Category Archives: FDA

MY OPINION: Letter To Senators Requesting Opposition To The GMO Labeling Bill

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I’m writing to tell you that I strongly oppose the Roberts-Stabenow compromise language on the GMO labeling bill.

I ask that YOU also oppose it.  This legislation would overrule Vermont’s consumer-friendly GMO labeling law, and prevent states from passing similar laws, and would create a confusing, misleading and unenforceable national standard for labeling GMOs.

Instead of a uniform labeling standard like Vermont’s law, the language allows text, symbols, or an electronic code to be used. This is intentionally confusing to consumers, and the information may be entirely inaccessible if the consumer does not have access to the internet.

Perhaps most shockingly, this bill imposes no penalties whatsoever for violating the labeling requirement, making the law essentially meaningless. Thus, this is a weak bill, full of loopholes, without any requirement to comply.

A law is meaningless and harmful if there are no penalties for not adhering to its requirements.

Are our Senators and Representatives so weak, that they are willing to have themselves and their families and children and friends eat food that may not be safe, in order to submit to the BIG CORPORATION LOBBYISTS?

The overwhelming majority of Americans favor GMO labeling. People have a right to know what is in the food they eat. The Senate shouldn’t stop states from passing laws that let that happen. Please oppose the Roberts-Stabenow GMO labeling bill.

HERE AGAIN, WE HAVE LAWS PASSED WITHOUT REPRESENTATION OF THE MAJORITY.  Remember the Boston Tea Party?  Why did the patriots dump the tea into Boston Harbor?  Because we were being taxed without representation in Britain.

The Congress passes too many bills into law without the majority of the citizens’ desires in mind.  The seats that Congress occupies on Capitol Hill can be filled with other individuals who are more willing to vote in favor of what the citizenry wishes.

This is a time of political upheaval.  More voters will be voting in this upcoming presidential and congressional election than in any other election.  There are a greater number of registered voters who have left the two major parties or registered Independent or are just totally confused as to which candidate for whom to vote.

 

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The FDA Has Finally Unveiled The New Nutrition Facts Label

The FDA has finalized the new Nutrition Facts label on packaged foods with changes that will make it easier for consumers to make informed choices about what they’re eating.

What is new on these labels?

  • Servings:  Larger, bolder type
  • Serving sizes updated
  • Calories:  Larger type
  • Updated Daily Values (%)
  • New:  Added Sugar
  • Change in Nutrients – Required
  • Actual amounts of nutrients – Declared
  • New footnote

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It’s about time!!!

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267% Price Increase for Ampligen

Ampligen’s manufacturer really doesn’t want the clinical trials to continue; otherwise, why would they slap on a 267% price increase? From $15,600 to $41,600 per year? It may be impossible for trial participants, who have uprooted their lives and their families’ lives, and moved to where the trials are being held, to continue.

Please read the following letter that Jeannette Burmeister wrote to Dr. Janet Woodcock, the FDA’s Director of the Center for Drug Evaluation and Research. asking for reasons and answers about this unbelievable price increase by the manufacturer, Hemispherx Biopharma, Inc.’s (“HEB”).

Thoughts About M.E.

I just sent the following message regarding Hemispherx’s extraordinary 267% price increase for Ampligen to Dr. Janet Woodcock, the FDA’s Director of the Center for Drug Evaluation and Research:

Dear Dr. Woodcock,

I am writing to you regarding a matter of grave concern for the patients in Hemispherx Biopharma, Inc.’s (“HEB”) AMP-511 open-label clinical trial for Ampligen, a drug highly effective for many ME (or as the FDA calls it “ME/CFS”) patients. I have testified at the Ampligen Advisory Committee meeting and other federal committee meetings in favor of FDA approval of the drug and I remain convinced that this drug should be approved by the FDA without further delay because many patients would benefit from it and because there are no other FDA-approved pharmaceutical interventions for ME.

