Eli Lilly tightens access to diabetes drug, frustrating some people with obesity

 Touted by celebrities, raved about by TikTok users, and advertised by med spas, a new class of drugs for treating diabetes and obesity has exploded in popularity for its weight-loss effects, leading to rippling shortages across several of the medications.

Amid the surge in demand, Eli Lilly and pharmacies have started to tighten access to the latest of this type of drug, tirzepatide, focusing on giving it to people with type 2 diabetes, the only population it’s authorized for so far. But that’s left another set of patients scrambling — people with clinical obesity who turned to the medication as one of their few options for treatment.

The class of drugs are GLP-1 receptor agonists, which mimic the effects of a hormone that can help people feel full. Within this group, Novo Nordisk’s obesity drug Wegovy and diabetes drug Ozempic have been in short supply for months due to manufacturing issues and increased demand. Lilly’s diabetes medication Trulicity has also been in tight supply, according to the drugmaker.

That leaves tirzepatide, sold under the name Mounjaro. Lilly said in a statement that the drug is currently not in shortage, but that the company is continuing to monitor availability of competitor therapies and “supply with a focus on access for people with type 2 diabetes.”

In October, Lilly made changes to a discount program for the drug, now requiring people to attest they have type 2 diabetes. The coupons allowed patients to get the drug for $25 a month when it would otherwise cost about $1,000. Some pharmacies are also now checking if people have a diabetes diagnosis before filling prescriptions.

Those moves have barred many people with obesity from using the medication. Their doctors had been prescribing it off-label, as data showed it to be effective in helping people with obesity shed weight, but patients are now having to stop the drug and see their weight and related health problems come back.

Though it’s understandable for Lilly to be focusing on the people its medication is indicated for, the situation is “unfair to everybody,” said W. Scott Butsch, director of obesity medicine in the Bariatric and Metabolic Institute at Cleveland Clinic. “It’s unfair to people who have obesity because there’s a drug that actually can very well help them and there’s a provider who wants to treat obesity, yet does not have access to a very reasonable treatment.”

Butsch noted that while patients with diabetes have some alternative medications available, people with obesity have fewer options. Regulators will be expediting their review of tirzepatide for obesity, but Lilly is expecting a decision late next year at the earliest. Additionally, many insurers don’t cover obesity drugs, considering them to be lifestyle treatments rather than medically necessary.

“It’s an unfair system,” Butsch said.

Megan Hoffman, a 47-year-old in Portland, Ore., has had obesity for over 20 years. She developed gestational diabetes when she was pregnant six years ago and now has pre-diabetes. Every attempt to shed weight wasn’t working, and “I just wanted to try to have a last-ditch effort,” she said.

Aided by Lilly’s coupon, she began taking Mounjaro in September, and “it’s a complete game changer,” she said. She experienced feelings of satiety that she didn’t have before, and she started to lose weight and see lower glucose levels.

But when she tried to get a refill this month, she said, her Walmart pharmacy refused to process her coupon without a type 2 diabetes diagnosis. She called the Walgreens and Safeway pharmacies in her area and they also refused.

Hoffman, who works at a nonprofit, is now considering taking on another job to afford to pay for the drug out-of-pocket. “I just want to live longer,” she said.

Shannon George, a 54-year-old in St. Louis, Mo., recounted offering to pay full price to get her refill at Walgreens last month, but the pharmacist still denied it without a type 2 diabetes diagnosis. George has had obesity for much of her adult life and was recently diagnosed with pre-diabetes and insulin resistance.

After she started taking Mounjaro in October, she not only began to lose weight, but her joint aches also started subsiding, she said. Now without the drug, her weight has fluctuated and her joint pain has come back. “It’s frustrating that I got teased with something that helped other things plus the weight loss, and now I can’t get it,” she said.

Lilly said its coupon program was designed to help commercially insured people with diabetes get Mounjaro as the drugmaker seeks coverage for the medication. “As we continue to broaden access for patients, we also want to continue to emphasize appropriate on-label utilization of the savings program,” the company said.

“Lilly only promotes Mounjaro consistent with its approved FDA indication and label and cannot comment on scripts for the treatment of indications outside of type 2 diabetes,” the drugmaker said.

Walgreens said it has not imposed a policy for pharmacists to check diagnoses before filling Mounjaro. Walmart said, “We rely on the professional judgment of our pharmacists when it comes to caring for our patients.” Safeway’s parent company Albertsons did not respond to requests for comment.

