There's Something About Mary

Drs. Rebekah Bernard, Niran Al-Agba, and Phil Schaffer discuss researcher Mary Mundinger's recent Wall Street Journal letter, which argues that the nurse practitioners studied in her 2000 JAMA publication were practicing without physician supervision.  The fine print reveals fascinating details left out of the headlines.

Referenced in the podcast:
https://www.youtube.com/watch?v=0BUGdOs74Q8&t=746s&fbclid=IwAR1hMRBFlgzV3gmgaBIDH744-5nX-RAa5-9xDd9nloDqQ4R0NTqOS5ESuoM 

PhysiciansForPatientProtection.org

Transcript

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Rebekah Bernard MD  0:07  
Hello and welcome to patients at risk a discussion of the dangers that patients face when physicians are replaced by lesser trained healthcare practitioners. I'm Dr. Rebekah Bernard. And I'm joined today by my co-host, and the co-author of our book, patients at risk, the rise of the nurse practitioner and physician assistant and healthcare, Dr. Niran Al-Agba. 

Niran Al-Agba MD  0:31  
Hi, I'm so excited to be doing this with you for joining me. 

Rebekah Bernard MD  0:34  
And we're also joined today by a special guest, Dr. Phil Shaffer. 

Phil Shaffer MD  0:39  
Good evening. Hi. 

Rebekah Bernard MD  0:41  
On September 9, 2020, the Wall Street Journal published an article entitled "The doctor won't see you now." The article, which was in favor of the increased use of nurse practitioners in healthcare, made some inaccurate remarks like saying that studies have suggested the quality of primary care provided by nurse practitioners is as good or better than care by doctors with comparable outcomes at an equivalent or lower costs. 

Now, we know that that's not true. It's something that we've revealed in our book. And the truth is that every study that's ever been done, which has included nurse practitioners has been done under physician supervision. 

So, I wrote a letter of response to the wall street journal that I'll share with you. What I wrote was, "I'd like to respond to the doctor won't see you now, on behalf of Physicians for Patient Protection, a grassroots organization of over 12,000 physicians. Studies that show equivalence in care between nurse practitioners and physicians are flawed. The largest comprehensive review of the subject analyzed 18 studies comparing nurse practitioner care to physician care. The studies had small sample sizes and short duration of follow up and only three were completed in the United States. Every study reviewed involve nurse practitioners working under physician supervision, most excluded high risk or complex patients and several studies had high degrees of bias. Not a single large scale study has compared the care provided by nurse practitioners practicing independently without physician supervision." 

So that was a letter that I sent in. A few days later, the Wall Street Journal published a rebuttal to my rebuttal by none other than Mary Mundinger, the veritable godmother of nurse practitioner practice. And this is what Dr. Mundinger wrote. "There is no room for misinformation in any debate about nurse practitioner and physician comparability. Rebekah Bernard argues that quote, studies that show equivalence in care between nurse practitioners and physicians are flawed, and that quote, not a single large scale study has compared the care provided by nurse practitioners practicing independently without physician supervision. Dr. Bernard is wrong on both counts. In 2000, the Journal of the American Medical Association published an article written by the chairman of the Department of Medicine at Columbia University, the chair of the Columbia Presbyterian Medical Center, physician contracting group, several other eminent physicians and me. The article was a report of a randomized clinical trial, which is the gold standard for medical research evaluation of more than 1300 patients subjects over two years that showed that nurse practitioners could provide the same care and achieve the same health outcomes for patients as care delivered by physicians. Columbia Presbyterian Medical Center authorizes full admitting and discharge privileges for the NPS. And York State gave them full prescriptive privileges. So the parameters of the comparison were valid. Numerous strong research studies from other practices have since been published in premier journals confirming these results."

 So today, we're going to discuss the study that Dr Mundinger references, and we're going to evaluate whether or not her claims are true. And there is no one better to break down the study and provide background information that my two co hosts who have extensively researched this topic. I'm going to turn it over to Niran to explain a little bit more about the study that Dr.Mundinger references, and why there may be some concerns about what she has said. 

Niran Al-Agba MD: The Mundinger study is one of the three studies that the Cochrane Library has included in their their studies when they look at this question of replacing physicians with nurses, and it's one of the three done in the United States. And according to Mary, it was done with independent nurse practitioners, which we know at that time in New York, that it was a state where supervision was required for non physicians to work with patients. 

