Return to the discussions on Sermo JACC Retracts AF Ablation TrialHigh Response Rates With Novel Drugs in ALLPatients Needing High-Dose Opioids May Have Genetic DefectsRA Patients Getting Older, With More ComorbiditiesOld Treatments Top New Cluster Headache Guidelines Slow MedicineBetter Care, With Less Slow Medicine: Digesting the Stomach Drain Data AspireAssist approval shows defects in FDA's device review process This article is a collaboration between MedPage Today® and: Earlier this month, the FDA approved a novel weight-loss approach: using a small tube – called an "A-tube" -- to drain stomach contents after each meal. The A-tube is placed just as a percutaneous endoscopic gastrostomy tube would be. But rather than using the tube for feeding, the A-tube is used by the patient to drain about a third of stomach contents into the toilet after each meal. In case you're curious, here are some additional details about the device:Patients should allow 20-30 minutes after each meal to drain stomach contents into the toilet.

The tube's diameter is smaller than a G-tube, so all food needs to be "thoroughly chewed" prior to swallowing. If the A-tube (brand name "AspireAssist") were a weight-loss pill, the FDA would have required at least two large, long-term, placebo-controlled randomized trials with efficacy and safety endpoints prior to approval.Small Puppies For Sale Red Deer However, as a device, the barriers to entry into the market are much lower. Diy Weight Loss PillsIn fact, the FDA's approval is based solely on an industry-funded feasibility study involving just 18 patients and another small industry-funded randomized trial involving 171 patients that has yet to be refereed through the peer-review process.Buy Bamboo Curtain In the trial involving 171 patients, AspireAssist appears to have led to weight loss.

According to the FDA's report, after 52 weeks there was a mean weight loss of 12.1% among patients in the A-tube group versus 3.6% among control patients. However, there were also a substantial number of adverse events associated with the A-tube, including pain, nausea, electrolyte disturbances, and a case of peritonitis. We also don't know whether the device can reduce rates of metabolic diseases like diabetes or hypertension as has been the case with bariatric surgical procedures (unlike the A-tube, bariatric surgery also impacts hormones and other internal regulators). Moreover, the A-tube might create new forms of eating disorders, and we do not yet know if the benefits outweigh the downsides from the patient's perspective. The streamlined approval process for medical devices also means that the FDA has made its regulatory decision before much of the data have been published in a peer-reviewed journal and scrutinized by the scientific community. It is possible there are important methodological shortcomings of this analysis that the FDA missed.

In fact, the industry researchers presented the findings in a misleading manner by reporting percentage "excess weight loss" rather than percentage "total weight loss" as the primary endpoint, which accentuates the magnitude of the result. In summary, obesity impacts quality of life and drives chronic conditions that shorten and reduce the quality of our patients' lives. There is clearly a need for continued innovation to identify new strategies for promoting weight loss. But from our Slow Medicine vantage point, removing food directly from the stomach after eating using an A-tube remains an experimental approach that is not ready for widespread use. We will await an adequately sized clinical trials designed to determine whether or not this new approach actually works, and if so, when it should be considered. More generally, the approval of the A-tube reminds us how inadequate the FDA's process is for reviewing and approving medical devices. "Updates in Slow Medicine" applies the latest medical research to support a thoughtful approach to clinical care.

It is produced by Pieter Cohen, MD, of Harvard Medical School, and Michael Hochman, MD, of AltaMed Health System in Los Angeles. Rachael Bedard, MD, is a palliative care fellow at the Mount Sinai Hospital in New York. To learn more, visit their Facebook page.Is this the equivalent of assisted bulimia? Fat shaming has become an accepted practice around the world, especially in developed nations such as America, where 160 million people are overweight. Unfortunately, instead of teaching citizens that their best defense against gaining weight (which predisposes one to diseases of affluence, such as heart disease, diabetes, and even cancer) is a healthy diet, exercise, positive thoughts, and purpose in life, mainstream media promotes the idea that quick-fixes, such as pills and various powders, are all the solution one needs. The issue is, clean eating and regular exercise are the only effective methods to lower one’s body weight to a healthy Body Mass Index (BMI) and protect oneself from developing illnesses later on in life.

Because many people are resistant to change, however, and would prefer to maintain their unhealthy habits, devices such as the stomach pump have been developed and approved by the FDA. CNBC News reports that earlier this week, the government organization approved a stomach pump, which is described as a “reverse feeding tube,” to help people lose weight. That’s right, the device is basically an exit pump that dumps part of the stomach contents into the toilet. Similar to gastric bypass surgery, the pump is designed specifically for morbidly obese people. It’s touted to help individuals who eat the wrong foods and/or can’t control their appetite to lose an average of 12% of their body weight. The agency relayed in a statement: “It is intended to assist in weight loss in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy.” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health (CDRH), stated in a press release:

“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy. Patients need to be regularly monitored by their health-care provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake.” The device might appeal to those who are frustrated with their weight and health because it is considered to be minimally-invasive. First, a tube goes from the inside of the stomach to a port on the outside of the abdomen. Patients can then attach the pump to the outside port as needed. The AspireAssist removes about 1/3 of the stomach’s contents a time. Keep in mind, though, food from the stomach will look considerably like vomit. Those who are squeamish probably shouldn’t invest in such a temporary solution for weight loss. The device has been hailed as ingenious by many but outrageous by others. After all, isn’t purging the contents of one’s stomach technically bulimia?