Posts Tagged Food and Drug Administration

Neotame the next aspartame? FDA doesn’t require labeling of chemical sweetener created by Monsanto

via: NaturalNews
Monday, February 06, 2012
By: Jonathan Benson

[NaturalNews] Correction: The original version of this article stated that some U.S. Department of Agriculture certified organic products may contain neotame. Since the publishing of this article, NaturalNews has obtained a letter from the USDA’s National Organic Program Deputy Administrator, Miles McEvoy, explaining that neotame is NOT permitted for use in products labeled certified organic, or in products that contain the label “made with organic [specified ingredient or food group]. You can view a copy of this letter here:
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088960.

And while Monsanto was the original creator of neotame back when it owned the NutraSweet Company, J.W. Childs Equity Partners II, L.P. today owns the NutraSweet Company, which includes ownership of neotame as well.

It could be lurking in the foods you eat every single day and you would never even know it. The U.S. Food and Drug Administration (FDA) has declared that one of Monsanto’s creations, a synthetic sweetener chemical known as neotame, does not have to be labeled in food products, including even in organic food products.

A modified version of aspartame with even more added toxicity, neotame received quiet and unassuming FDA approval back in 2002, even though no safety studies have ever been conducted on the chemical (http://www.neotame.com/pdf/neotame_fda_US.pdf). In fact, an investigation conducted by Feingold.org found only four studies relating to neotame in the MEDLINE database.

Two of these “studies” were not studies at all, and the other two were actually one duplicate study conducted by NutraSweet, the company that produces and sells neotame.

So just like with aspartame, the FDA has once again approved for use a dangerous sweetener chemical that metabolizes into formaldehyde when consumed. Except this time, the chemical contains added 3-dimethylbutyl, which the U.S. Environmental Protection Agency (EPA) has listed as one of the most hazardous known chemicals, and it does not have to be labeled on any of the products to which it is added.

“Neotame has similar structure to aspartame — except that, from it’s structure, appears to be even more toxic than aspartame,” writes HolisticMed.com on its page about neotame. “Like aspartame, some of the concerns include gradual neurotoxic and immunotoxic damage from the combination of the formaldehyde metabolite (which is toxic at extremely low doses) and the excitotoxic amino acid” (http://www.holisticmed.com/neotame/toxin.html).

The FDA, the European Food Safety Agency (EFSA), and the World Health Organization (WHO) all consider neotame to be safe for use, despite the fact that WHO actually published a paper seeking to establish acceptable daily intake levels for neotame. If neotame is so safe that it does not even have to be labeled, according to the FDA, then why do acceptable daily intake levels have to be established? And what is the point of establishing them in the first place?

This dog and pony show of special interest regulatory corruption is a travesty that will have global negative health consequences. Like most other toxins added to foods, neotame will most likely cause chronic damage over a long period of time, which means mainstream health authorities will get away with never having to admit that neotame is a dangerous toxin.

Sources for this article include:

http://articlesofhealth.blogspot.com

http://www.gaia-health.com

Read More At: NaturalNews.com

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Deadly anemia drugs like Procrit made billions – FDA kept their dangers a secret to protect pharma profits

via: NaturalNews
Monday, August 06, 2012
By: J. D. Heyes

[NaturalNews] The agencies and bureaucracies of our Leviathan government were created for our own good, we are constantly told, which is also the excuse we’re given anytime a group of lawmakers or citizens calls for any of them to be dismantled.

That excuse may no longer hold water for the Food and Drug Administration which, according to a recent Washington Post report, could have some liability in covering for a drug that a growing body of research says is dangerous and deadly.

For many years, the report said, three drugs known as Epogen, Procrit and Aranesp were among the top-selling prescription drugs in the U.S., raking in more than $8 billion annually for a pair of Big Pharma corporations – Amgen and Johnson & Johnson. In fact, these two companies were stars among stars; for a number of years, Epogen was the single costliest medicine under Medicare, costing U.S. taxpayers as much as $3 billion a year.

“The trouble, as a growing body of research has shown, is that for about two decades, the benefits of the drug – including ‘life satisfaction and happiness’ according to the FDA-approved label – were wildly overstated, and potentially lethal side effects, such as cancer and strokes, were overlooked,” the Washington Post reported.

Shocking, to say the least, but there’s more.

