CALDA News, Events & Blogs

LYMEPOLICYWONK: What Will It Be, Peer Review or Censorship: New Tick Borne Disease Journal

16

Aug

What are we to make of the recently launched journal “Ticks and Tick-Borne Diseases” that includes on its editorial board five members of the IDSA Lyme guidelines panel? Dr. Wormser, who chaired the IDSA Lyme guidelines panel, is an associate editor of the journal. Do you think that they might have a bias or might exclude others points of view? If so, is this peer review or is it censorship? Full story

LYMEPOLICYWONK: Saying what you mean and meaning what you say: Evidence, Science and the IDSA

10

Aug

Some people don’t think that evidence-based medicine is about evidence. They think it is about power and ownership. I was a bit stunned to read Cerar et al (coauthor Dr. Wormser) take on the author of a meta-analysis on Lyme disease by boldly declaring that her conclusion was “not evidence based.” Kind of makes you wonder whether evidence is in the eye of the beholder and whether Cerar and Wormser have authority to settle scientific debates by proclamation of what constitutes “evidence”. Much as a scornful Humpty Dumpty did in Alice in Wonderland: "When I use a word. . ., 'it means just what I choose it to mean – neither more nor less." "The question is," said Alice, "whether you can make words mean so many different things." Does scientific debate really boil down to WHO says and how LOUDLY they say it? Should it? More after the jump. Full story

LYMEPOLICYWONK: The CDC Definition of HIV: Does History Repeat Itself?

03

Aug

Does history repeat itself? Did you know that the initial CDC definition of AIDS did not include women? And, because it did not include them, women were not included in research and they were denied disability payments. So much for disease definitions just being about “surveillance”. It took them 4 years to change the definition and there were a lot of government hearings. Turns out the hearings were just for “show and tell”. Not real hearings intended to accomplish real things. Kind of reminds me of the IOM hearings going on right now. Here’s an interview from Maxine Wolfe in 2004 at ACT UP describing the scene. Let me know if you see any parallels here. I sure hope I don’t. Full story

LYMEPOLICYWONK: Thanks to Everyone Who Helped With the IDSA Petition!

29

Jul

CALDA and Time for Lyme (TFL) want to thank everyone for their help on the petition asking Connecticut Attorney General Blumenthal to further hold the IDSA accountable. Although the petitions were limited to Connecticut residents and the timing fell in the midst of school graduations with all of the time those entail, approximately 2,500 signatures were collected and are being sent to him. Full story

LYMEPOLICYWONK: Artful Dodgers, 1,2,3 : the IDSA, the NIH and the IOM Makes Three

28

Jul

What do Representatives Chris Smith and Frank Wolf have in common? They know how to ask the right people hard questions. What do the IDSA, the NIH, and the IOM have in common? They’ve honed the skill of the artful dodger. Representatives Smith and Wolf want to know why the NIH “stepped back” from its charge to run a state of the science conference and handed that hot potato to the IOM. One big difference between the NIH process and the IOM process? The NIH process considers bias a conflict of interest, meaning IDSA folks wouldn’t be sitting on an NIH panel. But, drum roll. . .the IOM permits panels to be biased and coincidentally has a panel that consists almost exclusively of IDSA folks, 4 of 6 panel members. Oh, and one more thing, the IOM is not technically considered to actually be ‘the government’. This is a picture perfect example of plausible deniability. The NIH didn’t stack a panel. The IOM did with IDSA folks. But, hey, they like bias and they are not accountable, are they? A copy of the letter from Representatives Smith and Wolf to Dr. Francis Collins of the NIH together with Collins response can be downloaded at the bottom of this blog post. Full story

LYMEPOLICYWONK: IOM Conference calls: A Phone to Nowhere?

26

Jun

I have to say, I have not heard encouraging things about the IOM process. Most folks think the IDSA simply plucked a friendly forum to reaffirm its beleaguered Lyme guidelines and the tainted Lyme review panel process. The big question is: Does this process have any substance or is it just a matter of going through the motions? Is anybody listening on these "listening" phone calls? Is the IOM offering to listen to anyone who cares? Full story

LYMEPOLICYWONK: Debate of the Century—Uncle Sam Wants You to Control Health Care Costs

26

Jun

There is a big debate going on now about how to control health care costs. (Surprised?) Obama has been relying on the Dartmouth Atlas project by John Wennberg to support his assertion that there is enormous waste in the medical system that varies by geographical region that needs to be curtailed. Gardiner Harris, a reporter for the New York Times, has taken issue with this assertion and lobbed criticism at some of the underlying assumptions in the Dartmouth Atlas project. Congress has started looking to control costs by enforcing reductions in higher costs areas like New York. Not so fast says the NY Times. Increased cost may also reflect higher quality care and before we act on data, we need to make sure we have it right. Merrill Goozner, has a good post on Gooznews dissecting the debate. I have followed Wennburg’s work for years and offered my 2 cents on his work and its implications for patients who need to have treatment options available. This debate is at the core of quality healthcare and individualized patient needs. My comments posted on the Goozner site as well as links for all follow the jump. Full story

LYMEPOLICYWONK: LYME IS PART OF A MUCH BROADER DEBATE ABOUT THE ROLE OF PATIENTS IN HEALTHCARE

21

Jun

The broad debate about the role of consumers in health care policy is important to the Lyme community. However, many of the things that have harmed Lyme patients, powerful unresponsive medical societies with conflicts of interest, the patients’ lack of voice in the process, and access to care limitations should concern every patient, regardless of the disease. An important article on patients and their skepticism for evidence based medicine appeared in Health Affairs this month. (“Evidence That Consumers Are Skeptical About Evidence-Based Health Care”). Ray and I responded to the article with an eletter, “Consumer Acceptance Depends on Whether Guidelines Reflect Patient Values”, which is published with the article. Links can be found after the jump. Full story

LYMEPOLICYWONK: IDSA guidelines: A cautionary tale about development of clinical practice guidelines

14

Jun

Dr. Stricker and I have published a new peer-reviewed article on the flawed IDSA Lyme guidelines development process, the antitrust investigation, and the lack of impartiality in the mandated review process run by the IDSA. The article is now the number 1 accessed article of the publisher with over 1600 hits in the week since it was published. (Johnson L, Stricker R. “The Infectious Diseases Society of America Lyme guidelines: A cautionary tale about development of clinical practice guidelines,” Philosophy, Ethics, and Humanities in Medicine;5:9 2010.) The article is open access. The two lead in quotes set the stage. The first is by one of the nation’s founding fathers, Thomas Jefferson: ‘Without health, there is no happiness’. The second quote is by Thucydides and speaks to power and its abuse. ‘The strong do what they can; the weak endure what they must’. An excerpt of the article follows the jump: Full story

LYMEPOLICYWONK: Health Consumers Skeptical About Evidence Based Guidelines

09

Jun

A new article in Health Affairs, Evidence that Consumers are Skeptical About Evidence Based Health Care, draws an important conclusion: “Clearly, consumers will revolt if evidence-based efforts are perceived as rationing or as a way to deny them needed treatment.” Bingo! This is why patients with Lyme disease are in revolt. Full story

LYMEPOLICYWONK: Odd Couples—CDC, NIH, IDSA, others? “Hey, what are you yelling about? We're playing a friendly game!”

08

Jun

The IDSA recently reaffirmed its beleaguered Lyme guidelines with a panel it selected of IDSA members. (Aren’t we all surprised?) Turns out the CDC can’t be quick enough to endorse the IDSA after the IDSA vindicated itself. Overly clubby, don’t you think? The IDSA’s cavalier dismissal of 1600 pages of peer reviewed evidence rebutting its guidelines recommendations actually took my breath away. Now, it seems that the NIH is handing the “hot potato” of a “state of the science” review of Lyme disease that it is mandated to do by law to an “independent” government group, the Institute of Medicine— which, also, surprise-surprise, is composed mostly of IDSA members (according to my sources 4 of 6 members), in what seems like a saga of deniable accountability. (I would so love to be wrong on this.) Full story

LYMEPOLICYWONK: Spin, spun and hung out to dry. Lyme, science and the truth barrier

03

Jun

We know spin when we hear it. Politicians like Bush (but not him alone) and talking points taken to the extreme. This is politics, right? So, why is Reuters calling research conclusions “spin” and why am I not surprised? Politicks as usual. At the IDSA hearing, one of the things that I asked the panel to do was to determine whether the conclusions of the key studies were supported by their findings or, instead, reflected the politics of this disease. A new study reported in Reuters talks about how conclusions and titles of studies become “spun” to support non-science agendas. Perhaps the bottom line is that you can take the science out of the man, but you cannot take the man out of the science. We regard science as sacrosanct, but inevitably it goes through the filter of a person, with all the human failings that entails, including observer bias, and, in our more jaded world, "spin". The Reuters article, tongue in cheek, says: “Scientists are no strangers to spinning their research, a new study -- presumably not spun -- shows.” Bottom line: ”In this representative sample of RCTs published in 2006 with statistically nonsignificant primary outcomes, the reporting and interpretation of findings was frequently inconsistent with the results.” Full story

LYMEPOLICYWONK: IDSA explains why “evidence” is not necessary for “evidence-based guidelines”

28

May

I suppose it was inevitable. The IDSA, due to inattention (hey, it happens with age), lack of oversight, control, or, shall we say, “iron fist” over its members, permits not one, but TWO poster sessions at its last annual meeting that point out that—drum roll—the IDSA guidelines across the board (not just Lyme guidelines) are just—well, not based on science or evidence for the most part. Thomas File, the author of this article, is on the board of the IDSA and he is with Summa Health System: He takes the IDSA defense and explains why evidence is not necessary for evidence based guidelines.. Full story

LYMEPOLICYWONK: IDSA PETITION –CT RESIDENTS URGED TO SIGN, DISTRIBUTE AND DELIVER!

06

May

Connecticut residents are urged to sign the petition to hold the IDSA legally accountable for violating the antitrust Settlement Agreement with the CT AG. Patients in the Lyme community are alarmed by the IDSA’s flagrant violation of the antitrust Settlement Agreement. Those in Connecticut are urged to sign the petition (link below in full story) electronically and to download a print version of the petition and take it door-to-door, at shopping centers, post offices and other public venues to gather signatures. We need to make our voices heard and we need to make them heard now. Paper petitions may be downloaded from the link below this blog post and should be mailed back no later than May 31st to Time for Lyme, 30 Myano Lane, Ste. 20, Stamford, CT 06902. If you are a Connecticut resident or you know anyone in Connecticut, please get this petition distributed and signed. The health and well-being of Lyme patients depends on it! Full story

LYMEPOLICYWONK: IOM Hearings—Same Old, Same Old?

