Jun 10 2009

Follow Up on Chronic Lyme Disease

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Comments: 15

In response to my post yesterday on Chronic Lyme Disease, commenter “tnkrbell” raised some new points that will take more than a brief comment to address.

Tnkrbell wrote:

Perhaps there is more to this situation then you are aware of considering that the CT Attorney General was forced to intervene here. They did just finish an investigation into wrong-doings with respect to ISDA guidelines for Lyme disease. That entire panel was found to be implicated in wrong doings including monetary dealings with insurance companies and a whole lot more. The whole panel was fired, allowing for new unbiased guidelines to be created (hopefully it will be unbiased anyway).The link for that press release is: http://www.ct.gov/ag/cwp/view.asp?A=2341&Q=414290

This is not quite what the press release says, and includes a bit of spin. First, the IDSA guidelines remain in effect, as per a settlement with the attorney general, and they are now in the process of external review. This is a good thing – the more independent review the better. We will see what effect this has on the guidelines.

The press release says nothing about “wrong-doings” – just that they did not meet guidelines for revealing potential conflicts of interest.

Blumenthal added, “The IDSA’s 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests — in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies — to exclude divergent medical evidence and opinion.

Having patents and consulting arrangements is not a “wrong-doing” and is extremely common in medical academia.  But current guidelines do call for their declaration. I am curious about the drug company concern – wouldn’t drug companies want their antibiotics prescribed? I don’t see a “big pharma” villain in this story.

This reminds me of the history of the CDC and the anti-vax lobby. They too can find apparent conflicts of interest anywhere and then make them sound as sinister as possible. None of this changes the science, as Blumenfeld admits.

In highly politically charged questions (vaccines, chelation, and Lyme) the scientific consensus is often challenged by probing for apparent conflicts of interest. This rarely invalidates the scientific opinion, in my experience, and is more about public perception.

But I am in favor of independent review, allowing dissenting opinions, and as much transparency as possible. I think we should have it on both sides, however. While crying about apparent conflicts on the side of expert panels, let’s not ignore the glaring conflicts of interest in CT politics. Lobby groups with a very strongly held minority opinion appear to have had a disproportionate effect on pushing this latest bill through the CT legislature.

Tnkerbell also goes into addition detail into the biology of B. burdorferi. There is obviously a great deal of complexity to this issue I did not discuss in one blog entry. But let me address the primary point – that there is biological plausibility to the notion of a chronic infection requiring chronic treatment. The fact is, I never challenged the plausibility of that concept. I accept this plausibility.

Ironically, the problem, in my opinion, with advocates of the chronic Lyme disease hypothesis is that they are being too dismissive of the biological plausibility that the symptoms they are calling chronic Lyme disease are not caused by a chronic active infection.

Because of the biological complexity of such questions, the most important data to clinical decisions are clinical trials looking a the net effect of treatment. At this point, the best trials we have are negative – they show no benefit (or dubious benefit) from long term antibiotics.

At this point that puts the burden of proof on those who think they work. If so – then come up with a regimen and prove it works in a clinical trial. If the evidence shows it works – I will happily revise my opinions to accommodate the new data.

Regarding the sensitivity of Lyme titers, tnkrbell writes:

The current test methods were actually created only for epidemiology studies and were never intended for use in patient diagnosis. There are reports of test accuracy being anywhere from 35% to 70% depending on who you ask.

Tnkrbell is doing some selective quoting. The 74% figure is only for acute phase Lyme disease – where there has not been time to develop antibodies in many patients yet. The same paper shows that the sensitivity of Lyme titers is 85-90% is convalescent (after a couple of months) Lyme and 100% in late phase Lyme disease. That’s right – 100% – in the category that is most relevant to the diagnosis of chronic Lyme disease.

It is misleading to say these are not intended for clinical diagnosis – they absolutely are. The titer is designed to be maximally sensitive – the limitation is primarily on whether or not there has been time to actually form antibodies. There are, in fact, more false positives than false negative with the titer.

There is also the Western Blot, which is a follow up test designed to be more specific – meaning fewer false positives. When used in combination, the Lyme titer and Western blot offer great sensitivity and specificity – suitable for clinical diagnosis.

There is also now Lyme PCR which is not used for routine diagnosis but is a very sensitive test for the presence of the spirochete itself, rather than looking for antibodies against the spirochete. This is often used in research, however, and can be used in specific cases.

