In October, 2009, researchers published a paper demonstrating a correlation between xenotropic murine leukemia virus-related virus (XMRV) and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). They found 67% of ME/CFS suffers were positive for XMRV and only 4% of healthy subjects were positive.

Government agencies, particularly the Centers for Disease Control, would be expected greet news like these reports with their full support and resources. But something much different happens—almost invariably.

Current estimates of the number Americans with MS are about 400,000. Estimates of U.S. prevalence of ME/CFS are about four million. Both of these diseases can rapidly become disabling and persist for years or decades. Any plausible suggestion of a pathway to cure or remission should obviously be investigated to its fullest by our best and most insightful researchers. But this rarely happens. Usually, government/academic/corporate machinery kicks into gear to smother the most innovative, perceptive research.

We can guess at reasons why, but in a secretive and manipulative system it gets hard to determine true causes.

It could be as simple as an agency, medical specialty, or corporation unwilling to admit they have been embarrassingly wrong for a long time. It could be the unwillingness of the medical doctor culture to deviate from their medical textbooks or professional group guidelines.

More cynically, it could be that medical resistance to new ideas comes from entrenched investment by drug companies, medical device manufacturers, and medical specialities profiting substantially from the status quo.

Health insurers could be the real cause of the problem. They like predictability. They would rather have a disease classified as incurable with predictable costs than have it be curable with unpredictable costs. This is particularly true if the innovation has a one-time, fairly substantial cost that does not entirely guarantee immediate payback in reduced insurance company payouts. Insurers only want to pay for things they build into the premiums they charged the previous three years.

As Ludwig Fleck explained in Genesis and Development of a Scientific Fact the medical profession is filled with uncertainties. When doctors encounter a new medical phenomenon there is a period of chaos where all sorts of explanations and recommendations are suggested. Then, at some point, a version of the phenomena is included in a vade mecum (handbook) that becomes the reality doctors use. (Yes, this is similar to points raised in Thomas Kuhn’s The Structure of a Scientific Revolutions. Kuhn acknowledged reading Fleck, but did not feel significantly influenced by his writings.)

Regardless of motivation, there is a pattern of behavior among our government backed researchers that is not good.

We see it in recent government-academic-corporate handling of CCSVI.

Zamboni published his first paper on CCSVI and MS in April,2009 (web availability December, 2008). Without the efforts of patient advocates, the news might have gone unnoticed. In February, 2010 Canadian news media picked up the story and in June, 2010 The New York Times published a fairly balanced article.

From the article:

“In my view the evidence is quite scanty and the biological plausibility is low,” said Dr. Stephen L. Hauser, the chairman of neurology at the University of California, San Francisco. Many neurologists agree. Dr. Hauser said there was much stronger evidence that the disease arose from genetic variations affecting the immune system.

Neurology specialists want to own MS. They prescribe expensive, injectable drugs that generally make patients feel worse and only produce improved symptoms about a third of the time. Science has little to do with this. Their popular theory of genetic differences in the immune system causing MS, were recently refuted in an extremely rigorous study in identical twins. There was no indication of genetic causation, nor has there ever been, but that does not change neurologists’ minds.

In a National Post article, in January, 2010, Dr. Mark Freedman states “I think there are going to be millions of dollars spent now to follow a hoax…. If I thought for one instant there was substance to this, I’d be all over it,”. Freedman is head of U. of Ottawa’s MS program.

Dr. Zamboni has always presented his observations with the great caution, saying only that we need to find out more. The vitriol directed at him is unwarranted, almost spectacular, and, depending on the career strategy of the journalist, either reported reasonably, or as vitriol confirmation.

With CCSVI, U.S. government agencies have yet to join the discussion. The CDC is, at its heart, primarily an infectious disease agency and does not look that closely at therapies not involving acute infections. The CDC has historically discounted infection as a possible cause of MS. 

But what about CDC response to a new possible cause and treatment for ME/CFS? The CDC has been actively trying to suppress evidence of infectious causes of ME/CFS since the mid-1980s. In October, 2009, Dr. Judy Mikovits reported in Science that her research group found evidence of XMRV in 68 of 101 patients (67%) as compared to 8 of 218 (3.7%) in healthy controls. The CDC immediately began research to show Mikovits wrong and show themselves right, advancing their advocacy of CFS as a psychological condition, just as they had for the last 25 years. And, the CDC’s study saw nothing, absolutely nothing. Their study tested 51 persons with CFS and 56 healthy persons. All had completely negative tests. 

But outside the CDC, researchers just weren’t with the CDC’s program of XMRV suppression. A National Institutes of Health/Food and Drug Administration (NIH/FDA) study showed a significant correlation between ME/CFS and the XMRV retrovirus.

Both papers were approved for publication, but once word got out there was a disagreement, both sides agreed to put their papers on hold. Right here, we have a problem. If researchers were doing real science, data should be a data and any observations, if legitimate, should published as soon as possible.

Despite the detente agreement, the CDC paper, denying a correlation between XMRV and ME/CFS was published July 1, 2010. The NIH/FDA paper confirming the correlation was put on hold. 

But this week there is news. On August 24, 2010, the NIH/FDA paper was released. Not only does it give remarkably good evidence for a correlation between XMRV-like viruses and ME/CFS, but it explains how the XMRV denialists might have produced their negative results.

Clinical medical research has become something much different from real scientific research motivated by desire to understand our world. It is mostly a propaganda tool using the whitewash of prestigious universities, institutes and agencies to give it credibility.

Marcia Angell resigned as editor of the New England Journal of Medicine in June, 2000. In 2009, in The New York Review of Books she says:

It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.

Sharon Begley recently wrote in Newsweek of how little useful comes from NIH sponsored medical research despite the $31B a year it costs taxpayers. This is a really bad thing. But what is worse is the sizable portion spent to stifle possible innovations that could help disabled and dying citizens. As with virtually everything political in the U.S. these days, everyday citizens end up financing corporate malfeasance. We pay for it in insurance premiums, drug prices, and taxes.

