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Tennessee Leads Coalition to Regulate Counterfeit Weight Loss Drugs

Tennessee and other states are urging the Food and Drug Administration (FDA) to take action against those who sell “counterfeit, unapproved and contaminated weight loss drugs.”

A press release from Attorney General Jonathan Skrmetti said he has led a “38-state and territory bipartisan coalition” that is asking the agency to regulate the sale of drugs with weight loss side effects. These drugs include Ozempic, Wegovy, Mounjaro and Zepbound. 

The FDA has addressed concerns for these “unapproved” drugs. They noted that these are “options for weight loss” but noted that illegitimate versions “do not undergo the FDA’s review for safety” among other testing.

A letter from the coalition to the FDA noted that while the states have a role in “protecting their own customers,” they need the agency to regulate counterfeits that originate outside of the United States.

“With its broad jurisdiction and resources the FDA is uniquely positioned to lead the campaign against dangerous adulterations of GLP-1 medications in the U.S. drug supply,” the letter said. “We urge the FDA to exercise its statutory authority through investigations, inspections, and enforcement actions to safeguard consumers.”

Skrmetti noted that while many rely on these drugs for health reasons, there are people taking advantage of this need. The Attorney General said  high demand and “tight supply” have created a lucrative market for counterfeits. He added that not only have these bogus products not been tested but pose a threat to the country’s “national security” and they have “infiltrated the U.S. supply chain.”

“These counterfeit or copycat drugs can be contaminated through shady supply chains running from China, Turkey, and other overseas suppliers, or they can contain entirely different drugs manufactured and packaged to look like GLP-1 drugs,” Skrmetti said in a statement.  “We are asking the FDA to lead efforts to safeguard our American supply chain and to work with other federal and state agencies to stop bad actors from producing counterfeit drugs.”

In a consumer protection warning against these items — known as GLP-1 drugs — Skrmetti mentioned  that online marketing and social media have helped their spread. While these sellers advertise these products for a “fraction of the price” they could be offering an “ineffective alternative.”

“Online health/wellness companies might try to bypass prescription requirements by offering to sell the active ingredient of GLP-1 drugs (semaglutide or tirzepatide) and marketing them as ‘not for human consumption’ or for ‘research purposes only,’” the warning said. The websites, however, will often provide consumers with tips on how to use the active ingredients to make their own versions of GLP-1 drugs at home.

The letter to the FDA said that the fake items only offer “active ingredients,” which creates additional issues for consumers. Users are then required to supplement the medication themselves, without the proper knowledge on how to administer injections.

“Patient error in self-dosing has contributed to the dramatic increase in reports of semaglutide overdoses in the U.S. Consumers may also expose themselves to danger by improperly storing active ingredients or using non-sterile equipment,” the letter said.

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Opinion The Last Word

The Rant

I think I have a man crush on Chris Christie. Yes, I know the New Jersey governor is a Republican and might be the next president if his lap-band weight-loss plan works out, but I love him. He’s like the Ralph Kramden of politics.

Oh, I forgot. Probably 80 percent of you reading this have no idea who Ralph Kramden was. He was the hilarious bus driver played by Jackie Gleason on the hit television series The Honeymooners back when television first became a thing in almost every home. My gosh, it was in black and white even. Do any of you remember that? When Christie was being interviewed by David Letterman (who has relentlessly poked fun at his weight) and he pulled that donut out of his pocket and said he didn’t know the interview was going to last so long — that was pure brilliance. I hope he came up with that on his own. And when he unabashedly gave Barack Obama props for his swift action after Hurricane Sandy for the world and the rest of the Republican Party to see, he proved that he’s his own man and not like the rest of those lemmings who try to thwart every single one of the president’s actions and blame everything bad that happens in the world on him. I’m just waiting for them to find a way to blame him for those three women being kidnapped and held hostage in that house in Cleveland, the explosion in West, Texas, and the return of the cicadas to the East Coast.

