July 20, 2005
Against an R&D Treaty
July 19, 2005
Genome Sequences for Tritryp Parasites Unravelled
In its 15 July 2005 issue, Science Magazine publishes an exploration of the genome sequences of the three so-called Tritryp parasites -- Trypanosoma cruzi, Trypanosoma brucei, and Leishmania major -- as well as additional studies and articles shedding further light on the biology of these three notorious parasites.
A team of international scientists has sequenced the genomes of three species of the parasitic protozoa that cause Chagas disease, African sleeping sickness, and leishmaniasi, which kill or cripple millions, primarily in tropical and sub-tropical countries.
One of the studies' key findings is the identification of gene sequences that are involved in the host-parasite relationship and in the regulation of the parasite metabolism.
Shulamit Michaeli, a HHMI international research scholar at Bar-Ilan University in Israel and co-author on the L. major paper, is optimistic about the impact of the work on drug development.
By providing information on virulence factors, critical enzymes in key metabolic pathways, and potential vaccine candidates, this study will advance tropical medicine by helping us develop new drugs against these diseases.
Trypanosomes are a type of single-celled microorganism that has developed elaborate schemes to evade the immune systems of their hosts. They are spread to humans through contact with infected animals. Trypanosoma cruzi causes Chagas disease, a devastating public health problem in Cental and South America and Mexico, while Trypanosoma brucei causes African sleeping sickness, and Leishmania major causes leishmaniasis.
African sleeping sickness, which affects people living in sub-Saharan Africa, is characterized by early fever and progresses to heart and kidney dysfunction, neurological destruction, and eventual death. Fever and heart impairment are also hallmarks of Chagas disease, which infects 16 to 18 million people, causing severe chronic illness and tens of thousands of deaths per year. Heart failure is responsible for most deaths from Chagas disease, which also causes liver problems and neurological impairments that can affect swallowing. Fever and liver disorders characterize leishmaniasis.
George A. M. Cross, the head of the Laboratory of Molecular Parasitology at Rockefeller University, says:
Because of their distinct evolution, trypanosomes present a plethora of potential drug targets, and potential drugs are almost certainly languishing in the chemical libraries of pharmaceutical companies. There have been several initiatives to tackle diseases of neglected people: The Drugs for Neglected Diseases Initiative exists entirely for the purpose of Tritryps drug development; the World Health Organization fosters drug research on neglected diseases; the Bill and Melinda Gates Foundation provides major funds; Medicines for Malaria Venture is a key organization. But we need resources and commitment on a far larger scale to transform drug targets into clinical successes. It is clear that the traditional pharmaceutical industry will not become effectively involved in this area, and the current promotion-and-reward system in academia does not attract or sustain the necessary human and financial resources. Consortia move slowly and are frequently restrained by similar problems, compounded by the egos of scientists and sponsors. What are the solutions, then? Perhaps we need research institutes that are solely dedicated to drug development for "diseases of the poor." Governments of the wealthier nations need to place such diseases higher on their priority lists, but we shouldn't hold our breath on that, even as these diseases continue to expand their geographical reach. What about other donors? There is an ominous call at the gates--can anyone hear it?
Access to Knowledge Treaty Website Launched
The A2K initiative is an effort to change the priorities of the World Intellectual Property Organization (WIPO) to encourage it to pay more attention to the needs of developing countries, and balance the benefits of easier access to knowledge and knowledge-intensive products such as medicines and software, with the benefits for greater innovation of copyright, patents and trademarks. The website brings together a group of international non-governmental organizations, governments, scholars, acticists and individuals which has been working on a proposed treaty.
July 11, 2005
Mali Success in Vaccination
According to the World Peace Herald, Mali is making great strides in increasing vaccination coverage.
While vaccination rates increased in most parts of the world during the 1990s, they fell dramatically in Africa. But Mali is one country bucking that dismal trend. Vaccination coverage here almost doubled, to 86 percent last year compared to about 45 percent in 1999. Malian officials hope to boost coverage to 90 percent over the next decade. "The government is increasingly considering vaccinations as a public health priority," said Safiou Osseni Raimi, a senior health officer at UNICEF, in Mali. "They're investing in buying vaccines and cold units to store them in, and in new strategies to deliver vaccines in rural areas. "They're realizing," he added, "that vaccinating children is a priority for parents and for the government."
G8 Leaders Focus on Global Health
The leaders of the G8 have recognised the central role of global health in promoting development and poverty reduction in their Gleneagles communique.
On the developement of vaccines, the communique says:
... (e) Building on the valuable G8 Global HIV/AIDS vaccine enterprise, increasing direct investment and taking forward work on market incentives, as a complement to basic research, through such mechanisms as Public Private Partnerships and Advance Purchase Commitments to encourage the development of vaccines, microbicides, and drugs for AIDS, malaria, tuberculosis and other neglected diseases.
