As Americans keep getting fatter, doctors ask: Where are the drugs?

Dec 22, 2010 By Jeannine Stein and Shari Roan

In their quest to find drugs to curb obesity, scientists have had about as much success as long-term dieters who want to stay thin - which is to say, very little. In fact, the last year has been so bleak on the research front that some experts are questioning whether a long-desired safe and effective diet pill can be found.

Advisory panels for the recommended against approval of two experimental drugs this year - Lorqess in September and Qnexa in July - citing unacceptable risks for unimpressive benefits. Another drug, Meridia, was withdrawn from the market in October after it was linked to higher risks of heart attacks and strokes.

Earlier this month, an advisory panel did finally recommend approval of a weight-loss drug: Contrave, a combination of two existing drugs, the antidepressant bupropion and the anti-addiction medication naltrexone. (FDA rulings for all three drugs are expected next year.) But it did so with a marked lack of enthusiasm, citing the medication's poor effectiveness and a need to closely track , such as , once the drug is in broad use.

As drug after drug falters or falls by the wayside, doctors who treat are growing increasingly frustrated. They say that the agency's standards for approving anti-obesity drugs are overly stringent and fail to recognize the health risks associated with carrying extra weight - at a time when almost 34 percent of U.S. adults are obese and almost 6 percent are morbidly obese, and when study after study has shown that the most that can be hoped for from diets and exercise, on average, is a 10 percent loss of body weight sustained for at least one year.

So gloomy is the climate for these drugs that some experts fear drug companies will out-and-out abandon the anti-obesity market.

"Every big company is going to get out of the game, and are not going to invest in the smaller companies to develop drugs," Dr. Donna Ryan, past president of the Obesity Society, said in October during that group's annual meeting in San Diego. "Everybody in the obesity field is upset. There is a lot of anger."

Obesity drugs in the U.S. certainly don't have a terrific track record. Fen-phen, a combination of appetite suppressants fenfluramine and phentermine, was hugely popular in the 1990s but was pulled from the market in 1997 after it was linked with primary pulmonary hypertension, a potentially fatal condition, and heart-valve problems. But the new generation of medications was supposed to be more finely crafted, and therefore safer and better.

The only prescription medication approved solely for weight loss is orlistat, a drug that inhibits fat absorption that is sold under the trade name Xenical or as a weaker over-the-counter version, Alli.

And though an FDA advisory committee did recently endorse expanding eligibility for Lap-Band surgery to allow people with less-extreme obesity to be candidates, obesity experts say that not everyone is eligible for surgery and that this decision, in any case, does nothing to serve people who are overweight, not obese.

The FDA treats drugs for obesity "as if they were in a different category," said Judith Stern, professor of nutrition and internal medicine at the University of California-Davis. "I think (it is) not taking it seriously as a disease, and I have no clue why. We have a problem that affects over 65 percent of the adult population ... the FDA should be jumping through hoops to give approval."

FDA officials would not comment on this year's advisory committee votes nor on its philosophy on obesity drugs. But in an era when the agency is holding all new drugs to more rigorous safety standards, it's clear that most of the new offerings haven't cut the mustard in the key equation of whether benefits outweigh potential risks.

"I understand the frustrations people have - but I don't think we have great medications," said Dr. Abraham Thomas, division head of endocrinology at Henry Ford Hospital in Detroit, who was acting chairman on the FDA advisory panels that reviewed Meridia and Lorqess (also known by its generic name, lorcaserin) and a member of the panel that reviewed Qnexa.

"It's a balance," Thomas added. Each panel carefully weighs a drug's effectiveness against its safety. If weight-loss results look good, then potential side effects (unless they're extremely serious) might not be weighed so heavily. But if a drug isn't very effective, "then the safety issues become magnified." So, for example, in the case of lorcaserin, panel members were hesitant to recommend approval because trials "barely proved" effectiveness, Thomas said.

Obesity experts counter that the agency and its expert panels don't properly appreciate the health risks associated with obesity - diabetes, heart disease, stroke, osteoarthritis, certain types of cancers and, possibly, dementia.

