Archive for the ‘Supplements’ Category

CoQ10 benefit heart failure patients

Tuesday, June 4th, 2013

Presenting the study at Heart Failure Congress 2013 of the European Society of Cardiology Heart Failure Association, lead investigator Dr Svend Aage Mortensen(Copenhagen University Hospital, Denmark) reported that major adverse cardiovascular events (MACE), a composite of unplanned hospitalization due to worsening heart failure, cardiovascular death, and the need for urgent cardiac transplantation and mechanical support, occurred in 14% of patients treated with CoQ10 compared with 25% of patients who received a placebo, a statistically significant difference (p=0.003). All-cause mortality was also significantly lower in the CoQ10-treated patients, with 9% dying compared with 17% in the placebo arm (p=0.01).

In addition to these outcomes, the Q-SYMBIO investigators reported that cardiovascular mortality and admissions for heart failure were significantly lower in those who received CoQ10. In their conclusions, the researchers stated that “CoQ10 should be considered as a part of the maintenance therapy of patients with chronic heart failure.”

Some, however, considered the recommendations to alter clinical practice on the basis of this 420-patient clinical trial premature. Dr Sanjay Kaul (Cedars-Sinai Medical Center, Los Angeles), for example, said he wants to reserve judgment on the data until they have stood up against the scrutiny of the peer-review process.

CoQ10 is an antioxidant involved in cellular-energy production. It is postulated that heart-failure patients, who have a measurable deficiency in CoQ10, would benefit from receiving the supplement.

The Q-SYMBIO study included 202 patients randomized to CoQ10 and 218 patients randomized to placebo. All patients included in the study had moderate to severe heart failure (NYHA class 3 or 4) and were receiving “current” pharmacologic therapy. Patients had an average ejection fraction of 31%, and the average age was 62 years. Within three months of treatment, investigators observed a trend toward lower levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP). The clinical improvements in MACE were observed after two years of receiving 100 mg of CoQ10 three times daily compared with those who received the placebo. In addition, 44% of those who received CoQ10 had an improvement in NYHA class compared with 45% of those who received placebo (p=0.047).

It is not clear as to the formulation used in the trial. The dose is 100 mg three times per day. We did discuss the difference between ubiquinone and ubiquinol in previous article. It would be good to also ascertain with measurable markers whether there was CoQ10 deficiency in the treated and placebo groups. It is not surprising to see benefits in such patients because coenzyme Q10 may be depleted in patients with heart failure and cardiomyopathy and those who are on statin treatment for high cholesterol.

The ratio of reduced to total Q10 concentration is also a useful biomarker of oxidative stress. Patients who have coenzyme Q10 deficiency also have increased risk of mitochondrial and cellular injury from excess production of free radicals.. Measurement of coenzyme Q10 concentrations in plasma can assist clinicians in detecting coenzyme Q10 deficiency states, and serve as a guide for dosing when oral supplementation is indicated.

We were not told of the formulation of the CoQ10 used in this study. Because significant inter-product variability in the absorption and bioavailability of coenzyme Q10 has been reported with over-the-counter (OTC) Q10 preparations, the Coenzyme Q10 test will also assist in verifying the extent of absorption of Q10 from those products.

Is this the beginning of the end for dietary supplements?

Friday, August 12th, 2011

There is an interesting development lurking in the US regarding the fate of supplements
that I thought would be of interest to some of you. I have copied the articles
of Warren Matthews, the founder and Chairman of Xtend-Life Natural Products
based in New Zealand and Bryon Richards that expressed their concerns and call
for consumers’ action. While there are concerns of the lack of regulation on dietary supplements,
there is a need to ensure that policies when put in place would not serve to profit certain vested interest at the
expense of the general public.{{{0}}}

Recently the US FDA issued a set of ‘guidelines’ for NDI’s
(New Dietary Ingredients). This has been anticipated for a long time but the
industry and others have been shocked at just how far the FDA have taken this.

What they are proposing would make the overwhelming majority
of supplements illegal because most ingredients being used have not been
approved. Even those which were in use prior to 1994 will still be affected.

