But that’s not how it worked out. With such common and deadly illnesses as heart attacks and stroke, physicians are loathe to experiment—they stick closely to protocol. This is especially true in the United States, where the fear of lawsuits makes doctors especially unwilling to deviate from what might be called the accepted standard of care. For three years after the publication of Fritz Sterz’ groundbreaking European study, a handful of American doctors fumed as the AHA refused to update its guidelines to require cooling as a treatment for cardiac arrest.
Stephan Mayer was especially steamed. In his view, as long as hypothermia was not considered “standard of care,” hospitals could rationalize not doing it. After all, if the AHA didn’t think it was absolutely necessary, many would ignore it. In 2005, its guidelines for treating cardiac arrest were re-written, as they are every five years, and they did list therapeutic hypothermia as a recommended treatment—but still not that elusive standard of care.
To shift that line, once and for all, would take a decision from the Food and Drug Administration. In 2004, an FDA panel that makes recommendations on medical devices gathered to discuss the evidence for hypothermia, and whether companies could specifically market cooling systems for the treatment of cardiac arrest patients. The European study was touted, along with a second study from Australia, which also showed that cooling helped survival. On the other side of the world, Mads Gilbert was certainly smiling as he followed the developments.
But things didn’t go as Gilbert and Mayer, among many expected. An influential FDA representative was not swayed by the evidence of a benefit from hypothermia. Dr. Julie Swain, a prominent cardiologist, laid into the two studies. She argued that they were too small to suggest a real benefit, and pointed to studies of hypothermia in other groups of patient—heart attack victims, and people who suffered head injuries —as showing no benefit at all. What’s more, she said, patients in those other studies suffered higher rates of side effects like shock and bleeding.
According to Lance Becker, who was at the meeting as an expert consultant, the mood in the room was tense. Becker tried to persuade the panel that hypothermia was worth the risk. Of course the studies were relatively small, he argued, since most cardiac arrest patients die before they even reach the hospital. He pushed on, saying that the two studies, together, provided more evidence of benefit than existed for many other, more accepted therapies. Another consultant, Dr. Joseph Ornato from Virginia Commonwealth University, backed Becker, saying the European and Australian studies were well-designed, and that it would be wrong—and extremely difficult—to wait for larger studies.
But the enthusiasm had gone out of the room. A third consultant, Dr. John Somberg from Cornell, was blunt. “Forget about their being in the New England Journal. I just do not believe these two studies meet any FDA advisory standard of approval.” Somberg, who was a former member of the FDA committee making the decision, went on to compare the two studies to a poorly balanced stack of cards. In the end, his opinion carried the day. Despite the efforts of doctors like Stephan Mayer, hypothermia would not become standard of care. The Ice Doctors had lost this battle.
Reached by phone four years later, Swain still hadn’t changed her mind. She told us that even at modest temperature levels the benefits of hypothermia do not outweigh the risks.
You may be wondering why I included this losing battle by the Ice Doctors. Well, herein lays one of the great challenges of medicine. When does an experimental treatment become a standard tool in the doctor’s bag? Move too slowly, and you’re holding back a treatment that could save thousands of lives. Move too quickly, and you might miss side effects. Look what happened in the case of Vioxx. The FDA approved Vioxx as an anti-arthritis medication, only to take it off the market five years later, when it became apparent that the drug was linked to heart problems. The FDA says Vioxx probably caused more than 88,000 heart attacks, in all. Maybe they all could have been avoided if the FDA had waited for more evidence before agreeing that the drug was safe.
Of course, critics like Swain and Somberg say the research on hypothermia is thin, and considering the potential risks, not enough to justify its widespread use. But there are major hurdles to actually doing more studies. In a true Catch-22, in 2008 the National Institutes of Health rejected a proposed study at Duke that would have tested therapeutic cooling against a non-cooling regimen, on the grounds that it wouldn’t be ethical to withhold cooling. If you think it’s confusing—you’re right. You’ve got the FDA saying it’s wrong to cool cardiac arrest patients because we don’t know if it works, the AHA saying it’s probably a good idea to use the treatment and the NIH saying the evidence is so strong, it’s unethical NOT to cool them.
