|
|
|
Browse by Tags
All Tags » CDC » FDA (RSS)
-
From Linda Weinmaster:
It is with deep sadness that I inform the autism community that we have lost another hero. Dr. Frank Engley passed away last night. It is no exaggeration to say that Dr.Engley was the very first scientist to raise the alarm of the dangers of thimerosal with his landmark paper. This last year infused him with a sense of purpose and determination to alert the world that the use of thimerosal must be stopped. He was deeply saddened that the FDA never followed through with his recommendations on eliminating thimerosal from all human biologicals. It was my honor and privilege to know this incredible man. I will miss his brilliance and sense of humor. You are my hero Dr. Engley. Linda Weinmaster Vice President No Mercury Trustee; Alan D. Clark Research Foundation
From Anne Dachel:
The efforts of Dr. Engley to prevent this disaster will be a lasting
tribute to him. We need to remind the public of his early findings:
"Doctor Frank Engley a researcher and microbiologist who served on boards with the Centers for Disease Control, the FDA, and EPA throughout the 70s and 80s.
"I am afraid they have a tremendous amount of pressure being brought to bear by the medical profession, by the pediatricians, by congress, and by industry, and so they are under pressure&and someday they will have to live with the fact with what they said is wrong," Dr. Frank Engley.
Dr. Engley says the FDA knew about the dangers of thimerosal back in the 70s and 80s, when he served on its boards.
"Industries did not comment. They thought it was just generally going away. And it practically did. They came out with another report. The FDA about eight years later, and about 1998." Dr. Engley said.
"I would say to you, the FDA is partly to blame for the mecuricals still being on the market all that length of time. If they would have followed through with our 1982 report, vaccines would have been freed of thimerosal and all this autism as they tell me would not have occurred. But as it is, it all occurred," said Dr. Engley."
|
-
Two weeks ago I took a break from blogging to spend time with family who came to visit. Last week was a work catch up week, and I have only begun to catch up with all that has happened in the autism world while I was gone. As I have been reading, I am seeing things that are surprising me. It is freaking me out a little. Something has changed around the Cedillo Trial. I have been following autism news for three years and I have never seen the kind of stories/events that are surfacing. Dave Weldon and Carolyn Maloney have introduced bipartisan legislation, the Mercury Free Vaccines Act of 2007. Autism Speaks has uncharacteristically decided to back it and oppose AB 16 in Sacramento that would mandate that the State of California automatically adopt any vaccine that the CDC puts on the schedule (and pushed the HPV vaccine). They have never taken a stance on vaccines before. AS is also listing mercury research that was funded by CAN before the merger on their web site, but someone who spends a lot of time on the site said they didn't remember every seeing this page there before. (Anyone know if this is new, or remember seeing it in the past?) AS has also stepped into the insurance coverage legislation in PA and announced legislative efforts on their web site. The CDC issued a response to Verstraeten/VSD on their web site with lots of references to thimerosal studies. (I haven't had a chance to read it yet), but how long has it been there? It is not dated and David Kirby, who is a guy who keeps track of these things, didn't even know it was there until a few days ago. The run up to the Wakefield MMR Trial has reignited doubt in the vaccine in the UK and articles like these are coming out:
At Last They Admit It, This Jab CAN Harm Your ChildThe Truth About MMR
DANGERS OF MMR JAB 'COVERED UP'The Autism Research Institute is now being backed by the giant Autism Society of America, which is now teaming up with Easter Seals who will now make Autism their priority. Over the last three years, my blog has been visited occasionally by CDC and NIH and a few other government agencies. These visits were few and far between, and always interesting to me when they happened. But now, ramping up with increasing frequency since about April, my blog has been regularly visited by The Powers that Be CDC, NIH, FDA, EPA, HHS, the House and the Senate, The Department of Justice (who are the governments "defendants" in the Cedillo Trial), The Department of Veterans Affairs, The US Forestry Service, The Naval Research Laboratory, Lawrence Livermore Laboratory, The US Census Bureau, dozens of foreign, state and local governments, a slew of Canadian government agencies, dozens of medical centers/health organizations/universities/dental schools including CHOP (Paul Offit's hospital), Johns Hopkins, The Cleavland Clinic, our pharma friends at Johnson & Johnson and Glaxo Smith Klein, Immunize.org, media corporations Tribune and Gannett, The World Health Organization and even one visit from the Nuclear Regulatory Commission Apparently the Department of Justice is curious to know when and if the Evidence of Harm movie will be coming out.  Here is my blog traffic graph for the last three years.  2005 - nice little blog with decent traffic. 2006 - took a break from blogging for most of the year. 2007 - Started to write again. Feb/March stats broke but I didn't notice. April was Autism Awareness Month (Damn that is a lot of awareness). May - residual autism awareness?? June - suddenly I am twice as fascinating as I have ever been on my best month! July - on track to have 8,000 visitors despite the fact that I have been on vacation most of the time. As much as I would love to believe that it is my brilliance that people are coming for, it is probably a safer bet that more people (and more people in positions of power to do something) are awakening to the reality that autism is preventable and treatable and are taking valuable time out of their day to investigate for themselves. Last month I said that the tide had turned. I think I might have been righter than I thought I was and that the tide might start moving faster than I had anticipated. Even if I had 40 hours a week to sort all this stuff out, I don't think I could do a decent job. I am just going to start posting references to stories with out much comment just so I can get as much out as possible.
