Prescription drugs

NIH Personalized Medicine Initative

The NIH will begin an effort to bring what has been called personalized medicine closer to reality in our health care system. The health organization has been charged with  starting enrollments  in 2016, hoping to reach a goal of million or more volunteers in three or four years.

“We have an incredible opportunity to advance research and make new medical breakthroughs through precision medicine, which tailors disease prevention and treatment to individuals based on genetics, environment and lifestyle,” Department of Health and Human Services Secretary Sylvia M. Burwell said in an NIH statement.

The initiative is part of the Precision Medicine Initiative, which President Obama introduced in January 2015. He allocated $215 million for the program in his 2016 budget, $130 million of which would go to the NIH of its part in the initiative.

The Precision Medicine Initiative is an effort to bring about what is called personalized, or precision, medicine to the U.S. health system. The FDA website describes personalized medicine as “tailoring of medical treatment to the individual characteristics, needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up.”

According to the NIH website, the study is being conducted to:

  • develop quantitative estimates of risk for a range of diseases by integrating environmental exposures, genetic factors and gene-environment interactions;
  • identify the causes of individual variation in response to commonly used therapeutics (commonly referred to as pharmacogenomics);
  • discover biological markers that signal increased or decreased risk of developing common diseases;
  • use mobile health (mHealth) technologies to correlate activity, physiological measures and environmental exposures with health outcomes;
  • develop new disease classifications and relationships;
  • empower study participants with data and information to improve their own health; and
  • create a platform to enable trials of targeted therapies.

While the initiative is admirable in its goals to improve medical care to individuals, one has to consider how easily it will be to get one million volunteers for a study of this kind. There is a history of distrust, which is not always unfounded, between government medical research and the citizenry. One look no further than the infamous Tuskegee syphilis experiments of 1932 to 1972 in which the U.S. government conducted experiments with rural black men with the sexually transmitted disease. Despite having the ability to treat and cure the men, treatment was withheld to track the natural course of the disease.

Steps must be taken to educate the public of the potential benefits of the study, especially in traditionally exploited and undeserved communities.  Without the necessary diversity, the Precision Medicine Initiative  will merely continue the sorts of problems with genereicized medicine and health care our system currently faces.

UPDATE: Science & Enterprise creator and editor Alan Kotok  has a March  story about a push to involve more minorities in medical research and clinical trials.

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