Understanding the Antitrust Investigation into the Lyme Disease Treatment Guidelines

anit trust investigation

For those of you who don’t know the whole story behind the controversy with Lyme, please read this article. It explains what happened a few years back when General Attorney Blumenthal launched an investigation against the IDSA guildeline writers.

The Reasons for the antitrust investigation by Connecticut Attorney General Richard Blumenthal. 

1. Lyme Guidelines suggest relying upon inaccurate testing for diagnosing Lyme.

2. The IDSA says its guidelines are voluntary, but they know that major insurers use their guidelines to deny coverage for long-term treatment of Lyme Disease, limiting patients in getting the appropriate care they need.

The Conclusion of the Antitrust Investigation:

In May 2008, Blumenthal concluded the investigation and announced the flaws he discovered in the Lyme Disease guidelines’ development.

1. The results were that the investigation revealed panelists’ connections to insurance and vaccine companies in violation of antitrust principles, and they’re failure to review potential conflicts of interest such as financial interests in drug companies, diagnostic tests, patents and consulting arrangements with insurance companies. He also found that there was bias in the selection committee, and exclusion of dissenting panelists.

2. Also found was misrepresentation of the guideline authors’ views as independent, and misrepresentation of the guidelines as voluntary. There were what they called “improper links” between the IDSA’s and the American Academy of Neurology’s (AAN) Lyme panels. The two panels shared key members, and were working on both sets of guidelines at the same time, which is a violation of IDSA’s conflicts of interest policy.

3. Doctors were pressured to conform to the beliefs that Lyme was not chronic. Any views of opposition were not considered.

Five IDSA panelists were found to have conflicts of interest:

1. Dr. Gary Wormser, the panel chair, received funds “from Baxter and Immunetics, and is one of the founders of Diaspex. Wormser also later  disclosed he was receiving grants that were related to Lyme disease from Bio-Rad, Biopeptides, Merck and AstraZeneca and that he owned equity in Abbott, and being retained in some medical-malpractice cases involving Lyme disease.”

2. R. J. Dattwyler, is a speaker for Pfizer and a part owner of Biopeptides. Later Dattwyler disclosed he had a financial connection to Baxter and serving as an expert witness in medical malpractice actions.

3. J. J. Halperin, was an expert witness on behalf of Lymerix (GlaxoSmithKline) the failed Lyme vaccine.

4. Allen C. Steere is a consultant for P. J. Krause and Baxter. This is a developer of a diagnostic procedure for a coinfection of Lyme. Later disclosed they found out Steere has a financial connection to GlaxoSmithKline and Viramed.

5.  Eugene Shapiro, elsewhere admitted to receiving grants for Lyme vaccines, testifying in Lyme-related medical malpractice actions, and reviewing Lyme disability claims for Metropolitan Life Insurance Company.

Click Here to Read the, “The Ties That Bind” an excellent article and chart that shows the ties between the IDSA and CDC and Lyme testing and politics.

The Outcome

The investigation resulted in a settlement that required that the guidelines be reviewed by a completely new panel that is free of conflicts of interest and represents a range of views.

New Issues

Many Lyme patients were not happy with the resulting review panel because its chair was a former IDSA president. The new panel elected totally excluded any candidates who supported long-term treatment. And after final reviews the panelists announced, Still no long term treatment was thought to be necessary.

The attorney general also found that the IDSA failed to follow its own procedures for appointing panelists. The IDSA’s procedures say that guideline panels should have a wide range of experts, therefor hearing all sides of different views.  But the attorney general found that the 2006 Lyme panel’s chairman had handpicked a like-minded panel. When one of the  members of IDSA’s 2000 Lyme guidelines panel \argued that chronic Lyme exists, the panel pressured him to conform, and removed him when he refused to conform to their veiws. And later when  scientists that had differing views on chronic Lyme tried to join the 2006 panel, the IDSA told them that it was fully staffed. Even though later they hired more like minded panelists.

