TUBERCULOSIS (TB) has a major impact on women’s sexual reproductive health and that of their children. For pregnant women living in areas with high TB infection rates, there are increased chances of transmission of TB to a child before, during delivery or after birth. The disease, especially if associated with HIV, also accounts for a high incidence of maternal and infant mortality. Unfortunately, there is little to no attention to women’s vulnerability in the current discussion and media blitz of a resurgent TB internationally, and in particular, sub-Saharan Africa.

In sub-Saharan Africa, TB is threatening to unravel public health developments gains around increased HIV awareness yet the solutions are not easy, particularly where they concern the well-being of women.

There is need for huge financial, human, research and technological investments to fight the problem, but such investments will work only if they radically put women’s health needs at the core.

More importantly is the need to align TB services and sexual reproductive health services, so that men and women know about the implications of the disease to their sexual lives and households.

In sub-Saharan Africa, however, there are pervasive systemic factors driving TB and drug resistance which cannot be ignored in the search of an effective solution to the problem.

A myriad of social and economic factors, as well as weaknesses in the health care system, inadequate laboratories combined with high HIV infection rates are fuelling the resurgence of the TB in the region. Food insecurity, poor sanitation and overcrowding also contribute to the easy spread of the disease.

According to WHO, although Africa has only 11% of the world’s population, it accounts for more than a quarter of the global TB burden with an estimated 2.4 million TB cases and 540,000 TB deaths annually.
Governments in the region are grappling with inadequate infrastructure and the increasing threat of drug-resistant strains and co-infection with HIV.

HIV infection increases the likelihood of active TB more than 50-fold. An estimated one-third of the 24.5 million people living with HIV (PLHIV) in sub-Saharan Africa also have TB.

For women in the region, the prospect of a growing TB epidemic is harrowing, but discussion about the disease rarely sheds light nor seeks to address women’s specific needs.

Given the high rates of HIV infection among women in the region – the majority of people living with HIV in sub-Saharan Africa (61% or 13,1 million) are women – it is clear that they are the largest group at threat to develop active TB, and more likely drug resistance.

Even with the availability of TB drugs women’s socio-economic status and gender roles including child-bearing and caring puts them at high risk of both HIV and TB infection.

For many women in the region, the costs required to access health care centers for TB treatment are usually out of reach due to poverty and undermined socio-economic positions.

The social stigma associated with a TB diagnosis and its association with HIV forces both men and women to delay going to get tested for the disease. In some cases, when men in marital relationships test positive for TB, they are likely to withhold the information, thereby increasing the likelihood to spread the disease to both their partner and children.

Moreover, women in the region are largely responsible for the upkeep of the family, including looking after children, which may also affect consistent uptake of TB drugs. When a woman is infected with TB, the likelihood of spreading the disease to young children is very high.
An additional concern for women is that the uptake of TB drugs interferes with contraceptive use, pregnancy, and fertility.

According to researchers, Rimfampicin, a key component of TB treatment can reduce the effectiveness of oral contraceptive pills and possibly other hormonal methods, such as implants, injectables and emergency contraception.
TB in pregnant women not only increases the rate of maternal mortality, but is also a major factor contributing to the risk of mother-to-child transmission of the disease.

A study conducted in South Africa revealed mother-to child-transmission of TB in 15% of infants born to a study cohort of pregnant women in which 77% were HIV-infected. Maternal HIV/TB coinfection also increases the risk of mother-to child transmission of HIV.

Screening and treatment for TB in pregnant women at antenatal clinics must therefore be a major public health priority in the region. Information about TB needs to be an integral component of sexual reproductive health services.
To be precise, women infected with TB need to be empowered so that they can take control of their own care and lives. (CNS)

Chief K Masimba Biriwasha - CNS
(The author, born in Zimbabwe, is a children’s writer, poet, playwright, journalist, social activitist and publisher. He has extensively written on health for Citizen News Service (CNS). His first published book, The Dream Of Stones, was awarded the Zimbabwe National Award for Outstanding Children’s Book for 2004)

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The Open Forum 4 on key issues in tuberculosis (TB) drug development is all set to begin in Addis Ababa, Ethiopia (18-19 August 2010). This Open Forum 4, will raise and address key issues in TB drug development, with a special focus on regulatory affairs. The Forum will include sessions on the current global TB drug development portfolio, key issues in the critical path to TB drug registration, designing pivotal trials, conducting registration trials in high TB burden countries , challenges in TB drug development for resistant disease and developing regimens containing multiple novel agents.
These meetings will bring together regulators, TB drug developers and other interested stakeholders, such as TB care providers, public health policy-makers, and community advocates from  industrialized as well as from high burden countries. Open Forum 4 will have a special focus on Africa and the regulatory challenges it faces.

