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Pamela Weintraub
Pamela Weintraub

Disappearing a disease: when guidelines lack balance, patients suffer

How to disappear a disease.

It was in October 2006 that the Infectious Diseases Society of America (IDSA) published its updated Clinical Practice Guidelines for Lyme disease. The document dismissed, out of hand, one side of an argument over Lyme that had been waged in the medical community for 30 years: Whether, after antibiotic treatment of 28 days, the sickest patients were cured of their infection or needed more treatment to get well. Instead of acknowledging the debate --or considering scientific evidence on either side of the issue-- the guidelines deferred to flawed studies supporting only one point of view. Without sufficient evidence, IDSA asserted that the debate had been settled, absolutely. In one fell swoop, these guidelines limited treatment, called the limited treatment a cure, and locked some of the sickest patients out of the Lyme diagnosis for good.

Drawing a line in the sand between their restrictive disease definition and the many patients now falling outside its bounds, IDSA excluded from diagnosis large numbers of the ill. While patients with grossly swollen knees and positive tests fell within the diagnostic circle, patients with the more subjective symptoms of fatigue, confusion, memory loss and pain were cast out of the Lyme fold, even if they passed the controversial, restrictive test --a Western blot viewed as crude compared to the technologies of genomics and proteomics coming online today.

The limitations on diagnosis and the reign of primitive testing meant that at any stage of illness, many patients could be missed. Early, easy-to-treat disease became late, hard-to-treat disease for patients who slipped through the Guidelines' diagnostic cracks --at least that's how patients saw it, and they were increasingly up in arms. But IDSA dug in its heels and brushed it off: It wasn’t much of an issue, the IDSA authors said in response to such complaints, because late-stage Lyme was rarely seen and virtually always cured, usually with simple doxycycline, in 28 days.

Expressing concern, Richard Blumenthal, the attorney general of Connecticut, launched an antitrust investigation into IDSA and its guidelines based on its exclusion of other points of view. The authors were also stakeholders and had too much to gain by maintaining the status quo, Blumenthal felt—from stature in their professions to the payoff from patents to the constant flow of grants. He found the conflicts of the IDSA authors to be profound: They consulted for big pharma and owned Lyme-related patents; they received fees as expert witnesses in medical-malpractice, civil, and criminal cases related to Lyme disease; and they were paid by insurance companies to field—and help reject—Lyme-related claims. Of the fourteen authors, nine received money from vaccine manufacturers and four were funded to create test kits: products that would be more likely to reap profit if the definition of Lyme disease remained essentially unchanged.

“These guidelines were set by a panel that essentially locked out competing points of view. Presumably, the IDSA is a nonprofit-making organization, but such organizations can still be used for anticompetitive purposes,” said Blumenthal. “This is not theoretical. It will come down to dollars and cents.”

IDSA, of course, denied it had any conflict, insisting its doctors could hardly profit from the cheap, short-term antibiotics they prescribed. The disingenuous disclaimer ignored the fact that IDSA panel members were profiting not from writing prescriptions but from grant money flowing through their labs to develop the vaccines, test kits, and companies their restrictive definition allowed.

IDSA insisted MORE grant money would flow were they to concede the patients were sicker, and that is true --but probably not to the stakeholders there today.

Last year IDSA and Blumenthal struck an agreement --the Lyme Guidelines panel would be reconstituted, and those with conflicts would be barred.

But the new panel, announced this month, is troubling as well, particularly because not a single member treats chronic patients --those who, for whatever reason, remain sick after the short-term treatment is done. Treatment guidelines constitute a consensus of opinion, but these guidelines will be written by those lacking contact with the sickest patients themselves.

The panel has been reconstituted and as it convenes, I'd like to make a request: This time examine, really analyze, the science. New research published in major journals from the Proceedings of the National Academy of Sciences to Emerging Infectious Diseases challenges the current panel conclusions. Do not turn a blind eye.

Important new work from the CDC challenges the current IDSA stance on prophylaxis, which insists a single dose of doxy will prevent infection at all. CDC immunologist Nord Zeidner has examined this work and found the statistics flawed and results skewed. As few as 20 percent of cases may be prevented in this fashion, CDC has found --not the 85% IDSA claims.

And then there is the work from professor Stephen Barthold, veterinary researcher and head of comparative medicine at the University of California at Davis. Barthold is one of the most rigorous pure scientists you can ever hope to meet. He and his Davis colleagues have found that when treated too late or too little, Lyme becomes chronic, with low levels of spirochetes embedded in tissue like collagen, dormant and resistant to drugs. What are the cytokine and chemokine cascades downstream of these infections? Can low levels of these immune molecules caused by dormant spirochetes account for the constitutional complaints of chronic disease? Do antibiotics suppress these immune cascades by keeping spirochete levels low? Might we find new antibiotics to eradicate the remaining bugs --or new immune treatments to stop the cytokine cascades?

