The Hill - A QuietRevolution -- and a Helping Hand

Op-Ed

By Representative Michael Burgess

Revolutions are usually pretty noisy affairs -- arriving, as they often do, on the heels of military battles and political upheaval.

But some revolutions, much like the fog in Carl Sandburg's epic poem, come to us -- quietly, unannounced.

That might be the case for one of the most profound revolutions of our time -- personalized medicine made possible by the mapping of the human genome. To be sure, the 2003 National Institutes of Health announcement that the genome-mapping project was complete came with much fanfare, quite properly so. For the first time, we could understand the working components that defined and regulated life.

But for all the attention, there seems, even now, little true recognition of what this new knowledge means for our health, as individuals and a nation, as well as for our health costs. In both realms, I believe -- both as a physician and a member of Congress -- that we are entering a golden age of medicine that will have a tremendous impact on patients. Congress must understand that and be ready to act to help enable this new era.

Knowledge about the human genome means that we now have the ability to tailor treatment to the exact genetic and molecular needs of the individual patient. That means the possibility of replacing trial-and-error medicine -- the kind that has been our only method of care since the dawn of mankind -- with care targeted to the precise needs of the individual. By understanding the genetic fingerprint of the condition and the patient, we could identify diseases much earlier, pick the most effective treatment for the individual patient much sooner, avoid treatments that would cause adverse effects, and know vastly more about which drugs to prescribe, in what dosage, and at what stage.

This ability comes about in large part from genetic tests. These tests represent the gateway to this new era of medicine. Consider these examples:

Some 30 percent of all breast cancers have an overabundance of what is known as the HER2 protein. In the past, these patients received standard chemotherapy, but because of this genetic mutation, chemo didn't help them. Today, genetic tests tell doctors which patients have HER2, allowing them to prescribe a gene-based drug that has been shown to reduce the risk of death by 33 percent and the risk of recurrence by 52 percent.

Similarly, some 40 percent of patients with metastatic colon cancer do not benefit from a standard cancer drug, suffering severe side effects because of a gene mutation called KRAS. Now, a genetic test can identify these people, allowing physicians to begin effective treatment much earlier. Because these colon cancer drugs can cost as much as $8,000 to $10,000 per month, a recent study found that genetic testing can generate more than $600 million in healthcare savings annually by avoiding the drug in those who cannot benefit from it.

Better targeted care through genetic tests is also occurring in other areas, such as heart disease, childhood leukemia, HIV and liver conditions.

While there is some growing understanding of the clinical impact of this new approach to medicine, few understand what it could mean for healthcare costs. Right now, studies show that 20-75 percent of pharmaceutical treatments do not generate an effective patient response -- in other words, they don't do any good. That means, because we are spending about $300 billion each year on drug therapy, we could be wasting anywhere from $60 billion to $225 billion each year.

There are many reasons for this, such as drug interactions or incorrect dosages, but about half of the time, patients do not respond to the drug because there is a genetic mismatch between the patient and the pharmaceutical. Using genetic tests to select the right drug that precisely fits the genetic nature of the patient's disease could potentially save something in the range of $30 billion to $110 billion each year.

But here's the catch. Despite this potential for savings, despite this potential to transform healthcare in the 21st century, the rules of the road for introduction of such tests into the real world of healthcare delivery are rooted in the old world of slow-motion regulation. Long, excessive reviews will stop this revolution in its tracks because genomics and genetic testing are in a state of constant change -- as conditions morph rapidly, as new diseases emerge, as new knowledge unfolds.

For that reason, I have introduced legislation that will make sure this revolution advances and matures. It provides a new, flexible, innovative form of regulation, allowing new tests to come online to meet changing needs and ensuring patient safety through responsible pre-market review and comprehensive post-market data gathering and analysis.

It is important to understand that nothing in the revolution of genomics and genetic testing is automatic. It requires devotion, hard work, financing, certainty and some degree of predictability for the private sector to turn the promise of genetics into the real revolution in care and healthcare economics it promises.

In Sandburg's poem, the fog comes into the harbor unnoticed, quietly, on cat feet -- and it exits just as quickly. This legislation, however, is designed to prevent this revolution from disappearing before our eyes. It offers a helping hand through reasonable, common-sense, 21st century regulation.

Burgess is vice chairman of the House Energy and Commerce Committee's subcommittee on Health, and chairman of the Congressional Health Care Caucus.

Source