Maybe we don’t need to speculate on why this is going on. Maybe we just need to stop doing it. We can sort through which senators and reps support this medical cartel and get them to change or get them out of office. XMRV and CCSVI are just recent examples coming to light. How many other medical problems are waiting for unbiased research and solutions?

(Cross posted on Daily Kos. You might want to read comments there.)

While staffing our table, yet again we were struck by the number and similar arc of people’s stories: health problems unresolved for years, a chance event that led them to the proper diagnosis of Lyme borreliosis, and successful treatment, usually out of state.

Also, yet again we were struck by a disconnect: the CDC’s reporting of six to eighteen Lyme disease cases in Oregon each year and a movie house in Portland, Oregon on a sunny afternoon with over 250 people, most knowing several people diagnosed with Lyme disease.

The world hears about the eighteen CDC Lyme disease cases in 2008 and nothing from the hundreds not meeting CDC criteria or process hurdles. We are encouraged by the people we talked to before and after the film that asked to participate in our census. Only by getting an accurate count of who has had L. borreliosis will proper diagnosis, treatment, and research be realized.

Whether you have attended Under Our Skin or not, if you know anyone who has or had Lyme disease or unresolved condition possibly related, please help us get them counted. We particularly need to count those who have received treatment and improved. Our census uses a survey that most people can complete online in less than twenty minutes. (Other ways to take the survey are available.) We issue controlled invitations; just send an email message to info@seranogroup.org or click here. Those of you who provided your email addresses at the Under Our Skin showing should receive your invitation soon.

Awareness of the size and severity of L. borreliosis is essential to getting the problem fixed. We appreciate your attention and help.

Dr. Marcia Angell, The New York Review of Books, Volume 56, Number 1. January 15, 2009 Drug Companies & Doctors: A Story of Corruption.  (Dr. Angell resigned as editor-in-chief of The New England Journal of Medicine in June, 2000. The Klempner study of a Lyme disease treatment was published in June, 2001.)

Klempner joined the editorial board of The New England Journal of Medicine after Dr. Angell resigned. You can read our evaluation of Klempner’s study here.

We don’t know why Audrey Longhurst, LN Yaddanapudi and the Online Distributed Proofreading Team pulled John Stokes’ book on syphilis off the shelf of Cornell University and put it into Project Gutenberg, but we are glad they did.

Reading Stokes’ book, we were struck by several things:

 
• In 1917, Stokes expected the general public to understand subtle and complex issues.
 
• The level of discourse exceeds most of what is published today for doctors.
 
• The parallels between Lyme borreliosis and syphilis are remarkable.

Syphilis and Lyme borreliosis

Without modern tests, drugs, and insurance codes, early twentieth century medical practice seemed to have the freedom to be perceptive, intelligent, and artful. Granted, syphilis and Lyme borreliosis are different diseases, but the similarities are great. Both are caused by spirochetes, bacteria that branched off early from other bacteria in the evolutionary tree. Both often start with a skin lesion and go into an indeterminate, often lengthy, period of quiescence which can quickly convert to active disease. Both have a special affinity for attacking the nervous system. Both left untreated can have devastating effects, producing many of the same symptoms: severe heart disease, plaques in various blood vessels and organs, dementia, crippling arthritis, pain syndromes, extreme fatigue, and general malaise. Both can cause blindness and deafness. Both can be fatal.

The big difference between the two is that Treponema pallidum, the spirochete that causes syphilis, lives only in humans, unable to tolerate temperature variation more than a few degrees from 98.6º F. It is completely dependent on the chemical and physical environment the human body provides. Borrelia burgdorferi, (Bb), the spirochete that causes L. borreliosis, moves readily between cold-blooded arachnids (ticks) and a wide variety of mammals, birds, and reptiles. With some effort researchers can grow Bb in test tubes, but In contrast the syphilis spirochete can be cultured only in live lab mammals. No one has ever been able to grow it in a test tube or Petri dish.

Persistence

This begs an obvious question: Which of these spirochetes is more likely to end up causing a human infection—the extremely fussy and dependent syphilis spirochete or the extremely adaptable L. borreliosis spirochete? The resourceful L. borreliosis spirochete, in addition to its single chromosome, has more than twenty plasmids, functioning chunks of DNA that it can shed to facilitate genetic recombinations making it extremely adaptable.. It can turn genes on and off in complex patterns to confuse and evade out our immune systems. The spirochete causing syphilis does not have plasmids. It has evolved to prosper solely in the human host, remaining there for years in the individual and for millennia in the species,

It is not in the best interest of parasitic or commensal bacteria—pick the adjective best reflecting you current opinion of the microbe—to kill their host before they have propagated sufficient copies in other hosts for species survival. By necessity, they evolve a life cycle that gives them opportunity to spread to other hosts. For the syphilis spirochete, it needs its host to stay alive long enough to spread to their newborns and sexual partners. L. borreliosis requires a similar lengthy life cycle. If nothing else, it has to make sure its vertebrate host stays alive long enough to infect next years ticks. Ticks are born sterile.

This is a much shorter life cycle than that of the microbial diseases that dominate CDC press releases. Pneumococci bacteria do not have to wait for childbirth or sexual unions to spread to more humans. A sneeze or a crowded elevator ride can do the trick. They live fast and furious lives. The syphilis and Lyme borreliosis spirochetes require slower, more persistent lifecycles spanning years, rather than days, to proliferate. (See Paul Ewald’s works listed below for details.)

That the L. borreliosis spirochete has evolved a strategy of proliferation definitely utilizing ticks, and sexual partners, and offspring is not surprising.

Going Underground

Europeans studied and pondered syphilis for 500 years, from the time Columbus’s sailors brought it to Italy from the New World until Alexander Fleming discovered penicillin, which did a pretty good job of keeping its worst effects dampened. Then, we pretty much forgot about syphilis and stopped paying it much attention. A side note: some recent research is beginning to ask what is going on with syphilis in our twenty-first century world of AIDS and a microbial ecosystem transformed by sixty years of antibiotic use. As just one issue, did syphilis really almost vanish when the AIDS epidemic appeared or did we just stop looking for it?