Medicare researches last year said, in an 84-page study, that they found among most kidney patients – the original and largest market for the trio of drugs – no solid evidence the medications made anyone feel better, improved their chances of survival or even had any “clinical benefit” outside of elevating one statistic for red blood cell count.

So while the drug companies had made tens of billions in profits over more than two decades, much of it from unsuspecting taxpayers, millions of patients were given dangerous doses of the medications to no advantage.

How?

Economic incentives, willing participants, congressional liability

“To answer the question, The Washington Post obtained the agreements between the drug makers and the Food and Drug Administration, reviewed thousands of pages of transcripts and company reports, and relied on new academic research, some by doctors who once administered the drugs but now look askance at the drug makers’ original claims,” the paper reported.

The paper said part of the blame comes from economic incentives built into the U.S. healthcare system, which can lead to inefficiencies and potentially deadly uses for drugs. But there is more here than simply that.

Drug makers cannot and will not manufacture and market drugs at a loss, that much is a given. But the FDA, according to the Post’s report, shares as much blame as anyone for this travesty. So, too, does Congress.

The paper said Amgen launched a well-funded research and lobbying campaign that was ultimately successful to win “far-reaching approvals” from the FDA. But both companies held drug trials that obviously missed (or ignored) the dangers while touting benefits that, 22 years later, would be disclosed as unfounded.

They also took more than 10 years to fulfill research commitments to the FDA, which – finally – moved to reign in the largest doses of the drugs. The agency was then stifled in its efforts by a “high-powered lobbying effort” aimed at Congress until lawmakers forced regulators to back off.

‘It was just easy to do’

Sound familiar?

The paper also points an accusing finger at doctors and hospitals.

“Americans might like to think that doctors focus on only their health. But physicians and hospitals have to pay the bills, too, and, in some cases, the more they treat a patient, the more they earn. This was especially true in the case of the anemia drugs: The bigger the dose, the more they made,” said the Post.

Incentives offered to them by the drug makers to increase doses ultimately worked. By 2007, some 80 percent of 175,000 dialysis patients on Medicare were being given the drugs at levels above what the FDA believes now is safe.

“It was just so easy to do – you put this stuff in the patient’s arm, and you made thousands of dollars,” Charles Bennett, endowed chair at the Medication Safety and Efficacy Center of Economic Excellence at the University of South Carolina and a critic of the use of the drugs in cancer patients, told the paper. “An oncologist could make anywhere from $100,000 to $300,000 a year from this alone. And all the while they were told that it was good for the patient.”

Sources:

http://www.washingtonpost.com

http://www.naturalnews.com/023852_patients_drugs_drug.html

http://www.naturalnews.com/Big_Pharma.html

http://www.drugs.com/stats/procrit

Read More At: NaturalNews.com

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Pharmaceutical Drugs are 62,000 Times More Likely to Kill You than Supplements

via: Mercola
by: Dr. Mercola
July 24, 2012

According to the Council for Responsible Nutrition, 69 percent of American adults take supplements. But are supplements dangerous? The UK-based, international campaign group, the Alliance for Natural Health International (ANH-Intl) recently revealed data1showing that compared to supplements, an individual is:

  • Around 900 times more likely to die from food poisoning
  • Nearly 300,000 times more likely to die from a preventable medical injury during a UK hospital stay, which is comparable to the individual risk of dying that active military face in Iraq or Afghanistan

Additionally, the data shows that adverse reactions to pharmaceutical drugs are:

  • 62,000 times more likely to kill you than food supplements
  • 7,750 times more likely to kill you than herbal remedies

The data, which was collected from official sources in the UK and EU, demonstrate that both food supplements and herbal remedies are in the ‘super-safe’ category of individual risk – meaning risk of death from their consumption is less than 1 in 10 million. The group has created an excellent graphic2 showing your relative risk of death from a variety of activities. Besides drugs and hospital injuries, you’re also more likely to die from being struck by lightning or drowning in your bathtub than having a lethal reaction to herbs or supplements…

According to the featured article on NewHope360.com3:

“ANH-Intl executive and scientific director, Robert Verkerk PhD, hailed the figures as shedding new light on the vexed question of natural healthcare’s safety. “These figures tell us not only what activities an individual is most or least likely to die from, but also what the relative risks of various activities are to society as a whole. It puts some real perspective on the actual risk of death posed by food supplements and herbal remedies at a time when governments are clamping down because they tell us they’re dangerous.

