TB drug trials in 'high gear'

Reprinted from IOL: News for South Africa and the World

November 08 2007 at 10:42AM

By Liz Clarke

The trail-blazing development of new drugs, which could help revolutionise tuberculosis treatment and save millions of lives in South Africa and the rest of the world, was announced in Cape Town on Thursday.

Scientists attending the 38th Union Conference on lung health at the Cape Town International Convention Centre say two drugs with "incredible promise" are advancing in clinical trials in TB patients.

Dr Maria Freire, CEO and president of the Global Alliance for TB Drug Development (TB Alliance) described the research advances as "an historic milestone" in the accelerated drive to halt the catastrophic number of lives still lost through a disease which, when treated correctly, is curable.

For thousands of TB sufferers, many with drug-resistant strains, a new arsenal of drugs is the life-saver they have been hoping and praying for.

Said a Khayelitsha clinic sister: "To tell someone there are no other drugs left is heart-breaking. Now we are seeing some light. This is great news."

One of the drugs, known as PA-824, is the first novel TB drug, developed on a not-for-profit basis, to enter testing in TB patients.

A second drug, moxifloxacin, while widely prescribed for respiratory ailments, is being tested as a new treatment option for TB combination therapy.

Moxifloxacin is entering a pivotal large Phase III clinical trial, beginning at six sites in South Africa, Tanzania, Kenya and Zambia.

If the substitution of moxifloxacin for an existing drug proves effective, approval from regulatory bodies could begin as early as 2010.

Research scientists at the TB Alliance said fast-tracking of new drug regimens is essential to help halt what the World Health Organisation has called an unfolding global tragedy.

Dr Mel Spigelman, the TB Alliance's Director of Research and Development said there was a global commitment to change the Cinderella status of TB.

"Powerful partnerships are making things happen," he said. "Scientists, pharmaceutical companies, global authorities are paving the way for a dynamic new approach to the way we treat TB.

"I would say we are in high gear. Instead of up to 24 years to get drugs tested and approved, we are working to speed up the process dramatically, still ensuring ethics, safety and efficacy."

The TB Alliance is a not-for-profit, public-private product development partnership, backed among others by the Bill and Melinda Gates Foundation.

Commenting on the drug announcement, Professor Anthony MBewu, President of the South Africa Medical Research Council and a member of the TB Alliance Board of Directors said the development of faster, simpler drug regimens was essential to eliminating the needlessly high burden of TB in Africa and around the world.

The conference, which has drawn more than 3 000 delegates from across the world, will also be looking at revolutionary new diagnostic tools for TB, which have not changed over the past 100 years.

Conference on Bioethics, August 2008, Egerton University, Kenya

The Division of Ethics of Science and Technology
Sector for Social and Human Sciences
UNESCO

Conference on Bioethics 12-14 August 2008, Egerton University, Kenya

The UNESCO Regional Bioethics Documentation and Research Centre at Egerton University, Kenya, is organizing a conference on bioethics from 12-14 August 2008. The conference will be held in the ARC Hotel of Egerton University. The main theme of the conference is "Bioethical Perspectives and Practices in Research, Medicine, Life Sciences and Related Technologies in sub-Saharan Africa". The thematic areas to be covered during the conference include: 1. Ethical implications in human research; 2. Ethical issues in animal experimentation in science; 3. Genetically modified organisms and products: an African Dilemma; 4. Biodiversity and Environment; 5. Biopiracy and Bioterrorism; 6. Alternative/complementary/traditional medicine; 7. Bioethical issues in African cultures and religions; 8. Ethical dilemmas in medicine; 9. Bioethics teaching in African institutions of higher learning; 10. Legal approaches in bioethics; 11. Is there a need for a Code of Ethics for researchers?

The conference will be conducted in English.

Manuscripts covering or related to the thematic areas are invited, and must reach the organizers by 30 May 2008. Participants are required to submit their registration forms and associated fees by 28 February 2008.

