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Would You Rather Die Thin or Live Fat?

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Eating Disorder thinking seems to be ignored by FDA advisors.  The newest advisory coming out of the FDA on Medscape News runs this headline over a thorough article by Michael O'Riordan: FDA Advisors Recommend Approval of Obesity Drug Qnexa.

Before you breathe a sigh of relief as your imagination gives you a slim body and permission to stop therapy, drop out of recovery programs, end your participation in support groups and pull out your credit card to buy high fashion tailored clothes, please do a Healing Your Hungry Heart pause exercise and read the fine print.

Specifically, the panel voted 20 to 2 in favor of approving Qnexa, stating that the risk/benefit ratio is appropriate in patients with a body-mass index (BMI) of >30 kg/m2 or >27 kg/m2 in patients with weight-related comorbidities. Despite some concerns over increases in heart rate, as well as concerns about potential birth defects in babies born to women taking the drug, particularly risks of cleft lip with or without palate, the panel felt the risks of untreated obesity outweighed these concerns.

Do people with eating disorders recognize risk/benefit ratios?  Do you? Did you before recovery or in early recovery?  Do you when you are in a triggering situation?

In my opinion, many of the physicians on the advisory panel do not understand or appreciate the workings of the mind of a person with an eating disorder.  "She died fat," is the ultimate defeat and, "At least she died thin," is the ultimate victory.

No realistic risk/benefit ratio awareness is in this kind of thinking.  If such an awareness existed and people could act on realistic risk/benefit information, we might not have eating disorders in the first place. Even at extremes, people know they are harming their bodies when they follow eating disorder demands.

Thinking behind the vote seems to be that better pharmacological solutions than what exist now are necessary because so many people are obese and because obesity has mortality consequences.

Dr. Elaine Morrato (University of Colorado, Aurora), who voted yes for the approval, said  ".. there are consequences to not treating obesity."

Okay, but does Qnexa treat obesity? This term does not make sense to me.  Treatment is for human beings.  Obesity is a consequence of factors, not an illness in itself. To me the questions are:

  1. Is Qnexa safe for human consumption in short and long term?
  2. Does it affect a human being's emotional demand to eat more than he or she needs to sustain health?
  3. Does it allow a human being to eat what is needed to sustain health?
  4. How can women be monitored to ensure that they are not nor will they become pregnant while taking Qnexa?
  5. Is there a screening for the presence of eating disorders?
  6. Is there psychological testing to ensure that people can make a realistic choice about risk/benefit ratio?
  7. In cases of weight loss is the weight loss maintained, or does the weight come back as it does in so many weight loss programs that show early weight loss that is considered success?

Risk/ration benefits come up in the panel's discussion more strongly when the panel agreed that a large outcome study is necessary to look at cardiovascular risks.  That makes abundant sense to me.  But, OMG, the panel also decided that a postapproval study would be sufficient.  Yikes.  That means people would take this drug with risks based on conjecture and minimal testing. They would not know what effects it could have on their lives. Would someone plagued with an eating disorder care? Would fantasy thinking, numbed awareness and the desire to be thin at all costs knock out any survival considerations?  Would he or she believe it's better to die thin than live fat?


Dr Sanjay Kaul (Cedars Sinai Medical Center, Los Angeles, CA), voted to approve the drug but urged the FDA to hold the sponsor's "feet to the fire" and get that outcome study done fast.

To my way of thinking, Dr Michael Lauer (National Heart, Lung, and Blood Institute, Bethesda, MD), is the real voice of reason and understanding.  He voted against approval. He said the surrogate outcomes are not substantial and that "approval would be a mistake based on hope and suppositions."

He said:

We've seen many cases in the history of medicine where we thought we understood the physiology or pathophysiology of disease and made policy decisions on the basis of that, and it turned out to be wrong once we actually looked, As a result, we caused an enormous amount of harm. In an epidemic as serious as obesity, we really need to do this right. We should have no trouble getting a trial put together and finding high-risk patients to answer this question [about cardiovascular risk].

Lauer added:

There is a real possibility that this agent, with the data we have available to us, may help people lose weight, may make the chemistry test look better, but it may end up causing heart attacks, stroke, or higher death rates. It would be a terrible, terrible shame if that were to happen and we didn't take the appropriate precautions.

Other panel members agreed.  Dr. Jenny Cragan (University of Pennsylvania School of Medicine, Philadelphia) wants data to fully assess the risks for birth defects.

The clinical trial the doctors want and may not get either as a condition for approval or after approval would include  11 000 patients at high risk for cardiovascular disease or patients with cardiovascular disease.  The study might also include patients with diabetes mellitus, hypertension, or dyslipidemia.

Of course, to my way of thinking, people at risk might not want to add more risk by being part of the study.  Or they might think the risk was worth it because the drug might improve their chances of living a quality life. I didn't see anything about testing possible study participants for eating disorders.

