Lyme Testimony

Reposted from Science-Based Medicine

As the saying goes, when you do not have the facts, argue the law. This tried and (?) true approach was successful in New York where a law was passed protecting those who are, shall we say, creative in treating patients with Lyme and 'chronic' Lyme.

The bill protects those from investigation of misconduct:

based solely on treatment that is not universally accepted by the medical profession.

The major bone of contention has been extended courses of IV antibiotics for 'chronic' Lyme, but there are a wide variety of treatments that may be used by so called "Lyme literate" doctors.

The number of therapies divorced from reality that are offered to Lyme patients is remarkable. I do not know if chronic Lyme patients have greater use of pseudo-medical therapies than other pseudo-diagnoses, but I am impressed by the offerings in a recent review:

Results. More than 30 alternative treatments were identified, which fell into several broad categories: these included oxygen and reactive oxygen therapy; energy and radiation-based therapies; nutritional therapy; chelation and heavy metal therapy; and biological and pharmacological therapies ranging from certain medications without recognized therapeutic effects on Borrelia burgdorgeri to stem cell transplantation. Review of the medical literature did not substantiate efficacy or, in most cases, any rationale for the advertised treatments.

Conclusions. Providers of alternative therapies commonly target patients who believe they have Lyme disease. The efficacy of these unconventional treatments for Lyme disease is not supported by scientific evidence, and in many cases they are potentially harmful.

Why a legislature would want to abandon consumer protections and protect those providing useless and potentially dangerous therapies eludes me.

There was a nice summary in the discussion which in many ways sums up the entire history of the Science-Based Medicine blog and its entries:

Two common themes characterized the websites referenced in this study. One was the reliance on anecdotes and testimonials from patients. The second was the veneer of scientific credibility, ranging from the medical credentials of the service providers to the use of seemingly technical terminology. In virtually all cases, these testimonials and scientific expositions were used promotionally to sell therapeutic services and products. Our review of the medical literature did not yield evidence to support these health claims.

Sadly, I suspect that the above paragraph will remain relevant for as long there is an internet. Plus ça change, plus c'est la même chose.

The malignant success in NY has inspired others to have similar laws metastasize to other states. They call me Dr. Metaphor for a reason. Oddly there is no super-hero or villain with that name. And here I though all the good names were taken.

In Oregon there was a similar bill before the legislature, which read:

Permit professionals regulated by the boards to diagnose and treat, in manners consistent with the standards of care guidelines developed by the International Lyme and Associated Diseases Society, Lyme disease and associated viral, bacterial and parasitic diseases; and

(b) Establish disciplinary procedures that consider as mitigating factor whether, in diagnosing or treating Lyme disease or associated diseases, a professional who is facing discipline followed evidence-based diagnosis and treatment guidelines not recognized by the boards.

I suspect similar laws will be showing up in your state. As part of the legislative process in Oregon, there are public hearings where anyone can testify for or against a bill. I thought it would be interesting to look at some of the testimony in favor of the bill for insight into the rationalization behind supporting the bill.

There was but one letter opposing the bill from the Oregon Health Authority. Otherwise it was all testimony in favor.

Of the 58 exhibits, 35 were from patients. They have a similar theme: odd symptoms, a diagnosis of Lyme by one non-standard test or another, refusal of Oregon doctors to recognize and treat the patients for Lyme for what are probably nefarious reasons, and occasionally some improvement with alternative therapy delivered in other states.

As an IDSA-sort-of-doctor, the suffering is compelling (although not due to Lyme). The lack of precise information about testing and treatment is aggravating, making an assessment of the validity of the patient stories impossible. I am well aware of unreliability of patient histories, especially when they have a dog in the fight.

Most appear to be patients who have received creative care from the alternative Lyme world. An example (bold are my additions):

Ashley to the East Coast, where she was examined, tested, and found to have Lyme disease, along with Babesia and Ehrlichiosis (three diseases almost nonexistent in Oregon). Her Lyme doctor was shocked that her absolute classical presentation was ignored by her doctors and specialists. She improved using the ILADS standard of care.

This doctor worked with Ashley's PCP's who could do supportive care in Oregon. Over the next several years, we and our daughter went through a cyclical routine of Oregon support doctors discontinuing her ILADS Lyme treatment and telling us residual symptoms were not Lyme. However, the symptoms recurred, and positive blood tests, including 2 positive PCR (DNA) tests (unreliable) indicated she was still infected.

When we asked the East Coast and California Lyme specialists why she was so difficult to treat they said because she went for 9 years without any treatment, and the bacteria had penetrated bone marrow and brain (not).

Ashley stabilized to an almost normal life routine by age 20, but she missed having anything resembling a normal childhood and teen years. At this time, she is happily married and has 3 healthy children.

Our family was terribly impacted. Our "vacations" were often spent traveling to out-of-state doctors. Our children missed out on many normal family activities. We can never get back those years. We've spent approximately $185,000 out of pocket

That is a lot of money. No wonder the Lyme literate doctors want legislative protection from their treatments. And they say we are shills.

Some of the diagnoses and clinical courses are quite fantastical, although from the spotty information given in the testimony a true analysis is not possible. It would be interesting to compare the testimony with the whole medical record, but that is unlikely to occur.

