Wegovy Weight Loss Drug Approved'So What's Next?

Mila Clarke Buckley, a YouTuber, shared her positive experiences with Ozempic in February 2018. This anti-diabetic medication is administered via subcutaneous injections every week. It was approved for the first time by FDA in 2017.She recalled that her high blood sugar (the hallmark of diabetes) had decreased over the past two months, her persistent and intense cravings for food had disappeared, and her weight loss was consistent. She also experienced nausea and constipation for a few days after she switched to a higher dose. This was almost enough to force her to stop using the drug. Buckley persevered through the initial turmoil and described it as a miracle drug that helped lower her blood sugar. This was a long-standing frustration she had shared in previous videos. Both her videos had comments from curious viewers and Ozempic users, who supported her claims of newfound success with managing diabetes and losing weight.AdvertisementIt was almost instant after I began taking it. In two months, I lost eight pounds. This was a huge success for me because I have always struggled with this," Buckley, a blogger, speaker and author who often talks about her diabetes experiences on her YouTube channel, told Gizmodo by phone. It's really amazing that it works in this manner. I need it for my weight loss, which was always something I wanted for myself. But I also needed it to help with my diabetes management.Buckley's review will soon be relevant for a greater number than the 34 million Americans who are currently diagnosed with diabetes. The Food and Drug Administration approved Novo Nordisk's latest video. It was designed to help obese people, which is a term that has been controversially referred to as having a higher body mass than 30.People will not feel less stigma if they have a medication that shows that their weight is not under their control.Doctors and scientists have both praised semaglutide, the active ingredient in both drugs. It is a game-changer in obesity treatment. This is because it has helped people lose significantly more weight than previous remedies. Also, it appears to have an effect on many aspects of our biology that are related to obesity like our metabolism.AdvertisementThere are still many obstacles that stand in the way of this potential. These include whether insurance companies will cover it or the unknown long-term risk of a treatment that is likely to be required for a lifetime. Experts and activists question the value of antiobesity medications and are concerned about the potential for medical fatshaming, pharmaceutical profiteering, and the open floodgates that Wegovys approval could open.Semaglutide is a member of a group of drugs called GLP-1 agonists. GLP-1 stands for hormone glucagonlike peptide 1. It regulates many bodily functions. Donna Ryan, a long-standing obesity researcher and professor emerita at Pennington Biomedical Center in Louisiana, says that one of these roles is to be part of natural balancing acts such as digestion and metabolism.It stimulates insulin production in the pancreas when blood sugar spikes. This stabilizes blood sugar levels. It slows down food emptying and reduces stomach acid production. This leads to a feeling of fullness. It also reduces appetite and cravings in the brain. GLP-1 drugs are similar to GLP-1 molecularly. They essentially increase the body's supply, but also stay longer in the body.These drugs are different from native GLP-1 because they have been modified to last longer. Ozempic has a half-life of just 1-2 minutes while native GLP-1 has over 150 hours. Ryan, who received consulting fees from Novo Norodisk, shared his story with Gizmodo via email.AdvertisementYou can balance the biological process that has gone haywire in people with diabetes by amplifying GLP-1. This is especially true for insulin. Type 1 diabetes does not produce insulin anymore, but type 2 and latent auto immune diabetes can continue to make it until their condition worsens. These metabolic issues can also be caused by obesity, which is a risk factor for type 2. GLP-1 drugs may be used to treat these problems.Researchers find semaglutide's biology fascinating, but also its actual results. Novo Norodisk published the results of the first of many large, double-blinded and placebo-controlled trials that tested semaglutide in obese patients earlier this year. People who received the drug once a week just under their skin lost significant weight compared to those who were given placebo. One pivotal trial reviewed for FDA approval showed that the average weight loss of a person from their baseline was 15% over 68 week.Wegovy, like Ozempic is administered subcutaneously every week in increasing doses to aid users adapt. It is approved for those with obesity, people with a higher BMI than 27, and people with at least one weight-related condition. This is the first approved new weight loss drug since 2014. Even that doesn't reflect the difficulty in finding a treatment that can help people lose weight.While exercise is a great way to live a long and healthy life, it's not the main driver of weight loss. It is important to eat healthy, but it can be difficult to sustain long-term weight loss even with a steady diet change. Most weight loss treatments are only temporary. Past treatments such as Fen Phen or 2,4-Dinitrophenol (DNP), were removed from the market due to their potentially fatal side effects. DNP, in particular, could cause heat stroke, which is when it raises the core