The important point is that researchers stopped observing and thinking much about spirochetes after 1950. They did finally investigate a borreliosis epidemic in the 1970s near Old Lyme, Connecticut, but it took a German expatriate researcher familiar with syphilis, Willy Burgdorfer, to identify its spirochetal cause. Unfortunately, the initial academic researchers followed standard medical-scientific procedure: simplify case definition, promote rote treatment, and devote research to supporting foregone conclusions. Little true insight has been gained since. L. borreliosis was force-fit into the modern model of assembly-line medicine where medical-industrial complex wants to treat doctors like technicians. Doctors are told to run a blood test and prescribe the drug indicated by the test results. If that does not work, they are pressured to extract themselves from the case at hand.

A commercial vaccine or test kit, hopefully one generating a continuous revenue stream, would have been another solution fitting into the modern medical model. But test development and vaccine attempts which dominated  L. borreliosis research have been colossal failures. The tests are not acceptably accurate and the vaccines did not keep people from getting sick. In fact, they often made people sick. As for the tests still in use, doctors just assume they mean more than they actually do. None meet acceptable standards for sensitivity.

Very few researchers have closely studied humans with L. borreliosis. Fewer still have applied sufficient critical, comprehensive thinking to the problem.

Returning to the Light

John Stokes closely studied humans with syphilis. His analysis and insight teaches expands what we know about spirochetal disease. Read past his discussion of mercury and arsenic treatments, substituting "antibiotics" and you will learn much. Apply Stokes knowledge and insight of  syphilis to L. borreliosis. and you will come away with a clear-minded, rational concept of spirochetal infections, something much different from what today’s textbooks say about Lyme disease. 

Read John Stokes’ book.

A modern review of syphilis

Other resources:

A journal article comparing T. pallidum and B. burgdorferi

Books by Paul Ewald on persisting infections:

Plague Time: The New Germ Theory of Disease Evolution of Infectious Disease

Although on that day my reaction was uneasiness with the doctor’s rigidity and close-mindedness, and despite knowing better, for the most part I used his standard for deciding what to believe about borreliosis for several years. If information was not coming from a journal indexed in PubMed or a similar source, for me it was questionable information. I was so biased that when shopping for a book on a medical subject, I generally would not buy it unless the author was an MD.

Trust

Biology, medicine, and health are subjects with some science and a great deal of uncertainty. We would like to defer to science to sort what is real from what is not. But this is hard, especially in medicine and health, because there are few absolutes and great potential for manipulation by people driven by forces other than a quest for knowledge and promotion of societal good.

I wanted validated information, too. The easiest, and seemingly best way to get it was to rely on journal editors and reviewers for the vetting process.

Then, reality descended when I actually read a few papers in medical journals instead of just their abstracts or summaries. These papers were in journals of good reputation, and often on subjects related to borreliosis. It was disheartening—more than disheartening. At times I felt like a child realizing there really was no Santa Claus.

Disillusion

Behind all the fine print and grandiose academic language, usually there was very little information, logic, or analysis. The greatest offenders were often the journals with the best reputations. The most unreliable authors were often those affiliated with the most prestigious institutions and universities. Regarding Lyme borreliosis, the oft-quoted Klempner study on a treatment for persisting borreliosis was a dreadful piece of work.

Even so, to this day, despite my many disappointments, I still give a knee-jerk deference to papers published established medical journals. Unlike the MD of my first Lyme disease conversation, however, I have been able to step back and become open to other sources. I no longer limit my information sources to medical journals or textbooks. Not that this made things easy. It takes some discipline to read a paper, focus on substance, and set aside automatic deference to a supposed authority.

To illustrate the wrong way of doing things—an expedient and professionally acceptable way to evaluate is by a process like this: if information is printed in JAMA assume it is true and accurate; if it is posted on a blog assume it is unreliable and not worth your time; For everything else, judge it by where it falls on this scale.

Redemption

Automatic acceptance of papers in medical journals is bad policy. Much printed in journals is unscientific advocacy dressed up in obscure academic language and accompanied by obtuse graphics—impressive on the surface, but manipulative in its intent and content.

It is probably easier for me to transition than the typical medical professional reader. I never joined, or wanted to join, any of their clubs. My undergraduate biology department was diverted by an arrangement where medical students from Rush Medical College in their first year could choose to spend it at my college. I saw an informal club form that I did not want to join, fighting for the first row of classroom seats. That club continued on to medical school and became the MD club. Most then joined a medical specialty club. I did not join any of those clubs and I certainly did not join the medical academics club.

But still, I want to read those prestigious medical journals, or maybe just their abstracts, and accept and believe them. If it is that hard for me, it must be harder for doctors who joined those clubs. But really—we all need to grow up.

Scientific method is not all that difficult to understand. Most of us leave grade school knowing its essence. That said, it takes time and mental effort to read a journal paper and analyze what is really being said, undistracted by journal name, authors names, and self-promotions in the abstract, introduction, and conclusions. We all need to make the effort, particularly with medical subjects. Put simply, it is irresponsible to accept journal papers uncritically or rely on editors and reviewers for qualification.

Evaluating a medical study does not restrict readers to be completely logical and linear, discarding their prior knowledge and observations. It is entirely appropriate for a reader to use what they know about the authors, their past history, and motivations. Just be certain you have your facts straight.

If there are other medical or even scientific areas where the literature has been manipulated as greatly as it has in Lyme disease, I do not know of them. All indications are that a small group of misguided individuals looked at the realities of Borrelia burgdorferi infections in the 1980s and decided their careers would go better if they promoted and campaigned for a paradigm that satisfied what they wanted from the world instead of advancing what is known about the disease. There was no a conspiracy, but something much more insidious: the transition of extreme, irresponsible policy into everyday business.

