Informed consent forms reflect Ethical and Religious Directives of the Catholic Church.
A recent report by Kate Howard of the Kentucky Center for Investigative Reporting on the withdrawal of federal funding for a University of Louisville research study conducted at Frazier Rehabilitation Hospital shines a bright light on how research –specifically research involving human subjects – is performed at the University of Louisville and in its partner institutions. The specific research protocol in question, directed by UofL faculty member, Dr. Susan Harkema, was intended to examine if adding the muscle relaxer Baclofen to a regimen of physical therapy on a treadmill improves or worsens function in patients who are partially paralyzed as a result of spinal cord injury. The study holds out what is in my opinion an insufficiently proven hope of a possible increase in ability to stand or ambulate. Many aspects of the study were criticized by both federal authorities and by the university’s own investigation. I believe those criticisms to be valid but will not address them in this article. In my own professional opinion, the study as designed and conducted had very little chance of producing meaningful data in any event.
Informed consent – The ethical core of human subject research.
Human subject research must be reviewed and approved by the University of Louisville’s research Institutional Review Board (IRB) using a rigorous national set of requirements and guidelines designed to put the interests of the research subject first. These rules comprise a ‘Federal Policy for the Protection of Human Subjects’ and collectively are called the ‘Common Rule‘. Violation of the Common Rule can result not only in grant support being withdrawn as it was here in Louisville, but in prohibition of future human subject research. To put things in perspective, this would be the equivalent of a death-sentence penalty from the NCAA. By contract, KentuckyOne has agreed to use the UofL IRB to supervise research performed in its facilities, including in University of Louisville Hospital.
Problems with informed consent.
The IRB’s own recent internal investigation revealed that that some Baclofen study participants signed the wrong consent forms. Specifically, this had to do with whether or not the research subject was aware that they would be personally responsible to pay for the (expensive) experimental physical therapy that is at the center of the research protocol. Initially some subjects were surprised to get very large bills for their participation on top of the unreimbursed travel and housing expenses required for the several-month study. The consent form had been changed by the IRB to make it clear that there were financial implications to participation.
I too was concerned about the informed consent forms used, but for a very different and profoundly more significant reason. In my opinion, full informed consent was not being given. Additionally, the template consent form required by the University of Louisville’s IRB had been altered to conform to the religious tenants of the Roman Catholic Church – changes which I and others had been promised would not occur. If these alterations to the standard informed consent form template were made without the documented express permission of the IRB, this would constitute a major violation of research protocol and ethics. If my University’s IRB did in fact approve the changes, my earlier concerns have been realized and I am ashamed for it. Let me explain. Continue reading “Termination of Baclofen Study at UofL Discloses Influence of Catholic Health Initiatives on University Research.”
The matter of compensation to UofL President James Ramsey that tipped public opinion of the University in a more critical direction is back in the news. Both Chris Otts of WDRB and Andrew Wolfson of the Courier-Journal reported yesterday on the release by the University of Louisville Foundation of its Form 990 Federal Tax Return for 2014. The University knew it would not be pretty and began to prepare the way with letters to supporters and posts to various social media. Pretty it was not– except for Dr. Ramsey and his senior supportive staff. Numbers taken directly from the compensation pages of the return listed President Ramsey’s salary from the Foundation alone as $2,428,886 with additional benefits of $362,500. His compensation included tax “gross-ups” to make up for any personal income tax he would have to pay. A great deal if you can get it, but not offered to most faculty or staff!
Even before the ink hit the page, Foundation Chairman and former UofL Trustee Chairman Robert Hughes broadcast an email to the UofL world at large highly critical of Mr. Otts. He accused Mr. Otts him of missing the point, vastly overstating Dr. Ramsey’s salary, having an agenda, and misleading the public with fairy tales. (I am accused of much of the same by the University’s internet trolls.) In my experience, Mr. Otts and Mr. Wolfson are both knowledgeable and careful reporters. If they have an agenda, it is in providing accurate and relevant information to their public. Continue reading “More Fireworks Over Executive Salaries at UofL.”
A Former UofL Lobbyist’s Perspective.
