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Monday, July 3, 2023

NYC moms are flocking to ‘shady’ clinics for off-brand Ozempic

 The ever-expanding popularity of weight loss injectables has NYC moms clamoring to get their shots — even if it means resorting to “shady” and “unethical” measures. 

Ozempic and Wegovy, brand name semaglutides initially designed for people with Type 2 diabetes, have surged in demand due to their controversial effectiveness as weight loss drugs

And despite the FDA’s warning against using off-brand semaglutide compounds due to their potential “adverse effects,” a shortage of brand-name drugs and their hefty $1,300-a-month price tag is motivating people to seek cheaper, more accessible options.

One 40-year-old fashion executive and mom of three who lives on the Upper East Side, who wished to remain anonymous, told The Post she is currently taking off-brand semaglutide in the hopes it will help her lose the excess baby weight, a “hush-hush” trend she said is permeating her affluent Manhattan neighborhood. 

“You see people and they lost 30 pounds and have this face that is smaller,” she said of the moms she knows who have mysteriously shrunk. Even though she suspects they are on semaglutide, she called Upper East Siders “judgmental” and suspects that “Ozempic shaming” keeps them from dishing out their diet secrets. She claims moms are more outspoken about it in other cities. 

“I actually had the idea to take it after seeing a post in a Midwest moms group,” she said. “One mom asked a question about taking it, and there were like 200 replies of women saying, ‘I took it, and I lost 50 pounds, and I had no side effects.'”

Some Upper East Side moms who feel pressure to lose baby weight are seeking out off-brand semaglutide to help them shed pounds.
Some Upper East Side moms who feel pressure to lose baby weight are seeking out off-brand semaglutide to help them shed pounds — despite the risks. Note: This photo is a creative illustration and not an actual depiction of moms getting semaglutide from clinics.

She called her primary care doctor a month ago to see if he could prescribe her a brand-name injectable to help her get back to her 118-pound pre-baby body. She’s struggled to lose weight after giving birth to twins via IVF in 2018 and getting pregnant with a baby girl just 9 months later. The mom, who is 5’2″ said she lost 20 pounds on her own, but her weight loss plateaued, and she suffers “a lot of pain” in her legs. 

“I said, ‘Hey, I’ve heard a lot of moms taking it, and is it safe? And do you think I can get a prescription from you?’” she recalled. He said: “‘Listen, it doesn’t hurt, but you probably won’t get covered by your insurance.’ So, he didn’t want to give me a prescription because I’m not obese, and I don’t have diabetes.”

When her doctor said no, she Googled “semaglutide New York” and said she found Elite Health Center NYC. 

“It’s super shady,” she said of her opinion on the weight loss center, but added it seemed “legit enough” after asking them questions over the phone. “It was important to me that they had a real location. So I Googled them to see if they have a real storefront that they’re not, you know, somewhere else,” she said.

She added they “seemed like they knew what they were doing,” and that after filling out an intake form from them, she had a “super fast” phone call with a doctor and a prescription that same day. 

“The doctor just wanted to make sure I was healthy and didn’t have any kind of disease. He knew that I wanted the medication to lose weight, but he didn’t really ask if I had an eating disorder or things like that,” she said. “He said I seemed like a great candidate,” she said. She claims that they didn’t order any medical labs, nor did she have to send any over.

A mom, who wished to remain anonymous, said she got a prescription for semaglutide after a telehealth consultation with Elite Health Center
A mom, who wished to remain anonymous, said she got a prescription for semaglutide after a telehealth consultation with Elite Health Center NYC. Pictured here is an ad from the clinic’s website.
elitehealthcenternyc.com

“I thought it was just too easy, but then I Googled him and he’s a real doctor, and apparently he’s also a cannabis doctor,” she alleged.

Around two weeks later, for $850 she said she got injectable semaglutide for the 12-week weight loss program delivered to her home. She’s been prescribed a starter dose of .25mg. After one month of taking it, she’s lost 5 pounds and said she hasn’t experienced any adverse side effects, but said that she’ll stop taking the meds if she does. 

Dr. Disha Narang, an endocrinologist and the director of Obesity Medicine at Northwestern Lake Forest Hospital in Illinois, told The Post compounded semaglutide is “not FDA approved and we don’t have any data on long-term efficacy.”

Furthermore, she said Eli Lilly and Novo Nordisk, the makers of diabetes drugs tirzepatide and semaglutide, “are going to be coming after a lot of these manufacturers that are making compounded substances.”

In a press release distributed last week, Novo Nordisk cited trademark issues and safety concerns and said it is taking steps to protect US patients “from the unlawful marketing and sales of non-FDA approved counterfeit and compounded semaglutide products claiming to contain semaglutide, while reinforcing the responsible use of Novo Nordisk’s FDA-approved medicines.”

“Novo Nordisk has commenced the filing of legal actions in the US against certain medical spas, weight loss or wellness clinics, and compounding pharmacies to cease and desist from false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide,” said the release.

