![]() ![]() Suppose a drug (that is effective) is administered to 100 million people. A drug is either safe or it isn’t, right? Well, that’s not how those who study the science of risk analysis think. How about safety? That seems to belong in FDA’s purview. ![]() In this case, we don’t need an FDA one-size-fits-all decision we need information at the individual level that doctors and patients can use to make decisions on effectiveness. Huber argues that molecular and genomic medicine is about how a drug reacts in an individual patient so that a drug that works for some people with a specific genetic profile would be effective-even if it would fail a conventional clinical trial. If the test group-the one that gets the drug-has a statistically greater number of cures than the control group, the FDA says the drug is effective and then, and only then, can it be used by patients. A clinical trial is composed of two groups of people, test groups and control groups. Essentially, the FDA requires three to four clinical trials (the fourth would be after the drug is on the market) to determine whether a drug is efficacious (and safe). Peter Huber writes convincingly in his book “ The Cure in the Code” about how the FDA’s ”gold standard” process of determining efficacy is actually last century’s standard and is no longer consistent with genetic science today. While this may seem like the job for an impartial scientific agency, a deeper look at this issue reveals some serious problems with granting the FDA a monopoly on these definitions. Obesity is a prime example of this.Īnother example, likely just as important as diet, is the government defining the “safety” and “effectiveness” for drugs and medical devices. Too often, we look to agencies to solve all public health problems rather than just the problems for which they have the mandate-and possess the necessary information-to solve. Department of Agriculture, the Environmental Protection Agency and the Food and Drug Administration (FDA). However, we also have public health agencies, including the CDC, the U.S. Mothers and fathers try to improve the health of their families. ![]() Each of us, by examining our own lifestyles, tries to determine the healthiest way to live. Why is it that we confuse “public health” with “public health agencies?” According to the Centers for Disease Control (CDC) “Public health is the science of protecting and improving the health of families and communities through promotion of healthy lifestyles, research for disease and injury prevention and detection and control of infectious diseases.” Under that definition, we may all be in the business of public health. ![]()
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