Monthly Archives: January 2015

3-D Printing of Prostheses to Be Trialled in Uganda

Malugimi Musoma

Researchers are to 3-D print cheap, custom-made prosthetics for child amputees in the developing world after winning CAD$112,000 (US$90,000) from the Canadian government.

The money is coming through the Grand Challenges Canada fund, which supports health-related innovation in developing countries.

“There are more than ten million people in the world with amputations, most of whom live in developing countries,” says Mitch Wilkie, director of international programmes at Christian Blind Mission Canada (CBM), the NGO leading the project. “Around 300,000 of them are landmine survivors and this number is growing by about 26,000 people annually.”

Conventional prosthetic sockets for the remaining part of patients’ injured limbs are made using plaster-of-Paris moulds, but these take up to a week to dry in the sun. Children also require at least two fittings a year – equivalent to around 25 prostheses over a lifetime – to adjust for body growth, making the process expensive for their families.

“We are confident that we can expedite this whole process with 3-D scanning and printing,” says Wilkie. The team hopes to produce prostheses in developing countries for around US$250. At present, they cost up to US$5,000 in developed countries.

The first step is to measure a patient’s residual limb using a handheld US$500 infrared laser scanner. This produces a digital, 3-D image in less than a minute through a freely available software called Socketmixer, which is used to design a matching prosthetic socket. The software is automatic, but once users have gained more experience in designing prostheses they can override its features to amend the resulting socket models, according to cbm Canada.

The digital model is then sent to a US$4,000 3-D printer that takes between six and 12 hours – depending on complexity and size – to print a socket using cornstarch-based plastic. The socket connects to a patient’s residual limb and a standard artificial limb provided by aid agencies.

But Martin Twiste, a prosthetics researcher at the University of Salford, United Kingdom, warns that the suggested materials need to be tested for durability before being used more widely.

He adds that the team could consider sending the digital socket image to a 3-D printer elsewhere in the world to avoid the high cost associated with buying one – in cases where the system would be used infrequently.

The CBM Canada team is currently teaching staff from the Comprehensive Rehabilitation Services for Uganda hospital to use the technology. It is also creating and testing sockets for four hospital patients, who already use traditionally made sockets, to gather their feedback.

Over the next six months, the team plans to conduct clinical field trials with 35 patients at the hospital to compare its technology with current methods.

“We want the technology to benefit as many amputees as quickly as possible,” says Wilkie. Should the trials prove successful, the team envisions offering a package comprising a scanner, software, computer, 3-D printer and training for US$10,000 to US$15,000.

[Courtesy AllAfrica News]

Ebola – the search for a vaccine

LONDON, 27 January 2015 – When Ebola hit West Africa last year, it was a disease with no sign of a vaccine or cure. To those affected that may have been an indication that the wider world didn’t care about them or the diseases that affected them, but in truth there has simply been no incentive for anyone to develop these therapies. Yet now pharmaceutical companies are racing to produce an effective vaccine, and on 23 January the British company GlaxoSmithKline shipped the first 300 doses of its candidate to Liberia to start phase II trials.

At an event in the UK Houses of Parliament to discuss the economics of developing such vaccines, Jon Pender, a vice president of GSK, said he had been surprised, in the circumstances, that companies had any possible candidates at all on their shelves which could be developed and tested. He challenged suggestions that this was just because Ebola epidemics happened in poor countries where there was little scope for profit.

“That isn’t the reason why we don’t have vaccines for Ebola. The reason we don’t have a vaccine is because it wasn’t a priority for anyone, and there are understandable reasons for that…. The number of people affected each year was very small and the overall disease burden, in comparison to other disease like malaria or HIV, is tiny. The fact is that in the forty years that we have known about Ebola, including the present outbreak, there have been about 24,000 known cases. There are that many cases of malaria every hour.”

Now, clearly, it has become a priority. So if it isn’t just about money, how do you persuade the pharmaceutical industry to work on a normally obscure disease like Ebola? Adrian Thomas is a vice-president at Janssen Pharmaceutical Companies, which is also now working to get an Ebola vaccine to market. He says, “The first question is, what is the strength of the science? The second thing is to what extent there is a reward for innovation or a willingness to risk-share. And the third is, will we actually reach people? I think we have to understand what are the clear priorities for global health…

“Some companies do it for the reputation, others do it for the science or for alternative incentives. Other companies do it for direct financial reward, and I think you have to understand what are the different incentives that are necessary across that spectrum.”

