Global Plan Fails At Crushing AIDS; New HIV Pill Comes With A Catch

NPR: Ambitious Plan To Stem HIV/AIDS Epidemic Meets None Of Its Goals
In 2015, global groups set ambitious goals to stem the HIV/AIDS epidemic. They aimed to bring down the number of new cases, particularly among children, teens and young women, by 2020 – and to bring up the number of people on HIV treatment. On July 21, the final report came out. No targets were met. (Wu, 7/29)

NPR: The Feds Are Making PrEP Free. But You May Still Have To Pay To Get It 
The federal government is making it much easier for Americans to get their hands on a potentially life saving treatment, if you have health insurance. It's called PrEP, a once-daily pill that is 99% effective at preventing HIV infections. PrEP has been around for nearly a decade, and health officials have long advocated for high risk people to take it, but usage has been limited due to the costs. Truvada, one of the medications authorized for PrEP, recently went generic, but used to cost upwards of $1,800 a month. The doctor's visits and lab tests can cost hundreds more. (Saloway and Benk, 7/29)

In other pharmaceutical and biotech news —

Stat: Congress Presses The FDA To Move Faster On ALS Drugs 
Lawmakers pressed a top Food and Drug Administration official Thursday for answers on why the agency has balked at approving medicines to treat the fatal neurodegenerative condition ALS. Two key politicians even called out specific drug candidates by name, a rare congressional boost for the biotechs behind them. The questions came during a hearing on neurodegenerative diseases hosted by the House Energy and Commerce committee that featured testimony from the National Institutes of Health, as well as patients and caregivers for conditions like Huntington’s disease and Alzheimer’s. But the lion’s share of questions were directed to the FDA’s drug center chief, Patrizia Cavazzoni. And most were about ALS. (Florko, 7/29)

Stat: FDA Threatens To Fine Drug Maker For Failing To Report Clinical Trial Results
For only the second time, the Food and Drug Administration is threatening to fine a drug maker for failing to submit required information about a clinical trial to a U.S. government registry. In a July 26 letter, the agency noted results of Phase 2 clinical test of a drug for treating acne rosacea had not been posted, even though the FDA contacted Accuitis last October about the issue. Acne rosacea is a condition that causes pus-filled bumps on the face and mostly affects middle-aged women with fair skin. Accuitis now has until Aug. 26 to post the data. (Silverman, 7/29)

Modern Healthcare: UnitedHealthcare, Cigna, Aetna All Unveil New Policies Restricting Biologics Use 
Six months ago, Angela Simmons Alvarez got a letter in the mail from her insurer, asking her to please stop taking ah drug she has relied on for nearly 20 years. She's not alone. Health insurers have been increasingly cracking down on members' use of high-cost biologic drugs, with UnitedHealthcare, Aetna and Cigna unveiling policies this year that force patients to switch to biosimilars or restrict the drug dosage an individual can receive. (Tepper, 7/29)

Stat: Research Into Centenarians’ Microbiomes Reveals Potential Clue To Longevity
New research into the microbiomes of centenarians reveals a potential clue to their longevity, adding to the scientific understanding that bacteria in the gut have major implications for our ability to fight disease. People who live past their 100th birthday are more likely to carry certain bacteria in their gut that produce powerful antimicrobial compounds, according to new research published Thursday in Nature. (Sheridan, 7/29)

Stat: What The Arrival Of The First Interchangeable Biologic Means For Health Care
The Food and Drug Administration’s decision on Wednesday to approve a long-acting insulin called Semglee (insulin glargine-yfgn) as the first interchangeable biologic licensed for the U.S. market represents a major step forward to greater competition and access for patients. What it means in practice, however, depends on where you sit. (Gillian Woollett, 7/29)

KHN: Diabetes Drug’s New Weight Loss Formula Fuels Cost-Benefit Debate
The long list of side effects that follow ads for the newer expensive drugs to treat Type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people — especially those with Type 2 diabetes, which is associated with obesity — may desperately want. So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for Type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit. (Appleby, 7/30)

In updates on the opioid crisis —

NPR: Was It 'Reasonable' To Ship 81 Million Opioid Pills To This Small West Virginia City? 
The outcome of a landmark federal opioid trial in West Virginia that reached closing arguments this week rests on two legally thorny questions. Was it "unreasonable" for three of America's biggest corporations — the drug wholesalers AmerisourceBergen, Cardinal Health and McKesson — to ship roughly 81 million highly addictive opioid pills to pharmacies in one small Rust Belt city on the Ohio River? (Mann, 7/30)

Stat: States Will Have To Decide Exactly How To Spend Opioid Settlement Money
The endgame of the sprawling mass of opioid lawsuits is starting to come into focus: Already, a settlement with Johnson & Johnson and three major drug distributors will pour billions of dollars into communities to combat the addiction crisis, with more to come. But what that looks like, exactly, will vary from place to place. States are likely to see lump sums of money doled out for years, and they will be left to decide how to spend it under the guideposts set up in the settlements. (Joseph, 7/30)

Stat: Siloed Overdose Data Pose Challenges For Researchers
As fatal overdoses once again rise — accounting for 92,183 deaths in 2020, a 30% increase from the year before — public health researchers are racing to develop better tools to prevent them. Some see promise in models that pull in data and spit out predictions about who is at highest risk of developing opioid use disorder or overdosing, giving health officials and physicians an idea of where to target strained prevention resources. But experts say that a scattered and siloed system to collect data on overdoses and outcomes is hamstringing efforts to further develop and deploy those models. (Lin, 7/30)

Also —

AP: Illinois Reports Winners Of 55 Marijuana Licenses In Lottery
There are 55 winners of Illinois’ lottery for licenses to operate marijuana retail stores officials said Thursday, but the licenses can’t be awarded until a judge rules on a challenge to the process. Awarding of the licenses by the Illinois Department of Professional Regulation have been delayed for more than a year, initially because of COVID-19-related issues. Problems with scoring the applications added to the delay. (7/30)

AP: 2 Rail Conductors Among 3 Charged With Prescription Scheme
Two New Jersey Transit conductors, including one who sits on the board of directors, took part in a fraud scheme involving expensive prescription drugs, according to charges announced Thursday by the Essex County prosecutor’s office. ... According to federal authorities involved in the larger probe, the scheme exploited the fact that some New Jersey state and local government employees had insurance that covered expensive compound medications such as pain, scar, antifungal and libido creams. Reimbursements ran as high as thousands of dollars for a one-month supply. Conspirators recruited government employees like teachers, police and firefighters to submit claims for prescriptions, based solely on the amount of money the insurance company would pay for them. (Porter, 7/30)