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Politics ‘Biotech era’ spawns scientific and political concerns

The beginning of a new social and political age is emerging, moving from the eras of physics and chemistry to the age of biology. The recent Industrial Age divided the world on how to control production and sharing the fruits of industry. This led to socialism, communism, and other reactionary “isms” bequeathing the deaths of hundreds of millions in the 20th century.

Today’s new Biotech Era is spawning concerns with a compelling agenda. Philosophical camps are mobilizing , camps of those championing the intrinsic value of life at all costs separated from those favoring utilitarian value systems. This is compounded with mixtures of politics and economics supporting capitalistic values opposed by liberal, socialistic value systems demanding common ownership, or no ownership at all.

Stem cell research is simply the latest issue in an accelerating life science public debate. Earlier issues like genetically engineered foods, Third World drug access and prescription drug price controls are gaining momentum. Now there will be added concerns about designer babies, cloned embryos, organ banks, and eugenically divided social castes. While these issues will not be resolved today, the life sciences industry will need to be prepared to discuss them.


– Public Perceptions

Unlike the issues of the Industrial Age, the profound depth of the science involved with the Age of Biology prevents scientists from being divorced from this discussion. The industry can no longer afford to ignore it! Scientists will have to “get their hands dirty.”

Political barricades have to be manned by people who are deeply knowledgeable and most importantly, articulate about these issues. And there are many who have had extensive experience leading this charge for public awareness, talking to the media and the concerned public.

The concern is, however, that in the massive effort to develop the future work force for California biotechnology, the education of spokespeople in how to wage the battle for the hearts and minds of the public has been forgotten.

This is the same public that votes in elections, funds programs, funds the life sciences industries and ultimately buys the products. This is the same public that is seeing the life sciences industries painted as godless, profit-driven global corporate empires that are playing God, destabilizing ecosystems and spreading genetic pollution across the planet.

Drugs don’t arise from a vacuum. They don’t appear on the pharmacy shelves from social or government programs. They become available to desperate patients when the companies here today and their hundreds and thousands of employees take on this enormous labor, this enormous risk to gamble everything on a 10- to 15-year effort to make the drug a reality.

Most of their efforts fail. Their few successes, the ones toiled over and hoped for, have to pay for their failures. The upside of these successes is the stake that makes it all work , leading to innovative products improving and saving millions of lives , and often creating fortunes. These are the stakes that drive the industry.

These stakes now driven by global economics have, unfortunately, political repercussions. Looking at the activities at the recent global trade conference in Genoa, Italy, provides some insight as to these consequences.


– What Can Be Done

Start with a formal program of educating the public and educational institutions on the ethical issues and their relationship to the political and economic ones.

Begin educating these students and future scientists on what makes the biotechnology and pharmaceutical industry operate. What makes American medicine the best in the world?

Educate them on the economic drivers in discovering and developing new drugs


including:

o Why it requires half a billion dollars to develop a single drug and take it to market.

o Why only one out of five drugs going into clinical trials, costing hundreds of millions of dollars, makes it to market.

o Why the marketplace pays these costs.

o Why the “obscene” profits of the industry are nothing more than a down payment on future products and research.

This is not taxpayer money as in defense or Social Security or the space program. These are private dollars invested for a return that includes a biotechnology return that is becoming more and more tenuous.

It’s a tenuous return that small legal changes could kill, drying up the pipeline creating the innovations driving the biotech revolution, and an industry that has been virtually eliminated in Europe because of the public unease with genetically modified food.

Social and academic institutions provide students with little insight on the economics of drug development: the issues, the risks, the role of capital and the vital role of entrepreneurs.

Another critical concern is the fact that while this technology springs from basic research in our universities and private and public research centers, there is a serious gap in translating this research into products. The post-discovery phase requires the ability for scientists to transition to applied research and development.

This is the part of the R & D; process that is the most critical , it makes the products real, capable of passing stringent FDA regulations, and becoming successfully marketable. This is where the bulk of the failures occur.

Programs are needed to develop professional degrees in bio/pharmaceutical marketing, bioinformatics, data management and a host of other critical commercial/industrial areas. Universities must focus on this applied biotech and they also have to fund it , the companies that desperately need these people (most of them trying to transition from their boutique research mode into commercialization) do not have the resources to do it themselves. Again, the economics are inexorably linked with the science.

What makes economics really work is not divorced from chemistry or molecular biology. Far from it. It enables the science to become real and meaningful in people’s lives. This is the global gestalt. Those that understand it will own the planet. Those who don’t will be reduced to demonstrating on the barricades.

These are real issues with real social, economic and political impact. This is something that everybody has to deal with. More importantly, it is something needed to prepare our students and young researchers to deal with.

It starts here in California , just as this state has led the planet in almost every technological and social issue; this is home to the world’s pioneers in biotech. It starts on the leading, bleeding edge, whether we like it or not.

It starts here.

Iannuzzi is the president of Mentus.

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