And so I'm just going to break down the study basically, from top to bottom. And I pulled this not only from the study paper, but I've actually gone through a book that Mary wrote about the experience and they call it the Columbia nursing experience because it started an entire clinic. And she had the goal, interestingly enough to give her some credit. She sort of foresaw the shortage of primary care physicians and she had her own thoughts about what the proper answer would be. And I would say that some of us feel more strongly that increasing residency slots and increasing primary care physicians in the country is probably a great solution. But this was kind of her solution. 

And so in a nutshell, she actually said activism needs to be based on empirical evidence. And so it's kind of ironic that here we are talking about empirical evidence that she did in her study. And the goal was to increase a nurse practitioner education because she thought it was a far better investment than opening more medical schools. So with that, the study subjects in her study were predominantly Hispanic women immigrants in their 40s, from a community with a population of about 200,000, half were at or below the poverty level. And severe illness occurred very infrequently in this population of kind of mid 40s women, which actually, Rebekah and I are both in that category right now. So it's kind of ironic that we're talking about. 30% spoke little to no English and 40% of the study subjects didn't complete high school. And the duration of the study was rather short, it was about six months in time. 50% of the study sample was seen between zero and two times over the six months. So we're not really talking about chronic conditions that we're seeing on a monthly basis, we're kind of talking about people who are seeing once or twice over that period. 

And now all patients. that's really important, we understand, were what's called ambulatory care sensitive, which means they were they were not, I don't want to say simple, but they had simple conditions that were diagnosed in an emergency room. And in general, those conditions were type two diabetes, asthma, and then hypertension, which is high blood pressure. Most of these study subjects that were enrolled came by referral through the ED Presbyterian Hospital or a specific local urgent care in the same area. This study did not include the evaluation, diagnosis and treatment of what we would call undifferentiated patients, meaning patients who kind of came with different complaints, and we had a smorgasbord of things to work up which we see in primary care clinics today. 

Interestingly enough, of the adult patients that were seen, 17% of these were routine annual exams. 10%, were seen for hypertension, and 7% were for regular women care, interestingly enough the pediatric patients, 66% of the visits were seen for well child checkups. So really basic pediatric care. We're not talking about sick children. 

The staff were interesting. This was not originally listed in the study, but I found this as I've done more research. There were four family nurse practitioners and three pediatric nurse practitioners working four hours per day, four to five days per week. So we're talking really about part time nurse practitioners in that they weren't working in a full time clinic that was running eight hours a day, 40 hours a week. All of these nurse practitioners - and this is really important - were assistant professor level, they were all appointed by the faculty to the Columbia School of Nursing. 

So we're talking about the top of the top in education, and actually three of the seven had doctorate nursing degrees or doctorate level nursing degrees, when they enrolled in this. One was the director of the geriatric nursing program, one was the director of adult nursing program, and one was the director of the pediatric nursing program at Columbia School of Nursing. So all of the faculty NPs underwent a special what we call residency training in dermatology, radiology and cardiology, and they were mentored by physician colleagues to conduct and learn ER evaluations as well as admit and co manage patients. 

Now, what's interesting is there's no description of the physicians who were doing the training or who they were, whose clinic they were compared. So we really don't have anything to offer. Again, it was a six month study. And then in a nutshell, the outcomes were that there was essentially no difference in care or outcomes. And I think I'm just going to let that sit there.

Because I think finding a difference in six months in women in their mid 40s, I'm not sure there are many studies that would find a huge difference, you're not going to see a lot of deaths, basically from high blood pressure in women in their mid 40s. And I think that's a fair way to kind of look at the study, as well as if you're doing two thirds of your care is, well child care. I'm a pediatrician. And I would say there's few pitfalls. When you're seeing well child checkups, you will pick up things from time to time, but not many life threatening conditions present during well child care. So again, I want to put into context that this was a pretty simple clinic with pre kind of decided conditions for those who had conditions and the rest were healthy. And I guess I'll take it from there Phil after kind of introducing the logistics of this study.

