Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the preservative be given to extremely young infants -- in one case, within hours of birth -- the estimated number of cases of autism had increased fifteenfold, from one in every 2,500 children to one in 166 children.
Verstraeten wasn't alone in expressing concern. The transcripts record Dr. Bill Weil, a consultant for the American Academy of Pediatrics, as saying, "You can play with this all you want,... [The results] are statistically significant." Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado whose grandson had been born early on the morning of the meeting's first day, said "My gut feeling? Forgive this personal comment -- I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on."But the conversation didn't then turn to ways to ensure public safety. Dr. Robert Brent, a pediatrician at Delaware's Alfred I. duPont Hospital for Children was more worried about the possibility that, "We are in a bad position from the standpoint of defending any lawsuits. This will be a resource to our very busy plaintiff attorneys in this country." Dr. Bob Chen, head of vaccine safety for the CDC, chimed in with the assertion that, "given the sensitivity of the information, we have been able to keep it out of the hands of, let's say, less responsible hands."Dr. John Clements, vaccines advisor at the World Health Organization, declared that "perhaps this study should not have been done at all," adding, "the research results have to be handled," that the results of the study, "will be taken by others and will be used in other ways beyond the control of this group."Adds Kennedy, at this point:
In fact, the government has proved to be far more adept at handling the damage than at protecting children's health. The CDC paid the Institute of Medicine to conduct a new study to whitewash the risks of thimerosal, ordering researchers to "rule out" the chemical's link to autism. It withheld Verstraeten's findings, even though they had been slated for immediate publication, and told other scientists that his original data had been "lost" and could not be replicated. And to thwart the Freedom of Information Act, it handed its giant database of vaccine records over to a private company, declaring it off-limits to researchers. By the time Verstraeten finally published his study in 2003, he had gone to work for GlaxoSmithKline and reworked his data to bury the link between thimerosal and autism.Vaccine manufacturers had already begun to phase thimerosal out of injections given to American infants -- but they continued to sell off their mercury-based supplies of vaccines until last year [2004]. The CDC and FDA gave them a hand, buying up the tainted vaccines for export to developing countries and allowing drug companies to continue using the preservative in some American vaccines -- including several pediatric flu shots as well as tetanus boosters routinely given to eleven-year-olds.
Former Senate Majority Leader Bill Frist, who received $873,000 in contributions from pharmaceutical companies, slipped a "rider" into a Homeland Security bill in 2002, protecting vaccine manufacturers from lawsuits brought by those who suffer vaccine injury--this despite the fact that any vaccine-injury cases ALREADY have to be brought to trial in a special federal Vaccine Court. Eli Lilly, the company that manufactures Thimerosal, contributed $10,000 to Frist's campaign fund the next day, then bought 5,000 copies of his book on bioterrorism.Kennedy adds:
The measure was repealed by Congress in 2003 -- but earlier this year, Frist slipped another provision into an anti-terrorism bill that would deny compensation to children suffering from vaccine-related brain disorders. "The lawsuits are of such magnitude that they could put vaccine producers out of business and limit our capacity to deal with a biological attack by terrorists," says Dean Rosen, health policy adviser to Frist.
But wait, there's more... On five separate occasions, Frist has tried to seal all of the government's vaccine-related documents -- including the Simpsonwood meeting transcripts.But what do we read about all of this in the mainstream press? Let's see, there was the study claiming that "autism is caused by drinkingduringpregnancy" this week, that got global play. Last year it was "autism is caused by watching television."And there are countless articles in the New York Times and Wall Street Journal assuring readers that "all reputable studies prove there's no link between vaccines and autism," that "autism rates have not gone down since ALL thimerosal was removed from ALL vaccines in 2001" and a great many characterizing concerned parents of autistic children as desperate for someone or something to blame for their children's condition or as lawsuit-hungry money grubbers.Have autism rates gone down since thimerosal was phased out of vaccines, starting in 2001? Nobody knows. Can you believe that? Seriously, there's been no effort on the part of the CDC or any other federal agency to gather national data on that front.California is the only state that keeps records of those receiving developmental disabilities services which are categorized by specific disability. It was California's numbers, in fact, which first confirmed what parents had long suspected---and "experts" long denied--that the rate of autism among young children in this country started skyrocketing in the 1990s. If California's rates went down, that might be an indicator that removal of thimerosal was making some kind of a difference, right? Let's just ignore the Associated Press article published in 2005 that announced "The number of new cases of autism in California has fallen for the first time in more than 10 years in what may be a bellwether for autism rates nationwide, according to new data compiled by the state Department of Developmental Services."Everyone else ignored it, after all. And any parent who tries to bring it up is branded a crazed Luddite, or worse. Michelle Malkin, with whom I don't always see eye-to-eye politically except on this topic, blogged "In defense of parents with informed vaccine skepticism" on March 24th:
Look, I could run you through the flaws in the studies routinely cited in that type of article (the Danish one, the Israeli one, etc.), or the differences in the way ethyl and methyl mercury break down in the body (not many), or the still-toxic and untested preservatives that have replaced thimerosal in multi-dose vials of vaccines, or the study performed at Columbia on the aberrant behaviors of infant mice injected with thimerosal, or the similarities in symptoms between autism and mercury poisoning,or the fact that among thousands of Amish people in Pennsylvania (virtually non-vaccinated, as a population) only a handful of kids were found with any form of autism--one who'd been adopted in China and three who'd received vaccinations--when the expected number per that population would be around 130 affected individuals, or the hypothesis that autistic kids may lack the proper metabolic apparatus to excrete heavy metals as quickly as "typically developing" kids, or statistics on how much mercury is stillin a number of shots administered routinely to infants and children and pregnant women (flu, tetanus, Rhogam, etc.)--because that's my version of the genius investor's "cabbages and sailing," these days.... (please run your mouse over the text of the previous two paragraphs to click through to studies cited--for some reason the hyperlinks aren't highlighted) But I don't want to bore you any more than necessary, and besides, as a "bad parent and bad citizen," I'll let Kennedy speak to the history of the issue instead:
During the Second World War, when the Department of Defense used the preservative in vaccines on soldiers, it required Lilly to label it "poison."In 1967, a study in Applied Microbiology found that thimerosal killed mice when added to injected vaccines. Four years later, Lilly's own studies discerned that thimerosal was "toxic to tissue cells" in concentrations as low as one part per million -- 100 times weaker than the concentration in a typical vaccine. Even so, the company continued to promote thimerosal as "nontoxic" and also incorporated it into topical disinfectants. In 1977, ten babies at a Toronto hospital died when an antiseptic preserved with thimerosal was dabbed onto their umbilical cords.In 1982, the FDA proposed a ban on over-the-counter products that contained thimerosal, and in 1991 the agency considered banning it from animal vaccines. But tragically, that same year, the CDC recommended that infants be injected with a series of mercury-laced vaccines. Newborns would be vaccinated for hepatitis B within twenty-four hours of birth, and two-month-old infants would be immunized for haemophilus influenzae B and diphtheria-tetanus-pertussis.The drug industry knew the additional vaccines posed a danger. The same year that the CDC approved the new vaccines, Dr. Maurice Hilleman, one of the fathers of Merck's vaccine programs, warned the company that six-month-olds who were administered the shots would suffer dangerous exposure to mercury. He recommended that thimerosal be discontinued, "especially when used on infants and children," noting that the industry knew of nontoxic alternatives. "The best way to go," he added, "is to switch to dispensing the actual vaccines without adding preservatives."...Rep. Dan Burton, a Republican from Indiana, oversaw a three-year investigation of thimerosal after his grandson was diagnosed with autism. "Thimerosal used as a preservative in vaccines is directly related to the autism epidemic," his House Government Reform Committee concluded in its final report. "This epidemic in all probability may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal, a known neurotoxin." The FDA and other public-health agencies failed to act, the committee added, out of "institutional malfeasance for self protection" and "misplaced protectionism of the pharmaceutical industry."
And now I'd like to quote some numbers recently put forth by a toxicologist named Michael F. Wagnitz, in a rebuttal letter to the editors of Pediatrics, the journal of the American Academy of Pediatrics.Wagnitz introduced his list by writing, "Parents get angry when they see the following numbers listed on the internet. These numbers have been out there for everyone to read for years."Here are the numbers he cited:
0.5 parts per billion (ppb) mercury = Kills human neuroblastoma cells (Parran et al., Toxicol Sci 2005; 86: 132-140).2 ppb mercury = U.S. EPA limit for drinking water http://www.epa.gov/safewater/contaminants/index.html#mcls20 ppb mercury = Neurite membrane structure destroyed (Leong et al., Neuroreport 2001; 12: 733-37).200 ppb mercury = level in liquid the EPA classifies as hazardous waste. http://www.epa.gov/epaoswer/hazwaste/mercury/regs.htm#hazwaste25,000 ppb mercury = Concentration of mercury in the Hepatitis B vaccine, administered at birth in the U.S., from 1990-2001.50,000 ppb mercury = Concentration of mercury in multi-dose DTaP and Haemophilus B vaccine vials, administered 4 times each in the 1990's to children at 2, 4, 6, 12 and 18 months of age. Current "preservative" level mercury in multi-dose flu (94% of supply), meningococcal and tetanus (7 and older) vaccines. This can be confirmed by simply analyzing the multi- dose vials.
Oh yeah, I forgot to mention that Wagnitz has a conflict of interest: he's the father of an autistic child.Way back near the beginning of this post, remember how I said that something happened this month which made me feel it was necessary to at long last write a blog post on, as it turns out, thimerosal?Here's the event I spoke of: the government decided in favor of the plaintiffs in one of the first Vaccine Injury Court autism test cases to go to trial.That's right, folks, a judge representing the United States government decided that the family of an autistic girl was entitled to a monetary award, because it indeed seems evident that her condition was caused by "routine childhood vaccinations."The anti-vaccine-hypothesis gang got started on spinning the verdict immediately--most by claiming that the girl, Hannah Poling, wasn't "typical" of autistic children, in that she had a metabolic disorder exacerbated by vaccines, and that therefore the metabolic disorder is itself responsible for her "autistic symptoms."There are still nearly 5,000 such cases pending in the special court. I would be cynical if I thought that might have something to do with the intensity of the spin.And yet... the online version of Time magazine had the courage to look at the facts of the case without the disimissive attitude so many of us have come to expect from the "mainstream" media, in an article titled “Case Study: Autism and Vaccines.”The piece opened as follows:
What happened to little, red-haired Hannah Poling is hardly unique in the world of autism. She had an uneventful birth; she seemed to be developing normally-smiling, babbling, engaging in imaginative play, speaking about 20 words by 19 months. And then, right after receiving a bunch of vaccines, she fell ill and it all stopped.Hannah, now 9, recovered from her acute illness but she lost her words, her eye contact and, in a manner of months, began exhibiting the repetitive behaviors and social withdrawal that typify autism. “Something happened after the vaccines," says her mom, Terry Poling, who is a registered nurse and an attorney. “She just deteriorated and never came back."
Hannah Poling's father, by the way, is a neurologist.Here's one official's response to the court's ruling in the Poling case:
"Our message to parents is that immunization is life-saving," Dr. Julie L. Gerberding, the CDC's director, said at a hastily convened conference call with reporters.
"There's nothing changed. . . . This is proven to save lives and is an essential component of protection for children across America and around the world."
Gerberding further commented:
“Let me be very clear that (the) government has made absolutely no statement indicating that vaccines are a cause of autism. That is a complete mischaracterisation of the findings of the case, and a complete mischaracterisation of any of the science that we have at our disposal today.”
The Time article, however, went on to say:
...there’s no denying that the court’s decision to award damages to the Poling family puts a chink--a question mark--in what had been an unqualified defense of vaccine safety with regard to autism. If Hannah Poling had an underlying condition that made her vulnerable to being harmed by vaccines, it stands to reason that other children might also have such vulnerabilities.
As blogger Kent Heckenlively wrote in response to the article "I found myself nodding along as I read, saying, 'Yes! Yes! They’re getting it!'”"One of the final paragraphs [in the article] is a statement which shouldn’t be controversial," he continues, "but when our community has said similar things we’ve been treated like we were primitives who wanted to take public health back to the nineteenth century." (And/or "bad parents," "bad citizens," "Bobo Sociopaths.")Here's the paragraph he's referring to:
It’s difficult to draw any clear lessons from the case of Hannah Poling, other than the dire need for more research. One plausible conclusion is that pediatricians should avoid giving small children a large number of vaccines at once, even if they are thimerosal-free. Young children have an immature immune system that’s ill-equipped to handle an overload, says Dr. Judy Van de Water, an immunologist who works with Pessah at U. C. Davis. “Some vaccines, such as those aimed at viral infections, are designed to ramp up the immune system at warp speed,” she says. “They are designed to mimic the infection. So you can imagine getting nine at one time, how sick you could be.” In addition, she says, there’s some evidence, "that children who develop autism may have immune systems that are particularly slow to mature.”
"It’s stunning to read a paragraph like the one above in a major publication like TIME magazine," says Heckenlively, "when it’s been part of the catechism of our movement for years. It’s as if we’ve been secret believers in God in some totalitarian state and the ruler just announced he’s considering a conversion." He also cites a report titled, "Vaccine Case - An Exception or a Precedent," from the CBS Evening News broadcast that aired on March 6, 2008, in response to the CDC having stated that Hannah Poling's case is "a singular event":
While the Poling case is the first of its kind to become public, a CBS News investigation uncovered at least nine other cases as far back as 1990, where records show the court ordered the government to compensate families whose children developed autism or autistic-like symptoms... including toddlers who had been called "very smart" and "impressed" doctors with their "intelligence and curiousity" . . . until their vaccinations.
But even if all those remaining cases pending in the Vaccine Court are ruled in favor of the plaintiff families, it doesn't mean that the families of the other estimated 500,000 kids with autism in this country will be able to sue for damages, under existing legislation. The federal government has set a three-year statute of limitations, dating from the first incidence of autistic symptoms in a child.
In light of that, I'd like to close this post with one more quotation from Dr. Marcia Angell's "farewell" editorial in the New England Journal of Medicine:
The pharmaceutical industry is extraordinarily privileged. It benefits enormously from publicly funded research, government-granted patents, and large tax breaks, and it reaps lavish profits. For these reasons, and because it makes products of vital importance to the public health, it should be accountable not only to its shareholders, but also to society at large.
