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Entries in FDA (55)

Wednesday
Nov282012

Outbreaks of Foodborne Illnesses Are Becoming Harder to Detect

New diagnostic tests for common foodborne pathogens such as Salmonella, Campylobacter, and Escherichia coli may hinder the ability of public health officials to detect multistate outbreaks. The problem is an inability to trace contamination to its source.

In 2009 Alicia Cronquist, an epidemiologist with the Colorado Department of Public Health and Environment noticed that several rural clinics in her state had switched from traditional laboratory tests that relied on growing a culture to rapid nonculture tests. In the past, when patients were suspected of having certain foodborne illnesses, doctors routinely sent a stool sample to a laboratory, which detected a range of potential bacterial culprits. (Some foodborne infections, like Listeria, are diagnosed with blood tests.) An isolate, or sample of the bacterial colony at fault, would then be forwarded to local, state or federal officials, who had the DNA tested to determine the organism's specific strain. The telling DNA sequence, or "fingerprint," was entered into the PulseNet system so that public health officials could see if samples from other newly diagnosed patients matched the information in the database. Analysis of when and where people contracted an infection of that specific strain can help lead to the source of contamination, allowing investigators to remedy the situation.

But, Cronquist says, over the course of a year, a clear shift in the types of tests being run in local labs had resulted in much less information being shared with her department. "We saw our surveillance data changing, and by 2010, almost 15 percent of total case reports were using the nonculture tests," she says.

The new tests do have a lot going for them. They provide quicker results to the physician and patient. They are often less expensive and, in some cases, may not require a stool sample at all. What is more, some of them can spot pathogens that the culture-based tests do not and diagnose more infections.

Tennessee's state epidemiologist Timothy F. Jones notes, for instance, that culture tests for E. coli look for the 0157 strain, which is among the bacteria that produce the Shiga toxin; that strain infamously accounted for the outbreak of food poisoning from spinach this year. "With the new rapid tests," he says, "we can actually detect the whole class of Shiga-toxin producing bacteria. The rapid test is detecting additional bacteria we would have missed before."

But adoption of the new tests has meant that health officials, like Cronquist, are not always getting the isolate required to do the DNA fingerprinting that is needed to help identify a source of contamination, such as E. coli in lettuce or salmonella in raw spinach.

In that way, Jones says, "these rapid tests put us back where we were when we didn't have the ability to do [DNA] fingerprinting."

The trend is particularly worrisome because other ways of protecting the public from foodborne illnesses are also stumbling. According to the Centers for Disease Control and Prevention, one in six Americans (or 48 million) become sick from a foodborne disease each year and 3,000 die. A study released late last month by the U.S. Public Interest Research Group indicated the problem is not improving in part because laws like the Food Modernization Safety Act continue to languish in the White House's Office of Management and Budget. And a federal monitoring program—the U.S. Department of Agriculture's Microbiological Data Program, which tested produce for pathogens—began to be shut down on November 12. 

Jay M. Lieberman, medical director of infectious diseases for Quest Diagnostics, which serves approximately half the physicians and hospitals in the U.S., says that the wide adoption of the new tests means that public health officials will need to come up with new ways to monitor and respond to new outbreaks. For example, health officials will need to work with the labs to figure out how to get an isolate or find another way to characterize pathogens.

"By connecting cases, we can find problems in the food supply we might not have found," says John Besser, deputy chief of theCDC's Enteric Diseases Laboratory Branch. "The challenge for us is to develop a test that will provide all the information that we need without going to the isolate step. That's a significant challenge, but we all believe it's doable."

At present, no one is working on developing a test that can help public health officials trace outbreaks, though several companies continue to develop the new nonculture tests, including Abbott Laboratories, BD, Cepheid and Luminex. Besser says he expects laboratories to quickly adopt them when they become available. For the labs, the new tests mean quicker, cheaper results requiring fewer highly trained staff.

Although the problem of tracking pathogens related to foodborne illness is new, similar concerns were raised when nonculture tests were developed for detecting the sexually transmitted disease gonorrhea.

"When it comes to gonorrhea, almost all testing is done by nonculture techniques now," explains Quest's Lieberman. In response to that sea change, the CDC set up a surveillance project that allows it to monitor trends in a new way. At specified labs in 28 cities across the U.S., cultures are run and isolates taken from samples collected from the first 25 men found to have urethral gonorrhea each month. With that limited data set, public health officials can still track outbreaks while also allowing for broader use of the new nonculture tests.

Although that procedure has worked well for gonorrhea, whether it will also work for foodborne illnesses remains an open question.

An irony of all of this, says the CDC's Besser, is that the new tests for foodborne pathogens may be better than the old ones, but if they disrupt the public health systems, they "could result in a lot more people getting sick. That is the unintended consequence."

http://www.scientificamerican.com/article.cfm?id=food-poisoning-outbreaks-become-harder-to-detect

Monday
Nov052012

Supplements not on an FDA approved list could disappear

Supplements not on an FDA “approved” list could disappear.

The NDI guidance interprets the rules for new supplements. After your protests got the first draft scrubbed, work on a second draft continues at FDA. A second meeting between FDA and “stakeholders”—mostly trade groups, with ANH-USA once again the only grassroots consumer group present—took place on October 16.

As we reported after the first meeting, the New Dietary Ingredients guidelines still pose a major threat. This is because FDA is trying to reaffirm the policies of the original guidance, particularly the elements that could remove huge numbers of supplements from the market.

