"...a condition called Southern Tick-Associated Rash Illness (STARI). This is a skin rash..." (no mention of systemic symptoms)
"Patients will return to NIH at 4 to 6 weeks following their first visit. At that time, they will answer questions about how they are doing..."
(Note, the CDC website states: "In the cases of STARI studied to date, the rash and accompanying symptoms have resolved promptly following treatment with oral antibiotics." http://www.cdc.gov/ncidod/dvbid/stari/index.htm )
[ 12. December 2006, 02:36 PM: Message edited by: ldfighter ]
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posted
Anyone who reads the newspapers knows that ethics is not the strong suit of NIH.
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trueblue
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Thought at first it was like Tuskegee, but not if physicians are permitted to treat with antibiotics.
The CDC has sent mixed messages about STARI & there's no clear protocol for doctors to follow.
This is a joint study with the CDC. Here's David Dennis of the CDC, Jan 2006 (from the journal Clin Inf Diseases - it's Dennis' reply to ILADS members who pointed out that antibiotics were found to help):
"Importantly, there is no evidence that antibiotics have any therapeutic effect on STARI. Such a conclusion could only be made after analyzing placebo-controlled trials."
[ 12. December 2006, 03:15 PM: Message edited by: ldfighter ]
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shazdancer
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This whole study is an ethical nightmare.
There is NO description of symptoms from STARI other than the rash. Even the most conservative descriptions note that STARI produces "fatigue, fever, headache, muscle and joint pains (CDC)."
The link to Medline Plus (the National Library of Science's easy reader website database) simply takes one to MP's homepage, and a search for "STARI" brings up several links to websites on rashes. There is no direct link on the medical study site to other STARI symptoms.
Tuskegee indeed.
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Tincup
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Isn't this a replica of how they first started the B. burgdorferi studies? And lots of people suffered because of it?
Can't remember the details but...
Wasn't it Bumsteere who had a mess of folks enrolled in clinical trials and later learned some of them jumped ship cause they weren't getting treatment.. after the Bumsteere gang withheld treatment from them... so they could "observe" the damage done by the spirochetes?
Me tinks we need to kick NIH... royally... but more importantly perhaps... the Ft. Collins lab. They appear to be a thorn in a bed full of other thorns! With them sticking out more so than not.
Soooooooooooooooooooo..
I guess this study is saying...
Anyone want to let a Lyme-like disease take over your body while we watch.. and be subjected to not one but THREE punch biopsies as a bonus... and then.. when all falls apart.. NOT be allowed any treatment because of the IDSA guidleines?
Heaven help those who wait for the CDC to get it right!
caat
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posted
No one in their right mind with any good information is going to volunteer for this. God help us.
I have an idea. If a short website devoted to STARI with the right key words and plenty of links was put up it would show on the search engines- especially google, within weeks. It should show on the first page of a google search.
I'd hope anyone volunteering for this study would do internet searches for it.
If anyone's interested I'd suggest linking to this thread and others with info on stari. And whatever else info is available.
If people are interested in collecting links and info and posting it here I'd be willing to put up a seperate site on my site. White background. Submit it to engines & do the keywords etc. It would have a long address but would show on the engines just fine.
That's all I could do right now- will have no energy for looking for info. I'll be starting babs therapy in 1 or 2 days.
Anyone interested?
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caat
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I wrote to one state representative about this. Will write to the other tomorrow.
This makes me feel like throwing up. Those people are sociopaths...
------------------------------------- what I wrote;
Please... is there a functioning ethics or oversight comittee for medical research?
which is currently recruiting volunteers. IT LOOKS LIKE TUSKAGEE ALL OVER AGAIN!
STARI or Masters disease is caused by a bacteria which is related to the bacteria which causes Lyme disease. It is included in the borrelia family of diseases. It IS another variant of Lyme disease. These systemic spirochetal diseases effect the heart, muscles, bones and brains of patients. It is highly unethical to conduct this trial without treatment.
This study paralels the Tuskagee studies on many many levels. It is evil.
Please consider bring this to an ethics reveiw and pressing for ethical treatment of humans in medical research.
