Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, October 24, 2017

War on Health: Profits Before Patient Safety


Keep in mind, according to CDC statistics, no one has died from the use of food or dietary supplements, yet now, thanks to the FDA, you’ve got 3x as much regulation for food and dietary supplements as you have for pharmaceutical drugs, despite the fact that pharmaceutical drugs have proved to be one of the top killers of American citizens.

The relationship between physicians and the drug industry doesn’t begin once you have your MD or once you own your private practice; it begins the day you hit medical school. Big Pharma often give medical students gifts on their very first day. These gifts are always “Big Pharma” propaganda disguised as education, or something medical industry related that leaves the hard pressed medical student feeling like, at least someone cares, because we all know how tough medical school is.

But why is it so tough? Why are there intern boot camps?  Why must medical students and residents go through Why is "the private group that oversees physician training in the United States proposed rolling back rules so that young doctors just out of medical school can work shifts as long as 28 hours"? I mean, who wants an exhausted medical student/intern/resident practicing their craft on you when you are at your most vulnerable? Well one answer is that "medical school functions as a highly efficient system of inDOCtrination to ensure that physicians are less likely to question or confront the systems of power."
Professors who have already been indoctrinated to think a particular way ensure discussions are kept "on topic," or within the traditional bounds of acceptable debate that do not challenge power. I personally have lost track of the number of times I have heard a professor say, "That is interesting, but it is just outside of the scope of the discussion we are trying to have." This is a highly efficient and subtle way of controlling thought.

It makes more sense when you consider modern medicine was founded by a robber barons and an oil tycoon in particular, John D. Rockefeller. The conspiracy to limit and eliminate competition from non-drug therapies began with the Abraham Flexner Rockefeller Report on Medical Education of 1910. Abraham Flexner was engaged by John D. Rockefeller to  “evaluate” the effectiveness of therapies taught in medical schools and other institutions of the healing arts. The Flexner report unequivocally recommended the closure of all the homeopathic and naturopathic medical schools, in other words, anyone or any institution who use natural medicines to heal.

Subsequently, federal alphabet agencies--FDA, CDC, etc.-- were created to enforce the allopathic model under the guise of "protecting" the American food and drug supply.   In actuality, these agencies serve the medical industrial complex, not American citizens as you will see in the following documentaries.  The reason is obvious: alternative, mostly inexpensive non-toxic therapies represent a potential loss of billions, if not trillions of dollars to allopathic (drug) medicine and drug companies, not to mention, there is nothing more threatening to elite power than a healthy, robust public.







Links:

Overdosed America: The Broken Promise of American Medicine by John Abramson, M.D.

AIDS, Opium, Diamonds, and Empire: The Deadly Virus of International Greed. by Nancy Turner Banks, M.D.

Treaties and International Agreements


Read more...

Saturday, November 23, 2013

Talk About False Advertising: Just Say No to no!no!

While the FDA is busy attacking legitimate companies like Blue Diamond for making truthful claims about walnuts, based on hard science, companies like PhotoMedex-Radiancy [PHMD], manufacturer of no!no! Hair Removal System engages in an extraordinarily heavy campaign of national television and Internet advertising to promote the sale of this product, making false claims, supposedly supported by science and research in order to rob decent people of their time and money.

As Radiancy documents submitted in court show, Radiancy deliberately engaged in a massive advertising campaign based on bogus claims lacking any scientific basis, including knowingly false claims that the no!no! "provides an effect similar to what lasers accomplish in the dermatologist office"; produces "laser-like results"; is "like laser and IPL [intense pulsed light] treatments, the heat gradually disrupts the hair growth cycle." Mimicking medical laser claims, Radiancy claimed that the no!no! Hair provided "up to 94% reduction in hair re-growth", allowed users to "get rid of unwanted hair and keep it gone" and "have a life of freedom from hair." As Radiancy admitted in papers filed with the court shortly before the settlement, it has dropped all such claims as a result of Tria's lawsuit.
In these hard-to-avoid infomercials, the aforementioned company declares that no!no! not only slows down hair regrowth, it actually helps keep it from growing back. It asserts that the use of their product results in “up to 94% less hair regrowth with no pain, no mess, no stress,” when it's an outright lie. Not only that, according to thousands of customer complaints, they refuse to honor their 60-day return policy unless the customer has the wherewithal to devote all of their time and effort to the refund, or the customer threatens with legal action.

Now, the manufacturer has not submitted these so-called "studies" about the use and efficacy of its product to the FDA and despite the fact that these blatantly unsupported claims are designed to mislead and deceive consumers into buying this expensive and ineffective, and even potentially dangerous product, the FDA ignores them.

In fact, a blinded, controlled, prospective clinical study by the Department of Ophthalmology, Dermatology, Otolaryngology, out of Vanderbilt University Medical Center, found that the no!no! Hair Removal System is no more effective than shaving with a razor.
CONCLUSIONS: Relative to shaving, the hot-wire (no!no!) device does not produce lessened hair density, decreased hair re-growth rate, greater duration of effect, nor induce changes in hair thickness and color. We conclude that the hot-wire device does not offer any benefit as compared to shaving.

Read more...

Friday, November 22, 2013

The FDA is Now the Walnut Police!

Life Extension Magazine published 57 articles about the health benefits of walnuts, so Diamond Foods   included the scientific data  about those health benefits on their website, however,  they provided this information without Big Pharma FDA approval. How dare they!  Anyway,  the FDA, totally ignoring the science, proceeded to send the company a warning letter stating that they must file a drug application in order to continue selling walnuts, threatening them with government seizure or injunction.

Ingesting nuts used to be considered unhealthy because of their high fat content. This misconception has changed over the past 18 years as human studies have revealed sharply reduced incidence of heart disease in those who consume walnuts.1-12

Unlike some nuts, walnuts provide a unique blend of polyunsaturated fatty acids (including omega-3s), along with nutrients like gamma-tocopherol that have demonstrated heart health benefits.13-24

The March 4, 1993, issue of the New England Journal of Medicine published the first clinical study showing significant reductions in dangerous LDL and improvement in the lipoprotein profile in response to moderate consumption of walnuts.14 Later studies revealed that walnuts improve endothelial function in ways that are independent of cholesterol reduction.1, 25-27

One study published by the American Heart Association journal Circulation on April 6, 2004, showed a 64% improvement in a measurement of endothelial function when walnuts were substituted for other fats in a Mediterranean diet.
Keep in mind, the FDA allows potato chip manufacturers to claim heart-healthy benefits, not to mention, walnuts aren’t the only food whose health benefits the FDA has tried to suppress. The bottom line is the FDA targets only those foods that really do benefit health, while allowing artery-clogging, obesity-creating foods to claim any kind of "health benefits" they want.  In other words, the FDA is basically a whore for Big Pharma and the agrichemical companies like DuPont and Monsanto.

Update: I had not realized I posted about this (below) previously, in 2011.

