Advantages and Safety of Clinical Research

By Henry J. Heimlich, M.D.
President, The Heimlich Institute

I would like to talk about what can be done with clinical research and why clinical research can not only be much more successful than any animal research, but how it can be done safely.

The Heimlich Institute sounds very impressive. We're proud of our work, but I'd like you to know there are only four of us. We carry out research, however, around the country and in other countries, at different institutions. What I'll tell you may seem very simple because you're seeing the finished product. Please bear in mind that the things told in moments, and the decisions seemingly made in moments, have taken many years to come to fruition, in several of these cases.

The reversed gastric tube operation, the Heimlich operation for replacement of the esophagus, which I came out with in the 1950s, is very simple. It is a matter of replacing the esophagus by making two tubes out of the stomach, which is really one large tube, and carrying the blood supply with the part of the stomach that will become the new esophagus. The new tube is made from the stomach, by inserting a double row of staples and cutting between them. Then you rotate this tube upward and join it to the throat and the new tube becomes the new esophagus. The old diseased esophagus is closed off and the person can eat normally.

I am pleased to say when I go to children's hospitals today that invariably the surgeons there tell me they used my esophageal replacement operation the previous week, most often on birth defects — congenital defects of the esophagus that have prevented swallowing and which, prior to this operation, required feeding through a gastrostomy tube. I'd like to tell you that I first did do this operation in a dog because that's the way I was trained to do things. I well remember, though, not only the anguish I had for the animal we used but also, in the laboratory where I then worked, seeing a half dozen little puppies whose backs had been broken. They were paraplegic and dragging their hind legs behind them and I can tell you that I never heard of anything coming out of the experiments on those dogs. Nothing at all. As I look back, we could have very easily first performed the esophagus operation on the first patient since he had inoperable, incurable carcinoma. It was so sound logically and physiologically that there should have been no objection.

The next thing I'd like to mention is what is known as the Heimlich Chest Drainage Valve. In writing a book at one point in the 1960s, I was describing the apparatus that's used in the hospitals to drain the chest after chest surgery. It requires suction and a complicated multi-chamber device that's expensive. In describing it, I said the fluid and air came out through the chest tube after surgery, but cannot flow back because of this complicated device, just like a valve. It was a simple step, then, to devise a valve which could replace the complicated system. As the lung expands, acting like the piston of a pump, it pumps out air and fluid from the chest and the valve prevents air and fluid from getting back into the chest, so the lung will not collapse.

The Heimlich Chest Drainage Valve was used extensively in our war in Vietnam and saved thousands of lives. You may be interested to know that in 1967, I rushed a case of these valves to an airport in New York where they were flown here to Israel and were extensively used in the '67 war and thereafter. In fact, every emergency kit today in this country and in most countries contains the valve. A simple plastic device.

An ordinary chest tube is attached to the valve. On the battle field, the tube is inserted into the chest through the bullet wound, a dressing is placed around it, and the valve is attached to the tube so that the air and fluid can flow out and nothing can flow back in. How was that tested? After being convinced it was a sound concept, I bought a simple toy, a flattened tubing — we call them a "Bronx cheer" in New York. When you blow on them, they make a razzing noise. It was the equivalent of a flutter valve. I attached it to tubing and sterilized it. When a patient came with a collapsed lung from pneumothorax, air in the chest, I simply attached this valve to his chest tube and sat with him all day, and it worked.

No animal experiments were required, and no other studies. I was able to convince the Becton Dickinson Company (B-D) to manufacture the valve and it has since been distributed in the hundreds of thousands a year.

A more recent device that we've been involved with has to do with giving oxygen to patients who have emphysema and other chronic lung disease. You've seen people with tubes around the head and the oxygen going in through prongs in the nose, nasal canulas. They're very irritating to the patient's nostrils.

But in addition, you see these patients struggling for each breath. Why are they struggling? Because, with every breath, they've got to suck the oxygen through what we call the dead space, from the nose on down to the chest. They are tied down to big tanks. Why? Because so much of the oxygen, 50–80 percent, is lost coming back out the nose and mouth.

As a chest surgeon, I knew that when a patient is not breathing well you perform a tracheotomy. A tracheostomy tube is inserted into the trachea, and they immediately breathe easy because you bypass the dead space, i.e., the patient does not have to suck air through the throat and larynx to get oxygen into the lungs. You can also get oxygen directly into the lungs by putting a catheter into the tracheostomy tube, and can suction out secretions that block parts of the lung.

