Inside the Numbers: The Columbia

Posted: Feb 11, 2003 12:00 AM
The Columbia space shuttle tragedy and the looming threat of war and new acts of terrorism have intensified the need for something that at first seems unrelated -- stepped up biomedical and advanced pharmaceutical research, and the rapid approval and improved accessibility of new drugs and medical treatments. During its ill-fated mission, the crew of Columbia was conducting advanced medical research, such as alternative means of treating prostate cancer. We owe these brave astronauts a lasting tribute to their heroic efforts. One potential tribute is in the hands of the U.S. Food and Drug Administration. In recent years, the FDA has allowed the approval process for new drugs and treatments to become pitifully slow, and the American people know it. Our poll of 1,000 Americans conducted in mid-January -- which had a margin of error of just 3 percent -- indicates that many believe the FDA should speed up the approval process for drugs "that are currently used in other countries." Forty-seven percent of respondents said they want approval of these medicines accelerated, while only 36 percent said they did not. The remainder were unsure. But it's hard to be unsure when one considers the FDA admitted as late as January that there's been a significant slowdown in the release of novel drugs. The number of truly groundbreaking pharmaceuticals approved by the agency dropped from 24 in 2001 to just 17 in 2002. And the availability of new medical devices declined from 56 in 2001 to only 32 last year. The United States is willing to risk the lives of astronauts who are carrying out advanced medical research that can be conducted only in space. It is also willing to put thousands of U.S. troops in harm's way to prevent potentially deadly biomedical weapons from being unleashed on the innocent. So why at the same time would the federal government not be willing to take the risk of checking off on promising treatments, or even cures, for deadly maladies such as cancer, heart disease, and other less known but equally harmful physical afflictions? Many family members have endured the cruel lottery-like procedure by which their loved ones must wait to see if they qualify for experimental drugs or treatments for their ailments, only to find that approval comes too late to help, or not at all. I personally experienced this anguish when a colleague slowly died of breast cancer while waiting in vain for the privilege of taking a last-chance drug not yet approved by the FDA. By the time she gained access to the drug, it was too late. The single mother passed away, leaving behind a young son. In 2000, Associate Professor Daniel Klein of Santa Clara University said that while it is almost impossible to estimate with complete accuracy, the snail's pace of the FDA's approval process likely contributes to the premature deaths of more than 50,000 Americans a year. Now the bureaucrats at the Food and Drug Administration claim to have seen the light. They have recently announced that although they don't plan to change their approval process anytime soon, they do plan to make it easier for pharmaceutical and biomedical research companies to understand it. Frankly, it defies logic that these huge drug companies and research firms would have great difficulty understanding the process they must undergo to gain approval for their products. According to numerous sources, the real problem is that the FDA's professionals pose so many questions to applicants that all of them simply cannot be answered to satisfaction. Some argue the cautious approval process assures safety. But tell that to a father and husband dying of a brain tumor. Explain to a low-income family that the generic version of an already proven medicine is not yet available, so they must pay a higher price for the drugs they need, or that they may have to go without them altogether. Those who monitor the healthcare industry are cautiously optimistic that "changes" within the FDA's bureaucratic structure may accelerate the approval process. But in all likelihood, it will take increased pressure from the general public to force the agency to move as quickly as its counterpart agencies in other countries. In the meantime, it would serve the United States well to compare our willingness to risk American lives in space, the battlefield and other danger zones, when at the same time we won't seriously consider allowing the gravely ill to "risk" access to desperately needed treatments.