Where are the drugs for tropical diseases?

On December 21, 2011, a terse communication appeared in the respected medical journal, Clinical Infectious Diseases . Its contents quickly spread like wildfire.

India’s foremost chest physician, Zarir Udwadia, had described how the Hinduja Hospital in Mumbai had come across 15 cases of what he described as Totally Drug Resistant (TDR) tuberculosis.

In October 2012, India received its second jolt, an extensive outbreak of dengue. With thousands in hospital and massive under-reporting of cases, The New York Times claimed that India had about 37 million cases of dengue annually.

According to the Centre for Disease Control and Prevention in Atlanta, the TB and dengue episodes have highlighted the problem of neglected tropical diseases and how conventional models of drug production and pharma research break down when it comes to Third World disease prevention.

India carries a “high burden” of tuberculosis deaths. Scott Halstead, a tropical disease expert, says it will take at least 10 years to develop an effective dengue vaccine.

Less than one per cent of drugs developed worldwide focus on Third World tropical diseases, resulting in them being “orphaned.” The problem is that we are so conditioned to think along patent lines that we have completely abandoned the community model of drug development.

Four approaches

Four approaches have been tried in this respect. The first is the charity route, where governments and charities subsidise developing country purchases. But it is impossible to determine how big the subsidy should be, how it should be allocated or what agency should oversee its disbursal.

The second is “Virtual Pharma” where philanthropies fund organisations that support private and academic research. But this suffers from the same R&D tangle as charities. Moreover, tropical disease research is badly under-funded and there is an absence of dynamic upstream research.

The third is what South Africa tried in 1997 with its controversial legislation to allow parallel importing of patented drugs and generic drug licenses. It flouted conventional IP wisdom and licensed generic drug companies to sell in the country, drastically bringing down the cost of AIDS treatment and fighting the US-led pharma majors in the process. The “generic drug” approach worked because there were already efficacious drugs in the market and the government had to simply tinker with the distribution regime. This is not the case with tuberculosis or dengue, where multiple mutations over the last 30 years have been received with zero drug research.

This vacuum is what the fourth approach aims to fix: the open source approach, adapted so successfully in the software field.

Open source

This method breaks the IP mould by licensing technology as open, so that anyone can use it, modify it, and improve it as long as the licensee doesn’t prevent anyone else from using it.

In a breakthrough 2004 paper, two lawyers and a computational biologist came together to suggest an open source model for biomedical research; they suggested a portal called Tropical Diseases Initiative which would allow biologists and chemists to volunteer their expertise on certain areas of disease. They would examine and annotate shared databases and perform experiments.

This kind of decentralised production where the basic information is freely available is already in place.

The significant difference lies in three areas. Firstly, existing open source regimes like Creative Commons and Biological Innovation for Open Society (BIOS), focus on the free exchange of technology; the research itself may not be collaborative.

Secondly, most examples of open source research have been centralised and are top down. However, this is a decentralised mode of research with collaboration and open sourcing at the basic commencement of research.

Thirdly, all the established open source regimes make the final technology available under a common open . The model suggested was that the final development of the drug would be awarded to a third party based on competitive bidding. This would follow the generic drug model and fair market competition would ensure that the drugs were available at the lowest possible price.

While there have been several attempts to constitute such open source biomedical research, one of the most highlighted is India’s Open Source Drug Discovery (OSDD) Project run by the Council for Scientific and Industrial Research(CSIR).

Under OSDD, all projects and research results are reported on the open source platform Sysborg 2.0 and anyone willing to avail funds for research can share their proposal on the platform which is peer reviewed.

Manifold benefits

The benefits are manifold. Not only does the absence of patent constraints help in keeping costs low, open competition ensures that the best product reaches the masses. Further, it can also focus on drugs whose patents have expired.

In addition, secondary use of drugs can be discovered since the cost of patent approval is zero under open source.

India’s OSDD has targeted tuberculosis with good reason. It has been over a year since the Hinduja reports and there has been no significant progress on treatment. The BCG vaccine remains the sole remedy against the disease. However, bacterium has shown significant resistance to drugs, with the development of the Multi drug resistant and Extreme Drug Resistant varieties.

What makes TB so deadly is its contagious nature andwhile the overnment has squabbled over nomenclature and the reputation of the country, the disease has slowly grown more virulent.

India’s celebrated Directly Observed Therapy (DOTS) which was credited with almost eradicating TB a few decades ago, has proven to be a spectacular failure in treating its drug resistant cousins, with a success rate of less than 2 per cent.

With both conventional programmes and drugs failing in the rise of a massive epidemic, OSDD remains the only sliver of hope to treat the sick, not just the sick who can pay.

(Dhruba is a scientist and studied journalism at the Asian College of Journalism, Chennai.