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caat
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oh gawd... at least dreamweaver has spell check.
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Aniek
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Wasn't somebody around here friends with an investigative reporter looking at Lyme issues? A reporter might be interested in doing a bit of research and finding more about the study.
Other option would be somebody contacting a friendly Congressperson who we already know is on our side and would be willing to send an inquiry to NIH.
-------------------- "When there is pain, there are no words." - Toni Morrison Posts: 4711 | From Washington, DC | Registered: Mar 2004
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posted
It would be a good thing to have something pop up if potential volunteers try to research STARI by googling. I wonder if instead of a website, maybe a wikipedia entry? Don't know what it would take to get this accepted, so maybe it is iffy. But if volunteers have only the CDC/NIH info to go on, they are in big trouble.
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posted
Regardless of this study, there has been recent debate over whether abx should be given for STARI at all (prompting my initial paranoia).
Here's Masters (discoverer of STARI aka Masters disease) replying to Dennis of the CDC:
"Dennis now claims to be 'highly circumspect' [1, p. 967] of an infectious cause, even challenging his previous recommendation for antibiotic therapy (David T. Dennis, personal communication).
"Our caveat--that 'although it is unknown whether this rash illness has an infectious etiology, it is important to emphasize that this study does not indicate the absence of a therapeutic role for antibiotic treatment' [8, p. 428]--was ignored.
"Felz et al. [9] recommend clinical management with doxycycline and attribute this rash illness to probable infectious etiology, and Kirkland et al. [10] suspect an infectious etiology and also recommend treatment with doxycycline. Smith and Steere concluded that "this illness may be provoked by an infectious agent" [11, p. 698]. One case was presumably caused by Borrelia lonestari [12].
"Dennis states that the patients in his Missouri study were 'without complications' [1, p. 967]. Actually, there were associated complications, but the short follow-up period excluded them. I know this because most of the study patients were under my care.
"One had a documented carditis on day 24 of follow-up, while the bull's eye rash was still present, but this fact was omitted from the article because the authors, who included Dennis, deliberately ended the study period on day 21!
"The original publication was carefully worded to reference only the study period [13], something not done by Dennis now [1].
"The Missouri State Epidemiologist and I were supposed to be coauthors of the original study [13], but we had concerns regarding the terms of our participation (e.g., as coauthor, I was not allowed to read the final publication draft unless I signed off in advance, indicating my agreement with it, although I would not have known what it said). Consequently, we refused to sign, and we published our objections separately [14, 15].
"'Not Lyme' is not tantamount to 'not treat,' and because we have not found an infection does not mean that one does not exist. Absence of proof is not proof of absence. Dennis' own study concluded that "the findings were consistent with, but by no means prove, an infectious etiology" [13, p. 477].
"The etiology of Missouri Lyme-like illness (a.k.a., southern tick-associated rash illness or Masters disease) is unknown [16]. Lyme erythema migrans can have a latent period followed by sequelae. I have seen hundreds of patients with such Lyme-like illnesses, and I believe that they also can have sequelae [17]. Note that this is not called a "common cold-like" illness.
Until we learn more, to even remotely suggest that I should withhold antibiotics is premature, unwarranted, and, well, rash.
[ 12. December 2006, 03:00 PM: Message edited by: ldfighter ]
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3greatkids
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Now,tell me again,who is SICK?
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"Whereas appropriate treatment of early Lyme disease is essential to minimize serious sequelae,... STARI may be a simple, self-limiting rash. However the natural history of STARI is inadequately understood, and the possibility of chronic debilitation cannot be excluded."
So why isn't that in the consent form?
[ 12. December 2006, 03:01 PM: Message edited by: ldfighter ]
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I realize the consent form for an observational study doesn't need to go into theories about a disease's etiology, but I was struck by the fact that STARI is defined merely as "a rash", when in fact it is an often systemic illness (for which antibiotic therapy is typically given). That is misleading, no matter what the context.
If in fact physicians are permitted to treat these patients while under observation, then I'm sorry to have brought this up & will delete/edit my posts that imply otherwise. Is there any way to confirm this?