May that sentiment go from Angell's lips to God's ears. And possibly Julie Gerberding's. And look, maybe it's not the vaccines or the thimerosal that made the rate of autism go from one kid in 15,000 to one kid in 116. It could be some new additive in peanut butter, or exposure to wheat bran and Sea Monkeys. I mean, until the mid-Seventies the "experts" claimed it was caused by overly intellectual, emotionally distant "refrigerator mothers." We know, at least, that that last hypothesis is a load of crap. But we don't know anything else. Isn't it time we expended a little more effort trying to really figure this thing out, and a little less of same calling the parents who are doing their best to make sense of and cope with the horrors of this disorder idiots? I can't speak for anyone else, but I'm pretty fucking sick of being told how stupid I am. I won't hold my breath waiting for that to change any time soon. Meanwhile: smoke 'em if you got 'em.Oh, yeah... conflict of interest: I'm the mother of a child who has autism
By Cornelia ReadThere's a topic I've wanted to blog about here for a long time, but it's pretty heavy stuff--not exactly the bright and breezy fare most people want to skim through online while sipping their morning beverage of choice. Over the last year or so, every time I said to myself, "hey, maybe this week, if I can just get my head around a way to make the info meaningful and compelling... to personalize it somehow so that it's not a complete drag to ingest, but yet not so bereft of necessary info that it's easy to blow off..." I'd end up scuppering the whole thing as impossible to convey. I'm still not sure I can make a blog post out of this that won't put you to sleep, but something happened this month that makes me feel like it's really, really important that I give it my very best effort right now, okay?I'm going to do my damnedest not to make this boring, or strident, or "you can save this child or you can turn the page"-esque. In fact, I'm not going to start off with the topic itself. I want to just loosely float two ideas first--kind of a warmup. Anedoctal stuff.The first thing is a story I read some years ago. I don't remember exactly when or where (the New Yorker? The Sunday New York Times?) It was just a snippet from an article about something else, but it's really stuck with me for a lot of reasons.The gist of it is that there was this guy--a journalist--who happened to be friends with an astonishingly successful investor. This investor had made serious BOATLOADS of money in the stock market, and one day his buddy, the journalist dude, got curious about the way his own line of work might be tied into his friend's success, so asked him which news outlets he'd relied on for accurate information on which to base his buying and selling decisions. Newspapers? Magazines? Television news reports?Here's what the investor said (I'm paraphrasing more, from here on out), "None." How can that be? asked his friend, to which the gazillionaire dude replied, "I realized a long time ago that there are two subjects in the world about which I know a great deal. One is sailing, and the other is cabbage varieties. And about twenty years ago, it occured to me that every time either sailing or cabbages were discussed in the mainstream press, the writers got nearly everything wrong.Well, after a while, I started to wonder why I believed them about things I didn'tknow about. I mean, what was the likelihood that they were conveying accurate, well-researched information on everything but boats and cabbage? So that's when I stopped relying on journalists' information as a basis for my business decisions. And I've made a great deal of money ever since."So, my Nakeds, do me a favor and think about a subject you really know by heart--I don't care what it is: your hometown, your favorite breed of pet, or classic muscle-car engines or ham radio......or a medical condition that you or someone near and dear to you has battled for a long time--something you have a bone-deep, working knowledge of. Got it?Now ask yourself... when there's an article on that topic in Time or Newsweek, or even the New York Times or the Wall Street Journal, do they get it right? Or do you, like me, tend to read those pieces expecting to be disappointed, and sometimes skip them altogether because even the headline is idiotic, because it's just such a goddamn drag to read the fulminations of some J-school grad who skimmed the clips file and/or gave the topic a desultory Google before banging together a cursory overview of same by deadline?Yeah, I thought so. Please file that feeling away for a bit. Which leads us to... Which can basically be summed up: the older I get, the less faith I have in "Miracle Medical Breakthroughs!"I mean, let's just look at the info propounded by "the experts" on the subject of diet and nutrition since I was in my teens: low-fat one decade, low-carbs the next...eggs will kill you, eggs will save you...Italians don't have heart attacks because they eat olive oil, French people don't have heart attacks because they drink red wine... blueberries are God, dark chocolate may save your life, monkeys live twice as long if you cut their calorie consumption in half, people in the Caucausus live to be 150 because they eat yogurt, salmon will make you smarter, pregant women shouldn't eat tuna sandwiches because they have too much mercury in them... And does anyone else remember those ubiquitous Seventies ads in the back of Cosmo and Seventeen about the kelp/B-6/cider vinegar/fourth-ingredient-I-can't-remember miracle weightloss program? That one sounded about as good as eating I remember one stepfather in the mid-seventies who dumped wheat bran on whatever he ate, because it was supposed to cure everything. Then after that he wouldn't eat salt. Then it was red meat. The year following was his swiss-chard period, I think. I was thank GOD away at school when he discovered high colonics, because he was also fond of lecturing all of us at the dinner table on the importance of whichever new thing he'd become a devotee of.He was incredibly boring--not to mention cranky--most of the time. And guess what? He died anyway, having arrived at the exact median age of life expectancy for an American male that year.So, you know--all those medical breakthroughs! pronouncements! miracles!...? I tend to reserve judgment.I'm not against western medicine--I love my penicillin and Excedrin and Motrin and Celexa and suture scars as much as the next person, and it's seriously wonderful that we've got smallpox on the run and don't have a whole lot of use for iron lungs anymore. But... I also keep in mind the fact that western medical practitioners spent several centuries touting the benefits of leeches and "a good bleeding," while pooh-poohing the radical idea that one might want to wash one's hands (or one's saw) before performing, say, an amputation.Let's take a look at another health issue that's seen a great deal of "expert" see-sawing over the course of, say, the last seventy years. Anyone remember these ads? I'm a little young to have run across them first hand:How 'bout we zero in on smoking for a minute, okay? I'm going to cite some stats and a bit of a timeline, briefly (click here if you want backup)The first study linking cigarettes to lung cancer was published in 1939.The first statement from the Surgeon General on the topic was published in the Journal of the American Medical Association in November, 1959.On June 7, 1962, another Surgeon General announced that he was establishing an "expert committee to undertake a comprehensive review of all data on smoking and health."On January 11, 1964, after some 15 months of intensive study, this committee--half the members of which were smokers-- issued its unanimous report stating that "cigarette smoking is a health hazard of sufficient importance in the United States to warrant, appropriate remedial action."The government recommended that a warning label be printed on all packs of cigarettes sold in this country as of January 1, 1965, and in all cigarette advertising six months later.The tobacco industry then prevailed upon Congress to change the proposed wording from "Caution: Cigarette 'Smoking is Dangerous to Health. It May Cause Death from Cancer and Other Diseases" to "Cigarette Smoking May be Hazardous to Your Health," with the passage of the Cigarette Labeling and Advertising Act of 1965.This act also prohibited the Federal Trade Commission and state and local governments from requiring any other label on cigarette packages and any warnings at all in cigarette advertising before 1969.Okay, got that? A reputable, peer-reviewed study links cigarettes to lung cancer in 1939, no official statement was issued by federal health officials until 1959AND the words "may be hazardous to your health" couldn't be included in cigarette ads--newspaper, magazine, radio, and television--until 1969.A New York Times editorial called Congress's cigarette labeling and advertising act "a shocking piece of special-interest legislation--a bill to protect the economic health of the tobacco industry by freeing it of proper regulation."An article in the Atlantic Monthly described the political maneuvering behind the legislation under the title "The Quiet Victory of the Cigarette Lobby: How It Found the Best Filter Yet--Congress."Now let's take a look at current tobacco-based revenues, campaign contributions, and lobbying expenditures of America's three biggest tobacco companies (citation):
Altria Group (Philip Morris)2006 Tobacco Revenues: $66.7 billion2008 Election cycle political contributionsby Altria Group PAC: $986,5002007 Lobbying expenditures: $7.2 millionReynolds American (RJ Reynolds)2006 Revenues: $8.5 billion2008 Election cycle political contributionsby RJ Reynolds PAC: $770,5002007 Lobbying expenditures: $1.95 millionLoews Corp (Lorillard)2006 Tobacco Revenues: $3.9 billion2008 Election cycle political contributionsby Lorillard PAC: $175,2502007 Total Lobbying expenditures: $1.96 millionOverall Tobacco Industry Political Contributionssince 1997: more than $34.7 million
Here endeth the second intro topic-- a recap: medical experts often reverse themselves over time, and it took the U.S. Government nigh on thirty years after the first study linking cigarette smoking to lung cancer to officially warn citizens about the dangers of smoking. Enter topic the third... If you think the tobacco companies spend a lot of money on lobbying and campaign donations, let's do a little comparison on how they rate compared to the pharmaceutical industry, in this country...
Tobacco (between 1997 and 2007): $34.7 million Pharmaceuticals (for same period): $675 million
Oh, wait, those figures aren't exactly comparable... that second amount is for lobbying alone--it doesn't include the drug companies' political campaign contributions, in the United States. Here's another figure that might give a small idea of the pharmaceutical industry's global clout --the amount spent on marketing (and "administrative costs") by the 11 biggest drug companies in 2004:
$100 billion
And here's what they reported spending on research and development that year: $50 billion. When Dr. Marcia Angell stepped down from her post as the edtior-in-chief of the New England Journal of Medicine last year, she published therein a scathing parting-shot takedown of the pharmaceutical industry's impact on contemporary medical practice. My favorite paragraph is the following, in which she says of the pharmaceutical companies' marketing budgets:
The industry depicts these huge expenditures as serving an educational function. It contends that doctors and the public learn about new and useful drugs in this way. Unfortunately, many doctors do indeed rely on drug-company representatives and promotional materials to learn about new drugs, and much of the public learns from direct-to-consumer advertising. But to rely on the drug companies for unbiased evaluations of their products makes about as much sense as relying on beer companies to teach us about alcoholism.
It's not just doctors and consumers who may be lead astray by these expenditures, however, but the very state and federal regulatory agencies we rely upon to safeguard the public health.Quoting from government transcripts obtained via the Freedom of Information Act, Robert F. Kennedy Jr. wrote in a 2005 article published in Rolling Stone that:
In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood conference center in Norcross, Georgia. Convened by the Centers for Disease Control and Prevention, the meeting was held at this Methodist retreat center, nestled in wooded farmland next to the Chattahoochee River, to ensure complete secrecy.The agency had issued no public announcement of the session -- only private invitations to fifty-two attendees. There were high-level officials from the CDC and the Food and Drug Administration, the top vaccine specialist from the World Health Organization in Geneva and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur. All of the scientific data under discussion, CDC officials repeatedly reminded the participants, was strictly "embargoed." There would be no making photocopies of documents, no taking papers with them when they left. The federal officials and industry representatives had assembled to discuss a disturbing new study that raised alarming questions about the safety of a host of common childhood vaccines administered to infants and young children. According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the agency's massive database containing the medical records of 100,000 children, a mercury-based preservative in the vaccines -- thimerosal -- appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children. "I was actually stunned by what I saw," Verstraeten told those assembled at Simpsonwood, citing the staggering number of earlier studies that indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity and autism.
They make "bugs" stronger, they make us weaker, and they hurt our ability to excrete toxic heavy metals. I read in Parenting magazine a few months ago thta 85% of pediatricians surveyed said that they prescribe antibiotics for kids entirely because they don't want to argue with parents--despite the fact that the children have viruses, not bacterial infections, and will not benefit from antibiotics at all. It's practically criminal--and we'll all be sorry, if we aren't already.
(NaturalNews) Eventually antibiotics are going to be seen as one of the worst things to ever come out of pharmaceutical science because in the end, they have made us only weaker in the face of ever increasingly strong super bugs that are resistant to all the antibiotics doctors have at their disposal. When we look at how deep the rabbit hole goes with antibiotics, we will get sick in our souls. Antibiotics have fulfilled their anti–biotic anti-life role leaving a long trail of death and suffering in the wake of their use.
Diseases include measles, scarlet fever, tuberculosis, typhoid fever, pneumonia, influenza, whooping cough, diphtheria and polio. All were in decline for several decades before the introduction of antibiotics or vaccines - Dr. Lawrence Wilson.
Antibiotics do not kill yeast. Many women find after taking antibiotics, they get vaginal yeast infections (because their normal bacterial balance has been lost). Antibiotics bring on fungal and yeast infections thus will eventually be seen as a major cause of cancer since more and more oncologists are seeing yeast and fungal infections as an integral part of cancer and its cause. With upwards of 40 percent of all cancers thought to be involved with and caused by infections, the subject of antibiotics and the need for something safer, more effective and life serving is imperative.
It may be some time before we really enter the predicted "post antibiotic era" in which common infections are frequently untreatable - Dr. Marc Lipsitch et al. (Harvard School of Public Health).
Antibiotics kill all bacteria in the body, including the ones we need.
An antibiotic is a substance produced by certain bacteria or fungi that kills other cells or interferes with their growth. In nature, these substances help some microbes survive by limiting the multiplication of other microbes that share the same environment. Antibiotics that attack pathogenic (disease-causing) microbes without severely harming normal body cells are useful as drugs but there does not seem to be any from the pharmaceutical companies that do not do damage. Dr. Lisa Landymore-Lin wrote all about this in her book Poisonous Prescriptions asking, 'Do Antibiotics Cause Asthma and Diabetes?' We are now beginning to question the role of antibiotics as a cause of cancer since they do lead to pathogen overgrowth especially in the area of yeast and fungi. Chris Woollams writes, "It is estimated that 70 per cent of the British population have a yeast infection. The primary cause of this is our love of antibiotics. Swollen glands? Take antibiotics. Tonsillitis? Take antibiotics."
Two studies in the recent past have shown an association between the use of antibiotics with higher incidence of breast cancer.
In one study the increased risk was small, and the importance of the link has been played down by UK breast-cancer experts, but the findings add weight to recent studies that have found links between antibiotics and other diseases. In the past few years, heavy antibiotic use has been linked to the inflammatory bowel disorder, Crohn's disease, and to children developing allergies such as Hay fever and asthma. And as we shall see below, antibiotics play a hidden role in autism and other neurological diseases.
The Journal of the American Medical Association has reported a study on 10,000 women in which women who took over 500 days of antibiotics in a 17 year period (dubbed 25 plus doses) had twice the risk of breast cancer as those that took none at all. Even women taking just one had a statistical risk increase to 1.5 times.
The consequences of resistance in some bacteria can be measured as increases in the term and magnitude of morbidity, higher rates of mortality, and greater costs of hospitalization for patients infected with resistant bacteria - Dr. Marc Lipsitch et al.
Broad-spectrum antibiotics are undiscriminating: in addition to "bad bacteria," they also kill healthy bacteria which normally live in the intestines and the vagina, and which are a necessary part of the indigenous flora to keep the body healthy. When the "good" bacteria are killed with antibiotics, then yeast, which is part of the normal flora of the body, can begin to overgrow because the antibiotics have altered the body's healthy terrain (internal ecological balance) allowing the yeast to hyperproliferate and cause many far-reaching, toxic symptoms.
But modern medicine so far continues to believe that antibiotics have played an important role in staving off bacterial infections since Alexander Fleming first discovered them in 1927. Many doctors are finally beginning to see that the effectiveness of these so-called miracle drugs has waned as some of the very bacteria they are meant to control have been mutating into new forms that don't respond to treatment. Many medical experts blame this phenomenon on both the misuse and overuse of antibiotics in recent years in both human medicine and in agriculture.
According to several studies, obstetricians and gynecologists write 2,645,000 antibiotic prescriptions every week. Internists prescribe 1,416,000 per week. This works out to 211,172,000 prescriptions annually in the United States, just for these two specialties. Pediatricians prescribe over $500 million worth of antibiotics annually just for one condition, ear infections. Yet topical povidone iodine (PVP-I) is as effective as topical ciprofloxacin, with a superior advantage of having no in vitro drug resistance and the added benefit of reduced cost of treatment.
According to a study published in the Journal of the American Medical Association, taking properly prescribed medical drugs was listed as the third leading cause of death in the U.S. Antibiotics were listed in this category because antibiotics can be deadly.
A 17-year-old St Margaret's College student in New Zealand has exposed multiple antibiotic-resistant bugs in fresh chicken sold in supermarkets? Jane Millar's discovery of a range of resistant bacteria in chickens that could compromise antibiotic treatment in humans is an important finding that the bacteria have developed resistance to antibiotics not used in the poultry industry but important for treating serious infections in humans.
We can create resistance to medically important antibiotics by using antibiotics that are presumably safe in agriculture - Jane Millar.
Jane bought six fresh chickens - free-range, barn-raised and organic – from a supermarket. She took samples from each bird and grew bug colonies, which she used to test different antibiotics. Apramycin is an antibiotic used sparingly by the New Zealand poultry industry to treat infections. The bacteria of two chickens tested resistant to apramycin. They also proved resistant to another two antibiotics from the same family - gentamicin and tobramycin - used for serious human infections. Gentamicin is not used by the poultry industry; tobramycin is restricted to human use only.
A recent risk assessment study commissioned by the U.S. Food and Drug Administration (FDA) has estimated that about 8,000-10,000 persons in the U.S. each year acquire fluoroquinolone-resistant Campylobacter infections from chicken and attempt to treat those infections with a fluoroquinolone.
Every day, new strains of bacteria, fungi, and other pathogenic microorganisms are becoming resistant to the antibiotics that once dispatched them with extreme prejudice.
"We know that antimicrobial resistance will follow antimicrobial use as sure as night follows day," said Dr. John A. Jernigan, deputy chief of prevention and response from the Center of Disease Control. "It's just a biological phenomenon." It turns out that the indiscriminate killing of harmless microbes damages the body in complex ways we are only beginning to understand. Powerful antibiotics introduced into the complex environment in our intestines cause mayhem, much like a series of bombs tossed into a market square. Antibiotic resistance is a widespread problem, and one that the U.S. Centers for Disease Control and Prevention calls "one of the world's most pressing public health problems."
One of the deadliest germs is a staph bacteria called M.R.S.A., short for methicillin-resistant Staphylococcus aureus, which lives harmlessly on the skin but causes havoc when it enters the body. Patients who do survive M.R.S.A. often spend months in the hospital and endure several operations to cut out infected tissue. Hospitalizations associated with a drug-resistant form of a Staphylococcus bacterium doubled over six years in the U.S. to nearly 280,000 cases in 2005. The death toll rose from 4,700 in 1999 to about 6,600 in 2005. It estimated that 94,000 Americans suffered invasive MRSA infections in 2005 and that about 19,000 died.
One out of every 20 patients contracts an infection during a hospital stay in the US. Hospital infections kill an estimated 103,000 people in the United States a year, as many as AIDS, breast cancer and auto accidents combined. The vast majority of lethal cases occur in hospitals and nursing homes, where open wounds and punctures provide the opportunistic staph a ready path to the bloodstream and organs. The dangers of infection are worsening as many hospital infections can no longer be cured with common antibiotics.
More than half the time, doctors and other caregivers break the most fundamental rule of hygiene by failing to clean their hands before treating a patient.
"Recently there has been an alarming epidemic caused by community-associated (CA)-MRSA strains, which can cause severe infections that can result in necrotizing fasciitis or even death in otherwise healthy adults outside of healthcare settings," is the word coming from the National Institute of Allergy and Infectious Diseases (NIAID) research team, headed by Dr. Michael Otto.
Necrotizing fasciitis is the so-called flesh-eating disease that can destroy healthy tissue and even kill patients. The team found that some strains on MRSA secrete a compound called phenol-soluble modulin or PSM. It attracts immune system cells called neutrophils, the researchers found, and then blows them up in a process called lysis. Neutrophils are key immune cells involved in clearing bacterial infections, so destroying them would allow the bacteria to thrive almost unmolested. "In the United States, CA-MRSA is now the cause of the majority of infections that result in trips to the emergency room. It is unclear what makes CA-MRSA strains more successful in causing human disease compared with their hospital-associated counterparts," they add.
When the peaceful activities of a normal microbial population are disrupted, malevolent bacteria may take full advantage of the opportunity to strike. The intestinal infection C. difficile colitis, now rampaging through hospitals around the world, is one of the worst such complication of antibiotic use.