temperature of the body too high. Although the most effective bariatric surgery can help people lose 20-30% of their weight, it is often a costly and life-altering option that very few people actually choose to take.AdvertisementThe results were impressive, and not comparable to any other drugs. Clifford Rosen, a New England Journal of Medicine editor who co-authored an editorial on Novo Nordisks research regarding semaglutide, said that there is strong reason to consider this drug for primary weight loss.Rosen is also the director of clinical research and translational research at Maine Medical Center Research Institute.Wegovy seems to be the miracle that weight-loss sufferers who are worried about their health and weight goals can only dream about. This is especially true after all the media attention and research showing that covid-19 has caused weight gain. It was estimated that 42% of Americans were obese between 2017 and 2018. It is likely that it will be more complex.One is the issue of medical coverage. Traditional weight loss procedures, despite their potential health benefits, are not covered by basic insurance plans. This means that Wegovy would not be covered by either the government through Medicare or Medicaid. Without coverage, Wegovy will cost between $1,000 and $1500 per month, which is approximately one-fifth the annual median household income in America.AdvertisementNovo Nordisk offers coupons to potential patients and other ways to cut down on out-of pocket costs. It is also trying to convince third-party pharmacy benefit managers and private insurance companies that Wegovy should not be considered an alternative treatment for chronic conditions like type 2 diabetes. It is not yet clear if these efforts will pay off.Gizmodo reached out only to Cigna regarding Wegovy from the many U.S. insurance companies. Cigna, its health services company Evernorth, announced shortly after the approval that Wegovy would be covered in its specialty weight management program. The program is offered through Express Scripts (the pharmacy benefit manager that merged in 2018 with Cigna). Employers would need to make sure that their employees have access to the plan. Employees would also have to purchase into it before they could get Wegovy. Cigna's baseline coverage for Wegovy is still up in the air.Cigna stated that Wegovy will be reviewed by our independent Pharmaceuticals and Therapeutics Committee, which will make a determination about coverage in the coming weeks.Public plan members are facing even worse consequences. The 2006 Medicare Part D statutes, which provide coverage for prescription drugs, exempt weight loss drugs from basic coverage. Although individual Part D providers may still be able to cover Wegovy under their plans, they are limited to enhanced plans and states Medicaid plans can cover these drugs if necessary. According to the current law, a representative for Centers for Medicare & Medicaid Services said that basic Medicare plans won't cover weight loss drugs, Wegovy included.AdvertisementThere are still long-term questions that remain about semaglutide, beyond the immediate financial challenges.Most common drugs, such as antibiotics, can only be taken for a short time until the condition clears up. It seems unlikely that semaglutide, at least for weight loss, will be one of these drugs. Novo Nordisk funded another trial in which people who had been on the drug for 20 weeks were compared with those who stopped taking the drug for 48 weeks. Both groups had a lower BMI than they did before the trial began. However, people who were off semaglutide lost more than half their weight, while those who were on it continued to lose.Although it is an acceptable length of time for a clinical trial, it will not be comparable to the many years or decades that may have passed since semaglutide was first introduced. Although it was well tolerated during trials, the most common side effects were the temporary gastrointestinal symptoms described in Buckley and other users. However, there are theoretical risks of longer-term or more serious side effects. GLP-1 has rarely been linked to acute pancreatitis (an inflamed pancreas), which raises concerns about a potential increase in pancreatic cancer risk. GLP-1 drugs have been shown to increase the risk of medullary thyroid carcinoma, a rare form of cancer.This issue could also be related to weight loss medications. After post-market safety data showed that people on the drug Belviq were more likely than others to get cancer, FDA requested that the FDA pull the Japanese pharmaceutical Eisai's appetite suppressant drug Belviq.AdvertisementSemaglutide is not known to be a risk factor for cancer. Some researchers found a link between medullary cancer and GLP-1 drugs. However, other research has not shown a link between GLP-1 and pancreatic cancer. GLP-1 drugs, including Wegovy are all recommended to warn patients about pancreatitis. Doctors should also warn them against prescribing them if there is a family history of medullary or other genetic mutations.These weight loss studies have been approved by the FDA based on short-term data. We don't have long-term weight loss drugs, if you think about it. For certain drugs, we are talking about five to ten years. This is a completely different game. Clifford Rosen acknowledged that there might be off-target effects. He said that the odds of finding something unexpectedly off-target are very slim. He also pointed out that type 2 diabetics have used these drugs for many years without major