Dr. Elliot Justin hadn’t been able to get an answer. He’d spent the better part of seven years trying to get New Jersey’s approval for a new medical procedure that might save the lives of dozens of state residents every year.
Finally, in November 2004 he found himself awaiting a meeting with the state’s Health Commissioner to resolve the matter. But that conference also failed to provide him answers. It did, though, give him an education that extended well beyond his medical training.
For those who think that greater government oversight in health care is desirable, it’s instructive.
Dr. Justin is a physician who’s been in charge of several New Jersey and New York emergency departments. He’s served on a number of New Jersey boards responsible for setting health policy, and won major awards for his work, including recognition as New Jersey’s American College of Emergency Physicians Emergency Medical Service Doctor of The Year. One of the innovations he previously pushed – getting permission for paramedics to use clot-dissolving drugs to treat heart attack victims in the field – is believed to have saved the lives of several dozen Garden State residents.
But somewhere along the line Dr. Justin ran afoul of people in the state Health Department. To understand the situation Dr. Justin is in you first have to know a bit about his business and the technology it requires.
Emergency medicine has two parts. One you see when you walk into the white-tiled rooms of the emergency department at your local hospital. The other is the field and ambulance units which serve as so-called first responders.
Very often it’s the first responders – emergency medical technicians (EMTs) and paramedics – who give you your most critical care if you’ve had an accident, coronary or stopped breathing.
There is not always a clear consensus though about what methods work best in treating people in the field as the science of treating critical patients is still developing.
It was only in the 1950’s that Cardio-Pulmonary Resuscitation (CPR) was invented. Of course, while it provided an immediate answer to the question of how to treat the heart of a patient whose heart stopped beating, it did not answer the question of how to insure that oxygen continued flowing to the patient’s brain if the patient’s heart did not re-start or a patient’s airways were blocked.
The general solution to the problem of getting air rapidly in which was introduced at that time was to place a mask and a bag – understandably called a bag-valve mask - over the face and to squeeze air into the wind-pipe, the trachea. Through the trachea the air could then move on to the lungs and the other organs. This method was rough and imprecise though, and in the 1970’s it became common to teach paramedics to put tubes directly into the trachea. Since effectively putting a bag and a mask on someone’s face to assist them with their breathing required some measure of skill, most paramedics switched to the then newer technique of endotrachial intubation or “intubating” patients. (Fans of TV medical dramas may recognize some of the terminology.)
Over time skills previously honed in placing bag-valve masks on patients declined. That’s unfortunate because intubation is not only time-consuming and, in many instances, simply impossible, but, what’s more, while paramedics can intubate field patients, EMTs aren’t even allowed to perform this procedure. And in general it’s EMTs who are the first to arrive at scenes of cardiac arrest. So, the only tools the EMTs have to use are bag-valve masks. But bag-valve masks are difficult to use and often lead to patient vomiting, what doctors call aspiration. Meanwhile, critical time – minutes - may slip away.
By the late 1980’s new and much simpler equipment for “bag-and-mask” breathing assistance had been developed. One of the best and cheapest of these “supraglottic” tools – typically costing just $10 per unit - is called a Laryngeal Mask Airway (LMA) device.
In the United Kingdom and Canada, the LMA has virtually replaced traditional bag-masks and endotrachial tubes in operating rooms. The United States is following in this practice.
According to Dr. Mike Murphy, a widely published author on the subject who trains approximately 1500 Emergency Room doctors and anesthesiologists per year through the classes he teaches in Emergency Medicine at the University of North Carolina-Chapel Hill, the Laryngeal Mask Airway “isn’t technically difficult. It’s easy to teach and easy to learn. It requires much less technical skill than intubation or the old bag-mask ventilation techniques.” Moreover, the greater speed with which it can be applied increases the rate at which oxygen gets into the lungs and then to a critically injured patient’s brain. According to Murphy, there is “no reason whatsoever” why it shouldn’t be used by first responders.
Murphy notes that there is a “quite a body of evidence” that LMAs are better than the traditional bag-mask no matter how well that is applied, and it “certainly” should be an alternative. In fact, first responders in New Mexico are already approved to use it, and the American Society of Anesthesiologists formally recommended its use for treatment of “failed” airways.
“There have been over two thousand journal articles on the use of LMAs in operating rooms, and I think maybe one was critical. There is no controversy about them,” Murphy says.
Dr. Justin, who makes a concerted effort to keep up with new ideas in his field, heard about LMAs some years ago, and back in 1999 he approached New Jersey’s Mobile Intensive Care (MIC) Advisory Unit board, which is responsible for approving new procedures, about whether he and his first responders could use them. The board approved a pilot project, and Justin thought he could start.
Then he was told that he would have to get the approval of a special committee to investigate the use of LMAs by Emergency Medical Technicians. Placed in charge of the committee was a critic of the idea.
Still, Dr. Justin was given the go-ahead to organize and plan the pilot-project. Two years of the run-around followed. Finally, in 2002 he was allowed to begin his pilot project. Its results were dramatic and clear-cut.
