“Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials,” said NVIC president Barbara Loe Fisher. “Merck’s pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls.”

The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo. A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.

Animal and human studies have shown that aluminum adjuvants can cause brain cell death and that vaccine aluminum adjuvants can allow aluminum to enter the brain, as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue. Nearly 90 percent of all Gardasil recipients and 85 percent of aluminum placebo recipients reported one or more adverse events within 15 days of vaccination, particularly at the injection site. Pain and swelling at injection site and fever occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

Hmm. This certainly throws a new wrinkle in the story.

You can read the full article over at Red Orbit.

I was listening to a discussion on the radio this morning about Gardasil and the issues that surround its use, and opinions seem to be pretty reasonable on all sides of the debate. Conservative group are not opposing the vaccine itself, but are arguing against making it mandatory. From the NY Times article on the subject:

“Despite rumors to the contrary, our organization doesn’t oppose the vaccine and we have taken no position regarding mandatory laws,” said Wendy Wright, president of Concerned Women of America, a conservative group based in Washington.

Some groups support the vaccine but oppose mandatory vaccinations because cervical cancer is caused by a sexually transmitted virus.

“We can prevent it by the best public health method, and that’s not having sex before marriage,” said Linda Klepacki of Focus on the Family, a Christian advocacy organization based in Colorado Springs.

That’s a very good strategy, but what if the husband you’ve saved yourself for just so happens to have HPV? While not having sex is certainly a sure-fire way to avoid HPV and other sexually transmitted diseases, women can still get HPV on their wedding night from their very first sexual contact. A vaccine doesn’t promote promiscuity, but rather protects you from a very very very very very common STD that many people (men especially) do not even know they have.

Making this vaccine mandatory may help ensure that it’s covered by insurance companies and federal programs which might otherwise choose not to pay for such an expensive drug (a 3-part series over 6 months, costing $120 per shot, so $360 total). From the same Times article above:

A federal program is expected to provide the vaccine to 45 percent of the children in the United States for whom it is recommended. But state programs that cover other children are having trouble buying other expensive vaccines.

North Carolina, for instance, spends $11 million annually to provide every child with seven vaccines. Gardasil alone would probably cost at least another $10 million.

“Increasingly, states are asked to make a Sophie’s choice about which diseases they will allow children to be hospitalized or killed by,” said Dr. Paul Offit, director of infectious diseases at Children’s Hospital of Philadelphia.

It will be interesting to see how all of this unfolds, but for now, it’s enough just to know that this vaccine has finally been approved. As Dr. Sedlis (the guest professor who lectured us on the interpretation of pap smears) jokingly said, if this vaccine becomes widespread, gynecologists are going to be out of a job in 20 years, since pap smears and the mangement of abnormal paps is their bread and butter. This is a vaccine that could possibly someday eliminate the need for routine pap screening for all women, and make cervical cancer, which is already rare in this country, all but obsolete. That’s pretty powerful stuff!

Addendum:
Slate Article: very astute break down of many of the issues surrounding the vaccine, including the costs, benefits and risks and moral issues, well worth reading.
Moderately Insane: HPV Insanity: interesting break down the risks v. benefits of the HPV vaccine, in very plain English.
Women’s Health News post on HPV vaccine, full of amazing resources, per usual.

The word goes something like this: About five years ago, I was broke (notice how much has changed in the intervening five years!). I had recently befriended a woman who lived in my neighborhood, and one evening, while hanging out at her house, I noticed that she had a bunch of terry cloth pads laid out next to her sewing machine, made from a cut-up bath towel. When I asked her what they were for, she introduced me to the concept of alternative, reuseable menstrual gear. I was, to put it mildly, a bit flabbergasted. Keep in mind, I was a good girl from the midwest, who’d only been living in New York City for two years at that point, and still hadn’t fully lost my shy, midwestern ways. The message that our society sadly pounds into the skulls of young women (myself included) is that your period is dirty, something that needs to be kept secret and “sanitary”, and most definitely hidden from others. As girls, we’re taught that menstruation is an unfortunate part of growing up, a curse, or at the very least, a major, monthly pain in the ass—something that needs to be tolerated and dealt with, but rarely something that should be celebrated and enjoyed. As part of our induction into womanhood, we’re inundated with ads from the feminine “hygiene” industry, promoting the benefits of this product over that, and encouring the idea that the selection of a feminine hygiene brand is an important rite of passage. All of this just compounds the sense of shame and embarrassment that so many of us feel about our bodies—magazines are full of ways for us to “fix” our bodies, lose weight and attract the man of our dreams by wearing the right clothes and smelling the right way. Commercials for pads and tampons rave about how fresh, clean and discrete their products are. Douches urge us to “cleanse” our (naturally dirty?) vaginas so that they’re strawberry-scented or flower-fresh (and cause untold infections in the process through drastic vaginal flora disruption).

