Surprising Number of Unregulated Chemicals Found in Food

Thursday, April 10, 2014 by Civil Eats
GRAS Out
by Twilight Greenaway

If you don’t recognize all the high-tech ingredients available in food and drinks these days, you’re not alone. Some of these new additions—such as glucosamine hydrochloride, gamma-amino butyric acid (GABA), or soy isoflavone extract—might show up in product marketing, while others, such as milk protein concentrate, will not. But whether new food additives are being promoted or not, a report released this week by the Natural Resource Defense Council (NRDC) says their novelty isn’t the only reason we should be paying attention.

In fact, a fairly large loophole allows chemicals and other new food and drink additives to bypass review by the U.S. Food and Drug Administration (FDA) because of a law passed in 1958. The law, which was intended to apply to common food ingredients like vinegar and vegetable oil—items that everyone could agree were safe to eat—allowed companies to deem ingredients in their products GRAS, or “generally recognized as safe.” Since then, the GRAS designation has continued to allow food companies to add ingredients to products without the need for FDA approval.

NRDC and others take issue with who is doing the “recognizing.” You see, while chemical companies have the option to offer up new additives for review by the FDA, they can also just call them GRAS and quietly start using them. And while the latter is considered the responsible thing to do, it’s increasingly less common.

NRDC looked closely at a list of companies, most of which have names like NutraGenesis, Biocell Technology, and NuLive Science and make additives that appear in things like energy drinks and sports bars—the relatively new gray area where supplements and food overlap. They found 275 chemicals from 56 companies, which, “appear to be marketed for use in food based on undisclosed GRAS safety determinations.”

“We took ingredients lists and matched them against FDA databases of regulated additives and we found a large number of additives on those ingredients lists that didn’t appear anywhere,” NRDC Senior Scientist and co-author of the report, Maricel Maffini, told Civil Eats. By process of illumination, she and her team were able to identify a list of so-called “self-determined GRAS ingredients.”

However, Maffini added, “We’re a research team, consumers don’t have the time or resources to do that.” In total, NRDC estimates that about 1,000 of the 10,000 additives used in food today have been added more or less on the down low by companies that don’t want to go through an official review process, don’t want their process known by competitors, or don’t want to face safety questions directly.

Thanks to a Freedom of Information Act (FOIA) request, Maffini and her co-authors got ahold of correspondence between a number of chemical companies and FDA staff members involved in review processes that resulted in withdrawals by the companies. If the FDA rejects a GRAS notice, it informs the company of its safety concerns and makes those concerns public. But if a company withdraws its request for review, the public is left in the dark.

In one example, Maffini and her team looked into a chemical called EGCG, made from an extract of green tea. “We found out the GRAS notice had been submitted to [the FDA] and withdrawn several times. However, it’s really popular in sports drinks, energy drinks, etc.,” she said.

“While the company was basically explaining that these types of purified chemicals were ‘just like green tea,’ FDA had concerns about EGCG,” Maffini said. In letters to the company, the agency pointed to studies that raised health questions, such as an association with fetal leukemia, and one paper that cited evidence that the chemical caused genetic damage in human cells.

And this is just one example. As the report reads, “companies found their chemicals safe for use in food despite potentially serious allergic reactions, interactions with common drugs, or proposed uses much greater than company-established safe doses.

Of course, NRDC isn’t suggesting that everything added to food under the GRAS rule is unsafe. The point is merely that, under the current system, there is no way for most consumers to know either way. And while many additives appear on ingredient lists, Maffini points out that when additives are used in “incidental” quantities, or included in categories like “natural flavors,” food companies have no obligation to disclose them.

NRDC has made a list of recommendations in the report, including that Congress require the FDA to be informed of GRAS determinations so it can confirm that each chemical’s use in food is, in fact, safe. The organization also wants to see the correspondence between FDA and the companies filing for GRAS review made public, even if they have been withdrawn. In other words, the group is pushing for a more transparent system all around. Until then, NRDC suggests that perhaps GRAS should stand for “generally recognized as secret.”

Major Food Manufacturers Push to Label Genetically Modified Products as “Natural”

Back to News
Tuesday, December 24, 2013

Food manufacturers who use genetically modified (GMO) ingredients want permission from the federal government to stamp their products with the word “natural.”

The Grocery Manufacturers Association has asked the Food and Drug Administration (FDA) to approve their plan, which would mean any food containing GMO corn, sugar and other such ingredients could be sold as “natural.”

One advocacy organization, the Environmental Working Group (EWG), blasted the food companies’ proposal.

Scott Faber, vice president of the EWG, called the association’s request “audacious.”

“It’s like they’re trying to get the government to say night is day and black is white,” Faber told The New York Times.

The request comes as food manufacturers are increasingly under attack from opponents of GMO ingredients. At least 65 lawsuits are pending in various courts aimed at forcing companies to stop using the word “natural” to describe products with GMO elements.

PepsiCo settled one such lawsuit in August over its use of the phrases “All Natural,” “All Natural Fruit” and “Non-GMO” on bottles of Naked Juices. The company said it would remove “All Natural” from the drinks’ packaging and pay consumers $9 million.

However, PepsiCo will still use “non-GMO” on the juices, even though they are not certified as such.

Decades Later, FDA Takes Action on Safety of Antibacterial Soaps

Oh, FDA...is there ANYTHING you won't approve without adequate testing to determine whether it's a health risk to the public? Public Service jobs don't pay well and have crazy turnover--gotta snag that cushy corporate corner office at one of the companies for whom you rubber stamp approval for everything they submit, doncha? Stack that paper!

Monday, December 16, 2013 by Common Dreams

“FDA is finally taking concerns about triclosan seriously."

- Andrea Germanos, staff writer


Commonly used antibacterial soaps are no better at killing germs than washing with plain soap and water, but may harm health and contribute to making bacteria resistant to antibiotics, the U.S. Food and Drug Administration announced Monday.

"New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits," Colleen Rogers, Ph.D., a lead microbiologist at FDA, said in a statement.

In its proposed rule issued Monday, the FDA states that makers of antibacterial soaps and body washes must now demonstrate the safety and effectiveness of those products, noting:

Several important scientific developments that affect the safety evaluation of these ingredients have occurred since FDA’s 1994 evaluation of the safety of consumer antiseptic active ingredients under the OTC Drug Review. New data suggest that the systemic exposure to these active ingredients is higher than previously thought, and new information about the potential risks from systemic absorption and long-term exposure have become available. New safety information also suggests that widespread antiseptic use can have an impact on the development of bacterial resistance.

Environmental and public health watchdog groups have long sounded the alarm about triclosan, a common anti-bacterial agent.

In 2008, Environmental Working Group found that

Triclosan has been linked to cancer in lab animals, has been targeted for removal from some stores in Europe for its health and environmental risks, and the American Medical Association recommends against its use in the home. It is also linked to liver and inhalation toxicity, and low levels of triclosan may disrupt the thyroid hormone system. Thyroid hormones are essential to proper growth and development, particularly for brain growth in utero and during infancy.

Triclosan breaks down into very toxic chemicals, including a form of dioxin; methyl triclosan, which is acutely toxic to aquatic life; and chloroform, a carcinogen formed when triclosan mixes with tap water that has been treated with chlorine. Scientists surveyed 85 U.S. rivers and streams, and found traces of triclosan in more than half.

Other studies indicate that it contributes to antibiotic-resistant bacteria.

According to reporting by Bloomberg, "Chemicals like triclosan were never intended for mass consumer use."

The FDA first proposed removing triclosan from some products 35 years ago, the Natural Resources Defense Council points out, but no final action from the FDA meant its use continued and grew.

In 2010, the NRDC sued the agency to make it issue a final rule on triclosan. Monday's proposal comes as a result of a settlement from that lawsuit.

