Michael Rosenthal

(3/2021) One of the greatest events in drug development in my lifetime was the creation of penicillin. When I was very young in the 1940s (I was born in December 1939) I developed an ear infection, which had the potential to do terrible things to my health – permanent damage to my hearing and even the chance of death were among the possibilities. To my good fortune, penicillin had just been developed. As I recall, I received 99 shots of penicillin (guess where!), one shot every three hours day and night. It worked! The infection cleared up, and I came out of it with normal hearing. Though I have the usual problem of hearing well against background noise, a common phenomenon with people my age, I have had good hearing all my life without the use of a hearing aid. As I recall, my father offered to reward me $1 per penicillin shot, but I don’t think I ever was successful in collecting it!

Before antibiotics, the smallest injury, a scratch or a blister, could get infected and even lead to death. The penicillin mold was discovered in London in 1928 by the Scottish biologist Alexander Fleming. He tried to extract the mold’s active substance that fought bacteria but was unsuccessful. In 1939 Australian doctor Howard Florey obtained funding from the Rockefeller Foundation in New York to study the substance further at The University of Oxford. His goal was to generate the mold’s active ingredient. It was not an easy task. The mold tended to dissolve in the process of extraction. Florey was eventually successful. Anne Miller was a 33 year old woman who lay delirious in a New Haven hospital in 1942 from septicemia following a miscarriage. Her temperature rose as high as 106 degrees, and no medical procedure known at the time helped her. An experimental drug at the time, a tablespoon of penicillin, was injected into her. Her temperature dropped overnight, and the next day she was up and eating again.

The tablespoon of penicillin that cured Anne Miller was half the amount of the drug available in 1942. Through trial and error, it was determined that penicillin was much more effective in fighting bacteria in animals than were sulfa drugs, which were the treatment for infections at the time. The need for such a drug was great at the time, due to World War II. Many millions of soldiers died from untreatable infections from relatively minor wounds and injuries. So penicillin research went on into the 1940’s, with care being taken to keep the research away from German scientists. Because of the wartime demand in Britain for other drugs, Florey and his colleague, Norman Heatley, made a deal with the Rockefeller Foundation in New York to produce penicillin. The United States had greater drug production capability, and the United States had not yet entered the war. It was 1941, and Florey convinced major United States pharmaceutical firms, Pfizer, Lilly, and Merck among them, to work on production of the drug, and he returned to Oxford. The entry of the United States into the war after Pearl Harbor made the development of the drug much more a necessity. A major scientific breakthrough came when a new method called deep-tank fermentation was developed to extract the penicillin drug from the mold. Further research in the USDA Peoria Lab worked to develop a potent mold that would hold up during the extraction process. Moldy fruit became a mainstay in development of a site for the fungal growth. An assistant lab researcher named Mary Hunt was the principal searcher for the best mold, and she earned the nickname Moldy Mary. By 1943 penicillin production became the number two priority of the U.S. War Department after the atom bomb project and to prepare for the D-Day invasion. There was soon enough penicillin being produced, 100 billion units per month, to treat every Allied casualty.

New drug development continues. The world’s deadliest infectious disease is…Tuberculosis! Though we don’t have that many cases in the United States, in 2017 it was reported by the World Health Organization that some 10 million people developed active tuberculosis and that 1.6 million people died from it. The disease, often called TB, is caused by a bacterium that has highly drug-resistant strains. It is curable, but requires a lot of pills, and drug-resistant strains have been developing.

A new antibiotic, Pretomanid, has been developed, has been approved by the FDA, and in combination with two other drugs, is a hope that tuberculosis might be brought under control.

Pretomanid is the second drug to utilize a special regulatory pathway at the Food and Drug Administration. The Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) was established by Congress in the 21st Century Cures Act in 2016 to speed development and approval of antibiotics to treat serious of life-threatening infections in a limited population of patients.

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One of the best sources of energy in my mind is wind power. It is as natural as can be, and utilization has minimal impact on the environment. There are those persons, as I’ve previously mentioned, who find the sight of wind energy generation unattractive. This is particularly true along the coast in New England.

The Empire State (that’s New York) Realty Trust has announced that it has made a major purchase of wind power from Green Mountain Energy and Direct Energy. This organization has been moving toward use of renewable energy in New York. The latest development is the Empire State Building and 13 other office buildings are now powered solely by wind. The Empire State Building has run on renewable energy since 2011. This commitment will avoid the production of some 450 million pounds of carbon dioxide, CO2, the equivalent of the emission of all of New York taxi cabs for a year.

Wind has become the most-used renewable energy source in the United States, generating about 9 percent of the nations’ energy last year. New wind power facilities are cheaper to build and to operate than almost all kinds of fossil fuel infrastructure. The vast majority of electricity generated in New York State currently comes from natural gas-fired and from nuclear power plants. However in 2019 New York passed legislation committing to meet 70 percent of its energy needs with renewable sources by the end of the decade, aiming to eliminate greenhouse gas emissions from is electric grid by 2040.

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