|
-
|
The following is a summary of the history of thimerosal. It is not a complete list, as there is much more information out there and many more details to the information that I have included, but it hits the high points and gives a good frame of referrence for where the discussion of the safty of this product and its relationship to autism and neurodevelopmental disorders should begin.
History of Thimerosal and Autism
- Invented in the 1920’s by Eli Lilly, thimerosal is 49.6% ethlymercury, a neurotoxin known to be more than a hundreds times more powerful than lead.
- Eli Lilly’s safety testing of the product consists of a 1930 study of 22 patients dieing from mengiococcal meningitis in an Indiana hospital. Patients are injected with the solutions and followed until their death, which is within days. Because the patients die of meningitis, they are declared to show no adverse reaction to thimerosal and the product is declared safe for use. Thimerosal is subsequently introduced for use in vaccines and in over the counter remedies as a preservative to kill bacteria in the product.
- When the FDA is created, Thimerosal is grandfathered in and is not subjected to any additional safety testing. The 1930 study remains the only safety testing done on the substance even after being in use for 75 years.
- Through FOIA requests and documents acquired as a part of discovery process in lawsuits against Lilly, it is clear that they have been warned about, and have been aware of the dangers of the product since at least 1947.
- In the 1950’s the use of thimerosal in teething powders for infants leads to a fatal out break of Acrodynia, or “Pink’s Disease”, a form of mercury poisoning. This illness has many symptoms in common with Autism.
- In 1963 Eli Lilly was forwarded an article that read in part: "There is another point of practical significance: does the parenteral injection of thimerosal - containing fluids cause disturbances in thimerosal-sensitive patients?" "It is known that persons that are contact sensitive to a drug may tolerate the same medications internally, but it seems advisable to use a preservative other than thimerosal for injections in thimerosal-sensitive people."
- On August 17, 1967 the Medical/Science department requests that the claim "non-toxic" on thimerosal labels be deleted in next printing run. Two weeks later the label is changed to "non-irritating to body tissues," and the phrase non-toxic omitted.
- In 1972 The British Medical Journal reports case of skin burns resulting from the chemical interaction of thimerosal and aluminum. "Mercury is known to act as a catalyst and to cause aluminum to oxidize rapidly, with the production of heat." The manufacturers who supply us with thimerosal have been informed." [Thimerosal is being used in vaccines which also contain aluminum].
- In the 1970’s six newborns at one hospital die as a result of having a thimerosal containing antiseptic wiped on their wounds.
- In 1982 the FDA reviews the use of thimerosal. Their statement reads in part: “At the cellular level, thimerosal has been found to be more toxic for human epithelial cells in vitro than mercuric chloride, mercuric nitrate, and merbromim (mercurichrom). "It was found to be 35.3 times more toxic for embryonic chick heart tissue than for staphylococcus areus." A 1950 study showed that thimerosal was no better than water in protecting mice from potential fatal streptococcal infection." "The Panel concludes that thimerosal is not safe for over the counter topical use because of its potential for cell damage if applied to broken skin and its allergy potential. It is not effective as a topical antimicrobial because its bacteriastatic action can be reversed." Additional language added to some Lilly labels: "As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product." The FDA orders the withdrawal of over the counter, thimerosal containing products within a 6 month period. It does not order removal from vaccines, but recommends that the issue be studied and that the incidence of neurological problems in unvaccinated populations like the Amish be compared to the vaccinated population. [22 years later no such study has yet been done. On July 19, 2005 Dr. Julie Gerberding, head of the CDC says that such a study would be difficult to undertake because of genetic confounders. This seems contrary to the scientific process because if indeed such a study is done and it is found that the Amish have a lower incidence of neurodevelopmental disorders, the next step would be to undertake genetic studies to see if their genes differ dramatically from the general population and if their differences can help us locate the genetic component of autism. In addition studies designed to see if the small number of vaccinated Amish differ in their risk for NDDs to the larger Amish population would offer information about increased risk from thimerosal.]
