Tag Archives: FDA

My Visit To Biotics Research

As many of you know, I have been lecturing quite regularly around the country for Biotics Research.  I lecture on the connection between neurologic conditions and nutrition.  We cover topics such as anxiety, depression, Parkinson’s disease, and Alzheimer’s disease.

While I’ve recommended Biotics supplements since I began practice 7(!) years ago, I never had the opportunity to see their corporate headquarters and manufacturing facility in person. All that changed last weekend with my trip to Houston, Texas to lecture and to visit their amazing facility.

My journey began with a very early morning flight from Manchester to Houston by way of Detroit.  If you live in Vermont or New Hampshire you know that direct flights are a luxury most of us rarely have the pleasure of!

I arrived early in Houston at about 11.  By noon I was in Rosenberg, Texas – the base of operation for Biotics Research.  When I arrived I had lunch with the owners of the company and keeping with the healthy theme, we all had salads.

After lunch, I was given a tour of the entire operation.  What an experience! I have always recommended Biotics products to my patients for two reasons; they are very effective, and perhaps most importantly, they are the highest quality in the industry. My tour of the facility just confirmed my convictions.

From the moment a raw ingredient arrives at the manufacturing facility to the time the supplement ships to you, it is accounted for, cataloged, checked and re-checked to ensure safety and efficacy.

Raw ingredients arrive at the facility and are quickly quarantined so they can be logged and tested for safety.  Although all raw ingredients come with a certificate of analysis stating the identification of the raw ingredient and some safety specs, Biotics retests ALL of it.  They look for several things.  They first do a quick check to identify the substance.  They must make sure they are getting what they think they are getting! Then safety checks begin. This is NOT the industry standard. Most companies rely on the raw ingredient suppliers to check their products. This is, of course, a conflict of interest. Many of you have been frustrated by back-ordered products from time to time from Biotics, and this is almost always because Biotics was forced to reject a batch of raw ingredient because of contaminants.  This is for your safety. It is actually a good thing!

After a raw ingredient has been identified it undergoes safety and potency testing. Potency must be known because supplements with little or no potency are useless at best and harmful at worst.  In addition to potency testing, they test the raw ingredients for heavy metals, solvents and pesticides.  The FDA has set standards for minimally acceptable levels of contaminants in raw ingredients for supplements.  Biotics has its own standards that EXCEED what the FDA requires.  Pretty awesome stuff!

There are thousands of square feet of production rooms, each made with hardened stone floors and steel ceilings so they can be power washed between each run of production to prevent cross contamination. After all, Biotics can’t make all 300+ of their products at the same time.  They must rotate production runs and this requires that the same manufacturing rooms and machinery be used for your GTA and your PheniTropic! What they must do to clean the production machinery is even more amazing.  They wheel each machine out of the manufacturing room, disassemble it and clean every nook and cranny possible! Sometimes this must be done daily! All of this is done to make the Biotics supplements safe and effective for you.

Once a product is finished, safety checks are still not done.  Each lot is randomly tested for quality after it has been quarantined to make sure that it is safe for sale. Biotics is so concerned about quality control, they even catalog the labels on the bottles just as they catalog the raw ingredients! It is all to make sure nothing in your product is unaccounted for at any time!

The history of Biotics Research is even more fascinating.  From their involvement in helping uncover the devastating health consequences of Love Canal to being the first American company to bring CoQ10 to the market, Biotics Research isn’t just a supplement producer. Research truly is part of their heritage. If you’d like to know more about their history, give me a call and I’ll be happy to speak to you about it.

My trip to Houston was a great one. Not only was I able to speak to almost 50 doctors about how to help their patients with chronic neurologic issues, but my visit to Biotics strengthened my resolve that quality supplements are a critical part of a health program.

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New Warning on Statins and Safe Alternatives

The FDA has come out with new warnings on statin medications.  The more we learn about these drugs, the clearer it becomes they are far over prescribed as the risk outweighs the benefit in many people who are taking them.

