Bernie Sanders Blocks Obama’s FDA Nominee Over Big Pharma Ties

Zach Cartwright | January 26, 2016
http://usuncut.com/politics/bernie-sanders-blocks-obamas-fda-pick-over-ties-to-big-pharma/ 
Today, Bernie Sanders made it clear to the Obama administration that Dr. Michael Califf would not be in charge of the FDA.
Sen. Sanders announced the hold on Califf’s appointment to head the Food and Drug Administration, citing his close ties to the pharmaceutical industry. According to the Centers for Disease Control, one in five Americans — approximately 35 million people — can’t afford to pay for the prescriptions their doctors write for them. And in 2014, Americans collectively spent a record $374 billion on prescription drugs.
“Dr. Califf’s extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies,” Sanders said in an official statement.
As seen in TIME’s profile of him, Dr. Califf ran a clinical research center at Duke University that received a majority of its funding from America’s largest pharmaceutical companies. Some of the biggest household names in Big Pharma, like Merck, Eli Lilly, and Novartis, paid Dr. Califf for consulting, in addition to four other drug companies and the manufacturer of a medical device.
“At a time when millions of Americans cannot afford to purchase the prescription drugs they require, we need a leader at the FDA who is prepared to stand up to the drug companies,” Sanders said. “We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government.”
Sen. Sanders’ decision to block Dr. Califf’s appointment to the FDA hardly comes as a surprise for those who saw the Vermont senator’s epic takedown of Dr. Califf during his confirmation hearings last November. During Sen. Sanders’ heated exchange with him, Sanders forced Dr. Califf’s hand, pointing out that since he supports the importing of fish products and vegetables from around the world, but not the importing of prescription drugs in Canada. Dr. Califf also refused to take an official position on whether or not he supports allowing Medicare to negotiate the prices of prescription drugs on behalf of seniors.
Watch the full video below:

FDA approves genetically engineered potatoes, apples as safe

By MARY CLARE JALONICK and KEITH RIDLER
Published: Mar 20, 2015

This undated handout photo provided by Okanagan Specialty Fruits shows an Arctic® Granny, left, Arctic® Golden, right, and Arctic® Granny slices. The Food and Drug Administration (FDA) on Friday approved the genetically engineered foods as safe, saying they are as nutritious as their conventional counterparts. The approval covers six varieties of potatoes by Boise, Idaho-based J. R. Simplot Co. and two varieties of apples from the Canadian company Okanagan Specialty Fruits Inc. (AP Photo/Okanagan Specialty Fruits)

BOISE, Idaho (AP) - Potatoes that won't bruise and apples that won't brown are a step closer to grocery store aisles, but some food suppliers say they don't want any part of it and others are staying silent.
The Food and Drug Administration on Friday approved the genetically engineered foods, saying they are "as safe and nutritious as their conventional counterparts."
The approval covers six varieties of potatoes by Boise, Idaho-based J. R. Simplot Co. and two varieties of apples from the Canadian company Okanagan Specialty Fruits Inc.
Genetically modified organisms, or GMOs, refers to food grown from seeds that are genetically engineered in a lab. Aware of potential resistance from consumers, Simplot officials say Innate potato traits come exclusively from genes from domestic potato varieties.
However, one of the company's oldest business partners - McDonald's - said it won't use the potatoes.
"McDonald's USA does not source GMO potatoes nor do we have current plans to change our sourcing practice," the company said in a statement Friday.
Burger King and Wendy's declined to comment.
Okanagan, based in British Columbia, wants to make apples a more convenient snack with its non-browning version. The company says bagged apples wouldn't have to be washed in antioxidants like they are now, a process that can affect taste. Company founder Neal Carter said Okanagan wants to see bagged apples become as prolific as bagged baby carrots.
"We know that in a convenience-driven world, a whole apple is too big of a commitment," Carter said.
The apples are dubbed Arctic Apples, and Carter said he wants them to be labeled as such. The first two varieties will be Granny Smith and Golden Delicious. Carter said there won't be significant plantings until 2017.
Simplot calls its potatoes Innate and the varieties selected include Ranger Russet, Russet Burbank and Atlantic.
"We're trying to improve potatoes so everyone gets a better experience, just like it's right out of the field," said Haven Baker, vice president of plant sciences for Simplot.
But it could be years before the average customer is able to buy one. The company has about 400 acres of Innate potatoes in storage from the 2014 harvest that it plans to deliver to growers, packers and shippers to be sent to a tightly-controlled network for use in small-scale test markets.
The company said those markets haven't been determined, and it's not clear how the potatoes will be labeled. The company said it's not selling Innate seed potatoes on the open market.
ConAgra, a major French fry and potato supplier through Lamb Weston to restaurant chains, said it won't use the potatoes.
"All Lamb Weston frozen potato products are made with non-GMO potatoes, in line with customer demand," a company statement said.
Food supplier McCain in a statement said its policy is to not use GMO potatoes. But the company also said it recognized the challenge of producing affordable food to meet demand and planned to monitor and possibly participate in research.
"Regulatory compliance and consumer acceptance for the use of any new technology will guide our actions," the company said.
Simplot says its potatoes will have 70 percent less acrylamide, a chemical that can be created when potatoes are cooked at high temperatures. And it's touting that as a health benefit, as some studies have shown acrylamide to be a potential carcinogen, though the National Cancer Institute at the National Institutes of Health says scientists "do not yet know with any certainty" whether the substance can be harmful in food.
The FDA in its approval Friday noted that acrylamide has been found to be a carcinogenic in rodents.
Simplot says its potatoes have 40 percent less bruising from impacts and pressure during harvest and storage then conventional potatoes, which the company said could reduce the more than 3 billion pounds of potatoes discarded yearly by consumers.
The FDA's review process is voluntary, but both companies asked for one. To review, FDA compares safety and data of the GMO food in comparison to conventional variety.
Gregory Jaffe, biotechnology director for the Center for Science in the Public Interest, in a statement Friday objected to the voluntary system for approving GMOs and said legislation is needed to make it mandatory.
____
Jalonick reported from Washington. AP Food Industry Writer Candice Choi contributed in New York.

© 2015 The Associated Press. All Rights Reserved
http://m.apnews.com/ap/db_268808/contentdetail.htm?contentguid=604NkKTt 

NYU Professor Uncovers How The FDA Systematically Covers Up Fraud & Misconduct In Drug Trials

Submitted by Tyler Durden on 02/18/2015 18:30 -0500
http://www.zerohedge.com/news/2015-02-18/nyu-professor-uncovers-how-fda-systematically-covers-fraud-misconduct-drug-trials
Submitted by Mike Krieger via Liberty Blitzkrieg blog,

That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.

From the Slate article: Are Your Medications Safe?

In the past week or so, I’ve come across several important articles that will leave any rational observer increasingly skeptical of the entire medial industry in the U.S. This isn’t something I say lightly, and I think it’s an absolutely horrific development for our society.
Just last week, Liberty Blitzkrieg published an article titled, Introducing “Physician Dispensing” – The Latest Troubling Medical Industry Scam, which expounded on why an erosion of trust in doctors is so troubling. If you missed that piece, I suggest going back and reading it. Here’s an excerpt:

Once the corruption reaches a certain level of societal saturation, you create a culture in which people simply stop trusting everyone and everything. For obvious reasons, this is a very dangerous development. There are people whom you need to trust for any civilization to function reasonably well. Police are one, but doctors are another. I can speak for myself when I say that I am not convinced that any medical professional I see has only my best interests at heart. I seriously wonder how he or she is balancing my health with the ability to earn more money. From conversations with friends and family, I have found that this is much more widespread than we would like to admit. This is incredibly bad and incredibly sad.

While that article was bad enough, it is nothing compared to what I just read by Charles Seife, a journalism professor at New York University. He and his students set out to research the FDA and how it deals with evidence of fraud and misconduct in pharmaceutical drug trials. What he found will shock and disturb even the most hardened cynic. If you are one of the 70% of Americans that take at least one prescription drug, brace yourself…
From Slate:

Agents of the Food and Drug Administration know better than anyone else just how bad scientific misbehavior can get. Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wildvideo. It’s a seemingly endless stream of lurid vignettes—each of which catches a medical researcher in an unguarded moment, succumbing to the temptation to do things he knows he really shouldn’t be doing. Faked X-ray reports. Forged retinal scans. Phony lab tests. Secretly amputated limbs. All done in the name of science when researchers thought that nobody was watching.

That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

We didn’t have to search very hard to find FDA burying evidence of research misconduct. Just look at any document related to an FDA inspection. As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted. My students and I looked at FDA documents relating to roughly 600 clinical trials in which one of the researchers running the trial failed an FDA inspection. In only roughly 100 cases were we able to figure out which study, which drug, and which pharmaceutical company were involved. (We cracked a bunch of the redactions by cross-referencing the documents with clinical trials data, checking various other databases, and using carefully crafted Google searches.) For the other 500, the FDA was successfully able to shield the drugmaker (and the study sponsor) from public exposure.

Think about that. Despite all that digging, they were able to link questionable data to specific drugs in only 20% of the cases examined.

It’s not just the public that’s in the dark. It’s researchers, too. And your doctor. As I describe in the current issue of JAMA Internal Medicine, my students and I were able to track down some 78 scientific publications resulting from a tainted study—a clinical trial in which FDA inspectors found significant problems with the conduct of the trial, up to and including fraud. In only three cases did we find any hint in the peer-reviewed literature of problems found by the FDA inspection. The other publications were not retracted, corrected, or highlighted in any way. In other words, the FDA knows about dozens of scientific papers floating about whose data are questionable—and has said nothing, leaving physicians and medical researchers completely unaware. The silence is unbroken even when the FDA itself seems shocked at the degree of fraud and misconduct in a clinical trial.