“These unlawful marketing and sales practices, including the use of Novo Nordisk trademarks in connection with these practices, have created a high risk of consumer confusion and deception as well as potential safety concerns,” the release continues. “Compounded products do not have the same safety, quality and effectiveness assurances as our FDA-approved drugs and may expose patients to health risks.”

Novo Nordisk added: “No FDA-approved generic versions of semaglutide currently exist.”

The Post reached out to Eli Lilly for comment.

While the FDA issued warnings against compounded semaglutide, as of now, compounding semaglutide or prescribing it isn’t against the law if there is a shortage of medication.

“When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act. As of May 2023, Ozempic and Wegovy are both listed on FDA’s Drug Shortages list,” the FDA reports on its website.

The mom chose Elite Health Center NYC because they "had a storefront" and "seemed like they knew what they were talking about." Though overall, the process seemed too easy.
The mom chose Elite Health Center NYC because they “had a storefront” and “seemed like they knew what they were talking about.” Though overall, she said the process seemed “too easy.”
elitehealthcenternyc.com

Even though drugs can be compounded during a shortage, it does not mean they are monitored for safety by the FDA.

“FDA has received adverse event reports after patients used compounded semaglutide. Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality,” the FDA has declared.

“Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”

Multiple clinic reps told The Post the compounded semaglutides they prescribe to patients come from a “trusted source” that doesn’t produce the meds with salt forms, and therefore they are safe. However, the FDA doesn’t approve compounded substances, and they don’t undergo the same level of scrutiny as FDA-approved drugs.

“There are no randomized controlled trials defending that, nor is there any level of concrete data,” Dr. Narang said of people claiming compounded drugs are safe because they don’t have salt forms. Because of this, she believes prescribing compounded semaglutide is “unethical.” Her opinion of compounded semaglutide is that it’s “not safe.”

The FDA has not yet responded to The Post’s requests for comment.

Moms, like the Upper East Side fashion executive, are seeking out compounded semaglutide because they don’t meet the criteria for insurance coverage for the brand name.

So far the only people who might qualify to get insurance coverage for FDA-approved Ozempic and Wegovy are those who meet national guidelines which include, “a BMI of 27 or above with a metabolic comorbidity such as diabetes, high blood pressure, high cholesterol, sleep apnea, and heart disease, or a BMI 30 or above without any other comorbidities,” Narang explained.

Narang, who is a mom herself, said she “absolutely understands the difficulty of getting off that last 10 to 15 pounds, but right now I’m not there to argue those guidelines specifications. We have a national crisis of obesity and increased weight, but we’ve got to go about this safely.”

Additionally, Narang said to be wary of anyone advertising a short term weight loss solution: “The whole intent of weight management with semaglutide of any of the GLP-1 agonists is that’s supposed to be a chronic therapy to be used longer term.”

Despite warnings from doctors, a simple Google search reveals that multiple telehealth weight loss programs and med spas in New York City are offering semaglutide injections, some of which are compounded.

In addition to Elite Health Center NYC, businesses like IV Drips, Drip Gym, ReBalance, and Skinney MedSpa advertise weight loss injectable services.

ReBalance and Skinney MedSpa did not immediately respond to The Post’s request for comment about what kind of injectables they use as well as their intake practices.

In response to being called “shady” by a client, an employee of Elite Health Center told The Post: “We’ve been established in the weight loss management arena since 2013Our reviews speak for themselves when it comes to our integrity and we are far from shady.”

“We’re not a fly-by-night johnny-come-lately company trying to cash in on helping people lose weight.”

The Post also spoke with Dr. Anthony Colantonio, who is the main physician affiliated with Elite Health Center NYC. He is a physician licensed to practice medicine in New York and New Jersey and also has a medical marijuana certification. In addition to being a doctor, he is an attorney who is licensed to practice in New York.

Colantonio estimated that 80% of the patients he sees are women “who have gained weight because of a previous pregnancy or pregnancy.”

When asked if he thought prescribing a semaglutide compound is safe he replied: “The compounded semaglutide that I prescribe through Elite Health Center is as safe as the Wegovy and Ozempic that I prescribe to other patients whose insurance company is willing to pay for it.”

“There are semaglutide compounded products out there that are either semaglutide salts or acetate. I don’t work with those compounds, I don’t prescribe those compounds. I prescribe semaglutide which is the exact same medication as Wegovy and Ozempic without the added marketing and research costs.”

"Ozempic semaglutide is patented by Novo Nordisk and it's delivered in a pen injectable form for weight management, and it's also delivered as a pen injectable for diabetes, and it's also available as an oral agent for management of diabetes," said Dr. Narang.
“Ozempic semaglutide is patented by Novo Nordisk and it’s delivered in a pen injectable form for weight management, delivered as a pen injectable for diabetes and also available as an oral agent for the management of diabetes,” said Dr. Narang.
Getty Images
He said he works with a pharmacy in Florida called Hallandale that he trusts and said that “in this time that we’re in, when Novo Nordisk has such a short supply of Ozempic and Wegovy, it is absolutely 100% safe to prescribe a compounded semaglutide as long as the physician is confident in the compounding pharmacy.”

