You are currently browsing the tag archive for the 'pharmacology' tag.
Erle Frayne Argonza
The United States seems to have come a long way in strengthening the institutional aspects of development concerns, by way of voucher systems. I still remember the voucher system instituted as intervention scheme to salve education ailments early this decade, and I hope evaluation studies were conducted to measure the levels of success of that intervention from state to state.
Here comes another voucher system by the United States, this version being applicable to tropical diseases. Accordingly, it is a boost for tropical disease drugs, which is welcome news for many developing countries. Among diseases that are eligible to the system are sleeping illness, leprosy and malaria.
The news is contained in an article below.
[28 August 2008, Quezon City, MetroManila. Thanks to SciDev database news.]
US voucher system to boost tropical disease drugs
Source: Intellectual Property Watch
14 August 2008 | EN | FR
A patient with malaria, one of the tropical diseases eligible for the scheme
Flickr/.ash
The United States is set to launch a prize system to encourage pharmaceutical companies to develop drugs for tropical diseases.
Sixteen tropical diseases, including sleeping sickness, leprosy and malaria are listed as eligible for the scheme.
Under the system, companies producing a drug or vaccine for a tropical disease can apply for a Priority Review voucher, which allows them a shorter approval time for another drug at a later date.
The shorter approval process would take approximately six months instead of ten, meaning that drugs could hit the market sooner and potentially be more lucrative. Thus, the vouchers are estimated to be worth around US$300 million.
Companies can also take advantage of the Orphan Drugs Act, under which drug developers receive tax credits, a waiver of the US Food and Drug Administration’s user fee and seven years market exclusivity on drugs that have no economic viability.
The first vouchers can be legally issued from 27 September 2008.
But the wording of the voucher law needs tightening up, say commentators, and some aspects — such as a rule stating that drugs can’t contain active ingredients that have been approved in another application — could restrict eligibility.
The Food and Drug Administration is currently drawing up guidelines on how the law will work in practice.
Erle Frayne Argonza
That serpentine fire can burn you or rather kill you. Make no joke about snake bites, as they are among those killers in our planet.
From Peru comes a heartwarming news about a new innovation in serum development to address the problems attendant to serpentine bites.
Happy reading!
[05 August 2008, Quezon City, MetroManila. Thanks to SciDev database news.]
Perú produce suero en polvo contra veneno de serpientes
Zoraida Portillo
24 junio 2008 | ES
[LIMA] El Perú aspira a convertirse en pionero en la región andina en investigaciones científicas para la producción de sueros en polvo contra las mordeduras de serpientes y otros animales ponzoñosos.
Así lo señaló Patricia García, jefa del Instituto Nacional de Salud, durante el lanzamiento del primer suero antibotrópico liofilizado producido en el Perú, el que contrarresta los efectos del veneno por mordedura de las serpientes bótrox (Bothrops atrox.), cuya mordedura tiene la más alta prevalencia en el país.
El suero es producto de ocho años de investigaciones y pruebas por científicos del Centro Nacional de Productos Biológicos, y fue lanzado oficialmente el 17 de junio en Lima. Con la misma fórmula maestra de los inmunosueros antiofídicos, no requiere refrigeración pues es en polvo, y tiene una vida activa de cinco años.
Durante el lanzamiento del producto, el ministro de salud, Hernán Garrido Lecca, informó que el suero está destinado principalmente a los pobladores nativos e indígenas de la amazonía peruana, donde ocurre la mayor cantidad de mordeduras de estas serpientes.
El primer lote, con 800 dosis, será despachado en los próximos días a los lugares más remotos.
Según el ministerio de salud,el año pasado 2.585 personas fueron mordidas por la bótrox. Por falta de atención inmediata, 52 murieron.
Un estudio realizado por Alfonso Zavaleta, de la Universidad Cayetano Heredia, al que SciDev.Net tuvo acceso, afirmaque el botropismo constituye la primera causa de envenenamientos fatales producidos por animales ponzoñosos cada año. Un tercio de los pacientes son niños.