Such was the case with the so-called RECORD 4 study. RECORD 4 was one of four large clinical trials that involved thousands of patients who were recruited at scores of clinical sites in more than a dozen countries around the world. The trial was used as evidence that a new anti-blood-clotting agent, rivaroxaban, was safe and effective. The FDA inspected or had access to external audits of 16 of the RECORD 4 sites. The trial was a fiasco. At Dr. Craig Loucks’ site in Colorado, the FDA found falsified data. At Dr. Ricardo Esquivel’s site in Mexico, there was “systematic discarding of medical records” that made it impossible to tell whether the study drug was given to the patients. At half of the sites that drew FDA scrutiny—eight out of 16—there was misconduct, fraud, fishy behavior, or other practices so objectionable that the data had to be thrown out. The problems were so bad and so widespread that, contrary to its usual practice, the FDA declared the entire study to be “unreliable.” Yet if you look in the medical journals, the results from RECORD 4 sit quietly in The Lancet without any hint in the literature about falsification, misconduct, or chaos behind the scenes. This means that physicians around the world are basing life-and-death medical decisions on a study that the FDA knows is simply not credible.

It’s not just one study, either. The FDA found major problems with sites involved in the other three clinical trials that were used to demonstrate rivaroxaban’s safety and effectiveness. RECORD 2, for example, was nearly as awful as RECORD 4: Four out of 10 sites that the FDA inspected showed evidence of misconduct, or other issues grave enough to render the site’s data worthless—including clear evidence of data falsification at one site. In aggregate, these problems raise serious doubts about the quality of all four key rivaroxaban studies—and, by extension, doubts about how seriously we should take the claim that rivaroxaban is safe and effective. The FDA is keeping mum, even as wrongful-death lawsuits begin to multiply.

In the decade since the Ketek affair, it’s hard to see any change in behavior by the agency. On occasion, the FDA has even actively approved and promoted statements about drugs that, according to its own inspectors, are based upon falsehoods. At the end of 2011, the FDA learned that an audit of a Chinese site involved in a key clinical trial of a different anti-clotting agent, apixaban, had turned up evidence of fraud: Personnel had apparently been fiddling with patient records. Worse yet, the fraud appeared to invalidate one key finding of the study. Just three months earlier, the researchers running the trial proudly announced in the New England Journal of Medicine that there was a “significant reduction in mortality” among patients who took apixaban compared with those who took the old standby, warfarin. Alas, the moment you exclude the data from the Chinese fraud site, as per standard FDA procedure, that statement went out the window. Yet look at the label for apixaban—the one approved by the FDA after the fraud was discovered—and you read that “treatment resulted in a significantly lower rate of all-cause death … than did treatment with warfarin,” backed up by the data set with the Chinese site included. In other words, the label is carrying a claim that the FDA knows is based upon fraud. In a written response to my questions on this subject, the FDA stated that, “The FDA extended the drug’s review period to address the concerns. However, the review team did conclude concluded [sic] that the data at that site and other sites in China did reflect meaningful clinical information; that was not what was considered unreliable.”

Again, this isn’t an isolated incident. I had previously encountered bogus data on FDA-approved labels when a colleague and I were looking into a massive case of scientific misconduct —a research firm named Cetero had been caught faking data from more than 1,400 drug trials. That suddenly worthless data had been used to establish the safety or effectiveness of roughly 100 drugs, mostly generics, that were being sold in the United States. But even after the agency exposed the problem, we found fraud-tainted data on FDA-approved drug labels. (The FDA still maintains its silence about the Cetero affair. To this day, the agency refuses to release the names of the 100-odd drugs whose approval data were undermined by fraud.)

The most common excuse the agency gives is that exposing the details about scientific wrongdoing—naming the trials that were undermined by research misconduct, or revealing which drugs’ approvals relied upon tainted data—would compromise “confidential commercial information” that would hurt drug companies if revealed. This claim falls apart under scrutiny. The courts have ruled that when information is provided by companies involuntarily, such as the information that an FDA inspector finds, “commercial confidential information” refers to proprietary material that causes substantial, specific harm when it falls into the hands of a competitor. It doesn’t cover embarrassing peccadilloes—or misconduct that might cause bad publicity when word gets out.

As usual, it’s all about protecting corporate profits.

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.

America’s new religion.
*  *  *
For related articles, see:
First is a MUST WATCH hilarious video by John Oliver: Video of the Day – John Oliver on Pharma Company “Marketing to Doctors”
Fraud Alert: FDA Allowed Drugs with Fraudulent Testing to Remain on the Market
The FDA is Caught Spying on its Employees and Creating an “Enemies List”
Introducing “Physician Dispensing” – The Latest Troubling Medical Industry Scam

The Complete History of Monsanto, The World’s Most Evil Corporation

By WakingTimes
June 20, 2014
http://www.wakingtimes.com/2014/06/20/complete-history-monsanto-worlds-evil-corporation/



Of all the mega-corps running amok, Monsanto has consistently outperformed its rivals, earning the crown as “most evil corporation on Earth!” Not content to simply rest upon its throne of death, atop a mountain of rotting corpses, it remains focused on newer, more scientifically innovative ways to harm the planet and its people.

As true champions of evil, they won’t stop until…well, until they’re stopped! But what is Monsanto and how did they get to be so obscenely evil in the first place? I think that’s the best place to start this journey, so grab a few non-GMO snacks or beverages and let’s go for a ride into the deep, murky sewers of their dark past.

1901: The company is founded by John Francis Queeny, a member of the Knights of Malta, a thirty year pharmaceutical veteran married to Olga Mendez Monsanto, for which Monsanto Chemical Works is named. The company’s first product is chemical saccharin, sold to Coca-Cola as an artificial sweetener.

Even then, the government knew saccharin was poisonous and sued to stop its manufacture but lost in court, thus opening the Monsanto Pandora’s Box to begin poisoning the world through the soft drink.



1920s: Monsanto expands into industrial chemicals and drugs, becoming the world’s largest maker of aspirin, acetylsalicyclic acid, (toxic of course). This is also the time when things began to go horribly wrong for the planet in a hurry with the introduction of their polychlorinated biphenyls (PCBs).

“PCBs were considered an industrial wonder chemical, an oil that wouldn’t burn, impervious to degradation and had almost limitless applications. Today PCBs are considered one of the gravest chemical threats on the planet. Widely used as lubricants, hydraulic fluids, cutting oils, waterproof coatings and liquid sealants, are potent carcinogens and have been implicated in reproductive, developmental and immune system disorders. The world’s center of PCB manufacturing was Monsanto’s plant on the outskirts of East St. Louis, Illinois, which has the highest rate of fetal death and immature births in the state.”(1)

Even though PCBs were eventually banned after fifty years for causing such devastation, it is still present in just about all animal and human blood and tissue cells across the globe. Documents introduced in court later showed Monsanto was fully aware of the deadly effects, but criminally hid them from the public to keep the PCB gravy-train going full speed!

1930s: Created its first hybrid seed corn and expands into detergents, soaps, industrial cleaning products, synthetic rubbers and plastics. Oh yes, all toxic of course!

1940s: They begin research on uranium to be used for the Manhattan Project’s first atomic bomb, which would later be dropped on Hiroshima and Nagasaki, killing hundreds of thousands of Japanese, Korean and US Military servicemen and poisoning millions more.

The company continues its unabated killing spree by creating pesticides for agriculture containing deadly dioxin, which poisons the food and water supplies. It was later discovered Monsanto failed to disclose that dioxin was used in a wide range of their products because doing so would force them to acknowledge that it had created an environmental Hell on Earth.

1950s: Closely aligned with The Walt Disney Company, Monsanto creates several attractions at Disney’s Tomorrowland, espousing the glories of chemicals and plastics. Their “House of the Future” is constructed entirely of toxic plastic that is not biodegradable as they had asserted. What, Monsanto lied? I’m shocked!

“After attracting a total of 20 million visitors from 1957 to 1967, Disney finally tore the house down, but discovered it would not go down without a fight. According to Monsanto Magazine, wrecking balls literally bounced off the glass-fiber, reinforced polyester material. Torches, jackhammers, chain saws and shovels did not work. Finally, choker cables were used to squeeze off parts of the house bit by bit to be trucked away.”(2)

Monsanto’s Disneyfied vision of the future:


https://www.youtube.com/watch?v=_-4-RUuuqQw&x-yt-ts=1421782837&x-yt-cl=84359240

1960s: Monsanto, along with chemical partner-in-crime DOW Chemical, produces dioxin-laced Agent Orange for use in the U.S.’s Vietnam invasion. The results? Over 3 million people contaminated, a half-million Vietnamese civilians dead, a half-million Vietnamese babies born with birth defects and thousands of U.S. military veterans suffering or dying from its effects to this day!

https://www.youtube.com/watch?x-yt-ts=1421782837&v=bCqok_UvwY0&x-yt-cl=84359240

Monsanto is hauled into court again and internal memos show they knew the deadly effects of dioxin in Agent Orange when they sold it to the government. Outrageously though, Monsanto is allowed to present their own “research” that concluded dioxin was safe and posed no negative health concerns whatsoever. Satisfied, the bought and paid for courts side with Monsanto and throws the case out. Afterwards, it comes to light that Monsanto lied about the findings and their real research concluded that dioxin kills very effectively.

https://www.youtube.com/watch?v=cW7q4ICXp0s&x-yt-cl=84359240&x-yt-ts=1421782837

A later internal memo released in a 2002 trial admitted “that the evidence proving the persistence of these compounds and their universal presence as residues in the environment is beyond question … the public and legal pressures to eliminate them to prevent global contamination are inevitable. The subject is snowballing. Where do we go from here? The alternatives: go out of business; sell the hell out of them as long as we can and do nothing else; try to stay in business; have alternative products.”(3)

Monsanto partners with I.G. Farben, makers of toxic Bayer aspirin and Hitler’s go-to chemical manufacturer that exterminated millions with it Zyklon-B gas during World War II. Together, the companies use their collective expertise in genocide to introduce aspartame, another extremely deadly neurotoxin, into the food supply. When questions surface regarding the toxicity of saccharin, Monsanto exploits this opportunity to introduce yet another of its deadly poisons onto an unsuspecting public.

