Author of Taming the Big Pharma Monster (Filament Publishing, May 2019, £14.99)
Straight answers are not easy to get out of Big Pharma. Smoke and mirrors abound, as patients try to get the lowdown on the medicines they take. Hope is not lost, however. Here are 10 things you may not have known, which might make you want to see some searching questions get proper answers, not fob-offs.
- Patents are awarded for products that could never have existed. Pharmaceutical companies do not have to prove they could get to market, and only one out of 10,000 molecules (compounds) get through. Something wrong there, don’t you think?
- Patents create multi-billion monopolies if a medicine is approved for sale. It works akin to roulette; gambling on thousands of molecules in the hope of the one big win; commonly known as a blockbuster.
- Four out of five clinical trials fail. In the last fifteen years, more than thirty last stage clinical trials in Alzheimer’s have failed, each trial costing in the billions. Where is the learning from the mistakes of others? There is none.
- Two hundred and forty-five out of every two hundred and fifty products entering the development pipeline fail. These products have been in pre-clinical assessment, again requiring huge investment of cash… and even more concerning, millions of animals culled.
- The industry clams it costs US$2.6 billion to develop a drug, that means over US$2 billion lay on the cutting room floor...and actually, this figure is dramatically inflated to help justify the high cost of medicines. The ninety-plus percent waste is still there though.
- There are no post-mortems on clinical trial failures, nor any learning points shared. If an aircraft failed in pre-launch testing, in-depth investigations would be required immediately and rectification demanded before trials continue - not so in Pharma, ever wondered why?
- Most of the resources needed to develop a medicine have been outsourced to third parties with no skin in the game. They are good companies in the main, but they have to satisfy their own shareholders for profits, so their objectives are often not aligned with the needs of patients.
- Copy-cat (generic) products are only necessary because Big Pharma stops making the original product, when it should still be able to make a heathy profit supplying them. It leaves previously loyal patient customers without solutions to their medical problems until less experienced companies step in.
- Generics are not always equivalent to the original product, yet we are led to believe they are. The active ingredient may be the same, but the non-active ingredients are often not, causing variation in performance of the medicine in the body.
- Last, but not least, pharma companies test their own products, with regulatory reviews only at the end of the process. With billions at stake, how much objectivity can be expected? All the regulators have as evidence that everything was done as required is a ‘common technical document (CTD)’ compiled by the company applying for the marketing licence.
If any of these pointers has piqued you interest, new book, Taming the Big Pharma Monster, written for anyone who takes medication to help explain the inner workings, bust the myths and expose the challenges surrounding the pharma industry, will take you on a journey of discovery, and show you a better way forward. http://www.pharmaflowltd.com/author/