For registration forms, queries or more information, please contact the organizers at:

Coordinator
UNESCO Regional Bioethics Documentation and Research Centre
Egerton University, PO Box 536
Egerton, Kenya
Mobile: +254 (0)722 443 717
Email: j_kkipkemboi@yahoo.co.uk

Chair, UNESCO Bioethics
Egerton University, PO Box 536
Egerton, Kenya
Mobile: +254 (0)720 853 844
Email: mathookoj@yahoo.com

Does Research Matter?

NIH-Funded Case Study: Research Ethics Committees in Africa Report Inadequate Funding, Staffing and Training

Throughout Africa, the number of people participating in health research is on the rise, yet surprisingly little is known about how research ethics committees – the critically important, independent review groups charged with protecting human subjects and reviewing protocols – actually operate. In a case study published in the January 2007 issue of PLoS Medicine, researchers from the Johns Hopkins Berman Institute of Bioethics and the Johns Hopkins Bloomberg School of Public Health aim to change that.

“Research ethics committees are designed to be third-party, independent review bodies to protect the welfare of research participants. But how are they set up in Africa? How do they operate? Some committees are hesitant to be too critical of studies, because in some African communities, a clinical study may bring jobs, medicines, or prestige,” said principal investigator Nancy Kass, ScD, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics and the Phoebe R. Berman Professor of Bioethics and Public Health at the Bloomberg School of Public Health.

“Our case study closely examined how these committees function in Africa. The results can now help us better understand some very real, on-the-ground challenges they face,” said Adnan Ali Hyder, MD, MPH, PhD, core faculty of the Johns Hopkins Berman Institute of Bioethics and assistant professor at the Bloomberg School of Public Health. Nancy Kass and Adnan Hyder also direct the Johns Hopkins-Fogarty African Bioethics Training Program.

The latest case study from Kass and Hyder included the active collaboration of nearly a dozen African researchers. The history and operational structure of 12 research ethics committees in nine African countries were examined. Key findings of the new report include:

• Research ethics committees in Africa are facing a number of challenges, including inadequate funding, staffing, and training. One quarter of the research ethics committees report that no operating budget is in place. Half of the committees report that funding comes from fees for reviews, while the remaining committees report that funding comes from government or foreign agencies. Fees vary from US $5 for reviews submitted by students to US $585 for industry studies.
  
• A lack of expertise in how to consider the ethical aspects of proposed research was frequently found. This often led to a disproportionate focus on the scientific and financial aspects of the research being considered. Research ethics training is infrequent, while two committees report that its own members have never received training.
• Ethics review is increasingly seen as part of the professional research culture. Further, the longer a committee has been in existence, the more likely it is to have depth and training in ethics and secure funding for its work.
• The number of protocols reviewed each year varies widely. Three research ethics committees reviewed eight to 12 protocols per year, three reviewed 30-50, five reviewed 100-250, and one reviewed 600 per year.
• Most of the committees report completing their reviews in one to two months (ranging from two weeks to more than three weeks).
• Committee sizes ranged from nine to 31 members. Basic administrative capabilities were in place, but varied. While nearly all of the research ethics committees kept minutes of their meetings, two committees reported that no standard operating procedures existed.
• Two of the research ethics committees surveyed thought it was difficult to offer a truly independent assessment of proposed research knowing that greater funding for their own institutions was at stake.
• Reported challenges include the tendency of a few research ethics committees to “rubber stamp” approvals in order to secure international funding.

While acknowledging that much more needs to be done, the case study’s authors say they were encouraged to learn that research ethics review in some parts of Africa is becoming more routine. This may be partly explained by the increasing number of African investigators submitting articles to international journals that require the approval of a local research ethics committee as a condition of publication. The case study suggests that national policies across Africa are needed to mandate the creation and monitoring of research ethics committees during a time when health research on humans is increasing. The authors suggest this is more likely to occur when international funders, aid agencies, and journals require it.