- In the 1930’s the average child only received three shots in their young life. Many vaccines are added to the schedule over the years, with an increase in the 1980’s and with 3 vaccines added to the schedule in 1991 alone. The current vaccine schedule calls for 22 shots.
- A Merck internal memo is obtained during discovery discloses that in 1991 a Merck researcher added up the amount of mercury that is in the new vaccine schedule and sounded an alarm at the company that children who are vaccinated according to it would receive amounts of mercury far and above that considered to be safe by the EPA. Merck takes no action in regard to the information.
- During the 1990’s, autism rates begin to rise dramatically. Parents complain to the health authorities that they believe that their children’s developmental disorders are related to their vaccines.
- In 1998, a researcher at the CDC does the same math that Merck did 7 years previously. She finds that children are getting as much as 125 times the EPA limit of mercury for their weight. The EPA limit is based on the ingestion of methlymercury in food by a healthy adult. Because 90% of ingested mercury is excreted in the digestive track and never enters the blood stream, even the EPA limit may be drastically lacking considering that thimerosal is injected directly into the blood stream and is not subject to the bodies natural defenses against toxic poisoning.
- In 1999, the CDC and the American Association of Pediatrics issue a joint statement saying that although they find no “evidence of harm” from the mercury exposure that children are getting in their vaccines, they are calling on vaccine manufacturers to remove it from vaccines on a voluntary basis as a precautionary measure because “some children may” get more than the EPA limit for mercury at their 6 month visits. Manufactures begin the process in 1999, but do not remove it from all vaccines.
No legal ban on thimerosal is issued.
No recall of the mercury laden vaccines is issued and companies continue to sell lots already manufactured. Some of these are still being used in doctors’ offices as of this writing in July 2005.
No statement is issued to pediatricians to alert them to the symptoms of mercury poisoning.
No recommendation is made to pediatricians to screen children who suffered the onset neurological imparment after vaccination for mercury toxicity.
- In November of 1999, the CDC commissions one of its new employees, a Belgian named Thomas Verstraten, to study the Vaccine Safety Datalink to find the risk of autism and other NDDs in relation to thimerosal exposure. Verstraten’s first draft of the study finds a relative risk above 7 for children who receive the highest dose of thimerosal to develop autism. In simple terms, such children have a more than a 600% higher chance of developing autism than children who don’t receive any thimerosal. (A relative risk of 2 is sufficient proof in U.S. courts to find for vaccine injury) Verstraten and other scientists at the CDC spend 4 years trying to change the study so that the relationship between the preservative and NDD’s is significantly reduced or eliminated. The Center for Disease Control will later describe these changes to the study as “improvements”. When the study is published in 2003, it concludes that “no consistent significant associations are found between thimerosal containing vaccines and neurodevelopmental outcomes.” By this time Thomas Verstraten, who is listed as a CDC employee on the study, has been an employee of GlaxoSmithKlein (a defendant in thimerosal law suits) for more than 2 years.
- In November of 2000, despite being born almost two months prematurely and despite the assurance from my pediatrician that he did not use thimerosal containing vaccines, my son Webster is injected with a DTaP vaccine that exposed him to 74.5 times the EPA limit for mercury exposure for his weight, just two weeks past his due date. He will go on to develop verbal apraxia and sensory integration disorder.
- In 2001 Bernard et. al. publish their hypothesis: Autism: A Novel Form of Mercury Poisoning. It reads in part: “Exposure to mercury can cause immune, sensory, neurological, motor, and behavioral dysfunctions similar to traits defining or associated with autism, and the similarities extend to neuroanatomy, neurotransmitters, and biochemistry. Thimerosal, a preservative added to many vaccines, has become a major source of mercury in children who, within their first two years, may have received a quantity of mercury that exceeds safety guidelines. A review of medical literature and US government data suggests that: (i) many cases of idiopathic autism are induced by early mercury exposure from thimerosal; (ii) this type of autism represents an unrecognized mercurial syndrome; and (iii) genetic and non-genetic factors establish a predisposition whereby thimerosal’s adverse effects occur only in some children.”
- In 2001 the Institute of Medicine is commissioned by the CDC to undertake a comprehensive review of all research into the thimerosal/autism connection. At their first meeting, Dr Stratton, head of the commission, when discussing what the process and product of the working group would be states that, “We said this before you got here, and I think we said this yesterday, the point of no return, the line we will not cross in public policy is to pull the vaccine, change the schedule. We could say it is time to revisit this, but we would never recommend that level. Even recommending research is recommendations for policy. We wouldn’t say compensate, we wouldn’t say pull the vaccine, we wouldn’t say stop the program”. When the transcript of the meeting is made public through a FOIA request, many interpret this to mean that no matter what they find, they will not publicly say that there is any link between the thimerosal and autism.