And whether or not he’d have a patient do bloodwork prior to receiving a prescription, Colantonio said that, “requiring labs depends on whether the patient has a serious medical issue…things like diabetes and bone marrow, issues like red blood cell issues, white blood cell issues, any serious kidney or liver malfunction, if they have any pancreas issues, if they have any malignancies. Most of those patients have had laboratory values done by their personal medical doctor.”

“If those lab values are within a normal range and their doctor is confident that they don’t need laboratory values, I might consider treating those patients,” he continued. Though not all of his patients are required to have bloodwork.

“Other patients who do not necessarily require laboratory values are patients who are overweight and have no daily symptomatology and don’t require testing of their organ function,” he added.

Colantonio, who has an in-office practice and a telehealth practice, said he has patients fill out an intake form on their medical history and their family’s medical information as well as their “social history, behavior history, medications, surgery, things along those lines.”

He then meets with patients in his office or remotely and asks about “recent physical examinations, recent surgery, and recent medical visits.”

“Based on my interaction with the patient and a thorough evaluation with the use of their medical forms, I make a decision whether the patient would be best served using semaglutide as a way to control their weight,” he said. If prescribed medication, he said he starts patients on a dose of .25mg per week, then he’ll double after 3-4 weeks if their “side effects are under control.” Patients can go up to 1.7mg per week.

Colantonio then has monthly check-ins with patients to track their progress.

When asked about the safety of simply telling a doctor a medical history over the phone and filling out forms, Narang said, “That’s not appropriate medical care.”

“There’s no record there. Patients often don’t know their medical history in detail. They don’t know their labs. There’s a reason why we’re trained to be able to analyze this information and make a proper, medical decision and safe medical decision based on their history and prior workup,” she said.

“Are they able to tell you what the risk of pancreatitis might be for that person or the risk of GI side effects for that person?” she said.”It’s really important to get a thorough history and you only end up being able to diagnose pancreatitis in the event itself, like in the E.R. and, you know, when they present with it,” she said.

Bracha Banyan, a nurse practitioner and the founder of concierge medical service IV Drips, also touts compounded semaglutide. She called the injections a “miracle helping hand” for her clients, many of whom are moms looking to lose “those last 10 to 15 pounds.”

"All of this stuff like micro doses, IVs, all of this stuff, there is absolutely I mean, I got to say, they're just making stuff up," said Dr. Narang.
“Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved” reports the FDA’s website. The brand name Ozempic is approved by the FDA.
REUTERS
“When you give birth you give your body up,” said Banyan. “[Moms] have a right to feel better about themselves and it doesn’t mean you have to be wealthy to get there.”

Banyan said IV Drips is an “extremely concierge luxury service” that “takes care of celebrities, and pretty much the top 10% income families in the world,” but that she wanted to make a service more accessible to everyone. She said that while people can opt to take a brand-name drug with her service, they’d be paying around “$5,000 just for five months,” and that’s “not affordable for most of the population.”

“We have a monthly program … the rate is so cheap, it’s like amazing. It’s $599 a month…The compound is all taken from FDA-approved pharmaceutical companies and they compound it with B12,” Banyan told The Post.

“You could buy Advil, you could buy Motrin, you could buy ibuprofen, at the end of the day the active ingredient is ibuprofen. Even when you buy Advil, it’s just branding. It’s the name and it still works the same,” she explained of using the compounded drugs versus the brand name. She also claimed that “a little bit of the half-life does change with Ozempic,” and that “sometimes people have less side effects [from] the semaglutide when it’s compounded.”

Banyan said in addition to virtual consultations and house calls, people in her program get their own nurse practitioner and have “check-ins all the time” to make sure they’re on track to lose their desired weight.

Even if they require labs and implement monitoring, Narang believes weight loss clinics offering compounded semaglutide are, “absolutely taking advantage of people’s desperation to lose weight.”

“There’s zero research behind what they’re saying. There is no evidence. Nothing,” she said, referencing the lack of FDA findings.

Narang also offered her opinion on facilities that add B12 to their compounds. “Coming up with their own ‘concoctions’ is suspect. Some med spas will fill various vitamins, B12, HCG etc. into their compounded substances and market it as a special cocktail,” she said.

In response to questions over whether or not compounded medications are safe, Banyan replied: “Compound pharmacies have regulations they have to follow. The importance of a brand or a company is the values that company or brand stands behind. Always make sure you are trusting in an established brand or company and that company is always implementing best standards of practice.”

Drip Gym, a clinic that began offering weight loss injectable services in March, told The Post it charges clients $499 a month “which covers four weekly semaglutide shots.”

IV Drips offers a weight loss program for $599 a month that comes with lifestyle monitoring and a compound of semaglutide and B12.
IV Drips offers a weight loss program for $599 a month that comes with a bloodwork review and lifestyle monitoring along with a semaglutide injection compounded with B12.
ivdrips.com

“Our clinic utilizes a generic version of semaglutide rather than brand-name medications like Ozempic or Wegovy,” Drip Gym said. No FDA-approved generic versions of Wegovy or Ozempic exist and it’s not known if they mean compounded semaglutide.

