One of the most vitriolic debates in medicine has come to the State House.
Desperate Lyme Disease patients say they are fighting for their lives.
They say doctors who treat their illness with long-term antibiotics are persecuted by the medical establishment.
They want lawmakers to pass legislation that they say will free doctors to treat Lyme Disease as they see fit.
On the other side are doctors equally convinced that long-term antibiotics are both ineffective and dangerous.
NHPR health reporter Elaine Grant has more.
For years, patients suffering from a host of symptoms that they call chronic Lyme Disease have said they encounter difficulty getting treated appropriately.
With its so-called “bucket of symptoms” that mimic numerous other ailments, Lyme Disease can be tough to diagnose.
And for a variety of political reasons, it can be even harder to treat.
Consider the case of Cathy Kettman, a fifty-six year old mother of four from Bow.
Several years ago, she went to the hospital with chest pains – but tests showed no heart disease.
She developed numerous other symptoms, and for five years she searched for a diagnosis.
Cathy Kettman: They sent me to neurologists, endocrinologists, rheumatologists, they sent me to Dartmouth, they sent me back and forth for nine months to Brigham and Women’s looking for a tumor, they were trying to rule out MS and lupus.”
At one point, she was so crippled that her husband had to carry her to the bathroom.
When they asked her family doctor to test her for Lyme Disease, the doctor refused to treat her.
Finally, a doctor in Maine diagnosed her with chronic Lyme.
And that’s the first point of contention in the debate over how to treat these patients.
At issue in the scientific community is the question of whether or not long-term, or chronic, Lyme Disease actually exists.
The Infectious Disease Society of America is a group of 8,000 doctors that sets the generally accepted medical standards for about 50 infectious diseases.
The IDSA says there’s no such thing as chronic Lyme.
Here’s retired Concord doctor Susan Savateer representing the group, testifying before the House Health and Human Services Committee.
Dr. Susan Savateer: “As physicians, we have to be very careful not to give patients a diagnosis of LD unless they meet clinical criteria. Patients with chronic symptoms, mostly subjective, musculoskeletal pain, fatigue, memory deficits, these are common symptoms in our society.”
The Centers for Disease Control generally agrees with the IDSA.
And both groups say there is no benefit – and a great deal of potential harm -- to treating patients with antibiotics for longer than four weeks.
Dr. Paul Mead is an epidemiology chief at the CDC.
Dr. Paul Mead: “The National institutes of Health sponsored several studies to evaluate, well, do antibiotics make these people better? And the answer was, not more so than placebo.”
Furthermore, Mead says, both the antibiotics and long-term use of intravenous drugs can cause a number of serious illnesses and even death.
And doctors who subscribe to the IDSA position say over-diagnosing persistent Lyme can lead them to miss other serious illnesses.
Patients could not disagree more vehemently.
The International Lyme and Associated Diseases Society directly opposes the IDSA.
ILADS says science shows that chronic Lyme is real and that long-term therapy can help.
But advocates say that, in the medical world, IDSA reigns supreme –and that causes doctors to fear following alternative guidelines.
They point to situations like that encountered by Kevin Young, a primary care physician in Plymouth.
Years ago, Young’s daughter came down with a mysterious illness.
She suffered from a variety of neurological problems including intermittent blindness, seizures, and cognitive problems.
Dr. Kevin Young: Over the next two years, she went from being honors English in high school to being unable to comprehend a newspaper article.”
Young sought help from specialists.
Dr. Kevin Young: “No one could explain her problem. During that time, I did follow IDSA guidelines. It was a scary time.”
Finally he gave his daughter antibiotics – for nine and a half years.
Today, he says she’s well.
But his treatment choice came at a professional price.
Dr. Kevin Young: A neurologist who saw my daughter not only questioned my medical judgment, but also threatened to report me for child abuse. He said due to our professional relationship over many years, he would not do that, but that does dramatize the conflict within the medical community.”
The conflict has become so nasty over the last two decades, advocates say, that doctors in many states, including New Hampshire, are afraid to treat Lyme patients.
Representative Gary Daniels: “This has had a chilling effect on the number of Lyme literate physicans who are trained or willing to treat Lyme patients…Many of our state residents are forced to travel beyond our state borders to find the treatment that they need.”
That’s State Representative Gary Daniels, a Republican from Milford.
He says doctors in other states have been prosecuted by medical boards for prescribing long-term antibiotics.
And although it’s never happened in New Hampshire, Daniels wants to make sure it won’t.
He’s sponsored a bill to protect doctors from prosecution by the Board of Medicine should they choose long-term treatment.
The New Hampshire Medical Society opposes the bill, saying physicians are already free to treat as they wish.
Lawmakers also question whether any other illness has received exemptions from medical oversight.
In response, advocates say the scientific community views Lyme differently.
And that has broader implications.
Pat Smith is president of the Lyme Disease Association.
Pat Smith: “We actually have cases where insurers have not paid for medical treatments due to the IDSA guidelines. We have cases where pharmacies have stopped giving patients their medicines because of the IDSA standards.”
Further complicating an already thorny issue is the question of the IDSA’s integrity.
Last year, Connecticut Attorney General Richard Blumenthal settled an anti-trust case against the IDSA.