03

May

Labor HHS 2010 appropriations language directed the National Institutes of Health (NIH) to“sponsor a scientific conference on Lyme and tick-borne diseases” and mandated that the conference represent the broad spectrum of scientific views…and provide a forum for public participation and input from individuals with Lyme disease.” Rather than conducting this review themselves as an NIH State of the Science conference as anticipated, the NIH subcontracted the work out to the Institute of Medicine. Looked at in the most kindly light, perhaps they regarded the Lyme controversy as “too hot to handle” or “not in my backyard”. A less charitable viewpoint would characterize the shunt to the IOM as “forum shopping”—a way of selecting a process that is most likely to favor a desired outcome. Full story

LYMEPOLICYWONK: Helene Jorgensen’s Comments to IOM Committee

01

May

I am posting the written speeches of those who commented during the public comment period of the IOM. The speech below is that of Helene Jorgensen, the author of “Sick and Tired: How America’s Health Care System Fails Its Patients”. Helene Jorgensen presented her own encounter with Lyme disease and addressed the flaws in the clinical treatment flaws to date. Her testimony is available as a downloadable pdf by clicking the link at the bottom of this blog post. Full story

LYMEPOLICYWONK: Ann Lyons’ Comments to IOM Committee

01

May

I am posting the written speeches of those who commented during the public comment period of the IOM. The speech below is that of Ann Lyons, Vice-President of Time for Lyme, who addressed the testing issues in Lyme disease as well as the disease definition issues related to Lyme disease. Her testimony is available as a downloadable pdf by clicking the link at the bottom of this blog post. Full story

LYMEPOLICYWONK:Podcasts from the Institute of Medicine: Lyme Disease: State of Science Hearings

30

Apr

Podcasts of the Institute of Medicine Hearing are now available and posted here! On April 29, the Institute of Medicine’s (IOM) Committee on Lyme Disease and Other Tick-borne Diseases: The State of Science held its first meeting in Washington, DC. Audio clips of the session are provided below. The open session lasted from 12:30pm to 5 pm. 2.5 hours were dedicated to presentations by government agencies and 1.75 hours were provided for patient comments, which were limited to 5 minutes each. The time limitation on patients resulted in a scattershot approach. It is very difficult to make cogent points within 5 minutes. The limitation also meant that, as a practical matter, only patients close to the DC area would commit to the journey. Full story

LYMEPOLICYWONK: Diane Blanchard's Comments to IOM Committee

30

Apr

I am posting the written speeches of those who commented during the public comment period of the IOM. The speech below is that of Diane Blanchard, Co-President of Time for Lyme, who addressed the issue of scientific bias and the importance of separating fact from opinion. She also emphasized that it was important to listen to patients drawing the parallel to the discovery of Lyme by Polly Murphy, a mother in a local community. Her testimony is available as a downloadable pdf by clicking the link at the bottom of this blog post. Full story

LYMEPOLICYWONK: Pat Smith's Comment before IOM

29

Apr

I am posting the written speeches of those who commented during the public comment period of the IOM. The speech below is that of Pat Smith, President of the national Lyme Disease Association, who addressed process issues with the IOM hearing and raised concerns regarding the lack of transparency of the process and the need for a greater opportunity for patients and other viewpoints to participate in the hearings. Her testimony is available as a downloadable pdf by clicking the link at the bottom of this blog post. Full story

LYMEPOLICYWONK: IOM LIVE BLOG PART III Public Comment

29

Apr

I have summarized the public comments made at the IOM hearing today. I intend to post the statements made by those speaking to the panel that are provided to me. Those who spoke included Pat Smith of the national Lyme Disease Assn., Diane Blanchard and Ann Lyons of Time for Lyme, Gregg Skall of National Capital, Helene Jargensen, author of Sick and Tired, Candy Brassard of the EPA, Rick Smith, Bob Smith, and Julia Rice, a former nurse. Others listed to speak who did not attend were Arthur Weinstein, Phil Baker, and Lynn Shepler. Full story

LYMEPOLICYWONK: IOM LIVE HEARING BLOG Part II

29

Apr

Please refer back to this site for new post on the hearings Full story

LYMEPOLICYWONK: IOM HEARING LIVE BLOG

29

Apr

Please refresh this to update comment. This is my live blog on the IOM Hearing. Full story

LYMEPOLICYWONK: IDSA Voting Procedures under Review by the Connecticut Attorney General

23

Apr

The Connecticut Attorney General is reviewing the IDSA report to determine whether the IDSA has complied with the terms of the antitrust Settlement Agreement. Attorney General Richard Blumenthal's initial review of IDSA voting procedures on the guideline recommendations found the IDSA violated the agreement by rigging the vote to favor no change in the guidelines. We have been informed that both Washington State Attorney General and the Attorney General in Pennsylvania have sent letters to the IDSA requesting that they comply with the Settlement Agreement voting procedures. In addition, US Legislator Chris Smith and US Senator Chris Dodd also wrote the IDSA expressing "deep concern" regarding the IDSA voting procedures. Faced with this scrutiny, the IDSA recast its vote on all recommendations to comply with the agreement--with a major exception. They refused to redo the vote on the one recommendation that required that diagnosis of Lyme could only be made if there is a positive blood test. This vote is critical because even under the initial flawed voting procedure the vote split 4 to 4 which means there was no consensus on the requirement that diagnosis be confirmed by positive lab tests. The Attorney General is currently reviewing the IDSA report to determine whether the IDSA has complied with the Settlement Agreement. The press release of the CT AG is set forth below. I encourage those concerned to contact the CT AG Office and let them know that you want the vote redone on the major issue of lab test confirmation for diagnosis. Details follow. Full story

LYMEPOLICYWONK: IDSA Reports No Change in Guidelines--The Fat Cat Ate the Canary

22

Apr

What happened? The IDSA has issued its official report of the Lyme review panel. “[A] special independent Review Panel has unanimously agreed that no changes need be made to IDSA’s 2006 Lyme disease guidelines.” Let me point out three faults with this statement. First there was no “independent Review Panel”. There was a panel that was selected by the IDSA, which intentionally excluded from the panel physicians who disagreed with their assessment—all community physicians who treat chronic Lyme were excluded from the panel. Second, some changes to the recommendations were proposed by the panel. Third, the determinations were not unanimous. The most important recommendation regarding the requirement of positive serology for diagnosis actually had a 4 to 4 vote split. I will spare you the long read—28 pages of text and give you the bare bones only version. Nothing changed. They are not even sure what the fuss was about, honestly. They never expected the guidelines to change, stacked the panel, paid the ethicist, ran the process, and achieved a foregone conclusion which “validated” their guidelines. Seems like the IDSA fat cat ate the canary. Full story

LYMEPOLICYWONK: IDSA APRIL DEADLINE

05

Apr

We are all concerned about the latest report from the IDSA statement that they plan to issue their final report regarding the IDSA guidelines review panel by the end of April. We are particularly concerned about whether the IDSA has corrected its voting violations. There may be other actions for the community to take as this unfolds, but right now, it is critical that we continue keeping the pressure on for other state AG’s to send letters to the IDSA (IMPORTANT: cc the CT AG) expressing concern about the voting violations and asking for compliance. Letters from legislators would also help spotlight the importance of the issue. Information on how to do this is posted on CALDA’s website along with the press release issued by CALDA, TFL and the LDA. Full story

LYMEPOLICYWONK: IDSA FINAL REPORT END OF APRIL!

03

Apr

The IDSA will issue its final report by the end of April. Did you catch that? Yes, it made an announcement and buried it deep within its website for enterprising spelunkers to find. I think this was another attempt to “not communicate something important.” Someone did find it though and posted it on the web. People joined in. They asked, “How on earth did you find that?” Full story

LYMEPOLICYWONK: Uncle Sam Needs Patients to Get Healthcare Reform Right

23

Mar

Recently, a group that writes guidelines asked for my input about the role of patients in the development of Evidence Based Medicine guidelines. With universal healthcare now ‘the law of the land’, treatment guidelines have become even more important. Preserving the integrity of the guideline development- process is what matters most. It is essential that patients play a role in the process that can so affect their lives. The question posed to me was why should those developing guidelines involve patients? My response follows. Full story

LYMEPOLICYWONK: Lyme Physician Protection in Minnesota

17

Mar

The Minnesota Board of Medical Practice (MBMP) has agreed to a five-year moratorium on the investigation, disciplining or issuance of corrective action based solely on long-term prescription or administration of antibiotic therapy for chronic Lyme disease. Minnesota joins a growing list of states that provide physician protection either through legislation or agreement, including California, Connecticut, Rhode Island, and New York. The MBMP took the action as a compromise to prevent pending physician protection legislation from passing. Any way you look at it, it was a good day for Lyme patients in Minnesota. Full story

LYMEPOLICYWONK: When is Mandatory, Mandatory? When Medco says so!

12

Mar

I have gotten a lot of reports from patients that Medco is refusing to dispense antibiotics because of the IDSA guidelines. At $51 Billion, let me repeat that $51 BILLION, dollar in revenue, Medco is the nation’s largest drug dispensing company. And, just for the record, they are over-riding the treatment recommendation of the treating physician and replacing it with, oh yeah, the IDSA “expert opinions” on treatment. This isn’t evidence based medicine, this is “eminence based medicine.” Their mission is to help “clients control the cost and enhance the quality” of prescription benefits. Looks like the IDSA is their friend. Complaints about Medco using these tactics have been becoming more frequent suggesting that this is not an isolated case and may be an across the board policy? If so, its reliance on IDSA guidelines to deny treatment across the board will have a serious adverse impact on patient lives. Full story

LYMEPOLICYWONK: Should the IDSA take a Tip from Toyota and Recall the Guidelines?

11

Mar

Another run away Prius hit the news today. I have one (first year). I share these concerns. Is this car safe? Should I really be driving it? Have they recalled my model? It made me think about the IDSA Lyme guidelines a bit. Why haven’t they recalled these guidelines? They actually harm patients. The real risk to patients is not that they will have the risk of a reaction to their antibiotics, it is that they will be treated under these guidelines. That they will remain ill. That the diagnosis will be missed. That the treatment when it comes will be too little, too late. That the medical society responsible for the high, high treatment failure rates will do nothing more than circle the wagons around their self interests. That patients matter less than vaccine and diagnostic test patents and preserving the reputation of a medical society that does not even have patients on the agenda. Full story

LYMEPOLICYWONK: IDSA and Lyme Hearings: TOP 10 Count Down for the Masters of Manipulation?