Clostridium difficile was first recognized as a hospital microbe in 1978. By 1996, it had increased to 31 cases per 100,000 people discharged from U.S. hospitals. In 2003, the most recent year for complete statistics, prevalence had risen to 61 per 100,000. C. diff is part of the natural flora, or bacteria, in the colon. "We're seeing all of the warning signs that this is the next MRSA," said former New York Lt. Gov. Betsy McCaughey, founder of the Committee to Reduce Infection Deaths, a Manhattan-based nonprofit. "It spreads like wildfire in hospitals."
Clostridium difficile is a spore-forming toxin-producing bacterium that is overtaking peoples' large intestines from which it mounts an attack on the bloodstream. Like MRSA, Clostridium difficile has become multi-drug-resistant. Although once a bacterium that mostly affected elderly, hospitalized patients, a bolder strain is crippling the robust. In emergency efforts to save some patients' lives surgeons remove the entire large intestine to prevent overwhelming infection.
One case had been treated by a dermatologist for an ingrown hair on his back and prescribed an antibiotic. He took only a few pills, but quickly became ill. Based on what his doctors told him, the short course of antibiotics proved sufficient to destroy virtually all the natural bacteria in his intestine - except C. diff, which was freed to ravage his colon.
Frequently, stethoscopes, blood-pressure monitors and other equipment are contaminated with live bacteria. Yet doctors and nurses almost never clean the stethoscope before listening to a patient's chest.
"It strikes precisely those hospitals which are more 'high-tech', and handle more serious illnesses. Applying more disinfectant is not the answer; some strains of germs have actually been found thriving in bottles of hospital disinfectant! The more antibacterial chemical 'weapons' are being used, the more bacteria are becoming resistant to them," writes Dr. Carl Wieland.
Health-care officials are increasingly concerned about emerging new forms of drug-resistant Tuberculosis (TB). According to the WHO, outbreaks of drug-resistant tuberculosis are showing up all over the world and threaten to touch off a worldwide epidemic of virtually incurable tuberculosis. An October 1997 survey by the WHO, the U.S. Centers for Disease Control and Prevention and the International Union Against Tuberculosis and Lung Disease estimates that 50 million people are infected with a strain of TB that is drug-resistant. Many of those are said to carry multi-drug-resistant tuberculosis, incurable by two or more of the standard drugs.
New DNA technology has found hundreds of previously unrecognized species in the traditional stomping grounds of the mouth and intestine, and traces of bacteria even in tissues previously thought to be sterile.
Lessons from Autism
Medical scientists at Arizona State University tell us that antibiotic use is known to almost completely inhibit excretion of mercury in rats due to alteration of gut flora. Thus, higher use of oral antibiotics in the children with autism may have reduced their ability to excrete mercury. Higher usage of oral antibiotics in infancy may also partially explain the high incidence of chronic gastrointestinal problems in individuals with autism.
Many physicians are unaware of lasting adverse effects caused by routinely prescribed medications such as antibiotics. Antibiotic therapy for minor colds and runny noses is a common practice. People routinely receive multiple courses of broad-spectrum antibiotics throughout life or are injected with long-acting corticosteroid medicine for joint or muscle pain. Once established, sub-clinical colonization with yeast in the body may persist unrecognized for many years. Antibiotics, such as tetracycline, can greatly increase yeast in the colon after only a few days.
The extensive use of antibiotics will make the condition of Candida much worse because it reduces heavy metal excretion, which is a food source for the yeast like organism and also killing the beneficial bacteria at the same time.
Normally, candida albicans lives peacefully in our intestines and elsewhere, in harmony with other flora that keep the yeast in check. Take an antibiotic and all this changes. By suppressing the normal flora, candida takes over and problems begin. In its mild form, the result is diarrhea or a yeast infection. Dr. Elmer Cranton says that, "Yeast overgrowth is partly iatrogenic (caused by the medical profession) and can be caused by antibiotics and cortisone medications. A diet high in sugar also promotes overgrowth of yeast. A highly refined diet common in industrialized nations not only promotes growth of yeast, but is also deficient in many of the essential vitamins and minerals needed by the immune system. Chemical colorings, flavorings, preservatives, stabilizers, emulsifiers, etc., add more stress on the immune system."
Children with autism had significantly (2.1-fold) higher levels of mercury in their baby teeth but similar levels of lead and similar levels of zinc. Children with autism also had significantly higher usage of oral antibiotics during their first 12 to 36 months of life. Reporting in the July 11, 2007 issue of the Journal of the American Medical Association, researchers say the use of antibiotics as prevention boosts risks for drug resistance while doing nothing to shield kids from future urinary tract infections (UTIs). Giving antibiotics to prevent recurrent urinary tract infections in small children not only will not help but will hurt these children. Prior use of antibiotics to prevent infection did boost the likelihood of developing a drug-resistant infection by nearly 7.5 times. Indeed, 61 percent of recurrent urinary tract infections were caused by a pathogen with antibiotic resistance, the researchers pointed out.
In a 2005 study, the antibiotic Augmentin TM has been implicated in the formation of autism. The study strongly suggests the possibility of ammonia poisoning as a result of young children taking Augmentin. Augmentin has been given to children since the late 1980's for bacterial infections.
Many physicians seem to be unaware that birth control pills comprised of the hormones estrogen and progesterone can also make the body more susceptible to fungal infections. If antibiotics are prescribed, it acts as a double whammy to ensuring a fungal infection will take hold by diminishing the protective bacteria in the intestines. Many pregnant women seek medical treatment for minor problems and are indiscriminately given antibiotics and this begins a long decline into problems that are complicated at each turn by OBGYN doctors at birth and by pediatricians who just love to poison children with the toxic chemicals found in vaccines. In many places in the world they still give mercury shots at birth.
Microforms poison us with their waste products.
The waste products are acetylaldehyde, uric acid, alloxin, alcohols, lactic acid, etc.
Antibiotics may be to blame for hundreds of children developing autism after having the controversial MMR jab. More than two-thirds of youngsters with the condition received four or more antibiotics in their first year, a British survey has revealed. It is thought the drugs weakened their immune systems, leaving them unable to withstand the impact of the triple jab. Allopathic medicine has been stubborn and slow to look at its abusive use of antibiotics. It's the same with vaccines, the holy grail of medicine. But with last-line-of-defence antibiotics failing on increasingly drug-resistant superbugs and young children's systems being destroyed by them you would think they would wake up and find some alternatives.
Antibiotics are mostly derived from fungi and are therefore classified as mycotoxins. Mycotoxins Are Poisons.
About the author
Mark A. Sircus Ac., OMD, is director of the International Medical Veritas Association (IMVA)http://www.imva.info/. Dr. Sircus was trained in acupuncture and oriental medicine at the Institute of Traditional Medicine in Sante Fe, N.M., and in the School of Traditional Medicine of New England in Boston. He served at the Central Public Hospital of Pochutla, in México, and was awarded the title of doctor of oriental medicine for his work. He was one of the first nationally certified acupuncturists in the United States. Dr. Sircus's IMVA is dedicated to unifying the various disciplines in medicine with the goal of creating a new dawn in healthcare.
He is particularly concerned about the effect vaccinations have on vulnerable infants and is identifying the common thread of many toxic agents that are dramatically threatening present and future generations of children. His book The Terror of Pediatric Medicine is a free e-book one can read. Dr. Sircus is a most prolific and courageous writer and one can read through hundreds of pages on his various web sites.
He has most recently released his Survival Medicine for the 21st Century compendium (2,200 page ebook) and is racing to finish his Winning the War Against Cancer book. Dr. Sircus is a pioneer in the area of natural detoxification and chelation of toxic chemicals and heavy metals. He is also a champion of the medicinal value of minerals and is fathering in a new medical approach that uses sea water and different concentrates taken from it for health and healing. Transdermal Magnesium Therapy, his first published work, offers a stunning breakthrough in medicine, an entirely new way to supplement magnesium that naturally increases DHEA levels, brings cellular magnesium levels up quickly, relieves pain, brings down blood pressure and pushes cell physiology in a positive direction. Magnesium chloride delivered transdermally brings a quick release from a broad range of conditions. International Medical Veritas Association: http://www.imva.info/
The sad thing is that these "blunders" (which seems too light a term) are not all in the past, as the article's subtitle implies. Consider thimerosal, the mercury preservative used in all vaccines until recently (and still used in many vaccines even now), despite the fact that mercury is one of the worst neurotoxins on the planet. Thimerosal was developed by Eli Lilly in 1930, and tested exactly once before Lilly began using it on the general population. Lilly "tested" thimerosal on 22 patients with meningococcal meningitis. Most of these patients died within a few days of taking thimerosal, but Lilly decided that the deaths were due to meningitis, not thimerosal, and went ahead with the use of thimerosal in products for all of us. How great! The FDA didn't have the teeth to review drugs back then, and once the FDA did have the power to perform such reviews, thimerosal was already grandfathered in. Double great!
Just for fun, how about another one? How about the DPT (diphtheria, pertussis, tetanus) vaccine? The reactions to that one were so bad that kids don't get it anymore. (They now get the comparatively safer DTaP, with acellular pertussis rather than whole-cell pertussis.) Read on for more information on the FDA's sloppy job...
FDA’s Biggest Blunders The Food and Drug Administration’s sordid drug recall past. By Jim Kling for MSN Health & Fitness
Merck’s Vioxx, a nonsteroidal anti-inflammatory (NSAID) painkiller, made headlines in 2004 when the company voluntarily withdrew it from the U.S. market following reports of increased rates of strokes and heart attacks in patients taking the drug chronically. Vioxx was the most famous of more than a dozen drugs withdrawn from the market since 2000.
But withdrawal of drugs is not a new phenomenon. In fact, the Food and Drug Administration (FDA) took on its modern form as a reaction to the horrific side effects of the drug thalidomide, introduced in Europe in the 1950s as a sleep aid and treatment for morning sickness in pregnant women.
By 1962, it was evident that thalidomide caused severe limb deformities, and Frances Kelsey, the FDA’s medical officer at the time, kept the drug off of the market. In Europe, 8,000 babies were born with defects resulting from the drug. That tragedy prompted a Congressional bill that gave the FDA the authority to raise the safety bar and require that companies prove the effectiveness of drugs before they could be marketed in the United States.
FDA failures
Recently, the FDA has come under attack for not living up to its mission. The agency failed to catch serious side effects in a number of drugs before they were approved, thus forcing embarrassing withdrawals.
Critics attribute these failures to the agency’s close ties with the medical industry. These close ties are exemplified by the 1992 Prescription Drug User Fees Act, which requires industry to pay user fees that help fund the agency’s review of new drugs for approval.
Part of the purpose of the legislation was to shorten the approval times and get drugs to market more quickly. But according to a 2002 report by the Government Accounting Office (GAO), the legislation ultimately caused increased workload for the FDA’s reviewers. There was also a slight increase in the percentage of drugs that had to be withdrawn from the market.
The side effect of withdrawing drugs
The flip side of the decision to withdraw a drug due to rare, serious side effects is that it can leave some patients with few therapeutic options. For example, some patients objected to the withdrawal of Zelnorm, a drug used to treat irritable bowel syndrome.
Seriously ill patients “should be able to take a risk,” says Peter Barton Hutt, senior counsel at the law firm Covington & Burling LLP, and former FDA chief counsel.
But Diana Zuckerman, president of the National Research Center for Women & Families, argues that it isn’t that simple.
“The problem is that patients aren’t really told ([about a drug’s risks). Doctors aren’t giving that information, partly because they don’t spend that much time with patients and partly because they don’t know themselves—they haven’t read all 10 studies (performed on a drug).”
The FDA’s Hall of Shame
Vioxx
What it is: Vioxx is a COX-2 selective nonsteroidal anti-inflammatory (NSAID) painkiller related to drugs such as ibuprofen and naproxen.
Why it was taken off the market: The result of a clinical study showed an increased risk of serious cardiovascular events such as heart attacks and strokes.
Expiration date: Merck withdrew Vioxx from the worldwide markets in 2004.
Bextra
What it is: Like Vioxx, Bextra is an NSAID painkiller.
Why it was taken off the market: Two short-term studies indicated potential increases in cardiovascular events such as heart attacks and strokes and increased risk of serious skin reactions. The FDA also concluded that Bextra had no unique advantages over other NSAIDs. FDA scientists decided that the known cardiovascular risks of other NSAIDs demonstrated in long-term trials justified a request for withdrawal.
Expiration date: Pfizer withdrew Bextra from the U.S. market in 2005.
Zelnorm
What it is: Zelnorm is a drug to treat irritable bowel syndrome (IBS).
Why it was taken off the market: 29 studies showed that 13 of 11,614 patients taking the drug had heart problems. One of 7,031 patients on placebo experienced the problem. About 500,000 people were taking the drug at the time of its withdrawal. Novartis continues to market the drug in Europe, citing its belief that the trial results were a fluke.
Expiration date: Novartis withdrew Zelnorm from U.S. markets in March 2007. IBS patient groups objected to the withdrawal, arguing that the benefits outweighed the risks. The FDA responded to complaints from patients and physicians by creating a restricted-access program for patients that have no therapeutic alternatives or who had satisfactory outcomes on previous treatment with Zelnorm.
Tysabri
What it is: Tysabri is a drug that treats multiple sclerosis.
Why it was taken off the market: After three patients in a clinical study developed progressive multifocal leukoencephalopathy (PML, a serious brain infection), the FDA halted trials of the multiple sclerosis drug until the company could prove that no additional cases of PML had occurred.
Expiration date: Biogen-Idec withdrew Tysabri from the worldwide market in 2005. In 2006 it was allowed back on the market with a risk-minimization program with mandatory patient registration and follow-up.
NeutroSpec
What it is: NeutroSpec is an antibody labeled with a radioactive marker that was used to diagnose appendicitis in patients that show some but not all of the clinical signs of appendicitis.
Why it was taken off the market: While the agent was on the market, 17 patients who received NeutroSpec experienced life-threatening side effects soon after it was injected, including shortness of breath, low blood pressure, and cardiac and pulmonary arrest. Two patients died. About 11,000 patients received NeutroSpec while it was on the market.
Expiration date: Palatin Technologies withdrew NeutroSpec from the U.S. market in 2005.
Cylert
What it is: Cylert is a drug used to treat Attention Deficit Hyperactivity Disorder (ADHD).
Why it was taken off the market: The FDA learned of 13 reports of liver failure leading to liver transplant or death. The number of cases reported was small, but patients taking the drug had a liver failure rate of 10-25 times the rate of liver failure in the general population.
Expiration date: Abbott withdrew Cylert from the U.S. market in 2005.
Permax
What it is: Permax is a drug used to treat Parkinson’s disease.
Why it was taken off the market: Two studies confirmed previous findings that Permax is associated with increased chance of blood backflow to aortic valves of the heart. Symptoms include shortness of breath, fatigue and heart palpitations. In 2006, about 12,000 patients received prescriptions in the US.
Expiration date: In 2007, Valeant Pharmaceuticals voluntarily withdrew Permax from the U.S. market. Two other companies, Par and Teva, withdrew generic versions.
Baycol
What it is: Baycol is a cholesterol-lowering drug.
Why it was taken off the market: Reports of sometimes fatal rhabdomyolysis—a severe muscle condition. All statins cause rare cases of rhabdomyolysis, but Baycol patients experienced it at a significantly higher rate than patients on other statins. The FDA received reports of 31 deaths related to Baycol.
Expiration date: Bayer withdrew Baycol from the U.S. market in 2001.
Palladone
What it is: Palladone is a narcotic painkiller in a slow-release capsule.
Why it was taken off the market: Severe side effects were reported when Palladone was taken with alcohol. Alcohol use caused high levels of the drug in the body, with potentially fatal effects such as the depression or halting of breathing and coma.
Expiration date: Purdue Pharma withdrew Palladone from the U.S. market in 2005.
Months before the Centers for Disease Control and Prevention made Atlanta lawyer Andrew Speaker the unwitting poster boy for drug-resistant tuberculosis, the agency and its advisers discussed a strategy to get more funding by publicizing the deadly strain of the disease, records show.
Frustrated that money for combating TB had dwindled as Congress favored newer threats from bioterrorism and bird flu, advisers suggested taking "drastic actions," according to December 2006 meeting minutes from the federal Advisory Council for the Elimination of Tuberculosis. The council is based at the CDC in Atlanta.
One strategy centered on publicizing the urgency of combating XDR TB — a rare, new form of extensively drug-resistant tuberculosis. "The implications of XDR TB for TB control in the United States should be compiled and communicated as a strong advocacy tool to increase the TB investment," the minutes state.
Five months later, CDC's lab diagnosed Speaker as having XDR TB, and the agency issued a federal isolation order — its first in more than 40 years — and held a national press conference about how he possibly spread the disease aboard international flights.
The actions were in stark contrast to the private way the agency dealt with 100 other TB cases involving airline travelers, both before Speaker and after, including an incident last month when a severely ill drug-resistant TB patient flew from India to Chicago.
"It's unheard of to have that level of public notice, " said Dr. Michael Iseman, a national TB expert and professor of medicine at the University of Colorado, where he has been one of Speaker's doctors. "I don't think it was constructive."