It is simply incorrect to say that our current diagnostic methods are not reliable. This is part of the CLD propaganda but does not reflect the current science.

I want to emphasize my position here – I am in favor of objectively and thoroughly looking at all the scientific evidence and coming up with the best science-based recommendations we can. The political controversy surrounding the question of Chronic Lyme, however, has hampered this process. It is possible that it has, among scientists, made dissenting opinions difficult to express – and we need to safeguard against overreacting to the political controversy. Therefore I am in favor of as much transparency and independent review as possible. But I believe it is the demonizing of scientists by CLD patient groups that has poisoned the scientific atmosphere of this question – then they decry the very poisoning that they created.
Also I do not believe that all the evidence and transparency in the world will end the controversy. As a commenter on my first blog entry on this topic wrote: “You will never convince me long term ABX is ineffective.”

As we work for keeping the scientific process as pristine as possible, we should also work against using the political process to rig the game – and that is exactly what CT has just done.

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15 responses so far

15 Responses to “Follow Up on Chronic Lyme Disease”

  1. tmac57on 10 Jun 2009 at 10:17 am

    Something that I have not seen discussed much , is what are the possible negative consequences regarding the long term use of the antibiotics used to treat CLD? Of course antibiotic resistance is always a concern, but aren’t their other possible serious side effects that would warrant caution ?

  2. pecon 10 Jun 2009 at 10:18 am

    “There is also now Lyme PCR”

    Then why don’t they use it on patients who claim to have chronic Lyme? Wouldn’t that settle the whole controversy?

  3. stompsfrogson 10 Jun 2009 at 11:08 am

    I heard antibiotics destroy all your good bacteria along with any of the bad stuff. That can’t be good. There’s like three bacteria for every one human cell.

    And you have all those hucksters that sell “probiotic” herbal supplements and fancy yogurts and stuff which probably don’t work otherwise they wouldn’t have to hype the crap out of them.

  4. Steven Novellaon 10 Jun 2009 at 12:41 pm

    PCR, unfortunately, is by itself not the answer. It is highly sensitive only for skin lesions and synovial fluid from joints. So it is good for confirming a rash is a Lyme rash, or that chronic arthritis is Lyme arthritis, but it is not sensitive for other types of Lyme.

    It also has a fairly high false positive rate, and is generally recommended only in patients who have positive titers.

    No single test in isolation is definitive. Titers, WB, and PCR have to be used in conjuction – but together they can produce fairly high sensitivity and specificity.

  5. CTPatrioton 10 Jun 2009 at 3:37 pm

    I have to say, Dr. Novella, after reading your first 2 posts on this issue, I was seriously wondering whether your tagline of skepticism and critical thinking were some kind of joke. This post, however, shows what I believe to be an appropriate amount of skepticism and, very importantly, an openness to reexamination of the science that is sometimes lacking on the other side of the Lyme debate.

    You seem to have one serious misconception about the political problem surrounding this disease. It did not originate with the patients, and your portrayal of them as misusing the political system to interfere in a medical/scientific dispute completely ignores the fact that this is exactly what the other side has been doing for years in order to ensure that no contradictory views of Lyme disease were allowed to take root.

    And while patients are lobbying for their own medical care, with no financial benefit to be gained from their actions, the IDSA crowd has much to be gained from the extensive lobbying that they have done over the years. For example, maintaining control over the definition of Lyme disease and keeping it as narrow as it is now, is of great benefit to those who perform insurance reviews and act as expert witnesses against patients seeking payment for extended antibiotics. Maintaining control over what diagnostic tests are approved by the FDA allows those with ownership in labs and who posess diagnostic patents to profit handsomely from their monopoly on testing procedures. And those who hold patents on vaccines stand to benefit by keeping the definition of Lyme disease as narrow and easily provable as possible.

    These are the kinds of conflicts, by the way, that the attorney general found, and they were not so benign as to have simply been acceptable had they been listed on the guidelines. I think a careful reading of the AG’s publishing’s on this topic along with the agreement for a new, conflict-free, panel make this more than clear.

    I guess the question for you, as a critical thinker and a skeptic is this — do YOU think it is acceptable for scientists who stand to benefit financially from their opinions rendered in authoritative medical guidelines to have a role in the creation of those guidelines as long as the conflicts are listed? Or do you think, considering the fact that medical guidelines like IDSA’s, will be used to form the defacto standard of care for an entire nation, should be created by authors who are free of such conflicts?