10

Mar

I’ve been getting a lot of email lately about the IDSA. Most of it is about the voting issues, but some of it is about other things they have done to “game the system”. Here’s a list of the top 10 questions patient ask me about the IDSA that begin with the word “why”? As Mark Twain says, “few things are harder to put up with than the annoyance of a good example”—or in this case, ten good examples of why the Lyme community should question the advice to “trust us, we’re the experts” when it comes to the IDSA. Let me know if you think there are any “whys” I left off the list. Full story

LYMEPOLICYWONK: RELATIVE WEIGHT--Specialty Societies vs Patients, AKA no contest

16

Feb

This is a chart of the relative importance of different stakeholders to big Pharma. (Click chart to enlarge.) I was really struck by how little weight patients were given (9%) compared to specialists (47%) and compared to key opinion leaders (21%). So if you take specialists and add key opinion leaders to that, 68% of drug companies thought that key opinion leader who are specialists would have the most influence on their company over the next 2 years. Wow! And, look at the lowly role of the general practitioner Full story

LYMEPOLICYWONK: Voting Violations--Which Way IDSA, the Right Way or the Might Way?

16

Feb

One of the problems with the IDSA reviewing its own guidelines is that it is not an independent process. The IDSA selected the panel, paid the ethicist, and sets the ground rules. And, now we have the IDSA manipulating the voting process to achieve a goal--protection of the IDSA professional reputation--that conflicts with the goal of providing quality patient care. Think about it. The vote on the lab test requirement for diagnosis was 4 to 4. 4 to 4 means there was NO consensus. Yet the IDSA chalked this up as a victory on its side by ignoring the two step vote requirement and flipping the supermajority vote in its favor. The IDSA is essentially saying 4 to 4 means the IDSA wins on this point. To the fox guarding the chicken coop, this makes perfect sense. Let me drill down into the detail so that what the IDSA did here is clear. Full story

LYMEPOLICYWONK: Testing the IDSA's Commitment

11

Feb

A recent article in the Greenwich Times addressing the "improper voting procedure” of the IDSA review panel contains a response from IDSA spokesman John Heys that the IDSA is "committed to ensuring the review panel conducts its review to the requirements of that action plan." Sounds a little boiler plate, huh? The next statement by Blumenthal though is more telling. He says that his office has yet to receive a response to the letter. That does not sound like much of a commitment. One has to wonder why it was necessary to write the letter of non-compliance in the first place and why the IDSA's only response to date has been to the press? "We hope there will be a response forthcoming shortly," Blumenthal said. So do we, so do we. . . Full story

LYMEPOLICYWONK: ILADS Calls on IDSA to Remove Barriers to Lyme Guideline Change

05

Feb

Responding to patient concerns, the President of ILADS, Dr. Robert Bransfield today delivered a letter to the IDSA calling upon the organization to remove barriers to guidelines change. The letter follows patient complaints to ILADS about the IDSA voting process, which were uncovered by the Connecticut Attorney General in the oversight of the IDSA Lyme guidelines review process. According to the Attorney General, the voting process used by the IDSA was in violation of the terms of the antitrust Settlement Agreement. The Attorney General has called upon the IDSA to redo the vote using the proper voting procedures. Text of the ILADS letter follows the jump. Full story

LYMEPOLICYWONK: IDSA Violates Settlement Agreement Voting Procedures

03

Feb

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 the Settlement 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. Full story

LYMEPOLICYWONK: Does IDSA Have Police Power? Can IDSA Regulate Lyme Tests?

30

Jan

There is a lot of flurry in the Lyme light about the IDSA recent letter in opposition to the physician protection bill pending in the New Hampshire physician protection legislation. This legislation follows on the heels of legislation already passed in California, Connecticut, and Rhode Island. Like breast cancer patients before them (who passed legislation in 20 states to secure the right to make treatment choices), Lyme patients are appealing to legislators to preserve their right to receive treatment for Lyme disease. The IDSA claims that its guidelines are not mandatory, but to my ears this sounds like double-speak. And, the newly elected President of IDSA, Dr. Whitley essentially admits as much when he complains about lab tests that are not “regulated” by the IDSA guidelines. What makes IDSA think that it has the “right” to regulate lab tests? Who says? How genuine is IDSA when it claims that its guidelines are really just “discretionary”? Come on, guys, one or the other, but you can’t play both sides of this issue with a straight face. Maybe we have to fall back to Lincoln or Bush, take your pick, about how many people you can fool. Full story

LYMEPOLICYWONK: Groopman: Who Knows Best—a Lesson for Lyme

28

Jan

A terrific article by Jerome Groopman, “Health Care: Who Knows Best”, appeared in the New York Times about the healthcare bills. Groopman’s article discusses how healthcare should be implemented in terms of guidelines and notes that there are two choices. The first is through mandates. The second is through “nudging” consumers in the right direction, but leaving the final choice to the consumer. (This approach is advocated by the author of the book Nudge, who is an advisor to Obama.) If this sounds like the Lyme debate, you are catching the drift. As we know, the distinction between mandatory guidelines that do not permit physicians and patients to make choices and guidelines that permit individuals to make their own choices, even if they are unpopular, can determine whether a patient has the opportunity to get well. The question boils down to this: Do the experts know best or do some decisions simply belong to the patient and the treating physician? Full story

LYMEPOLICYWONK: Oh, Canada! Important New Lyme Study

27

Jan

Drs. Janet and Felix Sperling of the University of Alberta published an entomology study on Lyme disease in Canada that is worth a read, especially if you believe that Lyme stops at the US border. Did you know that Lyme has now been recognized in every province in Canada? And that infection rates of ticks are 12.5%? More fast facts after the jump. Full story

LYMEPOLICYWONK: IDSA Calls for 10 New Antibiotics by 2020

17

Jan

In a press release issued at the end of last year, the IDSA called on the US and European Union to develop 10 new antibiotics by the year 2020. IDSA President Richard Whitley said that “creating a stable research infrastructure for antibiotic development” was essential to provide physicians with the tools necessary to effectively treat patients. That’s good news for the Lyme community because unacceptably high treatment failures occur with all current antibiotics used to treat Lyme disease and the rate of development of new antibiotics has been low. Pharmaceuticals have not been interested in developing new antibiotics because they do not generate the level of profit that drugs that are taken by a broad demographic over the course of a lifetime, like cholesterol medication, do. This is the good news. Now for the bad news. Full story

LYMEPOLICYWONK: MUS is DUMB—Doctors with Unexplained Medical Beliefs

17

Jan

You’ve all heard that the latest drum-roll from the rheumatologists at the IDSA hearing was essentially to say that Lyme patients have persistent symptoms and they started off with infection, but now we don’t “believe” in persistence—so what do you call it? How about “medically unexplained symptoms” or MUS for short? All of this seems to regard the real problem with Lyme disease as being what you call it. But patients know the real problem with Lyme disease is how you treat it, how you cure it, how you restore patients to their lives. Disease definitions like MUS are for drug-makers who sell drugs to a market, physicians trying to claim professional turf, and insurers trying to deny treatment reimbursement. They are not for patients. Abraham Lincoln had it right when he said: “How many legs does a dog have if you call the tail a leg? (Answer) Four. Calling a tail a leg doesn't make it a leg.” I’m not the only one who finds these acronyms aggravating and unhelpful. A post from the internet nails it: Full story

LYMEPOLICYWONK: Biofilms Made Easy

17

Jan

I had to post this image and encourage anyone interested in biofilms to go visit the website that hosts this interactive introduction to biofilms. Some of you know that biofilms have been implicated in Lyme disease. Drs. McDonald and Sapi recently published on this topic. The gist of the matter is that biofilms may be one of the ways in which bacteria persist in the body. They can provide a protective covering that antibiotics cannot penetrate. It’s a pretty esoteric subject matter, but this website describing how they work is pretty down home. Give it a visit if you get a chance. And, kudos to the University of Montana for making this available to folks like us who just need simple explanations so we know how things work! The link is after the jump. Full story

LYMEPOLICYWONK: IDSA Guidelines—Liberty or Dogma?

11

Jan

Buddha once said “a dog is not considered a good dog because he is a good barker. A man is not considered a good man because he is a good talker.” I would take it a step further and say “a doctor is not considered a good doctor because he is a key opinion leader.” No. The essence of a good dog is loyalty. The essence of a good man is his moral character. And, the essence of a good doctor is his ability to heal the sick and restore health. This can’t be done without holding the patient’s interest paramount. Patients and the concerns of patients are the core element around which medicine is organized. Without patients, there is nothing for medicine to address. Without treatment approaches that restore health, or failing that, improve patient health, medicine becomes a meaningless exercise in capitalism. How do we ensure that patient’s interests come first in treatment guidelines? Full story

LYMEPOLICYWONK: IDSA Hearings Delay has Lyme Patients on Tenterhooks

11

Jan

The IDSA hearing results were expected by the year end. Then were delayed—until “after the first of the year”. Perhaps the delay was caused by Dr. Duray’s resignation from the panel due to personal illness. We don’t know because we have not been told the reason for the delay or how long the delay will be. Patients are on tenterhooks awaiting the results and with good cause. Revision of the IDSA Lyme guidelines could make a world of difference for Lyme patients. According to a CALDA survey, 53% of patients with chronic Lyme have been treated according to the IDSA Lyme guidelines and 90% of these were not restored to health under the IDSA protocols. Isn’t the point of treatment guidelines to improve patient outcomes? And, if they don’t, shouldn’t they be revised? Full story

LYMEPOLICYWONK: Antibiotic Resistance—Holy Cow, It’s the Beef!

10

Jan

Antibiotic resistant infections killed more than 65,000 people in the US in 2009. But 70% of antibiotics, which can make animals grow faster, went to cows, chickens and pigs last year. Antibiotics in livestock provide a breeding ground for antibiotic resistant infections that can be passed on to humans. According to a recent AP article, animal fed antibiotics “can develop germs that are immune to the antibiotics. The germs then rub into scratches on farmworkers' arms, causing oozing infections. They blow into neighboring communities in dust clouds, run off into lakes and rivers during heavy rains, and are sliced into roasts, chops and hocks and sent to our dinner tables.” Full story

LYMEPOLICYWONK: Expired Drugs—Are they Effective, Safe?

