Ticked Off

The tick-borne bacterial infection, named for Old Lyme, Connecticut, where it was first diagnosed, is the subject of a pitched legislative battle—one that cuts across party lines. As in any battle, the fog of war is considerable. Lyme was first identified in 1975, making it a youngster next to bacterial infections like tuberculosis or syphilis. Even though some 300,000 Americans contract Lyme every year, comparatively little is known about it.

The procedure for diagnosing Lyme is iffy at best. It was long thought that Lyme patients always had a bull’s-eye-shaped rash at the spot of the tick bite. Later research suggested the rash occurs only in some cases, with estimates ranging from 30 to 80 percent.

Without the telltale rash, Lyme symptoms are hard to pin down. They include fever, fatigue, body aches, joint pain, and stiffness. They’re often labeled “flu-like.” Plug them into WebMD, and Lyme is just one of 99 different diseases and disorders ranging from hepatitis to dementia to “exercise or physical activity” that cause similar symptoms. Some patients spend years with the disease, bouncing from specialist to specialist (including psychiatrists) before receiving a Lyme diagnosis. In the midst of the political battle over Lyme, everyone agrees that educating physicians about how to spot the disease is crucial.

Even if Lyme is suspected, an accurate diagnosis is far from assured. The standard two-part blood test aims to detect the antibodies the body produces to fight the infection. Antibodies mean infection; no antibodies means no infection. At least, so goes the theory.

After a tick introduces the Lyme bacterium into the body, the immune system can take weeks to respond. The Centers for Disease Control is confident that “several weeks after infection .  .  . two-tier testing [has] very good sensitivity.” They don’t mention exactly how long “several weeks” is, and the recommendation to wait a month or so before testing is less than reassuring.

Still, with a positive diagnosis in hand, “patients treated with antibiotics in the early stages of the infection usually recover rapidly and completely.” Usually.

The controversy arises in the other cases. Some patients, especially those who don’t receive early treatment due to false-negative test results, develop more serious symptoms: muscle cramps and spasms, nausea and vomiting, seizures, memory loss, cognitive difficulty, and heart palpitations. Even after the recommended two to four weeks of follow-up antibiotics, symptoms can persist and worsen. The CDC and the National Institutes of Health refer to this as post-treatment Lyme disease syndrome (PLDS). Many patients and some physicians call it chronic Lyme disease.

The difference is important. The CDC is sure that four weeks of antibiotics are the absolute maximum necessary to defeat the infection and that PLDS is just the result of damage already done by the bacteria. Further treatment with antibiotics, they caution, provides no long-term benefit and poses major risks, both to patients and to public health.

Long-term antibiotic treatments are serious medical procedures. Powerful, intravenous drugs require a peripherally inserted central catheter or PICC—a tube inserted in an arm vein that connects a port on the inside of the elbow almost all the way to the heart. The risks of infection, blood clots, and tissue damage are serious. The antibiotics can suppress the immune system, sometimes requiring more IV treatments of immune-boosting drugs.

Using antibiotics in such doses and for such a common disease can pose general risks as well. Not without reason, public health experts are concerned that the overuse of antibiotics could create new strains of bacteria that are super-resistant to existing antibiotics. They also worry about patients who are misdiagnosed with chronic Lyme, but in fact have other ailments like subtle cancers that don’t receive necessary treatment.

Some doctors and patients, on the other hand, report near-miraculous results with long-term treatment. Despite the risks, a friend of mine with Lyme who’s had three PICCs for a cumulative total of 19 months still defends the treatment: “Having a PICC line put in is obviously very inconvenient and scary, but it’s worlds better than having seizures, memory loss, and inability to walk, talk, or feed yourself.”

Another Lyme patient I know was more than 50 pounds under his normal weight before getting a Lyme diagnosis and a PICC. While it didn’t reduce all his symptoms, it did allow him to regain a healthy body weight. According to a family member, “he would see 60 to 70 pound fluctuations when going on and off the antibiotics in pretty short amounts of time” even though “he had been eating and exercising the same way. No major lifestyle changes to attribute it to, the only thing that changed was whether or not he was getting medication to fight the infection.”

The CDC is, perhaps understandably, wary of anecdotes like these. One study of long-term antibiotics conducted by NIH found that 30 days of IV antibiotics had no effect. Some patients criticize the study, reporting that their symptoms eased only after long-er periods of treatment. The CDC maintains that it will change its position if the literature is convincing. The CDC’s critics claim that the latest research has already passed that point and CDC isn’t responding.

