NewsInferno.com, Steven DiJoseph
Published November 20, 2005
Experts See FDA's Practice of Allowing Potentially Hazardous Products to Remain on the Market While 'Further Studies' are Conducted as Unnecessarily Exposing the Public to Serious Health Risks
Many scientists, consumer advocates, and health professionals have wondered for years: Why does the FDA repeatedly err on the side of industry, rather than the public, when a question of safety is concerned?
Typically, whether the product is a prescription drug like Vioxx, Accutane, or the Ortho Evra birth control patch; or chemical compounds like C8 or PFOA (perfluorooctanoic acid), or phthalates, the posture taken by the FDA is to resist pulling an already approved product from the market until the proof of its danger to consumers is overwhelming.
Animal studies, whistleblower revelations, or reports of adverse reactions rarely, if ever, prompt the FDA to rethink its approval and pull a product from the market until it is proved safe. Instead, the product is allowed to remain on the market until its critics can muster sufficient evidence to reverse the slowly turning wheels of an industry-friendly agency.
Critics of the FDA believe once an arguable safety issue is raised, a product should be removed from the market until it is proven to be safe rather than the other way around. This is even more important with respect to products that were approved decades ago when advanced testing procedures or long-term scientific data were unavailable.
Today's state-of-the-art scientific tests are often far superior to those that were used to gain approval of a product in the 1970s, 1980s, or even the 1990s. Unfortunately, the FDA is so mired in commitments to lobbyists, political actions committees, and financial supporters affiliated with the pharmaceutical and chemical industries that the agency's objectivity is often compromised and frequently questioned.
Within the past few months, this very phenomenon has occurred with respect to several products and prescription drugs; in particular the chemical compounds known as phthalates and the Ortho Evra birth control patch.
* Phthalates, have been used for the past 50 years for everything from making plastic more flexible to slowing the evaporation process of perfumes to making nail polish that won't chip away. Phthalates, pronounced "thallets," are found in a variety of products such as cosmetics, hair sprays, deodorants, shampoos, nail polish, perfumes, body washes, skin creams, prescription pill coatings, insect repellants, detergents, vinyl products, medical equipment, food packaging, plastic and vinyl toys, shower curtains, and building materials such as pipes, vinyl flooring, and wallpaper. In the past year, environmental and consumer advocacy groups have begun to seriously challenge the safety of phthalates. Studies of the effects of phthalates on both animals and humans have now found several serious heath risks traceable to exposure, inhalation, or ingestion of phthalates. Just a few months ago, the European Parliament voted to permanently ban products containing phthalates citing evidence of damage to the reproductive system and an increased risk of asthma and cancer. A temporary ban had previously existed in Europe since 1999. While the FDA is currently conducting an ongoing investigation of the safety of phthalates, the agency continues to take the position that no risk is posed to phthalates in cosmetics. Consumer advocates and concerned scientists view this as nothing more than an ostrich-like approach to the mounting evidence that phthalates present serious health risks to humans. Thus, delaying the recognition of the risks by insisting on "further studies" is regarded as irresponsible since already completed human and animal studies have proven a link exists between phthalates and a number of serious long-term health problems.
* After years of debate over the safety of the Ortho Evra birth control patch ("the Patch"), the drug's manufacturer, Ortho-McNeil (a subsidiary of Johnson & Johnson), has finally acknowledged that women who use the product are at a significantly greater risk of blood clots, stroke, and death than woman who use other forms of oral contraceptives because those who use the patch can be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill instead. Critics of both the 'Patch' and the FDA's approval and monitoring practices, however, see the warning as simply another example of economics being placed above public safety. There has been a constant chorus of warnings about the extremely serious side-effects associated with the Patch from a number of experts as well as the consumer watchdog group, Public Citizen (
www.worstpills.org) and the Associated Press. Several lawsuits have already been commenced around the U.S. alleging that serious injuries and deaths have been caused by the Patch. Only two weeks ago, CBS News presented a significant story from Austin, Texas, concerning documents produced in the course of a pending lawsuit involving a young mother who was paralyzed by a stroke only 12 days after she began using the patch. She is now a total invalid. According to that story, Ortho-McNeil's own records show the company received some 500 reports of serious health problems associated with the patch between April 2002 and December 2004. During that time only 61 such reports were received with respect to all types of existing oral contraceptives. In addition, there were four times as many strokes in women using the patch as in women using oral contraceptives even though three times as many women were taking those other forms of birth control. Finally, the evidence indicates, that in medically confirmed cases, the risk of blood clots is 14 times as high with the patch. An investigative report published by the Associated Press on July 18, 2005 linked the birth control patch, which contains a combination of norelgestromin and ethinyl estradiol, to an increased risk of blood clots and deaths (compared to older contraceptives) in some young healthy women. Ortho-McNeil has routinely denied the allegations that these deaths and injuries were the result of Ortho Evra risk factors. It claimed that the "unsolicited reports" it received were not reliable evidence of a problem with the drug. The company also claimed its own investigation had not found any causal factor linking these deaths to Ortho Evra and relied on the absence of any reports of fatal adverse side-effects during the clinical trials as proof of the drug's safety. Ortho-McNeil's reluctance to accept even the possibility that the Patch could be at fault has lead to the drug being kept on the market without adequate warnings. Even today's press release and FDA advisory regarding new labeling requirements do not satisfy the Patch's many critics. In the eyes of those critics, the fact that Ortho-McNeil has notified the FDA that it has undertaken a "much larger study" with respect to the potential problem of blood clots, strokes, and death associated with the Patch is merely prolonging the time in which millions of women are exposed to an unacceptable risk of catastrophic injuries and death. Again, the FDA has permitted a drug to remain on the market notwithstanding extensive evidence that it is unsafe while it "investigates further."
Against this backdrop of repeated inaction by the FDA is the situation involving the potential health risks posed by DuPont's Teflon and one of the chemicals used in its manufacture as well as another DuPont chemical known as Zonyl RP.
As we have previously reported, for the past two years, there has been a growing concern over the safety of the manmade chemical known as C8 or PFOA (perfluorooctanoic acid) which can be found in everything from bread to birds, green beans to ground beef, dolphins to drinking water, and in the blood of up to 96% of the population of the United States.
The acid is used to manufacture Teflon coating for cookware and hundreds of other products like telephone cables, carpets, clothing, computer chips, chemical piping, and automobile fuel systems. Teflon currently nets DuPont a reported $200 million in profit a year. .
Because there are no known "natural" sources of C8, scientists are curious as to how the chemical enters the environment. C8 has also contaminated the groundwater in areas where Teflon is manufactured.
DuPont, which also pioneered the development of PFOA and continues to dominate its use, claims that the chemical is harmless to humans. It also disputes that C8 is released during normal cooking (as opposed to overheating).
Others are not so sure that either assertion is true. Studies have concluded that C8 is one of several toxic gases released by Teflon when it is heated to temperatures which, at their low end, are only slightly above normal cooking temperatures.
C8 has been shown to cause tumors in rats and fumes from Teflon coated cookware can cause what is known as "polymer fume fever," a condition which has been shown to kill birds even at low temperatures but which DuPont claims is harmless to humans if the cookware is used at a temperature of up to 500
