HPV infections seen in over quarter of U.S. women

[seriousstan]

WASHINGTON (Reuters) - More than a quarter of U.S. girls and women ages 14 to 59 are infected with the sexually transmitted human wart virus, which causes most cases of cervical cancer, U.S. health officials estimated on Tuesday.

That means human papillomavirus or HPV infection is more common than previously thought, particularly among younger age groups, the Centers for Disease Control and Prevention researchers said. Its prevalence was highest among those 20 to 24, with 44.8 percent infected, and nearly a quarter of teenagers aged 14 to 19.

This first solid assessment of the U.S. female prevalence of HPV infection comes about nine months after the Food and Drug Administration approved a vaccine against certain types of the virus to prevent cervical cancer.

Using data from a nationally representative group of 1,921 girls and women ages 14 to 49 who provided vaginal swabs in 2003 and 2004, researchers led by the CDC's Dr. Eileen Dunne found that 26.8 percent were infected with any type of this virus.

That rate translates to a total of 24.9 million U.S. girls and women, according to Dunne's team, whose findings were published in the Journal of the American Medical Association.

http://today.reuters.com/news/articlenews.aspx?type=healthNews&storyid=2007-02-27T213209Z_01_N27380525_RTRUKOC_0_US-HPV-WOMEN.xml&src=rss&rpc=22

[williesgirl]

1. Unfortunately, my daughter is one of them. Her doc recommends getting the shot anyway since

there are 5 strains of it that cause cancer. She gets the shot next week. It makes me nervous since I don't trust the pharmas, but here we go.

[Liberal Veteran]

2. Yeah right! The CDC is in cahoots with MERCK!!!!

And possibly the trilateral commission to poison our women with Gardasil!

:D

[seriousstan]

3. To what? Saving tens of thousands of U.S. girls/women from getting HPV?

I guess I should wait for Bill and Bob's Apothecary to develop a vaccine to 75% of cervical cancer. Right????

[Liberal Veteran]

4. I was being facetious

...and derisive of some of the controversy that has permeated discussions of HPV and gardasil lately.

I'm extremely supportive of this vaccine.

[seriousstan]

5. What in the world in my OP would have drawn that response?

[Liberal Veteran]

6. Just the subject matter.

I was making a side joke about some of the hysterics and tinfoil conspiracies that have cropped up in conversations about this subject matter.

Don't take it so seriously.....I thought trilateral commission part would be a dead giveaway that I was being facetious.

[Bridget Burke]

90. I guess you missed the last 300 threads on Gardasil

Some people thought Governor Perry's "mandate" was a bit premature. And that his motives may have been less than pure. Some validity there!

But the more persistent ones were dead set against the idea of any HPV vaccine. Some seriously anti-woman remarks were made.

Of course the usual "against all vaccines" folks crawled out of the woodwork, too.

[pnwmom]

7. You can joke all you want

but there are serious issues involved. I oppose the mandate because I don't think any vaccine should be mandated so soon after general release -- just as I avoid taking new drugs soon after release. The FDA considers the post-release phase to be part of the research period; quite often adverse effects are only discovered well after the release of a new drug or vaccine.

For example, the FDA has made a 180 degree turnaround on the use of certain pain killing medications, which were once seen as "wonder drugs" in terms of pain relief with few side effects. Now it seems that Gardasil is being pushed as a "wonder vaccine." How do you know that the FDA is not making another mistake? The only way is to let the vaccine be out on the market for a significant period of time, before a decision is made to mandate it for anyone.

SNIP

"In the past, many physicians would prescribe the Cox-2 drugs first," said Elliott Antman, a professor at Harvard Medical School who led a group of experts assembled by the heart association to study the issue. "We are specifically recommending that they should be used as a last resort."

SNIP


Cox-2 inhibitors such as Celebrex, Vioxx and Bextra were once seen as wonder drugs that reduced pain and inflammation without causing the stomach problems of earlier drugs. But Antman said convincing evidence now shows that these drugs not only increase the risk of heart problems but also seem to do little to reduce serious stomach problems.

The Food and Drug Administration has issued a number of warnings and alerts about the drugs, but Antman said many physicians and patients still clamor for them.

"These drugs were heavily marketed to the medical community and patients through direct-to-consumer advertising, and they were very widely used and still used quite widely," Antman said. "Fewer and fewer numbers of patients should receive the riskiest drugs. What has been done by many physicians is to make them the first line of treatment."

http://www.washingtonpost.com/wp-dyn/content/article/2007/02/26/AR2007022601264.html

[silverojo]

10. You're right

1) NEVER should parents be mandated to give their child any drug until its long-term risks are fully investigated (and even at that, parents should be allowed to opt-out if they so desire)

2) Your example of the Cox-2's is dead on. My aunt was given Celebrex for arthritis, and less than a month later she had a stroke. Then she got congestive heart failure, and was admitted into home hospice care. (Oh, yeah, NOW they tell us the horrible risks involved with this drug!)

Two weeks ago, she died while taking a nap in our living room. Today, her cremains were just delivered to our house. She now sits in an urn.

The moral of this story is, there's no such thing as a miracle cure. And it's very hard to sue the doctors or drug companies, because each of them covers the others' asses.

I don't want to see teens or young women develop severe health problems, because they were injected with a barely-tested vaccine when they were mere middle-schoolers.

[pnwmom]

11. I'm so sorry to hear about your aunt.

I also learned to be cautious about vaccines the hard way. My younger sister died of encephalitis, a known complication of the old DPT vaccine, after her third shot. But I only found about about this AFTER two of my own children had bad reactions to their first injections with the same vaccine (one had seizures).

[kutastha]

62. I'm with you guys

I got Type 1 diabetes the day after I ate a half a watermelon. As a med/peds physician I make sure I tell my patients not to eat watermelon

[kath]

78. Yep. And more than 50% of people who are in car accidents had eaten bread

products for breakfast that morning (toast, bagels, biscuits or English muffins). Therefore, everyone should stop eating bread for breakfast.

