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MORE EMAILS FROM THE FDA ON MERCURY TESTING

QaBy Twyla Ramos

On December 31, 2007, Age of Autism posted a series of emails between the CDC, the FDA, and me, in which I asked whether any government agency tests the mercury content of the vaccines which supposedly contain only a "trace" amount of mercury.  Neither the CDC nor the FDA, would answer my questions. (Read the piece HERE.)

The following month, I received an e-newsletter from the National Autism Association (NAA) which included a link to a January 17, 2008 letter from Representative Dan Burton to the FDA, demanding answers to questions raised by "a parent" in an email dialogue with the CDC and FDA.  In his letter (HERE), he asked the FDA for a response by February 11, 2008.

On February 14, 2008, to my surprise, I received an email from Christopher Middendorf, Chief of the Consumer Affairs Branch, Division of Communication and Consumer Affairs, Center for Biologics Evaluation and Research at the FDA.  He responded to my initial email sent to the FDA in November.  Our exchange is shown below.

----------------------------

From: Twyla Ramos
Sent: Tuesday, November 13, 2007 11:57 AM
To: CBER OCTMA Consumer Account
Subject: "Trace" amounts of Thimerosal in vaccines

The CDC says that: "Thimerosal still may be used in the early stages of making certain vaccines. However, it is removed through a purification process. When this process is complete, only trace, or insignificant, amounts of thimerosal are left (less than 0.3 mcg) and these amounts have no biological effect."

Does any governmental agency monitor and test vaccine products to ensure that this "purification process" is consistently effective and that the final product does not exceed 0.3 mcg of thimerosal?

Thank you very much,
Twyla Ramos
concerned parent

-----------------------------

From: Middendorf, Christopher (CBER)

To: Twyla Ramos

Cc: Middendorf, Christopher (CBER)

Sent: Friday, February 15, 2008 4:01 AM

Subject: Re: trace amounts of thimerosal

Dear Ms. Ramos,

Thank you for your recent  [recent? Ha! 3 months ago - TR]  inquiry to FDA's Center for Biologics Evaluation and Research (CBER) regarding thimerosal.

CBER, one of six centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.

In accordance with 21 CFR 610.2(a), samples of any lot of licensed product, together with the protocols showing results of applicable tests, may at any time be required to be submitted to the Center for Biologics Evaluation and Research (CBER) for review and confirmatory testing. CBER conducts directed testing for thimerosal in products when determined to be appropriate as part of the license approval process and the lot release program.  If a product never contained thimerosal in the manufacturing process nor in the final product, CBER does not perform testing for the presence of thimerosal.

There are some products that use thimerosal as part of the manufacturing process, but the thimerosal is removed before the final stages of production and is only present in trace amounts.  As part of the licensing process, FDA requires manufacturers to validate all testing procedures as well as the entire manufacturing process.  FDA reviews and verifies acceptability of the submitted information during licensing, lot release and inspections.  If the product contains trace amounts of thimerosal due to residuals remaining at the end of the manufacturing process, CBER performs testing during the product licensing phase to verify that the manufacturing process to remove thimerosal consistently achieves values below the residual target level, and assesses the validity of the data submitted by the manufacturer's laboratory. CBER routinely reviews data generated by the manufacturer's testing laboratory on the lot release protocol.  CBER laboratories may also perform testing on samples in order to maintain assurance that the manufacturer's process continues to produce product below the allowed upper limit established.

I hope this information is helpful to you.

Sincerely,

Chris Middendorf
Chief
Consumer Affairs Branch
Division of Communication and Consumer Affairs Center for Biologics Evaluation and Research US Food and Drug Administration 301-827-2000 This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

-----------------------------

From: Twyla Ramos
Sent: Friday, February 15, 2008 11:25 PM
To: Middendorf, Christopher (CBER)
Subject: Re: trace amounts of thimerosal

Dear Mr. Middendorf,

Thank you so much for your email.  I'm wondering why this information was not available when I contacted the FDA three months ago?  I initially corresponded with Lanessa Hill (Public Affairs Specialist, Consumer Affairs Branch, Division of Communication and Consumer Affairs, Center for Biologics Evaluation and Research) and with Patricia H. Harley (Consumer Safety Officer, Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Communication, Training and Manufacturers Assistance, Division of Communication and Consumer Affairs).  Were they not authorized to give out this information?  They stated the basic procedures, but refused to tell me whether this testing included tests for mercury.  Is testing for mercury something new?  When did the FDA begin testing thimerosal content in vaccines which are supposed to contain only trace amounts?

