METALLlC BLUE
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Medical groups differ on courses of treatment By Robert Miller Staff Writer Newstimes.com Article Last Updated: 05/12/2008 04:14:20 AM EDT
In the battle over how best to treat Lyme disease, a new settlement between Attorney General Richard Blumenthal and a major medical group might seem to offer at least a little hope of expanded treatment for those with the tick-borne disease.
That, however, would involve a change in the lines of debate over the disease, and it's not clear there will be any yielding.
The settlement, reached this month between Blumenthal and the Infectious Diseases Society of America, provides for a review of the IDSA's guidelines for treating Lyme disease -- guidelines that a second group of doctors, the International Lyme and Associated Diseases Society, say are strict and inflexible to the point of harming some patients.
But the IDSA's guidelines will remain unchanged until that review ends. And while the review process will include the participation of an ombudsman, the guarantee that opposing voices will get their say, and hearings that will be broadcast on the Internet, they may not yield a single change, said Dr. Eugene Shapiro, a pediatrician, epidemiologist and professor of investigative medicine with the Yale School of Medicine in New Haven.
Asked last week if the IDSA guidelines could remained unchanged after the review, Shapiro said flatly, "Yes."
"If the scientific data recommends a change, we'll be happy to change," Shapiro said. "But we have 25 years of research on Lyme disease. We feel very comfortable the guidelines will stand up to any scientific scrutiny."
Doctors who are opposed to the IDSA guidelines said they believe there's at least a chance their position -- that infection from the Lyme disease bacteria Borrellia burgdorferi can create a chronic illness that needs long-term treatment with antibiotics -- will gain some credence with the review panel.
"I hope it will lead to an improvement to patient care," said Dr. Steven Phillips of Wilton, who has been one of the doctors opposing the strict guidelines in favor of those in which doctors can tailor treatment to individual patients.
Phillips is a past president of the International Lyme and Associated Diseases Society, which believes there is ample scientific evidence to treat people for chronic Lyme disease.
"We've looked at the same evidence as IDSA and come up with significantly different conclusions," said Dr. Daniel Cameron of Mount Kisco, N.Y., the current president of the group.
This isn't a merely a spat between two opposing medical groups.
In a press release, Blumenthal's office pointed out that insurance companies now use the IDSA guidelines to restrict care for patients and refuse to pay for long-term antibiotic care.
"It's a good way to have people denied insurance," said Maggie Shaw of Newtown, a member of that town's Lyme Disease Task Force. "It also puts the fear factor in doctors.
"Here are two standards of care, but only one gets recognized," Shaw said. "It's because of the stranglehold the IDSA has on this."
The settlement between Blumenthal and the IDSA came after Blumenthal sued the group -- which represents about 8,000 infectious disease specialists in the United States -- in 2006 for antitrust violations.
Blumenthal said his investigation discovered many examples of conflicts of interest among the doctors who wrote the IDSA guidelines. He also said they refused to "accept or meaningfully consider" any evidence concerning chronic Lyme disease in writing the 2006 guidelines and blocked the appointments of scientists and physicians who differed with the IDSA view that all Lyme disease can be treated with two to four weeks of antibiotics and that chronic Lyme disease does not exist.
"Our focus has not been on medicine but the process," Blumenthal said. "There may have been violation of the law and it's my job to enforce the law."
Dr. Sam Donta, a Massachusetts-based infectious disease specialist, was on the panel that drew up the IDSA guidelines. Donta said he refused to sign off on the guidelines when the group refused to acknowledge that chronic Lyme disease is a problem.
--The issue should not be whether there's chronic Lyme disease, but why we're seeing these patients," he said
The review process established in the settlement, Blumenthal said, will be "fair, open and free of conflict." Donta said Friday he hopes to serve on the panel.
But in its own press release on the settlement, the IDSA emphatically denies there was any "significant" conflict of interest on the part of any of the doctors who wrote the 2006 guidelines, or that they excluded conflicting points of view while writing them.
In fact, Shapiro said, having stricter guidelines means doctors who follow the IDSA protocols see patients fewer times and prescribe only short-term regimens of generic antibiotics.
Shapiro said the IDSA agreed to the settlement simply to end any attempt by Blumenthal to take the case to court.
"The alternative was spending a lot of money in an expensive lawsuit," he said.
Shapiro said all the scientific evidence on long-term treatment of Lyme disease, including five double-blind studies in which some patients got antibiotics and others a placebo, show that long-term antibiotics did not cure the symptoms that people include in the diagnoses of Lyme disease.
"It's not that data isn't there. It is," he said, pointing out that 95 percent of all Lyme cases are successfully treated with only two or three weeks of standard antibiotics.