No, I don’t want Christie to be the next president. I want that to be Hillary Clinton with Newark, New Jersey, mayor Cory Booker as vice president (can you imagine how cool that would be?). But if the Republican Party big dogs that are in power now don’t do something to become more like Christie, they are going to stay smack where they are: in the dark. Not that I want them to shine and take over anything, but at least if more of them were like him the country would get out of the rut it’s in and move into the future.

So I hope Christie’s weight-loss surgery works, for health reasons if nothing else. I kind of like the way he looks now (I would love to see him bossing people around with a big cigar shoved in his mouth) and he carries himself well, but he probably does need the benefits of shedding a few pounds (as do I!). You never know. He might turn around and decide to be a Democrat and take revenge on those who dissed him for being friendly with Obama.

That, actually, would be pretty damn genius of him to do. He is a popular guy with a great sense of humor and sense of fairness and a level head and isn’t afraid to speak his mind. And he’s smart and doesn’t drone on and on and on and on and on like that wretched Lindsey Graham or that lunatic in South Carolina — what’s his name — Jim DeMint, who I guess resigned to go head up the brain-trust at the Heritage Foundation.

I’m no expert on politics, but I think Christie would do very well in the Democratic Party. I guess he would have to change some things about his philosophy since he is, after all, a Republican (I wonder why?) but he would probably be an easy convert. Can you imagine having that bulldog at Obama’s side when all of the rest of the Republicans are trying to stalemate everything he does? Christie looks like he might not be below punching some people out to make things happen.

Better yet, let’s get him converted to a Democrat without letting anyone know and get him to take over as president of the NRA. He would be a great infiltrator and get in there and smack some people around. And chasing all those nuts would be good exercise to help get some of that weight off.

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News

Form Fitting

Tbe fat or not to be fat is not the question. That one’s easy: Don’t be fat.

No, the real question is, how to not be fat. Ay, there’s the rub.

Ever since vegetable oils first got hydrogenated over a century ago, the Western diet has been a glutton’s paradise. Thankfully, the technology of losing weight has started catching up with the science of gaining weight. Be it weight-loss surgery or a carefully planned fitness regime, finding the real you under the flab is more possible now than ever.

The weight-loss option that has been grabbing headlines these days is surgery. There are a number of FDA-approved procedures that can effect dramatic loss of weight, but there are two primary ways to do it: reduce the capacity of the stomach, thereby restricting how much food is needed to make you full, or limit the absorption of calories by your digestive system, called malabsorptive procedures. Each has drawbacks or risks, but such techniques are shown to be very effective in patients who comply with the doctor’s orders.

At the Center for Surgical Weight Loss at St. Francis Hospital in Memphis, two common procedures are the Lap Adjustable Gastric Banding and the Roux-en-Y Gastric Bypass. Banding is a less-invasive, reversible way to restrict the stomach so that you require less food to make you feel full. Leslie Albers, RN, program coordinator at the center, says, “With the band, you can expect to lose around 50 percent of your excess body weight in 18 to 24 months if you are compliant with the program.”

The gastric bypass is more invasive but is potentially more effective at helping you shed those pounds. It’s a double whammy, being both restrictive — reducing the size of the stomach capacity — and malabsorptive. “The stomach size is reduced substantially with this type of procedure,” Albers says. “With the bypass, you can expect to lose around 60 to 80 percent of your excess body weight in 12 to 18 months if you are compliant with the program.”

Not everyone is a good fit for surgical weight-loss options. Only those who suffer from morbid obesity or have co-morbidities (other diseases or disorders) that exacerbate their obesity — such as diabetes, hypertension, or heart disease — are considered. Albers says that, in conjunction with the recommendation of the National Institutes of Health, at the Center for Surgical Weight Loss, “Candidates would be between 18 and 65 years old with a body mass index [BMI, a statistic that measures weight against height to determine obesity] of 40 or more or a BMI between 35 and 39.9 with documented co-morbidities or health problems caused by their weight.”

According to Albers, the pros of surgery are simple: “It will work if you do what you are supposed to do. It will help tremendously people who are unable to lose weight by other means. It will help get you to a healthier weight.”

