• Research Gone Wrong

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    Stem Cell Research Gone Wrong

    Ideas about research ethics formed in response to significant events involving unethical behavior by researchers. Below are some of the historically significant occurrences. More occur each year, raising suspicion among the public.  Although the most dramatic examples of unethical research involve medical interventions, the social and behavioral investigations that often accompany Praxis courses can also carry serious risk. Biological differences between and within species require scientists to proceed with caution when interpreting the results of any experiment. Animals of different ages, sexes, developmental stages, and of different health status can all respond differently to experimental treatments. It is no surprise, then, that humans respond differently to administered pharmaceuticals than other animals. The surprise comes when scientists, physicians, and regulatory officials are willing to risk the health of patients by relying on animal experiments to predict the effects of drugs in humans—sometimes with grave results.

    Every once in a while ugly truths sneak out from under the carpets of time, history, politics, science, and even the current ‘sacred cows’ within the medical domain. Facts that are uncovered result from dogged dedication that overtakes those who have seen the “light of day” and wish to share unknown histories with others who, in turn, can become empowered by that hidden knowledge. Such dedication to revealing the secret history of medical experimentation on children in Cold War United States became a reality in 2013 when authors Allen M. Hornblum, Judith L. Newman, and Gregory J. Dober published their phenomenal book, Against Their Will, The Secret History of Medical Experimentation on Children in Cold War America.

    Against Their Will offers a full menu of chapters dealing with medical research transpiring in the Cold War era, e.g., lobotomy, electroshock treatments, LSD-radiation-candy to induce cavities-ringworm-administered to children, thalidomide, DES given to …

    …while India has been polio-free for a year, there has been a huge increase in non-polio acute flaccid paralysis (NPAFP). In 2011, there were an extra 47,500 new cases of NPAFP. Clinically indistinguishable from polio paralysis but twice as deadly, the incidence of NPAFP was directly proportional to doses of oral polio received. Though this data was collected within the polio surveillance system, it was not investigated. The principle of primum-non-nocere [First, do no harm] was violated.” [Every link to the study on the Internet says it cannot be found, i.e., it’s been removed from Internet search engines capabilities. See this resource as corroboration.

    Catherine could not help but interject this question, “What do you think about the Cutter vaccine incident that created flaccid paralysis in vaccines in 1955?” Mr. Dober answered with, “Poor quality control, and it would not be farfetched to see it happen again in the future.” Well, it has and does happen routinely, and it’s not during research, but long after the research for the polio vaccines ended, as Catherine pointed out above.

    Since vaccine issues have been an integral part of Catherine’s research since the 1980s, she felt compelled to report what went on with them from authors who did their voluminous research. Catherine visited and interviewed Professor Newman in her Penn State office, and received a most welcome response to granting an interview, the questions of which were shared with her co-authors.

    To understand the motivations that brought the research and book into being, Catherine asked how long it took to collaborate on writing it, plus how was the writing load apportioned. Allen Hornblum said the discussions and research began around 2009 with his writing the manuscript with certain subjects and chapters taken by Newman and Dober, who passed their findings back to him to incorporate into the manuscript, since he’s a many-times published author.

    Dr. Newman offered that Greg Dober and she read much of the empirical work. Mr. Dober did vaccines, radiation; she did diet/skin/teeth, psychological treatment, psychological abuse, reproduction, and research misconduct. Mr. Hornblum did most of the interviews with Mr. Dober interviewing Cyril Wecht and digging up leads for personal interviews. Many still are reluctant to be interviewed, e.g., survivors of the “Monster Study,” which was the intentional creation of stuttering in normal children by researchers who criticized every utterance of the orphans in the ‘treatment’ group discussed in Chapter 9, Psychological Abuse. To learn what that unconscionable study entailed, click on this report.

    The book could have been twice as long, except the publishers, according to Newman, wanted focus to be on Cold War era medical research, thus the book’s title. Admittedly, the authors did not include information they found regarding research with preemie babies in the 1950s, research with Native American children, etc. Furthermore, she contends there are many studies they undoubtedly did not uncover.

    Mr. Hornblum says sections were cut out concerning the doctors’ trial at Nuremberg; the formation of the Nuremberg Code; efforts over the years to weaken the Code; many additional examples of unethical research; and more examples of questionable research practices that the book’s editor considered off target and unnecessary to the main thrust of the book, i.e., Cold War era medical research.

