Lyme disease—who is credible?

I recently had a pleasant, brief email exchange with Kris Newby, the producer of the latest medical advocacy pic, Under Our Skin. There’s been a number of similar movies lately, mostly about quacky cancer therapies. This one is apparently much better made, and follows the controversy regarding “chronic” Lyme disease.

I’d heard an interview about the movie on Diane Rehm, and was rather unnerved by it. It sounded like a typical I-drank-the-Kool-Aid-now-I’m-gonna-make-a-movie kind of thing. Still, I haven’t written about it, because I haven’t seen the movie. That’s going to change. Kris is being kind enough to send me a copy, despite my warning that I’m very likely to pan it.

Anyway, in our conversation, she recommended that I check out a particular piece in the Journal of Medical Ethics. Before I go into the significance of this paper, let me give you a little background. Stick with me here, I’ll make it brief.

Lyme disease is a tick-borne bacterial infection common in many parts of the U.S. and Europe. In the U.S., it is especially common in the Northeast, but is present in pockets elsewhere. It usually presents with a rash, and sometimes progresses to joint pain and can have neurologic symptoms as well. These joint and neurologic symptoms can occur several weeks after the initial infection. There is also an entity often referred to as “chronic Lyme disease“. This entity isn’t widely accepted in the medical community, but is strongly advocated for by a vociferous group of patients and doctors who believe that Lyme disease can cause all manner of very late-onset symptoms.

The controversy is a nice model for many similar controversies: the science doesn’t support the existence of the disease, but a dedicated group of activists, including some scientists and physicians, feel their extensive experiences more than make up for lack of data. What some of us have problems with is not only the lack of data, but also the willingness of people who believe in this to go about trying to prove it in unconventional ways, for example, relying on lab tests that are not validated. It certainly doesn’t help their cause that they attract a lot of kooks, but of course, it doesn’t really matter how many kooks the chronic Lyme folks have on their side; what matters is data, and if their data are the most convincing, their hypothesis wins.

Now, as we talked about yesterday, good ideas don’t always win right away. But if these ideas come closest to the truth, win they will, no matter who or what stands in their way.

And the chronic Lyme folks certainly believe that there are dark forces arrayed against them. You see, these folks think that Lyme disease causes all sorts of problems, and that there are many solutions, including long term antibiotic therapy. The data so far do not support this hypothesis. And this is where it gets interesting.

Medical societies often put out consensus statements about the best science-based way to approach diseases. These statements are in no way binding, but they are often taken quite seriously. For example, the American College of Physicians, my professional group, has a number of statements on the proper approach to upper respiratory tract infections, such as colds and sinus infections. The articles on the recommendations are printed alongside the justifications and data. In this case, the data do not support the use of antibiotics for most sinus infections, at least in the first week or two. This is mildly controversial, mainly because patients often believe that an antibiotic will make them feel better. The evidence belies this.

So the Infectious Disease Society of America (IDSA) has recommendations on the treatment of Lyme disease, which are shared by all the other relevant mainstream medical societies, and these guidelines specifically recommend against the long term use of antibiotics for supposed chronic Lyme disease.

Now, it is a fact that at this point, the data support these guidelines. The vast preponderance of evidence has failed to show any benefit to the use of antibiotics in this setting. This of course does not guarantee that the guidelines are correct, but it certainly is the best we have for now. If and when evidence comes along that is good enough and plentiful enough to convince the medical community otherwise, the guidelines will change. It may not happen overnight, but eventually it will, because no “conspiracy” is vast enough to hide scientific truth for long. But some people are unconvinced. In support of their cause, they have created several organizations, at both the local and national level, and have enlisted various “experts”. One thing many of these experts seem to have in common is that they are not actually regarded as experts by the rest of the medical community. The other fact about these organizations and professionals is that they often go outside the scientific process to advocate for their ideas.

For example, these groups convinced the Connecticut attorney general to investigate the IDSA for alleged anti-trust violations. This is highly unusual, and the case was settled when the IDSA agreed to review, but not necessarily change, their recommendations. Part of the allegation was that there was a massive conflict of interest. You see, because the guidelines recommend against long-term antibiotic therapy, insurance companies often will not cover it. Some folks see this as a vast conspiracy. Others see the guidelines as saving patients from ineffective, dangerous and costly treatments.

