Termination of Baclofen Study at UofL Discloses Influence of Catholic Health Initiatives on University Research.

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   Violation of the Common Rule can result not only in grant support being withdrawn as it was here in Louisville, but in prohibition of future human subject research.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.”

Family and Medical Leave Act Provisions Extended to All Same-Sex Married Couples.

Regardless of what the U.S. Supreme Court decides in resolving the lower court differences over whether individuals of the same sex can marry in all states, the tidal wave of change in both public opinion and law sweeping over the country only gets higher. The U.S. Supreme Court recently found in U.S. v. Windsor that gay and lesbian couples that were legally married could not be denied the ability to file their federal income taxes jointly from other states, even those which refused to recognize that marriage. To do so for federal tax purposes was found to be a denial of equal protection under the law and therefore unconstitutional. Since marriage status is relevant to a multitude of other civil matters, it is not surprising that other regulations or laws might be revised. So it came to pass last week when the U.S. Department of Labor (DOL) published its final rule on eligibility to take advantage of the Family and Medical Leave Act (FMLA). The rule goes into effect March 27, 2015.  A Fact Sheet and Frequently Asked Questions are available on the DOL website. Continue reading “Family and Medical Leave Act Provisions Extended to All Same-Sex Married Couples.”

Catholic Health Initiatives Bond Rating Drops Again.

In late January, Moody’s, a major bond-rating organization, downgraded the long-term debt of Catholic Health Initiatives (CHI) to A2 from A1. This was the third one-notch drop in as many years. According to municipalbonds.com, the downgrade “follows a fourth year of declining operating performance, and a second year of very poor consolidated results.” Other factors reported to have contributed to the weaker credit profile included “high leverage (which has more than doubled since 2011), declining liquidity, rapid expansion, high capital spending, and poor same-store utilization and revenue growth.” A prior negative outlook was maintained. The rating for CHI’s self-liquidity-backed commercial paper remained at P-1, the best rating possible.

moodys-rating-system

Continue reading “Catholic Health Initiatives Bond Rating Drops Again.”

Recent Court Decisions Impact University of Louisville Hospital.

Same-sex marriage advances– hospital secrecy recedes.

While I am sure it is coincidental, I find it ironic that on the same weekend the Supreme Court refused to take on the same-sex marriage issue in Washington– thus making such marriages legal in 11 additional states– the Kentucky Court of Appeals ruled that University Medical Center Inc. is indeed a public agency. I wondered what was happening to that lingering litigation. I will try to assemble and post the various briefs from the trial and appeals courts and try fill in the gaps. The opinion gives a useful overview of hospital history. Read it here. Continue reading “Recent Court Decisions Impact University of Louisville Hospital.”

Prohibition of Same-Sex Marriage in Kentucky Declared Unconstitutional.

The other shoe has fallen in a pair of court challenges from Louisville seeking to overturn Kentucky’s statute and constitutional amendment that prohibit same sex marriages or the recognition of the same as unconstitutional. The case began as Bourke v. Beshear demanding that Kentucky government and businesses apply law and regulation pertaining to marriage equally to legally married couples regardless of gender-mix. Judge John G. Heyburn, II found no fault with the Plaintiffs’ claim and ruled that Kentucky law’s on recognition of otherwise legal same-sex marriages to be unconstitutional. Kentucky’s Attorney General Jack Conway agreed and declined to appeal Judge Heyburn’s opinion which was ultimately stayed pending appeal and review by higher courts.

Seeking to rip out both vine and root, and ignoring the advice of other advocates who argued that the time was too soon to take on the basic issue of the prohibition of same-sex marriage in Kentucky proper, additional plaintiffs jointed the Bourke case which appropriately is now renamed Love v. Beshear. On July 1, 2014, Judge Heyburn found that Kentucky’s prohibition of in-state same sex marriages is unconstitutional under the equal protection clause. That order was also stayed pending expected review by the Federal Sixth Circuit Court of appeals in Cincinnati this August.

The finding.
IT IS HEREBY ORDERED THAT to the extent Ky. Rev. Stat. §§ 402.005 and .020(1)(d) and Section 233A of the Kentucky Constitution deny same-sex couples the right to marry in Kentucky, they violate the Equal Protection Clause of the Fourteenth Amendment to the United States Constitution, and they are void and unenforceable. Continue reading “Prohibition of Same-Sex Marriage in Kentucky Declared Unconstitutional.”

Catholic Health Initiatives Reports Increasing Financial Losses in Kentucky.

