September 2, 2009

Dr. Joshua M. Sharfstein
Deputy Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Dear Dr. Sharfstein,

I am writing you today about my concerns with the Gardasil vaccine. I have been researching this vaccine since January, when I determined that my daughter had started developing several illnesses post-Gardasil. Prior to Gardasil, my daughter was a healthy, energetic young lady. She played softball and was on the University of Dayton crew team. After her second shot, she contracted a severe case of pneumonia. That was the beginning of a series of illnesses that predicated her most recent hospital visit on 8/22/09.

Let me begin by telling you that I am only one person in a much larger group of families that I found on the internet. The group is called Lets_Talk_about_Gardasil@yahoogroups.com. There are many parents who found this site (I am certain there are many other similar sites) and we have all shared information on our daughter’s side effects and treatments since the Gardasil vaccine. Many of the girls have had constant seizures. Others have had more “minor” side effects such as hair loss, migraines, menstrual changes, stomach issues, etc. While these may not seem as serious to some doctors, to the parents of these girls – and to these girls – these are major side effects which can be and have been debilitating in many cases.

Several parents in the Lets_Talk_about_Gardasil@yahoogroups.com internet group have been working on gathering information on girls that have passed away or are ill as well as medical data for your review. The task is quite daunting and there is a great deal of information to collect in order to be comprehensive in our arguments AGAINST the vaccine. I am afraid that we will not be able to develop this paper prior to your meeting on September 9^th. I did, however, feel that it was imperative to provide you with some preliminary documentation as to my thoughts on the vaccine and some of the research that I personally have done. I have also come by some of this information through the postings of a few very well-educated mothers.

What I have found over the past several months is that my daughter and, as far as I can tell, all the other girls in our group are exhibiting side effects that are consistent with vitamin B deficiency. I have read several papers about PKD (Pyruvate Kinase Deficiency), which is part of a group of hereditary anemia disorders – hemolytic anemia. This deficiency, as I understand it, would cause ones red blood cells to function improperly and, therefore, affect the energy production of new red blood cells thus affecting many organs and tissues in the body. Oftentimes, this genetic trait is not realized until a person has severe health issues.

I’m sure you know that the purpose of adjuvants in a vaccine is to lower the immunity enough so that the body fights back to resist the virus presented in the vaccine, thus developing antibodies for the virus. If, however, the person receiving the vaccination has PKD, then the body would be further compromised by vaccine adjuvants which cause oxidative stress and the person receiving the vaccine would exhibit debilitating side effects (which is what has happened with many Gardasil girls).

IF hemolytic anemia is what is causing the severe side effects from this vaccine, every child should be tested for this trait prior to any vaccination. I personally feel that this type of anemia is probably under-recognized and would affect any child having “defective” red blood cells, as seen in sickle-cell, elliptocytosis (a genetic trait that many northern Europeans have), ovalcytosis (prevalent in SE Asia) or sperocytosis. Unfortunately, this type of testing was never done on my daughter and I still do not know if she has this hereditary trait. So far, the doctors have been unwilling to explore this as a possibility in my daughter’s case and, in fact, roll their eyes at my daughter when she suggests her illnesses could be caused by Gardasil. I have read that one of the outward signs of this type of anemia is jaundice, which my daughter had last December when she was sent to the ER for dehydration. I drove to Ohio to pick her up since she was unable to travel and I was shocked to see how yellow her eyes were (my mother died of liver cancer so I am well aware of the “look” of liver failure).

I have heard from many families who have severely ill daughters after Gardasil. Most of the girls were honor roll students and active athletes. It’s my understanding that strenuous activity depletes the niacin levels (NAD – also a B vitamin) to the point that these girls might be unable to produce enough for new red blood cell production. That, added to the fact that their bodies are overly taxed from the HPV vaccine and their genetic PKD deficiency … You can surely understand that this could be a recipe for disaster. Without sufficient NAD, the girls would most likely see interference in many physiological activities that would indicate symptoms like brain fog, hormonal changes, fatigue, depression, seizures … and the list goes on. And if I am correct in the vitamin B deficiency assumption, then it would also be possible that other vitamin production might be jeopardized since so many of the B vitamins are co-dependent. (Could this be the reason why the girls are experiencing hair loss … a biotinadase deficiency?)

Something that is less critical, but no less unimportant, is a fact that has been touched on by several reporters and medical persons. The Gardasil test trials showed side effects of placebo vs. vaccine. However, this is not really a true determination of side effects since the placebo in Merck’s study used aluminum as the adjuvant (rather than saline). One would not see significant differences between the two groups because both aluminum hydroxide and aluminum phosphate have, in the past, shown a causal relationship to multiple neurological issues. Honestly, the side effects of BOTH groups should have been added together rather than shown as separate entities. (See “The truth behind the vaccine cover-up” by Russell L. Blaylock, MD, attached, page 1720.)

Most recently, an article stated that Dr. Diane Harper, one of the lead researchers on the Gardasil vaccine and a previously paid consultant of Merck and GlaxoSmith has recently come out strongly AGAINST the vaccine. She is now stating that the vaccine can cause more issues than the HPV vaccine itself. (http://ecochildsplay.com/2009/08/28/gardasil-researcher-cautions-parents/#comment-76238). She has been very vocal against giving this vaccine to younger girls whose brains are still developing yet this fact has not been reported by the media. She cautioned scientists and political leaders in Europe against releasing Gardasil/Cervarix and suggested they wait another four years to see the longer-term side effects.

