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TwinkelToes:
USA TODAY
 
 
   FDA OKs first non-prescription diet pill
Updated 2/11/2007 9:58 AM ET  
 
The U.S. government has approved the first non-prescription diet pill to help fight the country's obesity epidemic as an advocacy group warned that the drug increases the risk of cancer.
 
 By Randolph E. Schmid, AP Science Writer
WASHINGTON — The nation's ongoing battle against obesity has a new weapon — the first government-approved diet pill that can be bought without a prescription.
Intended only for people 18 and older, the drug, called alli, is a reduced-strength version of the prescription diet drug Xenical.

The Food and Drug Administration on Wednesday announced its approval of sales of the lower-dose drug without a prescription, with officials stressing that it needs to be used in combination with a diet and exercise program.

"Using this drug alone is unlikely to be beneficial," said Charles Ganley, FDA's director of non-prescription products.

The new drug will be sold by GlaxoSmithKline PLC and the company said it is expected to be in stores by summer. While the final price has not been determined, it is expected to be about $1- to $2-a-day. Xenical is made by Roche Holding AG.

While some dietary supplements make weight loss claims, Ganley said this is the first non-prescription drug approved by the agency for that purpose.

Ganley said in trials, for every 5 pounds people lost through diet and exercise, those using alli lost an added 2 to 3 pounds.

When taken with meals the drug — known generically as orlistat — blocks the absorption of about one-quarter of any fat consumed. That fat — about 150 to 200 calories worth — is passed out of the body in stools, which can be loose as a result. About half of patients in trials experienced gastrointestinal side effects.

The new drug would contain half the dose of Xenical prescription capsules.

Also, FDA said people who have had organ transplants should not take over-the-counter orlistat because of possible drug interactions. In addition, anyone taking blood thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat, the agency said.

GSK Consumer health care, which will market the pill, said it chose the name alli — pronounced AL-eye — to indicate a partnership with consumers in their weight-loss efforts.

"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes," said Douglas Throckmorton, deputy director for the FDA's Center for Drug Evaluation and Research.

"OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health," he said.

But Sidney M. Wolfe, director of Public Citizen's Health Research Group called the approval "the height of recklessness."

Wolfe said studies have associated the prescription version of the drug with precancerous lesions of the colon.

Wolfe had opposed the switch to over-the counter sale, calling the plan a "dangerous mistake in light of its marginal benefits, frequent coexistence of other diseases, common, bothersome adverse reactions, significant inhibition of absorption of fat soluble vitamins."
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the release of this pill this is just another example of the gullibility of the American public and the grotesque cynicism of the FDA.  It will probably become the best-selling "patent medicine" of all time. I can just imagine the medically unsophisticated and desperate to  lose weight gobbling  these things  (and learning the hard way NOT to) in hopes that A PiLL will solve their weight problems.  But it will be great for the bottom line at GSK ! :x  and I guess that is all that matters to those in charge of the vast Medical Industrial Complex  running things now.  I simply cannot imagine that this stuff will be a wise thing for anyone to ingest in the long run.

JUst gimme my VCO and ELOO and leave  me alone in my happy little corner of the world.

"
 

andrea84:
I saw them talking about this on The View on friday, and Joy said that that's not good that it blocks 25% of fat.  She's Italian and has EVOO in lots of meals (and not foods fried in it), and she said that Italians know what they're talking about, that we need healthy fats b/c it keeps "your body lubricated."

More people making comments like this will help SLD be more accepted mainstream, no?

mpq:
"the release of this pill this is just another example of the gullibility of the American public and the grotesque cynicism of the FDA.  It will probably become the best-selling "patent medicine" of all time. I can just imagine the medically unsophisticated and desperate to  lose weight gobbling  these things  (and learning the hard way NOT to) in hopes that A PiLL will solve their weight problems.  But it will be great for the bottom line at GSK !   and I guess that is all that matters to those in charge of the vast Medical Industrial Complex  running things now.  I simply cannot imagine that this stuff will be a wise thing for anyone to ingest in the long run.

JUst gimme my VCO and ELOO and leave  me alone in my happy little corner of the world."

I was prescribed this medicine while I was doing Atkins and prescription medicine was putting on the pounds. The reason I do not take it now is because I do not eat enough fat to make the expense worth while. I do not consider myself "desperate" "gullible" 
or "medically unsophisticated. No pill solves all your weight problems, as SLD does not cure all, they are tools to aid.  I'm very happy that SLD is working so well for you. I've been on SLD since Nov and have lost 2 pounds, and I'm trying very hard to hang in there. Not all tools work for all people.
 

