India’s Central Drug Research Institute (CDRI) in Lucknow is actively studying whether existing drugs, such as leprosy medication, can be repurposed to take on myeloma, a form of blood cell cancer. Clinical researcher Sabyasachi Sanyal at CDRI has formed a partnership with the clinical hematology department at King George’s Medical University to screen FDA-approved drugs in chronic myeloid leukemia (CML) cells and found that an older leprosy drug called clofazimine, priced very low, was a inhibitor of these cells.
Screening over 1,000 Drugs
The Times of India reports that Sanyal and colleagues with CDRI, including Lucknow chief scientist Dr. Naibedya Chattopadhyay, have screened over 1,000 drugs in the pursuit of discovering an oral substitute for teriparatide—an injectable therapy for women suffering from post-menopausal osteoporosis. The Times of India reports Dr. Chattopadhyay’s commentary: “Our pre-clinical studies found that Pentoxifylline, a drug prescribed for treatment of a disease of peripheral artery, when given to osteoporotic female rabbits, mimicked effects of teriparatide including restoration of bone mass, strength, micro-structure and quality.”
What is driving these Indian researchers? Well, economy. If they can identify repurposed drugs, they can drive 85% of the costs out of the system. In a country such as India where tens of millions still live in poverty, this can be a matter of life and death.
All India Institute of Medical Sciences (AIIM) New Delhi
AIIM’ investigators are conducting similar research to that of CDRI—conducting extensive clinical trials to explore the repurposing of established drugs. Recently, Dr. Kameshwar Prasad, professor of neurology at AIIM, wrote a proposal to the Indian Council of Medical Research to set up a task force that will identify and validate economical alternatives to high cost therapies. In his proposal, he is conveying that the train has left the station: researchers and physicians across India are taking alternative paths to serve large patient populations lacking the financial wherewithal to prescribe to branded, expensive drugs. An example reported by the Times of India is a single cycle immune therapy for treatment of Guillain-Barre-Syndrome (GBS), an acute inflammatory disorder of the peripheral nervous system. Already, physicians are recommending far cheaper steroids that would appear to help treat the condition.
A National Survey: Indian Physicians Looking for Economical Alternative Drugs
It turns out, AIIM physician Dr. Bhavna Kaul conducted a survey of Indian physicians assessing the use of cheaper alternatives for drug treatments. As it turns out, most physicians and neurologists were already prescribing steroids since the standard treatment, immunoglobulin, wasn’t affordable by most patients. At least according to Times of India, the patient response has been satisfactory but TrialSite News cannot substantiate this claim.
The Costs Rise Beyond the Ability to Afford
The drug “Repurposing” industry is huge. Already the drug economy is massive—approaching $1.4 trillion in spend by 2020. In emerging economies and societies such as India, there is indeed massive middle classes now but many millions still live in dire poverty. And still tens of millions more (if not hundreds of millions) represent the working poor—branded drugs are beyond their economic means. The drug repositioning industry represents a massive opportunity to drive down costs. However, Times of India reports that roadblocks remain. From the lack of investment to drive repositioning trials and disinterested commercial sponsors, the economic returns are not robust. Moreover, India doesn’t offer the same patent protection for new uses of known drugs, requiring the government to step in and invest. Often, governments do not have the expertise or wherewithal for such programs.
Government Funded—Non-Profit Partnerships
Perhaps the path forward is partnerships involving government financing and third party academic and non-profit research institutes that can develop the repositioning strategies. For example, the Drug Controller General of India have funded demonstrations of the efficacy of repurposed drugs.
Call to Action: For those interested in the repurposing of drugs, the Indian contacts mentioned herein would be excellent people to talk to. We include their contact information here.
AIIM, Dr. Kameshwar Prasad, Professor of Neurology
AIIM, Dr. Bhavna Kaul