As with so many other modern political fights, both regulators and interest groups come armed with competing sets of facts and reasons for disbelieving the other side. Lyme patients, often desperate for help, sometimes turn to suspect practitioners. Dr. QingCai Zhang, a New York-based specialist in “modern Chinese medicine,” claims “modern Chinese herbal treatment with supplemental acupuncture applied to Lyme disease .  .  . yields a much better clinical outcome than the conventional stand-alone antibiotics approach.” His clinic also offers “modern Chinese” remedies for hepatitis, liver fibrosis, and cancer. The M.D.s and Ph.D.s at the CDC could be excused for being wary of second-guessing by acupuncturists.

Instead, the CDC has relied on more established experts. In the words of the agency’s chief of epidemiology and surveillance Dr. Paul Mead, the agency has “partnered with” the Infectious Disease Society of America (IDSA), a consortium of physicians and scientists, to define the scientific consensus on myriad diseases, including Lyme. The CDC has maintained relationships with the IDSA and other professional organizations for “quite a number of years,” including combining staffs with the IDSA to write Lyme treatment guidelines in 1996. (The IDSA did not respond to a request for comment on its relationship with the CDC.)

That partnership does not reflect favorably on the government. A 2008 investigation by then-attorney general of Connecticut Richard Blumenthal found that a panel convened by the IDSA in 2006 (this time without direct involvement by the CDC) to rewrite the Lyme treatment guidelines was riddled with conflicts of interest and scientific double-dealing. The investigation has been praised by Republican politicians like Rep. Chris Smith of New Jersey, co-chairman of the Congressional Lyme Caucus.

When one member of the panel disagreed with the majority and endorsed a view that chronic Lyme may be treated with long-term antibiotics, he was first pressured to change his mind and then dismissed from the panel. Other scientists skeptical of the orthodoxy petitioned to join the panel but were told there were no seats available. Later, the group expanded to include new members, all of whom toed the line.

The chairman of the panel was simultaneously chairing a committee writing similar Lyme guidelines for the American Academy of Neurology. Other panel members also sat on both bodies. Each committee cited the other group’s guidelines to corroborate its own, despite the fact that they were being written by some of the same people at the same time.

A new IDSA panel was convened in 2010 to revisit the issue free of ethical entanglements, this time with an ombudsman appointed by Blumenthal. While the new panel recommended a few dozen changes to the guidelines, the overall conclusion was the same: Chronic Lyme disease does not exist, and the risks of IV antibiotics outweigh any incidental benefits. These guidelines were posted in 2011 to the National Guidelines Clearinghouse, an HHS-run resource for doctors to find best practices for how to treat a wide range of diseases.

The clearinghouse has a five-year limit on guidelines, so IDSA’s 2011 posting expired last year. A competitor group, the International Lyme and Associated Diseases Society, submitted its own guidelines recommending long-term antibiotics for chronic Lyme. These are the only guidelines currently available on the clearinghouse, pending IDSA’s update.

Even so, the official CDC position holds that the “IDSA Lyme disease guidelines .  .  . continue to provide comprehensive, accurate information that patients can use in their health care decisions.” The CDC also continues to throw cold water on the idea of chronic Lyme: “It is not uncommon for patients treated for Lyme disease with a recommended 2 to 4 week course of antibiotics to have lingering symptoms of fatigue, pain, or joint and muscle aches at the time they finish treatment. In a small percentage of cases, these symptoms can last for more than 6 months. These symptoms cannot be cured by longer courses of antibiotics, but they generally improve on their own, over time.”

According to Dr. Mead, just because the ILADS guidelines are posted on the clearinghouse doesn’t mean they have the government’s imprimatur, and just because IDSA’s guidelines have expired doesn’t mean the research supporting them isn’t sound.

Between acupuncture peddlers on one side and embarrassing corner-cutting on the other, there’s more than enough suspicion to go around. To make matters worse, there’s money involved. The oral antibiotics the CDC recommends are substantially cheaper than the IV drugs some physicians prescribe for chronic Lyme. Insurance companies, already under stress, take advantage of the scientific uncertainty to deny coverage for the more expensive treatments. Tennessee Blue Cross/Blue Shield, as one example, considers long-term antibiotics “not medically necessary.” Most of their citations for that claim are from the CDC, NIH, and IDSA.

The CDC and NIH are committed to their findings, and patients struggle to find the care many see as their only hope. Patients and their advocacy groups turned to legislative action decades ago and found some success in statehouses. Last year was the first time they managed to get legislation through Congress, but the language has generated more controversy than it resolved.