Up until now it was OK to use an ingredient in a supplement
product provided that there was evidence that supported its safety. That system
has been working well and thousands of products have been developed on this
principle and millions of people have benefited by them. In other words, these
ingredients are OK to use in a variety of products.

However, the FDA has now suggested that not only each
ingredient has to be approved in its own right but each ‘product’ that contains
that ingredient will require an NDI approval specific for that ingredient in
that product. If the concentration of that approved ingredient in that specific
product is changed it will also trigger off a new NDI application. So, you
could have thousands of different NDI applications for the same ingredient but
in different products from hundreds of manufacturers.

To obtain that approval the manufacturer will have to come
up with hard scientific data that it is OK to combine that ingredient with another
ingredient in each specific formula. For example, combining grape seed extract
with grape skin extract. To provide that scientific proof is virtually
impossible even for a simple product…but, for a complex product such as many of
ours it is impossible.

Whilst these applications are being processed the product
will be withdrawn from the market. How the FDA will process what will amount to
10’s if not 100’s of thousands of applications are beyond comprehension. They
simply don’t have the resources and even if they did it would be an unwise use
of resources.

Synthetic versions exempt…

Some in the industry argue that this is the next step in an
attempt by the FDA to destroy the supplement industry or at least put the
majority of the industry ‘out of business’ and pave the way for synthetic
versions of natural ingredients. They may be right…particularly when you
consider that the synthetic versions of these natural ingredients as produced
by the pharmaceutical companies are exempt from these new proposed regulations!

This is not the only ‘unfair’ aspect of this proposed
regulation. There is a move by pharmaceutical companies to take effective
natural ingredients that have been proven in the dietary supplement industry
and start developing drugs from them. If they choose to do this then the FDA
can deny any NDI application for that ingredient from a dietary supplement
manufacturer even if that ingredient has been used for decades.

This is a very serious problem and the only way it is going
to be stopped is if enough people get up in arms about it and complain to their
law makers. I really do fear that the general public protest will not be strong
enough as so many people have so many other things on their minds in the
current difficult economic times. If you feel strongly about this issue please
let your lawmakers know your feelings.

The FDA’s Scheme to Reclassify Nutrients as Drugs

Tuesday, August 02, 2011 – Byron Richards, CCN

The FDA and Senator Durbin’s latest attack against the
dietary supplement industry should leave consumers for natural health options
at affordable prices up in arms. This attack will target some of the most
popular and effective dietary supplements, removing them from the free market
and placing them under control of large pharmaceutical companies. This move
will drastically drive up the price of dietary supplements while severely
limiting access to extremely safe and effective nutrients. For example, the
GlaxoSmithKline prescription drug version of DHA fish oil (at a therapeutic
dose) sells for $189 a month, whereas the equivalent, therapeutic amount of
molecularly-distilled DHA sells for $35 a month in the dietary supplement
marketplace. Proven to lower triglyceride levels at therapeutic amounts, it is
not surprising that DHA is one of the first nutrients the FDA plans to go
after. Other powerful nutrients, such as curcumin and resveratrol, are soon to
follow.

This is the second article in what will be a series of
articles on this critical topic. In my first article, “Senator Durbin & the
FDA Viciously Attack Dietary Supplements,” I outlined the scope and nature of
the attack and called readers to take action. And it is still critically
important that you do take action, so please visit our new TAKE ACTION page
immediately following reading this article.

The newly-proposed FDA regulations are complicated. We are just
beginning to understand the full scope of their ploy. The FDA is hoping that
the complexity of their regulations will confuse consumers so they do not
understand the coming changes and resulting repercussions. It is my job to give
you some concrete examples of how this will affect you.

It is not just DHA, curcumin and resveratrol that are slated
for pharmaceutical industry takeover, hundreds of other nutrients and herbs are
at risk. The unfortunate reality is if the FDA is allowed to carry out their illegal
strategy then thousands of products currently on the market are likely to be
deemed “misbranded drugs” and forced off the market under the FDA’s criminal
campaign to wipe out an industry, and ultimately gain even greater power and
profit.

