LETTER TO CONGRESS

April 17, 2008

Honorable Leaders of the United States of America,

I am contacting you today because I’m afraid if you don’t get the Lyme and Tick Borne Disease bills (HR-741 & S-1708) out of the committees where they are currently “stuck” and get them passed this session, we are going to lose more chronically ill patients to treatable but very serious infectious diseases.

I respectfully request that you push aside any pre-conceived notions you have about the Infectious Disease Society of America and the NIH for a moment and listen to what patients with tick borne diseases are facing on a daily basis. They desperately need your help because the situation has gone far past intolerable at this point, it is bordering on criminal. Citizens are counting on you to listen and to help them. I am writing to you on their behalf.

Please note- If everything were going smoothly in Camp A, Camp B wouldn’t be fighting for their lives.

A Dozen Reasons Why Congress Should Immediately Intervene to Protect the Public’s Health

1. The head of the NIH Lyme Disease program (Edward McSweegan) has failed patients, doctors and the US government which hired him to protect the public’s health. Among other atrocities, he was removed from his position, demoted and was taken to court for harassing Lyme disease patients and groups. According to a Washington Post article, (NIH Scientist Says He's Paid To Do Nothing, 07-04-2003), after being demoted, “McSweegan said he struggles to fill his eight-hour workdays by reading, exercising and writing fiction. He has self-published a bioterrorism thriller and a science fiction novel.” He admitted his duties, for which he received a lucrative salary, consisted of, “arranging coffee for lunches and forwarding messages… the kind of work you would get an intern to do." Rather than being removed from the scene entirely for his actions or lack there of, he continued to work closely with the IDSA on the development of their Lyme disease policies which have been highly contested by many across the country. While working with the IDSA and NIH, McSweegan continued his attempts (under the guises of “free speech”) to discredit not only Lyme patients, but support groups and doctors. Millions of lives are at stake. My opinion is that patients deserve better.

2. The Infectious Disease Society of America (IDSA), who recently proclaimed itself to be a “pre-eminent authority” in a letter to Congress, when in actuality members don’t treat chronic Lyme disease at all,, failed to mention they are currently under investigation by the Attorney General for fraud, anti-trust violations, monopolization, and exclusionary conduct directly related to their Lyme Disease Treatment Guidelines. In addition, doctors who don’t tow the IDSA line have been targeted and persecuted over the years for stepping out of the restrictive IDSA box and following their oath to, “first do no harm”.

3. There IS such a condition as chronic Lyme disease, in spite of what the IDSA is currently trying to get you to believe. It has been documented extensively over the years and the IDSA and others have been receiving millions, if not billions, in grant monies to study it. If it didn’t exist, the Red Cross wouldn’t exclude those with chronic Lyme from donating blood and insurers wouldn’t refuse to provide life insurance for those with the disease. Some patients suffering with chronic Lyme have been provided extended treatment. That treatment saves lives. Patients and their families (many now permanently disabled from the original delay in diagnosis and treatment) will NOT go away until they are sure others, especially children, are receiving adequate medical care. In addition, science, medical literature and clinical trials support antibiotic treatment.

4. The IDSA is so distressed by the possibility that researchers outside their tight-knit group will be allowed to sit at a table and present scientific evidence and recommendations to federal agencies which could prove them wrong, they are willing and continue to fight bills at state and federal levels and forfeit the much-needed $100,000,000.00 in research funding this bill would provide, just to keep from being exposed.

5. The IDSA is clinging to its own unsubstantiated and unproven theories, which are failing miserably in every direction. Tests miss 75% of people infected; the Lyme vaccine has been withdrawn from the market after prompting multiple law suits; sky-rocketing numbers of new Lyme cases have emerged; and inadequate treatment protocols have left people chronically ill, disabled and dying. They stand behind their failing practices in order to avoid being sued by hundreds if not thousands of people for illegal or immoral acts. By burying the bills in committee, members of Congress are unknowingly helping them conceal the truth, which could be considered aiding and abetting possible felonious acts. Obviously that is not your intention.

