Day: January 4, 2007

Development

Great News, but Innovative, Really?

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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.

Environment

Rolling Stone Magazine Expose' on the Pork Industry

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Excellent article, read in full, and let the next mass market pig you eat weigh on your conscience a little bit.

I have attended meetings organized by the North Carolina Environmental Justice Network recently, and Smithfield foods is high on their agenda for the mind blowing pollution that overwhelmingly affects the poor and rural African-American communities, for their appalling safety record, and early American style treatment of its workers. See this PBS video for more. It is truly heartbreaking to hear testimony from people who live near hog farms, how the stench is overwhelming, omnipresent, and travels in your clothes and system wherever you go.

Some Excerpts:

Rolling Stone : Pork’s Dirty Secret: The nation’s top hog producer is also one of America’s worst polluters

Smithfield Foods, the largest and most profitable pork processor in the world, killed 27 million hogs last year. That’s a number worth considering. A slaughter-weight hog is fifty percent heavier than a person. The logistical challenge of processing that many pigs each year is roughly equivalent to butchering and boxing the entire human populations of New York, Los Angeles, Chicago, Houston, Philadelphia, Phoenix, San Antonio, San Diego, Dallas, San Jose, Detroit, Indianapolis, Jacksonville, San Francisco, Columbus, Austin, Memphis, Baltimore, Fort Worth, Charlotte, El Paso, Milwaukee, Seattle, Boston, Denver, Louisville, Washington, D.C., Nashville, Las Vegas, Portland, Oklahoma City and Tucson.

To appreciate what this agglomeration of hog production does to the people who live near it, you have to appreciate the smell of industrial-strength pig shit. The ascending stench can nauseate pilots at 3,000 feet. On the day we fly over Smithfield’s operation there is little wind to stir up the lagoons or carry the stink, and the region’s current drought means that lagoon operators aren’t spraying very frequently. It is the best of times. We can smell the farms from the air, but while the smell is foul it is intermittent and not particularly strong.Unsurprisingly, prolonged exposure to hog-factory stench makes the smell extremely hard to get off. Hog factory workers stink up every store they walk into. I run into a few local guys who had made the mistake of accepting jobs in hog houses, and they tell me that you just have to wait the smell out: You’ll eventually grow new hair and skin. If you work in a Smithfield hog house for a year and then quit, you might stink for the next three months.

Epidemiological studies show that those who live near hog lagoons suffer from abnormally high levels of depression, tension, anger, fatigue and confusion. “We are used to farm odors,” says one local farmer. “These are not farm odors.” Sometimes the stink literally knocks people down: They walk out of the house to get something in the yard and become so nauseous they collapse. When they retain consciousness, they crawl back into the house.

Successful Farming magazine warned — six years ago. There simply is no regulatory solution to the millions of tons of searingly fetid, toxic effluvium that industrial hog farms discharge and aerosolize on a daily basis. Smithfield alone has sixteen operations in twelve states. Fixing the problem completely would bankrupt the company. According to Dr. Michael Mallin, a marine scientist at the University of North Carolina at Wilmington who has researched the effects of corporate farming on water quality, the volumes of concentrated pig waste produced by industrial hog farms are plainly not containable in small areas. The land, he says, “just can’t absorb everything that comes out of the barns.” From the moment that Smithfield attained its current size, its waste-disposal problem became conventionally insoluble.

Nice, huh! Still eating factory pork?