Isn't it funny how the FDA has no problem approving substances like aspartame that's responsible for more complaints to the FDA than any other additive considering that 75% of grievances to the FDA are the result of this highly toxic ingredient...an ingredient that the FDA lists 92 symptoms for, including brain tumors and death! Yet, wants to outlaw walnuts? Does anyone get the idea that the FDA may be trying to outlaw healthy immune systems?

But why would they want to harm we, the people? Well, it's not so much the desire to harm us, as it is their #1 priority to ensure Big Profits for Big Pharma, Big Agriculture and Big Chemical. Remember, they're people, too...far more important then the flesh and blood kind of people like us.

In July, Natural News reported that the FDA "quietly unleashed a regulatory scheme that, if fully implemented, could ban virtually all dietary supplements in the USA that were formulated after 1994".

Which brings us to walnuts are drugs. Yep, you read that right. Why? Because Blue Diamond wants to declare walnuts heart-healthy, so, the FDA says, "walnut products are drugs", and must be regulated as such.
FDA letter to "Blue Diamonds"
"Your walnut products are drugs...they may not legally marketed ...in the United States without an approved new drug application."
Two words to watch out for: Codex Alimentarius which was created in 1963 by UN Food and Agriculture Organization (FAO) and World Health Organization (WHO) to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO. Sounds innocent enough, right? Well, I'm sure it was until the pharmaceutical industry infiltrated. Now, it appears to be the propaganda arm of the international pharmaceutical industry. In other words, Codex alimentarius is one of the major entities behind the effort to take away our access to nutritional products and information.

Wasn't it Henry Kissinger who said, "Control oil and you control nations, control food and you control the people"? Well, it looks as if these words were more of an agnda, than merely a statement.


Natural Solutions Foundation is a “network of networks” created to disseminate the facts, challenges and triumphs in our shared battle to protect, preserve and defend our right to make our own health choices based on what we, not the government, believe are the best choices for ourselves.

Links:

Harvard study shows that nuts may reduce risk of death

Nut eaters were 25 percent less likely to die from heart disease, 10 percent less likely to die from cancer, and 20 percent less likely to die from diabetes as well as lung diseases. The study found that nut eaters enjoyed longer lifespans even if they did not exercise, avoided fruits and vegetables, and were overweight.

Read more...

Thursday, February 02, 2012

Bioethicists Conclude Human Life is About as Sacred as Weeds.

Is nothing sacred anymore? Does anything matter? Is there any intrinsic value to life? Apparently not, according to two nihilistic American bioethicists in an online article in the Journal of Medical Ethics. That's right. Humanity has no innate value, no purpose, no meaning. And unfortunately, these two prominent bioethicists are not alone in their thinking. So, what makes killing wrong? Well, according to these "experts", human life is only valuable if is productive. Hmmm...if I remember correctly, this kind of utilitarian thinking was the same kind of rationale used by Nazi Germany.

“[I]f killing were wrong just because it is causing death or the loss of life, then the same principle would apply with the same strength to pulling weeds out of a garden. If it is not immoral to weed a garden, then life as such cannot really be sacred, and killing as such cannot be morally wrong.”
Take Bill "reduce the population with vaccines" Gates , for instance, with his 500,000 shares , of   Monsanto stock. Developer/producer of GMO seeds/foods, and all types of poisons like DDT/agent orange, and who spreads their toxic GMO seeds in order to sue non-corporate farmers with patent infringement.  Read Monsanto: Harvest of fear.
“The world today has 6.8 billion people… that’s headed up to about 9 billion. Now, if we do a really great job on new vaccines, health care, reproductive health services, we could lower that by perhaps 10 or 15 percent.” -- Bill Gates
As it is, a significant portion of the developed world's population believe in nothing greater than themselves, which tends to make the dehumanization of others fairly simple. What exactly is dehumanization? Basically, valuing human life about as much as you value the weeds in your garden. It's viewing people as statistics, commodities, or as interchangeable. This, I would argue is a direct result of our ever increasing acquisitive society.

Consumption has replaced production, and everything and everyone is a consumer item. The brutal underlying values of a casino/"free" market consumerist society are inherently nihilistic, in that nothing we do, nothing we create, nothing we love has meaning. Thus, 'we the weeds people' are essentially disposable, like dirty Pampers.

Related Links:

Executive order 13139: President Clinton signed this order authorizing the Department of Defense to administer "new investigational drugs" to troops ---- with or without their consent ---- to protect them from biological, chemical or radiological agents during military actions.

Executive Order 13544,  whose goal is to severely limit private and organic farming

Public Law 105-85 Use of human subjects for testing of biological or chemical agents

S 510, the Food Safety Modernization Act precludes the public’s right to grow, own, trade, transport, share, feed and eat each and every food that nature makes. In other words, consolidated corporate control of your food.

Bill Gates, China jointly developing nuclear reactor

Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production, and food safety.

Read more...

Sunday, September 18, 2011

Watch How the FDA Suppresses a Cure For Cancer.

The following documentary is a MUST-SEE for everyone! I have yet to see anything so fully documented that exposes the extraordinary measures that the FDA will resort to in order to ensure that cancer remains the killer that it is, and  that Chemotherapy remains the torture-chamberous non-curing treatment that it is. Not to mention, this film, in addition to detailing the FDA's 14 year campaign to remove Dr. Stanislaus Burzynski, who found a cure for cancer, from society, also reveals the battle Dr. Burzynski had with the National Cancer Institute, who is just as bad.


"Our bodies contain two categories of genes that allow cancer to flourish: oncogenes, and tumor suppressor genes. When someone has cancer, they have a higher level of oncogenes switched on, with a higher level tumor suppressor genes switched off.

The goal is to tell the body to both switch back on the tumor suppressor genes, and turn off as many oncogenes as possible."
It comes to no surprise to most of us that the median annual American pharmaceutical company profits triples the median annual profits of all of the Fortune 500 companies. But, how does Big Pharma maintain these astounding profits? Well, through its gatekeeper: the FDA, and the National Cancer Institute.

"Big Phama" didn't manifest overnight. It was an ongoing process that started in the 1970s and 1980s.  At the time,  profitability of the pharmaceutical industry was two times greater than the median of all industries in the Fortune 500. In the 1990s, when the Prescription Drug User Fee Act (PDUFA)- which authorizes drug companies to pay "user-fees" to the FDA for each brand-name drug considered for approval, greatly speeding up the approval process - kicked in, the drug industry's profitability grew to almost four times greater than the median for all industries in the Fortune 500.

After the PDUFA was enacted, the part of the FDA that reviews new drugs received more than half its money from user fees and it grew by leaps and bounds.  Meanwhile, the part of the FDA that monitors safety, ensures manufacturing standards, and checks ads for accuracy deteriorated. Not only that, the approval process for brand-name drugs shortened to 3 months, from its previous 21 months. Yet, here it is 2011, and Antineoplaston Therapy has been waiting approval since 1977.

On June 21, 1977, Dr. Burzynski's attorney's investigated both state and federal law to find out if it was legal for him to start his own biomedical research company to make the Antineoplastons (non toxic cancer treatment) and administer them to patients within his private practice.  He found out it was legal as long as he avoided interstate commerce.

