There are some striking parallels here between the way that the Indian political and business elite are apparently falling over themselves to line up their citizenry as cost-cutting guinea-pigs in pharma clinical trials, and the way pharma and other GM crops are being pushed for testing in the developing world - for instance, the plans to test European-developed pharma crops in South Africa with its lax biosafety regime.

Even in the US pharma crops are being blocked by food industry and consumer concerns but governments in some countries, like India, appear to be hell-bent on reducing biosafety/regulatory hurdles just as the US is under pressure to increase its own.

Similarly, Monsanto's only hope of survival, given its multi-million dollar losses as its herbicide sales comes under increasing pressure and its GM seed sales are almost non-existent in lucrative markets like Europe and Australia, lies in pushing GM seeds into countries like India and Brazil which have now become its lifeline.
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Will India save the pharma industry from collapse?
With the promise of ethical treatments for cancer, parkinsons, ms, and diabetes, still lightyears away- is rapid testing in India a blessing in disguise?
Medscaper, October 25, 2003
http://www.alwayson-network.com/comments.php?id=6345_0_5_0_C

India emerges as new drug trial hot spot

Biotech entrepreneurs see Indian clinical trials which can cut costs by 60 percent as the difference between success and slow death.

Boosted by key changes in the drug regulatory system, India is poised to become an important player in the rapidly growing global clinical trials business. While some Western critics have charged that moving part of the U.S. Food and Drug Administration’s (FDA) mandated clinical trials is a kind of "medical imperialism," Indian industry leaders are cutting costs and saving time in new drug testing.

Leveraging its unique combination of English speaking medical personnel, an experienced pharmaceutical industry, expertise in medical data processing, and a vast and motivated patient pool, India's small but fast growing clinical trials industry has the potential to significantly lower drug development costs for U.S. and global companies. Drug trials in India may also mean the difference between life and death for startup companies in the biotech and medical device fields.

The business of pharmaceutical and medical device clinical trials is a $15 billion per year business in the U.S., and $35 to $40 billion globally, according to the industry group Pharma Research. A recent industry study from Business Communications Company of Norwalk, Connecticut, says that U.S.-based spending on clinical trials is growing fast at a 12 percent per year pace that should generate $26.5 billion by 2007.

The cost of new drug development is enormous. Boston’s Tufts Center for the Study of Drug Development, the leading research center of new drug regulation economics, calculates that total pre- and post-approval research including clinical trials averages $897 million per drug. But the time required for the trials process which may take 10 years is both a major factor in costs and an impediment to releasing beneficial new drugs. Some of the promising startups, which have created what might be highly beneficial new drugs, are strangled by both the amount of money and time needed to pass FDA-certified trials, as well as the FDA approval process itself. Last month, for example, a Santa Monica-based company, Balance Pharmaceuticals which had been working for 11 years on a promising drug for use against both breast cancer and fibroids, simply ran out of money and was unable to raise the $50 million necessary to finish clinical trials according to a report in the Los Angeles Times.

"The cost of drug development needs urgent attention," says Kiran Mazumdar-Shaw, founder of the clinical research organization (CRO) Clinigene, based in Bangalore. "Those that cost-effectively develop drugs in lower-cost countries like India will certainly gain a significant advantage over those that do not."

With a widespread base of highly trained scientists, doctors, technicians, support workers, and in some areas, robust IT systems (originally built to handle record and data management outsourcing for U.S. health care organizations), the cost of testing drugs is significantly lower in India. India can apply its healthcare infrastructure for the intensive record keeping and report filing required by clinical trials. A recent study by Rabo India Finance, a subsidiary of Rabobank, Netherlands, estimates cost savings of 50 to 60 percent, with the higher savings for the most-expensive Phase III trials, which can cost $100 million or more and take several years to complete in the U.S.

Multinational drug companies like Pfizer, Eli Lilly, Novo Nordisk, Aventis, Novartis and GlaxoSmithKline have been running Phase II and III clinical drug trials in India. Eli Lilly alone is conducting tests on 20 new drugs in India, and will include India in global testing next year with its important new inhaler insulin drug, Oralin. Pfizer has been conducting limited clinical trials in India for seven years, and is testing drugs for the treatment of schizophrenia, menopause and breast cancer. A variety of both India-based and global CRO firms that specialize in outsourced clinical trials management are working to expand India’s clinical trials business. Until this year’s important regulatory changes, they had not been able to expand beyond one percent of the global market.

There are more than 2,500 FDA clinical trials underway in the U.S. for new drugs. Because Phase II trials often use up to several hundred people and Phase III trials often require several thousand people, the need for a very large 'patient market' with a particular disease is enormous. The problem for biotech, pharmaceutical, and medical device companies is that it is increasingly difficult and expensive to find the large pools of people needed to thoroughly test new drugs and devices.

But cost saving is not India’s only advantage. Genetically and culturally, India is perhaps the most diverse country on the face of the earth, argues biologist Madhav Gadgil, who teaches at Bangalore's Indian Institute of Science. Genetic diversity is an important asset in testing new drugs because people with different genetic make-ups may respond to drugs in different ways, he notes.

Until last April's regulatory changes, companies running clinical trials could only conduct such tests in India after the FDA had signed off on earlier Phase II and III trials already run in the U.S. or elsewhere. Trials could be conducted in India, but not efficiently.