The problem with a tracheostomy is that a person cannot speak and it's an opening through which contamination can get in and cause pulmonary infections. To overcome these problems, yet retain the benefits of tracheostomy, I simply created a small device, the size of an intravenous catheter, a very tiny tube that is put into the trachea under local anesthesia, directly into the airway. It's held in place with a jewelry chain around the neck. Through this catheter you can administer oxygen directly into the lungs so the patient breathes normally without straining. You're also not wasting oxygen, since all the oxygen goes into the lungs, so a small container can last a whole day. There is no opening, and therefore, the patient speaks normally and contaminants can not enter.¹

When the patient is dressed, you don't know that he's taking oxygen because the tube runs under the clothes and out to the container. He carries a small container which will now last a good part of the day. These patients are made mobile and also, their appearance, of course, is improved. This was the first patient with a Heimlich Micro-Trach, and I can tell you, I didn't do any dogs before him. What would we have learned — and I know the demand was there to do it in dogs — what would we have learned by putting a tube into dogs? Absolutely nothing. We've been doing tracheostomies for years, a much more major operation. People have plastic tracheostomy tubes for years when their larynx has been removed for carcinoma. In 1980, we went ahead and did the procedure on a patient who now carries a small oxygen container in her purse.

We have treated hundreds of these patients and the procedure is being done around the country in large numbers and is approved by the FDA. We found that by putting a little sterile saline solution into the Heimlich Micro Trach, it forces a cough that expels secretions and also loosens the mucus. It seemed logical — logic is the important factor — that if we used this method in cystic fibrosis (CF), it would clear out the secretions that kill CF patients. Ninety-eight percent of CF children die due to the thick secretions in the lungs that block the lungs, causing infection and destroying the lungs. They die mostly in childhood or adolescence. Some now get to over age 20. So if you put the Micro Trach into a cystic fibrosis patient and they squirt a little saline through it, it obviously loosens the secretions, which they cough up.

In the last year-and-a-half, we have enlisted six cystic fibrosis centers in children's hospitals at universities around the United States — and we'll be happy to do it here in Israel, if you wish — and we have started treating these children. What sense would there have been to try to do animal experiments? It was possible to go to the internal review boards (IRB's) of these institutions, which decide whether you can do human "experimentation," and they all agreed that we could go ahead and do it. The logic was there. It is possible to convince the people in these clinical areas to proceed with a previously untried procedure, if you can show the logic and can convince them of the importance.

The CF project has progressed well enough so that we are now expanding to 5 or 6 more CF centers and by the end of the year, we will have collected enough data — no animal experimentation — enough data to have proved the procedure that is literally turning lives around for these children.

Well, let's come to the Heimlich Maneuver for choking. There was great pressure to do animal experiments for this. But what we did was very simple.

The Maneuver is performed by pressing upward under the diaphragm. How did we prove it? Again, dogs were unnecessary! We put a tight fitting mouthpiece in the subject's mouth, put a clip on the nose, attached the mouthpiece to an ordinary clinical respirometer, did the Maneuver, and got flow and pressure charts from which we derived the energy produced. We learned that you can expel 215 liters of air per minute by doing the Heimlich Maneuver, pushing up on the diaphragm and compressing the lungs. My associate, Dr. Edward Patrick, found that the energy produced by the Maneuver was sufficient to expel a choking object out the mouth. It was as simple as that.²

We also know that the methods that were being used on choking victims — hitting on the back and putting a finger in the throat — were all driving the object tighter into the airway, whereas the flow of air resulting from the Heimlich Maneuver caused a choking object to always move toward the mouth, away from the lungs.

But I have to tell you that for 35 to 40 years, doctors from the American Red Cross and Heart Association had been recommending putting a finger into the throat and using backslaps on choking victims and they weren't about to say they had been wrong all this time, even though all the medical literature said they were wrong. One of them took six humans and six baboons, and anaesthetized them, and he said "I put a piece of meat in their throat to test the Heimlich Maneuver and the other methods." And he said "I tied a string to the meat to pull it out if it didn't work." Well, at least he gave the baboons and the human subjects equal chances, but I'm sorry to say he also reported that one of the baboons had been fed before this was done and he vomited and aspirated and died. Totally useless.