“This is a good first step toward getting unsafe triclosan off the market,” said Mae Wu, an attorney in NRDC’s health program. “FDA is finally taking concerns about triclosan seriously."

While the proposed rule covers soaps and body washes, it leaves out products that don't use water like antibacterial wipes and sanitizers. The group Safer Chemicals Healthy Families points out that triclosan is widespread, and may also appear in products like toothpaste, cutting boards, yoga mats, textiles and household cleaners.

Big Pharma Markets to and Profits from a 'Can't-Pay-Attention Nation'

 Are you a child who would rather look out the window and imagine yourself flying or doing something else cool than doing math problems in school? Then you are psychologically ill. Here, drugs! Kids, remember--don't do drugs...except for these. They are just as bad as the ones they sell on your school playground and they don't make you better! In fact, all they do is turn you into an addict who will experience the pain of withdrawal symptoms once a rational human being with your better welfare in mind decides to save you by taking you off them. Doesn't that sound great? ~A.M.A.

Some of you might remember back in the days when it was illegal to advertise prescription drugs anywhere other than established medical journals and trade magazines, before Pharma companies started hiring strippers to make calls on doctors' offices and keep those ineffective overly prescribed drugs flowing to a nation of daydreaming overweight hypochondriacs. Oh, American Exceptionalism -- you are the greatest oxymoron/misnomer for a non-existent concept ever! Unless they changed the definition of exceptional to mean stupidly docile and unquestioningly gullible. Absurd, you say? Not anymore, folks. Not if you have a lot of money. Fun fact: the generic name for Adderall is "amphetamine salts." No attempt at misdirection there. You are making your child take a drug that would get you 10 years in prison if you bought it from anybody other than the legal corporate drug dealing establishments whose products actually have worse side effects than the illegal kind. And dig this: symptoms for ADHD are nearly as arbitrary as those for fybromyalgia or Lyme Disease--both of which were once considered non-ailments, malingerer's diseases. So, any random professional expert can observe a child acting like a child ("what? my child would rather be outside playing than inside at school being bored to death doing long division? Please prescribe a drug that will cause health complications later in life in addition to stunting their growth, killing their appetites and forming what might turn out to be a lifelong addiction, as well as creating a human now with a predilection toward addiction. A co-opted medical system profiting from selling useless AND dangerous chemicals as a bogus treatment for made-up illnesses. Another fun fact: for a drug to be approved by the FDA, all it has to demonstrate that it "as effective as the placebo," the sugar pill that makes "mind over matter" equally effective for your high cholesterol as the FDA approved $250 bottle of pills. So, if you get a disease, just convince yourself that consuming more sugar is the key to becoming healthy once again, Type II diabetes be damned.

Monday, December 16, 2013 by Common Dreams

Our Children are So Screwed

A twenty-year marketing campaign has made highly powerful stimulants into household names... and they're just getting started

- Jon Queally, staff writer


Having chemically-saturated the youth market, the drug marketeers for powerful stimulants like Adderall are now bringing their message to the adult masses. What came first: the disorder, the cure, or the marketing campaign to sell both?

“You’re talking about a product that’s having a major impact on brain chemistry. Parents are very susceptible to this type of stuff.” –Roger Griggs, pharma exec who now objects to ad campaigns

In the case of medicating a generation of children who were said to be "unusually hyperactive," the answer to that question is addressed by an in-depth investigation by the New York Times on Monday showing that the meteoric rise of diagnoses of attention deficit hyperactivity disorder (A.D.H.D.)—a trend that spawned a pharmaceutical gold rush over the last twenty years—was, in fact, fueled by an industry-led marketing campaign that targeted struggling children, worried parents, and an army of doctors willing to diagnose and prescribe.

And what's worse? The deep-pocketed, pill-pushers are now looking to expand.a 'Can't-Pay-Attention Nation'

As the Times reports:

The rise of A.D.H.D. diagnoses and prescriptions for stimulants over the years coincided with a remarkably successful two-decade campaign by pharmaceutical companies to publicize the syndrome and promote the pills to doctors, educators and parents. With the children’s market booming, the industry is now employing similar marketing techniques as it focuses on adult A.D.H.D., which could become even more profitable.

Dr. Keith Conners, a psychologist and professor emeritus at Duke University—who called the rising rates “a national disaster of dangerous proportions”—points out that though A.D.H.D is likely to occur in about 5 percent of the population, recent data from the Centers for Disease Control and Prevention show that the diagnosis had been made in 15 percent of high school-age children, and that the number of children on medication for the disorder soared from 600,000 in 1990 to 3.5 million today.
“The numbers make it look like an epidemic. Well, it’s not. It’s preposterous,” he told the Times in an interview. “This is a concoction to justify the giving out of medication at unprecedented and unjustifiable levels.”

In example after example, the marketing push created by the drug manufacturers show happy children and happy parents citing the wonders of the drugs, which go by their increasingly well-known names—stimulants like Adderall, Concerta, Focalin and Vyvanse, and nonstimulants like Intuniv and Strattera. As the Times reports,  

every single one of the companies who market these pills has been fined by the FDA for false advertising.

"The decision to start long-term medication should be motivated by observations of patients and physicians, not stimulated by rosy ads." –Kurt Stange, professor of family medicine

But the ads keep coming, it seems, because the ads work.

According to the Times:

Profits for the A.D.H.D. drug industry have soared. Sales of stimulant medication in 2012 were nearly $9 billion, more than five times the $1.7 billion a decade before, according to the data company IMS Health.

Even Roger Griggs, the pharmaceutical executive who introduced Adderall in 1994, said he strongly opposes marketing stimulants to the general public because of their dangers. He calls them “nuclear bombs,” warranted only under extreme circumstances and when carefully overseen by a physician.

Psychiatric breakdown and suicidal thoughts are the most rare and extreme results of stimulant addiction, but those horror stories are far outnumbered by people who, seeking to study or work longer hours, cannot sleep for days, lose their appetite or hallucinate. More can simply become habituated to the pills and feel they cannot cope without them.

According to Griggs and others, the idea that drugs like Adderall are being marketed directly to the public is perhaps the key flaw.

“There’s no way in God’s green earth we would ever promote” a controlled substance like Adderall directly to consumers, Mr. Griggs said as he was shown several advertisements. “You’re talking about a product that’s having a major impact on brain chemistry. Parents are very susceptible to this type of stuff.”

And Kurt Stange, a professor of family medicine and community health at Case Western Reserve University, agrees and recommends that this practice be banned.

In an op-ed published alongside the Times reporting, Stange writes:

Drugs have harms as well as benefits, and the harms are greater when drugs are indiscriminately prescribed. Consumer advertising, delivered to the masses as a shotgun blast, rather than as specific information to concerned patients or caregivers, results in more prescriptions and less appropriate prescribing.

There is no evidence that consumer ads improve treatment quality or result in earlier provision of needed care. Research has shown that the ads convey an unbalanced picture, with benefits and emotional appeals given far greater weight than risks. Clinicians can work to override these miscues, but this steals precious time from activities that can provide real benefit to patients. In the packed agenda of the patient visit, in which so many real concerns and evidence-based care are available to make a difference in people's lives, the intrusion of marketing risks harm.