TB has remained a public health challenge from ancient times. Hippocrates, the famous Greek physician, identified TB as a widespread and highly fatal disease in 460 BC. At that time, no one knew how TB was caused and no one knew how to treat it. It spread uncontrollably, killing most of its victims, irrespective of their social class. Pharaoh Tutankhamen, poet Keats, author George Orwell, composer Chopin, Peshwa Madhavrao 1, Princess Amelia-daughter of King George III, Kamala Nehru—wife of India’s first Prime Minister are some of the upper class who succumbed to TB.

Twenty-five centuries later, TB is still spreading and still killing nearly 5,000 people every day, or 1.8 million in 2008 alone. The World Health Organization (WHO) estimates that two billion people are infected with the TB bacteria. While some people with this latent infection will never develop active TB, five to 10 percent of carriers will become sick in their lifetime. Once active, TB attacks the respiratory system and other organs, destroying body tissue. The disease is contagious, spreading through the air by coughing, sneezing, or spitting. An estimated nine million new active cases develop each year.

It is second only to HIV as the leading infectious killer of adults worldwide. Nearly 170,000 children die from TB each year. Most of the TB patients belong to Asian and African countries.
The social and economic costs of TB are enormous, particularly because the incidence of TB is concentrated in adults between the ages of 15 and 54, who are the primary wage earners. The combination of the enormous burden of TB as well as the inconsistent availability of cost-effective interventions, make TB one of the highest priorities for action in international health.

In view of the seriousness of the problem, WHO in 1993 declared TB as a global emergency.
The current 40 years old regimen of treatment, takes too long to administer (at least 6-9 months to treat simple/ drug susceptible TB), and requires too many pills - an average of 130 doses, each consisting of four medicines (known as first-line drugs): isoniazid, ethambutol, pyrazinamide and rifampin.. Those who do not complete their treatment may develop drug-resistant strains that may take up to two years to treat with second-line drugs, or become untreatable with any existing antibiotics.

So, the need of the hour is to fuel development of new treatment methods, to make the treatment of this dreaded disease simpler and more effective.
Since the 1950s, researchers have known that TB treatment must be delivered in multi drug regimens (combination therapy) to prevent it from becoming resistant.

But in TB drug development drugs are developed individually and independently.  This conventional paradigm for TB drug development means that individual drug candidates are developed separately and substituted/ added, one at a time, into existing combination therapies.

Each substitution studied in clinical trials takes approximately 6 years to complete. So, a novel four-drug regimen would require a quarter century of development.  With more than 9 million new cases of TB each year, this is too long a wait for those suffering from the disease.

The Critical Path to TB Regimens (CPTR) Initiative is a cross sector initiative, which purports to reduce the amount of time needed to register novel regimens for tuberculosis and drug-resistant tuberculosis from decades to years.
CPTR members include the world’s leading pharmaceutical developers, global regulatory agencies, and civil society organizations, which are working together to speed up new TB drug regimens to the patients need them urgently.
CPTR has the potential to shorten development time to 6 years. Under this initiative, a diverse group of drug developers will allow their compounds to be tested in combination to find the best regimen, regardless of sponsor. This collaboration is a testament to a "patient-first" commitment from all parties and the realization that it will take many organizations working in partnership to stop TB’s devastating global effect. This is not a path which one can tread alone.

The CPTR initiative also seeks to advance the regulatory science that will allow for the most efficient, accurate, and robust evaluation and application of these new testing models as well as address issues related to the lack of clinical trial capacity and funding.

It is hoped that the CPTR Initiative will help in achieving these Millennium Development Goals, by bringing relief to millions of TB/HIV sufferers worldwide.

Shobha Shukla - CNS
(The author is the Editor of Citizen News Service (CNS) and also serves as the Director of CNS Gender Initiative and CNS Diabetes Media Initiative (CNS-DMI). She has worked earlier with State Planning Institute, UP, and teaches Physics at India’s prestigious Loreto Convent. Email: shobha@citizen-news.org, website: www.citizen-news.org)

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The 4th Open Forum Conference was held in Addis Ababa, Ethiopia on 18th and 19th August to address key issues in developing new drugs for tuberculosis, which kills nearly 2 million people every year and is becoming increasingly resistant to the current drugs. The conference, with a special focus on Africa, brought together regulators, scientists and other interested stakeholders, from all around the world, to share knowledge and build a proper infrastructure needed to adopt new and improved TB treatments. They deliberated over an innovative drug development model which will reduce the usual time taken to develop safer and more effective TB drug regimens by almost 75%.

