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Regeneron CEO & CSO: The Real Healthcare Problem Is Bigger Than You Think

This article is more than 5 years old.

By George D. Yancopoulos, MD, PhD, Founding Scientist, President & Chief Scientific Officer, Regeneron; and Leonard S. Schleifer, MD, PhD, Founder, CEO and President, Regeneron

Jamel Toppin for Forbes

As physician-scientists and biotech leaders, we have grown increasingly concerned about the current dialogue on the biopharma industry, which tends to focus on short-term issues such as drug pricing, at the complete exclusion of much bigger issues that threaten the long-term health of our nation and the very sustainability of our way of life.  In some ways, it’s akin to debating the current price of thermostats and air conditioning, while ignoring the potentially apocalyptic long-term impact of climate change.

As a case in point, a recent article in Forbes (by a journalist we respect greatly) discussed our company, Regeneron. The article showed an all-too-common willingness to trivialize a serious and debilitating disease, in order to suggest to the reader that drug companies are greedy and insensitive about drug pricing – the article flippantly referred to our recently-approved medicine for moderate-to-severe atopic dermatitis (or AD) as a $37,000 treatment for “skin rashes.” The intent was clear – to set a mocking tone that ridicules over-priced treatments for minor afflictions.  The problem is that independent experts conclude that AD should not be dismissed as a minor affliction, and that the drug is not over priced.  Moreover, describing moderate-to-severe AD as a simple “skin rash” is an egregious and offensive misrepresentation of serious human suffering.  It’s like characterizing AIDS as a “little infection.”

AD is a chronic inflammatory disease caused by a malfunction in the immune system, often occurring in association with related immune diseases such as asthma and food allergies. On average, AD patients in our approval studies had more than half their bodies covered with oozing, scaly lesions, and suffered from unrelenting itch – many describe AD as having poison ivy over much of their body that never goes away.  As one can imagine, AD affects the ability to sleep, concentrate and function in daily life. Before our first-in-class medicine Dupixent was approved last year, many patients with severe AD had lost hope.  The FDA designated Dupixent a “breakthrough treatment,” and highlighted the therapy in its annual review of drug approvals as one of two examples of important new treatments for major diseases.

There are insidious implications to trivializing a serious medical condition, and to minimizing the importance of breakthrough medical treatments.  In the short term, undermining the seriousness of a disease further stigmatizes and isolates patients, and makes it easier for insurers to block access to medicines for people who desperately need them. In the longer term, minimizing the importance of real medical breakthroughs can have even more cataclysmic ramifications.

We recognize the challenges of drug affordability, and how a complicated and baffling insurance system often leaves patients without access to life-saving medicines.  We have tried to do our part in terms of responsible drug pricing. We have publicly condemned egregious pricing behavior in our industry.  We have also tried to be responsible regarding our own pricing: we have not raised the price of our flagship medicine EYLEA (a drug for the most prevalent diseases that cause blindness in the U.S.) since we launched it in 2011, and we have typically priced our medicines under what the market expected. In the case of Dupixent, its price was hailed as cost-effective by the Institute for Clinical and Economic Review (ICER), a stringent independent watchdog of drug prices. Similarly, we recently reduced the cost of Praluent, our first-in-class drug for people with heart disease and uncontrolled bad cholesterol, to within the ICER-recommended range for insurers who agree to reduce restrictions that prevent patients from receiving this potentially life-saving therapy.  Despite our efforts at fair pricing, insurers are still denying coverage of these treatments to many patients; this can have devastating impact on patients’ lives.

But we fear there are even more important longer-term issues at stake. The tunnel-vision focus on drug pricing in this article – reflecting the current societal narrative – is diverting both talent and energy from the overwhelming healthcare crisis facing our society. Given the aging of our population and other lifestyle considerations, within the next few decades up to 20 million Americans will have Alzheimer’s disease, over 50 million Americans will have Type 2 diabetes, and over 100 million Americans will be obese. There will likely be outbreaks of frightening infectious diseases that are as yet unnamed. And cancer and heart disease remain major scourges.  Unless something changes soon, these and other diseases will create an unfathomable social and economic burden. Imagine the cost of institutionalization of millions of dementia patients, or the cost of transplant and amputation surgeries for the obese Type 2 diabetic population.

Innovative new treatments are one of the few hopes for curtailing this growing burden of disease. The dollars we are talking about in today’s drug pricing debate may eventually be considered a rounding error compared to what’s at stake in the future.

Many do not realize that coming up with innovative new treatments for major diseases is not easy. It is one of the hardest endeavors mankind undertakes. Despite thousands of academic centers and biopharma companies worldwide – employing millions of scientists and investing hundreds of billions of dollars – each year there are just a small number of truly innovative “first-in-class” drugs such as Dupixent approved by the FDA for major diseases.

Isn’t is astonishing, humbling (and frightening) that despite all this activity, each year we typically only have a small number of new truly breakthrough medicines?  Right now, there are no FDA-designated “breakthrough” treatments for Alzheimer’s, Type 2 diabetes or obesity. Without such treatments, society will simply not be able to deal with the impending burden of disease.  It takes decades to come up with breakthrough treatments.  If we don’t act now, it will be too late – if it is not already.

For this reason, we need many more people working on serious diseases both in academia and industry, and we need to provide them with far more resources.  It has to start with much greater investment in early-stage basic research through the National Institutes of Health. We also need to focus on attracting brilliant young people to the noble challenge of preventing and curing disease.  Today, many of these young people are turned off by the negative cloud around the life sciences industry. But we don’t mean to limit the recruitment of bright young minds to just one field.  We need our best young minds flooding into the sciences, backed by a society that celebrates, supports, invests in, and rewards their efforts to use the power of science to solve our world’s most important challenges – from healthcare to climate change.

We need responsible drug pricing, and we need to preserve the incentives. We need a strong flow of investment to support innovative ideas – and a strong, yet fair rewards for those few innovative medicines that actually reach the market.  Remember a branded drug’s price is tied to its patent, which is granted for only a limited period of time. Our Founding Fathers had the foresight to realize that innovation required an incentive; they established the patent system in our Constitution, realizing it would be an essential means to promote the innovation necessary to sustain a thriving society. As President Lincoln said about this Constitutionally-enshrined incentive system, “it adds the fuel of interest to the fire of genius.”

At Regeneron, we try to do our part on these long-term challenges.  We are a large biopharmaceutical company that was started and is still led by scientists.  Every day, we try to live up to our credo of “doing well by doing good.”  We invest one of the highest percentages of revenue back into basic research, and it took decades of investment before we were able to turn a profit.  We are investing hundreds of millions of dollars to build a critical “big data” genetics and health records resource of over 500,000 people that could empower new artificial intelligence (AI) approaches, and we are leading a life sciences consortium that will make much of this publicly available. We are also investing $100 million in the Regeneron Science Talent Search, the top high school science competition (previously known as the Westinghouse and Intel competitions), to inspire and engage the next generation of bright young minds.

We believe a culture that reveres science, that celebrates and rewards major advances, and that provides incentives for true innovation is our only hope for the future.  Changing the conversation on biomedical innovation today can have a real impact on how young people choose to use their talents – and their decisions could transform countless lives in the future.  Somewhere out there, there is a 16-year old whiz kid that has the power in their brain to cure Alzheimer’s disease.  Will he or she be willing to put in the decades of intense effort, with a high chance of ultimately failing, only to face little reward and criticism if successful? If we’re not careful, that kid might choose to come up with the next great gaming app, or become a hedge fund manager.  Is that what we really want?  We cannot afford to have the fire of genius flicker.  The very future of civilization as we know it might be at stake.