[nodehopper]

25. OMG

1. the mandate is a non-issue, as in every proposed incarnation it has very clearly had and will have an opt-out clause

2. under our current effed-up health system, a mandated vaccination is the only one that will be covered for low-income people. Make it optional, and low-income women are screwed out of access. Yes, it would be lovely if we had a different health care system, and we lobby for it and are working on it, but in the meantime, people are still getting HPV and cervical cancer.

[Bridget Burke]

91. There's a bill in the Texas House fighting Perry's mandate.

Part of the bill would forbid Gardasil from ever being mandated!

I can understand taking a dim view of anything Perry does. But this response is just wrong for the women of Texas.

[Liberal Veteran]

29. Yes, I am well aware of bad drugs making it to market.

But while you can name a handful of bad drugs that ended up being pulled, there are literally hundreds that made it to market without incident.

And again, we aren't talking about a drug per se, we are talking about a vaccine. Vaccines work by triggering an immune response that causes your bodies to create antibodies that will destroy the real virus when exposed to it. Your immune system has a memory and those memory t-cells will allow the body to instantly respond to a recognized virus.

The actual ingredients in a vaccine are eliminated from the body in a matter of days.

That's the thing here, there is really nothing new about the science and chemicals involved in this vaccine. It isn't the "new wonder drug" that works in some exciting new way. We literally have decades of work behind it. The only difference in this vaccine and any other vaccine that has been on the market, is that this one causes your body to produce different antibodies than those of previous vaccines (which is true of ALL vaccines).

Things that are the common concerns about drugs having long term adverse effects are simply not founded in good science when it comes this. Thalidomide for example, only causes birth defects if you are pregnant while taking the drug. The long-term toxicities associated with COX-2 inhibitors took place with people taking the drug daily over the course of a few years. Hell, the same thing can be said of the metabolic changes associated with antivirals used for HIV (which I take).

After a few days the only thing that is left behind from the vaccine is the antibodies your own body produced. And given that the Phase III clinical trial had a follow up of 2-5 years at this point, if there were going to be any severe adverse reactions, you'd probably have already heard about them.

[donsu]

36. agree

nt

[barb162]

56. I agree with you. People have died on some of these FDA

okayed meds.

[mzmolly]

33. Actually they are.

:hi:

[silverojo]

8. Yeah, yeah, push those drugs and shots!

The drug companies rake in millions, while nobody knows what the long-term risks are for the girls who get these "miracle" shots. :mad:

[seriousstan]

9. I'm willing to let our daughters die for the next 100 years to find out.

Much like we we should wait at least 1000 years to determine what the long-term climate change might be.

[pnwmom]

12. Do you understand that few deaths occur as a result of cervical cancer?

Only 1% of all cancer deaths are due to cervical cancer.

The widespread use of pap smears -- which will continue to be necessary even for women who've had the vaccine -- has steadily lowered both the occurance of cervical cancer and deaths from the cases that do occur.

[nodehopper]

26. link to that statistic please?

[Liberal Veteran]

30. Approximately 12000 diagnoses of cervical cancer per year....

....and approximately 4000 of those die.

And let's not overestimate or underestimate what pap smears have done. The actual decrease in number of cervical cancer diagnoses in the US has declined by 3.7% between 1975 and 2002.

That's a good thing, but still leaves a lot of women falling through the cracks and ANY cancer is bad thing.

If we can prevent a cancer, that's a hell of a lot better than detecting and treating it (or as they say, an ounce of prevention is worth a pound of cure).

[pnwmom]

39. I'll be fully in favor of the vaccine, once it's proven safe and effective.

But it's only just come out on the market -- and the experience of the last twenty years with the FDA shows that serious adverse effects often don't show up during pre-market testing.

Until we have a lot more experience with the vaccine, it shouldn't be mandated.

[Liberal Veteran]

51. Comparing vaccines and medications is not good science.

You are comparing something that will be out of your system in a matter of days to a drug that you take on daily basis as a rationale for concern. It's not like you take a shot of Gardasil every day which could lead some unforeseen long term additive toxicity.

And I will repeat, though no one seems to want to acknowledge it, that vaccination is a proven technology and the delivery system for this vaccine is the same one used in vaccines that have been on the market for decades. The only real difference is that it contains different proteins to cause a different immune response than say, a Hepatitis A vaccine.

Rationally speaking, the only measurable effect over four years of phase III studies was the presence of antibodies specific to certain types of HPV (which is EXACTLY what a vaccine is supposed to do). Realistically, if those antibodies are going to cause some toxic effect on the body, the same thing is going to happen when your body produces antibodies when exposed to the real thing and certainly there is no evidence to suggest that your body's immune response to HPV is dangerous. The only difference is that not having the memory cells to respond immediately to HPV when exposed, it gives the real virus a chance to become a chronic infection. Certainly there is no reason to believe the antibodies your body produces to destroy HPV are toxic to the human body.

There is a such thing as being reasonably cautious, but there is also a such thing as being overly cautious.

While I certainly respect your right to be concerned, I don't think that concern is warranted and is based more on making comparisons between two very different fields of pharmaceuticals.

[KittyWampus]

70. And ignoring the FACT that almost all young women spontaneously remit from HPV with no intervention

So WHY is this vaccine geared towards young women? Young women's bodies rid themselves of HPV naturally.

Why isn't this vaccine being 'mandated' for 35 year old women?

Oh, that's right. Because mandating shots for adults will never happen.

[Liberal Veteran]

72. Not to put too fine a point on it, but your are playing russian roulette

Yes, most HPV infections will self-resolve, but it's a total crapshoot as to who will self-resolve and who will go on to have a chronic infection that leads to cervical cancer. If you have some way of picking out who will beat HPV and who won't, then I'm sure there are some scientists who would love to see your research.

Every year, between 250,000 and 1,000,000 million women are diagnosed with cervical dysplasia and 80 to 90 percent of those women have an HPV infection and somewhere in the neighborhood of 30% to 50% of those may progress to cervical cancer.

The reason you want to immunize early is because two of the strains that are responsible for 70 percent of all HPV related cervical cancers is sexually transmitted, so around 11-13 years old is because that is almost always BEFORE they are sexually active and you want to immunize BEFORE they are exposed HPV.

This shouldn't be so difficult to understand.