However, it was not soon after that Burzynski's patients found themselves harassed by the Texas State Board of Medical Examiners(TMB) to file charges against their doctor, and the FDA started its witch hunt.

In 1983, the FDA obtained an injunction from a federal district court prohibiting Dr. Burzynski and the Burzynski Research Institute from shipping antineoplastons in interstate commerce without first obtaining the approval of the FDA. The injunction, however, did not preclude intrastate distribution of the antineoplastons.

On July 28, 1986, the TMB began investigating Dr. Burzynski, even though no formal complaint had been filed, and on November 18, 1986, a notarized agreement between Burzynski and the TMB was created requiring the doctor resent a list of 40 successful cases.  He submitted double that number. He never heard back.

On September 6, 1988, the TMB convened a hearing to decide whether or not to revoke Burzynski's medical license. Texas State Board of Medical Examiners vs. S. Burzynski

Dr. Burzynski faced numerous battles with the federal government over the years. Between 1986 and 1994, he was subjected to three federal grand jury investigations. No indictments were ever handed down. However, during that time federal officials raided his research clinic and confiscated his patients' medical records.

Then in March 1995, Dr. Burzynski appeared on the CBS TV show "This Morning," accompanied by three of his patients. That very afternoon, the FDA raided his clinic again. A fourth federal grand jury investigation got underway, and by November 1995, charged Dr. Burzynski with 40 counts of distributing a non-FDA approved drug in interstate commerce, 34 counts of mail fraud, and one count of contempt of court for violating the order against interstate delivery of Antineoplastons. Rep. Joe Barton (R-TX) noted that a grand jury's failure to indict someone after three attempts is "virtually unprecedented."

On February 9, 1996, US District Court Judge Sim Lake ruled that Dr. Burzynski cannot treat patients outside of clinical trials. In other words, he issued a death sentence for hundreds of Dr. Burzynski's patients.

This prosecution marked the first time the FDA had tried to jail a scientist for using a drug on which he was conducting FDA authorized clinical trials. This trial alone, which was not even based on whether or not antineoplastons work or not cost the American taxpayer $60 million, while costing Dr. Burzynski over $2.2 million!

On March 4, 1997, due to a dead-locked jury, a mistrial was declared.

The FDA still did not back down. A second federal trial got underway May 19, 1997 to try Dr. Burzynski on the contempt of court charge. A federal jury acquitted Dr. Burzynski on May 27, 1997.

At the same time, Dr. Burzynski was fighting the Texas Medical Examiner's Board and the FDA, the National Cancer Institute, under Dr. Michael Friedman, tried to co-opt his discovery and render it ineffective.

A former employee of Dr. Burzynski, Dvorit Samid, betrayed him when she partnered with Elan Pharmaceutical through her employment with the National Cancer Institute and tried to hijack Burzynski's discovery. The problem was that she used only one component of the antineoplaston, phenylacetate, which when isolated, has very little clinical effect.

When that didn't work, the National Cancer Institute said they would accept Dr. Burzynski's antineoplastons; however, only if they could revise the protocol that Dr. Burzynski had perfected. Burzynski refused. The NIC threatened with patent infringement. Finally, they came to an agreement. Yet, within a very short time, in March 1995, the NIC tried to drastically alter Burzynski's protocol to make his treatment less effective!!

Four years after the NCI trials were closed and two years after Burzynski defeated the FDA, winning his freedom, the NCI, in February of 1999, decided to vindictively publish the scientifically invalid Antineoplaston trials in peer-reviewed medical literature. However, whoever published the invalid trials forgot to leave out the dosage, which in some patients was 2.7 times lower than the protocol demanded, and in other patients, 36 times lower, and, in even other patients, 170 times lower!

Li-Chuan Chen, PhD, who worked as a scientist for the National Cancer Institute from 1991-1997, said that when the NCI or assigned entities conducted trials on alternative cancer therapies they always altered the protocol and let it fail in order to discredit the therapy. He went on to say, "Scientists never look at it carefully, because as he says, Popeye is telling you something and you don't question him...under the capitalist sun, there is nothing sacred."

Here's the kicker. On October 21. 1991, the United States of America as represented by the Department of Health and Human Services, along with "Inventor": Dvorit Samid filed a patent for Antineoplastons. On October 12. 1993, the US and Dvorit Samid file for a second patent on Antineoplastons. And on March 7, 1994, the US and Dvorit Samid file its most comprehensive patent spanning 111 pages. Seven months later they file a fourth one. On 6/6/1995, the US files its 5th, 6th, 7th, and 8th extended patent. The next day, the US files its 9th, 10th, and 11th patent. A few months later, Dr. Michael Friedman leaves his position at the NCI and becomes Deputy Commissioner of Operations for the FDA, working directly under Dr. David Kessler.

In the three years (1997-2000) after Dr. Burzynski was indicted, all of the US patents for Antineoplastons were approved. However, one paragraph within these patents, in particular, is quite revealing:


Since 2009, the  only obstacle in the way of Antineoplasmons is the $300 million pricetag on the final phase of FDA clinical testing...and the FDA's requirement that children with inoperable brainstem glioma to also under go radiation treatment in these Phase 3 trials, claiming it would be unethical to do otherwise. 



Links:

Big Pharma Deals to Preserve High Drug Prices Skyrockedted in FYI 2010

The Truth About Drug Companies by Marcia Angell

Pay-For-Delay: How Drug Company Pay-Offs Cost Consumers Billions


Families USA

Bush Administration Back Pharmaceutical Industies Over the Needs of Millions of Senior Citizens

Read more...

Monday, August 22, 2011

FDA Claims Walnuts are Drugs.

Isn't it funny how the FDA has no problem approving substances like aspartame that's responsible for more complaints to the FDA than any other additive considering that 75% of grievances to the FDA are the result of this highly toxic ingredient...an ingredient that the FDA lists 92 symptoms for, including brain tumors and death! Yet, wants to outlaw walnuts? Does anyone get the idea that the FDA may be trying to outlaw healthy immune systems?

But why would they want to harm we, the people? Well, it's not so much the desire to harm us, as it is their #1 priority to ensure Big Profits for Big Pharma, Big Agriculture and Big Chemical. Remember, they're people, too...far more important then the flesh and blood kind of people like us.

In July, Natural News reported that the FDA "quietly unleashed a regulatory scheme that, if fully implemented, could ban virtually all dietary supplements in the USA that were formulated after 1994".

Which brings us to walnuts are drugs. Yep, you read that right. Why? Because Blue Diamond wants to declare walnuts heart-healthy, so, the FDA says, "walnut products are drugs", and must be regulated as such.
FDA letter to "Blue Diamonds"

"Your walnut products are drugs...they may not legally marketed ...in the United States without an approved new drug application."
Two words to watch out for: Codex Alimentarius which was created in 1963 by UN Food and Agriculture Organization (FAO) and World Health Organization (WHO) to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO. Sounds innocent enough, right? Well, I'm sure it was until the pharmaceutical industry infiltrated. Now, it appears to be the propaganda arm of the international pharmaceutical industry. In other words, Codex alimentarius is one of the major entities behind the effort to take away our access to nutritional products and information.