Many were diagnosed for Lyme and other diseases using testing that may be suspect. Igenex is a popular but questionable lab, used rather than the standard two step testing. The CDC test, as they call it, has been validated by the gold standard: culture positive patients. I cannot find where Igenex has been validated, if it is on PubMed I could not locate it. The closest I could find was a report that:

IGeneX was rejected by New York three times for Lyme tests in the past decade for not having enough documentation to prove the tests worked.

And:

Several Lyme laboratories said they stood by their tests, but the process to get FDA approval was too cumbersome.

"You need a ton of documentation,'' time, and money, said Jyotsna S. Shah, vice president of IGeneX Inc., a Palo Alto, Calif., lab that performs more than 25,000 Lyme tests a year for hundreds of dollars each…

…In contrast, government and academic scientists contend that the IGeneX method is highly sensitive but not adequately specific, meaning it probably returns positive readings for many people without Lyme.

Sitting in a small conference room in a nondescript building near Stanford University, Shah said IGeneX's testing is backed up by solid science and that the company has been open about its methods. She pointed to two papers on its methods, a 2007 paper published in an alternative medicine newsletter and a 2010 paper in a journal that appears to be defunct. Neither publication is widely read or cited by other scientists.

The patients put a lot of faith in the validity of the alternative testing despite a lack of rigorous published evaluation. Perhaps because it provides the answer they want, motivated reasoning at its finest.

The most common of all follies is to believe passionately in the palpably not true. It is the chief occupation of the Lyme literate.
-- H. L. Mencken. Almost.

Reading the patient testimony made me sad. People suffering (I never deny the suffering of patients, only that the suffering is from Lyme), being diagnosed with multiple infections with unreliable tests and spending enormous amounts of time and money chasing the chimera of alternative treatments for their mythical illness.

More striking is that if the testimonies are correct, it documents medical treatments by the Lyme literate doctors that are, in my opinion, truly bizarro by my understanding of infectious diseases. Why such horrible medical care needs protection is understandable. Such care certainly cannot be justified by the best medicine and science.

Many of the patients noted that Lyme is an under recognized epidemic; I saw an epidemic of inappropriate tests, testing and treatment.

This was brought home by the opening testimony of the Oregon Lyme Disease Network.

They note many times more false Lyme diagnoses than real Lyme diagnoses in Oregon:

CLIA certified laboratory with CDC proficiency ratings, reported 166 CDC positive results on either Western Blot IgG or IgM test for Oregonians in 2014

Currently in Oregon Support Groups 817 patients, a combination of clinical diagnosis with supportive laboratory testing.

Patients currently in Support groups or in email connection with SG around the state: 817

While:

The State of Oregon, Cases of Selected Notifiable Diseases for 2014 — reported a total of 38 probable cases and 21 confirmed in Oregon for the year.

It is the kind of weasely statements that obscure the truth with misdirection. Lots of positive tests by labs that are certified but note they fail to mention if the tests are validated. In my opinion there are a staggering numbering of patients misdiagnosed and mistreated with Lyme.

The Oregon Lyme Disease task Force also says MDs (emphasis added):

Reject IgeneX laboratory telling patients it's a bad lab (not sure why they say this)

Really? You really can't discover why MDs might find Igenex questionable? It took me less five minutes to find why the non-standard Lyme testing is questionable.

No MDs testified in favor of the bill. I can see why. If the patient stories are any judge, the doctors who provided the care as mentioned in the patient narratives have reason to worry. I tend to be fairly liberal in patient care as often the what and how of patient care has uncertainty, but in the case of these testimonies? Gave me the heebie-jeebies.

There was a ND who did mention the benefits of naturopathic practice in Lyme:

I am indeed fortunate that I hold a license as a Naturopathic physician and as a consequence have a board that allows me to practice without the threat of losing my license if I choose to treat a patient diagnosis with Lyme disease.

As has been pointed out elsewhere, being a naturopath means never having to say you have standards.

So that was the testimony in favor of the bill. Patient stories of creative diagnosis and treatment and the need for those who provide those treatments to be protected and paid. Some disingenuous cherry picking from the Lyme organizations. A seeming lack of understanding why the ILADS guidelines and alternative testing are suspect and what constitutes best evidence. From my viewpoint, the testimony was a compelling argument for increased investigation into the practice Lyme literate doctors to protect patients. They did their cause little benefit.

There is a lot more information in these testimonials that would make interesting analysis if I had the time.

Despite all the testimony in favor of the bill, or perhaps because of it, the bill was amended to instead read:

The Oregon Health Authority, the Oregon Medical Board and the Oregon State Board of Nursing shall study clinical guidance regarding Lyme disease and the health outcomes related to the clinical guidance and shall report findings to the appropriate committees of the Legislative Assembly no later than March 1, 2016.

I am a newbie in the legislative arena and had a late start in the 2014–15 legislative session when Oregonians for Science-Based Medicine was started as part of SfSBM. I hope next season to start earlier and more comprehensively. That being said, Ore4SBM sent a letter opposing the bill to the Committee as well as a modified (snark free) version of my SBM post on Lyme.

The committee members also received a letter opposing the bill, written and orchestrated by yours truly, signed by 18 Oregon Infectious Disease doctors.

Did those actions have any effect to change the bill? No idea. But I like to think it did.

For now the standard for the treatment of Lyme will remain gold rather than the tin of the initial bill. It will not last. I have no doubt that further SCAM protection bills will be presented to Oregon, and other, legislatures.