Advertising also provokes a subtle shift in our culture -- toward seeking a pill for every ill. While there are many for whom stimulants and other medications can be a godsend, the case of attention deficit hyperactivity disorder is a prime example of how, too often, a pill substitutes for more human responses to distress. U.S. clinicians prescribe stimulant medication for A.D.H.D. at a rate 25 times that of their European counterparts. The complex decision to start a long-term medication should be motivated by the observations of teachers and parents and children, in the context of a relationship with a caring clinician − not stimulated by rosy ads.

 ~~~~~~~~~~~~~~

Isn't your child's health worth the risk of further increasing the obscene wealth of the officers, board and shareholders of  FDA approved and sanctioned legal corporate drug dealers? 

Why do you hate America?

7 Nasty Effects of BPA

BPA – The Plastic Chemical

by Mike Barrett
March 26th, 2013


Bisphenol A (BPA) is the widely used chemical found in many plastics, food can linings, and even on US dollars and receipts. Known as an endocrine-disrupting chemical that mimics the hormone estrogen, BPA has been linked to numerous negative health effects in countless studies. The worst part? While the Food and Drug Administration considered banning the chemical in March of 2012, the ban was denied, and BPA continues to be ubiquitous. So what exactly does mean? It means the entire U.S. is still subjected to the chemical’s negative effects.
Here are 7 nasty effects of BPA.

1. Breast Cancer

Breast cancer is slowly becoming one of the many well-known negative outcomes induced by BPA exposure. In fact, over 130 studies have confirmed the link between bisphenol A and to ailments like breast cancer, obesity, and reproductive problems. Ironically, the popular nonprofit Susan G. Komen for the Cure partners with many bottled water companies for their ‘For the Cure’ races across the nation. The problem, obviously, is that most of these plastic bottles contain BPA.

2. Early Puberty

While girls typically enter into puberty (or have in the past, at least) at just over ten years of age, studies show that this age has fallen by more than a year within only one generation. Some girls are even seeing breasts at 7 years old. Although there are other factors to consider, BPA may be to blame as well.

After examining 1,151 girls between the ages of 6 and 8 in the United States over a two year period, researchers found that multiple chemical classes were detected at high levels within the girls’ urine. About one-third of the girls went through puberty prematurely.

“Our research shows a connection between chemicals that girls are exposed to on a daily basis and either delayed or early development. While more research is needed, these data are an important first step in evaluating the impact of these common environmental agents in putting girls at risk,” lead researchers Dr Mary Wolff said.

3. Heart Disease

Some research has linked both BPA and phthalates to a disorder known as atherosclerosis. This disorder, which is the hardening of the arteries through the buildup of plaques, negatively impacts blood flow and ultimately increases your risk of heart disease. Shocking, the research is not the first of its kind. One team also found that individuals with higher levels of bisphenol-a in their urine were more than twice as likely to suffer from coronary heart disease than those with lower levels.

4. and 5. Infertility in Males and Females

Bisphenol a has been found to be adversely affecting male genital development, subsequently leading to compromised fertility health. One study examined the effects of BPA on the distance between the genitalia and the anus in males, known as the Anogenital distance (AGD). AGD is very important biologically for a number of reasons, and plays a prominent role in the health of one’s fertility. Researchers found that parental exposure to BPA during pregnancy was associated with shortened AGD in male offspring. In other words, high level BPA exposure led to offspring with AGD defects.

AGD has been linked to fertility in males, making BPA’s negative impact on the male reproductive system noteworthy. Men with an AGD lower than the median, which sits around 52 mm (2 in), have seven times the chance of being sub-fertile as compared to those with a longer AGD.

But males aren’t the only one’s suffering; BPA has been linked to reproductive issues in women as well. In one study, researchers found that BPA caused reproductive problems that can affect women, including abnormal egg development. The eggs of fetuses exposed to BPA had difficulty forming follicles, which ultimately increases the risk of eggs dying before maturation. Additionally, the researchers observed other abnormalities, showing signs that they would carry too many chromosomes as a result of not dividing during development. This could lead to miscarriages or disorders like Down Syndrome.

6. Sparks Multiple Negative Brain Alterations

Further adding on to BPAs long list of negative effects, some research has also found that the chemical disrupts a gene responsible for proper nerve cell function, ultimately leading to compromised brain development. Researchers of the study, published in the journal Proceedings of the National Academy of Sciences, discovered that BPA could damage central nervous system development by disrupting a gene called Kcc2.


“Our study found that BPA may impair the development of the central nervous system, and raises the question as to whether exposure could predispose animals and humans to neurodevelopmental disorders,” study researcher Dr. Wolfgang Liedtke, M.D., Ph.D., said.

Another study found that exposure to bisphenol-A early in life can spark changes in gene expression. The changes occur in a part of the brain called the amygdala, which can lead to increased levels of anxiety.

The study abstract states:


“Early life exposure to Bisphenol A (BPA), a component of polycarbonate plastics and epoxy resins, alters sociosexual behavior in numerous species including humans. The present study focused on the ontogeny of these behavioral effects beginning in adolescence and assessed the underlying molecular changes in the amygdala.”

7. Obesity

Last, but certainly not least, BPA may be one of many factors responsible for the obesity epidemic. One study found that high BPA exposure is associated with obesity in the general adult population in the U.S.

Another study, examining BPA concentrations in the urine of kids aged 6 to 19, found that obese children made up 22% of individuals with the highest BPA levels in their urine. About 10% of kids who had the lowest BPA concentration in their urine were obese.

Fluoride Is Literally Toxic Waste from the Phosphate Mining Industry

Chemicals Most Countries Ban Still Permitted in US Foods

Wednesday, January 23, 2013 by Common Dreams
Recent investigations highlight industry preference in FDA, expose frequent use of cheap and dangerous additives
- Lauren McCauley, staff writer

Spawned by a petition calling on Gatorade to remove a flame retardant from their sports drink, the Chicago Tribune released an investigation into the chemical ingredients that the United States and the Food and Drug Administration (FDA) are permitting despite frequent bans elsewhere.

Mississippi 15-year-old, Sarah Kavanagh, launched the Change.org petition after learning that Gatorade contains an emulsifier, brominated vegetable oil (or BVO), which is illegal to use as a food additive in the European Union, India, Nepal, Canada, Brazil and Japan because of its connection to reproductive and behavior problems.

"In the U.S. money rules and industry wields a lot of influence and that's how it has been for a while," said Michael Hansen, senior scientist at the Consumers Union, "but in Europe they take into serious consideration what their population wants, too. And why shouldn't the population be concerned about new things being put into food?"

Whereas other international authorities tend to err on the side of caution when it comes to evaluating food additives, in the US new food products "simply need an OK from experts hired by the manufacturers" giving the FDA the option to investigate later "if health issues emerge."

Though the FDA's mission is purportedly "to protect public health by ensuring that foods are safe and properly labeled," a second examination released Wednesday by the non-profit food watchdog, the U.S. Pharmacopeial Convention (USP), revealed that the amount of food fraud and mislabeled ingredients is up by 60 percent this year.

In comparison to their initial Food Fraud Database published in April 2012, the group found a surge in adulterated ingredients in common household products.

ABC News reports:

Among the most popular targets for unscrupulous food suppliers? Pomegranate juice, which is often diluted with grape or pear juice…additional sugar, or just water and sugar.

[Markus Lipp, senior director for Food Standards at an independent lab] added that there have also been reports of completely "synthetic pomegranate juice" that didn't contain any traces of the real juice.

USP tells ABC News that liquids and ground foods in general are the easiest to tamper with:

• Olive oil: often diluted with cheaper oils
• Lemon juice: cheapened with water and sugar
• Tea: diluted with fillers like lawn grass or fern leaves
• Spices: like paprika or saffron adulterated with dangerous food colorings that mimic the colors

Milk, honey, coffee and syrup are also listed by the USP as being highly adulterated products.

