Mea culpa: The Gritty and Confusing Details of the ACIP Recommendations for the Shingles Vaccine

Seems I missed some of the critical details of the "change."

Not nearly the picture I had portrayed in my last post, so I must share my mistake and thank Dan for elucidating my error.

For those, happily not worried about the minutiae of T cells and B cells and vaccine responses, you might read the following as a lesson I learned in the dangers of wishful thinking and not checking deeply into the facts.

As both a reporter of fact and as a scientist, I must quickly and fully admit and publish my errata.

Others might find a cautionary tale of the arrogance of big government, the dangers of decisions made by bureaucratic committees with their deft ability to impose their will and yet accept no responsibility for the consequences

Here are the details as explained by my friend, Dan who tells the story much better than I could.

Frankly, I am not enthused about the next step.

Brian

I suspect that you’re playing catch-up from your Middle East sojourn (a little rest, and the world is full of work). In that haste, you may have done a quick misread of the CDC-ACIP changes in re the shingles vaccine.

It is my understanding, of which I’m awaiting CDC – ACIP written confirmation, that the CDC – ACIP actually “cleaned-up” their integration between documents. Id est, the broader “General Recommendations on Immunization - Recommendations of the Advisory Committee on Immunization Practices (ACIP) as dated December 1, 2006 / 55(RR15);1-48” with the specific “Shingles Vaccine Information Statement” of 09/11/06 as revised 10/06/09, to better dovetail the latter with the broader 2006 white paper.

The broader “General Recommendations on Immunization …..” of Dec. 2006 has not been modified. The sectional title therein “Vaccination with Live-Attenuated Vaccines” still retains the language “Patients with leukemia, lymphoma, or other malignancies whose disease is in remission and whose chemotherapy has been terminated for at least 3 months can receive live-virus vaccines.” And therefore remains as dated December 1, 2006.

It is my understanding, as of my phone conversation with them today, that the CDC – ACIP has not been provided properly substantiated, valid, reliable, quantitative data for them to change their position. I had a “feeling” of suspecting something like this and is the reason I included in my email to Ron G. the Errata: Vol. 55, No. RR-15 to the still otherwise unmodified General Recommendations on Immunization, et cetera. I’m of the belief that the cornucopia nodes of such lacking data may repose in wait at places like MDACC, The Mayo Clinic, LIJ, NYP-WCMC, Dr. Hamblin’s olde haunts in the UK, in Cologne & Essen in Germany, Barcelona in Spain, Turin and Rome in Italy, et al.

On the other side of the argument, I sense the CDC – ACIP may have derived their position based on manifestations of leukemia other than that of CLL, e.g. childhood leukemia. I intend to follow-up on this aspect, should I receive back an email response. Should this prove to be the case, the extension of their argument as applicable to CLL may be fallacious. I sense the resolution lies with the T cells CD4 cut-off threshold limit, which if I understand correctly ties into Dr. Hamblin's 10/29/09 ACOR CLL posting (see below).

I have provided herewith a recap of past email correspondences and postings, as well as my email today to Dr. Kroger of the CDC – ACIP.

Regards,

Dan C.

Westchester, NY

In brief, let’s recap:

2008, Nov. 22: Dr. Hamblin posts “Shingles vaccine” at his website blog: http://mutated-unmuated.blogspot.com/search?q=shingles+vaccinehttp://mutated-unmuated.blogspot.com/search?q=shingles+vaccine

In paraphrase, the issue is the ACIP stance that the herpes zoster vaccine is safe for CLLers if we have been in remission for only 3 months.

2008, Nov. 24: Your post brings the foregoing issue to the attention of ACOR CLL Listserv members, asking that we bring the ACIP position to our individual doctors (hems/oncs), beseeching each hem/onc that disagrees to write the ACIP accordingly.

2008, Nov. 28: I had emailed you “off-list” to bring your attention to the CDC-ACIP’s “09/11/2006 Shingles Vaccine Information Statement”, noting among other things that it expressly states “- a history of cancer affecting the bone marrow or lymphatic system, such as leukemia or lymphoma”, and that since it’s the more detailed document that it could be argued as controlling. I had also suggested considering confronting them with potential liability issues, i.e., “fear of the law”, in addition to possibly doing one letter signed by numerous CLL mavens. (You did email me back, advising considering & would advise after up coming holidays).

2008, Dec. 17: Dr. Byrd had requested posting within the CLL ACOR Listserv (highlighting & underlining added) “….the varicella zoster virus vaccine which should not be given toCLL patients due to their immunocompromised state. Some practiceners are mistakenly giving this and it places CLL patients at risk. ….” (s/b “practitioners”).

