Great News, but Innovative, Really?

The “innovation” in this approach is not scientific, but economic.

Cheap drugs for poor nations | Guardian Weekly | Guardian Unlimited

Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine that is no longer under a 20-year patent to a multinational drug company and can be made and sold cheaply. The process has the potential to undermine the monopoly of the big drug companies and bring cheaper drugs not only to poor countries but back to the UK.

Okay, I may be missing something here, but this is not a scientifically innovative strategy. They are called Me-Too drugs. Pharma has been doing this for years. Read this article in the Stanford Medicine Magazine about exactly how this is done.

Nexium illustrates the drug makers’ strategy. Many chemicals come in two versions, each a mirror image of the other: an L-isomer and an R-isomer. (The “L” is for left, the “R” is for right.) Nexium’s predecessor Prilosec is a mixture of both isomers. When Prilosec’s patent expired in 2001, the drug maker was ready with Nexium, which contains only the L-isomer.

Is Nexium better? So far,

there’s no convincing evidence that it is, says Stanford drug industry watcher Randall Stafford, MD, PhD.

This is a well known and well used strategy. The Government Accounting Office (GAO) recently released a study which concluded that 68% of all drugs developed in the US between 1993 and 2004 were Me-Toos.

So, what is “innovative” and “revolutionary” about this approach is that non-profits are driving the drug development. By outsourcing the entire clinical trial to India, substantial savings are to be had. By not having to fund the US shareholders’ need for huge profits, enormous company overhead, high salaries, multi million dollar executive bonuses and marketing expenses that US/European pharma require, cost savings are potentially huge.

The downside? Well, unless the studies are run according to US/EU GLP/GMP guidelines, data quality, and therefore, drug safety can be suspect. The pedigree of the people involved in this effort makes it unlikely that the data is going to be suspect. If their ultimate aim is to sell these drugs in England, then they will have to meet the most stringent standards available.

Of course, these drugs will never hit the US of A. I can already hear the fear mongering, the safety doubts being raised, the “terrorists may get their hands on your pill” bogey, etc. But, Americans can afford to pay for their drugs more than your average Indian suffering from Hepatitis C can. Once the already teetering (by first world standards, of course!) healthcare system in the US gets closer to collapse (by first world standards, of course!), some of these “innovations” will become more viable in this most reactionary of countries.

I hope this model is proven to be viable.

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    Pesticide Exposure and India's green revolution

    Pesticide exposure in Punjab and Haryana is out of control. When I was growing up, the Green Revolution was idolized and idealized to degree that in hindsight seems a little excessive. But back then, this octupling of wheat and rice yields in Punjab and Haryana catalyzed the transformation of India from a country mired in famine and food shortages to one that occasionally runs out of room to store excess food. So, this story (courtesy of 3QD) caught my attention.

    Green.view | Chemical generation | Economist.com:

    IF INDIAN newspaper reports are to be believed, the children of Punjab are in the throes of a grey revolution. Even those as young as ten are sprouting tufts of white and grey hair. Some are going blind. In Punjabi villages, children and adults rare afflicted by uncommon cancers.

    The reason is massive and unregulated use of pesticides and other agricultural chemicals in India’s most intensively farmed state. According to an environmental report by Punjab’s government, the modest-sized state accounts for 17% of India’s total pesticide use. The state’s water, people, animals, milk and agricultural produce are all poisoned with the stuff.

    Ignorance is part of the problem. The report includes details of a survey suggesting that nearly one-third of Punjabi farmers were unaware that pesticides come with instructions for use. Half of the farmers ignored these instructions. Three-quarters put empty pesticide containers to domestic uses.

    The article concludes by saying that the government is encouraging the use of techniques including organic farming, more crop rotation, etc, and how this is ironically “reversing” the green revolution. But two separate issues are getting mixed up here. The green revolution was not won on excessive use of fertilizers, monoculture, excessive water use, and so on. Instead, the development of new hybrid, high yielding varieties of rice and wheat kick started the revolution. The wholesale adoption of water and input intensive agricultural techniques came along for for the ride with the rest of the revolution.

