Better Health Care Newsletter - June 2023

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New weight-loss drugs: miracle or mirage?

Medical experts are rethinking obesity, one of the major harms to Americans’ health.

After investigating why heavy patients after bariatric surgeries lose significant weight — and tend to keep it off — researchers have zeroed in on the role played by hormones in digestion and why so many people pack on unhealthy pounds.

In case you missed the media buzz, the trend-setters and weight-obsessed see cause for optimism in drugs that were targeted at diabetes but also cause patients to drop big pounds. Pricey prescription medications like Ozempic, Wegovy, and Mounjaro have become hot commodities in Hollywood and in other wealthy, appearance-fixated communities — so much so that diabetics who could see real medical benefits from the drugs can’t get them.

What five takeaways do regular folks need now about weight loss, especially by medication?

1. Obesity soars, as does fat shaming

Here’s one of the health contradictions of modern life: Even as a spiking number of people experience serious problems carrying excess weight, fat shaming and bias against the overweight have become significant concerns. Women, especially, experience unfair stigma.

All the ugly words and deeds don’t help in getting rid of excess weight, and they can be painful and detrimental to those at whom they are directed, as a recent Harvard Public Health magazine article reported:

“One might think fat shaming would be trending down as the size of the average American has gone up, but perceived weight bias is actually rising. Among women, it’s now even more common than racial discrimination, according to work by Rebecca Puhl and colleagues at the Rudd Center for Food Policy and Obesity at the University of Connecticut. They and others have found that most Americans see weight as a matter of personal choice and willpower —and people with larger bodies as undisciplined and lazy …”

Citing a 2016 study in Medical Anthropology, experts say that weight stigma humiliates the heavy throughout their lives, causing them anxiety about their dress, whether they can fit in seats and beds, and if they will be demeaned or abused in person or online. As the study noted:

“Fat shaming is rife online, from snarky social media comments on the latest celebrity weight gain to websites devoted to sharing ‘funny’ photos and stories of fat people and their gluttonous behavior … Weight stigma raises people’s risk of being bullied as children and impairs their prospects in education, careers, and successful romantic relationships. It also increases the risk of depression and suicide, and of disordered eating and avoidance of physical activity that can ultimately lead to more weight gain. What’s more, the chronic stress from living with such encounters can lead to dysfunction across multiple body systems.”

This bias is harmful in medical care, as the article noted:

“[F]at shaming abounds in clinical medicine, according to Puhl and others. One study found that physicians were the second-most-common source of weight bias (after family members). Some doctors report feeling frustration toward heavier patients, which can lead them to spend less time with these individuals during appointments and fail to refer them for diagnostic tests.”

Still, the prevalence of weight problems among Americans is too high. The federal Centers for Disease Control and Prevention estimates that among adults in this country 20 and older, 73.6% are overweight or obese. To be clear what this means: A man who is 5-foot-9 and carries between 169 and 202 pounds is considered overweight, while guys that height who weigh 203 pounds or more are deemed obese.

The CDC also has warned that one in five kids older than 6 is obese. The spiking and unchecked increase of weight problems among youngsters has alarmed the American Academy of Pediatricians. The influential group issued major guidelines, urging doctors to consider obesity a serious health concern and to treat it aggressively a stance that has raised its own concerns among some experts. As USA Today described the pediatricians’ urgent pronouncements earlier this year:

“The American Academy of Pediatrics issued its first comprehensive guidance for evaluating and treating childhood obesity, recommending early and proactive treatment for children as young as 2. The new guidance suggests doctors may prescribe weight loss drugs to kids 12 and older who have obesity and may refer teens 13 and older with severe obesity for weight loss surgery, though situations may vary … the guidance has drawn scrutiny from advocates and other experts who say it contributes to weight stigma and could fuel disordered eating. They also criticize the guidelines because there is no long-term data for how weight loss drugs and surgery affects children and teens.”