Many people with obesity, like Hoffman and George, have a high risk of developing diabetes. There’s much overlap between the two conditions, said Beverly Tchang, an endocrinologist and assistant professor of clinical medicine at Weill Cornell Medicine. “Obesity can lead to diabetes, diabetes can lead to obesity,” she said. “They’re very much intertwined, and to treat one but not the other seems inequitable.”

Tchang treats both types of patients and feels the drug shouldn’t be conserved for one group at the expense of the other.

It appears people “want to ‘save the medication’ for the people who ‘need it,’ and I understand that sentiment,” she said. But, she said, “we need to look at obesity as its own disease that is equally deserving of treatment.”

STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.

https://www.statnews.com/2022/12/07/eli-lilly-tightens-access-tirzepatide-mounjaro-diabetes-obesity/

‘I question what I know’: Top cancer specialist Otis Brawley on valuing orthodoxy in medicine

 Oncologist Otis Brawley has dedicated his career to advocating for orthodoxy in medicine. Now, he says, advances in cancer treatments and early-detection screenings are fast outpacing the medical community’s ability to assess them — warranting more caution lest doctors inadvertently cause more harm to cancer patients.

“I think we need to actually start policing ourselves better,” Brawley, a professor of oncology and epidemiology at John Hopkins University and former chief medical officer and executive vice president at the American Cancer Society, said at a STAT virtual event on Tuesday.

Brawley pointed out that a number of drugs for late-stage cancer patients that are FDA-approved do not yet have randomized control data to support them. Many of those drugs, he said, have received FDA approval because they can potentially increase patients’ median survival rates by three to four months. “One has to wonder, is the pain of taking the drug, including the financial pain, and side effects that come with it, worth the chance that you might have a three-month median survival increase?” Brawley asked. How to improve quality of life, he said, should remain an important consideration in the pursuit to extend the lives of cancer patients.

Similar concerns apply to cancer screenings, Brawley said, noting that with the development of several multi-cancer early detection (MCED) blood tests underway, “If we’re not careful, this is going to be the wild, wild west of screening.”

Brawley is an adviser to Grail, the largest MCED developer, and would not comment on specific products as a result. But he advised that in their current state, MCED tests should not be done in lieu of other standard screenings — particularly because there’s a risk of overdiagnosis, a phenomenon in which patients meet a pathological criteria for cancer, yet experience no symptoms or damage to their bodies. These patients could be encouraged to undergo unnecessary treatments for cancers that might never otherwise become a problem.

“We have a long history in medicine, going back to the Pap smear, where we have instituted screening without adequately assessing the test,” Brawley said, invoking other historical examples as precedents including chest X-ray screening for lung cancer in the 1960s and mammograms in the 1970s. The problems of overdiagnosis and overtreatment have led many medical professionals to conclude, “‘Let’s slow this down because we’re going too fast and we’re starting to hurt people,’” he said.

For decades, Brawley has been pushing back against the conventional wisdom to “find [cancer] early and cut it out.” In the 1990s, he began to question whether routine prostate-specific antigen (PSA) screenings were actually protecting men’s lives. “In metropolitan Seattle, the prevalence of men diagnosed with prostate cancer was higher than the prevalence of left-handedness,” he recalled.

It became apparent that some men risked undergoing treatment they did not need, which could be more harmful to them than the cancer itself. “In the 1990s, if you were diagnosed on Tuesday, you were told you need to have your prostate out by the end of the week,” said Brawley. Since prostate cancer screening guidelines have changed, the initial treatment for about half of men diagnosed with prostate cancer today is observation.

Now, as scientists edge closer to screening for cancer based on genetic risk factors, there is also a risk that people could enter into treatments for cancers they don’t end up developing in their lifetime. “We need to be very careful as we go forth with genetic testing,” Brawley said. “I’m very much in favor of studies to better figure out how to do it. We’re not ready to do it yet.”

Brawley also advised caution in the push to develop race-based cancer screening guidelines. “I’m just very, very concerned that that makes people think race equates with biology,” Brawley said. “The unintended consequence of focusing too much on race and ethnicity is, in the United States where we all see things through this racist lens, people tend to think that race determines things that it doesn’t really determine,” he added.

