Cattle Call —

I knew it was only a matter of time, but a major opportunity has arisen and I’m probably going to have to resign as Editor-in-Chief of Fierce, Freethinking Fatties.

As some of you know, I’m an amateur molecular biologist and inventor, and the FDA has recently approved a product I’ve created for use in adults. It’s an adjustable laparoscopic hepatic band called The Inhibitor™ and it uses an inflatable silicone ring to prevent excessive alcohol consumption.

As we all know, alcoholism is a major problem in the United States and over 85,000 people die each year due to alcohol-related health problems, which is 3.5% of total deaths, making it a close second to obesity-related deaths, which compose 112,000, or 4.6%, of preventable deaths. Of those 85,000 alcohol-related deaths, nearly 12,000 were caused by drunk driving accidents.

Some people have a difficult time controlling their alcohol intake, so I created The Inhibitor™ to aid them in responsible alcohol consumption.

The Inhibitor™ has gone through the clinical trials and been remarkably successful. The only minor problem found in long-term studies was that after seven years 40% of patients report vomiting once a week, but compared to the devastation caused by unhealthy drinking, we think it’s worth it.

Recently, the FDA approved The Inhibitor™ for moderate drinkers. As we all know, it’s a slippery slope from moderate, social drinking to full blown alcoholism. So, we welcome this news, not because it increases our client pool, but because we care. We really do.

And it’s because we care so much that there’s another segment of the population that desperately needs The Inhibitor™: teenagers.

There is currently an epidemic of teenage alcoholism and binge drinking. Over 5,000 teens die each year due to alcohol-related incidents, and the underage drinking rate is astounding, according to this study:

According to data from the 2005 Monitoring the Future (MTF) study, an annual survey of U.S. youth, three-fourths of 12th graders, more than two-thirds of 10th graders, and about two in every five 8th graders have consumed alcohol. And when youth drink they tend to drink intensively, often consuming four to five drinks at one time. MTF data show that 11 percent of 8th graders, 22 percent of 10th graders, and 29 percent of 12th graders had engaged in heavy episodic (or “binge1”) drinking within the past two weeks (6) (see figure).

And that’s not even taking into consideration the loss of life that teenagers who drink can expect. Conservative estimates suggest that drinking can shave 10-12 years off your life. I, for one, am willing to stop at nothing to prevent another wasted life

Fortunately, we’ve already been testing The Inhibitor™ on teenagers aged 14-18 since 2001, so we have ample evidence that The Inhibitor™ is the modern solution to teenage alcoholism. Granted, The Inhibitor™ has a failure rate of 40%, a complication rate of between 29% and 52%, almost 9% will drink even more than they did before the surgery, and 10% of those who have The Inhibitor™ will lose some of their hair, but considering the alternative, do we really have a choice?

And before the Alcohol Acceptance kooks start complaining, I’ll address some of their concerns as well.

While it’s true that teenage boys are slightly more underage drinking boys than girls, there’s a completely valid reason why 75% of those who signed up for our initial human trials were teenage girls. There’s also a completely valid explanation for why even though alcohol-related deaths are much higher in low income, minority neighborhoods, the majority of our trial participants are wealthy and white.

And as soon as our PR department gives me the positive spin, I’ll be happy to share it with you.

Suffice it to say there are unique dangers to being a teenage female alcoholic and the disparity certainly has nothing to do with our corporate imposition of traditional gender roles whatsoever. We just want our girls to be healthy for future reproductive servies.

Likewise, the fact that a girl on The Inhibitor™ is twice as likely to get pregnant does not imply that The Inhibitor™ has risky social consequences. After all, just think of how terrible life would be without The Inhibitor™. Just imagine what the scourge of alcoholism would be like without The Inhibitor™. Besides, babies give women a sense of prurpose and fulfillment, right? Oh, and we’ll counsel all girls on The Inhibitor™ about not fucking so many people.

But the biggest concern Iv’e heard is that the majority of our human trials have been for one year or less, and therefore we couldn’t possibly have a solid grasp on all of the long-term complications. To that I say, Poppycock!

Our teenagers are at risk NOW and we must do something NOW to save them from themselves. Granted, The Inhibitor™ only works  as a permanent medical device, but it is reversible, so anyone who isn’t pleased with the results they can simply have it removed.

And there’s absolutely no reason to suspect that having a foreign device clamped to a major organ for one or two or three years will have any lasting negative effects on a developing teenager’s body. I mean, come on, it’s reversible!

I hate that people look at me like I’m the bad guy for trying to single-handedly stop this rampant epidemic from claiming any more lives with The Inhibitor™. Rather than complain about the specious claims we make about our device, why don’t you do something productive, like join one of our test trials?

BOOM!

I gotcha again!

I’m not really a molecular biologist or an inventor. And I completely made up The Inhibitor™. HAHA! You’re so gullible.

I mean, really, what kind of person would think that, even if such a device existed, that the Food and Drug Administration would be so foolish as to approve this product for anyone, let alone teenagers.

Oh wait.

I recently mentioned on our Blogiversary that fighting Allergan’s attempt to reduce the minimum BMI from 40 to 35 (and 30 with comorbidities) would be my top priority this year.

Sadly, we were too late. The approval passed and now women (because three-quarters of lap band users are women) who have finally accepted that dieting won’t get them into a Size 2 will be able to rely on cosmetic lap bands to appease the socially-imposed obsession with weight. Weight loss surgery is supposed to be a last resort, not an elective enhancement.

While preparing for this fight with Allergan, I contacted two people who I had actively opposed this decision during the FDA’s hearing: Diana Zuckerman of the National Research Center for Women & Familes and Amy Alina of the National Women’s Health Network. The next day, Katie Ryan of NWHN informed me of the decision. But she then told me that they were preparing for yet another fight, this time to prevent the FDA from reducing the minimum age for the lap band from 18 to 14.