“Research ethics committees are expensive, so some countries will not create them until they are told to do so,” said Nancy Kass. “Until that happens, this report should help researchers working in Africa better understand the landscape of ethics review there. And while it doesn’t represent all African research ethics committees, the report can also help large funders better manage resources for capacity development on a continent where health research is critical.”

A recent report from the World Health Organization’s Africa Regional Office found that 36 percent of its member countries did not have research ethics committees.

About the Report

The Johns Hopkins case study examined research ethics committees in the Democratic Republic of the Congo, Ghana, Kenya, Nigeria, South Africa, Sudan, Tanzania, Zambia, and Zimbabwe. The case study was the result of collaboration with participants from the Johns Hopkins-Fogarty African Bioethics Training program, funded by the Fogarty International Center, National Institutes of Health. The Johns Hopkins-Fogarty African Bioethics Training Program began in 2000. The report is available at http://www.plos.org/press/plme-04-01-kass.pdf

Research Ethics Capacity Development

This abbreviated press release describes a recent case study published in the journal Academic Medicine. This story was also reprinted in: Aids Alert, RxPG News, The JHU Gazette, News Rx, Medical News Today, Science News Daily, Regulatory Affairs Professional Society, and Medworm.

When African professionals migrate to the United States or Europe, it's often called brain drain. In the world of research ethics, at least one training program is causing the opposite effect. Now entering its eighth year of operation, the Johns Hopkins-Fogarty African Bioethics Training Program (JH-FABTP) is the subject of a sweeping new case study published in the July 2007 issue of Academic Medicine. For the first time, the case study reveals some potent lessons in what it takes to deliver a successful, cross-cultural ethics training program.

The study describes the JH-FABTP in detail, assesses its outputs during four years, and analyzes the implications of the current model for further growth of this and similar programs. Program assessment is based on curriculum materials; application records; informal progress notes and evaluations; transcripts from the trainees’ coursework; resumes; and formal progress reports submitted by trainees. The framework used to assess the program is a systems approach, which explores inputs, processes, outputs, and outcomes of the training.

The JH-FABTP has largely been successful in providing research ethics education and motivating trainees to contribute in the field of research ethics in their countries. "We initially sought to increase the critical mass of African individuals professionally trained in ethics," said Nancy Kass, ScD, deputy director for public health at the Berman Institute of Bioethics and the program's director. "But it also turns out that our trainees are making institutional changes to policies, drafting new guidelines, and generally raising awareness of the need to support research ethics. And some trainees are not just doing these things in their home countries, but throughout the continent."

After studying in Baltimore for six months under the supervision of a mentor with similar research interests, trainees return to Africa to begin a six month practicum on the topic of their choice related to the ethics of research. "During the practicum, trainees implement all they have learned in the classroom," said Adnan Hyder, MD, MPH, PhD, the program's co-director and an associate professor of international health at the Johns Hopkins Bloomberg School of Public Health. "The last half of the program attempts to mitigate a familiar problem for researchers in Africa: trying to borrow principles of ethical review from developed countries. Instead, trainees contribute to the research ethics capacity of their home country by setting the agenda themselves. The process transforms students into effective researchers and advocates for the kind of research ethics that will actually work in their own countries."

In a region devastated by the HIV/AIDS epidemic, the trainees provide encouraging evidence of accomplishment in the global effort to work collaboratively with African professionals to develop their own ethics-based research methods. However, despite considerable successes, the program has encountered some expected and unexpected challenges. The Academic Medicine article demonstrates the importance of maintaining regular contact with trainees upon their return, particularly as many of these trainees face several other professional demands when they return home. The program’s directors have also learned to require monthly progress reports and to finance each practicum in stages to ensure timely completion.

The full article can be found free of charge at www.academicmedicine.org
Hyder, Adnan A., Harrison, Rachel A., Kass, Nancy, Maman, Suzanne, “A Case Study of Research Ethics Capacity Development in Africa,” Academic Medicine, 2007; 82:675–683.