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:
- Is Qnexa safe for human consumption in short and long term?
- Does it affect a human being's emotional demand to eat more than he or she needs to sustain health?
- Does it allow a human being to eat what is needed to sustain health?
- How can women be monitored to ensure that they are not nor will they become pregnant while taking Qnexa?
- Is there a screening for the presence of eating disorders?
- Is there psychological testing to ensure that people can make a realistic choice about risk/benefit ratio?
- 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."
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].
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?