1970s: Monsanto partner, G.D. Searle, produces over a hundred faked internal studies which claim aspartame to be safe, while the FDA’s own scientific research clearly reveals that aspartame causes tumors and massive holes in the brains of rats, before killing them. The FDA initiates a grand jury investigation into G.D. Searle for “knowingly misrepresenting findings and concealing material facts and making false statements” in regard to aspartame safety.

During this time, Searle strategically taps prominent Washington insider Donald Rumsfeld, who served as Secretary of Defense during the Gerald Ford and George W. Bush presidencies, to become CEO. The corporation’s primary goal is to have Rumsfeld utilize his political influence and vast experience in the killing business to grease the FDA to play ball with them.

A few months later, Samuel Skinner receives “an offer he can’t refuse,” withdraws from the investigation and resigns his post at the U.S. Attorney’s Office to go work for Searle’s law firm. This mob tactic stalls the case just long enough for the statute of limitation to run out and the grand jury investigation is abruptly and conveniently dropped.

1980s: Amid indisputable research that reveals the toxic effects of aspartame and as then FDA commissioner Dr. Jere Goyan was about to sign a petition into law keeping it off the market, Donald Rumsfeld calls Ronald Reagan for a favor the day after he takes office. Reagan fires the uncooperative Goyan and appoints Dr. Arthur Hayes Hull to head the FDA, who then quickly tips the scales in Searle’s favor and NutraSweet is approved for human consumption in dried products.This becomes sadly ironic since Reagan, a known jelly bean and candy enthusiast, later suffers from Alzheimers during his second term, one of the many horrific effects of aspartame consumption.

Searle’s real goal though was to have aspartame approved as a soft drink sweetener since exhaustive studies revealed that at temperatures exceeding 85 degrees Fahrenheit, it “breaks down into known toxins Diketopiperazines (DKP), methyl (wood) alcohol, and formaldehyde.”(4), becoming many times deadlier than its powdered form!

https://www.youtube.com/watch?v=3r864GIKD6A&x-yt-ts=1421782837&x-yt-cl=84359240

The National Soft Drink Association (NSDA) is initially in an uproar, fearing future lawsuits from consumers permanently injured or killed by drinking the poison. When Searle is able to show that liquid aspartame, though incredibly deadly, is much more addictive than crack cocaine, the NSDA is convinced that skyrocketing profits from the sale of soft drinks laced with aspartame would easily offset any future liability. With that, corporate greed wins and the unsuspecting soft drink consumers pay for it with damaged healths.

https://www.youtube.com/watch?x-yt-cl=84359240&v=pvFRLIjOLOU&x-yt-ts=1421782837

Coke leads the way once again (remember saccharin?) and begins poisoning Diet Coke drinkers with aspartame in 1983. As expected, sales skyrocket as millions become hopelessly addicted and sickened by the sweet poison served in a can. The rest of the soft drink industry likes what it sees and quickly follows suit, conveniently forgetting all about their initial reservations that aspartame is a deadly chemical. There’s money to be made, lots of it and that’s all that really matters to them anyway!

In 1985, undaunted by the swirl of corruption and multiple accusations of fraudulent research undertaken by Searle, Monsanto purchases the company and forms a new aspartame subsidiary called NutraSweet Company. When multitudes of independent scientists and researchers continue to warn about aspartame’s toxic effects, Monsanto goes on the offensive, bribing the National Cancer Institute and providing their own fraudulent papers to get the NCI to claim that formaldehyde does not cause cancer so that aspartame can stay on the market.

The known effects of aspartame ingestion are: “mania, rage, violence, blindness, joint-pain, fatigue, weight-gain, chest-pain, coma, insomnia, numbness, depression, tinnitus, weakness, spasms, irritability, nausea, deafness, memory-loss, rashes, dizziness, headaches, seizures, anxiety, palpitations, fainting, cramps, diarrhoea, panic, burning in the mouth. Diseases triggered/mimmicked include diabetes, MS, lupus, epilepsy, Parkinson’s, tumours, miscarriage, infertility, fibromyalgia, infant death, Alzheimer’s… Source : U.S. Food & Drug Administration.(5)

Further, 80% of complaints made to the FDA regarding food additives are about aspartame, which is now in over 5,000 products including diet and non-diet sodas and sports drinks, mints, chewing gum, frozen desserts, cookies, cakes, vitamins, pharmaceuticals, milk drinks, instant teas, coffees, yogurt, baby food and many, many more!(6) Read labels closely and do not buy anything that contains this horrific killer!

Amidst all the death and disease, FDA stooge Arthur Hull resigns under a cloud of corruption and is immediately hired by Searle’s public relations firm as a senior scientific consultant. No, that’s not a joke! Monsanto, the FDA and many government health regulatory agencies have become one and the same! It seems the only prerequisite for becoming an FDA commissioner is that they spend time at either Monsanto or one of the pharmaceutical cartel’s organized crime corps.

1990s: Monsanto spends millions defeating state and federal legislation that disallows the corporation of evil from continuing to dump dioxins, pesticides and other cancer-causing poisons into drinking water systems. Regardless, they are sued countless times for causing disease in their plant workers, the people in surrounding areas and birth defects in babies.

With their coffins full from the massive billions profits, the $100 million dollar settlements are considered the low cost of doing business and thanks to the FDA, Congress and White House, business remains very good. So good that Monsanto is sued for giving radioactive iron to 829 pregnant women for a study to see what would happen to them.



In 1994, the FDA once again criminally approves Monsanto’s latest monstrosity, the Synthetic Bovine Growth Hormone (rBGH), produced from a genetically modified E. coli bacteria, despite obvious outrage from the scientific community of its dangers. Of course, Monsanto claims that diseased pus milk, full of antibiotics and hormones is not only safe, but actually good for you!

Worse yet, dairy companies who refuse to use this toxic cow pus and label their products as“rBGH-free” are sued by Monsanto, claiming it gives them an unfair advantage over competitors that did. In essence, what Monsanto was saying is “yeah, we know rBGH makes people sick, but it’s not alright that you advertise it’s not in your products.”

The following year, the diabolical company begins producing GMO crops that are tolerant to their toxic herbicide Roundup. Roundup-ready canola oil (rapeseed), soybeans, corn and BT cotton begin hitting the market, advertised as being safer, healthier alternatives to their organic non-GMO rivals. Apparently, the propaganda worked as today over 80% of canola on the market is their GMO variety.

A few things you definitely want to avoid in your diet are GMO soy, corn, wheat and canola oil, despite the fact that many “natural” health experts claim the latter to be a healthy oil. It’s not, but you’ll find it polluting many products on grocery store shelves.

Because these GM crops have been engineered to ‘self-pollinate,’ they do not need nature or bees to do that for them. It’s like having sex with yourself to make a baby. Yes, Monsanto wants to take the fun out of that too. But all kidding aside, there is a very dark side agenda to this and that is to wipe out the world’s bee population.

Monsanto knows that birds and especially bees, throw a wrench into their monopoly due to their ability to pollinate plants, thus naturally creating foods outside of the company’s “full domination control agenda.” When bees attempt to pollinate a GM plant or flower, it gets poisoned and dies. In fact, the bee colony collapse was recognized and has been going on since GM crops were first introduced.

To counter the accusations that they deliberately caused this ongoing genocide of bees, Monsanto devilishly buys out Beeologics, the largest bee research firm that was dedicated to studying the colony collapse phenomenon and whose extensive research named the monster as the primary culprit! After that, it’s “bees, what bees? Everything’s just dandy!” Again, I did not make this up, but wish I had!

During the mid-90s, they decide to reinvent their evil company as one focused on controlling the world’s food supply through artificial, biotechnology means to preserve the Roundup cash-cow from losing market-share in the face of competing, less-toxic herbicides. You see, Roundup is so toxic that it wipes out non-GMO crops, insects, animals, human health and the environment at the same time. How very efficient!

Because Roundup-ready crops are engineered to be toxic pesticides masquerading as food, they have been banned in the EU, but not in America! Is there any connection between that and the fact that Americans, despite the high cost and availability of healthcare, are collectively the sickest people in the world? Of course not!

As was Monsanto’s plan from the beginning, all non-Monsanto crops would be destroyed, forcing farmers the world over to use only its toxic terminator seeds. And Monsanto made sure farmers who refused to come into the fold were driven out of business or sued when windblown terminator seeds poisoned organic farms.