“In addition to our weight loss program, we also provide other services such as IV vitamin therapy, hydrafacials, body sculpting, and more,” Drip Gym explained. Regarding questions about safety, the clinic said: “We prioritize the safety of our clients and adhere to strict protocols.” They said they couldn’t comment on the safety of other clinics but that, “It is important to select a clinic that has qualified medical professionals who can provide proper education about the medication being used, thoroughly explain potential side effects, and offer regular monitoring and support throughout the weight loss journey.”

Narang has a word of advice for moms looking to drop pounds.

“I think that I think that patients who are interested in losing weight, whatever BMI they’re at, need to consult a doctor [who practices obesity medicine] and make sure that they’re getting evidence-based information,” urged Narang.

“And then here’s my other question. I mean, these are women of childbearing age. We don’t know what’s in these compounded substances. Are these breastfeeding moms? Is that going to affect further fertility? We don’t know this,” she said.

Even for Upper East Side moms who go to an in-person weight loss clinic and manage to get insurance coverage for a brand-name prescription, getting ahold of the meds is no walk in Central Park.

A 38-year-old advertising executive and mom to a 3-year-old son who wished to remain anonymous is currently taking Wegovy after enlisting in a weight loss program at Weill Cornell — though she had to wait 6 months to get an appointment.

She didn’t purposely seek out a weight loss injectable, it was her doctor who recommended she take Wegovy because she is clinically obese and has high cholesterol. She said her doctor did “a lot of bloodwork” before prescribing the drug, and since she sees other doctors at Cornell, they already had access to her medical records.

"There's zero FDA approval for providing compounded semaglutide to patients," said Narang in response to claims the compounded drugs meet FDA standards.
While Ozempic is approved by the FDA, compounded drugs are not.
AFP via Getty Images

“I was able to get my insurance to cover it, and I paid $0,” she said. She is currently on a dose of 1.7mg.

She weighed 198 pounds when she started taking the medication in February, and since then has lost around 15 pounds “without even trying.” She hopes to lose at least 50 pounds. 

What took the most effort was trying to find a pharmacy that would fill her prescription. 

“At CVS, Walgreens, Duane Reade, any of the big retail pharmacies, it is very, very hard to find this drug. As soon as they stock up the people who already have prescriptions it’s already done,” she said. She tried mail-order pharmacies, and a mom-and-pop pharmacy across the street from her home, which carried it briefly but eventually stopped. 

Amazon was the only pharmacy I could find to get my prescriptions filled and sent to me,” she said, adding they ran out of the last dosage she was taking. She was at 1mg and had a two-week supply left, and had to go up to 1.7mg to get her prescription filled. 

Narang said her patients have experienced similar problems getting their prescriptions filled and their health has suffered because of it.

A shortage of Wegovy is making it hard for diabetics to get their meds in a timely manner.
A shortage of Wegovy is making it hard for diabetics to get their meds in a timely manner.
REUTERS

“We’re again in a shortage for Wegovy, so we can’t get that for patients who have been treated with it for weight management last year because of the unprecedented demand for our patients with diabetes,” she said. Since her patients were unable to get their meds in a timely manner, “they regained the weight, their blood sugars went up.”

In addition to causing a shortage, the demand and prevalence of the drugs have led to a spike in ER visits nationwide for side effects like diarrhea, nausea, bloating, and blurred vision.

And while the mom in the program at Cornell said she hasn’t been to the ER, nor has she had side effects akin to “Ozempic butt” or “Ozempic finger,” she suffered from “severe constipation” during her first six weeks on Wegovy.

On a positive note, she said she no longer has food cravings. “That part of my brain is just shut off,” she said, adding she also no longer feels the effects of alcohol when she drinks, so she tends to skip out on wine, which she calls “empty calories.” 

https://nypost.com/2023/07/03/upper-east-side-moms-flocking-to-shady-clinics-for-off-brand-ozempic/

How Bidenomics Generates More Debt And Inflation

 by Daniel Lacalle,

Estimates of United States growth have improved but remain massively below the Federal Reserve projections.

After the largest monetary and fiscal stimulus in recent years, growth remains well below trend and debt is significantly higher. It is interesting to hear Janet Yellen say that “trickle-down economics did not work” when this is the failed trickle down: massive government deficit spending leads to negative real wage growth and weaker GDP.

Current consensus real GDP growth for 4Q23 stands at 0.2%, significantly lower than the median projection of 1% in the FOMC’s June Summary of Economic Projections.

The latest figure, for example, shows the evidence of headline strength hiding weakness in the details. New durable-goods orders surged in May, but this headline growth disguised that core capital-goods orders were revised down again.

Even if we consider the optimistic assumptions of the Biden administration, which assume a 2% per annum GDP growth until 2032 and 3.8% unemployment, the United States federal government deficit would not fall below 5% of GDP even in 2032. That is a deficit that rises from $1.1 trillion in 2023 to $2.01 trillion in 2032, an accumulated deficit between 2023 and 2032 of $15.46 trillion. That is a 106% debt to GDP according to the Biden administration calculations even with very bullish estimates of growth that consider no recession or stagnation in the entire forecast period.