Last Thursday, Chris Otts of WDRB News may have been the first to report on Catholic Health Initiatives’ (CHI) most recent quarterly report to its creditors covering the 90 days ending March 31, 2014. Meant to be read in conjunction with last November’s audited annual report, the current unaudited update covers the first full year that CHI has controlled “substantially all of UMCs operations” at University of Louisville Hospital (ULH). The news report focused on the fact that KentuckyOne Health, the manager of CHI’s multiple hospital-related operations in Kentucky, had lost an additional $134 million on its “faith-based” hospital operations over that 90-day period. This stunning loss comes on the heels of an earlier report that KentuckyOne had lost $100 million in the six months ending December 31, 2013.

More than just financial data is provided.
The full report is in the public domain. My reading confirmed what was reported by others. However, I was struck more by other tidbits of information that confirm or add to our knowledge of what is happening behind the surgical drapes hung to to keep the rest of us from assessing the health of this hospital system of which a public asset is part. Continue reading “Catholic Health Initiatives Reports Increasing Financial Losses in Kentucky.”

New Documents Appearing In Kentucky Same-Sex Marriage Case.

Kentucky’s Appeal of Recognition of Legal Same Sex Marriage Decision.

Humans Merely Breeding Stock?  Say it isn’t so!

National and local media are reporting on the Commonwealth of Kentucky’s appeal of the February decision of District Court Judge John G Heyburn, II requiring the Commonwealth to recognize legal same-sex marriages performed in other states. The commentary available to me so far highlights a Commonwealth position that Kentucky has a legitimate interest in encouraging procreation to support long-term economic stability through stable birth rates. While that may be true of hog-breeding, I find the concept that the licensing of marriage for people of any sex be leashed to economic development to be outrageously offensive. I hope that a full reading of the brief will show that a misunderstanding of the text of the Appeal has occurred. After all, the appeal has our Governor’s name on it.

I have not yet read the brief in detail. The Courier-Journal gives a link to a site where the document can be read on-line, but I found a careful reading from the site to be difficult and it required me to give personal information to download the document. For my benefit and yours, I downloaded the 39 page brief from the Federal Court’s own website, along with the first of what is likely to be many Amicus briefs for or against. When I get an chance, I will comment more fully. Please feel free to do the same in the reply section below.

In the meantime, gay and lesbian healthcare workers in Kentucky are still being discriminated against at University Hospital at the same time we expect such employees not to discriminate against their patients!

[Addendum:  I had a chance to read through the appeal in its entirety.  Alas, a misunderstanding is not possible. The concept of humans as breeding stock is offered as the “legitimate state interest” that allows Kentucky to treat one group of citizens differently than another and therefore not to be in violation of the Equal Protection Clause of the Constitution. There is more, but “natural procreation” is the core of it.  If I can muster the stomach for it, I will outline the arguments later.]

What I fail to grasp, and what is not addressed in Kentucky’s appeal, is how refusing to recognize legal out-of-state marriages is going to increase the number of child worker-bees and improve the economy as argued. When our Kentucky legislators wrote these laws, did they actually believe that if denied the privileges of marriage, that same-sex Kentucky partners would otherwise dutifully engage in “natural procreation” with members of the opposite sex? Many children arise from same-sex marriages. Are we meant to assume that because “unnatural” artificial or surrogate methods are also often used in support of conception by same-sex partners, that their non-adopted children don’t count?  After a lot of blather about state’s rights and judicial activism, the appeal claims that the State’s action is “rationally based and free from invidious discrimination.” We’ve heard that argument before.  I don’t buy it for a moment. We know it for what it is. I am ashamed for Kentucky.

Peter Hasselbacher, MD
President, KHPI
Emeritus Professor of Medicine, UofL
May 9, 2014

Case 14-5291 Document #21: Appeal of Judge Heyburn’s decision.

Case 14-5291 Document #26: Motion to file Amicus Brief from North Carolina Values Coalition and Liberty, Life, and Law Foundation

Judge Heyburn Grants Further Stay of His Order Pending Resolution in Higher Courts.

Legal same-sex marriages in Kentucky will not be recognized on March 21st after all.

Breaking News, March 19, 5:40 pm

Late today, Federal District Judge John G. Heyburn issued an Order further staying his Order of Feb. 27 which found that Kentucky’s statutes and constitution prohibiting recognition of legal same-sex marriages to be unconstitutional. To allow the Commonwealth to prepare for practical administrative changes, he had already extended his Order until March 20th.

Observing that Judge Heyburn’s opinion “got it right,” Kentucky Attorney General Jack Conway declined to appeal the Judge’s decision. Subsequently, Governor Steve Beshear retained outside council to make such an appeal, and it was that to which Judge Heyburn was responding today.

Judge Heyburn found merit on both sides of the argument. You can read the four-page argument here and decide yourself where the greater merit lies. Ultimately, and recognizing that the Sixth Circuit Court of Appeals may take years before the appeals process is completed, the Judge decided to further stay his opinion. The Judge recognized how his decision would affect the married-couple plaintiffs.