Also high on the list: seafood. The number one fake being escolar, an oily fish that can cause stomach problems, being mislabeled as white tuna or albacore, frequently found on sushi menus.

Kavanagh, whose personal dismay launched the Gatorade petition and subsequent investigation, said it "shows greed" when companies use chemical additives and cheaper ingredients that could cause health problems.

"It shows that they care less about consumers than about how much money they spend and make," she added.

Gatorade has stated that no changes are planned to its US drink formulation despite the over 200,000 signatures gathered calling for the ban.

Warning: Anti-Depressants Causing Birth Defects, Miscarriages

Friday, November 2, 2012

Lisa Garber | Activist Post

Pharmaceutical companies regularly embellish the benefits and downplay the dangers of anti-depressants, and all medications for that matter—but this time, their profits could be inadvertently endangering and even killing unborn infants. Senior doctors know it and are finally raising their voices.

Tufts University School of Medicine’s Dr. Adam Urato decries the practice of prescribing SSRIs to pregnant women. “Study after study shows increased rates of newborn complications in those babies who were exposed to SSRIs in-utero,” he says. These complications include greater risk of autism, lung and bowel diseases, and more.

Doctors Failing to Properly Warn of Risks

Selective serotonin reuptake inhibitors (SSRIs) are the most common form of anti-depressants, many of which are prescribed to pregnant mothers by “general practitioners, not psychiatrists,” according to Dr. Alice Domar of Harvard Medical School. “You come in and you say I’m not feeling very well, I’m feeling lethargic so the physician writes a prescription.”

Urato says that although not proven, the outcomes of over 40 studies linking SSRIs to the endangerment of an unborn child are troubling enough to warrant further research. Family doctors must also properly caution pregnant women about the risks involved in taking SSRIs during pregnancy. (Many doctors prescribe them anyway because, if the SSRI works to improve the mother’s mood, it would lead to “a better pregnancy result.”)

Urato says “there really is not a shred of evidence” supporting the benefits of anti-depressants for pregnant women.

Big Pharma Just Wants to Get Paid

Urato unapologetically points to Big Pharma. “It is a fact that these antidepressants have been very lucrative for the pharmaceutical industry…. It stands to reason to me that the drug makers would rather that the risks of these agents in pregnancy not receive widespread attention as that would be a reason for many women to not take the drugs in the first place or to stop taking them—both of which are not good for sales of the product.”

Downplaying the risks of drugs is hardly a new game for Big Pharma. In the name of profit, GlaxoSmithKline paid celebrity doctors—like Dr. Drew—to push and make off-label claims of drugs. It’s also been found that 70 percent of advisors to the newest edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) have financial ties to pharmaceutical companies.

Not even the government is immune to funding. Although the Food and Drug Administration admits that antidepressants can worsen depression and increase risk of suicide, the public and private sectors alike push ineffective and harmful antidepressants on patients. This will likely continue despite an increasing number of studies linking SSRIs to pulmonary hypertension and cardiovascular malformations in newborns.

Be wary of taking medication during pregnancy, especially anti-depressants. “If you add up all the potential risks,” Domar says, “a lot of people would say they are unacceptable.”

Additional Sources:
The Telegraph
PubMed

FDA to Ban BPA from Baby Bottles; Plan Falls Short of Needed Protections: Scientists

The FDA, always getting to the party after everyone has already gone home and blogged about it. --jef

Tuesday, July 17, 2012 by Common Dreams

The US Food and Drug Administration announced Tuesday that the chemical bisphenol-A (BPA) is now officially banned from the manufacturing of baby bottles and sippy cups -- a move that researchers say still falls short of sufficient regulation. Environmental groups say more should be done to ban BPA from all consumer products including infant formula and food and beverage packaging, which are not included under the new rules.
 
 The F.D.A. said that its decision was a response to a request by the American Chemistry Council, the chemical industry’s main trade association, that rules allowing BPA in those products be phased out, in part to boost "consumer confidence."

The Environmental Working Group says the move is purely cosmetic, as most companies have already stopped using BPA for baby bottles and sippy cups due to public pressure. Allowing BPA to go unchallenged in products it is actually still used in is a blow to the anti-BPA fight.

“Once again, the FDA has come so late to the party that the public and the marketplace have already left,” said Jason Rano, Director of Government Affairs for EWG. “If the agency truly wants to prevent people from being exposed to this toxic chemical associated with a variety of serious and chronic conditions it should ban its use in cans of infant formula, food and beverages."

BPA is a synthetic estrogen that scientists say can disrupt the hormone system, interfere with development of the reproductive and nervous systems in babies and young children, and is likely carcinogenic.

In the US, BPA is an almost ubiquitous substance found in most food packaging, water bottles, and dental sealants. Roughly 90 percent of Americans have traces of BPA in their urine, due to exposure. Traces have also been found in breast milk, the blood of pregnant women and umbilical cord blood.

“This is only a baby step in the fight to eradicate BPA. To truly protect the public, FDA needs to ban BPA from all food packaging. This half-hearted action—taken only after consumers shifted away from BPA in children’s products — is inadequate. FDA continues to dodge the bigger questions of BPA’s safety,” said Dr. Sarah Janssen, senior scientist in the public health program at Natural Resources Defense Council.

FDA Engaged in Widespread Spying on Whistleblowers

Sunday, July 15, 2012 by Common Dreams
The Food and Drug Administration (FDA) engaged in widespread spying on its own scientists, a New York Times story exposes.

The surveillance began over a group of scientists "claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation," the Times reports.

The Times explains that the FDA used "spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show."

Stephen M. Kohn, the Executive Director of the National Whistleblower Center and the lead attorney for the FDA whistleblowers, says that the surveillance program described in the Times "was illegal. The story demonstrated how government mangers used a covert spying program to interfere with the ability of federal employees to lawfully report significant threats to the public safety to Congress, law enforcement officials and the American people. We hope that these public disclosures will mark the beginning of the end of government spying on employees who report misconduct to the appropriate authorities."

"It is well established that American citizens do not forgo their First or Fourth Amendment Constitutional rights when they work for the government. The opposite is true. The U.S. Supreme Court and numerous lower courts have recognized the importance of protecting government workers who expose wrongdoing. These protections are vital to a democratic society. Government whistleblowers are often the most important source of information exposing government misconduct, corruption and the waste of taxpayer money."

"The conduct by FDA managers, designed to undermine a group of doctors and scientists who reported significant health and safety violations, is deplorable. Those involved must be held accountable," stated Kohn.

GlaxoSmithKline settles healthcare fraud case for $3 billion

By David Ingram - Reuters

WASHINGTON (Reuters) – GlaxoSmithKline Plc agreed to plead guilty to misdemeanor criminal charges and pay $3 billion to settle what government officials on Monday described as the largest case of healthcare fraud in U.S. history.

The agreement, which still needs court approval, would resolve allegations that the British drugmaker broke U.S. laws in the marketing and development of pharmaceuticals.

GSK targeted the antidepressant Paxil to patients under age 18 when it was approved for adults only, and it pushed the drug Wellbutrin for uses it was not approved for, including weight loss and treatment of sexual dysfunction (one of its side effects is sexual dysfunction), according to an investigation led by the U.S. Justice Department.

The company went to extreme lengths to promote the drugs, such as distributing a misleading medical journal article and providing doctors with meals and spa treatments that amounted to illegal kickbacks, prosecutors said.

In a third instance, GSK failed to give the U.S. Food and Drug Administration safety data about its diabetes drug Avandia, in violation of U.S. law, prosecutors said.

The misconduct continued for years beginning in the late 1990s and continued, in the case of Avandia’s safety data, through 2007. GSK agreed to plead guilty to three misdemeanor criminal counts, one each related to the three drugs.

Guilty pleas in cases of alleged corporate misconduct are exceedingly rare, making GSK’s agreement especially unusual.

