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Topic: Ethics in Clinical Trials
August 8, 2014 | Posted By John Kaplan, PhD

Questions regarding the availability and utilization of experimental drugs for treatment of disease have moved to the forefront following the apparently successful use of an experimental treatment used for two American health workers treating the Ebola outbreak in West Africa. 

The questions that have been raised include both who such drugs should be made available to and under what circumstances they should be made available. An additional consideration is what processes should be put into place to assure that these decisions are made properly to allow patients with valid cases to obtain access while protecting ill people from inappropriate risks and suffering. An additional question which I will not delve into here is who pays for them. Health insurance does not pay for experimental treatments so someone else must. First I should clarify exactly what I mean by an experimental drug. I am referring to drugs that have a scientific rationale for their use and some scientific basis for believing they might work. I do not include cockamamie ideas with no reasonable basis simply because somebody thinks they should be used. I have previously written about physicians who chose to use unreasonable treatments.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website. 

March 17, 2014 | Posted By John Kaplan, PhD

Three eminent bioethicists have proposed, in an article published in the New England Journal of Medicine last month, that some comparative effectiveness research should not require informed consent from patients. I do not agree, at least not yet. Drs. Faden, Beauchamp, and Kass have provided a thoughtful justification for their position. However the circumstances in which this new scenario would work does not yet exist.

Let’s be more specific. These authors have been among those advocating what they term a learning healthcare system which blurs the line between clinical care and research but predicates both on a common set of research and clinical ethics principles.  Research and medical practice allows the system to learn and implement improvements. They lay down seven ethical principles to guide such a health care system. The first of these principles is to “respect the rights and dignity of patients.” It does not seem to me that you can meaningfully respect the rights and dignity of people and use them in clinical trials, even comparative effectiveness trials, without their permission. The seventh principle, “contribute to the common purpose of improving the quality and value of clinical care and health care systems” seems in some ways laudable but is dubious in the context of respect for rights. The first six principles define obligations of the participants in the health care system. This seventh principle describes an obligation on the patients to “participate in certain types of learning activities that will be integrated with their clinical care.” 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

October 8, 2013 | Posted By John Kaplan, PhD

My last blog, written just a few weeks ago, discussed the case of two neurosurgeons who had purposely introduced bowel bacteria into the brains of patients with glioblastoma, a process they termed “probiotic intracranial therapy”. In that blog I expressed the opinion that the physicians had inappropriately exposed their patients to excessive risk and compared the incident to assault. In the brief time since then high risk research has been covered in both the biomedical literature and the popular press. We have also seen more news regarding treatments with bowel bacteria indicating that fecal bacteria may well have their place in medical treatment. Their place, however, is in the gut not the brain.

In the journal Lancet, David Shaw argues that Institutional Review Boards “should never reject a study because it poses too high a risk to participants.” Institutional Review Boards are the mechanisms that review research protocols designed to be conducted with human subjects. Among the charges to Institutional Review Boards is to evaluate the balance between the potential benefits and potential risks of a proposed research project. When assessing protocols of prospective therapies they need to identify that there is adequate reason, both theoretical and experimental, to think the therapy might work. They should also assure that the risks of the proposed study do not endanger the participants out of proportion to the potential benefits. These dangers were excessive in the well known Tuskegee syphilis studies and similar studies in Guatemala as well as the supposed research in the Nazi atrocities. This horrendous history drove many of the protections we now use to safeguard human research participants.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

September 13, 2013 | Posted By John Kaplan, PhD

Today one can read the news media and regularly encounter stories about research misconduct and other questionable conduct by researchers. Having spent a career as a researcher and research ethicist I seldom see reports which shock me. There are millions of researchers making millions of research reports and these things happen. However the story of two neurosurgeons from the University of California at Davis School of Medicine was so egregious that it shocked even me.  Dr. J. Paul Muizelaar and Dr. Rudolph J. Schot so blatantly disregarded the ethical underpinnings for the conduct of research on human subjects that their only defense was that their actions did not constitute research. Much of my information on this incident comes from the excellent articles reported by Marjie Lundstrom of the Sacramento Bee as well as the insights of their editorial staff.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

March 2, 2012 | Posted By Posted By David Lemberg, M.S., D.C.
Dr. Ricki Lewis The Forever Fix
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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.

July 20, 2011 | Posted By Posted By David Lemberg, M.S., D.C.

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.

July 1, 2011 | Posted By Posted By David Lemberg, M.S., D.C.
Jennifer Miller
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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.

June 25, 2011 | Posted By Posted By David Lemberg, M.S., D.C.

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.

June 18, 2011 | Posted By Posted By David Lemberg, M.S., D.C.

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.

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ABOUT BIOETHICS TODAY
BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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