From Barnyard to Bedside: Is FDA in Control?
By David Schubert
June 22, 2006
If you survived for 100 years, you would think that your birthday would be a cause for celebration. This is not the case with the Food and Drug Administration, the agency responsible for the safety of our food and medicines. As with all of our science-based government agencies, the FDA has suffered greatly at the hands of the Bush administration, resulting in the resignation of many of its top scientists and administrators, a very low morale among its 9,000 employees, a loss of public confidence, and very recently a new lawsuit.
The FDA was originally the chemistry unit of the Department of Agriculture, but it became a separate agency following the publication of "The Jungle," Upton Sinclair's novel depicting Chicago's turn-of-the-century meatpacking industry. The health risks dramatized by Sinclair led the Republican White House of Teddy Roosevelt and a Republican Congress to pass legislation that was vigorously opposed by the food industry.
The Pure Food and Drugs Act passed in June 1906, requiring the correct labeling of food and drugs and allowing the federal government to seize dangerous products. In subsequent decades, the FDA acquired additional oversight responsibilities, including the regulation of medical devices, cosmetics, animal feed and, most recently, genetically engineered organisms.
In stark contrast to 1906, today we have a Republican White House and Congress that are unwilling to support not only the FDA but also any public health measure that is opposed by their industrial and ideological constituents.
Most of the FDA staff are hardworking professionals doing their best to keep the public safe by formulating regulatory policies based upon hard science. To be effective, they must be able to act independently and receive support from both Congress and the White House.
In this regard, states former FDA Commissioner Donald Kennedy in a recent Science Magazine editorial: "What I'd tell the few old friends left at the FDA is that you deserve better than you are getting".
Because of its origins, the FDA receives its appropriations from the congressional agriculture subcommittees that are dominated by red state conservatives. As a result, its funding is inadequate for the important role that it plays in our society, and the distaste of the Bush administration for this role is reflected by the fact that over the last six years the FDA has only had a confirmed commissioner for less that 20 months.
If the acting FDA commissioner, Andrew von Eschenbach, is confirmed by the Senate, he will have a number of difficult issues to address. In drug approval, the FDA has been accused of giving in to pressure from the pharmaceutical industry over questions relating to the safety of antidepressant use in children and insufficient testing of drugs such as Vioxx.
On the other side of the drug approval issue, the FDA was overruled by a federal appellate court in a decision that will now allow terminally ill patients access to unapproved drugs. In addition, Republican Sen. Sam Brownback of Kansas recently introduced a bill that would give patients access to drugs that are promising but have not been proven effective. These measures would make it much more difficult to conduct the clinical trials required to determine whether a drug is truly effective.
The first Bush administration made the serious mistake of allowing potentially dangerous genetically engineered plants into our food supply without any mandatory safety testing. This was done without causing public concern by creating the illusion that the safety testing of such food is done by the FDA. It is not, and there are no FDA safety-testing requirements. More recently, the FDA's own biotechnology committee was ignored when it recommended that the FDA adopt international standards for genetically engineered food testing.
Because of the FDA's continual refusal to take action on evidence that these food crops may present a health hazard, a lawsuit was filed June 7 by the Center for Food Safety to force the government to conduct mandatory safety testing of all genetically engineered foods and require labeling once they are approved. In a society where freedom of choice is demanded in many areas, people should also insist upon the information necessary to make an informed choice about what they eat.
While this lawsuit is in progress, it will be a challenge for the agricultural biotechnology industry to win both FDA and public approvals of genetically engineered cows that produce their own antibiotic (yes, it is in the milk!) and genetically engineered enviropigs that produce less phosphate in their feces, a major contaminate of our waterways. Enviropigs could become enviro-hazards if the gene that allows them to digest plant phosphate is transferred to feral pigs, allowing them to eat a wider variety of foliage.
In addition to industrial lobbies, religion is another powerful force behind the current regulatory policies of the FDA. While we tend to view with dismay the power of the Muslim clerics in the Middle East, our own fundamentalists now have an influence in FDA medical decisions. There are several recent examples, but the one that will have to be resolved soon involves the right of women to have access to the contraceptive called Plan B. It was approved by the FDA's own medical and scientific advisory committees, but has been administratively stopped by pressure from Republican conservatives.
Finally, on its birthday, the FDA should reflect upon its roots. The major source of mad cow disease in cattle is the practice of including meat, bones and blood from other animals in their feed. The inclusion of beef in cattle feed was stopped after it was determined that this was the method of its transmission. However, cattle are still routinely fattened with the blood of other cattle as well as with excrement, feathers and spilled feed from chicken coops. This practice was outlawed in Europe because of the potential for disease transmission from the cattle remains that are included in the chicken feed. Two years ago, then-FDA Commissioner Lester Crawford stated that this practice would also be banned in the U.S., but thanks to the powerful agricultural lobby, it is still in use.
For the FDA to continue safeguarding the health of our population against a wide range of potential health threats for the next 100 years, it must be able to function independently. To do this, it needs adequate funding as well as the unbiased support of Congress and the executive branch. The only possibility for a change for the better at the FDA is for the electorate to choose politicians who understand that public health and safety should be the supreme trump over corporate greed and misguided religious ideology.
Deficiencies in Federal Regulatory Oversight of Genetically Engineered Crops
By Brian Tokar
Those who question the appropriateness of local ordinances or state-level efforts to control the spread of genetically engineered (GE) crops often suggest that this technology is sufficiently well regulated by the federal government. But there is extensive evidence that federal oversight is not sufficient to protect farmers and the general public from the potential consequences of this technology. This briefing will attempt to address several salient questions:
- Does the federal government regulate genetically engineered crops?
- How does the USDA's oversight of GE crops in the field actually work?
- Is USDA oversight of GE crops adequate?
- How well do the EPA and FDA address environmental and food safety concerns?