The feminine hygiene industry is a billion dollar industry that feeds off of women’s insecurities and doubts, and has us all suckered into the idea that spending $200 on menstrual products a year is just an unavoidable part of being a woman. Let me put it this way: do you think men would spend $200 a year on hygiene products if they too had an unavoidable monthly biological process that was part of their healthy life-cycle? I’m guessing not. If men had menstrual cycles, I bet health insurance companies would have started covering the expense of their supplies long ago, since, after all, these products would be essential to the health of the insured, same way insurance companies will pay for prenatal vitamins, or the needles and glucometers of diabetics. Why should women be expected to pay out-of-pocket for something that’s part of their yearly health and wellness? (This is somewhat similar to the “logic” used when health insurance companies will pay for viagra, but refuse to cover birth control…but that’s a rant I’ll save for another day). Women have been using cloth for centuries. It’s only very recently that we’ve been expected to pay every month for the pleasure of bleeding onto pearly white, cotton pads.

One woman, in her lifetime, will go through close to 11,000 pads or tampons. That’s a huge amount of uneeded waste going straight to the landfill. The women on this earth account for 51% of the population. If all of us use 11,000 pads in our lifetimes…that’s gotta be a landfill the size of Australia! It’s worth switching to re-useable products for that reason alone, but wait, there’s more: disposable pads suck! Not only do they take up way too much space, and get tossed out after only a few hours of use, but the packaging that comes with the products (the boxes and applicators) are also nothing but landfill fodder, and often end up washing up on beaches. While the FDA assures us that tampon companies no longer use chlorine-bleaching processes to get those pure, snow-white results they’re looking for, this was a practice that was used for decades before the FDA recently outlawed it, and untold amounts of toxic dioxins have been released into our environment because of it, disrupting ecosystems and bioaccumulating in lakes and rivers. (The FDA was also very quick to dismiss the idea that the dioxins in tampons can cause TSS or possibly cancer, but even without the dioxins, tampons are still perfectly capable of causing TSS on their own, just by being such a lovely, squidgy vector for bacteria and infetion). Sadly, dioxin is a very persistent chemical, and even though companies now use chlorine-free bleaching processes, the damage has already been done. Our children and grandchildren will be drinking and eating trace amounts of dioxin in their water and food for decades to come, thanks to the toxic feminine hygiene industry. And I ask you this: why is it necessary that the cotton and rayon of pads and tampons be bleached in the first place? They’re not sterile products that are used for surgery or wounds; they don’t have to be bleached.

Anyway, to make a long story short, my initial reaction to my friend’s cotton pads was “eeewwww!!”, however, it didn’t take long for her arguments to make sense to me: 1) I was broke, and the idea of saving $200 a year not spending that money on pads was very appealing, and 2) I have always been trying to find ways to make my environmental footprint on this earth a little bit lighter, and using cloth pads seemed like a really simple thing to change, which actually has a very large cumulative impact. So I purchased a starter kit of reuseable cloth pads to take care of all my monthly needs and voila!, I was hooked. I’ll let others extol the virtues of free-bleeding, but for my own part, there was something deliciously empowering about taking this aspect of my life out of commercial, profit-driven hands, and into my own capable, human hands. There was also something immensely satisfying about blowing raspberries at the TV screen whenever an ad for tampons came on, and feeling smug and pleased with the knowledge that while other women spent money on pads every month, I didn’t! Course, this method required a certain non-squeamishness when it came to blood, and a willingness to wear heavy cloth pads in my underwear once a month (which did, I must admit, feel like I had a phone book between my legs every now and then), and of course I had to soak them and launder them appropriately. For about two years, this routine suited me just fine (and cloth pads are great, and continue to work well for millions of women around the world)…but then…THEN…I discovered the joys of the Keeper.

