Editor’s Note: The following is adapted from Breakout: Pioneers of the Future, Prison Guards of the Past, and the Epic Battle That Will Decide America’s Fate.
We are on the verge of an extraordinary breakout in health. Developments in science and technology could transform the way we live, how well we live, and how independently we live. For individual Americans, this could be a breakout of enormous importance.
Taxpayers should demand six important steps from the government immediately.
One: FDA Reform
The FDA is a major prison guard stopping the breakout in health. It must be overhauled. Its standards for evaluating new treatments and therapies are completely unsuited for the age of regenerative medicine, and the cost of getting these treatments approved in the United States will be absurdly high even compared with the absurdly high cost of getting normal drugs approved. There is a grave danger that breakthroughs in regenerative medicine will be made in American laboratories and then be introduced to patients in China, India, Japan, and Europe because FDA approval is too time-consuming and too expensive.
Furthermore, FDA reform must address the agency’s lethally low tolerance for risk. In addition to allowing Americans to obtain non-FDA-approved treatments with informed consent, the agency should begin to loosen its requirements in an age when we could track side effects and bad results in real time and make changes based on immediate data. Perhaps good preliminary results should be sufficient for doctors to begin prescribing many treatments as long as patients are connected to the constant monitoring technologies that Dr. Eric Topol described.
Two: Scoring Lifetime Savings instead of Annual Savings
As we begin to develop therapies that solve chronic conditions, government needs to develop new methods of scoring the costs of those therapies. Take, for example, the cost of kidney dialysis versus the cost of growing a new kidney. Kidney dialysis may be the cheaper treatment if you look at the budget for a single year, as Congress is apt to do. Once you are on dialysis, however, you remain on dialysis for the rest of your life. A debilitating experience, it requires two or three days a week at the clinic and the rest of the time spent recovering your strength. While the procedure may prolong your life, it also eliminates much of your ability to enjoy life and to earn a living. A regenerative kidney, on the other hand, would restore you to full health and enable you to return to work and to enjoy life to its fullest.
The challenge today is that a one-year score of the cost of dialysis versus a kidney replacement makes dialysis look less expensive. On the other hand, a lifetime cost of dialysis could soon make a regenerative kidney look like a bargain. This regenerative advantage becomes even more obvious if you include the difference between losing your job and depending on government payments and keeping your job and paying taxes.
There will be an explosion of research efforts if we can get to a fair scoring system for lifesaving breakthroughs.
Prizes should be developed for the most important cures. As I discuss in depth in chapter seven, prizes can play a major role in raising funds, encouraging pioneers, and achieving big breakthroughs faster and cheaper than through traditional bureaucratic efforts. Taxpayers pay nothing unless someone actually makes the defined breakthrough. At that point, we save money since we have technology that cures an expensive disease. An inexpensive kidney replacement to eliminate kidney dialysis would pay for itself in the first year or two. A cure for Alzheimer’s, too, would pay for itself almost immediately. Surely these breakthroughs would be worth substantial prizes.
Four: Creating Special Bonds and Taking Key Research Off-Budget
We should seriously consider taking major areas of basic research off-budget and issuing special bonds to pay them off. Today, we fund vital research at the pace the overall budget and the overall competition for resources allow. Yet if these fields of research could save tens of billions (or in some cases trillions) of dollars, we should not treat them the same way we treat standard earmarks. We should try to reach them as fast as possible. Every year of delay is money lost.
Instead of standard budgeting, we could fund them with money raised from disease-designated bonds. When the breakthroughs occurred that enabled us to save money, a fraction of the savings could go to pay off the bonds. This approach would liberate crucial basic research from the prison of congressional pork-barrel spending and enable us to achieve lifesaving breakthroughs as rapidly as possible.
Five: Reorganize the National Institutes of Health
The National Institutes of Health need a thorough reorganization to focus on the great breakthrough areas that could dramatically improve health. Each of the 21 institutes jealously guards its budget and its prerogatives. These include institutes for research in dentistry, “environmental health sciences,” drug abuse, alcohol abuse, and “minority health and health disparities,” among others. Much of the research is focused on esoteric topics with little prospect for achieving a real breakthrough. In fact, far too much of the NIH is a comfortable bureaucracy going through the motions, and the director does not have the ability to shift resources and create dynamic working groups in truly promising areas. The institutes’ work should focus almost exclusively on basic research in areas like brain science, genetics, and cancer.
Six: Congressional Hearings and Continuous Learning for Health Decision Makers
If you were to test the bureaucracy that pays for health care and the bureaucracy that regulates health care on the state of the arts in medicine, you would almost certainly find tremendous gaps in understanding. Similarly, if you examined the members of Congress and their staffs who have oversight of health issues you would find very fragmented understanding of the potential breakthroughs.
There are more scientists in the world today than in all of prior history combined. These scientists get better computers and better laboratory equipment every year. As they connect to each other all over the world, new discoveries spread with remarkable speed. Continuous learning will be essential for anyone trying to make decisions on health policy or to manage health outcomes. The American people must insist that public servants stay abreast of these changes.
Congressional hearings on the potential breakout may be one of the right kinds of venue for this learning. In the early 19th century, congressional hearings and reports played a surprisingly large part in opening up the West to settlement. In the 21st century, they could educate our leaders and the country about the breakthroughs that will help America break out.
— Newt Gingrich is author of Breakout: Pioneers of the Future, Prison Guards of the Past, and the Epic Battle That Will Decide America’s Fate.