One of the biggest problems of this neo-Keynesian approach to government budgets is that it leaves households with less money in real terms and the “anti-inflation” measures increase debt and inflation.

Take the American Rescue Plan.

It was supposed to be the helicopter money solution to the crisis, giving families cash and supporting consumption through the pandemic. Adjusted for inflation, Bloomberg Economics estimates the average household in the bottom 40% of the income distribution now has liquid assets worth $1,200 less than they did before Covid.

You wanted the stimulus cheque with printed money? You paid for it multiple times over in higher inflation.

The other key policy items of the Biden administration, the Inflation Reduction Act, the CHIPS and Science Act, and the Bipartisan Infrastructure Law were created to incentivize aggregate demand and boost investment in areas where the private sector seemed to be underinvesting. However, it was not the case. The problem is that the government does not have more or better information about the requirements of the real economy, assumes erroneously that the private sector did not invest because of some flaw in the market, and these massive federal expenditure programs generate more inflation as they add artificial demand created with newly printed units of currency to an economy that is already working at full capacity and full employment. Thus, it puts more fuel to the fire of inflation.

Bloomberg Economics warn that “If successful, the benefits of these projects will play out in the long term – and other deliverables, like reduced dependence on China and lower carbon emissions, won’t show up directly in the GDP data. In the near term, our view is that the costs in terms of higher inflation and recession risks offset the benefits and may even outweigh them”. Even if we assume a benign view of multiplier effects, the result is that these plans accelerate the risk of a recession by artificially tightening an already strong labor market and putting more pressure on supply chains.

The Inflation Reduction Act assumes a total of $500 billion in federal expenditure and tax breaks to accelerate investment in clean energy.

This was utterly unnecessary when the United States was already a global leader in renewable energy investments, and the program so far has created more inflationary pressures as artificial government spending added to an already hot industry. Furthermore, if there was an industry that required no further support from the government it was the clean energy sector, which had no impact from the pandemic on investor demand and ample financing capacity.

The same happens with the Bipartisan Infrastructure Law, $550 billion in new spending over five years, included a clearly unnecessary artificial boost to an already booming sector, driving prices much higher.

Even considering revenue-generating measures, and assuming they would work, the net effect “will be to add on average about 0.1% of GDP per year to the primary fiscal deficit during that period” according to Bloomberg Economics.

Launching multi-billion spending programs financed with newly created money and debt into an economy that was already running at full capacity has added to inflation and further debilitated the public finances. Meanwhile, the measures taken by the Federal Reserve to reduce the inflationary pressures -that were worsened by the government anti-inflation spending programs- make a recession more likely. The Federal Reserve must act to reduce the inflation that the government generates with its anti-inflation spending programs and by doing so, may create a recession as the rate hikes and monetary contraction hinder families and businesses. Brilliant.

When all this fails and revenues fall below estimates, growth deteriorates or leads to a recession, and debt soars, neo-Keynesians will say that another massive government spending program is required.

https://www.zerohedge.com/markets/how-bidenomics-generates-more-debt-and-inflation

'Medical education leaders see silver lining in SCOTUS endorsement of ‘holistic' review’

 After having a day to read through the Supreme Court’s decision on affirmative action, some medical school and educational leaders are more hopeful that a path exists for them to diversify future classes and the health care workforce as they scramble to understand its impact on the next admissions cycle and the class of 2024.

Several told STAT they saw the court’s ruling as explicitly endorsing the use of “holistic review,” a tool used increasingly by medical, dental, and nursing schools and other institutions to build classes that better reflect the demographics of the nation. For years, medical schools have been seeking to train physicians who better resemble the patients they treat — a key part of the effort to reduce health disparities.

That’s not to say there wasn’t still a lot of criticism of the decision. The American Nurses Association said in a statement Friday its leaders were “appalled” by the ruling and said it “signals the continuation of systemic and structural racism which has inflicted generational discriminatory trauma in terms of lack of access and academic and professional advancement.” The decision would no doubt impact nursing admissions processes, it said.

A wide variety of medical groups, from the American Medical Association to the American Cancer Society, had also decried the decision as undermining both the health of the nation and patient care.

The Association of American Medical Colleges, which represents the nation’s medical schools, has been encouraging the use of holistic review — in which an applicant is evaluated as a whole person, not just by empirical data such as test scores — to help medical schools diversify their classes.

It was also heavily involved in the two affirmative action cases, involving the admissions practices of Harvard and the University of North Carolina, from the beginning. The AAMC submitted an amicus brief to the court with reams of data showing that when physicians are from the same racial and ethnic groups as their patients, health outcomes improve.

One of the co-authors of that brief, AAMC Chief Legal Officer Frank Trinity, told STAT he saw the ruling as “deeply consequential” and “a significant change in law.”