And if I did jump the gun, sorry, but it's because I've been concerned ever since the CDC's Dennis downplayed the use of antibiotics for STARI (Oct 2005):
"Until studies indicate otherwise, physicians who observe EM-like rashes in patients who do not have known B. burgdorferi exposures should be highly circumspect of a diagnosis of Lyme disease or other infectious condition and should question the use of antimicrobials in its treatment."
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I couldn't find inclusionary criteria for the STARI study requiring patients to also be enrolled in the Lyme disease study. That study requires a CDC-defined Lyme diagnosis. Maybe I misunderstood?
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trueblue
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quote:Originally posted by MRB: Read the STUDY.
The inclusion criteria state that the participant must have been diagnosed in the past 14 days and not yet have received antibiotic treatment (at least not for more than a day). THIS MEANS THAT THE PARTICIPANTS WOULD BE CURRENTLY UNDER THE CARE OF A PHYSICIAN!!
I repeat..This is NOT A TREATMENT STUDY. How much more clear could they POSSIBLY be? They are requesting VOLUNTEERS with EARLY ONSET STARI-type rashes to provide tissue samples for study and research. This is NO way obligates the researchers (who may or may not be physcians) to PROVIDE TREATMENT. These are scientists conducing research on an illness.
You're jumping the gun here, big time. This is an OBSERVATIONAL study. There is no DECEPTION here, and to imply that is ridiculous. To equate this to the Tuskeegee horror is WAY out of line. The Tuskeegee victims were led to believe they were receiving TREATMENT.
The volunteers for this study simply agree (or do not agree) to provide tissue samples for scientists to study. They are not paricipating for the purpose of treatment.
Please for give me; I started that.
I went back and reread it, with slightly more brain this time, and MRB is absolutely right.
It is an observational study on the rash. Not a treatment study. There is nothing there that says people participating can't get treatment after the biopsy is taken.
I do think it's important that people who volunteer are well enough informed by their treating physicians that they do, and can, get apropriate treatment. I'm doubtful of the odds, though.
Again I'm sorry for not reading it correctly or understanding it properly.
-------------------- more light, more love more truth and more innovation Posts: 3783 | From somewhere other than here | Registered: May 2005
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quote:Originally posted by MRB: Check the "Eligibility" section.
It is the first requirement listed under "Inclusion Criteria" in the STARI study.
This looks like a "piggy backing" situation to me. I'm guessing the primary recruitment here is for Lyme dx'd folks in the 2nd study (the NIH one). They (i.e., the STARI researchers) are likely "piggy backing" on that study, and snapping up folks who also happen to have the STARI rash. They are obtaining samples from a group of folks who is already being followed and treated for Lyme disease. THAT - is my GUESS, mind you, not confirmed fact.
Makes sense, but what I don't get is that the inclusion criteria also state "when no alternative explanation for the rash can be found, and thought by the study physician to have a high likelihood to be due to STARI..."
Both Lyme and STARI cause the same rash, so if they're CDC-confirmed Lyme cases (as the Lyme study requires), isn't that an "alternative explanation"? (Not that this matters, I guess.)
I also thought it interesting that the Lyme study says the following, which the STARI study does not:
"Subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other of their disorders."
Maybe I'm still a little paranoid, thinking of the hostile exchange between Dennis, ILADS & Masters in Clinical Infectious Diseases. (Dennis concluded by saying the government should go after anyone who treats Lyme or STARI with long-term abx.)
Anyway, sorry to everyone for jumping to conclusions.
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posted
Last I heard, Alan Steere was the Head of Emerging Infectious Diseases at NIH. This certainly sounds like a "BUM" Steere!!!
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trueblue
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I'm still confused. If the eligibility in the STARI study includes being a participant in the other one...
Doesn't that mean you already need a CDC positive diagnosis of Lyme prior to getting your STARI rash and volunteering?
Is 20 participants over 5 years significant, studywise? Does it mean they think they might have difficulty finding 20 people who will qualify?
I'll shut up after this. I am obviously way over my head but am curious because something still seems off.
