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Off-brand Ozempic, Zepbound and other weight loss products carry undisclosed risks for consumers

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theconversation.com – C. Michael White, Distinguished Professor of Pharmacy Practice, University of Connecticut – 2024-10-09 07:34:00

C. Michael White, University of Connecticut

In just a few years, brand-name injectable drugs such as Ozempic, Wegovy, Mounjaro and Zepbound have rocketed to fame as billion-dollar annual sellers for weight loss as well as to control blood sugar levels and reduce the risk of heart disease.

But the price of these injections is steep: They cost about US$800-$1,000 per month, and if used for weight loss alone, they are not covered by most insurance policies. Both drugs mimic the naturally occurring hormone GLP-1 to help regulate blood sugar and reduce cravings. They can be taken only with a prescription.

The Food and Drug Administration announced an official shortage of the active ingredients in these drugs in 2022, but on Oct. 2, 2024, the agency announced that the shortage has been resolved for the medicine tirzepatide, the active ingredient in Mounjaro and Zepbound.

Despite the soaring demand and limited supply of these drugs, there are no generic versions available. This is because the patents for semaglutide – the active ingredient in Ozempic and Wegovy, which is still in shortage – and tirzepatide don’t expire until 2033 and 2036, respectively.

As a result, nonbrand alternatives that can be purchased with or without a prescription are flooding the market. Yet these products come with real risks to consumers.

I am a pharmacist who studies weaknesses in federal oversight of prescription and over-the-counter drugs and dietary supplements in the U.S. My research group recently has investigated loopholes that are allowing alternative weight loss products to enter the market.

High demand is driving GLP-1 wannabes

The dietary supplement market has sought to cash in on the GLP-1 demand with pills, teas, extracts and all manner of other products that claim to produce similar effects as the brand names at a much lower price.

Products containing the herb berberine offer only a few pounds of weight loss, while many dietary supplement weight loss products contain stimulants such as sibutramine and laxatives such as phenolphthalein, which increase the risk of heart attacks, strokes and cancer.

Poison control centers have seen a steep rise in calls related to off-brand weight loss medications.

The role of compounding pharmacies

Unlike the dietary supplements that are masquerading as GLP-1 weight loss products, compounding pharmacies can create custom versions of products that contain the same active ingredients as the real thing for patients who cannot use either brand or generic products for some reason.

These pharmacies can also produce alternative versions of brand-name drugs when official drug shortages exist.

Since the demand for GLP-1 medications has far outpaced the supply, compounding pharmacies are legally producing a variety of different semaglutide and tirzepatide products.

These products may come in versions that differ from the brand-name companies, such as vials of powder that must be dissolved in liquid, or as tablets or nasal sprays.

Just like the brand-name drugs, you must have a valid prescription to receive them. The prices range from $250-$400 a month – still a steep price for many consumers.

Compounding pharmacies must adhere to the FDA’s sterility and quality production methods, but these rules are not as rigorous for compounding pharmacies as those for commercial manufacturers of generic drugs.

In addition, the products compounding pharmacies create do not have to be tested in humans for safety or effectiveness like brand-name products do.

Proper dosing can also be challenging with compounded forms of the drugs.

Companies that work the system

For people who cannot afford a compounding pharmacy product, or cannot get a valid prescription for semaglutide or tirzepatide, opportunistic companies are stepping in to fill the void. These include “peptide companies,” manufacturers that create non-FDA approved knockoff versions of the drugs.

From November 2023 to March 2024, my team carried out a study to assess which of these peptide companies are selling semaglutide or tirzepatide products. We scoured the internet looking for these peptide companies and collected information about what they were selling and their sales practices.

We found that peptide sellers use a loophole to sell these drugs. On their websites, the companies state that their drugs are for “research purposes only” or “not for human consumption,” but they do nothing to verify that the buyers are researchers or that the product is going to a research facility.

By reading the comments sections of the company websites and the targeted ads on social media, it becomes clear that both buyers and sellers understand the charade. Unlike compounding pharmacies, these peptide sellers do not provide the supplies you need to dissolve and inject the drug, provide no instructions, and will usually not answer questions.

Peptide sellers, since they allegedly are not selling to consumers, do not require a valid prescription and will sell consumers whatever quantity of drug they wish to purchase. Even if a person has an eating disorder such as anorexia nervosa, the companies will happily sell them a semaglutide or tirzepatide product without a prescription. The average prices of these peptide products range from $181-$203 per month.

Skirting regulations

Peptide sellers do not have to adhere to the rules or regulations that drug manufacturers or compounding pharmacies do. Many companies state that their products are 99% pure, but an independent investigation of three companies’ products from August 2023 to March 2024 found that the purity of the products were far less than promised.

One product contained endotoxin – a toxic substance produced by bacteria – suggesting that it was contaminated with microbes. In addition, the products’ promised dosages were off by up 29% to 39%. Poor purity can cause patients to experience fever, chills, nausea, skin irritation, infections and low blood pressure.