You state that, in addition to testing as part of the license approval process, tests "may" be conducted later "to maintain assurance that the manufacturer's process continues to produce product below the allowed upper limit established".  Does this ever actually happen?  How rarely (or often) does testing of products occur after the license has already been approved?

Thank you so much.  I really appreciate your getting back to me.  It would put my mind at rest to know the answers to these additional questions.

Sincerely,

Twyla Ramos

parent

-----------------------------

From: Middendorf, Christopher (CBER)

To: Twyla Ramos

Cc: Middendorf, Christopher (CBER)

Sent: Tuesday, February 19, 2008 8:30 AM

Subject: RE: trace amounts of thimerosal

Dear Ms. Ramos,

Thank you for the follow-up questions.  I have to contact CBER's Office of Vaccine Research and Review (OVRR) for assistance in responding to your questions.  We have a Vaccines and Related Biological Product Advisory Committee meeting this week, so most of the people who will have the answers are out.  I will try to get something back to you early next week.

Thank you for your patience,

Chris Middendorf
Chief
Consumer Affairs Branch
Division of Communication and Consumer Affairs Center for Biologics Evaluation and Research US Food and Drug Administration 301-827-2000 This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

-----------------------------

From: Twyla Ramos
Sent: Tuesday, February 26, 2008 1:26 AM
To: Middendorf, Christopher (CBER)
Subject: Re: trace amounts of thimerosal

Dear Mr. Middendorf,

Hello.  I am just following up on my earlier email.  Have you had a chance to speak with your colleagues?  Thanks!

Twyla Ramos

-----------------------------

From: Middendorf, Christopher (CBER)

To: Twyla Ramos

Cc: Middendorf, Christopher (CBER)

Sent: Tuesday, February 26, 2008 4:57 AM

Subject: RE: trace amounts of thimerosal

Dear Ms. Ramos,

Yes, I have been in touch with our subject matter experts.  I'm trying to get clarification on a piece of information I was given.  Hopefully, I will have what I need today.

Again, thanks for your patience,

Sincerely,

Chris Middendorf
Chief
Consumer Affairs Branch
Division of Communication and Consumer Affairs Center for Biologics Evaluation and Research US Food and Drug Administration 301-827-2000

-----------------------------

From: Middendorf, Christopher (CBER)

To: Twyla Ramos

Cc: Middendorf, Christopher (CBER)

Sent: Thursday, February 28, 2008 11:39 AM

Subject: RE: trace amounts of thimerosal

Dear Ms. Ramos,

Not moving as quickly as I hoped, I'm trying to get the last bit of information to close this out.

Again, thanks for your patience,

Sincerely,

Chris Middendorf
Chief
Consumer Affairs Branch
Division of Communication and Consumer Affairs Center for Biologics Evaluation and Research US Food and Drug Administration 301-827-2000

-----------------------------

From: Twyla Ramos
Sent: Tuesday, February 26, 2008 11:01 AM
To: Middendorf, Christopher (CBER)
Subject: Re: trace amounts of thimerosal

Thanks again!

-----------------------------

From: Twyla Ramos
Sent: Monday, March 03, 2008 11:42 AM
To: Middendorf, Christopher (CBER)
Subject: Re: trace amounts of thimerosal

Still waiting...

-----------------------------

From: Middendorf, Christopher (CBER)

To: Twyla Ramos

Cc: Middendorf, Christopher (CBER)

Sent: Monday, March 03, 2008 9:08 AM

Subject: RE: trace amounts of thimerosal

Dear Ms. Ramos,

Thank you for your patience.  I have had request similar to yours, so I have attempted to put the information in a Q&A format.  There maybe some additional information that you did not request, however I believe this information answers your questions and clarifies previous responses.

How often does the FDA's conduct spot testing to evaluate thimerosal levels (quarterly, semi annually, etc) to verify independently that the manufacturer's testing results on the purification process?

Once confirmatory testing is completed during licensure, CBER does not routinely "spot check" products with "trace amounts" of thimerosal. A "spot check" may be initiated if there is a deviation from an approved manufacturing process and this deviation has the potential to lead to altered thimerosal levels, or through an assessment of other risk factors apparent during review of change Supplements, inspection, or routine data review. CBER routinely reviews thimerosal and/or mercury data generated by the manufacturer's testing laboratory as submitted on each lot release protocol. To ensure monitoring integrity, CBER does not publicize or otherwise inform manufacturers when testing occurs.

For products with more than "trace amounts", for example, products with thimerosal as a preservative, CBER reviews data generated by the manufacturer's testing laboratory in the lot release protocol. CBER laboratories may also perform testing on random samples in order to maintain assurance that the manufacturer's process continues to produce product below the allowed upper limit established. To ensure monitoring integrity, we don't routinely inform manufacturers in advance of testing which lots may be tested.