What you are suggesting is foolish. It would be like saying "Well, 82% of people who get smallpox are able to rid themselves of it naturally, so why vaccinate everyone?"

[mzmolly]

77. Injecting aluminum hydroxide into one's tissue is a form of roulette as well.

:hi:

[Liberal Veteran]

79. GASP! My Maalox and Mylanta are poisons??????

:eyes:

[mzmolly]

80. Well neuron death might explain a few things?

;) I kid, but you may be interested in this:

http://www.straight.com/article/vaccines-show-sinister-side

After 20 weeks studying the mice, the team found statistically significant increases in anxiety (38 percent); memory deficits (41 times the errors as in the sample group); and an allergic skin reaction (20 percent). Tissue samples after the mice were "sacrificed" showed neurological cells were dying. Inside the mice's brains, in a part that controls movement, 35 percent of the cells were destroying themselves.

"No one in my lab wants to get vaccinated," he said. "This totally creeped us out. We weren't out there to poke holes in vaccines. But all of a sudden, oh my God-we've got neuron death!"

At the end of the paper, Shaw warns that "whether the risk of protection from a dreaded disease outweighs the risk of toxicity is a question that demands our urgent attention."

He's not the only one considering that.

In closing ...

Neuroscience research is difficult, Shaw said, because symptoms can take years to manifest, so it's hard to prove what caused the symptoms. "To me, that calls for better testing, not blind faith."

Perhaps ingestion is not a quick as injection?

[Liberal Veteran]

82. I wouldn't be too quick to put my faith in non-peer reviewed research.

After all....I'd be happy to point you to a few sites that will tell you their research shows unequivocally that HIV is a harmless virus.

[mzmolly]

83. It's not non-peer reviewed research.

(NeuroMolecular Medicine, Volume 9, Number 1, February 2007)

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17114826

Here's another interesting study, somewhat related:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?itool=abstractplus&db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=17012879

[Liberal Veteran]

86. Yet amazingly, no reviews....

I can point to articles published in medical journals that say HIV doesn't cause AIDS. But it does. That particular link, while published, has no reviews attached.

[trudyco]

87. I don't agree with your logic

If research that has no reviews comes up with a negative for a new drug/vaccine to be introduced to the public, it behooves the FDA to require more peer reviewed independent research before introducing the vaccine. The burden of proof should be on the drug company to prove their vaccine is effective and SAFE, not the other way around.

How many women who get annual pap smears die of cervical cancer anyways?

Though there may have been research showing HIV doesn't cause AIDS somebody continued on and the correct research came out.

That's the point. This research shows that more research needs to be done before the vaccine is released to the public.

[mzmolly]

93. That is amazing considering it's supposedly so flawed.

Search pubmed for "aluminum neurotoxicity" you'll find 240 citations for your dismissal.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed

[rinsd]

69. In this country roughly 3000 women die of cervical cancer

"The widespread use of pap smears -- which will continue to be necessary even for women who've had the vaccine -- has steadily lowered both the occurance of cervical cancer and deaths from the cases that do occur."

A program combining both the vaccine and the yearly exam would go a long way to even futher reducing incidence of cervical cancer.

But where this vaccine will see a much larger impact will be outside of the US where such yearly exams are not widely available and some 500,000 women die of cervical cancer ever year.

Also we are speaking of people dying without mentioning that a hysterectomy is no picnic and that is a fate many women undergoe as well.

[depakid]

13. Here we go again- despite the epidemic

No matter what the evidence- no matter how serious the problem is, the anti-vaccine folks will spread their misinformation and paranoia, and Americans will end up not protecting their kids.

This is why we have vaccine schedules and why schools require parents to file them for our children, and there's no rational reason why the HPV vaccination shouldn't be added to the schedule for 6th grade girls.

The research and trials have been lengthy and thorough- and the results are so compelling that there's a worldwide scientific consensus regarding the safety and efficacy of the vaccine.

PBS Newshour discussed the JAMA article and the implications tonight- and of course they just had toe have a spokesperson from the so called "Concerned Women of America" to legitimize the fundie angles (which sound A LOT like the irresponsible "arguments" we've all read in these threads).

Here's the transcript:

http://www.pbs.org/newshour/bb/health/jan-june07/vaccine_02-27.html

And here's the doc that they had on to defend the rational position:

JUDY WOODRUFF: And now, more on the debate to make the vaccine for HPV mandatory for all school-age girls. And for that, we turn to Dr. Ralph Anderson. He is chair of the obstetrics and gynecology department at the University of North Texas Health Center. For the record, he does not have an affiliation with Merck, the maker of the vaccine.
........

Dr. Anderson, to you first. You believe, as I understand it, that the vaccine is not only necessary, you also believe that it should be mandatory. Am I correct about that?

DR. RALPH ANDERSON, University of North Texas Health Center: Yes. As a gynecologic oncologist, I see the ravaging effects of the HPV virus, both causing the warts and the various problems that that can create in individuals, and in the cancers of the cervix.

We have roughly 10,000 new cases of cancer of the cervix per year in this country, and we have approximately 4,000 deaths from cancer of the cervix.

I believe the medical merits of this vaccine are very real. I do believe that, with the statistics that have been shown earlier, that we can eradicate 90 percent of the venereal warts and approximately 70 percent of the cancers. And with that would go a great deal of morbidity and mortality.

In relation to the mandated portion of it, you can have opt-in and you can have opt-out policies. In using vaccinations in other areas, it is very clear that, when you use an opt-out policy, you get a larger number of people taking the vaccine than if you have an opt-in policy.

Much more: http://www.pbs.org/newshour/bb/health/jan-june07/vaccine_02-27.html
-------------

btw: The full JAMA article is free online (which is kind of unusual for them):

http://jama.ama-assn.org/cgi/content/full/297/8/813

And before anyone screams Merck conspiracy! Here are the disclosures:

Financial Disclosures: None reported.

Funding/Support: This study was supported by the Division of STD Prevention, Centers for Disease Control and Prevention.

Role of the Sponsor: The funding organization, National Center for Health Statistics, Centers for Disease Control and Prevention, assisted with the conduct of the study, in the collection and management of the data, and in the preparation and review of the manuscript.