La introducción del producto irá acompañada de capacitaciones a los proveedores de salud y agentes comunitarios de las regiones con ocurrencias de accidentes ofídicos, con el fin de estandarizar y mejorar el manejo de las mordeduras de serpientes e iniciar el registro de casos y uso de los sueros, para adecuar la producción a la demanda, indicó el ministro.
Erle Frayne Argonza
Good morning from Manila!
A heartwarming news from India and Vietnam concerns the reduction of prices of vaccines for cholera. To recall, India is among the countries that lead in bringing down pharmaceutical costs, thus saving the day for many poorer folks in the south who are relentlessly victimized by the rent-seeking practices of Western drug companies.
Enjoy your read!
[02 August 2008, Quezon City, MetroManila]
Cheaper cholera vaccine passes pilot trial
Sanjit Bagchi
23 June 2008 | EN | 中文
The current international cholera vaccine is too expensive for developing countries
Flickr/larskflem
A reformulated oral vaccine against cholera promises to be an affordable and effective weapon to combat the disease for people living in endemic areas of developing countries, according to a new study.
The internationally licensed cholera vaccine currently available is too expensive for use in developing countries, where it is most needed.
Vietnam produces its own two-dose oral cholera vaccine and distributes it through its public health system at US$0.40 a dose. Nine million doses have been delivered so far.
To kick-start the process of scaling up this vaccine in developing countries around the globe, the vaccine was reformulated to comply with WHO standards.
Researchers from India, Korea and Sweden conducted a pilot trial of the vaccine at Kolkota’s Infectious Diseases Hospital in eastern India. Cholera is endemic in Kolkota.
The study evaluated the vaccine’s safety and efficacy outside Vietnam.
Participants were healthy and included 101 adults aged 18–40 years and 100 children aged 1–17 years. They received two random doses of either the vaccine or a placebo, 14 days apart.
After immunization, 53 per cent of the adults and 80 per cent of the children showed at least a four-fold increase in their antibody levels against Vibrio cholerae O1, the predominant strain of cholera-causing bacteria.
Safety tests revealed that “no adverse event occurred more frequently in the vaccinated than in the placebo group”, say the researchers.
“Cholera affects a large number of children in developing countries, and so a vaccine that is safe and effective for children sounds impressive, and the development as a whole appears to be a step towards global rolling out of the cholera vaccine,” says Sumana Kanjilal, associate professor of paediatric medicine at Calcutta National Medical College Hospital, India.
The reformulated vaccine is now undergoing a trial in around 70,000 people in Kolkata. “If the vaccine is found to be safe and protective, this could pave the way for the use of this vaccine in the control of cholera worldwide,” the researchers write.
The study was published in PLoS ONE.
Erle Frayne Argonza
Magandang hapon! Good afternoon!
From Africa comes a heartwarming news about boosting their respective capacities for clinical trials. The shot in the arm will be through grant funds provided by the European and Developing Countries Clinical Trials Partnership (EDCPT). Entry points for project engagements will be certain specific diseases.
Enjoy your read.
[24 July 2008, Quezon City, MetroManila. Thanks to the SciDev database news.]
Clinical trials in Africa receive funding boost
Naomi Antony
6 June 2008 | EN | 中文
A malaria clinical trial investigator
WHO/TDR/Crump
The European and Developing Countries Clinical Trials Partnership (EDCTP) announced this week (3 June) that it will inject over €80 million (around US$124 million) into African medical research.
Half of this sum has already been approved and will go towards malaria research and the development of tuberculosis (TB) vaccines. The remainder, expected later this year, has been earmarked for HIV and TB treatment and for the provision of vaccines and microbicides.
The combined sum will be the largest approved by the EDCTP since it was established in 2003, and should reinforce the European Union’s partnership with Sub-Saharan Africa.