The handling of the Speaker case was so unusual that it has raised questions among other TB experts, including whether CDC publicized Speaker's case in a quest for more money.
CDC officials are adamant that the XDR funding strategy played no role in how they handled Speaker's case. The press conference was needed so CDC could quickly track down and test passengers, said Dr. Ken Castro, director of CDC's TB division.
CDC Media Relations Director Glen Nowak said he pushed for the press conference because of a belief in transparency and the likelihoo of significant media interest in the isolation order and an XDR TB case.
CDC Director Julie Gerberding's May 29 press conference announced that a man with XDR TB was being held in a hospital under a rare federal isolation order. She said the agency was notifying all passengers who flew with him on two international flights so they could get TB tests.
A media storm erupted as details emerged about the Atlanta lawyer's travel for his Greek wedding — despite being told not to fly — and the couple's frantic honeymoon run from health authorities, evading no-fly lists and border control checkpoints as they tried to get back to the U.S. for specialized treatment.
Despite the public perception of Speaker as a modern-day Typhoid Mary, tests at a Denver hospital later showed he didn't have the XDR TB that CDC cited in its press conference, but a more treatable form of drug-resistant TB. Nobody appears to have caught TB from Speaker, tests of more than 250 airline passengers show.
Tuberculosis experts say the Speaker case — because of its high profile — gave TB its biggest publicity boost in decades and helped secure rare funding increases for combating the disease.
"It was almost as if some prophecy was being fulfilled, " Dr. Michael Fleenor, chairman of the federal TB advisory council, which five months earlier had sent a blunt letter to Secretary of Health and Human Services Michael Leavitt warning that "our nation is facing an imminent airborne biological threat" from XDR TB.
The ability of CDC and local health officials to protect the U.S. "is slipping beyond recovery, " the letter said. That warning, like many before them, did nothing to increase funding.
Then Andrew Speaker hit the news.
'Fortuitous' case
After years of flat funding, the 2008 federal budget includes $140.4 million — a 4 percent increase — to combat TB in the U.S. It would have been a 9 percent increase if President Bush hadn't vetoed the Labor/HHS funding bill and required cuts.
CDC officials say bills seeking increased funding for TB aren't unusual and that agency officials have spoken out about XDR TB for years. They noted that Gerberding testified before Congress about XDR TB last March, two months before the agency had even heard of Speaker.
TB advocates and the CDC agree that Speaker gave funding legislation the traction it previously lacked. The Speaker case was "fortuitous," said Fleenor.
Dr. Alan Bloch, an expert in the airborne transmission of TB and measles, said he's wondered since last summer: "Was there a hidden agenda to use Andrew Speaker's case to get more money for TB control?"
Bloch, who spent 25 years at CDC before he retired in 2005, said the agency's response to Speaker seemed overblown, given that test results known to health officials and Speaker's lack of symptoms made him unlikely to spread the disease.
Bloch conducted the first national survey of drug-resistant TB and designed the expanded TB surveillance system that CDC used to identify the 49 XDR TB cases in the U.S. from 1993-2006.
Watching Gerberding's televised press conference in May, when she announced the CDC had issued the first federal isolation order since a 1963 case of suspected smallpox, Bloch said he assumed "this patient must be extremely contagious.''
"I had visions of a non-compliant patient who was the tuberculosis equivalent of TyphoidMary, who was highly infectious. When I found out this patient did not meet other criteria for being a very infectious case, I was puzzled."
The CDC has refused for nearly seven months to release documents under the Freedom of Information Act about any role the agency's XDR TB funding strategy played in its handling of the Speaker case.
CDC spokesman Nowak called any suggestion of a money motive "a slap in the face" to agency staff who work to protect the public. "The thought that we would have done all this to get publicity is laughable," he said.
Castro, the CDC TB division director, said the agency's actions were justified, because there was no way to know whether Speaker's disease status had worsened after he left Atlanta against the instructions of health officials.
Although Speaker voluntarily drove himself to meet CDC scientists on returning to the U.S., Castro said the isolation order was necessary, because Speaker had previously disobeyed health officials.
Low-risk patient
During a meeting last summer, members of the federal TB advisory council — which urged using XDR TB to help get more money — questioned CDC's approach, including the tracking and testing of passengers on the plane with Speaker.
"There was a discussion of should they have done anything, " Dr. William Burman, a member of the advisory council, said in a recent interview. "From the beginning, Andrew Speaker was of very low risk. Everyone knew that. CDC knew that."
Burman said CDC staff told the advisers Speaker's case met criteria for an investigation because the length of the trans-Atlantic flights made transmission possible and because he had XDR TB, which is very difficult to treat.
"But everyone involved knew the likelihood of transmission was very, very low, " said Burman, who is medical director of the infectious diseases clinic at Denver Public Health.
Burman says he suspects CDC would have faced criticism had it not held a press conference.
Dr. Lee Reichman, executive director of the Global Tuberculosis Institute at the New Jersey Medical School and a liaison on the advisory council, agreed. "They were damned if they did and damned if they don't, " he said.
Iseman, the Colorado TB expert who has treated Speaker, questioned the public health need to go public in a TB airline investigation in which officials can get manifests naming the other passengers and contact them privately.
"Andrew Speaker became the face of XDR TB — although he didn't have it, " Iseman said. "I would venture to say that Andrew Speaker and his family have had substantial, if not irreparable, trauma."
Iseman and other TB experts said the world of medicine is acutely aware of how HIV and breast cancer have become well-funded through aggressive advocacy and putting faces to the diseases.
Of CDC's investigations of 100 TB patients who in the past 18 months boarded planes — including five patients who flew with multidrug resistant TB — the only press conference the agency has held was in the Speaker case. Then again, Speaker was the only one believed to have XDR TB.
Tests at National Jewish Medical and Research Center in Denver, the renowned TB hospital which treated Speaker, later found he didn't have XDR TB, but a more treatable multidrug resistant TB, or MDR TB.
At a July 3 press conference announcing Speaker's new diagnosis, CDC officials said the agency would have responded the same way if they'd known he had MDR TB.
While no press conference has been held in the latest case of an airline passenger traveling with MDR TB, CDC officials say that's because they had an easier time getting the list of other passengers on the Chicago-bound plane with the woman than it had in the Speaker case.
Baseline TB tests must be given within eight weeks of possible exposure.
Foreign carriers and outbound flights make tracing potentially exposed passengers more difficult, said Dr. Martin Cetron, director of CDC's Division of Global Migration and Quarantine.
By the time the CDC was able to request the Air France list from Speaker's flight, two weeks had passed, and the airline took nearly a week to produce the names. The agency was able to secure the list from the woman's American Airlines flight in 14 hours.
That fact has allowed the CDC to privately track down the 44 passengers seated nearest to the woman on the Dec. 13 flight from New Delhi, India, officials said.
The woman, who was coughing on the flight, was so ill with TB she went to an emergency room a few days after arriving home in California.
In contrast, Speaker never coughed or had any TB symptoms; the disease was only diagnosed because it showed up on a chest X-ray after he suffered an unrelated injury. Still, all of the passengers on his two trans-Atlantic flights were advised to seek tests.
Castro said every TB case is different. If faced with the same circumstances as the Speaker case again, Castro said he'd handle it the same way, including going public.
"In this particular case, " he said, "we had no other choice."
TB: AT ISSUE
• Tuberculosis is a disease usually of the lungs caused by bacteria. It is spread through the air when a person with an active form of the disease coughs or sneezes.
• In the United States, there are about 14,000 new cases of TB each year and about 650 deaths. About 125 cases each year involve multidrug resistant TB, meaning the bacteria can't be killed by antibiotics commonly used to treat the disease.
• Scientists are particularly concerned about the emergence of new TB strains that respond to even fewer — or no — drugs. There have been 49 documented cases of these extensively drug resistant TB (XDR TB) cases in the U.S. from 1993-2006.
• Worldwide, 9 million people each year become sick with TB, and there are almost 2 million TB deaths.
Source: CDC, World Health Organization
COMPARISON OF TWO TB CASES
• MAY 2007
The patient: 31-year-old Atlanta lawyer
Diagnosis: Multidrug resistant TB*
Outward symptoms: None
Flights of concern: Atlanta to Paris; Prague to Montreal
CDC alert: Press conference advising all passengers be tested.
Isolation order: Yes, federal
• DECEMBER 2007
The patient: California woman
Diagnosis: Multidrug resistant TB
Outward symptoms: Severely ill, coughing
Flight of concern: New Delhi, India to Chicago
CDC alert: Private notification of 44 passengers seated closest to patient. No press conference.
Isolation order: Yes, local
* CDC initially announced a diagnosis of extensively drug resistant TB, but tests later showed he only had MDR TB (multidrug resistant TB).
Babies don't need fluoride. In fact, if they ingest it, they can suffer permanent damage to their teeth. That's why you should brush very young kids' teeth with Weleda (http://shop.weleda.com/item_detail.aspx?ItemCode=9802) or a similar brand, if you brush them at all. For kids under two years old, ask your doctor, who will probably tell you that wiping the teeth with a damp cloth is good enough.
FLUOROSIS We’ve all heard of the mighty fluoride building stronger, more cavity-resistant enamel for young and old teeth alike. But like most good things, too much is bad -- and that goes for fluoride, too.
Excessive fluoride can cause fluorosis, a condition caused by ingesting more fluoride than the body needs. It can occur as skeletal fluorosis, where bones become weak and brittle, or dental fluorosis, where a child’s permanent tooth comes out discolored.
Spot the Difference
Dental fluorosis most commonly affects children during the time when their teeth and gums are still developing (usually before six or seven years of age), but only appears when the affected teeth have erupted.
Chalky white lines or opaque white spots and patches appear -- an indication of a mild form of fluorosis, the type that occurs among the majority of children with this condition in the US. Extreme cases turn the enamel yellow or brown, or worse, can cause a pitted tooth surface. This discoloration is also called enamel mottling.
Clear Cause and Effect
Because fluoride is so easily available, it’s not hard to consume too much of it, specifically among children. Sources of fluoride may include:
- Tap water (city water) - Toothpaste and mouth rinse - Supplements such as drops, tablets and vitamins - Certain foods like baby formula, infant food and some beverages manufactured in cities with fluoridated water
Stopping Tooth Spotting
Easy as it may be to over-fluoridate, it’s just as easy to prevent fluorosis:
- Use unfluoridated baby tooth cleanser for kids younger than 2 years -aask your dentist for a recommendation
- Train your child with good brushing and rinsing habits to minimize swallowing toothpaste
- When using fluoridated toothpaste, make sure to place only a drop (as tiny as a green pea) for kids up to eight years of age
- Before giving children additional fluoride supplements or dental treatments, account for all sources of fluoride they may be getting
- Take care in using fluoridated water with your baby’s formula until after he or she is a year old, but do consult with your physician or pediatrician
Damage Control
Prevention is indeed better than cure, especially with fluorosis -- the damage it can cause is permanent.
As Melanie Phillips points out below, Dr. Wakefield has never said that the MMR vaccine causes all cases of autism, merely that it could be the trigger for some of them. The UK government is desperate to restore faith in their government-mandated trivalent vaccine. At least in the US we have the choice to get measles, mumps, and rubella shots separately (or with a medical exemption, not at all).
A couple of days ago, yet another story appeared claiming that fresh research had shown that there was no linkbetween the MMR vaccination and autism. This new research was said to have shown that, contrary to the claims made by Dr Andrew Wakefield, the surgeon at the centre of the MMR scare, there was no relationship between gut problems and autism, the core of his concerns. It also claimed that the discovery furthermore damaged the related theory that a gluten-free diet could help children with autism.
Dr Hilary Cass, from Great Ormond Street, said: ‘It is very distressing to have a diagnosis of autism, a lifelong condition.Many families are driven to try out interventions which currently have no scientific basis. For example, advocates of the leaky gut hypothesis offer children a casein and gluten-free diet which as yet lacks an evidence base.’
This particular observation is a telling indication that this study bears little relation to reality. For there are countless families whose autistic children’s suffering from gut problems has only been eased, and their autistic symptoms improved, by the introduction of precisely such a diet. ‘No evidence base’? Tell that to those families. It is their lived experience.
Second, despite the way this was presented in the media this is not a new piece of research at all. It is instead a recycled version of a study by Baird G. et al, published in the Archive of Diseases in Childhood on February 5 and reported in the press around that time. The study drew the following response from Andrew Wakefield:
…The study is severely limited by case definition in the context of the crucial ‘possible enterocolitis’ group. For inclusion in this group they required the presence of two or more of the following five current gastrointestinal symptoms:
current persistent diarrhea (defined as watery/loose stools three or more times per day >14 days),
current persistent vomiting (occurring at least once per day, or more than five times per week),
current weight loss,
current persistent abdominal pain (3 or more episodes [frequency not specified by authors] severe enough to interfere with activity);
current blood in stool;
plus:
past persistent diarrhea >14 days’ duration, and excluding current constipation.
We have over the last 10 years evaluated several thousand children on the autistic spectrum who have significant gastrointestinal symptoms. Upper and lower endoscopy and surgical histology have identified mucosal inflammation in excess of 80% of these children. Almost none of these children with biopsy-proven enterocolitis would fit the criteria set out above. Firstly, these children rarely have vomiting, current weight loss (as opposed to failure to gain weight in an age-appropriate manner), or passage of blood per rectum. The requirement is thus narrowed to a child having two of two relevant symptoms – current persistent diarrhea and current abdominal pain according to their criteria, plus a past history of persistent diarrhea excluding current constipation.
The requirement for the current presence of these symptoms, for 14 or more days continuously, shows a singular lack of understanding of the episodic, fluctuating, and alternating (e.g. diarrhea/constipation) symptom profile experienced by these children. In our experience, ASD children with histologic enterocolitis typically have 1 to 2 unformed stools per day that are very malodorous and usually contain a variety of undigested foodstuffs. This pattern alternates with that of “constipation” in which the unformed stool is passed after many days of no bowel movements at all, and with excessive straining. This group is entirely overlooked by the arbitrary criteria set forth in their paper. With respect to diarrhea and constipation, a detailed discussion of stool pattern in these children is available1 which further highlights the shortcomings of the above criteria. Moreover, the interpretation of pain as a symptom in non-verbal children, as it often manifests as self injury, aggressive outbursts, sleep disturbances, and abnormal posturing, is notoriously difficult. This interpretation requires an insight based upon the correlation of symptoms, histological findings, and response of symptoms to anti-inflammatory treatment. There is no evidence in the Baird et al. paper that these crucial factors were taken into account. This study’s inappropriate symptom criteria would explain the discordance with other reports that have revealed a high prevalence of significant gastrointestinal symptoms in general autism populations2,3.
It is surprising that Dr Peter Sullivan, a co-author on the paper, who presumably provided the above gastroenterological criteria, was not aware of the aforementioned limitations. In his role as a Defendant’s expert in the UK MMR litigation, he will have had access to the clinical records of autistic children with the relevant intestinal symptoms and biopsy-proven intestinal inflammation.
We suggest that the authors might wish to reflect on the ethical implications of setting the bar too high for the investigation of such children by ileo-colonoscopy, with the attendant risk of missing symptomatic, treatable inflammation.
Since the relevant MMR/autism children are considered to be those with regression and significant gastrointestinal symptoms, the appropriate stratification for between-group analyses of measles virus antibody levels has not been conducted; therefore the paper is difficult to interpret, adding little if anything to the issue of causation. Moreover, it is a major error to have presumed that peripheral blood mononuclear cells are a valid ‘proxy’ for gut mucosal lymphoid tissues when searching for persistent viral genetic material.
A further major problem in this study is the number of children who dropped out or who were unable to provide adequate blood samples. We know nothing about either the 735 children who were lost at stage two, or the 100 children for whom blood samples were not available. At the very least, we should be told whether the children who dropped out were likely to be representative of those who stayed in, with regard to the key issues of interest.
For reasons that will emerge in the near future, it would be of interest to know whether siblings of autistic children were included in either of the two control groups. This information is not provided.
As a general observation, this paper contributes nothing to the issue of causation, one way or another. Case definition alone is likely to have obscured the relevant group of autistic children. The study tells us nothing about what actually happened to the children at the time of exposure. We are increasingly persuaded that measuring things in blood many years down the line tells us very little about the initiating events in what is, in effect, a static (non-progressive) encephalopathy unlike, for example, subacute sclerosing panencephalitis, which is a progressive measles encephalopathy. The gut is a different matter, and analysis of mucosal tissues has been very informative, since here, in the relevant children, active ongoing, possibly progressive [AV1]4, inflammation has been identified.
None of Wakefield’s pointers to the irrelevance of or inadequacies in the Baird research was included in the news stories. Nor do these stories refer to other research studies which show a higher rate of gastro-intestinal problems among children with autistic-spectrum symptoms. The recycling of the Baird study was but the latest in a steady drip-feed of such items which appear to be part of a concerted campaign to ensure that the General Medical Council hearing into the conduct of Wakefield’s research, which is shortly due to resume, takes place in as prejudiced an atmosphere as possible. No stone is being left unturned by the medico-political establishment and its creatures in the media to ensure that this doctor is destroyed.