Read the transcript:

Hi everybody, this is Dr. Court bringing you another 90 Seconds of Knowledge. Today we’re going to talk about statin medications. This is the most popular class of drugs in the US and people use it to lower their cholesterol levels. And, potentially, although the evidence is not very good, reduce the evidence or the occurrence of heart disease.

Yesterday the FDA’s come out without new warnings. Number one, statins can potentially cause memory loss, confusion and other cognitive deficits. This may take a few weeks or a few years to manifest, and I’ve actually seen this in my patients. We get them off the statins and they do very well. Their cognitive abilities come right back so, it is apparently reversible.

The other warning is it does increase the risk of diabetes. It increases the risk of diabetes pretty significantly. It actually increases it by 27%. That’s a problem because diabetes significantly increases the risk of heart disease, the very thing that statins are supposed to protect us against.

It also increases HA1C or hemoglobin A1C. So, what that means is it prevents you from controlling your blood sugar very well, which is a big problem.

So, if we can’t use statins, what do we do?  Well, first diet and exercise. Those are the biggies. That’s really where we should focus. But if we do need some additional assistance there are some natural substances that work very well. Red yeast rice is one that is a natural statin. It is not without side effect. It is very much lower in side effect anyway, but you should always take CoQ10 when you’re taking any kind of statin whether synthetic or natural like red yeast rice.

There is niacin. Niacin works very, very well. Good old B3. It works exceptionally well. It lowers LDL’s. It lowers total cholesterol. What we want to focus on is the LDL.  And it also lowers lipoprotein A, a very dangerous, particular kind of cholesterol.

There are plant sterols. Plant sterols act by binding up the cholesterol that we eat and preventing us from absorbing it. There are medications that do that but the plant sterols are something that you can buy over the counter.

And then, of course, good old fish oil. We can’t talk about it enough. Fish oil has so much benefit. It reduces cardiovascular disease mortality better than anything. And, it reduces sudden cardiac death by 90%. It’s very, very effective. So, if you do one thing, take some fish oil.  Those are your options. The statins are still out there and they do have side effects but some of the natural options tend to have a lower side effect profile.

If you have any questions, let us know. We’ll be happy to answer them.

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Boost “Nutrition” Drinks Vs. Coca-Cola

It’s quite amazing what can be advertised as nutrition.  I recently saw in the news a company that sells walnuts was ordered to stop making factual and well researched claims about their walnuts because only drugs can make claims of that nature.  The FDA reasoned that if this company were to make these claims, they would have to reclassify walnuts as drugs!  Can you believe it?  I couldn’t.

While the above story is outrageous, what’s more so is the fact that something like Boost original nutrition drink can be advertised as a healthy meal replacement.  See my video below. It is absolutely ridiculous!

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Food Dyes Pose Serious Risk to Children and Adults

All of these foods contain artificial food dyes

Food dyes are an interesting subject.  Health groups have been calling for their removal from the market for years because of links to allergies, hyperactivity in children and cancer.  The food industry uses them for one sole purpose – to make food look more appealing.  That’s it.  We’re not even talking about flavor enhancers here (which have their own set of problems). Food dyes don’t make food taste better and have no nutritional value to them whatsoever.  They are nothing more than chemicals used to make us think our food is going to taste better.

Now the Center for Science in the Public Interest (CSPI) is calling for the removal of several of these dyes.  They say the three most widely used dyes, Red 40, Yellow 5, and Yellow 6, are contaminated with known carcinogens.  They also say that another dye, Red 3, has been known by the government for years to be a carcinogen yet it remains in our food supply.

Let’s take a look at some things that might open your eyes:

  • Every year about 15 million pounds of eight synthetic dyes end up in our food.
  • Per capita consumption of dyes has increased five-fold since 1955.
  • Children consume more dye per unit of body weight than adults and they are much more susceptible to their effects.
  • The FDA did not consider the risk to children when making their ‘acceptable level’ guidelines.
  • Most safety studies conducted on dyes were conducted or commissioned by food dye manufacturers.
  • Most of these studies lasted less than two years so long term affects could not be assessed.
  • The amount of artificial chemical allowed in any given dye is based on usage from 1990 and usage has increased by 50% since then.