2008, Dec. – 2009, Oct. – since your 11/28/08 posting asked others for action, it’s not surprising the issue waned with time (a phenomena that can be thrown into the baskets of other axioms, like, “I’m from the government and I’m here to help.”). Needless to say, the topic issue similarly comes and goes on the daily CLLSLL Yahoo digests, quite often back and forth on treatments, which Dr. Furman addresses.

2009, Oct. 29: In response to the topic issue again having risen, Dr. Hamblin notes within an ACOR Listserv post (highlighting & underlining added): “……virtually everybody still carries the virus in their nerve cells. The reason that it doesn't reactivate is that we have sufficient specific T cells to control it ….. The ban on shingles vaccine for CLL patients is based on theory not evidence, but it is the safer course. If the vaccine is to be banned then it makes sense to avoid contact with anyone excreting the virus. ….”

2010, Feb. – Mar.: Like the story of Lazarus, the topic of the shingles vaccine for those diagnosed with CLL rises again. On 03/03/10, Ron Goldsmith, ironically in “Phoenix”, AZ, succinctly summarizes the history of the topic, as well as providing the link to Dr. Hamblin’s 11/22/08 clearly written, easily read write-up of the topic’s issue. Noting the “bottom line: Shingles vaccine is not safe for CLL patients.”

2010, Mar. 06: This writer emailed Ron G. a brief of off-lists emails with Brian K. back in late Nov. 2008, providing an updated comparison between “09/11/2006 Shingles Vaccine Information Statement” and 10/06/09 revision. In sum the 2006 version states those with “a history of cancer affecting the bone marrow …” should not get the shingles vaccine, whereas the wording “a history” has been deleted in the Oct. ’09 revision. Moreso, whereas the Oct. 2009 revision additionally has the word “current”, i.e., should not get the shingles vaccine who “has a weakened immune system because of current:”. This writer had also included, i.a., Errata: Vol. 55, No. RR-15 to the still unmodified General Recommendations on Immunization - Recommendations of the Advisory Committee on Immunization Practices (ACIP) as dated December 1, 2006 / 55(RR15);1-48, because this writer found the wording “…can receive varicella and measles vaccine if CD4+ lymphocyte count is >15% …” of interest as possibly worthy for exploring in re CLL. Copied:briankoffman@sbcglobal.net, terjoha, rrfurman@med.cornell.edu.

2010, Mar. 07: Writer received off-list email from Dr. Furman: “It is also very, very important to emphasize that the Shingles vaccine has not been demonstrated to be effective in people with weakened immune systems. Thus, there is no know benefit and the potential for harm, making the risk: benefit ratio not at all favorable.”

2010, Mar. 07: Writer emails Dr. Furman: “….I find it incredulous that the CDC, APIC, et al can make such "no liability recommendations" without valid & reliable supportive documentation in place. There should be in place, readily available, valid and reliable quantifiable and or quantified variables upon which they based their risk evaluation and derived decision(s) to recommend. In absence of this, the first thing that comes to mind is litigation, which is one of the points I suggested to Brian as confronting them with. In reviewing their most recent updates, I walked away with an impression of them being obstinate, pompous, and arrogant. Needless to say, the ACIP has ample exculpatory language, to wit, their usage of such words as "suggestions" and "recommendations"; furthermore, after their rather well organized, rather detailed, flowing spiel, they do effectively shift the end point onto the practitioner, e.g., you, as to deciding what tests, results interpretation & recommendation of decision path to follow. …”

2010, Mar. 10: Brian emails writer: “…think this is a significant improvement in the text that better reflects the current state of knowledge about the safety of the vaccine in patients like me. …”

2010 Mar. 12: To resolve my dissonance, this writer called and spoke with CDC – ACIP Andrew Kroger, M.D. down in GA and subsequently emailed the following:

Start 03/12/10 email to Andrew Kroger:

“Andrew, as per our 2:00 P.M. phone conversation today.

Dan C.

Westchester, NY

In re above, two changes of note:

Æ Sept. ’06 version states “a history of cancer affecting the bone marrow …”, while “a history” has been deleted in Oct. ‘09

Æ Oct. ’09 version now states “has a weakened immune system because of current:”, note the word “current” did not appear in the Sept. ’06 version.

So, l et me just add this note from Dr Furman to bookend this story.

I really think the important piece of information is that there are no efficacy data for the vaccine in CLL patients and I suspect the benefit is likely extremely small given the immunodeficient state of untreated CLL and the even more immunodeficient state after treatment.
With the proven benefit, any risk becomes not worthwhile. I also see acyclovir and its derivatives as being so effective.

Rick Furman

So that's the story, so far. I will keep you posted of the byzantine changes, but I expect no breakthroughs.

Bottom line.

Don't jump to conclusions, happy or sad.

Check all the facts yourself.

Don't expect big anything (government, pharma etc.) to be looking out for you.

Admit your mistakes and correct them asap.

Don't give up spreading the truth.