6. The IDSA’s claim stating, “there are no convincing published scientific data that support the existence of chronic Lyme disease” is true, if you consider only their selected studies based on their own “unreliable” tests and you have financial ties that bind and/or conflicts of interest clouding your vision, as they certainly do. In reality there are thousands of studies the IDSA has ignored or dismissed which have one thing in common, they contradict the IDSA’s theories. No patient WANTS to have antibiotic treatment without good reason and solid science backing the protocols; and no doctor wants to prescribe treatment if it is not required to save lives, as the IDSA would have you believe. That deduction is as absurd and preposterous as a person wanting to have chemotherapy if they didn’t need it. Many patients on extended antibiotic treatment wouldn’t need to be on that protocol had they not been subjected to the highly unreliable tests which missed their infection initially, or had not been restricted to an IDSA treatment protocol that was arbitrarily set years ago, with no scientific proof it has ever cured anyone. The fact remains, the treatment prescribed to patients via the IDSA guidelines was designed and promoted by them to be “cost-effective”. According to Raymond Dattwyler, an IDSA Lyme Guideline author currently under investigation by the Attorney General for possible illegal practices, there were no studies backing the treatment duration recommended by the IDSA guidelines. He stated, “As far as duration of therapy [for Lyme disease], as Janet said, two to four weeks has been the standard, so usually three weeks seems to have been adopted, although I think that is somewhat arbitrary.” So much for evidence-based science! (Department of Health and Human Services, Public Health Services, FDA Anti-Infective Drugs Advisory Committee Meeting, 64^th Issue, Guidance Documents on Developing Antimicrobial Drugs. Thursday, July 30, 1998)

7. The IDSA often points out that some physicians are using, “laboratory tests that are not evidence based and are not regulated by the Food and Drug and Administration”. The fact is, only tests that are sold on the market need the FDA approval referred to by the IDSA in its letter, such as the tests promoted by their labs (or labs they owned before legal actions ensued). The labs preferred by patients and doctors alike are fully accredited and pass rigorous inspections. They have been approved by Medicare and all necessary regulatory agencies. The problem is the specialty tests and labs the IDSA objects to are superior to their FDA approved tests currently on the market and the superior test results are proving the IDSA theories wrong.

8. The IDSA has a habit of using scare tactics in an attempt to make their point, stating things such as, “long-term antibiotic therapy may be dangerous, leading to potentially fatal infections in the bloodstream as a result of intravenous treatment.” What they fail to mention are quotes by the IDSA authors themselves who have concluded, “B. burgdorferi [Lyme disease bacterium] does not acquire resistance to antibiotics.” IDSA members also warn of the probability of complications such as septicemia developing during IV therapy. They fail to mention studies indicating 90% of cancer patient’s IV catheters tested showed that infectious organisms had colonized as a result of the catheters and 2% of the patients developed septicemia as a result. Shall we deny cancer patients treatments because the medical procedures or medications involved in their treatment may have associated risks? No. Then why deny Lyme patients the same life-saving treatment?

9. The IDSA contends Lyme disease is not a chronic condition and consists of nothing more than, “non-specific symptoms such as muscle and joint pain, fevers, chills, fatigue, and difficulties with concentration or memory loss.” However, the FDA, NIH, CDC and others certainly don’t agree. For example, the FDA states, "Permanent damage to the joints or the nervous system can develop in patients with chronic late Lyme disease."(FDA. Dept. of Health and Human Services. CDRH Consumer Information. http://www.fda.gov/cdrh/consumer/lymedisease.html) The NIH also concluded there is more to chronic Lyme that the IDSA has shared with Congress, including fatalities. “Varying degrees of permanent joint or nervous system damage may develop in patients with late chronic Lyme disease. In rare cases, some individuals may die from Lyme disease and its complications.” (NINDS Neurological Complications Of Lyme Disease Information Page. NIH. National Institute of Neurological Disorders and Stroke. http://www.ninds.nih.gov/disorders/lyme/lyme.htm)

CDC studies have documented the following: “Chronic Lyme disease involves abnormalities in either the skin, the joints, or the nervous system. Abnormalities in the skin are rare, but include localized swelling especially in the ear lobe, arm pit, and nipple areas, and thinning of the skin on hands and feet [ACA presentation]… Chronic Lyme disease infection of the nervous system most often produces pain in arms or legs, along with weakness and/or numbness in the affected limbs. These problems are caused by Lyme disease infection of the spinal cord. With infection of the brain, a number of other problems can occur. These include headaches, severe fatigue, impaired vision, double vision, hearing impairment, facial paralysis, and difficulties with memory and thinking.” Notice these government agencies all refer to “chronic Lyme disease”, something the IDSA insists doesn’t exist in its letter to you.

