Merck's Gardasil Deflected Cervical Cancer: Study

does it protect heterosexual men from anal cancer? or only the homosexuals? effin' sloppy reporting.

(not blaming you, Ed. just sayin')

The wording used in the report is 'homosexual' but I suppose that if heterosexual men were having sex with other men they would be OK too.

I may have missed a bit, but I think the Merck release says "men having sex with men."

As sidelight, there is a promo blitz for Gardasil on several large colleges campuses right now--billboards, innumberable college newspaper ads, even coffee sleeves.

Cancer is mentioned little if at all. It's all about warts. Clearly, a shift from the "one less" campaign.

that would be "innumerable...."

I thought cervical cancer developed over a 10-15 year period. How does 48 months of data come to the conclusion that the vaccine does anything but reduce the incidence of viral infection which is a requirement for some casese of cervical or anal cancer to develop?

I agree that the article was very imprecise in it's choice of medical terms. While cervical carcinoma may indeed take 10-15 years to fully develop, what the study showed was reduction pf PRE-cancerous lesions, generally termed cervical dysplasia. Cervical dysplasia is the precursor to carcinoma in situ, which may then progress to invasive cervical carcinoma.

"Gardasil, you may recall, is approved to prevent cervical cancer "

No. I do not recall. Can we have the exact wording?

well, I guess it's a bonus that heterosexual men don't get anal cancer. of course that doesn't count the bisexual men. but maybe they don't get it either. just like they don't get teh HIV. bring on the added stigma!

I looked it up, riv. verbatim:

GARDASIL is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of cervical, vulvar, and vaginal cancers; precancerous or dysplastic lesions; and genital warts caused by human papillomavirus (HPV) Types 6, 11, 16, and 18.

nota bene: while the term *I* used is acceptable in the gay community, I will be more circumspect in the pharma community

and from the associated press report: "No men in either group developed anal cancer."

JiM - you are correct. It's the AP report cited by Ed which uses the term 'homosexual men'. Merck's release uses different language.

I had a question similar to episcadoc's.

I assume FDA has authorized Merck to advertise a la "one less" cervical cancer based on dysplasias, which does not seem unreasonable but worth clarification.

Another small "twist."

In general, promo material that mentions both the drug/vaccine name and the indication must also include risk info.

In addition, the "chemical" as well as brand name of the drug/vaccine has to be included.

Since the non-brand name of Gardasil is, in fact, "Human Papillomavirus Quadrivalent (types 6,11,16, and 18) Vaccine, Recombinant," this was included on the coffee sleeves. But no risk information was.

The FDA accepted the currently held standard that CINII/III is a obligate precursor of cervical cancer and as such prevention of an obligate precursor proves to them that there is prevention of cancer. It would be unethical to have a trial to an endpoint of cervical cancer when the acceptable standard of care is to treat at the precancer stage. That would require giving study subjects lower than the standard of care and is a no go. (Though many people on blogs and such seem to believe that Merck should have waited until women in the trial developed cancer in order to prove their efficacy for the vaccine, rather than giving them the proper standard of care and using a surrogate endpoint that is an obligate precursor of cervical cancer. That seems surprising to me, in truth.)

In addition, it is important to note that many men having sex with men are not self-identified as either gay or bisexual, so the use of such labels rather than using behavioral descriptors is problematic.

In vaccine trials for life-threatening diseases, surrogate endpoints are both standard and ethical. Example below is Thai trial of HIV vaccine in high-risk subjects, with viral load as endpoint.

http://content.nejm.org/cgi/content/full/NEJMoa0908492

The entire scientific underpinning (lack thereof) for safety and efficacy of "cancer vaccines" is tenous. The precedent has already been set with gardasil and cervarix. The ultimate goal for biopharma is government MANDATED vaccination of the entire population as cancer preventives. What politician can resist that argument?

Gardasil and Cervarix are particularly troubling, because changes behavior (condoms or abstinence) might arguably be more efficacious, and certainly much safer, in prevention of STDs.

There are many more "cancer vaccines", just waiting in the wings. Illegal off-label marketing as "cancer preventives" has already begun.

"prevented precancerous lesions on the cervix and genital warts in 89 percent compared to placebo". Were aluminum salts in the placebo arm of the pivotal studies?