However, after spending most of Thursday analyzing the majority opinion, he said he thought the ruling affirmed the use of holistic review, which can take into account a person’s experiences and racial background. The court said explicitly that nothing in the decision prohibited applicants from addressing their own race or experiences in their applications. “In my opinion, holistic review has received a boost by this decision,” Trinity said. “Admissions officers must treat each individual as an individual — that’s what holistic review is all about.”

The opinion drafted by Chief Justice John Roberts stated: “nothing prohibits universities from considering an applicant’s discussion of how race affected the applicant’s life, so long as that discussion is concretely tied to a quality of character or unique ability that the particular applicant can contribute to the university.”

A number of people who run admissions departments for professional schools said they were still digesting the ruling and could not yet comment specifically on how they would respond, or what changes they would make.

But medical schools posted statements saying they would continue to work to be inclusive in their admissions policies, and Nancy J. Brown, Yale’s dean of medicine, said in a statement that the school would continue the holistic approach to admissions it has employed in its pursuit of “diversity and inclusive excellence.” The school “considers each applicant’s commitment to medicine, maturity, and resilience, as well as measures of academic preparation, such as grades and MCAT scores. This will not change,” the statement said.

Others agreed that there were still paths forward, if admissions officers were willing to do the hard work of changing the status quo of who traditionally gets admitted. “The nice thing about this ruling is that maybe it will start some conversations,” said Mark Henderson, the associate dean of admissions at the University of California, Davis, medical school, which has worked to diversity classes despite a longstanding statewide ban on affirmative action. “There are many things that can be done.”

Others agreed. Ruth Simmons, the first Black president of an Ivy League university, Brown, and now a senior adviser to Harvard’s president, told CBS Morning News, “We’re still able to consider a diversity of factors … so I am not given to seeing this as being as detrimental as many.”

Asha Rangappa, a lawyer and assistant dean of admissions at Yale’s Jackson School of Global Affairs, tweeted that she thought the ruling would have less impact than others predict because it allowed more latitude for subjective admissions decisions.

“It seems to me that in making more explicit *how* a students’ background impacts experience/perspective, schools will have a much easier time DEFENDING why race mattered in admitting that person…and test scores, etc. become less of the comparison point,” she wrote.

Trinity said many medical schools would be waiting for guidance from the Department of Education on the court ruling. That guidance is expected within 45 days. In the meantime, Education Secretary Miguel Cardona urged higher education leaders to continue to strive to diversify their campuses and said in a statement: “Our commitment to educational opportunity for all Americans is unshaken.”

Trinity said the AAMC would continue to support member medical schools as they think through how the decision will affect their selection of the medical students entering school in 2024. In the meantime, he said he feared the impact the ruling may have on people from groups that have not been well-represented in medicine who are deciding whether or not they want to be physicians.

“What we’re most concerned about is the negative narrative. We have prospective students from different backgrounds that might feel discouraged,” he said.

“To the middle schoolers out there who are good at chemistry and may do well in medicine, we want you to aim high,” he said. “We need your talents and drive more than ever.”

https://www.statnews.com/2023/06/30/affirmative-action-supreme-court-holistic-review/

'Pharma can’t let Big Tech win the race for medical AI'

 Five years from now, when patients walk into a doctor’s office presenting symptoms of almost any condition you can envision — whether migraine, multiple sclerosis, or obesity — their physician will offer a new kind of treatment plan that involves both pharmaceutical-based medication and a prescription digital therapeutic. Accessible through the patient’s smartphone, the digital therapeutic will deliver personalized, evidence-based interventions to treat their condition, completed through daily lessons and game-like interfaces, all guided by sophisticated algorithms. Medication and digital therapeutic will work together to deliver the best possible outcomes, an approach that will have been well-established through extensive evidence and recommended by practice guidelines.

This future isn’t likely; it is inevitable. The only questions are: When will digital therapies become the standard of care, and who will lead the movement forward?

I first noticed the potential for software to treat disease back in 2012 when I coined the term “digital therapeutics.” Now, I see the industry is at an inflection point, primed for broad acceptance of prescription digital therapeutics. It is driven by emergence of the latest generation of technologies developed with the rigor of traditional medicines; the need for new business models in our increasingly burdened health care system; and the rapid increase in AI’s power and availability.

Prescription digital therapeutics deliver broad access to the latest in behavioral, cognitive, and skills-based interventions, democratizing care traditionally restricted to patients with access to specialists and academic centers. The more advanced applications also provide neuromodulatory mechanisms of action that safely target specific neural pathways inaccessible to biopharmaceuticals; their consistent use retrains the brain to make new connections for lasting results, providing therapeutic benefits with minimal side effects.

What’s needed is a leader to step forward and seize this opportunity to build the patient journey of the future. That leader must be pharma, not the tech industry.

Pharma has the exact capabilities to launch these new therapies effectively, at scale, in a way that is best for patients. And prescription digital therapeutics are the essential ingredient in the AI-enablement of pharma’s future: They are how pharma wins the race to bring AI to patient care.

