I’ll Have the Metformin and Liraglutide Please

After an average of four years of follow-up, the study found that participants taking metformin plus liraglutide or insulin glargine achieved and maintained their target blood levels for the longest time compared to sitagliptin or glimepiride. This translated into approximately six months more time with blood glucose levels in the target range compared with sitagliptin, which was the least effective in maintaining target levels. Treatment effects did not differ based on age, sex, race, or ethnicity.

However, none of the combinations overwhelmingly outperformed the others.

Two popular diabetes drugs outperformed others in large clinical trial — https://www.nih.gov/news-events/news-releases/two-popular-diabetes-drugs-outperformed-others-large-clinical-trial

BUT if you can Stay as Thin as You Can as Long as You Can maybe, just maybe you won’t develop DM2.

Omicron booster shots are coming—with lots of questions – Updated 9/2/22

The new shots target both the original strain of the coronavirus and the omicron BA.4/BA.5 subvariants that most people are catching now. This double-barreled vaccine is called a bivalent vaccine. https://www.npr.org/sections/health-shots/2022/08/31/1120241293/fda-authorizes-first-revamp-of-covid-vaccines-to-target-omicron

For the BA.4/BA.5 boosters, the companies have submitted animal data. They have not released those data publicly, although at the June FDA meeting, Pfizer presented preliminary findings in eight mice given BA.4/BA.5 vaccines as their third dose. Compared with the mice that received the original vaccine as a booster, the animals showed an increased response to all Omicron variants tested: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5.

Omicron booster shots are coming—with lots of questions — https://www.science.org/content/article/omicron-booster-shots-are-coming-lots-questions

Update 9/2/22

Some answers to commonly asked questions can be found in the Stat article.

On Thursday evening, Centers for Disease Control and Prevention Director Rochelle Walensky signed off on the recommendation made earlier in the day by the Advisory Committee on Immunization Practices, that the newly formulated vaccines be used.

Your questions on the new Covid vaccine boosters answered — https://www.statnews.com/2022/09/01/your-questions-on-the-new-covid-vaccine-boosters-answered/

What do we know about Covid-19 vaccines in under 5s?

How researchers and public health officials perceive the risk-benefit ratio of rolling out vaccines to under 5s varies around the world and depends on the impact covid-19 has had on that country. Sweden has had just a handful of fatalities in those aged under 18,6 and vaccines are still not available to children aged 5-11 years. But in Brazil the virus has killed an average of two children under the age of 5 each day7—a rate which equates to around one in every five deaths among under 5s worldwide. Understandably, doctors are keen to boost protection levels, fearful of the impact that future variants might have.

BMJ 2022;378:o1892 — https://doi.org/10.1136/bmj.o1892 (Published 23 August 2022)

Monoclonal Antibody RX and Covid Variants

Most monoclonal antibody therapies that neutralized early variants of the SARS-CoV-2 virus are less effective or not effective against the BA.2.12.1, BA.4, and BA.5 Omicron subvariants that currently make up almost 99% of infections in the United States, according to a report in Nature.

Evolving Omicron Subvariants Are More Resistant to Antibody Therapy — https://jamanetwork.com/journals/jama/fullarticle/2795047

Oops.

New Weight Loss Treatment Is Marked by Heavy Marketing and Modest Results – Kaiser Health News

By Julie Appleby June 22, 2022

First came the “edible billboard,” which appeared last year during the holidays in New York’s East Village loaded with cake treats. Then, in late January, came the national marketing campaign, with TV and digital media promoting the idea that trying to lose weight doesn’t mean a person can’t enjoy eating.

Those advertising messages are pushing a product named Plenity as a potential liberation from dieters’ woes. It’s a $98-a-month weight loss treatment that looks like a drug: Patients take three capsules twice a day. But it isn’t a drug. And its success in racking up lost pounds, on average, is modest.

Plenity is FDA-approved as a device, one that contains sugar-sized grains of a plant-based, absorbent hydrogel. Each grain swells to 100 times its size, cumulatively filling about a quarter of a person’s stomach. The three capsules containing them must be taken with two cups of water at least 20 minutes before eating. The gel is not absorbed and eventually exits the body in stool.

The treatment is also generally not covered by insurance.

“We thought we would price it low enough that most consumers can pay out-of-pocket,” said Dr. Harry Leider, chief medical officer and executive vice president of Gelesis, the maker of Plenity.

Although far less costly than some other prescription weight loss treatments, it still “isn’t affordable for someone in the low-income bracket,” said Jena Shaw Tronieri, an assistant professor and director of clinical services at the University of Pennsylvania’s Center for Weight and Eating Disorders.

Plenity is designed to help patients who want to eat less, and taking it is comparable to consuming a big salad before lunch and dinner, without the actual raw vegetables.

