Wednesday, July 31, 2013

Call Your Senators About SB959 NOW!


This is a portion of a letter that I just sent to Senators Hagan and Burr. They may vote on SB 959 tomorrow (July 31). This bill will compromise health care for women and men across the country. It is in response to the tragedy last winter when New England Compounding Company sent out contaminated steroids to physicians across the country. Many people died, even more are still sick. This bill allegedly is an attempt to keep that from ever happening
again. 

Unfortunately, it doesn't stop there. The restrictions on neighborhood compounding pharmacies and those from which I get ingredients for IV's that I give to patients and on doctors like me who use and prescribe compounded medications is ridiculous.

Please contact you senators across the country and tell them to vote NO on S.959.

For more information: http://www.anh-usa.org/compounding-bill-vote-possible-tomorrow/

My letter is below:

I understand that a substitute bill in the form of an amendment has been
proposed for S.959. The rewritten bill is now 189 pages long, up from its
original 50 pages. While there have been a few positive changes to this new
version, it remains a terrible bill that will, for millions of Americans,
cut off access to the important compounded medications on which they rely.
As your constituent I'm asking you to vote NO on S.959. 
Several new provisions in the bill are especially troubling. The first is
the potential loss of  estriol (the bioidentical hormone) which has a USP-NF
monograph. Legally, it can be compounded. Estriol is an anti-cancer
estrogen. It is very safe. It's incorporation into HRT prescriptions lowers
the risk of breast and other cancers for women. The bill would allow FDA to
identify bulk ingredients as "drugs not suitable for compounding" even
though they have a monograph as estriol does! This is a huge concern for me
and my patients. In the past, the FDA has attempted to ban bulk bioidentical
estriol at the request of Wyeth, a pharmaceutical company. Wyeth still
promotes Prempro for HRT even after it was proven to increase the risk of
cancer during WHI and up to 10 years later...even after women in the WHI
study stopped the drug. Wyeth even uses estriol in European formulations! 
The current language of the bill could allow FDA to regulate away my access
to that critical medication. Let's not forget: the regular prescription
drugs that the FDA promotes as an alternative to bioidentical estriol have
been proven to be very dangerous. This provision is a direct danger for
millions of women who depend on bioidentical estriol. 
Another section of S. 959 which directly affects women's health will let
compounded versions of "FDA-approved drugs" be banned as "copies" of the
drugs depending on how strictly that term is interpreted. This could
eliminate access to the much less expensive 17P in favor of the FDA-approved
Makena drug.  
The pharmaceutical companies and their representatives have a vested
financial interest in this bill. Even though they themselves praise the
safety and efficacy of bioavailable hormones, they bemoan the fact that
compounding pharmacies have the lion's share of the market, and they have
stated quite explicitly that they intend to take that share for themselves.
Their versions of the drugs are wildly more expensive than the compounded
versions and in some cases have been proven to be unsafe. Big Pharma is
trying to control the marketplace through legislation, and that's just not
right. And women will suffer needlessly. 
Please don't let FDA or drug companies use the smokescreen of compounding
regulation to seize huge new markets for themselves, leaving consumers with
vastly more expensive and less safe alternatives, or with no alternatives at
all! Please vote NO on S.959, the Compounding Medications Bill!
If you don't act, who will?
Thanks and blessings!

Monday, July 29, 2013

Men! Save Your Testicles (and Humanity): Avoid Roundup® and GMO/GE Roundup Ready® foods

The 2012 Farm Bill is still working its way through the legislature in Washington DC. It includes an amendment called the Monsanto Protection Act. The amendment prevents agribusiness giants like Monsanto from being held accountable for any health problems that may arise through genetically modified (GMO) or genetically engineered (GE) seeds.

Let me tell you why Monsanto might be thinking it needs protection.  Monsanto manufactures Roundup® and GMO/GE Roundup Ready® seeds.  These include alfalfa, canola, corn, cotton for cottonseed oil, soybeans, and sugarbeets.  Between 88 and 94 % of these crops are GMO/GE. These seeds grow into plants and are sprayed with Roundup® to control weeds.

Farmers were told that if they used Monsanto’s genetically modified seeds, they would need to spray less of the herbicide/Roundup.® False. It hasn’t worked out that way. To keep weeds down, they are actually having to spray more. A lot more. These days, every bite of a Roundup Ready® plant, plant oil, animal feed, or human food contains increasing amounts of glyphosate, the active ingredient in Roundup®.