    One would wonder why you are not more skeptical of research and guidelines conducted by such scientists, and why you so easily gloss over any conflicts of interest not involved with big pharma. Do you not think that the insurance industry has as much of a vested interest in the outcome of research and medical guidelines or are you blind to that?

    Chronic Lyme disease patients have become politically involved for the same reason that AIDS patients and others before them were forced to do so. The scientific community, for whatever reason, has left us in an ocean of uncertainty and used their political power in an effort to take away the only doctors and treatments that have worked for many of us.

    As for the vilification of IDSA affiliated doctors, all I can say is they should thank their lucky stars that Lyme patients are too sick and too politically correct to follow the model of ACT-UP. I personally believe that scientists who stand in the way of progress, whose science is shoddy, who misuse their authority to settle a scientific dispute through political power, who leave a trail of sick and suffering people in their wake and then do all that they can to ensure those patients cannot receive the care that helps them feel better, deserve to be vilified.

    Understand that the bill which passed in the CT legislature has one purpose – until there is a definitive answer as to what causes CLD, PLDS or whatever it is we have, leave us and our doctors the hell alone. You don’t want politics interfering with science? Then stop using state medical boards to punish doctors who treat outside the IDSA guidelines. And stop using influence on guideline pane;ls, conference committees and peer review boards to freeze out scientists and physicians with contradictory information.

    The bill in CT is nothing more than a response to the misuse of political power by those on the IDSA side.

  6. Steven Novellaon 10 Jun 2009 at 4:08 pm

    CTPatriot – Regarding conflict of interest – it depends on the conflict. They are not all created equal. Minor ones should just be reported. Significant conflicts that a reasonable person would think would unacceptably bias an individual should not be on a decision-making board.

    But here’s the thing – I know there is a lot of focus by the CLD community of IDSA – but they are not the alpha and omega of scientific opinion on this topic. I think the focus there is because there is something to focus on – COI that you can latch onto to dismiss the entire scientific consensus.

    I am not convinced the COIs are significant. Having consulted for an insurance company is not a serious COI, in my opinion. Many academics do it. It is a good way to make sure the insurance company guidelines make sense. Rather than complaining about it, we can help them make their standards comport to the science. It’s one way to look out for patients.

    Now – if they were bribed large sums of money to rig their decisions, that would invalidate their decisions. But I would need to see evidence of that.

    You wrote: “Chronic Lyme disease patients have become politically involved for the same reason that AIDS patients and others before them were forced to do so. The scientific community, for whatever reason, has left us in an ocean of uncertainty and used their political power in an effort to take away the only doctors and treatments that have worked for many of us.”

    See – that is what I just don’t get. Remember – I am a working physician and academic. I see how the system operates from the inside. It is not perfect – no human construct is. But it is also not monolithic. The type of power structure you imagine does not exist. There is no dark conspiracy. And physicians are perhaps the most wary of insurance companies. I just don’t see why doctors would want to withhold an effective treatment from a group of patient – one that can make them money, and make their patients happy. It just does not compute.

    The only reason I can see is the one that I have – the science simply does not add up. I, like most of my colleagues, just want to do what actually right for patients, based upon our best understanding of the science. If you won’t respect that – then we can’t have a conversation.

  7. CTPatrioton 10 Jun 2009 at 5:59 pm

    Dr. Novella, I absolutely do respect that you and most of your colleagues want to do what is right for patients and that you have a reverence for science. The same could certainly be said of the many doctors who patted people with ulcers on the head and told them they had too much stress in their lives.

    My primary point here is that, as you even admit, there are no clear cut answers for what CLD is, or how to diagnose it, or what causes it, or how to cure it. There is evidence that the infection can persist. There are a minority of doctors who have chosen to accept that science as meaningful and treat patients with longer courses of antibiotics, and they have had success in doing so. The patients who seek them out only arrive at that decision after exhausting all the other possible courses of action available from potentially well meaning doctors like yourself.

    So the very same thing could be said of doctors on the other side, who I am defending, and many of whom I have had the pleasure of meeting in the course of my activism. I can tell you that these are also highly dedicated practicianers who are using their best medical judgment to solve a mystery that science has no answer for.

    Were this simply too sides disagreeing with one another and agreeing to disagree until science has the answers, there would be no need for the law that was just passed in CT. But those on the IDSA side of the fence have chosen to prematurely settle this scientific dispute by eliminating the right of these doctors to practice as they see fit.