“Perhaps it is difficult for Plaintiffs to understand how rights won can be delayed. It is a truth that our judicial system can act with stunning quickness, as this Court has; and then with sometimes maddening slowness. One judge may decide a case, but ultimately others have a final say. It is the entire process, however, which gives our judicial system and our judges such high credibility and acceptance. This is the way of our Constitution. It is that belief which ultimately informs the Court’s decision to grant a stay. It is best that these momentous changes occur upon full review, rather than risk premature implementation or confusing changes. That does not serve anyone well.”

I have no doubt about the ultimate resolution of this issue. History will render its own judgements upon those who stand either in favor or in opposition to same-sex marriage. I already have.

Peter Hasselbacher
March 19, 2014

Kentucky Files Appeal of Judicial Order to Recognize Legal Same-Sex Marriages

[Addendum- March 19:  The official proceedings of the telephone conference of March 17, 2014 have been published (Document 70)  summarizing two principal orders of business.  The deadline for filing an amicus brief on the intervening matter of whether prohibition of gay marriage in Kentucky itself is unconstitutional was extended until May 2, 2014.  The Family Trust Foundation of Kentucky apparently plans to file such a brief.  Additionally, the motion by the Commonwealth to further stay his opinion concerning recognition of legal (out of state) same-sex marriage was taken under advisement by Judge Heyburn who will issue a separate order.]

What Happened Today (March 17) in Judge John G. Heyburn’s Courtroom?

Gov. Beshear’s attorneys pledge an appeal to Sixth Circuit Appeals Court tomorrow, March 18, if Judge Heyburn does not further stay enforcement of his decision requiring Kentucky to recognize legal same-sex marriages on March 20.

Last Friday, March 14, attorneys for Kentucky Gov. Steve Beshear filed an appeal to Federal District Court Judge John G. Heyburn to stay enforcement of his decision that Kentucky’s statutes and Constitution forbidding the recognition of legal out-of-state same-sex marriages are unconstitutional. If Judge Heyburn does not grant their request, Governor Beshear’s attorneys declared their intention to appeal to the Federal Sixth Circuit Court of Appeals to overturn the Judges decision tomorrow, March 18. The existing temporary stay given to allow the Commonwealth to prepare its compliance expires on March 20. There is not much time left!

Today, attorneys for the married same-sex couples filed their response to the Governor’s request. A telephone hearing was held in Judge Heyburn’s chambers today, but I do not know what was discussed. The session may have been as limited as accepting the Governor’s consent allowing the withdrawal of Attorney General Jack Conway and other attorneys from his office to withdraw from the case. No further hearings are scheduled on the court’s docket as of this evening. Continue reading “Kentucky Files Appeal of Judicial Order to Recognize Legal Same-Sex Marriages”

Kentucky to Appeal Judge Heyburn’s Order to Recognize Legal Same-Sex Marriages

Breaking News, March 4, 2014, 11:30 a.m.

Governor Steven Beshear’s office announced this morning that Kentucky will appeal last week’s final Order by Federal Judge John G. Heyburn II that declared Kentucky’s law and constitution forbidding recognition of legal same-sex marriages performed in other states to be unconstitutional and therefore null and void. The Governor indicated that a request will be made to Judge Heyburn to further stay his Order pending that appeal. His principle justification is that the matter, currently under dispute in several states, will likely be settled by the US Supreme Court and that should the Order be overturned, confusion will occur and disadvantage accrue to those who relied on the order in the interval.

A most interesting wrinkle in the Governor’s announcement is that Attorney General Jack Conway advised the Governor that he will not represent the Commonwealth further in this matter, and that the appeal and additional request for further stay will be conducted by other council. I have not yet seen a statement from the Attorney General on this matter. One might speculate that Attorney General Conway felt that he found no longer morally defend an unconstitutional  law, but that the Governor felt compelled to do so.  Some skeptics will likely suggest that this path of action takes the Attorney General (who has state-wide political ambitions) off the hook from making the no-win political decision described by several political editorialists this past week. I would like to believe the former possibility is more accurate. [Addendum: In fact, Tom Loftus reports in the Courier Journal that  Attorney General Conway announced earlier this morning that “Judge Heyburn got it right” and that by appealing he would be defending discrimination, something “that I will not do.”  I applaud General Conway for his ethical position.]

Judge Heyburn speculated at last week’s hearing that such an appeal from the Commonwealth might happen. From his comments, and from the confidence I perceive in his belief in the justness of his Opinion, I predict that Judge Heyburn will not grant a further stay of enforcement.

More information is likely to become available, and I will comment further as indicated.

Below are the full statements of both the Attorney General and the Governor.

Peter Hasselbacher, MD
President, KHPI
March 4, 2014 Continue reading “Kentucky to Appeal Judge Heyburn’s Order to Recognize Legal Same-Sex Marriages”