Wasn't it Henry Kissinger who said, "Control oil and you control nations, control food and you control the people"? Well, it looks as if these words were more of an agnda, than merely a statement.


Natural Solutions Foundation is a “network of networks” created to disseminate the facts, challenges and triumphs in our shared battle to protect, preserve and defend our right to make our own health choices based on what we, not the government, believe are the best choices for ourselves.

Read more...

Friday, July 08, 2011

FDA Set to Outlaw Nutrition.

Demonizing people, even though they pose no threat to the public appears to be the goal of the code enforcement bureaucracy that is out in full force, recently, as in the case of  Julie Bass of Oak Park, Michigan, who is facing 93 days in jail after being charged with a misdemeanor for planting a vegetable garden in her front lawn.



Moreover, the political agenda that drives these relentless code enforcement systems around the nation tend to zero in on self-sufficient living, the safety of dietary supplements, and/or anyone who dares to explore beyond the conventional unbending framework of government.

Take the FDA, who wants all super-foods, multivitamins, detox supplements, and medicinal herbal products created after 1994 stripped from store shelves, and outlawed across the nation. Never mind, the lethal drugs they knowingly allow to stay on the market for decades.  Chantix, which has been linked to more than 3,000 reports in the U.S. of serious side effects, including suicides, heart trouble and aggression, according to a Bloomberg article in 2008. Fast forward to 2011, Chantix has been found to increase the risk of heart attack or arrhythmia by 72%! What's the FDA's response? They're weighing the evidence. They're still not sure whether they will ban this killer drug.

Links:

The Inhumanity of Government Bureaucracies

Read more...

Friday, May 20, 2011

Are Potential Cancer Cures Being Ignored?

If you visit the following website, Cancer is DEAD: Cancer Killers from A to Z , you will find a vast array of mostly natural substances and compounds (over 90) with cancer fighting properties that most people don't know about, and the scholarly studies behind them. What is most interesting is that most of the studies listed were conducted by our government...some ten years ago!   Whoever compiled this list should be highly commended, as I'm sure it involved a lot of time and hard work. He or she also noted, in so many words, that this compilation is just the tip of the iceberg.

Apoptosis is key:

If you've been diagnosed with cancer:

For best hope, you need to know your specific cell line, and your blood work needs to be focused on common cancer precursors. Doctors don't always do either, as learned first hand. There are potentially hundreds of specific cancer cell lines in any given organ, each of which may have it's own unique dynamics compared to others that may afflict the same organ. For instance, lung cancer is often called either Small Cell or Non-Small Cell, while there are almost 200 known lung cancer cell lines. To best know where to invest your money and efforts in complementary treatments the cell line is key. Once you know your cell line go to Google Scholar and search for: 'cell line' cancer apoptosis. This will bring up virtually every study ever done on your cell line, and then you'll need to go through them trying to spot complimentary foods and compounds that you might acquire on your own.

One reason you should know your cell line is to know whether it is "estrogen positive" or "estrogen negative". Positive means the cancer may be proliferated via estrogen, and negative means it shouldn't be affected by estrogen . This is important because many foods and compounds that are useful to cancer fighting in general may increase estrogen levels and need to be avoided. This all also applies for androgen, but this research didn't seem to find too many foods that affect testosterone levels.

Blood work is important because there are many common blood elements that are often associated with cancer diagnosis. Some examples include copper and melatonin. High copper is often found in cancer patients, and it has been found that cancer cells feed off of copper, which means foods high in copper should be avoided and ideally drugs that strip copper from the body will need to be requested. Low levels of melatonin is common in cancer patients, therefore consuming melatonin supplements should be an ideal complimentary treatment should that be your case.
In addition, Natalie Wolchover reports on the "long road to a cure".
One of Salk's admirers is Evangelos Michelakis, a cancer researcher at the University of Alberta who, three years ago, discovered that a common, nontoxic chemical known as DCA, short for dichloroacetate, seems to inhibit the growth of cancerous tumors in mice. Michelakis' initial findings garnered much fanfare at the time and have recirculated on the Web again this week, in large part because of a blog post ("Scientists cure cancer, but no one takes notice") that ignited fresh debate with people wondering if it was true.

The mechanism by which DCA works in mice is remarkably simple: It killed most types of cancer cells by disrupting the way they metabolize sugar, causing them to self-destruct without adversely affecting normal tissues.

Following the animal trials, Michelakis and his colleagues did tests of DCA on human cancer cells in a Petri dish, then conducted human clinical trials using $1.5 million in privately raised funds. His encouraging results — DCA treatment appeared to extend the lives of four of the five study participants — were published last year in Science Translational Medicine.

The preliminary work in rodents, cell cultures, and small trials on humans points to DCA as being a powerful cancer treatment. That doesn't mean it's the long-awaited cure — many other compounds have seemed similarly promising in the early stages of research without later living up to that promise — but nonetheless, Michelakis believes larger human trials on DCA are warranted.

So, are potential cancer cures being ignored? I think it's safe to say, it is certain.

Read more...

Sunday, May 01, 2011

Morgellon's Disease is Not Science Fiction.

Take a closer look at the above to see fibers, plaques, nano-machines and other bizarre relics found in the bodies of Morgellons sufferers.
Okay, the picture above is pretty gross when you consider from what it's composed; nevertheless, it's true.  I've seen it for myself.

Morgellon's Disease is a mystery; it sounds like something out of a sci-fi thriller; however, it's not.  It's very real,  despite the FDA and CDC dragging its feet, and conventional medicine's claims that it may be a in the person's mind. Tens of thousands of people are suffering daily from this mysterious and devastating illness that is systemic, and manifests itself in different ways at different times.

One of my family members has struggled with Morgellon's symptoms of horror for years. Wounds that manifest fibrous material can last for years in one place and then, heal or partially heal, showing up on another part of the body. My family member experiences intense itching, sometimes accompanied by stabbing pain under the skin with lesions all over the feet and legs. Prior to that, the lesions were on the face and neck. What makes this disease such a nightmare is that there is not only no treatment available...there's not even any recognition of its existence. Many sufferers are told they're delusional.

Here's the thing: once Morgellon's breaks through the skin, it's undeniable. As the picture above demonstrates, the non-healing lesions discharge inorganic materials such as: threads, particles, and stuff that the human body is incapable of producing without the assistance of some insidious outside agent. There is a lot of evidence that genetically modified organisms (*Agrobacterium) may be able to explain this extraordinarily abnormal condition, which explains the FDA/CDC reluctance to acknowledge this disease. It is thought that genetically modified material, this bacterium penetrated successfully changed and corrupt human DNA.

