Future of Biotechnology for Medical Applications in 2005, Ethics & public opinion

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Ethics & public opinion

Two main questions regarding ethics and public opinion regarding biotechnology research:
1. What are the ethical drivers to prevent biotechnology to further develop?
2. What are the ethical drivers to support or speed-up biotechnological development?

There are a numbers of areas (drivers) that affect the general opinion regarding biotech, and a number of areas (drivers) that tries to form or influence the ethics of the industry. These drivers are structured as follows below:
A. Politics
· Laws and regulations
· Legislation
B. Biotech Industry
· Self regulation
· Corporate ethics
C. Media
D. Influence on development

A. Politics

Cloning and its enemies Of all the aspects of genetic research, none is more controversial than human cloning. E.G., the ethics committee of the American Society of Reproductive Medicine says that cloning for fertility treatment “does not meet standards of ethical acceptability.” In the wake of the cloning of Dolly the sheep, Bill Clinton announced a moratorium on human reproductive cloning in March 1997. However, this only stops federal money going to help the process. Today, a mere five states in the US —California, Louisiana, Missouri, Michigan and Rhode Island—actually have laws banning reproductive cloning (either temporarily or permanently), though Texas is thinking about one.

Most American politicians claim to be against cloning, but they are also nervous about restraining their genetics industry. In Dolly’s wake, Congress tried half-heartedly to pass an anti-cloning bill, but failed to work out a law that would satisfy both the anti-abortion camp and the drug firms.

Experts predict that genetic science will end up in the Supreme Court—not as one issue, but as a series of small cases that will together set a limit for what society will tolerate in the field. Those judges may be swayed by public opinion (and the presidents who appoint them certainly will be). A good bet is that attitudes to genetic research will be defined by the first human clone. If a cloned baby were to be born with terrible abnormalities, the public outcry against genetic research could be immense, and bans could be imposed on several fronts. On the other hand, if a totally healthy cloned child appears then every fertility clinic will possibly begin to offer the technique.

Legislative confusion Even the abortion marchers in Washington seem a little uncertain. Asked about the use of embryos in stem-cell research, two ladies from Missouri Right to Life appear opposed to it. They also dislike cloning, and they seem a little nervous about genetically modified food. (“It’s not natural, either.”) Did they know that their senator, Kit Bond, a fervent anti-abortion Republican, is, strangely enough, a leading supporter of GM foods? No, “but he’s a good Christian man.”

So far, the debate about genetic research has largely been a private academic squabble. Most of the running has been made by enthusiastic scientists who expect you to know what single nucleotide polymorphisms are. The sceptics are a ragbag of unlikely allies: a few academic political theorists, the Roman Catholic church, some anti-abortion zealots, the anti-globalisation brigade and a few mavericks (one American writer, Jeremy Rifkin, is working on a multilateral “Treaty to Protect the Genetic Common”).

B. Biotech industry

Self regulation The biotech industry has taken up the task to regulate itself, by forming industry organizations responsible to define ethical guidelines and principles. Organizations such as BIOTECanada, the U.S. Biotechnology Industry Organization, and the European Association for Bioindustries have adopted "Statements of Ethical Principles" outlining their commitment to ethical practice in the field of biotech. But industry-wide codes filled with vague promises are insufficient to the task of sustaining ethical conduct.

Several biotech companies have formed Ethics Advisory Boards in recent months, with more likely to join their ranks in the near future. The trend reflects a realization that biotech companies engage in research that raises difficult ethical issues. As these and other new technologies proliferate and mature, increasing numbers of companies are also seeking expert ethical guidance. They are looking for help both internal to the company, in deciding what products should be developed, as well as in dealing with the public's interest and concern about such research. Of late, biotechnology has generated a wealth of issues with few easy answers, ranging from privacy and genetic information, to informed consent, to who should be tested for genetic mutations, to the cultural problems of conducting clinical trials internationally among indigenous peoples. The industry has come to understand that it can not afford to alienate the public--which includes investors and consumers--with its science, for it is with the public that its fate ultimately lies.

The list of companies using bioethics specialists includes Glaxo Wellcome, Genzyme, SmithKline Beecham, Millennium Pharmaceuticals, Myriad Genetics, Pfizer, and Affymetrix, and is growing as technologies raise new questions and controversies which have no easy answers.