Whatever the reason, hospitals and doctors in the United States have been slow to adopt the treatment. Medivance, which makes the most widely used therapeutic cooling pads, says that just a few hundred U.S. hospitals—of nearly 6,000 total—have even installed the necessary equipment. This sluggish response is especially bewildering, considering the lifesaving success that’s taken place in institutions that do adapt the use of cooling. Just one example: after making hypothermia a standard protocol, in 2005, the University of Richmond Hospital reported that the death rate for cardiac arrest patients was cut in half.
I was incredulous that this lifesaving treatment could be ignored by so many. As I described it to my friends and colleagues, they thought it was outrageous. What was the reason? Raina Merchant, a physician and researcher at the Center for Resuscitation Science, tried to explain. Merchant has conducted a number of studies and surveys, talking to hospitals and doctors about their use of hypothermia and other therapies. She is 31 years old, an accomplished physician, but she looks almost like an undergraduate—petite, with studious glasses. She was dressed in a neat black dress. She is African-American, which stands out in the world of leading emergency physicians and cardiologists. I started right into it: why don’t more doctors use hypothermia, when the evidence seems to show it’s a lifesaver? “At first, we used to think it was because it wasn’t in the guidelines. But now, since 2005, we have that.” By this Merchant was talking about the modest recommendation from the American Heart Association. You might think it costs too much, but according to Merchant, that’s not the problem either.
When I take non-physicians to an ICU and show them the hypothermia equipment, they are always a bit surprised. I think they imagine futuristic ice tubs with bluish solutions coursing through the patient’s blood stream. The truth is, hypothermia is not especially high-tech. Doctors either pump cool saline or fresh water through a patient’s veins, or wrap cold solution-filled pads around the torso and extremities. Picture the opposite of a hot water bottle.
To be fair, the box used to cool and pump the iced slurry solution costs about $25,000. But even if $25,000 sounds like a lot of money, compared to therapies like dialysis, it’s cheap. Cost-benefit studies showed it would actually save money. Merchant told me, “If you cool even one patient and avoid complications, you save more than the cost of dozens of boxes. It’s cheaper to cool, than not to cool.” And even the box isn’t absolutely necessary. Ice bags will do the trick, although it’s harder to control the temperature. According to Lance Becker, for years heart surgeons in Russia would pack a patient’s chest cavity with ice until it was cold enough to stop the heart. Fritz Sterz, the Austrian anesthesiologist who pioneered the use of hypothermia in Europe, tells of a case where he used bags of frozen vegetables from a grocery freezer to cool a patient who had collapsed in a grocery aisle.
In other words, it is a recommended, rather cost-effective therapy. I had to ask: “What am I missing here?” In Merchant’s view, the biggest hurdle to widespread use of hypothermia is a psychological one. Her colleague in the Upenn emergency department, Dr. Ben Abella, explained. “It’s a paradigm shift,” he told me. “We’re using this for people whose eyes are yellow, they’re not moving, and you’re telling doctors to cool these people for 24 hours—then warm them up for a day, then take them to the cath lab. You’re doing all these things for people who look dead, sound dead and act dead. It’s asking a lot.”
It may be that lack of hope leads to inertia and apathy, but as I dug deeper, I found even more reasons therapeutic hypothermia has been slow to catch on. Here’s one that will probably make you angry: using hypothermia might be inexpensive and effective, but it isn’t nearly as simple as rolling out a new miracle drug. In this case, being inexpensive is not necessarily an asset, but a potential liability. For example, let’s say you’ve invented this new medication. You run studies comparing the new pill to a placebo, publish the results, and then—assuming it works—you send the sales team to tell physicians about it. If they’re convinced, they start writing prescriptions. There is no doubt money to be made.