As the 21st Century Cures Act worked its way through the lame-duck session at the end of 2016, Rep. Chris Gibson, a New York Republican, and Rep. Chris Smith saw a perfect opportunity to try to break the Lyme impasse. Along with former congressman Frank Wolf, they had been pushing a Lyme bill for years, trying to shoehorn the language into defense authorizations, the farm bill, NIH appropriations, and even a bill in the Foreign Affairs Committee. All their efforts were fruitless. Before his retirement in January, Gibson had managed to get the Tick-Borne Disease Research Accountability and Transparency Act through the House in 2014—though that’s as far as it got. Rep. Smith remarked that Congress’s response to Lyme had been “a deaf ear and a jaundiced eye.”

Back in the 1990s, Smith began a career-long push to get emerging diseases and disorders on the congressional agenda. A bill he and Gibson championed established the Interagency Autism Coordinating Committee in 1998, which brings together private and public experts to coordinate and advise all HHS policies relating to autism.

They tried to set up a similar committee for Lyme disease at the same time, but that failed. It would fail again repeatedly before passing as part of the 21st Century Cures Act last year. The Lyme language—which establishes an Interagency Lyme and Tick-Borne Diseases Working Group made up of federal agencies, patients, and physicians—was added to the bill while it was still in committee.

The chairman of the committee, Fred Upton, was supportive of the language, but ranking member Frank Pallone was opposed. After receiving a letter from a slew of fellow Democrats supporting the language, Pallone dropped his opposition in committee. Pallone was the lead Democrat from the House in negotiations with the Senate committee working on the bill. When the talks finished and the negotiators reported their agreements back to their respective chambers, the language had changed. The original draft had required “a diversity of scientific perspectives” on the working group; the bill that was reported back contained no such assurance.

Who made the change is still unknown. There’s a possibility it could have been Pallone. In the 2016 cycle, Pallone’s campaign and PAC received $30,000 (his second-largest overall donation) from Blue Cross/Blue Shield, which has a financial interest in maintaining the status quo policy against long-term antibiotics. (His office did not respond to repeated requests for comment.)

It was late in the year, and the new Congress would take over in January. With just 48 hours between the end of negotiations and the final vote, the Lyme advocacy groups, which can be fractious and prone to infighting, scrambled to formulate a coherent response. Some were focused on trying to restore the diversity guarantee, but with the clock ticking, other groups thought it safer to try to kill the bill. Without the diversity guarantee, the working group, which they considered their best hope to break the scientific gridlock, would become the latest way of boxing patients and their physicians out of policy-making.

One of the most prominent of these advocacy groups is the Lyme Disease Association, whose president, Pat Smith, is a matriarch of the Lyme patient community. Her first experience with Lyme came more than 30 years ago, when she was on her local school board in New Jersey. As more and more students fell ill, she pushed for Lyme education programs to teach students how to avoid ticks. Two of her daughters were later diagnosed with Lyme, requiring years of treatment.

Smith spent many of those 48 hours on the phone with everyone and anyone on Capitol Hill that would listen to her. Also trying to coordinate a response was the National Capital Lyme Disease Association, which focuses more than any other advocacy group on legislation.

Though they had spent decades pushing for Congress to address Lyme disease, and most of a year pushing for the Lyme provision in the 21st Century Cures Act specifically, they now found themselves in a corner. They were trying to corral the Iowa Lyme Disease Association, the Michigan Lyme Disease Association, TickTexas.org, the MayDay Project, and LymeDisease.org (formerly the California Lyme Disease Association). Getting Texans and Californians to agree on anything is tough; getting them to agree on major legislation within 48 hours was seemingly impossible.

The details are murky, but somehow, someone got Majority Leader Kevin McCarthy involved. He personally intervened, ensuring the diversity guarantee was put back in the bill before it passed. President Obama signed the law on December 13, 2016, with the diversity guarantee included. For the Lyme groups, the immediate crisis had been averted, but victory was far from assured.

Every member of the working group—whether from within the government or not—is appointed by the secretary of health and human services, Dr. Tom Price. Ensuring that “diverse scientific viewpoints” actually end up on the panel depends solely on him, and no one is sure where he stands.

Former congressman Gibson told me he suggested that Pat Smith be appointed to the panel (she already sits on a Lyme advisory panel within the Department of Defense), but there’s no indication anyone in HHS has given a moment’s thought to the Working Group, which has until the end of 2018 to produce its first report.

It may seem insignificant, who gets to sit on a government panel that doesn’t have any real responsibility besides writing white papers hardly anyone’s going to read. But there are bigger issues at play.

Many of the difficulties that have made Lyme disease a political issue—intellectual and scientific dishonesty, distrust of institutions, unaccountable government—plague American society generally. Congress has now tried to help. We’ll see how it goes.

Benjamin Parker is a reporter at The Weekly Standard.