The Pharmaceutical Industry’s Perfect Storm of Economic
Collapse

Mapping the human genome was supposed to usher in the next
generation of pharmaceutical “wonder” drugs. Scientists would identify a gene
or set of genes causing each and every disease. New biotech drugs operating at
the genetic level would fix the problems or compensate for them, ushering in
“The Golden Age of Cures” and reaping huge 21st century profits for the
pharmaceutical conglomerate.

This wishful thinking is not the case. Their first biotech
drugs have caused more death and injury than benefit. At the same time, rapid
advancements in tools to analyze gene function made it obvious that Mother
Nature already provided a treasure trove of potential golden cures—natural,
safe and effective substances already widely utilized in the dietary supplement
industry.

Multiple circumstances threaten hundreds of billions in drug
company profits. Their pipeline of new drugs with widespread consumer
application is scant, as they gamble their future on dangerous biotech drugs
with limited use. Hundreds of their top-selling drugs are losing patent
protection in the next few years, exposing them to generic competitors and
massively driving down inflated profits. Widely-publicized adverse side effects
and unnecessary deaths caused by many commonly-used pharmaceutical drugs have
cast suspicion over their entire industry.

On the political front, Congress is looking for ways to
control health care costs, even suggesting incentives for making people well—a
far different tune than paying for lifetime drug prescriptions that seldom
improve health. In fact, the gene science is actually proving that Western
Medicine’s drugs are damaging the human genome and are a significant cause in
the onset of many of the diseases of aging—the very diseases they are
pretending to treat.

Pharmaceutical companies define their primary assets as
patent-protected drugs, giving the drug 15 to 20 years of product sales with no
competition. It is vital for them to figure out a strategy to turn dietary
supplement ingredients, especially those that could be used for type 2
diabetes, cardiovascular disease, obesity, depression, Alzheimer’s, and cancer
treatment into drug company “assets,” eliminating from the free market many of
the most helpful dietary supplement ingredients while drastically driving up
prices for consumers.

The Poison-Dispensing Era of Western Medicine

Until the advent of the new gene-regulating drugs, virtually
all medications worked on the principle of poisoning the function of a cell or
enzyme system to hopefully produce a change that the doctor thinks
“beneficial.” If taking a drug results in a better-looking blood sugar, blood
pressure, or cholesterol number, then doctors automatically assume the person
is healthier. Rather, health has nothing to do with it. It is in the financial
interests of drug companies to dispense more and more drugs, on an ongoing
basis.

There is a night-and-day difference in quality of health
between a person who has good numbers because they are healthy and a person who
has reasonably-looking numbers because they are poisoned with drugs. Studies
using high doses of metabolic and cardiovascular drugs to attempt to drive
numbers down to the levels of healthy people invariably injure and even kill
the participants—clearly failing to improve health quality and extend lifespan.

To make matters worse, the pharmaceutical industry
fraudulently hides the actual risks of the drugs from both patients and
doctors. This includes slanting, to blatantly falsifying, studies routinely
published in medical journals and used for marketing, illegally promoting
off-label use of drugs, using funding to bribe research universities to publish
only favorable results and blacklisting researchers who refuse to accept, and
paying influential doctors to present their data as independent research at
medical meetings.

The scope and magnitude of the drug safety issue is a
nightmare. In 2006 the Institute of Medicine (IOM) conducted interviews with
FDA management and hundreds of FDA employees to ascertain issues leading to
drug safety problems. Widespread conflict of interest and many other issues led
IOM investigators to label FDA management as dysfunctional. Little has changed.

The Gene-Experimentation Era of Western Medicine

The human body is no slouch when it comes to elaborate
complexity. It is often the case that the same exact gene signal is “good” or
“bad” depending on the context in which it is activated. In fact, the same
genes often behave differently in different areas of the body. Unlike earlier
toxic drugs that force cell and enzyme behavior at a rather crude level,
biotech drugs turn gene signals “on” or “off” at a powerfully fundamental level
of cell function. Unfortunately for consumers, our understanding of genes is in
its infancy. There is daunting complexity in gene regulation, making use of any
gene-regulating drug highly questionable.