"They are framing weight loss as a cosmetic problem," Ryan said. "Obesity is a medical problem."

They point to studies showing that even modest weight loss - what might be considered just a drop in the bucket when measured against a person's total weight - can have surprisingly large effects. A 10 percent drop in weight can reduce the risk for Type 2 diabetes, lower blood pressure and help counter other problems such as sleep apnea and high blood cholesterol.

They say that a diet medication could be the catalyst needed to jump-start a successful weight loss program. "In my office a patient will come in and say, 'You know, doctor, I've lost some weight through diet and exercise, but I need something to help me kick-start (a serious weight loss program),'" said Dr. Ken Fujioka, director of nutrition and metabolic research at the Scripps Clinic in San Diego.

And they note that while several studies show that diet and exercise can produce about the same weight-loss percentages as medication, such programs - which can include supervised fitness instruction and pre-made meals - may not be realistic or affordable for most people, let alone viable for the long haul.

"When you look at interventions, they're done with volunteers and there are all kinds of people on the team, like psychologists and trainers," said Dr. Arya Sharma, professor of medicine at the University of Alberta in Canada. "You'll see the lengths they go to keep people motivated, and in the end they may get 3 percent to 5 percent weight loss."

Finally, most people can't maintain significant weight loss for more than a year or two through diet and exercise alone in part because the body kicks into a starvation mode and begins to conserve energy. Getting around this thorny problem has become one of the most significant scientific questions in the field - and may possibly, say obesity specialists, be a place where diet pills could help.

Some, such as Dr. Sidney Wolfe, director of the not-for-profit health research group Public Citizen, feel that more caution - not less - is in order when assessing these drugs. Contrave "is another drug that increases blood pressure and pulse, and it's possibly going to be approved - and that is a huge mistake. Losing weight is meaningless if it is nullified by increasing cardiovascular risks."

Wolfe knows that some doctors are frustrated by a lack of obesity medications. But that, he said, isn't justification for approving drugs that may have serious side effects. "If the overall benefits are outweighed by the risks, that's it. The FDA is part of the public health service, and we have to be aware that if they approve a drug, a doctor can prescribe it ... why would any doctor want to prescribe a drug like that?"

But obesity experts argue that risks can be managed. In a September statement to the FDA advisory panel regarding Meridia and the increased risk of cardiovascular events, officials from the Obesity Society noted that "the drug is intended for use in patients who do not have established cardiovascular disease." They note that other medications for serious disorders have been approved despite known adverse side effects.

It certainly makes sense to carefully scrutinize potential health risks of any new medication, especially because they have to be taken for a year or even longer, Ryan said. But diet drugs should not be held to a higher safety standard than other types of medications.

"Safety is important," Ryan said. "That is not to say that they have to be as safe as water."

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User comments : 35

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Ratfish
1 / 5 (2) Dec 22, 2010
How about a pill that stops people from eating grain?
rynox
not rated yet Dec 22, 2010
I've recently started counting calories (and have lost a lot of weight in the past three months), and two things really surprised me:
1 how easy it is to go over your BMR if you are not paying attention to the food you eat.
And,
2 how easy it is to get a handle on calories.

As food became cheaper, instead of decreasing the price of food, restraunts just gave you more. This is the problem: cheap food and what we do with cheap food. It's not a complicated problem. It is what it is.
jsovine
4.6 / 5 (9) Dec 22, 2010
How about people stop acting like a waste of space and attend to their body? If you're genuinely concerned with your weight, have the self-respect and the smidgen of actual willpower it takes to keep your body relatively healthy...

Drugs aren't a substitute for willpower.
jamesrm
1.5 / 5 (8) Dec 23, 2010
Get rid of the FDA, useless regulatory body thats probably in the hands of big pharma anyway, and let the market decide what works, you know the magic hand with no Conscience or morality, just a good clean profit motive.

rgds
jms
vinayababu
2.7 / 5 (3) Dec 23, 2010
Most essential thing is to understand why people become fatty, which is peculiar to developed countries. I would say it is the food habits. Unfortunately the 'problematic' food always are tasty making it difficult to avoid.