- In 2001 Verstraten presents a version of his study to the IOM. He begins his presentation by telling the panel that as of 8 am that morning, he had become an employee of Glaxo Smith Klein. Despite the conflict of interest and the drastic changes made over the course of the study, the IOM will rely heavily on the study in making their determination. Dr. Verstraten returns to Belgium and except for a letter published in Pediatrics, little is heard from him again.
- In March of 2002 my son Chandler, who was born one month early, is injected with Hepatitis B vaccine containing a “trace amount” of thimerosal, despite the fact that he has no risk factors for Hepatitis B, and he is still two weeks from reaching his due date. Within days he develops fevers and uncontrollable crying that lasts for three months and bowel problems that persist for two years until he is placed on the GFCF diet. He will go on to be diagnosed with both Autism and mercury poisoning at age 2. I later discover that the “trace amount” of thimerosal is still just over the EPA limit of mercury for his weight.
- In 2003 the Verstraten Study is published in Pediatrics with no mention of the conflict of interest of the lead researcher. Later a private contractor would testify before congress that he was ordered to destroy the original data sets used in the 1999 version of the study that found the dramatic link between thimerosal and autism in the interest of “patient confidentiality”. The entire Vaccine Safety Datalink is eventually moved to an offshore private company and can no longer be accessed by FOIA request.
- In February of 2004, the IOM rushes to hold public hearings where researchers on both sides of the issues present their studies. The meeting is considered to be a “draw” between the two sides by many of those in attendance. A link is neither proved nor disproved, but new research in to the mechanism of how mercury can trigger autism and NDDs in a genetically vulnerable sub population is presented, along with case studies of successful treatment of autistic symptoms based on the new research.
- In May of the same year, the IOM issues their final conclusion on the link between Thimerosal and NDDs. They state that, “the body of epidemiological evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism. The committee further finds that potential biological mechanisms for vaccine-induced autism that have been generated to date are theoretical only.” They then go on to take the unusual step of recommending that research into a link between the two be abandoned and funds be spent on other lines of inquiry. The conclusion relies heavily on Verstraten and several other epidemiological studies that are considered to implement fatally flawed methods and to be riddled with conflict of interest by members of the autism community. Parent groups are enraged. The IOM panel disbands.
- Later that year, Thomas Verstraten publishes a letter in Pediatrics in response to those who criticize his study and his conflict of interest. His letter does not address the substance of the charges made against the study and the changes that were made to it over it’s 4 year evolution, but instead says that continuing the debate the validity of the 1999 study would be a “waste of scientific energy and not to the benefit of the safety of US children or of all the children world wide that have the privilege of being vaccinated.” He goes on to say that any suggestion of impropriety on the part of himself, the CDC or GSK is an insult and accuses his critics of having “pitiable attitudes”.
- In July of 2005, in the face of continuing criticism of the IOM findings, the head of the IOM, Dr. Harvey Fineberg, issues a letter stating that Dr. Stratton’s 2001 comments that they would not say “pull the vaccine” or “change the schedule” were taken out of context and did not suggest that the IOM decision was compromised. Dr. Fineberg has not, despite requests, offered an alternative interpretation of what her comments meant in context.
- In March of 2005, Author David Kirby released his book, “Evidence of Harm - Mercury in Vaccines and the Autism Epidemic: A Medical Controversy” detailing the history of thimerosal in vaccines and its relationship to autism.
- In April of 2005 the CDC posts a notice on their web site stating that they were in the process of reviewing “Evidence of Harm” and would be responding to the book.
- In June of 2005 Robert F. Kennedy Jr. echoed the information found in the book and charged the CDC and Eli Lilly of malfeasance in covering up evidence of a causal effect between thimerosal and autism in an article published in Rolling Stone and Salon.com. It is entitled “Deadly Immunity: Robert F. Kennedy Jr. investigates the government cover-up of a mercury/autism scandal”.
- July 19, 2005. The CDC holds a press conference to: “communicate the importance of infants and children receiving their recommended vaccinations on time, and reassure parents that vaccines are safe. The renewed attention to the potential causal link between thimerosal, a vaccine preservative, and autism will also be addressed during the press conference.” Vaccine safety groups are not informed of the press conference nor invited. The conference presents no new information and does not answer important questions raised in Evidence of Harm or Deadly Immunity about the conduct of the CDC the IOM or the reliability of the research that continues to be used to show no link between thimerosal and autism.
- As of October 25th 2005 the CDC has yet to issue its response to “Evidence of Harm” or to “Deadly Immunity”.
|
|
|
|
|