A few months ago, someone anonymously sent me preliminary news reports about the University of Louisville’s engagement with politically conservative donors over the establishment of a new University Center. A fair amount has been written since about the UofL’s willingness, if not eagerness, to accept a grant from the John H. Schnatter Family to fund a new John. H. Schnatter Center for Free Enterprise within, but effectively independent of the School of Business. Insider Louisville and the Kentucky Center for Investigative Reporting have followed the matter closely. The grant itself is contingent on the University’s also accepting a grant from and sharing controlling interest with the Charles Koch Foundation. Most community concern stems from attached strings that restrict the academic viewpoints that can be addressed by the funding, and which give inordinate and inappropriate academic control to outside political and business interests. Read the Grant Contract yourself (6MB). As I lifetime member of the Academy, it made me shudder— and I am not alone. Alas, I do not think the University felt it was in a position to say no. Even as a non-University person, would you have agreed to all the provisions in this contract? If so, tell us why in your own name in the comments section. What parts of the contract do you believe are inappropriate? I don’t have enough room to do so here. Continue reading “Why UofL Can’t Say No to the Kochs or Papa John.”
In Reporter Michael McKay’s account of the UofL Board meeting earlier this month when progress towards the University’s 2020 Plan was summarized, and when the post-fraud “Audit” was formally presented; President James Ramsey commented on the University’s failure to earn a National Cancer Institute (NCI) designation for its James Graham Brown Cancer Center. Dr. Ramsey stated that it was unlikely that UofL would receive an NCI designation because the UK program is so close. (The Markey Cancer Center at the University of Kentucky was designated as an NCI Comprehensive Cancer Center in 2013.) Dr. Ramsey is said to have implied that UofL had been in talks for some sort of “partnership” with UK before that institution went on its way alone. These comments sound more to me like excuses than explanations. I found nothing in the NCI application documents that would indicate that distance from another center would be a factor. Indeed, depth of collaborations with other research and clinical centers is highly desirable if not essential.
Continue reading “Why Is There Only One NCI Cancer Center in Louisville?”
How good are we doctors in conveying the concept of risk to our patients and our community?
I recently met someone who donated a kidney to a person who was not a relative. My impression was that the recipient was previously a stranger, but I did not press that issue. I was overwhelmed by the staggering generosity of that gift. I am embarrassed to say that I do not know how I would respond if I were asked to donate.
Shortly afterwards in the impossibly large volume of medical journals that crosses the desk of even a retired physician, and proving the hypothesis that a person only sees what they are prepared to find, I noticed a research paper estimating the risk of kidney failure in a donor following the removal of one of the normal pair. The risk does not appear to be zero. I want to use that paper as a base to continue writing about conveying the results of medical studies and of risk to the public.
Why did Mother Nature Give Us Two Kidneys?
In medical school, and in common public wisdom, it is universally recited that we only need one of our two kidneys to live. That is true. As it happens though, there is little or no information about whether we would live as long or as well! It is known that as people age, there is an expected gradual decline in kidney function. It happens sooner and faster in people with hypertension, diabetes, and so on. It is reasonable to speculate that if starting out from a half-normal position, that a single remaining kidney might run out of steam sooner without it’s helpmate. The best way to definitively settle the matter would be to randomly divide in half a group of people who had committed to donate, only allow one group to do so, and then follow the lives of both groups to see if the donors develop kidney failure more frequently than the donor wanna-bees. I do not see that experiment happening, but the information would be relevant to a person deciding whether or not to donate. Continue reading “Does Donating a Kidney Increase the Risk of Kidney Failure For a Living Donor?”
Is informed consent being censored?
I take some pride that I have not, until now, had to retract anything of factual substance that I have written in these pages despite the fact that I have always invited others to offer corrections or to point out misinterpretations. I freely admit to offering a healthy amount of speculation about matters that turned out otherwise. However, I always identify speculation as such and do so in the interest of bringing a variety of issues into the arena of public discussion. However, I must now retract my earlier article congratulating KentuckyOne Health and the Catholic Church for joining the 21st century with respect to their apparent changing views on justified contraception and termination of pregnancy. I was wrong.
Continue reading “How Much Information Is There In Informed Consent at UofL?”
Catholic Church enters 20th century on reproductive health by passively accepting justifiability of contraception and abortion in its institutions.
The 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.
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. Continue reading “KentuckyOne Health Confronts Legitimate Role of Contraception and Abortion in Healthcare.”
How Not to Treat Idiopathic Pulmonary Fibrosis.