As I have repeatedly said, I have no idea whether Wakefield is correct or not in his concerns about the possible adverse effects of the MMR vaccine on a small sub-set of vaccinated children. Nor do I know whether any of the charges being levelled against him at the GMC has any legs. But I do believe — as I wrote in my series of articles on the subject for the Daily Mail in 2003 here, here and here — that many of the statements made by the Department of Health and medical establishment about the ‘proof’ of the vaccine’s unchallengeable safety are deeply misleading. And I also believe, having spoken to many parents of such children, that their experiences simply cannot be dismissed as they have been by the medical establishment. No-one has ever suggested that the MMR vaccine causes all or most of the incidence of autism. If Wakefield is correct, it is only a small proportion of children whose immune systems may be unable to cope, for whatever reason, which makes them particularly vulnerable to such ill-effects. And contrary to the message being pumped out by the medical establishment that the vaccine has been proved to be safe — by studies which are all either flawed, inadequate or irrelevant — the fairest and most accurate thing to say is that the jury is still out.
One of the most reprehensible weapons being wielded in the witch-hunt against Wakefield is the claim that anyone who gives any credence whatever to his concerns is responsible for the incidence of measles amongst children whose parents are as a result too frightened to give them the MMR vaccination. There are two obvious points to make in response to this piece of moral blackmail: 1) the whole panic could have been avoided by offering single measles, mumps and rubella jabs rather than the triple MMR, and 2) it is surely just as important as avoiding cases of measles mumps and rubella to avoid causing the kind of catastrophic damage to the brain and gut displayed by the children at the heart of this controversy.
And there is a further and quite appalling point to note. This whole saga started because parents of such children found that their family doctors were dismissing out of hand their children’s gut and brain problems, accordingly refusing to alleviate their suffering. Now, as a direct result of the animosity towards Wakefield that has been whipped up — and the fear that any doctor who suggests he might be right will similarly find him or herself at the receiving end of the medical establishment’s fist — children exhibiting this combination of gut and brain damage are finding it difficult to obtain treatment.
Another letter to the Archive of Diseases in Childhood from John Stone, the parent of an autistic child, makes terrifying and distressing reading:
In this regard it is worth noting the recent warning of the National Autistic Society (NAS):
‘The National Autistic Society is keenly aware of the concerns of parents surrounding suggested links between autism and the MMR vaccine. The charity is concerned that the GMC hearing, and surrounding media coverage, will create further confusion and make it even more difficult for parents to access appropriate medical advice for their children. It is particularly important that this case is not allowed to increase the lack of sympathy that some parents of children with autism have encountered from health professionals, particularly on suspected gut and bowel problems. Parents have reported to the NAS that in some cases their concerns have been dismissed as hysteria following previous publicity around the MMR vaccine. It is crucial that health professionals listen to parents' concerns and respect their views as the experts on their individual children…’
The NAS warning relates to the GMC hearing involving doctors Wakefield, Walker-Smith and Murch which is set to resume on 25 March approaching. I do not think it is being unduly cynical to query the publication of this study at the present time as a media event, bearing in mind that it seems to have been carried out five or six years ago. Moreover, the study has once again been promoted as refuting the Wakefield hypothesis when it in fact tests for a possibility that had not been proposed. Meanwhile, the plight of autistic children with gastro- intestinal symptoms is excluded both from the study and public attention, as if they did not exist. The NAS statement warned of ‘creating further confusion’ and this is precisely what this study and its media exposure has done.
As the resumption of the GMC hearing draws nearer, one has to ask whether this will serve the cause of truth and justice and the relief of suffering — or is it instead merely a show trial which will bring about the precise opposite?
Check out this NYT article on Monsanto's lobbying group, "AFACT," which pretends to represent farmers and is pushing REALLY HARD to get the government to ban milk labels letting you know whether cows have been treated with rBGH. As it turns out, consumers overwhelmingly choose milk from non-hormone-treated cows, and Monsanto stands to lose big bucks because its cow-abusing hormone is less and less popular.
It's a warning to those readers who think "industry group" means "industry group," rather than "lobbying group paid by megachemical company." Write to your government representatives and let them know you see through Monsanto's charade.
A new advocacy group closely tied to Monsanto has started a counteroffensive to stop the proliferation of milk that comes from cows that aren’t treated with synthetic bovine growth hormone.
The group, called American Farmers for the Advancement and Conservation of Technology, or Afact, says it is a grass-roots organization that came together to defend members’ right to use recombinant bovine somatotropin, also known as rBST or rBGH, an artificial hormone that stimulates milk production. It is sold by Monsanto under the brand name Posilac.
Dairy farmers are indeed part of the organization. But Afact was organized in part by Monsanto and a Colorado consultant who lists Monsanto as a client.
Afact has also received help from Osborn & Barr, a marketing firm whose founders include a former Monsanto executive. The firm received a contract in 2006 to help with the Posilac campaign.
Lori Hoag, a spokeswoman for the dairy unit of Monsanto, said her company did provide financial support to Afact. But Ms. Hoag asserted that the group is led by farmers, not Monsanto.
“They make all the governing decisions for their organization,” she said. “Monsanto has nothing to do with that.”
Afact has come together as a growing number of consumers are choosing milk that comes from cows that are not treated with the artificial growth hormone. Even though the Food and Drug Administration has declared the synthetic hormone safe, many other countries have refused to approve it, and there is lingering concern among many consumers about its impact on health and the welfare of cows.
The marketplace has responded, and now everyone from Whole Foods Market to Wal-Mart Stores sells milk that is labeled as coming from cows not treated with the hormone. Some dairy industry veterans say it’s only a matter of time before nearly all of the milk supply comes from cows that weren’t treated with Posilac. According to Monsanto, about a third of the dairy cows in the United States are in herds where Posilac is used.
And the trend might not stop with milk. Kraft is planning to sell cheese labeled as having come from untreated cows.
But consumer demand for more natural products has conflicted with some dairy farmers’ desire to use the artificial hormone to bolster production and bottom lines, and it has certainly interfered with Monsanto’s business plan for Posilac.
Cows typically produce an extra gallon a day when they are treated with Posilac. That can translate into serious money for dairy farmers at a time when prices are near record highs.
So Afact has embarked on a counteroffensive that includes meeting with retailers and pushing efforts by state legislators and state agriculture commissioners to pass laws to ban or restrict labels that indicate milk comes from untreated cows.
Last fall in Pennsylvania, Dennis Wolff, the agriculture secretary, tried to ban milk that was labeled as free of the synthetic hormone because, he said, consumers were confused. Mr. Wolff’s office acknowledged that it had no consumer research to back up his claim, and he eventually had to scale back his plans when consumer groups and Gov. Edward G. Rendell balked.
Instead, the state tightened up the language on milk labels to make sure it was more accurate.
But Posilac’s supporters haven’t given up.
In recent months, labeling changes have been floated in New Jersey, Ohio, Indiana, Kansas, Utah, Missouri and Vermont, according to Michael Hansen, who has tracked the issue as a senior scientist for Consumers Union, the publisher of Consumer Reports.
A Consumer Reports survey last summer found that 88 percent of consumers believed that milk from cows not treated with synthetic hormones should be allowed to be labeled as such.
Afact says it believes that such “absence” labels can be misleading and imply that milk from cows treated with hormones is inferior. In fact, the F.D.A. maintains that there is no significant difference between milk from cows that are treated and from those that are not.
Afact also argues that some consumers are paying a premium for milk that doesn’t include artificial hormones.
“We know it’s a technology that makes us money and is safe for our cows,” said Carrol Campbell, a Kansas dairy farmer who is co-chairman of Afact. Mr. Campbell said he became involved in the issue because his cooperative called him and asked him to stop using Posilac; instead, he found a new cooperative.
Ms. Hoag of Monsanto said her company was not actively pushing changes in milk labeling laws.
Advocates for Posilac, including Monsanto, have been complaining for years about milk labeled as free of artificial bovine growth hormone. In September 2006, Kevin Holloway, president of the Monsanto dairy unit, gave a speech in which he said the “fundamental issue” was dairy farmers’ ability to choose the best technology. “Dairy farmer choice to use a variety of F.D.A.-approved technologies is at risk,” he said.
That same year, the Monsanto dairy unit hired Osborn & Barr to handle, among other things, the Posilac brand, according to an article in the St. Louis Business Journal.
In 2007, Monsanto and several dairy organizations met by phone to “lay the groundwork” for a grass-roots organization, according to an online dairy industry newsletter.
Afact was created in the fall of 2007. In addition to receiving money from Monsanto, Afact has received help with its Web site from Osborn & Barr, said Monty G. Miller, a Colorado consultant who was hired to organize the group.
Afact believes that the push for milk from untreated cows is being driven by advocates like Consumers Union and PETA, “who make a profit, living and business by striking fear in citizens,” Mr. Miller said in an e-mail message.
The group also believes it will be hard for food retailers to “move away from the rBST-free stance without legislation and government policy,” according to an Afact presentation to dairy farmers in January.
In the presentation, Afact also listed “integrity,” “honesty” and “transparent” as “words we wish to embody.”
They could start by being more straightforward about who is behind Afact.
Note to parents: The government cannot force you to adhere to the CDC's vaccine schedule. If your children are all caught up by the time they enter school, you will not have any trouble with the authorities. If you choose not to vaccinate at all (or to reduce the vaccinations required by your state for entry into school), you can get a religious or medical exemption. Please consider these options and do not be cowed by the CDC's political agenda and big talk. You have the power to make life better and safer for your children.
By now, many parents in America have heard of the Hannah Poling court case. They know the government has acknowledged that vaccines contributed to autism in at least one little girl from Georgia. Understandably, they are worried, and they want answers.
But instead of frank talk from leading health officials, their concerns are being met with stonewalling, denial and misinformation.
By refusing to address what really happened to Hannah — by commanding parents to settle down and adhere to the nation's rigid immunization regime — officials will only drive people away from vaccines in anxiety-ridden droves.
But what if we could test children for underlying conditions that might increase their risk of vaccine injury and autism? And what if we allowed those at risk to slightly delay and spread out their shots?
It's a difficult, but not impossible, proposition. And I believe doing so would reduce the rate of autism, seizure disorders and even asthma in some children. And we would boost vaccination rates by restoring faith in the nation's teetering immunization program.
Why do I say this? New documents have surfaced in the Poling case that shine more light on how Hannah's vaccine injury led to autism.
A government document filed in the case last November conceded that Hannah's vaccines had aggravated an underlying disorder of the mitochondria. Mitochondria are the tiny powerhouses within each cell that convert food and oxygen into energy. Government officials acknowledged that Hannah's disorder led to a condition known as low cellular energy metabolism, which was aggravated by vaccines and ultimately led to an autism diagnosis.
It was a tantalizing admission but did little to explain just how the vaccines had aggravated the disorder or caused autism.
But on Feb. 21, the U.S. government made a second, unpublicized concession in the case. In addition to triggering autism, officials now admitted, Hannah's vaccines had also led to her "seizure disorder," or epilepsy.
And there was more. The November document claimed that Hannah had a mitochondrial "disorder." But by February, this was modulated to a mere mitochondrial "dysfunction."
That's because Hannah's underlying condition was asymptomatic and most likely environmentally acquired. It was not some rare, grave, inherited disease that would have progressed to autism anyway, as many officials contend.
The November report said Hannah's vaccine reaction had "manifested" as early-onset brain disease, with "features of autism spectrum disorder."
But the February report is more blunt. It says that Hannah's vaccines "caused" her "autistic" brain disease.
But the real bombshell was this: Hannah's autism was caused by vaccine-induced fever and overstimulation of her immune system, according to court documents. Her low cellular energy and reduced metabolic reserves, due to mitochondrial dysfunction, were overstressed by the contents of nine vaccines (including mercury) at once.
The Cleveland Clinic defines low cellular energy metabolism disorder this way: "The process of converting food and oxygen (fuel) into energy requires hundreds of chemical reactions, and each chemical reaction must run almost perfectly in order to have a continuous supply of energy. When one or more components of these chemical reactions does not run perfectly, there is an energy crisis, and the cells cannot function normally. As a result, the incompletely burned food might accumulate as poison inside the body."
The cause of Hannah's mitochondrial dysfunction is up for debate, though ample evidence exists to implicate heavy metals in air, water, food and vaccines as possible suspects. But the government has acknowledged that low cellular energy can increase the risk of immune system overdrive, and regression into autism.
Now, one would think that investigating — and preventing — such vaccine-induced overstimulation in susceptible children would be a top priority of health officials. But it is not.
Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, has vowed to "adamantly" enforce the one-size-fits-all vaccine schedule, no matter what happened to Hannah and other kids like her.
Frantic parents, desperate for answers, were admonished by Gerberding to "set aside this very isolated, unusual situation" in so-called Vaccine Court, even though "the court apparently made the decision that it is fair to say that vaccinations may have been one of the precipitators."
Gerberding was either grossly misinformed, or lying.
To begin with, this "decision" was not made by the court at all, but by medical personnel working for the Secretary of Health and Human Services, Gerberding's boss.
More important, the Poling case is neither isolated nor unusual. At least 12 other autism-related claims have been paid out in Vaccine Court to date, and perhaps hundreds more cases like Hannah's are pending.
Most striking is how typical Hannah's cellular dysfunction may be among children with autism. While extremely rare in the general population, at two per 10,000 people, it seems unusually common in autism — with estimates up to 2,000 per 10,000.
Many opinion leaders are calling on the government to release all relevant documents leading to the Poling concessions. The family has waived all claims to privacy, and the public has a right to know.
For now, all we have is the CDC Web site, which says that "simultaneous vaccination with multiple vaccines has no adverse effect on the normal childhood immune system."
But did Hannah have a "normal" immune system? Are other kids out there also metabolically primed for overstimulation from too many shots at once? Should their vaccines be spread out?
Instead of answers, we get adamant silence. This is not a matter of national security. It's a national emergency. Millions of parents are anxiously waiting for their government to tell them what the hell is going on.
Cutting boards used to prepare raw meat can be used to prepare salad or other uncooked food, transferring disease- causing bacteria and other agents from the meat to the salad. Wooden cutting boards have been widely used for centuries, while boards made from various polymers have been available since the early 1970s. Glass cutting boards are a third option to consumers. Research has shown that when bacteria were inoculated on both wooden and polymer boards, bacterial recoveries from wooden boards generally were less than those from plastic boards, regardless of new or used status (Ak et al., 1994a). These authors found no differences between wood types (basswood, birch, maple, maple plus walnut). Cleaning with hot water and detergents was found to be effective in removing bacteria, regardless of the species, wood type, or whether the wood was new or used (Ak et al., 1994b).
Ak, N. O., D. O. Cliver and C. W. Kaspar. 1994a. Cutting boards of plastic and wood contaminated experimentally with bacteria. J. Food Protect. 57:16-22. Ak, N. O., D. O. Cliver and C. W. Kaspar. 1994b. Decontamination of plastic and wood cutting boards for kitchen use. J. Food Protect. 57:23-30.
Parents get angry when they see the following numbers listed on the internet. These numbers have been out there for everyone to read for years. They are mathamatical facts backed by references. The way to quell parental fears would be for someone like Dr. Parikh to address these numbers. Using propaganda is not going to work and only makes the situation worse.
0.5 parts per billion (ppb) mercury = Kills human neuroblastoma cells (Parran et al., Toxicol Sci 2005; 86: 132-140).
2 ppb mercury = U.S. EPA limit for drinking water http://www.epa.gov/safewater/contaminants/index.html#mcls
200 ppb mercury = level in liquid the EPA classifies as hazardous waste. http://www.epa.gov/epaoswer/hazwaste/mercury/regs.htm#hazwaste
25,000 ppb mercury = Concentration of mercury in the Hepatitis B vaccine, administered at birth in the U.S., from 1990-2001.
50,000 ppb Mercury = Concentration of mercury in multi-dose DTaP and Haemophilus B vaccine vials, administered 4 times each in the 1990's to children at 2, 4, 6, 12 and 18 months of age. Current "preservative" level mercury in multi-dose flu (94% of supply), meningococcal and tetanus (7 and older) vaccines. This can be confirmed by simply analyzing the multi- dose vials.
The Thoughtful House in Austin, Texas, treats autistic children with biomedical interventions, rather than writing them off as psychologically damaged. A local Fox affiliate provides more information, including a video news clip (click the link below).
Autism is the fastest growing developmental disability. Some families of autistic kids often feel shut out and isolated with no where to turn. As FOX 7's Loriana Hernandez reports, the 'Thoughtful House' in Austin is giving families of autistic children from all over the world the support they need.
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Mucci LA, Dickman PW, Steineck G, Adami HO, Augustsson K. Dietary acrylamide and cancer of the large bowel, kidney, and bladder: absence of an association in a population-based study in Sweden. Br J Cancer. 2003 Jan 13;88(1):84-9.
National Toxicology Program (NTP). 2003. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Di-n-Butyl Phthalate (DBP). Ntp Cerhr Mon(4): i-III90.
Payne D. 2003. “Experts doubt study that calls acrylamide safe: carcinogen found in fried foods last year.” Medical Post. 39(7)21; February 18, 2003.