02

Jan

This is a little off topic for my blog, but something that is of high interest to patients. Patients ask all the time about the effectiveness and safety of “expired” drugs. A recent article that appeared in the Medical Letter examines the issue in detail. The article notes that generally manufacture expiration dates merely reflect the fact that the drug is “stable” at that point, they do not reflect when the drug becomes unstable. The conclusion of the article indicates that outdated drugs may be effective and safe for at least 5 years after the expiration. Notable exceptions include liquid suspensions and epinephrine in Epipen, which are not stable over time. The article also notes the following: " There are no published reports of human toxicity due to ingestion, injection or topical application of current drug formulations after their expiration date. Renal tubular damage has been reported after use of degraded tetracycline in a formulation that is no longer available (REF 2)." Other sources contain warnings about expired doxycycline, which may (or may not) be based on this outdated tetracycline warning, but patients may want to check with their doctors when using expired doxycycline to be on the safe side. Full story

LYMEPOLICYWONK: HAPPY NEW YEARS CHANGE MAKERS!

31

Dec

I wanted to post a piece of poetry that captured the spirit of the Lyme community to ring in the New Year. I found this great Jack Kerouac poem about people who create change. Then I found out it was not by Jack Kerouac, but actually was an ad for Apple computers. Still, it is a great piece that captures the essence of a community that tirelessly swims against the current trying to change the status quo. And now for that poem. . . Full story

LYMEPOLICYWONK: The More the Merrier—The Power of Small

29

Dec

I was reading a book today about the power of small groups. The book is called Microtrends. It is by Mark Penn. One of the things he said stuck with me: “It only takes 1% of the people making a dedicated choice—contrary to the mainstream—to create a movement that can change the world.” What he is talking about is the increasing fragmentation of America (the world, in fact) brought about by the internet and the collapse of normal distribution channels. Very small groups of people can now connect and be effective through the internet. And, the normal channels of distribution used to control information flow have collapsed. You see this in television where there are no longer three networks to choose from but over 200 channels. That’s fragmentation. Full story

LYMEPOLICYWONK: Impure Science—the Fine Art of Blowing Smoke

28

Dec

Have you read the LA Times op-ed that ran on December 16 by Daniel Sarewitz and Samuel Thernstrom? The piece is called “Impure Science”. It is blazingly good. The focus is on the global warming debate and recent suggestions of bias in email exchanges from one side of that controversy that were disclosed to the press. The take-home points though apply to any area, like Lyme, where there is divided science and polemic viewpoints. While the debates are shrouded in science, the real debate is not about science, but stakeholder viewpoints. When science is subject to interpretation by different stakeholder, the question is who controls the mike? Full story

LYMEPOLICYWONK: CDC Revolving Door Policy Suits Vaccine Manufacturers Just Fine

28

Dec

Have you ever heard the saying “what goes around, comes around”? How about “you scratch my back, I’ll scratch yours”. The revolving door between government and industry is cause for concern. The revolving door between the CDC and the vaccine industry is even greater cause for concern. The most recent revolving door has Dr. Julie Gerberding, the first woman to head the Centers for Disease Control and Prevention, being named president of Merck’s vaccine division. Do you think she knows a thing or two about vaccines and how to get them through the process? Do you think she has connections? Dr. Gerberding comes from an infectious disease background. Full story

LYMEPOLICYWONK: Dr. Paul Duray Resigns from IDSA Panel Due to Family Illness--Implications unknown

27

Dec

The IDSA panel list has been revised to reflect the fact that Dr. Paul Duray has resigned from the panel. The IDSA does not post this type of information as a stand-alone announcement. Instead, they revise their prior notices. So you have to keep a close watch on their website for changes. What they did was add to his listing the following: Resigned from the Panel on October 7, 2009, due to a family illness. I am sure that everyone’s heart goes out to Dr. Duray and we wish him and his family the best during this trying time. Let’s light a candle for Dr. Duray and his family. Full story

LYMEPOLICYWONK: Recognizing the problem is the first step—Persistence.

15

Dec

An important study by Dr. Stephen Barthold and Dr. Ben Luft was recently published. The title sounds a bit bleak, but don’t let the title fool you: “Ineffectiveness of Tigecycline against Persistent Borrelia burgdorferi”. This study is about how the little guy (Borrelia burgdorferi) always wins and survives despite antibiotic treatment—here tigecycline. To my mind, the findings on persistence are much more important than the finding that tigecycline doesn’t do the job. When one antibiotic doesn’t work, you try another, and if that one doesn’t work, well, you try another or you kick it up a notch and start trying combination antibiotics, like they do with tuberculosis. You don’t fold up the tent and go home because active infection requires antibiotic treatment. And, you won’t ever find out which antibiotic or combinations of antibiotic work, until you try them. So, roll up your sleeves, we have some work to do here. Full story

LYMEPOLICYWONK: Barthold and Luft--Persistence and Integrity in Science.

15

Dec

Breathe a sigh of relief. No, really. It is not that often in Lyme disease that one reads an unbiased study that speaks truth to power, that values integrity in science over dogma. So, pour a cup of tea and I will pull out the most important findings and conclusions about persistence from the recently published study by Dr. Stephen Barthold and Dr. Ben Luft, “Ineffectiveness of Tigecycline against Persistent Borrelia burgdorferi.” Here they are in a nut-shell for those with neither the time nor the inclination to read the entire study (though I must say it is highly recommended!). Full story

LYMEPOLICYWONK: Tee Time for Lyme

02

Dec

Someone I know. OK, a young woman whose father called me and who then met me at a support group. OK, a father who called me because my husband played tennis with a co-worker of his. Well, you know how small this world is when you meet someone else with a “rare” (shrug, smile, wink) condition like Lyme. Anyway, this person (drum roll) --Silver Feldman-- who missed a large chunk of high school because of Lyme and who turned 21 this last month took a graphic design class. Guess what her topic was? Don't you just love it when people give back to the community? Full story

LYMEPOLICYWONK: You can observe a lot by watching: Breast Cancer & Lyme Disease

01

Dec

The parallels between breast cancer and Lyme disease are not obvious, are they? I was surprised by them myself. Breast cancer patients have two treatment options (sound familiar?). Mastectomy removes the entire breast, while the newer procedure, a lumpectomy removes only the tumor and immediately surrounding tissue. Consider this: lumpectomies used to be controversial and were opposed by an entrenched medical establishment. It’s hard to imagine, isn’t it? Even harder to imagine is that women had to pass legislation in 20 states to obtain the right to choose between lumpectomy and a radical mastectomy. Physicians were afraid to perform lumpectomies for fear of losing their license. We have passed legislation in 3 states so far protecting physicians who treat Lyme in defiance of the IDSA guidelines from medical board action. But, wait there's more.. Full story

LYMEPOLICYWONK: Mammograms, pap smears and Lyme? Statistical lives vs personal lives. You choose.

22

Nov

Have you been following the news lately? So much about health care reform and guidelines revisions that appear to be blatant cost containment issues shrouded in statistical mumbo jumbo. The basis for the revisions to mammograms and cervical cancer screening (is it a coincidence that these are both female specific diseases?) is that it ‘makes sense’ based on a pure statistical analysis of lives saved and costs. Let me tell you something. Statistical lives matter only to those crunching numbers, read insurance companies (close read, ah well that would be the government, sigh). The personal life is everything. I don’t mind losing 1 in a 1,000, but I do mind losing my mother, my daughter, my sister. How about you? So how does this relate to Lyme disease you may be asking? Full story

LYMEPOLICYWONK: IDSA Lyme Guidelines—Do they violate the IDSA’s own rules on guidelines?

18

Nov

Patients think that the IDSA guidelines are harmful to their health because physicians, hospitals, and insurers rely on them to deny patients access to the care they vitally need to restore their health. Patients believe that the IDSA guidelines violate one of the cardinal rules of medicine, “First do no harm.” Depriving seriously ill patients of treatment is an egregious harm. But do the IDSA guidelines violate their own rules? Indeed, they do. Full story

LYMEPOLICYWONK: IDSA Lyme Hearing Panel--What to do when opinion is strong, but evidence is weak?

18

Nov

Now that two studies have shown that IDSA guidelines are generally long on opinion and short on evidence, what should the IDSA guideline panel do? The study by Lee, discussed in yesterday's blog, found that IDSA frequently makes strong recommendations, but that these strong recommendations are supported by strong evidence only 15% of the time. Dr. Maloney found that the majority of recommendations in the IDSA Lyme guidelines were based on the weakest level of evidence--expert opinion. Shouldn't clinical judgment only be suppressed when there is strong evidence? That's what the American Academy of Pediatrics says in its guidelines on making guidelines. Full story

LYMEPOLICYWONK: Researcher finds IDSA treatment guidelines long on opinion and short on science

15

Nov

IDSA guidelines are long on opinion and short on science. This is the stunning conclusion made by an infectious disease specialist at Drexel University, Dong Lee, MD in a poster presentation at the recent IDSA annual conference. Dr. Lee’s analysis is based on a broad review of 30 guidelines published by the IDSA between 1994 and 2009. More than half of the recommendations made by the IDSA in these guidelines were not supported by science. Full story

LYMEPOLICYWONK.ORG: When it’s a matter of opinion, whose opinion counts?

15

Nov

Doing a guideline review process correctly and vigilantly is important. It is also a difficult goal to pull off. The 2006 IDSA guideline development process was flawed, as Connecticut Attorney General Richard Blumenthal found in the antitrust investigation. That panel was hand-picked to represent a particular viewpoint on treating Lyme disease and it cherry- picked the evidence or interpreting the evidence in a manner that supported a preconceived viewpoint. When science is unclear or unfolding rather than acknowledging that fact, guidelines sometimes rely on 'expert opinion' to fill the evidence gaps. This is a big problem because evidence based guidelines are presumed to be based on evidence, not opinion. Substituting the 'expert opinion' of someone on a guideline panel is no better, (actually, it is worse) than leaving the matter open and allowing the treating physician to use their own expert opinion. Full story

LYMEPOLICYWONK: Anatomy of IDSA annual meeting: Vaccine Financial Ties

14

Nov

50% of the 272 speakers at the October 2009 IDSA annual meeting who disclosed conflicts, had ties to one or more of the five leading vaccine companies: Merck, GlaxoSmithKline, Sanofi Pasteur, Wyeth, and Novartis. Vaccine related financial ties with key members of the IDSA Lyme panel prompted the Connecticut Attorney General antitrust investigation into the development of the IDSA Lyme guidelines. Patients remain concerned about these interests because the IDSA guidelines placed commercial interests of vaccine manufacturers above patient care. Full story

LYMEPOLICYWONK: Weinstein Offers IDSA Panel a Dead End Road to Nowhere

13

Nov

I have been reviewing the IDSA transcripts and reread Dr. Arthur Weinstein’s testimony. Yesterday, I discussed Weinstein’s argument that chronic Lyme should be considered a somatic disorder in my post and concluded that his assertion is no more than an unproven hypothesis that should have no role in the treatment of patients. Today I tackle the second major assertion in his testimony—namely that one of the problems with diagnosing patients with chronic Lyme is that it delays early diagnosis and treatment for somatic disorder. The big question, of course, is whether the diagnosis of somatic disorder bears any fruit for patients or whether it is instead a dead end road to nowhere. Full story