Author Affiliations: Centers for Disease Control and Prevention, Atlanta, Ga (Drs Unger and Swan, and Ms Patel); and National Center for Health Statistics, Centers for Disease Control and Prevention, Bethesda, Md (Dr McQuillan).

Here's a diagram that sums up the data:

[KittyWampus]

71. Here we go, another DU'er ignores FACTS. Young women almost always rid themselves of HPV.

their own bodies shed this virus. So why vaccinate young women?

Why isn't this being sold to 35 year old women who would be more likely to actually NEED IT?

[Liberal Veteran]

75. And people almost always rid themselves of smallpox....

Which before vaccination had only a 18% fatality rate.

Most people naturally rid themselves of the flu.

Most people naturally rid themselves of polio (95% of polio infections are sub-clinical with very mild flu-like symptoms such as sore throat or light fever or are asymptomatic).

Most people naturally rid themselves of measles.

If you are sitting on some kind of sensor to tell us who will be able to beat a specific infection and who won't, by all means, share it with the rest of us.

Until then, mass vaccinations are the best way to prevent illness and deaths from diseases that have vaccines available.

[Contrite]

14. Studies show condoms are effective against HPV.

http://www.usatoday.com/news/health/2006-06-21-virus-protection_x.htm?csp=34

From what I've gathered, this is something big pharma stands to gain from, and the "fundies" somehow think that promoting condoms promotes sexual activity. So getting a shot won't?

I find it rather suspicious that this "solid assessment" comes out after the FDA approved this drug. Condoms are cheap, or free and the worst side-effect is breakage--and good ones don't leak.

How much money does Merck plan to make from this?

[depakid]

15. Condoms help- but will not prevent HPV in all cases.

From JAMA's Patients' Page:

Condoms help decrease HPV exposure but do not protect completely against all HPV transmission.

http://jama.ama-assn.org/cgi/content/full/297/8/912

[Contrite]

16. Neither does Gardasil.

Not every type of HPV is protected against.

[depakid]

17. But if you're vaccinated before you're exposed to the most serious

variants, you WILL NOT get those forms of the disease.

[Contrite]

18. I find this VERY scary.

On June 29, 2006, a panel of experts, the Advisory Committee on Immunization Practices, gave their approval for the vaccination of Gardasil on children as young as 9 years old. The ACIP recommended that Gardasil be placed on the childhood immunization schedule at the 11 to 12 year old visit. They also recommended that the vaccine be included in the federal Vaccines for Children Program, which would provide the vaccines free of charge to children under the age of 18 who are uninsured.<6>

Legislation has been introduced in the state of Michigan to make Gardasil mandatory. If passed, this would make it the first state to require that its school children be vaccinated.<7>

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

This is the first step in Federally MANDATED vaccinations of the population. And, remember, legislation has been written that HOLDS HARMLESS those pharmaceutical companies that manufacture it.

Read up on BARDA! And Project Bioshield!!

http://www.roanoke.com/editorials/wb/wb/xp-39477

http://pogoblog.typepad.com/pogo/2005/12/cloaking_barda.html

http://www.netscape.com/viewstory/2007/02/12/merck-tries-new-tactic-to-sell-vaccination-drug-force-girls-to-take-it/?url=http%3A%2F%2Fwww.yoursdaily.com%2Fbusiness%2Fstock_investing_merck_tries_new_tactic_to_sell_vaccination_drug_force_girls_to_take_it&frame=true

Stock Investing - Merck Tries New Tactic To Sell Vaccination Drug - Force Girls To Take It

Merck tells teenage girls - Use our vaccine or don't go to school!

President Bush, and the then Republican Congress created the prescription drug program for seniors in an attempt to reverse the tide for these companies. The drug manufacturers have been a major contributor to the Republican Party for more than a decade. Both Merck, and Pfizer have begun downsizing their sales forces in response to the slow down.

The problem for these companies is that they have gotten so big in terms of their sales bases, that they are having great difficulty generating new drugs on a scale that can compensate for the slowdown of their current portfolio of drugs. In addition many of these fabulous drugs currently being sold are going off patent protection, and that means a collapse in sales revenues. Once the generics take over, than it’s over for the original creator of the drug.

What has Merck done NOW?

Merck has created a new cervical-cancer vaccine. The American Cancer Society tells us that a little more than 11000 women this year will be told by their doctors that they have this terrible disease. What’s worse is that more than 3500 of those women will eventually succumb to it.

Let’s put this in perspective. About 180,000 women this year will be told they have breast cancer. About 40,000 of these previously diagnosed women will eventually die from breast cancer, and its complications. Between 8 times and 10 times the number of women who die from breast cancer, will die from heart disease this year. As you know breast cancer gets all the publicity compared to the other two diseases.

(snip)

Merck got TEXAS on board first

Could you believe it? Merck got Texas Governor Rick Perry to sign an executive order. Such an order negates the need for the Texas legislature to get involved. This order will require every young girl in Texas to receive the Merck vaccination Gardasil at $360 for three shots of the vaccine, and yes all three are needed. You are probably aware that there is a measles-mumps vaccine that has been on the market for years. The measles shot costs only $43 per dose by comparison.

The way the deal works in Texas is that unless you can demonstrate proof that you have taken the shots, you are not going to be allowed to go to school. At the moment it looks like your health insurance is going to pick up the cost, but of course there are millions upon millions of uninsured young people in this country. Who is going to pay for them? Apparently a former Chief of Staff to Governor Perry is a lobbyist for Merck, which is the same thing as saying she works for Merck, isn’t it. It’s amazing what a couple of dollars paid to a lobbyist can achieve.

(more at link)

[depakid]

19. I've never agreed with BARDA- it's a foul law, but I do believe in science

especially when it's backed by worldwide consensus and by the regulatory bodies in the EU, Britain, Canada and Australia- to name but a few.

What I don't believe in- in fact, what I decry is people who would encourage others NOT to protect their children against preventable diseases based on misunderstanding, paranoia and conspiracy theories.

This I find VERY SCARY- and though thankfully, it seems to largely be limited to America.

[Contrite]

20. The mandatory vaccinations are horrifying.

Making school attendance dependent on getting vaccinated is completely insane, police-state-type policy.

