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Prescription Diet Drugs

Summary & Comment

Obesity costs America a staggering $100+ billion in health care costs and weight-loss products and programs, according to the U.S. Surgeon General. And as the rate of obesity in America is growing, there has been a fundamental shift in how obesity is viewed-as a disease rather than simply poor lifestyle habits.

"Obesity used to be viewed as a lack of willpower in a patient... It was not viewed as a medical problem. Today I think it is.", according to Douglas Greene at the University of Michigan. The bottom line is that a growing consensus holds that the traditional approach to weight-loss - diet and exercise - is futile for the majority of people.

The market for prescription diet drugs has been bumpy, characterized by major product withdrawals, some nasty side effects, and moderate weight loss. The “magic pill” everyone is hoping for is still not here. Only two drugs (orlistat and sibutramine) have been approved for the long-term treatment of obesity.

Representatives of the pharmaceutical industry estimate that slightly more than two dozen obesity drugs are currently undergoing clinical trials. Meanwhile, another 32 experimental medications are in early-stage development, and six existing drugs approved for diabetes are being cross-tested for their effectiveness at reducing weight in overweight patients.

Currently there are more than a dozen new drugs for treating obesity either in or about to begin human clinical trials and there are 5 new drugs in clinical trials for diabetes, which may also produce weight loss. In addition, there are also at least 20 other drugs which impact feeding, appetite, metabolic rate, or weight regulation that are in pre-clinical or animal testing.

When will these drugs be released? FDA guidelines for phase 3 trials for drugs for obesity call for at least one year on therapy and at least one more year of follow-up. In theory, a weight loss drug with successful phase 3 trials could be approved in a little over two years after the initiation of phase 3 trials. In practice, it generally takes longer than two years. The likelihood is that not all of these drugs will make it to the market.

We may be entering a new era of "lifestyle drugs" aimed at tackling such things as: hair loss, aging skin, weight gain—all the lifestyle issues of the baby boomers. As a recent Business Week article pointed out, "At a time when people lay out $20 or $30 a month on cable TV, it seems likely they’ll pay as much for a lifestyle drug."… "Hundreds of millions of dollars are being poured into efforts to discover safe and effective treatments for obesity, anxiety, memory loss, depression, incontinence, and arthritis."

However, there is no guarantee that the new drugs being developed will work long-term, and the FDA is likely to set high standards for approval. Questions remain as to how long studies must last and what amount of weight loss is optimal. Some FDA advisers want the drugs to also reduce the incidence of such obesity-related problems as diabetes or hypertension. And, because obesity isn’t directly life-threatening like AIDS or cancer, the risk of taking a drug over the long term is weighed carefully against the benefit of weight loss.

In 1997, bariatricians and other doctors were swamped with demand from their patients for prescription diet medications. The ranks of the American Society of Bariatric Physicians (ASBP) tripled to record levels and prescriptions for the two drugs approved for use, the "fen/phen" combination, skyrocketed. "Fen/phen" refers to the combination of: Fenfluramine, and Phentermine.

It May Not Be Wise To Buy "Canadian" Drugs on the Internet

BestDietForMe.comIn December 2005, a probe by the FDA found that the majority of prescription drugs ordered from web sites believed to be Canadian pharmacies originate from out side Canada. This finding came from an inspection of packages ordered by U.S. consumers, that came into JFK, Miami, and Los Angeles international airports. Out of nearly 4,000 shipments, 43% were ordered from "Canadian" Internet pharmacies and were represented as being of Canadian origin. Of the 1,700 suspicious packages, 85% of the drugs weren't manufactured in Canada and in fact came from 27 different countries. According to the FDA: "This operation suggests that drugs ordered from so-called Canadian Internet sites are not drugs of known safety and efficacy."

In addition to having been falsely promoted, many of the drugs weren't adequately labeled in English to help assure safe and effective usage.

A significant portion of this Canadian Internet pharmacy business is related to weight loss drugs, such as: phentermine, Meridia, and Xenical. So, U.S. dieters looking for a bargain on the Web should be aware that they may not be getting safe or effective diet drugs, and in some cases they may not even be getting the drug they ordered, since some shipments are outright counterfeits.

Phentermine is sold under 18 different brand names. The most commonly used are: Phentermine, Fastin, Pondimin, Adipex-P, and Ionamin. Others include: Anorexin, Bacarate, Bontril, Melfiat, Obenil, Plegine, Preludin, Pre-State, Sanorex, Statobex, Tenuate, Tepanil, Trimtabs, and Voranil.