-------------------- more light, more love more truth and more innovation Posts: 3783 | From somewhere other than here | Registered: May 2005
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One thing that confused me is that people with the STARI rash meet the CDC case definition for Lyme, but Masters has said they don't want him calling it Lyme if it's not Borrelia burgdorferi.
It's an interesting dilemma if anyone wants to read Masters describe it:
posted
It is my understanding that the Tuskegee study was also a "natural history study," and that no treatment was provided. It was not a treatment study, however, the enrollees may not have been told that, so there was not informed consent.
The scandal was that even after a good treatment became available, some of the participants were not offered it. Others did get some treatment, which certainly made the collected data questionable. When the study started, the treatments were fairly toxic sorts of things like mercury, so the treatment could potentially have been worse than the disease. It was not until later that penicillin became available.
The other study mentioned above, that STARI participants also have to enroll in, is described as a natural history study, the long running intramural lyme study. In that one, the only people who are getting treatment thru NIH are CDC positive cases, which only a few people have achieved. The others must get treatment thru private docs, if they get it at all. This study in all of the some ten years it has been running, has not yet published the information they have that shows a positive response to abx. Meanwhile the lyme docs used by some of their patients were being persecuted, WHILE THE NIH HAD PROOF THAT THE TREATMENT WAS HELPING THEM!!!
I'm sorry, but the track record does not lead a prudent person to assume that their intentions are honorable, especially now that we are in the era of one dose cures early cases of lyme, and STARI, according to the CDC, is a harmless disease that cures itself.
ldfighter had it right.
[ 12. December 2006, 06:06 PM: Message edited by: lou ]
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Aniek
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The participants in Tuskegee were told they were being treated. The study was following the participants until death, but they thought they were getting treatment.
When a cure was discovered, they were not told of the cure or that they were not really getting treatment, so the study could watch them progress until death.
It is important to ask questions about studies. I do believe many participants sign up for studies with the hope of free treatment, and that is not always the case. But I don't think we are anywhere near repeating Tuskegee.
-------------------- "When there is pain, there are no words." - Toni Morrison Posts: 4711 | From Washington, DC | Registered: Mar 2004
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caat
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Yep, Lou's got it.
IMHO this thread is no longer good to be posted on the web site- contradicting information.
It makes no sense whatsoever that STARI or Masters study subjects would be required to participate in an unrelated Lyme study. The NIH veiws these as 2 different animals. I don't buy it. We are wasting our time here.
I have read US medical ethics guidelines in the past and I beleive they forbid research where people who have damaging illnesses and who could get worse without treatment undergo long term observational studies without treatment. Regardless of "informed" consent. That's probley why the NIH is downplaying infectious origins and damaging effects. The Tuskagee studies were probably the inspiration for some of the ethics guidelines.
The doctors in the Tuskagee studies underwent criminal court trials afterwards, BTW, not malpractice trials... The victims of those studies were years later given a formal goverment appology. Tuskagee was a VERY big deal.
If anyone knows anyone in telivision reporting it could be a story if anyone can describe the issues in plain english. Oprah would probley have a righteous feild day with this.
I don't have the energy to look this stuff up right now. I'll probley be flat out within 1 or 2 days. But I can still format a web page or 2.
If anyone has the energy to look stuff up and post links I can extract reasonable and verifiable information from the post(s) and some links & format them onto a web page. Please post sources (links or whatever).
I'd suggest;
any studies or doctors statements refering to benifits or potential benefits of antibiotic treatment
US federal guidelines for medical ethics
any scientific or doctors reports of STARI/Masters patients with illness
any well written short (!) personal histories from STARI patients. Hopefully those who have been tested for STARI have been told the results.
I would also suggest that if it's going to happen that it happen ASAP. Because I'll bet NIH or someone will have a mis-information site up soon.
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posted
Bad Blood: The Tuskegee Syphilis Experiment (ISBN: 0029166705) by James H. Jones (Hardcover - 1981)
In this book, it was stated that some of the enrolled patients did get treatment elsewhere, but remained in the study, thus making the collected data contaminated, since it mixed together treated and untreated patients.