This gave the company a virtual monopoly as terminator seed crops and Roundup worked hand in glove with each other as GMO crops could not survive in a non-chemical environment so farmers were forced to buy both.

Their next step was to spend billions globally buying up as many seed companies as possible and transitioning them into terminator seed companies in an effort to wipe out any rivals and eliminate organic foods off the face of the earth. In Monsanto’s view, all foods must be under their full control and genetically modified or they are not safe to eat!

They pretend to be shocked that their critics in the scientific community question whether crops genetically modified with the genes of diseased pigs, cows, spiders, monkeys, fish, vaccines and viruses are healthy to eat. The answer to that question is obviously a very big “no way!”

You’d think the company would be so proud of their GMO foods that they’d serve them to their employees, but they don’t. In fact, Monsanto has banned GM foods from being served in their own employee cafeterias. Monsanto lamely responded “we believe in choice.” What they really means is “we don’t want to kill the help.”

It’s quite okay though to force-feed poor nations and Americans these modified monstrosities as a means to end starvation since dead people don’t need to eat! I’ll bet the thought on most peoples’ minds these days is that Monsanto is clearly focused on eugenics and genocide, as opposed to providing foods that will sustain the world. As in Monsanto partner Disney’s Sleeping Beauty, the wicked witch gives the people the poisoned GMO apple that puts them to sleep forever!

2000s: By this time Monsanto controls the largest share of the global GMO market. In turn, the US gov’t spends hundreds of millions to fund aerial spraying of Roundup, causing massive environmental devastation. Fish and animals by the thousands die within days of spraying as respiratory ailments and cancer deaths in humans spike tremendously. But this is all considered an unusual coincidence so the spraying continues. If you thought Monsanto and the FDA were one and the same, well you can add the gov’t to that sorry list now.

The monster grows bigger: Monsanto merges with Pharmacia & Upjohn, then separates from its chemical business and rebrands itself as an agricultural company. Yes, that’s right, a chemical company whose products have devastated the environment, killed millions of people and wildlife over the years now wants us to believe they produce safe and nutritious foods that won’t kill people any longer. That’s an extremely hard-sell, which is why they continue to grow bigger through mergers and secret partnerships.

Because rival DuPont is too large a corporation to be allowed to merge with, they instead form a stealth partnership where each agrees to drop existing patent lawsuits against one another and begin sharing GMO technologies for mutual benefit. In layman’s terms, together they would be far too powerful and politically connected for anything to stop them from owning a virtual monopoly on agriculture; “control the food supply & you control the people!”

Not all is rosy as the monster is repeatedly sued for $100s of millions for causing illness, infant deformities and death by illegally dumping all manner of PCBs into ground water, and continually lying about products safety – you know, business as usual.

The monster often perseveres and proves difficult to slay as it begins filing frivolous suits against farmers it claims infringe on their terminator seed patents. In virtually all cases, unwanted seeds are windblown onto farmers’ lands by neighboring terminator-seeded farms. Not only do these horrendous seeds destroy the organic farmers’ crops, the lawsuits drive them into bankruptcy, while the Supreme Court overturns lower court rulings and sides with Monsanto each time.

At the same time, the monster begins filing patents on breeding techniques for pigs, claiming animals bred any way remotely similar to their patent would grant them ownership. So loose was this patent filing that it became obvious they wanted to claim all pigs bred throughout the world would infringe upon their patent.

The global terrorism spreads to India as over 100,000 farmers who are bankrupted by GMO crop failure, commit suicide by drinking Roundup so their families will be eligible for death insurance payments. In response, the monster takes advantage of the situation by alerting the media to a new project to assist small Indian farmers by donating the very things that caused crop failures in the country in the first place! Forbes then names Monsanto “company of the year.” Sickening, but true.

More troubling is that Whole Foods, the corporation that brands itself as organic, natural and eco-friendly is proven to be anything but. They refuse to support Proposition 37, California’s GMO-labeling measure that Monsanto and its GMO-brethren eventually helped to defeat.

Why? Because Whole Foods has been in bed with Monsanto for a long time, secretly stuffing its shelves with overpriced, fraudulently advertised “natural & organic” crap loaded with GMOs, pesticides, rBGH, hormones and antibiotics. So, of course they don’t want mandatory labelling as that would expose them as the Whole Frauds and Whore Foods that they really are!

However, when over twenty biotech-friendly companies including WalMart, Pepsico and ConAgra recently met with FDA in favor of mandatory labeling laws, this after fighting tooth and nail to defeat Prop 37, Whole Foods sees an opportunity to save face and becomes the first grocery chain to announce mandatory labeling of their GMO products…in 2018! Uh, thanks for nothing, Whore.

https://www.youtube.com/watch?x-yt-cl=84359240&v=x2WUY7Abgjc&x-yt-ts=1421782837

And if you think its peers have suddenly grown a conscience, think again. They are simply reacting to the public’s outcry over the defeat of Prop 37 by crafting deceptive GMO-labeling laws to circumvent any real change, thus keeping the status quo intact.

To add insult to world injury, Monsanto and their partners in crime Archer Daniels Midland, Sodexo and Tyson Foods write and sponsor The Food Safety Modernization Act of 2009: HR 875. This criminal “act” gives the corporate factory farms a virtual monopoly to police and control all foods grown anywhere, including one’s own backyard, and provides harsh penalties and jail sentences for those who do not use chemicals and fertilizers. President Obama decided this sounded reasonable and gave his approval.

With this Act, Monsanto claims that only GM foods are safe and organic or homegrown foods potentially spread disease, therefore must be regulated out of existence for the safety of the world. If eating GM pesticide balls is their idea of safe food, I would like to think the rest of the world is smart enough to pass.

As further revelations have broken open regarding this evil giant’s true intentions, Monsanto crafted the ridiculous HR 933 Continuing Resolution, aka Monsanto Protection Act, which Obama robo-signed into law as well.This law states that no matter how harmful Monsanto’s GMO crops are and no matter how much devastation they wreak upon the country, U.S. federal courts cannot stop them from continuing to plant them anywhere they choose. Yes, Obama signed a provision that makes Monsanto above any laws and makes them more powerful than the government itself. We have to wonder who’s really in charge of the country because it’s certainly not him!

There comes a tipping point though when a corporation becomes too evil and the world pushes back…hard! Many countries continue to convict Monsanto of crimes against humanity and have banned them altogether, telling them to “get the f#<k out and stay out!”

The world has begun to awaken to the fact that the monster does not want control over the global production of food simply for profit’s sake. No, it’s become clear by over a century of death & destruction that the primary goal is to destroy human health and the environment, turning the world into a Mon-Satanic Hell on Earth!

Research into the name itself reveals it to be latin, meaning “my saint,” which may explain why critics often refer to it as “Mon-Satan.” Even more conspiratorially interesting is that free masons and other esoteric societies assigned numbers to each letter in our latin-based alphabet system in a six system. Under that number system, what might Monsanto add up to? Why, of course 6-6-6!

Know that all is not lost. Evil always loses in the end once it is widely exposed to the light of truth as is occurring now. The fact that the Monsanto-led government finds it necessary to enact desperate legislation to protect its true leader proves this point. Being evicted elsewhere, the United States is Monsanto’s last stand so to speak.

Yet, even here many have begun striking back by protesting against and rejecting GMO monstrosities, choosing to grow their own foods and shop at local farmers markets instead of the Monsanto-supported corporate grocery chains.

The awakening people are also beginning to see they have been misled by corporate tricksters and federal government criminals poisoned by too much power, control and greed, which has resulted in the creation of the monstrous, out-of-control beast.

And as the people vote against that by choosing not to buy GMO poisons, Monsatan’s limbs continue to get hacked away slowly but surely, driving it to its knees for the final organic sword thrust into its blackened heart. It is this that will end its reign of terror for good!

Sources:

(1,3) http://bestmeal.info/monsanto/company-history.shtml
(2) http://www.sourcewatch.org/index.php/Monsanto
(4,5) http://www.pfnh.org/article.php?id=65

http://www.wakingtimes.com/2014/06/20/complete-history-monsanto-worlds-evil-corporation/

The FDA and HCFA: Unconstitutional Regulatory Agencies

Author: James A. Albright, MD

In regard to the deleterious changes that have taken place in the field of medicine, the regulatory agencies that have had the most damaging effect on the Constitution are the FDA and HCFA. Indeed, the history of the government's involvement in medical care provides a textbook example of the natural history of a command (a managed or collective) economy. In a command economy, power is centralized, which means it is an authoritarian system. Furthermore, when power is centralized, rules and regulations to control the system, particularly costs, inevitably become increasingly oppressive, due to the lack of incentives for self-control that exist in a market economy. For example, most physicians know that the measures implemented by the government (HCFA) to control Medicare have become more onerous each year. In fact, it has reached the point where most physicians know that severe penalties, even imprisonment, can be imposed if they bill too much and, as incredible as it may seem, even if they bill too little.(1) It is no surprise that few physicians actually know the details of what is and is not permitted, nor what the penalty might be for any given infraction.

Most physicians are well aware of the day to day agitations which result from government policies, and many have heard about some of the more sensational problems which occur.(2) The basic issue concerns the regulatory agencies in general. For example, in 1994, the estimated cost of economic, social, and environmental regulation topped $647 billion (as much as $6,457 per family), according to the General Accounting Office.(3) The FDA is one of these regulatory agencies and, in fact, it may be the most unaccountable of them all. Over the past 30 years, the FDA has inflated its powers so much that regulatory gridlock is now a greater menace to public health than thalidomide ever was.(4) The presumed "protection" provided by the system is illusory.