Much of the meeting was dedicated to a discussion about how to create a list of “grandfathered” dietary ingredients (supplements). These supplements would have been sold prior to 1994, the year the underlying law, DSHEA, was passed and therefore would not require jumping through further regulatory hoops before being sold. The question was: what evidence would be required to show that a supplement was sold prior to 1994?

FDA says such a list won’t necessarily be final, and won’t be the only supplements allowed to be sold. But we could easily conceive of that being the outcome if left to the agency. We are also concerned that FDA wants to set the evidentiary bar so high that many supplements which were definitely sold prior to 1994 still won’t pass.

According to FDA, any of the following is sufficient to prove that a supplement was marketed before DSHEA was passed: an invoice, a bill of lading, a product label, or a catalog, provided it clearly indicates a date. But many companies don’t have this kind of documentation from eighteen years ago! For example, pyridoxamine (a B6 vitamin) was marketed before DSHEA, but no one in the industry has been able to provide the documentation required by FDA. Even signed affidavits from industry members have been inadequate in FDA’s eyes.

What if a dietary ingredient is, and has always been, in our food? Doesn’t that mean it was “marketed” before 1994? Not to the FDA. The supplement must have been separated out of the food, and sold for its own properties. Human beings have consumed the antioxidant resveratrol for millennia because it’s found naturally in the skin of grapes. But no one in the industry has yet been able to prove that resveratrol was marketed as a separate ingredient or was found on the label of a food or supplement before 1994.

The problem is a little different with P5P. P5P is the only form of vitamin B6 that the body can use directly. It’s produced naturally in the body: all other forms of B6, whether in food or in supplement form, must be converted to P5P first; without it we die. Most of us don’t get enough B6 in our diet, and some people lack the enzymes needed to convert pyridoxine into P5P.

There shouldn’t be any problem grandfathering P5P since there is no question that B6 was sold prior to 1994. But the FDA says no. If the form of B6 sold earlier was not P5P, if the label didn’t say P5P, they won’t grandfather it.

As we have previously reported, a drug company, Medicure Pharma, wants sole use of P5P and has petitioned the FDA to ban its use as a supplement entirely. Although Medicure has yet to market a drug made from P5P, it has already petitioned FDA to have the supplement banned now.

This idea of taking what we cannot live without and turning it into a controlled prescription drug is shocking. But this could only be the beginning. We are concerned this new “approved” list of supplements will be used by drug companies to knock out competition from other supplements effortlessly.

For a supplement to get on the grandfathered list, the FDA says it cannot be “chemically altered”—and the definition of that term was another bone of contention at the meeting. Many grandfathered ingredients, because they now go through different (and often safer) manufacturing processes than they did before 1994, could therefore be considered “chemically altered” by the FDA. So either supplement producers would have to revert to pre-DSHEA manufacturing processes, or else they would no longer be on the grandfathered list! Consumers would get the short end of the stick either way, but the FDA doesn’t care.

As we pointed out when the first draft of the guidance was issued, FDA’s stance is so extreme that a ripe apple would be considered “chemically altered” when compared to an unripe apple! Logic would suggest that the production process should not matter if the end ingredient is basically the same.

In all of this, FDA seems to be targeting new, improved, or technologically advanced supplements, presumably because they see them as potential competitors to drugs. If they keep cutting-edge supplements off the market, drug companies can also make big money by selling the older version of the supplement, as Pfizer does with its Centrum multivitamin that we discussed last week.

Here’s another example of why this question of a grandfathered list is so important. Vitamin E is a powerful antioxidant that prevents cell structure damage, boosts the immune system, reduces cholesterol, lowers the risk of developing cancer, thins the blood, helps skin repair itself, and even strengthens your hair. And everyone “knows” that vitamin E was sold prior to 1994. It currently appears on a trade association’s list of grandfathered dietary ingredients. However, this has not yet been vetted or approved by the FDA. If the proper documentation can’t be found, either vitamin E would be off the grandfathered list, or else some forms of E might be listed and others might not. This is important because different forms of the vitamin work very differently. Vitamin E in the form of mixed tocopherols may prevent breast cancer, among other benefits, whereas the common alpha-tocopherol form may not. Some researchers and integrative doctors actually warn against taking alpha-tocopherol alone because it may interfere with the body’s use of the other forms of vitamin E.

Unfortunately, this information has been buried by the media. All of the research on vitamin E that the media has been reporting—and badmouthing—has used alpha-tocopherols instead of mixed tocopherols, as Dr. Jonathan Wright points out in the current issue of his Nutrition and Healing newsletter.

We are pleased that the FDA is including stakeholders at the NDI guidance redraft meetings. We are pleased that consumers were included by inviting us. But there are reasons to be very watchful. We don’t want a grandfathered list that will not only exclude many supplements actually sold before 1994, but will also make it easier to reject all newer supplements. With vigilance and your help, we won’t let that happen.

http://www.anh-usa.org/fda-grandfathered-ingredients-rule-and-vitamin-e/

Monday
Oct292012

Chemistry Council trying to lobby Washington to cut off funding for research on carcinogens

Every two years, the National Toxicology Program (NTP), which operates under the banner of the Department of Health and Human Services (HHS), releases a congressionally-mandated report entitled the "Report on Carcinogens" (RoC) that identifies various agents, substances, mixtures, or exposures that are known to cause cancer. But the American Chemical Society (ACS), which represents many of the biggest names in the cancer-causing chemical industry, is currently trying to lobby Congress to stop the publishing of this important document.