Rather than focus on racial differences in health that are, by and large, determined by socioeconomic factors, Brawley advised physicians to address health disparities by ensuring that everyone gets adequate treatment. He is frequently asked whether Black women should be screened for breast cancer earlier in life, starting at age 35. “But nobody ever asked me about the fact that 40% of Black women over 50 don’t get screened, period,” he said. “And if we could provide that 40% with adequate screening, adequate diagnosis, and adequate treatment, the number of lives that could be saved and the number of life years that could be saved are far greater than if screening works for Black women aged 35 to 44.”

Brawley further advised the medical community to be wary of making extrapolations beyond what is known from clinical trials. “If the patient doesn’t fit the clinical trial or is way out of qualification for going in the clinical trial, we shouldn’t treat them with the drugs in the clinical trial,” he said.

Throughout his 35-year career, Brawley said, his rule of thumb has been to abide by the advice he received from a Jesuit priest before he went to medical school: “‘Remember, there are things you know, things you don’t know, and things you believe. Doctors have this terrible problem of confusing what they believe with what they know.’

“I question what I know more than anything else,” Brawley continued. “Because oftentimes what I know, or what we in medicine know, turns out to be wrong.”

https://www.statnews.com/2022/12/07/otis-brawley-cancer-orthodoxy-in-medicine/

Biden administration unveils dashboard to track nonfatal drug overdoses

 The Biden administration is rolling out a new tool meant to help prevent drug deaths: a nationwide database that tracks nonfatal overdoses.

The dashboard, known as the Non-Fatal Opioid Overdose Surveillance Tracker, will offer fresh insights about overdose rates, the drug supply, and the effectiveness of local emergency response efforts, the White House said.

If effective, the tool could help fill a major information gap. In most of the country, it isn’t known exactly how many people experience drug overdoses but survive — making it difficult to steer resources to specific cities or neighborhoods that need them most.

“Experiencing a nonfatal overdose is one of the most important predictors of a future fatal overdose,” said Rahul Gupta, the director of the White House Office of National Drug Control Policy. “The new nonfatal opioid overdose dashboard allows us to provide first responders, clinicians, and policymakers with real-time, actionable information that will improve our responses and ultimately save lives.”

The dashboard will display data from as recently as two weeks ago, Gupta said, making it the most current and comprehensive estimate of drug overdoses available. Currently, the Centers for Disease Control and Prevention provides estimates of drug overdoses with roughly a six-month lag.

The system will use reports submitted by local emergency response departments to a database housed at the National Highway and Traffic Safety Administration. Ann Carlson, the agency’s acting administrator, called the new tool a “treasure trove” of information derived from an existing database that nearly 95% of the country’s EMS agencies already submit data to voluntarily.

Gathering more precise data about nonfatal overdoses, Gupta said, represents a first step toward reaching more people experiencing addiction and at risk of overdose. Patients who survive an overdose, he said, are between two and three times more likely than the general public to eventually die from one.

Currently, however, estimates of nonfatal overdoses are scattershot at best. One recent survey from Tennessee showed that for every overdose death, there were eight hospital discharges for a nonfatal overdose — meaning the true ratio of nonfatal to fatal overdoses is far higher. It’s unclear, too, whether the ratio is roughly consistent across the U.S. or varies by location.

The tool will track four key metrics: the nonfatal opioid overdose rate, the average number of times first responders administer naloxone to each patient, EMS response time, and the percentage of overdose victims who aren’t transported to a medical facility for additional care.

During a call with reporters on Wednesday, Gupta said the dashboard will “allow us to know, and for local first responders to know, where these overdoses and poisonings are happening, and how to not only administer naloxone but also make sure there’s a timeliness in response.”

He acknowledged, however, that the tool does have limitations.

In particular, the tool will only capture opioid overdoses that involve 911 calls. Instances of drug poisoning involving methamphetamine, among other substances, would not be included — nor would opioid overdoses where an individual is revived by a friend or family member.

https://www.statnews.com/2022/12/08/biden-administration-unveils-dashboard-to-track-nonfatal-drug-overdoses/

'Pausing breast cancer treatment for pregnancy appears safe'

 Young women diagnosed with breast cancer often must delay pregnancy for years while they take hormone-blocking pills.

A reassuring new study finds they can take a two-year break from these drugs to get pregnant without raising their short-term risk of cancer coming back.

“This is really good news for young women and their doctors and their families,” said Ann Partridge of Dana-Farber Cancer Institute in Boston, who led the study. Results were being discussed Thursday at the San Antonio Breast Cancer Symposium.