* "Tumor-Causing Plant Bacteria May Infect Human Cells"
Emma Patten Reuters Health News January 31, 2001

NEW YORK - A soil bacterium that causes lumpy tumors on plants may be able to 'jump kingdoms' and insert its tumor-causing DNA into human cells, new research findings suggest. The bacterium, called Agrobacterium tumefaciens, contains a small piece of DNA that can insert itself into the DNA of a host cell and initiate a tumor. Agrobacterium is already known to cause plant tumors, but researchers wanted to test whether the bacterium could similarly insert its DNA into human cells.

Dr. Vitaly Citovsky from the State University of New York, Stony Brook, and colleagues found that the plant bacterium was able to attach to human cells and insert its DNA into human cells just as it does with plant cells. Whether Agrobacterium is dangerous to humans is unclear, however. "Here (insertion of DNA into) human cells has been observed in laboratory conditions; whether it may be relevant biologically in nature remains unknown," the researchers note in the current early edition of the Proceedings of the National Academy of Sciences.
[...]
One implication of this study, said Citovsky, is the potential for genetic flow between bacteria and animals. Another implication is that the basic biochemical and cellular reactions involved in the Agrobacterium-plant cell interaction probably exist in the animal kingdom as well.

SOURCE: Proceedings of the National Academy of Sciences Early Edition
* From The Institute of Science in Society
Until quite recently, the genetic engineering community has assumed that Agrobacterium does not infect animal cells, and certainly would not transfer genes into them. But this has been proved wrong.

A paper published earlier this year reports that T-DNA can be transferred to the chromosomes of human cancer cells [1]. In fact, Agrobacterium attaches to and genetically transforms several types of human cells. The researchers found that in stably transformed HeLa cells, the integration event occurred at the right border of the Ti plasmid's T-DNA, exactly as would happen when it is being transferred into a plant cell genome. This suggests that Agrobacterium transforms human cells by a mechanism similar to that which it uses for transformation of plants cells.


From what I know about

A group of fibers was sent to a forensic scientist at the Tulsa Police Crime Lab in Oklahoma for analysis. After analysis and the cross reference of morgellons fiber with national database of the FBI, the Morgellon's fibers did not match up to any of the known fibers within the database. Other studies suggest that these fibers can withstand temperatures of up to 1400 degrees Fahrenheit.

In the video below, Tulsa medical research lab is one of the only places studying Morgellon's; however, considering T. Boone Pickens is involved, whatever they discover, if anything, should not be accepted as the final word.

Read more...

Friday, February 04, 2011

Operation Innovate to Zero Gets a Little Help From the FDA.

Don't you wonder why more Americans than ever before are burdened by expanding waistlines, multiple chronic illness, and "out of the X-files" type affliction, such as the controversial Morgellon's Disease?  The disease that the CDC has yet to reveal its findings, despite constant inquiry that started over ten-years ago.





The following will be easier to follow, if, first, you understand that, according to the FDA, anything used to treat disease is considered a drug... anything! Therefore, that anything is subject to regulation by Monsanto the FDA.  And second, "Codex Alimentarius" (latin for food rules),  is not about consumer protection at all. It's chief reason for existence is to serve the economic ambitions of multi-national corporations, in particular, the pharmaceutical industry.

The same industry that Bill Gates is dedicating his philanthropical career, ( 500,000 shares in Monsanto) as he tries to lower the population of the planet, through vaccines, health care and reproductive health.



Really, Bill, what's next? Handing the control of our food over to Monsanto?  Oh, wait...

What's so scary is that since  Senate Bill 510, now H.R. 2751:FDA Food Safety and Modernization Act, is law, and President Obama's appointed Antichrist's Monsanto’s own Michael Taylor - who designed the FDA’s GMOs (Genetically Modified Organisms) friendly policy, allowing GMOs on the market without any investigation into its safety, without labeling, and who wrote the FDA’s guidelines on recombinant bovine growth hormone (rBGH), banning dairies from labeling their milk “rBGH Free“ while serving as the FDA’s Deputy commissioner for policy -  as Food Safety Czar, our food may very well cease being food, if it hasn't already.  And, we may have to get prescriptions for oranges, apples, spinach...hell, maybe even the right to walk around the block, if Monsanto the FDA finds out those things actually treat disease.  Unfortunately for us, we can't even rely on claims of no genetically modified ingredients.

Proof of the FDA's knowledge - thanks to the Alliance for Bio-Integrity's lawsuit (Alliance for Bio-Integrity et al., vs. Shalala, et al.) to gain mandatory safety testing and labeling of food,  FDA internal memoranda about the hazards of genetically engineered foods - can be found here.  Not to mention, Wikileaks revealed that former President Bush was conspiring with Monsanto to force the global sale and use of hazardous-to-life-as-we-know-it GMOs. And now that H.R. 2751 passed, it gives Monsanto unlimited power over all US seed, food supplements, food and farming.

Hence, the recently approved genetically engineered alfalfa.

So, what's so bad about genetically modified food? Well, think cell invasion.  In order to move genetic material from one organism to another that do not normally interact, you've got to find an agent such as bacteria or viruses, since they're so good at penetrating and establishing themselves in the cell, to allow the transformation to take place. For example, Monsanto uses e-coli to recombine with the modifying dna that will create the genetically engineered dna inserted into the organism targeted for modification.  (See video below for all methods).



Several documented studies, compiled in the book, Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods , which was distributed to Congress, breaks down the health risks, genetically engineered food presents. Amongst other things, it can alter your DNA, change your brain waves, destroy your immune system,  destroy your organs and, if that's not enough, it can render you infertile.  Moreover, it actually cuts the productivity of crops.

So, there you have it. The multinational pharmaceutical industry seizing the opportunity to line their pockets with profits of providing "safe" nutrition with their FDA approved food substitutes and the biotechnology companies playing genetic rhoulette, resulting  hazardous-to-life-as-we-know-it GMOs.

Links:

Open Letter To The GAO: Michael Taylor, Monsanto Attorney Should Be Removed From The FDA Because Of Conflict Of Interest, Aspartame Approval Reinvestigated And Banned

Monsanto buys 'Terminator' seeds company

Read more...

Wednesday, February 02, 2011

Aspartame: The Product That Makes the Funeral Director's Life that Much Easier.

Well, it saves them a step or two, as they can mostly bypass the embalming process. Why? Because Aspartame (AminoSweet, Equal, NutraSweet, Spoonful, Canderel, E951, Benevia, etc.) pretty much does it for them.You see, upon ingestion, aspartame is broken, converted, and oxidized into formaldehyde in various tissues. So, thanks to Donald Rumsfeld, Ronald Reagan and aspartame - we'll get to that later- you or your loved ones arrive, at the funeral home, either partially or fully embalmed.  Joe the Funeral Director can

I mean, come on...haven't you noticed how waxy people look lately? Some even exhibiting that "in the coffin" glow? 

Anyway, it's really hard to avoid embalming yourself aspartame that's 180 times sweeter than sugar, as it's in everything from gum (aspartame works like nitroglycerin under the tongue, goes through saliva straight to the brain) to diet drinks to yogurt to Metamucil, and everything in between.

