Posts Tagged ‘Neglected tropical diseases’

Published in Forbes on November 22, 2011. Read the original article here

My last post discussed the reasons why neglected diseases have historically been neglected, the growing efforts to eradicate them, and why pharmaceutical companies should develop more drugs for them.

Unfortunately, the traditional economics of drug development are stacked against neglected diseases, which disproportionally affect the world’s poorest populations. Drug development is a costly and time-consuming process, and even if a pharmaceutical company did develop a viable drug for a neglected disease, they would have virtually no way of recouping their investment.

Luckily, there are many other ways the private sector can address neglected diseases (which are defined here as the seventeen neglected tropical diseases, malaria, and tuberculosis). I spent last week speaking with top officials from pharmaceutical companies, research groups, and intellectual property organizations to understand what the for-profit pharmaceutical industry can realistically do to push research forward on these diseases. All of the solutions presented below have, importantly, already been tested in the real world.

Without further ado, here are – in no particular order – the top five ways Big Pharma can address neglected diseases.

1) Create cross-sectoral research partnerships for neglected diseases
Though pharmaceutical companies have generally shied away from independently developing drugs for neglected diseases, several are open to creating drugs with partners. Just this past Thursday, Novartis and collaborators, including Scripps Research Institute and Swiss Tropical and Public Health Institute, discovered a new dual-acting class of anti-malarial compounds. “It was a multi-disciplinary, multi-continental effort,” said Paul Herrling, head of corporate research at Novartis. “Each partner brought unique knowledge and skills needed to obtain the common goal.”

Other pharmaceutical companies have also created partnerships for neglected diseases. Sanofi has, for instance, partnered with non-profit drug developer DNDi to develop medicines for up to nine NTDs. GSK has similar partnerships with foundations including Medicines for Malaria and the Global Alliance for TB Drug Development. In most cases, the partnerships are funded through a combination of sources, including the private sector, government, and other donors.

Partnerships for neglected diseases appear to be on the rise across the pharmaceutical industry. The International Federation of Pharmaceutical Manufacturers and Association (IFPMA) found that partnerships for neglected diseases have increased five-fold from 2005, and that today, 80 percent of neglected disease research efforts are done through collaborations. Mario Ottiglio, Associate Director of Public Affairs and Global Health Policy at IFPMA, said, “[Partnerships are] basically a very pragmatic solution to address market failure in neglected diseases. Pharmaceutical companies bring adequate resources, while academia and government bring the epidemiological context.”

This does not mean, of course, that every research partnership is guaranteed to succeed. Scientifically speaking, neglected diseases are quite complicated and few efforts will yield positive results. Robert Sebbag, Vice President of Access to Medicines at Sanofi, also discussed how strong relationships are crucial to the success of a partnership. “Each partner has to respect and trust each other,” he said. “They must also have a common objective.” Without those fundamentals, he said, everyone will assume the worst in each other and the fruits of collaboration will be lost.

2) Join patent pools for neglected diseases.
Patent pools are created when two or more companies agree to cross-license certain products or technologies. Recognizing the need for shared progress in neglected diseases, the World Intellectual Property Organization (WIPO) and BIO Ventures for Global Health recently created a patent pool, WIPO Re:search, for neglected diseases. In addition to maintaining a searchable database of relevant intellectual property, it will also facilitate new research partnerships.

“Most pharmaceutical companies have some form of CSR programs. They also have intellectual property. This is basically an effort to put those two things together,” said Francis Gurry, Director General of WIPO.

Since it was only created this year, the potential of a patent pool is yet to be seen. However, Gurry has high hopes. “In the best case scenario,” he said, “[WIPO Re:search] will help create partnerships between public and private entities… which over a five or ten year period will create good candidates for products.”

Many pharmaceutical companies have responded positively to the effort, and seem generally willing to share intellectual property related to these unprofitable disease areas. Sebbag from Sanofi believes it is a “very good step forward” in neglected disease research, and a GSK spokesperson said the program was “a natural evolution” of existing efforts in the field.

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Published in Forbes on November 9, 2011. Read the original article here.

What do schistosomiasis, cysticercosis, and lymphatic filariasis have in common?

