How A Polish Immigrant In The USA Directed Major Victory Over Hepatitis B

Because they were extracted from human blood, the first-generation hepatitis B vaccines developed in the early 1980s had significant drawbacks, including high cost, low availability, and the possibility of unsuspected contamination (HIV/AIDS). This was the impetus for development of a genetically engineered vaccine against this liver-destroying disease in the late 1980s, the first genetically engineered vaccine of any kind.

Although he never saw the genetically engineered hepatitis B vaccines, without the contribution of Dr. Wolf Szmuness they might never have been developed. As his name suggests, Dr. Szmuness was not an America. The story of how he came to New York City in the 1970s to carry out his life-saving work reads like high fiction.

Wolf Szmuness was born in 1919 into a middle-class Jewish family in Warsaw, Poland. He was a young medical student when in September 1939 the Nazi invasion of his country caused him to flee into Russia.

As for everyone else, life for Wolf during the war was extremely hard. He suffered from malnutrition and tuberculosis, exacerbated by freezing cold and harsh conditions in the coal mines of Siberia while he worked to defeat the Nazis. When the authorities became aware of his medical knowledge, he was put in charge of health matters for his fellow workers, a change of duties which probably helped him and others survive until the end of hostllities.

After the war he remained in Siberia, where he completed his medical degree and met his wife, Maya. The family -- Wolf, Maya and daughter Helana -- later moved to the Ukraine, where Maya nearly died from hepatitis caused by a post-operative blood transfusion. This was the beginning of Dr. Sameness' intense interest in the disease.

In 1959, some two decades after fleeing the Nazis, Dr. Szmuness and family returned to Warsaw with the promise of a good job and a good apartment. However when they arrived, there was neither. Finally he found a job in Lublin and continued his work in public health, epidemiology and, most importantly, hepatitis.

In 1967 the family left Poland for the United States. They arrived at New York's Kennedy International Airport with only a few of dollars in their pockets and virtually no prospects.

Fortunately, Maya quickly found a job in a necktie factory while Wolf, now nearly 50 years old, spent months in a fruitless search. Finally, he was able to secure a job as a laboratory technician at the New York Blood Center. He was quickly given more responsibility and more freedom, then his own laboratory. Within five years, in 1974, the Blood Center created a new Department of Epidemiology especially for Wolf Szmuness to head.

Between 1973 and 1978, Dr. Szmuness ran a series of crucial epidemiological studies to determine who were the people most at risk from hepatitis B, where the major pools of infection existed, how many carriers there were, etc. Through these studies, he discovered that the homosexuals of New York City would provide the idea population for clinical trials on a new hepatitis vaccine.

Why "ideal"?

In the first place, the results of clinical trials on vaccines are expressed statistically; consequently, the chosen population must be large enough to give statistically valid results -- thousands of people, not just a handful. The New York homosexual population was sufficiently large. Additionally, the hepatitis B infection rate among homosexuals was nearly 10 times higher than in the general population.

The clinical trials were an exercise both in medical research and delicate diplomacy. Over the previous few years, New York homosexuals had "come out of the closet", so to speak. However, in the late 1970s the stigma of being homosexual was still great, so many of them did not want the fact of their situation to become too public. Moreover, they were deeply suspicious of being used as "guinea pigs". Nevertheless, once a major public relations effort had convinced them of the legitimacy of the undertaking, they gave full cooperation.

The complexity of the trials, as well as their size and delicacy, sometimes caused Dr. Szmuness to push his team exceptionally hard. But no harder than he pushed himself. Whenever someone complained, he reminded them how lucky they were never to have worked in the coal mines of Siberia, as he had done.

In September 1979, the routine of the trials turned into high drama. Interpretation of clinical data suggested that many more of the volunteers receiving the vaccine were developing hepatitis non-A non-B (today known as hepatitis C) compared to the placebo control group. The question was: Could the vaccine itself be inducing non-A non-B infection?

The moral dilemma was apparent. If there was the slightest chance that the vaccine itself could cause non-A non-B infection, then continuing with the trials would mean condemning some of the volunteers to illness, and even death. However stopping the trials would mean postponing availability of a hepatitis B vaccine for years, condemning many other people to illness and death.

The problem was resolved when an explanation for the anomaly was found.

Since there was no blood test for hepatitis non-A non-B, volunteers in the placebo control group who caught both viruses would probably be diagnosed only for hepatitis B. On the other hand, if the vaccine group were actually being protected against hepatitis B, it was quite normal that statistically they would show a much higher incident of non-A non-B infection. The difference in non-A non-B infection in the two groups was therefore already good evidence that the vaccine was working. The trials continued and the effectiveness of the blood-derived vaccine was firmly established.

Dr. Szmuness once said that he was never happier than when he was conducting these hepatitis B clinical trials. Indeed, he began to feel that his whole life had been a preparation for this work. But he also knew that throughout his life, every time he found happiness, it didn't last. Shortly after completing the trials in 1980, he was diagnosed as having lung cancer. He died in June 1982 at the age of 63.

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