Because the latest RoC lists formaldehyde, a chemical commonly used in both consumer and industrial products, as a definitive cause of cancer, and styrene, another common household chemical, as a suspected carcinogen, the chemical industry is up in arms about its potential profit losses. So in the spirit of Big Tobacco's approach to dealing with inconvenient science, the chemical industry is now desperately trying to muddle the scientific process by paying off Congress to not only withhold the truth about these and other deadly chemicals, but also to prevent the public from accessing this information by blocking funding for future publishings of the RoC.

"The way the free market is supposed to work is that you have information," Lynn Goldman, Dean of the School of Public Health at George Washington University (GWU), is quoted as saying by the New York Times (NYT) about the importance of the RoC report. "They're (thechemical companies) trying to squelch that information."

Similar stall tactics were used by the chemical industry back in the 1930s when the safety of asbestos was first called into question. Just like today, industry lobbyists at that time denied all the emerging science about the serious dangers of asbestos, insisting that it was all "ill-informed and exaggerated" bunk, according to the NYT. The chemical was eventually exposed and banned in the 1980s, of course, but by this point, millions of people had already been needlessly exposed to asbestos, with roughly 10,000 of them now die every year as a result of asbestos-related disease.

"The industrial chemical formaldehyde and a botanical known as aristolochic acids are listed as known human carcinogens," says a National Institutes of Health (NIH) announcement about the eight new substances added to the 2011 RoC, which the chemical industry is trying to keep under wraps. "Six other substances -- captafol, cobalt-tungsten carbide (in powder or hard metal form), certain inhalable glass wool fibers, o-nitrotoluene, riddelliine, and styrene -- are added as substances that are reasonably anticipated to be human carcinogens." (http://www.niehs.nih.gov/news/newsroom/releases/2011/june10/)

You can read the full 2011 RoC here:
http://ntp.niehs.nih.gov/?objectid=03C9AF75-E1BF-FF40-DBA9EC0928DF8B15

 

 

 

 

Monday
Oct292012

Another Study Finds GMO Compounds in 100% of Pregnant Women and Fetuses

In many ways we are searching for real science, not funded by the GMO companies themselves, to tell us the truth about genetically modified organisms and their dangers. Because these companies control access to their chemicals and any related research, what we have is little. But from the little we know, there is much to fear concerning genetically modified organisms.

Most recently, scientists in Canada conducted a study on pregnant and non-pregnant women, looking for the chemicals found in pesticides related to genetically modified foods. What they found was frightening indeed.

100% of Women Had At Least 1 of These Toxins

According to GreenMedInfo.com, the scientists were looking for 5 basic toxins. Those include: 

  • Glyphosate (Monsanto’s Roundup herbicide)
  • Gluphosinate (an herbicide)
  • AMPA (a metabolite of glyphosate)
  • 3-MMPA (a metabolite of gluphosinate)
  • Cry1Ab (the Bt toxin of gluphosinate)

All women had at least one of the toxins present in their blood, but there were differences between the pregnant and non-pregnant women. A large percentage of non-pregnant study subjects had both glyphosate and gluphosinate in their blood, while the pregnant women did not. However, 100% of pregnant women studied had 3-MPPA in their blood and 93% had Cry1Ab. Even more troubling—100% of fetal cords studied had 3-MPPA and 80% had Cry1Ab.

So, not only do all women likely have some of these GMO toxins in them, but they are passing it on to their children. This is similar to the research conducted by a German university finding glyphosate in all urine samples tested.

What does this all mean and what are the immediate dangers? That’s where more research is needed, though research is tightly controlled by the companies with the patents. We know that 3-MPPA is a propionic acid. According to GMI’s report, this means it is classified as a Bad Actor Chemical and has warnings of cramping, burning, nausea, shock, vomiting, and sore throat if ingested. As for Cry1Ab, Greenpeace reports that it is an immunogen, meaning it creates an immune system response and could possibly increase the existing problem of antibiotic resistant infections.

All five of these compounds that the researchers looked for in their study subjects are classified as Generally Recognized As Safe (GRAS). Yes, these chemicals that carry serious warnings when offered under other circumstances– the same ones that kill pests– our government assures us, are safe.

What can you do? Whenever possible, steer clear of products containing GMO ingredients. Also, support California’s Proposition 37, which will require the labeling of such ingredients and could pave the way for other states and even the nation to follow suit. Additionally, DE-support Monsanto, a company shelling out millions to go against Prop 37 and spreading lies about GMO labeling.

http://www.activistpost.com/2012/10/another-study-finds-gmo-compounds-in.html

Wednesday
Oct242012

FDA Censors Academic Freedom at UC Davis Regarding Raw Milk Benefits?

Okay class, pay attention.

Today’s subject of discussion: academic freedom.

Enough with the groans, everyone. I know it’s not the sexiest topic when it comes to food issues, but you may change your attitude when you hear the story I’m about to tell you.

Two weeks ago, I wrote a post about what I thought was a well balanced scientific assessment, by a prominent
international science writer, of several large-scale research studies out of Europe about the potential health benefits of raw milk (with the unsexy title, “The evidence around raw milk”). It was published in SPLASH, the newsletter of the International Milk Genomics Consortium (IMGC), which is housed at the University of California, Davis.

The IMGC has been doing research for years on the benefits of mother’s milk, and obtains financial support from the California Dairy Research Foundation (CDRF), a nonprofit arm of the state’s conventional milk industry.