Though more common in older women, breast cancer is increasingly diagnosed during childbearing years for reasons that aren’t clear.

For patients whose cancers are fueled by hormones, treatment involves surgery, then spending five to 10 years taking either a hormone-blocking drug that can cause birth defects or newer drugs called aromatase inhibitors and a monthly shot to shut down the ovaries.

Partridge estimates 6,000 U.S. women a year want to get pregnant but must take hormone-blocking drugs.

“They don’t want to hear from breast cancer again, but they also don’t want to put their lives on hold,” she said.

The study followed 516 women after surgery for early-stage cancer. All then spent at least 18 months taking hormone-blocking drugs. The women stopped hormone-blockers for up to two years to get pregnant, deliver, and breastfeed. Then they restarted cancer therapy.

After three years, about 9% saw cancer come back, similar to the rate seen in a set of similar women in a separate study who stayed on hormone-blocking therapy. There were nine deaths, “below expected rates for this population,” Partridge said.

More than 300 babies were born to women in the study. Among them was Brayden, now 4, the son of Amy Bianchi.

“He’s perfect in every way,” Bianchi said. “I couldn’t imagine my life without him. We couldn’t imagine our family without him.”

Bianchi felt a lump, which turned out to be breast cancer, when her firstborn, Mia, was 18 months old. Doctors advised against another pregnancy, but she learned of the research and signed up.

“If I had listened to the first few doctors or oncologists that I spoke with, I would have lost all my hope,” said Bianchi, 42, of Niskayuna, N.Y. “I would have very quickly accepted that I would never have the family that I had envisioned.”

She was able to breastfeed her son for six months before resuming hormone-blocking therapy, which she’ll continue until 2026.

Researchers will follow Bianchi and the other study participants and report on the longer term safety.

“Will we see a difference at 10 years?” asked Hope Rugo of University of California, San Francisco’s Comprehensive Cancer Center who was not involved in the study. “For the moment, this is incredibly encouraging data. It should give practitioners and patients confidence” as they discuss ways to benefit from cancer therapy while starting a family.

https://www.statnews.com/2022/12/08/pausing-breast-cancer-treatment-for-pregnancy-appears-safe/

RSV vaccine race in balance as FDA sets May date for Pfizer decision

 The FDA has started its review of Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, fast-tracking the biologics license application (BLA) with a decision due in May 2023.

The short review time sets up a neck-and-neck race between Pfizer and GSK, which is also expecting the FDA’s verdict on its rival candidate in that month. At the moment, there is no FDA-approved vaccine for RSV, a common viral infection that causes around 177,000 hospitalisations in the over-60s in the US each year and 29,000 deaths.

The vaccines will come too late for this year’s RSV season in the US, which is expected to be particularly severe as there were fewer cases during the pandemic and immunity among the population is at a low ebb.

Data from the Centres for Disease Control and Prevention (CDC) has suggested that seniors are being hospitalised with RSV at this point in the season at a considerably higher rate than seen pre-COVID-19.

“The FDA’s acceptance of the BLA for our RSV vaccine candidate is an important regulatory milestone in Pfizer’s efforts to help protect older adults against RSV,” said Annaliesa Anderson, Pfizer’s chief scientific officer, vaccines R&D.

It also “demonstrates additional progress toward what has been an elusive public health goal – reducing the overall burden associated with this infectious disease,” she added.

The FDA is reviewing Pfizer’s vaccine – dubbed RSVpreF – on the results of the phase 3 RENOIR trial, in which 37,000 adults aged 60 or over were randomised to a single 120 μg dose of the shot or a matched placebo.

RSVpreF was found to be 86% effective in preventing severe lower respiratory tract infections (RTI), defined as three or more symptoms, and 67% effective at preventing milder RTI, defined as two or more symptoms.

Pfizer is also developing a version of the vaccine aimed at expectant mothers, designed to protect against RSV illness in newborns. Here. It has a clear lead over GSK, which was forced to abandon trials of its RSVpreF3 vaccine in maternal populations as it investigated a safety signal. The bulk of the market is, however, expected to be in older adults.

