LYMEPOLICYWONK: CALDA CALLS ON NIH TO STOP TICK FEEDING STUDY ON ETHICAL GROUNDS
CALDA has just sent a letter to National Institute of Allergy and Infectious Diseases (NIAID) asking them to pull the plug on an experiment that threatens to harm Lyme patients. The study involves allowing live tick larvae to feed on patients. It is impossible to ensure that ticks are truly sterile and do not carry unidentified pathogens. In addition, tick saliva as well as Borrelia burgdorferi suppress the immune system of patients. Both factors place patients who enroll in the study at risk. Because of this, we feel the study is unethical and could harm patients. Keep reading for details. . .
A significant number of Lyme patients who receive antibiotic therapy have persistent symptoms. There is currently no test that can determine whether treated patients continue to have active infection. The NIH is recruiting patients with chronic Lyme symptoms to see if active infection can be determined by xenodiagnosis. (NIH Protocol Number 10-I-0139 (ClinicalTrials.gov Identifier NCT01143558), “Searching for Persistence of Infection in Lyme Disease)
Tick xenodiagnosis essentially uses ticks to confirm infection. This study allows researchers to place tick larvae to feed on patients. The theory is that the tick will pick up Lyme bacteria, which will multiply in the tick so researchers can detect them more easily by PCR or other means.
The researchers attempt to reduce these risks by using newly hatched larval ticks raised in a laboratory that don’t carry known pathogens. But not all tick pathogens have been identified and some are transmitted from female ticks to their young without a blood meal. In fact, since the discovery of Lyme in 1981, researchers have identified more than 15 tick-borne bacteria that weren’t known before. Ticks may also carry viruses and protozoa.
Allowing tick larvae to feed on patients may expose them to yet-unidentified diseases. Indeed, one of the purposes of the study is to “assess the safety of the planned xenodiagnostic procedure in humans.” Because of the safety risks to patients, CALDA believes this study is unethical.
Please stay tuned for future updates on this.
You can follow additional comments on Lyme policy at www.lymepolicywonk.org. You can contact Lorraine Johnson, JD, MBA at email@example.com.
- January 21, 2011 at 9:45 pm
Good Grief! Who hired Dr. Mengele to conduct a study for the NIAID?
- January 22, 2011 at 12:20 am
Um, so chronic Lyme patients usually don't have circulating Bb, so what exactly is the point of this? So a tick who feeds on a chronic Lyme patient will not multiply Bb because it's hard to pick up Bb from the blood. Maybe if the tick fed on live brain tissue or the spinal cord or an eyeball or joint it would be better. 😉
- January 22, 2011 at 4:55 pm
I wonder if there is some other way to use the blood of chronic patients, maybe in another way to prove the same point, without endangering the patients.
But then, persistent infection has already been proved in chronic cases in humans and animals, so why is this study needed at all. Just study and learn from existing already performed research.
The xenodiagnosis study would have been more convincing if the principal investigator had not already made it clear, in his previous work, that he did not believe in chronic lyme disease. That being the case, why should we support more NIH grant money going to him, and take a chance on acquiring unexpected pathogens? The NIH needs to fund unbiased lyme research.
- January 22, 2011 at 5:29 pm
The nymphal stage, a year matured beyond virgin larvae, after acquiring Borrelia from a rodent, transmits multiple life forms of active Borrelia burgdorferi to humans with the essential aid of wild nymphal stage saliva. The Borrelia have not been damaged/ dormancy altered by prior antibiotic exposure. A question arises if immature larvae, not nyphal stage, have the same matured saliva and ability to transmit Borrelia from human hosts, post anbiotic treatment, to new sterile mice with the same culturability and PCR DNA sensitivity as a test. Has the methodology proposed in the study been established.? HarolSmith
- January 22, 2011 at 8:07 pm
There was some research back in the 90's that showed that ticks are able to "find" and pass-on Bb infections from animals even when careful lab science cannot detect proof of infection. I discussed the possibility of this kind of study with Dr. Burgdorfer at one of the LDF annual conferences (in Stamford, CT). He obviously had had the same same thought, but had rejected it. He stated that the problem with such a study was that it would be totally unethical because there is no way to breed ticks that are free of potentially harmful bacteria, viruses and parasites.