The IMGC has begun extending its research in recent years to cow’s milk. Potentially dangerous territory, as we all know, since those who regulate milk in the U.S. think everything that needs to be known about milk is  known, as in pasteurized milk is wonderful and unpasteurized milk is deadly dangerous.

But the newsletter article from the IMGC didn’t reinforce that view. Yes, it summarized statistics from the U.S. Centers for Disease Control about the dangers of raw milk (“The CDC estimates the risk of a glass of raw milk causing a disease outbreak is at least 150 times that of a glass of pasteurized milk,” it said at the very outset.)

But after summarizing the CDC data, it explained potentially positive implications of major research studies out of Europe on raw milk. “The data suggest that raw milk can cause both trouble and advantage to a human body…To be sure, heating milk to 72°C for 15 seconds reduces the odds of a bad belly, but does it also destroy complex proteins and other components that could bolster human health? Apparently so.”

Then, it poured gasoline on the flame it had ignited, by saying that  “there is strong evidence that (raw milk) benefits young children…” And, turning a roaring fire into an inferno, it added that “the world needs studies testing whether large numbers of grown-ups suffering from asthma, hay fever, and similar medical problems see their allergies dampen down after drinking raw milk for a prolonged period.”

In retrospect, such statements were akin to standing on street corners in 1491 and shouting out that the world was round. My post went up Oct. 2, presumably a day or two after the October issue of SPLASH went up, with three articles. By last Friday, only two of the articles were still available to all visitors.  “The evidence around raw milk” had disappeared.

The one- paragraph intro to the third article, “The evidence around raw milk”, was there as well, but when you click to read more, you are taken to a page asking for your log-in info. So I registered, figuring I could access the article that way. When I received a link to get a password, and got onto the site and tried to call up the article in question, it said “Insufficient Privileges.” The article had been pulled. And off to the left column of the page, where it showed who had been on the page before I got there, the most recent name was that of John F. Sheehan, the U.S. Food and Drug Administration’s Director of Plant and Dairy Food Safety. (Damn, the evidence the Internet sometimes leaves behind!)

So what exactly  happened to the raw milk article? The word I have on pretty good sources (I don’t  want  to identify them because this stuff is so sensitive that jobs and  careers could be placed  at risk) is that someone from the FDA (Sheehan?) contacted the CDRF and demanded that the SPLASH raw milk article be removed. I’ll make an educated guess that the FDA was upset because the SPLASH article asserted that the European research indicates pasteurization may “destroy complex proteins and other components that could bolster human health.”

I make that guess because Sheehan testified on just this subject before the Maine legislature in 2011, in connection with a (successful) effort by the FDA to block legislation that would have made it easier for small dairies to sell raw milk directly to customers.

He argued in his testimony that the European research on the role of proteins in conferring health benefits, and  their sensitivity to pasteurization couldn’t have been correct. “Pasteurization does not destroy milk proteins,” he claimed. “Caseins, the major family of milk proteins, are largely unaffected by pasteurization. Any changes which might occur with whey proteins are barely perceptible.”

Back to our lesson on academic freedom. The FDA obviously has a different view of “truth” than the European researchers. And certainly, the issue hasn’t been resolved. It requires further research and analysis. That is what academic freedom is all about–analyzing, researching, debating, discussing.

The view underlying academic freedom is that no one holds a monopoly on truth. It explains why professors get tenure–so they will feel free to express their views on scientific (or other research) despite the political pressures of the day. Censoring scientific papers is a big no-no within the tradition of academic freedom.

I have no way of knowing whether anyone  at UC Davis or CDRF protested to  the FDA that pulling the raw milk article was  a serious infringement  on academic freedom. But I  can guess at  what  the FDA  reaction would  have been–something like if you were to tell an underworld enforcer trying  to sell you “protection”  that  such  practices  are  against  the  law. A laugh, and then a question: “Who you gonna complain to?”

But perhaps the FDA should be looking over its shoulder, and asking a different question: How long can it keep  its finger in the dike and preventing the Truth from asserting itself?

http://healthimpactnews.com/2012/fda-censors-academic-freedom-at-uc-davis-regarding-raw-milk-benefits/

Wednesday
Oct172012

Mike Adams - Don't celebrate yet, but a grassroots victory against GMO deception is now inevitable  

The battle against genetically modified organisms being secretly engineered into our foods now has only one possible outcome: Victory for the People... and defeat of the corporate quack scientists and the outrageously dishonest and sinister biotech industry that has shoved GMO down our throats for a decade or more.

In terms of victory, I'm not just talking about Proposition 37, although that could very well be a turning point that accelerates the consumer victory. But even if Proposition 37 doesn't pass, the end of the line for hidden GMOs in our food is fast approaching. The word is out. People are getting informed. There's absolutely no going back to the era of "GMO ignorance," and the truth about GMOs causing cancer, infertility, organ damage and other deadly health problems is circulating everywhere.

Read More:

http://www.naturalnews.com/037562_GMO_grassroots_victory_food_labeling.html

 

Monday
Oct152012

Fighting for Prop 37: The Truth that $36 Million Can’t Hide

The people's movement for our right to know what's in our food has hit a critical fork in the road: the moment when it's time to ask ourselves and each other -- how hard are we willing to fight for our basic right to know what's in the food we're eating and feeding our families?