We know it is hard to give up cherished, ingrained beliefs. But we are optimistic about the possibilities of transformation. The Serano Group intends to work to transition professionals away from the false comfort of uncritical acceptance of medical journal articles and rote repetition of flawed dogma. Making this transition is a responsibility you owe yourself and everyone else.

Resources

Many papers in Nature and BMJ have obvious and significant errors.

The CDC and IDSA advocate underdiagnosis of Lyme borreliosis, ignoring much of the available science. A few quotes, some from guideline authors themselves, show the irrationality of requiring an EM rash or positive antibody tests (ELISA or Western Blots)  for diagnosis.

 

"The absence of significant antibody titers to B. burgdorferi is not uncommon in Lyme disease, especially in early disease. ...Although it was initially believed that patients with neurologic Lyme disease generally have antibodies to B. burgdorferi, this may not always be the case. ...We would advise that in an endemic area, the differential diagnosis of nonspecific muscle and joint aches without rash should include Lyme disease—even in the absence of antibodies to B. burgdorferi."

  Nadelman RB, Pavia CS, Magnarelli LA, Wormser GP. Isolation of Borrelia burgdorferi from the blood of seven patients with Lyme disease. Am J Med. 1990 Jan;88(1):21-6. PMID: 2294761  (Abstract)

 

Since coauthoring this paper, Gary Wormser has become a medical politician for the view that Lyme borreliosis is overdiagnosed. He regularly supports the opinion that antibody tests for B. burgdorferi are important, if not required, for diagnosis, contrary to his own research.

Research since 1990 continues to confirm the inadequacy of common Lyme disease tests:

 

"Lyme borreliosis patients who have live spirochetes in body fluids have low or negative levels of borrelial antibodies in their sera.”

    Tylewska-Wierzbanowska S, Chmielewski T. Limitation of serological testing for Lyme borreliosis: evaluation of ELISA and western blot in comparison with PCR and culture methods. Wien Klin Wochenschr. 2002 Jul 31;114(13-14):601-5. PMID: 12422608 (Abstract)

 

Similary, research has never established an EM rash as a predominant symptom:

 

"In our series, only 27% of children with neurologic abnormalities due to LD had a history of EM or arthritis."

  Bingham PM, Galetta SL, Athreya B, Sladky J. Neurologic manifestations in children with Lyme disease. Pediatrics. 1995 Dec;96(6):1053-6. PMID: 7491220 (Abstract)

 

Why does the CDC endorse EM rash or antibody tests as nearly essential for Lyme disease diagnosis?                     ]]> tag:seranogroup.org,2009:index.php/site/ideas/1.33 2009-05-03T15:54:34Z 2009-09-25T21:29:35Z Joel Spinhirne jspinhirne@seranogroup.org http://seranogroup.org Bill Moyers said, “Secrecy is the freedom tyrants dream of”.  Unless there is a really good reason, decisions should not be made behind closed doors. For a published medical study, it is particularly hard to think of a good reason for secrets. Certainly, when it comes to an infectious disease, like, say, borreliosis, everyone should be telling everyone everything they know. When they don’t, something else is going on.  So, let’s ignore the merits and minutiae of the what the authors and supporters of the onerous IDSA guidelines for Lyme disease say. We are not going argue about their illogical statements and their dubious research. Instead, let’s just take a look at how many secrets they have. And, maybe ask why, if they are on the up-and-up, they need so many.  So, in no particular order, here goes…

Nothing But Tests

Steven J. Dumler did a 2-year evaluation of Lyme disease tests. He divided subjects into three classes based on symptoms and history: probable, possible, and unlikely for Lyme disease. The Journal of Clinical Microbiology let him publish without disclosing the test results of the three groups. Through a convoluted scheme, he obscured the fact that he threw out all the subjects with negative results and only analyzed subjects having positive tests, completely disassociated from any real-world phenomena other than the fact they produced a positive test. He has refused numerous requests to disclose who tested positive and who tested negative in his study. The journal editor, Andrew Onderdonk, supportive of the IDSA ideology, has refused to ask Dumler for his results.  Dumler’s study would classify a person bitten during the summer outside of Old Lyme, Connecticut by an identified Ixodes scapularis tick having DNA evidence of Bb, who left the tick attached three days, who had a flu-like episode and a physician-observed a 20 cm EM rash, followed by a swollen knee, as having NO EVIDENCE OF LYME DISEASE, just because the person had a single test and it was negative. He does not hide this detail,  but does not bother to mention it, either.

The Most Famous Lyme Study Ever

Mark Klempner was chief investigator on one of the most quoted (particularly by insurance companies) studies on persisting Lyme disease. He made numerous measurements pre-treatment and, if he made these measurements post-treatment, he has never reported them. The only result he analyzed came from a general questionnaire where each patient self-rates their physical and mental health. This questionnaire, the SF-36, generates eight scores, each on a scale from 0 to 100. Klempner has refused to disclose these scores for the groups studied. Instead, he used mathematically derived summary scores that one of the principals of the company who licenses the SF-36, Mark Kosinski, has stated never to use without disclosing the eight underlying scales. Maybe Kosinski decided to quiet his objections when Klempner made him a co-author of the paper in the prestigious New England Journal of Medicine.

Results Held Hostage

Eugene Shapiro is quoted in a letter to a journal that he cannot provide the results from one of his papers because the results were “in storage”. Doesn’t Yale University use computers? Maybe the results were “in storage” in a far corner of a disk drive, too far away for Shapiro to get to. And, don’t you put your results in storage so you can get them out to answer challenges and questions?

Behind Closed Doors

In 1991, organizers of a Lyme disease conference had to be ordered to allow submission of papers whose views and research contradicted IDSA ideology. Durland Fish was unhappy. (No link because the journal Science still wants $15 to display the article, Science 5 June 1992: 1384-1385) Since 1992, the IDSA faithful convene regularly at private Gordon conferences where dissenting opinions and research are not permitted.