2. Surgeries help advance a new option

With Americans pouring a king’s ransom into diet plans and taking other unsuccessful efforts to lose weight, surgeons devised their own path to obesity reduction. And it has played a prominent role in the latest re-examination of obesity and its causes.

In recent years, specialists have pushed bariatric weight-loss operations designed to reduce or alter the stomach or small intestine, limiting patients’ food consumption and their gut’s ability to absorb what they eat. This has evolved for some surgeons into laparoscopic, or minimally invasive surgery.

The advance of these procedures has been fraught, with exaggerated claims about them, fast-buck fraudsters exploiting patients, and discoveries about the proper patients for them and certain operations (lap bands) that worked poorly in comparison.

Over time, doctors and the public have figured out that weight-loss surgery can be helpful, notably for seriously obese patients — and not those who desire lesser or cosmetic reductions. The procedures require a long-term commitment by patients, especially with careful eating and exercise. The surgery is not risk free, and it comes with its own potential side effects. But it has become an important option for treating some patients with major problems with excess pounds.

The rising popularity at one point of bariatric surgery also fostered further digging into the already substantial research on how and why patients successfully lost weight. This has led to deeper knowledge about the role of hormones in the gut (including glucagon-like peptide 1 or GLP-1 and growth hormone RELeasing peptide or ghrelin). It also has advanced knowledge on the regulation of hunger, appetite, and the feeling of fullness or satiety when humans eat.

Big Pharma needed little prompting to invest big in the study of gut hormones, weight loss and diabetes, a chronic health condition in which obesity plays a giant, damaging role. Drug company executives recognized early on that their industry could be on the brink of a potential financial bonanza: a pound-melting pill or injection.

3. Do new weight-loss drugs work?

 

Ozempic. Rybelsus. Wegovy. Mounjaro. These drugs — and others likely to follow — have captured the public consciousness with an intriguing possibility: Can popping pills or taking shots keep us thinner and provide a convenient way to win the war on fat?

Almost two years ago, the New York Times described research on the potency of Ozempic in treating diabetes via regular injections. Researchers noted how the drug — introduced in 2017 and known by its generic name as semaglutide — affected patients’ blood sugar, appetite, and most importantly, their weight (a major aggravating factor in diabetes). As the newspaper reported of published data from a Northwestern University clinical trial using semaglutide at higher dosages and principally as a weight-loss measure:

“Nearly 2,000 participants, at 129 centers in 16 countries, injected themselves weekly with semaglutide or a placebo for 68 weeks. Those who got the drug lost close to 15% of their body weight, on average, compared with 2.4% among those receiving the placebo. More than a third of the participants receiving the drug lost more than 20% of their weight. Symptoms of diabetes and pre-diabetes improved in many patients. Those results far exceed the amount of weight loss observed in clinical trials of other obesity medications, experts said.”

The drug maker Novo Nordisk followed up its Type 2 diabetes-care Ozempic and Rybelsus (semaglutide taken orally) with a higher-dosage formulation targeted at weight loss and known as Wegovy. Eli Lilly has gained much attention with its diabetes drug Mounjaro.

The medication, with a different active ingredient, tirzepatide, has shown in off-label use “sharper reductions in blood sugar levels and greater weight loss than” drugs with semaglutide, such as Ozempic, Rybelsus, and Wegovy, the New York Times reported.  The federal Food and Drug Administration has approved Mounjaro for Type 2 diabetes treatment but not for weight loss.

Once the FDA has green-lighted a drug for use on U.S. markets, doctors, generally speaking, may prescribe it “off label” at their professional discretion for patients with other conditions.

But diabetics — the patients who may benefit most from Ozempic, Rybelsus, and Wegovy — have encountered shortages in supplies of the drug, especially as the weight-obsessed in Hollywood and other wealthy and glamor- and looks-focused areas of the country persuade physicians to provide the medication and scoop up supplies.

Much still must be learned about weight, obesity, hormones, and medications that help patients shed pounds. The latest weight-loss drugs, promising as they appear to some, have significant downsides (see below).

