About 2 weeks ago, Dr Anna Giuliano, Chair of Cancer Epidemiology and Genetics at Moffitt cancer Center, called me and asked if I would agree to testify before the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) at their 2 day meeting Oct 21 and 22nd in Atlanta. The ACIP is, among other things, considering either to make a Limited recommendation, a Broad recommendation or No recommendation on the Gardasil vaccination for boys. The difference in the 3 is huge with a Broad recommendation meaning the shots would be covered by insurance and covered by individual states' own free shots programs. At least that's the way I understand it.

I immediately called Brian and asked him to go instead of me but unfortunately he will be speaking in Canada and that has been planned for months so we are stuck with me. This is akin to Brian or Jerry addressing the American Institute of CPA's on a technical tax issue. I feel like a fish out of water. I have talked to Brian I will be representing the OFC and as expected he has given me plenty of insight to incorporate into my testimony which I have composed mentally over and over but am here at my office today putting it to paper. I still haven't been told how long I can speak so it's hampering my entire thought process.

Wish me luck but according to Anna, we are fighting an uphill battle but hey I have become accustomed to that over the last 3 years concerning the male connection to HPV so that part I easily accept.

David,

I think you will do just fine. You certainly have impressed me with your knowledge on the topic. You may not consider yourself an expert, but you are someone that has personally been impacted by the HPV virus, which is something that many of the "experts" can not testify about.

Good luck!

You'll do great! I'm hoping they make a pro-decision on vaccination for boys before my son gets much older. I'd be willing to pay for it, but my doctor's office won't do it. I thought that I had read that it was FDA approved for boys...was that my bad?

Anyways, give it all you got, you'll do great!! I don't know that we could do the clever word play like you did above for Brian, calling him Brain on your message above...but, we'll think of something for you. :-)

David actually understands all this much better than he lets on. I am quite comfortable with him representing the foundation at this meeting, and am sure that he will do a great job. He knows very well the importance of this to future generations. The children vaccinated now will not be part of any interaction with HPV+ oral cancers in the future, and this fast growing segment of our patient population will quickly diminish in just 2 generations of vaccinations, vs, growing like wildfire which is what it is doing today.

Only one paper has been published opposing vaccinating young boys, and that is the one that we talked about in another thread from Harvard. It will be very easy to disassemble that poorly thought out paper. Their numbers are based on something that David understands completely, since the authors and he are number crunchers.

They based the numbers on two core false premises. That the average cost for treatment is $43,000 dollars. This is, as anyone who has been through this knows, completely inaccurate, and based on a paper that looked at ANTERIOR OF THE MOUTH TONGUE CANCERS, which are often treated with a surgical only solution. Today, those numbers in an HPV world are worthless. His associate at Moffit will easily make the point that 50%+ of newly diagnosed patients are HPV+, and as such - later stage POSTERIOR OF THE MOUTH finds - and according to NCCN guidelines, treated with radiation, chemo, and sometimes surgery..... average cost about $200,000 plus. Their estimates of the incidence of HPV positive lesions is off by at least 30% or more. Now if you redo the math, vaccination programs for boys makes complete fiscal sense.

Of course they never even considered the cascade of financial problems that cost money (from somewhere, private pay, insurance, state, and federal) they didn't count, that happens to lost patients who were the bread winners of families that now end up on welfare programs, or even the consequences of survivors who can no longer work in their previous vocations because they cannot talk, eat/swallow properly, etc. and the long term costs of their disease and treatment based disabilities.

David will be a great representative for the foundation and the cause.

David,

Having been a witness to your TV appearance as well as your previous testimony about HPV, there is no doubt in my mind that you will be extemely effective in this situation.

What an honor to be asked to do this. You will do great.

Margaret,

No your brain is not frozen yet. A Advisory Committee of the FDA did recommend the vaccine be given to boys and men ages 9 through 26 but based it's recommendation of Merck's application submitted on ONLY genital warts caused by HPV 6 and 11. The FDA will consider it's committee's recommendation sometime before years end and then it will become official.

Getting the vaccine approved for boys for ANYTHING is better than nothing and since the vaccine has proven effective against HPV 16 and 18, those that cause the cancers we are concerned with, then getting the vaccine will eliminate those strains and anything that they could have caused post infection.

Also keep in mind that we couldn't have waited for Merck or anyone for that matter to prove to the FDA that the vaccine works in preventing say oral cancer as that would have taken decades for them to vaccinate thousands of 9 to 26 year old males today and then wait and see what happens when they turned 50 or 60. I would have been 102 and doubt Moffitt would have asked me to represent the life threat of a male acquiring cancer from the HPV virus.

Thanks Brian for your confidence BUT I still wish I would be watching you address this Committee rather than me. Just saying...

David,

We all know you will be fine and have great confidence in your ability to make a case. My only worry for you is the weather. Hopefully it is at least 80 degrees while you are there otherwise...you may "freeze" at a very crucial moment.

Seriously, I totally understand your angst, but just know you will do a great job.

Deb

David

I also have seen your video clips and read the assorted newspaper interviews so I know how telegenic and personable you are. OCF will be in good hands. I often had to give speeches (more like persuasive arguments) without a time estimate so I found it useful to have a few "sound bites" (eg." the Harvard report's numbers and its accounting basis make Enron & Tyco's books look good in comparison")that I could expand on if I had time. You are the perfect advocate here since the Harvard report and other news stories all focus on the monetary aspects for male vaccination. Go get em Tiger
charm

Awesome David. I would wish you "luck" but I know your skill and passion are all you need to make this speech/appearance a success. What a huge opportunity to truly make a difference.