Are the results of FDA spot-testing in this regard available to the public?The public can obtain the results of confirmatory testing performed in support of BLA's and Supplements and any post licensure testing results through the Freedom of information Act
(http://www.fda.gov/opacom/backgrounders/foiahand.html#request)

Is testing for mercury something new?

No, testing for mercury has been taking place ever since its use as a preservative was advocated.

When did the FDA begin testing thimerosal content in vaccines which are supposed to contain only trace amounts?

Testing of vaccines for confirmation of removal or reduction of thimerosal levels begins concurrent with each submission of the supplement application to remove thimerosal or submission of a new product application. CBER performs testing during the application review phase to verify that the manufacturing process to remove thimerosal consistently achieves values below the residual target level, and assesses the validity of the data submitted by the manufacturer's laboratory.

Sincerely,

Chris Middendorf
Chief
Consumer Affairs Branch
Division of Communication and Consumer Affairs Center for Biologics Evaluation and Research US Food and Drug Administration 301-827-2000

-----------------------------

So, there you have it.  The FDA says that they perform testing during the product licensing phase, but, "Once confirmatory testing is completed during licensure, CBER does not routinely 'spot check' products with 'trace amounts ' of thimerosal. A 'spot check' may be initiated if there is a deviation from an approved manufacturing process and this deviation has the potential to lead to altered thimerosal levels, or through an assessment of other risk factors apparent during review of change Supplements, inspection, or routine data review."

Not sure why this information was too top secret or unknown to be released by the lower level FDA personnel back in November.

Today I sent one more email to Mr. Middendorf, asking a few additional questions.  Without congressional intervention, I don't know whether I will receive any answers.

-----------------------------

From: Twyla Ramos

To: Middendorf, Christopher (CBER)

Sent: Saturday, April 05, 2008 8:10 PM

Subject: Re: trace amounts of thimerosal

Dear Mr. Middendorf,

Thank you for this additional information about thimerosal content testing in vaccines.  From the timing of your initial email to me, I assume that your email was prompted by the January 17, 2008 letter to the FDA from Congressman Dan Burton, in which he spoke of an email exchange between "a parent" and the CDC and FDA.  (I am assuming that parent was me, although nobody has confirmed this.)  Representative Burton asked the FDA to respond to him by February 11, 2008, three days before your email to me.

I have been wondering about another question asked by Representative Burton, which is not addressed in your email:  "Has the FDA determined a safe reference dose for injected ethylmercury and thimerosal for adults and children?"  If so, how was such a determination made?  I have read the following information about mercury:

0.5 parts per billion (ppb) mercury = Kills human neuroblastoma cells (Parran et al., Toxicol Sci 2005; 86: 132-140).

2 ppb mercury = U.S. EPA limit for drinking water http://www.epa.gov/safewater/contaminants/index.html#mcls

20 ppb mercury = Neurite membrane structure destroyed (Leong et al., Neuroreport 2001; 12: 733-37).

200 ppb mercury = level in liquid the EPA classifies as hazardous waste.
http://www.epa.gov/epaoswer/hazwaste/mercury/regs.htm#hazwaste

How do we know that even "trace" amounts (defined as "less than 0.3 mcg") are safe?  I have read that the only testing of thimerosal was done in 1930 on a group of terminally ill people who died as expected, and on a group of dogs who became ill so thimerosal was declared unsuitable for use in dog vaccines.  Surely there must be some basis on which to decide that it is safe to inject trace amounts of mercury into a baby?

Also, why does the FDA continue to allow much more than a trace amount of mercury in flu shots, although flu shots can be made mercury-free simply by packing the shots individually, at only a slightly higher cost?  How on earth can these shots be o.k. for pregnant women, babies, and children?

In addition, in The Vaccine Book, Dr. Robert Sears says that he was unable to find any testing to confirm the safety of injecting aluminum into babies at the levels contained in many vaccines.  Could you please tell me how it was determined that aluminum in vaccines is safe?

Thank you in advance for addressing these concerns.

Sincerely,

Twyla Ramos

concerned parent

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Not quite enough for the bunco squad. Try to trip 'em up on the safe exposure level angle. They've had plenty of time. Make 'em sweat.

Thanks, Dr. G., for that info. I figured that there's no process at FDA for this. The system is designed to sweep problems under the rug. Reports are made to VAERS and then what happens to them? Nothing.