I would say the Number one food to avoid/control is the ice cream, second is the milk and its products, then comes the sweet wine and alcoholic drinks, and sweet drinks which have become part of daily menu.Americans use lot of fats. It is surprising that dieting is seldom resorted to even by people who are fatty.
ryggesogn2
1.7 / 5 (6) Dec 23, 2010
"Placebos work -- even without deception"
Make one up.
Skeptic_Heretic
4.6 / 5 (9) Dec 23, 2010
Here's an idea. How about rather than using a pill to lose weight, fat people can simply put the fork down and go for a walk.

Laziness has become institutionalized in the US. This is jsut another sign of the decay of our society.
Ethelred
4.6 / 5 (9) Dec 23, 2010
Get rid of the FDA,
Yes do. We can go back to dying from drugs that are completely fake and sold so someone can make a buck without working. We can have people use ethylene glycol as a sweetener. Radium as a cure all. Thalidomide as a sedative.

You can try them first.

Ethelred
alq131
1 / 5 (6) Dec 23, 2010
well, let's die from FDA approved foods that are completely fake instead... ;|

Actually, the problem might be that the foods don't kill us fast enough. Maybe going back to lead as a wine sweetner, we might just get a handle on the obesity and alcohol problem...

patnclaire
3.9 / 5 (9) Dec 23, 2010
Don't forget to look for the culprit. High-Fructose Corn Syrup. Corn fed livestock get fat. Corn fed people get fat. Everything is loaded with High Fructose Corn Syrup. Lets go fund Fidel and buy his sugar. None of that white refined sugar. Give it to us brown. That way we can simplify our foodstuffs and help the Cuban people. I hear the refuse from making sugar makes for great bio-fuel. No more artificial sweeteners to give us cancer. No more corn syrup to fatten us up. One simple American Policy change from Obama would sure solve a lot of American problems.
Modernmystic
1 / 5 (3) Dec 23, 2010
Get rid of the FDA,
Yes do. We can go back to dying from drugs that are completely fake and sold so someone can make a buck without working. We can have people use ethylene glycol as a sweetener. Radium as a cure all. Thalidomide as a sedative.

You can try them first.

Ethelred


Or continue to die because they keep safe drugs off the market...like they did beta blockers for ten years.

That killed about 100,000 people in the US.
Skeptic_Heretic
4.2 / 5 (5) Dec 23, 2010
Or continue to die because they keep safe drugs off the market...like they did beta blockers for ten years.

That killed about 100,000 people in the US.
Incorrect dosages of beta blockers or combinations with other drugs killed more people than that prior to approval for use of beta blockers in heart diseased patients. There was a lack of guidelines which was perceived to be very dangerous and evidence of harmful DDR from the NHS.
Caliban
4.3 / 5 (3) Dec 23, 2010
Get rid of the FDA, useless regulatory body thats probably in the hands of big pharma anyway, and let the market decide what works, you know the magic hand with no Conscience or morality, just a good clean profit motive.

rgds
jms


@jms,

Sarcasm noted.
Doctors, of course, should be saying "Why not get of your spotted backside, get some excercise, and stop eating over-processed crap exclusively."

Unfortunately, though, too many doctors are merely marketing organs for Pharma -continually trying to define more-or-less normal human variation as pathological, so that new drugs of questionable safety/efficacy can be sold to ignorant, instant-gratification-seeking consumers, to make mo' $$$.
Mira_Musiclab
3.3 / 5 (3) Dec 23, 2010
I want good regulation and testing, but I also think in it's current form the FDA needs to go. It's become a shill for Big Pharma, not a gatekeeper anymore.

Just look at studies and approvals involved in the realm of antidepressants. Paroxetine and Duloxetine being some prime examples of research-suppression in order to rail those drugs through approval.
Modernmystic
2.2 / 5 (5) Dec 23, 2010
Or continue to die because they keep safe drugs off the market...like they did beta blockers for ten years.

