Is FDA About to Greenlight a Drug Banned in Other Countries?

Is Our USFDA our Friend?

                            SPONSORS

            The Solution For Disease FREE Health.

                  http://bit.ly/RGNZ0i

World's #1 Publisher of Information About Alternative Cancer Treatments

                      http://bit.ly/ZVR6Qw

            Cancer Can Be Cured and Is Cured.

               http://CANCERCUREHERE.COM

Is FDA About to Greenlight a Drug Banned in Other Countries?

warning-fda-approvedIf enough people raise their voices in protest, we can
prevent it. Action Alert!

Remember the controversial diabetes drug Avandia? In 2010 we told you about
two FDA drug safety reviewers who warned the agency that Avandia posed
serious risks of heart attack and heart failure when compared with other
diabetes drugs. Since then, the drug has been removed from the market in most
countries and has been under severe restrictions in the US.

In a combined meeting of separate FDA advisory committees, 20 of 26 panelists
voted to recommend removing or modifying Avandia’s highly restrictive label
and distribution system. Five voted to keep the restrictions in place, while one
panelist voted to remove the product from the market altogether.

There has been only one large, randomized trial for the safety of
rosiglitazone, the drug that is marketed as Avandia. That trial—sponsored by
GlaxoSmithKline (GSK), the drug’s manufacturer—was called RECORD
(Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in
Diabetes). Serious flaws were found in RECORD’s methodology, its results were
questioned, and the trial was widely discredited.

In 2010, FDA required GSK’s RECORD results to be reexamined and re-
adjudicated. What was the FDA’s motivation for reviewing Avandia? GSK didn’t
request that the drug be reviewed. Could it be, as Steve Nissen suggests in
Forbes, because FDA “is seeking to avoid accountability for its role in the
Avandia tragedy”? FDA’s official position is that they asked for the re-
adjudication because of “the public interest in Avandia, the extensive
history of the product, and the continued uncertainty of the risk surrounding
this drug.”

Duke University’s Clinical Research Institute (DCRI) was selected for the
re-adjudication, and they found that the risk for cardiovascular death,
myocardial infarction (MI), and stroke to be virtually the same as the
original study concluded. Because these new results reaffirmed GSK’s
findingsthat the drug was no more unsafe than other diabetes products in
its class,

The panelists were sufficiently reassured that the drug was safeenough
to lift restrictions.

Unfortunately, other data paint a very different picture:

    In 2005 and 2006 GSK secretly conducted an analysis of cardiovascular
safety of Avandia, and concluded that the drug increased the risk of heart
attacks and related events by 30%. Since two-thirds of diabetics eventually
die of cardiovascular complications anyway, this 30% hike is terrifying.

    In 2006 GSK informed the FDA’s Center for Drug Evaluation and Research
(CDER) of the secret analysis, but FDA and CDER agreed to conceal this hazard
from patients and practitioners.
    During a public hearing, independent FDA statisticians reported an 80%
increased risk of heart attack. Avandia is estimated to have caused 83,000
heart attacks in the United States alone.

    Adverse effects caused by the drug are currently the subject of over
13,000 lawsuits against GSK. As of July 2010, GSK has agreed to settlements
on more than 11,500 of these suits.

    Last year, GSK pled guilty of criminal conduct, partially for concealing
the hazards of Avandia. The company paid a $3 billion fine—the largest in US
history.

In addition, the re-adjudication process itself was biased. GSK prepared the
study materials before submitting them to Duke for analysis, rather than
allowing the university to review the raw data. (On the widespread problem of
publication bias, see our article in this issue.)

On top of that, key members of the 2010 advisory committee that decided to
place restrictions on Avandia in the first place were not part of the 2013
meeting. Of the twenty-seven member panel, fourteen of the experts were on
the panel last time, and they were the people with a more favorable attitude
toward Avandia. This is in contrast to the other experts who did not serve on
the panel a second time—like Steven Nissen, who was one of the most outspoken
critics on the panel. FDA claims all panelists were invited, it does not
appear they made a huge effort to ensure their participation; Nissen says he
was not re-invited. With all of the big nay-sayers out of the picture, it’s
no surprise the panel voted to lift the restrictions on this dangerous drug.

