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Conference rocks::weight_control

Title: Weight Loss and Maintenance
Notice:**PLEASE** enter notes in mixed case (CAPS ARE SHOUTING)!
Moderator:ASICS::LESLIE
Created:Mon Jul 09 1990
Last Modified:Tue Jun 03 1997
Last Successful Update:Fri Jun 06 1997
Number of topics:933
Total number of notes:9931

917.0. "FDA Approved Anti-Obesity Drug" by BIGQ::BERNIER () Tue Apr 30 1996 12:39


	From the Worcester Telegram & Gazette, Tuesday April 30th
	(Copied without permission)

	WASHINGTON - 	The Food and Drug Administration approved the first
	new anti-obesity drug in 22 years yesterday, a controversial medicine 
    	that essentially fools patients into feeling full so they lose 
	weight.

	Dexfenfluramine won FDA approval over the objection of consumer
	advocates and some doctors, who fear it could cause brain damage
	or a rare but dangerous lung disorder.

	But the FDA said brain damage so far has been found in only animals,
	and the lung ailment is rare.  Consequently, obese Americans can use 
	Dexfenfluramine longer than is allowed for any other appetite 
	suppressant, the agency ruled.

	Dexfenfluramine, created by Interneuron Pharmaceuticals, will be sold
	by Wyeth-Ayerst Labratories under the name Redux.  It will hit the
	pharmacy shelves this Summer and cost consumers approximately $2. per
	day the company said.
    
    
T.RTitleUserPersonal
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917.1CSC32::P_SOGet those shoes off your head!Wed May 01 1996 14:4421
    
    So, who'll be the first to try it.  Not me.  2$ a day for the rest
    of your life and possible brain and lung damage does not make this
    an attractive product to me.  
    
    The major problem I see with this product is that it targets the
    symptoms of obesity and not the cause, IMHO.  I am 50 pounds 
    overweight.  I did not gain any of that weight because I was
    hungry.  I eat for emotional reasons and I don't stop eating
    because I am full.  I stop because the food runs out, plain
    and simple.  Maybe others are not like me, in that case, go
    for it if you think it will work.  But, I am doing it the
    old fashioned way, slowly but surely.
    
    If anyone does try it, please let us know how you do.  I 
    am really interested in how successful this drug will be.
    
    This is all just my own opinion, I will be greaty pleased to
    find out I am wrong.
    
    
917.2Me first!BIGQ::BERNIERThu May 02 1996 12:1912
    
    I don't believe one will have to take is for the rest of their life, 
    just until their goal is reached.  With successful behavior modification 
    and proper vitamin intake while taking it I don't see why one can't be 
    successful. 
    
    I'll let you know how it works.
    
    (My brain is already damaged and the lung disorder is *rare*)
    
	
    
917.3I don't think so...SCAMP::PENNELLAThu May 02 1996 18:209
    I agree with .1   I myself will not be using this.  I am 100 lbs
    overweight and I also eat for emotional reasons, not because I'm
    hungry.  I think being motivated to eat healthier and excersise will be
    what helps me loose weight... and a good psychiatrist!!  I have trouble
    taking aspirin for a headache... no, thanks I'll pass on the new drug! 
    With my luck I'd be one of the "rare" ones who develop the lung
    trouble!!
    
    Terri
917.4Give Me the Pills!IMTDEV::KELLYFri May 03 1996 19:396
    I, on the other hand, would probably give it a try!  I absolutey
    HATE to be hungry when I want to control my weight and I have not
    been satisifed with the products on the market so far.  They either
    don't work or they give me the jitters.
    
    -Nancy
917.5here's an earlier article on Redux, prior to approvalTNPUBS::PAINTERPlanet CrayonMon Jun 03 1996 22:4683
    
    AP 29 Sep 95 0:30 EDT V0962
 
    Copyright 1995 The Associated Press. All rights reserved.
 
    FDA Rejects Obesity Drug Sale

    ROCKVILLE, Md. (AP) -- A new drug effectively fools obese patients into
    feeling full so that they will lose weight, scientists told the Food
    and Drug Administration. 