We will all be waiting to hear how it went.

Donna

David:

The subject information you have furnished on this forum that I have read is invaluable, and proves that you are the "perfect" person to present it before the CDC. You will do a remarkable job, and the entire forum is behind you.
julieann

When you said you are representing OFC i guess you mean us lol.Try to get it right on the night!!!! Now stop whining and get on with it.

best of british luck David

love liz

My remarks include not only information about my ordeal and it's HPV connection but gruesomely detailed descriptions of the terminal part of our cancer as well as some statistics on OC overall. I have also included some wisdom from Brian so he can feel as if he were there like I'm sure he would want to. I still haven't finished it yet. By coincidence I am taking another employee with breast cancer to Moffitt for her first meeting with her surgeon tomorrow so I plan to have lunch with Dr Guiliano so we can compare our remarks to make sure we don't overlap and waste our precious time.

I want to correct one thing I said in Margaret's reply post and that is the FDA has just recently licensed the Gardasil male vaccine so now this Committee's recommendation will have a greater immediate effect if they advocate a Strong recommendation.

David, you will have 100 times more information on this aspect of OC than the time they give you to speak - your fans have great confidence in you. Jane and Dick

The story is now out. Not everything that we hoped, but some progress.

Thank you David for being OCF's voice at this important meeting. Your presentation was well received.

http://oralcancernews.org/wp/us-advisers-decline-to-push-gardasil-for-boys/

Thanks David, for what I'm sure was a well spoken plea for getting boys and men vacinated.

As Brian said, not what we hoped for, but at least we got something.

Thanks David!!

David,
Thanks for doing a good job. It pains me everytime I hear the cost factor in relationship to the number of people affected or the lenght of life or quality of life provided. Even one life is priceless. Quality of life is very subjective and we often base our ideas on "what if." We certainly have more than enough evidence from the postings here to convince anyone that the vacine could prevent much pain and suffering, save lives and actually save money by reducing one of the causes of oral cancer. It seems that if the "cold facts" actuarial community would factor in the overall cost of lost production time from patients, family and friends we would get a more realistic picture of the actual cost.

David, thank you for doing this. You have a wealth of information and I have learned so much from your posts. Our sons, husbands, brothers, fathers deserve to be protected from the ravishing effects of HPV and this dreadful oral cancer.
Good luck with your presentation and thank you for representing us.
nancy

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.

Great job. Thanks for the summary and taking time from your private life to fight for what is right. You are truly an amazing individual.

I recommend you for an honorary Dr. before your name.

Awesome job David. Wow - sounds like an intimidating process just to get into the auditorium. Thrilled you were there to represent us.

And....seeing your breath outside in the morning?? Did you get a chill on your little Florida cheeks (either set!)??

Donna

David, thank you for doing this what an ordeal!

Well done old timer,that warrents another dance in the park.

Latest medscape story on the meeting

http://www.medscape.com/viewarticle/711125?src=mpnews&spon=7&uac=82040FG

Famous Dave (not the ribs guy),

Nice quotes from you in this report. The way I see it, unless someone tests and reports on the ability of these vaccines to work against oral cancer, we are talking to a wall.

Penile and anal cancers are very uncommon and warts are not killers, so there is no real clout here.

Hi Brian:

I tried to log in (when I opened highlighted url) with my user name and password, but got the message that it wasn't valid? Now what am I doing wrong?
julieann

But Jerry there is a huge burden, both financial and mental a male or female for that matter, carries with genital warts and a problem that is becoming all the more presence is RRP (Recurrent Respiratory Papilloma) in infants born to mothers that carry the HPV and as Brian so aptly put it "men are the reservoirs for the HPV virus."

And to a group, MSM, anal and penile cancers are their battle flag. I predict we may see this committee endorse the vaccine for MSM as soon as next Feb leaving heterosexual men to fend for themselves.

Bottom line is with a current 17% HPV vaccination rate amoung females and the gov't not pushing the vaccine on males, coupled with a 80% infection rate, we will never see the end to HPV.

Jerry and others,

The problem with doing a study on the effectiveness of the vaccine against oral cancer is that it would take decades to prove as you would have to start when the vaccine was most effective (pre sex) and follow the group until their 40's, 50's and maybe even 60's.

It is a fact that HPV causes 70% of Oropharyngeal cancers.

It is a fact that HPV16 is the main culprit.

It is a fact that the Gardasil vaccine is almost 100% effective against HPV16.

It is a fact that the vaccine produces almost 2 times the antibody against the virus as our body naturally can.

It is a fact that the earlier we catch cancer, the better the chance we have of curing it.

It is common sense that preventing cancer is 100% better than stopping it.

So why can't these people on the committee understand that?

Probably because they never been personally affected by it.

YET !!!!!!!

[quote=Brian Hill]Latest medscape story on the meeting

http://www.medscape.com/viewarticle/711125?src=mpnews&spon=7&uac=82040FG [/quote]

Brian, it's password protected....


KC

I typed in my OCF user name and password, but it will not let me in; says they're not valid. Is that what I'm supposed to type in (OCF username and password?) Thanks.
julieann

KC,

I'm pretty sure Brian posted that article last week in the ORAL CANCER IN THE NEWS section.

Kevin,

I believe that anyone can join and get a password for Medscape.

I have one and read it.

[quote=davidcpa]KC,

I'm pretty sure Brian posted that article last week in the ORAL CANCER IN THE NEWS section. [/quote]

Thanks David... I'll check !

KC