Through their pilot program, his team of paramedics and Emergency Medical Technicians employed the LMA on several dozen heart-attack patients. LMAs were used successfully on 84% of the patients they were tried on. This is an unprecedented rate. The first-responders concluded LMAs were faster to use and much more effective than the conventional bag-masks they had been applying. What’s more, they noted that the LMAs could be applied in situations where only one first responder was present while the traditional “bag-mask” requires three hands – meaning two aides must be present. The project found that LMAs even produced a better rate of getting heart-attack patients to survive to a later hospital discharge than paramedics had had in using “intubation”. And remember: while paramedics can attempt “intubation”, Emergency Medical Technicians in New Jersey aren’t even allowed to attempt it because it’s thought to be difficult for them. (Dr. Justin says the result is “not necessarily causal [proof], but it’s a provocative association that should certainly be explored”.) Moreover, an anesthesiologist I spoke with who is using the technique in Texas said his results tended the same way.
Now, those findings about the life-saving potential of LMAs came more than three years ago and five years after the pilot program was proposed. So what is the state’s position?
Well, that’s a little hard to determine. The Senior Assistant State Commissioner of Health, James Blumenstock, refused my requests to answer questions on the matter directly – or even through a spokesman. Instead, the Department released a bland statement stating their “support” for the trials. Most pointedly, the state would not explain why they put a doctor in charge of reviewing the pilot program, William Gluckman, who has publicly questioned the use of Laryngeal Mask Airway devices. No comment was provided to my query whether the Commissioner’s office was troubled that Dr. Gluckman told me that he wasn’t familiar with the pilot data and thought it was “not my job to look at the numbers” in his role as the head of the committee reviewing the program. Nor would the Commissioner’s office explain why Gluckman was still in charge of reviewing the program when – as he admitted in his interview with me – he’d skipped all but one of the committee meetings that have been arranged to review findings on the subject.
And everyone, it seems, has someone else to blame for the repeated delays in getting the new procedure accepted. Karen Halupke, Acting Director of the state Office of Emergency Medical Service, suggested that I might do better to talk to a member of the review board, Dr. Jennifer Waxler. Dr. Waxler said I should speak with a Dr. Brennan. Dr. Brennan referred me to the state. Gluckman referred me to the state.
The state, of course, won’t answer questions.
Moreover, although the state promised to make all records relating to research on LMAs public, it has, in fact, chosen to keep a wide range of documents relevant to the case concealed. Provided to me, these documents show that New Jersey re-interpreted the pilot program’s findings by recording as an “unsuccessful” attempt to use the device any actually successful use of it in the field in which records on the specific instrument size number of the device used was absent, the size was slightly off from what might ideally be desired (even if it was effective in the patient) or the patient records were in some other ways incomplete – regardless of any benefit to the patient.
Documents also show that a principal concern of the state is the possibility that LMA use might lead to patient aspiration - vomiting. Yet the state would not answer my questions about why this was relevant given that the risk of patient vomiting appears to exist at a much higher rate with the currently used bag-valves. Likewise, the state would not discuss its analysis of the pilot program’s data.
In addition, in his interview with me, that state designated point man for reviewing the project, Dr. Gluckman, conceded that while he has continued to argue for use of the conventional bag-valve technique that he has no data on its success rates, nor any specific evidence to dispute first-responders claims that the bag-mask had much lower rates of success than did the newer LMA device.
Regardless, Dr. Justin has had to respond to state requests that the pilot program – which had shown such remarkable results - re-train all of its personnel, re-write its training manuals, re-submit those and then provide whatever missing chart information it says that EMT workers failed to provide previously on another set of dozens of patients.
Why doesn’t the state just call New Mexico’s state office and find out why they are permitting use of the device by first responders? As with every question, the state won’t provide any explanation. Doctor Gluckman says he thinks he did call someone in New Mexico – but claims that he can’t remember their name or even anything which was said.
In the meantime, Dr. Justin was being told that if he acted without state approval that his medical license would be threatened. Dr. Justin is not one who suffers fools gladly. Might he have offended someone high up in the state bureaucracy? Or is it just a matter of everyone with power trying to avoid being put in a position where they might be blamed if something new about which they know hardly anything – and have made little or no effort to learn – should not go on some occasion quite as planned?
This was the situation he found himself in when he went to meet with former state Health Commissioner Clifton R. Lacey.
Dr. Justin was delighted to find that Lacey was (at last) an attentive listener. It seemed that the Commissioner, who was about to leave his job, agreed with and understood everything Dr. Justin was saying. He understood the implications of Justin’s data. He grasped that Justin had gotten a recommendation to ahead way back in 1999.
So what was the problem?
The Commissioner smiled and looked at him with a mixture of warmth and amusement. Then he explained the situation. As an emergency physician if Dr. Justin encountered a patient who had had a cardiac arrest, he’d “shock” him and bring him back to life.
Presented with the same situation, the state would have a meeting, the Commissioner explained. Then, when the body began to smell, they would have another meeting. Finally, they would dump the body. It was the nature of the state to be bureaucratic. There was nothing more to it than that.
The Commissioner then said that he didn’t know whether Justin even needed state approval, and as far as he was concerned they didn’t need more research. But, if Justin was convinced that the extensive oversight given him meant that state approval was required, granted the threats made against him, then he would try to get approval for him. To that end, the Commissioner promised to press his own aide, Blumenstock, and Halupke to approve the procedure. This, Justin was told, might come by the Fall of 2005 – or maybe 2006.
Of course, as the Health Commissioner would no longer be serving at that time and would no longer be Blumenstock’s boss, he couldn’t absolutely assure Dr. Justin that the policy change would be put through. More meetings might have to follow.
It’s now 2007, and nothing has changed. But New Jersey residents are still dying and suffering brain damage because EMT workers can’t get bag-masks on them fast enough