According to court documents, the IDSA Lyme review panel was found to have conflicts of interest, including ties to drug and insurance companies.
The IDSA is reviewing its guidelines, but no major changes are expected.
Legislation virtually identical to New Hampshire’s passed unanimously in Connecticut last year.
Similar bills are pending in Massachusetts, Minnesota, and Virginia.
With 92 cases per 100,000 people, New Hampshire has the highest reported incidence of Lyme Disease in the country.
For NHPR News, I’m Elaine Grant.
"During an antitrust investigation of the IDSA guidelines development process for the 2006 Lyme disease treatment guidelines, AG Blumenthal’s office uncovered significant procedural deficiencies, including conflicts of interests of the panel members. A settlement was reached, and the IDSA is breaching it. The IDSA is manipulating the voting process to favor no change in the guidelines. The AG has sent the IDSA a letter requesting that they redo the vote in compliance with the agreement.
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 theSettlement 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.
What happened? The IDSA used an “improper voting procedure,” based on a process of its own design, which blatantly violates the Settlement Agreement and undermines the integrity of the voting process. The IDSA consented to the voting procedure in the Settlement Agreement and confirmed its understanding of the required voting procedure in an internal memo from the IDSA to the panel before the panel met. The Attorney General’s letter and the IDSA internal memo to the panel can be downloaded by clicking the link below this post..
What voting process was required and how was it violated? The Settlement Agreement requires a two step voting procedure, with each step requiring a supermajority vote (6 of 8 panelists). The first vote asks the question whether each of the contested guideline recommendations is “medically/ scientifically justified in light of all of the evidence and information provided.” This vote requires a supermajority of the panel (6 of 8) in order for a guideline recommendation to stand. In essence, it asks “did the panel that adopted the 2006 guidelines get it right”? The second vote, also by supermajority, determines whether the guidelines require no changes, partial revision or complete revision.
The IDSA’s flawed voting procedure combined the two voting steps into one. First, the panel failed to conduct the vote to determine whether the science was sufficient to support the guideline recommendations. Next, the panel substituted its own procedure for the second step in the voting and required a supermajority for any change. This process effectively flipped the supermajority requirement to favor no change to the guidelines.
From the get-go, two significant points stand out:
· The IDSA failed to voluntarily comply with the Settlement Agreement in good faith.
· Absent oversight by the AG pursuant to the Settlement Agreement, the IDSA would have carried out a corrupted process that blatantly violates the agreement—and it might never have been discovered.
Patient groups are appalled that so far the IDSA, which should conduct an honest review and assessment of the evidence supporting the IDSA recommendations, has chosen to manipulate the voting requirement to influence the outcome, in clear violation of the Settlement Agreement and the scientifically based review and voting process which it provides. This turns evidence-based medicine on its head.
Can the process be saved? Patient groups, along with the public at large, expected that the IDSA would comply with the Settlement Agreement in good faith. It is, after all, a settlement agreement with the Attorney General of the State of Connecticut. When the IDSA panel so deliberately violates the voting procedures, as expressly confirmed by the words of the IDSA’s own internal memo, and refuses to comply with the Attorney General’s request, there can be only one conclusion: The ability of the IDSA to run this process with integrity is extremely suspect and any outcome must be viewed critically.
Other examples of abuse by IDSA of settlement process: This is not the first time legitimate questions have been raised regarding the IDSA’s willingness and reliability in performing its obligations with integrity under the settlement process. For instance, the IDSA was charged with selecting the panel and chose to exclude divergent viewpoints (including physicians who treat chronic Lyme disease). One panelist was removed by the panel after patients complained because he had served on another Lyme guidelines’ panel− a direct violation of the settlement agreement. Another panelist had also served on a previous Lyme guidelines’ panel, but despite patient complaints, was not removed.
Patient organizations call upon the IDSA to hold an individual vote on whether each of the guidelines’ recommendations is medically/scientifically justified in light of all the evidence as requested by the Attorney General. If IDSA fails to do so in good faith, patients continue to rely upon the Attorney General to continue to enforce the Settlement Agreement."
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An example of the IDSA manipulation of the voting procedure.
The guidelines mandate that Lyme cannot be diagnosed without a confirming diagnostic test.The tests are known to be insensitive and flawed. Requiring a positive test means that many patients with Lyme disease will fail to be diagnosed. One panel vote described in the AG’s letter was whether this recommendation should be revised. Four of the eight panel members voted for change, without the panel first having voted to determine whether the recommendation was supported by the science. As the AG’s letter points out, this clearly means that had the panel voted in accordance with the Settlement Agreement, this recommendation would have failed as not properly supported by the medical/scientific evidence. Why? A vote to uphold this recommendation would have required 6 votes; however, the 4 votes calling for revision (even
though predicated on a flawed procedure) plainly indicates insufficient evidence to support the recommendation. Thus, (a) the IDSA failed to vote to determine whether the science supported the recommendation, (b) substituted its own procedure regarding revision (requiring a supermajority vote to revise), and (c) thereby manipulated the voting requirements to achieve a result in its favor.
You can follow additional comments on Lyme policy at www.lymepolicywonk.org. You can contact Lorraine Johnson, JD, MBA at lbjohnson@lymedisease.org.
