines are available for many of these diseases, and research continues to document their safety and efficacy when administered individually or in combination,” said Dr Margaret Chan, WHO Director-General. “Generous drug donations by pharmaceutical companies have helped relieve some of the financial barriers and allowed programmes to scale up coverage.”

Leading research-based pharmaceutical companies have already provided high-quality medicines free of charge for hundreds of millions of poor people suffering from such diseases, mainly in remote areas of Latin America, Asia and Africa, according to the WHO.  In coordination with the launch of this report, additional long-term industry commitments to combating neglected tropical diseases were announced today, including:

• Novartis renewed its commitment to donate an unlimited supply of multidrug therapy and loose clofazimine for leprosy and its complications.
• GlaxoSmithKline announced a new five-year commitment to expand their donation of albendazole through WHO, in addition to their current donation for lymphatic filariasis to treat school-age children for soil transmitted helminthiases in Africa. The commitment includes 400 million doses per year for this purpose.
• Sanofi-aventis has agreed to renew its support for the WHO programme to eliminate sleeping sickness, and its support for Buruli ulcer, Chagas disease and leishmaniasis for the next five years.

This continued support will ensure that necessary resources will be available also to move forward in combating leishmaniasis, Buruli ulcer and Chagas disease. In addition:

• Bayer has started discussions with WHO on how to evolve their current commitment to fight sleeping sickness and Chagas disease.
• EISAI has committed to work towards the global elimination of lymphatic filariasis by providing diethylcarbamazine (DEC) and
• Johnson&Johnson has recently also announced expanding its donation of mebendazole to supply up to 200 million treatments per year for treatment of intestinal worms in children

Despite these commitments from innovative drug makers, Dr. Chan added, “Production of medicines used to treat NTDs must be made more attractive to companies that manufacture generic pharmaceuticals.” It is important to note that many of these products are off- patent, but generic companies have not invested in their production.

“Neglected tropical diseases blight the lives of a billion people worldwide and threaten the health of millions more,” said Dr. Chan in the report.

The WHO report provides an overview of 17 neglected tropical diseases and provides details on their prevalence, distribution, economic and social impact as well as prevention and control strategies. Examples of these diseases include:

• Lymphatic filariasis – a mosquito-borne disease that causes intestinal worms and disfigures limbs and genital parts, costing an estimated $1.3 billion a year in lost productivity in Africa and South East Asia.
• Dengue fever – about 1 million confirmed cases of dengue are reported annually to WHO. The aggregated annual economic cost of dengue was estimated to be at least US$ 587 million. Preliminary adjustment for underreporting could raise this total to US$ 1 800 million
• Trachoma – in 57 countries where trachoma is endemic millions of people have irreversible visual impairment and blindness caused by the disease, and more than 40 million people are in need of treatment. The economic cost of trachoma in terms of lost productivity is estimated at US$ 2.9 billion annually.
• Chagas disease continues to persist in the Region of the Americas, but the estimated number of infected people has fallen from approximately 20 million in 1981 to around 10 million in 2009. A recent study in Colombia estimated an average expected annual cost per patient with chronic Chagas disease of US$ 1028. On average, the estimated lifetime cost of treating a patient with chronic Chagas disease in Colombia is US$ 11 619.

“The involvement of the pharmaceutical industry in NTDs, and subsequent donations made to support their control, have increased access to high-quality medicines free of charge for hundreds of millions of poor people,” according to the report. “The increasing willingness and commitment of local and global communities of partners to work with endemic countries have brought resources, innovation, expertise and advocacy to efforts to overcome NTDs. Intersectoral collaboration, involving education, nutrition and agriculture, has reinforced NTD control.”

New study highlights the importance of partnerships in improving public health.

The Cameron Institute – a Canadian not-for-profit public policy think-tank – released a report highlighting the importance of public-private partnerships and of intellectual property protections to improving global health.  The evidence in this report (Pharmaceutical Access in Least Developed Countries: on-the-ground barriers and industry successes) strongly supports North-South, public-private partnerships as the preferred means by which to improve access to care and public health outcomes in least-developed countries.

Sustainable development is the way of the future for both North and South.  In order for there to be sustainable healthcare enterprise and optimal health outcomes in the least-developed countries, there must also be the necessary infrastructure, health human resources, political stability, and professional administrative legal structures.

– Dr. D. Wayne Taylor Ph.D., F.CIM, Executive Director of The Cameron Institute

The 200-page report shows that the research-based pharmaceutical industry has sponsored or participated in over 150 public-private partnerships that have successfully improved access to drugs – as well as health outcomes – for the 50 least developed countries.

Click here to download the full report.

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.

WSJ opinion – Africa’s Health Crisis

An interesting opinion from the Wall Street Journal about challenges and barriers to improving public health in Africa.

How to Worsen Africa’s Health Crisis: Killing off drug patents will kill off innovation and patients.

By ALEC VAN GELDER

Faced with Africa’s devastation by HIV/AIDS, people are looking for scapegoats. Global pressure groups and now the World Health Organization are targeting “Big Pharma.” The drug companies do make easy targets but that doesn’t make them villains. The life-saving treatments they create remain Africa’s best hope. The misguided battle against pharmaceutical companies’ patent rights will only make Africa’s health crisis worse.

Intellectual property rights for AIDS drugs are “the biggest public health challenge” as they make them too costly for most Africans, Hans Hogerzeil, head of the WHO’s Essential Medicines program, recently said. They are “a barrier to access,” he previously claimed, but the real barriers are the lack of infrastructure and the diversion of aid money. Fewer than 5% of WHO’s 423 Essential Medicines are currently protected by patents; mostly advanced “second-line” anti-AIDS medicines.