Would you join in an study where the outcome studies are based on a composite of death/MI/stroke? The reluctance to to a pre approval or even a post approval study may have something to do with delays in bringing the drug to market and therefore, delays in immense profits created by vast numbers of people rushing to find a pill they believe will make them thin at last.

As it stands now, this drug, which the panel says is the best so far in dealing with obesity, has been tested on surrogates.  Surrogates means substitutes. It's not clear to me from this statement who actually participated in the tests. The Vivus website mentions 2487 patients in the their 56 week test, but does not describe them. Who were they? Plus, in terms of side effects, the Vivus site does not mention birth defects.

I'm spelling out these thoughts with a link to the Medscape article because, in this competetive marketplace and rush to make it happen culture we live in, this weight reducing drug may be available before broad, deep and solid testing is done.  The drug probably will come out with a lovely name that inspires hope. The marketing will minimize the risk and maximize the wishful dreams of people struggling with weight in a thin worshiping culture.

People will take the drug, experience some benefits, contribute to the positive publicity and fan the flames of eagerness to participate and lose weight.  And then, the happy bubble may burst.  Unknown consequences, maybe dire, maybe heartbreaking, maybe lethal, show up. Nobody knows for sure.

The panel has no doubt that Qnexa is associated with weight loss in the first year of treatment. But there is an increase of weight in the second year.  That sounds like what happens after many diets too. Chronic dieting often results in weight loss followed by weight gain. That's a red flag for me and a major signal that a long term study is needed, one that moves beyond the 2 - 4 year weight cycling that occurs with many weight loss programs.

Also, Qnexa is related to increases in heart rate ( 1 to 2 beats per minute) and the increased risk of cleft lip with or without cleft palate (two - fivefold).

The outcome studies are vital because, as Morrato noted, tens of millions of patients might be treated with this drug. In such numbers, risk of known and unknown side effects can increase.

Where do you stand in terms of evaluating risk/benefit ratios in your life?
  • Does your eating disorder thinking play havoc with your judgement?
  • Are you clear in your judgement but can't act in your own best interest?
  • Have you had the experience of knowing an action or inaction wasn't good for you and went ahead anyway?
  • Would you rather die thin or live fat?
  • Are you willing to evaluate and say "No" or "Yes" to what is healthy and reasonable for your recovery and your life?

The issues raised by the FDA panel in looking for criteria to approve Qnexa can serve as a template for examining your own powers of discrimination, evaluation, self care and realistic understanding of your ability to appraise risk/benefit ratios in your life.  What do you think?

 

 

Comments  

PTC
0 # First of all, can they name the thing soPTC 2012-02-24 05:08
First of all, can they name the thing something that is pronouncable?? :-) Qnexa, what's up with the QN together?

My ED thinking definitely screws with my judgement. In my younger years, I did try diet pills, but I was always too scared to take more than one, so in that case I think I sort of used good judgement. Right now, however, my foot has been killing me and yet I'm still walking around everywhere and am about to hit the treadmill at the gym, although I don't know how long I'll be able to run before moving over to a different machine. My hip is also injured, but that is what it is, so it doesn't worry me anymore. I'll probably go get my foot checked out, although I think it's tendonitis and a "fallen arch." So, I am constantly doing actions that I know aren't good for me, but I do them anyway.

I would rather live healthy. I don't want to "live fat" because I don't think it's healthy, but I don't care if I die thin.

I feel like I am sort of evaluating things right now. I started with a new T yesterday, since mine is on maternity leave, and she has a little different approach. She's going to weigh me every week, which my other T was doing anyway, but this one hasn't said that I need to be a certain weight. My real T says I need to be a certain weight or she won't see me, so it's constant stress for me when I get weighed. When this one weighs me, I don't care if I weigh less than I should because I'm not going to get "fired." I'm trying to evaluate my life and decide if I'm happy staying here in my ED, or if I really want to get better. It's not easy.
mylifex2
0 # quick remark. Qnexa is a combination drmylifex2 2012-02-24 05:47
quick remark.
Qnexa is a combination drug of Topamax (anti-seizure drug/mood stabalizer) and Phentermine (half of the banned Phen-Phen drug from years ago).
I have taken Topamax and Phentermine separately. I can tell you that Topamax is dangerous in and of itself due to the dopey effect it has on its users. I would run red lights on Topamax. I couldn't focus or concentrate at work. I felt like my mind was going so slow. Phentermine is available over the counter now. I have abused this in the past...in fact, I think there is some in my purse now, although I haven't used it in weeks. It makes my heart beat so fast, makes me nauseated. Of course, I don't want to eat when I feel like that...but I really don't like feeling like that either.
So the thought of putting those two together makes my mind spin. I want to add more to the conversation, but just wanted to put this out there.
tracy
shh
0 # I have issues with obesity drugs...in fashh 2012-02-24 06:48
I have issues with obesity drugs...in fact I have issues with pharaceutical companies full stop, I feel it is a very exploitative industry, as material gain and profits will always come first above the welfare of those using the drugs. I'm not saying that pharmaceuticals are bad, but I think there are definitely ethical issues there.