One of the first things I wrote about on these pages was the importance of having good evidence backing up what we doctors do to people, and how commercial editorial policies of medical journals have at least the potential of denying doctors and their patients timely knowledge of information that might inform their medical choices. I thought of that article again when I looked at one of the several email news summaries I get from various organizations.
One of the highlighted items that caught my eye was a report that “Combination therapy for pulmonary fibrosis appears to increase risk of death [and] hospitalization.” Several of the diseases I used to treat included pulmonary fibrosis and were notoriously difficult to manage. I clicked the “More…” button and was led to this week’s New England Journal of Medicine. The article provides a stunning example of how we physicians still allow ourselves to be led down the garden path of ineffective medical care. Continue reading “Why Do We Physicians Still Practice So Much Ineffective Medicine?”
In an earlier entry, I was critical of what I call the “press release” variety of medical reporting in which the news report is based heavily or entirely on a press release by individuals or institutions who have a financial or other vested interest in shaping the presentation. In many, if not the majority, of these the difference between informing and marketing is not discernible to me. It is therefore only fair to give credit for what I think is an example of excellent medical reporting. As described below, I was also impressed at the value added to conventional newspaper reporting by its associated Internet capabilities. The article provides an example of the pre-publication embargo system used by some major medical journals with what I think are both positive and negative implications.
The Article and Report.
On Tuesday, February 8, New York Times reporter Denise Grady published an article, “Lymph Node Study Shakes Pillar of Breast Cancer Care.” My sometimes faulty memory tells me I saw her article Monday evening on the New York Times website. The article Ms. Grady reported on was officially published in the February 9 issue of JAMA, the Journal of the American Medical Association: “Axillary Dissection vs No Axillary Dissection in Woman With Invasive Breast Cancer and Sentinel Node Metastasis, ” by Armando E. Giuliano and coauthors; vol. 305:569, 2011. I received my personal copy of the Journal on Wednesday the 9th.
I spent over two hours studying this seven page paper. It was heavy going for me and would have been largely impenetrable to a layperson. It goes against my grain to be paternal, but there is no way for a layperson to understand the significance of the research or how it might relate to them without help. In fact, even I needed some help to put things in perspective, and I confess some of that help came from Denise Grady.
To summarize the paper in an obscenely brief manner, 891 women with breast cancer that had already metastasized as far as the lower lymph nodes in her axilla (armpit) were randomized to 2 different treatment plans. Half the women went on to what was then the standard treatment of extensive removal of all the lymph nodes in their axilla. The other half had no additional surgery beyond the biopsy of the low sentinel node that showed the metastatic cancer. All of the women had a lumpectomy and radiation to the breast, and almost all had additional adjuvant or prophylactic chemotherapy. The patients were followed for as long as eight years. There was no difference in the survival or cancer recurrence rate in either group. Continue reading “On Excellent Medical Reporting”
My discussion of the reporting on the extremely high rate of major spinal fusion surgery in Louisville has generated its own follow-up. On Jan 17, Courier-Journal reporter Patrick Howington contributed a front-page article about the legal battle of five Louisville orthopedic surgeons over an estimated $60 million in royalty fees.
Wow! The Chamber of Commerce must be proud. This is the kind of big-time health care and research money on which Louisville’s city fathers, and its business and university communities have pinned their hopes for the future. So why am I embarrassed over this? Should I be? Would I be if the money were coming to me? I think there is plenty of embarrassment to go around.
It is embarrassing for me as a physician to see other physicians fighting so publicly over money. While certainly within their legal rights, this dispute over money by these professionals reminds us that even for physicians, the practice of medicine is at its base a business. There has always been an inherent tension in the patient-physician relationship: what is best for the patient may not always be what is best for the physician. The professional ideal resolves any such conflicts in favor of the patient. As more and more outside players insert themselves between and around the patient-physician relationship, the vectors of tension become more complex and more difficult to resolve. I predict we will increasingly appreciate such policy difficulties as the structure of our healthcare system changes. Our debates over capitation, managed care, or physicians as employees provide examples where the nature of the patient-physician relationship has been tested. During the last year in Louisville, several prominent contract battles between insurance companies, doctors, and hospitals continues to disrupt the vulnerable contract between patients and their physicians. Continue reading “Battles Royale in Louisville”