    But a bitterly divided FDA panel couldn't put aside worries about a
    theoretical risk that it could cause brain damage, so the government
    advisers voted 5-3 Thursday to reject the drug's sale in this country. 

    The issue remains open, however, after a panelist won a revote. 

    "I cannot live with my conscience tonight," proponent Dr. Nemat Borhani
    of the University of California, Davis, said after he was outvoted. 

    His impassioned plea for the first new obesity drug in 22 years
    prompted the panel to revote -- but after three opponents had gone
    home. The three supporters again voted yes, two opponents voted no, and
    the ballot remained open Friday for the three missing panelists to
    finally decide the issue. 

    Interneuron Pharmaceuticals Inc. said its dexfenfluramine helped 40
    percent of patients studied lose up to 10 percent of their body weight,
    twice that lost with diet alone. The majority lost 5 percent to 10
    percent. 

    But when dexfenfluramine is given in ultra-high doses to animals it can
    permanently alter their brain chemicals. There is no proof that this
    happens in people and dexfenfluramine would only be given to Americans
    in one-tenth of the dose found to be risky. Still, the finding worried
    the FDA panel. 

    Two doctors raised the fear that Redux -- the drug's brand name --
    could hurt patients. Redux given at high doses cripple animals' ability
    to produce serotonin naturally after the drug is stopped, studies show. 

    These drugs "should be used with the greatest caution if at all," said
    Lewis Seiden of the University of Chicago. 

    Some FDA panelists questioned whether Seiden's concern was relevant
    because the animals were given doses 20 to 30 times higher than any
    person would take. The company said it has seen no sign of brain damage
    in the 10 million people who have taken Redux in the 65 countries where
    it is sold. 

    The panel said Interneuron should answer the concerns with a
    well-designed two-year trial of Redux in Americans. 

    The panel also was more concerned with indications that Redux could
    cause a fatal lung disease in certain patients. This disease, primary
    pulmonary hypertension, affects one or two of every million people, but
    obliterates the lungs' ability to get oxygen to the heart. 

    But most of the panelists agreed that Redux's risk was very small --
    and acceptable -- for this disease. One study shows that at worst Redux
    could cause 10 deaths in five years from this disease, compared with
    the hundreds of obesity-related deaths the drug could prevent in the
    same time, said Gerald Faich of the University of Pennsylvania. 

    Not everyone responds to the pill, however, and the company suggested
    that doctors discontinue therapy for any patient who does not lose four
    pounds within the first month of taking Redux. 

    Obesity, defined as being more than 20 percent over ideal weight,
    causes 20 million new illnesses in the United States yearly and kills
    300,000. 

    Doctors typically urge patients to diet and exercise to drop the
    pounds, but almost all the few who succeed regain the weight within
    five years. The FDA has not approved any drug that can be used by these
    patients for more than several months because of concerns about risks.
    The majority of approved obesity drugs are amphetamines, which can be
    addictive. 

    The only nonamphetamine treatment is called fenfluramine, and
    Interneuron is seeking to sell a chemical relative of that drug for
    patients to use for years at a time. Dexfenfluramine is safer and
    possibly more effective than its older cousin, the company said. 
917.6This was forwarded to me, fyiTNPUBS::PAINTERPlanet CrayonTue Aug 06 1996 23:5886
From:   Worst Pills/Best Pills News, July 1996, p.1
        Public Citizen's Health Research Group
Editor: Dr. Sidney M. Wolfe

Dexfenfluramine (Redux): A Diet Drug Without Proven Value and Possible
Serious Adverse Effects

In a reckless and irresponsible move, the Food and Drug Administration 
(FDA) had disregarded the advice of neuroscientists (specialists in 
brain chemistry and physiology) and approved the diet drug 
dexfenfluramine (Redux) for long term use.  At issue is 
dexfenfluramine's potential to cause serious neurotoxicity (changes in 
structure and function of the brain.)

