Innovation and Regulation in Pharmaceuticals

I am a caregiver and patient advocate for my mom. I am also a proud co-founder of Give to Cure. My dynamic and awesome co- founder, Lou Reese, is a passionate advocate for Alzheimer's Disease, and the CEO of a biotech company. Where I believe industry regulation is important for consumer protection, he believes that its restraints often choke the very solutions we need.

Together, as entrepreneurs and philanthropists, we created Give To Cure (GTC). GTC is a non profit that pushes forward innovative research and funds clinical trials to accelerate cures. Today we are working to find a cure for Alzheimer's Disease.

When news broke about the outrageous price gouging on EpiPens, a vital life-saving device, we (as both friends and colleagues) discussed the pharmaceutical industry's merits and problems. While my opinion might differ, I believe understanding both sides of an argument is vital to finding compromise - especially in today's political climate. Thus I am both pleased and proud to share the following guest blog, written by my friend, Lou Reese:

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When Heather Bresch raised prices on the EpiPen, she chose to increase corporate profits through price gouging rather than innovation. The first myopically helps shareholders of her company and the bottom line; the second helps the bottom line as well, but also drives distribution of health to society by delivering new medicine with exciting and compelling benefits. Price gouging is deplorable and offenders should be held accountable. But we should avoid demonizing an industry that has doubled our life expectancy over the last century, and instead, recognize and embrace what has enabled such improvement in our health - continual innovation fueled by heaps of creative talents, time and money. That means incentivizing innovation.

The winding road of a drug from lab to patient takes on average $1 billion and upwards of 20 years, with a success rate of less than .01%. To some, the lottery looks like a better bet. So when a new drug comes to market, its price tag (often expensive) is usually a reflection of the time and resources that went into developing the drug and an attempt to recoup those investments, while mitigating the losses on all of the compounds that failed along the way. Addressing this high price of health through regulation that curbs the ability to earn a return on investment threatens to stifle critical innovation. We should consider an alternate approach - more innovation and less outdated regulation.

Fortunately, American history has already showed us a path. Over seventy years ago, FDR and the March of Dimes cure-funded a vaccine for polio without a dollar of federal or state funding, and rid the world of the most frightening and economically crippling disease of the day. It was achieved in breakneck speed through focusing the research targets, revamping an existing organization, mobilizing leading scientists, and accessing sufficient capital. Imagine if we could recreate that history; if we could focus resources on research bottlenecks such as the "translational valley of death" in the drug development process; if we could help existing research organizations such as the NIH become more efficient in their grant-making processes; if we could harness new sources of investment from the general public through cure-funding, simultaneously enabling more research and empowering individuals to participate in the global quest for better health; if we could mobilize a new generation of scientific minds through educational programs such as STEM. Imagine if we could work together with industry to embrace these initiatives and deliver new drugs faster and more cost-effectively.

My father used to tell me that "if you want to move an oil tanker 90 degrees you are pretty much out of luck (his language was a bit more colorful). But if you nudge that same tanker just 1 degree and wait 500 miles, you'll look back and be in a whole new place." That's where we are today. We can't expect to change the industry overnight, but by investing in innovation through a series of nudges, we have the ability to change the paradigm of drug development.

Guest Blog By Lou Reese, Co-Founder of Give to Cure and Co-CEO of United BioMedical.