What’s the problem with glyphosate? Scientific evidence is growing that glyphosate has a toxic effect on the testicles, reducing both sperm production and testosterone levels. Below I have freely quoted from an article on line at www.greenmedinfo.com by Sayer Ji. I have inserted my comments:
  • A disturbing new study published in the journal Free Radical Medicine & Biology implicates the herbicide Roundup®, and its main ingredient glyphosate, in male infertility, at concentration ranges well within the EPA's "safe level" for food. Unfortunately, the EPA’s “safe level” allows Roundup® herbicide residues in your food at concentrations that are a million times higher than amounts already shown to be carcinogenic. (That’s a topic for another day__ERV.)
  • Performed by Brazilian researchers, the study found acute Roundup® exposure at low doses (36ppm, 0.036g/L) for 30 minutes induced cell death in Sertoli cells in prepubertal (young__ERV) rat testis.  Sertoli cells are known as "mother" or "nurse" cells within the testicles. They are responsible for maintaining the health of sperm cells, and are required for normal male sexual development. (If all Sertoli cells die, no further sperm can be made.__ERV)
  • Roundup herbicide exposure was found to induce oxidative stress (producing an excess of free radicles__ERV) and to activate multiple-stress response pathways within affected cells, and was associated with an increase in intracellular calcium (Ca2+) concentration leading to Ca2+ overload, and cell death.
  • Thirty-minute incubation tests with glyphosate alone (36 ppm) also increased Ca2+ uptake. Both Roundup® and glyphosate were observed to down regulate reduced glutathione levels. Glutathione is an antioxidant (electron donor) found within every cell in the human body. It’s important to protect it against oxidative stress. It also maintains a wide range of biochemical reactions such as DNA and protein synthesis and repair, amino acid transport, prostaglandin synthesis, amino acid and enzyme activation, (and elimination of mercury__ERV). A dysregulation of glutathione can result in a wide range of adverse effects.
  • The researchers noted "Glyphosate has been described as an endocrine disruptor affecting the male reproductive system; however, the molecular basis of its toxicity remains to be clarified. We could propose that Roundup® toxicity, implicating in Ca2+ overload, cell signaling misregulation, stress response of the endoplasmic reticulum and/or depleted antioxidant defenses could contribute to Sertoli cell disruption of spermatogenesis that could impact male fertility." (Glyphosate reduces the effective glutathione supply resulting in damage to cellular communication, cellular factories and integrity of the cell wall.__ERV)
This study adds to a growing body of research implicating Roundup® herbicide in male infertility:

  • A Nov 26, 2011 male rat study published in the Archives of Toxicology on line revealed maternal exposure to glyphosate disturbed the masculinization process and promoted behavioral changes and histological and endocrine problems in reproductive parameters. (Testicles affected before birth of male baby rats causing permanent changes__ERV).
  • A 2010 male rat study published in the Archives of Toxicology revealed prepubertal exposure to commercial formulation of the herbicide glyphosate alters testosterone levels and testicular morphology, leading researchers to describe the herbicide as "a potent endocrine disruptor.” (Young rats affected.__ERV)
  • A 2011 study published in the journal Toxicology In Vitro found a glyphosate-based herbicide induced necrosis and apoptosis (death) in (mature) rat testicular cells in vitro, and testosterone decrease at lower levels. In the study, Roundup® and glyphosate at concentrations as low as 1 part per million produced a testosterone decrease in sperm cells by 35%. (Older rats affected__ERV.)
  • A more recent 2013 study in male rats published in the journal Ecotoxicology and Reproductive Safety found glyphosate (in combination with another pesticide) provoked severe oxidative stress in male testes, resulting in inhibited testosterone production and disrupted gonadotropin levels. (Older rats again__ERV.)
  • A 2007 study published in the journal Reproductive Toxicology found that Roundup® herbicide altered the structure of the testis and epididymal region (part of the tubular spermatic duct system), as well as the serum levels of testosterone and estradiol, in male ducks, leading the researchers to conclude that Roundup® "...may cause disorder in the morphophysiology of the male genital system of animals." (Frog and rabbit testicles have also been damaged by glyphosate.__ERV)
  • (What does all this mean? __ERV) Given the growing body of research clearly revealing Roundup's® toxicity to the germ line of animal species, the argument can be made that this herbicide has contraceptive properties and therefore genocidal consequences. By directly affecting the biologically immortal cells within the testes, whose DNA contains over 3 billion years’ worth of information essential for the continuation of our species as a whole, Roundup® should be considered an instrument of mass destruction.
  • At the very least, the precautionary principle should be applied. (The precautionary principle states that if an action or policy has a suspected risk of causing harm to the public or to the environment, in the absence of scientific consensus that the action or policy is harmful ,then the burden of proof that it is not harmful falls on those taking an action. Meaning Monsanto. The European Union made the application of the precautionary principle a statutory requirement years ago__ERV.)  Any chemical (including glyphosate) that signals the potential to disrupt or destroy our species' germ line cells should be banned unless the manufacturer can prove beyond a reasonable doubt that it is safe to exposed populations.
At www.greenmedinfo.com you can find out about more about the wide spectrum of adverse health effects now linked to glyphosate-based herbicide formulations such as Roundup®, view our research articles on GMOs, as well as view and download our free biomedical PDF on glyphosate/Roundup® research.