What's more, it has been linked to many diseases, and/or symptoms, thereof, including: Multiple Sclerosis, Diabetes, Parkinsons, Lupus, Graves Disease, Epilepsy, Hyper/hypothyroidism, ALS, Migraines, brain tumors, etc . Aspartame damages the mitochondria, the powerhouse of the cell, so it interacts with drugs and vaccines. But, that's not all it does, it does so much more because aspartame is a molecule which contains:

40% aspartic acid, an excitotoxin that literally stimulates neurons to death causing brain damage.

50% phenylalanine, which comes with a PKU warning for those who can't metabolize phenylalanine. However, it's a wonder anyone can, as phenylalanine floods the brain as a neurotoxic isolate, which lowers the seizure threshold, and depletes serotonin. As we know, this can cause a variety of psychiatric behavioral problems, and if you're already taking an antidepressant, it most definitely interacts with it.

10% methanol, free methyl alcohol, which is basically what converts to formaldehyde and formic acid.

Now, if you call up the aspartame makers, or one of the federal agencies that "protect" us from all that's bad, they will try to tell you that there is more methanol in oranges, and they're right; however, the methanol in oranges binds to the pectin which takes it right out of the body, not to mention, the ethanol is the classic antidote for methanol poisoning. Nature knows what it's doing. The FDA, CDC, and so forth...not so much, or maybe they do, and they're just plain evil (see Congressional reports, buried investigations in links section). As Mel Fabregas wrote:
"More than 90% of all FDA complaints are attributed to Aspartame, yet the very same government agency that is supposed to protect us is allowing these poisons in our food supply. Some of these excitotoxins are chemicals that we have been fooled into thinking will help us live longer and healthier lives."
And I might add, thinner lives.

And-possibly due to ​aspartame's endocrine disrupting properties-it will not help you keep the weight off! Conversely, it fattens you up, because it creates carbohydrate cravings.  Sneaky bastards don't want you cutting out the carbs...that might eat into their profits, after all.  Therefore, one could conclude that aspartame plays a part in the current obesity epidemic, not to mention, the rapid increase in the diabetes rate. Not only can aspartame precipitate the disease, it can stimulate and aggravate diabetic retinopathy and neuropathy by destroying the optic nerve; can cause  diabetics to go into convulsions; and the methyl alcohol can interact with insulin which may cause loss of limbs.

According to Dr. Betty Martini, there are records that show aspartame was listed by the Pentagon in an inventory of  perfected biochemical warfare weapons submitted to Congress. Which leads right into Rumsfeld and Reagan's role in getting this "biochemical warfare weapon" approved for human consumption.

In September of 1980, the Board of Inquiry (FDA) concurred and denied the petition for aspartame'. In 1985, Donald Rumsfeld, Searle Labs, CEO, at the time, said he would "call in my markers" to get aspartame approved. The next day, President Reagan (Rumsfeld was on President Reagan's transition team), at 3 AM, placed a call to FDA Commissioner, Jere Goyan, and fired him, knowing it would take 30 days to get someone in to overrule that Board of Inquiry. President Reagan then wrote an executive order, making the FDA powerless to do anything until the newly appointed Arthur Hull Hayes took over.

According to Dr. Martini, President Reagan may have promised Rumsfeld the VP position, and when he chose Bush; Rumsfeld felt Reagan owed him; hence, the "call in my markers" remark.

And, there you have it: "the nature of the game".

Please allow me to introduce myself
I’m a man of wealth, and taste,
I’ve been around for a long, long year
Stole many a man’s soul and faith…
Pleased to meet you
Hope you guess my name,
But what’s puzzling you
Is the nature of my game.

Links:

AJINOMOTO, ASPARTAME & BRAIN TUMORS: RECIPE FOR DEATH!
by Dr. Betty Martini
We seem to hear a lot about mass murderers these days: insane, demonic sociopaths who thrill to the terror and agony they inflict. On a gigantic scale history names great masters of destruction: Who can number those slain by Hitler, Stalin, and Mao? To collect such a stupendous price the mind of the people must be saturated with propaganda, packaged lies relentlessly fire-hosed into the public consciousness until the world is upside down: evil is virtue; slaughter is holiness, dying for the emperor, the fatherland and the 1,000 year Reich or a twisted religion is the supreme glory. All these crimes breed in the egocentric brains of ambitious morally stunted men full of hubris and hate, consumed with pride & greed.

The same greed, the same hubris, the identical fatal fanaticism resides in the boardrooms of gigantic corporations. Consider Enron, WorldCom, Arthur Anderson and the French medicos who released AIDS-contaminated blood for transfusions. When the crime surfaced these guardians of health sold the sewage to poor nations there to infect millions for generations to come. Heinous condemnation of millions to lingering death! Would not a fair price be to infect these despicable, heartless human scum with their own vaccines? Instead these lords of liquidation with lettered names retire to their chateaus, servants and limousines to tally blood money. Twenty years later they dine in smart cafes and saunter the streets of Paris unpunished! The crime was so deep, the bloodguilt so broad, that a hundred mass murderers got a free pass! "O the Humanity, the Humanity."

Congressional Record - Vol. 131 No. 58 - May 1985 Links to pdf version on Dr. Martini's site.

Congressional Record 1985b. "Aspartame Safety Act," Congressional Record, Volume 131, No. 106, August 1, 1985, page S10820-10847. Links to pdf version on Dr. Martini's site.

UPI Investigative Report 1987 NutraSweet: Questions Swirl
(Editor's note: UPI Investigative Reporter Gregory Gordon spent eight months examining industry research into popular artificial sweetener, NutraSweet and the Food and Drug Administration's handling of the
product permeating the diet food and drink markets. here is the first in his three-part report.)

Adverse Reactions to Aspartame:Double-Blind Challenge in Patients from a Vulnerable Population

SURVEY OF ASPARTAME STUDIES: CORRELATION OF OUTCOME AND FUNDING SOURCES

The Bressler Report
In Searle's original studies they were caught removing brain tumors from the rats and putting them back in the study. Dead rats that died were resurrected on paper. Neoplasms were filtered out. FDA Jerome Bressler's honest Audit Report exposed it all. After he retired from the FDA I thanked him for his honesty and courage in telling the facts. He told me his report was much worse, but the FDA retyped and removed the worst 20%. He also discussed this with Doctors H. J. Roberts and Russell Blaylock. Doctor H. Roberts asked his congressman to have the FDA release this 20%. They refused, claiming it was confidential. In denying a Congressman this data FDA broke the law, but they do it all the time, as they're a law unto themselves, like you! Bressler's report wasn't confidential, it was just so bad that FDA couldn't let anyone see it.
"With the public concern over childhood obesity and diabetes, few are being told of the overwhelming evidence that early exposure to excitotoxins (as found in aspartame) consistently produce gross obesity and insulin resistant diabetes, just as we are seeing in our youth." -- Dr. Russell Blaylock, neurosurgeon,
Sources:

Veritas with Mel Fabregas - Great show. It's supported 100% by subscriptions, and it's worth every penny...and a whole lot more. No censoring. No advertisements. No interruptions.  Mel asks great questions and he makes it all about the subject, giving his guests all the time they need to explain. Not to mention, his guests are the most interesting guests I've ever heard.