    When they do that, they are taking away the ability of patients to receive the care that has helped them feel better. That, in my opinion, violates the oath taken to “first do no harm” because the IDSA affiliates are using their power to interfere with my medical care.

    As to your point about “dark conspiracies”, I never alleged a dark conspiracy so please don’t twist my words. But you know all too well from medical history that it is entirely common for the top researchers in a given area to accumulate so much influence and power that they essentially are ceded control of the conventional wisdom on an illness, and because of the way things are structured in this country, they are able to exert their influence over every facet of medicine and politics as relates to that illness.

    You have to be blind not to see that with respect to Lyme disease research. It is literally the same names that pop up everywhere you turn, on the science, on the peer review committees, on the insurance case reviews, as the expert witnesses against LLMD’s, lobbying the politicians not to listen to CLD patients, and so on.

    You’re right that the IDSA is not the “alpha and omega of scientific opinion.” So why do we focus on them? Because they have chosen to put themselves forward as an ardent defender of a very biased and unscientific (as we see it) definition of Lyme disease, one that happens to exactly match that of the 15-20 scientists who have exerted control over the disease for the last 30 years. In effect, the IDSA has become their pimp.

    When the IDSA was shown that the authors of their Lyme disease guidelines had serious conflicts of interest they had the opportunity to express embarassment at not having done a better job at managing the creation process. When presented evidence of bias by the authors, the IDSA had the opportunity to express some sort of contrition. But they chose, instead, to arrogantly defend their guidelines in much the same way that the tobacco industry defended their science for years. Not only did the IDSA go into total PR mode, but they decided to become a lobbying force for the status quo and have exerted their political influence, something they are far more well funded to do than patients are, against legislation that would provide funding for Lyme disease research and to interfere in the doctor patient relationship by supporting the prosecution of doctors who do not follow their guidelines.

    The IDSA has earned every bit of scorn they’ve gotten from CLD patients. Where Lyme disease is concerned, they long ago tossed away the mantle of scientific objectivity.

    Lastly, your claim that consulting for insurance companies is beneficent has about as much credibility with me as a doctor claiming that consulting with drug companies ensures that our drugs are safe. Perhaps this is true in your case. But you cannot possibly say it is true for all doctors who consult with insurance companies.

    Here’s a hypothetical for you. Let’s say you have a doctor who performs Lyme disease case reviews for an insurance company and he makes $700+ for each one that he does. Now let’s say that the insurance company hired him because they know he is biased against CLD and that he will likely reject any claims for extended treatment. Don’t you think the possibility exists that this scientist just might be inclined to hang onto that bias regardless of evidence to the contrary in order to keep that insurance job? And might he not be inclined to further bias his research and his Lyme disease treatment guidelines in order to assure his continued flow of insurance income?

    Surely you aren’t telling me that this couldn’t happen, are you? Surely you aren’t telling me that insurance consultants are somehow more pure than pharmaceutical consultants. And you well know there have been a rash of reports recently of fraud and corruption in medical research by scientists who were consultants to big pharma.

    And even where it is not overt corruption, look at the studies regarding doctor prescriptions and their relationship to the perks they receive from the pharmaceutical companies. It is obvious that the closer the ties, the more the perks, the more likely a doctor is to prescribe a particular companies product (or in some cases, bias his research and opinions in their favor). So please don’t try and tell me that the same forces don’t exist with regard to other conflicted industries.

  8. weingon 10 Jun 2009 at 6:21 pm

    ‘The same could certainly be said of the many doctors who patted people with ulcers on the head and told them they had too much stress in their lives.”

    I don’t know of any doctors who did that. We had Maalox and Mylanta, anticholinergics, then we had H2 blockers and finally the PPIs. These were not cures, but they were effective treatments. The data on long term antibiotics for chronic lyme shows they are just not effective as a treatment nor as a cure.

  9. krisnewbyon 10 Jun 2009 at 8:43 pm

    Dr. Novella,

    The original evaluation of Lyme testing was done without knowledge of the importance of different Borrelia burgdorferi strains. New research by Dr. Ben Luft out of Stony Brook shows that the Lyme is much more antigenic than previously thought, and that some strains are much more neurologically invasive than others. So, what the experts are saying is that much of the diagnostic work has to be redone, taking strain differentiation into account. In other words, the old diagnostic studies had selection bias, in that they tended to chose the less invasive bulls-eye rash patients as the “positive” subjects, rather than the harder-to-identify neuro-invasive patients, which had the more serious infection.