Perhaps most important is the new work on strains out of such prestigious institutions as SUNY Stony Brook, University of California at Berkeley, and University of California at Irvine. There are hundreds of strains worldwide, according to the experts that I interviewed. Most important here is the issue of invasive disease. Of 20 strains most prevalent on the East Coast and studied at Stony Brook, just 4 were found to cause invasive disease and 10 were found to cause just a rash --they could not spread beyond the skin.

The implications are profound. One of the most important is that if just 4 strains of the 20 cause disseminated infection, then the roster of rash-based studies on the treatment of early Lyme disease, conducted from the 1980s to the present --and held as high evidence by IDSA-- would have to be reassessed. Take a moment to ponder the simple math: It would be impossible to accept results based on the assumption that 100 percent of Lyme rashes can cause invasive disease when a significant percent cannot. Some of the classic studies claim very high cure rates for early infection; yet if the causative strain were of the rash-only variety, then even orange juice would be a “cure.” Are recommended treatment protocols truly curing most of those with early, invasive borreliosis, as IDSA contends? Or has noise from rash only strains obscured less rosy results?

The work on strains could alter how we diagnose and treat the disease in the years to come, according to Alan Barbour, director of the Pacific-Southwest Regional Center of Excellence for Biodefense and Emerging Infectious Diseases at the University of California Irvine and one of the world's foremost spirochete experts. "If some strains are more likely than others to spread in the blood, and by that route to other tissues, then identification of the strain a person is infected with could help guide therapy. Some strains may call for a longer course of antibiotics," he states.

The answers won’t be found in the twentieth-century technology of the Western blot, by today’s standards crude yet still trotted out by IDSA as evidence absolute that they are right. (The Western blot for Lyme is so flawed that even its major manufacturer says he has found numerous "band" patterns more accurate than the one in use today.) Instead of relying on flawed 20th century technology, we must look to the science of the twenty-first century, including state-of-the-art genomics and proteomics that allows for the sequencing of every gene and protein involved in every stage of Lyme. With evidence of this calibre we won't have to fight over the truth: We will know what's going on.

“What we will find,” says Ben Luft of Stony Brook, “are proteins we never tested for on our ELISAs and Western blots—proteins we were never even aware of. But they will be the critical markers for invasive, infectious Lyme disease. Perhaps people who test negative on the old tests will become positive when we look for the right markers,” he adds.

This kind of approach would take the blinders off Lyme disease research, reversing the funneling of thought that has gone on for decades. “I don’t want to be critical about the past, but more is possible now,” Luft says of Lyme’s old guard.

In defending its turf, this old guard has continually pitched its science against the anecdotal stories of very sick patients, as if the antiseptic "objectivity" of one trumps the sheer desperation of the other, proving they must be right. This is a cop-out. The original IDSA panelists must stop comparing their neat but porous studies to the travails of some embattled Lyme doctor, and must instead be made to hold their work up to that of other university-based scientists. The new panelists will have to hold them to this second standard if they are going to do the job. As someone who has traveled the country for six years interviewing these scientists to write my book, Cure Unknown: Inside the Lyme Epidemic, I can tell you unequivocally that many of the top researchers at the top institutions in the world do not think the original IDSA panel got it right.

In the spectrum of scientific opinion on these issues the old panel represents an extreme right wing of thought --not compared to other infectious disease doctors, who have simply followed their lead, but compared to other researchers, especially the true bench scientists who actually study the organism in the lab. It behooves the new panel to go beyond the work of the old panel in their examination of the science, I just don't know if they will

We must move on --but will the new Guidelines panel help? Given the history of the Lyme struggle and the politics at IDSA, the odds seem low. In the State of Connecticut, where Lyme disease was first widely studied in populations, hearings pit the two sides: Those who want to rubber stamp the current IDSA guidelines versus those who want protection for doctors defying them when patients stay sick; those who say we know all there is to know about Lyme disease right now versus those who say that only further research will light the way and help patients get well. The fight goes on. But while you can skew the evidence in your guidelines, you can't stop the march of science. You can try to disappear a disease --but in the face of a burgeoning epidemic with ever more people sick, would you really want to succeed?

Pamela Weintraub is the author of Cure Unknown: Inside the Lyme Epidemic and senior editor at Discover Magazine.

About the Author
Pamela Weintraub

Pamela Weintraub is the Executive Editor at Discover magazine and author of Cure Unknown: Inside the Lyme Epidemic.

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