LYMEPOLICYWONK: IDSA Hearings—Weinstein’s Pet Theory Shouldn’t Trump Patient Care

12

Nov

I have been reviewing the IDSA transcripts and reread Dr. Arthur Weinstein’s testimony. Weinstein testified in support of the IDSA Lyme guidelines at the IDSA hearing on July 30th. He argued that chronic Lyme disease is a ‘somatic’ disorder involving a “serious amplification of symptoms” and states that he “doesn’t pretend to know the etiology (cause) of the pathophysiology”. He does though assert that the serious amplification of symptoms is associated with patients who have more psychiatric morbidity and is fostered by the labeling the disease “chronic Lyme” by advocacy groups and others that believe in a traditional medical cause for symptoms. This post is part of a twofer. Today, I ask if Weinstein is right that post treatment Lyme disease is a somatic disorder or if this is simply his pet theory. Tomorrow, I ask if the somatic disorder diagnosis provides patients with good patient care. Full story

Lyme disease: Losing your innocence in science

06

Nov

Having Lyme means losing your innocence, utterly, in science. It's true. I am remembering the night I explained evidence-based medicine to a friend whose daughter had Lyme. I explained that in Lyme evidence-based medicine was a “tool” for persuasion in a polemic argument. He was stunned. His daughter had Lyme. He believed in science. He had trouble, real trouble, getting his daughter diagnosed and treated. He knew the problems of Lyme from the inside out. But it hadn’t occurred to him that science wasn’t “pure” science. That researchers followed their bias, their pet theories, their commercial interests in designing and interpreting studies. It was an interesting moment with this sharp and concerned father while he tried to understand the depth of the problem in Lyme. It was a moment when innocence is utterly lost for the first time to those who know how the system of science “ought” to work. Full story

Lyme Policy Wonk: Beam me up, Scotty. See you after the jump!

28

Oct

Why do we do what we do? Sometimes we win, but there are many, many (too many) bumps in the road on the way to success. How do we keep our perspective in the face of an adversary that seems unrelenting---vested, no entrenched, in a medical dogma that leaves patients on the side of the road? A medical society that believes that the views of patients are really--(really?) not relevant to the question at hand? I, for one, want to walk the road of other diseases that have been abandoned and forsaken by the medical establishment. But my road (and those of other illnesses), leads to success. And success--is all about the journey. Touching lives one by one until our day in the sun. Full story

Lyme Policy Wonk: Fresh back from the conferences!

28

Oct

Fresh back from the Columbia/LDA conference and the ILADS conference in Washington, DC. I love going back for these conferences because I see all the people I have talked to over the year and so rarely lay eyes on. I love the energy of the conference. This year, the ILADS conference had break-out sessions on evidence-based medicine and research. These were working groups with a lot of discussion generated—the type of discussion that only occurs when people are together in the same room and real time conversation occurs sparked by ideas. This was energizing to me. Full story

Lyme disease: Reader not aMUSed with MUS category --Call for acronyms

09

Oct

My recent post on MUS (medically unexplained syndrome) and why that doesn't apply so much to a disease of known etiology drew an interesting comment from a reader. This person says that maybe other (more creative) acronyms are appropriate. Do you have a favorite acronym for Lyme? The post follows. Full story

LYMEPOLICYWONK: IDSA Lyme Conflicts of Interest--Tell me more!

12

Oct

Merrill Goozner, a highly regarded medical ethicist, posted a recent commentary on conflicts of interest, "No Light at the End of the Tunnel on Disclosure." The commentary expresses his disappointment at the paltry level of self-disclosure of conflicts even under legal pressure. Those of you following the IDSA antitrust action commenced by Attorney General Richard Blumenthal in Connecticut may recall that the conflict of interest disclosure level of the IDSA panel members increased dramatically AFTER the investigation was launched. It's remarkable how helpful another set of eyes, particularly those of an official, can be when drafting conflict of interest disclosures. My commentary to Merrill's post follows: Full story

LYME POLICY WONK: "The IDSA will not hesitate to change its guidelines"-- True or False?

09

Oct

If you don't read medical journals or medical ethics journals, you may have missed a comment made by Dr. Ann Gershon in the Southern Medical Journal. She is responding to an article by Susan Ronn that was published together with an editorial by me and Dr. Stricker. It took me a couple of times reading this, but I think she made a promise based on a dare. She says: "If and when there is credible evidence of the existence of chronic Lyme disease and of the benefits of long-term antibiotic therapy to treat it, IDSA WILL NOT HESITATE TO CHANGE ITS GUIDELINES TO REFLECT THIS EVIDENCE." Full story

IDSA Lyme Double Speak

07

Oct

Have you ever noticed how the IDSA says one thing, but really means and does another? For instance, how they say that their guidelines are there to protect patients when in fact they amount to medical abandonment? They are so stringent that sick patients are left completely without treatment options? Or how they say they are all about scientific evidence when in fact their guidelines are based primarily on expert opinion--the expert opinion of researchers with commercial ties to vaccine manufacturers, Lyme tests, and insurers? Or how they say their guidelines are not mandatory, but their members enforce their guidelines by testifying at unprofessional conduct hearings and the IDSA opposes physician protection legislation that would essentially make compliance with their guidelines truly voluntary? Or how they say they are worried about doctors who treat chronic Lyme making money off of sick patients, but they are not concerned about conflict of interest on their guidelines panels? This is called double speak. Saying one thing, doing another. George Orwell described this type of practice "newspeak"--words "deliberately constructed for political purposes: words, that is to say, which not only had in every case a political implication, but were intended to impose a desirable mental attitude upon the person using them." I'd say we could all use a little more plain talk. Full story

Taming the beast: No MUS, No Fuss!

28

Sep

Patients with Lyme disease know how important the definition of an illness can be. We know that the difference between chronic Lyme and Post Lyme Disease Syndrome is the difference between receiving treatment and being medically abandoned. So what’s with all the “new” language at the IDSA hearing about medically unexplained symptoms? MUS for short. No fewer than 3 IDSA speakers use this expression: Drs. Weinstein, Shapiro, and Wormser. It was like they synchronized talking points. First, let me tell you what MUS and PLDS have in common—no antibiotic treatment. Because—guess why? Because the term MUS applies to diseases of unknown etiology— diseases with no identified cause. But wait, you say. Doesn’t Lyme disease have a cause? You might assume that given that the bacteria has been identified, Lyme disease has a cause and isn’t really “unexplained”? Full story

IDSA Lyme Hearing: Wormser-- Talk About Exaggeration!

22

Sep

Talk about exaggeration. No really--at the hearing. Dr. Carol Baker asked Dr. Wormser the $200 question: Why exaggerate if the truth will do? She was talking about the use in the guidelines of words like "vast majority" when the real percentage was 65%. And her question was why not let percentages speak for themselves? If the truth is 65%--why not simply say 65%. Is it just me, or does Wormser sound irritated at the question? His response after a drill down is that he would not use the expression "vast majority" to refer to anything less than say--90%. Excuse me? Did I hear that right? 90%. Really? Ok, let's break it down for him. Full story

IDSA Lyme Hearing-- Contested Recommendations

16

Sep

Most of you know the hearing on July 30th before the IDSA hearing panel was about "contested recommendations" in the IDSA 2006 guidelines. These are recommendations and language in the IDSA guidelines that we contest or take issue with. They are important because they provide the road map for what the IDSA hearing panel must review. Contested recommendations must be evaluated by the panel. In order to remain in the guidelines, a supermajority (7 of the 9 panel members) must find that the contested recommendation is supported by the medical/scientific evidence presented at the hearing or otherwise submitted. Full story

LYME POLICY WONK: CALDA survey results are in!

08

Sep

Ask the Lyme community a question, or two or 30 and they answer! When we asked for input before the IDSA Lyme hearing, we had 3,600 completed surveys within 2 months—that’s astounding! I want to thank everyone who participated. The survey results provide very important information for the Lyme community and will be useful to describe the extent of the problem that patients have being timely diagnosed, treated, reimbursed, seriously ill and the devastating effect the guidelines have on patients health. Full story

Wall Street Journal Weighs in On Patient Choice (YES!!!)

01

Sep

There is a fabulous article on the importance of patient choice in universal health care in the Wall Street Journal. The article, "Sorting Fact from Fiction," is by Groopman . I recommend that you take the time to read this important piece, which identifies many of the issues Lyme patients have been raising for some time. I posted a comment to the article drawing the analogies to Lyme disease, which follows. You may want to weigh in on this important topic. Full story

IDSA Hearing: Putting on a Good Face?

29

Aug

Those who attended the IDSA guidelines hearing were struck by the even-handed tone of the proceedings established by the Chair, Dr. Carol Baker. It was both unexpected and disarming, and not a small accomplishment given the polarity of the debate. At the same time, there was a feeling of cognitive dissonance—this was not the public face presented by IDSA President, Dr. Ann Gershon—who, in the face of the ILADS submission of over 1,600 pages of scientific evidence contradicting the guideline recommendations, steadfastly maintains there is no evidence of persistence. So what gives? Is this a case of “good cop/bad cop”? Are perceptions deceiving? Is this all a matter of managing public perception? Putting on a public face? Full story

Why do some states zig while others zag?

