Pharmaceutical crops: Promise or peril?

BOZEMAN — Imagine hepatitis vaccines produced in corn, rabies vaccine in alfalfa, and anti-cancer drugs in potatoes. What seemed like science fiction not long ago is now science reality.

Genetically engineered crops are not only being targeted to produce pharmaceuticals, but these crops are already being grown in agricultural fields throughout the United States.

From MSU News Service

http://bozemandailychronicle.com/articles/2004/02/23/news/cropsbzbigs.txt

"The acreages are still small, but there is potential for large increases in acreages as companies turn to crops to produce drugs," says Bob Peterson, a risk assessment researcher at Montana State University-Bozeman. The impact of this technology on agriculture could be substantial.

"It sounds strange, but these pharmaceutical crops can actually produce human and animal drugs more efficiently than any other way," says Peterson.

In some cases, there is no other way to produce some of the new, therapeutic proteins except in plants.

But, using genetically engineered crops to produce drugs poses questions not shared by other manufacturing methods. "Many of these questions arise from the simple fact that the crops are being produced in the open environment, which is a unique aspect in drug manufacturing," says

Peterson. How risky are these crops to people, wildlife, and

agriculture? We need a way to understand the risks so we can make good decisions about how to regulate the technology.

In a recent article published in the journal "Trends in Biotechnology," Peterson and Charles Arntzen of Arizona State University in Tempe propose a framework for assessing the risks posed by pharmaceutical crops. Instead of reinventing the wheel, they advocate using a science-based risk assessment method, which is well-established for many other technologies. In the article, they discuss how the existing method can be used for pharmaceutical crops.

The key to the risk assessment approach is to consider not only if a pharmaceutical crop has the possibility of causing an adverse effect, but also to determine the probability of an adverse effect happening.

"Because of the lack of toxicity, many pharmaceutical proteins that will be produced in plants will challenge our ability to define an environmental hazard," says Peterson. It is much easier to conduct risk assessments with pesticides. They are usually toxic to some plants or animals.

Many pharmaceuticals can be grown in crops, and regulations will need to assess them on a case-by-case basis, he added. It would be a waste of money to impose a rigid regulatory scheme for these proteins that is similar to the way pesticides are regulated.

"Basically, we are talking about using food crops to produce non-food products. From a regulatory perspective, the crops are part of pharmaceutical manufacturing. Understanding the risks posed by this reality is important for all aspects of agriculture" Peterson said.

This technology offers opportunities for Montana crop growers and businesses, he added.

"By working actively with this technology and its issues, Montana could become a leader in plant-based biopharmaceutical research and production," Peterson said. His work is being supported, in part, by a USDA special research grant to the Institute for Biobased Products at MSU.

An important aspect of risk assessment will be better communication with the public.

"If people don’t understand the process, they’re not going to trust the decisions," says Peterson.

The next steps for Peterson will be to conduct risk assessment research on pharmaceutical crops either currently being grown in the field or being considered for field production. He will do this in collaboration with researchers at Iowa State University in Ames.