    Regarding the authors’ perception of medicine’s and pharmacology’s current predatory position with regard to its belief that it knows it all and that there is no room for deviation from its set agenda in some respects, which Catherine questioned, Greg Dober responded with,

    The commercial agenda has been prevalent since the beginning of modern medicine in America. The AMA wanted licensure to remove quackery. The AMA lobbied to have osteopaths and others banned from medicine, etc. The AMA wanted control over the med schools. (See Flexner Report) For me, this attitude isn’t surprising in health care. Unfortunately, it has carried over to pharma over the years. It is more lucrative to treat chronic illness for a lifetime than to find cures. Pfizer spent 4 billion dollars marketing Viagra when it first came out to the market. As long as there are shareholders and return on equity that CEOs must account for, they will continue to dominate the market with whatever they can sell. See the book, Our Daily Meds by Melody Peterson. Peterson in her book notes about a company that had a drug but no disease. The CEO told his people, go out and find me a syndrome!

    After reading the book, two questions gnawed at Catherine, so she had to ask the authors for answers. The first was, “Why do you think so many in government and medicine looked the other way during those sordid days of ‘research’ until rather recently in time, i.e., the late 1960s?”

    Professor Newman answered with this:

    We start from the premise that the authority and god-like power ascribed to medical doctors especially over the first many decades of the 1900s was mixed with the strongly popular eugenics perspective of these doctors. Eugenecists assumed that persons who were poor or sick or psychologically unstable or of low intelligence as assessed by IQ tests had bad genes and, therefore, should not reproduce and/or could be used for risky research since they were quite simply not valued. As demeaning as I think the word ‘subjects’ is in describing one’s sample, as opposed to a word like ‘participant’, these exploited and devalued children were often referred to as material for the study or even as inmates.

    Now add to this almost ‘perfect storm’ of eugenics and powerful doctors, the third component that we provide as a context for these studies, which is the patriotism engendered by fear of the enemy in World War II and the Cold War with concerns of atomic bomb radiation effects, mind control and the torture of prisoners of war, and then the concern over another enemy – contagious diseases. All of this fear and rah-rah conforming patriotism led to a sense that vulnerable and devalued populations could be included in the research about such issues as a service to their country, since they could not serve in more typical ways. So the context of how good people do evil things and how others do nothing to stop it may now be a bit better understood.

    The other question Catherine asked was­­­­, “How did writing this book affect you personally, and your perception of the medical arts?”

    Dr. Newman replied,

    I think I was more aware than most on faculty given my long time concern about research ethics and the violations of ethical principles that I am very sensitive to when I read journal articles or discuss research. But, the sheer quantity of such unethical research was staggering. What stunned me was the clear distinction between treatments or enrichments that had the likelihood of yielding a positive result being conducted with healthy children in their own homes with parents but if risks/harms were possible or likely, then these especially vulnerable children that we focus on were targeted with no informed assent from them or informed consent from parents in most cases.

    She concluded, in retrospect, with,

    I think the students in my courses are always engaged by this information and I hope it effects their perspective going forward as they read, think about, or even conduct research with human participants – notice I don’t even use the term human ‘subjects’, as I find the term so suggestive of exploitation. It was interesting about four months ago when Allen and I brought some of the victims of research abuses [named in the book] onto my campus to speak. The students in the audience became quite emotional even though some had only come because their instructors offered extra credit. However, if you lead them to the important and relevant material, change can happen.

    After Catherine submitted a prepublication courtesy copy of this article to Dr. Newman, she emailed back, “Another important piece in the book is the fudging or fabricating of data by researchers whose false conclusions then had repercussions for other children.”

    Catherine heartily recommends Against Their Will. One point she would like to emphasize is Dr. Newman’s remark above about informed assent and/or informed consent from parents. That is key and most appropriate today, especially with regard to vaccinations. Parents are not told the critically important information about the adverse effects of vaccines, which should be mandated by law for informed consent, since vaccinations are quasi-surgical procedures that insert foreign and toxic materials into children that can and do cause harm.

    Where were the CDC and FDA when the horrors of medical research were going on and documented in this book? We have to extrapolate from the past to make the future safer in medicine. The book Against Their Will offers the best place to begin, and Catherine cannot congratulate the authors enough for their efforts to bring to light of day, a dark and hidden past. Kudos!

    According to some estimates, adverse drug reactions are responsible for 2.2 million hospitalizations and 106,000 deaths annually. Furthermore, as many as 50 percent of FDA-approved drugs are withdrawn or relabeled due to unanticipated side effects in humans. A shockingly low 56 percent of known human teratogens are positive in one of six species surveyed. Below are a few selected examples to illustrate the dire need for better, more human-specific drug safety tests.

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