Mission Possible World Health International   Dr. Betty Martini's website. She is the founder of the global volunteer force, Mission Possible International, which is committed to removing the deadly chemical aspartame from our food.  She has been doing this for 14 years with operations in most states and over 30 countries of the world. She works with the world experts who write the reports you will find on their web pages. She spent 22 years in the medical field before this, and created the first health delivery system in the US. She can be seen in the aspartame documentary, Sweet Misery: A Poisoned World.

Read more...

Saturday, January 01, 2011

What is the Food Safety Modernization Act, Really?

On the surface, it certainly sounds like the S. 510:FDA Food Safety Modernization Act (FSMA) was created with the "best of intentions" as it is designed to give added protection to consumers from food contamination.  However, we know better, right?  "Best of intentions" in our current corpocracy doesn't compute. 

So, what else could possibly motivate our legislators?  Could it be an excuse to create even more bureaucracy, therefore taking further control of our lives, without taking any of the responsibility?  Because what is the point of adding five more federal agencies? The Department of Agriculture, Department of Health and Human Services, the Center for Disease Control, the Environmental Protection Agency and even the Department of Homeland Security?  And that's in addition to the Food and Drug Administration!

Consider this. These  new regulations are not required for food grown outside the United States. So, as prices sky-rocket on American produced or local organic food, incoming food, from other countries  that doesn't have to meet any of the food safety regulations, saturated with all of those dangerous chemicals and/or hormones, will be able to charge far below the price of locals.   So, as a result, it's possible, once the  FSMA goes into action,  consumers will end up buying the extremely toxic food, grown beyond the scope of regulation, from the multinational corporate farms; hence, rendering the FSMA, the FP[oison]MA.  

Aha! There is the rub, and the reason: securing multinational profits!  Because, in the end, this food safety bill will place enormous new burdens on small to mid-sized farms in the US, driving them out of business, not to mention, erecting new barriers to potential local food-producers.

Some even say that this bill will or could make it illegal for people to grow their own food. Well, as crazy as that sounds, when you consider how corporatized our government is now, and when you consider that so many activists are trying to convince people to starve the multi-nationals and instead, build up their local economies, anything is possible. Moreover, there are large gray areas in this bill, open wide to interpretation.

Yep, to be sure, those super-sized, over-hormoning, deplete the nutrients, corporate farms will benefit, as always.

Read more...

Thursday, March 18, 2010

Big Pharma or Us?

Generic drugs make up 70% of all prescriptions, and according to House Energy and Commerce Committee chairman Henry Waxman, "in the last decade alone, generic drugs have saved consumers, businesses and state and federal governments $734 billion." Despite that savings, the cost of drugs continues to escalate. In large part this is due to what is regarded as the future of health care: biotechnology drugs, or "biologics".

Simply put, biologics are protein based drugs made from living organisms - hamster ovaries, mare's urine, pig intestines, blood - grown inside living cells, as opposed to chemicals, normally showing better efficacy and safety than conventional drugs. Used to treat everything from cancer to multiple sclerosis to psoriasis, biologics currently make up about 20% of the pharmaceutical market - predicted to make up half the market by 2015 - and are the fastest-growing class of medicines, with more than $40 billion in annual sales in the United States.

However, the FDA has no authority to approve lower-cost, generic versions, biosimilars or “follow-on biologics” (“FOBs”) so, these drugs very rarely face competition from generic copies. FOBs (generic form of biologics) could save patients, insurers and our government anywhere from $67 billion to $108 billion during the first decade, and between $236 billion to $378 billion over the next two decades according to the Generic Pharmaceutical Association.

The contentious issue here is the length of time that brand names can hold a monopoly before the FDA can approve the entry of generic competitors. Competition from generic drugs has substantially reduced prescription drug prices and overall prescription drug expenditures, increased access to therapeutic drugs for more Americans, and hastened the pace of innovation.

The provision in proposed health care legislation would allow pharmaceutical companies to extend monopolies to 12-years exclusivity once the product is licensed by the FDA. Even after 12 years, this legislation would allow a pharmaceutical company to extend market protection for its biologic by making minor modifications to the drug to effect dosing, for example.

Generic brand medications only make up for 17 percent of all profits, and generic prescription companies are more focused on the hit that consumers will take financially if longer terms of exclusivity are given to brand-names and biologics. Brand names and biologics, however, are more focused on their profits.
So, why do biologics need a 12-year instead of a 5-year monopoly?

The answer is, of course, profit, and not just a little profit...a lot of profit. According to the pharmaceutical trade association, the average research and development costs are approximately the same for biologics as they are for conventional drugs. Not only that, generics face higher than normal barriers to entering the market. The FTC recently released a report entitled, “Follow-on Biologic Drug Competition” which addressed questions that have arisen about whether the price of biologics might be reduced by competition if there were a statutory process to encourage biosimilars or FOBs to enter and compete with pioneer (brand name) biologics once a pioneer drug’s patents have expired. The FTC did not recommend biologics any years of exclusivity protection.
Based on these findings, the Report concludes that patent protection and market-based pricing will promote competition by FOBs, as well as spur biologic innovation. It states that legislation to put a process in place for the abbreviated FDA approval of FOBs is likely to be an efficient way to bring FOBs to market, because of the time and cost savings it would provide.

In addition, the Report states that the 12- to 14-year regulatory exclusivity period is too long to promote innovation by these firms, particularly since they likely will retain substantial market share after FOB entry. The Report concludes that special procedures to resolve patent issues between pioneer and FOB manufacturers before FDA approval, which are not needed,
could undermine patent incentives and harm consumers. Finally, the Report states that FOB manufacturers are unlikely to need additional incentives – such as a 180-day marketing exclusivity period – to develop interchangeable FOB products.
Links:

Act and Myth of Exclusivity Incentive

Competition Counts

Frequently Asked Questions About Therapeutic Biological Products

Emerging Health Care Competition and Consumer Issues

See How Pay-for-Delay Settlements Make Consumers and the Federal Government Pay More for Much Needed Drugs: Hearing Before the H. Subcomm. on Commerce, Trade, and Consumer Protection, Comm. on Energy and Commerce.

Read more...

Friday, May 25, 2007

Medical Marijuana One Step Away from FDA Development Process

WASHINGTON D.C. – A U.S. Department of Justice-appointed judge submitted her final recommendation to the U.S. Drug Enforcement Administration (DEA) on May 15, calling on the agency to end a forty-year government monopoly on the supply of research -grade marijuana available for Food and Drug Administration (FDA)-approved studies. With this monopoly broken, new studies could lead to medical marijuana’s availability in pharmacies as a legal, prescription drug. DEA Deputy Administrator Michele Leonhart must now accept the judge’s recommendation in order for the ruling to take effect, though she has no deadline for doing so and may choose to reject the recommendation.

