Tina J. Garcia
544 South Solomon Street
Mesa, Arizona 85204
480-830-2788
July 7, 2005
Julie Gerberdine, M.D., Director
Center for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA 30333
Re: Role of the Center for Disease Control and Prevention
in the Lyme Disease Diagnosis and Treatment Dilemma
Affecting Thousands of Patients Nationwide
Dear Dr. Gerberdine:
Due to the fact that I have not yet received a response from you related to my letter dated May 23, 2005, I am enclosing a copy in case you did not receive it. Also enclosed is a copy of my letter to Victorio Vaz at the Arizona Department of Infectious Disease Services. I had previously forwarded a copy of this letter to you; I just want to make sure that you have this letter, also.
I spoke to Larissa Minicucci at the CDC on May 25, 2005. I inquired as to what steps the CDC has taken to correct the misuse of the surveillance case definition, per Public Law 107-116 signed by President Bush on January 10, 2002. Ms. Minicucci informed me that the CDC has received many calls related to this issue, but the Law is merely a “recommendation” and not required; therefore, the CDC has not done anything with regard to this issue. In addition, in an email from Ms. Minicucci on May 25, 2005, she referred me to the state health department and the state medical board for physicians’ inappropriate misuse of the surveillance case definition. As you will see by the enclosed copy of the Committee Report for Public Law 107-116 retrieved from the Lyme Disease Foundation website, responsibility for alerting physicians regarding the misuse of the case surveillance definition falls squarely upon the shoulders of the CDC.
I have highlighted the paragraphs which are directly affecting my life and the lives of thousands of other Lyme disease patients nationwide. I would like to draw your attention to these highlighted paragraphs:
Julie Gerberdine, M.D., Director
July 7, 2005
Page Two
“The Committee recognizes that the current state of laboratory testing for Lyme disease is very poor. The situation has led many people to be misdiagnosed and delayed proper treatment. The vaccine clinical trial has documented that more than one-third (36 percent) of the people with Lyme disease did not test positive on the most sophisticated tests available. The ramifications of this deficit in terms of unnecessary pain, suffering and cost is staggering. The committee DIRECTS (emphasis added) CDC to work closely with the Food and Drug Administration to develop an unequivocal test for Lyme disease.”
Please provide me with detailed information as to the current status of the
development of an unequivocal test for Lyme disease.
In addition, according to the CDC Morbidity and Mortality Weekly Report from August 11, 1995 / 44(31);590-591, which includes the Recommendations for Test Performance and Interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease, the diagnostic criteria implemented at that conference is still being utilized by laboratories across the nation today (except for the progressive highly-specialized tick-borne disease labs). At this conference, the CDC, along with the other agencies listed in the Report, eliminated from the Western Blot test two Borrelia burgdorferi bacteria proteins, outer surface protein A
(OspA – 31 kDa) and outer surface protein B (OspB – 34kDa). It is my understanding that the OspA was the protein from which the Lymerix vaccine (pulled from the market) was made, and the OspB was the intended component of next-generation vaccines. This made sense for the vaccine trials, but has had detrimental effect upon the chronically-ill Lyme disease patients which no longer meet this vaccine-oriented diagnostic standard. This diagnostic criteria is still being utilized by laboratories across the nation today, MORE THAN TEN YEARS LATER, because your agency has had a blind eye to this problem. When patients such as myself are excluded from diagnosis due to the vaccine-oriented diagnostic criteria, we are excluded from treatment as well. I have included copies of my lab results from IGeneX Lab in California, which show that on both the Western Blot IgM and IgG, I tested equivocal for OspA (31kDa) and low positive for OspB (34kDa). Also enclosed are my results from Sonora Quest-Quest Diagnostics in California which shows that this lab only tests for the ten CDC-required bands, as compared with sixteen bands at IGeneX. The Sonora Quest-Quest Diagnostics Western Blot did not test me for OspA (31kDa) or OspB (34kDa). The Sonora Quest-Quest Diagnostics test used the vaccine-oriented diagnostic criteria implemented at the Second National Conference on Serologic Diagnosis of Lyme Disease. Which is the more complete test? IGeneX, of course.
The CDC, along with the Association of State and Territorial Public Health Laboratory Directors, the Food and Drug Administration, the National Institutes of Health, the Council of State and Territorial Epidemiologists, and the National Committee for Clinical Laboratory Standards, OMITTED the OspA (31kDa) and OspB (34kDa) from the diagnostic testing criteria at the Second National Conference on Serologic Diagnosis of Lyme Disease held in October of 1994. The decision to omit these two highly-specific bands of Borrelia burgdorferi were done to accommodate the Lymerix vaccine WHICH HAS SUBSEQUENTLY BEEN REMOVED FROM THE MARKET!
Julie Gerberdine, M.D., Director
July 7, 2005
Page Three
It is IMPERATIVE that the CDC take a proactive stance by demonstrating that CONTROL and PREVENTION of Lyme disease is of utmost importance to this agency. The CDC can do this by abandoning the vaccine-oriented research which is no longer applicable and instead utilize the MOST CURRENT research available regarding testing of Borrelia burgdorferi. I believe that if the CDC would take an active interest and a proactive stance, the previously omitted bands of OspA (31kDa) and OspB (34kDa) could be put back into the diagnostic criteria utilized by laboratories nationwide.
The CDC is not ignorant of the problem of Lyme disease and other tick-borne infections ravaging patients in this country today. Dr. Gerberdine, you and your agency have a responsibility to take positive action, action which will be beneficial to LYME PATIENTS instead of being beneficial to other private interests. The day has come for the CDC to prove to the American public that it truly has our best interests as its priority!