That killed about 100,000 people in the US.
Incorrect dosages of beta blockers or combinations with other drugs killed more people than that prior to approval for use of beta blockers in heart diseased patients. There was a lack of guidelines which was perceived to be very dangerous and evidence of harmful DDR from the NHS.


You got a source?
Skeptic_Heretic
4.2 / 5 (5) Dec 24, 2010
You got a source?

Howard L. McLeod, Pharm.D, professor of medicine, genetics, molecular biology and pharmacology, Washington University School of Medicine, St. Louis; David E. Lanfear, M.D., Henry Ford Hospital, Detroit; Sept. 27, 2005, Journal of the American Medical Association

http://www.webmd....pressure

http://news.bbc.c...4382.stm

Argon
1 / 5 (2) Dec 25, 2010
"In fact, the last year has been so bleak on the research front that some experts are questioning whether a long-desired safe and effective diet pill can be found."

A safe and effective diet pill has already been known for decades, it's called Methylphenidate.

It is a powerful appetite suppressant! It improves cognition in general and improves academic performance by entire letter grades in college students.

see
http://en.wikiped...henidate
for more details(article focuses on use in children mostly).

For use in Adults see:
http://www.nature...29a.html
and
http://www.ajcn.o...308.full
and
http://www.nature...45a.html
yyz
5 / 5 (4) Dec 25, 2010
"A safe and effective diet pill has already been known for decades, it's called Methylphenidate."

Methylphenidate is a phenylethylamine derivative related to amphetamine, methamphetamine, phentermine, fenfluramine, chlorphentermine among others. It has an addiction potential similar to other Schedule II anorexics (eg amphetamine & methamphetamine) and has been widely abused (even by college students!). It's not a safe OR effective drug for weight loss with long term use(6 months or more).
chrisp
5 / 5 (5) Dec 26, 2010
Going with a drug-based solution is perhaps one in an array of choices, but only for an extremely small percentage of obese people. For the rest, it's essentially a preventable disease.

Since moving to Japan from the U.S., I've noticed a big difference in my diet and physical activity. The food in Japan (if you eat more traditional foods) is mostly fat-tree, very low in sugar and in carbs. Japanese society only recently is being threatened by American-like fast food chains. However its ancient culture has always placed food in high esteem. Also, people bicycle everywhere, walk a lot more, and if you're in the city, take the stairs to the train platforms.

In the U.S., an obesity epidemic won't be enough incentive for Americans to change how they eat and exercise. There's going to have to be a revolution in the way Americans view health; but the food industry and the people it disserves will try to defend the status quo.
Modernmystic
1 / 5 (3) Dec 27, 2010
You got a source?

Howard L. McLeod, Pharm.D, professor of medicine, genetics, molecular biology and pharmacology, Washington University School of Medicine, St. Louis; David E. Lanfear, M.D., Henry Ford Hospital, Detroit; Sept. 27, 2005, Journal of the American Medical Association

http://www.webmd....pressure



I'm still waiting for a source that confirms, and I quote:
"Incorrect dosages of beta blockers or combinations with other drugs killed more people than that prior to approval for use of beta blockers in heart diseased patients."

Neither of the two you provided did that...

Please provide a source that does or retract the lie. Thanks.
Skeptic_Heretic
4 / 5 (4) Dec 27, 2010
"Incorrect dosages of beta blockers or combinations with other drugs killed more people than that prior to approval for use of beta blockers in heart diseased patients."

Neither of the two you provided did that...

Please provide a source that does or retract the lie. Thanks.
Did you read the first paper I cited? Sorry, it's not online any logner but your local library will have a copy of the J-AMA

He's another article that cites that paper as well.
http://www.laleva...ard.html

How many more do you need?
Modernmystic
1 / 5 (4) Dec 27, 2010
I need one that states the numbers of people killed by incorrect dosages of beta blockers or combination with other drugs which are over 100,000 people.

That's the claim you made. Back it up.

Noting you've provided has done that yet.
Skeptic_Heretic
4 / 5 (4) Dec 27, 2010
Then go read the paper I cited.
Modernmystic
1 / 5 (4) Dec 27, 2010
Then go read the paper I cited.


