Safety kills when the FDA does too much
Health Care Op-Ed
By: Sally C. Pipes
3.7.2007
San Francisco Examiner, March 7, 2007
WASHINGTON - Today, it takes a pharmaceutical company about 12 years to 15 years to develop a new drug and see it through the approval process of the Food and Drug Administration. All too often, as these breakthrough medicines slowly wind their way through the FDA’s bureaucratic maze, patients die while waiting for cures. Development of the miracle drug Avastin started in 1989. Yet it wasn’t approved for the treatment of colon cancer until 2004. Who knows how many lives could have been saved in the intervening years? If anything, Congress should streamline the FDA approval process. But to the detriment of patients, some members are actually trying to make the process even more complex in the misguided belief that this will improve patient safety. Sens. Chris Dodd, D-Conn., and Charles Grassley, R-Iowa, just introduced a measure to create an office within the FDA to oversee drug safety after the approval process is supposedly finalized. Meanwhile, Sens. Edward Kennedy, D-Mass., and Michael Enzi, R-Wyo., have also introduced legislation to expand the FDA’s authority to impose safety requirements. Similar legislation will certainly follow in the House. But adding more bureaucracy to the FDA won’t make our drugs any safer. Instead, it will just increase the cost of drug development even more. It already costs nearly a billion dollars to develop a new drug. And if the cost becomes so high that companies cannot recoup their investment, they will simply stop inventing new drugs. Tough luck for those hoping and waiting for the invention of the next miracle cure. Researchers at the University of Connecticut’s Center for Healthcare and Insurance Studies found that between 1960 and 2001, $188 billion in research and development in the drug industry was lost as a result of government interference. That money would have gone to develop new, perhaps life-saving, medicines. These “lost” medicines, according to the researchers, could have saved 140 million life-years. Unfortunately, we’ll never know if this lost research could have generated a cure for Alzheimer’s, Lou Gehrig’s, cancer, diabetes or AIDS. The fact is that all new drugs carry risks. Sometimes, those risks are vastly outweighed by the benefits. And sometimes those risks aren’t discovered until millions of doses have been prescribed. Doctors are aware of these facts. Unlike Kennedy, Enzi, Dodd and Grassley, America’s physicians know that almost every drug carries some risks. Even the recommended dosage of Tylenol has been known to cause liver damage in healthy adults. And regular aspirin carries a host of risks, including dyspepsia, heartburn, blood loss, dizziness and vertigo. With this knowledge in mind, most doctors believe that the FDA is generally too cautious when approving new drugs. According to a recent survey of orthopedic surgeons conducted by the D.C.-based Polling Company, 76 percent of orthopedists described the FDA approval process as “too slow,” and 60 percent believed that the FDA hindered their ability to treat patients. Further, 70 percent of the surgeons surveyed believed that unapproved therapies should be available as long as they carried appropriate warning labels. Even more important, nearly eight in 10 surgeons believed the public does not fully understand the “human cost” of FDA regulation. Nor, it seems, does Congress. Sally C. Pipes is president and CEO of the Pacific Research Institute and author of “Miracle Cure: How to Solve America’s Health-Care Crisis and Why Canada Isn’t the Answer.”. She can be reached at spipes@pacificresearch.org.
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