Proposition 37 is the  litmus test for whether there is actually a food movement in this country, writes Michael Pollan in an article to appear in Sunday's New York Times Magazine. It may also be the litmus test for whether there is democracy left in this country.

After months of sky-high support in the polls, just 10 days of relentless pounding propaganda by the pesticide industry has made a significant dent in support for Proposition 37 and our right to know if our food is genetically engineered.

So worried are the pesticide companies about California consumers having labels on genetically engineered foods that they are spending one million dollars a day flooding the airwaves with a tidal wave of deception about Prop 37.

As proof of the dishonest tactics in play, in just the past week, the anti-consumer No on 37 campaign has been accused of misleading voters by Stanford University (twice), the Academy of Nutrition and Dietetics and by three major newspapers.

Yet most voters are seeing only one face and hearing only one voice in the debate about Prop 37 - that of notorious pesticide-industry front man Henry Miller. Who is Henry Miller? And can easily discredited pesticide-industry lies really win an election? 

Easily Discredited Pesticide-Industry Lies

Hour after hour in every media market across the state, Henry Miller appears on TV to explain his views about Proposition 37. The ad campaign was exposed as dishonest at the outset, when Stanford University forced the anti-Prop 37 campaign to yank the ad because it falsely identified Miller as a doctor at Stanford (he is actually a researcher at the Hoover Institution), and used images of Stanford's vaulted buildings to push a political position in violation of university policy.

The edited ad was soon back on the air -- one viewer in San Francisco reported seeing it 12 times in one day -- pounding voters with Henry Miller's message that Prop 37 "makes no sense." But a lot of things that make sense to the rest of us don't make sense to Henry Miller: for example, that DDT was banned for a reason, or that exposure to radioactive elements after a nuclear power plant meltdown is not a health benefit. (Read all about the extreme views of the No on 37 science spokesperson here.)

Henry Miller is the perfect poster guy for the lack of credibility of the pesticide giants' campaign against our right to know what's in our food.  Who are they going to trot out next, the president of the Flat Earth Society?

The only honest thing about the No on 37 ads is the disclaimer that tells us who's funding this campaign of deception -- Monsanto and Dupont, the same companies that told us DDT and Agent Orange were safe.

Setting the Record Straight

Yet incredibly, it's working. Henry Miller's hypocritical script in a misleading ad campaign that was discredited as soon as it began has taken a bit hit out of the support for Prop 37.

In the ad, Miller claims the exemptions included in Prop 37 are "illogical" and included "for special interests." As if the companies for which he is working - the biggest special interests of all - would be in favor of Prop 37 if it were even stronger.

They would not. For the record, the exemptions are common sense. They follow the trajectory of labeling bills in the Europe Union and all around the world. Prop 37 will cover the vast majority of genetically engineered foods that consumers are eating - the food on supermarket shelves.

Meat, milk and eggs would be labeled if they came from genetically engineered animals. There are no genetically engineered animals in the human food supply right now, but if there were, they would have to be labeled. Which will come in handy since the first GE animal is on its way to our dinner plates - a salmon genetically engineered with an eel to grow twice as fast. Wouldn't you want to know if you were eating such a thing?

Because Prop 37 is designed to be simple and business friendly, it does not require labeling for cows that eat genetically engineered feed. It would not be a simple matter to track what cows eat. More to the point, that exemption is common around the world. It didn't make sense for California to try to leapfrog over the rest of the world with our labeling law, when we have been trying to catch up with the rest of the world for 15 years.

Yes pet food would have to be labeled if it contains genetically engineered crops like corn or soy. That's because the standard definition of food under the Sherman Act considers pet food to be food - so argue that one with the legislature.

As for other story lines the opposition is shopping -- there will be no increased costs to consumers with Prop 37. Doesn't it seem strange that these companies would spend tens of millions of dollars to convince us that adding a little ink to their labels will force them to raise the cost of groceries? And as for "shakedown lawsuits," that makes no sense when you consider the fact that there are no incentives for lawyers to sue under Prop 37.

The only shakedown lawsuits related to this issue are the thousands of farmers Monsanto is suing for planting their own seeds to grow food. In case you missed it, consider this chilling sentence from last week's Washington Post: Monsanto "has filed lawsuits around the country to enforce its policy against saving the seeds for the future." Policy against the future? Sounds about right.

Pet Food for Thought

While Californians are mired in debate about pet food versus steak, the real question facing voters is this:  Are we going to allow out-of-state pesticide and junk food corporations tell us what we can and can't know about what's in the food we eat?

"What makes you think you have the right to know?" asks Danny DeVito in a a parody video supporting Prop 37. "Knowing if you're buying or eating genetically engineered food is not your right."

"Maybe move to Europe or Japan if you want that right," says Kaitlin Olson. "Or China," adds Dave Matthews, because, "Here in American you don't get the right to know if you're eating genetically modified organisms."

Unless, unless: We demand that GMOs get labeled. Unless we vote yes on Prop 37. Unless we influence every single California voter we can to do the same.