Profit may not be everything, but the companies are not setting out to lose money. In this case they have been incentivized with public money – American, Canadian or European – to pay development costs, and assurances from the global vaccine alliance GAVI that there will be a market for any successful vaccine they produce, with up to $300 million available to pay for it.

Médecins Sans Frontières has been campaigning on the high and rising price of vaccines and the lack of transparency in the pharmaceutical industry, and earlier this month it published a new edition of its campaign document, the Right Shot.

Rohit Malpani is director of policy and analysis for MSF’s Vaccine Access Campaign. He told IRIN that despite substantial sums of public money poured into the development of an Ebola vaccine, very little was being demanded of the companies in return. “These vaccines are being developed with full public funding,” he says, “compensating the manufacturers for whatever investments they have to make, and for the cost of the clinical trials. Yet at this stage it is very non-transparent what the costs of development are, and not clear what guarantees there are about the outcomes and how they will ensure affordability. Governments are just writing them blank cheques.”

MSF welcomes the fact that GAVI has earmarked money to buy any successful vaccine, since that sends a signal to the manufacturers that there is a market, but thinks that GAVI should also be more demanding. Malpani says, “We are still not sure at what price it will be sold to GAVI. MSF would prefer that it is sold at or near cost. And if any cost is not covered by public funding, it’s better for that to be compensated directly, rather than through higher prices for the vaccine. The idea would be to de-link the cost of development from the final price.”

GAVI negotiates lower prices for the vaccines it buys for developing countries, but it is likely that the US or European governments will also want to stockpile some of these vaccines for their own use, and they are likely to have pay more. Malpani says MSF accepts that, but remarks that “if these countries have already paid for the development, it does seem inappropriate that they should pay all over again through high prices.”

MSF is certainly not against the development of Ebola vaccines, and intends to take part in some of the phase II clinical trials, probably at its facilities in Guinea. Julien Potet, their policy advisor on vaccines, says that planning the trial has been “a bit of a moving target”.

“Cases are declining a lot, and to demonstrate a protective effect is more difficult in a setting where there are limited or no cases. But we hope to vaccinate two groups – health workers because they are particularly exposed to the virus, and also to ring-vaccinate people who have been in contact or have a case in their neighbourhood. This is the plan today, but of course it could change.”

Others working on the response to the epidemic have more reservations about the vaccine programme. Mukesh Kapila, professor of global health at Manchester University, has just returned from West Africa. He found the affected countries alive with all kinds of stories and rumours, and he worries that time isn’t being taken to prepare people for the idea of the vaccine trials. “I am afraid they are going to think, ‘Oh, all these companies are coming to test some half-baked vaccines on black people here in Africa’. And the impact might be to put off people at risk from coming to get help, because they think, ‘Oh God, I’m going to be vaccinated’. When we do these trials for antibody response, it’s important that we do them on white people as well as black people, partly because it is important scientifically, but also because it’s important for public perception.”

More widely, Kapila thinks the rush for a vaccine may be counter-productive. “The panic associated with this epidemic has led to a lot of short cuts, with people rushing through the early phases so that human trials can start quickly. Everything may be fine, but we still don’t know how effective the vaccines are going to be. Are they going to give 90 percent protection? 80 percent? Or only 50 percent? That wouldn’t be enough.”

Kapila told IRIN: “People are expecting a vaccine to be the solution to this epidemic and it can’t be. A vaccine is no substitute for the laborious public health measures of identifying index cases, tracing and isolating contacts. By looking to a Promised Land where a vaccine is going to come and solve all our problems, we risk undermining these more important public health efforts. A huge amount of public money is going into vaccines. Once we have started we might as well finish, but I am sceptical whether it is a useful effort, on either public health or social and economic grounds.”

[Courtesy of IRIN]

Heightened HIV risk for people with disabilities

Inaccessible health services for people with disabilities (PWD), combined with social stigma and violence, contribute to high HIV risk – a gap that must be filled if the disabled are not to remain disproportionately vulnerable to HIV/AIDS, say health experts and activists.
“People with disabilities are at increased risk for exposure to HIV infection. HIV, in some cases in itself, can cause disability,” said Jill Hanass-Hancock, a senior researcher at the Health Economics & HIV/AIDS Research Division (HEARD), a South African research institute.

Globally there are an estimated one billion people living with a mental or physical disability, according to the UN World Health Organization. Many live in low- or middle-income countries and have poorer health and little formal education compared to the general population.