Is glyphosate contributing to the progressive lowering of male fertility and testosterone levels that has been going on for years? 10-15 years ago, there were forecasts that within 75 years men will be sterile.

If you have enough information and want to take action to protect your testicles, and the rest of your body and humanity, do these things:
  • Get educated. There is a lot of information available on the web. There is wisdom at the following sites:
    • www.drvaughan.com search for glyphosate
    • http://www.greenmedinfo.com has excellent information about natural treatments and environmental toxins.
    • http://www.foodrevolution.org/blog/non-gmo-apps/  has descriptions of 10 food apps for avoiding GMO/GE foods or others that you are sensitive to.
    • The Institute for Responsible Technology provides excellent resources. Jeffrey M. Smith who wrote the book “Seeds of Deception” and recently released the movie, Genetic Roulette, maintains this site. You’ll find guides for feeding families and infants, and for eating out. Recommendations from this site include:
      • Tip #1: Buy Organic: Organic producers cannot intentionally use GMOs or GEs.
      • Tip #2: Look for "Non-GMO" Project Verified Seals.
      • Tip #3: Avoid At-Risk Ingredients: If it's not labeled organic, or doesn't have a Non-GMO Project Verified Seal, then avoid processed food products with ingredients made from these GMO crops: Corn, Soybeans, Canola, Cottonseed and Beet sugar.
  • Canola or rapeseed oil and cottonseed oil are widely used in processed foods.
  • Sugar Avoid anything not listed as 100% cane sugar since GMO beet sugar recently entered the food supply. To avoid it, look for organic and non-GMO sweeteners, candy and chocolate made with 100% cane sugar, evaporated cane juice or organic sugar.
  • Aspartame Avoid this artificial sweetener also known as NutraSweet and Equal. It’s derived from GM/GE microorganisms.
  • Also if you have an infant or are expecting, you should be aware that infants and children are more sensitive to the dangers of genetically modified foods.  Unfortunately infant formula contains genetically modified food.  Independent laboratory tests show significant amounts of GE soy in Similac Soy, Enfamil Pro Soybee, Wal-Mart soy, and Gerber Good Start Soy.  All the formulas distributed by the government's WIC program contain GMO/GE food brands. If you cannot breast-feed, choose only organic formulas.
  • Vote for healthier food with your pocketbook. Don’t buy GMO/GE food if you have any other choice.
  • Tell farmers at the market, grocers, and restaurant owners that you want non-GMO/GE food. Period. Go to www.nogmogso.com for information on how to take action locally.
  • Get involved in the campaign to eliminate GMO/GE foods from the food chain to protect our futures. Contact your Senators and representatives and tell them to reject the Monsanto Protection Act and vote FOR the Genetically Engineered Food Right-to-Know Act. This is a big first step. This will allow us to easily choose whether we eat or do not eat GMO food. Unfortunately, eating organic isn’t enough. In one study, glyphosate was found in 60-100% of all US air and rain samples tested, and another 2012 study found that glyphosate widely contaminates groundwater.
  • Do not use Roundup® or plant GMO seeds.
  • Lastly, protect your body and your children’s bodies:
    • Take probiotics to outnumber the germs in the gut that have been infected with the Roundup Ready® DNA.
    • Take a mineral supplement to replenish the minerals that are bound up by Roundup®.
    • Take alpha lipoic acid and Vitamin E to protect  your testicles  (and other cells) from the damaging effects of glyphosate.
    • Use infrared sauna to sweat out accumulated pesticides and herbicides.
    • Do a cleanse at least twice a year.
    • Be brave. You will hear people disparage the movement to get rid of GMO/GE food. You will read a lot of criticism. There is money, power and greed behind those opposed to the ideas in this article. Remember, the American Academy of Environmental and Occupational Medicine has urged physicians to have their patients avoid GMO/GE foods since 2009. Even in 2009, they recognized that people consuming GMO/GE foods will develop diseases caused by the food. Now we are seeing how right they were.

Thursday, July 25, 2013

Food Sensitivity Testing Can Relieve Migraines

I was recently interviewed by Fox 8 WGHP regarding the importance of food sensitivity testing in relieving conditions like migraines. Here's the segment:

Sunday, July 7, 2013

HB 695

This is about NC HB 695 that was passed by the Republicans in the Senate of NC on Wednesday night. This bill will do away with Planned Parenthood and close all but one abortion center in the state. I put several helpful links below.  Please take action to preserve women’s right and access to safe health care in this state.