FDA should focus more on advisory panelists who have true conflicts of
interest. A 2007 law placed caps on the number of waivers that could be
granted allowing experts with conflicts of interest; a 2012 law removed those
safeguards. When there are no restrictions on experts with conflicts of
interest serving on FDA advisory panels, more drugs with dangerous side
effects could certainly enter the market.

God Bless Everyone & God Bless The United States of America.

Larry Nelson
42 S. Sherwood Dr.
Belton, Tx. 76513
cancercurehere@gmail.com

Cancer Treatments...

More   Cancer Treatments... 

                        SPONSORS

            The Solution For Disease FREE Health.

                  http://bit.ly/RGNZ0i

World's #1 Publisher of Information About Alternative Cancer Treatments

                      http://bit.ly/ZVR6Qw

            Cancer Can Be Cured and Is Cured.

               http://CANCERCUREHERE.COM

           Continued From Last Post

How Enzymes Might Help Treat Cancer

    Bromelain is a proteolytic enzyme (an enzyme that digests proteins). In the Planta Medica study, it was injected directly into the abdominal cavity. Getting enzymes from your digestive tract into your bloodstream isn't as easy as it would seem, as enzymes are very susceptible to denaturing and must be helped to survive the highly acidic environment in your stomach. They are often given an "enteric coating" to help them survive the journey through your digestive tract.

    And then, there is the matter of absorption. For nearly 100 years, medical dogma insisted that enzymes taken orally were too large to pass through the digestive tract wall.

    However, there is now a good deal of research that they can indeed pass through your intestine intactiii and into your bloodstream and lymphatic system, where they can deliver their services to the rest of your body... one of the mysteries of medical science.

    Now that we know this is possible, systemic oral enzymes have been used to treat problems ranging from sports injuries to arthritis to heart disease and cancer, particularly in European countries. But most of the research has been published in non-English language journals.

Is Cancer the Result of Diminished Pancreatic Enzymes?

    This systemic use of enzymes is just now taking off in the United States, but the use of enzymes to treat cancer has its roots all the way back to 1911 with John Beard's The Enzyme Treatment of Cancer and Its Scientific Basis. Beard believed cancer was a result of diminished pancreatic enzymes, impairing your immune response. A study in 1999iv suggests he may have been right on target.

    Ten patients with inoperable pancreatic cancer were treated with large doses of oral pancreatic enzymes (along with detoxification and an organic diet), and their survival rates were 3 to 4 times higher than patients receiving conventional treatment. Proteolytic enzymes can be helpful in treating cancer because they help restore balance to your immune system. Dr. Nick Gonzalez in New York City, NY has also done a lot of work on enzymes in cancer treatment and has written a book on the subject.v

    Some of the ways proteolytic enzymes can be helpful in the fight against cancer are:

        Boosting cytokines, particularly interferon and tumor necrosis factor, which are very important warriors in destroying cancer cells.
        Decreasing inflammation.
        Dissolving fibrin: Cancer cells hide under a cloak of fibrin to escape detection. Once the cancer cells are "uncloaked," they can be spotted and attacked by your immune system. It is also thought that fibrin makes cancer cells "stick together," which increases the chance for metastases.
        German studies have shown that systemic enzymes increase the potency of macrophages and killer cells 12-fold.

    Fortunately, you get (or should be getting) many enzymes from the foods you consume—particularly, raw foods. These directly help with your digestive process. The more raw foods you eat, the lower the burden on your body to produce the enzymes it needs, not only for digestion, but for practically everything. Whatever enzymes are not used up in digestion are then available to help with other important physiological processes.

    This is one of the reasons why it is so important to eat a diet rich in fresh, organic, raw foods. You may even want to try juicing some of your vegetables, and the core of your pineapple, as a way of getting more nutrients—and enzymes—into your body. In the event you use enzymes in supplement form, it is crucial that, in order for enzymes to be used systemically, they must be consumed on an empty stomach. Otherwise, your body will use them for digesting your food, instead of being absorbed into the blood and doing their work there.