“Medical marijuana is one step away from the FDA development process, where it should be. Science, not politics, needs to determine whether medical marijuana should be made legal, and the DEA has so far tried to block the scientific process,” said University of Massachusetts-Amherst Professor Lyle Craker, who six years ago petitioned DEA for a license to grow research-grade marijuana for use in privately-funded, FDA-approved studies that aim to develop the plant into a legal, prescription medicine. “I hope that the Deputy Administrator acts quickly to allow this critical research to move forward.”

On May 15, DEA Administrative Law Judge Mary Ellen Bittner submitted her recommendation to the DEA’s Deputy Administrator in which she found that it is “in the public interest” to end the federal monopoly on the supply of marijuana that can be used in FDA-approved research, held by the National Institute on Drug Abuse (NIDA).

Following nine days of hearings, testimony and evidence from both sides, including from researchers who reported that the government denied their requests for marijuana for use in FDA-approved research protocols, Judge Bittner concluded that, “NIDA’s system for evaluating requests for marijuana has resulted in some researchers who hold DEA registrations and requisite approval from [HHS and FDA] being unable to conduct their research because NIDA has refused to provide them with marijuana. I therefore find that the existing supply is not adequate.” She added, “Respondent’s registration to cultivate marijuana would be in the public interest.”

The American Civil Liberties Union (ACLU) represents Craker in the proceedings, and pointed to the groundswell of support for medical research and calls for marijuana to go through the FDA development process without delay to determine whether it could be made available to patients in pharmacies.

“The DEA has forced patients to get their medicine from the street corner instead of from pharmacies by blocking the very research that would put the medical marijuana issue through proper regulatory channels,” said Allen Hopper, legal director of the ACLU Drug Law Reform Project. “The time has come for the government to stop putting politics before science and to allow the research, not the politicians, to decide whether medical marijuana should be made legal.”

Legal papers filed throughout the proceedings pointed to the fact that marijuana is the only Schedule I drug the DEA has prohibited from being produced by private laboratories for scientific research. Other controlled substances, including LSD, MDMA (also known as "Ecstasy"), heroin and cocaine, are available to researchers from DEA-licensed private laboratories.

In contrast, NIDA has remained scientists’ sole source of marijuana, despite the agency’s repeated refusal to make marijuana available for privately-funded, FDA-approved research that seeks to develop smoked or vaporized marijuana into a legal, prescription medicine. During the legal proceedings, the ACLU and others argued that such research conflicts with NIDA’s core mission, which is to study the harmful, not potentially medicinal, effects of drugs of abuse. In addition, researchers report that marijuana available through NIDA is of low quality and variety and is not optimized to meet FDA standards for prescription drug development.

Professor Craker’s proposed facility to grow high-quality medical marijuana for research purposes will be funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit pharmaceutical company with plans to develop marijuana into a fully legal, prescription medication.

“For decades, we’ve been told by the politicians that marijuana has no proven medical value while scientists have been denied the ability to prove otherwise,” said Rick Doblin, Ph.D., president and founder of MAPS. “Judge Bittner’s recommendation marks a shift in this debate. I look forward to facilitating for marijuana the same rigorous, scientific research required to bring all other prescription medicines to market.”

Thirty-eight members of the U.S. House of Representatives, Massachusetts Senators John Kerry (D-MA) and Edward Kennedy (D-MA), and a broad range of scientific, medical and public health organizations have joined Professor Craker in challenging the federal government’s policy of blocking administrative channels and obstructing research that could lead to the development of marijuana as a prescription medicine. These organizations include the Lymphoma Foundation of America, the National Association for Public Health Policy, the Multiple Sclerosis Foundation, as well as several state medical and nurses’ associations.

Despite federal prohibition, 13 states have enacted legislation protecting patients who use medical marijuana with a physician’s recommendation from prosecution under state law, and national polls consistently find that roughly 75 percent of Americans support the use of medical marijuana.

Read more...

Thursday, December 07, 2006

Bullet Proof Teeth?

Fibers used in bullet-proof vests quadruple toughness of dental composites

Fiber-reinforced composites are so strong that dental bridges made with them can be attached with less invasive techniques to adjacent teeth.

Vistasp Karbhari, a professor of structural engineering at UC San Diego, has developed fiber-reinforced polymer composites as strong, lightweight materials for aerospace, automotive, civil and marine applications, so he thought, “If they work so well in highway bridges, why not dental bridges"”

In a paper scheduled for publication in Dental Materials, Karbhari and Howard Strassler, a professor and director of Operative Dentistry at the University of Maryland Dental School, report the results of detailed engineering tests on dental composites containing glass fibers as well as the type of polyethylene fibers used in bullet-proof vests.

Karbhari and Strassler found that the toughness of fiber-reinforced dental materials depends on the type and orientation of the fiber used. Their report, available at the Dental Materials website, shows that braided polyethylene fibers performed the best, boosting toughness by up to 433 percent compared to the composite alone.

Many of the strength and durability tests reported in the paper are not currently required by the U.S. Food and Drug Administration (FDA), which regulates dental composites as class II prescription devices. The agency requires eight minimum tests plus biocompatibility tests to ensure that dental composites are safe and nontoxic.

“Fiber-reinforced composites are now widely used in the aerospace and automotive industries and the experience we’ve gained in these applications can be applied in a more rigorous way in dentistry and medicine to tailor performance to exacting requirements,” said Karbhari. Dentists began using particle filled composites 10 years ago as an alternative to ceramics and mercury-containing metal amalgams. Strassler selected three commercially available fiber-reinforced composites for analysis.

Howard Strassler, a professor and director of Operative Dentistry at the University of Maryland Dental School, said makers of fiber-reinforced dental composites need a much better understanding of how their...

Dental composites made with glass or polyethylene fibers are sold as pliable ribbons that dentists mold into the required shape and then harden with curing lights. “Many reinforcing fibers can add strength and toughness to dental composites,” Karbhari said, “but if they are improperly aligned they could actually accelerate damage to existing teeth.”

“What’s been missing until now is a rigorous, reproducible way to test the durability and resistance to breakage for these materials,” Strassler said. “Makers of fiber-reinforced dental composites need a much better understanding of how their products actually perform as part of a restoration, crown, or bridge, and this study provides an analytical standard with which all composites should be evaluated in the future.”

The three products tested were a 3-millimeter-wide ribbon of unidirectional glass fibers, a 3-millimeter-wide ribbon of polyethylene fibers woven in a figure-8 stop-stitch leno-weave, and a 4-millimeter wide ribbon of polyethylene fibers woven in a biaxial braid. The resistance to breakage and various measures of toughness of the three preparations were compared to the dental composite alone.

“All three fiber fabrics dramatically increased the durability and strength of the dental composite, but the polyethylene fibers braided in a biaxial ribbon performed best,” said Karbhari. “The tests required by the FDA indicate that fiber-reinforced composites are safe, but those tests are only partially informative. Our analyses show that we can optimize these materials to match and improve performance of teeth, for greater durability, toughness, and resistance to breakage.”

Read more...
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