While the VAERS data suggests that both lots U and X are severely problematic, these lots numbers have yet to be recalled by Merck. (There were two lots redacted in a FDA warning letter to Merck dated 4/28/08.) We have some indication from Dr. Harper that there was extra yeast put into one of more of the lots numbers. If in fact, certain lots numbers had more yeast, then you might conclude that the side effects of the vaccine could be exacerbated in those lot numbers. (“The scientific work to date seems to suggest that aluminum salts in vaccines are safe,” Dr. Harper said. But she told Medscape Oncology that she heard that 1 lot of Gardasil might have had an accidentally high yeast concentration, and this might be why there are problems. “No one knows for sure,” Dr. Harper said. ) - http://holfordwatch.info/2008/07/28/is-the-aluminium-content-of-gardasil-a-potential-peril-unlikely/. As I wrote earlier, we already know that aluminum salts are NOT safe.

I must mention that, during my research of this vaccine, and while exploring the possibility that my daughter was niacin deficient, I came across a great deal of information on impairment of nicotinamide (NAD) in PKD individuals (http://bloodjournal.hematologylibrary.org/cgi/reprint/69/4/999). It is estimated that 10% of people inherit a genetic NAD deficiency. This would be exacerbated in individuals who are athletic (perhaps excessively) and also in those who consume excessive amounts of alcohol (some might say a majority of college students). Niacin production is also inhibited by fluoride – more so with higher amounts of fluoride (as may happen if one were to have a fluoride treatment at the dentist’s office). During my research on the topic, I thought it curious to find a WIPO paper – World Intellectual Property Organization – http://www.wipo.int/pctdb/en/wo.jsp?wo=2007017261&IA=EP2006007865&DISPLAY=DESC that cites nicotinic acid (niacin) as being able to cure all sorts of disease. The author of this paper is none other than a pharmaceutical company. Why would people still have these sorts of issues today if they know that nicotinic acid can cure what ails them? I would suggest that it is because these companies are in the business of making money. If they cure these issues, then “new” medications would not be the billion dollar money-makers that they are today. It is their business to keep selling medicine – and lots of it.

I also would be remiss if I did not mention one last paper I found that has the very same polysorbate 80 ingredient that is in Gardasil. This ingredient has long been known to cause fertility issues in mice. The WIPO paper I cite is a vaccination process that would impair fertility of cats and dogs. While it may be a stretch to consider this paper as an indication of what might be happening with Gardasil (since so many girls are developing menstrual issues), it was curious to find that this vaccine has the same polysorbate 80 ingredient and the same vaccination process – several shots over a short period of time – which seems eerily similar to that of Gardasil. http://www.wipo.int/pctdb/en/wo.jsp?wo=1999034825&IA=US1998027658&DISPLAY=DESC

When we realize that not even Merck knows the efficacy of their own vaccine and has estimated that children may have to be re-vaccinated every five years, does it honestly make sense that we would want to re-inject millions of children with both aluminum and polysorbate 80 every few years when we know both these ingredients are dangerous? Common sense would tell you that it is not. Especially when the average age of a woman diagnosed with cervical cancer is 48. It would especially not make sense if there was no pre-screening for certain genetic traits that would make this exponentially more dangerous for so many.

My daughter Bridget (and many others in our group) is slowly recovering from this vaccine. She’s on a gluten-free/sugar-free/dairy-free diet with vitamin supplements (vitamin B complex, vitamin D, vitamin C, and niacin). It is a slow road back to good health and may take some time. She still has setbacks but I am optimistic for her future health. I do worry if she will ever be able to have children. Unfortunately, so many other girls have not been so lucky. They didn’t find the help they needed in time.

Dr. Sharfstein, I have written in the past to many congressmen, including Representative Henry Waxman, whom I recently found that you worked with for some time. I have yet to hear back from anyone except Senator Burr, who kindly wrote a letter to the FDA on my behalf asking several questions about the vaccine. There is a great deal of reservation about this new vaccine and the media has reported on it many times. I am humbly asking that you take a look at the data in this letter and question if there may be a genetic trait that binds these girls together. If this is the case, every child that has PKD would be affected by this and perhaps other vaccines and it would be further complicated by a predisposition for niacin deficiency. If I am wrong about PKD, then there is something else that is triggering these devastating and life-threatening side effects. There are too many girls who have died and who are being diagnosed with severe health issues after receiving this vaccine. It surely requires closer consideration and/or perhaps a “hold” until the source or reason behind the side effects is determined.

Thank you for taking the time to read my findings and assumptions. I am certain you will agree that all the girls experiencing side effects are NOT coincidental. Merck has even updated it’s warnings to include more severe side effects. I would appreciate any feedback and hope that you will be able to, at the very least, shelve this vaccine until all the side effects have time to surface, be well-documented and studied. Many families are counting on you to do the right thing – to pull this vaccine. Please, don’t let anymore children be injured.

Most sincerely,

Roberta Boyce

92 Birklands Drive

Cary, NC 27518

BOYCEMR@aol.com