FDA Decision May Double Weight Loss Surgeries
More people may soon be losing weight through surgery. That’s because the FDA is reviewing a study by Allergan. Allergan is a pharmaceutical company that hopes to increase the number of people who qualify for surgery.
The FDA is already responding favorably to the study. It just issued a press release saying the surgery offers “statistically significant decreases in weight loss.”
And if the bid is approved, Allergan plans to to target teenagers next.
But there’s evidence that the expensive surgery poses side effects. It even resulted in death for one 27-year-old woman. Plus, it only reduces weight… without offering the many health benefits that come from losing weight through a healthy exercise and diet program.
Going the Lap-Band Route
Allergan has requested that the FDA review a new study. The study was funded by Allergan. It shows that people who opt for surgery – using the company’s Lap-Band device – lose weight.
So how does Lap-Band work? Doctors surgically implant an artificial pouch at the top of your stomach. The “upper stomach” pouch is attached to your stomach through an outlet called a stoma. And because the pouch is so small you feel fuller quicker. Which, in theory, means you eat less.
In a bid to show the benefits of the surgery – and allow more people to qualify for it – Allergan has produced a study for the FDA to consider as the basis for its decision.
The study followed 149 people who each had the surgery. None of them qualified for surgery under the current threshold. The study reviewed their progress over 12 months. At the end of one year, about 65 percent had lost 30 percent of their excess weight.
But this doesn’t mean 30 percent of overall body weight. They lost up to 30 percent of excess weight. So if they were 50 pounds overweight, they lost one third of that. In other words, about 17 pounds in total – over one year.
The operation costs about $17,000 to $20,000. Allergan is keen to promote the surgery as a cheaper, less risky alternative to gastric bypass surgery. They note that the Lap-Band route is less invasive and costs less. (Gastric bypasses cost $20,000 to $30,000.)
Lap-Band Is Less Risky
Allergan is keen to note that the Lap-Band is less risky than a gastric bypass. The incisions are smaller. So the overall trauma is less. But that doesn’t mean it’s safe. Or without its share of side effects.
Other studies show that a third of patients have the band removed. They cite side effects as one reason and short-term benefits as another.
But the results of the surgery can be much worse.
A 2008 study shows that four out of every 1,000 patients die within 30 days of surgery. That breaks down to one in every 250 people. A follow-up survey suggests that deaths occurring after one month are simply not reported.
The Allergan study certainly doesn’t reference Rebecca Quatinetz. She died last year at age 27. Just two months after getting Lap-Band surgery.
Her mother – a New York lawyer – is speaking out about the dangers of the surgery. She went on record with The New York Times. “Before they start putting the Lap-Band on patients,” says Stephanie Quatinetz, “the public has to be made aware of how dangerous this is.” FDA Decision Pending
The FDA is currently reviewing the Allergan study and considering Allergan’s request to lower obesity classifications. If they do, more people will qualify for the Lap-Band surgery.
If the FDA approves the request, the number of Americans eligible for surgery will double.
Currently, weight loss surgery is approved for people who have a body mass index (BMI) of 40 and above. People with diabetes or high blood pressure are eligible with a BMI as low as 35.
The requested threshold to qualify for Allergan’s surgery is a BMI of 35; 30 for those with health problems.
Those figures are much more significant than they sound. Government statistics show that a five-point difference in BMI will double the number of people who qualify for surgery.
The same statistics show that 20 percent of adult Americans have a BMI of 30 to 35. Fewer than 10 percent have a BMI higher than 35.
In simple language, a man who is 5 feet 9 inches tall needs to weight at least 270 pounds to qualify for surgery right now. If the bid is approved, he’ll only need to weigh 203 pounds.
“You’re talking about millions and millions of people who would meet these criteria,” says Dr. George Blackburn, the associate director of Nutrition at Harvard Medical School. “Let’s make sure by the most rigorous research that this is safe and effective.”
And he doesn’t think there’s been nearly enough research done.
So why change things now? The FDA approved the original guidelines for weight loss surgery in 2001. The Mayo Clinic estimates that more than 220,000 Americans had bariatric surgery in 2009. That’s double the surgeries performed in 2003.
Allergan’s obesity products generated $258 million in revenue last year. Most of those sales came from Lap-Band sales.
But one glance at recent financial reports shows that Allergan is losing sales – fast. Sales of its obesity products – mainly Lap-Band – have slipped by four percent. Company execs say it’s because of the tight economy.
Allergan’s requested change in the weight loss surgery policy will create a much wider revenue source. In fact, the FDA approval may boost sales to $390 million in 2016. That’s according to Louise Chen, an analyst with Collins Stewart LLC in New York. If unemployment continues to decrease it’s even better news for Allergan. Chen estimates sales could climb to $500 million.
Allergan also wants to begin marketing the surgery to teenagers. They’re already seeking FDA approval to do just that. And some doctors are already operating on extremely obese teenagers. Lowering the BMI requirement will open that avenue to a much wider group.
Take Control of Your Health
At the end of the day, this option cuts out fat. But fat is just a symptom of a deeper underlying problem. Weight loss surgery doesn’t repair the damage done to the cardiovascular system. But eating well can do that.
While Lap-Band is cheaper and less risky than gastric bypass operations… a simple diet is at least as effective and offers no risk or expense.
Plus it offers a healthy change that can be maintained long-term. Whereas studies show Lap-Band surgery offers short-term benefits.
Don’t believe a natural safe option can be as effective as drugs or surgery?
A recent study – published this year – shows that a low-carb diet achieves better weight loss than the drug Orlistat.
So what’s the best option for a sensible weight loss program that also promotes all-round health?
You need a diet that is high in protein and healthy fats. You can ensure that protein and fat is healthy by opting for hormone-free, grass-fed meats and cage-free eggs.
You also need a diet that has a good ratio of omega 3 to omega 6 fatty acids. Great sources for omega 3 fats are wild-caught, cold-water fish and simple walnuts.
Your diet also needs to be low in carbs and grains, which spike blood sugar and wreak havoc on your hormones, leading to fat production.
This kind of diet helps you to lose weight sensibly and safely. It also helps you combat health issues like inflammation, which is a root cause of diseases like arthritis, diabetes, and heart disease.
When you load that diet up with antioxidant-rich fruits like berries and cherries you also build up your energy and immune system. Which helps you fight disease.
You can read more about eating a diet that promotes weight loss and good health right here.
Or sign up to get a full report on balancing protein, fat, and carbs in our in-depth health advisory newsletter, Natural Health Dossier.
To your health,
NHD “Health Watch”