The Yes on 37 campaign is a true people's movement for our right to know what's in our food. We will not be stopped. When California voters go to the polls this November, they will value their right to know what's in their food, rather than leaving it up to the pesticide industry and Henry Miller to make those choices for us. But in order to win this, every single one of us has to fight like hell to make it happen.

read more.. http://www.nationofchange.org/fighting-prop-37-truth-36-million-can-t-hide-1350097249

Monday
Oct082012

Sayer Ji -- Mammograms Linked To An Epidemic of Misdiagnosed Cancers

For most of the twentieth century, mastectomy was the first line treatment for Ductal Carcinoma In Situ(DCIS), and younger patients were more likely to undergo the procedure. Even after lumpectomy andradiotherapy were shown to be at least as effective for invasive cancer as mastectomy, still in 2002, 26% of DCIS patients were still receiving mastectomy.1

The most common scenario today following diagnosis of DCIS is for the oncologist to recommend lumpectomy, followed by radiation and hormone suppressive therapies such as Arimidex and Tamoxifen. The problem here is that women are not being educated about the nature of DCIS or the concept of "non-progressive" breast cancers. There is still the black and white perception out there that you either have cancer, or do not have cancer.

In a poll on DCIS awareness published in 2000, 94% of women studied doubted even the possibility of non-progressive breast cancers.2  In other words, these women had no understanding of the nature of DCIS. And why would they? Major authorities frame DCIS as "pre-cancerous," implying its inevitable transformation into cancer. When the standard of care for DCIS is to suggest the same types of treatment used to treat invasive cancer, very few women are provided with the information needed to make an informed decision.

Early detection through x-ray mammography has been the clarion call of Breast Cancer Awareness campaigns for a quarter of a century now.  However, very little progress has been made in making the public aware about the crucial differences between non-malignant lesions/tumors and invasive or non-invasive cancers detected through this technology. When all forms of breast pathology are looked at in the aggregate, irrespective of their relative risk for harm, disease of the breast takes on the appearance of a monolithic entity that you either have, or don't have; they call it breast cancer.

The concept of a breast cancer that has no symptoms, which can not be diagnosed through manual palpation of the breast and does not become invasive in the vast majority of cases, might sound unbelievable to most women. However, there does exist a rather mysterious clinical anomaly known as Ductal Carcinoma In Situ (DCIS), which is, in fact, one of the most commonly diagnosed and unnecessarily treated forms of "breast cancer" today.

What women fail to understand—because their physicians do not know better or have not taken care to explain to them—is that they have a choice when diagnosed with DCIS. Rather than succumb to aggressive treatment with surgery, radiation and chemo-drugs, women can choose watchful waiting. Better yet, a radical lifestyle change can be focused on eliminating exposure to chemicals and radiation, as well as improved exercise and nutrition. This choice is not being made in most cases because the medical community is not informing their patients that there is such.  

Is X-Ray Mammography Finding Cancer or Benign Lesions?

Ductal Carcinoma In Situ (DCIS): Cancer or Benign Lesion?

Between 30-50% of new breast cancer diagnoses obtained through x-ray mammography screenings are classified as Ductal Carcinoma In Situ (DCIS).3  DCIS refers to the abnormal growth of cells within the milk ducts of the breast forming a calcified lesion commonly between 1-1.5 cm in diameter, and is considered non-invasive or "stage zero breast cancer," with some experts arguing for its complete re-classification as a non-cancerous condition.

Because DCIS is almost invariably asymptomatic and has no palpable lesions, it would not be known as a clinically relevant entity were it not for the use of x-ray diagnostic technology. Indeed, it was not until the development and widespread application of mammography in the early 1980s as the central push behind National Breast Cancer Awareness campaigns that rates of DCIS diagnosis began to expand to their present day epidemic proportions.4,5 It is no wonder, therefore, that the United States, which has one of the highest x-ray mammography rates, also has the highest level of DCIS in the world. As of January 2005, an estimated one-half million U.S. women were living with a diagnosis of DCIS.6

Proponents of breast screenings claim they are saving lives through the early detection and treatment of DCIS, regarding it as a potentially life-threatening condition, indistinct from invasive cancers. They view DCIS a priori as  "pre-cancerous" and argue that, because it could cause harm if left untreated it should be treated in the same aggressive manner as invasive cancer. The problem with this approach is that while the rate at which DCIS progresses to invasive cancer is still largely unknown, the weight of evidence indicates that it is significantly less than 50%—perhaps as low as 2-4%. 

Indeed, the 10-year survival rates of patients with DCIS (96%-98%) post-treatment speaks volumes to the relatively benign nature of the condition.7,8  Another study found that at the 40-year follow-up period 40% of DCIS lesions still had no signs of invasiveness.9  Adding even more uncertainty, another study showed that coexisting DCIS independently predicts lower tumor aggressiveness in node-positive luminal breast cancer, indicating its possibly protective role. 10

Watchful Waiting (Around Doing Nothing of Use)

A solid argument can be made that watchful waiting is the most appropriate response to the diagnosis of DCIS, and that in many cases DCIS would be better left over-diagnosed and under-treated. As one paper discusses:

"The central harm of screening is over-diagnosis—the detection of abnormalities that meet the pathologic definition of cancer but will never progress to cause symptoms." 11

A solid body of evidence has emerged suggesting that when DCIS is left undiagnosed and untreated rarely will it become malignant. DCIS was in fact poorly named from the outset, as it is does not behave like most carcinomas (cancers).  Cancer, like the constellation named after it, derives from the Greek word for Crab, indicating the manner in which is expands outward in uncontrolled growth. In situ means exactly the opposite, "in place." An unmoving cancer is therefore a contradiction in terms. These problems with classification have not gone unnoticed in the medical journals: 

"Despite the presence of the word carcinoma, ductal carcinoma in situ (DCIS) is the poster child for this problem (a senior pathologist involved in developing classification systems confided to one of us that he regretted the use of the term carcinoma in DCIS). No one believes that DCIS always progresses to invasive cancer, and no one believes it never does. Although no one is sure what the probability of progression is, studies of DCIS that were missed at biopsy (1,2) and the autopsy reservoir (3) suggest that the lifetime risk of progression must be considerably less than 50%." 12

The true irony here is that while participation in x-ray mammography is considered by the public a form of breast cancer prevention and "watchful waiting," it has become—whether by design or accident—a very effective way of manufacturing breast cancer diagnoses and justifying unnecessary treatment. This is not unlike what has been seen with prostate cancer screenings that track Prostate Specific Antigen (PSA); the aggressive treatment of lesions/tumors identified through PSA markers may actually increase patient mortality relative to doing nothing at all. 

