Category: Healthcare Ethics

The Ethics of “Placebo-Controlled” Studies

Funny thing. When we hear the term “placebo-controlled study,” the methodological purists amongst us generally think that is a good thing. After all, without a placebo control arm, how would we know whether benefits apparently produced by a therapy were, in fact, actually placebo effects. But check this out. What you will see is a situation in which the circumstances of “placebo control” raise significant ethical questions. Why? Several reasons. Most tellingly, because the study participants were disproportionately “disadvantaged” inner city children of color.  AND. Because the placebo control involved withholding a standard treatment for patients with Vitamin D deficiency. AND. Because the study lasted almost a whole year, with standard therapy being withheld for this entire time for the control group. 

Bottom Line. Think about this one for a couple of minutes. The real kicker here is that this research could have been done without the placebo control arm. The reason it wasn’t?  It would have taken longer and been more expensive. 

The right question, as posed at the end of this piece, deals with how the heck institutional review boards at several major institutions signed off on this research. Exactly the kind of unethical research such boards are intended to prevent. 

How indeed!!!

The Ethics of Telemedicine

In my On Doctors’ MindsSM research that tracks the adaptations that office-based physicians have made to the COVID-19 pandemic, I have been fascinated to learn about how quickly clinicians were able to adapt to telemedicine, and some of the hurdles they encountered going up the learning curve involved in using this new technology.

But check this out. What you will see is a discussion of whether it is ethical for a physician to limit the treatment of unvaccinated patients to telemedicine visits. Survey results revealed that 69% of doctors thought this was ethical given the risk such patients pose to medical staff. A medical ethicist weighing in on the same topic agreed, but put in the caveat that if a patient’s condition requires personal contact for good treatment, e.g., in the management of a movement disorder, it was incumbent upon the practitioner to either allow personal visits or refer the patient to an HCP that would provide such service.

Bottom Line. Think about it. The COVID-19 pandemic brought with it, among many other things, a slew of new and important ethical questions with which healthcare providers must wrestle daily. As with so many aspects of the pandemic, I am thinking that the results of these wrestling matches will substantially modify thinking in the field of medical ethics for years to come.

If not forever!

Hospital CEO’s Behaving Badly

Several posts ago, we discussed the non-physician CEO who was allowed to make the first incision on a surgical patient in his hospital. Both the CEO and the surgeon involved in this debacle wound up getting summarily fired. Wow!!!

Want to see another hospital CEO behaving badly? Check this out.  What you will see is the young CEO of a small hospital stealing narcotics for his personal use from the hospital pharmacy.  

Bottom Line. I alluded to this in the previous post, but let me say it again. Pardon the Psychologist in me coming out, but I have thought quite a bit  about the lot of MBA Hospital Administrators. Many articles have been written in recent years concerning the resentment and pushback that these poor guys and ladies encounter when they are seen as trying to tell the MD’s in their charge “how to practice medicine.” Increased efficiency and all of that.

Is this a stressful situation for many of them?  

You bet!

The Medical Ethics Of Covid Vaccine Research

Issues of “medical ethics” are always dicey. The last one we discussed was the sticky wicket of how to decide which COVID patients should get ventilators when the lack of availability of this equipment was a real problem. Not an easy decision. Luckily, this time of shortage has largely been ameliorated in the US.  

But check this out. We now see an important new issue of medical ethics emerging. Here we learn that the use of “challenge studies,” where a vaccine is administered to a volunteer and then the subject is purposefully exposed to the disease, can greatly speed up the development of a vaccine. We also learn that thousands of volunteers have already stepped forward to accept this risky role.  

So, what’s the “ethical quandary” here? Two things, actually. First, is it ethical to expose someone to a potentially fatal virus for which this is currently no treatment?

Second, while the volunteers may indeed be “altruists,” it is also quite possible that they are in fact “mercenaries” who have signed up for the high financial incentive usually granted to subjects in such dangerous studies. If this is the case, the study would unfortunately place the financially disadvantaged at risk of being bribed to place their health in danger.

Bottom Line. SO. Should a challenge study be done here at all? I am going with a no on that one. And that, my friends, would make the second issue moot.

What do you think?

Moral Marketing

Check this out. What you will see is an important new book that goes to a place that I’m betting most of us, certainly including me, haven’t thought much about before. In this work, my old friend Karen Tibbals explores the issue of whether brands should take a position on social issues. One line from her description of the book will help to clarify the point of this book:

“Take Nike for example. They took Colin Kaepernick’s side, and the brand gained consumers in its chosen market. But taking sides is a potential minefield if you don’t do it correctly.”

Yup. When I saw Nike take a major stand with the guy who spearheaded the take-a-knee-during-the-NFL-National Anthem- movement, I was scratching my head as to how that would all turn out. I also wondered how the heck you would conduct a priori marketing research on this that would help to assess the risk of disaster.  

Karen’s background, which includes years of doing pharmaceutical marketing research and a stint at a seminary, provides her with a virtually unique set of credentials relevant to this and similar questions. And providing research and consulting on this area of endeavor is what she is now doing for a living. Fascinating!  

Bottom Line. True confession. I have been trying to get my pharmaceutical clients to take a stand on such issues as physician burnout and suicide for over a year now. Although these issues are of tremendous import to their customer base, nobody has wanted to touch these issues with a ten foot pole. Are they concerned about the “minefields” to which Karen refers?  

