Don’t Expect New Weight Loss Meds for 10 Years or More

As a culture we don’t plan for a sudden halt in scientific advancements. Our tendency is to expect progress to be rapid and continuous. My prediction is that in certain areas of medical science we are likely to see not only a halt in progress but a slipping backward. In particular, the realm of medical weight management is in complete disarray at this time. Two new drugs designed to induce weight loss have been shot down by the FDA in the last few months. The first is Qnexa, developed by Vivus Inc. Interestingly, Qnexa combines two drugs already approved for use in the U.S. One of the drugs is phentermine which is a medication used for decades as an appetite suppressant. The other is a common drug used to treat seizures with the brand name Topamax (topiramate) which also induces weight loss. The drug performed admirably in clinical trials with most participants losing over 10% of body mass. The FDA cited excessive risks of the drug in its statement of rejection. One wonders why the drugs are still being marketed separately if they are so dangerous.

The latest drug to be rejected by the FDA is Lorgess (lorcaserin), developed by Arena Pharmaceuticals. This drug, not as effective as Qnexa, produced 5% body mass loss in about half of participants in clinical trials. Lab animals showed a tendency to develop breast tumors when exposed to the medication, adding to the FDA’s decision to reject the drug application based on safety concerns.

I am a strong advocate of drug safety and regulation. On the other hand we know obesity, and with it Type 2 diabetes, is epidemic in the U.S. I regard weight loss as the “holy grail” when treating type 2 diabetes and yet it is the most difficult goal to achieve. Any drug which could assist in weight loss is highly desirable in the treatment of Type 2 diabetes. Not only does blood sugar improve with weight loss but also blood pressure and cholesterol readings show declines. All three of these parameters are known to be prime contributors to the main cause of death in diabetics, cardiovascular disease.

It has already been 10 years since the last drug was approved specifically for a weight loss indication. The failure of these two latest medications to achieve approval is certain to cause the pharmaceutical industry to severely curtail if not abandon further investment in this type of drug development.

Why is the FDA so reluctant to approve a weight loss pill? This is a complex issue but requires an answer. A new weight loss inducing medication is certain to be highly anticipated and widely prescribed. Therefore, from the very first day of approval the FDA must take responsibility for the well being of millions of people who are likely to take the medication. We are a society which demands our medications deliver miraculous cures with no side-effects. If someone perceives they have been injured by a medication our legal system is primed to unleash brutal retribution on everyone remotely involved in the approval process. Abuse and injury with a medication designed to cause weight loss is almost a certainty. This is a no-win situation for the administration of the FDA.
I predict it will be at least another 10 years before a medication for weight loss is approved by the FDA. Unless there is a change in the climate of litigation in this country it will take longer than that. In the meantime the only new developments in weight loss drugs will be the result of exploiting appetite suppressant effects which are the “side-effect” of medications approved for other purposes.

Gary Pepper, M.D.

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  • Isabel De Los Rios

    There is no doubt that weight loss is often a seriously huge concern for several several people and not only women. It is usually a probelm that also effects man at all ages. I actually feel that all you have to have is will power and you’ll be in a position to make the massive change in your life.

  • Good Post. Better then the simillar post I found last Wednesday on Blogspot

  • hank frier

    Interesting article. I am surprised that the FDA has difficulty with two drugs that have long-term safety profiles. However, the FDA has increased sensitivity to weight loss drugs, especially combinations, mainly due to the lessons they learned from the fen-phen debacle were heart valve problems arose.

    Having worked in the area for many years I agree with you re: that it will be a long time before a new drug (s) appear on the scene. Altering an individuals energy intake is not a simple accomplishment. There are over a hundred different regulatory mechanisms controlling food intake. The chemicals made in the brain that are associated with food intake alterations are considerable. If you change one chemically others will be altered to maintain homeostasis. The liver, intestines and the fat cell all regulate food intake as well. To develop a single drug that controls food intake is herculean.

    On the energy output side little success has been made there. Altering the biochemical processess is difficult if not outright dangerous. We have been looking at futile cycles, increasing metabolic rate (mainly by increasing heart rate – not a good thing) and increasing the heat produced by the individual (luxusconsumption) with little success.

    Again it seems that the best and safest way to lose weight – change one’s attitude about food and one’s attitude about physical activity. Combining both of these requires a change in lifestyle. Once the individual understands this and puts lifestyle practices in place as daily habit weight loss can be achieved.

    Hank Frier

  • Tony Kingkade

    The heck with the FDA! Drugs are not the solution. There is no one on earth who became obese because they were deprived of a drug. Solving the problem is totally up to you and is the solution. Everyone wants an easy solution to a hard problem. Aint happinhg. It’s personal. It might not be easy, but It’s time to take personal resposibility. You decide; you are in control.

  • Al

    “It has already been 10 years since the last drug was approved specifically for a weight loss indication.”

    Did you mean xenical aka Alli ?

  • Tracy

    What is your opinion of using HCG injections or lozenges to aid in weight loss?

  • Damien

    There are people who can’rt seem to lose weight with exercise and diet alone. Or probably, they were doing it in the wrong manner. Diet and exercise is still the best for weight loss but try to consider some factors that could hinder a person from being successful to these natural ways of losing weight. I, for one had been struggling to lose weight. My bloodline happens to have a trail of Obesity. I have been consciously doing all efforts to lose weight and for more than 10 years of doing that, i’m still oversize. I have sought medical help and I was advised to take diet pills with precaution. I tried Prescopodene and it sure did curb hunger pangs. Now while on the pill, I did my part as well. I eat small meals a day and regularly visits the gym. I love the energy booster because it helps me keep up with exercising. I happen to lose 6 kilos on my first month and for me, that’s a first! I know it’s not safe to stay on a pill for a long time so I am planning to stick to exercise and my diet program after getting my desired weight goal. just saying that taking diet pills for weight loss isn’t a bad idea after all. Cheers!

    • Catrina

      I also have the same difficulty. How did you do with the pill. I am also looking forward to try a pill then couple it with exercise but I am not just sure what kind of pill tot ake. It’s a real scare to simply purchase online especially now that I’ve been reading mixed reviews and blogs containing details about how other pills cause side effects. If you could give me some tips, I’d be more than happy to try this pill. Thanks.