Mylan Pharmaceuticals is really feeling the heat. An outpouring of outrage over its exorbitant pricing for EpiPen has caused it to announce plans to offer a generic version of the product for half the $600+ dollars of the branded version. The EpiPen is a self-injecting device used for life-saving rescue of individuals with anaphylaxis, a severe form of allergic reaction. (See my recent article for background.) Mylan joined the new “gouge-em if you can” industry club by buying a old standard drug and jacking up the price to astronomical amounts assuming we patients had no recourse but to raid our kids’ college accounts to pay for it. How broken is a system that has the same company selling the same drug at two vastly different prices in the same country? I guess Mylan assumes it is still acceptable to rip-off patients with health insurance. This face-saving move is yet another confirmation of the hypocrisy of our two-or-more-tiered healthcare system, and the absurdity of our drug pricing non-system. The only way for Mylan to get out of this public relations hole it is digging is to give EpiPen away for free as a public service to anyone who needs it! Continue reading “Mylan Drug Company Drops Price of EpiPen – Sort Of!”
Why do they do it? Because they can– and because we let them!
Mylan, the manufacturer of the EpiPen, an auto-injector used to inject epinephrine beneath the skin, has raised the price of its product some 800% between 2009 and 2016. The active drug itself is a traditional generic that costs very little. Mylan has copied a business model of buying a standard drug that is essential for some and jacking up the price to more than what desperate people are willing or able to pay. It was easy to do so because Mylan lost its major competition and because individuals with “good” health insurance are insulated from having to pay the full price in the drugstore. The price of the usual prescription for EpiPen is reported to have risen from $100 in 2009 to around $600 today. The pricing of this medical device that makes it convenient to carry and administer epinephrine is another of the innumerable examples of the failure of our healthcare system to protect the interests of individuals with medical needs and to tolerate predation such as this. Continue reading “Another Drug Company Rips Off the Public: Mylan’s EpiPen.”
An improved goldmine of information not otherwise available to the public and a flood of opioids.
On August 18, CMS released the second iteration of its cost-and-utilization database of prescription drugs written for patients covered by Medicare Part-D Medicare which includes beneficiaries in Part-C Managed Care and stand-alone Medicare Part-D Prescription Drug Plans. Compared to the updates of Medicare’s other 2013 public-use healthcare utilization files, this release seemed delayed and I feared the program’s continuing implementation had been quashed by the pharmaceutical industry lobby and its friends as was a 2013 initiative to provide the public with average retail drug prices. The wait was worth it.
Although restricted to the two specific Medicare populations mentioned above comprising some 70% of all Medicare beneficiaries, the database is unique in that the names and other identifying information about individual prescribers are disclosed to the public. Although the drug companies themselves know who is prescribing their products, to my knowledge, this degree of transparency for the public is unique – and therefore doubly valuable. The top 25 opioid prescribers to this population are listed below. Continue reading “Medicare Updates Its Prescription Drug Utilization Database.”
In an exercise of stunning hypocrisy, Kentucky Governor Matt Bevin warned the remaining former UofL Board of Trustees members that should they meet against his advice, that anything they do will be invalid because they are illegally composed in terms of race, gender, and political party registration. He obviously disagrees with the decision of Circuit Court Judge Philip Shepherd who granted a temporary injunction against the dissolution of the former UofL Board which Bevin replaced with 10 obviously hand-picked new appointees. The Governor has a right to disagree and the ability to appeal the judicial decision in an unthreatening prescribed manner. However, essentially giving Bevin or Ramsey-friendly former trustees an excuse not to show up is a disturbing way to proceed and does not inspire confidence that the Governor is not being driven by the political motivation he ascribes to others. [Some of the former board were apparently listening. See below for today’s new developments.]
Show me a legally empaneled Board –any Board.
There is little doubt that the several statutes defining a required composition of the controlling boards of the state’s various academic entities has been much ignored for some time and by several governors. I shared my opinion earlier that the entire system of University Board appointments is irretrievably broken and needs to be replaced in its entirety. If the governor is serious about his concerns, he needs to examine the current composition of all the relevant Boards, and to deem those out of compliance illegally constituted as well. Governor, I believe you have been badly advised. By your own words and logic, your own Governor’s Postgraduate Nominating Committee that you recently largely reconstituted, is on its very face more illegally constituted that of the UofL Board you compel to sit on their hands as their University burns. By your own words and logic, any of your Nominating Committee’s actions are equally illegal and invalid– including the nomination of the ten UofL trustees you recently attempted to seat. The advice you have been given allows a reasonable person to perceive your motives to be more politically driven than in the name of efficiency, and makes your pronouncements sound less than gubernatorial. Let me explain. Continue reading “Governor Bevin Continues To Block UofL Board of Trustees.”
We are not ready in so many ways.
