It promises to help patients lose five-to-ten percent of their weight (according to clinical trials) when combined with diet and exercise. But is this what America’s overweight patients really need?

Lorcaserin, the drug name for the prescription diet pill Belviq, was approved by the FDA today, making it the first weight loss drug to receive such approval since Orlistat (Alli) in 1999. This comes just weeks ahead of what is anticipated to be an FDA approval for Qnexa, another weight loss drug.

“In two clinical trials, Lorcaserin helped patients lose 5.8 percent of their body weight after a year. That’s about ten pounds for a 180 pound person. Big deal,” said our resident dietitian Mary Hartley, RD.

The drug works by controlling the appetite by making the brain think its fuller sooner. It’s fared well in clinical trials, and will have to undergo six more studies after its in market to ensure long-term cardiovascular health and to determine Belviq’s risk factor for heart attack and stroke. This makes the in-market patients unassuming guinea pigs, according to Hartley, and that isn’t right.

“The advisory committee decided that the benefits of the drug outweighed the risks heart value problems, but the drug manufacturer was made to conduct post-marketing studies to assess long-term cardiac events such as heart attack and stroke. That makes the patient a guinea pig. No thanks.”
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UPDATE May 25, 2012: Yesterday’s vote regarding Senator Durbin’s proposed amendment to the pending FDA Safety and Innovation Act was tabled. A Senate vote of 77 to 20 has removed Durbin’s amendment from consideration in the overall bill.

Durbin sponsored an amendment that would change the current FDA regulation of natural supplements and potentially cause many products to be removed from shelves. His amendment was introduced on Tuesday, May 22 and the voting took place two days later. In two days’ time supplement industries, consumer rights organizations, along with the Natural Products Association (NPA), American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN) and Citizens for Health sent word to their supporters urging them to contact their Senators to oppose Durbin’s plan. As a result, the amendment was not passed and no change will occur to the current law regarding natural supplements. According to the Natural Products Insider, AHPA President Michael McGuffin is very pleased.

“I have worked with my colleagues from each of the other supplement trade associations over the last several days in this call for prompt and cooperative action, and I am pleased that this effort reaffirms the incredible unity of the dietary supplement industry when legislative threats to DSHEA emerge.”

A vote that takes place today could mean a major change for the supplement industry.

Illinois Senator Richard Durbin has proposed an amendment that would require supplement manufacturers to register with the FDA. Due to the terms of this amendment, if passed, many supplements will be ripped from shelves within the next 30 days.

The vote is scheduled to take place this afternoon, Thursday, May 24. If Durbin’s plan is accepted, a mandate will be placed on supplements requiring information to be provided to the FDA. That information includes a description of the supplement, a list of ingredients, a label for all supplements, and updated information for each new, reformulated, or discontinued product. All of these requirements will fall under the Senate FDA Re-authorization for User Fees bill.

If this amendment passes, supplement companies that fail to register with the FDA within 30 days will be considered “mis-branded” and may be subject to severe financial fees and possibly even jail time.

Currently, supplements operate under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This act states that the manufacturer is responsible for ensuring the safety of a supplement before it is marketed. The FDA is only involved if a product is found to be unsafe after it’s on the market.

While the amendment will affect pills and natural food supplements, Durbin seems to be most concerned about the content of energy drinks. He has even referenced a case of a young woman who died as a result of using an energy drink. The senator wants the FDA to evaluate the difference between a drink and a liquid dietary supplement, and feels energy drinks are dodging regulations by claiming to be a dietary supplement. If they were categorized as drinks they would have to be regulated like all other food and drink products.

Natural supplement suppliers and users have had a short window to petition their local senators and encourage them to vote against the amendment. Due to this, tomorrow may bring major change to the natural supplement industry as we know it.

Also Read:

Energy Drinks May be Doing Permanent Damage to Your Teeth 

Supplements 101: 4 Beneficial Diet Supplements 

Create Your Own Supplement Bar

Californians seem to be doing everything right these days. Achieving the tall and slender beach-body look, eating less than kids in other states, and now likely voting to enforce a new law that would require labeling of genetically engineered food. Is there anything they aren’t doing right? Well, maybe.

If approved, California would be the first state in the nation to require GMO labeling. And according to a recent poll by California Right to Know, it’s likely to happen as nine out of 10 California voters want the labeling to be enforced.

However, new research on the effectiveness of food labeling suggests it may not be the one-cure-fix-all solution Californians, and other health-conscious Americans, are looking for. This is because a labeling initiative may end up making it harder for consumers to know what’s in their food, since it makes the definition of ‘natural’ food very unclear.

When we think of the word natural when it relates to food, we think organic, healthy, and no artificial preservatives, flavorings or ingredients. But apparently the term natural is becoming much harder to define, especially since the federal government has refused to make the term any clearer, allowing food companies to continue labeling their food as ‘natural’ when it may very well not be.
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UPDATE 7/17/12: Qnexa was approved by the FDA on July 17, 2012. This marks the second weight loss drug approval in 2012; the first weight loss drugs approved since Alli in 1999. The prescription drug will be sold as Qsymia.

The inmates are running the asylum. Reversing an earlier decision, the medical experts on FDA’s Endocrinologic and Metabolic Drugs Panel cleared the way for approval of the new diet drug Qnexa. Qnexa (PHEN/TPM) is a combination of phentermine and topiramate (PHEN/TPM). Topiramate is used to treat seizures and prevent migraine headaches and phentermine is approved for the short-term treatment (i.e. a few weeks) of obesity. PHEN was half of PHEN/FEN, the discontinued diet drug that led to valvular heart disease and potentially fatal pulmonary hypertension, primarily in women. Qnexa is indicated for “BMI greater-than or equal to 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity),” the group with the highest heart disease risk.

The panel decided that the complications of obesity outweighed the risk of heart problems. It’s hard to believe they were swayed by the research. The 2010 study published in the Lancet reported that people who took the highest dose of Qnexa (not the lower approved dose) lost at least 10% of their body weight and showed improvements in their risk cardiac factors. Clinical trials by the manufacturer showed 45% of subjects treated at the low dose lost > 5% of baseline body weight following one year of treatment. No one seems to care that we’re talking about a 10 to 15 pound weight loss on a 200 pound person. Do we need a drug for that, especially one that comes with heart disease risk? No matter because the results showed statistical significance in a placebo control study.
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Qnexa, a diet pill created by Vivus, Inc., that claims to help dieters lose 10% of their weight when combined with diet and exercise, has been approved by the FDA advisory panel in a landslide vote of 20-2.

The panel had previously rejected the the pill due to safety concerns, which has left its opponents concerned. Since the FDA typically follows the advice of its advisory panel, the drug is likely to be approved by mid-April.

Previous concerns about the drug are still present. And if the pill does go on shelves, potential users should be aware of that. One of Qnexa’s main ingredients is phentermine, a type of amphetamine that stimulates the nervous system and increases heart rate and blood pressure. It’s commonly used in diet pills since it suppresses appetite, and was woefully recognized as the “Phen” in the weight loss drug Fen-Phen, which was yanked from the market by the FDA in 1997 after being deemed too dangerous for consumption.
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