I suppose ultimately people have a right to die however they wish to, but that choice needs to be an "informed choice" and people need accurate information to base their choices upon.

Ultimately, I figure I would like to die feeling like I have taken responsibility for myself...for me that is trying to reach a healthy weight and stay there without pharmacological interventions, in my opinion drugs can't "fix" this kind of problem, they may "help" for some people, but for many I think they just provide a sense of false hope, and allow people to continue to not take full responsibility for themselves
mylifex2
0 # the diet pill industry knows exactly whamylifex2 2012-02-24 18:35
the diet pill industry knows exactly what they are doing. They are targeting people who are desperate, and who will go to extreme and dangerous measures to reach their weight loss goal. I have never been prescribed diet pills, but I have taken my share of the ones sitting on the grocery shelves. I have taken more than the prescribed amount recommended because I thought "more is better. more is faster. more will ensure that I don't eat". I have had moments where I didn't care about potential side effects of these drugs. I have had moments where I would rather die thin than live fat. yes, I have done things to my body that are unhealthy...poured tons of laxatives into an already starved body, thrown up weight watcher meals because it was "too much", then excercised to make sure I got all the calories..I would say that lately, however, and lately meaning gradually over the past few months, I have used better judgement to guide my eating disorder habits. I don't always do the smart thing...but I think I am doing less dumb things...lol.
Joanna, I am trying to take your workout advice..I am taking a couple of days off every week, and I stick to a 45 minute workout. I get so tired anymore, part of which is my macrocytic anemia...my B12 deficiency caused by years of malnutrition...until recently, I would workout in pain because of shin splints or sore joints..I have decided I may not do the marathon...there will be more later.
Joanna, maybe you could use this type of topic as a magazine article discussion to raise awareness of the dangers of diet pills. I would be glad to share examples of how awful they made me feel, and how they don't work. It really does have to be a whole mindset change...pills just temporarily cover the issue, they don't fix the underlying problem that led to being overweight to begin with...now THAT would be a pill worth finding.
tracy
Laura R
0 # It is hard after growing up with a dietiLaura R 2012-02-25 21:31
It is hard after growing up with a dieting mom and being praised for all of my life for being thin and seeing so many media messages that reinforce thin as good to try to believe that at 50 being thin is not OK. I understand now that "too thin" is dangerous but I'm still fighting my strong belief that as long as I'm medically stable I don't need to gain more. I don't know what I weigh but this week I feel myself reacting to how my clothes feel and it scares me a little. I don't want to lose but I also don't want to gain :sad:
pinkjoanna
0 # Hi Laura, Thank you for this comment.pinkjoanna 2012-03-02 12:33
Hi Laura,

Thank you for this comment. You share this dilemma with many others who suffer from an eating disorder.

I'm beginning to write posts that include thought provoking and I hope, inspiring, words from notable women.

When you have an eating disorder your attention gets waylaid from expansive and deep perceptions that can enrich your life and the lives of those around you. Thinking gets focused, like a laser beam, on all things connected to food, eating, weight and appearance.

Relief never comes because whatever is accomplished in weight gain or loss can always change if you lose your intense focus on your fat/thin/scale mentality.

My hope is that these ideas from amazing women can interrupt the eating disorder mind freeze and open you and others to other things to think about. You might not feel frightened as your body moves toward health if you are focused on accomplishing something in life that is truly meaningful to you.

What do you think?
Robert Johnson
0 # Not to be too cynical, but it's hard notRobert Johnson 2012-04-02 19:12
Not to be too cynical, but it's hard not to notice the "exa" (as in anorexia) prominently featured in the name of this drug that people will seek out in the hope of becoming thin.

Just a coincidence I'm sure, but at the same time, I suspect there's a measure of thought put into these seemingly-meaningless names.
pinkjoanna
0 # Dear Robert, I feel confident that thpinkjoanna 2012-04-02 23:09
Dear Robert,

I feel confident that the "exa" is no coincidence. The association to anorexia is an association to being thin.

I've heard women say, "Oh, I wish I had a little anorexia" so I could keep my weight down.

Just this weekend I heard a nurse talking about working in wards of women with anorexia. She said she and other nurses felt angry and sad because they couldn't lose weight and it was so easy for the patients.

Good grief. I said that state of mine comes from ignorance of the illness. You wouldn't wish you had a little cancer because cancer patients become thin. That thinness is about wasting away. So is anorexia.

But the not so subtle "exa" in the name of this drug may well be there to capture the attention of women who think a little anorexia would be the answer to their dreams.

Thanks for posting, Robert.

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