problems.These weight loss studies have been approved by the FDA based on short-term data. We don't have long-term weight loss drugs, if you think about it. For certain drugs, we are talking about five to ten years. This is a completely different game. Yes, there are some off-target effects.Other weight loss products have been known to be addictive. These drugs were often stimulants. They can reduce appetite and provide a feeling of euphoria which can lead to addiction. None of the experts I spoke to thought that Wegovy would pose a similar risk to stimulants, or at least not in the same manner. Ryan stated that it does not seem to alter mood and anyone trying to take a higher dose of Wegovy would likely be discouraged by the increased risk of nausea and vomiting. Ryan also said that there was little chance of it being used by people who are not prescribed, such as people with eating disorders like anorexia.AdvertisementPeople with anorexia may want to try Wegovy. I'm sure people with this condition would also want to try it. However, it would be difficult to obtain it and no reputable doctor would recommend it. The GLP-1 RAs in Brazil are removed from the label to aid cosmetic weight loss. However, this has not happened in the U.S. The $1,300 monthly price is deterrent.Every drug has side effects and risks. This must be weighed against the potential benefits to determine if it is worth the risk. Many experts and the FDA believe that semaglutide is able to treat obesity better than any other prescription drug.This is a way of framing obesity and fatness as something that can be fixed, although there are varying opinions on what that something is. Current medical consensus says that obesity is a chronic condition that is caused by a complex combination of factors that are not always controlled, such as our environment and genetics. This can lead to poor health and a loss of quality of life. While many people may agree that obesity is a serious problem, they still view it as a failure of willpower and lifestyle, despite all the evidence to the contrary. However, there are many people, including doctors and academic researchers, who doubt both of these prevailing narratives. For some, Wegovy doesn't represent a paradigm shift; it is just more of the same propaganda that they have seen throughout their lives.It was instant, these alarms in me, because I was like "There's no such thing" as a game-changing drug. Marquisele Mercedes, a researcher and activist in the fat acceptance movement, spoke to Gizmodo via phone. Because pharmaceutical companies are notoriously sloppy, I was completely like, This is not the end of the story.AdvertisementMercedes wrote an extensive critique of Wegovy's approval and the praise it received in late June. She noted, among other things that Novo Nordisk funded the trials that were approved and that many of those involved in these studies or who promoted the success of Wegovy received research funding or outside payments from Novo Nordisk. This is a common practice that results in industry-funded research tend to be more positive than those from non-industry research.Mercedes pointed out that Victoza was once the subject of a federal lawsuit and had to pay $60 million to settle it. This was in response to its marketing efforts to doctors to downplay the potential risks of medullary cancer caused by Victoza, an anti-glp-1 drug. (At the time, FDA had also endorsed Victoza because of its additional benefits in reducing stroke risk in patients with type 2 diabetes.These arguments aside, Mercedes and other critics of the fat acceptance and body positive movements suggest that the underlying premise behind weight loss treatment may be less sound than many think.This assumption is so deep that if you are fat it will be bad for your health. Harriet Brown, a journalist and author who writes about weight loss science, said that it is not being questioned. She has argued in the past that diets and other tired methods of weight loss have been counterproductive and ineffective for helping people remain healthy.AdvertisementMany people are unhappy with the standard BMI measurement of health. For example, two people with the same body mass index (BMI) can have very different bodies depending on their height and how much fat and muscle they have. It is more confusing to realize that higher BMI does not necessarily correlate with poorer health. Some studies have found a paradox in obesity, in which people who are obese or overweight live longer and have better health outcomes than those with normal BMI. People on the extremes of BMI have the worst outcomes.Researchers have suggested that although people with obesity may experience some health problems, many of those issues can be attributed in part to the stigma surrounding weight and discrimination that they are subjected to by others, including their doctors. This could even prevent them from engaging in healthy lifestyles like exercising. Studies have shown that obesity can lead to permanent health problems for people who lose weight only to gain it again.I would like to know if this drug actually makes people healthier.The debate about obesity and health is still raging. There's a stronger connection between obesity and certain conditions, especially type 2 diabetes. However, most people who are obese do not get diabetes. It does raise the possibility that obesity is not a death sentence. Some researchers even advocate for the abandonment of BMI as a primary screening tool. If that is the case, Wegovy might