Not to mention the fact that the ages at which they want to start the vaccinations--9-year-old girls?

Particularly when there is no liability and no FOIA sunshine.

[depakid]

21. What's horrifying is the diseases that people can get- AND

the fact that libertarian types with little or NO understanding of medical science seem to be driving health policy with appeals to emotion and incessant fear campaigns.

It makes me ill just thinking about all of the girls who'll get infected because of this insanity -which is precisely why school districts all across the nation already have immunization requirements in place.

There's no rational reason why this vaccine should not be included in the schedule for girls- and later all kids at an appropriate age.

The American Academy of Pediatrics has already said as much.

See: http://www.aap.org/healthtopics/immunizations.cfm

[pnwmom]

34. Adverse drug reactions are the leading cause of death in the U.S.

and the FDA is not doing enough to protect the public.

There are plenty of "rational reasons" why this new vaccine should not be MANDATED at this point.

http://72.14.253.104/search?q=cache:Q_7sbM2JB10J:www.wramc.amedd.army.mil/departments/dci/downloads/Tri-Srv-CI-May02/Sharav%2520Presentation.doc+list+%2B%22withdrawn+drugs%22+%2Badverse+%2BFDA&hl=en&ct=clnk&cd=20&gl=us

CONFLICTS OF INTEREST

Presented by Vera Hassner Sharav

14th TRI-SERVICE

CLINICAL INVESTIGATION SYMPOSIUM

Sponsored By


THE U.S. ARMY MEDICAL DEPARTMENT

And

THE HENRY M. JACKSON FOUNDATION FOR

THE ADVANCMENT OF MILITARY MEDICINE

May 6-8, 2002

Physicians reading the current issue of JAMA2 will be startled to learn that a team of Harvard University professors are advising physicians NOT to prescribe new drugs to their patients because their safety has not been established—despite FDA approval. Adverse drug reactions,3 they acknowledge, is the leading cause of death in the U.S. They analyzed the 25- year record of drug label changes (between 1975 to 1999) as they appeared in the Physician’s Desk Reference and found that 548 new drugs were approved during that period. Of these 20% required subsequent black box warnings about life threatening drug reactions, half of these adverse effects were detected within 2 years others took much longer. Sixteen drugs had to be withdrawn from the market because they were lethal.

. . . . They found that clinical trials are underpowered to detect uncommon, but potentially lethal drug reactions. Their design, biased selection, short duration, and accelerated approval process almost ensures that severe risks go undetected during clinical trials. The JAMA report validates the findings of a Pulitzer Prize winning investigative report in the Los Angeles Times by David Willman.4

Willman uncovered evidence demonstrating the adverse consequences of the 1992 Prescription Drug User Fee Act (PDUFA), the law that brought industry money and industry influence to the FDA. The approval process for new drugs was accelerated and the percentage of drugs approved by the FDA increased from 60% approval at the beginning of the decade to 80% approval by the end of the 1990s. Willman reported that the FDA was the last to withdraw several drugs that had been banned by European health agencies. There was a concomitant precipitous rise in the approval of lethal drugs: between Januray1993 and December 2000, seven deadly drugs were brought to market only to be withdrawn after they had been linked to at least 1,002 deaths.5 In a follow up article, August 2001, 6 Willman reported that the list of lethal drugs withdrawn since Sept 1997 had jumped to a dozen--9 had been approved after 1993.

None of the drugs were for life-threatening conditions, one was a diet pill, another for heartburn, another an antibiotic that proved more dangerous than existing antibiotics. The approval of these drugs illustrates the collision between corporate interests and the public interest. Corporate interests revolve around maximizing profits through the marketing of new, expensive drugs, but corporate interests collide with public safety interests. FDA’s “expert advisory panels” demonstrate FDA’s loss of independence. Most advisory panel members have undisclosed financial ties to the manufacturer whose drugs they recommend for FDA approval.4

Corporate influence in academia

Until 1980 a firewall existed separating industry and academia to ensure that academic pursuits were independent of commercial influence. When the Bayh-Dole Act of 1980 encouraged “technology transfer,” that firewall was removed, allowing federally funded universities to patent and license inventions developed by faculty members. Researchers and institutions were free to enter into ventures and partnerships with biotechnology and pharmaceutical companies—and they did. It is estimated that of the $55 billion to $60 billion spent by the biomedical industry on research and development, large companies spend one fifth at universities, small companies spend one-half.8 With the flow of corporate money, came corporate influence and control. The culture within academic institutions changed: business ethics swept aside the moral framework within which academia had functioned. Gone were such niceties as intellectual freedom and a free and open exchange of ideas, so was full disclosure of research findings. Gone was the culture of social responsibility, or a social conscience. Finally, the absence of independent, third party review has put the integrity of the process and the quality of the products in jeopardy.

SNIP






http://www.pharmabiz.com/article/detnews.asp?articleid=11316§ionid=46

The seven are among hundreds of new drugs approved since 1993, a period during which the FDA has become known more for speed than caution. In 1988, only 4 percent of new drugs brought to the world market were approved first by the FDA. In 1998, the FDA''s first-in-the-world approvals spiked to 66 percent.

The drug companies'' batting average in getting new drugs approved also climbed. By the end of the 1990s, the FDA was approving more than 80 percent of applications for new products, compared with about 60 percent as the decade began.

The seven unsuccessful drugs alone generated U.S. sales exceeding $5 billion before they were withdrawn.

Once the world''s unrivaled safety leader, the FDA was the last to withdraw several new drugs in the late 1990s that were banned by health authorities in Europe.

``This track record is totally unacceptable,'''' said Dr. Curt Furberg, a professor of public health sciences at Wake Forest University. ``The patients are the ones paying the price. They''re the ones developing all the side effects, fatal and nonfatal. Someone has to speak up for them.''''

http://pubs.ama-assn.org/media/2004jer/1130.dtl#jama

According to background information in the article, "For medicines that are effective, prompt approval provides rapid access to the health benefits of new drugs. At the same time, U.S. patients are increasingly the first to receive new medications, some of which are subsequently discovered to have serious adverse effects. As a result, the challenge of early detection is increasingly borne by the U.S. postmarketing
systems."