Thank You Dr. Mercola

God Bless Everyone & God Bless The United States of America.

Larry Nelson
42 S. Sherwood Dr.
Belton, Tx. 76513
cancercurehere@gmail.com

Cancer Treatments...

Another Cancer Treatment....

                            SPONSORS

 

            The Solution For Disease FREE Health.

                  http://bit.ly/RGNZ0i

World's #1 Publisher of Information About Alternative Cancer Treatments

                      http://bit.ly/ZVR6Qw

            Cancer Can Be Cured and Is Cured.

               http://CANCERCUREHERE.COM

Surprising Cancer-Fighting Benefits of Pineapple Enzyme

    One of the reasons why conventional cancer treatment is such a dismal
failure in the United States is because it relies on chemotherapy.

    Chemotherapy drugs are, by their very nature, extremely toxic and
typically work against your body's natural ability to fight cancer, e.g.
destroying host immunity instead of supporting it.

    One of the biggest drawbacks to chemotherapy is the fact that it destroys
healthy cells throughout your body right along with cancer cells, a "side
effect" that often leads to accelerated death, not healing.

    Another devastating side effect of chemotherapy is the way it actually
supports the more chemo resistant and malignant cell subpopulations within
tumors (e.g. cancer stem cells), both killing the more benign cells and/or
senescent cells within the tumor that keep it slow-growing, or even harmless.

    As a result, this unleashes a more aggressive, treatment-resistant type
of cancer to wreak havoc on the body.

    A handful of natural compounds have been discovered, however, which
exhibit an effect called "selective cytotoxicity."  This means they are able
to kill cancer cells while leaving healthy cells and tissue unharmed.

    This type of cancer treatment is intelligent, targeted and will not
result in the death of the patient from "collateral damage" in what is
increasingly a failed war not against the cancer being treated, but the
patient's own irreversibly devastated body.

Bromelain in Pineapples Kills Cancer Cells Without Harming You

    One such compound is bromelain, an enzyme that can be extracted from
pineapple stems. Research published in the journal Planta Medica found that
bromelain was superior to the chemotherapy drug 5-fluorauracil in treating
cancer in an animal study.i Researchers stated:

        "This antitumoral effect [of bromelain] was superior to that of 5-FU
[5-fluorouracil], whose survival index was approximately 263 %, relative to
the untreated control."

    What makes this impact particularly impressive is that the bromelain
worked without causing additional harm to the animals. The chemo drug 5-
fluorauracil, on the other hand, has a relatively unsuccessful and dangerous
track record despite being used for nearly 40 years.

    As written by GreenMedInfo:

        "As a highly toxic, fluoride-bound form of the nucleic acid uracil, a
normal component of RNA, the drug is supposed to work by tricking more
rapidly dividing cells -- which include both cancer and healthy intestinal,
hair follicle, and immune cells -- into taking it up, thereby inhibiting
(read: poisoning) RNA replication enzymes and RNA synthesis.…

        When a person dies following conventional cancer treatment it is all
too easy to "blame the victim" and simply write that patient's cancer off as
"chemo-resistant," or "exceptionally aggressive," when in fact the non-
selective nature of the chemotoxic agent is what ultimately lead to their
death."

    Selective cytotoxicity is indeed a property that is only found among
natural compounds; no chemotherapy drug yet developed is capable of this
effect. Aside from bromelain, other examples of natural compounds that have
been found to kill cancer cells without harming healthy cells include:

        Vitamin C -- Dr. Ronald Hunninghake carried out a 15-year research
project called RECNAC (cancer spelled backwards). His groundbreaking
research in cell cultures showed that vitamin C was selectively cytotoxic
against cancer cells.

