LYMEPOLICYWONK: Full Disclosure. IDSA Enforces Its “Voluntary” Guidelines
In 2008, then-Connecticut Attorney General, Richard Blumenthal, criticized the Infectious Disease Society of America (IDSA) guidelines authors for their conflicts-of-interest with vaccines, Lyme test kits and insurance and their failure to disclose these. Since then, their disclosures have been more robust. Apparently, medical journals got that message. Take their disclosure in a recent letter in Lancet by the IDSA gang (link below). Here’s the thing though, most of the conflicts listed involve the IDSA authors testifying against their competitors in medical malpractice testimony and testimony before medical boards. You might recall that when I testified before the IDSA review panel in 2009, the panel seemed shocked when I said that because the IDSA enforced its guidelines, they could hardly be considered voluntary. But if you take a look at the recent disclosures by the IDSA gang, you may wonder that they have time to do anything else, like research, given their aggressive interest in driving out competitive viewpoints. In fact, 6 of the 10 authors of the Lancet letter have testified against competitors. It makes you think these scientists have an anti-competitive ax to grind. It also makes you wonder why Lancet fails to see when scientists have lost the key to the kingdom of science–impartiality.
Here’s the breakdown:
Paul G Auwaerter has participated in expert testimony in two medicolegal suits about possible Lyme disease.
John J Halperin has served as an expert witness in several medicolegal cases concerning Lyme disease.
Robert B Nadelman served as an expert witness in malpractice litigation involving Lyme disease and acted as a consultant for Guidepoint Global, providing advice about Lyme disease.
Susan O’Connell has provided unpaid expert testimony to a fitness of practice hearing for the General Medical Council.
Eugene D Shapiro has been an expert witness in malpractice cases involving Lyme disease.
Gary P Wormser has been an expert witness in malpractice cases involving Lyme disease. He also was an expert witness in a disciplinary action for the Missouri Board of Registration for the Healing Arts.
Both Wormser and Dattwyler continue to have conflicts of interests with Lyme diagnostic tests, which are required for diagnosis under the IDSA guidelines. GPW has received research grants from the Centers for Disease Control and Prevention, the National Institutes of Health, Immunetics, BioRad, DiaSorin, and Biomerieux; has equity in Abbott (not known to have any approved product for Lyme disease). (That’s an odd disclosure, right? What does he mean Abbott has no “approved” product for Lyme disease. I suppose the fact that they are working on a vaccine doesn’t count?) Both Wormser and Shapiro disclose that they are “members” of the American Lyme Disease Foundation. (In actuality, they are members of the Board of Directors.)
The full disclosure reads:
PGA has participated in expert testimony in two medicolegal suits about possible Lyme disease. RJD is part owner of and has stock in Biopeptides Corporation, has received grant support from the National Institutes of Health for the development of new serological assays for diagnosis of Lyme disease, and holds one patent and one patent pending for a peptide diagnostic agent for Lyme disease. JJH has served as an expert witness in several medicolegal cases concerning Lyme disease and has equity in Abbott, Bristol-Myers Squibb, Johnson and Johnson, and Merck; no products from these companies are referred to in this letter. RBN served as an expert witness in malpractice litigation involving Lyme disease and acted as a consultant for Guidepoint Global, providing advice about Lyme disease. SO has provided unpaid expert testimony to a fitness of practice hearing for the General Medical Council. EDS and GPW have been expert witnesses in malpractice cases involving Lyme disease and are unpaid board members of the America Lyme Disease Foundation. GPW has received research grants from the Centers for Disease Control and Prevention, the National Institutes of Health, Immunetics, BioRad, DiaSorin, and Biomerieux; has equity in Abbott (not known to have any approved product for Lyme disease); and was an expert witness in a disciplinary action for the Missouri Board of Registration for the Healing Arts. The other authors declare that they have no conflicts of interest.
Here’s my piece of testimony before the IDSA antitrust hearing on the issue of the IDSA legally enforcing its guidelines.
Dr. Parsonnet: Thank you for your presentation. I have a question for you. In your talk, you said that the guidelines are, I think you were using the term “enforced by IDSA itself”. And, I mean, I think there’s two issues. One is what’s in the guidelines, and then what is done with the guidelines by others, some of which is certainly not under the jurisdiction of IDSA. So, when you said the guidelines are enforced by IDSA itself, what do you mean?
Lorraine Johnson: What I mean is that IDSA physicians testify against physicians who are not complying with these guidelines.
Dr. Parsonnet: Is that IDSA or certain individual members because you consider this to be a systematic effort by IDSA to enforce guidelines or just individual physicians?
