Lyme treatment debated as patients suffer

This is the last of a three-part series on controversies over diagnosing and treating Lyme disease. This week will focus on controversies over treating the disease.

Lyme disease is not only difficult to treat in its later stages due to the bacterium’s unusual physical characteristics, but also to the treatment guideline’s controversy on when to use what antibiotics on which patients and for how long – forcing many doctors and patients to fend for themselves.

Lyme bacterium Borrelia burgdorferi is difficult to treat because of its ability to take on three forms: as a corkscrew-shaped spirochete, a cell-wall-deficient organism, and a tightly bundled cyst, according to scientific literature.

Readying for quick proliferation, the Lyme spirochete unfolds from its dormant, symptomless “cyst” shape into its active, havoc-wreaking “corkscrew.” In chronic late-stage Lyme (approximately 3 months following a bite with inadequate treatment), the clever bacteria seek out collagen-rich body parts by literally corkscrewing their way into knee joints, knuckles, eyeballs, the heart and central nervous system as if each was a fine bottle of French Bordeaux.

But extricating the corkscrews from the corks has proven difficult.

According to a 2004 paper on future-drugs.com, once comfortable in its new home, the clandestine critter can coil itself up into a very small, hard-to-treat ball of pure trouble. In this cyst state, it maintains “intracellular asylum” from standard antibiotics, and only sometimes be readily treatable by potent drugs such as Flagyl – if treatable at all.

Putting aside the bacterium’s personal “cork” affinity, much conflict surrounds how long to treat both early- and late-stage Lyme, and with what type of antibiotics, i.e., the less expensive oral versus exorbitant intravenous form.

In a 2004 study partially funded by the U.S. Centers on Disease Control and Prevention, early-stage Lyme can be treated with several oral antibiotics: doxycycline, amoxicillin, cefuroxime axetil, penicillin, ceftriaxone or cefotaxime. “The standard course of treatment is for 14-28 days,” the study says, “. . . though a physician may elect a longer course of treatment.”

But some doctors disagree. Though the study states early-stage patients “usually recover rapidly and completely with no subsequent complications,” at a recent local Lyme forum, retired Sibley Hospital internist Tom Connally strongly recommended a 21-day dose at minimum.

Patients not receiving adequate treatment enter the much-dreaded late-Lyme phase and are in for a heap of challenges. In 2006 – after much hullabaloo by pro-patient advocacy groups – the original 2000 CDC-approved treatment guidelines were revised slightly and “strengthened,” according to a June 2008 “Clinical Advisor” review of the guidelines, so that some early-stage cases (such as arthritis) could receive treatment for a longer period.

However, pro-patient Lyme Disease Association President Pat Smith says the new guidelines don’t go far enough in that they still disallow treatment for most late-Lyme cases. In fact, “Clinical Advisor” states, “There is little evidence to suggest that [Lyme] infection persists after initial therapy.” It continues, “Because extended antibiotic therapy is unproven while the risks are well documented, the [guideline] authors do not recommend this . . . ”

And this is what bugs late-Lyme sufferers about inadequate bug treatment. Smith says the guidelines treat many patients’ subjective symptoms as nothing more than a non-treatable “syndrome.” The guidelines instruct doctors to tell patients there is a “lack of evidence for prolonged treatment” and to instead treat patients’ complaints “symptomatically,” cutting off their antibiotics.

In 2007, the debate escalated when the highly regarded New England Journal of Medicine published a disparaging article, which concluded: “Chronic Lyme disease is the latest in a series of syndromes that have been postulated in an attempt to attribute medically unexplained symptoms to particular infections,” throwing Lyme in with “chronic candida” and “Epstein-Barr,” which “have now lost credibility.”

Smith points out that the NEJM authors and other pro-guideline, CDC-affiliated researchers have many “vested interests,” some even holding patents for future Lyme vaccines. Indeed, scrutinizing the NEJM paper, disclosed conflicts of interest include: receiving lecture fees and grants from pharmaceutical companies; serving as expert witnesses in medical-malpractice Lyme cases; holding patents on “diagnostic antigens”; and reviewing Lyme disease disability claims for an insurance company.

Virginia Congressman Frank Wolf (R-10th), putting on pressure for new guidelines, stated in a letter to a government agency that the outdated guidelines “ . . . have been responsible for insurance company denials of Lyme disease treatments.”

But for right now, according to Smith, a guideline update to include more aggressive treatment for late-Lyme patients is at a standstill. In response to antitrust accusations by Connecticut Attorney General Richard Blumenthal that the guidelines contained “serious flaws,” an unbiased panel was convened to review the guidelines which made 25 non-binding recommendations.

But this backfired.

Smith said the guideline authors are now hiding behind this review saying no guideline update needs to take place anytime soon – as their bylaws require – as Blumenthal’s panel did the job for them.

The problem, Smith says, is that very few people – let alone doctors – will ever take the time to review the Blumenthal panel recommendations for late-stage Lyme and patient suffering will continue.

Meanwhile, the outlook for Lyme research is also not good. In 2009, Smith says, Lyme incidence – whose reported numbers are notoriously low – surpassed HIV/AIDS. But Congressional funding in 2010 for Lyme was a mere $8 million versus the President’s 2009 HIV/AIDS budget request of $24.1 billion.

In a meeting with Smith years ago, former CDC Director Julie Gerberding summarized how all the Lyme controversy will iron out in the future: “It will be an evolution,” she said, “not a revolution.”

But as web-like as Lyme issues have become, it may indeed take revolt from suffering patients to turn this huge bug bite around.