One example of this problem involves diabetes drugs Avandia
and Actos, which turn on the gene PPAR gamma. This gene signal helps to break down
triglycerides. These drugs also stimulate the formation of new fat cells, which
are more metabolically fit and therefore produce more adiponectin that stops
insulin resistance. Thus, in theory, they are potentially great drugs for
lowering triglycerides and benefiting people with type 2 diabetes. As these
drugs became blockbusters it was soon observed that the patients taking them
were experiencing devastating side effects. These drugs have no way to know the
context in which they should be operating. They activate PPAR gamma in the
wrong places, such as the heart, leading to a 40 percent increased risk for
heart failure or heart attack. Additionally, inappropriate PPAR gamma
activation in bones causes them to break more easily.

The FDA rushed these drugs to market despite the objections
of its own safety supervisor who wanted to employ a black box warning for heart
failure. In other words, the FDA knew about the risks but prevented the public
from understanding them, and still allowed the drugs to go to market. This was
a major scandal at the FDA. The FDA has finally restricted Avandia, but Actos
remains available in full swing. Actos has recently been highly restricted in
Europe, but in America, the FDA continues to drag its feet. This is likely
because the FDA has mud on its face for approving these biotech nightmares in
the first place and would rather consumers suffer injury and even die than look
bad. The mainstream media fails to aggressively report on or investigate this
tragic issue as they are large recipients of drug company advertising dollars.
Even when one of their own, Tim Russert, was likely killed by Avandia or Actos,
they turned a blind eye.

DHA is a Superior and Intelligent Gene-Regulating
Nutrient

The plot thickens. Nature’s nutrient DHA, typically in fish
oil, is a powerful
activator of PPAR gamma
, helping to break down triglycerides as well as
make new metabolically-fit fat cells that boost adiponectin and help fight type
2 diabetes—the exact objectives of Big Pharma’s Avandia and Actos. DHA is a
near-miracle nutrient for the heart and overall cardiovascular health and also
supports strong bones. It has all of the benefits of Avandia and Actos and none
of the side effects.

And this is why Big Pharma is so interested in taking over
many dietary supplement ingredients. The nutrients know how to work in harmony
with gene function in the human body, since nutrition was a key part of human
evolution. These nutrients appear to have inherent intelligence that no drug
could possibly have. They understand the context of the gene signal and thus
support the beneficial gene activity. They know how to behave differently in different
areas of the body to promote
healthy function at every turn
.

Under the FDA’s new draft guidance that redefines the 1994
Dietary Supplement Health and Education Act (DSHEA), the FDA targets many
nutrients for elimination from the market, and DHA is one of them. DHA is a
component of fish oil, which is a pre-DSHEA nutrient. This means that it should
be grandfathered in and not subjected to the newly-published New Dietary
Ingredient (NDI) guidelines.

Various companies have been able to concentrate the DHA as
well as remove toxins from the oil, enabling consumers to take higher amounts
of the most important ingredient in fish oil. Consumers can now easily and
safely reach doses of DHA that are consistent with studies showing extreme
health benefit. Such doses of DHA are known to be safe, have been tested in
clinical trials sponsored by the National Institutes of Health (NIH), and are
consistent with the amounts consumed by people who regularly eat fish.

The FDA’s point man on NDI guidance issues, Daniel
Fabricant, has been telling the supplement industry what to expect. In a recent
webinar
he was asked, “Should it be necessary to submit an NDI notification
over a small change in the ratios of the long chain omega-3 fatty acids EPAto
DHA in one fish oil supplement versus another? Is this really a big safety
issue?” Shockingly, Fabricant responded “If it is a different ingredient, a
different chemical entity, then it should trigger an NDI notification.”

Fabricant is saying that any modification of basic fish oil
should trigger an NDI notification. This is utter nonsense, but it is exactly
what the FDA is attempting to do. What Fabricant did not bother to say to the
supplement industry webinar audience was that an NDI application for modified
fish oil would be denied, since GlaxoSmithKline already has a fish oil
prescription drug on the market called Lovaza. Again, shocking.

Yes, the new guidance document makes it clear that if an
existing drug contains any form of the nutrient DHA, a NDI will not be allowed
(section IV.C.8-11). In other words, if modified DHA did not require an NDI
notification, it qualified as a grandfathered nutrient, an obvious part of fish
oil. But if the FDA decides that the newly manufactured form of the nutrient,
in this case DHA, is different than its typical concentration in food, it can
require that nutrient to have an NDI notification. By retroactively applying
this definition to nutrients that compete with drug applications, that nutrient
will automatically be denied NDI status. As of now, this is the intended fate
of DHA. It is gravely unfortunate, as DHA is one of the most beneficial and
effective nutrients offered by the dietary supplement industry.