Given that the Zika virus and the mosquitoes that carry it from one human to another have been advancing north from South America through the Caribbean and Mexico, and that parts of the USA share the same permissive semi-tropical environments necessary for the disease to spread, most public health scientists and officials have assumed that home-grown Zika disease and its sequela would show up in the course of time. Officials in North Miami, Florida believe that time has come. Even with all the warning in the world, Congress could not be persuaded to act before leaving Washington for vacation. Imagine, public health being sacrificed at the altar of political control and the national shackling of anything having to do with women’s health policy to a self-defined pro-life lobby and the religious dogma that supports it. The failure to prepare now, as it has been in the past, is all about control of the levers of power that drives political life.
People, including pregnant women who have contracted Zika virus, have been present in the USA for some time, having caught the disease while traveling abroad in endemic areas, or having acquired the disease sexually from partners who did the traveling for them. (Yes, Zeka is also a sexually-transmitted disease.) Since the virus can linger for months in various places within the human body, we can assume that transfer of the disease by nonsexual intimate contact or exposure to body fluids is also possible. Blood donors in parts of Florida are already being told not to do so, and testing of donated blood for the virus more broadly is being advocated. It is likely that Zika is here to stay for a while, if not forever. “So what?” you may ask. Continue reading “They’re Here! Zika-bearing Mosquitoes now present in USA.”
I missed one of the three initial meetings these last two weeks of the newly appointed and possibly legal University of Louisville Board of Trustees, showed up for one that had been abruptly cancelled, and could not wait out some six hours of executive session of the last one to learn first-hand its decision about Dr. James Ramsey’s tenure as President of the University. No matter. The run-up and results have been dispassionately reported by others including Chris Otts of WDRB, Andrew Wolfson of the Courier-Journal, Joe Sonka of Insider Louisville, Kate Howard of the Kentucky Center for Investigative Reporting, Kyeland Jackson of the Louisville Cardinal, and others who have shown the bright light of responsible journalism on things our University can be proud of – but also on the shameful if not illegal goings on that would otherwise have remained in shadow. I will not summarize all that has occurred. I encourage my readers to review their previous work and my own prior reporting of the self-serving machinations that have brought our local University to its knees.
[Addendum: As I was finishing these words, Frankfort Circuit Court Judge Philip Shepherd granted Attorney General Andy Beshear’s request for a temporary injunction, thus putting the dismissal of the former Board on hold and rendering the new Bevin-appointed Board invalid. The injunction allows the agreement on Ramsey’s resignation, the granting of degrees to recent graduates, and authorizing the appointment of Professor Neville Pinto as Interim Provost to stand. The order assumes that collusion between Ramsey and Governor Bevin occurred before the dismissal of the previous Board. More about this at a later time. I will finish this article as I originally intended.]
Attendant troubles at the Medical Center.
It is no secret that in my opinion, the house that Ramsey, Dunn, and their administrations built is collapsing – as much from leadership style as external challenges. Just today we learn that Medicare has given our University Hospital a single star in its ranking of acute-care hospitals for overall quality. It joins only 129 of 3617 hospitals nationally at the bottom of the list. Yes, University Hospital along with others serves a large proportion of patients facing socio-economic disadvantage, but a few years ago we would have received three or even four stars or the equivalent. This did not have to happen. We can recover, but it will likely take as many years to do so as it did to collapse. The rising opinion of many at the University is that we must unwind our relationship with KentuckyOne and Catholic Health Initiatives whose bond-rating has just taken another hit and is facing troubles of its own nationally and in Kentucky. Because University Hospital is supporting Jewish Hospital financially, I doubt the KentuckyOne will easily consent to dissolution. I am rereading the Joint Operating Agreements with attention to conditions of termination. It will be neither easy or inexpensive to do. Substantial penalties are built in should the University unilaterally withdraw. In addition, I doubt that even UofL or the Commonwealth know how much of CHI’s colossal debt they have agreed to be responsible for. Continue reading “UofL’s Prolonged Agony is Over – Not!”
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.”
Another short-notice meeting of the possibly legally appointed UofL Board of Trustees is scheduled for tomorrow. The first item on the published agenda is consideration of the resignation of President James Ramsey. The next and only other item on the agenda, making it seem like a decision has already been made, is consideration of transition planning and search for a next president.
I was unable to make it the last meeting and was preparing an analysis of the reports in the Courier-Journal, Kentucky Center for Investigative Reporting, Insider Louisville, WDRB-41, and the Louisville Cardinal. I will submit my additional thoughts later, along with a summary of tomorrow’s meeting.
In interviews over the past weeks was mention of a buy-out of Dr. Ramsey’s contract. One question that I hope will be asked tomorrow is, “if President Ramsey has resigned, why is an issue of buy-out even be on the table?” Surely given all that has come before, no additional financial burden should be placed upon the shoulders of an already debt-burdened student body. The presence of student questioners clearly influenced the outcome of last week’s consideration of the University’s budget with its 5% raise in tuition. Additional seven-figure payments to Dr. Ramsey will surely raise objections by others than myself.
We shall see what we shall see.
Peter Hasselbacher, MD
Emeritus Professor of Medicine, UofL
25 July 2016