Qu W, Bi X, Sheng G, Lu S, Fu J, Yuan J, et al. 2007. Exposure to polybrominated diphenyl ethers among workers at an electronic waste dismantling region in Guangdong, China. Environ Int 33(8): 1029-1034
RiceDC, James J. 2007a. Brominated Flame Retardants: Third annual report to the Maine Legislature. Augusta, Maine: Maine Department of Environmental Protection, MaineCenters for Disease Control and Prevention.
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Short BG, Steinhagen WH, Swenberg JA. 1989b. Promoting effects of unleaded gasoline and 2,2,4-trimethylpentane on the development of atypical cell foci and renal tubular cell tumors in rats exposed to N-ethyl-N-hydroxyethylnitrosamine. Cancer Res 49(22): 6369-6378.
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Caving to Industry Pressure, EPA Fires Chair of Chemical Panel
WASHINGTON – Under pressure from chemical industry lobbyists, the Bush Administration fired the chair of an expert science panel at the Environmental Protection Agency that was evaluating the safety of a neurotoxic fire retardant, according to documents obtained by Environmental Working Group (EWG).
EPA is to issue by March 28th a reassessment of the human health risks from Deca, an industrial fire retardant used in electronics and other consumer products, and widely found in Americans’ blood and breast milk. But last summer EPA removed Dr. Deborah Rice, a Maine state scientist and author of an important study of the chemical, as chair of the external advisory panel for EPA’s review of fire retardants.
Her firing came after a protest from the chemical industry, which claimed Rice had a conflict of interest as a result of her testimony before the Maine Legislature, on behalf of her agency, in favor of phasing out Deca. EPA also removed her comments from the panel’s final report on Deca’s safety.
While the EPA and the chemical industry thought the presence of one of the country’s preeminent experts on the toxic fire retardant Deca had no business chairing the advisory panel, scores of individuals with direct financial ties to the chemical industry remain on a number of different external advisory panels.
An EWG review of 7 external expert panels convened last year under EPA’s Integrated Risk Information System (IRIS) found 17 members with direct or potential conflicts of interest, including employees of companies who make the chemicals under review or scientists whose work was funded by industries with a financial stake in the panel’s outcome.
“This is clear evidence of a blatant double standard where, the interests of the chemical industry come before the public’s health,” said Jane Houlihan, vice president for research at EWG. “When the government removes top scientists from positions because they express concerns over potential health risks from industrial chemicals – at the same time leaving dozens of scientists with direct ties to the chemical industry on review panels – something is very wrong.”
In a May 3, 2007 letter to EPA, American Chemistry Council lobbyist Sharon H. Kneiss complained that Rice had shown an “appearance of bias” when she testified before the state legislature on behalf of the Maine Centers for Disease Control in favor of phasing out Deca. The letter and related documents are available at http://www.ewg.org/reports/decaconflict.
Rice was the panel member most knowledgeable about Deca, which is a developmental neurotoxin. A retired EPA scientist, Rice co-authored an important study on the chemical’s toxicity to the brain and nervous system during development. She also spearheaded a regulatory review mandated by Maine law to investigate the feasibility of replacing the fire retardant with less toxic chemicals.
“Under this logic the only people eligible to sit on science advisory panels at EPA are individuals that have never uttered a single remark or written a single word expressing concerns over the chemical in question, or people with financial ties to the chemical industry,” added Houlihan. “This bias in favor of the chemical industry places our most vulnerable populations at even greater risk from chemical exposure.”
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EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment.
It is unclear what effect removing Dr. Rice and her comments will have on the final PBDE values. EWG’s line-by-line comparison of the panel report before and after EPA stripped Dr. Rice’s comments from the document shows that the altered document is now missing at least two major concerns relevant to Deca’s risks to humans (EPA 2007a):
·Dr. Rice noted that EPA had provided no scientific basis for its assumption that the single-day exposure for PBDE-induced brain damage demonstrated in animal studies could be used to predict daily PBDE exposures to humans. EPA had used single-day exposures as sub-chronic (multi-day) exposures and had used an uncertainty factor of 3 rather than 10 to translate them to the PBDEs that impact humans from conception through adulthood. EPA’s rationale was that the study targeted a “unique critical window of vulnerability.” However their only citation was a university thesis that cited a 1968 publication identifying post-natal day 10 in rodents as a critical day.
Dr. Rice objected to this, and cited a review article she co-authored in Environmental Health Perspectives that discussed many periods of brain vulnerability to developmental toxicants. EPA’s recognition of this data gap would result in an additional factor of safety applied to the Agency’s safe dose (the reference dose, or RfD). Now Dr. Rice's comment and publication exposing the Agency’s baseless assumption is completely missing from the panel review document.
·Dr. Rice noted that health risks of PBDEs would be additive. Tetra, Penta and Hexa congeners are exclusively sold and used in mixtures and it would be impossible for a person to be exposed to them independently. Deca and the other congeners are commonly detected in people and household samples, which indicate daily exposure to all 4 types. Each group shows the same pattern of low dose toxicity after single day exposures. Health risks from these fire retardants would be additive. This comment reflects a view of additive chemical risks widely accepted across the scientific community but absent from EPA’s proposed methods for assessing Deca risks. Dr. Rice was the only panelist to note this important deficiency in EPA’s method. Because the agency removed her comments, the panel review document no longer reflects this important point. EPA’s failure to consider additive risks will result in a vastly less protective health standard for each chemical.
·Dr. Rice suggested different combinations of Uncertainty Factors be used in the translation of single day rodent exposures to daily safe ingestion values for humans. The overall impacts are concentrations 3 to 35 times lower than proposed by EPA.
Other tactics of the bromine manufacturers to protect the use of their toxic products have recently come under scrutiny. On January 26th, 2008 the Washington Post published an exposé linking tobacco companies' efforts to fight fire-safe cigarettes with the same bromine-producing chemicals who had converging interests, as both benefited from an increased reliance on chemical fire retardants to combat cigarette ignitions. The Washington Post reported that a single lobbyist, Peter Sparber, represented both tobacco and bromine producers, and funneled money to the National Association of State Fire Marshalls, who for more than a decade fought for increased use of chemical fire retardants in place of less toxic methods to control ignition sources like cigarettes (Shin 2008).
EPA has now acceded to demands of the bromine industry to alter documents that will be used to set agency health standards. The result of these actions could compromise public health protections from these ubiquitous and toxic pollutants.
17 conflicted reviewers
EPA has only voluntary guidance to govern the selection of external reviewers. Of critical importance in peer review is independence of experts who are validating EPA's work. EPA's Peer Review Handbook highlights the independence of reviewers as the core issue in panelist selection:
“EPA should always make every effort to use peer reviewers who do not have any conflict of interest or an appearance of a lack of impartiality, and who are completely independent” (EPA 2006).
EPA does not expressly prohibit the inclusion of reviewers with a financial stake in the panel outcome: “In fact, experts with a stake in the outcome — and therefore an appearance of conflict — may be some of the most knowledgeable and up-to-date experts because they have concrete reasons to maintain their expertise" (EPA 2006). Yet Dr. Rice, who has no financial conflict, was removed by EPA from the Deca panel, while the agency continues its widespread inclusion of industry-affiliated scientists, some with very direct financial conflicts of interest.
EWG reviewed 7 External Review panels convened to assess new health standards for EPA's IRIS program in 2007. We found indications of direct or potential conflict of interest for 17 panelists. These scientists receive direct payments from industries who stand to benefit from weakened regulation, have a history of advocacy to reduce safety standards for chemicals, or have made broad public statements about the safety of chemicals under review.
Public statements that could indicate bias
Dr. Rice was kicked off of the Deca review panel because of an apparent "appearance of bias" when she testified before the Maine legislature on behalf of her employer, the Maine CDC, in favor of restrictions on the chemical to protect health. Yet other scientists who have made public pronouncements about chemicals remain on EPA panels. EPA Guidance states "[A]s a general rule, experts who have made public pronouncements on an issue should be avoided" (EPA 2006), but the agency has a double standard when sticking to this guidance, as evidenced by our investigation of Dr. Lorelei Mucci of EPA's acrylamide panel:
Acrylamide and Lorelei Mucci. EPA’s Science Advisory Board has convened an External Review panel that met for the first time on February 20th, 2008 to review EPA’s work to update the safety standard for acrylamide, a carcinogenic pollutant in food and a chemical used in a wide range of industries (EPA SAB 2008). The panel includes Lorelei Mucci, an epidemiologist at Channing Labs at Brigham and Women’s Hospital and Harvard School of Public Health in Boston, who has made numerous public statements discounting acrylamide’s cancer-causing potential. For this and other statements, reports of Dr. Mucci’s work have been characterized by respected scientist Dale Hattis as “scientific overreaching” (Hattis 2003).
Our review of her published studies and public statements shows that Dr. Mucci has on numerous occasions drawn inferences from her study findings that inappropriately discount links between acrylamide and cancer. In one case she noted that “There is little evidence of an association between any specific baked or fried potato product and cancer risk” [emphasis added by EWG] (Riddell 2007). Dr. Mucci’s study in fact found a 60% increased cancer risk in people when she assessed acrylamide exposures from all foods combined, although the study group was too small for that result to reach statistical significance (Mucci 2003). She further stated to the media that “The levels individuals are generally exposed to through food do not appear to increase the risk," even though these statements were critiqued by toxicologists of the sponsoring health agency, who note that a single study cannot support a complete discounting of risk (Payne 2003). In addition to the cancers studied by Dr. Mucci, acrylamide has been linked to pancreatic cancer in exposed workers, and thyroid and reproductive and central nervous system cancers in rodent studies, associations that have not been assessed in humans (EPA 2007i).
In August 2007 Dr. Mucci was widely quoted in media reports following her presentation at a chemical industry conference of preliminary study findings, saying, for example, “The intake of acrylamide, no matter how much is consumed, is not a breast-cancer risk factor” (Riddell 2007). Just 5 months after these first widespread reports, a new study was published measuring a more than doubling of risk of estrogen-related breast cancers among women with high exposures to acrylamide in food (Thonning 2008). This new work relied on direct measurements of acrylamide bound to women’s red blood cell hemoglobin, instead of the crude diet surveys used in Mucci’s studies.
ACC and other industry groups have vigorously defended the inclusion of expert reviewers from industry, even those who have a direct financial stake in the outcome of panel decisions, stating “…bias (or ‘partiality’ under government ethics rules) is both unavoidable and unobjectionable” (Barrow 2006).
Career consultants with a clear record of work to weaken health standards on behalf of industrial clients
Two panelists with clear links to polluting industries have made well-documented attempts to influence EPA health standards by carefully designed research to erode traditional safety factors.
Dibutyl phthalate and Dr. Elizabeth (Betty) Anderson. Chemical industry consultant Betty Anderson chaired EPA’s 2006 panel that has recommended that EPA weaken by a factor of 3 the safety standard for the plasticizer chemical called dibutyl phthalate (DBP) (EPA-NCEA 2006a). This chemical is used in food packaging, nail care products, and a wide range of plastic consumer products, and is also a ubiquitous pollutant in people. Anderson had no particular expertise in toxicity of this chemical to qualify her as panel chair.
However Anderson's employer, Exponent, was simultaneously under contract with ACC's Phthalate Ester Panel to discredit a key epidemiological study that found everyday exposures were linked to reproductive system damage in baby boys (Exponent 2006). Exponent scientists concluded that "data from this study are not sufficient to show any correlation between phthalate exposure and changes to the anogenital distance in the infant males." ACC's Phthalate Ester Panel is made up of manufacturers and users of the chemical including: BASF Corporation, Eastman Chemical Company, ExxonMobil Chemical Company, Ferro Corporation and Teknor Apex Company. The Panel has collectively funded more than $15 million dollars of research, not including research conducted by individual companies (ACC 2008). Exponent later completed a risk review for toy manufacturers to defend the use of a related phthalate in children's toys (TIA 2007).
The proposed weakening of EPA’s safety standard that Anderson's panel recommended is remarkable given the volume of scientific studies published since EPA first established DPB safety standards in 1990 indicating that the chemical is toxic in lower amounts than previously believed. In studies of people, at what are considered “background” levels of exposure (Marsee 2006), DBP is now linked to sperm damage, asthma, obesity, insulin resistance, and birth defects of the male reproductive system (NTP 2003).
Dr. Anderson achieved the same magnitude of reductions in EPA health protections for a different chemical (phosphine) as a consultant to the tobacco industry. Anderson’s conflicts have been the subject of recent investigative reports, and include issues surrounding her work on asbestos and with the tobacco industry (McDaniel 2005; NRDC 2007; Thacker 2007). She chaired the EPA panel on DBP the year after her work with R.J. Reynolds to weaken health standards was discovered and published in a scientific journal.
A 2005 publication in Environmental Health Perspectives and a 2006 investigative report by science writer Paul Thacker, published in Environmental Science & Technology, revealed that in 1999 Dr. Anderson, then of the firm Sciences International, helped R.J. Reynolds Tobacco fend off EPA restrictions on a chemical fumigant called phosphine, in part with her offer to use her official position with a scientific journal to expedite study publications:
“I believe that the approach with the greatest likelihood of affecting EPA’s position is to prepare and publish in a peer-reviewed journal a scientific paper or article that describes the current science on the toxicity of phosphine.” … “Since I am currently Editor-in-Chief of the international journal Risk Analysis, perhaps the peer-review process could be expedited, if we decide that it is the journal of choice” (McDaniel 2005; Thacker 2006).
Risk Analysis published Anderson’s paper in October 2004, and did not disclose that two of Anderson’s co-authors were employed by R.J. Reynolds Tobacco Co. Anderson has defended her actions by noting that the study was not, in the end, expedited (Anderson 2006). R.J. Reynolds considered their work with Anderson to be among its important accomplishments, according to a 1999 company document: “R&D led the Phosphine Coalition in addressing the scientific issues involved when the Environmental Protection Agency (EPA) proposed a new phosphine exposure standard,” … “The efforts of the Coalition saved [Reynolds] many millions of dollars” (Thacker 2006).
Documents in the national tobacco papers library reveal that her influence went beyond her journal connection. Notes of a meeting between EPA, Anderson and her clients disclose that “the meeting was very cordial and the Coalition participants were very encouraged by the Agency's reaction to Dr. Anderson's ideas for relaxing the current proposed exposure standard of 0.03 ppm” (Seckar 1999). Anderson’s own memo reveals her hand in convincing EPA to reduce its safety factor for health standards: “I believe EPA has conceded a 10-fold [safety] factor reduction to 3…” and she strategizes on other measures to reduce the safety factor by still more: “I believe it will be difficult, though not impossible, to demonstrate the relationship between the pharmacodynamics in animals and humans is deserving of a factor of 3 if the right studies can be designed” (Anderson 1999).
The DBP panel Anderson chaired proposed to EPA a 3-fold weakening of EPA’s the safety standard. EPA has yet to finalize the standard. In addition to Dr. Anderson, the 2006 DBP external review also included Edwin Garner, who was employed by Research Triangle Institute International, a contractor who performed a number of industry-funded studies of phthalate toxicity (Fennell 2004; Tyl 2004 among others).
Ethylene Oxide, James Swenberg and VernonWalker. Frequent EPA panel members Dr. Jim Swenberg of the University of North Carolina and Dr. Vernon Walker of the industry-funded Lovelace Respiratory Research Institute conduct industry-funded research to demonstrate that mutagens do not cause cancer in humans, work at odds with findings from a large body of scientific evidence. Chemical manufacturers, including the Chemical Manufacturers Association (now the ACC) and International Institute of Synthetic Rubber Producers, have funded their original research (CSPI 2006) into the relationship between mutation and cancer in rodents, and potential impacts to humans (Rusyn 2005; Swenberg 2000; Walker 2000; Walker 1990). Dr. Swenberg was a panelist for 1,1,1-trichloroethane (EPA-NCEA 2007f) and both were consultants to the ethylene oxide panel (EPA-NCEA 2007h).
EPA’s draft assessment ethylene oxide values, released in September 2006, proposed tightening the agency’s 1985 inhalation standard of 3.6 parts per billion to 0.06 parts per trillion, based on compelling new evidence of cancer in exposed workers (EPA-NCEA 2007h). This dramatic strengthening of the health standard raised significant concerns among manufacturing industries. The assessment is based upon the agency conclusion that the chemical was a carcinogen via gene mutation. This evidence was vigorously disputed by Drs. Swenberg and Walker in a series of publications funded by chemical trade associations (Rusyn 2005; Swenberg 2000; Walker 2000; Walker 1990).
As consultants to the Science Advisory Board’s ethylene oxide review panel, the scientists promoted their research along with a new “framework” for evaluating genotoxicity and risk assessment that contradicted EPA’s proposed approach (EPA-NECA 2007h). The framework attempts to distinguish between chemicals that cause mutations to DNA and chemicals that cause cancer. This was used to discount observations of cancer in exposed workers, arguing that while ethylene oxide was a known mutagen, those mutations did not lead to cancer. Dr. Swenberg’s framework was lifted from an ACC-funded publication he co-authored, and added as an appendix to the peer reviewer’s comments. The paper co-authors Vernon Walker and Richard Albertini, prepared ACC’s public comments to EPA on the mutagenicity issue, which employed identical logic (Albertini 2006).
