THE MOST IMPORTANT EVENT IN THE HISTORY OF MEDICINE

Created the myth that new medicines are just 'accidental findings'

THE PENICILLIN ‘MYTH’

In May 2017, a paper was published by Robert P. Gaynes, MD.

Titled The Discovery of Penicillin – New Insights After More Than 75 Years of Clinical Use. It presents a dramatic re-interpretation of the penicillin story. It explains in detail how Governments, pharmaceutical companies, physicians, regulators, universities and other key stakeholders worked together collaboratively to bring penicillin to market.

This is in direct contradiction of the commonly held perception that penicillin, and its role in fighting infection for patients globally, was an accidental finding.

The paper explains that while Alexander Fleming discovered strong evidence that a mould he found in a culture dish on return from holiday was killing bacteria, he lacked the skillset to isolate the active ingredient within the mould.

It took over ten years before a team at Oxford University, headed up by Howard Florey, was able to isolate the active ingredient. They were able to make enough to produce small quantities for pre-clinical and clinical trials, which resulted in increased evidence that the compound could beat infection.

They lacked the skills, however, to make the kind of quantities that would be required to service the enormous market awaiting this breakthrough treatment. In June 1941, Florey and his fungal expert colleague Norman Heatley, travelled to the United States.

They meet with Charles Thom and Andrew Jackson Moyer, both with the US Department of Agriculture (forerunner to US FDA). Moyer suggested changes to the manufacturing process that resulted in “exponentially greater amounts of penicillin” being produced.

This led to successful mass production of penicillin to satisfy the demands of the World War II. The article comments

“Unprecedented United States/Great Britain cooperation for penicillin production was incredibly successful.” Moyer applied for a patent of the manufacturing process in 1945, which was granted in 1948.

The paper explains “The Fleming Myth” was down to an article in The Times following an interview with Fleming, but Florey and his staff refused to comment.

This myth has become hard coded into the industry psyche, perpetuating a public illusion that medicines are ‘discovered’ through serendipitous findings of a new molecular entity.

Our vitally important message here is that until a medicine can be manufactured to the scale necessary to supply the projected patient population, if does not exist.

Note also that the patent was awarded to Moyer in 1948 for the manufacturing process – there was no patenting of the molecular compound.

WHAT DOES THIS MEAN FOR THE FUTURE OF MEDICINES?

There is good news, and there not so good news.

On the plus side, it tells us that if Fleming, Oxford University and the USDA (Moyer) had been working together as soon as the discovery was made by Fleming, it would have taken roughly a quarter of the time to get to market. Imagine that!

The not so good news is that pharmaceutical companies don’t want you to know that—not good for the business of creating patent monopolies to market the bones out of and create blockbusters ($1Bn+ sales).

Rest easy though, there is more good news. The penicillin myth, and much, much more, is covered in my book Medicines for the 21st Century: Safe, Better, Cheaper.

Slightly more less than good news, it’s not published yet…

…but it will be soon! More good news to finish with!!!