Noncommercial Humanitarian

Gary Wormser has disclosed his financial interest in Diaspex, which he describes, in entirety, as a company having no products or services. We applaud Dr. Wormser for providing full disclosure. But, in April, 2009, Dun & Bradstreet gives the same address for Diaspex as for Cenogenics, listed as a manufacturer of medical diagnostic products including “syphylis (sic) serology reagents”. Gary Wormser’s company that, remember, has no products or services is listed as providing Noncommercial Research and Development in the Social Sciences and Humanities.

Who Makes Up Rules?

In 2005, Justin Radolf attacked the innovative and perceptive treating physician Dr. William Harvey in The Dallas Morning News saying Harvey was “making up his own rules”. In 2003, Radolf had been found guilty of falsifying data to get research grants. After that, he repeatedly sued the University of Connecticut for using his admitted fraud as a reason not to allow him to receive grants. (In this case, the legal system got it right. Radolf’s suits were unsuccessful.) He’s back to getting NIH grants and being quoted as a Lyme disease authority.

Don’t Write

In the mid-1980s, Lyme borreliosis researchers began finding their research routinely censored. The Lyme Disease Foundation created their own journal in 1994 to provide an uncensored forum for research. The LDF received some NIH funding support and has been vehemently attacked by IDSA ideologues ever since. The journal ceased publication in 2002.

Don’t Read

The fifth edition of the textbook Infectious Diseases of the Fetus & Newborn Infant, edited by Jack S. Remington, Philadelphia : Saunders, 2001, had a balanced and comprehensive 100-page chapter on congenital Lyme borreliosis. This chapter was excised and replaced with a few pages of Eugene Shapiro dumbing down the whole subject to a few pages non-scientific IDSA ideology in the 2006 edition. (Thank you to Dr. David Martz for finding this.)

Steere

Alan Steere has so many secrets, it is hard to pick just a few. Writing up his version of what citizens explained to him was going on in Old Lyme, Connecticut, he cited at least 15 literature references on EM rash in June, 1977. Why didn’t he stress that EM rashes respond to antibiotics? Why did he try so hard in 1977, and for the next 30 years to turn borreliosis into a new disease, preferably a rheumatologist’s disease?  Secrecy was the standard operating procedure for Steere’s clinical trial for the Lymerix borreliosis vaccine failure which had 10,936 participants in 1995. Participants were informed of symptoms of borreliosis and asked to look for signs during the trial. They were told to call their doctor if they observed symptoms. Of the 1,917 that called in and were evaluated, 269 were determined to have borreliosis. What was wrong with the other 1,648? How many of them were infected? Remember: if you are conducting a vaccine trial, you want nobody to have the disease going in and certainly nobody to have the disease after the shot. Would a vaccine manufacturer want over-diagnosis or under-diagnosis? (Online access to the paper costs $31.50. Systemic symptoms without erythema migrans as the presenting picture of early Lyme disease, Am J Med. 2003 Jan;114(1):58-62.)

Poor Sales

The reason IDSA supporters repeatedly cite for the failure of the Lymerix vaccine is “poor sales”, which is a little like a football coach saying his team lost because the other team scored more points. Perhaps the failure of the vaccine was due to its inability to protect against borreliosis and its tendency to make well recipients sick or crippled, something rarely reported but fairly well-known to the participants. We do not think this was patient hysteria.  Class-action lawyers became involved not when contacted by patients, but when a group of doctors, worried they would be sued for malpractice after giving people the vaccine, went to the lawyers seeking protection.

Summing Up

Just perhaps, the IDSA Lyme disease guideline authors are completely accurate and ethical. Maybe they have nothing to hide. Perhaps they just have personality quirks that compel them to behave furtively, acting almost like criminals.  Another explanation is they might have some facts in hand that contradict their religious-like dogma. You can decide. It might help if you talk to any of the hundreds of thousands of citizens and their doctors who have experienced something completely different from what the IDSA says is true.

The Blood Transfusion Question

Even some of the most staunch Lyme disease ideologues like Gary Wormser know this:  Survival of Borrelia burgdorferi in human blood stored under blood banking conditions. Nadelman RB, Sherer C, Mack L, Pavia CS, Wormser GP. Transfusion. 1990 May;30(4):298-301. PMID: 2349627 (Note that the big shift in turning Lyme borreliosis into a hard-to-catch, easy-to-cure dogma did not swing into full force until the early 1990s. Fortunately, the National Library of Medicine keeps records of pre-dogma papers.)

Jumping into the historical timeline, we see Eugene Shapiro, the same guy seen in the film Under Our Skin harassing treating physicians and making outrageous statements, already cranking up the denialism campaign in 1994:

The risk of acquiring Lyme disease or babesiosis from a blood transfusion. Gerber MA, Shapiro ED, Krause PJ, Cable RG, Badon SJ, Ryan RW.J Infect Dis. 1994 Jul;170(1):231-4. PMID: 8014507

We have not analyzed this paper, but from the abstract it seems the authors are basing their conclusions on testing for antibodies to Bb six weeks after a transfusion and using clinical assessments by doctors with a bias toward diagnosing as few cases of Lyme disease as possible. Six weeks is pretty early to expect seroconversion from Bb infection and certainly only a weak indication patients were Bb-free. Antibody testing has been repeatedly shown to miss cases of culture- and DNA-positive infection. Shapiro’s entire case is weak, certainly less evidence than what a responsible doctor would like to see for assurance that Bb is not transmitted by blood trasnfusion. And, by the way, his study showed Babesia, a borreliosis coinfection that can cause serious disease, can be transmitted by infusion.

(This is the same Eugene Shapiro quoted in a medical journal that he cannot provide data from one of his studies because he keeps his data “in storage”.)

There is a startlingly small number of published scientific studies that look at blood transfusion transmission of Bb. Readers can look at the literature and decide whether the question has been answered with enough certainty. Keep in mind it is extremely hard to culture Bb or find DNA-RNA evidence, our most definitive indicators of Bb infection, so not finding that type of evidence is typical.