As far as trusting that this STARI study is ethical and useful and will treat patients fairly, all you have to do is look at both the intramural lyme study already underway and the Klempner extramural study.....these demonstrate the track record and the thinking at NIH. And I would point out again that the intramural study does NOT require patients to get treatment, either thru NIH or privately. This is entirely up to the patients and their purses and insurance companies.
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david1097
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Without seeing the materials being sent to Dr who will offer the opertunity to be in the study to their patients, we cannot say much. The outline that is provided simply states in very concise terms what the study is designed to determine. It will be the consent form that makes the difference.
A consent form MUST make the enrollee aware of the pro's and con's of entering in the study. Ths study its self is honourable and ethical provided it can obtain particupants in an ethical fashion. One must keep in mind that there are some scenarious where there would be people willing to enroll, one big one is if the person declines treatment after being informed, for what ever reason.
The point I m trying to make and I feel is important is that is is not wrong to propose an experiment to conclusively find the cause of Stari (which by all acounts is likely a slightly different variant of lyme) but it would be wrong to misinform (ie not inform) people of the treatment options and provide a summary of the scientific debate as to the need for treatment.
It would also be very unethical if they recruit volanteers for the project (which in the end will result in the researchers recieving a patent for the tests that use the anitgens from the organism that they find)by purposely withholding information under the excuse that the information is "not peer reviewed" or some similar bu11sh1t story.
In the end we really need to see how the recruitment will be done before one has a credible complaint.
As a positive note, if a lyme like spirocete is identified, if will finally crack open the lyme testing debate as it will have definatively proven that the lyme tests as they exist do not account for all variants of Lyme (which is already known by many in clinical settings but not acknowledged by the CDC/NIH/IDSA group)
In the end there are pro's and con's. I personally would like to see such a study take place PROVIDED they can find volanteers in an ethical fashion.
STILL I have a much better idea to avoid all ethical issues.
GET THE RESEARCHERS TO INFECT THEMSELVES WITH THE TICKS IN QUESTION. THEN THERE IS NO ISSUE OF ETHICS AT ALL.
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caat
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"It would also be very unethical if they recruit volanteers for the project (which in the end will result in the researchers recieving a patent for the tests that use the anitgens from the organism that they find)by purposely withholding information under the excuse that the information is "not peer reviewed" or some similar bu11sh1t story. "
well, yeah. You know that's what will happen.
:sigh:
I thought there was something in the ethics standards that in long term observations of human study subjects with degenerating conditions that the subjects had to be provided with medical attention *relevant to their condition*. So that the condition was not allowed to degenerate without interference for the studies sake.
Of course "relevant to the condition" for STARI AFAIK, right now, is "antibiotics are not necessary". Grrrr
The Tuskagee doctors had the same legal argument- that antibiotics would not have helped the patients. So... they were "justified" in not really treating patients. They *did* recieve medical attention- asprin etc.
I don't know if I read that in US federal guidelines, WHO guidelines or an online formal discussion of one of those.
Anyhow, there is no way we could get info on those doctor's forms. BUT a senater or representative might.
It would be interesting for them to look at a cover letter too if there is one. Does it outline what treatment is not acceptable for submital to the study, and is there a financial reward to the doctor for submiting patients?
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caat
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BTW, they already did identify the organism. They did an analysis of it's dna and placed it in on the family tree somewhere. It's close or the same as one that's been infecting cattle in Texas for a long time.
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posted
Sometimes, the more things change, the more they stay the same.
With all the powers that continue trying to eliminate or limit treatment for those infected with spirochetes, some of us may end up like the black men in the Tuskegee study.
Obviously, STARI or Masters Disease is borrelia, just a different strain than that discovered at Lyme, CT. I suspect that Masters Disease has been in my family for several generations. I could have both strains.
Studies require a control group. If a treatment such as medication is being tested, one group gets a placebo. When a person provides consent, they do not know which group they will be in.
That presents ethical problems, given that we need effective treatment so badly.
LLMD's are really on the front line and are finding out what works. It is like we can't wait on the research, but have to find an LLMD we trust.