New drugs development for TB treatment seemed to have been stalled until a decade ago, with no new treatments in the pipeline. But thanks to the initiatives taken by the Global Alliance for TB and due to investments in TB research by global funders, there are, at present, 10 new compounds in the pipeline, three of which are in clinical trial stages.
Mel Spigelman, MD and CEO of the TB Alliance agreed that "Today there is unprecedented hope for better treatments for tuberculosis. Now that there are promising compounds in the global pipeline, it is important to speed them through clinical development so they can reach the millions in need."

Since the 1950s, researchers have known that in TB treatment (or for that matter, treatment of other diseases as well), mono therapy is dangerous as it creates drug resistance. So, to be effective, it must be delivered in multidrug regimens. Moreover, the current TB therapies are long and complicated, and also incompatible with commonly used HIV infection. The current treatment, for drug sensitive active disease, uses 4 drugs which need to be administered daily for at least 6 months. Treatment for multidrug resistant TB (MDR) is still longer and requires more expensive and toxic drugs.

Under the traditional paradigm, TB drugs were developed and registered separately, and substituted/added one at a time, into existing combination therapies. For each substitution, the drug had to be tested in clinical trials, which normally takes 6 years. So, a novel four drug therapy would have required a minimum of 24 years, before it could benefit those who needed it urgently.

The new TB drug development model focuses on testing novel combination-drugs together in the development stage, rather than individual drugs. This would drastically reduce the development time for building new regimens.

"This collaboration harnesses innovation to speed availability of a shorter and more effective treatment for TB," says Margareth Ndomondo Sigonda, pharmaceutical coordinator of the New Partnership for Africa’s Development. "It is important for global regulators to harmonize regulatory guidance and provide efficient regulatory processes for new TB regimens to speed adoption and make an impact."’

The Minister of Health of Ethiopia rightly believes that, "New technology and innovation are necessary to defeat tuberculosis. This event is important because Africa’s regulators, systems, and, above all else, people, must be prepared to fully maximize the promising innovations coming through the pipeline."

This innovative model is part of a wider programme called the ‘Critical Path To TB Drug Regimens (CPTR)’ which was launched by FDA Commissioner Margaret Hamburg on March 17, 2010, and is led by the Bill and Melinda Gates Foundation, the TB Alliance, and the Critical Path Institute. It aims to reduce the broad obstacles facing TB drug development.
The take home messages after two days of intensive deliberations, reiterated that the diagnosis, treatment and care of tuberculosis continues to be immensely challenging, not only in the context of Africa, but other countries too, having a high burden of the disease. On the one hand, inadequate resources are impeding development/testing of new drugs while on the other hand, weak health systems are constraining time bound deliverables to the affected community. However, in this dismal scenario, there have been a few success stories too (in Lesotho, Georgia and Ethiopia). As Dr Spigelman rightly said, "Big progress comes from small numbers."

According to him, the way forward has three major components:
(i) A strong political will, which is committed to take care of public health. Without this key element the fruits of labour of developers of new drug regimens will not be able to reach the affected community.
(i) Innovations, to optimize the use of the limited resources available. An innovative approach to make the system work more efficiently will result in ‘doing more with less’.
(ii) Linkage, of all the individual areas of expertise of experts from diverse fields. Researchers, pharmaceutical developers, regulatory agencies and civil society organizations - all need to work not only in their individual capacities, but also together. Everyone needs to be informed about what everyone else is doing.

Only then will it be possible to overcome obstacles and speed up the urgently required new TB regimens to reach the people who need them most.
Together we shall overcome one day, which is not far away. (CNS)

Shobha Shukla – CNS
(The author is the Editor of Citizen News Service (CNS). She has worked earlier with State Planning Institute, UP, and teaches Physics at India’s prestigious Loreto Convent. Email: shobha@citizen-news.org, website: www.citizen-news.org)

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Esophageal cancer is malignancy of the esophagus which is a muscular tube through which food passes from the pharynx (throat) to the stomach.Esophageal cancer can occur anywhere along the esophagus.

Difficulty in swallowing or Pain swallowing is the first symptom in most patients. Fluids and soft foods are usually tolerated, while hard or substances like bread or meat cause much more difficulty. Pain, often of a burning nature, may be severe and worsened by swallowing, and can be spasmodic in character. An early sign may be an unusually husky or raspy voice.

Other symptoms may include Chest Pain and Fatigue. However, it should be noted that Early esophageal cancer typically causes no signs or symptoms.

The treatment is determined by the cellular type of cancer, the stage of the disease, the general condition of the patient and other diseases present. On the whole, adequate nutrition needs to be assured, and adequate dental care is vital.

wiki

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