Phil Shaffer MD  9:30  
Well, thanks. I want to re-emphasize what you were saying that Cochrane collaborative, which is in medicine, one of the major review organizations that reviews all aspects of medicine, has undertaken a review of this literature twice once in 2005, one in 2018. And the 18 papers you were talking about. They had to go through 9000 papers to get 18 that were a sufficient quality to evaluate. And only three were in the US. The other 15 are outside the US. And really not relevant to what we're talking about. Because we don't know how those people were trained, we don't know much about how they're employed in their health systems, 

Niran Al-Agba MD  10:12  
Great points I completely agree.

Phil Shaffer MD  10:15  
 And of these three studies, one was written in 1967, even before CT scanning existed, to give you an idea of how old it was

Niran Al-Agba MD  10:25  
That's before Rebekah and I were born. 

Phil Shaffer MD  10:28  
Oh, my. I was around. I was not doing medicine at the time, fair enough. The other two papers were 21 years ago. And then Mundinger's paper was 20 years ago. And we need to make an important point here, that NP education has changed dramatically in the last 10 years. And the NPs that they were putting into their studies are not similar to what we have now. 

So we went through this paper with a fine tooth comb, and she talks about the nurse practitioners as being nurse practitioners, says nothing about how they were trained, and you pointed out how they were trained. We have found YouTube video which she describes how they were trained, I'm gonna quote it directly, quote, they went through the training the medical resident went through for the first nine months, and they learned how to do ER evaluations, they learned how to co manage patients in hospital, how to call for help, how to evaluate labs, and x ray findings that they hadn't gotten in their conventional training. In a sense, they would be much more able to be compared to the physicians in the trial, close quote.

Rebekah Bernard MD  11:40  
So Phil, what you're saying here is that these nurse practitioners really cannot be extrapolated to the way that nurse practitioners are trained in general. They're getting much more training than what most nurse practitioners would have out of school.

Phil Shaffer MD  11:55  
Right, just as she says, most nurse practitioners don't get trained in how to evaluate labs and x rays. They have zero training and x rays, I'm a radiologist, I pay attention to that, and they get no training at all. 

So the typical nurse practitioner now is getting a year and a half to two years of, of book training, and then 500 hours of clinical training. And these people in this study, as Niran said, were associate professors and higher. So they did not tell the readers this point, which is critical. So the the points that we need to make about this is that they got far more training than the usual NP, and they're No way, in no way representative of NPs as a group. And really to identify them only as nurse practitioners is misleading. The representation that they give us, when she talked about this in the YouTube video, it was clear, she knew about this when they wrote the paper, but they made a conscious decision not to reveal it. Now, when you're writing scientific papers, the methods are crucial. And you are supposed to reveal everything about your methods so that if anybody wants to read it carefully, to understand it clearly or reproduce it, it's all right there. And she did not do that. 

Another point is this study was about primary care only. And in the last few years, whenever questions about nurse practitioner care come up, they always bring this up. And they sort of expand the scope in imply that, that this pertains also to specialty care. And now, in Ohio, only 30% of nurse practitioners are doing primary care, and 51% are in some sort of specialty care. So it doesn't really apply because of that.

Rebekah Bernard MD  13:51  
Well, you know, one of the things that Niran and I have discussed, we're both primary care physicians and we get a little disappointed when we hear talk of well just let nurse practitioners or PAs do - just let them do primary care, because primary care can be extremely challenging. And I think one of the points in this study that was done by Mary Mundinger, or was that areas that were being analyzed, were very specific. It was diabetes, hypertension, and asthma, and just specifically those issues, whereas primary care encompasses all of these things in combination, and many other issues as well. So the primary care has come a long way from what I think the idea of it, which was just very simple problems and just refer out. Primary care is actually become really complicated, especially as more patients have chronic disease.