So in other words, again this panel, like the 2000 panel, was clearly biased. 

When they wrote their new guidelines: 
* The IDSA left out any research that didn’t fit into their definition of Lyme and refused to even consider information regarding the existence of Chronic Lyme.

Here are some Points that Have Lyme Patients Scratching their Heads

The IDSA says:

“Clinical findings are sufficient for the diagnosis of erythema migrans, but clinical findings alone are not sufficient” to diagnosis other signs of Lyme. Patients without an EM rash must have 2 positive Lyme tests “using the 2-tier testing algorithm recommended by the CDC.”

The CDC Says:

*  “This surveillance case definition was developed for national reporting of Lyme disease; it is not intended to be used in clinical diagnosis.”

So Patients Ask:

If the CDC says they are not sufficient enough for diagnosis, why are we using them?

The CDC Reports:

That only 68% of Lyme patients meeting its surveillance definition have EM rashes.

* Its two-tier test requires positive ELISA and western blot tests for a diagnosis. The CDC relied on studies showing that this two-tier approach had sensitivities of 33% and 57% for early-and late-stage Lyme respectively. This leaves 22% of patients untreated with early-stage Lyme and 43% untreated of late-stage Lyme, since standard EM rashes disappear in early-stage Lyme.

So Patients Ask: Why are we using tests that leave 22% untreated in the early stages?

The IDSA guidelines recommends:

Only up to 28 days of antibiotics, even for late-stage neurological Lyme. They say: “There is no convincing biologic evidence for the existence of symptomatic chronic B. burgdorferi infection among patients after receipt of recommended treatment. Antibiotic therapy has not proven to be useful and is not recommended for patients with chronic for more then 6 months with subjective symptoms after administration of recommended 10-to 28-day treatment.

Yet, the same IDSA panelists said elsewhere:

that Lyme’s successful yield rate for blood cultures is below 10%. So why do the IDSA guidelines call these cultures the “gold standard?”

So Patients Ask: Why are the IDSA panelists putting out contradictory statements regarding there being no evidence of the infection persisting past 28 days of antibiotics if there is no test that can successfully tell us if we are still infected? Shouldn’t the fact that we are still having lingering symptoms show them otherwise?

When reviewing the Lyme Guidelines:

The guidelines rejected a study that used a new method to culture the bacterium in 97% of 47 guideline-treated patients because the germ was found with microscopes, not DNA tests, and because two other studies with 22 guideline-treated patients couldn’t culture it.

So Patients Ask: Why was this study rejected? Why does it matter what method they used to discover the persistent bacteria in patients?

* The IDSA’s guidelines will not say “Chronic Lyme,” instead they state that chronically ill patients suffer from post-Lyme syndrome. This is defined as “unexplained chronic subjective symptoms following treatment with recommended antibiotic regimens.” It is their way of denying persistent infection and making it seem there is another reason for ongoing symptoms.

So Patients Ask: If someone gets Strep throat and the first course of antibiotics doesn’t work fully, then doctors give you another course. Why are Lyme patients not treated with the same respect? Where is the evidence and research showing that there has been damage done to cause our symptoms and that it is not a persistent infection? If there are no accurate tests to show we still have a persistent infection, then how can we rule that out?

More Articles Regarding the Investigations

Attorney General’s Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees To Reassess Guidelines, Install Independent Arbiter

Here is the IDSA agreement:
An Agreement between the Attorney General and the IDSA

Unprecedented Antitrust Investigation into the Lyme Disease
Treatment Guidelines Development Process

Final Report of the Lyme Disease Review Panel of the Infectious Diseases Society of America

The Ties That Bind

Unprecedented Antitrust Investigation into the Lyme Disease Treatment Guidelines Development Process

Lyme advocates call out IDSA, accusing them of ‘deliberate misinformation campaign’

Lyme Disease Guidelines Panelists Engage in Coordinated Propaganda Campaign





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