“We cannot talk about reducing HIV and its co-morbidities if you exclude this 15 percent of the world’s population,” added Hanass-Hancock, speaking at the AIDS 2014 Conference, hosted by the International AIDS Society in Melbourne on 20-25 July.

Data are scarce; most national HIV monitoring or surveillance programmes do not specifically track incidence among people with disabilities.

An 2014 meta-analysis of data and data from STD testing by STDAware.com from Sub-Saharan African countries showed that PWD are 1.3 times (1.48 for women) more at risk of contracting HIV than people without disabilities.

The 2014 “Gap Report” published by the Joint UN Programme on HIV/AIDS (UNAIDS) listed PWD as one of the key populations “left behind” in the global HIV response.

The no sex myth

Central to the struggle of PWD to gain inclusion in HIV response is breaking down the assumption that they are not sexually active and therefore do not need HIV services.

A 2014 Human Rights Watch (HRW) report on Zambia documented PWD describing how healthcare workers thought of them as “asexual”.

“People with disabilities are people first. They have the same needs and desires when it comes to relationships and being sexually active,” said Rosangela Berman Bheler, senior adviser at the UN Children’s Fund (UNICEF).

Others caution that PWD are at greater HIV risk due to other factors.

“PWD are four times more vulnerable to sexual abuse and violence. This increases their risk for HIV infection,” said Muriel Mac-Seing, HIV/AIDS protection technical adviser of Handicap International.

According to UNAIDS, “vulnerability, combined with a poor understanding and appreciation of their sexual and reproductive health needs, places people with disabilities at higher risk of HIV infection.” A 2012 article in The Lancet showed that people with mental and intellectual disabilities were at particularly high risk of abuse and violence.

Access barriers

Betty Babirye Kwagala, a medical counsellor for The AIDS Support Organization in Uganda, said the root of the heightened risk for people with disabilities can be seen in basic infrastructure.

“Services are not accessible – literally. Many health facilities do not have ramps or doors wide enough to accommodate people in wheelchairs,” said Kwagala who has had a physical disability since a car accident when she was 19. Five years ago she was diagnosed with HIV.

In her work as a medical counsellor, Kwagala has seen first-hand the lack of information and education materials suited for the needs of PWD, and a parallel lack of knowledge among health workers about how to communicate.

“How can a health worker who does not know how to use sign language communicate with someone who is deaf? They usually use gestures. But you cannot use gestures when prescribing medication,” said Kwagala.

Hanass-Hancock acknowledges bridging communication and understanding between health workers and PWD is critical to increasing the uptake of HIV services. But, she warns, such interventions need to take social conditions into consideration.

“People with disabilities often depend on a care-giver. This has a great impact on getting information privately and confidentially,” said Hanass-Hancock, adding that strategies such as SMS outreach and counselling for hearing impaired people, or easy-to-understand picture books for people with intellectual disabilities need to be developed.

Data gap

HRW’s research in Zambia, where one in 10 people has a disability, recommends a “twin-track approach starting with existing healthcare services more accommodating to PWD by simple things like widening doors”. PWD-specific interventions should be developed as well, they argue, and needs for either approach should be supported by improved data.

“We need to disaggregate the data to break it down by disability because all disabilities are different and will require different interventions. Then we can talk about creating tailor-fit services for them,” said Rashmi Chopra, a researcher on disability rights at HRW.

Lack of information – including about health and HIV – can leave PWD especially vulnerable inhumanitarian emergencies.

The Sphere Standards, which set out best practice in the delivery of humanitarian aid, encourage humanitarian actors to disaggregate data in their assessments, programming, and monitoring and evaluation tools by, among other things, noting if there is a disability involved.

However, Handicap International has critiqued the Sphere recommendation as insufficient to “mainstream a highly heterogeneous group such as [people with disabilities]”, and says recording the type of disability is crucial.

Despite the data gap, campaigners remain hopeful, saying the discussion has advanced from the days when the intersection between HIV and PWD was not even recognized.

“We must not forget that this is a dignity and human rights issue: most countries in the world – including donor countries – have ratified the UN convention on the rights of persons with disabilities (CRPD). It’s time for them to be responsible for their disabled citizens,” said Muriel Mac-Seing, HIV and AIDS protection and technical adviser for Handicap International.

CRPD, which has been ratified by 147 countries, mandates that governments “provide persons with disabilities with the same range, quality and standard of free or affordable health care and programmes as provided to other persons, including in the area of sexual and reproductive health and population-based public health programmes.”
[Courtesy IRIN]