As the US Food and Drug Administration (FDA) embroils in scandal after scandal, Americans need to re-examine the once revered and touted federal agency as the protector of public’s health. Although nearly 40% of Americans claimed that their confidence in the FDA has fallen due to the recent revelations, still 70% of Americans believed in the FDA’s ability to ensure the safety of prescription drugs and foods for the consumer market.
Does the FDA work for the interest of the American people, for the drug and food corporations, or for the political propaganda of the White House?
When medical professionals, scientists and analysts consistently doled out statistics showing more than half of Americans that have become obese, one might surmise that the FDA has not been protecting the people’s health. When the FDA approved numerous dangerous prescription drugs despite warnings from the experts and allowed various genetically modified (GM) products to be unlabeled on the food market, one might deduce that the FDA has been working in collaboration with the pharmaceutical and biotech companies. When questionable GM foods and certain drugs with harmful side-effects were banned in other parts of the world while these same GM foods and drugs were given a nod in the United States, one might conclude that the FDA has been functioning as a political propaganda of the Bush Administration favoring biotechnology and big business.
Known as the "the strictest regulatory agency in the world," the FDA is now under scrutiny not only in the American arena but also on world stage. The reputable FDA, as the pillar of integrity run by the elite medical professionals and scientists, has finally been disgraced by its internal documents made public from lawsuits. In debunking the myths of the FDA, these damaging files revealed the corruption within the system, the discord among the staff members, and the influences of political power and of corporations.
Myth One: New foods and drugs have been extensively tested for safety.
Contrary to scientific consensus on GM food, the FDA official policy declares that the process of genetic engineering is the same as traditional breeding; therefore, GM food does not require safety testing. U.S. biotech companies can voluntarily submit food safety testing data to federal regulators for review. According to the U.S. Center for Science in the Public Interest, when the FDA requested additional information, biotech companies complied only half the time, narrowing the scope of FDA's evaluation of data for food safety. Furthermore, a biotech manufacturer is allowed to introduce a genetically modified food without even informing the government or consumers. Worse still, the FDA ignored independent studies that showed severe harm to laboratory animals fed with GM food in order to boost biotech companies with their novel food creation.
A series of scandals involving dangerous drugs — COX-2 inhibitors, antidepressant drugs and statin drugs that are known to cause serious injuries and even deaths — have now put the FDA in the spotlight for gross negligence in giving them the green light. In November 2004, Dr. David Graham, a chief drug safety researcher, testified before the Senate — disclosing the dangers of these prescription drugs and the censorship of scientists who spoke against the agency’s drug safety review process. The fact that such harmful drugs have made it onto the market — Vioxx, Meridian, Bextra, Accutane, Crestor, Serevent — only attests to the dysfunction of the FDA’s procedure for testing drug safety.
Myth Two: Approval of foods and drugs was based on sound science.
Despite the world banning GM foods, the United States stands alone in promoting GM foods as safe for human consumption. The FDA insists that GM foods are no different from natural foods — an unscientific claim. According to technical experts, the processes of genetic engineering and natural breeding are indeed different, and they lead to different risks. The procedure of introducing an unrelated gene to a cell in a lab is not the same as the process of natural genetic selection in Nature over the years. Scientists warned that GM foods might create a unique set of risks — unknown toxins, allergies, nutritional problems, and diseases that could not be revealed in short-term testing. Due to the genetic nature of the altered food, long-term observation on each genetically modified variety is necessary in order to determine the safety of the food product.
After a decade of marketing GM foods in the U.S., evidence of detrimental effects has been piling — farmers now face setbacks with economic woes (unable to sell GM products on the world market) and new kinds of environmental problems (super weeds and natural crop fields contaminated with GM seeds blown in by the wind); diminishing number of common field insects; and human health problems related to food have dramatically soared (obesity, allergies, diabetes, and lymphatic cancers). Although no study has ever been made to connect these health problems with GM food, the fact that a growing number of Americans have become unhealthy since the infiltration of GM food on the market in 1994 should make any GM product a suspect.
As for scientific peer-review on drug approval, the recent testimony of Dr. David Graham clearly illustrated the culpability of the FDA — siding with a company’s manipulated drug safety testing results over its own scientists’ warning against a drug's ill effects. Obviously, if the drugs had been approved by the FDA based on sound science, there wouldn’t have been so many lawsuits and recalls of drugs that the White House (under George W. Bush) interceded, pushing for a “tort reform” to relieve the FDA of product liability.
Myth Three: FDA serves and protects the public’s health.
Nowadays, the FDA serves and protects the corporate wealth. Everything the FDA has done in the last decade indicates that it values pharmaceutical and biotech industry profits over the health of the public. Furthermore, the FDA has become the instrument in carrying out the policies of the Bush family's dynasty. In 1992, the FDA Commissioner David Kessler confirmed the White House ’s influence in shaping the FDA’s policy (under George Bush) by responding in his memo that the FDA would assure “the safe, speedy development of the U.S. biotechnology industry.”
The fact that GM foods are unmarked on the food market demonstrates the FDA’s collusion with biotech companies in a mass public deception — passing GM food as traditional food. It’s estimated that 75% of processed foods — boxed cereals, other grain products, frozen dinners, and corn products — contain some genetically modified ingredients. Around half of Americans don't even realize that GM foods are being sold in supermarkets — and they're wondering why their diet is getting worse.
The fact that 100,000 people being killed and at least 2 million injuries each year caused by legal prescription drugs, according to the Journal of the American Medical Association, implicates the FDA's cozy relationship with pharmaceutical companies — approving toxic drugs at the expense of public’s health. After all, pharmaceutical companies pay the FDA for reviewing their drugs. It’s not surprising that the FDA approved 68% of new drugs today, compared to only 2% of new drugs approved a decade ago.
The fact that two-thirds of the FDA’s own scientists don't think the agency can adequately monitor the safety of drugs, according to a survey conducted by the Human and Health Services in 2002. The actual distrust of FDA's own staff in the agency ought to send a loud and clear message to the public. Furthermore, the FDA seems to go out of its way to protect the financial interests of drug companies — silencing its own scientists; burying negative evidence of dangerous drugs; discrediting nutritional supplements, herbal medicine, vitamins and other natural remedies for health benefits; and the latest, blocking the importation of cheaper prescription drugs from Canada.
To evaluate the FDA's competency and efficiency as a federal agency, statistics can speak louder than rhetoric:
- The Death by Medicine research showed more than 750,000 Americans died annually by conventional medicine;
- COX-2 inhibitors killed 60,000 Americans;
- Rezulin killed 10,000 people and damaged the livers of 100,000 before being pulled from the market;
- NSAIDs killed some 40,000 patients each year from intestinal bleeding;
- 76 million food-related illnesses occurred each year.
Unfortunately, there were far more unreported cases of injuries from prescription drugs and over-the-counter drugs than the reported deaths of consumers. Without a doubt, Americans are having more health problems than a decade ago.
Can we trust the FDA NOW?
(First published on UniOrb.com, June 1, 2005)