Aluminum has been found in post mortem specimens of neurofibrillary tangles of Alzheimer's disease.

http://www.ncbi.nlm.nih.gov/pubmed/1490424

By 18 months of age our cummulative exposure to aluminum is 4,925 micrograms.

http://www.thinktwice.com/aluminum.pdf http://www.scribd.com/doc/18952433/Aluminum-in-Vaccines

It is time for independent studies on this vaccine. How can Merck even state that Gardasil protects MOST women from cervical cancer. If I was a business using the term "most" I would be laughed out of the board room. How can Merck even make such a claim? The vaccine has only been on the market for three years - there is no track record for this. In fact, the National Vaccine Information Center has posted 272 reports of abnormal pap smears to VAERS two years post vaccination. There are other reports of cervical lesions, and cervical cancer. Do you know what HPV stands for? "Help Pay for Vioxx." Move over Merck - there are now 17,000 adverse reactions and 60 deaths reported to VAERS. In fact in the FDA VRBPAC report it states that if a woman has already been exposed to HPV and gets the vaccine her chances of getting cervical cancer increase by 44.6%. So when you mean MOST women are protected from cervical cancer - just exactly who do you mean?

The prospect of "innovative" new "STD vaccines" and "cancer vaccines" is market-based medicine's dream come true. Probably utterly irresistable to our lawmakers. Safety and efficacy have become superfluous, for any new biological.

Earlier in the thread patrons mentioned the fear of cancer vaccines. It's interesting how many are in development yet data elsewhere shows how effective higher doses of Vitamin D3 can be in prevention of cancer, as well as other conditions. Simple: of course pharma doesn't want to hear it but there's plenty of data, including dosing by the Canadian Canadian govt. This is a very good site with what seems like a good scientific rationale http://www.vitamind3world.com/index.html

Christopher: Nothing in medicine is without some risk. Personally, I'd feel a whole lot safer on high dose Vitamin D3, than on one of the new "cancer" innoculations. But that's a personal choice, not medical advice. There's a growing body of literature that D3 is acting much more like a hormone with wide-ranging effects, than like vitamin. Many of us are D3 deficient. The potential cancer prevention property you mention is promising and needs further study.

patrons - understood. I think most of us would prefer to avoid long term medication if at all possible yet many of the benefits available to us through diet, lifestyle are ignored.

A reminder of two articles that coincided this week. One in NYT described the increasing number of gastric bypass surgery procedures carried out on children and adolescents (US) to help deal with obesity. Sad. The other was from Mike Milken who wrote about US health reform and the need to devote equal attention to prevention as to cure. He presents some eye-watering statistics. If anyone is nterested here's a summary of both articles with links: http://tinyurl.com/yk8skrt

Christopher - do you know who owns the D3 site? I can't find any credentials on it.

harpy - I do know that a physician is behind it and that the links you see there are all to published data. It surprised me how much info and data there is out there but the public health people and industry of course are in no hurry to highlight this. I'm surprised at the former but not the latter. As I mentioned in a mangled post above, the Canadian Govt is mandating dosing, I think partly because of insufficent natural sunlight and what seem to be quite clearly demonstrable benefits.

As the only way to be certain to avoid HPV transmission is to avoid sexual contact with anyone who has ever had sexual contact with anyone else (and this does not even include intercourse...simple skin to skin contact can transmit the virus) EVER, this leaves most humans, who are sexual beings, in the lurch. Since there is no total genital condom, short of painting on a latex skin with every act of intercourse, sex, even with a condom, entails some risk. How many woman married as virgins, but still ended up with cervical cancer because their partners were not?

It is not as simple as some would believe.

And as for Leslie Botha's complete misstatement (and clear anti-HPV vaccine bias), this is emblematic of the problem that arises when people don't understand the complexity of HPV (no men, you can't go to the doctor and see if you have it and there is no treatment for anyone even if you are found to have it), HPV and its relation to genital and head and neck cancers (HPV 16 & 18 are responsible for 70% of all cervical cancers...those are the major bad strains) and don't understand the issues involved in vaccinology (no vaccine is 100% efficacious, but by comparison to most HPV vaccines are some of the most efficacious ones out there), as well as the great spin of anti-vax sites like NVIC that would have many major infectious diseases return to plague us again (with their dishonest implications that VAERS reports indicate causality between vaccine and adverse event, when VAERS is a reporting system that cannot assess causality since there is no denominator or comparison group to make that assessment. The CDC uses the Vaccine Safety Datalink in order to look at causality in any potential signals raised by VAERS. To date, in mutiple reviews, there have been no causal links found.)

I've got a 2 1/2 year old daughter and I'm an adolescent medicine physician. I believe in science and evidence based medicine, and I'm trained in epi and biostatistics so that I can critically analyze data. All I can say is that I would rather her have a safe vaccine in addition to all the healthy lifestyle approaches she will receive than to have any risk of ending up with the "treatment" for cervical dysplasia that may include removing pieces of her cervix.