The agreement to settle the charges “is unprecedented in both size and scope,” said James Cole, the No. 2 official at the U.S. Justice Department. He called the action “historic” and “a clear warning to any company that chooses to break the law.”

The settlement includes $1 billion in criminal fines and $2 billion in civil fines.

GSK said in a statement it would pay the fines through existing cash resources. The company announced a $3 billion charge in November related to legal claims [ID:nL5E7M315A].

NEW ‘ERA’ AT GSK

Chief Executive Officer Andrew Witty said the misconduct originated “in a different era for the company” and will not be tolerated. “I want to express our regret and reiterate that we have learnt from the mistakes that were made,” he said in a written statement.

The GSK settlement surpasses what had been the largest criminal case involving a drugmaker in U.S. history. In 2009, Pfizer Inc agreed to pay $2.3 billion to settle allegations it improperly marketed 13 drugs.

The cases follow a trend of U.S. authorities cracking down on how pharmaceuticals are sold, in part because of the rising cost of providing drugs through government programs.

Part of civil fines address allegations that, from 1994 to 2003, GSK underpaid money owed to Medicaid, the healthcare program for the poor run jointly by states and the federal government. The company had an obligation to tell the government its “best prices” but failed to do so, prosecutors said, and $300 million of the settlement will go to states and other public health authorities.

A portion of the $2 billion in civil fines may go to a group of whistleblowers who contributed to the government’s investigation and who are eligible to share in the recovery under the False Claims Act. Cole said the amount has not been determined.

‘INTEGRITY’ PLAN

As part of the settlement, GlaxoSmithKline agreed to new restrictions by the U.S. government to prevent the use of kickbacks or other prohibited practices. The inspector general of the U.S. Department of Health and Human Services will oversee the “Corporate Integrity Agreement” for five years.

The company will not be able to compensate its salesmen based on sales goals for territories. It was also required to change its executive compensation program to allow the company to “claw back” certain pay for those engaged in misconduct.

Witty said GSK’s U.S. unit has “fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct.”

Prosecutors have not brought criminal charges against any individuals in connection with the GSK case, although the settlement expressly leaves open that possibility. Cole declined to comment on the possibility of future charges.

Almost exactly a year ago GSK agreed to pay nearly $41 million to 37 states and the District of Columbia in an unrelated case about substandard manufacturing processes at a Puerto Rico factory.

In 2010, the company took a $2.4 billion charge in connection with Avandia to settle claims from patients.

GSK’s shares were positive on the New York Stock Exchange on Monday, up 1.6 percent to $46.29 at 1400 EDT.

The case is U.S. v. GlaxoSmithKline LLC, U.S. District Court for the District of Massachusetts, No. 12-cr-10206.

Should the FDA approve Big Pharma marketing drug treatments to healthy people?

Monday, May 21, 2012 by: Melissa Melton

(NaturalNews) This week, the U.S. Food and Drug Administration (FDA) will consider allowing an anti-HIV drug to be promoted to otherwise healthy, HIV-free people as a purely preventative measure for the first time. If approved, Gilead Sciences will be able to market Truvada to anyone who might be considered "at risk" for contracting the disease based on lifestyle and other factors (such as sexual orientation). Normally, HIV-infected patients take Truvada to slow viral replication. Under the new guidelines, doctors would begin openly touting this therapy as a glorified prophylactic to people who do not have HIV based on fear they might contract it someday (and all at the low price of just $14,000 a year).

According to Truvada's own website, treatment side-effects may include lactic acidosis, a serious medical condition that can lead to death. Truvada patients can suffer impaired kidney function and "serious liver problems" such as enlargement and hepatotoxicity. In lab tests, Truvada has also been shown to cause osteopenia or changes in bones that make them more susceptible to fractures.

One of the two studies used to back this new approval push was funded by none other than the Bill and Melinda Gates Foundation. This is the same organization that financially backed untested polio vaccines recently linked to more than 47,000 cases of paralysis in India. Bill Gates has also espoused the idea that money used to provide end-of-life care to the elderly could be better spent paying teacher salaries instead (Youtube.com).

So far, FDA response has been favorable. With the organization's recent proposal to make many prescription drugs available over-the-counter (thus maximizing use and profits), it is hardly surprising. The problem with allowing medications to be marketed this way is that it opens the door for all pharmaceutical companies to start requesting allowances to market all kinds of drugs to otherwise healthy people purely under the guise of fear masked as prevention. Under this logic, should overweight people considered to have poor diet and exercise habits start taking insulin shots to prevent type 2 diabetes? Should someone with a family history of cancer take chemotherapy treatments just in case? Where does the line get drawn? If approved, this decision will be a slippery slope rife with so much potential for Big Pharma abuse, it is hard to even contemplate.

Though it may be stating the overly obvious, instead of pushing expensive and potentially dangerous medical treatments on otherwise healthy people, would it not make more sense to simply work harder to promote healthier lifestyle choices?

Sources for this article include:

http://online.wsj.com/article

http://www.naturalnews.com/035627_polio_vaccines_paralysis_India.html

http://www.msnbc.msn.com/id/47340784

Scientists Cry Fowl Over the FDA's Regulatory Failure

Friday, April 27, 2012 by the Guardian/UK
Overuse of antibiotics in factory farming kills thousands every year, yet the industry is force-feeding chickens pharmaceuticals
by Richard Schiffman


In 2005, the antibiotic fluoroquinolone was banned by the FDA for use in poultry production. The reason for the ban was an alarming increase in antibiotic-resistant campylobacter bacteria in the meat of chickens and turkeys – "superbugs", which can lead to a lethal form of meningitis that our current antibiotics are no longer effective against.

Antibiotic-resistant infections kill tens of thousands of people every year, more than die of AIDS, according to the Infectious Diseases Society of America. This problem is on the rise because antibiotics are recklessly overused, especially in the commercial livestock industry, where 80% of all antibiotics manufactured in the US end up.

Fluoroquinolone used to be fed to chickens primarily to stimulate their growth. But why did the banned substance show up recently in eight of 12 samples of "feather meal", the ground-down plumage leftover from commercial poultry production?

This was just one of the mysteries uncovered in a study conducted jointly by the Johns Hopkins Center for a Livable Future and Arizona State University. The research, published last month in the journal Environmental Science & Technology, uncovered a whole slew of other drugs in the feather meal that the scientists had not expected to find there.

Traces of the arsenic compound Roxarsone, for example, were present in almost all of the samples. Farms administer arsenic to chickens to turn their flesh just the right shade of pink that consumers find attractive. Yet, in June 2011, the FDA gave Pfizer 30 days to discontinue selling Roxarsone, a proven carcinogen. So why is it still showing up in our chickens?

Other substances that the scientists found include acetaminophen, the active ingredient in Tylenol, Benadryl, an antihistamine, even Prozac, an antidepressant. Farms feed chickens these mood-altering drugs to reduce their anxiety. Chickens are anxious because they are bred on overcrowded and filthy factory farms. Stressed-out birds develop meat that is tough and unpalatable, so they need to be sedated. Yet, chickens on tranquilizers sleep all the time and do not eat enough. So they are given high doses of caffeine (which was also found in the feather meal) to keep them awake at night to feed and fatten up.

So, here is the deal. We create hellish conditions for our livestock, then we drug them to keep them numb. Then we drug them again to wake them from their pharmaceutical stupor. Then we drug them to grow faster. Then we drug them so their flesh will look healthier. Then we drug them to withstand the disease epidemics that our overcrowding has created.

Then, of course, we drug ourselves every time we take a bite of factory-farmed poultry.

"We were kind of floored," Keeve E Nachman, a co-author of the study told the New York Times. "It's unbelievable what we found." While Nachman says that the levels of arsenic and the witches' brew of other drugs and chemicals in the chicken samples may not be high enough to harm humans, he is not betting his own health on it.

"I've been studying food-animal production for some time," the researcher said, "and the more I study, the more I'm drawn to organic. We buy organic [in my family]."