Niran Al-Agba MD  14:41  
You know, I do want to say one quick thing to that. There's a lot of places where she's written that she equates medical school to becoming an RN. So I just want to be clear that she sort of equates the medical school training that we get to the bachelor's degree RN training that they get and then looks at a DNP degree as equivalent to doing a residency and I think what's interesting as you talk about this study when she said on YouTube, they got more trained to equate with residency, me that actually says maybe underneath at all, that is a little misleading that she's saying the DNP covers the training of a medical resident because here you have these DNPs. Three of them were doctorates out of seven, and they still needed additional training, as you said, be closer to what residents were getting. So again, it's just thinking, when you can't compare an RN degree to an MD agree, I think once a graduate degree in one's an undergraduate degree. Absolutely. And

Rebekah Bernard MD  15:35  
I mean, one of the things that Mary Mundinger points out herself in a later study that she released was that the DNP, or Doctorate of nursing practice, only about 15% of them are actually clinical, most of them are more of an academic type of degree where they're learning more research and less clinical skills.

Phil Shaffer MD  15:53  
In her YouTube video, she does say that her experience with this project led her to understand that NPs needed more training. And her vision for the DNP was to make it clinical and to make it competitive with medicine. And that's not how it's played out. It's become an administrative degree.

Rebekah Bernard MD  16:14  
And it's so interesting that she says that in her YouTube video, and yet if you read this letter to the editor that she wrote, she makes it sound as if her study has confirmed that nurse practitioners can, she actually says, quote, that the study showed that nurse practitioners could provide the same care and achieve the same health outcomes for patients as care delivered by physicians. So I mean, that's a pretty bold statement, considering that what we're hearing is that the study really just showed a very small amount of information in a few very particular instances in extremely low-risk patients over six months.

Phil Shaffer MD  16:51  
Right. And that touches on one thing that I've picked up by reading their literature, and that is they don't go into the, into the subtleties. In other words, many of their papers are can they follow an algorithm once the patient's been diagnosed? Can they just keep up with the treatment? Nothing about seeing a patient for the first time learning, you know, how did they interview them? How did they get the information out of them? What differential diagnosis did they come up with? For the patient? How do they narrow down that differential diagnosis? And how do they devise a treatment, most of these patients are handed to them on a silver platter with a diagnosis and a treatment in place? And the whole question of the research is, can they just keep doing it.

Niran Al-Agba MD  17:42  
When I was doing kind of this review what I came to the conclusion of, and again, I really I actually, as I read more about Dr. Mundinger, who does have a doctorate in public health, she really I think, had her heart in the right place as far as expanding scope and care for people who could not get access to physicians. So I think she had this awareness which I commend her for early on that there was going to be a shortage of physicians. And what's interesting is this was her answer. 

But where I think there's a problem is she in, in total, misunderstood primary care. And, you know, she says things like, primary care is much simpler than it used to be. It's not like the specialty care, no longer requires the level of training at once did. And what's interesting is she goes on to say selecting and using referrals for specialists is part of their role. And what she's missing is when we're out in small areas, we don't have a lot of specialty backup. And so we really are seeing what's called undifferentiated patients who are coming in off the street with a host of things that we need to kind of puzzle, solve or problem-solve to put together and they think, unfortunately, because of that miscalculation about what primary care consists of, that's how we've landed where we are today, where we have this disconnect, like you said, with more administrative education as opposed to clinical education. And this idea that a primary care doc just follows an algorithm. And I would argue that that's actually not true. I would say, in my experience, I feel like primary care, we follow fewer algorithms because sometimes we just get on a whopper of a patient that surprises the heck out of us. So more so sometimes I think than in specialty clinics,

Rebekah Bernard MD  19:19  
you know, I tend to agree that I think her heart is in the right place. But I have heard some comments that she has made an awful lot of money in her role. Phil, could you address some of what you've discovered about her role in United Healthcare and some of the potential financial gain?

Phil Shaffer MD  19:38  
Sure. When we were looking into this paper, we found that at the time that the paper was written, she was on the board of directors of United Healthcare, and of course, as a board member, she gets payments. She also received stock options and other stock considerations. But the other thing I need to point out is legally when you're a member of a board of directors of a company, it's your fiduciary responsibility to advance all of the interests of the company and not to do anything that would harm the company. So that is a powerful motivation to take care of the company. Now, she was on the board of directors for many years, I think she started in 97, or 98, and went through into the 2000s, maybe 2010. And throughout this period, she was getting stock and stock options. And we found online a valuation of her stock holdings in 2013 that amounted to $72 million. So she had powerful conflicts of interest. And it's important to note that these were not revealed anywhere. They weren't revealed in the paper as they should have been, they weren't revealed thereafter, we had to find these for ourselves. And, these are among the worst conflicts of interest I've ever seen in a medical paper.