In many ways, we on this message board, are ahead of the overall medical community and the government on the best treatment. We can't just wait on them to catch up.
quote:The point I m trying to make and I feel is important is that is is not wrong to propose an experiment to conclusively find the cause of Stari (which by all acounts is likely a slightly different variant of lyme) but it would be wrong to misinform (ie not inform) people of the treatment options and provide a summary of the scientific debate as to the need for treatment.
I agree that it would be unethical to withhold information in this way, and I was at first suspicious because both the CDC and new IDSA guidelines imply treatment is not needed for STARI.
But as MRB pointed out, participants in this study are required to be enrolled concurrently in a Lyme disease treatment study. That study is here:
If this is true, then all STARI patients in the study will be getting treatment (because they'll get it as subjects of the Lyme disease study).
They must be going by CDC surveillance criteria as a basis for Lyme diagnosis (STARI EM rash fits the CDC Lyme definition).
But what's strange and confusing is that if you go by more recent statements from the CDC (Dennis posts above) and by the IDSA guidelines, they don't want patients suspected of having STARI diagnosed with Lyme. They don't want them to get treatment. They're moving away from that as fast as they can. (So by their new recommendations, there would be no patients who qualify for both studies.)
CDC & IDSA have suggested that STARI is NOT caused by a Borrelia species and that it does not require antibiotics. IDSA guidelines describe STARI as a rash with "mild viral infection-like symptoms resembling Lyme disease" (why not say bacterial, if it resembles Lyme?)
The guidelines also say: "The panel is unaware of a proven case of B. burgdorferi infection acquired indigenously in any state south of Maryland or Virginia ... most [STARI] cases do not appear to be caused by any known Borrelia species..."
Borrelia lonestari was isolated from one STARI patient, and cultured from lone star ticks. But in a different study, all 30 patients were PCR negative for B. lonestari, which is why they're saying that's not it... but I don't see how that suggests it's not a related strain (or some other Borrelia sp.)
So if the subjects are all getting treatment as Lyme study participants, I don't see a problem with this study... but given the new STARI non-treatment recommendation of the CDC & IDSA, I agree this is the kind of thing we have to watch.
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lymie tony z
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ONE QUESTION?
If these participants in the STARI research are being allowed to be treated by their own physicians presumably with antibiotics....
And the NIH is not giving antibiotics....or treatment of any kind...
Can a conclusion by NIH ultimately be that antibiotics are NOT necessary for treatment of STARI because they did not include treatment of this kind in their study?
This may mean that they(NIH)may literaly conclude that STARI resolves on it's own!
This indeed sounds eerily similar to the double dumb blond err blind study done by BumSteere and company to declare extended antibiotic use to resolve lyme disease is unwaranted.
Half truths or sins of omission me thinks??
So legally they may be able to conclude this...
However Ethically it would be an atrocity!
Just wondering....zman
-------------------- I am not a doctor...opinions expressed are from personal experiences only and should never be viewed as coming from a healthcare provider. zman Posts: 2527 | From safety harbor florida(origin Cleve., Ohio | Registered: Jan 2004
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david1097
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caat, do you have the reference to the findings?
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caat
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It's Borrelia lonestari. This isn't where I first saw that it had been identified. I first saw it in an online article that the people working on the dna analysis wrote. I understood very little of that article but it did mention they thought it was simular or identical to another species.
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posted
I guess nobody is reading the previous posts, re treatment in the second (intramural)study that STARI people will also be enrolled in.
Here is what ld fighter said:
"So if the subjects are all getting treatment as Lyme study participants, I don't see a problem with this study... but given the new STARI non-treatment recommendation of the CDC & IDSA, I agree this is the kind of thing we have to watch."
THE ONLY PEOPLE GETTING TREATMENT FROM THE SECOND STUDY ARE THOSE WITH CDC POSITIVE TESTS, last I heard that was 2 or 3 out of 60 some enrollees. And that treatment was not longterm from NIH. If others wanted treatment, they had to find a private doc, pay for treatment or fight their insurance entirely on their own.
This is my last post on the subject. Anyone who does not know the history of what has happened with lyme research at NIH is going to misjudge the current research as well. They will read the description of the STARI study and assume it will be handled honestly. Those who do not learn from the past are doomed to repeat it.
