News

Photo: CDC/ Dr. Mae Melvin A recently released clinical report from the US Centers for Disease Control and Prevention details a case of a Colombian man who developed cancerous tumors on his lungs and liver that were comprised of tapeworm cells, rather than human cells. An estimated 75 million people are infected by Hymenolepis nana, the most common human tapeworm, however, this is the first reported case of cancer spreading across species to humans. The team suspects that the tapeworm vector did not have cancer, but rather that one of its eggs mutated within the patient’s gut into cancerous cells. International Partnership for Microbicides (IPM), a member of the GHTC, is conducting Phase I clinical trials of a novel HIV and AIDS prevention method known as DS003. The drug binds to a protein on the surface of the HIV virus, preventing it from entering human immune cells. The trial will involve three stages, during which nine women will receive the drug and three will receive a placebo, enrolling 36 volunteers in total. At each stage, the participants will receive increasingly higher doses, from 1 to 10 mg, assuming that the previous stage demonstrated the drug to be safe and tolerable. The drug will be tested as a vaginal tablet, and if successful, DS003 will likely be tested in vaginal rings and/or in combination with other antiretroviral drugs. The fastest and most accurate tuberculosis (TB) diagnostic test will soon be available as a portable and more affordable device, making it more accessible in low-resource settings. Cepheid Inc.’s GeneXpert was endorsed by the World Health Organization in 2010, and its use increases the accuracy of diagnosis by 39 percent, however, the machine costs US$17,000 and requires electricity, refrigeration, and access to a computer. The new GeneXpert Omni will be rolled out early next year at a fraction of the cost—$2,895 for the machine and $10 per cartridge. The Omni runs on a battery and connects to a smartphone, weighs just 2.2 pounds, and can diagnose drug-resistant TB along with 23 other diseases.

PATH/Dan Chang New rapid diagnostics are urgently needed to prevent unnecessary use of antibiotics and curb the growing problem of antimicrobial resistance, according to a new report from the United Kingdom’s Review on Antimicrobial Resistance (AMR). The report calls for greater investment to develop and support adoption of quicker and more precise diagnostics tests. Antibiotic overuse and growing resistance The rise of drug-resistant bacteria poses a significant health threat to people around the world. Unnecessary use of antibiotics is helping drive this rise in resistance, but since the 1940s, there has been little improvement in the way bacterial infections are diagnosed. The report points out that most antibiotic prescriptions are issued by medical professionals who are making a diagnosis empirically without using a diagnostic test. The fact that diagnostic tests are relatively expensive but antibiotics are cheap means it is less expensive for doctors and their patients to skip the test and issue the antibiotic prescription in case it proves helpful. Diagnostic tests are also time-consuming. It can take 36 or more hours to identify whether a person has an infection, so doctors often put sick patients on a treatment before a diagnosis can be confirmed. The scale of this problem can be quite dramatic: The report highlights one study on patients with respiratory problems which found that more than two-thirds of courses of antibiotics were likely to have been inappropriately prescribed for conditions other than infections or for infections caused by viruses, which aren’t responsive to antibiotics. Rapid diagnostic tests—which will allow doctors to identify within minutes whether an infection is present—can prevent unnecessary prescription, and more refined tests—which enable doctors to identify the exact strain of the bacterial infection and the antibiotics to which it is resistant or susceptible—will enable doctors to more precisely prescribe narrow-spectrum antibiotics, which will help slow the development of resistance. Incentivizing development of diagnostics A CDC scientists examines antibiotic resistant bacteria. CDC/ Melissa Dankel While new rapid diagnostics are urgently needed, the report points out that there is little commercial incentive for drug developers to invest in diagnostics, since their use would lead to decreases in the number of antibiotics purchased. The report proposes the use of “Diagnostics Market Stimulus pots” that would provide a revenue stream for developers of products that meet a recognized area of need. These developers would receive “top-off” payments when products are purchased by healthcare providers, thus raising the commercial benefit of investing in diagnostic development to match the societal need for these products. The report also calls for greater investment in early stage research, referring to its previous report which called for an AMR innovation fund of US$2 billion over five years to boost funding for such research. “For far too long we haven't recognized the huge cost to society of increasing resistance when we use antibiotics that we don’t need—such as antibiotics for flu which have no effect except to increase the chances of superbugs developing," said Lord Jim O'Neill, chairman of the AMR review. "To avoid the tragedy of 10 million people dying every year by 2050, the world needs rapid diagnostics to improve our use of antibiotics. They are essential to get patients the right treatment, cut down on the huge amount of unnecessary use, and make our drugs last for longer." A diagnostic “wish list” To inform investment efforts in diagnostic research and development, the report includes a “wish list” of diagnostics that could be game changers in curbing antibiotic resistance. Below are of few of those identified in the report: Rapid diagnostics that could be used at home to indicate bacterial or viral infections. These would potentially reduce visits to the doctor and so reduce healthcare resource consumption. Biomarker panels to distinguish whether patients admitted via A&E [accident and emergency] for pneumonia or fever have bacterial infections or not. A bedside test that would reliably exclude any infection. This should reduce the empirical use of antimicrobials and could also often be used as part of the treatment protocol for sepsis.

The Global Health Technologies Coalition (GHTC) is pleased to announce that the International Vaccine Institute (IVI) has joined the coalition’s membership. IVI is an independent nonprofit international organization headquartered in Seoul, South Korea that conducts research to discover, develop and deliver safe, effective, and affordable vaccines for global public health. “IVI was founded on the belief that the health of children in developing countries can be dramatically improved by the use of new and improved vaccines,” said Jerome Kim, IVI’s Director General. “Since our founding, we’ve collaborated with the scientific community, nonprofits, governments, and industry to facilitate the development and introduction of vaccines in countries where they are most needed. We are excited to join GHTC and look forward to working with the coalition to educate policymakers about the critical importance of vaccine R&D in tackling the leading causes of disease and disability in developing countries.” IVI was established in 1997 as an initiative by the United Nations Development Programme under the recognition that there was a need for an international organization with the mandate to improve the health of children in developing nations through vaccines and vaccination. IVI operates today under an international treaty signed by 35 countries and the World Health Organization (WHO). IVI is involved in all areas of the vaccine spectrum from vaccine discovery in the laboratory to vaccine development and evaluation in the field to facilitating sustainable vaccine introduction. The institute conducts lab research from its Seoul headquarters, as well as clinical and field research in more than 20 countries in Asia, Africa, and Latin America. Among its achievements, IVI led an international product development partnership for the inactivated oral cholera vaccine. The vaccine was prequalified by WHO in 2011, making IVI one of two nonprofit organizations that successfully brought a vaccine to WHO prequalification. “GHTC is excited to welcome the International Vaccine Institute to our membership,” said Erin Will Morton, GHTC’s Coalition Director. “Since its founding nearly two decades ago, IVI has established itself as a leading actor in vaccine research and development. We look forward to partnering with the institute to promote policies and investments that accelerate the development and introduction of lifesaving vaccines in low-income countries.” For more information about the International Vaccine Institute, visit www.ivi.int.