We went through the other methods of doing the Maneuver that were obvious — no need to test them, except on people. If one can't reach around a choking person, then the rescuer places the choking person in the supine position (on his back), which enables the rescuer to use his weight to perform the Maneuver.

I'm going to take more time with this one because I think it's the perfect example of what we've heard this morning and what this meeting is about. I first described and published the Heimlich Maneuver in 1974, calling it "subdiaphragmatic pressure." In three months, it had saved enough lives so that the editors of the Journal of the American Medical Association (JAMA) named it the Heimlich Maneuver. I had published the method in a medical journal. Then I did something which at that time would have been considered unethical — I had the publisher notify the press of this procedure.

Today, doctors in the States have advertisements in the newspapers, but at that time, if your name was in the newspaper, it was terrible. The purpose of the publicity was to discover whether it would be successful and not harm anybody. What was quoted in the newspaper was the same thing as in the scientific article: "We don't know if this method of pressing up under the diaphragm will work, but your alternative is to let a person die when they choke or to slit open their throat on the spot and do a tracheotomy." It was, thereby, disseminated to millions of people — and that's the way a vaccine is tested — it was a clinical, research test. The millions of people knew, "either let 'em die or you can try this." And within a week, we started receiving reports resulting from these newspaper stories, of lives being saved with the Maneuver and those reports led the newspapers to say "We have saved a life from our previous story." That's how the method became widely disseminated. Another form of clinical research. We also got reports very shortly after the Heimlich Maneuver came out, within the first year, of the Maneuver saving drowning victims who had not recovered with the Red Cross, Heart Association recommended methods. They recommend doing mouth-to-mouth resuscitation as the first step in rescuing a drowning victim. The reports we received were from topnotch first-aiders. They said, "I did the Heimlich Maneuver and water from the lungs gushed out of the mouth and the person recovered." We finally got reports from the chief fire-surgeon of Washington, D.C., a fire chief in Florida, authoritative people, showing that drowning victims were saved by the Heimlich Maneuver after mouth-to-mouth failed, by getting the water out of the lungs.³

I come back to the report we heard this morning. The typical thing was "Well, those are anecdotal reports." If you want to belittle a report and say "Go back and use animals," you say, "That is an anecdotal report." But it's not an anecdotal report if it's the chief fire surgeon of Washington, D.C., who is an advisor to the Red Cross on water safety. So we had to go on and collect more cases and look into why the Maneuver was saving lives, and what we found was that a mistake had been made in 1960, 30 years ago.

Prior to that time, the methods of saving lives were pressing on the lower back with the person lying out flat, called artificial respiration, rolling a person over a barrel, or draping a person over a horse and trotting the horse. We now realize that each of these methods were crude Heimlich Maneuvers. They were intermittently pushing up on the diaphragm.

In 1960, the American Red Cross and American Heart Association came up with mouth-to-mouth resuscitation and they said, "This is the best form of artificial respiration. This is the best way to get air into the lungs." That may have been true for heart attacks, but they forgot that the lungs of drowning victims are filled with water. And when the lungs are filled with water, you can blow all day and not get the air, the oxygen, down to the part of the lung where it will absorb into the bloodstream.

We didn't have to do animal experiments. We didn't have to do expensive experiments. There's a logic in research. Again, as was mentioned this morning, you get the idea that is the solution and then you prove it.

You've all done this experiment as children, I'm sure. You put a straw into a glass of fluid, and put your finger over the straw. Take the straw out of the fluid and the fluid remains in the straw, because as the fluid descends a little bit, it creates a vacuum above compared to the outside atmospheric pressure. That is why if a person has drowned or near drowned and you tilt their hips upward, the water will not come out of the lungs.

If you take that same straw with fluid in it and your finger covering one end and put the other open end in your mouth, you can blow all day and your air is not going to get to your finger, or comparably, to the lung. When you blow, you'll see the fluid move, and if you do mouth-to-mouth, you'll see the chest move, but your air is not getting into the lungs, just the water is moving. If you squeeze the straw, the fluid will come out. In the same way, if you do the Heimlich Maneuver and push up on the diaphragm, the fluid will be squeezed out of the lungs. That's why these people are recovering and why the Maneuver should be the first thing used to save drowning victims. If they don't recover after the water stops flowing out of the lungs, then you can do mouth-to-mouth, but first you've got to squeeze the water out of the lungs.