    You can read more about it in my blog here:
    Discovery of new Lyme strains invalidates current tests
    http://underourskin.com/blog/?p=127

    and here:
    Lyme discoverer Willy Burgdorfer breaks silence on heated controversy
    http://underourskin.com/blog/?p=191

    I certainly agree that not all conflicts are created equal, but as the researcher behind the Lyme documentary, UNDER OUR SKIN, I consider the IDSA guidelines authors’ conflicts to be quite significant.

    The most important conflict has to do with the upcoming Baxter vaccine and the author’s commercial interests in the compatible C6 peptide tests. But the easiest one to explain is this one:

    In the 2006 Lyme Guidelines, testing became mandatory for non-rash patients, and 9 of 14 authors and/or their employers
    had the potential to profit from this recommendation. Before this edict, there were about 2,000,000 Lyme tests run a year. Now there will be more. And lead author Dr. Wormser’s university, NYMC, has founded 5 test kit companies since he started researching Lyme disease. Do the math. This is a lot of money.

    You can hear more details in our film which will be in theaters this summer.

    Kris Newby, Senior Producer
    http://www.underourskin.com

  10. taustinon 10 Jun 2009 at 8:47 pm

    Conflicts of interest can be a mighty tricky thing. Those who have a financial interest in a standard of care often also have considerable scientific expertise in the issue. Often, quite a bit more expertise, and it’s unethical to exclude them from the process. They certianly should be part of the process to develop a standard of care, so long as they aren’t the only ones involved.

    That’s why transparency is so important. Don’t exclude data from researchers with connections to “big pharam,” include it with information about that conflict so that intelligent people can make intelligence judgements of its value.

  11. CTPatrioton 10 Jun 2009 at 11:05 pm

    weing, your point is well taken. But I would dispute your assertion that the data on long term antibiotics is conclusive of anything at all, unless you mistakenly believe that 1 month of Rocephin followed by 2 months of doxy is (a) long term and (b) representative of the outcome for ALL antibiotic protocols of all durations.

    As you are surely aware, some illnesses, like TB for example, require much longer duration to be effective.

    Additionally, I believe that Fallon’s study showed clear and objective evidence that “long term” antibiotics were indeed effective at improving symptoms, but that the improvements were transient, lost when antibiotics were stopped. It seems to me that when you see things like blood flow in the brain normalizing and brain lesions clearing (as the NIH found with at least one patient during their intramural study) that the antibiotics are doing SOMETHING of value.

  12. tmac57on 10 Jun 2009 at 11:30 pm

    CTPatriot- You seem very willing to believe that there are unethical Drs willing to prostitute themselves to conspire to deny patients needed treatment for personal financial gain.Are you not equally concerned that other unethical Drs might be willing to take advantage of patients presenting with a constellation of symptoms that could be any of several medical conditions, but are given the CLD diagnoses and started on IV antibiotics which could be very lucrative for the Dr?:
    From Quackwatch:
    “Outpatient intravenous therapy is a multi-billion-a-year business. It remains largely unregulated and can cost patients thousands of dollars per week. Price gouging, drug markups, kickbacks, and self-referral of patients by physicians with financial ties to infusion companies have occurred. In 1995, for example, Caremark, Inc., pled guilty to mail fraud charges for entering into illegal contracts with physicians by paying them to refer Medicaid patients to use Caremark’s infusion products [19]. In Michigan, prosecutors charged a physician and Caremark employees with scheming to over bill Blue Cross/Blue Shield for drugs and equipment for patients with Lyme disease [20]”
    So you see, your distrust of the ethics of Drs can cut both ways on this issue. Are you prepared to say that only your side is the upstanding trustworthy one?

    20.Kelly F. Lyme disease alleged to be false diagnosis. Ann Arbor News, June 19, 1998.

  13. CTPatrioton 11 Jun 2009 at 4:11 am

    tmac… I absolutely share that concern about doctors getting kickbacks from IV companies and feel that is an equally disturbing conflict of interest and profit motive. I have not experienced any LLMD’s who operate that way, but I’m sure they exist. The ones I am most familiar with have been, if anything, very conservative about the use of IV, only using it as a last resort, and as far as I’m aware, had no relationships with the IV companies.