10

Aug

Ever wonder what is going on with surveillance numbers? How come some states go up, up, up and others go down? If you look at Lyme surveillance in the US from 1990 to 2007 and just consider did cases go up or down, it can get pretty interesting. I don't know what to think when cases go down. Did all the ticks move out of dodge? Did the doctors quit diagnosing? Did people finally get the message and stay in doors with a book? Did the disease definition change? Is there a new department of health head? Did staffing go down? Did certain areas of the US just fall off the books because they were told there was no Lyme south of the Mason Dixie? I don't have answers. This is a list of those states that zigged when others were zagging. Tell me your thoughts. Full story

GIVING THANKS

06

Aug

Last Thursday, the historic review of the IDSA 2006 Lyme guidelines was held in Washington, D.C. Eighteen people presented arguments for and against the guidelines. We don’t know how the IDSA panel will act in the face of this deluge of previously suppressed information, but we do know that we have grown enormously as a community and that the skill-sets we developed on this project will continue to have a positive effect in the future. I want to share with you a little of the background of the action and acknowledge people who have joined in this massive undertaking over this period. Many others have contributed, and I apologize if I have overlooked anyone’s contribution to this effort. Full story

IDSA HEARING: Panel asks for "Under Our Skin" DVDs

05

Aug

The Infectious Diseases Society of America has requested Open Eye Pictures to furnish copies of the documentary "Under Our Skin" to each member of the Lyme guidelines review panel. Full story

IDSA Hearing--Reflections

05

Aug

The IDSA Lyme disease guidelines review hearing on Thursday was an historic event both in medicine and in the Lyme community. It is the first time an organization has been required to hold hearings and review treatment guidelines that were created by a panel with conflicts of interest. It is also the first time that a broad debate of both sides of the Lyme controversy over diagnosis and treatment with physicians and researchers has been held. Full story

Lorraine Johnson IDSA Review Hearing Speech

02

Aug

The IDSA has now posted links to all of the presentation videos. I decided to retape my video outside the hearing so that it will not be subject to the IDSA's decisions about how long to post or keep the archive. The video on the IDSA site includes the Q&A and reflects the proceedings that day. Full story

How to watch archives of IDSA hearing and copies of speakers' slides

02

Aug

Here's information about how to access different parts of the July 30 hearing. Full story

IDSA HEARING: Follow the hearing and comment 8 a.m.-5 p.m. ET, July 30

30

Jul

We are providing blog updates of testimony throughout the day. Full story

IDSA Virtual Lobby Now Open - VIEW LIVE WEBCAST

28

Jul

The IDSA Virtual Lobby is now open (see link below). In addition, the IDSA has posted a terms of use on the virtual lobby--these terms are the IDSA's one-sided view of how copyright restrictions etc should play out. You do not need to read the terms before viewing the presentations and you SHOULD NOT. The IDSA is not entitled to post any restrictions on viewing, period, beginning and end of story. I would not want to give them any argument that people read their terms before viewing and the best way to ensure that is to simply not view the terms before viewing. Full story

IDSA HEARING - Is your computer ready to watch July 30 Lyme webcast?

27

Jul

The upcoming IDSA Lyme panel review hearing will be streamed live over the internet. Test your computer now to make sure it is ready for access the webcast. Full story

LYME POLICY WONK: Lorraine Johnson ready to testify before IDSA Lyme panel

27

Jul

CALDA CEO Lorraine Johnson is now in Washington DC, prepared to testify at Thursday's historic hearing before the IDSA Lyme guidelines panel. Included in her report will be results from some 3500 surveys submitted by Lyme patients in recent weeks. From now through Thursday, please refer to our "IDSA Hearing" blog for latest developments. Full story

IDSA HEARING: Late breaking news--no registration required

27

Jul

This just in from Lorraine Johnson: We have been discussing concerns regarding the IDSA hearing viewing restrictions with the Connecticut Attorney General’s Office, who has assured us that the registration requirement has been lifted and provided us with other information about the hearing. The information is fluid and more details may emerge. I will keep you posted on this as news develops. Full story

When is a public hearing not public—the sequel?

24

Jul

The IDSA settlement agreement calls for an open public meeting which must be aired live over the internet. I have serious concerns about the restrictions the IDSA is imposing on people who want to watch the hearings and am discussing these with the Connecticut Attorney General’s office, but meanwhile I want to provide you with information so that if you want to watch you are prepared. Full story

Listen up! Speak out and be heard! Help CALDA represent your views to the IDSA!

16

Jun

The Infectious Diseases Society of America’s new Lyme disease guidelines review panel will hold a one day hearing on July 30. This hearing is part of the antitrust settlement that the Connecticut Attorney General negotiated. Of the 18 speakers selected to testify, two are patient advocates, including me. The testimony will be aired live on the internet on July 30 so stay tuned. STAND UP AND BE COUNTED CALDA is conducting a survey of individual Lyme experiences to give you a chance to have input. Results of the survey will be included in my testimony to the IDSA panel. Full story

It's about time! IDSA Lyme hearing speech limits

22

Jul

It's about going from the abstract to the concrete. Getting out the stop watch and thinking about just how long is 15 minutes. It's enough time to eat lunch or do an errand. But how long is 15 minutes in words? I haven't had to give it much thought until recently. It turns out 15 minutes translates into a number of words. In speeches the pace is generally between 120 and 160 words per minutes. So, if you do a scripted speech for 15 minutes, you have between 1,800 and 2,400 words. Now, if I could only master the art of speed read and teach the panel to speed listen, we'd be off to the races!

CALDA, LDA and TFL Press Release on IDSA Hearing

22

Jul

CALDA, the national Lyme Disease Association and Time for Lyme have issued a joint press release regarding the IDSA Lyme review hearing, which is schedule for July 30th in Washington D.C. The release highlights the growing opposition to the IDSA guidelines, the importance of acknowledging the full spectrum of science in Lyme disease, and the importance of permitting clinical judgment and treatment options for patients. Concerns are also raised about the current process, which Attorney Lorraine Johnson points out is not impartial because IDSA controls the process and has selected both the panel members and those who may present before the panel. Of critical importance is that fact that no physicians who treat chronic Lyme disease were selected to sit on the panel. The testimony will be aired live over the internet on July 30th. Full story

Attorney General Blumenthal Speaks Out! Now hear this. . .

20

Jul

If you have not read the recent editorial by Attorney General Blumenthal published today in “The Day”—you are in for a treat. Despite the IDSA’s protests that the guideline review process is “voluntary”, Blumenthal observes that the IDSA “effectively admitted the flaws by agreeing to a review and reassessment of its 2006 guidelines by a conflicts-free panel”. Full story

Pick a little, talk a little--How to make a speech for IDSA Lyme review panel

14

Jul

Well, as you can see, I’ve reached the cutting and pasting portion of writing my speech for the IDSA Lyme Guidelines Review Panel—a bit like making a quilt. You start off with yards of different fabrics, cut them into little squares and eventually reassemble them into the quilt, tying off the edges carefully and trying not to prick yourself with the needle on the way. As a patient advocate, I am allotted 15 minutes to make my point and leave the podium. By the way, it is a lot more difficult to write a 15 minute speech than a 45 minutes speech—size matters. It’s like Mark Twain said: “I didn't have time to write a short letter, so I wrote a long one instead.” Full story

Andy Schlafly of AAPS Takes on Autism Treatment--lessons for Lyme

09

Jul

Andy Schlafly of AAPS describes the efforts of AAPS to work with patient groups in health care reform for autism. His comments on how important it it to speak out and for patients and physicians to join together to combat over-zealous medical boards that go after physicians who treat patients is compelling. He points out that the medical board in Texas is in cohoots with insurers behind the scenes and that this has impeded legislative efforts. Take a look at his video. The parallels with Lyme are striking. Full story

Talking the talk

29

Jun

Terrence McNally at KPFK, a local public radio station in Los Angeles interviewed me, Andy Wilson, Mandy, and Dr. Horowitz on June 23rd about the film, Under Our Skin, and about the antitrust settlement. It is a good listen if you have not heard it. The link to the podcast is below. A close friend snapped the picture of me in the booth. Full story

Gunfight at the OK Corral-- Pistols at dawn! The Sequel--Stricker & Johnson reply to President of IDSA

06

Jun

A couple of weeks ago, I suggested you look the “pistols at dawn” action at the OK Corral between IDSA president, Dr. Ann Gershon, and Dr. Stricker and me on the IDSA guidelines, antitrust law, and Lyme disease. Drum roll. . .The reply by Dr. Sticker and me is now posted on the Journal of Medical Ethics website. This lively debate is a breath of fresh air to the Lyme community. Full story

IDSA announces presenters and order of presentation

01

Jun

The Infectious Diseases Society of America has selected presenters to speak before its Lyme disease guidelines review panel on July 30. (This is part of the guidelines review process mandated by the IDSA’s settlement with the Attorney General of Connecticut.) The speakers representing patient advocates are Tina Garcia, of the Lyme Education and Awareness Program (LEAP) and me. Three researchers that are not affiliated with either ILADS or IDSA will speak: Drs. Brian Fallon from Columbia, Ben Luft from Stony Brook, and David Volkman, previously from the National Institute of Health (NIH). The following members of ILADS will be presenting: Drs. Daniel Cameron, Ken Liegner, Steven Phillips and Raphael Stricker. In addition, Allison Delong, MS, of Brown University, and Dr. Donta, a member of IDSA, will present. Those advocating for the IDSA guidelines include Drs. Phillip Baker (President of the American Lyme Disease Foundation and previously with NIH), Barbara Johnson (Centers for Disease Control), Eugene Shapiro, Sunil Sood, Allen Steere, Art Weinstein and Gary Wormser. Full story

Gunfight at the OK Corral-- Pistols at dawn! IDSA President takes aim at Stricker and Johnson article on flawed Lyme guidelines.

22

May

You need to take a look at the “pistols at dawn” action at the OK Corral. The article by Dr. Stricker and me on the IDSA guidelines, antitrust law, and Lyme disease has drawn the heat of Dr. Gershon, President of IDSA. This type of exchange is good. It highlights issues. It clears the air. Remember a duel is not a brawl. It is a controlled battle between gentlemen of honor with a certain level of dignity expected of all participants. I don’t know, it still makes me think that I ought to put on a combat helmet before putting put pen to paper. Full story

Strung up, strung out or simply entangled? Johnson & Stricker lay down the law on how IDSA became entangled with antitrust.