Public Citizen's Health Research Group wrote FDA Commissioner David 
Kessler on April 29, 1996 in support of the opinion of 22 
neuroscientists who asked that approval be deferred until the safety 
question could be answered.  The scientists were worried because 
neurotoxicity has consistently been found in a variety of laboratory 
animals given dexfenfluramine.  Some of the scientists contacted the FDA 
in 1993 and again in 1995 asking that the effects of dexfenfluramine on 
human brains be studied carefully before the drug was released for 
general public use.  The FDA did not take this advice and recently 
cleared dexfenfluramine for use for periods up to one year.

The proposed studies in humans would have been possible because 
dexfenfluramine is not a new drug.  Pondamin (fenfluramine), another 
diet drug, has been on the U.S. market for 20 years and is 50 percent 
dexfenfluramine.  Dexfenfluramine as a single drug has been available in 
Europe since the early 1990s.  Scientists have developed methods, using 
modern brain imaging devices, to test for possible neurotoxicity in 
people who have taken dexfenfluramine.

The request to delay dexfenfluramine is logical, sound, and in the best 
interest of public health.  If the answer to a potentially serious 
safety problem can be obtained before a drug is approved it is only 
sound public health policy to get it.  Waiting to look for neurotoxicity 
until after dexfenfluramine is released just makes guinea pigs of the 
American people in a very large experiment.  Wyeth-Ayerst, maker of 
dexfenfluramine, says it will do post-marketing surveillance to check 
for possible neurotoxicity.

Dexfenfluramine is not a "break-through drug" - one of those rare 
medications that offer a significant, proven benefit that other drugs 
lack.  The scientific evidence shows dexfenfluramine results in weight 
loss so meager that it is of unknown value in reducing the health risks 
of obesity.  Not only that, but the drug is associated with a rare but 
serious adverse reaction, primary pulmonary hypertension.

These are the facts about dexfenfluramine:

- On average, studies show that persons taking dexfenfluramine over a
  period of one year may lose up to 7.5 pounds more weight than others
  who take a dummy dose (placebo).

- Those who use dexfenfluramine for longer than three months are nine 
  times more likely to develop primary pulmonary hypertension than those
  who have never used the drug.  Primary pulmonary hypertension is not 
  a simple rise in blood pressure that can be treated with ordinary
  antihypertensives (drugs to lower blood pressure); rather, it is a
  potentially fatal adverse drug reaction.  Drugs used to lower blood
  pressure often do not work to treat primary pulmonary hypertension 
  and when they do not, in extreme cases the patient may require a 
  heart-lung transplant.

- Drug regulatory authorities in France and the United Kingdom have
  restricted the use of dexfenfluramine to three months because of its
  association with primary pulmonary hypertension.

- Neuroscientists are worried about dexfenfluramine's neurotoxic
  potential in humans.

There are no "magic bullets" for losing weight and keeping it off.  
Changing eating habits and exercise are the only known ways to reduce 
the long term health risks of obesity.

------------------------------------------------------------------------
The Health Research Group was co-founded in 1971 by Ralph Nadar and 
Sidney Wolfe in Washington, D.C., to fight for the public's health, and
to give consumers more control over decisions that affect their health.

To subscribe to this newsletter, the annual subscription price is $16.00
(12 issues).  Mail subscriptions to: Worst Pills Best Pills News,
Circulation Department, 1600 20th Street NW, Washington, DC 20009.

917.7Well, it's here....BIGQ::BERNIERTue Aug 27 1996 05:1223
    
    
    
    
    
    
    This is the first time I've seen an advertisement for this.  I've lost
    18 pounds in the last several months but am actually 20 from goal.
    
    This is tempting.......
    
    An Ad in "Worcester Magazine":
    
    WEIGHT LOSS PROGRAM * Doctors supervised weight loss management using
    		          fenfluramine and phentermine.
    
    			* Comprehensive program includes medication,
    			  Education and behavioral counseling.
    
    			  Vernon Medical Center (Worcester, Mass.)
    
    
                           
917.8Input from Am. College of Sports MedicineSMURF::BOLANDTue Aug 27 1996 15:3216
    I just finished a week long course with the American College of Sports
    Medicine. They discussed this program and told us it was only for
    people who were very over weight. The doctor who spoke said it should
    be used as part of a program that included learning about diet,
    exercise and therapy to deal with emotional issues around food. 
    