The shift to prescription digital therapeutics requires players who put evidence first, who have strong commercial and regulatory arms, and who have deep expertise in shifting the standard of care to embrace new therapies. Pharma ticks every box. With proven prescription digital products backed by compelling evidence, either at hand or well into development, pharma should have no problem enlisting payers, policymakers, and prescribers. It’s been done before when a new category of therapeutics arises, whether for biologics in the 1980s, immunotherapy and CAR-T in the past decade, or gene therapy today. Pharma must stop viewing prescription digital therapeutics as digital health projects, which is an area where they have historically struggled to succeed, and embrace them instead as new therapeutic programs, where pharma is the expert, bar none.

Using AI to enable more effective, efficient operations is underway everywhere; that’s advisable. We see companies working to bring AI and machine learning to bear in drug discovery, manufacturing operations, commercial launch campaigns, and clinical trials. But those efforts are about efficiencies, not products. Efficiencies are table stakes. Products are the bet that will drive future growth.

To that end, pharma companies may ask, “What will be our killer idea? What will be our equivalent of ChatGPT?” The answer is prescription digital therapeutics.

They are the key to achieving everything pharma wants to do with digital. The reasons are threefold.

First, prescription digital therapeutics deliver AI-driven outcomes to end users: patients. Highly adaptable and personal to each user, prescription digital therapeutics are aligned with pharma companies’ aspiration of putting patients at the center of care. By securely collecting data, prescription digital therapeutics use AI and machine learning not only to engage patients, but also to modify and individualize their treatment, driving truly personalized care and better outcomes.

Secondly, AI-powered digital biomarkers, captured by prescription digital therapeutics via increasingly sophisticated sensors on a patient’s smartphone, deliver insights that can be used to quantify a drug or treatment’s effect. Digital biomarkers enable clinicians to more fully understand a patient’s experience of disease, facilitating personalized support, and allow developers to use the information and predictive power they provide to transform how care is delivered.

Finally, prescription digital therapeutics drive the long-term, high-quality data collection essential for AI to benefit pharma companies. By leveraging prescription digital therapeutics to gain real-world data insights, drug companies inform their portfolio planning and enable development of ever more effective treatments. Without prescription digital therapeutics to drive a direct relationship with patients, the data pharma can access will always be secondhand and imperfect. Realtime, high-fidelity insights will be essential to health care’s value-based future.

If pharma doesn’t step up now, this moment will pass the industry by.

In June, Apple announced iPhone’s iOS 17 update will include new mental health and vision companion apps. Amazon and Google are also making inroads into the space, Amazon through acquisition of RxPass, PillPack, and One Medical, and Google through extension of its Vertex AI tool suite to health care, including its recently announced partnership with the Mayo Clinic. Big Tech’s growing interest in AI-based health care solutions signals that the software ecosystem that will define health care’s future is being shaped now. If pharma fails to seize the opportunity to lead by introducing prescription digital therapeutics into clinical care, they risk becoming a cog in the wheel of Big Tech’s data-driven patient journey of the future.

In that future, patients lose out on the clinical rigor pharma brings to the space. Pharma also suffers. The industry cannot thrive by waiting for the next blockbuster; it’s an unsustainable market strategy as payments shift to value-based and outcomes-driven approaches. The AI-enabled pharma company of the future is a holistic provider of patient care, focused on outcomes, not just scripts.

Prescription digital therapeutics unlock that potential, and in doing so closely align pharma’s capabilities, patient interests, and future economic needs. Companies that continue to think of digital therapeutics as “nice to have,” as a commercial add-on, or as a companion app will be left behind. A pharma company without prescription digital therapeutics will be one without a truly AI-enabled future.

Pharma companies that wait for someone else to drive the first commercial success in this space will likely miss the boat. Big Tech is positioned to step in, which could lead to proliferation of digital solutions that will lack the clinical rigor of medicines. Health systems, electronic health record providers, and digital health companies that use Big Tech’s growing portfolio of AI tools will become the primary owners of AI in the patient journey. In short, if Big Tech remains the only entrant in this race, pharma could be edged out from ever realizing the AI-powered benefits prescription digital therapeutics would confer on them. And tomorrow’s patient journey will rest increasingly in the hands of algorithms in which pharma has had neither authorship nor insight.

Prescription digital therapeutics work. Pharma needs only invest in them as meaningful new pipeline assets, and then ensure their success through their strong relationships with providers and disease area specialists, their expertise with payers, and their commercial infrastructure. The pharmaceutical companies that do the heavy lifting now will have a head start in the AI-enablement of their products and pipeline. Catching up in the world of software is not easy. Move now, or get left behind.