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caat
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Yep, OK they are required to participate in the lyme one as well. I still can't beleive that...
BTW, the STARI bacteria is very very unlikely to show up as a pos on any type of test for lyme. It's lyme- yes, it's a Borreliosis, but it's a different species.
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caat
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posted
found an internal notice about this study to members of the Wilderness Medical Society, a group of doctors... -------- http://www.wms.org/Updates/STARI1.htm
some exerpts; "Symptoms and Diagnosis: The typical clinical finding is a roughly circular erythematous rash centered on the site of the tick bite. Central clearing may be present. Investigators emphasize that the rash is essentially identical to erythema migrans.
Other symptoms that may be present include fatigue (50 percent), headache (43 percent), muscle stiffness including stiff neck (36 percent), and fever (29 percent). However, signs and symptoms of the second or third stages of Lyme disease do not ensue, even in patients who are not treated." [...] "Although B. lonestari is widely accepted as causative, not everyone has endorsed this etiology, particularly Lyme disease advocacy groups that consider Lyme disease to be more widespread than generally recognized. Masters and others have pointed out that although Lyme disease serology results were often negative, the results frequently differed from the results in control individuals without Lyme disease.
In 2001, an individual exposed to ticks in Maryland and North Carolina developed a rash indistinguishable from erythema migrans after an A. americanum tick bite. DNA typical of B. lonestari was identified in a skin biopsy taken at the leading edge of the rash and in the tick, which had been removed by the individual's physician. Serologic testing for Lyme disease was negative. " ----------------------- ??
You know... parts of this seem like a chess game to me.
IF STARI does not require treatment, and does produce a EM rash. And lyme produces an EM rash but (HA!!) also DOES show a pos on a lyme test, then with an EM rash without a positive test it is no longer nescessary to treat. Must be STARI...
Of course if people get really really sick during this study then maybe that's not how it will go.
But what are the chances of people who are very sick staying in this study?
This is a 5 YEAR study.
"Other symptoms that may be present include fatigue (50 percent), headache (43 percent), muscle stiffness including stiff neck (36 percent), and fever (29 percent). However, signs and symptoms of the second or third stages of Lyme disease do not ensue, even in patients who are not treated."
now how do they know that seeing as I don't think they've ever followed a group of untreated parients? Oh... wait!!
Posts: 1436 | From Humboldt county ca usa | Registered: Mar 2002
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quote:THE ONLY PEOPLE GETTING TREATMENT FROM THE SECOND STUDY ARE THOSE WITH CDC POSITIVE TESTS, last I heard that was 2 or 3 out of 60 some enrollees.
Ok, now I'm alarmed all over again. I just assumed that "All diagnostic tests and treatments will be according to standard medical practice for the disease" meant that anyone with an EM rash would at least get a "standard" course of antibiotic treatment. If not, this is a nightmare.
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david1097
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From the DNA anaysis, it looks like stari deviates from B Miyamoto only as much as the north american does from the european strain of lyme. B Miyamoto has been discussed in a significant number of asian publications.
Based on the fact that they already know the caustive agent and they know it is a borrela ,I suspect that the only reason for the trial is to try to verify the antigens they come up with to patent a test. The antigens are relatively easy to produce if you have a culture in place, which it sounds like there already is, or could be done relatively easily (assuming they have found a suitable media.)
The fact that they are doing a punch biopsy would to me seem to indicate that they want to use this biopsy sample as a quality control measure to validate the quality of the specicivity of the antigens that they use to quantify the patients antibodies. With this they can claim that the antigen test (likely elisa) has been validated against biopsy confirmed patients. If you do not have biopsy confirmed test cases, the argument for qualfication is much much less convonving as how do you confirm your test is working?
This will be a money maker for someone. the participants shoudl also get a piece of the action.
ALSO... If antibiotics are given too early, the antibody response will be muted and thus the reason they don;t want the enrollee's to have the antibiotics.