You use the Heimlich Maneuver for drowning in the same supine position as for choking, with the victim lying on his or her back. Your hands are in the same position under the rib cage. For a choking victim, however, you leave the victim's face as it falls naturally, facing upward, because if you turn the head and there's a solid object in the throat, it can't get out of the twisted throat. For rescuing drowning persons, you turn the victim's face to the side so that the water that comes out of the lungs flows out the mouth.

I learned a lot this morning in finding out why people do animal experiments after clinical work is completed. As I've studied drownings, I found some terrible, terrible things.

I read to you from a paper by a Cleveland Clinic physician, published in 1987.⁴ It has long been known that with seawater drownings, if the person recovers, they have less lung damage than after freshwater drownings (freshwater damages the lungs). So Dr. Orlowsky said, maybe, if the tonicity of swimming pool water could be altered to a solution less injurious to the lungs, improved survival of and ability to resuscitate near-drowning victims might result. He said "We anaesthetized 33 mongrel dogs, then instilled the drowning fluid down the endotracheal tube using a hypotonic saline solution that would not destroy or inactivate surfactin and would move out into the alveoli." He said that it looked like, maybe, if you put salt in swimming pool water, it would help avoid late deaths of people who near-drowned and were rescued. Dr. Orlowski said, "it would cost approximately $60 to convert an average 50,000 gallon swimming pool to a .225% sodium chloride. However, the effects of the sodium chloride on metallic pipe fittings, pumps and heaters would have to be addressed." Why not address the pumps and the pipes before you drown 33 dogs? How ridiculous.

The following is from a paper by a Pittsburgh physician, "Resuscitation Following Freshwater or Seawater Aspiration":⁵ "Pilot experiments were performed on 13 unanesthetized dogs whose lungs were flooded by pouring water through a funnel into a cuffed tracheostomy tube. In these well-oxygenated dogs, which were breathing normally, the lungs were flooded with seawater and drained 60 seconds later. The dogs struggled, showed later some signs of pulmonary edema. Spontaneous recovery did not occur if flooding was continued until profound arterial hypotension had developed. Because of the species variation, which you heard about from Dr. Gordon, we cannot tell whether the same pattern may occur in man. It is unlikely, however, that in man, breathing movements continue that long." After going through dozens of other dogs, in the same study, and taking other people's studies, this is his conclusion: "These data cannot simply be applied to man. They suggest, however, that resuscitative efforts in the rescuing of drowning victims must consist of more than rescue breathing." If you look at these papers and many others, you'll find in the back of them references describing drowning hundreds of dogs with similar ridiculous results.

This useless sacrificial research can be stopped if we take time, and use the press, which is very friendly. An article I wrote appeared in all the papers in Florida at a time when an anesthesiologist at the University of Florida was preparing to drown 42 dogs in order to study the Heimlich Maneuver. This was after the Maneuver had been approved for saving drowning victims by the American Red Cross and American Heart Association, after many saves had been reported. These are some of the words I used: "Firstly, let me state unequivocally, this experiment is unnecessary and it is cruel. All scientists engaged in research are beholden to prevent unnecessary loss of life, both human and animal. To do otherwise is to jeopardize our right and privilege to conduct research."

Then on February 12, the University of Florida Committee on Care and Use of Laboratory Animals (in the usual peer review, with peers reviewing themselves) approved the plan to drown 42 dogs. After the pressure came from animal rights groups, suddenly the experiment didn't need 42 dogs to prove the research goal, it was reduced to 22 dogs in order to test the use of the Heimlich Maneuver to remove water from the lungs of drowning victims. Why, then, were 42 dogs needed originally? Please note that the committee does not address the question, "If the researchers are permitted to drown 42 dogs, will this produce scientific results of value for humans?"

I made the following statement in the press: Drowning 42 dogs is unlike human accidental drownings and will not yield significant results for the following reasons:

Dr. Modell's dogs are to be anaesthetized. People who drown are not anaesthetized. Anesthesia diminishes the rate and depth of respiration and causes other physiological changes.

 

It has not been explained how a dog's breathing and heartbeat will be arrested, as occurs in drowning.