    It is important to note that the doctors who advocate longer courses of abx for Lyme disease don’t control the standard of care for Lyme treatment in this country nor have they attempted to control the standard of care (meaning they are not forcing other doctors to follow their guidelines). Corruption, if it exists, will only impact the practice of that one physician. Whereas corruption by one or more research scientists involved with writing medical guidelines can impact the practices of every physician in the country.

    This issue, to me, is a red herring used to tar and feather all LLMD’s thus justifying the disregard of anything they may have to contribute to the discussion of Lyme disease. The Quackwatch article you quote from, it should be noted, was written by Edward McSweegan, who is not an unbiased bystander here. He has spent years harassing and defaming LLMD’s and CLD patients, in some cases using pseudonyms on message boards and anonymous e-mails, all while employed by the NIH. In fact, he lost his job as Lyme disease program officer because of his underhanded and unethical behavior. So while he raises some important issues, one needs to consider the source and his motives when evaluating his information.

    One other item of interest to illustrate how the IV issue was overblown and possibly misused to cause harm to legitimate doctors. Here in CT back in 1993, Dr. Lawrence Zemel filed a complaint with the state medical board against Dr. Phillip Watsky alleging that Watsky was overdiagnosing, overtreating and profiteering off of Lyme disease. This was based entirely based on heresay gleaned from a patient of Watsky’s and based on the fact that Watsky’s name was listed on a Lyme disease referral number that was managed by a home IV company.

    The medical board was prepared to take Watsky to trial over his Lyme disease treatment methods until confronted with an intervention by representatives of the patient community and the facts — Watsky had no relationship whatsoever with the IV company, had no idea his name was on their referral line, was not getting kickbacks from any IV company, and Lyme patients were only 5% of his practice.

    The case was dropped, but it provided enough of a scare to Watsky that he stopped taking Lyme patients.

    One other point I would like to make is that there seems to be this attitude that LLMD’s are preying on poor innocent patients who don’t know any better. Most of the CLD patients I know did a tremendous amount of research before making the choice to see an LLMD and went in with their eyes wide open. Most of the LLMD’s I have met, two in particular, are voracious consumers of scientific data and made their treatment decisions based on, in my opinion, very well reasoned interpretations of that science. Unlike my personal physician, whose entire knowledge of Lyme disease came from reading an article or 2 in NEJM and attending Lyme symposiums, these LLMD’s have studied every bit of science they could get their hands on and have an encyclopedic knowledge of it.

    I can’t speak for all patients, but let me use myself as an example. After 4 years of misdiagnosis despite a deer tick bite in an endemic area and a positive Western Blot, as I wandered from one doctor to the next, none of whom could figure out what was wrong with me, I took my health care into my own hands and began studying the literature. With Lyme appearing to still be a possibility, I ended up in the office of an LLMD who made a good enough case to me with his clinical opinion backed up by a positive PCR, that I decided that was the road I would travel. I didn’t naively accept what the doctor told me, however. I gathered every bit of science I could find and studied it myself so I could form my own opinion about the alternatives I was being presented.

    Having graduated Cum Laude with an engineering degree, I’m not exactly a dummy and certainly not incapable of reading and understanding (most) medical research. Over the years, I’ve collected an entire file drawer full of articles (hundreds of them) not to mention countless more stored on my hard drive. I became convinced by the science that CLD could very well be a persisting infection and as a result of my own study of the literature chose to try extended antibiotics and see what happened. I don’t believe I would be well enough to share these thoughts with you today were it not for that decision. While I am far from cured, I put a living hell behind me.

  14. tnkrbellon 11 Jun 2009 at 4:36 am

    Steven,
    The “wrong doings” I wrote about refer to the COIs, including dealings with insurance companies and yes, with big pharma. Having Lyme disease patents etc is not wrong. However not declaring Lyme disease patents etc when you are on the board that regulates treatment of Lyme disease is wrong in my books (and totally unethical).

    If all of the circulating guidelines and information about a particular disease is painted all rosy and happy (ie: easy to diagnose, easy/quick to treat, everyone lives happily ever after, lalala) Insurance Inc is smiling, Pharma Ltd does their research with no competition. Antibiotics R Us doesn’t even bother researching since there is no need, no money to be made according to the circulating information. As time goes on the circulating info starts to change, more people are becoming ill. The need for treatment has arrived and who cashes in? Pharma Ltd of course. Insurance Inc is okay with it after all they did save millions already. And with any luck they have already changed their policies to reflect the changes.