"So, here is the deal. We create hellish conditions for our livestock, then we drug them to keep them numb. Then we drug them again to wake them from their pharmaceutical stupor. Then we drug them to grow faster. Then we drug them so their flesh will look healthier. Then we drug them to withstand the disease epidemics that our overcrowding has created... Then, of course, we drug ourselves every time we take a bite of factory-farmed poultry."Organic chickens are bred without artificial growth hormones and antibiotics. They are fed organically grown vegetable foods rather than the ground-up animal products – bones, feathers, blood, excrement, fishmeal and diseased animal parts – which their conventionally grown brethren receive. They are also raised free-range with plenty of space, sunlight and opportunities for exercise to keep them healthy. A 2001 study conducted at the University of Perugia found that chickens produced this way actually taste better than conventionally bred birds.

Yet, organic poultry is a lot more expensive to raise. While the market is growing steadily for organic birds, it still comprises less than 1% of the poultry sold in the US today (pdf). So, food scientists argue that the standards for conventional chickens and turkeys need to be strengthened.

"We strongly believe that the FDA should monitor what drugs are going into animal feed," Keeve Nachman urged, adding that, based on what the researchers discovered, they had little confidence that the animal food production industry could be left to regulate itself.

Earlier this month, the FDA announced what looked at first glance like sweeping new guidelines on the use of antibiotics in livestock. The new rules, however, are strictly "voluntary", and, while they do recommend restricting the use of antibiotics to stimulate growth, they would still allow them to be prescribed by a veterinarian for animals that are "either sick or at risk of getting a specific illness".

Critics contend that the words "at risk of getting a specific illness" provide factory poultry farms a loophole big enough to drive a truck through. Margaret Mellon, senior scientist at the Union of Concerned Scientists, said in a press statement:


"The outlined process appears to give the companies the opportunity to relabel drugs currently slated for growth promotion for disease prevention instead. Such relabeling could allow them to sell the exact same drugs in the very same amounts."

Public interest groups like the Union of Concerned Scientists say the time has come for the FDA to stop proposing half-measures and demonstrate that it is serious about preventing a looming public health disaster. It needs to ban dangerous antibiotic use in the raising of livestock, and to conduct rigorous on-site inspections to insure that the ban is enforced.

Our Chemical Cocktail Evaluated in New Report

Friday, April 20, 2012 by Civil Eatsby Paula Crossfield

When it comes to the chemicals used in food packaging, there is much we still don’t know. After a recent U.S. Food & Drug Administration (FDA) decision last month to not put further restrictions on bisphenol-A (BPA), a new report today in the Washington Post takes a closer look at studies that reveal that such endocrine-distrupting chemicals are not only ubiquitous, they might also be harmful at much lower doses than previously thought.

The FDA allows around 3,000 chemicals, including BPA and phthalates–a family of chemicals used in lubricants and solvents and to make polyvinyl chloride pliable–at low doses, long considering them additives though they migrate from the packaging instead of being purposefully added by the food manufacturer. But these chemicals are notoriously hard to trace, and have not been studied for their cumulative effects.

“Finding out which chemicals might have seeped into your groceries is nearly impossible, given the limited information collected and disclosed by regulators, the scientific challenges of this research and the secrecy of the food and packaging industries, which view their components as proprietary information,” writes Freinkel, author of Plastic: A Toxic Love Story, who wrote this story in collaboration with the Food & Evironment Reporting Network. “Although scientists are learning more about the pathways of these substances–and their potential effect on health–there is an enormous debate among scientists, policymakers and industry experts about what levels are safe.”

What has scientists worried is the fact that endocrine disrupters like these interfere with the body’s natural hormone system. Animals studies on BPA, for example, have found that doses of the chemical below the FDA-approved threshold administered during critical stages of development can effect behavior, breast and prostate cells, and brain structure and chemistry. According to recent studies, around 90 percent of Americans have BPA inside their bodies.

Freinkel explains how plastic food packaging is a major source of these potentially harmful chemicals. Other studies have shown phthalates passing into food from processing equipment and food-prep gloves, gaskets and seals on non-plastic containers, inks used on labels–which can permeate packaging–and even the plastic film used in agriculture.

The report highlights an upcoming study that found a particular phthalate, called DEHP, in many of the 72 different grocery items evaluated. Studies have associated low-dose exposure to this chemical with male reproductive disorders, thyroid dysfunction, and subtle behavioral changes.
Last month, the FDA denied a petition to ban BPA, saying in a statement that while “some studies have raised questions as to whether BPA may be associated with a variety of health effects, there remain serious questions about these studies, particularly as they relate to humans and the public health impact.”

You can read the full report here on the Food & Environment Reporting Network’s Web site, which also features additional reporting on the topic.

Chinese Melamine or American Vioxx: Half a million dead and no questions asked

Valuing Human Life in China and the U.S: Take Your Pick

by RON UNZ

In contrasting China and America, pundits often cite our free and independent media as one of our greatest strengths, together with the tremendous importance which our society places upon individual American lives. For us, a single wrongful death can sometimes provoke weeks of massive media coverage and galvanize the nation into corrective action, while life remains cheap in China, a far poorer land of over a billion people, ruled by a ruthless Communist Party eager to bury its mistakes. But an examination of two of the greatest public-health scandals of the last few years casts serious doubt on this widespread belief.  

What follows is an extraordinary report by Ron Unz, publisher of the American Conernative, part of his larger feature just published by the TAC,  “China’s Rise, America’s Fall. “ Ron makes the charge that perhaps 500,000 or more premature American deaths may have resulted from Vioxx, a figure substantially larger than the 3,468 deaths of named individuals acknowledged by Merck during the settlement of its lawsuit. And almost no one among our political or media elites seems to know or care about this possibility. 

Ron writes to us : “I remember back in 2005, I was reading my morning newspapers, as I always do, and noticed those tiny, buried items about the unprecedented drop in the American death rate.  Hmm I said, I wonder if that might have anything to do with all those other stories about that deadly drug recently taken off the market and all the resulting lawsuits.  I never got around to looking into it, and apparently nobody in the media did either.  

“Then, a few weeks ago, I was talking to Dan McCarthy the TAC Editor, complaining to him about how totally incompetent and dishonest the MSM was, and mentioned the totally ignored 2005 mortality drop as an excellent example.  He’d obviously never heard of it and had also completely forgotten about the Vioxx scandal, but said I really should think about writing something up.  So I decided to combine it with some of those other things about China I’d been complaining that the MSM tended to distort or ignore.  

“When I went to the CDC website, it only took me about 10 minutes to get the public data confirming that just as I’d guessed, Vioxx had probably killed around 500,000 Americans, but virtually nobody in the whole country knew or cared.  It’s a little like if a meteor destroyed Pittsburgh and killed everyone there, but the media never reported it, would anyone really notice?  From a philosophical perspective, if nobody knows about it, did it even really happen?” 

First, consider the details of the Chinese infant formula scandal of 2008. Unscrupulous businessmen had discovered they could save money by greatly diluting their milk products, then adding a plastic chemical compound called melamine to raise the apparent protein content back to normal levels. Nearly 300,000 babies throughout China had suffered urinary problems, with many hundreds requiring lengthy hospitalization for kidney stones. Six died. A wave of popular outrage swept past the controlled media roadblocks and initial government excuses, and soon put enormous pressure on Chinese officials to take forceful action against the wrongdoers.

China’s leaders may not be democratically elected, but they pay close attention to strong popular sentiment. Once pressed, they quickly launched a national police investigation which led to a series of arrests and uncovered evidence that this widespread system of food adulteration had been protected by bribe-taking government officials. Long prison sentences were freely handed out and a couple of the guiltiest culprits were eventually tried and executed for their role, measures that gradually assuaged popular anger. Indeed, the former head of the Chinese FDA had been executed for corruption in late 2007 under similar circumstances.

