Showing posts with label human papilloma virus. Show all posts
Showing posts with label human papilloma virus. Show all posts

Wednesday, October 21, 2009

Gardasil Optional, Not Recommended, for Boys--Will You Pay for It?

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It’s up to you now. The Advisory Committee on Immunization Practices voted almost unanimously to tell doctors that they’re free to give boys the Gardasil vaccine as a way of avoiding future bouts with genital warts—which affect about one percent of the population—but they’re not going to recommend it as a routine vaccination.

Nor do they plan to recommend it as an “anti-cancer” vaccine, which is the way it’s been sold to many millions of girls. Although the HPV virus can cause esophageal, anal, testicular, penile and perineal cancer in boys, such cancers are very rare, and even then a large percentage aren’t associated with the human papillomavirus. The only real advantage would be to protect future partners.

Merck, with billions on the line, had determined that the vaccine would be very cost-effective for boys by assuming that the vaccine would be 100 percent effective in preventing cancer and that the vaccine would cost $400 per child—at $360 for the cost of the shots alone, that doesn’t leave much to pay the cost of three visits to the doctor.

A Harvard study, however, went on the assumption that the vaccine would be 75 percent effective and cost $500 per child, and found that the cost of vaccinating boys would be spectacularly cost-ineffective.

The Advisory Committee apparently agreed with Harvard.
There is certainly no reason to assume that Gardasil will be 100 percent effective. Merck’s own study of more than 4,000 boys didn’t even find that, and Gardasil trials have shown the HPV vaccine to be just 17-45 percent effective in preventing cervical abnormalities in girls thus far. Gardasil has also been associated anecdotally with a number of rare, but serious, side effects, including autoimmune diseases and a form of ALS.

Meanwhile, it’s doubtful that many insurance companies will now pay for Gardasil for boys, although government programs may do so for those on Medicaid. Parents might prefer to be sure that their children understand the importance of getting annual exams as adults and of eating fruits and vegetables, avoiding smoking, being circumcised, getting sufficient sleep, and limiting the number of sexual partners—all factors that are known to substantially cut the risk of getting a persistent HPV infection.

So are you willing to fork over the cash yourself? Do you think Gardasil’s worth it?

Tuesday, August 4, 2009

Australia Approves Gardasil for Women Up to Age 45

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Australia’s Therapeutic Goods Administration (TGA), roughly the equivalent of the United States’ FDA, has approved the Gardasil vaccine for use by women up to age 45. Previously, it had been approved only for ages 9-26. The vaccine was developed by Professor Ian Frazer, who was named Australian of the Year in 2006.

Earlier this year the FDA refused to allow Gardasil to be used in older women, citing the need for completion of an ongoing 48-month study and an analysis of the data.

The FDA’s caution may well spring from background information provided for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) back in May 2006. The Committee was extremely concerned about data that showed that when the vaccine is given to a woman with a dormant or harmless form of HPV, the virus can become activated, increasing the likelihood of precancerous lesions developing by a startling 44.6 percent. The vaccine does not clear existing infections.

The TGA’s decision was likely spurred by a recent Columbian study funded by Gardasil maker Merck. It found that the vaccine was 91 percent effective in preventing new infections in women aged 24-45 if—and this is a big 'if'—they had never previously had HPV or cervical disease. The Australian public health service will not provide the vaccine free of charge for women under or over the ages of 12-26 as it clearly is not cost-effective, recommending instead that women continue to be vigilant about getting regular Pap smears.

Gardasil protects against two cancer-causing strains and two genital-wart causing strains of human papillomavirus (HPV). There are thought to be more than 100 strains of HPV, about 40 of which can cause cancer, and about 80 percent of the population will be infected with it at some point in their life. Some 95 percent of infections are shrugged off by the body within about 18 months, leaving a natural immunity to that strain. Only persistent infections can cause the lesions that might eventually become cervical cancer. Most lesions are easily detected during an annual Pap smear test in developed nations, although cervical cancer is a major killer in some countries where women do not have access to routine health care.

Monday, May 4, 2009

Gardasil and the Fake Medical Journal Scandal

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By Kristin Johns @ http://www.gardasilhpv.com/

Maybe this doesn’t really belong in a blog focusing solely on Gardasil and HPV, but my jaw hit the ground so hard when I read about this little shocker that I just can’t help myself. And it sure sheds a horrifying light on the lengths that Merck, the manufacturer of Gardasil, will go to for the sake of sales.

Turns out that Merck made up an entire fake medical journal for marketing its osteoporosis drug Fosamax.