But they already may be playing a beneficial role in getting regular folks as well as medical experts to reconsider deeply held views about the overweight and obese, as health journalist Julia Belluz wrote in a recent New York Times Op-Ed:

“We tend to believe body size is something we can fully control, that we’re skinny or fat because of deliberate choices we make. After talking to hundreds of patients with obesity over the years and to clinicians and researchers who study the disease, let me assure you: Reality looks a lot less like free will.

“The advent of new and effective obesity drugs offers a stark illustration of this little-appreciated fact of physiology. The debates the medicines prompted also show how little we appreciate about obesity … At the very least, though, the way the [weight-loss] drugs work can teach us that people who are larger did not necessarily choose to be, just as people who are smaller did not — and are not morally superior. This ‘isn’t a free pass, either to individuals who do have the capacity to choose better, nor does it take the heat off of food industries,’ said a University of Sydney nutritional biologist, Stephen Simpson, but it’s ‘evidence that obesity isn’t a personal lifestyle choice.’”

4. Those hard-to-ignore negatives

While popular media reports may play up the significant weight losses that patients experience while taking new weight-controlling drugs, no one should overlook the medications’ downsides.

As the New Yorker magazine reported about the complications of taking Ozempic and Wegovy:

“Initial side effects (diarrhea, vomiting, constipation, dizziness, nausea) can be gnarly enough to send people to the E.R. Patients can also experience hair loss, a result that—like the gaunt look that has been termed, not without Schadenfreude, ‘Ozempic face’—is caused by rapid weight loss rather than by the drug itself. In rare cases, patients might develop renal failure, pancreatitis, or intestinal obstruction …”

The New York Times reported an extreme and rare side effect of taking weight-loss drugs: malnutrition. The newspaper said this:

“[S]ome people taking Ozempic can experience such intense lack of appetite that they do become malnourished,” said Dr. Andrew Kraftson, a clinical associate professor in the division of metabolism, endocrinology, and diabetes at [the University of Michigan’s] Michigan Medicine. Doctors say it is important that people are given clear guidance on proper diet and nutrition while on the medication. People who experience extreme outcomes from the medication may need to stop taking it altogether.”

But even as doctors cut some patients off from weight-loss drugs, those who can tolerate them find other challenges with the medications: They discover that they are costly, potentially thousands of dollars annually. And, for now, health insurers and government programs like Medicare won’t cover them or will put patients and their doctors through an ordeal to justify payment for them in weight-loss care.

The rising concern about weight-loss drugs and their cost — among employers, insurers, and taxpayer advocates — cannot be ignored, as some expert estimates see the annual added cost for Medicare alone in covering just Wegovy for older patients could exceed $27 billion.

The high cost of these medications has a whopping long-term worry, too: For now, the drugs, at best, make obesity a chronic condition. Translation: Patients see the pounds melt away, but only as long as they keep taking the expensive drugs.

Let’s say this part loudly: Doctors and patients lack rigorous, long-term research on these hot weight-loss drugs. They already know that patients who take them and then stop doing so regain weight — sometimes adding more pounds in a powerful “rebound” effect.

5. Still vital in weight control: Diet, exercise, sleep, and more

 

Despite the promise that many see in medication-based ways to control weight, tried and true approaches aren’t going away.

Good doctors still will be telling those on the latest drugs that they — like all of us who struggle with a few (or many) extra pounds — also must be eating with care, moving around as much as they can (exercising), getting plenty of restful sleep, not smoking, avoiding excessive consumption of alcohol, and minding the harmful role of stress in their lives.

Sure, the new meds may help users drop and keep off pounds. But those with sufficiently serious weight issues to really need the drugs must follow traditional approaches to boost their health. And this perhaps is an important, collateral point the latest drugs underscore: Weight is just one metric of our well-being. Maintaining it at lower, healthier levels is a positive.

