Food and Drug Safety

With Food and Drugs, Safety First

 
How safe is the food we eat? How safe and effective are the drugs we take and the medical devices we use? These are questions one might expect the U.S. Department of Agriculture and the Food & Drug Administration to answer with quick and reassuring replies. Unfortunately, examples of unsafe food and drugs in recent years have been far too common, and in some cases, all too deadly.
 
In late 2004, for example, pharmaceutical manufacturer Merck & Co. Inc. announced that it was voluntarily withdrawing its blockbuster pain medication, Vioxx. The company revealed that a clinical trial had demonstrated that long-term use of the pain-relief product resulted in a nearly doubled risk of heart attack or stroke. Some 20 million people had taken drug by then. Should the Food & Drug Administration have known earlier? Should it have recognized the risks, and denied approval to the product, or at the very least insisted on more research to rule out the possibility? According to The Hidden Lesson from the Vioxx Fiasco, a 2005 report from CPR’s Rena Steinzor and Margaret Clune Giblin, FDA failed to protect the public in the Vioxx case because it had become an example of a “hollow government” agency – lacking the resources to do its job adequately, and missing the political will to fight for those resources and to reign in companies eager to take excessive risks.
 
Another conspicuous failure gave rise to the Mad Cow controversy of 2003-04. In that instance, Department of Agriculture officials rushed to the aid of the beef industry after an instance of the deadly and contagious disease turned up in an American herd of cattle.   Rather than clamping down on the industry to make sure it was following safe practices, the Department launched what CPR’s Tom McGarity described as a series of public relations efforts aimed at bolstering confidence in American beef, whether that confidence was warranted or not.
 
These and other instances of unsafe food and drugs working their way into the consumer market are examples of a failed system of regulation and enforcement. Often the failure is the result of neglect – a lack of political will to spend the money required to conduct meaningful research and enforcement. Sometimes the cause is ideological: a conviction that government should “get off industry’s back,” because such regulation is unnecessary, that the “rare” instances when unsafe food or drugs are produced and sold are self-correcting for the manufacturer, because they would suffer economic consequences. That argument likely holds little appeal to the families of the estimated 88,000 or more Americans who suffered heart attacks because they took Vioxx.
 
Learn about CPR Member Scholars’ work to ensure the safety and efficacy of the nation’s drugs and medical devices, and the safety of the nation’s food supply:
  • Hollow Government and the FDA. Read "The Hidden Lesson of the Vioxx Fiasco: Reviving a Hollow FDA," by Rena Steinzor and Margaret Clune Giblin. (CPR White Paper #514, October 2005)   Or read CPR's news release on "The Hidden Lesson of the Vioxx Fiasco."  Or read CPR's Tom McGarity's January 2005 letter to the USDA protesting an effort by the peach and nectarine industry to drive up prices for its product by banning from the marketplace fruit that has purely cosmetic flaws.
  • Mad Cow. Read about Thomas McGarity’s work on Mad Cow disease.
  • Biopharming. Are genetically modified crops safe? Many consumers in the United States and abroad don't think so, and many scientists are worried. Read op-eds by Thomas McGarity on the subject: "U.S. pitches EU a hard ball," on the Administration's "faith-based" approach to the regulation of genetically modified food crops, published in the June 24, 2003 Sacramento Bee; or "Trouble Down on the Biopharm," on USDA secrecy as it affects the prospects of genetically modified crops accidentally corrupting food crops, March 2003.
  • Organic Foods. Read CPR's March 10, 2003 editorial memorandum on the organics rider in the FY 2004 Omnibus Appropriations bill, passed by Congress and signed into law. The measure would have resulted in meat raised on chemicals and pesticides being falsely labeled "organic" in grocery stores. Or read "Reckless Riders," an opinion column by Thomas McGarity on an appropriations rider undercutting federal labeling of "organic" meat, February 2003.
  • Obesity Liability. Should the companies that super-size our food, or that load even the lowliest vegetable with great quantities of fat be held liable for the obesity epidemic to which they contribute?  In 2004, the U.S. House of Representatives is quite sure that question cannot be left to the courts, and has enacted legislation aimed at stopping such lawsuits before they start. Read Douglas Kysar's op-ed in the Orlando Sentinel, March 17, 2004.