The Center for Science in the Public Interest is claiming that the FDA is not upholding the law for the following reasons:

  • Red 3 and Citrus Red 2 should be banned under the Delaney amendment, because they caused cancer in rats (some uses were banned in 1990), as should Red 40, Yellow 5, and Yellow 6, which are tainted with cancer-causing contaminants.
  • Evidence suggests, though does not prove, that Blue 1, Blue 2, Green 3, Red 40, and Yellow 6 cause cancer in animals. There certainly is not “convincing evidence” of safety.
  • Dyed foods should be considered adulterated under the law, because the dyes make a food “appear better or of greater value than it is”—typically by masking the absence of fruit, vegetable, or other more costly ingredient.

Click here for a summary of studies on food dyes

There are 9 dyes currently approved for use in the United States.  Many previous dyes have been banned because they have caused adverse affects in laboratory animals.  In fact, the British government had asked manufactures, as of last December 31st,  to completely phase out use of dyes and the European Union is requiring that every food containing dye come with warnings.  Below is a summary of each dye and its potential problems.  This list is from the CSPI.

  • Blue 1 was not found to be toxic in key rat and mouse studies, but an unpublished study suggested the possibility that Blue 1 caused kidney tumors in mice, and a preliminary in vitro study raised questions about possible effects on nerve cells. Blue 1 may not cause cancer, but confirmatory studies should be conducted. The dye can cause hypersensitivity reactions.
  • Blue 2 cannot be considered safe given the statistically significant incidence of tumors, particularly brain gliomas, in male rats. It should not be used in foods.
  • Citrus Red 2, which is permitted only for coloring the skins of oranges not used for processing, is toxic to rodents at modest levels and caused tumors of the urinary bladder and possibly other organs. The dye poses minimal human risk, because it is only used at minuscule levels and only on orange peels, but it still has no place in the food supply.
  • Green 3 caused significant increases in bladder and testes tumors in male rats. Though the Food and Drug Administration (FDA) considers it safe, this little-used dye must remain suspect until further testing is conducted.
  • Orange B is approved for use only in sausage casings, but has not been used for many years. Limited industry testing did not reveal any problems.
  • Red 3 was recognized in 1990 by the FDA as a thyroid carcinogen in animals and is banned in cosmetics and externally applied drugs. All uses of Red 3 lakes (combinations of dyes and salts that are insoluble and used in low-moisture foods) are also banned. However, the FDA still permits Red 3 in ingested drugs and foods, with about 200,000 pounds of the dye being used annually. The FDA needs to revoke that approval.
  • Red 40, the most-widely used dye, may accelerate the appearance of immune-system tumors in mice. The dye causes hypersensitivity (allergy-like) reactions in a small number of consumers and might trigger hyperactivity in children. Considering the safety questions and its non-essentiality, Red 40 should be excluded from foods unless and until new tests clearly demonstrate its safety.
  • Yellow 5 was not carcinogenic in rats, but was not adequately tested in mice. It may be contaminated with several cancer-causing chemicals. In addition, Yellow 5 causes sometimes-severe hypersensitivity reactions in a small number of people and might trigger hyperactivity and other behavioral effects in children. Posing some risks, while serving no nutritional or safety purpose, Yellow 5 should not be allowed in foods.
  • Yellow 6 caused adrenal tumors in animals, though that is disputed by industry and the FDA. It may be contaminated with cancer-causing chemicals and occasionally causes severe hypersensitivity reactions. Yellow 6 adds an unnecessary risk to the food supply.

I always encourage my patients to eat as naturally as possible and this is one of the main reasons.  These chemicals, basically derived from petroleum, are clearly not as safe as the food manufacturers would like you to think they are.  While not all of these dyes pose a serious threat, why risk it?  You can bet that if you buy a packaged food and it is brilliantly colored, it has one or more of these dyes in it.  That is also problematic as these dyes have been studied alone and not it combination with one another.  No one knows what the safety of these dyes are when consumed with other dyes.

Natural Alternatives

There are options for food coloring out there.  Many natural colors exist that work just as well as the synthetics and are known to be safe.  I’ve listed some below for your reference.