It joins a growing selection of prescription weight loss and obesity treatments, from old-school oral medications that are often low-cost generics to far pricier brand-name injectable diabetes drugs newly repurposed as weight loss treatments. Results varied widely among trial participants; 59% of those who got Plenity lost at least 5% of their body weight, although the rest did not meet that threshold.

Plenity, whose active ingredient is a form of cellulose, embraces a strategy that has been used for decades by some people: to feel full before eating a main meal, thus reducing the calories they take in. Studies have shown that “if you fill up on broth-based soup or vegetables before a meal, you will feel fuller and eat less,” said Tronieri. She noted that filling up with water doesn’t produce the same satiating effect.

Still, some patients say that they “hate vegetables” and that “capsules are a lot easier,” said Dr. Christina Nguyen, medical director of obesity medicine at Northeast Georgia Health System. She is not affiliated with Gelesis but has been prescribing Plenity since its soft launch in late 2020.

So far, Gelesis credits the marketing campaign with helping it pick up 40,000 new customers in the first three months of the year, adding $7.5 million in revenue, although the company still lost money in the first quarter.

So where does this latest treatment fit as a potential weight loss tool for the more than 70% of American adults who are overweight or obese?

“I’m glad to see it on the market, but I tend to want more weight loss in patients than what I’m looking at with this device,” said W. Timothy Garvey, professor at the University of Alabama at Birmingham and director of the university’s Diabetes Research Center.

Gelesis reported that participants in its clinical trial who used Plenity lost on average 6.4% of body weight — above the 5% that many physicians say is a good target threshold. For a 200-pound person, that would equal almost 13 pounds. Still, that’s only a bit better than the 4.4% weight loss, on average, that people given a placeboin the six-month trial experienced. All 436 participants were put on diets that averaged 300 calories a day less than they needed to maintain their weight.

Nguyen said she tells her patients they must change their eating and exercise habits or Plenity won’t work. “You have to be realistic and set expectations,” she said. “What I’ve seen with Plenity is weight loss of about 5%.”

She noted it has relatively few side effects — mainly gastrointestinal, such as bloating, nausea, constipation, or flatulence — and the FDA has approved it for use in people with lower body mass index numbers than required for many other prescription products.

Plenity’s average weight loss is comparable to or below that of some other oral medications and is far less than that of the much more expensive new additions to the market such as Novo Nordisk’s Wegovy, a once-a-week injection that costs $1,300 a month. Wegovy helped patients lose nearly 15% of their body weight over 17 months, on average, according to clinical trials. In April, Eli Lilly said an injectable drug it is testing helped patients achieve an average weight loss of 22.5%. More details were released June 4.

“We don’t see Wegovy as a competitor,” said Leider, of Gelesis.

Nor does Leider view the weight loss products available without a prescription as competitors.

Leider said Gelesis sought FDA prescription approval for the treatment, rather than over-the-counter status, because “there’s a whole wall of nutritional supplements and products” and “we felt it was absolutely important to do the study and prove it scientifically works.” Down the road, “once we’ve built the brand,” Gelesis could seek over-the-counter status, he added.

As with other treatments, weight loss with Plenity can vary widely, he noted. Study data shows 27% of those given the treatment were considered “super responders,” losing an average of 14% of their weight. Patients with diabetes or prediabetes may respond better than those with normal blood sugar levels.

Still, it didn’t work for 40% of participants in the trial.

“If you take it for two months and you’re not losing weight, it may not be the therapy for you,” Leider said.

Patients can request Plenity from their physicians. In a move aimed at setting it apart from other treatments, Gelesis offers potential patients another choice: skipping an in-office visit entirely by requesting the treatment online. It has partnered with Ro, a direct-to-patient platform, which provides its network of affiliated physicians for online health assessments and delivers the treatment to eligible customers. Ro is also alarge purchaser of Plenity, placing a $30 million prepaid order in late 2021.

Ro, originally named Roman, launched in 2017 and initially focused on men’s health concerns, including erectile dysfunction and hair loss. It has since expanded to cover other conditions.

Online visits with physicians through Ro are free, including those for weight loss. Patients must answer questions about their health and experiences trying to lose weight.Pregnant patients, people younger than 22, and those allergic to Plenity’s ingredients should not take it.

Information provided to Ro is not protected under the federal privacy law called the Health Insurance Portability and Accountability Act, or HIPAA, but CEO Zachariah Reitano said all data is stored in “HIPAA-compliant” ways.

Ro added Plenity to its offerings because of the clinical trial results and because it saw a business opportunity with weight loss. Help for “challenges with weight management” was one of the top items his customers requested, Reitano said.