… According to Dr Verkerk, the new figures should help to pressure UK and European authorities to reduce regulatory burdens on natural health products.”

With a Super-Safe Track Record, Why are Supplements Under Attack?

Vitamins, minerals and herbal supplements have a tremendously safe track record, yet they are often singled out as being potentially dangerous by government agencies like the US Food and Drug Administration (FDA). This – the notion that dietary supplements are unsafe — was the premise behind the FDA’s Draft Guidance on New Dietary Ingredients (NDI), which would have required the supplement industry to prove the safety of natural ingredients that, in many cases, have been on the market and used safely for decades!

Fortunately, public outcry made the agency agree to take another look at their proposed guidance and to issue a revised draft4. It’s still not known when the revisions might be completed.

The original NDI draft essentially claimed dietary supplements are unsafe and must be carefully tested in order to “protect consumers.” The proposed safety thresholds even exceeded those required by pharmaceutical drugs — despite extensive toxicological data showing supplements are FAR safer than drugs. As detailed above, drugs are 62,000 times more likely to kill you than supplements!  Why on earth would supplements need more stringent safety thresholds than drugs?

It’s an obvious attempt to eliminate competition for the drug industry.

Data from the United States fully corroborates the featured UK data. For example, according to the latest data from the US National Poison Data System (2010 report)5, NO deaths were attributable to vitamin and mineral supplements that year. And, as noted byOrthomolecular Medicine News Service last year6, Americans easily take more than 60 billion doses of nutritional supplements every year, and with zero related deaths this is an outstanding safety record:

“Well over half of the U.S. population takes daily nutritional supplements. Even if each of those people took only one single tablet daily, that makes 165,000,000 individual doses per day, for a total of over 60 billion doses annually. Since many persons take far more than just one single vitamin or mineral tablet, actual consumption is considerably higher, and the safety of nutritional supplements is all the more remarkable.Over 60 billion doses of vitamin and mineral supplemnts per year in the USA, and not a single fatality. Not one. If vitamin and mineral supplements are allegedly so ‘dangerous,’ as the FDA and news media so often claim, then where are the bodies?”

The Drug Industry is the Real Health Threat

In striking contrast, drugs are known to cause well over 125,000 deaths per year in the US when taken correctly as prescribed – yet the FDA allows fast-track approvals and countless new additions of poorly tested drugs to the marketplace that must later be withdrawn due to their lethal consequences.

It is simply incomprehensible that any rational approach would seek to vilify supplements over drugs when the data in no way, shape or form supports it. The most likely motive for this position is financial greed that can put your life in jeopardy. According to the US National Poison Data System7 the following drug categories are among the most lethal:

  1. Analgesics, sedatives, hypnotics, and antipsychotics
  2. Cardiovascular drugs
  3. Opioids
  4. Acetaminophen combinations
  5. Antidepressants

Slightly lower down on the list you find drugs like muscle relaxants, anti-inflammatory drugs, hormones, antacids, anticoagulants, and antihistamines.

Continue Reading At: Mercola.com

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FDA caught spying on its own scientists to muzzle whistleblowers

via: NaturalNews
Monday, July 23, 2012
By: S. D. Wells

[NaturalNews] A massive covert and secret operation by the FDA to seek out and muzzle several of THEIR OWN SCIENTISTS, those who were seeking to blow the whistle on the FDA’s own fraud and unethical handling of information regarding cancer treatment methods, has been completely exposed. The issue actually began as a dispute between the scientists and their superiors at the FDA, in which the scientists accused the latter of “FAULTY REVIEW PROCEDURES,” which directly led to the approval of the CANCER CAUSING mammogram and colonoscopy imaging machines.
(http://newsfeedresearcher.com)

The U.S. Food and Drug Administration secretly kept critics of its policy under surveillance, which is the epitome of a U.S. government agency creating a chilling fear for anyone trying to expose the fraud of the cancer “chronic care mismanagement” industry. The whole operation ensnared 21 workers, including journalists and Congressional officials.