 

Dr. Modell intends to put water into the lungs and stomachs of dogs through a tube. People, when drowning, cough, gasp and inhale deeply, flooding the lungs with water. The situations are entirely different.

 

How much water will Dr. Modell put into the animals' lungs? A small amount of water will not endanger a dog's life and may not be expelled by the Heimlich Maneuver. An extra large volume of water in the stomach will cause vomiting, with or without the Heimlich Maneuver. The result will, therefore, be based on the experimenter's bias.

 

How do you perform mouth-to-mouth resuscitation on dogs? If done through a tube inserted into the windpipe, it bears no relationship to human resuscitation. In humans, much air goes into the stomach during mouth-to-mouth, even to the extent of bursting the stomach, especially in drowning victims, because water blocks portions of the lungs.

 

And we beat them!

Questions

Question: Is it easier to obtain research funds for animal-related research?

Answer: I know people think that for some reason, our institute has all kinds of research funds. We don't. We get them mostly by private and semi-public foundations around the United States. I've had one government research grant. The problem is that if you are creative or innovative and have something that has not been tried before, it's very difficult to get government funds. If you're not a huge university institution, it's difficult. The reason is that they will give large grants to the so-called "safe" procedures, the ones they've been working on for years and years, like injecting all kinds of junk against cancer into animals.

I intended to apply to the National Cancer Institute for a procedure for otherwise incurable cancer that I know has some merit. They invited me to present the project, after which the head of the committee turned to me and said "If you do this in animals, I'm sure we'll be able to give you some money for it." It was that quick and that was it. Instead, we are using this procedure in two or three other countries, and it has merit.

I'd like to tell you about another piece of research we're doing and, again, with a certain type of thinking, you can convince people, I'm sure, that animal research is not necessary. You won't convince those who get the big grants for using animals.

I don't know how many of you know about Lyme disease. It is the fastest-spreading disease in the world today. It's caused by the bite of a tick. Lyme Disease has been present in Scandinavia and Northern parts of Europe, but unknown as an isolated disease, as a definitive disease, for 100 years. It is the fastest spreading disease throughout Europe, Asia, and the United States, particularly. In all the northeastern United States, this tick is present in the lawn. This particular tick is spreading by being carried on birds and other animals.

The tick bite injects spirochetes, corkscrew-shaped bacteria. The spirochete is identical morphologically to the spirochete that causes syphilis. The DNA of each is different. The symptoms of the disease are identical. It infects the skin first and then there are two later stages, wherein it gets to the brain and spinal cord. It's a horrible disease that causes mental changes, severe headaches, joint pains, paralysis, blindness, and total disability. If you catch it in the first stage, the skin stage, you can cure some patients with massive doses of antibiotics, but you can't catch it early in more than 50% of infected people because there's no visible evidence of it after the tick bite. You pick this tick up off your lawn or from your dog, who carries it. It affects adults and children and it's congenital, it passes on through the placenta.

I'm fortunately old enough to have recalled that neurosyphilis, syphilis of the brain and spinal cord, was frequently incurable, both with the arsenical drugs prior to antibiotics and with antibiotics, because the drugs cannot get into the nerve cells to destroy the spirochetes, and the spirochetes survive for months and years, with acute exacerbations that eventually destroy the person's life. In 1917, a paper was published by Wagner-Jauregg, a Hungarian in Vienna. He gave a curable form of malaria, benign tertian malaria, Plasmodium vivax, to neurosyphilis patients, and let the malaria fever run every other day for two to three weeks. That cured the neurosyphilis, killed all the spirochetes, then the malaria was cured with quinine within a few hours. He won the 1927 Nobel Prize for that discovery. Malaria therapy continued for 20 to 30 years after antibiotics, until 1960–1970, at which time it had wiped out neurosyphilis.

Since Lyme disease and syphilis are both caused by spirochetes, have the same three stages, and cannot be cured with antibiotics after the first stage, it was logical to conclude that Lyme disease may be cured using malaria therapy. After peer review, I published this method in the April 26, 1990 New England Journal of Medicine.

[Addendum: The first Lyme disease patients are being treated with malaria therapy. All were severely disabled with painful arthritis and neurological disorders for up to nine years, despite years of intravenous antibiotics. Remission of symptoms, temporary or prolonged, has occurred, indicating that further studies are warranted to determine how malaria therapy has produced these favorable results.]