  • Caramel coloring made from caramelized sugar, used in cola products and also in cosmetics.
  • Annatto a reddish-orange dye made from the seed of the Achiote. (Some are allergic to this one.)
  • A green dye made from chlorella algae.
  • Cochineal a red dye derived from the cochineal insect, Dactylopius coccus.
  • Betanin extracted from beets.
  • Turmeric (curcuminoids)
  • Saffron (carotenoids)
  • Paprika
  • Elderberry juice
  • Pandan Pandanus amaryllifolius, a green food coloring
  • Butterfly pea Clitoria ternatea, a blue food dye

I see many children in my practice that struggle with attention and hyperactivity.  Those symptoms are often alleviated by removing all artificial sweeteners and dyes from the diets of these children.  In terms of overall health, stick on the edges of the grocery store.  Skip the middle aisle where all of the processed junk is kept.  That is what will contain the dyes you want to avoid.

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Swine Flu Pandemic? How Big Pharma used its power to scare the world

Remember the swine flu?  Last year it was all you heard about on the news.  Each evening we were shown statistics that gave us an up-to-the second tally of deaths linked to H1N1.  “Experts” were encouraging everyone to get the vaccinated against this serious threat.  Local clinics were swamped with terrified people demanding the vaccine for their entire family.  All of this was because the World Health Organization (WHO) declared that the swine flu was a world wide pandemic.

Now the British Medical Journal (BMJ) has published an article accusing the World Health Organization of conflicts of interest with regard to H1N1.  The authors accused the organization of exaggerating the severity of the virus, and of taking advice from experts with ties to vaccine- and antiviral-producing pharmaceutical companies.

Almost exactly one year ago Dr Margaret Chan, the director general of the World Health Organization announced to the world that there was pandemic in full effect.  She told us that she had consulted with leading scientists, doctors and virologists to make her decision.

The WHO offers advice to governments for situations just as these.  If there is a major pandemic they advise governments on how to handle it.  Following the WHO’s advice, governments bought billions of dollars worth of vaccines, oseltamivir (Tamiflu) and zanamivir (Relenza).  And according to the BMJ, the vast majority of it is sitting unused.

The First Sign that Something was Up

For some reason, the WHO changed the definition of ‘pandemic.’  In response to the chicken flu outbreak in 1997 in Hong Kong, the WHO began to organize a pandemic preparedness plan.

The WHO’s first influenza pandemic preparedness plan was stark in the scale of the risk the world faced in 1999: “It is impossible to anticipate when a pandemic might occur. Should a true influenza pandemic virus again appear that behaved as in 1918, even taking into account the advances in medicine since then, unparalleled tolls of illness and death would be expected.” (From the BMJ)

The WHO is rightfully concerned about a flu pandemic of that scale.  An estimated 50 million people, about 3% of the world’s population (1.6 billion in 1918), died of the disease. A total of 500 million, or 1/3 were infected.  How could the WHO compare the swine flu last year to the 1918 flu?  They aren’t even close.

The WHO has been accused of removing the words “enormous numbers of deaths and illness” from the definition of pandemic.  I guess if you remove those words the 1918 influenza pandemic and the swine flu “pandemic” of 2009 could be categorized together.

Maybe, just maybe, this is the problem

The initial preparedness program was written entirely by people who stood to gain from frightening the world into stockpiling antiviral drugs (namely Tamiflu and Relenza).  Roche, is the manufacturer of Tamiflu, and GlaxoSmithKline, manufacturers Relenza.  Both companies had employees on the committees advising Dr. Chan on whether or not to issue a pandemic warning.  On the initial preparedness program it said:

“R Snacken, J Wood, L R Haaheim, A P Kendal, G J Ligthart, and D Lavanchy prepared this document for the World Health Organization (WHO), in collaboration with the European Scientific Working Group on Influenza (ESWI).” What this document does not disclose is that ESWI is funded entirely by Roche and other influenza drug manufacturers. Nor does it disclose that René Snacken and Daniel Lavanchy were participating in Roche sponsored events the previous year, according to marketing material seen by the BMJ/The Bureau. (From the BMJ).