    He was very clear that this should only be done with a doctor and
    limited to people whose weight is having a serious impact on their
    health. 
    
    After this course I didn't have any day dreams about trying this. Of
    course as someone who has struggled for years, I wanted to think this
    would be magic. This course stressed exercise (cross train), learn how
    to eat and drink water. It was a big class and every person came in
    with a bottle of water. The presenter on water said "oh, I see I am
    preaching to the choir". 
917.9I'm going on this..ACISS2::SEIBERTRThu Aug 29 1996 16:0640
    Hi,
    
    I am going on this program soon.  I do have a lot of weight
    to lose...about 100lbs.  I am going through a doctor.  He did
    a nice presentation for his new patients on our first night
    in which he said basically what you guys have been talking about..
    that there can be side effects (the most common he has seen
    is diarrhea).  The side effects are almost polar opposites
    of each other depending on what drug you are most sensitive to-
    for example: sleeplessness and drowsiness.  There can be a very
    serious side effect of Pulmonary-something which impacts your
    heart and lungs and can be fatal.  This is extremely rare, but
    a hazard that people need to be aware of.
    
    On our first night, I was in a group presentation, and the
    second time in we did the labs.  He checkes everything out
    carefully from all the hormones, thyroid, cholesterol, lipids..
    etc.  We have to keep a diary of what we eat and we have to
    go in every week for a check up-every three months he will
    redo the blood.
    
    One other thing he keeps track of which rather impressed me was
    he does a pie chart of our muscle weight compared to our fat
    weight.  For example, people may be tempted to abuse the drugs
    by not eating correctly.  They will lose weight, however their
    percentage of body fat will actually increase because the body
    has burned muscle instead of fat.  He has a scale which you stand
    on barefoot that somehow gives him a reading of body fat.  If he
    thinks you are abusing the drugs he will take you off of them.
    He also said that this program is not for anyone "who wants
    to lose a couple pounds to get back into their Gloria Vanderbuilt
    jeans."
    
    Overall, I feel I am getting good care while on this program.  
    As soon as I get my prescription filled, I will enter a note.
    Hopefully, I will not be one of those that gets the lung disease..
    I am nervous about that.  I really feel I need the help of this
    program so here I go...jumping off another cliff.
    
    RS
917.10a little moreACISS2::SEIBERTRThu Aug 29 1996 16:1319
    After that long note, I forgot to mention in our weekly
    check ups we will be going over eating better and excercising.
    He wants to get me up to 5 days a week of walking.  Right now
    he said start doing something small, even a little 15 min walk
    around the block with my dog (who could use a little excercise too).
    He will be doing our blood pressure and listening to our hearts
    and getting feedback on any side effects too.
    
    He very strongly discouragad drinking alchohol and we practically
    had to sign a form saying we were not trying to get pregnant
    while taking the drugs.  If we want to go off the pills, he
    recommended slowly getting weaned off opposed to stoping cold
    turkey..however if we did get pregnant..then we are to stop
    taking them immediately.
    
    Well, I think I covered all the points so far....
    
    RS
    
917.11Me Too!STOWOA::FRANCOEURThu Aug 29 1996 16:1513
    RS, good luck.  Please let us know how your are doing.
    
    I have an appointment with my doctor on Sept 9th to discuss my going on
    weight loss program.  I have a little over 100 lbs to take off and I
    need help to do it.  I have tried everything, I think I have gaines and
    lost 1000 lbs in my lifetime.  Everytime I take it off it creeps back
    on and adds more.  With the help of this pill, according to the reports
    that I have read, I will be able to use it to maintain the weight lose.
    Hopefully the doctor will approve my trying it.
    
    Wish me luck.
    
    Pat
917.12good luck!!ACISS2::SEIBERTRThu Aug 29 1996 16:217
    Pat--good luck!!  Unfortunately (or fortunately!!) I got
    a new job at Comdisco and will be leaving Digital--Sept 6th
    is my last day.  I want to try to get at least one more
    note in here after I am taking the pills.
    