    Perhaps that is not an accurate portrayal as far as the ISDA is concerned but the ISDA Lyme panel created that impression through their own behavior. No-one forced them to pick and choose who they wanted to include (or disallow) as members on their panel. No-one told them not to declare these potential COIs. Did they just forget to tell lol? Is it ok to do because “everyone does it these days”? What do they expect people to think? Should we all just brush it off and call it a day. Trust is something that is earned, not something that is blindly and freely passed out.

    I wasn’t quoting that paper you refer to (with my statistics) but I will now:
    “All of the serum specimens in this panel were from patients whose case satisfied the CDC Lyme disease case definition (6). In addition, all of the samples had been tested at the CDC with commercially available kits: ELISA was performed with Lyme Screen II”
    “All of the patients in the Tufts panel met clinical criteria for Lyme disease diagnosis, as described previously” (previously refers to the previous quote)
    So that means all of these samples were previously tested and all had positive results prior to being included in this research. Some were obviously rejected on the basis that they had negative results. The criterion for inclusion in these panels was a positive test result? Isn’t that what is supposed to be tested here in the first place? So basically they all started out with a positive result and then some became negative. Hmmm.

    And during the study they were testing with the C6 ELISA. Who uses C6 ELISA to test for Lyme disease? The usual is the ELISA. This research paper does confirm the lower accuracy found with ELISA vs C6 ELISA. It was written in 1999. And it is now 2009. If the C6 ELISA is a proven “gold standard” test then why are we not using it today? Is it too costly?

    Did any of these researchers even bother to study one actual blood sample under a microscope as a basis for any of their proof? As I said before, in my opinion, the only sure fire way to test the test is to physically observe whether or not these bacteria are doing the backstroke through the culture media on the plate under the lens of the microscope. And it has been done. And when it has been done the results are not the same as the ones you are quoting. And beside that you only included one study to base all of your assumptions? You must have more…. Check out reference [6] in my 1st comment for evidence or [1], [2], [3], [4] or [5] for that matter. It is all relevant.

    You state “At this point, the best trials we have are negative – they show no benefit (or dubious benefit) from long term antibiotics.”
    Okay, I just read a totally different theory in that very same paper you have been referencing and I quote
    “Long courses of antibiotic therapy may be required if chronic infection ensues, sometimes with a prolonged convalescence or an uncertain outcome (31, 33).”

    You also say you don’t refute some of the biology included in my last comment. It is all very current with more studies underway. My intention in sharing the biology with you was to illustrate that extended antibiotic treatment may be required in order to keep this disease at bay. It may even end up being beneficial in eradication of large numbers of these pathogens (and maybe not..we don’t know just yet).

    If you held the power to make “the” decision would you really choose to disallow treatment for a patient before more is known and such treatment has been conclusively proven to be futile?

    You know, there is research on both sides of the camp here, some supports and some dismisses the usual theoriesl. One thing I have noticed is that the leg doesn’t seem to know what the arm is doing here. For instance there is reliable evidence for the formation of the alternate forms of Bb undetectable with current tests and unaffected by antibiotics, there is reliable research on antibiotic resistance in chronic cases etc and there are plenty of reports of less than adequate testing. Each piece of research actually correlates with the other. If these groups got together, pooled their information and then did some clinical studies they would probably come up with some pretty amazing findings.

    CTPatriot, you rule!! I have a university degree in engineering too…

  15. sonicon 11 Jun 2009 at 5:59 am

    A special protection for doctors taking a specific course of action?
    This seems really strange to me and I would hope that this would not stand.
    When I worked in a hospital I noticed that the whole ‘standard of care’ issue was messy- very human and many doctors very self-assured.
    But I can’t imagine that we will be better off with the politicians getting more involved.
    At least the doctors are really experts, and they are trying to help the people they see, in person. This makes them much more likely to do the right thing than untrained people who never deal with actual patients (as is the case with politicians.)
    When I worked in the hospital there was one doctor who I thought sometimes did things that were more in the interest of his wallet than the patient. But he was one of many and I’m not certain my accusation is correct.

    The doctors are people and fallible, but from my observation they do what they do to help the people entrusted to their care.

    It is a nightmare to imagine my future medical care will be determined by a vote in some state senate chamber.
    Yikes!

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