Drs. Swenberg and Walker’s fingerprints can be found on the external review panel conclusions. The review panel's cover letter to EPA describes a division within the review committee with respect to the proper characterization of ethylene oxide as a human carcinogen (EPA-SAB 2007a). Dr. Swenberg’s influence on the treatment of mutagenic chemicals has potentially major implications for EPA’s evaluation of carcinogens. Safety values for carcinogenic chemicals include an additional 10-fold uncertainty factor to account for greater vulnerability of children if they are exposed during development. The move to classify a known mutagen as a “non-carcinogen” would allow regulators to skirt the 10-fold uncertainty factor and permit greater exposures of children and others to mutagenic chemicals.
Scientists employed by the companies who make the chemicals under review
EPA Guidance identifies financial ties to a regulatory decision as a clear conflict of interest. “Generally, a conflict of interest arises when the person’s financial interests are affected by his/her participation in a particular matter, when he/she, his/her associates or other individuals whose interests are imputed...would derive benefit from incorporation of their point of view in an Agency product, and/or when their professional standing and status or the significance of their principal area of work might be affected by the outcome of the peer review” (EPA 2006). The most direct type of financial conflict is employment by or stock ownership in a company who would be directly impacted by the proposed value. We did not have any information regarding financial holdings of panelists and were unable to gauge this potential for conflict, though we did find that at least 1 panelist was directly employed by a company who manufactured the chemical in question.
Ethylene Oxide and Robert Schnatter. EPA selected Robert Schnatter of ExxonMobil to sit on their expert panel charged with producing an assessment of the cancer potential of the chemical ethylene oxide. ExxonMobil manufactures ethylene oxide. The chemical is used to make other common chemicals, to fumigate spices, and to sterilize medical equipment (EPA 2006b). It is also considered a potential contaminant in many types of personal care products (CIR 2006c), and is a confirmed mammary carcinogen (Rudel 2007). An employee in this situation might disagree with his employer on the need for stronger public health protections, but might feel inhibited from expressing anything but the position of company executives. Schnatter’s inclusion on a panel reviewing a chemical manufactured by his employer clearly violates EPA’s policy to “always make every effort to use peer reviewers who do not have any conflict of interest...” (EPA 2006).
Scientists who consult to companies who make the chemicals under review
Acrylamide and Dale Sickles. EPA selected Dr. Sickles for its expert review panel on the common food contaminant and carcinogen acrylamide (EPA-NCEA 2007i). His scientific research at the University of Georgia has been funded by companies who manufacture or market acrylamide for industrial uses, including CYTEC and American Cyanamid, according to a review by the Center for Science in the Public Interest (CSPI 2007).
1,1,1-Trichloroethane and Matthew Reed. Dr. Reed, of Lovelace Respiratory Research Institute, was an external reviewer for petrochemical 1,1,1-Trichloroethane (EPA-NCEA 2007f). He coordinates inhalation health effect studies for the NationalEnvironmentalRespiratoryCenter. The center is funded by chemical, petroleum, motor vehicle, and power generation industries (LRRI 2008).
2,2,4-Trimethylpentane, Susan Borghoff, Brian Short and Deborah Barsotti. These 3 scientists were reviewers for the 2,2,4-trimethylpentane panel (EPA-NCEA 2007e). The Borghoff and Short, along with previously mentioned panelist James Swenberg and Vernon Walker, have co-published 4 peer reviewed articles that were funded by the Chemical Industry Institute for Toxicology (CIIT), and led them to conclude that the toxicity mechanism did not apply to humans (Short 1989a; Burnett 1989; Short 1989b; Short 1987).
Borghoff's work with CIIT was supported by Lyondell Chemical Company, which manufactures this chemical (TERA 2007).
Short, of Allergan, Inc., has published 7 research papers funded by the Chemical Industry Institute for Toxicology (CIIT) (including 4 mentioned above on the chemical he reviewed) (Short 1989a; Burnett 1989; Short 1989b; Short 1987; Borghoff 1993; Borghoff 1990; Swenberg 1987).
Barsotti was another panelist. Her employer MACTEC Engineering's clients include Dow, DuPont, ExxonMobil, Shell Oil and Unocal, and manufacturers of the chemical she reviewed (MACTEC 2008).
Ethylene oxide and James Klaunig. Dr. Klaunig from Indiana University School of Medicine, served on the ethylene oxide panel (EPA-NCEA 2007h). Dr Klaunig has received research support from ethylene oxide manufacturer DowAgro and the American Chemistry Council (CSPI 2006). His work on a related chemical, 2-butoxyethanol, was funded by the ACC’s Ethylene Glycol Ethers Panel, which later merged with the Ethylene Oxide Panel (Klaunig 1999).
Food contaminants and the International Life Sciences Institute (ILSI). The acrylamide review panel included 3 panelists who were affiliated with ILSI, Deborah A. Cory-Slechta, Penelope Fenner-Crisp, Jeffrey Fisher (EPA-NCEA 2007a). ILSI receive the base of their funding from food producers, including Proctor and Gamble, plaintiffs in a lawsuit challenging California’s attempt to label acrylamide-containing foods. One panelist, Jeffrey Fisher, also participated in the 1,1,1-Trichloroethane panel (EPA-NCEA 2007f). TCE is also a food contaminant.
ILSI has come under substantial scrutiny in Europe, where they attempted to publish a book on alcohol addiction without revealing (and in fact obscuring) that the alcohol industry had funded the publication. Publishers were unable to determine the degree to which the alcohol industry had exhibited editorial control of the process, but concluded that ILSI had falsely represented themselves as a ‘non-profit scientific entity,’ deliberately obscured the role of the alcohol industry funding (Edwards 2001; Room 2002).
WHO barred ILSI from participation in global food standards due to the influence of food producers (Heilprin 2006). EPA, however, appeared to have no qualms about including 3 ILSI members on their expert panels for 2 common food contaminants.
Nitrobenzene, Bruce Allen and Richard Pleus. Both Allen and Pleus sat on EPA’s expert panel for nitrobenzene in 2007 (EPA-NCEA 2007d). Nitrobenzene is primarily used to make aniline, and in dyes, drugs, pesticides and synthetic rubber. Allen lists among his previous clients ACC, Ciba-Geigy, CIIT, Lockheed Martin, the US military and other governmental bodies (GBA Associates 2008).
Pleus works for the consulting firm Intertox with heavy involvement with polluters. Dr. Pleus serves as an expert for the media on behalf of the Council on Water Quality — a group funded by Lockheed Martin, Aerojet, Tronox and American Pacific Corporation, in these companies’ efforts to influence EPA health standards for the rocket fuel ingredient and common water contaminant perchlorate (Council on Water Quality 2008).
Tetrahydrofuran and Nancy Kerkvliet. Kerkvliet was a panelist on EPA's tetrahydrofuran review (EPA-NCEA 2007j). She is faculty at Oregon State University is also on the Board of Directors of the AnnapolisCenter, an industry-funded research group (CSPI 2008). The AnnapolisCenter "... actively argues against the idea that global warming is the result of burning fossil fuels. They also advocate increased logging for better forest health and question rising mercury levels among other things. The AnnapolisCenter is funded primarily by the National Association of Manufacturers." (Exxon Secrets 2004)
The recent panels have included other experts who work for some well-known industry-oriented consulting groups: Exponent, Sciences International, and ChemRisk, each of which has a long history of collaboration with polluting industries including expert testimony, risk assessments and original bench science. At a minimum these panelists should be asked to disclose their personal business relationship to chemical manufacturers.
So the EPA convenes a panel about toxic fire retardant Deca, and then cans the one person on it who has expressed a negative view of this toxic product. The EPA thinks it's just fine, though, to keep plenty of people who are on Big Chem's payroll on the panel.
Quote
EPA Axes Panel Chair at Request of Chemical Industry Lobbyists | Environmental Working Group
EPA Axes Panel Chair at Request of Chemical Industry Lobbyists
Published February 29, 2008
EPA Axes Panel Chair at Request of Chemical Industry Lobbyists
At the request of a chemical industry lobbyist, the Environmental Protection Agency removed the chair of an expert peer review panel charged with setting safe exposure levels for a toxic fire retardant that contaminates human blood and breast milk, according to documents obtained by Environmental Working Group (EWG). After doing the industry’s bidding, EPA then retroactively stripped all of the chair’s comments from the panel’s published report and republished the altered document.
In a letter to the EPA, a lobbyist for the American Chemistry Council argued that the panel chair, Dr. Deborah Rice of the Maine Center for Disease Control and Prevention, should be thrown off the panel because she exhibited an “appearance of bias” when she represented her agency's position in favor of restricting uses of Deca in her testimony before the Maine legislature. EPA acquiesced and removed Dr. Rice from the panel. The Agency first tried to cover up its actions by stripping any mention of Dr. Rice and all of her comments from the original published review document, and reposting the altered document on the web with no indication that any changes had been made. Months later they issued a disclaimer that Dr. Rice had been removed for a “perception of a potential conflict of interest.” The omission of the chair’s comments from the review document could result in a significantly weaker safety standard for the chemical, which EPA intends to propose at the end of March 2008.
EPA’s sacking of Dr. Rice reveals a dangerous double standard where scientists and experts working for state or federal health agencies can be removed from EPA advisory panels simply because they express the views of their agency in public as a part of their job responsibilities. Meanwhile, numerous scientists with direct financial ties to the manufacturers of chemicals under review, or with publications and public statements touting the safety of chemicals they are evaluating, remain as active participants on these panels.
Deca is a developmental neurotoxin used in electronics and other consumer products, from a family of fire retardants known as PBDEs (polybrominated diphenyl ethers). The targeted expert, Dr. Deborah Rice, was the panel member most knowledgeable about Deca risks. A retired EPA scientist and life-long public servant, Dr. Rice co-authored an important study on Deca toxicity to the brain and nervous system during development. She also spearheaded a regulatory review mandated by Maine law, to investigate the feasibility of replacing Deca with less toxic chemicals. Her transgression, according to the industry complaint, was that in testimony before the Maine legislature, Dr. Rice displayed an “appearance of bias” simply by stating her agency’s position in support of state legislation to restrict Deca.
EPA Stacks Panels With Industry-Biased Scientists
EPA has institutionalized the practice of loading key public health advisory panels with individuals sympathetic to or employed by the chemical industry. EWG examined seven EPA panels established in 2007 that use non-EPA scientists to evaluate the agency's proposed safe daily exposure levels, or "reference doses,” for important commercial chemicals where the agency is concerned about human exposure. In this small snapshot we identified 17 individuals who were employees of companies that make the chemicals under review, scientists whose work was funded by industries with a financial stake in the panel outcome, or scientists who have made over-reaching public statements about the safety of the chemical in question.
To our knowledge, EPA’s decision to remove Dr. Rice as chair of the Deca review panel represents the first time EPA has kicked a scientist off any panel for expressing concern about a chemical's health risks. Removing panelists because they state their concerns about a chemical's toxicity, while promoting scientists with clear financial ties to the regulated industry, sends a dangerous signal that EPA will not tolerate the views of individuals who believe in precaution in the face of evidence that a chemical presents a legitimate health risk.
Chemical Industry Used Allies inside the Agency to Bump Panel Chair
The chemical industry’s trade association, the American Chemistry Council (ACC), submitted their demand for Dr. Rice’s removal to Dr. George Gray of EPA’s Office of Research and Development (ACC 2007). Before joining EPA Dr. Gray headed up an organization funded by the ACC called the Harvard Center for Risk Analysis, well-known for their studies and advocacy to dismiss concerns about chemical safety.
ACC acted on behalf of their Brominated Flame Retardant Industry Panel (BFRIP) in making their demands to EPA. Recent media reports reveal that other efforts by the Bromine Industry to keep Deca on the market have included hiring a lobbyist who also represented the tobacco industry and the National Association of State Fire Marshalls in advocating for increased use of chemical fire retardants in place of fire-safe cigarettes and other commonsense methods to reduce fire risk (Shin 2008).
Rice's Removal From the Panel Could Weaken the Safety Standard
EWG’s line-by-line comparison of the panel report before and after EPA stripped Dr. Rice’s comments from the document shows that the altered document is now missing major concerns relevant to Deca’s risks to humans, particularly infants, children, and other vulnerable populations. EPA’s failure to consider these points could substantially influence their decision on an appropriate safety standard for the chemical:
Dr. Rice noted that EPA had no scientific basis for its assumption that a single day of Deca exposure linked to brain damage in animal studies is the most critical period of vulnerability for animal and human brain development. EPA’s recognition of this data gap would result in an additional factor of safety applied to the Agency’s daily safe dose (the reference dose, or RfD). Now the panel’s recognition of the data gap and the Agency’s baseless assumption is completely missing from the panel review document.
Dr. Rice noted that Deca risks should be considered in tandem with risks from related PBDEs that are also common blood and breast milk pollutants. Since all congeners being evaluated show the same type of neurotoxicity, health risks from these fire retardants would be additive. This comment reflects a view of additive chemical risks widely accepted across the scientific community but absent from EPA’s proposed methods for assessing Deca risks. Because the agency removed her comments, the panel review document no longer reflects this important point. EPA’s failure to consider additive risks would result in a vastly less protective health standard for Deca.
The EPA Double Standard
Over the past seven years it has become common practice for scientists with conflicts of interest and well-known, pro-industry biases to serve on and even lead EPA advisory panels. Some examples include:
Direct financial conflict – Scientists employed by the companies who make the chemicals under review.
Dr. Robert Schnatter sits on EPA’s expert panel charged with producing an assessment of the cancer potential of the chemical ethylene oxide, a mammary carcinogen used as a fumigant and hospital equipment sterilizer. Schnatter works for ExxonMobil, a manufacturer of the chemical he is charged with reviewing. EPA chose Schnatter for the panel despite the obvious contradiction his appointment presents to their policy to “always make every effort to use peer reviewers who do not have any conflict of interest...” (EPA 2006).
Public statements that could indicate bias.
Dr. Rice was removed from the PBDE panel for making public statements indicating that she had formed an opinion about the safety of the chemical. Yet similar statements have been made by many other reviewers examining other chemicals, almost always to the effect that the chemical under review is safe. Consider Lorelei Mucci, of the Harvard School of Public Health, who sits on a panel slated to review EPA’s proposed revisions to the safety standard for acrylamide, a contaminant of baked and fried food (EPA SAB 2008). Dr. Mucci has made numerous public statements discounting the health risks of acrylamide. As just one example, in August 2007 she claimed in the media that “The intake of acrylamide, no matter how much is consumed, is not a breast-cancer risk factor” (Riddell 2007). At the time she made this statement, findings from laboratory and epidemiology (human) studies conflicted on this point. Just months after her statement, a new study found more than double the incidence of estrogen-related breast cancers among women with high exposures to acrylamide in food compared to women with lower exposures (Thonning 2008). For her history of similar statements, reports of Dr. Mucci’s work have been characterized by respected scientist Dale Hattis as “scientific overreaching” (Hattis 2003).
Career consultants with a clear record of work to weaken health standards on behalf of industrial clients.
EPA panel chair and industry consultant Dr. Betty Anderson secured a panel decision to support EPA’s proposed 3-fold weakening of the health standard for a plastics chemical and common human pollutant called dibutyl phthalate (DBP) (EPA 2006b). The year that Dr. Anderson reviewed EPA's draft standards, her employer, Exponent, was under contract with ACC's Phthalate Ester Panel to discredit a key epidemiological study that found everyday exposures to DBP were linked to reproductive system defects in baby boys (Exponent 2006). The next year Exponent released a defense of a phthalate used in children's toys funded by the Toy Industry Association (TIA 2007).
In her work for chemical makers, Anderson clearly expressed her goal to weaken health standards. Memos written by Anderson and housed in the national tobacco library show that she lobbied EPA for a more than 3-fold weakening of health protections on behalf of R.J. Reynolds. She first designed work to “bolster our position that [safety factors] used by EPA… can be dropped” (Anderson 1999a), and then relayed her success to her client at Reynolds: “I believe EPA has conceded a 10-fold [safety] factor reduction to 3…” (Anderson 1999b). She also advocated for two types of studies that could further weaken health standards: “Both or either [type of study] could remove the factor of 3.” Remarkably, in that statement she is predetermining findings from studies she had yet to design (Anderson 1999b).
In another example that illustrates the same type of conflict, frequent EPA consultants James Swenberg and Vernon Walker conduct industry-funded research to demonstrate that mutagenic chemicals do not cause cancer in humans. Their findings conflict with a wealth of established scientific evidence. Dr. Swenberg was a panelist for 1,1,1-trichloroethane, and both were consultants to the ethylene oxide panel.
Scientists who consult to companies that make the chemicals under review.
EWG’s review revealed that in 2007 EPA panels included at least 13 additional members whose employers have worked for or have been funded by companies who make the chemicals they are charged with reviewing. Industry consultants are inherently conflicted as panel members, since companies hire consultants who will represent what they consider to be their best interests. On panels, a consultant's support for strengthening health standards could compromise their chances to win contracts from chemical manufacturers, while their expressions of rationale for weakening health standards immediately raise their prospects for future contracts. It takes a unique consultant, one willing to risk losing future personal income, to support strengthening public health protections when it’s needed.