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


Some withdrawn drugs:

Fen-phen (popular combination of fenfluramine and phentermine)
1997
Phentermine remains on the market, dexfenfluramine and fenfluramine – later withdrawn
terfenadine
1998
Withdrawn due to risk of cardiac arrhythmias; superseded by fexofenadine
mibefradil
1998
Withdrawn due to dangerous interactions with other drugs
troglitazone
2000
Withdrawn due to risk of hepatotoxicity; superseded by pioglitazone and rosiglitazone
alosetron
2000
Withdrawn due to risk of fatal complications of constipation; reintroduced 2002 on a restricted basis
cisapride
2000s
Withdrawn in many countries due to risk of cardiac arrhythmias
cerivastatin
2001
Withdrawn due to risk of rhabdomyolysis
rapacuronium
2001
Withdrawn in many countries due to risk of fatal bronchospasm
rofecoxib
2004
Withdrawn due to risk of myocardial infarction
mixed amphetamine salts (Adderall XR)
2005
Withdrawn in Canada due to risk of stroke. See Health Canada press release
hydromorphone extended-release (Palladone)
2005
Withdrawn due to a high risk of accidental overdose when administered with alcohol
pemoline
2005
Withdrawn from U.S. market because of hepatotoxicity
natalizumab (Tysabri®)
2005-2006
Voluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July, 2006.

[Lance_Boyle]

35. Dear Gawd. Take Vera with an ocean's worth of salt.

She's way off the deep end of anti-pharma nutjobism.

[pnwmom]

37. She's quoting from a referreed article by Harvard University researchers

in the Journal of the American Medical Association. That article is also cited below in that post, if you care to read it.

[depakid]

41. Of course, the article and its implications have nothing to do with vaccination

Though that point seems to elude some people....

[pnwmom]

47. The safety and effectiveness of vaccines is proven, and the vaccines

are approved for release, in exactly the same way as with drugs -- through the regulations regarding "investigational new drugs, " which is handled through the FDA. The same conflicts and problems that occur with new drug approvals can occur with new vaccine approvals.

[Morgana LaFey]

40. How dare you

How fucking DARE you demean and denigrate a DUer posting a peer reviewed article that way?

[Lance_Boyle]

44. I don't believe I

"demeaned" or "denigrated" anybody here. Vera Sharav is a well-known anti-pharma nutjob. I don't believe she is a poster here, but even if she is, she's still a well-known anti-pharma nutjob. :shrug:

[pnwmom]

48. Given that her presentation was sponsored by the Army and the

Henry Jackson center -- hardly bastions of "anti-pharma nutjobs" -- I feel that her credentials are well established.

As opposed to some DU'ers, who could be in the employ of or stockholders of the pharmaceutical industry, as far as I know.

[mzmolly]

84. Says who?

Ms. Sharav has developed a database to track ethical violations in research and failure to disclose drug hazards. Her advocacy efforts include: suspension of EPA pesticide experiment (CHEERS) on children (2005); federal investigations on the use of children in foster care in experimental AIDS drug and vaccine trials (2004); suspension of smallpox vaccine on children (2002); suspension of "violence prediction" experiment exposing 6-11 year old NYC boys to fenfluramine (1998); organized testimonies by victims of unethical research before the National Bioethics Advisory Committee (1997). These testimonies led to a prize-winning series in the Boston Globe, "Doing Harm: Research on the Mentally Ill" (1998), the shut down of 29 clinical trials at the National Institute of Mental Health (1999), culminating in the prize-winning book by Robert Whitaker, Mad in America (2001).

Mrs. Sharav served on the Children’s Workgroup of the National Human Research Advisory Committee (2001-2002); she has testified before national policy advisory panels including: the Institute of Medicine (against prisoner experiments (2005); against human pesticide experiments (2002); FDA hearings on antidepressants and the risk of suicide (2004 and 2006), the National Bioethics Advisory Committee (1997), military ethics forums and academic forums, and consumer advocacy forums (2006). Among her recent publications: Screening for Mental Illness: The Merger of Eugenics and the Drug Industry, Ethical Human Psychology and Psychiatry (2005); Conflicts of Interest in Biomedical Research Harm Children With and Without Disabilities," Journal of Disability Policy Studies (2004); "The Impact of FDAMA on the recruitment of children for research," EHPP (2003); "Children in Clinical Research: A Conflict of Moral Values," American Journal of Bioethics (2003); The ethics of conducting psychosis-inducing experiments," Accountability in Research (1999).

http://www.ahrp.org/cms/content/view/28/88/

Why is anyone who questions corporate drug pushers deemed a loon?

[HiFructosePronSyrup]

52. If a person's going to be disingenuous...

they should get called on it.

[nodehopper]

58. WHY IS EVERYONE IGNORING THE FACT

that mandatory vaccinations are a misnomer--you can opt out--while making them "mandatory" allows them to be state-funded, and thus allows low-income women access to them?

This OMG THEY ARE MANDATORY IT IS TERRIFYING meme comes from a position of ignorance (willfully ignoring the fact that you can sign off on a sheet of paper and NOT DO IT) and privilege (willfully ignoring the fact that mandating the medicine is the only way to make it affordable for a large part of the population).

[mzmolly]

85. Many people don't realize that you can opt out, and one can only do so

in some states with a medical exemption or for religious reasons. Also, when a parent opts out of a mandatory vaccine, they are at times accused of neglect, no matter how much thought went into such a decision.

:shrug:

[nodehopper]

95. you can opt out for personal reasons

it does not have to be religious. And who exactly is accusing people of neglect? Gossip and neighbours' opinions isn't something that should affect policy decisions; I am sure some people assume that tattooed or pink-haired parents are also neglectful and unfit.

In any case, I am much more down with an educational campaign to inform people of their choice to opt out of the vaccine, than a campaign, based on the "oh, but people don't realize they can refuse this" rationale that will disenfrenchize low-income women and will prevent them from have state-funded access to this vaccine.

[mzmolly]

96. Not in all states. You can in opt out inTexas however.

Also, I think any "recommended" vaccine should be state funded, there shouldn't have to be a mandate.

