WHO Releases new Tuberculosis Report

The World Health Organization released its’ thirteenth report on Tuberculosis control this week, which provides information and statistics related to the numbers of cases and numbers of deaths due to TB in 196 countries.   The report stresses the link between HIV and TB, suggesting that roughly 25% of people who died from TB in 2007 were HIV patients.  9.3 million new TB cases were detected world-wide in 2007, and 1.4 million, (15%), occurred in people infected with HIV.  This is a significant increase over what had been found in previous years, likely because aid agencies have increased the number of TB patients that they are testing for HIV.

It is not surprising that patients with HIV become infected with TB – when one considers that these patients sit side-by-side in health centers: the TB-infected individual coughing into the air, while individuals with a compromised immune system breathe the same air.  This fact has led some aid workers to suggest that health centers in areas with high rates of TB and HIV be open to the air where possible.

The report also discusses progress towards Millenium Development Goals, as well as assessments of the “Stop TB Strategy”.   According to the WHO, this report is “the definitive source of information about the national and international response to the worldwide TB epidemic.”

Canadian researchers begin first phase of human trials in new TB vaccine; 11 other TB vaccines in various stages of research at facilities around the world

Tuberculosis, the world’s second deadliest infectious disease could finally meet its match in a new vaccine developed by researchers at McMaster University.  The new vaccine is at least five years away from broad use, if it can be shown to be safe, effective and practical to make and distribute — and if another team doesn’t get there first.  The development, announced yesterday, means McMaster is now in the hunt to stop tuberculosis, making it the first Canadian team among about 12 worldwide in various stages of testing new TB vaccines.

TB is the world’s second leading infectious killer, after HIV, and is responsible for nearly two million deaths worldwide each year. It is caused by an insidious bacterium that can live in the body for decades before overwhelming its host.

The McMaster vaccine — now known as AdAg85A — has proven effective in animal testing, and the university is to start recruiting healthy volunteers next month for the first phase of human trials, which will take 12 to 18 months.  Those will measure the safety of the vaccine and its ability to trigger the desired immune response.

Later trials would take place in parts of the world where TB is endemic, and measure whether that response is enough to stop the disease from developing.

The McMaster vaccine uses live adenovirus – the type responsible for the the common cold – as the vehicle to carry the TB gene responsible for immunity.  The cold virus would live just long enough to trigger the body’s immune response and introduce the TB gene, rendering the subject immune from tuberculosis.

Though the familiar BCG vaccine has been used against TB for about 90 years, it offers protection only against childhood tuberculosis. The new McMaster vaccine would be used as a form of booster shot to protect against adolescent and adult TB.

Read more about this research online at The Hamilton Spectator.

The FDA and innovation

A well-run FDA is crucial to ensuring that Americans continue to get access to the best new therapies in a timely fashion.  Lengthy and costly approval periods–which average 10 years and $1 billion per product under consideration–raise important questions about whether the FDA is doing its part to make sure innovative new therapies can reach patients who need them.

According to a recent article in Forbes, “negative media and congressional attention exacerbate this problem and can make the agency reluctant to grant final approval to new products. In fact, there is some evidence that approvals of products in Phase III, the last level of assessment before products go to market, has declined in recent years–indicating that FDA officials may be nervous about the folks who are looking over their shoulders. This timidity has been particularly worrisome when it comes to approving new cancer drugs as well as antibiotics, which are needed to combat increasingly resistant infections contracted during hospital stays.”

With an already stretched budget and talk of expanding the FDA’s role, the new commissioners (President Obama has reportedly selected Margaret Hamburg and Joshua Sharfstein to serve as commissioner and deputy commissioner, respectively) face a big challenge.

WHO public consultation on innovative R&D financing

The World Health Organization has recently opened a public online consultation focused on identifying new and innovative sources of funding to stimulate medical R&D.

The web-based public hearing is open to individuals, civil society groups, government institutions, academic and research institutions, the private sector and other interested parties between 7 March to 15 April.  Information on the consultation process, a submission form and copies of documents posted to date are available online at http://www.who.int/phi/public_hearings/third/en/index.html.

In providing your contributions, the WHO suggests that you may wish to consider the following:

• Focus on diseases that disproportionately affect developing countries;
• Feasibility of the financing model proposed; and,
• The expected contribution to fostering innovation and building R&D capacity.

Modelling the proposal on R&D needs for a specific disease or group of diseases and/or including any existing examples at national or international levels may facilitate better understanding of the concepts and ideas proposed.

The proposals will be reviewed by members of the WHO Expert Working Group on R&D Financing, and will be further discussed at the second meeting of the Group in June 2009.

Canadian sentenced for creating counterfeit drugs

Recently, there has been significant media coverage of the ongoing efforts of IMPACT, the WHO, many national  governments and other organizations to eliminate the distribution of counterfeit medicines.  For the most part, stories of counterfeit medicines have focused on African countries.  While counterfeit medicines are certainly more prevalent in areas of Africa than in many developed countries, we often forget that we’re not immune to the problem.

Following the seizure of 2 million dollars worth of counterfeit medicines, a man pleaded guilty to manufacturing and selling fake prescription drugs in Canada.  What is the penalty he’ll pay for endagering patient’s lives?  Less than two years in jail…

Waterloo man sentenced for creating counterfeit drugs - (570 News)

A Waterloo man pleaded guilty yesterday to a string of charges following the seizure of 2-million dollars worth of drugs.

45-year-old Fernand Reis. — a self-taught chemist –was found in possession of counterfeit prescription drugs and steroids. He admitted in court to selling the drugs online to various nutrition and health businesses in Kitchener, Hamilton and the Toronto area.

Reis pleaded guilty to 15 counts of possession for the purpose of trafficking, trafficking and importing drugs to Canada.

In a plea deal, he was sentenced to the equivalent of 22 months in jail.

Multi-Sector Partnerships in Global Public Health

Following a full day of meetings at the United Nations’ Economic and Social Council’s Special Event on Philanthropy and the Global Health Agenda (see the previous posting), ECOSOC’s President H.E. Sylvie Lucas hosted a reception (co-sponsored by CARE and the Global Health Progress initiative).  Leaders from various nations, the global health community, biopharmaceutical companies and international non-governmental organizations (NGOs) mingled and continued an informal discussion on health partnerships and advancing the global public health agenda.

A news release issued by the hosting organizations quoted several of the speakers at the evening event, including Chris Singer, President of the International Section at the Pharmaceutical Research and Manufacturers of America (PhRMA) who stated that “We are all in this together.  Promoting and strengthening partnerships to improve global health is something research-based biopharmaceutical companies remain strongly committed to.”