Besides verging on the unpronounceable, they are all classified as neglected tropical diseases (NTDs). NTDs are a set of diseases – seventeen, by the World Health Organization’s count – that collectively affect over a billion people, but have historically received little attention. The most common NTDs, including those listed above, are caused by parasitic worms or protozoa. Others, such as leprosy and trachoma, are the result of bacterial or viral infections.

Though caused by a range of pathogens, NTDs share some important characteristics. First, many are diseases of rural poverty. Most neglected diseases affect the poor in the developing world, particularly in Africa and Asia, but some have also been found in “pockets of poverty” in the United States. For instance, hundreds of thousands of Americans, most of whom are Hispanic immigrants, suffer from Chagas disease. Second, most NTDs cause bodily impairment and disability (i.e., they have high morbidity) but are not very lethal (i.e., they have low mortality). Some result in blindness, others in unseemly swelling, and still others in impaired cognitive development. Most patients do not die, but the morbidity often hinders wage-earning capacity, thereby creating a vicious cycle of poverty.

These and other characteristics have unfortunately led to neglected tropical diseases being, well, a bit neglected. Since most policymakers live in urban centers, geographically separated from the rural areas with high NTD prevalence, there has traditionally been limited awareness of NTDs. Similarly, because NTDs cause more disability than death, they have historically flown under the radar of many public health efforts. Perhaps most importantly, the populations NTDs disproportionately affect have little money to spend on medicine, resulting in what Peter Hotez, President of the Sabin Vaccine Institute, calls “the business plan from hell.”

How can we change this status quo? What needs to happen for the pharmaceutical industry, academic researchers, and other key players begin investing more seriously in diseases that debilitate over a billion people?

To some extent, the status quo has already begun to change. It has not yet changed nearly enough, and there is ample room for the pharmaceutical industry to invest more in NTDs, but it is important to acknowledge how far the fight against neglected diseases has come.

The term “neglected tropical diseases” was only coined in 2005; before that, each unpronounceable disease fought its own uphill battle with limited success. WHO Director-General Margaret Chan explained in 2007 the benefits of having a catch-all term: “When these diseases are viewed together, we gain critical mass. We get a better grip on the scale of the economic and social consequences as well as the health burdens. Arguments for giving these diseases higher priority become more powerful, more persuasive.”

Since the term was coined, there has been considerable activity in the neglected disease space from governments, donors, pharmaceutical companies, and nonprofits alike. The US government, the UK government, and the Bill & Melinda Gates Foundation have collectively pledged or spent over $200 million on NTD prevention and treatment by 2013. Pharmaceutical companies have donated billions of doses of drugs to various NTD control programs. Some, such as GSK and Merck, have also entered “patent pools” to allow cross-licensing of NTD innovations. The Global Network for Neglected Tropical Diseases has engaged in NTD advocacy and on-the-ground coordination efforts. They also run a frequently updated blog, End the Neglect, that discusses NTD news and reminds readers that “just 50 cents” will provide a year’s worth of treatment against several NTDs.

There has also been a marked increase in NTD product development. The nonprofit pharmaceutical company OneWorld Health, which is partly funded through the Gates Foundation, conducts R&D for drugs against kala-azar (visceral leishmaniasis) and hookworm. It also ties up with for-profit pharmaceutical companies, such as Sanofi-Aventis and Anacor, to develop and manufacture some of their medicines. “Pharmaceutical companies have become more interested in NTDs than they were five to ten years ago,” said Richard Chin, CEO of OneWorld Health. “They would have sent us to their PR department before, but now they send us to their research department.”

Chin noted how their for-profit partners have invested significant time and money into the partnerships: they put their scientists on NTD projects at their expense and allowed OneWorld Health to manufacture drugs in their facilities. Many other product development partnerships (PDPs) for NTDs, such as PATH and the Sabin Vaccine Institute, seem to function along similar lines.

These developments are impressive, especially given the short time frame, but there is still a long way to go. This is perhaps most evident in the product development space. Hotez believes the pharmaceutical industry is “generally doing very well” in donating drugs, manufacturing space, and time to NTDs, but says most have invested relatively little in developing NTD drugs and vaccines themselves. Direct pharmaceutical investment has greatly helped the fight against the “big three diseases” (that is, HIV/AIDS, tuberculosis, and malaria): most recently, GSK invested in a malaria vaccine that is in final rounds of a large-scale clinical trial. Similarly, pharmaceutical companies can invest in drugs and vaccines that spur improvements in NTD morbidity rates.

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