This is huge. This is astonishing. This is disgusting.

And this is the reason for the analogy above. The statistics I cited for alcoholism and teenagers was all true. Almost 29% of seniors in high school have engaged in binge drinking within two weeks of the study. Binge drinking can lead to immediate death (as opposed to the oft-cited 8 years of life expectancy lost due to adolescent obesity), yet where is the national outcry? Where are the “SAVE THE CHILDREN” martyrs like MeMe Roth?

Meanwhile, the statistics I gave regarding the “success” of The Inhibitor™ are taken directly from studies on adolescent lap band trials. I searched Google Scholar for and found quite a few trials, but the majority are for a year or less. I will be posting a more in-depth analysis of the data (for our science nerds) in the near future, but here are a few key highlights:

• Hair loss: “Other complications included mild hair loss in 5 patients” [out of 53 patients]
• Hair loss: “Nutritional complications included … mild subjective hair loss in 14 patients.” [out of 73 patients]
• Complication rate: “The overall complication rate was 29%, with a 25% incidence of pouch enlargement in adolescents”
• Complication rate: “Of our patients, 52% had complications requiring reoperation”
• Failure rate: “According to Bariatric Analysis and Reporting Outcome System, the long-term outcome was regarded as a failure in 40%, fair in 4%, good in 28%, very good in 20%, and excellent in 8% of patients.”
• Weight gain: “Post-LAGB weight gain was observed in 15 of 88 adolescents at 6 m post-LAGB and in 4 of 45 adolescents at 12 m post-LAGB.”
• Race and gender: “In California, Girls represented only 43% of the overweight adolescents. In contrast, they accounted for 78% of the adolescent patients who underwent surgery … We also observed that whites and females disproportionally underwent bariatric procedures more often despite lower rates of being overweight when compared with nonwhites and males.”
• Pregnancy (PDF): “However, T.H. Inge (unpublished data) reported a twofold increase in teen pregnancy in his female LRYGB patients.”

As a side note, I extracted the available gender information from all the studies I read (including the meta-analysis) and found that in all the clinical trials I read about, 1,367 of the guinea pigs were girls, while 459 were boys. That means that 74.8% of experimental adolescent lap band subjects were females. This corresponds with the statistics on bariatric surgery in general:

A total of 136 fully extracted studies, which included 91 overlapping patient populations (kin studies), were included for a total of 22,094 patients. Nineteen percent of the patients were men and 72.6% were women, with a mean age of 39 years (range, 16-64 years).

Finally, I want to point out some passages on adolescent bariatric surgery from this book I found on Google books. The book is all about pediatric obesity and it had some interesting comments on WLS and childhood obesity that caught my eye. For example:

The re-operative rate for AGB, however, is not insignificant (8-10%)… A major theoretical advantage of AGB for adolescents is its reversibility. Moreover, surgical complications and vitamin deficiencies are less frequent and less severe than those observed after RYGB. Nevertheless, more long-term investigations are needed to fully assess the role of AGB in children.

Emphasis mine. The author calls for more long-term investigations. So far, there have not been many long-term (over five years) studies on adolescent lap band surgery.

Now, the most complicated part of offering this surgery to adolescents is that compliance is mandatory for even a remote chance at success. Compliance is dependent upon the maturity of the person receiving the surgery. The author of this book urges extreme caution when screening candidates for pediatric lap bands.

Verbalization of understanding the consequences of non-compliance should generally not reassure the multidisciplinary bariatric care team that an individual will comply with recommendations. Emotional maturity should be assessed by confronting adolescent patients when they deviate from expected behavrios. Oppositional defiance when confronted with irresponsible behavior is a particularly worrisome response from an adolescent candidate for bariatric surgery and should raise significant concerns about the individual’s maturity.

Now, in theory, this is great. They’re trying to provide guidance for how to screen mature vs. immature candidates. But those who are pushing the surgery will emphasize theory over practice. There is a controversy in California over a series of billboards that offers weight loss surgery at 1-800-GET-THIN. The CEO of Allergan criticized the billboards, but guess what: this is the result of making a medical device legally available to every quack doctor with a scalpel and a fucking billboard.

Do you really think 1-800-GET-THIN gives a fuck whether your fat teen is emotionally mature? Do you really think they’re seriously vetting potential clients out of concern for their health and safety? Maybe the CEO detests misleading or flippant advertising of lap bands, but he doesn’t control what happens after the device is approved. Making the lap band more widely available simply broadens the pool of prospective customers, and THAT is what Allergan cares about, not health, not welfare.

Finally, the author makes a compelling argument against lap band as preventative medicine:

Proponents of surgical intervention in obese adolescents often argue that obesity co-morbidities such as type 2 diabetes may become irreversible if we do not intervene aggressively at an early age. This may be true, but it is difficult to reconcile that hypothesis with the surgical data that shows apparent reversal of longstanding type 2 diabetes in young and middle-aged adults.

In short, approving the lap band for kids, especially at this stage before long-term trials have thoroughly proven its safety and efficacy, is not just irresponsible, it’s malfeasance in the first degree. If the FDA approves the lap band for teenagers, they will have proven, yet again, that the Hippocratic Oath means nothing compared to the American Golden Rule: he who has the gold makes the rules.

When it comes up for a hearing in the FDA, we will be ready this time. We will not sit idly by and allow corporate interests to mutilate our girls in the name of “health.” We need every single body on this fight and we need your voices sending a unified message to the FDA: not now, not ever.

I’ve created a Facebook group to inform people once the approval process gets rolling. At that point, we will begin an aggressive campaign to oppose this decision from beginning to end. Please join us and help stop Allergan before it’s too late.