The penicillin story is well known. For those that need reminding, the mother of all antibiotics was discovered in 1928 by Alexander Fleming. On his return from holiday, he noticed that in one of his agar plates, bacteria had not grown. He obtained an extract from the mould in the plate, naming it ‘penicillin‘. The rest is history…or is it?

…actually, no. The REAL story goes like this[i].

Fleming did not have the wherewithal to properly identify the mould strain or make it in any quantity. It took a team at Oxford University, headed by a gentleman named Howard Florey, to purify enough penicillin to run pre-clinical (1939) and clinical (1941) studies. They were a great success, but they didn’t know how to make sufficient quantities to supply the market.

In 1941, Florey and a fungal expert, Norman Heatley, visited the US to mull over the problem. The scenario was put to a microbiologist named Andrew J Moyer, an expert in moulds, working at USDAs Northern Regional Research Laboratory in Peoria, Illinois. He and his team came up with the idea “to culture the penicillin in a mixture of corn steep liquor and lactose, thereby greatly increasing the yields and production rate.”[ii]

Moyer applied for a patent in May 1945, which was awarded three years later.[iii] He was inducted into the National Inventors Hall of Fame in 1987.

So why did the myth persist?

An article in The Times reported the breakthrough in Oxford, but failed to mention Fleming or Florey. Fleming’s boss wrote to The Times, extolling his virtues and Fleming talked freely to the press at the time. Florey didn’t say a dicky bird to the press. So the real account of it was never told.

To paraphrase, the whole story goes like this:

• Fleming discovered a mould he called penicillin, but couldn’t characterize it.
• Florey’s team in Oxford isolated and purified enough to make test quantities.
• A J Moyer’s team devised the commercial process and patented it.

So what is the takeaway here?

Fast forward to the industry as it is today. Based on his discovery, Fleming would have patented as many molecular structures as he possibly could, in the hope that one of them was the magic bullet. His chances of finding it would have been almost zilch; one in 10,000 according to the US Government Accountability Office. He would have selected 250 of those molecules and got five to testing in the clinic (the other 245 go in the bin). The one that got to market would probably not have been penicillin, rather a poor relation with the bones marketed out of it.

Let’s reflect on this then.

If Fleming HAD patented his discovery, penicillin and all its many derivatives would not have seen the light of day. He didn’t have the faintest idea how to identify the active ingredient (molecule) or make it for patient use.

Ask yourself, based on the evidence above, does it REALLY make sense to award patents to molecules? How many other ‘penicillin’s’ remain unavailable to the world because a patent stopped others  having a go with that same molecule?

We have to change patent law, and I know how.

References:

[i] Gaynes R. The Discovery of Penicillin—New Insights After More Than 75 Years of Clinical Use. Emerg Infect Dis. 2017;23(5):849-853.

https://dx.doi.org/10.3201/eid2305.161556

[ii] “Historical Patents – The Automobile and Penicillin”, Article One Partners

https://www.articleonepartners.com/blog/historical-patents-the-automobile-and-penicillin/

[iii] “Method for production of penicillin: US 2442141 A”, Google

http://www.google.co.uk/patents/US2442141

“Too little is known about a molecule’s potential to become a drug when it enters development. Only one in 250 development programs succeed.

Example, almost thirty drugs failed in clinical trials for Alzheimer’s in the last fifteen years. The theory behind most of them has now been dropped for another, which has seen at least one PhIII failure.

For evidence, we trace back to 1976 and the world’s first blockbuster. Since then, the industry has paid insufficient attention to the suitability of molecules chosen to go into development.

We then discuss how outsourcing critical assets resulted in Big Pharma becoming a dried up prune compared to the fulsome plum it used to be.

The effect of these two strategic errors has created the issues we see today, sky-rocketing drug prices, clinical trial failures, $bn for damaging side-effects, me-too drugs, shortages, counterfeiting, price gouging.

It concludes with a call to action for politicians:

“Don’t fight the system, change the rules and the system will change itself”

…and the rule change required is explained.

Click on the link below to learn more:

Disrupting Pharma Only Politicians Can Do It

In previous posts, I promised to outline a new model for drug development, and now is the time to lay out the first of a few founding principles. As the title suggests, I am advocating focus on the patient, but with a twist on current hype around involving the patient in determining their medical destiny—it is the healthcare professional who is the center of the drug development process, not the patient. This may seem perverse, but in doing this, the patient, and that means most if not all of us, benefits in the end. I liken it to the role of a gardener growing vegetables in Find It, File It, Flog It, as follows:

“Returning from the metaphor to the real world of pharmaceuticals, with patients replacing vegetables, Big Pharma has now opened the back door and taken a step into that unfamiliar “garden” territory. It is actually talking with patients. Will talking with patients help?

Talking with patients is a bit like asking the vegetables what makes them so big and strong. They wouldn’t have the faintest idea. You would need to be a gardener to know that, and Big Pharma has never been a fan of gardening, in the metaphorical sense. Big Pharma has grown up taking trips to the supermarket to get its food.

Conversations with patients are necessary, of course, in the same way it is important to keep going into the garden to see how the beans are doing. That can involve some deep understanding of the needs that vegetables have, but it is a delusion to believe those interactions will change anything unless the family changes its ways. Yet there is no sign that is happening. The culture is reinforcing any attempts for change to accept the challenges on the horizon.”

So here we have it. In a nutshell, the message here is that Big Pharma must engage deeply with healthcare professionals at the earliest stage of drug development, not hand them a fait accompli when it is all but over. The present method of running clinical trials with a handful of investigators funded by the drug companies themselves, will not cut the mustard.

Time for Big Pharma to stop patenting every molecule in sight and begin thinking of how to solve healthcare professionals issues in delivering medicines to patients.