Throughout these events, American media coverage was extensive, with numerous front-page stories in our leading newspapers. Journalists discovered that similar methods of dangerous chemical adulteration had been used to produce Chinese pet food for export, and many family dogs in America had suffered or died as a result. With heavy coverage on talk radio and cable news shows, phrases such as “Chinese baby formula” or “Chinese pet food” became angry slurs, and there was talk of banning whole categories of imports from a country whose product safety standards were obviously so far below those found in Western societies. The legitimate concerns of ordinary Americans were fanned by local media coverage that sometimes bordered on the hysterical.

However, the American media reaction had been quite different during an earlier health scandal much closer to home.

In September 2004, Merck, one of America’s largest pharmaceutical companies, suddenly announced that it was voluntarily recalling Vioxx, its popular anti-pain medication widely used to treat arthritis-related ailments. This abrupt recall came just days after Merck discovered that a top medical journal was about to publish a massive study by an FDA investigator indicating that the drug in question greatly increased the risk of fatal heart attacks and strokes and had probably been responsible for at least 55,000 American deaths during the five years it had been on the market.

Within weeks of the recall, journalists discovered that Merck had found strong evidence of the potentially fatal side-effects of this drug even before its initial 1999 introduction, but had ignored these worrisome indicators and avoided additional testing, while suppressing the concerns of its own scientists. Boosted by a television advertising budget averaging a hundred million dollars per year, Vioxx soon became one of Merck’s most lucrative products, generating over $2 billion in yearly revenue. Merck had also secretly ghostwritten dozens of the published research studies emphasizing the beneficial aspects of the drug and encouraging doctors to widely prescribe it, thus transforming science into marketing support. Twenty-five million Americans were eventually prescribed Vioxx as an aspirin-substitute thought to produce fewer complications.

Although the Vioxx scandal certainly did generate several days of newspaper headlines and intermittently returned to the front pages as the resulting lawsuits gradually moved through our judicial system, the coverage still seemed scanty relative to the number of estimated fatalities, which matched America’s total losses in the Vietnam War. In fact, the media coverage often seemed considerably less than that later accorded to the Chinese infant food scandal, which had caused just a handful of deaths on the other side of the world.

The circumstances of this case were exceptionally egregious, with many tens of thousands of American deaths due to the sale of a highly lucrative but sometimes fatal drug, whose harmful effects had long been known to its manufacturer. But there is no sign that criminal charges were ever considered.

A massive class-action lawsuit dragged its way through the courts for years, eventually being settled for $4.85 billion in 2007, with almost half the money going to the trial lawyers. Merck shareholders also paid large sums to settle various other lawsuits and government penalties and cover the heavy legal costs of fighting all of these cases. But the loss of continuing Vioxx sales represented the greatest financial penalty of all, which provides a disturbing insight into the cost-benefit calculations behind the company’s original cover-up. When the scandal broke, Merck’s stock price collapsed, and there was a widespread belief that the company could not possibly survive, especially after evidence of a deliberate corporate conspiracy surfaced. Instead, Merck’s stock price eventually reached new heights in 2008 and today is just 15 percent below where it stood just before the disaster.

Furthermore, individuals make decisions rather than corporate entities, and none of the individuals behind Merck’s deadly decisions apparently suffered any serious consequences. The year after the scandal unfolded, Merck’s long-time CEO resigned and was replaced by one of his top lieutenants, but he retained the $50 million in financial compensation he had received over the previous five years, compensation greatly boosted by lucrative Vioxx sales. Senior FDA officials apologized for their lack of effective oversight and promised to do better in the future. American media conglomerates quietly mourned their loss of heavy Vioxx advertising, but continued selling the same airtime to Merck and its rivals for the marketing of other, replacement drugs, while their investigative arms soon focused on the horrors of tainted Chinese infant food and the endemic corruption of Chinese society.

This story of serious corporate malfeasance largely forgiven and forgotten by government and media is depressing enough, but it leaves out a crucial factual detail that seems to have almost totally escaped public notice. The year after Vioxx had been pulled from the market, the New York Times and other major media outlets published a minor news item, generally buried near the bottom of their back pages, which noted that American death rates had suddenly undergone a striking and completely unexpected decline.

The headline of the short article that ran in the April 19, 2005 edition of USA Today was typical: “USA Records Largest Drop in Annual Deaths in at Least 60 Years.” During that one year, American deaths had fallen by 50,000 despite the growth in both the size and the age of the nation’s population. Government health experts were quoted as being greatly “surprised” and “scratching [their] heads” over this strange anomaly, which was led by a sharp drop in fatal heart attacks.

On April 24, 2005, the New York Times ran another of its long stories about the continuing Vioxx controversy, disclosing that Merck officials had knowingly concealed evidence that their drug greatly increased the risk of heart-related fatalities. But the Times journalist made no mention of the seemingly inexplicable drop in national mortality rates that had occurred once the drug was taken off the market, although the news had been reported in his own paper just a few days earlier.

A cursory examination of the most recent 15 years worth of national mortality data provided on the Centers for Disease Control and Prevention website offers some intriguing clues to this mystery. We find the largest rise in American mortality rates occurred in 1999, the year Vioxx was introduced, while the largest drop occurred in 2004, the year it was withdrawn. Vioxx was almost entirely marketed to the elderly, and these substantial changes in national death-rate were completely concentrated within the 65-plus population. The FDA studies had proven that use of Vioxx led to deaths from cardiovascular diseases such as heart attacks and strokes, and these were exactly the factors driving the changes in national mortality rates.

The impact of these shifts was not small. After a decade of remaining roughly constant, the overall American death rate began a substantial decline in 2004, soon falling by approximately 5 percent, despite the continued aging of the population. This drop corresponds to roughly 100,000 fewer deaths per year. The age-adjusted decline in death rates was considerably greater.

Patterns of cause and effect cannot easily be proven. But if we hypothesize a direct connection between the recall of a class of very popular drugs proven to cause fatal heart attacks and other deadly illnesses with an immediate drop in the national rate of fatal heart attacks and other deadly illnesses, then the statistical implications are quite serious. Perhaps 500,000 or more premature American deaths may have resulted from Vioxx, a figure substantially larger than the 3,468 deaths of named individuals acknowledged by Merck during the settlement of its lawsuit. And almost no one among our political or media elites seems to know or care about this possibility. A recent Wall Street Journal column even called for relaxing FDA restrictions aimed at avoiding “rare adverse events,” which had been imposed after the discovery of “unanticipated side effects of high-profile drugs like Vioxx.”

There are obvious mitigating differences between these two national responses. The Chinese victims were children, and their sufferings from kidney stones and other ailments were directly linked to the harmful compounds that they had ingested. By contrast, the American victims were almost all elderly, and there was no means of determining whether a particular heart attack had been caused by Vioxx or other factors; the evidence implicating the drug was purely statistical, across millions of patients. Furthermore, since most of the victims were anyway nearing the end of their lives, the result was more an acceleration of the inevitable rather than cutting short an entire young life, and sudden fatal heart attacks are hardly the most unpleasant forms of death.

But against these important factors we must consider the raw numbers involved. American journalists seemed to focus more attention on a half-dozen fatalities in China than they did on the premature deaths of as many as 500,000 of their fellow American citizens.

The inescapable conclusion is that in today’s world and in the opinion of our own media, American lives are quite cheap, unlike those in China.