Talk about a bone-headed (sorry) scam. The Australasian Journal of Bone and Joint Medicine was published by Elsevier, famed for heavyweight scientific journals such as The Lancet, and contained favorable data for Merck products like Vioxx and Fosamax. According to TheScientist.com, the journal so closely mimicked a traditional, peer-reviewed journal that one George Jelinek, an Australian physician and member of the World Association of Medical Editors, testified in court that "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication for MSD[A]" (a Merck subsidiary).

The Scientist’s information came from a look at testimony in a lawsuit filed against Merck by a man who believes his heart attack was caused by Vioxx. “The Federal Court has heard that Merck & Co "prepared and gathered" doctors and academics to write the company's own research on Vioxx, which was then published in prestigious medical journals as independent studies…The drug company also allegedly produced an entire journal—called The Australasian Journal of Bone and Joint Medicine—and passed it off as an independent peer review publication,” reported The Australian on April 9.

The journal apparently had no acknowledgement anywhere in its pages that it was funded solely by Merck, and the editorials were basically summaries of the articles with scant references. In happy phrase, Honorary Editorial Board member and rheumatologist Peter Brooks admitted that he had in the past put his name on a few “advertorials.” Advertorials?

Oh, God. What have medicine, science, and indeed publishing, come to?

I want to believe in medicine and science, I really do. I want to be able to go to my doctor and believe what he says and take his advice. I want to believe that when our pediatrician advises me to get my girls that 3-shot series of Gardasil vaccinations, she’s read up fully on it in objective, well-written and peer-reviewed journals that cover properly-conducted trials. I want to believe that Merck genuinely tries to cure diseases, not just to make money hand-over-fist like some cheap Main Street emporium marketing fashion to gullible teenagers.

But good grief, they’re making it increasingly hard.

Luckily I know enough responsible, ethical scientists and doctors to know that the once-honorable traits of all-encompassing curiosity and genuine caring still exist. I’m pretty sure that my doctor wouldn’t dream of adding spurious medical credibility to “advertorials.”

But on my shelf, I have a little green bottle that I dug out of an ancient dump. Once upon a time, according to its raised lettering, it contained “Doctor Kilmer’s Swamp Root Kidney Cure." I’m starting to wonder whether a few of my medicines shouldn’t go up on that shelf right alongside it.

Thursday, April 30, 2009

Why Potential Gardasil Side Effects Aren't Reported to VAERS

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The whole issue of the vast inadequacies of the VAERS (Vaccine Adverse Event Reporting System) has become a bit of a brain worm for me. After all, in general I’m a believer in vaccines, but it’s essential that we know everything about them that we can—and thoroughly investigate every single possible connection with an adverse event or side effect.

Because (to badly paraphrase John Donne) any child’s death or disability diminishes us, and particularly so if we could have prevented it.

The VAERS issue came up because the parents of Jenny Tetlock asked officials to look into the possibility that the extraordinarily rapid-onset paralysis that was killing their daughter could be connected with the Gardasil vaccination she’d recently received. The huge VAERS database turned up no comparables. And yet when the Tetlocks started a personal blog appealing for help they found two very strong comparables, girls who had also just received the vaccine when they develped a similar form of paralysis. Those other two cases, it turns out, had simply never been reported.

Which has led me to wonder how much VAERS actually encourages reporting. (VAERS reports can be filed by anyone, including parents or patients as well as doctors, nurses and pharmacists). So I duly trotted off to our pediatrician’s office and picked up a flyer—you know, the information sheet you’re handed before you get a vaccination, explaining what, why, and who.

Troll down to section 5, which covers risks. It says that the HPV shot does not appear to cause any serious side-effects (fair enough; there have been no definitive connections that I know of) and that although it COULD cause a serious problem such as a severe allergic reaction, the risk of any vaccine causing serious harm or death is very small (again, fair enough, if you’re talking about direct causation. We don’t know a whole lot about the other kind one way or another).

It explains that mild reactions include pain at the site (duh!!), redness or swelling at the site, mild fever, itching, and moderate fever. Fine.

Then I start to get crabby.

“Life-threatening allergic reactions from vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccination.”

Now, that’s reasonable, followed as it is in section 6 by an explanation of the symptoms of severe allergic reaction—high fever, behavior changes, difficulty breathing, wheezing, hoarseness, hives, paleness, weakness, a fast heart beat or dizziness. After advice about what to do, it requests you to ask your doctor to contact VAERS, or do so yourself, if you or your child experience a severe allergic reaction and explains how. Again, fine.

So why am I crabby?