By contrast, a single doctor, as compared to a big company, no matter how motivated, can’t just start writing prescriptions for hypothermia. He or she has to convince a hospital to buy the equipment; it might not be terribly expensive as medical equipment goes, but it’s enough that a purchasing committee needs to get involved. And it gets even more complicated. A cardiac arrest patient is as likely to be treated as a neurology patient as a cardiology patient, and in either case he or she almost certainly starts in the emergency department. All three of those departments have to not only agree that hypothermia is useful; they have to agree on where to get the money to buy the gear. Then they have to figure out a protocol for identifying patients who would be helped by the treatment—and train people to do it properly. This would be hard enough in a single hospital department; with two or three departments involved it can be a bit like herding cats. Even a good idea, without the millions of dollars that are often backing a new drug, have a hard time getting off the ground. There is a sometimes ugly underbelly of medical progress, and this is just one example of it.
On the UPenn website, Becker and his colleagues have posted the hypothermia protocols from more than two dozen medical centers. There’s no special qualification; someone just has to be willing to email the institution’s guidelines. Since setting up the website, the Center for Resuscitation Science has received thousands of emails from hospitals who want to set up their own hypothermia programs. The hope is that by making the details easily and publically available, they’ll inspire others to start—and take away the excuse that it’s all too complicated.
You see, what Raina Merchant found is that the most common reason that hospitals start using hypothermia is when there’s a doctor, or even a nurse, who knows about hypothermia and talks it up among their colleagues. If there’s no local champion, no one gets cooled. Like a lot of things in medicine, it boils down to word of mouth. The squeaky wheel. Simply put, despite all the technology and years of studies, hypothermia still needs champions like Stephen Mayer.
In early 2009, the New York Fire Department started a bold new experiment, cooling cardiac arrest patients in the field. “The plan is to make therapeutic hypothermia the first thing out of the bag, right after defibrillation,” says FDNY Medical Director John Freese. “Once we get the breathing tube and an IV placed, we’ll just give everyone two liters of cooled saline.”27
In preparation, Freese has had to identify which hospitals are able to efficiently cool patients coming in from the field. After all, it would make no sense to cool a cardiac arrest victim in their home, only to let them warm up 30 minutes later when they reach the hospital. The process has not been tension-free. There was shouting at one meeting, when the head of a major hospital group said he didn’t want to publically compare survival rates at different hospitals—it might embarrass someone. Still, similar efforts are underway in Arizona, Wisconsin and Seattle.
Lance Becker insists that doubters are missing the forest for the trees, that whatever side effects exist are minimal in contrast to the life preserving power of cold. “No matter which direction you go, whether you’re conservative or aggressive, we know it will save people’s lives. How many lives have lost, because we delayed implementing this for a year or two? I have to think that we’ve lost lives, because we’ve failed to move aggressively.”
The practice of medicine is changing constantly. The innovation isn’t always for the better—ask one of the women who took thalidomide in the 1960s, to ward off morning sickness. And innovation is never easy—most of the first heart transplant patients died within hours or days. But the next round of transplants went better, and then better, and today thousands of heart transplant patients live rich lives because of the bold pioneers of the 50s and 60s, and their brave subjects. What I have learned is that this cycle: desperation, desperate measure, apparent miracle, insight, common practice—shifts the line in the sand. That’s how medicine moves forward.
From the book, Cheating Death: The Doctors and Medical Miracles that Are Saving Lives Against All Odds by Sanjay Gupta, MD. Copyright © 2008 by Sanjay Gupta, MD. Reprinted by permission of Grand Central Publishing, New York, NY. All rights reserved.
Sanjay Gupta, MD, is a practicing neurosurgeon and associate chief of neurosurgery at Grady Memorial Hospital and assistant professor at Emory University Hospital in Atlanta. He is Chief Medical Correspondent at CNN, a columnist for Time Magazine, and a contributor to 60 Minutes and The CBS Evening News with Katie Couric. For more information, you can visit: http://drgupta.cnn.com/H35