20

May

Some more light reading for those late nights when nothing is on the tube and you’re wondering how IDSA got ensnared in antitrust law with its Lyme disease guidelines. Just how flawed was its guidelines development process? Why is it important to democracy that opposing viewpoints be heard before vital freedoms—like your ability to choose among treatment options—are taken away. When do medical societies have an obligation to not suppress legitimate medical controversies? And, what is the drill for the settlement process anyway? If you have comments on the article, send them to me at johnson.lorraineb@gmail.com Full story

Ground Zero Lyme Disease: Check out Pollack's AG article

11

May

If you haven't read the article by attorneys Elliott Pollack and Christine Collyer in the Connecticut Law Tribune, "Attorney general challenges controversial Lyme disease guidelines", I suggest you check it out. Those familiar with the Jones case in Connecticut will recognize their names. Early on in the case, I had the pleasure of working with these attorneys and have appreciated the high level of competency and professionalism as well as their dogged pursuit of justice for Dr. Jones. Connecticut is ground zero for Lyme disease--with the Jones case, the Connecticut Attorney General antitrust investigation against IDSA, and the pending state legislation that would provide protection for treating physicians. Full story

Germany Says No to IDSA Lyme Guidelines

29

Apr

The German Society of Lyme Borreliosis submitted its objections to the IDSA Lyme disease review panel. The society protested the application of the IDSA guidelines in Germany, emphasizing the poor lab test sensitivity, persistence of the organism, and seriousness of the illness. Full story

The UK Says No to IDSA Lyme Guidelines

27

Apr

Lyme Disease Action (in the UK) filed a submission with the IDSA contesting the IDSA 2006 Lyme disease guidelines. The submission points out that the presentation of Lyme disease in the UK may be different than the presentation in the US, and the application of the guidelines in the UK lead to under-diagnosis and under-treatment of patients with Lyme disease. Full story

The spectacular, spectacular--The Association of American Physicians and Surgeons (AAPS) takes IDSA to task

24

Apr

The Association of American Physicians and Surgeons (AAPS), which represents physicians and surgeons in small practices, sets the IDSA Lyme disease guidelines in its cross-hairs. Why? Because the physicians need flexibility and the IDSA guidelines are mandates that restrict the ability of physicians to provide individualized care. The full text of the AAPS letter to the IDSA follows: Full story

ILADS Submits

23

Apr

Pop the cork off the Champagne and let the fireworks rip! ILADS made its document submission for the IDSA Lyme disease review panel. And the weight of evidence was staggering-- Full story

At the Gala

24

Apr

Every now and then you gotta kick up your heels. This year I headed back east for Time for Lyme's GALA. The Young People's Chorus of New York City gave an amazing performance of internationally inspired songs. Actor, Director and Writer Lou Diamond Phillips of Lyme Life gave a compelling speech and a rousing performance singing with the band--including the song LA BAMBA--which had everyone up dancing. The picture is me leaning in to talk with Dr. Luc Montagnier, a Nobel Prize winner for his discovery of HIV, who was honored at the GALA.

Panel stacking: It's not magic. It’s deception

21

Apr

The IDSA trots out bad faith move after bad faith move to ensure that their Lyme disease guidelines are rubberstamped quickly and quietly. IDSA took first things first--which means stacking the panel has been front and center in its cross-hairs for some time. Full story

Patients know enough medicine to smell a rat

20

Apr

Most guidelines panels are heavily populated by academics. Why is that? Take the IDSA guidelines Lyme disease panel in 2006—all academic researchers. Researchers are good at science, but what about medicine? Does good science make good medicine? Not necessarily. Full story

Do not forget: Applications for Lyme disease review panel Due April 17th

06

Apr

Applications for the IDSA panel are due April 17th. Time is slipping away. Do not forget this important date. The application for presenting is an electronic application that is available on the IDSA website. The actual panel hearing is scheduled for July 30th. If you have made a submission or are planning on making one, you may wish to refer to that submission in your application so that the panel realizes the importance of your presentation. Priority is going to be given to researchers and physicians. If you have questions regarding this, please contact me at johnson.lorraineb@gmail.com

IDSA Lyme disease review panel date set for July 30th! New calendar attached

06

Apr

The IDSA has set the review panel date for July 30th. None of the other calendar dates have changed. The applications for the panel are due April 17th, document submissions are due April 24th, and selected presenters will be notified by May 15th. If you intend to apply to present or are making a document submission, please let me know and send me a copy of your application or submission at johnson.lorraineb@gmail.com Full story

JAMA to conflict of interest breaches—silence is golden

03

Apr

JAMA is having a personality conflict with itself. After publishing 3 very strong articles on the ethics in guidelines development, it has asked those who question ethics violations in JAMA’s publications to keep quiet about them. In JAMA’s view, conflict violation in its journal should be discussed only if and when JAMA decides to discuss them. This sounds like a policy designed to silence whistle blowers at a time when we need more whistles and fewer muzzles. Not surprisingly, the Association of Health Care Journals has come out against JAMA on this one. Full story

Let's give a hand to Volkman--a little thank you can go a long way

31

Mar

Sometimes someone does something so wonderful. Really! Something so wonderful that you have to stop, take a breath, exhale, and look again. In this world, the world of patients with Lyme disease, it happens rarely. And, when it does, we need to acknowledge it, and, more importantly, we need to acknowledge those who do the right thing no matter what. When someone outside this community steps up to bat for us, well, we should just stop what we are doing and give thanks. Here is my thank-you to Dr. David Volkman. (p.s. you can write one too) Full story

JAMA to IDSA--Can you hear me now? Now? How about Now?!

31

Mar

Merrill Goozner continues his insightful beat on conflict of interest articles by JAMA this year. Count them, one, two, three by JAMA--THIS YEAR--SO FAR--AND ITS ONLY MARCH! Does this mark a trend? A turning point for conflicts of interest in Lyme disease? In medicine? Do medical societies have an obligation to hold certain truths to be self evident--that patient concerns come before industry interests and ties? Full story

IDSA: Caution when opening--contents under pressure

28

Mar

When is an open hearing not an open hearing? How do you give the appearance of being open without, well, actually being open? How do you deal with the issue of public accountability in Lyme disease guidelines when you would rather not? I'd say the IDSA open hearing, which excludes the public from participating, but allows them to "view" the proceeds from a safe distance probably fits the bill. And that, my friends, is what the IDSA intends to do. Hold a public hearing that fits the "form" but not the "substance" of a public hearing. In this way--the IDSA does not have to face the patients whose lives it is destroying. This is a one sided communication device--something the patients are quite used to, but something the IDSA should set aside in favor of accountable transparency. If you are going to talk the talk , you ought to walk the walk. Let's call this hearing what it is-- one more way to "silence the sick".

IDSA NEW DEADLINES Schedule--Time to get on the stick

27

Mar

The IDSA has a new schedule for the Lyme disease guidelines review process—applications are open—submissions of contested recommendations are extended—hearing date is not set. A table of the scheduled events follows. The open public hearing turns out to be, well, not quite so open (no one but presenters can attend?). The IDSA plan here is to air it live over the internet on the IDSA website and hightail it out of town. Full story

IDSA Application Process Open--Certain restrictions may apply

28

Mar

The IDSA has extended the time to apply for the Lyme disease guidelines review panel. The window closes April the 17th so those who are interested are encourage to apply promptly. The application process requires two applications, one on content and the other on conflicts of interest. Both forms need to be submitted by the deadline. Although anyone can apply to present, clinicians and researchers will be given preference. The IDSA panel will advise those who are accepted as presenters by May 15th. The deadline for submitting documents and research has been extended to April 24th. In addtion, any presentation materials must be submitted prior to the hearing. Members of the public will be able to view the hearing live on the IDSA website. A taped archive will be available online after the hearing. Full story

IDSA makes it official--input period extended for all to April 24th!

27

Mar

Yes, we have an extension! Yes, it is official! Yes, Yes, Yes. . . .(don't get me going) Full story

Volkman submission to IDSA--Smells like courage to me

26

Mar

David Volkman, Emeritus Professor of Medicine and Pediatrics at SUNY, Stony Brook, and previously Senior Investigator with the National Institute of Allergies and Infectious Diseases, has submitted the attached letter to the IDSA pursuant to its document submission process. He has performed both clinical and bench research in Lyme disease since 1985. Given his impeccable credentials, outlined in the first paragraph of his letter, his submission should carry considerable weight with the panel. Among other things, he points to the suppression of research and stifling of the types of investigative inquiry necessary to begin to address pressing issues for Lyme patients—the need for better testing, the need to acknowledge persistence and start looking for treatment protocols that help patients get better, the need to keep surveillance definitions outside the arena of patient diagnosis, the need to acknowledge the usefulness of PCR testing, and the need to avoid prophylaxis regimens that may promote chronic Lyme. His letter smells a little bit like “courage” to me—a pretty rare commodity these days. Full story

Shifting sands of time--IDSA calendar revisions at hand

26

Mar

The IDSA is expected to extend the time period for document submissions to the 24th of April. Jennifer Padberg expects to post a new calendar of events early next week, at which time she also expects the application process for presenters to be opened. The presentation date will likely be pushed until summer. Presenters will be selected by the IDSA, the ombudsman, and the Connecticut Attorney General. ILADS-affiliated speakers will be permitted an equal amount of time for presentations. I will post more news as it becomes available.

Annals of Neurology -- Fair and balanced reporting is alive and well

24

Mar

If you have not read the recent article by Brenda Patoine, "Guideline-Making gets tougher: Action by state attorney general over Lyme disease guidelines stirs debate, " I recommend you do. It is a good reminder that reporters can still do the in depth coverage of complex issues and hold their ground on reality based reporting. Full story

Silencing the sick-- IDSA wages calendar warfare

21

Mar

How is it possible for the IDSA to have a public guidelines review on Lyme Disease hearing date set for April 27th when it hasn’t notified speakers that they will be speaking at the hearing? When it hasn’t even selected speakers? When it hasn’t even posted applications for speakers on its website? When it hasn’t reserved a room for the event? You’d think this group had never held a conference before—but wait— it holds annual conferences! So this organization KNOWS how to prepare for and hold a big event that will have a number of speakers; it knows how to reserve a room; and even how to select speakers and give them time to prepare. In fact, it has already worked out all of these details for its own annual meeting in October, which is more than 6 months away. They have a list of speakers, the assigned topics and reserved facilities— the whole nine yards. Full story

Is evidence based medicine bankrupt?

28

Feb

Merrill Goozner at Gooznews cites a recent JAMA article by Tricoci showing that nearly half of the recommendations in treatment guidelines are not based on clinical trials, but rather, are based on no more than the expert opinion of those on the panel. This leads to the rather obvious conclusion that evidence based medicine is largely bankrupt. Only 11% of recommendations for heart disease were based on multiple randomized trials. Full story

IDSA Panel--Document submission changes

24

Feb

In response to concerns raised by patient's organizations and physicians about the document submission process--which initially tried to limit submissions to five pages--the IDSA has changed its document submission process. The IDSA is now requesting that submissions be 10 pages or less with an acknowledgment that they will consider all submissions regardless of length. For a submission to be considered by the panel though it must specify what recommendation is being contested. This is because the scope of this panel is simply to consider and weigh the scientific evidence for contested recommendations. Full story

Stimulating distrust?

19

Feb

On February 17, 2009, President Obama signed into law a stimulus program that includes $1.1 billion for comparative effectiveness research. The Partnership to Improve Patient Care, a coalition of patient groups, physicians and pharmaceuticals, warned that the research might be inappropriately used to “limit treatment options for patients.” A health care e-list that I’m on has become an active war zone on this issue. (Full disclosure—I am a combatant.) Full story

Gostin JAMA article--Politics as usual?