Because the very, very clear implication is that an immediate allergic reaction is the only serious side effect or adverse event that could possibly be connected to Gardasil—or any other vaccine, for that matter. There's not even a mention of Guillain-Barré syndrome, although a recent study found that there appears to be an increased risk of its appearance in the two to six weeks following vaccination with Gardasil.

No wonder the parents of those other paralyzed girls didn’t think to report the paralysis to VAERS. There may be a connection, there may not be. There may be a connection between other adverse events and Gardasil, or there may not be. It may be reasonable to say that if a vaccine can, even rarely, immediately cause your body to react badly, it could also cause a slower adverse reaction in some people. Or it may not be. But the government body that advises parents to get these vaccines for their kids has a duty to investigate fully and to encourage the reporting of ALL potential reactions, not just immediate and severe allergic reaction; and so do the companies that sell the vaccines.

There’s a petition for reform of the VAERS system over at http://www.thepetitionsite.com/1/oneclickonelife, or you can access it via the site http://oneclickonelife.org/.

I don’t care whether you think Gardasil is the devil in disguise or the best thing since Starbucks ice cream: please zip over there and sign it. Regardless of your views on vaccines or experience with them, our kids deserve the best immunizations and the best monitoring systems we can give them.

Tuesday, April 28, 2009

Double-Speak in Spain over Gardasil Convulsions

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According to Reuters América Latina, Spain’s Agencia Española del Medicamento y Productos Sanitarios (AEMPS) and Europe’s Agencia Europea de Medicamentos (EMEA) have cleared Gardasil for take-off.

The two organizations have shrugged off any possibility that the continuing convulsions suffered by two young girls in Valencia, and by a third girl in the Balearic Islands, could be related to Gardasil. All the girls started convulsing and lost consciousness within hours of being injected with the anti-HPV vaccine. A few days later the entire batch of Gardasil was withdrawn, and although Spain’s vaccination program resumed shortly, its Ministry of Health convened a panel of experts to look into the matter.

The two girls in Valencia, at least, have suffered repeated and debilitating bouts of convulsions and have been rushed to Intensive Care several times. Experts are at a loss to explain or cure the problem and the families are, understandably, distraught and angry. Little is known about the third girl, whose case was far less widely publicized.

The two panels found no biological link between the girls’ convulsions and the shot, largely because they could find no similar cases in Spain despite the large number of vaccines given. They did, however, note that administration of the vaccine could well have “precipitated” the illness—in other words, it acted as a trigger.

That confuses me. Isn’t that a link?

According to VAERS (the Vaccine Adverse Event Reporting System) 359 cases of convulsions and 13 cases of epilepsy post-Gardasil have been reported in the U.S. to date—always bearing in mind that VAERS is a purely voluntary system and suffers acutely from both over-reporting and under-reporting.

If it were me investigating the relationship between Gardasil and convulsions, I’d certainly want to look into possible trigger mechanisms. It is distressing to see that the people entrusted with public health are willing to say that, statistically-speaking, of course there is no connection— “just” a potential trigger.

But heck, I’m just the parent of a potential statistic.

Monday, March 23, 2009

Why Gardasil Was Created: Jade Goody Dies of Cervical Cancer

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Gardasil is such a controversial and flawed vaccine that it seems as if many people can think of it only as a much-hyped profit center for Merck.

But 27 year-old British celebrity Jade Goody’s death of cervical cancer on Sunday, Mother’s Day in Britain, reminds us that yeah, cervical cancer can kill. If an HPV infection is NOT shrugged off, as most are, and you don’t get an annual Pap smear to find pre-cancerous lesions early, then it can eventually kill. And we should take it seriously.

Which is why researchers probably saw the Gardasil vaccine as the Grail—regardless of what Merck did with it afterwards, by fast-tracking it to approval and marketing it aggressively; whatever your feelings about Gardasil, we have to give researchers credit.

Jade Goody was a dental assistant when she soared to fame on the reality TV show Big Brother which endlessly films contestants corralled in a house for weeks at a time. Born to drug-addicted and impoverished parents she was brash, ignorant, and opinionated, soon becoming notorious for malapropisms such as "They were trying to use me as an escape goat."

But her survivor nature won her many fans, and perversely, she soon became a celebrity just for being a celebrity. There was one hell of a row when she put a racist slant on bullying during the filming of a follow-up Celebrity Big Brother, calling Bollywood actress Shilpa Shetty “Shilpa Poppadum” and snickering at her accent. Mixed race herself, though, she not unreasonably explained that “I treat everyone like that.” The two made it up, and in fact Goody learned about her cancer on camera during the filming of an Indian Big Brother.