The misadventures of the device section of the FDA are well-known.(5) Some of the more memorable cases include the Bjork-Shiley heart valve implanted in 86,000 patients between 1979 and 1986, with a success rate of 99.5 percent. But it was pilloried by the government because it fractured in 0.5 percent. In other words, it saved the lives of 191 individuals for every valve that fractured. This raises the question of whether perfection is a reasonable standard for any mechanical device, a standard that the 51,000 patients who were still alive in 1992 might question.

Other infamous cases include a defibrillator made by Physio Control, which functioned properly more than 99.995 percent of the time. This product was the victim of scurrilous reporting by the news media, combined with heavy-handed tactics from Congress and the FDA.

The most recent, widely reported fiasco was that of breast implants. In spite of multiple epidemiological studies showing no relationship between breast implants and either connective tissue disease or carcinoma of the breast, FDA Commissioner David Kessler precipitated actions which resulted in a $43 billion legal settlement in 1994. Then, in the absence of data showing any link between breast implants and the alleged ailments, an FDA spokesman, Bruce Burlington, head of the Center for Devices and Radiological Health (CDRH), said the agency would maintain the same course it had set before the studies were reported. A Wall Street Journal editorial stated, "This, after billions of dollars have been put up to pay off the Plaintiffs' lawyers, after mastectomy patients have been terrorized, and after companies and careers associated with the implants have needlessly washed over the falls."(6)

Orthopaedic surgeons received an overnight education on the FDA from pedicle screws. Numerous research studies have shown that pedicle screws provide the strongest possible fixation in the spine. In fact, a non-medical observer, even an astute school child, could look at a vertebra and immediately recognize where the strongest part is. This explains why pedicle screws are often used clinically for certain problems.(7,8) Clearly, they provide optimum treatment for certain conditions. Yet, for many years, the FDA refused to approve pedicle screws. Because there was no logical explanation for this position, a neutral observer might conclude that the underlying purpose was to transfer funds into the hands of plaintiffs' lawyers since the actions of the FDA precipitated a massive class-action lawsuit.(9) The defendants included physicians and professional organizations such as the American Academy of Orthopaedic Surgeons, the Scoliosis Research Society, the North American Spine Society, the Orthopaedic Trauma Society, the Orthopaedic Research and Educational Foundation, the American Association of Neurological Surgeons, and the Congress of Neurological Surgeons, as well as countless individual physicians and major companies that manufacture the devices. (One company, Sofamore Danek, had approximately 3,000 lawsuits filed against it.) The professional societies and their members were accused of fraud and illegal collusion with orthopaedic companies by sponsoring academic meetings where scientific papers on pedicle screw devices were presented. Ironically, the companies that manufacture pedicle screws and the physicians who use them should be commended, not condemned.

After inflicting such enormous costs on society, both monetarily in legal costs and professionally in patient care, in 1998 the FDA reversed course and reclassified pedicle screw spinal systems from Class III to Class II for certain indications,(10) i.e., after countless years of resisting undeniable evidence, the FDA reluctantly admitted a serious error. Whatever the reasons, there is little question that the effect of the FDA's actions had an adverse effect on patients in this country.

Although this discussion has focused on actions of the device section, the drug section has a similar, if not more alarming history.(11)



Potential Solutions



It is now obvious the basic structure of the regulatory system needs to be changed or abolished. To simply put on the brakes by restructuring HCFA and the FDA either by reordering their priorities or by legislation, might work for awhile. However, as long as these agencies continue to exercise unconstitutional legislative and/or judicial power, the current problems and dangers to society will persist. The reason is that the history of authoritarian systems is well-known.(12-14) Examples of such systems have been repeatedly demonstrated over the past 60 years, not only in Nazi Germany and the former Soviet Union, but also in most of the underdeveloped countries in the world. There is little question that the FDA and HCFA are exhibiting the same dangerous attributes that are inherent in authoritarian systems.

The current question is: "What can be done to change the FDA and HCFA into organizations that have a positive, rather than a negative, effect on society?" There are several possibilities.

Constructive change could come from Congress, but we should not expect a revolution because Republicans now face the same political incentives and restraints previously faced by the Democrats and, unfortunately, they are beginning to act similarly. Thus, the most desirable solution would be for the United States Supreme Court to take the lead and re-establish the authority of the Constitution as the Supreme Law of the Land.

Numerous proposals have been offered to change the structure of the FDA. These range from a plan to provide funding strictly from royalties derived from products approved by the agency, to limiting its function to the determination of safety. One of the more sensible suggestions would alter its mission to that of product certification. No longer would it engage in excruciatingly detailed rule-making and law enforcement. Consumers, therefore, would be free to purchase products lacking FDA certification, and sellers would be free to sell uncertified products without government interference.(15)

Defenders of the current system claim that such a "drastic" change would be too dangerous because charlatans and imposters would flood the market with ill-devised and harmful "remedies." But such a response is irrational, because the evidence suggests otherwise. The prime example presented by defenders of the status quo is thalidomide. Yet, it is now known that the market had already solved that problem prior to the government-imposed sanctions. In effect, the government simply provided another example of what Professor E.G. West termed the "galloping horse" phenomenon.(16) In reality, market forces and their ramifications, including our legal system, provide the most effective methods of protecting the public from harmful drugs and devices. Enforcement of the Constitution, together with more sensible guidelines, would unleash the most effective controls.

In the final analysis, as stated by Ludwig von Mises in 1927, "The ultimate outcome in the struggle between libertarianism and totalitarianism will not be decided by arms, but by ideas. It is ideas that group men into fighting factions, that press the weapons into their hands, and that determine against whom and for whom the weapons shall be used. It is they alone, and not arms, that, in the last analysis, turn the scales."(17) It is ideas that led to the fall of the Soviet Union. Although some state that it was predetermined and that it was merely a matter of time before it fell, nothing is predetermined. The course of events is influenced by unexpected forces and directed by men of vision and resolve.

In the recent past, for example, the determination and wisdom of Ronald Reagan set the course in world affairs, which led to an outcome which was nothing less than the fall of the "Evil Empire." We can benefit from this lesson if we set our sights on the ultimate triumph of individual rights over totalitarian forces, whatever form they may take. We must attack this issue on a philosophical basis, while at the same time maintain pressure at every level. Therefore, it is imperative that we look beyond our next transaction and not lose sight of the ultimate goal, which is the triumph of liberty. If we remain steadfast in this resolve, the future is clear. By choosing this path, we cast our lot with those who would preserve high quality medical care, together with those who would guarantee liberty for every citizen.

It is one thing to claim that the function of government is to determine whether or not a given product is safe or not safe for citizens to use. But in a free society, there is no justification for forcing people to do what the government states is best for them. To do so is tyranny. Peter McWilliams succinctly calls it, "The absurdity of consensual crimes in a Free Society."(18) The absurdity hits home with the realization that any adult with a terminal illness who is given up as a hopeless case by the medical establishment can be put in jail for trying certain alternative therapies because the FDA has determined that such treatment might prove harmful.

The historic and continuing struggle of citizens against government oppression must be fought at several levels. Vigilance in opposing specific actions that infringe on citizens' rights is critical. However, the battle will not be won at that level alone. Our major focus must address the philosophic issue by concentrating on the concept of Constitutional Supremacy and the rule of nondelegation to expose the unconstitutional structure and actions of the FDA and HCFA (and other regulatory agencies). Equally important, we must pressure our "public servants" at all levels of government to simply adhere to the vows they take when sworn into office. At that time, they promise to uphold the Constitution. It is a travesty that most of them break this vow immediately after swearing to uphold it. Justice Joseph Story had strong opinions on this issue. He felt that if a judge departs from the original meaning of the Constitution, he acts on his own personal opinion of the public good or wise policy --- i.e., he usurps powers not given to him by the people through their Constitution. Therefore, he is no longer interpreting the Constitution, but amending it in a manner contrary to what the document itself permits.(19)

Justice John Marshall's driving interest was to establish the Constitution as the supreme law of a tripartite system. What does this mean in practical terms? Is it relevant or is it simply a concept of theoretical interest only? For much of the 20th century, we failed to honor constitutional principles and the executive branch has increasingly exercised legislative powers. However, in recent decisions the court has begun to address this issue, so we, as Benjamin Franklin, may be viewing a rising, not a setting, sun.(20)

Most dramatic was the recent case where the court firmly declared that the line item veto was unconstitutional.(21,22) The decision was based on the separation of powers. It was emphasized that Congress has no authority to delegate legislative power to the executive branch. Indeed, Alexander Hamilton in rejecting the idea that Congress could delegate its authority to any other power stated: "There is no question which depends on clearer principles than that every act of a delegated authority, contrary to the tenor of the commission under which it is exercised, is void. No legislative act, therefore, contrary to the Constitution can be valid."(23)

More recently, in Washington Legal Foundation v. Friedman, Federal District Court Judge Royce C. Lamberth ruled that the FDA could not prevent pharmaceutical companies from informing physicians of valuable off-label (not FDA approved) actions of drugs.(24) The decision was based on First Amendment rights. This decision was followed by an Act of Congress on November 21, 1998: The FDA Modernization Act (FDAMA) which attempted to overrule the Friedman court decision by legalizing the FDA's unconstitutional regulations.(25) This law was enacted to amend the Federal Food, Drug and Cosmetic Act.(26) In response to an appeal by the government, the court reconsidered its decision made in July 1998, with an opinion on July 28, 1999.(27) The court stated that the FDA's claims were "preposterous" and akin to "constitutional blackmail." The decision firmly upheld the court's decision in 1998 and the FDAMA was ruled unconstitutional. The ruling states that the "Defendants shall not in any way prohibit, restrict, sanction or otherwise seek to limit any pharmaceutical or medical device manufacturer or any other person" ...from publicizing any information on off-label uses of drugs or devices "...previously published in a bona fide peer-reviewed professional journal." It would be reasonable to expand these same criteria for the initial approval of a drug or device.

