Personalized Medicine Versus Obamacare

Personalized medicine recognizes that each of us may be different from every other individual. Where those differences are discovered, it seeks unique therapies. What I call cookbook medicine urges doctors to treat all patients with similar symptoms the same way. It implicitly assumes we are all alike.

Right now science is headed in the direction of personalized medicine. ObamaCare is pushing us in the opposite direction. Your life could hang in the balance.

Take the case of Dr. Lukas Wartman, a St Louis physician who developed a rare form of leukemia that is usually rapidly fatal and for which there is no effective treatment. He and his colleagues at Washington University refused to accept defeat. They worked round-the-clock for many days using the universitys 26 sequencing machines and a supercomputer. As descried by Gina Kolata in The New York Times:

[T]hey discovered a single gene mutation in his cancer cells that was producing a protein that appeared to be stimulating the cancers growth. It turned out that a new drug existed that was targeted specifically at shutting down the offending protein, a drug that to that point had been used only for kidney cancer. When they administered the drug to Dr. Wartman, his cancer went into complete remission.

In contrast to this case, consider what happens in a typical clinical drug trial, under the FDAs traditional guidelines. An experimental group receives the drug and a control group receives a placebo. Then the drug is approved if the experimental group significantly improves relative to the control group, on the average. If there is no significant difference, the drug is rejected as not effective.

But wait a minute. Usually when a drug is found to be ineffective, there are a few experimental patients who react positively to it. Why are we ignoring them? The answer: randomized controlled trials implicitly assume that all the patients are alike. So if one or two patients get better, thats assumed to be an anomaly. If the drug were responsible, it would have worked for all the other patients as well. Interestingly, almost all the best research on cancer care these days is rejecting the FDA approach. If some patients respond favorably to a drug even when most do not researchers want to know if genetic differences explain the results.

Gina Kolata reports:

One study at Memorial Sloan-Kettering Cancer Center tested a drug called Everolimus that is approved for kidney and breast cancer. Researchers asked if it could treat bladder cancer. Forty-five patients received the drug. Two responded.

Under ordinary protocols, researchers would have decided the drug doesnt work. But in this case, they tried to find out why two patients got better. In the case of one patient:

The investigators found out why. Her cancer had a mutation in a gene that made it dependent on a protein, mTOR, for growth. Everolimus squelches the activity of mTOR. The woman is still taking Everolimus, and her cancer has not recurred.

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Personalized Medicine Versus Obamacare

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