Rebekah Bernard MD  21:01  
So Mary Mundinger was on the board of United Healthcare, and United Healthcare is a large employer of nurse practitioners. So I guess the question is, what kind of gain is there for someone to show that nurse practitioners can provide the same care as physicians, especially when you're receiving compensation from a company that hires those clinicians? That's the question that I think is on a lot of our minds.

Phil Shaffer MD  21:27  
Yeah. And we also need to point out that AARP is tightly aligned with United Healthcare. I get AARP notices American Association of Retired Persons, and they are always trying to sell me United Health Care Products. AARP also is always present when lobbyists are looking for money to lobby legislators for nurse practitioner full practice authority. So these two companies work together and United Healthcare has a strong interest in employing nurse practitioners and using them.

Rebekah Bernard MD  22:03  
So, I think that in summary, the letter that I wrote to Wall Street Journal where I said that, based on the research that Niran and I have done for our book, we can really uncover no credible studies involving the care provided by nurse practitioners or physician assistants that showed safety and efficacy without physician involvement and physician supervision. And that's true for every single study included in the Cochrane Database of those 18 that you pointed out Phil, and Dr. Mundinger has responded saying that's not true because the one I did was involving independent nurse practitioners. But what we're explaining here is that the nurse practitioners in the Mundinger study were number one, receiving much more training and education than a typical nurse practitioner. Two, they were receiving patients that referred from physicians already diagnosed. Three, they were practicing in New York State, which had a requirement for a collaborating physician, which meant that nurse practitioners could always call upon a collaborating physician for help. And there was a certain requirement that I believe collaborating physicians had to review a certain number of charts or spend a certain amount of time with the nurse practitioners that they worked with to be to have that agreement in place. That all sound about right, Niran?

Niran Al-Agba MD  23:24  
It does. And I guess I would just add that each of the nurse practitioners selected their own collaborating MD, and so they got to pick them. And then she makes a point of saying that the nurse practitioners were well served by the arrangement because a physician would respond immediately if medical assistance was required. And finally, any time they were admitted to the hospital, there's an entire protocol written, that the physician had to see the patient and sign off on the orders within 24 hours. And interestingly enough, the pediatricians actually, that were part of this study, if a pediatric patient needs to be admitted, they insisted on co admitting. So in that case, it was a real supervisory approach. It was less collaborative and more supervisory when it involves sick pediatric patients. So again, like I think Phil has alluded to that even her letter to the Wall Street Journal seems to have some misleading pieces to it, when you really delve into the details really wasn't an independent study. And I would still stand by what we said in our book, which there have been no credible studies that have evaluated unsupervised or free practice nurse practitioners with full practice authority, and comparing that to a standard clinic in primary care. And the question is, we need that data. 

Rebekah Bernard MD  24:37  
That's interesting because this study that she references is now about 20 years old. And there has been independent practice in many states of the country for quite a number of years at this point. So you would think that by now, there would have been time to put together that data, but yet I haven't seen any published data that has been well done that demonstrates safety or efficacy of Nurse Practitioners or PAs practicing independently without directly working with a physician or having access at least to a physician.

Niran Al-Agba MD  25:07  
Yeah, especially when you're talking about the gold standard, which would be randomized, controlled, you know, blinded studies. And obviously, this is actually I think the only one that even came close. And obviously, when you delve into the details like we've talked about, it really isn't an independent study. 

Rebekah Bernard MD  25:24  
Well, thank you so much. I want to thank my co-host, Dr. Niran Al-Agba. I'd like to thank our special guest, Dr. Phil Shaffer. I think this has been really illuminating and helping us to understand a little bit more about the issues and clarifying some of the research that's out there in the misconceptions that patients are getting. To learn more about this topic, please check out our book. It's called "Patients at Risk: the rise of the nurse practitioner and physician assistant in healthcare," you can get that on Amazon or at Barnes and noble.com. And also, if you're a physician and you'd like to learn more about helping out and getting more involved, we encourage you to join physicians for patient protection. Our website is physiciansforpatientprotection.org.  Stay tuned. We'll have another episode hopefully in the near future. Thank you so much for joining us.

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