(f) Supporting the Polio Eradication Initiative for the post eradication period in 2006-08 through continuing or increasing our own contributions toward the $829 million target and mobilising the support of others. We are pleased that the funding gap for 2005 has been met.
(g) Working with African countries to scale up action against malaria ... to help ensure access to anti-malaria insecticide-treaded mosquito nets, adequate and sustainable supplies of Combination Therapies including Artemisin, preumptive treatement for pregnant women and babies, household residual spraying and the capacity in African health services to effectively use them ...
IAVI has issued a statement welcoming the G8 communique.
Owen's comment: As expected, this commitment on creating market incentives does not go beyond the commitment already made by the G7 Finance Ministers at their meeting in London. However, it does usefully reiterate the importance of such a commitment complementing, and not replacing, public funding and public-private partnerships.
On funding of vaccine R&D ball is now in the court of the Italian Finance Minister Siniscalco who has a remit to report back to the Finance Ministers by the end of the year.
July 07, 2005
PharmaManufacturing Interview on Strong Medicine
PharmaManufacturing.com has an online interview with Rachel Glennerster and Michael Kremer, authors of Strong Medicine: Creating Incentives for Pharmaceutical Research on Neglected Diseases (Princeton University Press, 2004).
In it, Michael Kremer says:
Overall, industry has been sympathetic to this proposal because the basic idea is to provide a market for these diseases, which is how firms are used to operating for diseases prevalent in rich countries. Firms see market incentives as preferable to reductions in intellectual property rights, or having governments micromanage the research process. In the past, a number of pharmaceutical firms have done valuable work out of a sense of corporate social responsibility, but programs such as advance purchase commitments align incentives for developing socially valuable products with private sector incentives -- providing firms with a strong business case to undertake R&D on these diseases. The next steps will be for a coalition of sponsors -- governments, private foundations, or international organizations such as the World Bank -- to put such a commitment into practice.
Democracy Arsenal: Ten Things To Do About Africa
Over at Democracy Arsenal, Suzanne Nossel looks at ten things that President Bush could do if he is serious about Africa.
Second in her list is:
2. Launch a major push on vaccine availability. One of the less noticed but potentially pathbreaking outcomes of pre-G8 summit finance minister meetings was an agreement to expedite efforts to pre-purchase massive quantities of newly developed vaccines for distribution in African countries. The administration historically has been loath to intervene in the pharmaceutical industry's practices for making treatments and vaccines cheaply available in poor countries. U.S. leadership will be critical to this plan, and Bush should provide it. (Check out this blog [Vaccines for Development] for more details on how the plan will motivate faster vaccine development.)
July 01, 2005
The Impact of Vaccines
Very interesting table, orginally from CDC and reproduced on the Parents of Kids with Infectious Diseases website showing the impact of vaccines on disease in America:
Maximum Annual vs. 1995 Cases of Vaccine-Preventable Diseases in the U.S.
|Disease||Maximum Annual Reported Cases in the Pre-Vaccine Era (year)||Reported Cases in 1995**||Percentage Change in Morbidity|
|Congenital Rubella Syndrome||20,000 * (1964-5)||7||(99.46)|
|Invasive H.influenzae||20,000 * (1984)||1,164||(94.18)|
|Poliomyelitis (wild)||21,269 (1952)||0||(99.99)|
*Estimated because nationalreporting did not exist in the prevaccine era. **Provisional total.
Source: Advisory Committee on Immunization Practices, CDC
As the website says, the table:
outlines nine diseases and the effect vaccines have had on their incidence in the U.S.. It's easy to see the result: in 1995 there were only 6,815 reported cases of all 9 of these diseases put together, compared to 1.6 million reported cases when these disorders ran unchecked through the population. The pre-vaccine figure, 1.6 million, represents an enormous degree of human suffering and loss.
Hib Vaccine a Success in Gambia
The BBC reports that, according to a new study published in British medical the Lancet the routine immunisation of Gambian children has stopped the spread of Hib disease.
June 30, 2005
LA Times on Advance Market Commitments
The Los Angeles Times has an editorial today calling for the introduction of Advance Market Commitments to create incentives for the development of a malaria vaccine.
The proposal endorsed by G-8 finance ministers aims to speed up vaccine research using a market-type concept that is catching fire in international aid circles: the "pull" program. So far, nearly all the research into malaria vaccines has resulted from "push" programs -- money is given to researchers in the form of grants. The money pushes the research forward. In a pull program, sponsors commit to a guaranteed payment to whomever can come up with an effective vaccine -- it "pulls" researchers in by creating the kind of commercial jackpot they could aspire to if they were working on a cure for a more "affluent" disease.
... Malaria isn't the only disease for which advance purchase commitments are being studied, but it and HIV were identified by Britain's Brown as the likeliest candidates. Brown has already pledged about $1.9 billion toward such a commitment. The G-8 finance ministers have asked Italian Finance Minister Domenico Siniscalco to come up with a concrete proposal for a vaccine program by the end of the year. After that, sponsors will have to decide if they're willing to pay for it, and how much.