Believe me, once I was finally sold on the beauty and sustainability of cloth pads, I was a true-blue, born-again convert, however, I have found that I prefer the Keeper to cloth pads, which means that in my book, it’s really very VERY good. This little cup is a latex product that fits inside of your vagina and functions a lot like an OB tampon, collecting your menstrual flow without drying out your vaginal walls. It requires insertion with your fingers, and periodic emptying (your collected flow can be conveniently emptied into the toilet, then the Keeper can be wiped off and reinserted); I must admit, it does take a little bit of effort to learn how to get it in and out, but once you master it, this is by far the easiest form of menstrual protection I have ever used, AND it’s ecologically friendly, sustainable, reuseable, and relatively cheap, given that you only have to buy one, and then you’re set for the next 10 years. Another beauty of using a menstrual cup is the fact that you don’t have to change your cup nearly as often as you have to change a tampon. On light days, towards the end of my bleeding cycle, I can happily put my Keeper in during my morning shower, and leave it in all day, and forget that it’s even there. And then, at the end of your cycle, all you have to do is wash it out with antibacterial soap, let it soak overnight in a bowl of water mixed with a tablespoon of hydrogen peroxide, white vinegar or tea tree oil, and that’s it. So, for those of you who like functionality of tampons (and the lack of phone-book-between-your-legs), but would also like to stop feeding the fat purse of the toxic feminine hygiene industry, and do our planet a major favor, a menstrual cup is definitely the way to go. The Mooncup and Divacup are also every bit as fantastic as the Keeper, they’re just made out of silicone instead of latex, so for those of you with latex allergies, rest assured, there are menstrual cups out there for you, too!

That’s pretty much the end of my schpiel. I know that what works for some women certainly won’t work for all women, but I urge you to think about your menstrual choices. Once you start using alternative methods, you begin to wonder why you ever needed a 7th-grade introduction to feminine hygiene products in the first place. I started using alternative methods about five years ago, and I haven’t once looked back.

For further reading:

The Wise Wound by Shuttle, Redgrove & Drabble.

The Woman in the Body by Emily Martin.

Looks pretty strange, doesn’t it? Has anyone ever used one of these things? Supposedly it works much better than a regular speculum because it doesn’t allow the vaginal walls to collapse inward and obstruct the view, it’s always warm, always sanitary, and a lot softer, more comfortable and less threatening-looking. It’s inserted like a tampon, and then inflated once it’s inside the vagina like a blood pressure cuff. Nifty, ultra-luxe, and definitely designed for private practices that can shell out for the more expensive, new product.

We all got samples, and I gave mine a whirl. My overall impression was that on your average nulliparous woman with an anteverted uterus, this probably works like a charm…but what about women with deeply posterior cervices and retroverted uteri? And the FemSpec is opaque, so how are you supposed to get a good look at the vaginal walls, while you’re in there? The sales rep insisted that “the doctor” will have no problem visualizing the vaginal walls during removal of the FemSpec, but I’m not quite convinced. She also assured us that the extra lever that comes with every FemSpec means that “the physician” will have no problem visualizing those posterior, hard-to-reach cervices. She kept using the pronoun “he” as well.

I’m sure on some level she must have realized that she was talking to a room full of midwives and future midwives, but maybe she was nervous, and unable to deviate from her script, and it just didn’t quite click in her brain. Maybe she had no idea that saying doctor all the time might not fly so well in a room full of midwives who do paps just as often as docs. Maybe she’s just a new, young saleswoman who hasn’t yet learned that you court whatever audience you’re giving your pitch to. In any case, it kind of rubbed me the wrong way.

I’m still hardly competant at using the conventional speculum, let alone the new one. It will be really interesting to see if these actually start to infiltrate the market, and which clinics (if any) will begin to use them. As for me, I’m reserving judgement until I have an opportunity to actually use one in a clinical setting, but a note to FemSpec: teach your sales reps that midwives and physician assistants and nurse-practitioners and sometimes even nurses ALL use speculums, not just doctors. A more all-inclusive sales pitch might actually improve your sales.