Personalized Medicine

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Patient’s DNA May Just Be The Signal to Tailor Make Medication.

Whatever the disease is, experts say that most drugs work for only about 50% of the people who take them due to the patient’s genetic makeup. The result is much of the nation’s approximately $300 billion that is spent annually on drugs is wasted and innumerable patients are being exposed unnecessarily to side effects.

With “personalized medicine,” genetic screening and other tests give doctors more evidence for tailoring treatments to the individual patient, potentially improving care and saving patient’s money. The genetic screening test typically costs $100 to $600.

Personalized medicine determines which drug is best for the individual patient, rather than continuing to treat everyone the same hoping to benefit the lucky few.

For example the colon cancer drugs Erbitux and Vectibix do not work for 40 % of patients whose tumors have a specific genetic mutation.

During the month of December 2008, the Food and Drug Administration held a meeting to discuss whether patients should have a genetic screening to narrow down the use of the drugs that cost $8,000 to $10,000 a month.

A genetic test might also help doctors determine the optimal dose of Warfarin, a blood thinner used by millions of Americans. Tens of thousands of patients are hospitalized each year due to internal bleeding from an overdose of Warfarin or a blood clot from an insufficient dose.

Regardless of all the potential, experts see formidable obstacles for personalized medicine. Dr. Gregory Downing, who heads efforts by the Department of Health and Human Services to encourage personalized health care, said “It’s going to take 20 to 30 years for all this to fall into place.”

The obstacles for personalized medicine include drug manufactures that are not inclined to develop or encourage tests that may limit the use of their drugs. Insurance companies may not pay for tests that could cost a few thousand dollars. A major obstacle for the makers of the tests, who hope their business becomes one of health care’s next big growth industries, is proving that their products are accurate and useful.

There is not a recognized process for evaluating genetic tests, many of which can be marketed by laboratories without F.D.A. approval. Whereas before drugs can be sold to the public they must have clinical trials to prove they do what they claim they do in order for them to be approved by the F.D.A.

Despite all the obstacles, personalized medicine is the future. Even the drug companies, that have been worried that genetic testing would reduce their sales, are starting to realize that their medicines might not be approved or paid for without better evidence that they work.

Edited by Dr. Gar C. May

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