Meanwhile, the rivalry between the two pharma companies has also spilt into the courts. In June, Pfizer filed a lawsuit seeking to invalidate three patents covering GSK’s vaccine in a London court.

https://pharmaphorum.com/news/rsv-vaccine-race-in-balance-as-fda-sets-may-date-for-pfizer-decision/

Vanguard Quits Climate Alliance In Major Blow To Woke Investing

 In a mighty blow to Environmental, Social and Governance (ESG) investing, Vanguard, the world's second-largest asset manager, announced it's withdrawing from a major financial alliance against climate change: the Net Zero Asset Managers (NZAM) initiative.

NZAM, which Vanguard joined in 2021, bills itself as "an international group of asset managers committed to supporting the goal of net zero greenhouse gas emissions by 2050 or sooner, in line with global efforts to limit warming to 1.5 degrees Celsius; and to supporting investing aligned with net zero emissions by 2050 or sooner."

Last month, Consumers' Research joined 13 state attorneys general in filing a complaint against Vanguard with the Federal Energy Regulatory Commission (FERC), charging that the firm was violating its agreement to control utility company shares passively.  

"Committing to net zero isn’t an abstract goal," wrote Will Hild, executive director of Consumers' Research, in a Dec. 1 Wall Street Journal op-ed. "The Net Zero Asset Managers Initiative requires its members to prescribe specific emissions targets for industry sectors, especially utilities."

"The International Energy Agency’s net-zero road map envisions eliminating fossil fuels from electricity generation by 2050. That would require every American utility to remake its operations radically."

Vanguard's exit comes at a time of increased saber-rattling and legal maneuvers by Republicans against investment firms pursuing woke agendas in general and anti-fossil-fuel agendas in particular.

Congressional hearings are in the works, and various state legislatures are readying anti-ESG measures. On Dec. 1, Florida CFO Jimmy Patronis announced the state would withdraw $2 billion in assets managed by BlackRock. "Florida's Treasury Division is divesting from BlackRock because they have openly stated they've got other goals than producing returns," said Patronis. 

Here are two key excerpts from Vanguard's statement about its withdrawal: 

"Industry initiatives [like NZAM] can advance constructive dialogue, but sometimes they can result in confusion about the views of individual investment firms. That has been the case in this instance, particularly regarding the applicability of net-zero approaches to the broadly diversified index funds favored by many Vanguard investors." 

"We have decided to withdraw from NZAM so that we can provide the clarity our investors desire about the role of index funds and about how we think about material risks, including climate-related risks—and to make clear that Vanguard speaks independently on matters of importance to our investors."

That's welcome news. The idea that -- of all firms -- Vanguard would subordinate its investors' interests to those of an international climate change consortium was particularly disheartening. 

An industry maverick: Vanguard founder Jack Bogle is considered the father of the index fund (Photo: Vanguard)

Founded by the legendary Jack Bogle, the firm stands apart with a unique ownership structure in which Vanguard's mutual funds own the Vanguard Group. That structure positions the firm to put the interests of its investors first.

Overlaying an ESG agenda on fund management and proxy-voting betrays Bogle's founding vision, by using investor assets to pursue social goals -- at high risk of harming returns in the process.  

It remains to be seen just how far away from the ESG ledge that Vanguard is stepping. The firm said the exit from NZAM "will not affect our commitment to helping our investors navigate the risks that climate change can pose to their long-term returns."  

Malvern, Pennsylvania-based Vanguard reiterated its commitment to provide specific "products designed to meet net zero objectives." That's how it should be -- Vanguard and others should provide that warped investment approach only to those who specifically seek it out.     

Meanwhile, NZAM still counts most of the world's largest asset management firms among its roughly 290 signatories, including BlackRock, State Street, JPMorgan Asset Management and London-based Legal & General. Fidelity, Pimco and now Vanguard are three notable exceptions.   

As of Nov. 9, NZAM firms represented some $66 trillion in assets, according to the group. The loss of Vanguard -- the world's second-largest asset manager -- puts a $7 trillion dent in that figure. Here's hoping other firms follow Vanguard's lead in charting a new course that puts investors first.  

https://www.zerohedge.com/markets/vanguard-quits-climate-alliance-major-blow-woke-investing

Baudax Bio Initiates Phase II Clinical Trial Evaluating BX1000 in Patients Undergoing Surgery

 Baudax Bio, Inc. (NASDAQ:BXRX) a pharmaceutical company focused on innovative products for hospital and related settings, today announced the initiation of a clinical study evaluating the safety, tolerability profile, and intubation conditions of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery.

https://finance.yahoo.com/news/baudax-bio-initiates-phase-ii-130000290.html