{"id":2154,"date":"2013-05-17T07:34:15","date_gmt":"2013-05-17T11:34:15","guid":{"rendered":"http:\/\/www.khpi.org\/blog\/?p=2154"},"modified":"2013-08-19T13:04:40","modified_gmt":"2013-08-19T17:04:40","slug":"kentuckyone-health-confronts-legitimate-role-of-contraception-and-abortion-in-healthcare","status":"publish","type":"post","link":"http:\/\/www.khpi.org\/blog\/kentuckyone-health-confronts-legitimate-role-of-contraception-and-abortion-in-healthcare\/","title":{"rendered":"KentuckyOne Health Confronts Legitimate Role of Contraception and Abortion in Healthcare."},"content":{"rendered":"

Catholic Church enters 20th century on reproductive health by passively accepting justifiability of contraception and abortion in its institutions.<\/strong><\/span><\/p>\n

See Partial Retraction<\/span><\/a><\/h2>\n

Background<\/strong>.
\nThe Roman Catholic Church, Catholic Health Initiatives (CHI), and KentuckyOne Health (KOH) most certainly had only an incomplete understanding of what they were getting into when they assumed management earlier this year of a secular University of Louisville Hospital and also effective control of the academic medical practices of the University’s faculty and trainees. These religious organizations must now also learn how to deal with contemporary academic research standards. KentuckyOne is promoting its intention to participate in the University’s clinical research enterprise. Indeed, Jewish Hospital has been doing so for many years. Increasing clinical research is also a prominent part of the UofL’s commercial research enterprise.<\/p>\n

As Catholic organizations, CHI and KentuckyOne expect University employees, physicians, trainees, and patients to accept its religious tenants with respect to medical care. Indeed, trainees are now required to attest that they have received training about those religious directives. I suspect these faith-based organizations were unaware of the extent to which the Church itself was going to have to, in turn, confront and modify some of its traditional dogma in order to participate in the clinical practices and research of a modern, science-based University and Medical School. By entering the contemporary world of research; CHI, KentuckyOne, and their supervising Catholic Church have tacitly acquiesced to the reality that contraception and abortion are integral to scientific and medical standards of honest and ethical clinical research. Even if unintended, this is a break-through of historic proportions in the history of religion. I congratulate the Catholic Church for allowing its medical mission to enter the 21st Century. Allow me to explain how the Church is being forced to confront and partially alter its previously sacrosanct medieval dogma.<\/p>\n

Informed Consent in Medical Practice.<\/strong>
\nFor even routine contemporary medical practice, the concept of informed consent is always<\/span> implied. Patients have an ethical and legal right to be informed of the benefits and risks of the treatments being suggested and given an opportunity to accept or modify treatment plans according to their personal preferences. This right belongs to the patient and is not subject to limitation by a hospital, the patient’s physician, or a physician’s employer. Usually in everyday medical practice, the consent process consists of a dialog between the doctor (or other provider) and the patient. Frequently however, and especially when potentially harmful therapies are involved, the consent process is put in writing as when being admitted to a hospital or preparing for surgery.<\/p>\n

Consent for Clinical Research.<\/strong>
\nThe consent process for clinical research is particularly rigorous and is always<\/span> put in writing because the full risk and benefit to the patient are by definition not known and patients are vulnerable to abuse. Even in my professional lifetime, medical history contains horror stories about research being done on patients without their knowledge, let alone their consent. Such consent is detailed and fully lays out all known and potential risks. All aspects of research on humans, including informed consent, are supervised by the sponsoring institution’s Institutional Research Board (IRB), which itself is subject to oversight and certification by state and federal agencies. The informed consent language used must be acceptable to the IRB and is carefully crafted to protect the research patient’s interests as fully as possible. The University of Louisville has long provided uniform template language that researchers are required to use as the foundation for all individual studies.<\/p>\n

Rigorous supervision is also important for the sponsoring institution because if there are lapses in the ethical conduct of a research study, all federally sponsored research and most other research funding can be terminated. This has unfortunately happened several times in recent history including in otherwise well-thought-of institutions. Because lapses in the ethical conduct of research still occur, compliance with federal guidelines is not optional. As a practical matter, compliance with ethical medical and scientific standards also helps protect an institution and its researchers from lawsuits as it is possible to sue a hospital or doctor for lack of fully informed consent.<\/p>\n

Cancer Chemotherapy and Similar Powerful Drugs.<\/strong>
\nParticular care is taken with research involving cancer chemotherapy or treatments using powerful and potentially dangerous drugs. The diseases being treated are not trivial and the treatments themselves can be lethal or cause severe lifelong morbidity. Cancer chemotherapy (and radiotherapy) can have profound effects on a person’s reproductive health, including causing sterility. Additionally, genetic mutations can be induced by the treatment that may affect the offspring of both male and female patients. If a female patient is or becomes pregnant in the course of therapy, there may be profound effects on her fetus or her pregnancy. Children fathered by men undergoing such therapy are similarly at risk, including for a period after the therapy.<\/p>\n

