For example, the Food and Drug Administration was originally conceived to regulate two entirely different industries: food and drugs.

“Pharming” is what happens when we mix the two. Specifically, animals — and eventually perhaps insects, plants and even bacteria — are converted into “farms” (or “pharms,” for pharmaceutical) for making drugs.

How? Genes are primarily protein factories, and most new drugs being developed these days are protein-based. So if you can find (or design) a gene that makes a desirable protein, it’s possible to transplant that gene into an organism that doesn’t normally carry it.

Though the concept is simple, it has staggering implications. For example, for many years, people took replacement hormones that were actually derived from animals, not quite the same as the human equivalents. To this day, many women still take estrogen from horses rather than the human estrogen now available. Likewise, human growth hormone (HGH) was extracted from animal glands and given to short children.

Such practices often carry undesirable side effects. Fortunately, those days are rapidly ending, and pharming will accelerate this process. The reason is simple economics: When it’s possible to design a pig that produces true HGH and harvest that, then the cost of production becomes comparable to that of normal pig HGH. The implications go far beyond hormone replacement.

Recently, the European Medicines Agency decided to review a new drug that helps people at risk for deep-vein thrombosis. These people need a particular protein that their bodies cannot manufacture. This is a potentially fatal condition, and soon, those afflicted with it will have a treatment thanks to a unique goat. This goat has a human gene, so it makes the vital protein in its milk. Such a goat is called “transgenic” — meaning it mixes genes from different species.

GTC Biotherapeutics (GTCB: Nasdaq) of Framingham, Mass. has created this special goat protein, as well as 65 other therapeutic proteins in the milk of its transgenic goats and cows. Several other small companies are in hot pursuit. Of late, the pharmaceutical industry has become one of the most price-sensitive. There are several key reasons:

– Growing pressure to allow reimportation, which will force the industry to cease using American consumers to subsidize others in price-capped countries
– Numerous scandals regarding safety and manipulation of the FDA
– Drug prices that have been outpacing the consumer price index.

The net effect of all these pressures is an industry in desperate need of a way to bring products to market faster, less expensively and more reliably. Pharming offers an easily scalable (just make more goats) and cost-effective (goats are easy to grow and maintain) way to make drugs.

Because the drugs are, in many cases, the actual human equivalent protein rather than a close substitute, safety concerns also greatly diminish. Speaking of safety concerns, critics often object that if such transgenic creatures (called “chimeras” by the industry) were to escape into the wild, they would wreak havoc with the gene pool. In the case of transgenic bacteria, the organisms are crippled so they cannot survive something in the outside world, usually direct sunlight. With respect to animals such as goats, the issue has not been fully addressed.

Another unknown factor is the possibility of transmitting viruses or prions from animals to humans via pharmed medicines. These concerns will have to be addressed as pharming moves forward, because the potential advantages are too huge to ignore…

Consider terrorism. In Japan, sarin nerve gas was used to attack train passengers. It could happen again. Nexia Biotechnologies (NXB-H.V: CDNX) is under contract with the U.S. Army to develop a safe defense against nerve gases. Current treatments are themselves harmful to anyone who has not been exposed to nerve gas. Unfortunately, it is not always possible to determine if someone has been exposed before treatment must be administered.

Nexia’s pharmed drug can be administered without fear of side effects. In any event, pharming is coming, and it has implications far beyond what’s now being researched by the drug industry. For example, scientists have discovered that goat’s milk is an ideal medium in which to grow spider silk, which is an extraordinarily strong chain of proteins. Spider silk has many potential industrial applications, most of which have not been economically feasible due to its scarcity.

It is possible, for example, to build cables from spider silk that can support far more weight than steel cables, yet with greater flexibility and weighing a fraction of the steel equivalent. This will have advantages in earthquake-prone areas as well as wherever the weight of the cables is an issue, such as launching them into space.

Pharmanufacturing, anyone?

To your profitable future,

Jonathan Kolber
April 26, 2006

Pharmaceuticals and Farming Get Cozy was originally featured in the Penny Sleuth.