I honestly believe that if the treatment for male HPV disease was surgical removal of pieces of the penis, we would NOT be having any of these conversations.

Let's stop sex-shaming. Let's use our medical and public health reasoning abilities and stop believing hype and half-truths.

Teen doc - It is appalling that FDA allowed Merck to put aluminum salts in the placebo arm of some of the pivotal studies upon which Gardasil's market approval was based.

http://www.generationrescue.org/binstock/090318-GardasilPlacebo-Binstock.htm

Both Gardasil and Cervarix have aluminum adjuvants.

http://en.wikipedia.org/wiki/Immunologic_adjuvant

http://en.wikipedia.org/wiki/Cervarix

http://www.whale.to/vaccine/cervarix_also_contains.html

Do we have any real clue as to what long term effect repetitive stimulation of our natural immune system might have with each jab? e.g., with metals, adjuvants, preservatives, uncertain biologic recombinants.

In preventive medicine, the buck stops with safety. The burden of proof lies with the vaccine proponent, not the healthy skeptic. Is the point missed on you, that the most zealous vaccine proponents just happen to be subsidized by the multinational drug consortium? e.g., Merck, Glaxo, Novartis. Personally, I don't want my health choices dictated to me at the point of a needle, by entities that really don't have my best interest at heart.

Harpy and Christopher - Dr Mayer Eisenstein, M.D., J.D., M.P.H. has a website called homefirst.com which has all kinds of fun facts regarding Vitamin D3.

http://homefirst.com/info-1/current-health-news/vitamin-d3.html

There’s a short U tube video presentation on Vitamin D3 at the above link, along with some VERY interesting dosing information.

The longer I practice medicine, the more of a naturopath I am becoming. Just imagine a world in which all of the bilge we see in DTC ads was replaced with just proper guidelines for vitamin and mineral supplementation.

Patrons: If you are going to rely on antivax pseudoscience rather than actual scientific data, there is no point in continuing. Aluminum has been used safely as a vaccine adjuvant since the 20s. Yesterday it was thimerosol, today aluminum (something you get a larger dose of in your antacid than any vaccine, BTW), tomorrow it will be something else.

You want to buy into the vast medicalindustrialcomplex conspiracy theories, please have at it. Some of us have real science to attend to. Sigh...

Teen Doc- thanks for the well written response to anti-vax talking points. You forgot that in-between thimerosol and now aluminum it was too many antigens (vaccines) given at one time.

So sorry, Teen doc. I'm afraid we have nothing more to discuss. You can't handle the truth.

You are dead wrong about aluminum: there is no logic to your comparison of parenteral administration of aluminum adjuvants to oral antacids.

http://www.thinktwice.com/aluminum.pdf

http://www.scribd.com/doc/18952433/Aluminum-in-Vaccines

I highly recommend the recent article titled, _GMC Damning Wakefield Verdict Does Not Address Autism-Vaccine Validity_, February 16, 2010, by Vera Sharav at the AHRP.org website (Alliance for Human Research Protection).

http://www.ahrp.org/cms/index2.php?option=com_content&do_pdf=1&id=664

http://www.ncbi.nlm.nih.gov/pubmed/9481001?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=1

http://fourteenstudies.org/pdf/primates_hep_b.pdf

http://www.naturalnews.com/z028142_mumps_vaccines.html

http://edition.cnn.com/2010/HEALTH/02/08/mumps.outbreak.northeast/index.html?hpt=T2

http://www.naturalnews.com/027956_H1N1_vaccine_CDC.html

re: D3, and beyond indiv diffs, we seem to know very little about what optimal levels are (although something about deficiency). Given the ways things have played out with vitamin E, beta carotene, ascorbic, etc., my guess is that--at the very least--things will become "complex."

Hey Teen doc - before I give up on you, I'd really like to recommend the following link, particularly the comments to the link by Jennifer Craig, Ph.D. and Dr K. Paul Stoller, M.D., FACHM, whose quotes I have excerpted below.

http://childhealthsafety.wordpress.com/2009/01/13/secret-british-mmr-vaccine-files-forced-open-by-legal-action/#US_Developments

K Paul Stoller, MD, FACHM, on January 13th, 2009 at 3:42 pm Said:

The truth that vaccine policy is not about science or safety but about money and politics is finally seeing the light of day.

We have a choice to make about not only holding responsible parties accountable for destroying the lives of untold children around the world, but whether we want to destroy the human genome by the continued injection of dirty vaccine that punches holes in our immune systems.

The history of vaccine in littered with horrible mistakes and skulduggery – from the SV40 virus given to millions in the polio vaccine to the continued use of mercury and other heavy metals. The fact is even the best MMR vaccine is contaminated with avian retro virus and reverse transcriptase. This is criminal!