Her disease progressed in the glare of camera flashes. She was criticized roundly for selling her life, including the rights to film her fantasy wedding to fiancé Jack Tweed while she was dying: she answered that she was storing up as much money as possible for her two young sons so that they would never live as she did as a child.

Goody did a great deal in Britain to highlight the need for regular exams. Although cervical cancer is not prevalent—in the US it ranks 14th on the list of cancers—and it rarely presents itself in young women, serious lesions resulting from persistent HPV infection do appear to be increasing. In Britain the highest grade of pre-cancerous change, CIN3, in 20-24 year-olds has risen from 15.8 percent of all cases in 1999 to 19.3 percent of all cases in 2004.

Gardasil has its issues, and I won’t be getting it for my daughters. But at least Merck’s scare tactics have raised awareness of HPV and the need for precautions, and I thank them for leading me to look at the alternatives (February 9, March 10).

Hopefully my girls will be sufficiently aware of HPV that they will never suffer as Jade Goody has. My thoughts and prayers go with her.

Tuesday, March 10, 2009

Will Carrageenan or GML Prove More Effective in Preventing HPV Than Gardasil?

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Could either (or both) of two commonly-used natural compounds—compounds that most people already consume frequently and safely—work better for preventing HPV infections than the Gardasil vaccination?

The short answer is that scientists don’t quite know yet, but things look extremely promising.

The Gardasil vaccine protects the body from the two strains of HPV (human papilloma virus) that currently cause approximately 70 percent of cervical cancer and the two that cause genital warts. That leaves more than 100 strains of HPV merrily making whoopee. Yikes!

And although many suspected side effects of the Gardasil vaccine, including autoimmune disorders, have been reported, one of the scariest things about it is the potential for replacement diseases. These can develop when unaffected strains of any pathogen rush to fill the void, and it’s exactly what happened with Prevnar. The pneumococcal vaccine had to be reformulated, and will doubtless have to be reformulated again and again as strains like drug-resistant 16A “unexpectedly” become even stronger.

In the case of Gardasil, because many people have lifelong exposure to HPV, multiple booster or reformulated shots seem likely—not such a good thing for the girls whose reaction to Gardasil increases with each of the three shots. Clearly anything that would reliably block ALL strains of HPV would be a vast improvement.

GML

Glycerol monolaurate (GML) recently made headlines when researchers at the University of Minnesota discovered that a vaginally-applied gel containing the naturally occurring compound protected monkeys from becoming infected with HIV.

GML is already widely used as an antimicrobial and anti-inflammatory agent in food and cosmetics, and it is extremely cheap. If the discovery pans out, cheers will be heard around the world. It would have the potential to save millions of lives.

And the compound would very likely protect against other sexually transmitted infections, too—including all strains of the dread HPV. It has already been shown, at least in vitro, to inhibit growth of nearly all sexually transmitted diseases as well as other causes of vaginal infections, yet it doesn’t affect normal bacteria. Because it is so cheap and could probably be sold over-the-counter, it could rapidly become very widely used.

Research is continuing.

Carrageenan

Scientists have been zeroing in on carageenan for a while. Although it’s derived from red seaweed, even the most anti-health food zealot has probably consumed it many times as a thickener in their ice cream, beer or toothpaste

Drs. Douglas Lowy and John Schiller, senior research scientists at NIH's National Cancer Institute, are currently not only working on an HPV shot to be used in developing countries (where the benefits almost certainly outweigh the risks) but also on formulating a preventative ointment, on the principle that since shots are expensive both to buy and to administer, they should look for a simpler approach.

In July 2007 the scientists reported that they had found that a lubricant containing carrageenan was able to very successfully block HPV infection in mice. They’re now organizing a clinical trial to find out whether it will work as effectively in humans.

Interestingly, their study also threw up the possibility that over-the-counter vaginal contraceptives containing the spermicide nonoxynol-9 (N-9) could actually substantially raise the risk for genital HPV infection in women.

A note of caution: As a food additive, carrageenan is suspected of playing a role in intestinal inflammation and possibly inflammatory bowel disease. Also, South African trials of Carraguard, a microbicide containing carrageenan, found it could be safely applied on a daily basis but was ineffective against HIV.

Bottom line: Some personal lubricants already contain carrageenan, so although it would be unwise to rely on them as an HPV preventative at this point, using one liberally (remembering that HPV is spread skin-to-skin) is probably not going to do you any harm and could well have a protective effect. Choose carefully to avoid potential clashes with spermicides etc.