        Eggplant extract: Solasodine rhamnosyl glycosides (BEC), which is a
fancy name for extracts from plants of the Solanaceae family, such as
eggplant, tomato, potato, Bell peppers, and tobacco, also impact only
cancerous cells leaving normal cells alone. Eggplant extract cream appears to
be particularly useful in treating skin cancer. Dr. Bill E. Cham, a leading
researcher in this area, explains:

            "The mode of action of SRGs [glycoalkaloids solasodine rhamnosy
glycosides (BEC)] is unlike any current antineoplastic [anti-tumor] agent.

Specific receptors for the SRGs present only on cancer cells but not normal
cells are the first step of events that lead to apoptosis in cancer cells
only, and this may explain why during treatment the cancer cells were being
eliminated and normal cells were replacing the killed cancer cells with no
scar tissue being formed."

        Turmeric (Curcumin Extract): Of all the natural cancer fighters out
there, this spice has been the most intensely researched for exhibiting
selective cytotoxicity.ii Remarkably, in a 2011 study published in the
Journal of Nutritional Biochemistry, rats administered curcumin, the primary
polyphenol in turmeric, saw a decrease in experimentally-induced brain tumors
in 9 out of 11 treated, while noting that the curcumin did not affect the
viability of brain cells "suggesting that curcumin selectively targets the
transformed [cancerous] cells."

         Continued

God Bless Everyone & God Bless The United States of America.

Larry Nelson
42 S. Sherwood Dr.
Belton, Tx. 76513
cancercurehere@gmail.com

Stent Patients as Likely to Die...

 Stent Patients as Likely to Die, Have Heart Attack continued...

   

                      SPONSORS

            The Solution For Disease FREE Health.

                  http://bit.ly/RGNZ0i

World's #1 Publisher of Information About Alternative Cancer Treatments

                      http://bit.ly/ZVR6Qw

            Cancer Can Be Cured and Is Cured.

               http://CANCERCUREHERE.COM         
  

Stent Patients as Likely to Die, Have Heart Attack continued...

Then, about half the participants also underwent angioplasty, usually with stents.

Over the next five years, 19% of those in both groups died or had a heart attack. Similar numbers of people in both groups -- about 12% -- were hospitalized for heart problems.

However, there were some benefits to angioplasty. People who had the procedure were 40% less likely to need another procedure to open up blocked heart arteries. And, particularly in the first two years, they reported better quality of life and less frequent episodes of chest pain.

But over time, some of the differences started to dissipate. By five years later, 74% of people who had angioplasty were angina-free vs. 72% of those who got drugs alone, a difference so small it could be due to chance.

Results Stun Medical Community

Boden notes that COURAGE is "the first properly-sized study to answer the question of whether angioplasty and stents reduce the risk of death and heart attacks in people with stable coronary artery disease."

The results came as a shock to many in the cardiology community -- even to the researchers themselves.

"The study was designed with the hypothesis that the combination of angioplasty and optimal medical therapy would be superior," Boden says. "But the results do not support its benefit in reducing heart attacks and death when used as an initial management strategy."

So why would so many doctors recommend a costly procedure without strong evidence it works?

The average cost of having an angioplasty was $38,000 in 2003, according to the American Heart Association.

Nissen thinks it’s because “it seems so intuitively obvious: If you open up a block artery, you’ll fix the problem.”

American Heart Association President Raymond J. Gibbons, MD, chief of cardiology at the Mayo Clinic, adds that there’s a financial incentive for doctors. "People get paid for how many procedures they do," he tells WebMD.

But this study "clearly shows there is no advantage to PCI [percutaneous coronary intervention, or angioplasty] as an initial strategy. It’s unnecessary," Gibbons says. "Angioplasty should be reserved for patients [who can’t be helped] by medical therapy."

Adds Nissen, "This study will change a lot of thinking. The benefits of angioplasty in people with stable chest pain is very modest, at most. It should be reserved for patients for intolerable symptoms."
Results Questioned

But many doctors who perform angioplasties say the procedure’s proven benefits in relieving angina, or chest pain, is getting lost in the shuffle.