Why are these antiviral drugs considered so important in a pandemic?  Because vaccines are likely to take months to be available in the numbers required for a true pandemic of the scale that hit in 1918.  These antivirals could be life saving if a truly virulent strain of flu emerged.  They would also be a windfall of revenue for the pharmaceutical companies making them.

Of course, there are many natural remedies that boost immunity very effectively, but they are not marketed because they don’t have the big money of Roche or GlaxoSmithKline behind them.  That’s for another blog though.

The WHO says it checked into the backgrounds of the people it relied on to make its guidelines which called for countries to stockpile antiviral drugs.  It says it investigated the financial ties of these scientists to the pharmaceutical industry.  But, according to the BMJ they are refusing to release the information they gathered in their investigations.  This lack of transparency is concerning.

Because of these recommendations that the WHO put forward, mostly established by scientists with significant ties to Big Pharma, Roche and GlaxoSmithKline made $12 billion on antiviral drugs with the lion’s share going to Roche and Tamiflu ($10 billion).

And all this for drugs that should have never been approved for use in the US! An FDA advisory committee originally recommended that Relenza not be approved because it had safety concerns and showed very little benefit over placebo in US trials.  The FDA did not adhere to the advice of its committee (it is not required to) and approved it because “they would feel better if there was something on the market in case of a pandemic,” and  “it wasn’t a scientific decision.”  This is according to Dr. Michael Elashoff who was a former employee of the FDA, and was the statistician working on the Relenza account.  This fact, according to Dr. Elashoff paved the way for Tamiflu’s approval later that same year.

Dr. Chan wants the WHO’s work on H1N1 examined.  She asked for an independent review of how the WHO handled H1N1 in January.  Hopefully this will produce some results, but I doubt it.

Traditional medicine is filled with conflicts on interest from Big Pharma.  This is just another example.  The swine flu was not a major pandemic and according to the WHO “the overwhelming majority of patients experienced mild symptoms and made a rapid and full recovery, even without medical treatment.”  If that was the case, and I believe it was, why did they instruct countries to stockpile billions of dollars worth of pharmaceuticals?  I think the answer is clear.  Big Pharma was able to strategically place scientists on influential panels to sell drugs.

During the swine flu “pandemic” I recommended that patients take a little extra vitamin C, D, and A, get plenty of rest and eat as healthy as possible.  Those recommendations are far safer than running out and vaccinating yourself or prophylactically taking Tamiflu, both of which have serious side effects.  Remember, a conservative approach is almost always the best way to tackle a problem.

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Chemical Banned in 160 Countries Injected into U.S. Livestock Before Slaughter

Ractopamine, aka Paylean and Optaflexx, is banned in 160 countries, including Europe, Taiwan and China. If imported meat is found to contain traces of the drug, it is turned away, while fines and imprisonment result for its use in banned countries.

Yet, in the United States 45 percent of pigs, 30 percent of ration-fed cattle, and an unknown percentage of turkeys are pumped full of this drug in the days leading up to slaughter.

Why?

This drug, manufactured by Elanco Animal Health, increases protein synthesis. In other words, it makes animals more muscular … and this increases food growers’ bottom line.

Adding insult to injury, up to 20 percent of ractopamine remains in the meat you buy from the supermarket, according to veterinarian Michael W. Fox. Yet this drug is marked “Not for use in humans,” and is known to increase death and disability in livestock.

Why is Ractopamine Allowed in U.S. Meat?

While other drugs require a clearance period of around two weeks to help ensure the compounds are flushed from the meat prior to slaughter (and therefore reduce residues leftover for human consumption), there is no clearance period for ractopamine.

In fact, food growers intentionally use the drug in the last days before slaughter in order to increase its effectiveness.

“How does a drug marked, “Not for use in humans. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask” become “safe” in human food? With no washout period?” asks columnist Martha Rosenberg.

She answers:

“The same way Elanco’s other two blockbusters, Stilbosol (diethylstilbestrol or DES), now withdrawn, and Posilac or bovine growth hormone (rBST), bought from Monsanto in 2008, became part of the nation’s food supply: shameless corporate lobbying.

