Actually given the voting criteria established by the Chairwoman of the voting committee this outcome is the BEST we could have achieved. Here's what I mean:

SHORT VERSION:

The ACIP voted to give the vaccine it's Permissive Recommendation, less than it's full endorsement which is a Routine Recommendation, BUT it voted to include the vaccine in the VFC (Vaccine For Children) federally funded program meaning any male or their parent that asks for the vaccine and they qualify, it will be given free and it also means major health care insurers usually end up covering it.


LONG VERSION:

First off, boy what a day; what an experience. Getting up at 3 am; seeing my breath in Atlanta; having to drive through a picket line of idiots dressed in contamination suits and signs and TV crews at the entrance to CDC; having the cab stopped over a pit with cameras to view the undercarriage while security guards made everyone exit the car to search it and the trunk while patting us down; then going through another set of detectors just like the airport inside the CDC; finally realizing the magnitude of what I was about to face; walking into the auditorium which would seat 200+ standing room only before the meeting began; all of this before 8 am when the meeting started.

First part of the am was spent discussing whether or not to recommend a newly FDA approved Bivalent HPV vaccine mfg by GSK which only protects females against 16 and 18 as compared to Gardasil's 6, 11, 16 and 18. What a process. HUGE DOLLARS at stake. That went way over it's allotted time and now we (2 from Moffitt and me) were starting to fear our 3 pm return flight was going to be missed so Anna was on her Blackberry. Basically the ACIP recommended (Routine recommendation which is the best).

Query: Why in the world would someone want to give their daughter a vaccine that only protects her from HPV 16 and 18 when she could get one protecting her from 6, 11, 16 and 18 for $2.00 more a shot?

Now to the male vaccination. Remember the vaccine was only licensed for Genital Warts. Also keep in mind that one of the criteria that the ACIP MUST consider is the cost of Quality Adjusted Life Years (QALY) that adding this vaccine to a previously approved female vaccination program would cost. Also realize that if 100% of females were vaccinated then the cost to add the male vaccine would be the highest as the only beneficiaries could be what they called MSM (Men having Sex with Men). Now the Committee was presented with 5 different QALY studies which all started off with assuming a minimum of a 30% female vaccination rate (even though historically statistics show that only 17% of females get all 3 shots) and then going up from that. They also only considered the benefits of reducing the medical costs associated with eliminating male genital warts. So you can imagine, relatively speaking, the cost of QALY's was very high. Some studies did attempt to add the costs associated with oral, anal and penal cancers but the Committee was told that "UNTIL we are presented with proven data and the drug is approved for those diseases, we can not consider them in our recommendation."

The voting Committee (the inner committee) consists of 15 cream of the crop hand picked immunization medical experts in their own fields. Next there is a "outer" committee consisting of non voting members representing all the major players in a federally funded immunization program who can ask questions and make their recommendations known but can't vote. Believe me if your name didn't have a Dr or PhD with it you were either me or the security guards at all the doors.

Most, if not all, of the outer members spoke in favor of the highest recommendation and said not to include known HPV diseases was not proper.

Next came the speakers who had previously registered and been approved to speak. Back tracking, when I was told I would be speaking but not how much time I had, I first pulled out a 10 min speech I already had and modified it. Then I talked to Brian who said I would probably be limited to 3 or 5 mins so I cut it down to 7 and then to 5. Then I finally talked to a Committee staff on Monday who told me 3 mins. I tried and tried but the best I could do was 3:23 and that's what I went up with. Now the Chairwoman announced that she was going to have to cut the speakers time to 2 minutes due to running late and she was going to ask the speakers to speak in the order that they signed up and BAM, "would David Hastings please step up." Believe me there was NO way I could have cut ANOTHER 1 plus out of my planned remarks so I told her that I had been told that I was to have 3 mins and I would do my best....no way I said to myself.

I guess since she had already made up her mind and probably wanted to eat lunch she stopped all speakers after 6 of us had spoken against her.

Then the Committee voted to give their Permissive recommendation which was not the whole enchilada but was close.

The next vote was to determine if the Committee would include this vaccine in the VFC ( Vaccines For Children's) federally funded program and that vote was just as, if not more important, than the first as it would mean that if approved then the federal gov't would buy and administer this vaccine free to qualified uninsured or under insured males. It also usually meant that major health care insurers would probably go along. The Committee APPROVED this.

This now means that if a male or their parent asks for the vaccine they will get it.