But Cameron said the double-blind studies, all with a small number of patients, only show that Lyme disease is complicated.
"The evidence is quite mixed," he said.
And the trials often look at the effect of just one type of antibiotic on patients, Donta said.
"If one doesn't work, do you say all antibiotics don't work?," he asked. "If one cancer drug stops working, do you not try and find another? There's insufficient information in the guidelines for physicians to make a decision."
Phillips of Wilton said many peer-reviewed articles published in medical and scientific journals make the case that chronic Lyme disease does exist.
What they hope the new review of the IDSA guidelines do, they said, is take all this into account and give doctors a chance to treat each case individually, rather than with a one-size-fits-all approach.
"Let the doctors have some flexibility," Cameron said.
shazdancer
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I love this quote from Shapiro,
quote:In fact, Shapiro said, having stricter guidelines means doctors who follow the IDSA protocols see patients fewer times and prescribe only short-term regimens of generic antibiotics.
Yes, he will see patients fewer times, because they FIRE him when his treatment fails and move on to someone else.
I am struck by how these guys are trying to salvage their egos and bias the pool of potential panelists by making these statements in the press.
-- Shaz
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Michelle M
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How cool that Dr. D was the dissenter who wouldn't sign off on the Guidelines!!! Yay! I LOVE THAT!! Go, Dr. D!
This is a good article.
Michelle
Posts: 3193 | From Northern California | Registered: Apr 2005
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northstar
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In fact, Shapiro said, having stricter guidelines means doctors who follow the IDSA protocols see patients fewer times and prescribe only short-term regimens of generic antibiotics.
my oh my, dont the insurance companies just llloooooove that!!
Shapiro said all the scientific evidence on long-term treatment of Lyme disease, including five double-blind studies
my oh my, now the study count is up to FIVE, count 'em, FIVE studies. It used to be three.
95 percent of all Lyme cases are successfully treated with only two or three weeks of standard antibiotics
Great, and the other 5%???? Lets see, 0.05x 230,000 lyme cases per annum=
(sing it out now)
11,500 cases per annum of treatment resistent cases PER YEAR.
oh, those must be those labeled "post lyme syndrome". If that is the case, then Shapiro's statement should be 100%. He cannot account for those 11,500 cases per annum with ANY study.
One wonders what his departmental budget and accounting looks like, after that lack of ability, or maybe his tax returns!! Or his checkbook!!
Donta said.
"]If one doesn't work, do you say all antibiotics don't work?," he asked. "If one cancer drug stops working, do you not try and find another? There's insufficient information in the guidelines for physicians to make a decision."
Exactly. This is so true. Misuse of statistics with the swipe of a pen. Shapiro knows better, so he cant claim ignorance. How does he sleep at night? The insurance companies had better pay attention to his propensity to dishonesty.
The IDSA ID's had better pay attention to his propensity to dishonesty. Maybe you ID's are being jerked around too? You will never know if you blindly accept?
Maybe the House of Representative Health Committee panelists and Pallone had better do their homework, because you may be jerked around too. Watch where you are stepping.
Northstar
[ 12. May 2008, 11:01 AM: Message edited by: northstar ]
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METALLlC BLUE
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See, Dr. D is a good guy. He means well, he's trying to help.
-------------------- I am not a physician, so do your own research to confirm any ideas given and then speak with a health care provider you trust.
shazdancer
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If memory serves, Dr. D was on the 2000 panel.
In 2006, a few ILADS docs asked to be included, and they were told the panel was already complete. Wormser then went on to empanel other people he wanted. It was one of the points Blumenthal got them on.
-- Shaz
Posts: 1558 | From the Berkshires | Registered: Jul 2001
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posted
Dr. D was either kicked off or voluntarily left the 2000 panel, depending on whom you believe (him/Blumenthal or IDSA). I wonder if that means he can serve on this new panel, since he wasn't one of the final 2000 authors?
(To clarify I should have said 'kicked off if he was going to maintain his position on chronic Lyme'. Which he did.)
[ 12. May 2008, 12:21 PM: Message edited by: ldfighter ]
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METALLlC BLUE
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I'll ask Dr. D about that. I see him soon.
-------------------- I am not a physician, so do your own research to confirm any ideas given and then speak with a health care provider you trust.
Geneal
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posted
I liked the article. I keep thinking
"and so the plot thickens".
By all means keep it in the media and hammer away the IDSA's take on Lyme.
Public opinion is easily swayed by the media and their potrayal of events.
I hope we are gearing up to do the same. Our stories must be told.
BTW, Northstar I love your math!