The NIH should be investing taxpayer money to assure the blood supply is safe from Bb instead of funding commercial interests trying to make a Lyme disease vaccine. A Lyme borreliosis vaccine is highly unlikely to ever be successful because of the complexities of borreliosis and the increasing evidence indicating that Bb immunity will not come from a vaccine. Efforts to produce Lyme disease vaccines in the 1990s were abysmal failures.

The Bigger Picture

Before looking at other probable ways that Bb is transmitted, it might help to look at Dr. William Harvey’s paper that asks the right questions and deals directly with the reality of illness from borreliosis. Often, it is best to start by acknowledging broader realities, as Dr. Harvey does.

In summary, Dr. Harvey relates how multiple members of families were being diagnosed with multiple sclerosis in his area. Multiple sclerosis is a condition that is difficult to tell from Lyme disease and has no reliable test for diagnosis. Often, what one doctor calls multiple sclerosis can just as easily be diagnosed as Lyme disease and the patient responds dramatically to antibiotics. This begs an obvious question…

Non-sexual transmission

Are there any indications that Bb can be transmitted by close, non-sexual contact?
In 1986, the NIH, working with other researchers, put uninfected mice in a cage with Bb infected mice. All of the uninfected mice had evidence of Bb infection 42 days later.

It is well established that Bb is found in urine. Willy Burgdorfer, the discoverer of Borrelia burgdorferi, unfortunately got Lyme borreliosis when urine from an infected rabbit splashed into his eye. As with blood transfusions, not enough research has been done on transmission by other body fluids.

Sexual Transmission

Syphilis, another spirochetal disease closely related to Lyme borreliosis, is. of course, sexually transmitted. Bb has been found in human semen. In April, 2001, Dr. Gregory Bach presented a paper at the International Scientific Conference on Lyme Disease showing that in 42 tested Lyme borreliosis patients, 14 had DNA evidence of Bb in semen or vaginal fluids. These results were not published in a medical journal, probably because of censorship, pervasively common at that time, or perhaps because of lack of funding for treating physicians doing research.

On April 27, 2009, the National Library of Medicine listed 8576 medical journal papers related to Lyme disease. They listed one paper regarding sexual transmission of Lyme disease, and that was a chance mismatch of a word combination. Searching “sexual transmission Borrelia” produced three results: two of them duplicates and all concerning ticks having sex with ticks.

For quite some time, we wanted to get most, if not all, of our information on borreliosis from medical journals. Gradually, we found that the journals routinely censor valid work, often publish sloppy and illogical papers, and their peer review consists mostly of an if-you-approve-my-paper-I-will-approve-yours system. This was a disappointment, because we really believe good science can help society answer questions.

Back to the Ticks

Most of the foregoing are details of a big subject. This article is not trying to make the best scientific case for non-tick transmission of Bb; that would be the subject of a book, maybe several books. We are only trying to explain why we do not spend much time or effort talking about ticks here. Bottom-line, tick transmission of borreliosis has been covered pretty well elsewhere while we see almost no research evaluating the risks of non-tick transmission.

The Precautionary Principle and Borreliosis

Many people concerned about the environment advocate use of the precautionary principle: if an action or policy might cause severe or irreversible harm to the public or to the environment, in the absence of a scientific consensus that harm would not ensue, the burden of proof falls on those who would advocate taking the action or endorsing the policy. Since the policy of endorsing denial of non-tick transmission of Bb definitely has potential to cause severe or irreversible harm to the public, the precautionary principle applies.

Of course, be ever-vigilant about tick bites. You can certainly contract severely disabling, possibly fatal, diseases from a tick bite. What precisely you should do after a tick bite is still an open question. Most of the research on this subject has been done by some of the least reliable Lyme disease researchers. But, no one, especially not public health officials, should assume you can get Lyme disease only from a tick.

The budget of the state of Connecticut wasn’t sufficient to take on so large a battle, so the AG agreed to a compromise that lets the IDSA review their deeply flawed guidelines using IDSA members to review what other IDSA members swear to. Yes, it was a little hard for us to be optimistic about the outcome. We did not plan to submit anything.

But, David Volkman, Ph.D., M.D. Emeritus Professor of Medicine and Pediatrics SUNY, Stony Brook, NY submitted a startlingly honest statement to the IDSA review panel. We had already done a fair amount of work looking into the IDSA’s bad science (only to be censored), so we thought it only right to support Dr. Volkman.

Let all hope that some members of the IDSA, especially those reviewing the egregious guidelines, get up some morning and decide to acknowledge reality.  Take a look.

 
• the Lyme politicians are properly and perfunctorily dismissed early on
 
• the reality of the microscope is emphasized
 
• the reality of who is sick and dying is acknowledged
 
• citizen scientists are included as coauthors
 
• the work of the best borreliosis researchers is included
 
• biology, rather than medical culture, predominates

Some of the academic-speak, particularly in the abstract, might discourage you, but give this paper a close reading. It deserves the time invested.

After public health officials gave the “Lyme disease” label to a mischaracterized set of Borrelia infections in the late 1970s, they soon began a campaign of error management, often finding success by formalizing their missteps. Their biggest mistake was they thought they could turn Lyme borreliosis into an easy to treat, geographically limited disease. Then they said tests were better than any facts could justify. Next, they were convinced they could control Lyme disease with a vaccine

They were appallingly wrong each time. Citizens have complained loudly, but not always effectively. Thousands more are kept ignorant of their infections and lives are left in shambles. Health care dollars are squandered as government agencies try to save face and somehow turn all this into a money-maker for private interests producing test kits and vaccines.

The program has continued for thirty years. Fixing this mess requires a series of steps. First, we need a transparent history of what happened. Then, we can focus on the government agencies and the motivators perpetrating this medical and financial disaster. Following that, citizens can begin asking the questions about how their tax dollars are spent and demand changes.

To help in this process, The Serano Group works to tell the history of the problem and to encourage the best use our governmental and private resources. An important part of this program is to identify the techniques used in supporting misguided crusades. Individuals can then be alert to diversions and focus on making the best decisions for their own health, advocating appropriate societal choices.