Researchers Hid, Ignored Bad Results in Massive Drug Trial Corruption

April 17, 2012
Patrick Gallagher | NaturalSociety

Pharmaceutical medication has always been very highly regarded in society, and its continued use shows that many individuals seem to use it without knowing — or more likely, even thinking — about the content of the drugs that they so hastily consume. Recently there has been yet another study that shows the Food and Drug Administration, trusted by millions and yet funded with trillions to overlook some of the most detrimental health risks, cares even less about drug trial regulation than previously thought.

The study reveals the varied corruption deeply rooted within the FDA, vying for approval of drugs that serve no medical purpose, sometimes with more harmful effects than good. Specifically, the drug Tamiflu (oseltamivir) — the drug praised as the be all end all cure for the ‘deadly swine flu epidemic‘.

The entire article debunks the use and distribution of the effectively worthless drug, as well as the FDA’s reasons for approval:

“If sales can be considered a proxy for utility, the controversies surrounding even the most successful drugs (such as blockbuster drugs) seem all the more paradoxical, and have revealed the extent to which the success of many drugs has been driven by sophisticated marketing rather than verifiable evidence… Prior to the global outbreak of H1N1 influenza in 2009, the United States alone had stockpiled nearly US$1.5 billion dollars worth of the [drug].”

The researchers continue:

“This analysis, conducted by Kaiser and colleagues, proposed that oseltamivir treatment of influenza reduced both secondary complications and hospital admission. In contrast, the Food and Drug Administration (FDA), which approved Tamiflu in 1999 and was aware of these same clinical trials, concluded that Tamiflu had not been shown to reduce complications, and required an explicit statement in the drug’s label to that effect.”

This study only covers one single drug that has only been approved solely for profiteering; the FDA is known to have approved thousands upon thousands of commercial drugs from the big pharmaceutical corporations over the decades, with many questioning their serious side effects. Such is the case with highly-popular cancer drugs, which have been shown to make cancer worse and actually kill the patient more quickly. It has become abundantly clear that citizens cannot and should not place any sort of trust in many of these corporate-pushed these medications and their supposed ‘benefits’.

Cited:http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001201http://blogs.mercola.com/sites/vitalvotes/archive/2012/04/13/massive-corruption-revealed-to-be-at-the-core-of-many-drug-approvals.aspx

FDA Deletes 1 Million Signatures for GMO Labeling Campaign

Mike Barrett - March 30, 2012
BlacklistedNews
While the Food and Drug Administration has seemingly reached the limit for unbelievable behavior, the agency’s decisions continue to astound and appall consumers and health activists alike. In the agency’s latest decision, undoubtedly amazing thousands of individuals yet again, the FDA virtually erased 1 million signatures and comments on the ‘Just Label It’ campaign calling for the labeling of genetically modified foods.

FDA Deletes 1 Million Signatures for GMO Labeling Campaign

The ‘Just Label It” campaign has gotten more signatures than any campaign in history for the labeling of genetically modified foods. Since October of 2011, the campaign has received over 900,000 signatures, with 55 politicians joining in on the movement. So what’s the problem here?

Evidently, the FDA counts the amount of signatures not by how many people signed, but how many different individual letters are brought to it. To the FDA, even tens of thousands of signatures presented on a single petition are counted as – you guessed it – a single comment. This is how, despite over a million supporters being gathered by the petition, the FDA concluded a count of only 394.

“This is an election year and there are more than a million people who say this is important to them. This is petition has nothing to do with whether or genetically modified foods are dangerous. We don’t label dangerous foods, we take them off the shelves. This petition is about a the citizens’ right to know what they are eating and whether or not these foods represent a novel change.” said Andrew Kimbrell an attorney for the Center for Food Safety, one of the partner groups on the Just Label It campaign.

The argument as to whether genetically modified foods are dangerous is a whole discussion on its own, but for the FDA to completely sidestep away from the labeling of GM foods is completely and utterly irresponsible. Consumers have every right to know what they are consuming. Needless to say, biotechology giant Monsanto the devil is against GMO labeling, claiming that it would mislead consumers since GMOs are ‘perfectly safe’. Of course there is plenty of evidence proving that GMOs are not completely safe, and how they affect life in the long-term is questionable to say the least. Either way, there is enough controversy surrounding the issue which is cause for alarm for millions of people, and Monsanto’s opinion on GMOs safety is a sorry excuse for not labeling foods as GM. Is the FDA avoiding such an issue because so many ties exist between genetically modified makers like Monsanto and the agency?

The bottom line is that you have the right to know what is in your food, and what your food IS. Denying that right, whether it be by the essential deletion of millions of signatures on a petition, or by ignoring the voices of thousands of people on the street, is taking power away from the people.

Money Talks, Science Walks: Millions Spent to Weaken FDA

Friday, March 30, 2012 by Common Dreams
Pharmaceutical, medical device, biotechnology industries spend $700 million ahead of crucial legislation

 

According to the Union of Concerned Scientists (UCS), the pharmaceutical, medical device, and biotechnology industries spent over $700 million in lobbying between 2009 and 2011, surpassing other special interest spending such as big oil and insurance industries.

The extreme spending comes as this year's 'industry-friendly proposals' face the House and Senate, such as legislation limiting the FDA’s drug and medical device scrutiny.

"Congress is also considering legislation that would relax conflict-of-interest standards for federal advisory members at the FDA, allowing scientists with a financial stake in the outcome to vote on panels that approve or reject drugs and medical devices," states UCS.

* * *

Drug and Health Product Industry Spent $700 Million on Lobbying (UCS):

Pharmaceuticals companies and related trade groups spent more than $487 million on lobbying over this three-year period, while biotechnology firms and their trade groups spent more than $126 million and device manufacturers and their trade groups spent more than $86 million.

By comparison, the oil and gas industry spent more than $467 million and the insurance industry spent nearly $481 million during the same three-year period.

While these companies differ in their specific objectives, a central lobbying target for all of them is the Food and Drug Administration (FDA), which must evaluate new drugs and medical devices for safety and efficacy as well as monitor them after they enter the market.

“All this money skews the debate and diminishes the public’s voice on these issues,” said Francesca Grifo, director of the Union of Concerned Scientists’ Scientific Integrity Program. “What’s at stake here is FDA’s ability to make independent, science-based decisions that affect our health and safety.” [...]

The analysis also showed that these industries were generous with their campaign contributions, giving nearly $6.3 million to 70 lawmakers who served on relevant committees from 2009 through 2011.

This year, several industry-friendly proposals are pending in both the House and Senate, including legislation that would reduce the FDA’s scrutiny of medical devices, relax conflict-of-interest standards at the agency, and emphasize speed and innovation over adherence to the FDA’s science-based standards for safe and effective drugs and devices.

* * *

Money Talks, and What It’s Saying May Harm the FDA (UCS/Celia Wexler):

This year, Congress has proposed changes that would harm the agency’s ability to protect public health and safety. It would be a lot easier for drug, device and biotech industries to get their products to market, in some cases with even less scrutiny than the FDA gives these products now. [...]

What do all those millions buy? Public Citizen recently reported that during the third and fourth quarters of 2011, at least 225 lobbyists walked the halls of Congress and executive branch agencies, making the case for medical device companies. All those boots on the ground build relationships with the key congressional and executive branch players in Washington.

The same holds for campaign contributions. Donations to Members of Congress don’t buy votes. But they do buy access. It’s a lot easier to get the ear of a member of Congress when you’re at a fundraising cocktail party and you can just walk over and have a casual chat. The member of Congress can ensure that the chat is followed up with an in-depth discussion with his or her senior aides.

The money these companies give is smart money. It’s targeted where it has the greatest impact. As we report today, key members of one House subcommittee and one Senate committee received nearly $6.3 million in campaign contributions since 2009.