Hugs,
Geneal
Posts: 6250 | From Louisiana | Registered: Oct 2006
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MariaA
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This is one of the best articles I've seen on the treatment "controversy", also, there are some good comments in the comments section (along with one or two raving nuts, which is typical for news articles that enable online comments).
Here's what I wrote in the comments:
For an example of a very flawed double-blind study often cited by the IDSA guidelines authors to back up their allegation that long-term antibiotics don't help chronic lyme patients, see this analysis (by a firm that specializes in analyzing medical studies for hidden bias for use in court cases):
In brief: the often-cited Klempner study took a very small number of patients who had already had treatment failures with antibiotics (meaning they were difficult cases for whom antibiotics don't work well), then treated them for only 30 days with an IV antibiotic and for only two months with oral doxycycline, and then did a subjective symptom survey of the patients and other subjects who received placebo instead of antibiotics.
The study's authors then proclaimed that because the survey results didn't differ between the treated patients and those who received placebo, this proves that long-term antibiotics don't do anything for Lyme.
In reality, the study didn't really treat it's patients with anything remotely resembling 'long-term antibiotics', and picked an oral antibiotic that frequently fails to show results in those patients who experience antibiotic treatment failures.
There were many other flaws- the Verim Research analysis summarizes some of them on page 6 and 7 of the PDF, which are a good introduction to the entire issue of Lyme treatment controversy.
Chronic Lyme patients who are lucky enough to have access to a lyme-literate doctor are often treated with 6 months to many years of antibiotics. For those for whom simple treatment doesn't work (and for some people it's specifically doxycycline or amoxycillin that don't work), doctors may progress to using combinations of antibiotics, or longer treatment with IV.
Doxycycline is a first step for many patients but when it doesn't work more expensive antibiotics, and combinations of antibiotics, are usually prescribed by knowledgeable doctors such as members of International Lyme and Associated Diseases Society (www.ilads.org).
The Klempner study was designed with many built-in conditions that seem designed to predispose it's small sample size of subjects to treatment failure, and the IDSA guidelines authors seemed to base their guidelines literature review on similar studies, hand-picked to prove their extreme position.
When the 2006 guidelines were announced, the ILADS president produced a statement that there were something like 1800 good studies on Lyme treatment in existence, but that the IDSA guidelines authors had hand-picked the worst 400 to prove their point.
-------------------- Symptom Free!!! Thank you all!!!!
posted
Not going to be much good faith efforts by IDSA, based on Shapiro's remarks. Those guys are going to cheat their way into another guideline just like the last one or no change at all. Someone had better be watching their every move and have a plan for what to do when they cheat.
Anyone who expects fair dealing from that group has not been paying attention. There is nothing too low or unethical that they will not do.
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The IDSA seems to be predicating their decision on the fact that chronic lyme patients don't usually "get better" even on extended antibiotics. I assume that they mean IV Rocephin as the antibiotic of choice, but clearly for many patients even a "ILADS" Rocephin protocol isn't enough.
What about coinfections? What about viruses? Of course people didn't get better on rocephin if they had multiple pathogens (many, like Babesia, are known not to react to rocephin!)
This should be the first thing that ILADS points out. Also, shouldn't any ammunition that IDSA currently utilizes become void because of Dr. Fallon's study.
It was scientific, and proved that active infection persists through even an extended rocephin course. There's no debate anymore as far as that is concerned.
Honestly, I don't really see how they can bull**** themselves out of this one.
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bettyg
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quote:Originally posted by seibertneurolyme:
Northstar -- Good analysis. But you forgot their other favorite buzzword -- post Lyme AUTOIMMUNE syndrome.
Maria A -- Very well thought out comments.
Lou -- Sad to say I agree with you.
Bea Seibert
BEA, DITTO; you summed it up perfectly; great article; let's use it to OUR ADVANTAGE.
Maria, thanks for sending feedback to newspaper!! well done!
BLUE, could you post direct link of this article so I can read and post the other feedback letters here, and form in my neuro head my own letter to send in!! thx
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METALLlC BLUE
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P.S. I wrote to NBC WWLP News, and sent them this article, as well as the AG press release, and a brief summary of why they should produce a news report on Lyme Disease and other tick-borne illness. I told them to contact me.
-------------------- I am not a physician, so do your own research to confirm any ideas given and then speak with a health care provider you trust.
groovy2
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posted
95% of people being Fixed with shot term ABX
Total BS --
I know Exactly One person that was cured with shot term ABX --my sister in PA.
She saw bullseye on her stomic First day- started ABX on Day 2 -
she did 400mg doxi for 6 weeks --
she knew about Lyme disease because one of her sons has been sick with Lyme for Many years -- Jay --
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