Because of these facts, the informed consent process for clinical trials has evolved to routinely advise women of childbearing potential to use one if not two methods of effective contraception, and for men to use a condom. Indeed, trials may require such contraceptive methods as a pre-condition for eligibility to participate in the trial. The University of Louisville has required its researchers to include such language for a long time. Individual drug companies and others sponsoring such research may, and often do, require the use of even stronger language on which the UofL IRB would have to approve and sign off on.<\/p>\n

Should a woman become pregnant while in a research study, UofL’s required informed consent language instructs the pregnant woman to immediately contact her physician for advice, including discussion about termination of the pregnancy in her best interest or that of her fetus. Surely this is one of the most difficult decisions a woman and her partner could possibly confront. Nonetheless, the ethical informed consent process assumes this is a decision that belongs to the woman alone and which she is entitled to make based on full disclosure of the magnitude of the risks and alternatives. The following language from the most currently available consent form on the UofL website is identified as coming from the Heart-Lung Institute of Jewish Hospital in 2012 while it was already part of KentuckyOne.<\/p>\n

“Before starting this research study, females able to have children will have a pregnancy test. Talk to your doctor about the best method of birth control to use while you are in this study. It is important that you call your study doctor at _____ right away if you become pregnant or father a child during the course of this study. If you or your partner becomes pregnant, a decision may have to be made whether or not to end the pregnancy.”<\/p><\/blockquote>\n

To be fair this puts the Catholic Church and its operatives in a difficult spot. The Church forbids contraception and certainly prohibits termination of pregnancy at any time for any reason. \u00a0It prohibits partnerships with organizations that do because it places the church in a state of scandal. This is a problem for the Church for which a work-around, a “don’t ask… don’t tell” policy, or passing the ethical buck downstream is not possible. The Church and its hospital operatives had to decide whether to participate in the contemporary ethical and scientific practice of medicine, or whether to stick to their infallible, non-scientific thinking. \u00a0It looks like they chose to participate. \u00a0Although I am focusing on the practice of medicine within clinical trials, the exact same issues apply in the routine practice of medicine. \u00a0Readers of this series of articles will know I have been critical of religious limitations still being placed in that arena.<\/p>\n

To Change Or Not To Change?<\/strong>
\nGiven the above, when I heard from a reliable source within the greater oncology community that KentuckyOne had requested that the University IRB change its informed consent language with respect to reproductive issues, I foresaw an insurmountable problem for both the Church and our research community. To omit the current standard language would be to present the research subject with less than fully informed consent\u2013 a situation that the University would have to refuse to obey, and, as a lifelong academic physician, I would have to condemn in the strongest possible terms. A willingness by the University of Louisville, the James Graham Brown Cancer Center, or researchers at other KentuckyOne institutions to alter their current informed consent language in this way would shout to the the community that the interests of the patient do not come first, exacerbating such concerns already rising in our new world of academic commercial research. I have to ask if such willingness to offer less than fully informed consent would jeopardize the critically necessary accreditation of the University’s IRB and federal research programs?<\/p>\n

Is It Really True?<\/strong>
\nWhat I heard was alarming and believable enough that I called the University of Louisville IRB office that oversees research at UofL Hospital, KentuckyOne Health, the James Graham Brown Cancer Center, and some research at Norton Hospital. I told the office why I was calling and asked if the specific standard language required for clinical trials had been changed. I was carefully told that changes in template language are often requested and made, but that no changes had been made with respect to the specific reproductive language. I was referred to the current template language posted on the IRB’s website and gratifyingly, the standard medically appropriate language was still in place.<\/p>\n

I was not quick enough on my feet to ask if requests for exceptions<\/span> to the language by KentuckyOne had been made or would have been acceptable to the IRB. Because the intent of my questions was quite clear and I was not told otherwise, I must assume that KentuckyOne has agreed to work within the current standard research protocols designed to protect both patients and researchers. And why should it not? I congratulate the Church for respecting the deeply-held ethical principles of the scientific community. After all, how could the University of Louisville community retreat from this bedrock principle of patient protection! \u00a0This is a break-through concession by the Church to the modern secular world, and a softening of the mandatory substitution of religious dogma for evidence-based medicine and science. The kind of religious censorship of science that Galileo had to deal with is thus passing further into history. This apparent new tolerance acknowledges the truism expressed in these pages and in every medical school with which I have been associated, that just as it is not possible to separate physical from mental health, it is not possible to separate reproductive and sexual health from from the rest of the human condition.<\/p>\n

Graven in Stone?<\/strong>
\nI am unaware of how far up the chain of command this confrontation between religious and research ethic has travelled. Certainly local decisions within the Church can and have been overturned by higher authority. It is my opinion that I did not misunderstand the information conveyed to me by my oncology correspondent or by the University’s IRB office. Because I always hope for accuracy, I ask KentuckyOne and the University to respond to this article so that they may make their positions available to the public they serve as unequivocally as possible. IRBs are not closed back rooms. \u00a0It seems to me that this is good news for the clinical research community of Kentucky and deserves to be disseminated.<\/p>\n

Peter Hasselbacher, MD
\nPresident, KHPI
\nEmeritus Professor of Medicine, UofL
\nMay 17, 2013<\/p>\n

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