Passing up a cost-effective way to save the lives of millions of children wouldn't just be immoral, it would be fiscally irresponsible. Malaria is a prime cause of global poverty, instability, overpopulation and misery. If the G-8 members cannot agree to kick in $4 billion to make this disease a thing of the past, the whole notion of multilateral development assistance will have proved a sham.
June 24, 2005
Interview with Jean Stephenne / GSK Biologicals
Interesting interview with Jean Stephenne, the President and General Manager of GSK Biologicals, the Rixensart, Belgium-based vaccine unit of GlaxoSmithKline PLC, which accounts for more than a quarter of worldwide vaccine sales. By emphasizing the global role of vaccines and investing heavily in neglected diseases such as rotavirus, malaria, TB and AIDS, Stephenne has revolutionized the vaccine industry and helped create a new paradigm of public-private partnerships.
Are advance purchase commitments more effective in encouraging early- or late-stage development?
Jean Stephenne: Both are important. For products that also have profitable markets in the industrialized world, such as our new rotavirus vaccine, we need to find financing mechanisms that will allow these vaccines to reach the developing world now -- not 20 years from now when there is finally a large enough private market in these countries. For these vaccines, R&D costs are already supported by the industrialized world, so financing mechanisms should focus on the challenge of supporting manufacturing and distribution.
The situation is different for diseases like AIDS, TB and malaria. For these diseases, there is no rich country market to support the immense R&D costs, so donors ideally need to step in at the beginning of the process. So there are two very different mechanisms that we need to put in place, and we are having discussions with the G8 and the World Bank to find the appropriate mechanisms.
Andrew Farlow Replies to My Letter in the FT
There is a consensus that committees are not especially good at such things. They would be incapable of setting contract terms for vaccines a long time in advance that did not risk heavy revision later, struggle to provide incentives for "quality" and follow-on innovation, fail to ensure long-term supply and affordability given the lack of competition and access to intellectual property and know-how at critical stages, and generate high investment risk for biotechs and reputational risk for large pharmaceutical companies.
The Girl in the Cafe - Watch it on HBO on Saturday
HBO is showing The Girl in the Cafe on Saturday June 25th at 8pm.
This is a romantic comedy about the Millennium Development Goals, by Richard Curtis, who wrote Four Weddings and a Funeral, Love Actually, Notting Hill, and who is one of the leading figures in the Make Poverty History Campaign.
British All-Party Malaria Group Calls For More Action On Malaria
The British All-Party Parliamentary Malaria Group has warned that efforts to tackle poverty in Africa are doomed unless they also tackle the continent's burden of malaria. A new report entitled "Tackle Malaria Today: Give Tomorrow a Chance" (pdf) says that "any new initiative for Africa must be accompanied by a massive and sustained science-based and operationally practical scale-up of efforts to stamp out malaria on the continent".
The report quotes Mozambique's former Prime Minister, Pascoal Mocumbi, who warned that "malaria traps countries in a vicious cycle of poverty and ill health. Progress by African countries in expanding their economies and reducing poverty over the past decade is now endangered by a failure to use our collective knowledge, wisdom and resources to bring essential medical advances to bear for the benefit of all our citizens".
The All-Party Parliamentary Malaria Group calculates that tackling malaria is highly cost effective. The World Bank estimates that malaria cuts African GDP by 1.3 percent every year, costing African economies 12 billion US dollars annually.
The report warns that lack of funds remains the major obstacle to malaria vaccine development. Total annual funding for vaccine development has increased from 42 million dollars in 1999 to 85 million in 2004, which is still only a tenth of what is being invested in HIV vaccine development.
The report welcomed Gordon Brown's call, in November 2004, for an advance purchase commitment.
AIDS Vaccine Advocacy Coalition - Take Action
An interesting website on how you can incorporate advocacy for AIDS vaccines into your work and your life.
June 23, 2005
Nature Magazine on Public Private Partnerships
Nature Magazine looks at the way that public private partnerships are contributing to the development and use of vaccines in developing countries.
"Unless we develop a step-by-step program to understanding the disease burdens and the benefits of vaccination programs, we're going to get less-than-optimal results," says Adel Mahmoud, president of Merck & Co.'s vaccine division.
More information could help fix the perpetually fractured cycle of supply and demand, which has long stymied the availability of new vaccines. For decades, UNICEF and others estimated need simply by counting the number of children who could be immunized. But that practice could inflate the demand by more than 50% and, if the medicine went unused, leave manufacturers with sizable losses. This inability to accurately predict global demand prompted producers to vastly limit their production quantities. Curtailed supply then kept prices inflated, which further discouraged the countries from committing to the vaccines.
"You may talk about demand -- but if there's no assurance that the product will be purchased, then that demand is only theoretical," says Mahmoud. "The difficulty has always been, how can a company like Merck assist the demand of the global marketplace and be assured of getting a fair return on our investment?"