Lorraine Johnson: I don’t know if the IDSA has a policy on it, but I know that the fact of the matter is that whether it’s because the IDSA members are reading the guidelines and taking them as sacrosanct, or whether it’s because they believe that they are under a directive to do that, they are doing it.
Dr. Parsonnet: But when you say that IDSA enforces it, I think it implies that the organization is enforcing these guidelines rather than what you seem to imply now that individual members of IDSA we’re independently testifying in individual cases. I wonder whether that just doesn’t add a little bit to this.
Lorraine Johnson: You know organizations act through their members. An organization is a separate distinct legal entity. It can’t walk; it can’t talk, so it acts through its members. If the IDSA wanted to have its members not testify against physicians who do not comply, they could easily ask their members not to do it.
Dr. Parsonnet: Well, I as a member, I would never do it, what my organization tells me to do. I do treat patients for Lyme disease and chronic symptoms. And I’ll do what I think is in the best interest of the patient regardless of what my society says.
Lyme disease: Uphill Struggle: http://www.nature.com/nature/journal/v439/n7076/full/439524a.html
Auwaerter PG, Bakken JS, Dattwyler RJ, Halperin JJ, et al. Lyme disease antiscience –Authors’ reply. The Lancet Infectious Diseases. 2012;12(5):362-3. http://www.lancet.com/journals/laninf/article/PIIS1473-3099(12)70056-7/fulltext
NEWS: “The Lancet” publishes rebuttal letters by Lyme advocates https://lymedisease.org/news/lyme_disease_views/lancet-lyme-rebuttals.html
NEWS: Authors of IDSA guidelines call Lyme advocates “anti-science” and “a threat to public health.” https://lymedisease.org/news/lyme_disease_views/lancet.html
Attorney General’s Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees To Reassess Guidelines, Install Independent Arbiter (May 1, 2008) http://www.ct.gov/ag/cwp/view.asp?a=2795&q=414284
The LYME POLICY WONK blog is written by Lorraine Johnson, JD, MBA, who is the Chief Executive Officer of LymeDisease.org, formerly CALDA. Contact her at firstname.lastname@example.org.
- June 16, 2012 at 10:56 am
Anti trust – IDSA has been treating Lyme and Associated infected individuals and/or their families as “live-stock” for self-gain – period.
- June 16, 2012 at 2:54 pm
Lyme and other tick born diseases exist. Chronic Lyme/Assoc. disease exist. We are humans (not “live-stock”) dealing with serious medical disability up to reported (90%) after misdiagnosis in negligent Breech of the (CDC) Standard of Care.
Lyme/Assoc. disease chonically ill patients demand their rights of “choice” of (ILADS.org) Standard of Care – (HIPAA) privacy, dignity, integrity, respect – and a chance to complete wellness – without retaliation persecution, and prosecution by the (ISDA.org) gang in the courts – with unlawful discrimination of their rights, privileges and immunities under (ADA) Federal law.
- August 14, 2012 at 9:33 pm
Could you comment on your opinion and views on why there have been no class action lawsuits against either the IDSA, the CDC, insurance companies or other medical organizations given the massive and admitted number of people harmed plus the enormous amount of testimony around the IDSA guidelines? It seems like an obvious target for the big class action firms. Am I missing something?
- September 4, 2012 at 8:37 pm
Yes, I too have been wondering about this and cannot find any answers!
- September 28, 2013 at 9:59 am
I have been bitten by ticks on my property in central Florida . I have feral hogs, Deer ,etc. I have all the symptoms of Lyme . I got bit in early winter and only had the swollen bite of a tick that had dropped off or got scratched off. This red sore area lasted 3 months itching and red sore would not heal.The Doctor gave me 10 days of Doxy and sent me on my way.They said L.D. is a Northern disease. I got Antibiotics on line for Birds and Fish on the second month of treatment with 4 to go before I stop . I got bit by Lone Star Ticks (Amblyomma americanum) and American dog tick) & Gulf Coast tick): Rickettsia parkeri rickettsiosis .All saved in alcohol. CDC – Doxycycline Shortage PRICES JUMPED 10 X Times AMOXOCILLIN is your best bet .
- September 28, 2013 at 10:26 am
Arthritis and Lyme Disease , MY Arthritis did not improve until my second month of therapy and my toes on my left foot are numb but before my whole leg was swollen and numb and my left hand lil pinky and ring finger are numb. Anyone with Lyme seeing a doctor after a month do not be surprised if they refer you to a psychiatrist . Hospital ER’S are a big waste of time .I had to research this myself to get the treatment before it turns into a severe neurologic
disease. Bells Palsey etc. I will take my chances with antibiotic therapy …
We invite you to comment on our Facebook page.
Visit LymeDisease.org Facebook Page