- January 23, 2011 at 2:23 pm
There is some evidence that Bb will go into circulation when stimulated by Tick saliva antibodies.
This action could represent a form of "re-infection" each time the LD patient is bit, even by n0n-infected ticks.
This is an important hypothesis as it has the potential to explain the increase in Lyme virulence despite the fact we know Bb infections date back to the early 1900s.
Polly Murray observed this worsening after each tick bite in members and it has yet to be explained.
As a chronic Lyme patient I would give my informed consent to be in this study, though I believe I would not pass the entry criteria.
If properly done (a big IF I acknowledge) this study could shed light on multiple questions:
a) Shed additional evidence for chronic infection
b) Confirm that tick bites alone, can worsen symptoms
c) confirm if motile Bb can be cultured from host blood after tick bite
d) Confirm the possibility Lyme incidence has increased due to increased tick population and exposure independant of virulence of the Bb strains
IMHO this research should not be objected to on ethical grounds, but instead should be scrutinized fro proper study design such that the answers to the above can be achieved.
- January 23, 2011 at 5:51 pm
As a nurse practitioner and epidemiologist, as well as a chronic Lyme disease sufferer, I am appalled and horrified about such as study. Nobody can , at this point, detect the many different forms of Bb, not to mention co-infections, to ever say that any tick is free of such diseases. They are playing with peoples lives.
- January 23, 2011 at 6:31 pm
Maniacs in government.
Thank you for your response, Lorraine.
- January 23, 2011 at 8:02 pm
This is what needs to be done: all those "experts" who claim Lyme is not chronic or persistent need to be bitten by various ticks (from different parts of the US and Europe carrying the disease, being sure to leave the ticks attached for several days and then squeezing the ticks when removing them (or, heck, save all that attempt at recreating what happens to ordinary folk and just directly be inoculated with garinii, borgdorferi, and various accompanying co-infections). Since they are sure all this can be cleared up very quickly with a couple of weeks of antibiotics or even no antibiotics (even then, could not possibly become chronic), then they should have no qualms about volunteering. In fact, they can include their family members too–spouses and children and elderly parents. Then wait and see what happens, monitoring with bloodwork, for symptoms, etc., for the next four years. Of course, as they know, nothing bad will happen.
- January 24, 2011 at 7:41 pm
As many of you may already know, Ritchie Shoemaker, MD, has recently released "Surviving Mold", a significant update to "Mold Warriors", describing in detail the biochemical effects of chronic inflammation, and the sensitivities that frequently develop in those 24% of the population who are genetically susceptible. There is a Visual Contrast Sensitivity test available (or about to be) online, as well as a screening questionnaire.
Without engaging in the question of whether Bb can "hide out" and not be vulnerable to antibiotics for long periods of time, many people's immune system, once assaulted, can develop incredible sensitivities to many things. Chief among them may be mold. It takes very very very little for a very very very short period of time, once sensitized (I know two people who have repeatedly reacted seriously to unbelievably small amounts within 5-10 minutes, e.g., in a store or in the woods).
Shoemaker offers symptom lists, screening and tests your Dr. can order for confirmation, including MMP-9, C4A, MSH, VIP, VEGF, TGF Beta-1 (Transforming Growth Factor Beta-1) and HLA DR, the genetic predisposition (along with a "Rosetta Stone" for decoding the results). He gives normal ranges for each test, and outlines (in the book, at least) a 14 step process he believes is required for such individuals to recover, which includes removal of the individual from the triggering environment. It includes the use, if indicated, of cholestyramine (CSM) to sequester the biotoxin and VIP restoration to aid in recovery.
Many Lyme sufferers already know the levels of some of their cytokine markers.