As part of its surveillance, the FDA swept up thousands of confidential emails the scientists had with lawyers, journalists, Congressional staff and even President Obama. Although the investigation began with only five scientists, it is now revealed that the massive campaign is still in operation to suppress over 80,000 pages of documents and end the whistle-blowing on all fronts. The FDA has been caught red-handed trying to cover up a scam which adds to the blight of the $100 billion cancer industry, which is fed and bred by the FDA.

Muzzling the whistleblowers fails

This latest “SNAFU” is part of a broader, two-year long campaign to counter inside and outside critics of the agency’s medical review process. The FDA was most interested in intercepting and destroying confidential letters to at least a half-dozen Congressional offices and oversight committees, but unfortunately for the FDA, one of their private document handling contractors posted the personal emails to a public web site by mistake for a few days, and that’s when a few Congressional staff members, who are actually sympathetic to the scientists, saw the emails from the whistle-blowers. Drafts and final copies of letters the scientists sent to President Obama about safety concerns were also included.

In March of 2010, an article in The New York Times examined the safety concerns about imaging devices and quoted two agency scientists, who would later come under surveillance. Dr. Robert C. Smith and Dr. Julian Nicholas served as “ringleaders” for the group of “complaining” scientists. Lawyers for G.E. Healthcare wanted surveillance placed on the scientists because they were exposing to the media the fraud and danger of their mass money making devices. (http://www.nytimes.com)

Scientists’ computers were monitored down to the last keystroke, according to The New York Times. The FDA had pressured scientists to approve medical devices despite their own reservations about health risks, and wanted to make sure the scientists weren’t communicating this coercion with anyone. Democratic Rep. Chris Van Hollen fumed after he learned that he was on the list, saying, “It is absolutely unacceptable for the FDA to be spying on employees who reach out to members of Congress to expose abuses or wrongdoing in government agencies.”

This is proof that the cancer scam has been covered up for decades (since WWII). The fact that the FDA is spying on employees who reach out to members of Congress to expose fraud is just the tip of the iceberg. After the surveillance began, four of the five scientists lost their jobs. The unnamed scientists are suing the FDA, and say their treatment was in response to their claims of SAFETY ABUSE within the FDA.

Radiation and chemotherapy- The chemical holocaust

The bottom line is that Western medicine and the cancer industry in general offer no cures. In fact, a cure would destroy the industry by wiping out billions of dollars in profits that drug companies, radiologists and oncologists are counting on right now. This is precisely why the cancer industry dares not tell women the truth about vitamin D; for example, which prevents 77 percent of all cancers, including breast cancer. That is precisely why the “chronic care industry” has a blackout on vitamin D information while pushing hard for annual mammograms and colonoscopies that continue to cause cancer and generate repeat business. (http://www.conspiracyplanet.com)

On top of it all, global cancer rates are expected to increase by 50 percent by 2020, according to the latest report from the International Agency for Research on Cancer (IARC), a branch of the World Health Organization (WHO). Cancer is responsible for more than 12 percent of the 60 million deaths worldwide from any and all causes, and cases in the U.S. alone have increased nearly 20 percent just since the year 2000. It’s time to look into NATURAL CURES and stop believing in the agencies which profit from sickness.

Sources for this article include:

http://www.cbsnews.com

http://www.redorbit.com

http://www.nytimes.com

http://www.wsws.org/articles/2003/apr2003/canc-a26.shtml

http://www.conspiracyplanet.com

Read More At: NaturalNews.com

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Glass particles found in injectable cancer drugs; massive FDA recall issued

via: NaturalNews
Friday, July 20, 2012
By: J. D. Heyes

[NaturalNews] Having to deal with the mental and physical pains of cancer is bad enough, but it’s worse when you have to fear the medicine used to treat it.

Hospira, the world’s leading provider of injectable drugs and infusion technologies, announced in June that it will recall four of its cancer drugs and other medications both in the United States and from around the world – the fourth month in a row the company has had to warn the healthcare industry of issues related to its products.

In a joint release with the Food and Drug Administration, Hospira blamed the glass supplier for the injectables in recalling 19 lots of carboplatin, cytarabine, paclitaxel and methotrexate, which were shipped between September 2011 and April of this year. According to the release, vials of these drugs have been discovered with “visible particles embedded in the glass located at the neck of the vial.”

Glass particles in the medicine, in other words.

