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Dr. Ricki Lewis is a science writer with a Ph.D. in genetics. Her newest book, The Forever Fix: Gene Therapy and the Boy Who Saved It, a narrative nonfiction book from St. Martin’s Press, is arriving in stores on March 13.

In our wide-ranging interview, Dr. Lewis discusses

• How gene therapy can extend a child’s life, in some cases by years
• Issues encountered in deciding whether a child should enroll in a gene therapy trial
• How participants should be chosen for clinical trials
• How problems with the informed consent process initially derailed gene therapy
• "Therapeutic misconception"
• How gene therapy may benefit patients with Parkinson's disease and macular degeneration

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

In 2008 prescription medications accounted for $291 billion in sales in the United States. In 2000, the drug industry employed more than 625 lobbyists (there are only 535 members of Congress). Big business. Big money. Big power. Power versus principles — this is an eternal dialectic. If power rules, we might as well shred the Belmont Report right now.

Universal ethical standards are meant to apply universally — not locally and selectively, at the whim of the more powerful agency. They are designed to protect the more vulnerable among us — us referring to the international community. And in an ethical world, standards of care should refer to the highest, not the lowest, common denominator.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

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Jennifer Miller is the Executive Director of Bioethics International, the leading U.S. provider of person-centered bioethics programs for the healthcare, life sciences, and biotechnology sectors.

A physicist and bioethicist by training, Ms. Miller has wide-ranging interests in biomedical research and development, public health, and disaster preparedness ethics. Recently, the Susan G. Komen Foundation awarded her a grant for research and program development in biopharmaceutical ethics including nuanced questions surrounding informed consent, access, confidentiality, and conflict of interest. A powerful and effective speaker, she has been featured on CBS News and AP News and on the cover of Science Magazine’s Career section.

In our 6-30-2011 BIOETHICS TODAY conversation, Ms. Miller discusses

• Bioethical issues in globalization of clinical research
• The AZT 076 and Trovan cases
• The ethics of placebo-based trials
• Ethical relativism
• The way forward — transparency, education, and oversight

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

Randomized clinical trials (RCT) may be the Tyrannosaurus rex of the clinical research field. Formidable, very powerful, and doomed to extinction.

The as-if-ripped-from-today's-headlines 1991 article, "Of Mice But Not Men: Problems of the Randomized Clinical Trial",¹ recommends reevaluating the preeminence of this method of conducting clinical research. Insisting on RCTs represents clinging to tradition in the face of new imperatives.

Clinical research has become big business. All the parties are in bed with each other. The fact that physicians are paid per referred research subject is profoundly disturbing.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

Ethical relativism provides a flimsy moral gloss condoning questionable activities of global pharmaceuticals in developing nations. But the Emperor has no clothes. Ultimately, there’s no such thing as a little bit of ethics.

Conflicts of interest are easy to overlook in the rush to approve new, important “research”. The rush to do so is very real. In the last 20 years clinical trials have become big business. And, most clinical trials are now largely controlled and conducted by the pharmaceutical industry.¹ Even more alarming, much of the work of these trials is outsourced to contract research organizations (CROs). In 2004, more than 40% of pharmaceutical drug development expenditures had been committed to outsourcing.² In 2001, CROs generated $7 billion in revenues.

The implications are clear. Clinical trials can no longer be accurately categorized as research. Clinical trials are a business activity, items on the balance sheet of global pharmaceutical corporations.

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.