This all can be easily undone, though, with a sedentary lifestyle, smoking, boozing, and downing excesses of fatty, salty, sugary, and highly processed foods.

While health experts long have warned regular folks against everything in the previous paragraph, it also is true that the latest diet drugs may bolster users against these health harms. As the New York Times reported:

“No standard nutritional guidelines have yet been established for patients taking Ozempic or other medications that work similarly, like Wegovy and Mounjaro. Doctors usually give similar dietary recommendations to people taking drugs like Ozempic and other patients who are trying to lose weight or who have diabetes, said Dr. Robert Gabbay, the chief scientific and medical officer of the American Diabetes Association. That means following a diet that is high in fruits, vegetables and fiber, like the Mediterranean diet, said Dr. Janice Jin Hwang, the division chief of endocrinology and metabolism at the University of North Carolina School of Medicine. Avoiding high-fat foods is also critical because they can make people taking Ozempic feel uncomfortably, even painfully full, Dr. Gabbay said. He urges people to eat slowly and pause halfway through a meal, assessing how full they actually are. ‘You could power through a cheeseburger and fries in five minutes,’ he said. ‘But wow, are you going to feel like you way overate.’”

Doctors and patients also report that the weight-loss drugs, as they affect the body’s digestive regulation and appetite, can diminish users’ desire for certain foods (especially those high in sugar and fat) and for alcohol (!). These effects have attracted attention and are under further study.

The consensus recommendations, for most regular folks, of course, change little and can be summarized: Eat less overall. Consume more plants, sustainable fish, and nuts. Reduce your intake of beef, pork, sugar, salt, and highly processed or commercial foods (including restaurant meals) that feature less healthy portions and ingredients. Skip the fast food and eating on the run. Instead, take time to cook (simply) and dine with friends and family.

As always, it is important for patients to maintain a solid relationship with a primary care doctor and to discuss ways to sustain and improve their health — including any medically appropriate weight control efforts.

Rx shortages are rampant, not only for diet drugs


For our pill-popping nation, this is shaping up to be a summer of discontent.

Even as Big Pharma keeps raking in sky-high profits, it is struggling to meet demand for its products, including for pricey and popular weight-loss / diabetes drugs. As the New York Times reported of the larger pharmaceutical worry:

“Thousands of patients are facing delays in getting treatments for cancer and other life-threatening diseases, with drug shortages in the United States approaching record levels. Hospitals are scouring shelves for supplies of a drug that reverses lead poisoning and for a sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still scarce following the winter flu season when doctors and patients frantically chased medicines for ailments like strep throat. Even children’s Tylenol was hard to find.

“Hundreds of drugs are on the list of medications in short supply in the United States, as officials grapple with an opaque and sometimes interrupted supply chain, quality and financial issues that are leading to manufacturing shutdowns. The shortages are so acute that they are commanding the attention of the White House and Congress, which are examining the underlying causes of the faltering generic drug market, which accounts for about 90% of domestic prescriptions.”

As for the suddenly trendy weight-loss medications, the Washington Post reported this:

“[S]oaring demand for the drugs has ignited a mad scramble, exposing some of the most persistent problems in the nation’s health-care system, including supply shortages, high costs and health-care inequities. Tensions are surging as patients with diabetes and those with weight problems sometimes compete for the same medications, which are self-administered in weekly injections. Some doctors worry that the drugs, which might have to be taken for life, will overshadow the need for lifestyle changes involving diet and exercise.”

The causes of the current drug shortages are complex and are rooted, in part, in Big Pharma’s obsession with maximizing profits, notably by manufacturing and sourcing its products overseas in cheaper markets like India and China. Americans got an ugly dose during the coronavirus pandemic of how industry efficiency efforts lead to “supply chain” snafus, shortages — and potential harms to U.S. patients. Big Pharma’s battles are also legend against advocates’ efforts to reduce drug prices by fostering the manufacture and availability of generic alternatives.