    Hopefully, the Punjab government will not stop at writing reports, but start grassroots education projects with the farmers to encourage sensible farming techniques that take the good parts of the green revolution and leave the bad parts out.

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    Meanwhile, in the other India

    While India prepares to spend many billions of dollars on fighter jets, it cannot provide clean water for its citizens.

    Cholera-diarrhoea toll mounts to 164 in Orissa-India-The Times of India

    Cholera and diarrhoea, having assumed epidemic proportions in three tribal dominated Orissa districts, have so far claimed 164 lives as officials confirmed five more deaths in worst-hit Koraput on Thursday.

    The death toll, which had mounted to 159 on Wednesday, further rose to 164 with confirmation of five casualties in Dasmantpur block of Koraput district, Chief District Medical Officer (CDMO) R K Agarwal said.

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    The water-borne diseases had assumed epidemic form in nine blocks of these three backward districts located adjacent to each other though separated by hills and the waterspread of the vast Indravati reservoir.

    Despite state government’s claim to have effectively controlled the spread of the diseases, residents of the affected areas alleged that the administration had failed to provide adequate medical facilities to the patients.

    This is disgusting and very symptomatic of the urban-rural divide that exists in India. Unless the government can provide basic infrastructure to its rural citizens, all those fancy malls and F16s mean little.

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    Yes, I read the Times article about this subject too, but Tom Philpott and P. Sainath writer better and more eloquently.

    India, food, and modernization | Gristmill: The environmental news blog | Grist

    That “promising biotechnology” is Monsanto’s Bt cotton seed, genetically modified to ward off the cotton bollworm. Indian farmers have been desperate to get their hands on it because they think they need it to compete with their lavishly capitalized and subsidized U.S. peers.

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    Well, that’s one way to clear the land of “inefficient” farmers.

    For the enduring scam that is BT cotton, read this.

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    newsobserver.com | Beauty, bucks sought in bird trail

    SWANSBORO – With hundreds of colorful birds already visiting and calling Eastern North Carolina home, the state is encouraging bird lovers to bring their binoculars and billfolds to watch them. The N.C. Birding Trail unveiled this week links dozens of sites long known to birders as packed with rare, popular or threatened species, such as the endangered red-cockaded woodpecker.

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    hey, who’re you calling a nerd!!

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    Indian Parliament Discusses Climate Change

    India stresses on Kyoto standards-India-The Times of India

    The discussion on global warming in Parliament will end with the statement of environment minister A Raja, possibly on Monday. He is bound to restate the country’s position on climate change in the international arena — that countries must bear “a common but differentiated responsibility” for climate change, a phrase that is the central pin of the Kyoto Protocol.

    De-jargonised, it means, while every country is adding to the problem, there are some that are more responsible than others, and should, therefore, bear the burden and costs of cleaning up more than the smaller culprits

    More highlights…

    The US, between 1950-2003, emitted 10 times more carbon dioxide than India did. Europe emitted 8.5 times more. Yet US and Australia, two of the biggest emitters of greenhouse gases, have refused to ratify the Kyoto Protocol (which asks developed countries to reduce their emissions) on the pretext that developing countries like India and China are not undertaking emission cuts.

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    But renewable energy, of which the vast majority is wind power, accounts for more than seven per cent of India’s installed generation capacity – a rate that compares favourably with much of the rest of the world. India is the world’s fourth largest wind-power market.”Wind power is growing tremendously. If you want a wind plant you’ll have to book a year in advance,” said Chandra Bhushan, associate director at the New Delhi-based Centre for Science and Environment.”There’s been years of progressive policies and recognition for a long time that India will face a shortage of fossil fuels.”

    Gulfnews: Energy-hungry India slowly becomes wind superpower

    Some numbers for comparison: The U.S has about 14,000 MW of installed capacity with 5,000 more on the way. This represents about 1.4% of the > 1 million MW of installed capacity. At least when it comes to one of the cheapest and cleanest forms of renewable energy, India is ahead of the US as far as its renewable energy portfolio goes!

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