A widely publicized non-prescription diet drug named alli, which is believed to cause weight loss by blocking fat absorption, finally hit the drugstores nationwide this weekend, according to an announcement made June 12 by GlaxoSmithKline, the marketer of the diet drug.

Alli, made by Roche of 60 mg orlistat, the active chemical that has been used for years for a prescription version known as xenical, obtained FDA approval in the February of 2007 for marketing in the United States as an over-the counter weight loss drug .

The drug is indicated for those who are overweight, but not obese adults age 18 or older.  Those who are obese are advised to consult with their physicians and xenical, which contains a higher dose of orlistat, 120 mg per capsule, may be the option for them to use to help them lose weight.

Alli is no wonder drug, Glaxo has suggested and consumers should not expect to lose lots of weight overnight.  In addition, the drug needs to be used together with a low calorie, low fat diet and the wannabe successful losers need also to do physical exercise.

The drug can help lose 50 percent more weight when a dieter follows a weight loss program including use of a low calorie, low fat diet and exercise, designed by the drug marketer.  If one could lose 10 pounds in a course of four or six months following a low calorie, low fat diet and doing required physical exercise, he could lose 5 extra pounds when he also uses alli.

The efficacy of alli is not as desirable.  A study conducted by Dr. James Anderson of the University of Kentucky and presented at the 2005 annual meeting of NAASO, the Obesity Society in Vancouver, British Columbia shows that during a course of four months, overweight people who were on a low calorie and low fat diet and also used the drug lost 5 percent of their baseline weight and those who were on diet only lose 3.3 percent.

Among the study participants, 36 of those who were on the specific diet and also used the weight loss drug lost more than five percent, compared to 28 percent of those who were on diet only. Also, 57 percent of the alli/diet users compared to 42 percent of those on diet alone lost more than three percent of their baseline weight during the four-month study.

According to Glaxo, alli can help reduce fat absorption by 25 percent under the conditions specified in its weight loss program.  That is, when one takes 2000 calories (the weight loss program needs a low calorie diet) with no more than 75 grams of fat (the program needs a low fat diet containing no more than 30 percent of the total calories), the weight loss drug can block absorption of 19 grams of fat, which is equivalent to 152 calories, about 7 percent of the total calories.

It seems undisputable that alli or even rimonabant (acomplia) or subutramine (medidia) may likely help lose certain amounts of weight, said Jaj Padwal and Sumit Majumdar of the University of Alberta.  But they stressed long-term risks and benefits of these medications are unknown.

Padwal and Majumdar published an article in the Jan. 6, 2006 issue of The Lancet, a prestigious British medical journal, after reviewing all the published studies on the risks and benefits of the noted drugs, to say that long-term studies are needed to determine if losing weight on those drugs actually reduces the risks of heart attack, stroke and diabetes associated with overweight or obesity.  They pointed out that the ultimate goal is to get a person to be healthier, but not to make him or her look better. 

They noted that the dropout rate from alli-based weight management program is high, apparently due to the fact that the participants need to take care of what they eat and they need also to do physical exercise or maybe the fact that the drug caused some embarrassing side effects.

Alli helps weight loss by blocking fat absorption. Because of this, users of the drug are at risk of malnutrition as they cannot adequately absorb fat-soluble nutrients or vitamins such as vitamin D, E, K and beta-carotene.  

The FDA reminds patients in a statement published on its web site that they should take a multivitamin while using alli.

Although Alli is indicated for adults age 18 or older, certain groups of people may not attempt to use it as it may potentially cause malnutrition.   It should not be used by people who have problems absorbing foods or gallbladder problems and women who are pregnant or are breastfeeding or those who are using certain medications.

Trials did not show any major adverse effects, meaning it is generally safe, but use of alli was found to cause some side effects such as causing gas with discharge, oily discharge, increased number of bowel movement, oily spotty, oily or fatty stools, urgent need to have a bowel movement and inability of controlling bowel movement.

These side effects can be more significant among those who do not stick to a low fat diet. Because of this, Glaxo recommends patients use dark underwear. 

The worse concern that the drug may increase cancer risk came from Public Citizen, which filed a petition to the FDA asking the agency to ban alli and its "siblings".  The consumer group calls the benefits of the OTC drug is marginal while its long-term safety is not known.   But the FDA denied the petition, obviously.

Dr. Sidney Wolfe of the consumer organization said early that animal studies by Roche, which makes the drug, show that the chemical used in alli caused aberrant cyptic loci, precancerous lesions in the colon in rats.  

When the FDA approved alli, Dr. Wolfe, Director of Public Citizen’s Health Research Group releases a statement as follows:

At a time when colon cancer is a leading cause of death and disease in the United States, the Food and Drug Administration’s (FDA) decision to approve, for over-the-counter (OTC) use, a drug that clearly causes pre-cancerous lesions of the colon (aberrant crypt foci or ACF*) is the height of recklessness and shows a profound lack of concern for the public’s health. This marks the first time, to my knowledge, that the FDA has approved a drug for over-the-counter use despite knowing in advance that the drug causes either cancer or pre-cancerous lesions. This decision raises very serious questions about the competence of former National Cancer Institute Director Dr. Andrew von Eschenbach in allowing the approval of a drug that may well increase the incidence of colon cancer in this country.

Emphasizing that this risk is not accompanied by any documented benefit, the label of the prescription version, Orlistat, has been required to state that “The long-term effects of orlistat on morbidity or mortality associated with obesity have not been established.”

In opposing the over-the-counter approval a year ago, we stated that “the switch of orlistat to OTC status would be a serious, dangerous mistake in light of its marginal benefits, frequent co-existence of other diseases, common, bothersome [gastrointestinal] adverse reactions, significant inhibition of absorption of fat soluble vitamins [A, D, K and E], and problematic use in the millions of people using the blood thinner warfarin (Coumadin)” (the latter because of orlistat-induced Vitamin K deficiency).

We strongly urge people not to use this potentially dangerous drug, and we predict that, like the rapidly declining sales of the prescription version, the over-the-counter version will turn out to be a loser after enough people have a bad experience with it.

*The connection of ACF with carcinogenesis is so well-recognized that the appearance of ACF in rats is used by many groups to test the potential carcinogenicity of chemicals. For example, the Environmental Protection Agency (EPA) uses an ACF assay in its tests of possible carcinogens. In April 2006, after opposing the OTC switch, we petitioned the FDA to ban the prescription version of orlistat, Xenical, because of the two studies documenting its ability to cause ACF. There are no human studies of long enough duration or follow-up to make any acceptable statement allaying concerns about human cancer from orlistat.

But Dr. Wolfe's argument in the petition to the FDA and in the statement have met strong opposition from Glaxo and Roche which explained with opinions from other experts that aberrant crypt foci are in no way an indicator of colon cancer risk. 

Anyway, the OTC drug costs $2 per day, according to Glaxo and it is sold in a bottle of 90 capsules for $60.  The drug can be taken for a period of six months, meaning that a six month regimen would cost $360, plus unknown amounts of time and effort spent on selection of foods and physical exercise.

The worse part is, the lost weight will likely come back to those who stop taking alli if they do not change their lifestyle, early studies showed. A healthy lifestyle, which is no secret to many people, includes a low fat diet, moderate physical exercise and avoidance of drugs, a scientist affiliated with foodconsumer.org suggests.