“The Committee is distressed in hearing of the widespread misuse of the current Lyme disease surveillance case definition. While the CDC does state that “this surveillance case definition was developed for national reporting of Lyme disease: it is NOT appropriate for clinical diagnosis,” the definition is reportedly misused as a standard of care for healthcare reimbursement, product (test) development, medical licensing hearings, and other legal cases. The CDC is encouraged to aggressively pursue and correct the misuse of this definition. This includes issuing an alert to the public and physicians, as well as actively issuing letters to places misusing this definition.”
I DO NOT accept the stance that the instructions in the previous paragraph are “recommendations”, and therefore, the CDC does not need to act upon those instructions. The CDC has been encouraged to act upon information provided to them regarding a devastating, debilitating disease, namely Lyme disease (including co-infections), that is afflicting people in this nation. The agency that you direct is called the Centers for Disease Control and Prevention. I believe that you are obligated to make sure that the agency you direct, which utilizes taxpayer dollars, lives up to its name for the sake of the people of this nation who are entrusted in your care. It is the CDC’s obligation to do everything within its power to CONTROL this disease. Having cases reported to the CDC just isn’t enough and does not justify its existence! I believe the CDC is required to go the extra mile and follow the recommendations above to “AGGRESSIVELY PURSUE AND CORRECT the misuse of this definition. This includes ISSUING AN ALERT TO THE PUBLIC AND PHYSICIANS, as well as ACTIVELY ISSUING LETTERS TO PLACES MISUSING THIS DEFINITION!!” Please do not inform me that the CDC is not aware of who is misusing the surveillance case definition. Please send an alert to ALL physicians.
Julie Gerberdine, M.D., Director
July 7, 2005
Page Four
“The Committee recommends that the CDC strongly support the re-examination and broadening of the Lyme disease surveillance case definition by the Council of State and Territorial Epidemiologists. Voluntary and patient groups should have input into this process. Currently there is just one definition (“confirmed case”) of seven possible categories. By developing other categories while leaving the current category intact, the true number of cases being diagnosed and treated will be more accurately counted, lending to improved public health planning for finding solution to the infection” (emphasis added).
Please note that voluntary and patient groups should have input into this process. Please consider my correspondence as documented, pertinent input.
“National Institutes of Health – Office of the Director Lyme Disease
The NIH is encouraged to include a broad range of scientific viewpoints in the process of planning and executing these efforts, including community-based clinicians with extensive experience in treating these patients (emphasis added), voluntary agencies who have advocacy in their mission, and patient advocates.”
I challenge the CDC to work amiably with community-based clinicians with
extensive experience in Lyme disease treatment from ALL areas and groups, not
just selective individuals. The CDC must utilize information of ALL diagnostic
and treatment views to prevent bias against Lyme patients.
Secondly, it is very distressing to read the information shown as “NEW” on the CDC Lyme Disease Home Page under “Scientific Literature”. This study is entitled “Inaccurate Information About Lyme Disease on the Internet. The results of this evaluation show that, among just a few others, only the CDC and FDA websites contain accurate information on Lyme disease. It totally invalidates what Lyme disease patients and physicians are saying about Lyme disease. I am absolutely certain that I can speak for the majority of Lyme patients in saying that the CDC website has little to no value in assisting patients with their disease. I have found only two items of relevance to assist me with my situation. I am afraid to mention what they are for fear that they would be removed from the website, knowing that those items are helpful. That is a very strong statement to make about a government agency whose purpose is disease control and prevention
If I had relied upon the CDC website for a list of symptoms and treatment information last December when I was so extremely ill, I probably wouldn’t be here today. Instead, I relied upon information from ILADS (International Lyme and Associated Disease Society). The CDC should not flatter itself in presenting to the public that it is the all-knowing expert of Lyme disease. The CDC has a lot to glean from the Lyme-experienced physicians associated with ILADS, but first it needs to open the doors to learning.
Julie Gerberdine, M.D., Director
July 7, 2005
Page Five
I’m sure the CDC paid Wolkers Kluwer Health a great sum for that biased study entitled “Innacurate Information About Lyme Disease on the Internet.” Why couldn’t you have used those funds to advance our knowledge and testing of this voracious infection? It is quite obvious from the CDC’s stance that the agency is in the ring to fight, not as an ally, but as a contender with Lyme patients nationwide.
This is a problem because many physicians refer to the CDC for information. What message is the CDC sending to physicians nationwide? They are setting up people afflicted with painful, debilitating Lyme and co-infections for failure in obtaining diagnosis and treatment. If a physician reads that article and a patient who believes they have Lyme disease presents to the office with info from the Internet, the physician will automatically dismiss that info as invalid. What is the CDC really trying to prevent? To a Lyme disease patient, it looks like they’re trying to prevent diagnosis and treatment.
The CDC should be leading the research for accurate testing and education of the medical community with the MOST CURRENT research, but it is not doing so; instead, the CDC is complacent with issuing outdated, vaccine-oriented diagnostic criteria to laboratories and state health departments and pursuing ludicrous studies of Internet websites, studies of which invalidate information from patients and Lyme-experienced physicians and researchers.
It has been more than three years since Public Law 107-116 was signed by President Bush. On behalf of all Lyme patients suffering from lack of or delayed diagnosis and treatment, I publicly demand an accountability for action taken and demand current and future action to be taken by the CDC to assist Lyme patients in obtaining diagnosis and treatment.
I would appreciate your addressing all the issues raised in this letter. Thank you and I look forward to a prompt response.
Sincerely,
Tina J. Garcia
:tjg
Enclosures
Cc: Association of State and Territorial Public Health Laboratory Directors
Food and Drug Administration
National Institutes of Health
Council of State and Territorial Epidemiologists
National Committee for Clinical Laboratory Standards