The Food and Drug Administration (FDA) has gleaned excessive attention for mishandling various products. There were safety issues surrounding Vioxx and other drugs as well as the prolonged political machinations around the emergency birth control drug Plan B. The flight of its officials and top leaders has been noteworthy. In this week's Journal of the American Medical Association (JAMA) 2005; 294:2395, Howard Markel, MD, Ph.D, comments on the developments in "Why America Needs a Strong FDA".
The FDA is a crucial government agency that now has an almost cloyingly cozy relationship with the pharmaceutical companies, the author contends, and the political fallout surrounding recent problems has undermined the agency's critical role. The FDA cannot be an effective regulator when its reputation is riddled by scandal and distrust.
Markel outlines the long history of "this fabled and beleaguered agency" with two events that he says mark the rise of the organization and now its slide. The FDA came into its own with the passage of the Pure Food and Drug Act of 1906. Apparently the law was well needed, as foods were consistently tainted when reached consumers:
"...a cornucopia of chemicals routinely was poured on vegetables to make them appear green and cover any evidence of decay; brown sugar often was cut with ground-up lice (which apparently looked a lot like sugar), and flour often was adulterated with anything white, from plaster of Paris to chalk and talcum powder. Worse, many of the medicines and soothing syrups were bolstered with alcohol, cocaine, morphine, arsenic, and a host of other decidedly unhealthy agents."
Companies advertised in misleading ways and prepared food and drugs in grotesquely unsanitary conditions. Markel writes that Americans were incited to stand up to irresponsible food and drug companies, as people brought attention to the issue. Upton Sinclair wrote "The Jungle", a "purposely disgusting" novel about the revolting practices of the meat-packing industry that helped bring public attention to the problem. Many others pushed for proper health regulations, including Harvey Washington Wily, and Samuel Hopkins Adams.
"[M]uckraking journalists and writers who incited millions of readers to protest for clean foods and drugs cannot be discounted...The result of all this public education and social agitation was that American citizens would no longer stand for being poisoned, cheated, or endangered by irresponsible food and drug companies."
The other "bookend", he writes, began with deregulation in the Reagan administration. Markel writes that the slide of the FDA's effectiveness was precipitated by budget cuts and increased documentation requirements that left fewer resources for pursuing investigations and aberrant organizations. The agency continued in this southerly direction-
"...during the Gingrich revolution of the early 1990s...[and] in recent days, as the George W. Bush administration pursues health and science policies based more on politics and ideology than scientific data"
Markel points out that Americans depend on the FDA to curb industrial impulses that tend to place profits over safety. In fact, Americans probably take for granted the role that the FDA plays in "watching over" their food and medicine. Yet today, as in the last two centuries, we need a strong, functioning FDA, divorced from the drug industry and led by people not linked to it.
Newsweek also highlights the subject this week in an interview with Marcia Angell in, "The Public is Waking Up", a title that defies the facts of the article. She comments on some of the barriers to improving the FDA in the current political climate. Acts like the 1992 Prescription Drug User Fee Act [PDUFA] allow that drug companies pay fees to the FDA for reviewing drugs, while the lobbying strength of pharma prevents passage of legislation that would strengthen the FDA. She argues that people really aren't "waking up":
"...I'd like to see the public a little savvier about what is going on. They are being taken to the cleaners. Many people are still intimidated by this idea that drug companies are producing medical miracles and if you mess with them the miracles will stop.
The FDA is important, as it acts as a buffer between profit interests and health. Privatization has tipped the public healthcare boat so it is leaning precipitously to the gunwales. Markel argues that the state and the FDA need to be revitalized to recover objective oversight of commercial food and drugs. Angell observes that its not likely to happen during this administration. Both authors argue for greater public awareness and involvement with the issues.