The Lyme disease picture gets mixed up with what we call “science”. We would like to think that science illuminates and improves our world. Instead, science gets used as a tool for personal, institutional, and commercial gain. We are not anti-science; on the contrary, we fully support science that clarifies and educates rather than obscures.

The Serano Group intends to converge on the problem from two directions: from the big picture viewpoint and from the careful examination of detail. With infectious diseases, the close-up view is very close: often microscopic or molecular. A single case of person getting sick and getting well can be a most important detail.

But as with most things, solving borreliosis and associated disease problems involves dealing with the vast middle ground between big picture analysis and close-up detail. Problems originate and require fixing at the point of implementation: in governmental budget meetings, lobbying activities by trade groups, development of short-sighted policies by insurance companies, and big pharma’s quasi-education of medical professionals.

This strikes many of us as too complicated to deal with and maybe even too perverse to think about. The harsh reality is that people suffer horribly for years and die just so a tiny portion of the population can advance careers and fit in comfortably at their established institutions. Distorted views and misguided efforts perpetuate, becoming less noticeable as they become everyday activity. The easiest personal choice is to just pick a side. When one side has the language, titles, and endorsement of special expertise, most simply choose to defer to purported experts.

But just as blind trust in financial institutions, the executive branch of government, and corporate systems have failed us miserably for our economic and physical security, blind trust in the medical-government-corporate system has created and perpetrated the Lyme disease mess, causing unquantified harm. Hearing this is neither pleasant nor uplifting.

For personal well-being and to help the physical and economic health of our society, get informed, reflect, and demand change. The Serano Group hopes to help you with information and research. Learn more, think critically and do not accept opinion solely because the source claims to be expert. Don’t think that any of this is too hard for you to understand. Learn the methodology of misinformation and where it comes from.

It should not be coming from our government.

It usually takes a specific, direct patient-doctor encounter for citizens and their families to see the true nature and extent of the problem.

The ignored reality is that Borrelia infections, including Lyme disease (Lyme borreliosis), often attack the central and peripheral nervous system and can cause extreme pain, loss of motor function, cognitive decline, and psychological problems. Endocrine and immune system dysfunction are also common. Untreated, Lyme borreliosis can produce blindness, disability, and death. These symptoms and outcomes are nearly identical to syphilis, another spirochetal disease that has been studied for centuries.

This situation did not develop overnight. When confronted with the reality of increasing prevalence, morbidity, and mortality of Borrelia infections in the 1980s, a small group of public health officials cultivated and promoted researchers willing to advance a simplistic agenda. Instead of searching for effective methods of diagnosis and treatment, they advocated minimizing the prevalence and virulence of borreliosis. The routine promotion of ignorance and misstated fact defies belief. The persistence of this process shows too clearly the inability of the research and medical communities to self-regulate. When the majority of the medical establishment accepts extremist, illogical views, specific harm results.

Science continues to play an embarrassingly small role in Lyme disease except as a tool for larger political and commercial interests. Medical journals process Borrelia studies differently than any other research. Papers are published stating most positive Lyme disease test results are false and all negative test results true. DNA evidence from PCR tests, accepted as sufficient to mete capital punishment in the legal system, is regarded insufficient and unreliable for diagnosis of Lyme disease. When citizens are given a rote treatment for Lyme disease and remain ill, guidelines state physicians should assume the infection has been eliminated; and, because textbooks decree the treatment should always work, the only explanation permitted is that a new, unidentifiable disease process has begun. Absurdities compound until new absurdities are not even noticed or debated.

Beyond organizational and institutional involvement, lack of individual responsibility is primary to the problems of Lyme disease. Terribly misguided institutions would not exist without willing individual participation to produce biased studies and approve compromised policy.

Beyond the distortion, there is a reality. Much can be learned if resources are not squandered on propaganda science perpetrating a misguided agenda. Philanthropist George Soros has said that propaganda does society its greatest disservice by obscuring the truth, thereby preventing advances in our knowledge. When truth is obscured, we cannot learn from either our mistakes or successes.

Correcting this abysmal situation requires efforts on two fronts. First, from a global perspective, a new framework for conceptualizing borreliosis is required. Rather than repeat fabricated theories for the disease—including tick-bite, EM rash, limited geography and inaccurate test definitions for the disease, and a single-treatment-cures-all dogma—we need to accurately characterize the scope and boundaries of borreliosis. Secondly, from an individual’s perspective, which is where all medical treatment should be focused, we must examine detailed realities of the disease and devise the best diagnosis and treatments so we can proceed sensibly. Society cannot allow the irresponsible conclusions institutionalized for the last twenty years to continue condemning individuals to needless pain, disability, and death.

The Serano Group is a small organization and conventional wisdom says we should find some way to work with or influence larger organizations. But, after twenty years of support groups and a few independent researchers attempting reconciliation, it is obvious the CDC, NIH, and the IDSA are unable or unwilling to accept rational approaches to investigating and characterizing borreliosis. Replacement of the present commercial Lyme disease model is necessary.

None of this is radical or revolutionary. It is a return to basic, sound medical practice where we identify microbial causes of disease, treat with the most effective antimicrobials available until infection is controlled, and provide care necessary to improve individual functioning and overall health. This is conventional, mainstream medicine. Calling it anything else is part of the propaganda.

The Serano Group strives to provide accurate information regarding issues of health and disease and endeavors to expose and publicize medical propaganda crippling and killing our neighbors. Appeals to ignorance producing doctors that say they cannot act on or consider Lyme disease until there is a definitive clinical trial is a ruse. Very little in medicine is done this way. We need to look at the realities of our world and respond to protect our citizens' lives and health.

Past Lyme disease program directors at the NIH have been so extreme in their positions that they have finally gotten the federal government’s equivalent of the boot, meaning they were told to sit at their desk and do nothing. The last holder of the post, Philip J. Baker, recently moved from his government job to executive director of the American Lyme Disease Foundation, a nonprofit dedicated to promoting commercial medical establishment opinions on Lyme disease. He also just wrote a public relations piece promoting biased and unsubstantiated positions on Lyme disease. So just how were federal funds spent on Lyme research during his tenure?