This is a blatant power play to hand the entire high-grade
DHA market to GlaxoSmithKline, one of the largest drug companies in the world.
Lovaza already costs five to seven times what a similar amount of high-grade
DHA costs—imagine how high their price will go up when there is no competition.

The Rise of Epigenetics

The new frontier of science is the field of epigenetics. A
true genetic change means there is a change in the DNA sequence. Epigenetics
explains factors that are not such DNA changes. Rather, epigenetic changes
relate to how genes are expressed. Some are set in response to early
environmental influences such as prenatal malnutrition or nutrient deficiency.
As cells split and divide, however, epigenetic factors play a large role in
determining life-long  human health and are strongly linked to poor health and the onset of
disease. Epigenetic weaknesses magnify during aging and are major factors in
the cause of cancer, heart disease, neurological and cognitive disorders,
obesity, diabetes, infertility and sexual dysfunction.

This new science is finding that when toxins interfere with
the human genome, they can cause lasting damage in the form of adverse
epigenetic changes which can occur at any point in one’s life. This is not
simply an issue of pollution. Researchers are now demonstrating that regular
use of many drugs
can cause adverse toxic epigenetic changes, a finding
that has alarming implications for today’s medical practices. Up to this point
in time, drug safety has not involved studying the impact of any drug on
epigenetics. Science now has the ability to see what is going on in this realm.
The pharmaceutical industry and the FDA, unsurprisingly, have no interest in
understanding and considering this new, ground-breaking information as the
public would significantly reduce their intake of drugs.

On the hand, research on dietary ingredients is showing them
to be powerful regulators of epigenetics and some show extreme promise for
helping to treat metabolic disease and even cancer. Nutrients are showing that
they possess “intelligence” and are able to tell the difference between a
stressed and struggling cell (one with epigenetic weaknesses) and a cell with
cancer. In the case of the stressed cell, the nutrients can fix it. In the case
of the cancerous cell, the exact same nutrient can actually help kill the
cancer without any adverse side effects—even overcoming mechanisms that make
cancer resistant to drug treatments. Two of the very best nutrients in this
category are curcumin and resveratrol, making them potential prizes for the
pharmaceutical industry.

As I reported in my recent article, “Curcumin Helps Change
Gene Function to Combat Cancer
,” curcumin and resveratrol are under
extensive genetic study at the MD Anderson Cancer Center. Regarding cancer,
these researchers are at the forefront of all things drug and biotech. The last
commissioner of the FDA, Andrew von Eschenbach, was in charge at the MD
Anderson Cancer Center before joining the FDA. Researchers at the MD Anderson
Cancer Center are practically drooling over the virtues of curcumin and
resveratrol. Some quotes from their recent study include the following:

Recently, natural compounds, such as curcumin,
epigallocatechin gallate (EGCG), and resveratrol, have been shown to alter
epigenetic mechanisms, which may lead to increased sensitivity of cancer cells
to conventional agents and thus inhibition of tumor growth. Curcumin
(diferuloylmethane), a yellow spice and the active component of the perennial
herb Curcuma longa, commonly known as turmeric, is one of the most powerful and
promising chemo-preventive and anticancer agents, and epidemiological evidence
demonstrates that people who incorporate high doses of this spice in their
diets have a lower incidence of cancer. Furthermore, epidemiological evidence
exists indicating that there is a correlation between increased dietary intake
of antioxidants and a lower incidence of morbidity and mortality…. How curcumin
exerts its powerful anticancer activities has been thoroughly investigated, and
several mechanisms of action have been discovered…. curcumin exerts its
biological activities through epigenetic modulation.