Most recently, the Supreme Court ruled that the FDA's attempt to regulate tobacco was unconstitutional.(28) It was a bold and much needed, if belated, decision. More serious is the court's continuing failure to recognize that many and probably most "laws" (regulations) written by regulatory agencies are unconstitutional.

The recent decisions of the Supreme Court, together with the fact that the unconstitutional actions of the FDA and HCFA have deprived American citizens of optimum medical care, point toward the next logical step: A constitutional challenge must be made in the form of a legal case. To have standing in court, the plaintiff must be an individual, or a body, who was damaged by an unconstitutional action of either HCFA or the FDA. This could either be a physician, or a patient, or even an institution. The recent announcement that the Association of American Physicians and Surgeons (AAPS) is considering such a case is very encouraging. For maximum benefit, the case must be one which not only will receive a favorable opinion from a District Court, but one which the Supreme Court will elect to accept for consideration, rather than simply accepting the District Court's opinion.

In recent years, the Supreme Court has accepted far fewer cases than in previous years. Yet, this fact should in no way discourage the development of such a case, because the court's powers are limited and it may simply be waiting for a suitable case (or series of cases). The court has no legislative power, so it can only make decisions on cases presented to it. There is a real possibility that a suitable case has never appeared.



Conclusion



The unique value of our Constitution is the balance of power it establishes between three equal branches of government. Once discovered by our Founding Fathers, this concept immediately captured their imagination, and it became the central driving issue during the Constitutional Convention in 1787. The Founders understood the danger that results when any two of the three powers are exercised by a single branch: When the lawmaker also becomes the enforcer, or the accuser becomes the executioner. As a result, the Founding Fathers specifically created a Constitution that separated these three powers between three equal divisions of government.

Likewise, there no longer is any doubt that the regulatory agencies, including the FDA and HCFA, now have legislative, as well as executive, powers. Such imbalance was defined by James Madison as tyranny, because power is transferred from the people to the government. Thus, the concentration of power in the hands of regulatory agencies has resulted in an authoritarian system where power has been extracted from the people and centralized by the government.

The first step toward recovery is recognition of the problem.



References/Notes



1. Orient JM. Can "health care fraud" be ended? Medical Sentinel 1998;3(4):124-130.
2. Trasby TR. What has government done to our health care? Cato Institute, Washington, DC, 1992.
3. Crews CW, Kerrigan K. Here's a winning issue. Wall Street Journal, editorial page, March 7, 1996.
4. Driscoll JA. Cure for FDA-induced pain. Wall Street Journal, editorial page, February 8, 1996. Regulatory gridlock should not be compared with the much ballyhooed "government gridlock" which is actually the system of checks and balances the framers created to prevent runaway government.
5. Higgs R. Wrecking ball: FDA regulation of medical devices. Policy Analysis #235, Cato Institute, Washington, DC, August 7, 1995.
6. Higgs R. Hazardous to our Health? FDA Regulation of Health Care Products. Oakland, CA, The Independent Institute, 1995, pp. 64-66.
7. Dick, W. Internal fixation of thoracic and lumbar spine fractures. Lewiston, NY, Hans Huber Publication, 1989.
8. Berkman EF, Cruse RN, Mukherjee DP, Sadasivan KK, Albright JA. A comparative biomechanical evaluation of the thoracolumbar burst fracture in human and canine spine. Orthopaedic Transactions 1994;18(2):77.
9. White JS. The pedicle screw lawsuits: Can CME finally come out of the shadows? Medical Economics, September 1998, pp. 40-46.
10. Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems. Federal Register, July 27, 1998, Vol. 63, No. 143, pp. 40025-40041.
11. Higgs, Hazardous to our Health? op. cit., pp. 13-27.
12. Albright JA, Bleck, EE, Ricardo-Campbell R. Health care in the United States: What we should keep and what we should change. Essays in Public Policy, Hoover Institution, Stanford University, 1994, p. 9.
13. Hayek F. The Road to Serfdom. Chicago, IL., University of Chicago Press, 1944, p. 100.
14. Bastiat F. The Law. The Foundation for Economic Education, Irvington-on-Hudson, NY, 1950. Translation of 1850 Edition.
15. Higgs, Hazardous to our Health? op. cit., pp. 97-101.
16. Seldon A. Capitalism. Basil Blackwell Ltd, Oxford, UK, 1990, p. 258. When the solution to a problem is already in place, but not widely recognized, "the occupational disease of politicians is to succumb to the inducements of the political process to 'interfere' by putting themselves at the head of 'prospering systems' in order to win credit for their wisdom and public spirit but often to end by obstructing them. Professor West accused the politicians of jumping onto 'a galloping horse.' " Almost invariably, the outcome is a progressive deterioration of the program at issue.
17. Mises L. Liberalism: The Classical Tradition. The Foundation of Economic Education, Inc. Irvington-on-Hudson, NY, 1996. Translation of 1927 edition, translated by Ralph Raico, p. 51.
18. McWilliams P. Ain't Nobodies Business If You Do. Los Angeles, CA, Prelude Press, 1993.
19. Story J. A Familiar Exposition of The Constitution of the United States, 1840. Reprinted by Regency Books, Lake Bluff, IL, 1986, pp. 68-70. Forward by Edwin Meese III, p. 12.
20. Madison J. Notes of Delegates in the Federal Convention of 1787. Reissued by Norton & Co., NY and London, 1987, p. 659. At the conclusion of the Federal Convention in 1787, while the last members were signing the Constitution, Madison reported that Doctor Franklin looked toward the President's chair at the back of which a rising sun had been painted. He was heard to say that painters found it difficult to distinguish between a rising and a setting sun. He said he often looked at that sun but due to the "vicissitudes of his hopes and fears" during the convention, he was unable to tell whether it was rising or setting. But now, he said, "... I have the happiness to know that it is a rising and not a setting sun."
21. City of New York v. Clinton and Snake River Potato Growers v. Rubin, 985 F Supp. 168, p. 169. (D.D.C.) February 12, 1998. The court held that "...the Line Item Veto Act violates the procedural requirements ordained in Article I of the United States Constitution and impermissibly upsets the balance of powers so carefully prescribed by its Framers. The Line Item Veto Act therefore is unconstitutional."
22. Clinton v. City of New York, WL 333013 (U.S.) p. 14, 1998. Supreme Court of the United States, June 25, 1998. The court held that the Line Item Veto Act "...would authorize the President to create a different law - one whose text was not voted on by either House of Congress or presented to the President for signature." Furthermore, "such change must not come by legislation but through the amendment procedures set forth in Article I of the Constitution." Therefore "The judgment of the District Court is affirmed."
23. Hamilton A, Madison J, Jay J. The Federalist Papers. New York, New American Library, No. 78, p. 467.
24. Washington Legal Foundation v. Friedman, 13F. Suppl. 2d 51 (D.D.C.) July 30, 1998).
25. FDA Modernization Act. Dissemination of Information on New Uses. Public Law 105-115 (S. 830). Title IV, Section 401, November 21, 1998.
26. Federal Food, Drug, and Cosmetic Act Section 554(d), as amended 21 U.S.C.A. Section 360aaa-3(d), 1999.
27. Washington Legal Foundation v. Henney and Donna Shalala. 1999 WL 557679, *2, *6 (D.D.C.) July 28, 1999. The Court held that "...the FDAMA largely perpetuates the policies held unconstitutional by the court on July 30, 1998 and therefore may not be applied or enforced by FDA." The court held that the Central Hudson Test (447 U.S. 557, 1980) applied: "If the speech is truthful and nonmisleading, the government must demonstrate a substantial interest that is directly advanced by the regulation without burdening substantially more speech than necessary."
28. Food and Drug Administration, et al., v. Brown and Williamson Tobacco Corporation 153 F. 3d 155 (98-1152) USC, March 21, 2000.


Dr. Albright is Professor and Chairman of the Department of Orthopedic Surgery at Louisiana State University Medical Center in Shreveport, Louisiana. His e-mail is jalbri@ortho.lsumc.edu.

Dr. Albright does not have a conflict of interest with any of the products discussed in this article, although as an orthopedic surgeon, he has performed numerous laboratory studies on pedicle screws and associated implants.

Originally published in the Medical Sentinel 2000;5(6):205-208. Copyright © 2000 Association of American Physicians and Surgeons (AAPS).

http://www.haciendapub.com/medicalsentinel/fda-and-hcfa-part-ii-unconstitutional-regulatory-agencies


Tag Archives: FDA

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By Michael Snyder

An incredible discovery that was recently made in Russia threatens to shatter conventional theories about the history of the planet.  On Mount Shoria in southern Siberia, researchers have found an absolutely massive wall of granite stones.  Some of these gigantic granite stones are estimated to weigh more than 3,000 tons, and as you will see below, many of them were cut “with flat surfaces, right angles, and sharp corners”.  Nothing of this magnitude has ever been discovered before.  The largest stone found at the megalithic ruins at Baalbek, Lebanon is less than 1,500 tons.  So how in the world did someone cut 3,000 ton granite stones with extreme precision, transport them up the side of a mountain and stack them 40 meters high?  According to the commonly accepted version of history, it would beimpossible for ancient humans with very limited technology to accomplish such a thing.  Could it be possible that there is much more to the history of this planet than we are being taught?