So, in the mainstream of science-based medicine, this is essentially a non-issue. No significant evidence has yet shown up to overturn our current approach to Lyme disease. This hasn’t stopped the chronic Lyme advocates. And this takes us back to our movie producer and her suggestions to me. If you think way back to the beginning of this piece, you’ll recall that Kris recommended I check out a piece in the Journal of Medical Ethics. I did. I was impressed, but not for the reasons she hoped.

I have a strong interest in medical ethics, although I’m not an ethicist myself. Still, I’m generally familiar with the jargon and the writing styles. This piece reads like no ethics article I’ve ever seen. It is basically an advocacy piece for the concept of chronic Lyme disease, and starts from an entire set of problematic assumptions. First, the title: Attorney General forces Infectious Diseases Society of America to redo Lyme guidelines due to flawed development process
. That’s actually not true:

The main actions of the agreement include:

Complete resolution of the Attorney General’s investigations, issues, and potential claims and causes of action against IDSA and its volunteer panel members.

The current Lyme disease guidelines remain in effect. The medical and scientific basis of the 2006 guidelines remains in place and unchallenged.

IDSA will convene a review panel to determine whether the 2006 Lyme disease guidelines should be revised or updated. Howard Brody, MD, PhD, who has been jointly selected by the Office of the Attorney General and IDSA, will serve as an ombudsman who will have a limited role that will focus on screening potential conflicts of interest. The ombudsman will not be involved in the operation of the review panel. Any proposed changes to the guidelines would require a supermajority vote of 75 percent of the panel.

In other words, the IDSA agreed to change nothing in return for the CT AG returning to practicing law rather than medicine. Any ethics article that starts with a lie is unlikely to continue well. In fact, it goes on to assume as fact statements such as, “the diagnosis and treatment of Lyme disease has been suppressed, with profound healthcare implications for patients, their families and their communities.” This is not fact. This is opinion, and a controversial (and wrong) one at that. Now the paper uses this topic to explore ethical issues in conflicts of interest, the use of guidelines in general, and basically rehashes the “health care freedom” argument, which is basically a quasi-libertarian argument to allow patients access to any care, no matter how bad.

So, after reading this, I was curious: who are the authors? Are they infectious disease docs? Ethicists? Once I started looking at the first author, I was hooked.

His name is Dr. Raphael Stricker. He’s a hematologist, that is, someone who studies blood, blood banking, blood disorders, and the like. He is not an infectious disease specialist, the specialty that usually treats Lyme disease (although other specialties, such as neurology and rheumatology are not infrequently involved). Take a look at his CV, especially his research experience. You’ll notice that it seems to drop off after around 1993. Well, that’s not unusual. People don’t always stay in research forever. (Further down, he’s working for ILADS, the “chronic Lyme” advocacy group—curious). Anyway, further digging shows a possible reason for his drop off in research:

An investigation conducted by the University found that Dr. Stricker falsified data for a manuscript and a PHS-supported publication reporting research on AIDS. In the manuscript, Dr. Stricker selectively suppressed data that did not support his hypothesis, and reported consistently positive data whereas only one of four experiments had produced positive results. In the publication, Dr. Stricker reported that an antibody was found in 29 of 30 homosexuals, but not found in non-homosexuals. However, Dr. Stricker’s control data, which he suppressed, showed the antibody in 33 of 65 non-homosexuals. The falsified data was used as the basis for a grant application to the National Institutes of Health. The ORI concurred
in the University’s finding. Dr. Stricker executed a Voluntary Exclusion and Settlement Agreement in which he has agreed not to apply for Federal grant or contract funds and will not serve on PHS advisory committees, boards or peer review groups for a three year period beginning April 1, 1993. The publication “Target platelet antigen in homosexual men with immune thrombocytopenia” in the New England Journal of Medicine, 313: 1315-1380, 1985 has been retracted (New England Journal of Medicine, 325: 1487,1991).

Hey, he even made the New York Times!

So, in this debate about “chronic Lyme disease”, who is credible? Is it the experts in the field who have looked at the preponderance of data? Or is it a movie producer citing an ethics article which contains incorrect statements of fact and is written by a non-expert in the field who was banned from NIH funding for falsifying data?

Kris, you didn’t convince me to take you more seriously with your reading recommendations, but hey, I’ll still check out your movie. Hopefully it’s more entertaining than Expelled.

Posted in: Science and Medicine

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