The EDCTP links 14 member states of the European Union, as well as Norway and Switzerland, to countries in Sub-Saharan Africa, largely by providing resources for joint clinical trials, capacity building and networking activities.
In particular, EDCTP funds projects to create and develop capacity for ethical review of clinical trials and to improve regulatory frameworks for drug approval.
Charles Mgone, executive director of EDCTP, told SciDev.Net that the new funding will go to help all these activities, with the “lion’s share” being given over to clinical trials.
“Quite often when there is North–South collaboration, the ideas come from the North, the money comes from the North, even the principal investigators come from the North,” says Mgone.
“These [EDCTP-funded] projects empower Africans, enabling them to take ownership over the projects and do the work. Looking at the 27 projects we have approved, around 24 of them have African principal investigators working in Africa.”
Victor Mwapasa from the Malawi College of Medicine is one such example. He and his colleagues are looking at whether antimalarial drugs, specifically artemisinin-based combinations, are safe to use in two particular groups — those who are HIV positive and children aged under six months.
“Most studies looking at the safe use of antimalarials have tended to omit very young children, those who weigh less than five kilograms or are under six months old,” Mwapasa told SciDev.Net. “But this is a high-risk malaria group.”
Mwapasa says he is excited to be part of such a large collaboration with African and European researchers.
His team’s research will also be carried out in Mozambique and Zambia. “We rarely do research together, despite sharing the same problems,” he adds.
Erle Frayne Argonza
Good day!
From the African continent comes welcome developments about HIV treatment response. The results of studies across countries show intervention processes could be one possible area for improving treatment response altogether.
Happy reading.
[22 July 2008, Quezon City, MetroManila. Thanks to SciDev updates.]
====================================================
Pharmacy records ‘can predict HIV treatment response’
Carol Campbell
27 May 2008 | EN | 中文
A doctor at a HIV treatment clinic in Swaziland
Website/HIV-AIDS
New research suggests that pharmacy records can be accurate, and cost-effective, indicators for predicting whether HIV patients in the developing world are at risk of treatment failure.
Failure of first-line antiretroviral drugs (ARVs) is detected in the developed world by measuring the amount of HIV circulating in a patient’s blood. In resource poor settings, however, the WHO recommends that CD4 cell testing — a measure of the health of the immune system — is used.
But CD4 tests indicate treatment failure after it has occurred, while using pharmacy records to measure treatment adherence could indicate patients at risk of treatment failure before it happens, the researchers say.
Using medical insurance data from the private insurance programme Aid for AIDS, researchers tracked adherence to medication among nearly 2000 HIV-infected adults in nine southern African countries — Botswana, Lesotho, Malawi, Mozambique, Namibia, South Africa, Swaziland, Zambia and Zimbabwe.
The researchers calculated adherence by comparing the number of months a patient was prescribed drugs with the number of months the drugs were actually dispensed from pharmacies.
“We assessed the ability of a simple measure — whether the patient collected their monthly medication on time — to predict virological failure,” says clinical pharmacologist Gary Maartens from South Africa’s Groote Schuur Hospital at the University of Cape Town and an author of the research.
They found that monitoring adherence was more accurate than monitoring changes in CD4 levels to determine whether a patient’s treatment had failed in the first year after starting ARVs.
“If the patient’s adherence to medication was tracked, potential health problems could be red-flagged immediately,” co-author Michael Hislop from Aid for AIDS told SciDev.Net.
He said the system could work within the public health system with the correct technology and systems. At present, however, only the private health sector has the resources to track adherence, and the researchers say more research needs to be carried out into the effectiveness of adherence monitoring in public health clinics.
Tracking adherence in order to identify and intervene with vulnerable patients should mark a policy switch, the researchers write, “a reason for clinics to organise these data in a way that can be used in simple algorithmic approaches to patient care”.
The research was published in PLoS Medicine last week (May 20).
Link to paper in PLoS Medicine
erleargonza
Recent Comments