Extensive research over the past five decades has indicated
that curcumin reduces blood cholesterol levels; prevents low-density
lipoprotein oxidation; inhibits platelet aggregation; suppresses thrombosis and
myocardial infarction; suppresses symptoms associated with type II diabetes,
rheumatoid arthritis, multiple sclerosis, and Alzheimer disease; inhibits HIV
replication; suppresses tumor formation; enhances wound healing; protects
against liver injury; increases bile secretion; protects against cataract
formation; and protects against pulmonary toxicity and fibrosis. These
divergent effects of curcumin seem to depend on its pleiotropic molecular
effects, including the regulation of signal transduction pathways, and direct
modulation of several enzymatic activities. Most of these signaling cascades
lead to the activation of transcription factors.

Interest in the effects of dietary compounds such as
resveratrol which activate class III HDACs (sirtuins) is growing rapidly
because of their demonstrable role in extending lifespan and in reducing, or
delaying, age-related diseases including cancers…. Resveratrol, a natural
compound found in the skin of red grapes and a constituent of red wine, is
believed to play a significant role in the reduction of cardiovascular events.
Multiple studies have shown that resveratrol can activate sirtuin 1 (SIRT1), a
histone deacetylase, and inhibit p300. Sirtuins, the class III HDACs, are
widely distributed and have been shown to regulate a variety of
physiopathologic processes, such as inflammation, cellular senescence and
aging, cellular apoptosis and proliferation, differentiation, metabolism, stem
cell pluri-potency, and cell cycle regulation.

Experimental evidence accumulated in the recent years
clearly supports the idea that dietary nutraceuticals such as curcumin have
great potential as epigenetic agents.

These researchers go on to cite all of the human safety and
efficacy trials with curcumin, resveratrol and many other natural substances.

This is not dietary supplement companies extolling the
virtues of these powerful nutrients. These are mainstream drug development
researchers, stunned by the ability of nutrients to regulate epigenetics to
support health and at the same time combat diseases that plague large numbers
of people. The inherent capacity of these nutrients outshines that of any drug.

There should be no question in anyone’s mind as to why the
pharmaceutical industry wants to claim these powerful nutrients as patent-protected
drug assets. The question is more about how they plan to pull off this major
scheme, this heist, from the dietary supplement industry.

Curcumin (tumeric) has been around for thousands of years
and is consumed in very large amounts in Eastern and Middle Eastern cultures.
This means the basic spice is protected by DSHEA. Unfortunately, curcumin has
relatively poor bioavailability and raw material companies have sought to
produce purified extracts with advanced production technology and combine
curcumin with other nutrients such as piperine, which can elevate the
biological activity up to 2,000 percent. Researchers at MD Anderson Cancer
Center have conducted cancer research specifically with one such curcumin
product, made by Sabinsa, and found it very promising.

Under the proposed FDA guidelines for NDIs, such curcumin
extracts would retroactively become NDIs as they were not available prior to
1994. The immediate impact would be the removal of curcumin from the dietary
supplement market while submitting an NDI application. Sabinsa, however, has
already been granted several investigational new drug applications for their
curcumin complex as they work with researchers at MD Anderson Cancer Center.
Under the new FDA guidelines the net result would be eliminating all high grade
curcumin extracts from the dietary supplement market, as no NDI will be granted
for any ingredient that is under investigation as a new drug. Sabinsa, a
dietary supplement raw material supplier, will be able to sell its rights to
its curcumin compound to the highest pharmaceutical bidder while all other
competing curcumin extracts, including Sabinsa’s product, will be forced off
the dietary supplement market.

It is a similar story for resveratrol, which is also under
investigation as a new drug. In fact, numerous highly-effective and therapeutic
extracts will be targeted in this way by the pharmaceutical industry. The FDA
has a glaring conflict of interest and can easily approve investigational new
drug applications for any nutrient of interest to the pharmaceutical cartel,
automatically blocking them from entry or existence in a competitive dietary
supplement marketplace. Dietary supplement companies could spend millions
trying to get the FDA to pass a NDI application. The FDA just sits on the NDI
application, to ultimately approve the nutrient as an investigational new drug
and deny the dietary supplement company’s NDI application.

Consumer options for therapeutic nutrition will rapidly
dwindle. What is left on the market will be far more expensive and many
nutrients will no longer be available without prescription. Once the
pharmaceutical industry gains control of the nutrient, the new price will be
ten to fifty times what consumers pay now.