We wish the new Lyme Borreliosis and Related Diseases Program Director, Joseph J. Breen, great success in increasing our understanding of borreliosis.

Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease, New England Journal of Medicine, 2001. 345(2):85-92.

Klempner, M. S., Hu, L. T., Evans, J., Schmid, C. H., Johnson, G. M., Trevino, R. P., Norton, D., Levy, L., Wall, D., McCall, J., Kosinski, M., Weinstein, A.  

The NIH-funded Klempner study is often cited as important to our understanding of treatment for Lyme disease. At The Serano Group, we find the study interesting mostly because it shows how easy it is to manipulate research and how readily scientists, journalists, and the public accept this type of bias uncritically. (You can read our detailed analysis of the study here, but you may want to continue reading for background.)

While the study has been discussed often since its 2001 publication, its primary failure as a piece of research is rarely mentioned: the study measured hardly anything post-treatment. The Klempner study tested a single treatment for patients with persisting Lyme disease and was unable to discern anything. The only question that remains is how hard did they try?

Typically, research not demonstrating anything is hard to get published. But due to political and commercial pressures to promote a distorted Lyme disease agenda, this study was rushed to press and continues to be cited as important evidence that persisting Lyme borreliosis does not exist and should not be treated.

Of course, this violates a basic tenet of research. Science just does not work this way. You can do an experiment that indicates something exists because the thing studied seemed to cause an effect. But, you can’t claim something does not exist because you did an experiment and did not demonstrate anything. To have an indication, let alone evidence that something does not exist requires many experiments trying every possibility of showing the thing exists using the most sensitive available measurements.

There are two reasonable possibilities for the Klempner study outcome: either the treatment tested does not do anything or Klempner did not have methodology sufficient to measure the difference. A third possibility is that he did find differences and failed to disclose them.

The Serano Group uses the Klempner study as a litmus test. Any individual or organization promoting it or citing it as evidence is suspect for bias. The study shows so little and tries so hard to see nothing that only extremists, academic sycophants, and the uninformed would find it meaningful.

To summarize: 64 subjects with symptoms indicating persisting Lyme disease were treated with two grams intravenous antibiotic ceftriaxone (Rocephin) daily for 30 days, followed by 200 mg daily oral doxycycline for 60 days. Another 65 subjects received a non-drug treatment looking like the real antibiotics, a placebo. Three months after completing treatment, subjects completed a check-the-box self-assessment of their general health, the standard SF-36 questionnaire. The SF-36 generates eight scores, 0-100, which Klempner does not report or analyze. Instead, he reduces the eight scores to two summary scores of physical and mental status. These scores were not reported either, but simply rated “Improved”, “Worse”, or “Unchanged”. Once each subject’s score was reduced to this single rating for mental and physical health, statistical analysis was performed. The analysis found the treated group did not appear significantly different than the placebo group. (The study also stated subjects filled out a Fibromyalgia Impact Questionnaire, but did not report results.)

That, despite all the fine print, is all the Klempner study shows for evidence. The same groups that say only objective data should be used for any Lyme disease decisions suddenly based the conclusions of their multi-million-dollar study on a subjective patient self-assessment of their medical condition.

There were many other areas of the study where the cards were stacked. Researchers specifically selected subjects who had already failed at least one treatment similar to the one being tested. The tested treatment was light considering how sick the subjects were and then only 75% compliance was required. A negative change in mental score trumped a positive physical score change and vice versa. The limited number of 64 treated subjects was highly likely to miss anything less than a dramatic treatment effect. Many medical studies have thousands, if not tens of thousands subjects.

The study did present detailed data about objective measurements done before treatment, but if similar post-treatment measurements were made, they were not disclosed. If the subjects were evaluated by a nurse or doctor, this was not mentioned. If they were asked if their joints still hurt, if they still had headaches, or whether they could sleep at night, this was not disclosed. Instead, subjects filled out the general health questionnaire which specifically is NOT to be used to assess a medical condition. The SF-36 designers state never to use summary scores without disclosing the eight 0-100 scores. Even the summary scores were not analyzed: t;he subjects were scored the equivalent of a 1, 2, or 3. This is the sum total of post-treatment data Klempner disclosed.

Repeatedly, Lyme disease ideologues say the study showed that just as many symptoms improve on placebo as on treatment, yet no symptoms were measured nor were subjects even asked about them, except in a very general way. (You can look at the SF-36 here.)

This should give us all great pause. To state the obvious: it does not appear Klempner really wanted to see a difference between the treated and untreated. The paper looks like science, but there really is very little there. Why would the IDSA, AMA, NIH, and CDC use this study as a primary indication to not treat patients with persisting borreliosis? Why would thousands of health insurance benefit denials be based on 64 patients?

The Infectious Disease Society of America lets a small number of ideologues, which include Mark S. Klempner, write its Lyme disease guidelines and then uncritically rubber stamps them, citing their 8000 members who are in support. Philip J. Baker, an extremist for the commercial view of Lyme disease, was Lyme disease program officer at the NIH during the Klempner study. Insurance companies continue to cite the Klempner study as justification not paying for any extension of treatment for Lyme disease, even though only only one treatment was poorly evaluated.

In September 2002, Klempner was named an Associate Editor of The New England Journal of Medicine. He then was able to not only perform bad research but be allowed to censor good research.

In October 2003, the National Institutes of Health awarded Boston University Medical Center, where Mark S. Klempner was assistant provost for research, $128-million to build Biosafety Level 4 laboratories for the study of dangerous microbes. Klempner was the principal investigator receiving the grant.

This is not the way our government should do business. And, none of this has anything to do with providing rational health care for anyone.

(Full disclosure: one of the volunteers for The Serano Group, Inc. analyzed the Klempner study in their private consulting business. You can read that analysis here.)

The Serano Group’s updated analysis of the Klempner study is here.