To me given that they know this information before hand (or at least they should know it unless they are totally inept) the evidence of the day is that all of these borella infections do need antibiotic treatment of some description. If they do not inform the participants of this there is something definately wrong.
At least in my opinion.
Posts: 1184 | From north america | Registered: Feb 2003
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quote: Based on the fact that they already know the caustive agent and they know it is a borrela ,I suspect that the only reason for the trial is to try to verify the antigens they come up with to patent a test.
Maybe this is their goal, but both the CDC and IDSA do NOT acknowledge a Borrelia species as a cause (and the NIH surely doesn't either). They've backed away from this.
After they isolated B. lonestari (related to B. miyamoto) from one patient, Wormser published a study where none of 30 STARI patients were PCR positive for B. lonestari. Then in early 2006 CDC Lyme director David Dennis wrote the following:
"[STARI] is not Lyme disease; bacterial causes seem unlikely on the basis of advanced microbiological and molecular studies... there is no evidence that antibiotics have any therapeutic effect on STARI."
Based on this and similar statements, I'd say no one in the NIH is going to lose sleep if their STARI study patients aren't getting treatment.
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caat
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"After they isolated B. lonestari (related to B. miyamoto) from one patient, Wormser published a study where none of 30 STARI patients were PCR positive for B. lonestari. Then in early 2006 CDC Lyme director David Dennis wrote the following:
"[STARI] is not Lyme disease; bacterial causes seem unlikely on the basis of advanced microbiological and molecular studies... there is no evidence that antibiotics have any therapeutic effect on STARI."
Seems to me they are going back and forth on this. I think they are just covering their butts with these statementsd depending on which way the wind blows. They are afraid of going to court.
They have absolutely no evidence I don't think for the statement it does not cause much harm. They certainly do not have irefutable evidence.
Yeah, they are probley refining tests for this, but I have a feeling they are ALSO looking to see what sort of damage lonestari does to the human body. I think they WANT to see damage!! They want to document it. That is SICK and twisted.
They haven't been able to culture it yet.
OK, sure, they can't culture it. YET. I doubt if it will take 5 years to figure out a medium.
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caat
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David, do you know of any online information on B miyamoto? In English? Any symptoms susceptabilities etc? All I could find was dna stuff.
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david1097
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I just did a dumb google search and for borrela miy..(how ever you spell it) then I did a second search with human infection added on. Both came up with a lot of hits, many in viewable pdf in english.
Posts: 1184 | From north america | Registered: Feb 2003
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B. miyamotoi - couldn't find information on symptoms but they say it's more related to the relapsing-fever Borrelia than to Lyme Borrelia. (B. miyamotoi is also in California and New Jersey, and who knows where else.)
caat
Frequent Contributor (1K+ posts)
Member # 2321
posted
I did some reading on this last year, and I remember something in one of those dna reports saying STARI is more closely related to the relapsing fever group but presents more like lyme borreliosis. I would probley not be able to find that again though, sorry, it was just one sentence in a longer report on dna chemistry. It was just a sort of an "aside".
The chemistry stuff is way over my head. I just sort of speed read through those looking for small "asides" and then try and place them. I guess I'll have to start bookmarking those...
So far the mepron is not kicking my butt. It's just a pleasant, slightly hallucinagenic state of mind along with the expected crappiness. LOL. So, maybe I'll be able to look more than I thought Posts: 1436 | From Humboldt county ca usa | Registered: Mar 2002
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posted
Is it possible that Masters disease or STARI was changed by biowarefare researchers with genetic engineering to B. Burgdorferi or Lyme disease?
I read somewhere that the genome of Lyme has some blanks, suggestive of gene splicing. It could have been changed to make it more potent and/or to spread faster.
It seems silly for anyone to deny the EM rash from STARI is an EM rash or say it only appears like one. If you see a duck, your aren't just seeing something that looks like a duck.
The guys creating the disinformation about diagnosis and treatment should not be underestimated. They have to know what is going on.
They may rationalize that what they are doing is in the interest of national security. They may get numerous awards and numerous pensions when they retire. . .or we can work on making them accountable for their actions.
This is probably a related issue if Congress investigates the war and/or health issues of returning troops.
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