TwinkelToes:

--- Quote from: mpq on February 12, 2007, 09:10:22 am ---"the release of this pill this is just another example of the gullibility of the American public and the grotesque cynicism of the FDA.  It will probably become the best-selling "patent medicine" of all time. I can just imagine the medically unsophisticated and desperate to  lose weight gobbling  these things  (and learning the hard way NOT to) in hopes that A PiLL will solve their weight problems.  But it will be great for the bottom line at GSK !   and I guess that is all that matters to those in charge of the vast Medical Industrial Complex  running things now.  I simply cannot imagine that this stuff will be a wise thing for anyone to ingest in the long run.

JUst gimme my VCO and ELOO and leave  me alone in my happy little corner of the world."

I was prescribed this medicine while I was doing Atkins and prescription medicine was putting on the pounds. The reason I do not take it now is because I do not eat enough fat to make the expense worth while. I do not consider myself "desperate" "gullible" 
or "medically unsophisticated. No pill solves all your weight problems, as SLD does not cure all, they are tools to aid.  I'm very happy that SLD is working so well for you. I've been on SLD since Nov and have lost 2 pounds, and I'm trying very hard to hang in there. Not all tools work for all people.
 


--- End quote ---

mpq--I am so sorry you felt  I sounded like I was condemning EVERYONE (as  "gullible" and "desperate" ) who uses some kind of "pharmaceutical aid" to help with weightloss or other health problems. My concerns are for those who are unwary or too-trusting and medically unsophisticated  who will  see the headlines and think they have found the Holy Grail of easy weightloss,  and damage their health with unsafe use of this product  (also see Sidney Wolfe's remarks)  I recall statements in magazines, including Womens' World where they glibly claim " eat all you want and lose weight" ( just do this  or that easy thing and you will have quick and easy weightloss.)  They seem to have one of those each week.  :(  Just watch what happens with this latest pill to go OTC--it will be hyped to the skies and hopeful people will run out and waste money on something they cant tolerate  without using caution  in their fat ingestion--which many are unwilling or unable  to do  And it is only a matter of time until WW  (and others) has a simple-minded article about Alli.  Many people dont read the fine "print" explaining the proper use of  weightloss programs, drugs and supplements and get into trouble as a result.

If you re-read my statement again, you will see that I thought I was referring to a certain type of person who will  latch onto Alli without becoming properly informed of its use.  Again, I'm truly  sorry if it sounded to you like I was including "everyone" who uses such an aid.  (In fact, I have friends right now who are on prescribed meds for appetite control and I certainly do not consider them desperate, gullible  or medically unsophisticated.  But I am sure you will agree that sadly,  many people do indeed fit into that category.)  Additionally, the remarks by Sidney Wolfe (who is a greatly respected scholar  in the field of  public health research) really do give me concerns about longterm use of OTC Zenical.

As an illustration of what I mean about misuse of a suppllement, I remember a joke from  years ago about the first highly-publicized "weightloss product" Metracal the meal replacement drink .  A woman walks into the doctors office and says to him, "Doc, this Metracal stuff is a total failure.  I want to sue--I've gained 10 pounds in the two weeks I've been on it."  The surprised doctor says, "My goodness, Mrs Jones, this is terrible.  Are you sure you are using it every day?"  "Oh yes, I drink a whole can of it after every meal!"  And this is what will probably happen to some trusting souls who see the headlines about Alli and think it offers them hope of quick weightloss without effort.

As for my own weightloss, it has been 5  pounds since last September--not a lot to brag about (and because of the holidays and a back problem resulting in inactivity, even that figure has bounced up and down on the scale a lot.  :cry:)  After all that time, why I stick to SLD is because it does help with AS and as a result, a hope of future weightloss even tho very slow.  (And because the people here at this forum are so helpful, full of creative ideas, kind, AND FUN--(especially Frenata and her wild sense of humor--when I need a smile, I hunt up one of her wryly honest  posts )
 
And about your own slow weightloss, as I often have to remind myself about mine, ANY loss (or even no loss) is sure better than any gain.   :lol:   Hang in there and hopefully someday you and I will be bragging about our success!

PS--I agree with you that not all plans work for everyone, even SLD--we each have our own  unique body chemistry and as is so often said here, what leads one person to success may not help the next.  I guess that makes human beings a lot like snowflakes (except that, alas,  we dont "melt".   :wink:  )

More PS--I think the line in your signature about says it all!!

TwinkelToes:
Another added thought to my above remarks.  when I read a sad farewell from someone for whom SLD hasnt worked no matter how hard they have tried and are leaving the plan, I  never   think "oh well, that person is a failure"  (I myself have left other WL plans after all, as most memebrs here have)  Sometimes a person who cannot make one approach work will have great success with another  plan or even a diffferent way of doing the one they are using.  Many of us have found that "tweaking" SLD to our own unique needs makes it work  better for us.  I get good AS from SLD but a  back problem keeps me from exercising right  now and I have never lost weight (or controlled it)  on any eating (or non-eating ;) ) plan unless I have also been exercising!

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