Doctors and patients alike are clamoring about the health risks posed by drug shortages. As the New York Times reported:

“The scarcity of generic forms of chemotherapy to treat lung, breast, bladder, and ovarian cancers has only heightened concerns. ‘This is, in my opinion, a public health emergency,’ said Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine and a president-elect of the Society of Gynecologic Oncology, ‘because of the breadth of the individuals it affects and the number of chemotherapy agents that are in shortage right now.’ The American Cancer Society last week warned that delays caused by the shortages could result in worse outcomes for patients.”

Mental health experts have assailed the months-long shortfalls in supplies of Adderall, a medication in widespread use to treat attention deficit/hyperactivity disorder, especially among younger patients.

With the weight-loss medications and many other drugs, shortages compound the U.S. medical system’s glaring problems with economic, gender, racial, and other disparities. The Washington Post noted that black and Hispanic women disproportionately battle obesity and diabetes and potentially could benefit in significant ways if their doctors prescribed the new weight-loss drugs. At the same time, though, these groups may lack the financial resources to compete with wealthy, white patients seeking minor weight losses and vacuuming up limited supplies.

The folks who run this country are deeply riven by politics these days, leading to gridlock, especially in the nation’s capital and in the looming run-up to the 2024 presidential campaign. But analysts and advocates have forecasted for a while now that lawmakers and the Biden Administration may find rare grounds for agreement and action on prescription drug affordability and access. Millions will be waiting and watching.

History gives cause for skepticism about pharma weight solutions

 

History gives skeptics ample ammunition to look with wariness at highly promoted weight-control efforts starring new drugs.

As the Washington Post reported of the public’s experience with medications touted for a time as miraculous aids to diet and the treatment of obesity:

“Complicating matters is the tumultuous history of weight-loss medications. For years, diet drugs were viewed as vanity treatments or outright quackery, and many were pulled from the market because of dangerous side effects, including death. After World War II, amphetamines, which suppress appetite but can be addictive, were used widely for weight loss. In the late 1990s, ‘fen-phen’ — a combination of fenfluramine and phentermine — was withdrawn after fenfluramine was linked to heart valve problems. Phentermine is still used. As recently as 2020, a drug called Belviq was voluntarily withdrawn amid concerns that it raised the risks of cancer.”

Chemical Engineering News, a publication of the nonprofit American Chemical Society, dug into the history of weight-loss drugs and reported further details about their troubled recent past:

“The 1970s and 1980s were a long dry spell for new weight-loss drugs. That ended in 1996, when the FDA approved dexfenfluramine as a stronger version of the previously approved weight-loss drug fenfluramine. Both drugs were part of a class of appetite suppressants called serotonergic anorectics, which work by lowering the amount of serotonin in the brain. Doctors had previously paired phentermine with fenfluramine, in an infamous combo dubbed fen-phen. Then came reports of heart valve damage in people taking fen-phen. In 1997, the FDA pulled fenfluramine and dexfenfluramine off the market, marking the beginning of a merry-go-round of regulatory rejections, approvals, and withdrawals for weight-loss drugs.

“Meridia (sibutramine) was approved by the FDA in 1997 and then withdrawn from the market in 2010 because of side effects that included an increased risk of heart attack. Rimonabant, the first blocker of cannabinoid receptor 1 for weight loss, was approved in Europe in 2006 but pulled 2 years later after the drug was linked to thoughts of suicide. Belviq (lorcaserin), a small molecule that stimulates a serotonin receptor, was pulled in 2020 after 8 years on the market because it was shown to increase the risk of cancer.”

By the way, doctors and patients need to conduct their own due diligence about new medications, especially about their side effects.

As recently as 2016, researchers provided a harsh reminder that even rigorous-seeming studies need careful reading, as was the case with information publicly disclosed about the diet drug orlistat, marketed in this country as Alli. As the science and medical news site Stat reported not that long ago about this medication:

“A weight-loss pill taken by millions of patients in the last two decades has been propped up by problematic clinical studies that ‘systematically understated’ the drug’s potential harms, according to a new analysis.