Women diagnosed with DCIS are simply not given the option to decline treatment. The problem is illustrated below:

"Because the 'best guess' is that most DCIS won't progress to invasive cancer, the risk of over-diagnosis would be expected to be greater than 50%. The problem with over-diagnosis is that it leads to overtreatment. Because it is impossible to determine which individuals are over-diagnosed, almost everyone gets treated as if they had invasive cancer." 13  

Over-diagnosis is a huge problem, discussed in greater depth here:

"Over-diagnosis plays havoc with our understanding of cancer statistics. Because over-diagnosis effectively changes a healthy person into a diseased one, it causes overestimations of the sensitivity, specificity, and positive predictive value of screening tests and the incidence of disease (13). As the MLP and a recent analysis of Surveillance, Epidemiology, and End Results (SEER)1 data illustrate (14), over-diagnosis also markedly increases the length of survival, regardless of whether screening or associated treatments are actually effective. However, over-diagnosis does not reduce disease-specific mortality because treating subjects with pseudo-disease does not help those who have real disease. Consequently, disease-specific mortality is the most valid end point for the evaluation of screening effectiveness." 14  

Ultimately DCIS over-diagnoses contribute to the appearance that conventional breast cancer screenings and treatments are more successful and less harmful than they actually are, while at the same time making the industry far more profitable than otherwise would be the case.  ∆

Sayer Ji is the founder of GreenMedInfo.com, the world's largest, open source and evidence-based natural medicine and toxicology database, with close to 20,000 indexed across 2500 Diseases and 1500 Substances. He can be reached at Sayerji@greenmedinfo.com

References

1, 10 Overdiagnosis and overtreatment of breast cancer: Rates of ductal carcinoma in situ: a US perspective. Breast Cancer Res. 2005 Nov. 11. PMID: 1657703

2 US women's attitudes to false positive mammography results and detection of ductal carcinoma in situ: cross sectional survey. BMJ 320 : 1635 doi: 10.1136/bmj.320.7250.1635 (Published 17 June 2000)

3.  The management of ductal carcinoma in situ of the breast. Endocrine-Related Cancer. 2011 8 33-45.

4,6 NIH State-of-the-Science Conference. Diagnosis and Management of Ductal Carcinoma in Situ (DCIS), Sept. 2009 Source: http://consensus.nih.gov/2009/dcisstatement.htm

5 The Dark Side of Breast Cancer Awareness Month  GreenMedInfo.com. 2011 Oct 1.

7 Ductal carcinoma in situ (DCIS): are we overdetecting it? http://breast-cancer-research.com/content/6/S1/P23

Mortality among women with ductal carcinoma in situ of the breast in the population-based surveillance, epidemiology and end results program. Arch Intern Med. 2000 Apr 10;160(7):953-8. PMID: 1761960

Coexisting ductal carcinoma in situ independently predicts lower tumor aggressiveness in node-positive luminal breast cancer.  Med Oncol. 2011 Oct 8. Epub 2011 Oct 8. PMID: 21983862

11, 12, 13  The Sea of Uncertainty Surrounding Ductal Carcinoma In Situ – The Price of Screening Mammmography. Journal of The National Cancer Institute  2008 Feb. 12. PMID: 18270336

14  Overdiagnosis: An Underrecognized Cause of Confusion and Harm in Cancer Screening. Journal of The National Cancer Institute  2000 PMID: 10944539

Read more.. http://www.greenmedinfo.com/blog/mammograms-linked-epidemic-misdiagnosed-cancers

Wednesday
Sep192012

William Malaurie -- Yes, GMOs are poisonous!

*French researchers studied privately for two years, 200 rats fed GM corn. Tumors, serious diseases ... a massacre. And a bomb [for the] GMO industry. 

This is a real bomb that launches this September 19 to 15 hours, the very serious American journal "Food and Chemical Toxicology" - a benchmark for food toxicology - publishing the results of the experiment conducted by [the] team [of] French Gilles-Eric Seralini, professor of molecular biology at the University of Caen. A cluster bomb [for] scientific, medical, and industrial policy. It sprays indeed an official truth: the safety of genetically modified maize. 

Heavily toxic and often fatal

Even at low doses, the GM study proves heavily toxic and often lethal to rats. So much so that, if it were a drug, it should be suspended forthwith pending further investigations. Because it is the same GMO found on our plates through the meat, eggs or milk.

In 2006, this is a true thriller that begins this research, the project manager, Gilles-Eric Seralini discloses itself conclusions in a book to be published next week ("All guinea pigs", Flammarion, in bookstores September 26).
Codenamed Vivo

Until 2011, the researchers worked under conditions of quasi-underground. They have their encrypted emails and the Pentagon, have banned all phone conversation and even launched a study decoy as they feared a coup de Jarnac multinational seed.