Please call the Governor and Speaker Tillis. See instructions below.

An updated version of the text of my email to Governor McCrory and the Speaker of the House Rep. Tillis appealing to them to reject or veto the Bill is below.

You have a unique opportunity to demonstrate that North Carolina is not an extreme, hostile state like Texas by rejecting HB 695. This bill will be in front of you soon and I am counting on you to reject this bill.

During my training to be a physician, I worked at Planned Parenthood in Kalamazoo Michigan. When I moved to North Carolina to live and practice medicine, I received my annual medical care at Planned Parenthood for years because it was reasonably priced and I was paying off student loans.
Now as a physician in practice for over 30 years, I appeal to you to reject and/or veto this law that would deny women access to good health care when they most need it. This bill would close all but one of the clinics that perform abortions in North Carolina. And it would close all Planned Parenthood offices.

Abortions happen at profoundly sad and conflicted times. No woman that I know is EVER happy to get an abortion. There are no good choices when a woman is pregnant and cannot bear or care for the child with love and support. Please consider that these tough decisions should be made by women working with their physicians when a woman is pregnant and does not want to be. Or has a health problem that will get worse if the pregnancy continues. Or is pregnant because she was violated.
I am old enough to know that abortions will continue to occur if this law passes. Women will continue to get abortions...and when they return to the backstreets...there will be blood on the hands of every North Carolina Senator, Representative and even Governor  who voted "YES" for this bill.

From Planned Parenthood:

HB695, also known as the worst bill we've seen this legislative session for women's health, could reach the NC House of Representatives as soon as Tuesday, July 9. Together we can show legislators that we refuse to stand by as this bill becomes law.

Here's how you can take action (Share with friends!):

-Join the Planned Parenthood Action Network (PPAN) to receive our most current political updates and actions here.

-Donate to our Public Affairs efforts here.

-RSVP for Moral Monday Rally, July 8th at 4:45 pm. Remember to wear pink/purple.

-Urge Speaker Tillis and Gov. McCrory to reject HB695. Calls are very effective. If you get their voicemail, leave a message. If you don't get through, try until you do.

Call the Governor. Politely and succinctly ask the staff member who answers to tell the Governor to uphold his campaign promise not to support the passage of new abortion restrictions, including HB695. 919-814-2000.

Call Speaker Tillis. Politely and succinctly tell the staff member that you oppose HB695. This bill will now go back to the House for consideration. The more calls the Speaker gets, the less inclined will they be to take up the bill in its current form. 919-733-3451.
Email Gov. McCrory and Speaker Tillis here.


Friday, July 5, 2013

Pharmaceutical Compounding Quality and Accountability Act

There is a bill working its way through the US Senate, Senate Bill 959, the “Pharmaceutical Compounding Quality and Accountability Act”, which was written in response to the deaths of 53 people who died as a result of fungal contamination of a compounded injectable steroid late last year. Dr. Vaughan is here today to talk about the US Senate’s response to this tragedy.

Anchor: How did this tragedy ever happen?

Dr. V: Contamination is always a potential problem when making pharmaceuticals. The New England Compounding Center (NECC) did not follow proper protocols for testing for sterility of the injectable steroid. 53 people died and over 700 others are still being treated for their infection.

Anchor: How does Senate Bill 959 address this?

Dr. V: Everyone expected the Bill to require extra regulation and inspection of compounding pharmacies. As a physician who orders from compounding pharmacies, just like the local hospital, we have already had to make changes tracking every component of every IV for an individual patient.

Anchor: What kinds of patients use a compounded prescription?

Dr. V: If a child cannot swallow a pill or is sensitive to a component of a pill, a compounding pharmacist can prepare that medication as a liquid. Many make special preparations for pets. My patients prefer getting bio-identical hormone replacement therapy (BHRT) from compounders. Men with low testosterone get it in creams that are much more concentrated than those advertised on TV. Women use creams, pills, troches, or pellets. Compounding gives greater choice in strength and method of delivery. It’s more personalized

Anchor: What will be the impact if this bill passes?

Dr. V: In its current form, it will deny patients medications and nutrients that are life giving and lifesaving. I encourage anyone interested in this to do research on the web. Make your own decision. Then let your representatives know how you feel. If you are on compounded prescriptions, do it now. I want to do everything possible to avoid another disaster like last year. Even so, I think S.959 gives the FDA too much authority to ban the most common BHRT treatments used by millions of women and men. They tried to do this in 2008 with the female hormone estriol but did not have the authority to enforce its actions. S.959 gives them full authority to ban commonly used BHRT. I’ll be talking about this and Andropause next Wednesday, July 10th at 6:00 PM at my office. Go to my website for details.

Anchor: Thanks Dr. V. She’ll be back....