“Danish researchers who reviewed data summaries and published journal articles found that seven drug trials funded by the drug maker Roche in the 1990s downplayed the frequency of apparent side effects like diarrhea or incontinence. The drug, known to scientists as orlistat, and marketed in the US as Alli, has generated hundreds of millions in sales but has slumped in recent years in part because of a reputation for unpleasant gastrointestinal side effects.”

Alli, in brief, produced lesser weight losses (~10 pounds) by blocking the body’s absorption of fat. The consumed foods don’t disappear in the body and must be excreted. But users quickly found that it took eating or drinking very little (say a “grande” of that popular coffee shop ice cream-like drink with an Italianate name) to go beyond the makers’ recommended, single-sitting consumption of fat — with embarrassing results.

Users reported that, despite their most conscientious efforts, they found themselves running to bathrooms and still ruining clothes and bedding, and even needing disposable adult diapers when trying to deal with the explosive consequences of this weight-loss drug.

Recent Health Care Developments of Interest

Here are some recent developments reported in mainstream media that might interest you:

For regular folks who run afoul of the law, the consequences can be swift and dire. That’s not so for doctors, hospitals, and others in the U.S. medical system, Reuters determined. An investigation by the news service found that “at least 540 doctors and health care practitioners collectively paid the government hundreds of millions of dollars to negotiate their way out of trouble via civil settlements, then continued to practice medicine without restrictions on their licenses despite allegations that included fraud and patient harm …That figure is the result of the first-ever comprehensive analysis of federal civil settlements and state disciplinary actions. Separately, more than 2,200 hospitals and health care companies likewise negotiated civil deals to sidestep prosecution for alleged offenses that included paying bribes, falsifying patients records, and billing the government for unnecessary patient care … In many of those cases, the physicians, staffers and top brass who purportedly committed those misdeeds were not named publicly by prosecutors or forced to pay settlements themselves.”

With the encouragement of federal authorities and their purported cost-saving policies, patients have flocked to free-standing vascular surgery clinics for what they hope will be minimally invasive procedures to relieve pain and worse from fat-clogged veins and arteries in their limbs. Instead, an investigation by the Pulitzer Prize-winning website ProPublica finds a “Wild West” frenzy for risky, costly and often unwarranted operations that harm patients. ProPublica zeroes in on suburban Maryland surgeon Jeffrey Dormu, finding he “was part of a small pool of physicians performing a disproportionate number of treatments. From 2017 to 2021, the analysis shows, the top 5% of doctors conducting atherectomies — about 90 physicians overall — accounted for more than a third of all procedures and government payments, totaling nearly a billion dollars … [The U.S. government] paid Dormu more than $30 million in the past decade for vascular procedures he performed on hundreds of patients.”

Vacancy rates are soaring in the crucial positions of nursing home inspectors, USA Today reported, based on the digging of congressional investigators. Thirty-one states and the District of Columbia report 20% vacancy rates, with Kentucky (83%), Alabama (80%), and Idaho really lagging (71%) in keeping the watchdogs working. After the coronavirus pandemic tore through facilities, sickening and killing disproportionate numbers of staff and residents, politicians and regulators, as well as owners and operators pledged to improve infection-control and other measures in nursing homes. But if inspectors, hired by states, aren’t on board to provide front-line oversight of the facilities, how will they be improved?

With research and data piling on and experts relentlessly re-evaluating what they know, patients may need to keep a running scoreboard on important aspects of their medical care. In brief, and in case you missed it, as the New York Times has reported: 1. A key federal advisory group now says that women at average risk of breast cancer should start getting mammograms at age 40, rather than 50 2. Too many older men may be undergoing testing and treatment for prostate cancers, many of which are slow-growing and less threatening than once thought. 3. Gay and bisexual men will be allowed to donate to the nation’s desperately short blood supply, as regulators now focus on recent sexual activity of all donors as a risk factor for infections.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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