David Benshoof Klein is CEO and co-founder of Click Therapeutics. He is also guest faculty at the Biotechnology Program at Columbia University, NYU’s Stern School of Business, and the Columbia Business School, and was managing director at Opus Point Partners, senior consultant at Pfizer, and a strategic advisor for several publicly traded and privately held life science companies.

https://www.statnews.com/2023/07/03/prescription-digital-therapeutics-pharma-big-tech/

'As psychedelics near approval, there’s no consensus on how they work'

The founder of Field Trip, a chain of shuttered ketamine clinics currently facing insolvency, put forward an unexpected theory of how psychedelics work to treat depression last month. “The truth is, almost all of the effect of psychedelic-assisted therapy could be placebo,” said Ronan Levy, speaking at a five-day conference on the emerging field of psychedelic medicine. “Personally I don’t have a problem with that. The outcomes are the outcomes, and that’s really what matters in my view.”

While there’s evidence to support the idea (which, if correct, would make Field Trip’s $5,250 price for six ketamine sessions an unusually expensive placebo effect), attendees at Psychedelic Science 2023 heard an array of explanations for the potential benefits of psychedelic drugs for people with various mental illnesses.

Some researchers attribute a therapeutic effect to a combination of physical changes in the brain — though where, exactly, is still uncertain — plus personal experiences while high and in the days following psychedelic treatment. Or maybe the strength of the mystical experience while on psychedelics determines the psychological response. Or, it could be entirely biochemical.

“How do you make sense of it?” said Boris Heifets, anesthesiology professor who studies ketamine at Stanford University. “Some of it just has to be wrong.”

The confusion and combination of evidence presented at the conference reflects a field still in the early stages of trying to disentangle a potential medical treatment. Many types of psychedelics — both traditional drugs, such as MDMA and psilocybin (the psychoactive compound in magic mushrooms), and newer, modified versions — are under investigation as treatment for a range of mental health conditions, including depression and post-traumatic stress disorder. Though there are plans to submit trials on MDMA for PTSD to the Food and Drug Administration for approval later this year, none of the medications has yet been definitively proven to work. And the question of how they work is very much up for debate.

“There’s an awful lot of uncertainty,” said Fred Barrett, cognitive neuroscientist and director of Johns Hopkins Center for Psychedelic and Consciousness Research. “Part of that uncertainty comes from the very small amount of data that exists.” The research to tease out the mechanisms of psychedelics is based on animals or studies of humans with small sample sizes, meaning there’s no definitive evidence yet.

The divergence of theories and lack of clarity receives little attention in journal press releases and media coverage of psychedelics, which often portray these drugs as transformative agents that work by enhancing “neuroplasticity,” rewiring the brain and creating a child-like state of learning. The concept of “neuroplasticity,” though, is too general to be meaningful. “Anything you do, any change in behavior is nominally plasticity,” said Heifets. “It’s a very broad statement.”

Some of the earlier work on how psychedelics affect the brain was led by psychologist and neuroscientist Robin Carhart-Harris, who started his investigations at Imperial College London and is now a professor of neurology and psychiatry at the University of California, San Francisco.

According to Carhart-Harris’s research, which uses fMRI imaging to track brain activity, psilocybin disrupts the typically organized activity in the default mode network, an area of the brain associated with introspection, making existing thought patterns less dominant and creating the opportunity to develop new perspectives.

“It starts with breaking down habits of mind and brain and behavior,” he told STAT. “In psychopathology of mental illness, it would be excessive order: Getting stuck in a rut in depression, getting stuck on a feeling of relief and addiction.”

In an interview at the conference, Carhart-Harris said he is 80% confident in his theories, which have the intuitive appeal of combining neuroscience and psychology. Even if they are right, though, he acknowledges there’s still more to uncover. “If you were to say to me, ‘Do you know it all about how psychedelics work in the brain,’ I would say very quickly, ‘Absolutely not.’”

Others do not share Carhart-Harris’s certainty, arguing the limited data and specificity make it difficult to test. “It’s not quite well enough specified to be a model that you can interrogate reliable brain circuits with in a well-disclosed fashion,” said Barrett.

Barrett has published work showing that psychedelics reduce activity in the claustrum, a brain area called “the seat of consciousness,” which helps people switch between mental states (for example, from calm to urgent action), and was also a researcher on separate studies showing they could be disrupting the thalamus loop, a brain region that provides a filter for sensory information going to higher levels of the brain for decision-making.

Meanwhile, research from Gul Dölen, a neuroscience professor at Johns Hopkins University, highlights psychedelics’ impact on an area of the nucleus accumbens that is associated with social reward learning. Dölen finds mice are more sociable after being given MDMA, suggesting the drug creates a state where there’s an increased sense of reward from social experiences.

“I don’t think these are blatantly contradictory theories, but they do make different predictions,” said Barrett.

The question of where and how psychedelics create changes is crucial, Thomas Insel, former head of National Institute of Mental Health, told STAT after his talk. “Neuroplasticity is a very vague concept. It means a lot of different things, and when we’re talking about neuroscience and behavior, it matters where things are happening,” said Insel.

Dölen’s recent work on social reward is a “pretty frigging cool” paper, said Insel, though he cautioned it was only in mice. “When I was at NIMH, I used to say that if you’re going to get Alzheimer’s disease, first become a mouse because we can cure you.”

https://www.statnews.com/2023/07/03/psychedelics-ketamine-mdma-ptsd-how-they-work/