You can get started learning at http://www.survivingmold.com/
I recommend the book. For some (maybe you or someone you love), it could be a lifesaver. (for me, it's someone I love)
- January 25, 2011 at 2:34 am
Ticks can carry numerous pathogens, bacteria and parasites. There is no way to truly screen a tick for every disease-causing organism unless it is possible to test for every strain of bartonella, babesia and every other possible infection-producing organism. Even then, organisms can be missed. Also, with a good chance that there is another harmful organism in the "Bb-free" tics, if a tic is on a person for several days then that person's immune system can also react due to the presence of other infections, while weakening in defense against Bb already present. There is also a possibility that due to numerous strains of Bb, many of them could not be guaranteed to be absent in a tic. Is there anything else that can be done to stop this stupidity? Writing to officials, filing an "unethical" report (if there is such a thing), the fact that the lead researcher is biased according to previous work, etc… If not any of these options, much more media coverage? It astounds me how the most academically educated and intelligent person can insist on an idiotic and illogical plan just to prove a biased opinion, and how hardened such a person can be when compassion is the best response (especially considering their profession of choice). Why is this researcher going to all of the trouble to "prove" what he is already biased toward – why does this matter so much to him to try to "disprove" a chronic disease that has obviously affected so many? What in the world happened to this researcher for him to become so obsessed about this, when he could just turn his attention to another subject within his profession that would help patients heal (the main goal of practicing medicine)? Such a researcher/doctor is probably not doing too well psychologically and should be checked…
- January 26, 2011 at 8:20 am
If all this is explained to the volunteer, that the ticks might harbor unknown diseases etc, I think this should go ahead if it has a chance to prove presisting infection.
These people are volunteering because they want to try to prove chronic infection. I think it is up to them to make their decision, as long as they are fully informed of any risks. I'd do it.
Once again, if they aren't fully informed, then the tests should not be done.
- March 23, 2012 at 9:21 am
I am a tick magnet , Lyme 3x,(extremely ill 1st time) see more benefit to participating in this study then not. Have done research,studied informed consent. As an outdoors person, high likelihood for re-infection,as is chance of contacting unidentified pathogens ,viruses and protozoa .My cousin died of Ehrlichiosis.My options are to give up the outdoor sports,activities I enjoy or spend the rest of my life slowly poisoning myself with DEET.(as Permethrin residue on clothing is toxic to cats).
The original NIH study I’m in ,is to ascertain better testing methods for Lyme .Have had superior testing including CSF,scans,etc & treatment at NIH than with a personal doctor.( Whom as many of you state- deny existance of Chronic Lyme & believe Lyme is over diagnosed )
I am aware that Bb a spirochete bacteria ,as is Syphilis , can hide out and reappear.What if Lyme & other tick borne illness’s,” cured or not” ,unidentified pathgens ,viruses and protozoa can be transmitted by our blood? There goes the blood bank–AND the folks who are on the receiving end,including the most vulnerable–babies and cancer patients.
As we know, prolific white-footed mouse,thought to be the main reservoir -are everywhere.In MD.deer are loaded with ticks,even in winter ,as are cows.” Bb has been found to exist in urine and colostrum of infected cattle; therefore, the possibility of transmission between cows should be considered. The Lyme bacterium has also been found in blood, milk, synovial fluid, and spontaneously aborted fetal tissue. Bb can survive in frozen milk, but is killed during pasteurization.” I have not found studies testing if humans get Lyme from the infected meat (especially connective tissue) of animals.
Researchers are always trying to prove or disprove beliefs. CAN a tick pick up Lyme bacteria, which will multiply in the tick so researchers can detect them more easily by PCR or other means?They do in mice and monkeys.
One has to weigh the benefits and the negatives.IF the ticks become infected,this will benefit me. If not-hopefully the research will benefit those who are suffering terribly from this disease. Somehow I do not see that as unethical.What is unethical is the doctors who believe Lyme is over diagnosed,and will not test or treat it.
With all the unknown about Lyme including possible(and unknown) sources of infection, and as a high risk individual,I believe that I am making the right choice. So I will be caring for my TICKle family,keeping em dry,well fed,& try not to squash em. Praying the study will find something. Praying for all of those who have this hideous disease.
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