Corporate ethics Stakeholders are increasingly seen as not only shareholders and investors, but to a wider range of individuals, groups or communities. As genomics begins to move from the laboratory to the marketplace, the need to find innovative ways to include civil society and its unheard voices as partners in the debate surrounding ethics and genomics takes on new urgency. In the world of corporate biotech, this need manifests itself as a need for innovative understandings of stakeholder-driven management. The “stakeholder problem” in corporate ethics can be understood in terms of the question, “For whose benefit, and at whose expense, should firms be managed?” Traditional management frameworks gave managers a near-exclusive responsibility to shareholders and investors. More modern “stakeholder management” implies instead a range of responsibilities to various individuals, groups, and communities.

Mechanisms for ethical consensus are missing! So who will watch the bioethicists? At present, it is a relatively small number of individuals who act as advisors without any mechanism for building ethical consensus among their ranks. That there is a need for industry-wide norms, "rather than relying on the integrity of a few individuals." Such norms for business, the clinic and research would reflect some sense of policy. BIO is today the only group with legitimacy in the position to do this.

To date, there have been no reports of companies suspending ongoing research or product development on ethical grounds, at least among public companies. How bioethical issues are grappled with at private companies -- if they are considered at all -- remains murky, and will until bioethics trickles down into privately funded science. However, BIO has come out strongly against human reproductive cloning and relevant companies.

C. Media

Confusion of issues (mainly regarding abortion) Unfortunately, a clear and vigorous debate on some biotechnologies isn't happening in the United States. The biggest conversation right now is about embryonic stem cell research. One reason is because the media is applying abortion categories to an issue that has virtually nothing to do with the right to "choice." One of the problems has to do with the media's use of labels. What does it mean to say "anti-abortion activists" or "anti-abortion groups"? Does it mean that abortion is the primary issue that that such groups address? Or does it refer to any group that holds a negative view of abortion, no matter what else they do? I dare say that most people who hear an "anti-abortion" label would believe the former, not the latter. And on this issue, a number of people and groups have publicly declared their opposition to this research who either don't address abortion per se or don't make it their primary focus. The main coalition against this research, The Coalition of Americans for Research Ethics, not only has not taken any stand on abortion, but they have many organizations and people who back them who certainly don't fit an "activist" mold.

The media has created confusion in the public by creating the false impression that the issue of destructive human embryo research is intertwined with abortion. But the core issues in destructive human embryo research are not about a conflict of rights between mother and child. The issues are more like, "Is the embryo property to be done with as its owner wills? Does the Nuremburg Code, which demands human beings give consent for experimental research, apply to those who cannot give consent, such as embryos?" The confusion can cause the public to use abortion rights categories to try to understand complex moral issues of biotechnology instead of looking at an issue itself.

D. Where are ethic questions most likely to influence development?

America is likely to be the most important battleground regarding biotech development ethics for several reasons. First, it has the most advanced biotech industry. Second, some of these ethical questions overlap the tortured abortion debate. Third, Americans have always leapt at perfectionist fads, whether plastic surgery or playing Mozart to educate babies in the womb. Fourth, America’s legalistic culture makes the ethical fudges that are common in Europe very difficult. And, fifth, despite all these things, American politicians and regulators seem almost completely unprepared for what is about to hit them.

Conclusion: Strategic Drivers

A. Politics: · The main ethical resistance comes from the US anti abortion lobby, which affects (and stalls) the legislation process in the US, which is in the forefront of development. Politicians try to satisfy both the anti-abortion lobby as well as the biotech research development · The outcome of future (human) cloning experiments and publics opinion thereof can be a very important driver for future attitudes towards genetic research · American legislations will drive the ethical restrictions on biotech development · Public opinion basically does not have an impact on the biotech research, as most issues are too complex for a normal person to understand

B. Biotech Industry · Most public companies are organizing themselves in organizations to ensure that certain ethic ground rules are followed. Again, most issues are too complex, so basically the biotech industry has to regulate itself, which will not be sufficient! · More modern “stakeholder management”, i.e. ethic management and control provided by various individuals, groups, and communities will be an important future stakeholder · A major problem and negative driver is the publicity of privately held biotech companies, who does not have to answer to any ethical organizations, working e.g. on cloning projects · The establishment of industry-wide norms, rather than relying on the integrity of a few individuals, will be another important driver for the biotech industry development

C. Media · The media has created confusion in the public by creating the false impression that the issue of destructive human embryo research is intertwined with abortion · The confusion can cause the public to use abortion rights categories to try to understand complex moral issues of biotechnology instead of looking at an issue itself.

D. Influence on development? · America is likely to be the most important battleground regarding biotech development ethics


Sources

http://www.biotechethics.ca/

http://biotech.about.com/od/ethics/

http://bioethics.gov

http://www.bio.org/bioethics/

http://www.bio.org/aboutbio/history.asp

http://www.cbhd.org/resources/biotech/mcconchie_2001-04-05.htm