10. If the IDSA’s theory were true (it isn’t) about antibiotics being able to help patients ONLY because of an “anti-inflammatory effect” they possess, then so be it. The IDSA would still lose their argument that patients should be denied antibiotic treatment on that basis too. Evidence from basic science and clinical research support the conclusion that when an antibiotic is not utilized for its bacterial effects, it may still be a safe and effective agent for the treatment of conditions such as:

prostatitis, chronic sinusitis, acne, staphylococcal exotoxins, rosacea, inflammatory bowel disease, rheumatoid arthritis, Crohn's disease, lung cancer, neutrophilic dermatoses, asthma, periodontal disease, ulcerative colitis and other inflammatory diseases such as dermatitis herpetiformis, Wegener's granulomatosis, leukocytoclastic vasculitis, Fox-Fordyce disease, bullous lupus erythematosus, vitiligo, discoid lupus erythematosus, pyoderma gangrenosum, pustular psoriasis, scleroderma, and ankylosing spondylitis, to name a few.

The use of antibiotics for many conditions has gained acceptance and has been deemed relatively safe, according to multiple sources. For example, one study reported, “In conclusion, there do not seem to be theoretical or demonstrated disadvantages in terms of ethical or pharmacological considerations of using “immunostimulating” antibiotics.” (MARIE-THE´RE´SE LABRO* INSERM U 479, Faculte´ Xavier Bichat, 75018 Paris, France.) The following antibiotics have been used strictly for their “anti-inflammatory” affects for the conditions listed above- Tetracyclines, Minocyclines, Gentamycin, Doxycycline, quinolones (Cipro and many more), perfloxacin, Erythromycin, macrolide antibiotics (roxithromycin, erythromycin, azithromycin [Zithromax]), Clarithromycin, Amoxycillin (Imacillin), Bactrim (trimethoprim-sulfamethoxazole), metronidazole (Flagyl), Cephalexin, penicillin G, chloramphenicol, streptomycin, and Clindamycin. Yet, the IDSA recommends against the use of all of these antibiotics for Lyme (many which have been used successfully in the past on numerous patients), except of course, for the least expensive drug on the list, Doxycycline, and even that drug is limited to a short, “cost-effective”, and as already pointed out by Dattwyler (IDSA), an arbitrarily set course.

11. The IDSA guideline authors have not only refused to recommend antibiotics necessary to successfully address bacterial infections, they have further restricted access to any treatment by recommending against the use of all alternative therapies, including such common items as over-the-counter supplements (i.e. vitamins, etc) to improve a chronically ill patient’s overall health. At this point patients are worried the next thing that will be denied them by the IDSA will be the very air they breathe.

12. The actions of the IDSA panel members, since the investigation was launched by the Attorney General into their alleged illegal practices, are telling. Several IDSA members have gone to other organizations (American Academy of Neurology and New England Journal of Medicine) and sat on their panels to promulgate “cookie cutter” treatment guidelines, which they now present as “independent corroboration” of the IDSA guidelines. Several members of the IDSA panel sat on the AAN panel, including the chairman of each panel. In addition, several authors of the NEJM guidelines also were on the IDSA panel. The IDSA’s suggestion that the advisory committee, provided for in the bill, exclude the participation of certain people, namely patients and the community physicians who treat them, is a continuation of its exclusionary tactics. The IDSA has virtually controlled research in Lyme disease for the past 30 years with no improvement in the patient’s quality of life. Enough is enough.

For years the IDSA guideline authors have aggressively fought the inclusion of anyone into their small circle who wasn’t of the same like pocket book. Their actions over the years, and here today, are highly questionable to say the least. Reasonable people must ask themselves, why would IDSA members continuously and aggressively lobby against bills, at both the state and federal levels, that would provide for more research funding (which they would be entitled to receive through grants also)?

Isn’t that similar to cutting off your nose to spite your face? Why would they exclude evidence, facts and important details from Congress? Why would they rather let the shameful situation facing people across the country continue unchecked than welcome assistance (both financial and scientific) with open arms? What’s going on here?

Please realize if this bill isn’t passed and the federal advisory committee isn’t assembled immediately, it could be decades before any progress is made. I respectfully request your consideration of the circumstances in question and ask that you immediately bring the Lyme and Tick-Borne Disease Act up for a hearing to further shed light on the current abuses outlined above.

We can’t afford to wait. Millions of lives are at stake. People with tick borne diseases are not only fighting a bacterial infection, they are fighting a war that only you have the power to stop. Please do!

Sincerely,

Lucy Barnes, Director

Lyme Disease Education and Support Groups of America