Checking out for a while, but responding to respondents first. :hi:

[Bridget Burke]

92. Many vaccines are mandated for school attendance.

And "concerned" parents can always get around those regulations. For ANY vaccine.

Here's how you do it in Texas: www.dshs.state.tx.us/immunize/school/school_exclusion.shtm

[xchrom]

23. merck isn't the only drug company involved in creating gardasil

it was created with sanofi pasteur in france.

[Contrite]

54. More on that and GlaxoSmithKline sells Cervarix.

GlaxoSmithKline's Cervarix jab targets two strains of the human papillomavirus.

Glaxo fires shot over Merck's bow
Glaxo launches study comparing experimental cervical cancer vaccine to Merck's Gardasil.
By Aaron Smith, CNNMoney.com staff writer
January 18 2007: 1:05 PM EST

NEW YORK (CNNMoney.com) -- The British drugmaker GlaxoSmithKline fired a shot over Merck's bow on Thursday, by launching a study comparing its own experimental vaccine for cervical cancer to Merck's Gardasil.

http://money.cnn.com/2007/01/18/news/companies/glaxo/index.htm

Sanofi Pasteur is selling Gardasil, which is Merck's product.

http://www.medicalnewstoday.com/medicalnews.php?newsid=54511

[nodehopper]

27. yes but

for the types of HPV it DOES protect against (which cause 70% of the cerv. cancer cases), the protection is over 95%, whereas condoms only protect at 70% WITH PERFECT USE.

ideally, people would use both.

[xchrom]

22. you can get hpv from fingers.

it isn't necessary for there to be full on sexual contact to get the hpv virus.

[bettyellen]

24. they are not good protection, but thanks for PRETENDING to care about cervical cancer prevention

your other posts here give away your complete lack of concern for infected women.
what bs.
:hi:

[Contrite]

45. I suffered from a cervical infection that required a hysterectomy.

When I was 32 actually. So, I do support cervical cancer prevention.

I am questioning the rush to market here, the fact that the shots are very expensive--bringing lots of revenue to Merck over and above the money derived from other vaccination drugs--that they are being forced on kids as a requirement of school attendance, and that there is legislation that will protect Merck from liability lawsuits.

[bettyellen]

49. so why do you stress "only 1%" of cancers are from HPV?

that shows a lack of concern over that 1% that i find frightening.

[Contrite]

50. I didn't stress that.

I linked to an article reporting this:

Merck has created a new cervical-cancer vaccine. The American Cancer Society tells us that a little more than 11000 women this year will be told by their doctors that they have this terrible disease. What’s worse is that more than 3500 of those women will eventually succumb to it.

Let’s put this in perspective. About 180,000 women this year will be told they have breast cancer. About 40,000 of these previously diagnosed women will eventually die from breast cancer, and its complications. Between 8 times and 10 times the number of women who die from breast cancer, will die from heart disease this year. As you know breast cancer gets all the publicity compared to the other two diseases.

This new anti cervical-cancer vaccine is a wonderful creation, and everyone at Merck who participated in its creation should feel great pride in their work. What about the executives, and marketing people at Merck. Well, that’s a different story. Merck has decided to attempt to force the use of this vaccine onto every female pre-teenager, and teenager in America. They are pulling out all the stops in an attempt to influence every legislator they can find to mandate this vaccination be given to children regardless of their parent’s wishes.

[bettyellen]

65. A HALF MILLION WOMEN PER YEAR DIE BECAUSE OF CERVICAL CANVCER

it's nothing if not significant.
comparing it to heart disease, what's the fucking point if that. apples and oranges.

[nodehopper]

59. I would like to see a citation for that 1% figure

I have asked for it in other threads, and I never get it. I spend about 20 minutes today trying to find corraboration for that number via google and pubmed, and have not been able to do so.

[Contrite]

63. Gynecologic Cancer Foundation figures

500,000 women worldwide die of cervical cancer annually
50-60 million women in the U.S. have a Pap test each year
3-5 million women in the U.S. have an abnormal result
12,200 new cervical cancers diagnosed in the U.S. per year
4,100 deaths from cervical cancer in the U.S. per year

Taken from a Powerpoint presentation on the NCCC website

www.wcn.org/gcf

A virus—the Human Papillomavirus, or HPV—causes almost all cases of cervical cancer. HPV is a common sexually transmitted virus that usually goes away by itself. Most people with HPV never even know they have it.

HPV is a family of very common viruses that cause almost all cervical cancers, plus a variety of other problems like common warts, genital warts and plantar warts. HPV also causes cancers of the vulva, vagina, anus, and cancers of the head and neck. Women and men become infected with HPV types that cause cervical cancer through sexual intercourse and sexual contact. Most women and men will be exposed to HPV during their lifetime.

The most common cancer-causing types of the virus are 16 and 18. This is important to know because these two types alone cause about 70% of all cervical cancer. The cervical cancer vaccine is designed to protect against these two types.

An HPV infection rarely leads to cervical cancer. In most women, the cells in the cervix return to normal after the body's immune system destroys the HPV infection. However, some HPV infections do not go away and may remain present in the cervical cells for years. Long-standing infection can lead to changes in the cells that can progress to cancer.

http://www.cervicalcancercampaign.org/

The 1% figure may have come from this:

http://www.reproline.jhu.edu/english/3cc/3refman/cxca_hpv1.htm

It is estimated that for every 1 million women infected, 10% (about 100,000) will develop precancerous changes in their cervical tissue (dysplasia). Of these, about 8% (8,000 women) will develop early cancer limited to the outer layers of the cervical cells (carcinoma in situ ) and roughly 1,600 will develop invasive cancer unless the precancerous lesions and CIS are detected and treated.

(1% of 100,000 is 1,000, close to 1,600)

[bettyellen]

64. (so it would be 1.6% at minimum) HALF MILLION WOMEN DIE worldwide each year...

looks like the 1%, like other things is made up.
:shrug:

[Contrite]

67. The 1% figure is the percentage who get cancer from HPV infections

Not the number of women who die from cervical cancer.

The number of women who die from cervical cancer is a half million annually.