EWG calls on EPA to clarify their guidance with respect to public statements by panel members, and commit to a transparent process for resolving allegations of bias. In order to restore public confidence in the peer review process EPA must:
Reinstate Dr. Rice as the chairperson of the PBDE (Deca) expert review panel;
Remove the altered panel review document from public record and restore the original panel review document that included Dr. Rice’s comments; and
Promptly issue an updated health standard for Deca that adequately protects public health and that thoroughly considers Dr. Rice’s comments, including the issue of additive risks from multiple related fire retardants that widely contaminate the U.S. population.
However, EPA’s double standard for panel experts is much broader than the single panel assessing Deca health standards. In order to maintain the integrity of peer review for agency decisions, EPA must:
Collect information regarding all current and past financial ties between prospective panelists and companies who might benefit from weakened safety standards;
Create formal, public records of their determination of bias for each scientist selected as reviewer; and
Release all records of any similar instances in which EPA has removed panel members or published altered versions of EPA expert reviewer submissions.
EWG is submitting a Freedom of Information Act request to EPA to turn over all documentation collected by the Agency or its contractors regarding potential conflicts of interest for external review panels during 2006 and 2007. This includes a request for files documenting inter-agency discussions of potential conflicts for individual reviewers, including Dr. Rice, and any communication with outside parties (like ACC) about the external reviewers.
Review Panel Timeline
Documents obtained by EWG reveal that EPA dismissed the chair of their high-profile external review panel at the request of the American Chemical Council (ACC) representing the interests of the companies who produce the toxic fire retardants under consideration (BFRIP). EPA’s move is in conflict with their own voluntary guidance documents. These require, at a minimum, that their handling of allegations of bias be transparent and well documented for the public (EPA 2006).
Timeline of EPA and industry actions
EPA is updating its 1989 Deca safety standard, and creating new standards for other PBDE fire retardants as well, including Tetra, Penta, and Hexa PBDE. The process began with a literature review in 2002. In late 2006, EPA posted their draft risk calculations for public comment and announced the expert review meeting (EPA-NCEA 2007d).
12/22/2006
EPA posts their draft health standards for Deca and other PBDEs in the Federal Register, and announces the first expert panel meeting.
mid-Feb 2007
Dr. Rice of Maine CDC testifies before Maine Legislature on the need for use restrictions on Deca.
2/22/2007
PBDE Expert Panel convenes, with Dr. Rice as chair.
3/22/2007
EPA posts final Expert Panel report as a pdf file. The document includes Dr. Rice's comments.
5/3/2007
ACC demands that EPA kick Dr. Rice off the expert panel.
6/15/2007
ACC meets with EPA to discuss their concerns with the process.
8/13/2007
EPA kicks Dr. Rice off of the panel, strips her comments from the Expert Panel report, and republishes the altered version. The document contains no mention of Dr. Rice and no record of EPA's actions to remove her comments.
9/21/2007
ACC writes EPA. They request that EPA post the reasons for removing Rice on EPA's website.
11/26/2007
EPA posts 3rd version of Expert Panel comments. This version adds a disclaimer about the removal of Dr. Rice, and notes that EPA is not considering her comments in its final safety standard for Deca.
1/8/2008
EPA responds to second ACC letter
3/28/2008
EPA is expected to issue its final safety standard for Deca.
In January and February 2007, before the External Review panel met, Dr. Rice's agency, Maine CDC, released a joint report with Maine EPA, reviewing the need for use restrictions for Deca PBDE and the suitability of alternative fire retardants. Dr. Rice was a co-author. The report concluded that "safer alternatives are available to meet flammability standards for TVs, mattresses and residential upholstered furniture" (Rice 2007a).
Dr. Rice was asked to testify before the Maine Legislature and offer her opinion about a bill that would restrict Deca in products sold in Maine. She presumably echoed the Agency conclusion in testimony in February 2007. Dr. Rice was in a unique position to make such comments as she was the co-author of a low dose study (Rice 2007b) that confirmed the neurological deficits observed in the principal study used to derive the reference dose for Deca PBDE (Viberg 2003).
Deca in consumer products, people, and the environment
Over the past 5 years, numerous investigations have substantiated the widespread accumulation of PBDEs in people, wildlife and the environment. In response to these findings, bromine companies agreed to voluntarily phase-out 2 of the 3 forms of PBDEs in 2005. The third form, Deca, is still in widespread use in televisions and computer monitors, although 2 U.S. states recently passed restrictions and many other states are considering similar legislation.
CDC recently reported that nearly all of the 2,000 people they tested have detectable concentrations of many PBDEs in them. CDC’s tests did not include Deca due to analytical difficulties, but Deca has recently been reported in human samples from Europe, Central America, Asia and several small studies in the United States (Athanasiadou 2008; Bi 2006; EWG 2003; Qu 2007). Laboratory studies show single day exposures during sensitive periods of brain development result in permanent changes to rodent attention and behavior (Rice 2007b; Viberg 2003; Viberg 2008). It is not currently known how those doses compare to the daily exposure for Americans, but EPA’s draft risk calculations are a first step to set daily safe exposure levels for people. EPA’s external review committee was reviewing the risk calculations to translate these studies into daily safe exposure values for human beings.
2/22/2007 PBDE Expert Panel convenes. The EPA contractor convened the advisory panel of 5 scientists to provide EPA with a rigorous review of the scientific basis for the agency's proposed health standards. Expert reviewers were asked to answer a set of questions from EPA regarding the completeness of the Agency's literature review, the adequacy of data and the appropriate use of uncertainty factors in EPA’s derivation of a daily safe exposure level, or Reference Dose (RfD) (EPA-NCEA 2007e).
3/22/2007 EPA posts Expert Panel comments. The document contains the individual comments from 5 reviewers (EPA 2007a). Dr. Rice is listed as panel chair. She raises several issues that others did not address. Nonetheless the 5 expert reviewers are generally in agreement with EPA’s selection of low dose studies and the general steps taken to translate those to daily safe exposures that do not risk human health.
5/3/2007 ACC demands that EPA remove Dr. Rice from the Deca panel. ACC’s Sharon Kneiss wrote to ORD Assistant Administrator George Gray a former head of a consultant group that receives ACC funding, to ask that he personally intervene in the process (ACC 2007). ACC, acting on behalf of BFRIP, the Brominated Flame Retardant Industry Partnership, alleges that the panel is not an “independent, third-party review” because Dr. Rice is a “fervent advocate of banning deca-BDE.” In an interview with a local paper Dr. Rice stated that “there is no question” that Deca PBDE should be eliminated from commerce because it was a persistent toxin that accumulates in the food chain. ACC alleged that, “[T]here is no doubt that [Dr. Rice] has taken a very public position concerning a regulatory determination that is fundamental to the very issues presented to the panelists in the draft IRIS Toxicological Reviews” (ACC 2007).
ACC fails to note that Dr. Rice’s testimony was solicited by the legislature and offering her expert opinion was in fact a requirement of her job. However, unlike industry-employed scientists (who often serve in this capacity) Dr. Rice has no direct or indirect financial incentive to sway panel findings.
6/15/2007 ACC meets with EPA in person to express concerns about Dr. Rice and the proposed risk values. There is no public record of the discussion during this closed door meeting.
8/13/2007 EPA posts 2nd version of Expert Panel comments as a pdf file. All of Dr. Rice’s comments are omitted. In August, EPA posts an identically formatted document that omits Dr. Rice’s name and all of her comments (EPA 2007d). The new pdf file was placed on the same webpage, and the title page still listed the date of the report to be February 2007 (EPA-NCEA 2007b).
9/21/2007 Nancy Sandrof of ACC writes EPA on behalf of Bromine producers (BFRIP). ACC writes a second letter requesting that EPA post the reason for removing Rice on EPA's website and take steps to assure that Dr. Rice's comments not influence the other reviewers or the overall outcome. They ask that EPA not use the Viberg study--showing neurological impacts to mice given a single dose of Deca--for the risk assessment and request a delay in the publication of final values.
11/26/2007 EPA posts 3rd version of Expert Panel comments as a pdf file. Document contains 4 reviewers, EPA discloses Rice's removal. In November, EPA posted a third version of the Expert Panel comments with a new disclaimer that reads: "Notice: EPA modified this report in August, 2007 to include only four of the five reviewers’ comments. One reviewer’s comments were excluded from the report and were not considered by EPA due to the perception of a potential conflict of interest" (EPA-NCEA 2007c). The new pdf file was placed on the same webpage as the previous 2 versions. However the webpage now has a similar disclaimer. The report title page still lists the report date of February 2007.
1/8/2008 George Gray of EPA responds to ACC. Dr. Gray writes the Bromine Manufacturers via ACC to confirm that they have posted a disclaimer about the removal of Dr. Rice. An EPA review showed that she did not influence the other panelist. He confirms that EPA will continue to use the Viberg study as a point of departure for their RfDs, as every external reviewer agreed with this decision. He hints that a yet-to-be-published EPA study has confirmed low-dose neurotoxicity after single or repeat doses. Finally, he clarifies that the IRIS assessments have been delayed to provide time to address final interagency review comments.
What a surprise. Since Big Pharma has every freaking American scarfing down pills of some kind, our tap water is polluted with all kinds of antibiotics and hormones that water treatment plans don't even try to remove. Great.
Immediate Release: Monday, March 10, 2008 Contact: EWG Public Affairs (202) 667-6982
WASHINGTON - A wide range of pharmaceuticals that include antibiotics, sex hormones, and drugs used to treat epilepsy and depression, contaminate drinking water supplies of at least 41 million Americans, according to a 5-month investigation by the Associated Press National Investigation Team released today.
“Environmental Working Group's (EWG) studies show that tap water across the U.S. is contaminated with many industrial chemicals, and now we know that millions of Americans are also drinking low-level mixtures of pharmaceuticals with every glass of water,” said Jane Houlihan, EWG Vice President for Research. “The health effect of this cocktail of chemicals and drugs hasn't been studied, but we are concerned about risks for infants and others who are vulnerable. Once again, the press is doing EPA‘s work when it comes to informing the public about contaminated tap water.“
Environmental Working Group analysis shows that of the top 200 drugs in the U.S., 13 percent list serious side effects at levels less than 100 parts-per-billion (ppb) in human blood, with some causing potential health risks in the parts-per-trillion range. EWG calls on EPA to take swift action to set standards for pollutants in tap water that will protect the health of Americans nationwide, including children and others most vulnerable to health risks from these exposures.
Drug residues contaminate drinking water supplies when people take pills. While their bodies absorb some of the medication, the rest of it is flushed down the toilet. Drinking water treatment plants are not designed to remove these residues, and the AP team uncovered data showing these same chemicals in treated tap water and water supplies in 24 major metropolitan areas around the US. EWG's national tap water atlas shows tap water testing results from 40,000 communities around the country.
All of the pharmaceuticals reported in drinking water supplies are unregulated in treated tap water—any level is legal. Not only has the EPA failed to set standards for pharmaceuticals, but also they have failed to require utilities to test for these chemicals. The drug residues in tap water join hundreds of other synthetic chemicals Americans are exposed to daily, as contaminants in food, water, and air, or in common consumer products. EWG found an average of 200 industrial chemicals, pesticides and other pollutants in umbilical cord blood from 10 babies born in the U.S., indicating that our exposures to toxic chemicals begin in the womb, when risks are greatest.
EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment. The group's research on tap water is available online at: http://www.ewg.org.
Increased incidence of cancer, increases in antibiotic-resistant bacteria ... sounds like yet another great idea (recombinant bovine growth hormone) from the folks who brought you Agent Orange. Thank God consumers are making good decisions for themselves even when the FDA is not. Too bad the FDA doesn't support labeling of other food products containing Monsanto's genetically engineered ingredients, so consumers can't decide for themselves.
Milk doesn't always do the body -- or the grocery tab -- good.
This is because conventional milk products often come from cows that have been given synthetic hormones and a bevy of antibiotics. But opting for untainted organic products can mean paying a steep premium for your milk, yogurt or American-cheese singles.
Luckily things are starting to change.
Acknowledging consumer wariness, major food companies and grocery stores are steadily moving toward milk products that lack these troublesome chemicals.
The flap over hormones in milk began in the early 1990s, when MonsantoMON won FDA approval for rBGH, a synthetic growth hormone made via a process that involves gene splicing. You can read all about the controversy at sustainable table and the Organic Consumers Association.
In a New York Times op-ed last June, FDA alumnus Henry I. Miller touted Monsanto's product as the answer to rising milk and corn prices and to farm-related environmental issues by pointing out that it allows cows to produce more milk while eating less and using less farmland.
Common sense suggests that such a phenomenon probably isn't good for the cows over the long term. And how healthy can milk be if it comes from overworked, stressed-out animals?
Miller goes to great lengths to hammer home his point that the hormone "poses no risk to human health."
But safe and free of side effects are two very different things -- a point Miller handily refuses to acknowledge. Any time we introduce man-made chemicals to our bodies, or the food chain, there are collateral effects. Consumers should be informed and able to weigh the risks and benefits before they opt to ingest (or even potentially ingest) such compounds.
I became wary of conventional dairy two years ago, after reading in the New York Times about a link between hormones in dairy foods and the rising rate of twins in the U.S. As an avid consumer of milk and cheese and a woman of child-bearing age, I was pretty sure I wanted to avoid this particular side effect.
I began to shop organic, but was aghast when I headed to the dairy aisle and discovered that organic milk cost at least double what the regular stuff does.
Luckily, I'm not alone in my discomfort over industrial dairy. Sales of organic milk have been rising in recent years, even as overall consumption of milk remains flat, according to a USDA report. The report notes that milk and yogurt are often the first organic foods that consumers try.
The food industry has caught on to this preference and is giving consumers more choices at varying price points.
In addition to being chemical-free, organic milk comes from cows that eat organic feed and spend time outside with access to grazing pasture. But as organic milk has become widely available -- Wal-Mart WMTnow sells it -- adherence to the spirit of these requirements apparently varies. The Cornucopia Institute did a survey of organic brands not long ago and rated them on a scale of one to five cows for how well their suppliers execute the USDA's organic standards.
A potential difference in quality is important because there is a wide price range within the high-end organic category. At a local supermarket in Brooklyn prices soared from $3.99 per half gallon for Organic Valley, which garners four cows from Cornucopia, to $5.29 for Dean Foods' Horizon label, which received only one cow. The store's one brand of conventional milk cost $1.89 for a half gallon. In another store, a brick of Organic Valley organic cheddar cheese cost double its counterpart from KraftKFT.
If you're willing to give all organic labels the benefit of the doubt, stores like SafewaySWY, Whole Foods WFMIand CostcoCOST stock private label dairy products that carry much narrower premiums. But several of them rate only one or two cows for not responding to Cornucopia's questions.
And if you're more concerned with your own health than with the happiness and comfort of a cow herd, you can skip the organic option altogether and just look for milk, cheese or yogurt that are labeled hormone-free. Trader Joe's sells a full line of them.
Dean FoodsDF aims to have all of its many regional milk brands rBGH-free by the end of this quarter, according to a spokesperson, but it doesn't always label them as such. KrogerKRpromised last August to transition to hormone free milk supplies for its several supermarket chains by early this year.
StarbucksSBUXsources its milk, whipped cream and half and half from dairies that are rBGH free and Chipotle Grill CMGdoes the same with its cheese and sour cream.
Meanwhile, Crain's Chicago Business reported in January that Kraft Foods is launching a new line of American cheese singles that will be free of synthetic hormones.
One incentive Kraft has for the move is that foods with a hormone-free label often carry higher prices than other brands, though they aren't nearly as expensive as organic foods. In my local grocery, Farmland Dairy , which delivers hormone-free milk to the New York City area, costs $2.19 for a half gallon, about 30 cents more than other milk.
These moves by big companies are gradually pushing Monsanto's hormone out of the food supply -- less than 20% of milk now comes from hormone-treated cows.
I'm confident Uncle Sam will sooner or later catch up with consumer sentiment and curtail the use of hormones in dairy cows, as it has with poultry and pigs. In the mean time, I'm glad that clear labeling and more options allow me to make an informed choice about just what goes into my moo juice and what gets left out.
I guess it doesn't surprise me that someone who could respond so callously (strike that--not respond at all) to the autism epidemic is OK with monkeys needlessly suffering, but this is still pretty awful stuff. Step down, Dr. Gerberding, before you make us all even more embarrassed to be human beings.
Multiple recent inspections of laboratories at the Centers for Disease Control and Prevention (CDC) have uncovered abysmal conditions in which animals died as a result of negligence, incompetence, inadequate veterinary care, insufficient staffing, and poor communication. Even in the CDC's Biosafety Level 4 laboratories, which work with the most dangerous germs such as Ebola, Hanta virus, and Marburg virus, inspectors found problems with veterinary care and infection control. In the wake of these findings, PETA is demanding that Julie Gerberding, the person who presided over this systemic disorder, be replaced as director.
Inspectors were appalled to find the following:
Two monkeys had died of dehydration when faulty sipper tubes left the monkeys with no access to water.
Three additional monkeys were accidentally given fatal combinations of medications.
A sixth monkey died as a result of inept record-keeping and poor communications.
Animals suffered exacerbated pain and distress through routine procedures that were conducted improperly. One chimpanzee was subjected to 10 attempts at a needle biopsy of her liver, even though more than three attempts are considered excessive by the CDC.
Cages were extremely crowded and encrusted with excrement.
Worker safety was jeopardized as a result of poor practices and infection control problems.