But don’t undergo the surgery without being ready to overhaul your lifestyle. Your diet and especially your eating habits, beginning during the weeks after surgery, will never be the same again. That need not be a bad thing, Albers says. “One hundred percent of our patients say that their quality of life has improved after surgery.”

Short of surgery, science has also made inroads into more effective methods of fitness, including new kinds of exercise equipment and tailoring fitness regimes to the individual. For the morbidly obese, that can mean easing in to an exercise system rather than jumping in with both feet.

Billy Tune, Fitness Manager at Collierville’s Prairie Life Fitness Center, says, “The more weight [someone’s] got on them, it’s going to be really hard on their joints. Somebody who is severely obese who is starting off running — it’s not going to be the best activity for them. They’re going to get tendonitis, their hips are going to bother them, their back might hurt, feet, you’re going to get all sorts of problems there.” Instead, Tune recommends water aerobics, elliptical machines, or riding a non-weight-bearing stationary bike to start with.

InsideOut Gym, in Midtown, has a program called SweatShop, an intense, six-week boot camp replete with homework exercise for serious-minded overweight people. “It builds toward the end,” Lisa Buckner, co-owner of the gym, says. “[Participants] exercise like crazy, but they also [learn] how to exercise.” Past participants have lost 12 to 15 pounds or have lost 14 inches in six weeks. “They get an exercise prescription,” Buckner says.

For fitness to work, Tune and Buckner both say, it needs to be a part of your everyday life: a lifestyle change. Buckner takes that idea personally. As she says, “I’m the former 260-pounder who lost 100 pounds and kept it off.”

Tune says fitness is a necessary part of everybody’s health plan, even for those who have gotten weight-loss surgery. “I always tell them, even if they get that surgery, they still need to come in [to the gym], or they’re going to end up right where they were before,” he says. “The surgery’s going to be negated.

“That’s the problem. You can slowly stretch your stomach back out again to where it was before. If you keep taking in more calories, go back to those old habits, you’re going to put the weight back on down the road.”

Furthermore, Tune feels that, to really impress the importance of fitness on those who are going to have weight-loss surgery: “They should start exercising before the surgery, because then they get that habit, and once they get out they can continue exercising. I just hate to see people who get that surgery and then go right back and think they can start eating again. The surgery’s going to help, but long-term, they definitely need to exercise and diet correctly.

“Even if you look great on the outside and you get the surgery, the most important muscle in your body is your heart. If you’re not training your heart and you’re not eating right, you can look great but still not feel great.”

Buckner says that careful monitoring of the exercise of those who have had weight-loss surgery is very important: Since they don’t eat as much, they use up their food energy much more quickly.

Surgery or no-surgery fitness? Making that choice can be very difficult. Albers says, “Deciding between surgery or other weight-loss methods is very personal. By the time most people reach us, they have tried every diet out there. They have struggled with their weight and the problems caused by their weight for years. We know that only a very small percentage of people can lose weight with diet and exercise and maintain that weight loss.

“In addition, most people can only lose 5 to 10 percent of their excess body weight with diet and exercise, and if you have 100 pounds to lose, 5 to 10 pounds is not very helpful. The surgery helps get people on a level playing field with the rest of us who are trying to maintain. Without surgery, a large number of people cannot get close to a healthy weight.”

Neither surgery nor strict fitness is a panacea. Diet is the essential, once-and-future number-one rule for wellness. Health begins with nutrition, no matter what else you do. Albers says, “Diet is very important with both surgeries, and exercise is the catalyst that really jumpstarts weight loss. Weight-loss surgery is only a tool. Both surgeries require a lifestyle change to be successful.”

Tune says, “Most people just come in [to the gym] and they do the [weight training], but that’s only about 10 percent of it. Diet and cardio are everything. Your cardio and your diet are going to really be a difference in your body composition — mainly your diet.”

But getting the pounds off and keeping them there is Rule 1A. If you can do that, you’re well on your way to a life spent living well.