The number of women who develop cervical cancer from HPV infections is about 1%. So although millions can have HPV infections, only ONE PERCENT of them will develop cervical cancer from their HPV infections.

Does that clear it up for you?

[bettyellen]

88. what's the percentage of cervial cancer patients who have HPV?

[INDIA]

31. Let me tell you from personal experience...

That is not always true. I ALWAYS practiced safe sex, and still ended up with the damn thing.

[donsu]

38. agree - parents should be stressing the condom issue with their

daughters.

don't use condoms - get STDs and or pregnant

including oral/anal sex

[nodehopper]

42. use condoms perfectly 100% of the time

and still end up with HPV 30% of the time.

not to mention, what does one do about condom use when one wants to have children? HPV doesn't distinguish between recreational and procreational sex.

[shawn703]

28. I thought HPV was more prevalant than that?

Maybe it was just horror stories people were telling, but I thought the number of people infected with HPV was 50-75% and many people go through life never knowing they had it?

[mzmolly]

32. Ahhh more PR for Merck. HPV has many strains most are not related to cancer.

But lets not let facts get in the way of profit. :hi:

[Contrite]

43. That's just it. Most are not related to cancer.

And Gardasil does not protect against all of the types of HPV.

Is taking the drug worth the risk, particularly in view of the new "no liability" legislation? Further, what about the "mandatory vaccination" legislation?

[mzmolly]

46. Agreed.

:hi:

[Liberal Veteran]

53. Sophistry....

Merck is very clear that this vaccine only works on the two types of HPV that are responsible for 70% of cervical cancers.

Regardless, the prevalence of HPV in the general public is cause for concern. Genotyping to determine the exact strain of HPV costs approximately 600 dollars a test.

If we can eliminate the worry over two specific strains responsible for 70 percent of HPV related cervical cancers through vaccination, then by all means, that's seems like a much more cost effective and beneficial use of our health dollars than genotyping every single year to make sure you haven't acquired one of the oncogenic strains of HPV or treating a cancer that we had a chance of preventing.

And you know what? Profit is not a bad word. If they make a decent profit from this vaccine, they have earned it....it is the fruits of their labors. I expect to profit from my labor also.

[Contrite]

55. But what if they profit by mandatory vaccination at taxpayer expense?

The problem is this is being forced on the public through legislation. It should be a matter of choice.

Also, by making it mandatory, think how much more money Merck can make versus the shots recommended by doctors only and paid for by insurance. In fact, think of the load off the insurance industry itself if legislation provides it for free. Why do you think Rick Perry was heavily lobbied to pass the legislation in Texas and Merck is hiring new lobbyists at lighting speed?

Further, do you not have a problem with the fact that there will be no liability and no FOIA access to pertinent data under BARDA?

What if the drug makes someone ill or kills them?

[nodehopper]

60. if it's an optional vaccine

then it won't be affordable to low-income women. Also insurance companies won't cover it. So really it will only be optional for the well-off. The poor, the population that is already more at risk because their access to other healthcare is limited by our wonderful system, would be screwed.

[Contrite]

61. It doesn't have to be forced to be free.

It can be optional and free if the CDC is REALLY concerned about stopping the spread of HPV. It can still be offered at free clinics, and Merck still collects tax money.

But it should not be mandatory, and there should not be a hold harmless to the manufacturer if something goes wrong, nor should there be a shroud of secrecy around any documents concerning the drug and its clinical trials and actual field results.

[nodehopper]

66. maybe it shouldn't have to be that way

but under the current health system that's the way it is. Mandated medicines are funded, even though all of them have opt-out clauses, and optional vaccines are out-of-pocket expenses. Hep B wasn't funded until it became mandatory. While we all have ideas about what the gov. and CDC SHOULD do, and hopefully we all advocate and lobby for it, evaluations and decisions about the present day have to be made based on the reality of current policies.

[Contrite]

68. If it were established that all HPV infections caused cervical cancer

at an epidemic proportion then it should be/could be free and/or mandated--like polio immunizations were in the '50s (and you should read up on that one). But, as it stands, ONE PERCENT of all women who contract HPV infections actually develop and die of cervical cancer. That does not constitute an epidemic.

The research shows that having annual Pap exams is the best prevention/precaution. If anything should be mandated and/or free perhaps it should be Pap smears for early detection.

[mzmolly]

76. The fact is that HPV in and of itself is not cause for alarm.

The attempt to muddy the waters is what concerns me.

[barb162]

57. That's a pretty high rate, one that surprised me when I read

about it earlier today.

[superconnected]

73. I have a very hard time believing that number.

It says a quarter of the swabs had it but what were the young women in there getting swabbed for anyway. Probably because they noticed a problem.

I do not believe that means 1/4 of all US women have it. I would expect it to be a far bigger deal than that news article if that were actually the case.

[superconnected]

74. The link is bad.

I think it is important to follow that link, and research more.

It is a huge financial profit for the company that sells the drugs for this.

I don't doubt some people get it. But before announcing it's a pandemic, I need to know more. 25% would be a huge proportion even for a pandemic. Pandemic are enormously huge just hitting 200k.

I'm going to call bullshit on this one.


-------------------------------------------------------------------------
Right in the middle of the article -

"This first solid assessment of the U.S. female prevalence of HPV infection comes about nine months after the Food and Drug Administration approved a vaccine against certain types of the virus to prevent cervical cancer."

[Synnical]

81. HPV this week, last year it was Bird Flu

Don't know what to think or believe.

[salitine]

89. Every woman who catches the HPV virus from now on has a legitimate lawsuit against the government.

I'm serious, Every woman who gets it from now on has a legitimate lawsuit. The Anti-virus is there. It would save lives. Government says "God dosent want that" because the government has NO MONEY.

[nodehopper]

94. whoa

first of all, the vaccine does not protect from all strains of the virus. Two of the strains it protects from cause 70% of all cervical cancer cases, but it doesn't protect you 100%. Secondly, the government isn't saying "god doesn't want that," (not out of altruism, mind you, but Merck is Big Pharma--which, by the way, doesn't render the vaccine ineffective) the anti-science anti-vax people seem to be the ones most up in arms against it.