Cite something that backs up your claim...

I could say that the FDA intentionally approved pain medication which caused heart attacks. I could say I had a source for it at your library. I'd be lying too.

Would that convince YOU?
Skeptic_Heretic
5 / 5 (3) Dec 27, 2010
I could say that the FDA intentionally approved pain medication which caused heart attacks. I could say I had a source for it at your library. I'd be lying too.

Would that convince YOU?
Difference between you and I is the fact that I gave you the exact item you're requesting. You're refusing to look it up. I wouldn't refuse to look it up. If you sent me to the library looking for the exact date, author, and book title, I'd go get it and see if you were full of crap. Especially if you cited secondary articles that support your assertion.
Modernmystic
1 / 5 (3) Dec 27, 2010
I could say that the FDA intentionally approved pain medication which caused heart attacks. I could say I had a source for it at your library. I'd be lying too.

Would that convince YOU?
Difference between you and I is the fact that I gave you the exact item you're requesting. You're refusing to look it up. I wouldn't refuse to look it up.


OK I'll bite give me the issue and the article. It's going to tell me a specific number of people killed, and it's going to be over 100,000 right? How many people EXACTLY is it going to tell me? Do you know? Is this just coming out of your memory?

I'm not wasting my precious time unless you can be specific about what this alleged paper is going to say.
Shootist
2.3 / 5 (3) Dec 27, 2010
As Americans keep getting fatter


They keep living longer.

http://aging.sena...ing1.pdf
GSwift7
2.2 / 5 (5) Dec 27, 2010
I have an idea: Plant trees and grass all the way around the entrances to places like supermarkets and office buildings. At least 100 yards to the nearest parking space (besides handicap). I would say build the buildings up on hills as well, but it's not possible to make people walk up-hill both ways.

My dad is fat because he constantly eats, he takes huge portions and eats everything on his plate, then he has seconds. He eats till he feells full, every meal. Then he has snacks and stuff between meals. He makes horrible choices, like eating fatty fried foods in stead of steamed or baked foods. He eats WAY too much salt (as do most people), and way too much starch as well.

I changed jobs once and gained 40 lbs in 6 months. I joined a gym and lost it in 3 months.

On the other hand, as a smoker I know it's hard to change a habit when you don't want to. I think my dad is happy the way he is, and I love him. Let him eat.
alq131
5 / 5 (6) Dec 27, 2010
GSwift7,
building on that point, you could take the FDA's "food pyramid and make it real! Imagine a grocery store where candy, cake and processed foods are at the very apex...stairs only, or maybe even a rock-climbing wall to get to them (no "for assistance ask an employee" policy allowed)...
ziprar
4.3 / 5 (3) Dec 27, 2010
Its a lost cause. Americans are getting fatter and will keep doing that. In a mean time, you can look for stock of some promising pharma researching a antiobesity pill and make some nice $$$
mertzj
not rated yet Dec 28, 2010
Its sad people choose to eat over being fit. Fat people say it cant be helped. How many fat Ethiopians have you seen?
Husky
not rated yet Dec 29, 2010
Sell every burger with laxatives mixed in , the MacLax, or the ShakeNRace
jjoensuu
5 / 5 (1) Dec 29, 2010
This article header should have been "As Americans keep getting fatter, doctors ask: Where are the drugs that allow us to make more ca$h out of this situation?"
Ratfish
not rated yet Dec 29, 2010
Sell every burger with laxatives mixed in , the MacLax, or the ShakeNRace


Laxatives don't affect the nutrient acquisition from the food, only the water absorption. This is why it's ridiculous for those with eating disorders to abuse them.
mysticshakra
1 / 5 (1) Dec 30, 2010
Once again, the "drugs will save us" paradigm reigns supreme.

Here's an idea, block all healthcare options for conditions that are self inflicted like obesity. if you refuse to stop over eating and you refuse to exercise daily then you have to live with the consequences without invention through medicine or the rest of society. Same goes for idiots who smoke and get cancer from it. You're on your own.

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