    Thanks,
    RS
917.13Redux - (Dexfenfluramine)BIGQ::BERNIERTue Sep 03 1996 02:266
917.13last noteACISS2::SEIBERTRThu Sep 05 1996 17:369
    Well, this will be my last note.  I started taking 
    the drugs yesterday.  I could definetly feel something yesterday.
    I felt kind of jumpy-exactly the same as when I took Dexatrim.
    I was not hungry at all, in fact it was hard to eat.  I was
    thristy.  Today, I'm not jumpy at all.  I feel pretty much
    the same as I usually would.  I am not hungry though and I am
    more thirsty than usual.  So far so good...
    
    Renee
917.14a little moreACISS2::SEIBERTRThu Sep 05 1996 21:0013
    Oh one other thing I noticed... it seems as though my
    taste buds are extremely sensitive.  I can ***really**
    taste food.  I had something that was greasy and normally
    that wouldn't bother me but it was almost too gross to eat
    this time around.  When I get hungry, even though I don't 
    "feel" hungry, I can tell that I am hungry because I get
    kind of spacey and more thirsty-as soon as I eat I am ok.
    
    I can see how someone could abuse these very easily....they
    are definetly more powerful that anything I have tried in the
    store (Dexatrim and so on).
    
    Renee
917.15Well, here goes....BIGQ::BERNIERMon Sep 09 1996 09:589
    
    
    Well, I started taking "Redux" recently.  (Dexfenfluramine HCI
    Capsules)  Like the couple previous notes mentioned I feel 'full'
    and some things seem to 'gross' to eat.  I also walk 4+ miles a day
    (which I have been doing right along.)  A friend of mine has been on
    the fenfluramine and phentermine combo and lost 20 pounds to date.
    (a little over a months time)
                              
917.16My Last ChanceSTOWOA::FRANCOEURMon Sep 09 1996 17:288
    Well, I had my appointment with my doctor this morning and he is
    putting me on the fenfluramine and phentermine combo.  He said that he
    hasn't prescribed "Redux" to anyone yet because he hasn't read enough
    about it and he wants to look into it further.
    
    I will keep updating on the progress.
    
    Pat
917.17ASDG::CALLMon Sep 09 1996 19:174
    There is an article on the redux pill in the readers digest this month.
    My Mother started on this pill...she is taking the Herbalife. She said
    her doctor told her it was ok to take both...The jury is still out on
    this one...
917.18UPDATE - 1 1/2 WEEKSSTOWOA::FRANCOEURTue Sep 24 1996 16:4413
917.19How do they do that?NPSS::HYLNDR::BADGERCan DO!Thu Sep 26 1996 14:235
917.20NONE OF THE HMO'S COVER THESE PRODUCTSSTOWOA::FRANCOEURThu Sep 26 1996 17:3421
917.21PROGRESS REPORTSTOWOA::FRANCOEURThu Oct 03 1996 15:3614
917.22ANOTHER UPDATESTOWOA::FRANCOEURMon Oct 28 1996 15:1711
917.23DSSDEV::PELLANDTue Nov 19 1996 21:1922
917.24Final UpdateSTOWOA::FRANCOEURWed Dec 11 1996 18:3115
917.25Update...BIGQ::BERNIERWed Mar 12 1997 07:509
    
    I started the Phen-fen this week.  I haven't had any noticable side
    effects as of yet except for the dry mouth.  I have had a tremendous
    loss of appetite.  I still get hungry but feel full quickly.  
    
    I did the Redux some time ago with limited success.  I lost 26 pounds
    but managed to gain 15 back while in Europe last month.
    
    
917.26list of drugs??ADISSW::HAECKMea culpa, mea culpa, mea maxima culpa!Wed Apr 23 1997 22:1411
    I am looking for a list of drugs used for appetite suppressants.  Once
    I have the names I can search the web for the other information I want. 
    But when I tried searching for the key-words that I could think of the
    pointers were just too many.  All of my attempts to narrow down using
    yet more key-words didn't help much.  
    
    So, does any one know of, or have, such a list? 
    
    I will be seeing my doctor early next month and he had mentioned he
    might prescribe one if I wasn't having any luck losing weight on my
    own.  Which I haven't :-(