For years, historians and archaeologists have absolutely marveled at the incredibly huge stones found at Baalbek.  But some of these stones in Russia are reportedly more than twice the size.  Needless to say, a lot of people are getting very excited about this discovery.  The following comes from a Mysterious Universe article…

Read more at http://investmentwatchblog.com/newly-found-megalithic-ruins-in-russia-contain-the-largest-blocks-of-stone-ever-discovered/#M2y2QhdqIMrgpdps.99

Scary Emerging Scientific Consensus: There's No Such Thing as Safe Plastic

The plastics industry has a big propaganda denial campaign in the works.
my Goodman:"Are any plastics safe?" That’s the title — that’s the question of a new exposéby Mother Jones that may shock anyone who drinks out of plastic bottles, gives their children plastic sippy cups or eats out of plastic containers. For years, public campaigns have been waged against plastic containing BPA, Bisphenol-A, a controversial plastic additive. But a new investigation by Mother Jones magazine has revealed that chemicals used to replace BPAmay be just as, if not more, dangerous to your health than their cousin compound.
BPA is still widely used in everything from the lining of soup cans to printed receipts, even though studies show it mimics the behavior of estrogen in the human body, and have linked it to breast cancer, diabetes, obesity and heart disease. Just last week, a study estimated the use of BPA in food and beverage containers is responsible for some $3 billion a year in healthcare costs. But because BPA can hamper brain and organ development in young children, it’s been banned in bottles and sippy cups since 2012. Now new studies show the plastic products being advertised as BPA-free, and sold by companies such as Evenflo and Nalgene, Tupperware, are still releasing synthetic estrogen.
The Mother Jones report goes on to look at how the plastics industry has used a Big Tobacco-style campaign to bury the disturbing evidence about the products you use every day.

We’re joined in Washington, D.C., now by Mariah Blake, staff reporter with Mother Jones magazine. Mariah, welcome to Democracy Now! Just lay out what you have found.

Mariah  Blake: Well, essentially, there is relatively new research showing that the vast majority of plastics, at least commercially available plastics that are used for food packaging, contain BPA-like chemicals, so chemicals that are what they call estrogenic. And the 

AG: And explain what BPA is.

MB: So BPA is a chemical that mimics the hormone estrogen. And estrogen plays — we all have estrogen in our bodies. It plays an essential role in various bodily functions and is also very important in human development, so the development of our brain, the development of our organs. However, too much or too little of this hormone, basically, especially during early childhood or prenatally, can set you up for disease later on in life. So, exposure — what the research shows is that exposure in the womb can then lead to breast cancer, diabetes, increased aggression, really sort of a staggering list of health problems later on in life.

AG: And so, talk about what has happened since BPA has been banned.

MB: So, yes, and many people will recall that in 2008 the dangers of BPA became very widely known. There was a scare. Major retailers pulled BPA from their shelves. Customers began demanding BPA-free products, especially for children. And many manufacturers began introducing products that were BPA-free. And all of us who have children have these BPA-free products in our home, most likely. One of the — so — and in many cases, it turns out that the chemicals that were used to replace BPA, or the plastics contained chemicals that were, you know, similar to BPA — at any rate, many of these chemicals had not been tested to see whether they had similar properties to BPA, whether they mimicked estrogen, in essence. And it turns out that many of them do. So, the implication is that they could have similar effects on human health.

AG: You begin your piece by telling us the story of Michael Green and his daughter.

MB: Yes.

AG: Talk about that experience.

MB: So, Michael Green is — he had a two-year-old daughter. He’s somebody who works in the environmental health field. And he had heard — he had seen research suggesting that BPA-free plastics may have posed some of the same problems to human health. And — but he told me this very moving story about himself and his two-year-old daughter. Somebody else in the family had given his two-year-old daughter this pink plastic sippy cup with a picture of a princess on it, which she just loved. And every night at dinner time, they would have this battle of the wills over this pink plastic sippy cup: He wanted to give her the stainless steel sippy cup; she wanted the pink plastic sippy cup. And in the interest of maintaining peace in the household, occasionally he gave in and gave her this pink plastic sippy cup. But the decision really weighed on him. And I think that those of us who have children — I have a three-year-old son — can relate to this situation, where sometimes you do the expedient thing in the interest of peace, but you wonder if it’s the best thing for your child. And in this case, he decided that he would try to answer that question. And he runs this environment health organization, and he collected sippy cups from Wal-Mart and Toys"R"Us — Babies"R"Us, I’m sorry — and he sent them to an independent lab in Texas to be tested. And he found out that in fact roughly a third of them did contain estrogen-like chemicals.

AG: And that pink sippy cup?

MB: His daughter’s sippy cup was leaching estrogenic chemicals. So his fears were founded.

AG: And what can that do to her?

MB: This is the big question. We know a lot about BPA. BPA is one of the most studied chemicals on the planet. And we know that these chemicals generally are associated with a range of negative health effects. But the specific effect of any given chemical varies slightly from chemical to chemical, and we actually don’t know what chemical is leaching out of that sippy cup. So it’s impossible to know. I mean, there’s a very high correlation with breast cancer, for example, with all of these estrogenic chemicals, and with certain developmental problems. But other specific diseases vary from chemical to chemical. So, Michael Green, the way he describes it is an unplanned science experiment that we’re doing on our families all of the time.

AG: We’re going to break and then come back to this discussion and talk about Big Tobacco, what Big Plastic has learned from Big Tobacco. We are talking to Mariah Blake, a staff reporter with Mother Jones. Her story is in the new issue of the magazine. It’s called "The Scary New Evidence on BPA-Free Plastics: And the Big Tobacco-Style Campaign to Bury It." Stay with us.

[Break]

AG: This is Democracy Now!, democracynow.org, The War and Peace Report. I’m Amy Goodman. We are with Mariah Blake, staff reporter for Mother Jones magazine. "The Scary New Evidence on BPA-Free Plastics: And the Big Tobacco-Style Campaign to Bury It" is her new piece. What is the campaign to bury the information, Mariah Blake?

MB: Well, there are multiple facets to the campaign, but the primary — the primary objective is to cast doubt on the scientific evidence linking these chemicals to human health problems. So — and there are various ways this is done. In the case of BPA, for example, the industry funded studies, which were biased studies that found that this — that the chemical was not harmful to health. And there’s a sort of network there. They published them in certain journals that, in many cases, had links to the tobacco industry. They relied on scientists that, in many cases, had helped to discredit the science linking smoking and secondhand smoke to disease. So, in many ways, this is — they didn’t only borrow strategies and tactics from Big Tobacco; they are actually relying on the same cadre of experts that Big Tobacco relied on to bury — to bury the truth about smoking.

AG: I want to turn to a video made by the plastics industry featuring the vice president of Eastman’s specialty plastics division, Lucian Boldea, speaking in the video made by the company. A pregnant woman is one of the people shown buying plastic products as Boldea speaks.

Lucian Boldea: We understand that there are concerns about plastic materials that are used in consumer products that consumers use every day. Those products include water bottles, baby bottles and food storage containers. We can see how available information about plastic materials can be confusing and how it can be difficult for consumers to tell what is really safe. We want you, the consumer, to know the facts behind our clear, tough material named Tritan. Consumers can feel confident that the material used in the product is free of estrogenic activity.

Consumers should have high expectations of the products that they use, and no one is tougher on our products than the researchers and engineers at Eastman Chemical. Most importantly, we have used reputable, independent, third-party laboratories that have used well-recognized scientific methods to prove that Tritan is free of estrogenic activity. Numerous regulatory agencies around the world have independently reviewed our data and have approved the product for use in food contact applications. Some of the world’s most recognized brands trust Tritan as their ingredient.

AG: That was Lucian Boldea, who is president of Eastman Chemical’s specialty plastics division. Can you respond to this, Mariah Blake?

MB: Well, the Eastman product, called Tritan, which is the product that Boldea is speaking about in this video, is actually one of the primary focuses of my investigation. A number of independent scientists have tested this product and found that it is actually more estrogenic than polycarbonate, which is the plastic that contains BPA. And Eastman Chemical, according to internal documents which were released as part of a lawsuit, has taken pains to suppress the evidence showing that its products — or that this product, in particular, is in fact estrogenic.

AG: So how is it the EPA isn’t regulating this?

MB: Well, and this is one of the most surprising things to me when I read this — when I was reporting the story. So, there are about 80,000 chemicals in circulation in the United States. Virtually none of those chemicals has been tested for safety, or a very, very small fraction of those chemicals has been tested for safety. In general, chemicals are presumed safe until proven otherwise under the U.S. regulatory system. So, when a chemical like BPA is removed from a production line, the industry will substitute another chemical that is untested, and we really, in many cases, just don’t know the health effects of that chemical. So, it’s largely an unregulated realm.

AG: Tell us about George Bittner.

