I admit I have been critical of Pharma leadership, and my frustrations are starting to show in articles such as No More Lip Service – Just Do It. However, Pharma is at a crossroads, and these companies can’t afford to continue with business as usual. There are several interrelated issues that will either be their death knell or slingshot them to the head of the pack. This series will explore those issues.
We had it all wrong
Mara Aspinall further validated this theory at a 2008 conference. She asserted that if you presented with cancer at a hospital which organized departments by body part (gastrointestinal, breast, lung, etc.), then the chances of you responding to treatment are left to chance. If you want proper treatment you can trust, you would need to go to a hospital organized instead by molecular pathway as the diagnosis otherwise will be inaccurate.
While I am on Rheumatoid Arthritis, Robert Plenge – VP of Merck Research Labs in Boston – stated in a blog: “For a disease such as RA, many skilled physicians prefer the word ‘syndrome’ over ‘disease’, to emphasize this point exactly. RA is not one disease; rather, it is a collection of distinct but overlapping diseases which make up a crude category we current call rheumatoid arthritis. Intuitively, most physicians believe that if we could understand these disease subsets, then we could treat patients more effectively by picking the right medications (most of the time, but not all of the time) and predicting the right outcomes (with greater precision).”
What many in the industry don’t appear to realize yet, is that it soon won’t be just about the drugs alone, but about the successful linked pairing of a diagnostic and a drug. Companies that create this combination successfully will be the leaders of the future.
My poster child for precision medicine and diagnostic pairing is Herceptin. I love this drug for so many reasons. Almost everything I see about the future of Pharma, I can point to something around Herceptin and things they did right with this drug (including using our analytics, but that is another story).
To accurately be treated with Herceptin, you have a diagnostic test and if you have the HER2 positive gene expression, then Herceptin is your drug. Also, it works reliably in these patients. However, if you have breast cancer without this gene expression, you would be wasting both time and money on Herceptin.
Essentially, a diagnostic and a drug are paired like a lock and key. If Herceptin had done clinical trials without the diagnostic, it probably would not have got approval as not all the patients would have been HER2 +ve, in which case the lives of the hundreds of thousands of people it saved would not have been possible. In fact, having the diagnostic not only got it approved and saved lives, but also got it done much faster (the typical 5-10 years was reduced to 2 years due to having the right patients in the trials), and the cost of the trials was also significantly reduced due to the precision of the diagnosis and applicable drug.
When you change your mindset to fit this new reality, you will be able to see the massive impact on nearly every aspect of Pharma.
Clinical trials
Currently many patients in clinical trials are not actually good candidates for that treatment, so it takes a long time to ensure you have enough good data to show safety, efficacy, etc. Better targeting will change this.
Operations and organizational structure.
The constant restructuring and outsourcing are products of the outdated blockbuster model. In the new era, Pharma will be able to reduce costs, increase efficacy and reduce side-effects while increasing value, outcome, profit and share without giving up control of important aspects of their business.
Marketing
If you’re not hitting the right audience with the right message, you’re wasting your marketing dollars. Pharma companies that embrace change will have access to better analytics, information and services that go beyond the pill, and the only way to really get this right is by using analytics.
I’ll elaborate more in upcoming blogs. Stay tuned.
Conclusion
Precision medicine is changing much of what we thought about several conditions and, along with it, the drugs used to treat people who have those conditions.
By pairing diagnostics with specific drugs, Pharma companies are able to offer more value to all parties. From patient treatment and hospital costs to clinical trials to the reduction of lawsuits, the potential savings to the system are staggering.
Consider Herceptin. The drug costs $79,181 per patient when a diagnostic is not used. But when it is used only with patients who will respond, the cost drops to $53,738—a difference of $25,443.
And think of all those drugs that failed to get approval after clinical trials did not show efficacy in enough patients. If you could find the gene expression and molecular pathway of the subgroup of patients that responded, those drugs could possibly be resurrected and, in fact, save many lives.
This approach of testing for precision with a diagnostic adds more cost initially – which is probably why it is not already being embraced widely. However, that’s short-term thinking. Pharma companies should be considering how they can better pair a diagnostic with a drug if they want to succeed in the long-term.