Even though it’s not covered by his insurance plan, patient Rene Morales said the $98 a month he spends is worth it. “If I spend that [much] on coffee, I can spend it to benefit my health,” said the 51-year-old, who is president of a skateboard company in Montclair, California, and was made available for an interview by Gelesis.

He started taking Plenity in late January after his doctor brought it up during his annual physical. Morales said he has lost 15 pounds from his original weight of nearly 280 pounds and wants to stay on the treatment until he has dropped 30.

Morales said the treatment is also helping him reshape his view of food and focus on smaller portions: “I’ve come to [the] realization that you don’t have to pile your plate up to enjoy your food.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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More Amphetamines Please

Prescription medications have become easier to obtain online during the pandemic, when regulatory officials waived requirements for in-person examination before certain types of drugs are prescribed. Truepill is still fulfilling Schedule III and V drug prescriptions from licensed clinicians. But the company is suspending delivery for Schedule II drugs like Adderall, which the Drug Enforcement Administration classifies as having a high level of potential abuse. In the case of stimulants, misuse has been linked to adverse effects, like heart failure or paranoia…

In behavioral health, particularly, there are concerns that providers examining patients for the first time in short, video-based appointments may not be able to detect important diagnostic cues like body language, given the range of symptoms certain conditions can present with. Some experts have also said they’re worried about whether such quick appointments let providers get in-depth enough to decide on the best course of treatment, including non-drug options.

A clash over online Adderall prescriptions is raising new questions about telehealth – https://www.statnews.com/2022/05/04/cerebral-truepill-adhd-prescriptions/ – accessed 5/4/22

Lets put on the Wiggles & pop a couple Ritalin
Papa don’t blame mama or tell her how lazy shes been
Its been prescribed by a doctor and the doctor said it ain’t no sin
So lets put on the Wiggles & pop a couple Ritalin

Wiggles & Ritalin by Reckless Kelly

Amphetamine Dependence Overview – https://www.sciencedirect.com/topics/neuroscience/amphetamine-dependence

Some days I just love my job.

A Patent-Free Covid Vaccine for the World

While Big Pharma corporations took billions of dollars in public funding to help develop vaccines from which they then reaped enormous profits while often charging exorbitant prices, Hotez and Battazzi created Cobervax with $7 million, mostly from private investors. One of these, Austin vodka distiller Tito’s, contributed $1 million to the effort.

Texas Team Applauded for Giving What Big Pharma Refuses: A Patent-Free Vaccine to the World — https://www.commondreams.org/news/2021/12/30/texas-team-applauded-giving-what-big-pharma-refuses-patent-free-vaccine-world

And for whatever reason everyone seems to be out of stock for an at home rapid Covid-19 antigen test.

If I drank vodka I would only buy Tito’s for the rest of my life.

Are You Still Thinking About a Booster Shot?

What worries me is that what we now know in the United States is even if you’ve been vaccinated against Covid, you can incubate and replicate these variants, or even perhaps the native virus, in your nose, because we have incomplete immunity in the nose in someone who’s been vaccinated fully against Covid.

Corey Casper is the CEO of the Infectious Disease Research Institute and a professor of medicine and global health at the University of Washington.

The science behind booster shots – https://www.opb.org/article/2021/08/24/the-science-behind-booster-shots/

Experts say “waning immunity” is concerning, but it isn’t as scary as it sounds. The vaccines still work, and for most people, still provide a high level of protection against severe disease. “It’s been a challenge,” says Mark Slifka, an immunologist at Oregon Health and Science University. “because some people will say, ‘well the vaccines aren’t working.’ And that’s a misconception. Vaccines are still providing 90 percent protection against mortality and hospitalization.” Breakthrough infections have increased but infections are still three times more likely in unvaccinated than vaccinated individuals. Of those infections, only 3.9 percent have led to hospitalization in vaccinated patients compared to 9 percent in those who remain unvaccinated.

Six Questions About Waning Immunity to Covid-19 Answered — https://www.smithsonianmag.com/science-nature/six-questions-about-waning-immunity-to-covid-19-answered-180979135/

No political agenda here, no conspiracy theories. I’m just sharing some informative articles and hope you find them helpful as you navigate the Never Ending Pandemic.

Still Thinking About a Booster Shot?

When someone who has had a mild case of COVID is vaccinated, the antibody level in their blood doubles compared to an unvaccinated person who has been infected by the virus. Their antibodies are also better able to prevent spike-ACE-2 interaction.

Université de Montréal. “COVID-19: The older you are, the more antibodies you have, study finds.” ScienceDaily. http://www.sciencedaily.com/releases/2021/11/211108081455.htm (accessed November 9, 2021).

A very small study with very interesting findings.

Also see Thinking About a Booster Shot?