The story of the operation - codenamed Vivo - [involves] the difficult recovery of GM maize seeds NK 603, owned [and] patented [by] Monsanto, through an agricultural college in Canada. Then harvested and the repatriation of "big jute bags" [via]the port of Le Havre in late 2007, before making croquettes in total secrecy and the selection of two hundred lab rats called "Sprague Dawley". [The result?] Chilling: "After less than a year of genetically modified maize menus differentiated says Professor Séralini, it was a slaughter among our rats, [of] which I had not imagined the magnitude." 

Serious diseases, mammary tumors

All groups of rats, whether fed with GM maize treated or untreated with Roundup herbicide, Monsanto, or fed with water containing low doses of herbicide found in GM fields are hit by a multitude of serious diseases in the 13th month of the experiment. In females, this is manifested by explosions chain mammary tumors that reach up to 25% of their weight. Males, are purifiers organs, liver and kidneys, which are marked with abnormalities or severe. With a frequency of two to five times greater than for rodents fed non-GM corn.

Comparison implacable rats GMO therefore trigger two to three times more tumors than non-GMO rats whatever their sex. At the beginning of the 24th month, that is to say at the end of their lives, 50% and 80% of females are affected GMOs against only 30% among non-GMO.

Above all, tumors occur much faster in rats GM: twenty months earlier in males, three months earlier in females. For an animal that has two years of life expectancy, the difference is considerable. For comparison, one year for a rodent is roughly the equivalent of forty years for a man ... 

Demand accountability

It is these strong conclusions Corinne Lepage , in a book that seems to Friday, September 21 ("The truth about GMOs, is our business", Editions Charles Léopold Mayer), intends to demand accountability from political and experts, French and European health agencies and the Brussels Commission, which have so long opposed by all means and the principle of a long-term study on the physiological impact of GMOs.

This battle, the former Minister of Ecology and First Vice-President of the Committee on Environment, Public Health and Food Safety in Strasbourg, the leading fifteen years in the Criigen (Committee for Independent Research and Information on genetic engineering) with Joel Spiroux and Gilles-Eric Seralini. A simple association 1901 which has yet been able to meet end to end funding of this research (3.2 million euros) that neither INRA, CNRS neither, nor any public agency had judged advisable to undertake.
A study funded by Auchan and Carrefour

How? Another surprise by asking the Swiss Foundation Charles Léopold Mayer. But the owners of the supermarkets (Carrefour, Auchan ..), who gathered for the occasion together. Since the mad cow disease, in fact they want to protect themselves from any new food scandal. So much so that it is Gérard Mulliez, founder of the Auchan Group, which provided the initial funding. 

The study by Professor Séralini portend a new murderous war between pro and anti-GMO. Health agencies they require urgently similar studies to verify the findings of French scientists? It would be the least. Monsanto, the largest seed firm global transgenic leave she do? Unlikely: its survival would be at stake for a single plant GMOs, there are hundreds of varieties. Implying at least a dozen studies from 100 to 150 million euros each!
The time of truth

Except that in this new confrontation, the debate can no longer be bogged down by the past. September 26 dice, everyone can see the film in the cinema shock Jean-Paul Jaud, "All guinea pigs?", Adapted from the book by Gilles-Eric Seralini, and the terrible images of rats stuffy in their tumors. Images that will go around the world and the Internet, as it will be broadcast on Canal + (the "Grand Journal" September 19) and France 5 (October 16 in a documentary). For GM, the era of doubt ends. The time of truth begins.

Read more.. http://bit.ly/UngEH0

Tuesday
Sep112012

Jennifer Browdy de Hernandez -- We Eat by the Grace of Nature, Not by the Grace of Monsanto

“Organic, schmorganic,” fumes New York Times columnist Roger Cohen sarcastically in an article entitled “The Organic Fable.”

He bases his sweeping dismissal of the organic foods movement on a new Stanford University study claiming that “fruits and vegetables labeled organic are, on average, no more nutritious than their cheaper conventional counterparts.”

Cohen does grant that “organic farming is probably better for the environment because less soil, flora and fauna are contaminated by chemicals…. So this is food that is better ecologically even if it is not better nutritionally.”

But he goes on to smear the organic movement as an elitist, pseudoscientific indulgence shot through with hype.

“To feed a planet of 9 billion people,” he says, “we are going to need high yields not low yields; we are going to need genetically modified crops; we are going to need pesticides and fertilizers and other elements of the industrialized food processes that have led mankind to be better fed and live longer than at any time in history.

“I’d rather be against nature and have more people better fed. I’d rather be serious about the world’s needs. And I trust the monitoring agencies that ensure pesticides are used at safe levels — a trust the Stanford study found to be justified.”

Cohen ends by calling the organic movement “a fable of the pampered parts of the planet — romantic and comforting.”

But the truth is that his own, science-driven Industrial Agriculture mythology is far more delusional.

Let me count the ways that his take on the organic foods movement is off the mark:

Organic food may not be more “nutritious,” but it is healthier because it is not saturated with pesticides, herbicides, fungicides and preservatives, not to mention antibiotics, growth hormones and who knows what other chemicals.

There are obvious “health advantages” in this, since we know—though Cohen doesn’t mention—that synthetic chemicals and poor health, from asthma to cancer, go hand in hand.

Read more.. http://www.commondreams.org/view/2012/09/08-3