Donald Baim, MD, chief medical officer of Boston Scientific, a manufacturer of drug-eluting stents, says, "COURAGE is not a catastrophic failure. [It shows that angioplasty plus stents] improves symptoms."

Marty Leon, MD, of Columbia University Medical Center, says, "There are so many deep flaws in the way this study was executed and planned. It was rigged to fail," and it did. "This study should not affect treatment patterns."

Boden says the criticism is unfounded, pointing out that the researchers purposely studied people at medium to high risk of having a heart attack or dying -- "the very people you would expect to benefit most from the procedure."

 By Charlene Laino

WebMD Health News
Reviewed by Louise Chang, MD

God Bless Everyone & God Bless The United States of America.

Larry Nelson
42 S. Sherwood Dr.
Belton, Tx. 76513
cancercurehere@gmail.com

Heart Disease...

Many Stent Procedures Unnecessary

                            SPONSORS

            The Solution For Disease FREE Health.

                  http://bit.ly/RGNZ0i

World's #1 Publisher of Information About Alternative Cancer Treatments

                      http://bit.ly/ZVR6Qw

            Cancer Can Be Cured and Is Cured.

               http://CANCERCUREHERE.COM   


 By Charlene Laino
WebMD Health News
Reviewed by Louise Chang, MD

March 26, 2007 (New Orleans) -- Hundreds of thousands of Americans may
undergo unnecessary angioplasty and stent procedures to open clogged heart
arteries each year, a landmark study suggests.

The long-awaited results show that people with stable coronary artery disease
who got common medications to lower blood pressure and cholesterol levels
were no more likely to die or to have a heart attack over the next five years
than those who also underwent angioplasty with stents.

Of the more than 1.2 million angioplasty procedures performed each year, at
least 50% of them are done on an elective basis in people with stable
coronary artery disease, says Stephen Nissen, MD, president of the American
College of Cardiology (ACC) and head of cardiovascular medicine at The
Cleveland Clinic.

In people with coronary artery disease, plaque builds up in the arteries,
making it harder for blood to get through, thereby depriving the heart muscle
of oxygen. This can lead to chronic chest pain that worsens during exercise
and to heart attacks.

During angioplasty, a balloon at the end of a long tube is threaded through
an artery in the groin. The doctor shimmies the probe up through the
patient's leg and into the arteries of the heart, inflating the tiny balloon
at the spot where the vessel has narrowed.

To keep the vessel open, doctors usually add a stent to the end of the
balloon catheter. These metal, mesh-like tubes prop open clogged arteries to
restore blood flow.

Angioplasty Still Best for Some

The study's results do not apply to people who get stents because they are in
the midst of a heart attack or whose chest pain suddenly gets worse, doctors
stress. For them, angioplasty is a proven lifesaver.

Additionally, angioplasty is better at relieving the chest pain associated
with angina, says researcher William Boden, MD, of Buffalo General
Hospital/Kaleida Health in Buffalo, N.Y.

"For an individual patient, angioplasty may still be the best option," he
tells WebMD. "But there has been an implication that if you give patients
drug therapy rather than angioplasty, you’re giving them less than optimal
treatment.

"Now we know that if you opt for medicine, you are not putting patients at
risk," Boden says.

The study, known as COURAGE, was released at the annual meeting of the
American College of Cardiology and simultaneously published online by The New
England Journal of Medicine.

Stent Patients as Likely to Die, Have Heart Attack

The researchers studied 2,287 people with stable coronary artery disease who
experienced chest pain for about two years, with an average of 10 episodes
per week. All had at least a 70% blockage in one or more heart arteries.

All participants were put on optimal drug therapy, which includes
nitroglycerin to control chest pain, beta-blockers to control heart rate, ACE
inhibitors for lowering blood pressure, and statins to lower cholesterol.

Everyone was also urged to exercise more and lose weight and quit smoking, if
needed.

                Continued

God Bless Everyone & God Bless The United States of America.

Larry Nelson
42 S. Sherwood Dr.
Belton, Tx. 76513
cancercurehere@gmail.com