Lyme Guideline Limbo

When last we spoke on the subject, I mentioned that the organization leading the charge against acknowledging and allowing treatment for patients with Lyme which doesn't go away after a short course of antibiotics is the Infectious Disease Society of America's (IDSA) Lyme Disease Guidelines Panel (LDGP.)

I also mentioned that this group was investigated by the Attorney General of Connecticut.

Before we continue on, we have to be clear about what the Attorney General was investigating. This was not an investigation of the science or the medicine. As reported: 

Blumenthal thanked members his office who worked on the investigation -- Assistant Attorney General Thomas Ryan, former Assistant Attorney General Steven Rutstein and Paralegal Lorraine Measer under the direction of Assistant Attorney General Michael Cole, Chief of the Attorney General's Antitrust Department.

That's right. The Antritrust Department. I'm no lawyer. I'm certainly no expert of antitrust laws, but I think I get the general idea. Antitrust laws are designed to make sure that business markets are not manipulated by unfair practices which eliminate the chance of fair competition. I do know that they originated in the US in response to monopolies in industries such as oil and transportation. You can read about the birth of those laws here.

Since I'm not versed in the intricacies of this area of law, I have to trust that the Attorney General and his people understood how they might apply to a non-profit, special interest society which is impacting the delivery of health care. You can see the use of antitrust language in their findings:

Blumenthal's findings include the following:

• The IDSA failed to conduct a conflicts of interest review for any of the panelists prior to their appointment to the 2006 Lyme disease guideline panel;
• Subsequent disclosures demonstrate that several of the 2006 Lyme disease panelists had conflicts of interest;
• The IDSA failed to follow its own procedures for appointing the 2006 panel chairman and members, enabling the chairman, who held a bias regarding the existence of chronic Lyme, to handpick a likeminded panel without scrutiny by or formal approval of the IDSA's oversight committee;
• The IDSA's 2000 and 2006 Lyme disease panels refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease, once removing a panelist from the 2000 panel who dissented from the group's position on chronic Lyme disease to achieve "consensus";
• The IDSA blocked appointment of scientists and physicians with divergent views on chronic Lyme who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though it was later expanded;
• The IDSA portrayed another medical association's Lyme disease guidelines as corroborating its own when it knew that the two panels shared several authors, including the chairmen of both groups, and were working on guidelines at the same time. In allowing its panelists to serve on both groups at the same time, IDSA violated its own conflicts of interest policy.

What is clear here is that the Attorney General was not making a medical assessment. He was making a process assessment. That is, he was looking at whether the process through which the guidelines were published was a fair and open process where competitive ideas were given a fair chance to be considered. For instance, is the panel really going to consider all evidence when the chair is able to "handpick a likeminded panel"? What you can see in these findings is a process wherein there was a preconceived notion and the panelists were chosen based on an understanding that they would not challenge that notion.

There is also collusion. The IDSA's group shared chairmen, authors and panelists with another, supposed independent, medical society who released Lyme Disease guidelines. Yet, never did the two organization reveal how related their groups were, creating the illusion that they reached their conclusions independently. Why the deceit?

Why indeed. What could motivate two not-for-profit organizations to do this? Here's an example of their self-defense:

"The Infectious Diseases Society says it's never been proven whether these patients still have Lyme disease or something else. The group continues to defend its standards, which say short-term antibiotics are effective for nearly all patients. Long-term antibiotics are unproven and potentially dangerous, because overuse of the drugs can lead to drug-resistant infections, the society says."

This is in response to the antitrust charges. Note that they are not debunking the charges themselves. Also notable is that the IDSA doesn't require proof that Chronic Lyme doesn't exist, they require proof that it does. A patient is diagnosed with an illness, gets the proscribed treatment and is still suffering from all the same symptoms, does not test positive for anything else, and they can't prove it's not persistent Lyme, but they can deny them treatment.

The third thing to note is that their objection about the existence of persistent Lyme seems to be attached to their concern about the use of long-term antibiotics. If we decide that a persistent infection could be effectively treated with something else, would they still deny the existence of a persistent infection? I can certainly see the value to a robust exploration of the efficacy of long-term antibiotics. Hey, let's do some more research. Showing that one antibiotic didn't work, does not eliminate the possibility that another might.  But even if antibiotics are not the answer, that's a different question than whether a persistent infection exists. So, I wish they would de-couple these two points.

Still, no matter their defense of their medical opinion, they are not defending their process. They are capitulating to the findings. This renders the opinions of the group suspicious.

And it still begs the question, "why?" Was it to protect the world from antibiotic overuse? Well, let's go back to the Attorney General's report:

"The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests -- in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies -- to exclude divergent medical evidence and opinion. In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions. As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards."

Unfortunately, the motivation doesn't appear to be altruistic. While the not-for-profit organization that this panel is supposed to represent may not have questionable motivation, the individual members of the panel itself do. Money. Its so often about money. The panelists had financial interests in drug companies and Lyme tests? And had consulting arrangements with the very industry that is denying us treatment? These same people are testifying in court against other doctors? How are they credible?

How can we trust the work product of a group of people with such varied conflicts of interest? We can't. Therefore, the IDSA agreed to have a conflict-free panel created to review the guidelines. They agreed to a public process and voting procedure that would ensure that divergent research, clinical experience and scientific and medical opinion would be considered as they questioned whether the guidelines needed to be revised.

There have been questions along the way about whether the IDSA was meeting the spirit of the agreement in its openness. The supposedly public hearing did not allow press, the room was closed. Only after some public pressure did they agree to have the proceeding streamed online.

Worse, they violated the agreement about the voting procedure such that it would be almost impossible for the outcome to require a guidelines revision. I'll write a separate post about the details of that. The bottom line is that the review process is now hung in limbo. Meanwhile, the restrictive guidelines which are used by insurance companies to deny treatment are still in place.

I don't understand how such a suspect work product can be justifiably used. There are other medical societies which publish different guidelines. (see ILADS) Clearly there is no universal medical opinion. We know there is no definitive science. Yet, the IDSA, the group shown to have conflicts of interest, is allowed to monopolize control over the dispensation of treatment to hundreds of thousands of suffering people. How is this legal? And when does the Attorney General get to say, "Hey, we signed an agreement to avoid the conclusion of my investigation. You violated that agreement, so now I will press forward."? If his antitrust charges are proven true, are these criminal violations? I don't understand enough about the pertinent laws to assess that.

What I do know: its morally reprehensible. I don't know how these people sleep at night.