“In the event in which particulate matter could be injected into a patient, there may be the potential for patient injury where medical intervention may be required. Signs and symptoms might include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms,” said the joint statement.

Drugs in U.S., abroad recalled

Daniel Rosenberg, a spokesman for Hospira, told the Pharma Web site FiercePharmaManufacturing, in an email: “Hospira has not received any reports of adverse events related to these lots. The root cause is a supplier glass defect, and we have taken corrective action to prevent this from occurring again. For U.S. customers, replacement product from other lots is available and no drug shortages are expected as a result of this recall.”

In addition, the company has said recently it was recalling drugs from a number of other nations ranging from Canada to Norway, Australia and Vietnam, reports said. Those global recalls don’t include cytarabine; however, but do include other drugs such as heparin, desferrioxamine, oxaliplatin, fluorouracil and epirubicin.

In his email, Rosenberg said it’s possible that some countries could experience temporary shortages of the drugs but added, “In most cases, we will have replacement stock available, and we don’t anticipate major disruptions for the majority of our overseas customers.”

The Pharma Web site noted that shortages stemming from drug-maker manufacturing problems have been a major issue over the past couple of years, particularly at Hospira, which the site says “has found itself in the middle of it.” The company is one of four other generic medication producers named in a House committee report recently that are linked to grave shortages of drugs in the United States, due to FDA actions requiring each to correct quality control issues on their production lines.

Hospira has also borne the brunt of a new legal strategy: Patients or their families filing suit against drug makers who say a shortage of medications they were taking worsened their medical conditions and, in some cases, even led to death.

Continue Reading At: NaturalNews.com

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FDA Approved HIV Preventative Pill Marketed to Uninfected Public

via: OccupyCorporatism
by: Susanne Posel
July 20, 2012

The Food and Drug Administration (FDA) has approved Gilead Sciences’ Truvada, the first pharmaceutical drug to prevent the virus that causes AIDS.

Some of the senior members of Gilead Sciences include:

  • John C. Martin, Chairman and Chief Executive Officer, who served on the Centers for Disease Control/Health Resources and Services Administrations Advisory Committee on HIV and STD Prevention and Treatment and was a member of the Presidential Advisory Council on HIV/AIDS and worked for competitors Bristol-Myers Squibb and Syntex Corporation
  • Robin L. Washington, Senior Vice President and Chief Financial Officer who was a former accounting analyst for the Federal Reserve Bank of Chicago
  • Kevin Young, Executive Vice President, Commercial Operations, who was appointed Commander of The British Empire for his service to the healthcare and pharmaceutical industries

Margaret Hamburg, FDA commissioner, released a statement saying that the approval by the FDA “marks an important milestone in our fight against HIV.”

Marketed as a preventative for people who at high risk of contracting HIV through sexual activies, Turvada is supported by public health advocates that believe this pill will slow down the spread of HIV. In America it is estimated that 1.2 million people have HIV. With this new antiviral drug, it is proposed that 240,000 HIV carriers will not be able to continue to spread the disease.

Gilead Sciences combined two separate drugs to create Truvada. The genetically engineering of the preventative is praised by the FDA to answer the assumption that condoms are not effective. The pharmaceutical corporations are working hard to convince the general public that their drugs are the only answer to our problems; whether with regard to healthcare or psychology or simply controlling social behavior as with addiction vaccines .

The inception of HIV/AIDS began in the late 1970’s when the World Health Organization (WHO) went into Africa under a small pox vaccine initiative . Suddenly, in 1981, the first recorded incident of HIV was “discovered” in the same places where WHO had conducted the small pox vaccine campaigns.

Continue Reading At: OccupyCorporatism.com

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FDA Spies On Whistleblowers’ Personal Information … Then Uses It to Smear Them

via: WashingtonsBlog
July 18, 2012

Regulators and Politicians Work Hard … to Protect Corporate Wrongdoing and Smear Whistleblowers

When one of the most respected radiologists  in America – the former head of the radiology department at Yale University – attempted to blow the whistle on the fact that the FDA had approved a medical device manufactured by General Electric because it put out massive amounts of radiation, the FDA installed spyware to record his private emails and surfing activities (including installing cameras to snap pictures of his screen), and then used the information to smear him and other whistleblowers:

Continue Reading At: WashingtonsBlog.com

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