not be the answer to our prayers. It isn't because it doesn't work as planned, but because it is trying to solve a perceived problem of fatness that may not be as dire as some believe.AdvertisementI would like to know if this drug actually makes people healthier. Brown stated that we don't know the answer.Since decades, social movements that deal with fat activism have been around. Recently, however, they have received more positive attention since concepts such as body positivity and body positivity have become mainstream (if ever productively). There will be many people who are eager to use Wegovy. Wegovy will not be a quick way to lose weight for many potential users. Researchers and doctors who specialize in obesity argue that having an effective antiobesity medication on hand will reduce the stigma surrounding obesity. It will make it clear that obesity is not a matter or willpower. Instead, doctors will be able to manage it with a reliable method.Raychel Vasseur was one of the initial customers of Calibrate. This company is aiming to help people lose fat by combining nutritional and lifestyle counseling with prescription medications, especially GLP-1 drugs. (Donna Ryan, one of Calibrates scientific advisers, is also one of Calibrate's first customers). Vasseur said that she was hesitant about taking medication to aid weight loss. After consulting her Calibrate doctor she decided it was the best way to manage her metabolic issues and her overall health. In an email, she stated that the medication has helped her reduce cravings for unhealthy foods and the fatigue that she experienced after eating them.Wegovy will likely be just one of many innovative obesity treatments in the coming months and years. Many pharmaceutical companies are currently conducting clinical trials for GLP-1 candidates and drugs that mimic other gut hormones. Novo Nordisk published preliminary results of a Phase 1 trial of semaglutide and the amylin analog cagrilintide. These drugs seemed to have a greater weight loss than semaglutide, although there were more adverse effects such as nausea, vomiting, or indigestion in the combination group.AdvertisementDonna Ryan and other researchers are optimistic that future studies will show that GLP-1 drugs can help obese people lose weight, as well as improve other indicators of health. She is one of the many scientists behind the SELECT study, which measures cardiovascular outcomes in overweight and obese patients who have had a history or cardiovascular disease.She said that one of the obstacles to obesity medicine is that there has not been any evidence that weight loss can improve hard outcomes such as death, stroke, or heart attack. This is the reason why obesity has been portrayed as something that can easily be controlled.Calibrate members can sign up for a year-round program that costs $129 per monthly or $1,550 annually. The company claims that it will work with private insurance companies to make sure drugs such as Wegovy are covered. However, those with high deductibles will still need to meet their out-of pocket limit. Calibrate claims that it will reimburse customers if they are not satisfied with their insurance coverage.For those on Medicare who wish to use Wegovy, this might not be as much of an issue in the future. In March, Senators Kevin Cramer, Tom Carper, and Bill Cassidy (R.LA) reintroduced The Treat and Reduce Obesity Act. This legislation would eliminate Medicare's restriction on coverage for obesity treatments. This bill is rare in these days and has received support from many organizations related to obesity and public health. It also received support from companies that could benefit from it, such as Novo Nordisk. In recent years, two of its co-sponsors were given significant campaign donations by the insurance or healthcare industry.AdvertisementIt is possible that Wegovy could be the beginning of a new era in obesity research and treatment. It may improve people's health and lead to weight loss. People like Brown and Mercedes worry about what the future holds if Wegovy is as successful and popular as they hope. Even mediocre weight loss medications like Novo Norodisks Saxenda, which have recently made $1 billion annually in sales, are not as profitable.Mercedes mentions that there are potential side effects of Wegovy. Mercedes also disagrees with the notion that having more effective anti-obesity medications available will make it easier for fat people. She believes that fatness is still a disease and should not be treated as such.Mercedes stated that it doesn't matter if you continue to stigmatize the condition. She cited research that showed that people who believe obesity is a disease don't have a tendency to discriminate against fat people. People will not feel less stigma if they have a medication that shows that their weight is not under their control.Brown and Mercedes also said that they don't mind anyone wanting it.AdvertisementI can understand the appeal of weight loss and would encourage anyone to pursue it. However, I ask them to think about why they are taking this drug. Are you willing to take this drug every day for the rest of you life because you believe it will make your body healthier? Brown stated that the jury is still out on this. However, people will have other reasons for wanting to live smaller bodies in this fatphobic culture. How can you deny that? This whole diet cycle has been a challenge for me many times. If your health is your primary concern, there are many more productive ways to think about it.