July 2012 - Page 4

Answering Infertility with Genetic Modification: Evolution or Playing God?

3779 views

I am the middle of 5 children. We are all from the same parents who are still married. Since the time I was 5 years old, there has never been a time when there wasn’t a toddler in our house. I’m 30 years old now. I think I’m officially immune to baby fever. The gene to love shopping at malls and having babies somehow skipped me and I’m happy for that. However, the older I get I see it happen. First, one of my girlfriends gets infected and then, it quickly passes to each and every one. I don’t know if it’s through touch or some sort of mental telepathy, but it happens quick and there’s no stopping it. I call it the,  I want a baby and I want it now syndrome. The only known cure is reproduction.

More and more I watch couples around me struggle with infertility. I had one friend go to multiple fertility centers across the US trying to get pregnant with endometriosis. She was finally successful and jokes that her baby, “spent his inheritance getting here.” My sister, happy mother of 2, has had a horrible year with two miscarriages. After multiple tests, they discovered that she has a blood clotting disorder and hopefully she will be able to carry full term next time.
Keep Reading

Is Social Networking as Rewarding as Sex?

1667 views

You can learn a lot about someone based on their posts, tweets, updates and other social networking tools. There is the obsessive narrator, “OMG I just had a bagel and boysenberry cream cheese for breakfast,” “I’m in line at the grocery store and I have to pee soooo bad,” “Vacuuming!” Then there are the my-life-is-so-much-cooler-than-it-was-in-high-school-so-now-I-have-to-brag-and-make-it-sound-even-more-amazing-than-it-probably-really-is, “I just went skydiving and now I’m going to a [insert whoever is cool right now] concert!” or “I just met [insert random celebrity] at the airport, OMG!” There are the Debbie-downers, “Ugh, could god punish me any more than he is? I mean seriously, can anything possibly go worse because it’s clearly never going to get better at this point. FML” There are the I’m –so-witty-I’m-going-to-post-clever-comments-that-only-a-handful-of-people-as-clever-as-me-will-understand posters, “Purple penguins tap dance while earth worms snooze in the tantric tundra trampoline park.” And then there are the rest of us who probably do a mix of all of the above.

Why is it so appealing to post random facts or experiences to an online community of hundreds of people you may or may not know? According to a new study conducted by Harvard researchers Diana Tamir and Jason Mitchell, because it feels good.

Have we Forgotten the Tale of Narcissus?

Narcissus needs to make room in his river, because according to this study, “Humans devote 30–40% of speech output solely to informing others of their own subjective experiences” (I can think of a few dates that were overachievers in this department). When online, however, we blow poor Narcissus right back out of the river; research revealed that over 80% of social media posts are “announcements about one’s own immediate experiences.”

I have often commented to friends and family that it is a shame that we have these amazing tools at our fingertips to pass information, start grassroots campaigns, revolutions, truly change the world and while some people/organizations manage to do that, most talk about our favorite subject: ourselves. I have often wondered what the result of social media will be in younger generations who are posted online from the day they are born (be honest – how many of you have posted pictures of your newborns?). It has already drastically changed the world of recruiting and business networking, college and professional schools; can we even imagine what cyberspace will do to dating and marriage? Who knows maybe it will lower the level of divorce if we take a moment to read what our spouse/partner posts about him/herself?

The Same as Sex?!

Perhaps my cynicism of the growing online world is just the cantankerous Luddite in me. Then again, the study found that people would pass up monetary reward in order to talk about themselves (they obviously weren’t as broke as I was in college). It reveals (and headlines have gone wild with this one) “humans so willingly self-disclose because doing so represents an event with intrinsic value, in the same way as with primary rewards such as food and sex.” Furthermore, “Self-disclosure was strongly associated with increased activation in brain regions that form the mesolimbic dopamine system, including the nucleus accumbens and ventral tegmental area.”

Apparently the test subjects have not discovered OMing science behind orgasms.

And of course, all snarky comments aside, this study was important to understand the social behaviors and evolution of the society we live in. The researchers concluded:

In an ultimate sense, the tendency to broadcast one’s thoughts and beliefs may confer an adaptive advantage in individuals in a number of ways: by engendering social bonds and social alliances between people; by eliciting feedback from others to attain self- knowledge; by taking advantage of performance advantages that result from sharing one’s sensory experience; or by obviating the need to discover firsthand what others already know, thus expanding the amount of know-how any single person can acquire in a lifetime. As such, the proximate motivation to disclose our internal thoughts and knowledge to others around us may serve to sustain the behaviors that underlie the extreme sociality of our species.
 
For more information the published results of the study can be found here.

Thank You Lucine Supporters

1948 views

Last week Lucine entered a grant competition – Mission Small Business, that required us to collect 250 online votes for Lucine Biotechnology. After 2.5 days, we reached our goal and qualified for the next step – the review.