And think about it. For which drug classes would taking a stand on a social issue seem appropriate and relevant? AIDS/HIV medications? Contraceptives? Opioids? Psychotropics? Vaccines?  

Should any of these take a “stand” on a social issue, and if so, what?

A Little Hypocrisy???

Check this out. What you will find is an article informing us that Rite Aid is upping the age requirement to purchase tobacco products to 21.  Walgreens “coincidentally” did the same thing on the same day.  

So where is the hypocrisy here? A couple of places. First, this move seems to suggest that it is safe and okay for people 21 and older to buy cigarettes. How can an organization that is increasingly trying to become a bigger player in “health care” offer up carcinogens for sale? Conversely, to their credit, CVS phased out tobacco products in 2014!!!

To sweeten the dose of hypocrisy, Rite Aid claims that it is doing everything it can to reduce the risk of smoking. Things like placing tobacco products in less conspicuous places in their stores, training pharmacists to counsel patients on smoking cessation, etc. Aw, c’mon!!!

Bottom Line. Let’s not kid ourselves. Or allow ourselves to be kidded. For chains like Rite Aid and Walgreens, tobacco is big business. But inquiring minds want to know. Should important links in the health care chain be selling products known to produce deleterious effects on their customers’ health?

Res ipsa loquitur!

Can You Put Me To Sleep?

Check this out.  What you will see are the lamentations of an ER doctor about patients’ requests to be “put to sleep.” There are a couple variants of this request. Most of the cases the blogging physician discusses involve the request for a brief journey into LALA land by patients who want to avoid the pain of a relatively quick and minor procedure. Understandably, these requests are routinely denied based on the reality that for the doctor to accede to the request would typically place the patient in undue jeopardy. As the doctor intones, “Do you remember Michael Jackson?”

The second type of request I found really eerie. Geriatric patients requesting that the ER doctor euthanize them to exit a life without meaning and to avoid going back to the nursing home. Obviously, this type of request is universally denied.

Bottom Line. Amazing. We all know that all kinds of weird cases show up in the ER, with all kinds of strange requests. BUT. Drive-through doctor-assisted suicide? The mind boggles!

Sex, Cars, Money, And Dementia

Check this out. What you will see is a very thought-provoking article by a physician whose professional work centers on the field of bioethics. Seems that a husband visited his wife, suffering from dementia, in a nursing home. While he was there, they had sex, an act for which he later got arrested. Yes, arrested! The blog post tells the whole tragic story. It also raises a major question. When it comes to dementia, what is the appropriate balance of freedom versus controlled safety in areas like sex, money, and driving an automobile? Further thought reveals that this is only a special case of the question as to how much should society make people do health-related things that are “for their own good,” versus value individual autonomy. Bottom Line. Although this post not surprisingly does not provide the “final answer” for these huge and increasingly important questions, it does provide good elements of practical guidance. Like, nursing homes should have published policies and procedures for dealing with sex, so as to avoid the debacle described above. And banks can institute procedures that check for unusual banking behavior that might indicate that a patient with dementia is being scammed. All little steps, but increasingly important and practical ones in a population that is aging and needs to wrestle more and more with such thorny issues. 

The Pain Hustlers

I’m sorry!  The story I am sending you today sort of goes on forever. BUT. All of this verbiage is necessary to tell the full, multi-faceted story of how opioids are being marketed to prescription mills via unscrupulous tactics. Yes folks, once again these tactics include the kind of bogus “speaker fees” we have talked about before here. But there is more. Much more. This time, unlike in the last case we discussed, both pharmaceutical executives and practitioners were indicted and sentenced. Of all the many words included in this story, I found the most startling to include the description of the INSYS hiring practices. These included the hiring of sales representatives right out of college, thus ensuring their naivete and malleability. The fact that they were paid below scale wages, with the difference made up in bonuses and stock options, helped to ensure their compliance with the company’s party line. Bottom Line. As I read these reports of pharmaceutical company sales malfeasances, I am struck by the fact that they all seem to be historical in nature. The story in this article begins in 2012. The reader is sort of led to infer that such illegal sales practices have now been eliminated, with all sales approaches now being on the up and up.  Are they?

Some Got Away With It, Some Didn’t!

Check this out. What you will see is a classic gotcha. Seems that several years ago, a pharmaceutical company engaged in a rather iffy marketing tactic. They engaged at least one physician as a “paid speaker” at “med ed” events held in her office. Interestingly, no other physicians attended these events. Rather, they consisted of the physician having breakfast or lunch with the company’s PSR. She did this 30 times, and got paid over $20,000!!! Funny things is, the payment is not the problem. Nope. Rather, the doctor has now been found guilty of two other charges stemming from the meetings. First, during the meetings the doctor allowed the Rep to view patient records. A definite no-no. The real kicker is that she lied about all of this to investigators, grabbing herself a really nasty conviction for Obstruction of Justice. Sentencing has yet to occur, but it looks like she might well be headed for jail! AND. Although the president of the aforementioned pharmaceutical company was indicted, he was acquitted over strong objections from the prosecution. Bottom Line. Looking in the chronological rear-view mirror, it is amazing to see the promotional stunts that were pulled over the years. The irony of one doctor getting slammed while so many, physicians and pharmaceutical company minions alike, just counted their money and ran like hell, boggles the mind!