This week the president renewed his determination to bring the resources of the federal government to the side of patients. This was a welcome move in 2016, and it is welcome today. The government must step in where the free market is failing. This year has seen a punishing market downturn after a pandemic run on biotech and genomics stocks, and the president's support can provide a much needed shot in the arm for the therapeutic and diagnostic industries. Beyond that, there are systemic failures happening in the medical market which are not working for patients and government action is needed on three fronts: stimulation of basic and translational research, regulation to keep patients safe and the market itself healthy, and acting responsible and visionary as the largest payer in the system.
Let's not be confused. Cancer research and treatment is not a moonshot. It is more like looking into the James Webb Telescope. It will be mankind’s ongoing discovery and journey of health and life extension. It was refreshing to hear the president move from talking about “curing cancer” to "end cancer as we know it" and curing "cancers" in his speech this week on the 60th anniversary of JFK’s famous call to land man on the moon.
"We choose to go to the moon in this decade and do the other things not because they are easy, but because they are hard.” -JFK
Accompanied by an executive order, the speech was strong on vision and light on specifics. That is ok when the vision inspires government agencies toward continuing reforms on the side of the patient. The president named a director to head the new government division which he established this past March called ARPA-H, which will be modeled after DARPA with the focus being human health rather than defense. The new director, Renee Wegrzyn, has been the VP of business development at Ginkgo Bioworks and had worked at previously at DARPA.
Biden set the goal of cutting cancer death rates by at least 50% in the next 25 years. He said that America could be summed up in one word, “possibilities.” Most of the specifics the president talked about happened during the Obama administration, such as the order that all federally funded cancer research be available to all for free. Biden also mentioned the trials.cancer.gov program set up back when he began the Moonshot in 2016. So what is new? We shall see. Already there has been $2 billion committed for biomanufacturing here in the U.S.
We are coming off a brutal summer when the market has taken a big toll. Stocks in the diagnostics and tools industry are down 70% from their pandemic highs and still down from their pre-pandemic levels. But it is not just a case of low stocks—the precision medicine industry is in retreat, and this ultimately means less breakthroughs for patients. Thousands of people were laid off this past summer. Budgets have been tightened. This has been the opposite of a moonshot year economically.
The Market Hangover
The president and the government can provide a big boost, particularly when there is no fundamental reason for the market frown. It’s mere financial caprice. The pandemic saw many average Americans sitting at home with extra time and money on their hands—and it’s true, some government money—and that American fell in love with stocks and biotech stocks. The infatuation appears to be long over. And the industry is suffering from that hangover.
American medicine is built on an empirical tradition that trusts its data from two sources: instruments which gather information directly from natural biology and the free market. When the market turns its back on a product or an industry, Americans throw in the towel. And why not? But what if this product is good for patients? In that case is the market data just noise? For the past few months there has been a paralysis as as to how to interpret the current market. We have seen company after company shed jobs and some of the industry’s prized and visionary CEOs be sacrificed on the market chopping block. This is highly unfortunate, but a tradition going back generations.
Eventually the market will come around. It always does, even if this is a particularly punishing downturn. Longer term, the precision medicine industry is facing some issues that can only be solved with government leadership and action. President Biden is spot on. We need vision on the scale of going to the moon in the 1960s. Leaders in the precision medicine industry know this, and they must come together and double down to address core underlying problems that are not only scientific, but natural conflicts in the medical market.
Old Problems, New Opportunities
First of all, there is the translational problem. We do good science, but so often it doesn’t make it into the clinic. There is now an entirely new discipline of science that has been designed and devoted to this problem called implementation science. A new assay will be developed which will become a genetic test, and it will be hailed as the next great breakthrough and an obvious no brainier for human health. But for some reason it does not make it into clinical care. Why not? This is the 64 million dollar question that this new science pursues. We used to say the problem was the education of doctors. Then we said we needed more genetic counselors. Now we say the issue is perverse incentives. The existing healthcare system would make less money if the test were adopted. And so it isn’t. It's a sad state of affairs. And how can the free market fix a problem which in fact it has created? Will implementation science be able to confront it? Or is this just kicking the can further down the road? What we need is the will power as a community to adopt the right values, to be on the side of the patient.
Take MRD testing, for example, or minimal residual disease testing offered by multiple genetic testing companies this year. This is a blood test that will tell patients if they still have cancer by checking the actual cancer in their blood. If patients test negative, they do not need to have more chemotherapy treatments. What a win for patients. And yet the test has seen very low adoption rate so far, around 1%. Because it’s not a win for everyone. It’s not a win for those companies that have been selling chemotherapy unnecessarily. This has been the free market conflict between the diagnostics and therapeutic industries for years, and only strong leaders perhaps through government can solve it. In the case of MRD testing, CMS might require that if there is a good blood test available, then it is required before further chemo is approved.
Second, cancer research is moving beyond genomics. This is the age of 3D biology. There are a new array of technologies that now must be funded and supported. We need a new institute at the NIH in addition to the Genome Institute called the Institute of Spatial Biology.
Cancer and Beyond
In his speech the president emphasized the importance of cancer by saying it is the number two killer of Americans. Well what about the number one killer, heart disease? Due to downsizing this summer as a result of market forces, genetic testing companies are giving up on their cardio programs--not because they are not critical tests, but because they are not being reimbursed. This is a tragedy in human health brought on by over reliance on our market system. Who will champion cardiology? Will the next president have a Cardio Moonshot? Why not?
Biden did mention other diseases such as heart disease and Alzheimer’s. In truth it is a cancer moonshot for all disease. But cancer is important to Biden. He lost his son Beau to cancer, and it is personal, and politicians need a story to win midterm elections. That is understandable. We all have lost friends to cancer. And we all have friends who have survived. I have a friend who is now eight years on the other side of breast cancer. She told me she watched the Ken Burns series about cancer based on Sid Mukerjee’s book “Emporer of All Maladies.” It’s the history of how far we have come with cancer.
She said, “I’m so glad I got my cancer now and not 20 years before.”
How far we have come indeed. This journey will never end.