As a pharmacist, writes Mark Duman, MRPharmS, Director of MD Healthcare Consultants, albeit one no longer in clinical practice, I’m embarrassed that my ‘profession’ gets paid for non-delivery.
By that, I mean that approximately 50% of people don’t take their medicines as prescribed. Broadly speaking, and based on a £14 billion annual medicines spend by the NHS, that equates to £7 billion worth of product not reaching its maximum potential. And that’s assuming that the outcomes claimed for the medicines researched and valued according to clinical trials are actually replicated in real life. The same could be said of the pharmaceutical industry. It, too, currently pays for supply … and not outcomes. And that’s where I thought the waste issue ended.
That was until I read Hedley Rees’ Find It. File It. Flog It. Despite the tongue-in-cheek title and comparisons throughout to sausage making, this book is a real gem. It’s a clarion call to all in pharma to wake up to the current erroneous and overly expensive drug discovery process.
It also highlights how the industry has outsourced so much of its expertise that it’s at risk of not having any left. But more than identifying the problems, it also, with testimonies from knowledgeable witnesses, outlines how drug manufacturers can solve these issues.
So what’s the beef? The Find It. File It. Flog It. (FFF) approach to drug development needs to be abandoned and replaced with a truly patient-centred approach, says Hedley Rees. Ever since Glaxo won the marketing battle with its ulcer drug Zantac in the early 1980s (beating down the previously released Tagamet developed by Smith, Kline and French), pharma has been struck with a crippling addiction – namely, gambling on serendipitous discoveries in the hope of making blockbuster returns.
And so began the era of the blockbuster, and with it the notion that patented compounds, with a licence to sell, could make huge returns. This FFF approach to drug development involves discovering a compound and patenting it (find it), placing it into a development pipeline intended for regulatory approval to market (file it), and then marketing the approved product with the utmost verve and vigour (flog it), which became the reigning paradigm for drug development and exists to this day.
Subsequently, the resulting lifestyle it has spawned has encouraged Big Pharma to engage in two crippling activities: outsourcing critical assets and abandoning out-of-patent products in a misguided attempt to satisfy investor demands to maintain blockbuster earnings. This has had the opposite effect. By outsourcing these assets, industry divested its ability to develop new products.
The latter has resulted in more than 80% of products sold today resting in the hands of generic companies, which have been growing like topsy. The large, R&D-based pharmaceutical companies are now having to target increasingly shrinking patient populations, charging swinging prices in an attempt to maintain blockbuster returns. Hence, we have the commotion from US politicians and many other industry stakeholders.
This would not have been so damaging if the Big Pharma companies had held onto the people and facilities involved in developing new products for market; but that hasn’t been the case. Fuelled by blind optimism regarding the power of the patent, these critical assets were allowed to go; and, as a consequence, Big Pharma companies now have to depend heavily on third parties to develop their products. Professional as these third parties are, they do not have the skin-in-the-game that clinical trial sponsors and product license holders have.
Is there a cure to this affliction? Yes, says Hedley, the cure lies in beating the addiction, starting by accepting that Big Pharma needs a fundamental change. It cannot continue launching molecules into development with little understanding of whether they will work or not. But, the only stakeholders who can make change happen are the CEOs of Big Pharma companies. Their predecessors discovered a wonderful way to build businesses, as described by Merck founder George W. Merck: “We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been!”
And, in conclusion, Mark proposes a formal response — and even a debate — to the issues raised in Hedley’s book. Not only from those in industry but also from those in trade associations such as the ABPI, EFPIA & PhRMA and regulators, especially in this time of financial authority. In summary, says Mark: “If you work in or around medicines, you must read this book.”