A third of meetings on the Food Safety and Inspection Service’s public calendar in January 2009 were with Elanco, a division of Eli Lilly — or about ractopamine.”

Massive Industry Lobbying Gets Agribusiness What it Wants … at Your Expense

Industrial agriculture lobbyists wield incredible power in Congress, and the fact that ractopamine is in U.S. meat is a shining testimony to this.

Time magazine put it quite well when they described current farm policy as “a welfare program for the megafarms that use the most fuel, water and pesticides; emit the most greenhouse gases; grow the most fattening crops; hire the most illegals; and depopulate rural America.”

There are too many conflicts of interest to name, but, for example, you may be surprised to learn that former Iowa Governor Tom Vilsack is now the Secretary of Agriculture, an appointment that took place despite massive public outcry.

What was needed for an effective Secretary of Agriculture was someone who would develop and implement a plan that promotes family-scale farming and a safe and nutritious food system with a sustainable and organic vision.

What we got was yet another politician who’s already made room in his bed for the industry lobby. Overall, Vilsack’s record is one of aiding and abetting Concentrated Animal Feeding Operations (CAFOs) or factory farms (the ones that use chemicals like ractopamine) and promoting animal cloning.

Cozy Connections Allowed rbGH Hormones in Your Dairy Products, Too

Michael Taylor, a former vice president of public policy and chief lobbyist at Monsanto Company, is now the senior advisor for the U.S. Food and Drug Administration (FDA).

Who is Michael Taylor?

He is the person who not only “oversaw the creation of GMO policy,” according to Jeffrey Smith, the leading spokesperson on the dangers of GM foods, but also oversaw the policy regarding Monsanto’s genetically engineered bovine growth hormone (rbGH/rbST).

This growth hormone, which has been banned in Canada, Europe, Japan, Australia and New Zealand because of cancer risks and other health concerns, was approved in the United States while Taylor was in charge at the FDA. Smith writes:

“Taylor also determined that milk from injected cows did not require any special labeling. And as a gift to his future employer Monsanto, he wrote a white paper suggesting that if companies ever had the audacity to label their products as not using rbGH, they should also include a disclaimer stating that according to the FDA, there is no difference between milk from treated and untreated cows.”

Taylor’s white paper, which again was untrue as even FDA scientists acknowledged differences in the rbGH milk, allowed Monsanto to sue dairies that labeled their products rbGH-free!

In a similar vain, the FDA’s Center for Veterinary Medicine’s Office of Surveillance and Compliance sent a 14-page warning letter to Elanco regarding ractopamine three years after its approval for use in pigs. They accused the company of withholding information about “safety and effectiveness” and “adverse animal drug experiences.”

Nonetheless, the next year the FDA decided to approved ractopamine for use in cattle, too, and later for turkeys as well.

What Should You do if You Don’t Want Drugs and Chemicals in Your Food?

As the U.S. agriculture industry now stands, antibiotics, pesticides, GM ingredients, hormones and countless other drugs are fair game in your food. So if you purchase your food from a typical supermarket, you are taking your chances that your food is teeming with chemicals and drugs — even those that have been banned in other countries.

So please do your health a favor and support the small family farms in your area. You’ll receive nutritious food from a source that you can trust, and you’ll be supporting the honest work of a real family farm.

It all boils down to this: if you want to optimize your health, you must return to the basics of healthy food choices. Put your focus on WHOLE foods — foods that have not been processed or altered from their original state — food that has been grown or raised as nature intended, without the use of chemical additives, drugs, hormones, pesticides and fertilizers.

It’s as simple as that!

It is not nearly as daunting a task as it may seem to find a local farmer that can supply your family with healthy, humanely raised animal products and produce. At LocalHarvest.org, for instance, you can enter your zip code and find farmers’ markets, family farms, and other sources of sustainably grown food in your area, all with the click of a button.

Once you make the switch from supermarket to local farmer, the choice will seem natural, and you can have peace of mind that the food you’re feeding your family is safe.

Above article via www.mercola.com

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