The Lucine Team would like to thank all of our supporters who took the time out their busy schedules to vote for us. We would especially like to thank those supporters who not only voted for us, but advocated for Lucine by posting our requests on the various social networks. We had support from England, Norway, Poland and across the US. In Southern Nevada #vegastech was instrumental in rallying the Twittersphere. Thank you Lucine Supporters.

The results of the Mission Small Business grant competition will be announced September 15. We’ll keep you posted.

 

Why Few Women Trust the FDA

4064 views

Critics of Lucine and our e-journal Hormones Matter often suggest that we are biased against the pharmaceutical and medical device industries and that, we should trust the FDA on all matters of women’s health. After all, we wouldn’t want to be considered one of those wacky conspiracy, alternative health blogs or a bunch of mommy bloggers (for reference, I rate moms as some of the best arbiters of BS when it comes to health). Admittedly however, much of the information on the blogosphere is horribly slanted or so devoid of actionable intelligence that it offers no more than pablum – even from the more reputable sources. But I digress.

With those criticisms come claims that begin with the ‘FDA approved…’ a particular treatment or device, or ‘after reviewing the data, the FDA found no merit to’ research suggesting that a certain drug or device was indeed dangerous. I have to admit that it often feels like I am biased. Perhaps I am little less apt to trust this industry or the regulatory oversight than others. I am certainly wary of the magic pills (oral contraceptives, HRT, anti-depressants) that are marketed as cures for all that ails the female population (without supporting data). But then, just when I think it is safe to trust again, reports like this come to light.

J&J Sold Vaginal Mesh Implant After Sales Halt Ordered

Bloomberg News reported last week that Johnson and Johnson (J&J) continued to sale Gynecare Prolift, a vaginal mesh implant, for a full nine months after FDA ordered it to halt sales. Prolift is a surgical mesh device used to treat pelvic organ prolapse, a common condition in women who have had children.

The basis of the complaint was the five-fold increase in death and serious injury associated with this product.

Bloomberg News reports:

J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said.

J&J determined the safety of this product on its own. Called ‘equivalence’ this is a common form of FDA approval requiring the applicant show merely that a device or test is ‘equivalent’ to some older, previously approved device or test. With low risk devices or tests this is a mostly reasonable way to garner approval. In higher risk devices, however, such as those that are surgically implanted, meeting equivalence is hardly sufficient for approval, especially if the older devices are themselves, dangerous or otherwise inadequate.

While the FDA ultimately “…disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter…” to halt sales, this was 2 years after J&J had already been selling the products to surgeons. By then hundreds of millions of dollars had been made and tens of thousands of mesh products had been implanted in women. J&J ignored the letter and continued to sell Prolift.

What’s worse than J&Js blatant disregard for the human safety is that the FDA ultimately caved and cleared the product in 2008, despite the fivefold increase in death and serious injury. Even a halted clinical trial failed to incite sufficient motivation to remove this product from the market. In 2009, the clinical trial designed to evaluate the safety of Prolift was halted when researchers found that >15% of women experienced erosion. Erosion of the mesh caused “pain, scarring, painful intercourse, bleeding scarring and closing of the vagina eroding into the bladder and bowel. Mesh erosion through the vagina is also called exposure, protrusion or extrusion. Many of these problems required additional medical or surgical treatments and further hospitalizations.” Despite the findings of the clinical trial, the products remained on the market.

As of 2010, J&J had reported sales of $295 million in the US alone. J&J did agree to re-label the device and in 2011 the FDA began considering re-classifying vaginal mesh products from a moderate risk product to a high risk product. I guess we should be grateful (insert snark). In the mean time, women continued to suffer and die. It is only recently, after hundreds of lawsuits, that J&J applied to recall Prolift and other vaginal mesh products. According to a J&J spokesperson:

“We came to this decision after carefully considering numerous factors” including “the commercial viability of these products in competitive and declining worldwide markets, the complexities of the regulatory environments in which we operate, and the availability of other treatment options for women,” 

Notice, that it was market factors, not product safety, behind the decision. The report goes on to say that products will be phased out on a region by region basis over the next year. I guess there is no rush to recall these products since J&J admits no health or safety concerns and the FDA approved the product. I sure would hate to be the last region in the recall.

So no, I do not trust the FDA to protect my health. I am afraid many other women, some of whom are mommy bloggers (yes, I am a mom and I blog), scientists and proponents of better health don’t either. Yet, we still must make decisions that affect our health and our family’s health. To all the women responsible for family health decision: verify, then trust.

Resource to Verify Medication Safety

AdverseEvents.com : this is a fantastic site run by a private company that allows individuals to list and view adverse events and side effects for every medication on the market. It is free to the user.  If you are an  Yaz, Yasmin or Ocella user, I encourage you to look up those medications and compare their side effect profiles to other drugs. This site does not list medical devices. If any of our readers know of a similar site for adverse events associated with devices, please share.