I have been a study participant for over three years. Last night, I learned through ME Action’s blog (http://www.meaction.net/2015/08/10/ampligen-price-increases-substantially-available-soon-in-europe/) that the…

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Amid All The Issues Before Congress, Marijuana Has Made A Step Forward

 

Marijuana’s path toward a potential federal approval or decriminalization has not been easy and signs of further difficulties are apparent.  It could be years before researchers and drug companies feel comfortable with the results of their completed trials and experimentation and those in the future. As you might be aware, the cannabis these drug companies use for their experiments are provided by our Federal government which is grown in VERY SECRET farms.

One pharmaceutical company has discovered in excess of five dozen cannabinoids it hopes to use to help cure a number of chronic and/or serious diseases.

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Due to the fact that our Federal government lists marijuana as an illicit drug, and until that changes, the research by drug companies will basically slow down because of the legal stumbling blocks in their path, and more importantly, the costs.

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Surprisingly, Congress, just recently passed legislation that hopefully, will protect businesses that legally sell marijuana in states that have passed marijuana legislation, from any interference and/or prosecution by federal agencies.

Is there an important possible stumbling block to becoming law?  Yes.  The bill passed by Congress has to be signed into law by President Obama.

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Letter to President Obama re: National Institutes of Health

Tomorrow, I’m mailing yet another letter to President Barack Obama.  This time, it’s in reference to Dr. Francis Collins, Director of the NIH.  There is a workshop planned for September 2014, which, in my opinion and that of other M.E. advocates, should not be taking place.  Please read on:

Re: M.E. (myalgic encephalomyelitis) and Dr. Francis Collins, Director of the NIH (National Institutes of Health)

Dear Mr. President;

Today, my letter is about the planned Pathways 2 Prevention (P2P) workshop, projected to take place September 2014 to discuss the “Role of Opioids in the Treatment of Chronic Pain.”

My daughter is suffering from M.E. Her quality of life is greatly diminished:  she has body pain all the time; suffers horrific headaches; and many other symptoms.

Chronic pain is a huge national problem, and there are many issues associated with opioid treatment. So you would think that NIH would have made an effort to involve stakeholders from across the chronic pain community, right?

There was no patient representation on the Working Group for the meeting. Working Group members provided their input at a meeting held August 28–29, 2013. Multiple advocacy organizations in the fibromyalgia community had no idea the workshop was even happening, including the National Fibromyalgia and Chronic Pain Association. At least one opioid drug manufacturer was also completely unaware of this Workshop – despite having a regulatory affairs office.

I, and many other advocates for ME/CFS, have asked Dr. Francis Collins to cancel the P2P Workshop and reexamine the best way to collaborate with the ME/CFS research and clinical community. The NIH has failed to engage stakeholders in a meaningful and substantive way. The P2P Program is simply not designed to do this, and now there is more proof of that from another planned P2P Workshop.

I think what we’re seeing is indicative of NIH’s mindset. Unlike FDA, which has made great strides towards incorporating patients’ input into decision making, NIH is an ivory tower of researchers with limited history of engaging patients and other stakeholders. It may not even occur to them that they need to do this. NIH is not just failing to engage with ME/CFS stakeholders in the P2P process; NIH is failing to engage with ANY stakeholders through P2P (Pathways 2 Prevention).

In closing, I would like to point out that this planned workshop’s purpose of discussing opioids in treatment of chronic pain has a direct impact on all patients who experience great pain, no matter from which disease they suffer. As an advocate for M.E., I ask that you investigate why no patients’ input is being included in the planned workshop, and why Dr. Collins has approved this project which may harm, rather than help, those who suffer great pain.

Sincerely,

The FDA is Using Cutting-Edge Technology in Investigating Foodborne Illnesses

This whole genome sequencing technology was used to help strengthen the FDA’s evidence of a strain of Listeria bacteria.  Listeria was responsible for a multi-state outbreak of a cheese product.

The type of cheeses in which Listeria was found.

Some of the types of cheeses in which Listeria was found.

To read more about this breakthrough technology used to help keep our foods safe, click here.