Sibutramine - FDA hearing results

[jikeda at garnet.berkeley.edu]

LYNN McAFEE'S CONFLICT OF INTEREST STATEMENT:

>	As to any conflict of interest with the diet and pharmaceutical 

>industries - I've given them plenty of money and they've never given me 

>anything.

>-----------------------------------------------------------------------------

>

>	I am Lynn McAfee from the Council On Size & Weight Discrimination and I 

>would like to take this opportunity to address a number of issues regarding 

>anti-obesity drugs.    

>

>	First, I would like to suggest that a way be found to include the 

>drop-out rate in the effectiveness number.  I find it very strange that a 

>drop-out rate for a supposedly successful drug is 50%, while placebo is

40%, as 

>was the case with Redux.  If the drug works so well, shouldnt it have a lower 

>drop out rate than placebo, even taking into account side effects.   It just 

>seems so unlikely to me that people who were desperate enough about their

weight 

>to take an experimental drug, and were successfully losing weight, would

wake up 

>one morning and say Never mind.  Ive decided Id rather be fat.  Thanks 

>anyway.  Something else is happening here.  

>

>	I also would like to see the drugs studied in varied populations.  Past 

>experience with other drugs, such as anti-hypertensives, have shown us that  a 

>more representative distribution of  ethnic groups and gender is important.  

>Groups affected with co-morbid conditions shouldd be studied and analyzed

as to 

>effectiveness as well as  improvement in co-morbid condition.   I would also 

>like to see what happens to people with co-morbid conditions as they gain back 

>weight.  Its possible that they would be left worse off than if they had not 

>taken the medication and lost the weight.    

>

>	My last point with regard to effectiveness is my concern with the 

>necessity of people sticking to a low-calorie diet for a lifetime.  This

has not 

>proven possible until now, and I wonder if , even with medication, it is truly 

>realistic for people to keep up that level of dieting intensity indefinitely.  

>The people in the Weintraub study pretty much dedicated their lives to

dieting, 

>and yet even they had trouble maintaining weight loss by the end of the

study.  

> The pharmaceutical companies are saying that if we dont live the life of a 

>Weight Watchers Counsellor WE will have failed the drug.  And while Weight 

>Watchers has taken a lot of money from us over the years, I dont think even 

>they can afford to hire all thirty-four million of us.  It seems to me the

point 

>of using medication is to make weight maintenance achievable.  If people

cannot 

>stay on this very restricted diet, then the medication has failed, not fat 

>people.  This is an important point.  Perhaps a group should be given

medication 

>and asked to eat more normally so we can see if the medication has an

effect on 

>their caloric intake and weight over time.  This might be a truer test of what 

>will happen in the real world.  

>	Id also like to make a few comments about some of the morbidity, 

>mortality and economic impact figures that are often used by obesity 

>researchers.  

>

>	 For example, Shape Up America literature says ...medical 

>researchers... have calculated the cost to society for obesity-related

diseases 

>at more than $100 billion annually.    But reading on, you see that $33

billion 

>of that money is for weight reduction products and services.  This number

even 

>includes diet soda!  This is a classic case of misdirection.  In fact, since 

>Shape Up America is sponsored largely by various weight reduction products

and 

>services their goal is to increase this number, not decrease it!     

>

>	Likewise, the highly touted Nurses Study takes what is a very small 

>number of deaths and creates some rather sensational relationships that really 

>need to be looked at with care.    This study has been presented without 

>criticism, as obesity research gospel, but there are criticism of this work

that 

>should be heard.   I am not saying that the mortality figure for fat people is 

>the same as it is for thin people.  I am saying that while these sensational 

>numbers may help get much needed funding for obesity research,  we should be 

>certain that these are the right numbers to use when calculating the risks and 

>benefits of these drugs.  

>

>	Finally, I want to share with you some of my thoughts about sibutramine. 

> I have had 3 conferences with the Knoll people since January, and have been 

>very pleased with their openness in showing me their data on effectiveness and 

>safety and answering my many questions. 

>

>	The best thing to be said about this drug is that its not Redux.  Its 

>not a serotonin-releasing drug, so Ive been told it wont have the problems 

>with neurotoxicity and PPH that Redux has.  The main problems are

hypertension 

>and pulse rate.  While these are worrisome problems, they can at least be 

>monitored.  

>

>	The concern I have is regarding effectiveness.  As a consumer advocate, 

>this is  very important to me.    For many decades, we have been paying

billions 

>of dollars a year for weight loss technology that just plain doesnt work.

But 

>because of the safety concerns I have about Redux I would have gladly accepted 

>sibutramine as long as the effective rate was roughly equivalent. 

>

>	However, two days ago I learned about a 2-1/2 year effectiveness study 

>that concerns me greatly.  The sponsor will undoubtedly be presenting it to

you 

>shortly, but based on the abstract  published in Obesity Research last

week,  

>it appears that sibutramines weight maintenance ability is not satisfactory.  

>There was a mean weight loss of 6 kg at 40 weeks, but by 60 weeks there was a 

>steady weight regain and by 96 weeks the weight loss maintained was only 2.6 

>kg.  Of equal concern is the drop-out rate:  only 15% of the subjects

completed 

>the ninety-six week study.   This is quite serious.  Are these people going to 

>experience a worsening of their co-morbid conditions when they regain weight?

>

>	In the same journal, a paper based on information from the Swedish 

>Obesity Study states  All risk factors are improved by weight reduction but 

>when measured after one year of weight stability, 5-10 kg weight reduction is 

>required to detect the changes.  The value of small weight reductions is thus 

>questioned.  If this study is correct, the weight loss maintained will be

well 

>under  5 -10 kg and so improvement in co-morbidity factors is questionable.

>

>

>

>	I was frankly devastated by this information.  On a personal level, I 

>wanted and needed this drug to work.  But its not fair, its not right, to

put 

>us through yet another ineffective and expensive weight reduction plan.  We

pay 

>not just  for drugs and doctor visits and new clothes, we have to go

through yet 

>another cycle of feeling successful when we lose weight and feeling like 

>personal failures when we gain it back.  I dont know how many of you have had 

>the experience of losing a large amount of weight and gaining it back, but

it is 

>emotionally devastating.  We cannot be subjected to this again.  We can no 

>longer accept less than what we deserve:  safety and effectiveness.

>	    

>

>	

>	

>

>

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>

>

>

Joanne P. Ikeda,MA,RD
Cooperative Extension Nutrition Education Specialist
Department of Nutritional Sciences
University of California, Berkeley
CA 94720-3104

Phone (510)642-2790
FAX (510)642-0535
E-Mail: jikeda at garnet.berkeley.edu