MB: OK. George Bittner is a neuroscientist at the University of Texas, and he has launched an independent lab called CertiChem — it also has a sister company called PlastiPure — and it tests products for estrogenic activity. And he — working with a prominent Georgetown professor, he and his staff tested, I think it was, 455 commercially available plastics that are on the market and published a paper in Environmental Health Perspectives, which is the premier NIH journal, which found that virtually all commercially available plastics have estrogenic activity. And among the plastics he tested were Tritan products, several Tritan products. And this publication, this finding, prompted a pretty big backlash from the industry. So he ended up being targeted by the industry as a result and, in fact, was sued by Eastman, which is — many of the documents that formed the basis of my story were released as a result of that lawsuit.

AG: I want to read from a memo that Eastman’s senior chemist, Emmett O’Brien, wrote after customers began asking about George Bittner’s tests that showed that Tritan may still be estrogenic. O’Brien describes a meeting with Whole Foods executives who were considering replacing their polycarbonate bulk food bins with ones made from Tritan. He wrote, quote, "We called Bittner a mad scientist. They didn’t know his name actually. They asked twice, by two independent people, what we thought of them. I hemmed and hawed (ducked and dodged) saying I prefer not to comment, but we joked and pushed and flat out said the guy was 'shady' — with this non-stereotypical crowd it was a good term." O’Brien added, "They asked if they could do their own tests — I mentioned the cost is very high and they were quick to chime in that the tests take very long." Can you respond to that, Mariah Blake?

MB: I think you chose the most telling possible quote. So this was effective — this was the strategy they used. Firstly, they worked to discredit Bittner, and they did this through a campaign of personal character assassination and by calling his business practices into question. And secondly, they worked to discredit the science. So, one of the things that Eastman did was they claimed that the test that Bittner is using, which relies on a specialized line of breast cancer cells, had been rejected by the EPA, when in fact it hadn’t. The EPA is considering using this very line of breast cancer cells for its own screening program for what they call endocrine-disrupting chemicals. BPA is one of those.

So, the other thing they did was they commissioned their own research, so they paid labs to perform research which found that Tritan was not estrogenic. And — but if you look at — if you look at the research closely, you’ll see that it is — the studies are essentially designed in a way that guarantee that estrogenic activity will not be found. So, for instance, they use a type of rat; it’s called a Charles River Sprague Dawley rat. This rat is known to be insensitive to estrogen, so it can withstand doses, according to one Japanese study, a hundred times higher than a human female can withstand, with — and show absolutely no effect. They also used doses that are below what is known as the no-observable-effect level, so the doses that are known not to cause an effect. And they then published their own study in a scientific journal, which is — has numerous tobacco industry ties, finding that Tritan was in fact not estrogenic. So, that is essentially how they responded to the finding that their product contained these chemicals that are potentially harmful to human health: They attempted to cover it up.

AG: Your report cites some leaked minutes from a 2009 meeting of the BPA Joint Trade Association, whose members include the American Chemical — the American Chemistry Council, Coca-Cola, Del Monte. During the meeting, they explored messaging strategies that included using what they called, quote, "fear tactics." For example, "Do you want to have access to baby food anymore?" The attendees agreed that the "holy grail" spokesperson was a, quote, "pregnant young mother who would be willing to speak around the country about the benefits of BPA." Mariah?

MB: Yes, and this is one of the most disturbing things I discovered during the course of reporting this, is that in their efforts to portray plastics as safe, they oftentimes target the groups who are most vulnerable to the effects of these chemicals. So, prenatal exposure and exposure during early childhood is potentially the most harmful, and oftentimes the marketing of these products targets pregnant women, targets families with children. And also, Eastman, for example, in their efforts to portray their products as safe, also targeted these specific groups.

AG: Can you talk about Nalgene bottles, Evenflo — is it Evenflo? — Tupperware, Rubbermaid, CamelBack?

MB: Yes, all of these companies produce at least some products that are made with Tritan, so — and they’re not alone. There are hundreds, probably, of companies that use this. This is the only plastic on the market that markets itself as being free of all estrogenic activity, so many companies that cater to consumers who are concerned about their health and many of the high-end consumer brands have started using this plastic. I think the thing to keep in mind is that Eastman misrepresented their product to their customers, as well. So these brands are not necessarily to blame for this. They have been told by Eastman that Eastman produced — performed independent, third-party testing and found no evidence of estrogenic activity. And so, in many cases, it appears that these companies are trying to do the best thing for their customers, but they were not given — they were not given accurate information about the plastic that they use in their products.

AG: Last week, NPR did a report, "Maybe That BPA In Your Canned Food Isn’t So Bad After All." Can you talk about that?

MB: Yes. So, this is based on a recent study that was performed by FDA scientists. This is a $30 million taxpayer-funded study. And the FDA used many of the same tactics that the industry uses. For instance, they used the Charles River Sprague Dawley rat. The other thing about this study is that the lab appears to have been contaminated. So the control group of rats — these are the rats that are supposed to not be exposed to BPA, so that you can — you have some sort of a baseline to measure the animals that have been exposed to this chemical — they were somehow accidentally exposed to BPA. I have been talking to scientists about this and am planning to write about this later this week. And the academic scientists I have been speaking to say that this essentially — this raises very serious questions about the validity of the findings, and it’s unclear whether any conclusions can be drawn based on this study.

AG: What most shocked you in all your research, Mariah?

MB: Boy, that’s a good question, because there were a lot of — a lot of shocking things I discovered. I would say there’s a couple things. One, the fact that so few of the chemicals that are in the products we use every day have been tested for safety. So, as I said, there are 80,000 chemicals that are in commercial use in the United States; only a tiny fraction of those have been tested for safety.

Two, how easy it is for the industry to bias that safety testing in their favor. I had — obviously, many of us know about Big Tobacco and the way they were able to essentially buy science saying their products were safe. But I was not aware that that was happening on such a grand scale today. And it really is. You know, plastics — as I worked on the story, it became evident to me that plastics — that this is not the only industry — the plastics and chemical industry are not the — is not the only one that is using these tactics. These tactics are fairly widespread.

And I guess, on a micro level, one of the things that surprised me most, in Bittner’s testing, he looked at various types of commercially available plastics, and one of the types of plastic that was most frequently estrogenic was the corn-based plastic, so the plastic that is biodegradable, that you often find in restaurants — health food restaurants, health food stores, that this is potentially one of the most harmful types of plastic.

AG: Explain that again.

MB: So, Bittner looked at various kinds of plastic, Bittner and his colleagues, when they tested plastics. There’s a variety of different kinds of plastic — polyurethane, PET-P, polycarbonate — all these different kinds of plastic. So he broke it down by types of plastic. He tested a number of samples of each one. And he — in the final paper, they showed which ones — what percentage of each type of plastic tested positive in their tests. And there is a type of plastic that is — frequently you’ll find it in Whole Foods, you’ll find it in health food stores. It is corn-based, and it is marketed as biodegradable. Oftentimes there are forks made out of this, for example, in health food restaurants. I believe the statistic was 95 percent of samples made out of this kind of plastic tested positive for estrogenic activity.

AG: So what are you going to do with your three-year-old? What have you decided to use?

MB: Well, what I’ve already done is removed all plastic from my home. So, I have switched to natural materials. We use glass or stainless steel for our Tupperware, for our sippy cups, for everything that we possibly can. Plastic is unavoidable, so we still buy food packaged in plastic, because there is no alternative. But we try to minimize it.

AG: Saran Wrap?

MB: Saran Wrap, actually, in Bittner’s tests, I believe it was somewhere around 99 to 100 percent of plastic wraps tested positive for estrogenic activity.

AG: And where does the EPA come down when you question them about when they’re going to be regulating some of this, in the way that they regulated BPA?

MB: Well, the EPA still does not regulate BPA. The FDA — the FDA banned BPA in sippy cups and bottles at the request of the industry. So — and they still — the agency still insists that BPA is safe. So the industry asked the FDA to ban it, because they wanted to reassure parents that their products are safe. There has been no meaningful regulation of any of these chemicals, with the exception of phthalates. And in the case of the EPA, they have a program which was supposed to screen these 80,000 chemicals for what’s called endocrine disruption. So, endocrine-disrupting chemicals are chemicals that mimic hormones, like BPA. And they — this was supposed to be at least partially done by 2000. They still haven’t fully vetted a single chemical. So the industry has managed to throw stumbling blocks in their path. And delay is the name of the game, essentially, sowing doubt and delay. So —

AG: And how much does the plastic in water bottles and juices leach into the water and the juices?

MB: PET or PETE, which is most commonly used for water bottles, is — I believe 75 percent of samples in Bittner’s study leached estrogenic activity. There is another study performed by a scientist in Germany which also found that this particular type of product was estrogenic. So, it seems, based on the available evidence, that many or most of these bottles leach estrogen.

AG: And the longer the bottle of water you buy sits, is the water becoming increasingly contaminated?

MB: Well, there are certain factors that increase the risk of these chemicals being released. So, exposure to UV rays, heat, if they’re put in a dishwasher, these are the things that are known to increase — increase the risks that these chemicals leach out of plastics. So, with reusable plastics, in particular, this is a concern. If you boil them, if you put them in your dishwasher, if you leave them in your car, that causes plastics to break down, and it’s more likely that estrogenic chemicals will leak into whatever those containers contain.

AG: Well, Mariah Blake, we want to thank you for your research, staff reporter with Mother Jones magazine. Her story is just out in the new issue; it’s called "The Scary New Evidence on BPA-Free Plastics: And the Big Tobacco-Style Campaign to Bury It." We’ll link to it at democracynow.org. You can also follow her on Twitter. Later today, she’ll be doing a Twitter chat with readers.

This is Democracy Now!, democracynow.org, The War and Peace Report.

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