Global plan fails to crush AIDS; The new anti-HIV pill comes with a trap

NPR: Ambitious plan to stem the HIV / AIDS epidemic falls short of any of its targets

In 2015, global groups set ambitious goals to stem the HIV / AIDS epidemic. They aimed to reduce the number of new cases, especially among children, adolescents and young women, by 2020 – and to increase the number of people on HIV treatment. On July 21, the final report came out. No targets were met. (Wu, 7/29)

NPR: Federal authorities make PrEP free. But you may still have to pay to get it

The federal government makes it much easier for Americans to get their hands on potentially life-saving treatment if you have health insurance. This is called PrEP, a once-daily pill that is 99% effective in preventing HIV infections. PrEP has been around for almost a decade, and health officials have long advocated for people at high risk to take it, but its use has been limited due to costs. Truvada, one of the approved drugs for PrEP, recently became generic, but was costing up to $ 1,800 per month. Doctor visits and lab tests can cost hundreds more. (Saloway and Benk, 7/29)

In other pharmaceutical and biotech news –

Stat: Congress urges FDA to move faster on ALS drugs

Lawmakers on Thursday pressed a senior Food and Drug Administration official for answers on why the agency has balked at approving drugs to treat the deadly neurodegenerative disease ALS. Two key politicians have even called specific drug candidates by name, a rare boost in Congress for the biotech 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 the disease. Alzheimer’s. But the lion’s share of the questions have been directed to the chief of the FDA’s pharmaceutical center, Patrizia Cavazzoni. And most were about ALS. (Florko, 7/29)

Stat: FDA threatens to fine drugmaker for failing to release clinical trial results

For just the second time, the Food and Drug Administration is threatening to fine a drug maker for failing to submit required clinical trial information to a US government registry. In a July 26 letter, the agency noted that the results of the Phase 2 clinical trial of a drug for the treatment of acne rosacea had not been released, although the FDA contacted Accuitis last October. on this subject. Acne rosacea is a condition that causes pus-filled bumps on the face and mainly affects middle-aged women with fair skin. Accuitis now has until August 26 to release the data. (Silverman, 7/29)

Modern healthcare: UnitedHealthcare, Cigna and Aetna all unveil new policies restricting the use of biologics

Six months ago, Angela Simmons Alvarez received a letter in the mail from her insurer, asking her to stop taking a drug she had relied on for almost 20 years. She is not alone. Health insurers are increasingly cracking down on members’ use of expensive biologics, with UnitedHealthcare, Aetna and Cigna this year unveiling policies that require patients to switch to biosimilars or restrict the dose of drugs an individual can to receive. (Tepper, 7/29)

Stat: Centenarian microbiome research reveals potential clue of longevity

New research into the microbiomes of centenarians reveals a potential clue to their longevity, adding to 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 potent antimicrobial compounds, according to new research published Thursday in Nature. (Sheridan, 7/29)

Stat: What the arrival of the first interchangeable biologics for healthcare means

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 cleared for the US market represents a big step towards increased competition and access for patients. What this 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 advertisements for expensive new drugs to treat type 2 diabetes sometimes includes an unusual warning: they can lead to weight loss. This side effect is one that many people – especially those with type 2 diabetes, which is associated with obesity – can desperately want. So it’s no surprise that some of the same drugs are being reformulated and rebranded by manufacturers as a new treatment for obesity. No longer confined to the crowded area of ​​treatment for type 2 diabetes, which affects about 10% of Americans, they join the much smaller number of obesity drugs, which affect 42% of Americans and are ready to be exploited at for profit. (Appleby, 7/30)

In updates on the opioid crisis –

NPR: Was it “reasonable” to ship 81 million opioid pills to this small town in West Virginia?

The outcome of a landmark federal opioid lawsuit in West Virginia that resulted in closing arguments this week hinges on two legally thorny questions. Was it “unreasonable” for three of America’s biggest companies – drug wholesalers AmerisourceBergen, Cardinal Health and McKesson – to ship an estimated 81 million highly addictive opioid pills to drugstores in a small town in Rust Belt on the Ohio River? ? (Mann, 7/30)

Stat: States will have to decide exactly how to spend the opioid settlement money

The end of the sprawling mass of opioid lawsuits is beginning to take shape: already, a settlement with Johnson & Johnson and three major drug distributors will pour billions of dollars into communities to fight the addiction crisis, and more to come. But what that looks like, exactly, will vary from place to place. States will likely see lump sums distributed for years to come, and they will be left to decide how to spend them according to the beacons put in place in the settlements. (Joseph, 7/30)

Stat: Silo overdose data poses challenges for researchers

As fatal overdoses rise again – accounting for 92,183 deaths in 2020, a 30% increase from the previous year – public health researchers are rushing to develop better tools to prevent them. Some see promising models in models that collect data and spit out predictions about who is most at risk for developing an opioid use disorder or overdose, giving health officials and doctors a clue. where to target strained prevention resources. But experts say a scattered and siled system for collecting data on overdoses and outcomes is hampering efforts to further develop and deploy these models. (Lin, 7/30)

Also –

AP: Illinois reports winners of 55 marijuana licenses in lottery

There are 55 Illinois lottery winners for marijuana retail store operating licenses, marijuana retail officials said Thursday, but the licenses cannot be awarded until after. ‘a judge will not rule on a challenge to the process. Licensing by the Illinois Department of Professional Regulation has been delayed by more than a year, initially due to issues related to COVID-19. Scoring issues added to the deadline. (7/30)

AP: 2 railway drivers out of 3 accused of prescription regime

Two New Jersey Transit drivers, including one who sits on the board of directors, were involved in a fraud scheme involving expensive prescription drugs, according to charges announced Thursday by the Essex County District Attorney’s Office. … According to federal authorities involved in the larger investigation, the scheme exploited the fact that some New Jersey state and local government employees had insurance that covered expensive compound drugs such as pain-relieving creams, healing, antifungal and libido. Refunds reached thousands of dollars for a one month supply. The conspirators recruited government workers like teachers, police and firefighters to submit prescription claims, based solely on how much the insurance company would pay for them. (Doorman, 7/30)