Question: Why wasn't the Heimlich Maneuver developed and accepted 100 years ago?

Answer: I don't know. I guess no one thought of it. There were interesting things. After I came out with it, I received a letter from a Police Chief who mentioned that 30-some-odd years before, his 6-year-old son was choking and he was rushing to get help and he fell on the child and it popped the object out. As a matter of fact, the Heimlich Maneuver, by the way, again, for your interest, is saving a lot of animals. It does work in animals. We have reports of dogs and cats who were choking, who have been saved.

Question: In the artificial esophagus, what happens to the gastric mucosa and what about hydrochloric acid and enzyme secretion?

Answer: I was at a medical meeting in 1950, and they were describing that the method of removing a cancer of the lower esophagus and enabling them to swallow was to bring the stomach up and anastomose it, join it to the esophagus in the chest. They reported that the acid from the stomach regurgitated up into the esophagus and caused severe inflammation, and eventually stricture, bleeding and ulceration. At that moment, I recalled that the upper part of the stomach, the cardia, secretes acid. The lower part of the stomach, the antrum, does not secrete much acid. It is a non-acid-secreting part of the stomach. So my original concept was not to replace the esophagus. I was trying to think of how you could get the antrum up, the non-acid-secreting part of the stomach, to join it to the esophagus, rather than using the cardia which secreted all the acid. The method I desired turned out to enable replacement of the esophagus — the first time in history an organ had been totally replaced.

Just as an aside, I was at a medical meeting when I first considered this possibility. I had lunch with the chief of our chest surgical department and drew my operation for him on a napkin. He said, "Ah, I don't know if that's so good, if that'll do anything." The usual reaction. It was then that I went to another institution and got permission to do the procedure.

Question: In the Israeli Army they teach paramedics how to introduce a trocar catheter on dogs. What would be your response to that, Dr. Heimlich?

Answer: I don't know what the trocar catheter is for. Is that for oxygen? I might just say, I had a wonderful experience in 1977. I came at the invitation of the Israeli Army because they had used my valve so much. Every place they took me, to the underground bunkers, to the Sinai, every first aid kit had the Heimlich Valve on top.

Regarding training the military, several things have happened in the States. Just a few months ago, I don't recall exactly when, I read in the newspapers that, at two centers in the States, they had been shooting goats through the thigh to teach military doctors to repair such bullet wounds. This newspaper article was about the fact that such methods had now been eliminated at one of these centers and it was just a matter of time before it would be eliminated at the other. In particular answer to your question, I saw a television program just a couple of weeks ago and they showed that the Pentagon, the military surgeons and nurses, are now being attached to civilian emergency rooms in hospitals, particularly in Washington, where, it showed, it's like a battlefield anyway.

Certainly, they're going to learn a lot more by just waiting until the patient comes in who needs the valve. If they're there long enough, they're going to see it put in. But I can tell you that without any training at all, corpsmen in Vietnam simply knew to put it in and put a dressing around it. They had no training at all, and certainly not on animals. There wasn't time for that. And a doctor one time wrote me that of 34 men shot in the chest on Hill 881, 32 got off alive with the Heimlich Valves draining chest wounds. So, I just think the use of animals is an exercise that can be avoided. I don't think it has any great value.

[Note: During the course of this meeting, I met with the Senior Medical Officer of the Israeli army. He agreed that he would eliminate inserting chest tubes into dogs.]

References

1. Heimlich, H.J.: Oxygen delivery for ambulatory patients. How the Micro-Trach increases mobility. Postgraduate Medicine 84:68–79, 1988.

2. Heimlich, H.J. and Patrick, E.A.: The Heimlich Maneuver. Best technique for saving any choking victim's life. Postgraduate Medicine 87:38–53, 1990.

3. Heimlich, H.J. and Patrick, E.A.: Using the Heimlich Maneuver to save near-drowning victims. Postgraduate Medicine 88:62–73, 1988.

4. Orlowski, J.P.: Effects of tonicities of saline solutions on pulmonary injury in drowning. Critical Care Medicine 15:126–130, 1987.

5. Safar, P.: Resuscitation following fresh-water or sea-water aspiration. Acta Aesthesiologica Scandinavica (Suppl) 9:99–107, 1961.