- The Washington Times - Thursday, April 21, 2011

ANALYSIS/OPINION:

Researchers at Washington University just unveiled the genomes of 50 breast cancers - the largest study of its kind. Their findings confirmed what many scientists and physicians had long suspected: that each cancer, like each individual, is unique.

As scientists have learned more about the complexity and variability of diseases like cancer, many have given up on finding magical medical “cure-alls.” Instead, the most innovative science today is working to match the right drug to the right patient at the right time. This young but rapidly advancing field is known as “personalized medicine” - and it has the potential to transform health care.

With personalized medicine, physicians tailor treatments to a patient’s unique genetic, genomic and environmental information. Because each of these factors influences how an individual metabolizes a drug, patients can have dramatically different responses to the same treatment.

While some patients may thrive on a particular drug regimen, others might show no improvement. Still others could suffer a dangerous adverse reaction - and end up worse off than before they started treatment. Personalized medicine seeks to prevent such negative reactions by pinpointing the individual differences that impact health outcomes.

This is no small challenge. One study suggests that, on average, an approved drug will work for just 50 percent of the people who take it. The more complex the disease, the less likely a given treatment will work for more than a fraction of the patient population. As a class, for example, drugs designed for cancer are effective for just 25 percent of patients - and doctors generally do not identify those patients in advance.

As a result, personalized medicine requires a broad array of treatment options to work. Yet even as scientific research is pointing toward more individualized therapies, the government is moving in the opposite direction - attempting to control heath care costs by limiting treatment options.

Because patients and ailments vary, a cheaper option may not work for everyone. In some cases, the more expensive treatment might prove the best option for a particular subgroup of patients - if only they can get access to it.

Access to those treatments could become much more precarious if the government is successful in its efforts to deny regulatory approval to treatments it considers a bad value. Just consider what’s happening with the drugs Lucentis and Avastin.

Lucentis and Avastin are both used to treat an eye condition known as advanced macular degeneration (AMD). The two drugs share a similar chemical makeup and are manufactured by the same company, Genentech. Some argue they are interchangeable - except that Avastin is considerably cheaper than Lucentis when used to treat AMD.

Encouraged by the possibility of significant cost savings, the National Institutes of Health initiated a study to determine whether Avastin should be substituted for Lucentis - even though Avastin isn’t FDA-approved to treat AMD.

The results - due out later this month - ultimately could require all Medicare patients to try lower-priced Avastin before they can receive Lucentis. Worse, the government could refuse to cover Lucentis for Medicare and Medicaid patients.

No one is objecting to patients using Avastin if they and their doctors determine that’s the best choice for them, but patients shouldn’t be forced to do so. Such fail-first policies fail patients and drive up health costs by forcing test and retest of treatments by patients who are unresponsive to a preferred therapy.

Even as the government is pushing Avastin on eye patients, it’s restricting the drug’s use for breast cancer patients. Again, the crucial factor is cost - when formulated for cancer, Avastin is extremely expensive, sometimes costing $100,000 per year.

In revoking its approval for Avastin, the government argued that the drug, on average, doesn’t prolong life for most patients. What it didn’t mention is that a particular subgroup of patients - known as superresponders - enjoyed months and even years of additional life thanks to Avastin.

As a society, we should encourage physicians to identify those patients for whom Avastin can have the greatest effect - not take it off the table for everyone.

The government may realize some short-term savings with this approach, but it will sacrifice greater savings down the road. Worse, innovation will be hampered if government policies determined by Washington, D.C.-generated studies and boards trump on-the-ground medical practice.

One of the more promising innovations is targeting treatments to individuals based on their unique genetic makeup. Companies already are pursuing the possibilities, such as identifying the genotype of a cancerous tumor and then smart-bombing it with potent and modified therapeutics. If allowed to come to fruition, personalized medicine can drive down health care costs - by improving health outcomes, reducing the incidence of dangerous side effects and steering doctors away from treatments that are ineffective for their particular patients. Denying the opportunity at the outset is short-sighted and costly.

Joel White is the executive director of the Coalition for Affordable Health Coverage.

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