17

Feb

How is it that one week JAMA publishes an article by Sniderman and Furberg, "Why Guidelines Require Reform", on the urgent need to for guideline reform and the next week they publish a piece by Kraemer and Gostin, "Science, Politics and Values", that could have been written by a PR firm for the IDSA, berating the Connecticut Attorney General for trying to accomplish just that? Full story

JAMA--Why guideline making requires reform

20

Feb

A recent article by Sniderman and Furberg, "Why Guideline Making Requires Reform" is a remarkably comprehensive over-view of the pitfalls of evidence based guidelines. The Full story

Chronic Lyme Disease and the "Axis of Evil"

14

Feb

A recent publication authored by Feder and correspondence to that publication defined the 'Axis of Evil' in this controversy as physicians who treat patients with needlessly prolonged courses of antibiotics, 'specialty laboratories' that perform 'inaccurate' Lyme testing and the internet, which promotes 'Lyme hysteria'. Dr. Stricker and I published a counter article taking on each of the three elements of the "Axis of Evil", one by one (Future Microbiology, Volume 3, Number 6, December 2008 , pp. 621-624(4)). While this version of the article is available on Pub Med, the full version (which contains footnotes) is available for purchase by the publisher Future Science . Full story

Q&A: IDSA Public Input Period

09

Feb

On February 2, 2009, the IDSA announced the opening of the 60-day public input period. The period expires at 5 pm on April 3, 2009. While many issues remain to be sorted out, this posting presents some of the currents Q&A issues that patients are raising. Full story

Protesting the panel: Putting pen to paper

08

Feb

In another post, I pointed out problems with the composition of the IDSA panel—namely, that the IDSA panel is biased toward the IDSA perspective because physicians who treat chronic Lyme were entirely excluded and some of the panel members have known biases. A number of patients have contacted me who want to do something. This post will let you know who, what, and where you can write to have the best chance of getting your voice heard. Full story

Lyme panel: Selection and exclusion bias

05

Feb

Most patients who write me share my concern about the composition of the IDSA panel, and with good cause. Our reasons for concern are two-fold. We are concerned about who was selected for the panel. And, we are concerned about who was rejected from the panel. Full story

Rejects! NY Times Rejects Another Letter from Johnson/Stricker

08

Feb

Over the years in the trenches, Dr. Stricker and I have written a number of letters jointly or individual to the New York Times. Not a one has been published. And, we are not the only ones--leading some patients to question what it is the NY Times has against Lyme patients. It's enough to make one wonder about fair and impartial journalism. A number of patients groups have written the NY Times Ombudsman to protest its uniformly one sided view of Lyme disease. Clearly, the topic of Lyme is timely, controversial and newsworthy. Yet only one side seems to merit the cost of ink by the NY Times. Full story

Weintraub to IDSA: Listen to the steady heart beat of true science, leave the past behind, and move toward the future

05

Feb

If you have not read Pam Weintraub's Disappearing a disease: when guidelines are biased, patients suffer I suggest you take a breath and head over to her blog on Psychology Today. Pam Weintraub is the author of "Cure Unknown: Inside the Lyme Epidemic", the seminal book on the politics and science underlying Lyme disease. I recall telling a friend and attorney who simply did not understand why there should be a controversy when so many people were ill--why would any physician, those men in the white coats, deliberately leave patients ill, untreated, and without hope. Since when did medicine become a science of closed doors, double locked against the needs of patients? Full story

IDSA Lyme Disease Review Panel Announces Public Input Period and Hearing Date

02

Feb

The IDSA review panel has announced that the period for the public to submit information to ensure that all points views are taken into consideration is open. Submissions must be received by April 3 and should not exceed 5 pages. The public hearing date has been set as April 27th in Washington DC area. Information on how to apply to be a presenter will be forthcoming. Full story

IDSA guidelines panel list as of 2/1/09

01

Feb

Some of you are aware that the original list of 10 panel members is now 9 because Weinstein was removed. For convenience, I am posting the current list of IDSA panel members with Weinstein removed. Full story

Medical antitrust actions--Does "might make right"?

30

Jan

Antitrust law is concerned with constraints of trade that foreclose consumer choice. Guidelines developed by medical specialty societies that have monopoly power (like the IDSA) can become de facto legal standards for the practice of medicine. When they foreclose treatment options and the exercise of clinical judgment, they constrain consumer choice. Typically, laws are passed in the United States through a democratic process that allows many groups to have a voice in the law before it is passed. Antitrust laws make an exception to guidelines or standards that are developed by groups that have expertise in an area (for instance, computer chips and medicine) so long as they play fair. The reason for this exception is that the level of expertise required in these areas makes it reasonable for "experts" rather than laymen to be setting the rules. Full story

Gooznews takes on conflicts in guidelines

30

Jan

Gooznews posted an interesting commentary on guidelines, conflicts of interest in guideline development and over reliance on expert panels when there are gaps in evidence. Merrill Goozner is a health care ethicist and this is not the first entry on his blog that has caught my attention. You might want to check it out. His post is premised on the recent article by Sniderman in the Journal of the American Medical Association (recent issue), which does a remarkably job outlining the problems with control in evidence based medicine, how "opinions" of the panel members are recharacterized as "science" in the form of evidence based guidelines. Some of the comments to Goozner's post are interesting. One person responds that "Evidence-based medicine has morphed into pharma-based medicine and HMO-based medicine". I thought Goozner's post was a good opportunity to point out some of the problems with the IDSA guidelines. My comment follows: Full story

The IDSA panel--Q and A

26

Jan

Many people have questions about the IDSA panel, its selection and where we are in the process. This posting I will attempt to answer some of the more common questions. Full story

Conflicting views on conflicts—throwing the baby out with the bathwater

22

Jan

Conflicts of interest are not good for medicine. Why? Because when a physician has a conflict a secondary considerations (such as a lab referrals, vaccine research grants, or revenues from proprietary diagnostic tests) may compete and trump concerns about the best care for the patient. The last Lyme disease guidelines by the IDSA suffered from an abundance of conflicts of interest and no oversight. In fact, the Attorney General found extensive conflicts of interests among the IDSA panel that developed those guidelines. (Click title to read full article.) Full story

Weinstein Off the IDSA Guidelines Review Panel!

27

Jan

Arthur Weinstein's role on the IDSA's Lyme guidelines review panel was short lived. Today's list of panel members posted on the IDSA website excludes him. Patient groups were alarmed when he was included in the IDSA's panel list posted by the IDSA on Monday. Weinstein was at NYMC with Dr. Gary Wormser, who was the chair of the 2006 IDSA guidelines panel, which the Connecticut Attorney General investigated and found had been riddled with conflicts of interest , excluded divergent points of view and suppressed scientific evidence. Weinstein was a co-author on the Klempner study, on the safety monitoring board for the vaccines, and involved in the flawed western blot testing (Dearborn Conference). His removal from the panel is a step in the right direction for Lyme patients. Full story

IDSA Announces New Guidelines Panel--Balanced or Biased?

24

Jan

The IDSA panel list for the Lyme disease guidelines review panel were announced on Monday. The IDSA has a history of stacking its guidelines panels with like-minded experts and excluding divergent points of view. For patients this has meant limited or no treatment options. Imagine a prostate cancer panel of surgeons only—radiation, hormone treatment and watchful waiting might no longer be viable treatment options. How well-informed would surgeons be of alternatives to surgery? After the antitrust investigation launched by the Connecticut Attorney General, the IDSA was forced, as part of its settlement agreement, to have its 2006 Lyme disease guidelines reviewed by a new panel. The 2006 panel was riddled with conflicts of interest, exclusion of divergent viewpoints, and suppression of scientific evidence. (Click on title to read full article.) Full story

Bias and patient autonomy—what's the connection

24

Jan

Everyone is entitled to their own opinion. So why do we care about bias in medical guidelines? Because opinion should not dictate patient care. Think of the prostate cancer patient who sees the surgeon who recommends surgery, the radiologist who recommends radiation treatment, and the internist who recommends watchful waiting. Everyone knows that one’s position depends on where one sits. The surgeon may genuinely prefer surgery and when he recommends it to his patient, the patient realizes that he is, after all, talking with a surgeon and that surgeons are likely to favor surgery. He also knows that he can walk down the street a bit and talk with the radiologist and get his perspective. The point is that even though the patient is given conflicting advice, at the end of the day the decision is his. He chooses among treatment options and the physicians respect his decision. This is called autonomy—a recognition that patients are entitled to make choices among health care options. Full story

Opinion based medicine

23

Jan

For those who haven’t read, the recent New York Times article, "Plenty of Guidelines, but Where's the Evidence?" by D. Sanghavi, M.D., I suggest you check it out. Sanghavi discusses the problems caused by centralized guidelines in medicine particularly when there is an evidence gap—when guidelines are based on opinion rather than a careful review of all of the evidence. And, this issue of centralization of medicine through guidelines is becoming more important as the push for national health care heats up. Full story

Attorney General findings--IDSA wrong doing

31

May

In May 2008, after an extensive investigation, the Attorney General announced a settlement of the antitrust investigation into the IDSA guidelines development process. The settlement requires that the IDSA put together a new panel free from conflicts of interest, permit the introduction of evidence opposing its viewpoints, and hold a public hearing (aired live on the Internet) on controversial recommendations of the guidelines panel. Full story

The IDSA Guidelines Re-Evaluation Process

13

Sep

In May 2008, the IDSA agreed to re-evaluate its guidelines as part of the settlement agreement for an antitrust investigation by the Attorney General of Connecticut, which found significant conflicts of interest on the original panel, suppression of scientific evidence, and exclusion of panel members with opposing viewpoints. This is the first time a guidelines panel has been forced to re-examine its guidelines under antitrust law. Full story

IDSA Now Accepting Applications For Panel Members For Guidelines Review Panel

14

May

The IDSA is now accepting applications from clinicians and scientists for a seat on its new Lyme disease guidelines review panel, which will consist of 8-12 members (including the chair) “who, as a group, reflect a balanced variety of perspectives and experience across a broad range of relevant disciplines, ranging from clinical experience in treating patients with Lyme disease to experience in investigating the best methods to diagnose and treat Lyme disease or other infectious diseases.” Full story

Attorney General Press Release: IDSA Lyme Disease Guidelines Flawed and Driven by Conflicts of Interests

01

May

On May 1, 2008, the Connecticut Attorney General announced a landmark settlement against the Infectious Diseases Society of America in connection with its guidelines for treating Lyme disease. The IDSA guidelines are relied upon by insurers throughout the nation to deny seriously ill patients treatment for chronic Lyme disease. The Attorney General found substantial conflicts of interest among the panel members on the IDSA guidelines who held commercial interests related to diagnostic tests, vaccines, and insurance. In addition, the Attorney General found that the panel suppressed scientific evidence and excluded opposing views from the panel. Full story