Finding a profitable drug will require some luck. Researchers believe obesity results from a number of genetic and environmental factors. The hope is that doctors will one day have a variety of drugs to customize treatment of overweight persons.

Many doctors believed that these newly popular drugs, used in combination, would work better than any diet drugs still on the market (i.e. diethylpropion and mazindol), and that it represents a long-overdue change in the way the medical profession views weight control. Many doctors believe that medication may be the best way to correct a serotonin imbalance. Others, however, think it just exposes patients to more potential side effects, or that overuse or abuse may become a problem.

These medications generally work best when combined with exercise programs, and are found to be least effective when overeating takes place mainly for psychological reasons (depression, stress, loneliness).

Some obesity experts fear the Redux scare will cause long-term damage to the notion of treating obesity with drugs. Also potentially hurt are the prospects of new diet drugs, working differently, that await FDA approval or are in late stage clinical trials, and in the development of new agents." Personnel at the American Society of Bariatric Physicians (obesity specialist physicians) are afraid the problems are going to cause a setback in the approval of new agents.

It appears that the FDA may be moving toward easier approval of obesity drugs. A draft proposal indicates that human trials required for the drugs’ approval may be shorter and won’t have to show as many benefits as earlier-proposed guidelines. If the FDA approves the changes, a new generation of anti-obesity prescription drugs are more likely to reach the market over the next several years. Before dexfenfluramine, the agency had not approved one since the 1970s.

Pharmaceutical firms say that the new anti-obesity drugs should only be used along with strict programs of exercise and diet. However, we all saw how fast Redux caught fire with dieters who merely wanted to lose a few cosmetic pounds. The discovery of a flawed fat gene is no excuse to junk the treadmill and toss out the calorie counters. That was the unanimous message from nutritionists, fitness experts and diet coaches.

It would be simplistic to say that currently-used diet medications, and future ones under development through the early part of this century, will render obsolete commercial weight loss programs and other commonly used over-the-counter do-it-yourself products. Not everyone will be able to afford the ongoing costs. Not everyone will be candidates for such treatment. Some of the therapies may include taking injections, a turn-off for the squeamish. Others may prefer a more "natural" approach to weight management - proper diet and more exercise.

The role of many physicians in weight management is also suspect. Traditionally, doctors have not had the time to counsel their patients in depth about smoking cessation or losing weight. And, the psychological/emotional issues related to obesity are crucial. Will doctors that don’t specialize in treating obesity (i.e. general practitioners, etc.), increasingly squeezed by managed care and growing caseloads under HMOs, have the time to motivate, cajole, counsel and offer the peer support that commercial weight loss organizations such as Weight Watchers, Jenny Craig, or eDiets.com offer? BestDietForMe.com/Marketdata analysts don't think so.

Prescribing diet drugs can become a "cash cow" for many doctors whose incomes have been squeezed by managed care. The "diet industry" sometimes also attracts doctors with troubled pasts. Penalties for dispensing bad weight loss counseling are rare and minor. They may keep physicians out of insurance plans, but that doesn’t matter much in weight loss and other optional medical services, since insurance rarely covers diet plans and patients pay their doctors "out-of-pocket".

Leptin

Preliminary results from early studies on the use of daily injections of genetically engineered leptin are reporting weight loss among some genetically obese subjects. Higher doses may be needed for higher weights. The most common side effects were pain at the injection site and headache. There appear to be no significant adverse effects on major organs, including the heart, liver, kidney, central nervous system, or gastrointestinal tract. It also does not appear to affect insulin levels, a previous concern.

According to the Wall Street Journal, Genomics-based obesity drugs are being tested in human trials. After years of analyzing the human genome, scientists at Millennium Pharmaceuticals say they have finally found a gem; an obesity drug that works by changing metabolism.

Traditionally, obesity drugs have been appetite suppressants, which often come with severe side effects. The new drug, co-developed with Abbott Laboratories of North Chicago, is part of a new class of medications that seek to alter metabolism.

Known by the name MLN4760, the drug is based on the discovery of a gene that provides instructions for the production of an enzyme that scientists believe helps prompt the body to store fat. The drug doesn’t act directly on the gene, but rather inhibits the enzyme’s action- theoretically prompting the body to burn fat, rather than store it. It is still too early to tell if the drug will be a success. Most early-stage drugs in fact fail.

 

Overview | Betahistine | Didrex | Diethylproprion | Leptin | Meridia

Phendimetrazine | Phentermine | Rimonabant  | Xenical and Alli

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This page last updated: 2/27/2007

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