Hi Garbo, As I mentioned in another post, there was a TV program, I believe it was Dateline a number of years ago where they discussed hot lots that were not recalled. (In this case there were a number hot lots, each having had around 100 serious reactions and 10 deaths, if I recall correctly.) The FDA said recall was based on some number that was proprietary information of the vaccine manufacturers! They interviewed a parent whose child had been seriously disabled by one of the lots after quite a few others had either been killed or maimed. She was understandably angry that the lot had not been recalled, which would have saved her child.

Awesome reporting. Thanks for sticking with it. I have a follow up question: Does FDA or any of its subdivisions interface with VAERS (Vaccine Adverse Event Reporting System) to monitor for "hot lots" of vaccine and test lots with high numbers of adverse reports? If yes, has any vaccine lot ever been recalled based on such testing? What number of adverse event reports would trigger such testing? Is there any notification process by which these test results would be made immediately available to the public and those receiving the vaccine in question would be informed of any results of the testing? What rules, if any, govern the time frame in which such testing, recalls, and notifications must be executed? If I reported an adverse event, how might I obtain any testing results for that vaccine lot? If there is no interface between VAERS and FDA, is there another federal entity that is responsible for testing "hot lots" of vaccines?

I'm not suprised at all that they haven't tested vaccines since licensure. It's truly dispicable that our elected officials have allowed this to happen. I have just met with every senator and rep. in central Illinois and let them all know that since they have passed the Illinois mercury free vaccine act in 2006 ( to a litany of media coverage I might add) they have allowed the Illinois Dept. of Health amend this law each year since, so that they could inject our pregnant women and babies with mercury ( with, of course, not even a one inch column on page eleven of the most obscure newspaper in their districts). I have let each and every one of these legislators know that they will not get away with this another year. every one of their constituents will read about their lack of concern for the poisoning of our children, I've given them my solemn vow!

I have always been curious about this...How hard would it be for someone to get a vial of vaccine and have it tested themselves? In all seriousness, is this possible? Getting multiple vials of multiple brands could be quite informative. I'm willing to bet some brands play by the rules more than others.

Thanks for your investigation!

This trace amount "math" is being used across the board. When you read nutrition information on packaged foods that say "no trans fat", look for the asteric. Our food producers can now say that there is NO trans fat per serving if there is just a trace amount. If someone eats 4 cookies instead of 2, they get trans fat because the trace amount adds up. Maybe the CDC would understand cookie math with thimerasol????

These people/agencies are ridiculous. Didn't they also use the term "trace amounts" before they started filtering it out, too? So, they used to contain trace amounts and now they still do? Is it any wonder more and more people don't trust the vaccines they push on us and their beloved, beyond reproach schedule?

My mom had a saying, "You made your bed, now lie in it."

Thanks Twyla, excellent work!

Thank God that you can keep all of this information straight in your brain. Keep up the good work because our childrens futures depend on it.
I would love to see statistics for all of the children of parents who work at the CDC and FDA. Have their kids been given single dose vaccines?

Twyla, Congressman Burton's work definitely originated from your Age of Autism article in Dec 07. I printed that article and mailed it to him. I thought it was important for him to know about.

"For products with more than "trace amounts", for example, products with thimerosal as a preservative, CBER reviews data generated by the manufacturer's testing laboratory in the lot release protocol. CBER laboratories may also perform testing on random samples in order to maintain assurance that the manufacturer's process continues to produce product below the allowed upper limit established. To ensure monitoring integrity, we don't routinely inform manufacturers in advance of testing which lots may be tested."

Twyla, it seems as though for vaccines with more than a trace amount of thimerosal (flu shots?) the FDA relies on the manufacturer as per a "lot release protocol." Hmmm, what is a "lot release protocol" anyway?

I see that they did not answer the question about how often these tests are done (if at all - if that is what "may also perform testing" means). The tactic seems to be to fudge the answer in a string of long words so that by the time you get to the end of the sentence you forget how it began. Or even what the question was!!


So, basically the FDA is saying that they have never preformed this testing?

Thanks Twyla for initiating these excellent questions. Your persistence is admirable.

Can't wait to see if you get a response to your tough and painfully accurate e-mail, or if Dan Burton will have to get involved again? I fear you'll be sending more "still waiting" e-mails.

Keep us posted.

Very interesting. I am quite alarmed that,"Once confirmatory testing is completed during licensure, CBER does not routinely 'spot check' products with 'trace amounts ' of thimerosal. A 'spot check' may be initiated if there is a deviation from an approved manufacturing process and this deviation has the potential to lead to altered thimerosal levels, or through an assessment of other risk factors apparent during review of change Supplements, inspection, or routine data review." This seems absurd and reckless.

Twyla, your follow-up questions are excellent! Please let us know when you hear back. It is good to see aluminum being questioned directly.

Thanks, again, for your hard work and determination to get answers for us!

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