Lyme Policy Wonk

A recent article in the Greenwich Times addressing the "improper voting procedure” of the IDSA review panel contains a response from IDSA spokesman John Heys that the IDSA is "committed to ensuring the review panel conducts its review to the requirements of that action plan." Sounds a little boiler plate, huh? The next statement by Blumenthal though is more telling. He says that his office has yet to receive a response to the letter. That does not sound like much of a commitment. One has to wonder why it was necessary to write the letter of non-compliance in the first place and why the IDSA's only response to date has been to the press? "We hope there will be a response forthcoming shortly," Blumenthal said. So do we, so do we. . .

Responding to patient concerns, the President of ILADS, Dr. Robert Bransfield today delivered a letter to the IDSA calling upon the organization to remove barriers to guidelines change. The letter follows patient complaints to ILADS about the IDSA voting process, which were uncovered by the Connecticut Attorney General in the oversight of the IDSA Lyme guidelines review process. According to the Attorney General, the voting process used by the IDSA was in violation of the terms of the antitrust Settlement Agreement. The Attorney General has called upon the IDSA to redo the vote using the proper voting procedures. Text of the ILADS letter follows the jump.

On Monday, February 1, 2010, the Connecticut Attorney General sent a letter to the IDSA expressing “concern” over “improper voting procedures” used by the IDSA in the Lyme guidelines review voting process. The IDSA may soon approve hearing determinations based on this improper voting procedure. The Attorney General requested that the IDSA redo the vote to comply with the Settlement Agreement. The four-page Attorney General letter was released in response to a Freedom of Information Request made on behalf of patient groups for information regarding the IDSA’s compliance with the Settlement Agreement.

There is a lot of flurry in the Lyme light about the IDSA recent letter in opposition to the physician protection bill pending in the New Hampshire physician protection legislation. This legislation follows on the heels of legislation already passed in California, Connecticut, and Rhode Island. Like breast cancer patients before them (who passed legislation in 20 states to secure the right to make treatment choices), Lyme patients are appealing to legislators to preserve their right to receive treatment for Lyme disease. The IDSA claims that its guidelines are not mandatory, but to my ears this sounds like double-speak. And, the newly elected President of IDSA, Dr. Whitley essentially admits as much when he complains about lab tests that are not “regulated” by the IDSA guidelines. What makes IDSA think that it has the “right” to regulate lab tests? Who says? How genuine is IDSA when it claims that its guidelines are really just “discretionary”? Come on, guys, one or the other, but you can’t play both sides of this issue with a straight face. Maybe we have to fall back to Lincoln or Bush, take your pick, about how many people you can fool.

A terrific article by Jerome Groopman, “Health Care: Who Knows Best”, appeared in the New York Times about the healthcare bills. Groopman’s article discusses how healthcare should be implemented in terms of guidelines and notes that there are two choices. The first is through mandates. The second is through “nudging” consumers in the right direction, but leaving the final choice to the consumer. (This approach is advocated by the author of the book Nudge, who is an advisor to Obama.) If this sounds like the Lyme debate, you are catching the drift. As we know, the distinction between mandatory guidelines that do not permit physicians and patients to make choices and guidelines that permit individuals to make their own choices, even if they are unpopular, can determine whether a patient has the opportunity to get well. The question boils down to this: Do the experts know best or do some decisions simply belong to the patient and the treating physician?

Drs. Janet and Felix Sperling of the University of Alberta published an entomology study on Lyme disease in Canada that is worth a read, especially if you believe that Lyme stops at the US border. Did you know that Lyme has now been recognized in every province in Canada? And that infection rates of ticks are 12.5%? More fast facts after the jump.

In a press release issued at the end of last year, the IDSA called on the US and European Union to develop 10 new antibiotics by the year 2020. IDSA President Richard Whitley said that “creating a stable research infrastructure for antibiotic development” was essential to provide physicians with the tools necessary to effectively treat patients. That’s good news for the Lyme community because unacceptably high treatment failures occur with all current antibiotics used to treat Lyme disease and the rate of development of new antibiotics has been low. Pharmaceuticals have not been interested in developing new antibiotics because they do not generate the level of profit that drugs that are taken by a broad demographic over the course of a lifetime, like cholesterol medication, do. This is the good news. Now for the bad news.

You’ve all heard that the latest drum-roll from the rheumatologists at the IDSA hearing was essentially to say that Lyme patients have persistent symptoms and they started off with infection, but now we don’t “believe” in persistence—so what do you call it? How about “medically unexplained symptoms” or MUS for short? All of this seems to regard the real problem with Lyme disease as being what you call it. But patients know the real problem with Lyme disease is how you treat it, how you cure it, how you restore patients to their lives. Disease definitions like MUS are for drug-makers who sell drugs to a market, physicians trying to claim professional turf, and insurers trying to deny treatment reimbursement. They are not for patients. Abraham Lincoln had it right when he said: “How many legs does a dog have if you call the tail a leg? (Answer) Four. Calling a tail a leg doesn't make it a leg.” I’m not the only one who finds these acronyms aggravating and unhelpful. A post from the internet nails it:

Buddha once said “a dog is not considered a good dog because he is a good barker. A man is not considered a good man because he is a good talker.” I would take it a step further and say “a doctor is not considered a good doctor because he is a key opinion leader.” No. The essence of a good dog is loyalty. The essence of a good man is his moral character. And, the essence of a good doctor is his ability to heal the sick and restore health. This can’t be done without holding the patient’s interest paramount. Patients and the concerns of patients are the core element around which medicine is organized. Without patients, there is nothing for medicine to address. Without treatment approaches that restore health, or failing that, improve patient health, medicine becomes a meaningless exercise in capitalism. How do we ensure that patient’s interests come first in treatment guidelines?

The IDSA hearing results were expected by the year end. Then were delayed—until “after the first of the year”. Perhaps the delay was caused by Dr. Duray’s resignation from the panel due to personal illness. We don’t know because we have not been told the reason for the delay or how long the delay will be. Patients are on tenterhooks awaiting the results and with good cause. Revision of the IDSA Lyme guidelines could make a world of difference for Lyme patients. According to a CALDA survey, 53% of patients with chronic Lyme have been treated according to the IDSA Lyme guidelines and 90% of these were not restored to health under the IDSA protocols. Isn’t the point of treatment guidelines to improve patient outcomes? And, if they don’t, shouldn’t they be revised?