Jennifer Craig, Ph.D, on January 16th, 2009 at 8:19 am Said:

Having read the history of all vaccines, this does not surprise me at all. The first smallpox vaccine was never shown to decrease smallpox incidence or deaths and hundreds of people were injured by the vaccine. Yet this nonsense has gone on now for over 150 years. When are people going to realise that injecting a toxic brew straight into a child’s bloodstream is voodoo medicine. The wonder is that so many children survive.

Jennifer Craig, Ph.D, on March 11th, 2009 at 6:47 pm Said:

Most people assume that a vaccine is composed of selected viruses in a sterile fluid to which preservatives have been added. Not so.

Vaccines are suspensions derived from the manufacturere’s ‘incubation tanks’ in which the viruses are produced from substrates of mashed bird embryo, minced monkey kidneys or cloned human cells. These suspensions are filtered before use but only to remove particles larger than viruses. The point of the vaccine is that it contains viruses, so these must not be filtered out. Therefore, anything smaller than a virus remains.

These remains include what the manufacturers call ‘degradation products’ – parts of decayed viruses or cells, unknown bits and pieces, foreign protein particles, viral oncogenes (might cause cancer), added chemicals and DNA fragments.

How to remove contaminating DNA has caused some concern to the Authorities, which is comforting. In 1986, the US government recommended a weight limit of 100 picograms of contaminating DNA per vaccine dose. However, this has proved so impossible a standard to achieve that they now allow one hundred times that amount, i.e. 10 nanograms per vaccine dose.

In other words, the vaccines we inject into our children are liquids filled with unknown particles, most of which come from cells of non-humans: from chickens, monkeys, and even from cancer cells. Plus the DNA of other species. No wonder so many of them are chronically sick.

I'm too old to personally worry about about Gardasil. However, I did have a very painful case of H. Zoster postherpetic neuralgia a few years ago, my second such attack. If Zostavax had been available sooner, I definitely would have taken it, aluminum or any other additives notwithstanding.

Transformed American: Thank you. As a geriatric parent of a toddler, I'm sickened (pardon the pun) by the ridiculous antivax hysteria that will end up killing more children. I trained before HiB vaccination and during measles outbreaks and saw the devastation. Do I want that for my kidlet? Of course not. And even though she is vaccinated, the decrease in herd immunity still puts her at risk. On one of my photography boards (my hobby) a mother just lost her son to pertussis of all things. WTH! Makes me ill. As the parents of many an autistic child has said to me, I'd rather have an autistic child than a dead one.

Patons: Oh yes, the medicalindustrialcomplex and BigPharmaTM are creating these vaccines to do what? They are money losers. One Pfizer riser type product makes infinitely more than any vaccine ever could. And they are not repeatedly used like cholesterol pills or, uh, Viagra. They are preventive. So what is this grand conspiracy trying to do to our kids and to what end? There are no BigPharmaTM treatments for autism. And these alleged other effects you and your other antivax ilk speak of are too rare for BPTM to make money in treating, so what is the point other than all doctors, public health officials and vaccine manufacturers are evil. Right down to the lunch lady in the cafeteria, all evil and not caring for human life, not even their own children. Is this what you're telling me? If so, like I said, we've nothing more to talk about.

Pharmavet: As someone who had never had varicella, I certainly did get Varivax as soon as it was available. I don't play with the herpes viruses.

Teen Doc - perhaps we should call you and Dr Offit the "tin men" of our times. Postmortem brain studies have identified aluminum in neurofibrillary tangles of Alzheimer's disease. Here did it get there? Blood flow follows non-Newtonian fluid dynamics. Blood behaves like a colloid. Electrostatic charges in blood are important. Aluminum salts are highly charged. The zeta potential of aluminum salts has direct profound effect upon the hemorheologic properties of blood, promoting both stasis and hypercoagulability. A great pathologist by the name of Rudolf Virchow (1821-1902) understood what predisposes us to blood clots.

http://en.wikipedia.org/wiki/Rudolf_Virchow

I doubt the aluminum is getting there from the antacids you took for heartburn. Have you ever wondered why we see many brain MRI reports with nonspecific small vessel ischemic changes and lacunar infarctions? Could a small lacunar infarction ever cause cortical de-afferentation? I don't known. We should ask a neurologist. Why don't we ask Dr Andrew Moulden, M.D., Ph.D.? When medical historians look back on the times in which we live, whose name will be remembered? Paul Offit? Andrew Moulden? From where I stand, there is no doubt who will remembered and why.