In this study, some companies never even shipped the drug, telling the buyers they needed to pay an additional fee to have the product clear customs.

If a consumer is harmed by a poor-quality product, it would be difficult to sue the seller, since the products specifically say they are “not for human consumption.” Ultimately, consumers are being led to spend money on products that may never arrive, could cause an infection, might not have the correct dose, and contain no instructions on how to safely use or store the product.

Will prices for brand-name products come down?

To combat these alternative sellers, pharmaceutical company Eli Lilly began offering an alternative version of its brand-name Zepbound product for weight loss in September 2024.

Instead of its traditional injection pen products that cost more than $1,000 for a month’s supply, this product comes in vials that patients draw up and inject themselves. For patients who take 5 milligrams of Zepbound each week, the vial products would cost them $549 a month if patients buy it through the company’s online pharmacy and can show that they do not have insurance coverage for the drug.

After a grilling on Capitol Hill in September 2024, pharmaceutical company Novo Nordisk came under intense pressure to offer patients without prescription coverage a lower-priced product for its brand-name Wegovy as well.

In the next few years, additional brand-name GLP-1 agonist drugs will likely make it to market. As of October 2024, a handful of these products are in late-phase clinical trials, with active ingredients such as retatrutide, survodutide and ecnoglutide, and more than 18 other drug candidates are in earlier stages of development.

When new pharmaceutical companies enter this market, they will have to offer patients lower prices than Eli Lilly and Novo Nordisk in order to gain market share. This is the most likely medium-term solution to drive down the costs of GLP-1 drugs and eliminate the drug shortages in the marketplace.The Conversation

C. Michael White, Distinguished Professor of Pharmacy Practice, University of Connecticut

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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In Disney’s ‘Moana,’ the characters navigate using the stars, just like real Polynesian explorers − an astronomer explains how these methods work

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theconversation.com – Christopher Palma, Teaching Professor, Department of Astronomy & Astrophysics, Penn State – 2024-12-20 07:17:00

Wayfarers around the world have used the stars to navigate the sea.
Wirestock/iStock via Getty Images Plus

Christopher Palma, Penn State

If you have visited an island like one of the Hawaiian Islands, Tahiti or Easter Island, also known as Rapa Nui, you may have noticed how small these land masses appear against the vast Pacific Ocean. If you’re on Hawaii, the nearest island to you is more than 1,000 miles (1,600 kilometers) away, and the coast of the continental United States is more than 2,000 miles (3,200 kilometers) away. To say these islands are secluded is an understatement.

For me, watching the movie “Moana” in 2016 was eye-opening. I knew that Polynesian people traveled between a number of Pacific islands, but seeing Moana set sail on a canoe made me realize exactly how small those boats are compared with what must have seemed like an endless ocean. Yet our fictional hero went on this journey anyway, like the countless real-life Polynesian voyagers upon which she is based.

Oceania as shown from the ISS
Islands in Polynesia can be thousands of miles apart.
NASA

As an astronomer, I have been teaching college students and visitors to our planetarium how to find stars in our sky for more than 20 years. As part of teaching appreciation for the beauty of the sky and the stars, I want to help people understand that if you know the stars well, you can never get lost.

U.S. Navy veterans learned the stars in their navigation courses, and European cultures used the stars to navigate, but the techniques of Polynesian wayfinding shown in Moana brought these ideas to a very wide audience.

The movie Moana gave me a new hook – pun not intended – for my planetarium shows and lessons on how to locate objects in the night sky. With “Moana 2” out now, I am excited to see even more astronomy on the big screen and to figure out how I can build new lessons using the ideas in the movie.

The North Star

Have you ever found the North Star, Polaris, in your sky? I try to spot it every time I am out observing, and I teach visitors at my shows to use the “pointer stars” in the bowl of the Big Dipper to find it. These two stars in the Big Dipper point you directly to Polaris.

If you are facing Polaris, then you know you are facing north. Polaris is special because it is almost directly above Earth’s North Pole, and so everyone north of the equator can see it year-round in exactly the same spot in their sky.

It’s a key star for navigation because if you measure its height above your horizon, that tells you how far you are north of Earth’s equator. For the large number of people who live near 40 degrees north of the equator, you will see Polaris about 40 degrees above your horizon.

If you live in northern Canada, Polaris will appear higher in your sky, and if you live closer to the equator, Polaris will appear closer to the horizon. The other stars and constellations come and go with the seasons, though, so what you see opposite Polaris in the sky will change every month.

Look for the Big Dipper to find the North Star, Polaris.

You can use all of the stars to navigate, but to do that you need to know where to find them on every night of the year and at every hour of the night. So, navigating with stars other than Polaris is more complicated to learn.

Maui’s fishhook

At the end of June, around 11 p.m., a bright red star might catch your eye if you look directly opposite from Polaris. This is the star Antares, and it is the brightest star in the constellation Scorpius, the Scorpion.

If you are a “Moana” fan like me and the others in my family, though, you may know this group of stars by a different name – Maui’s fishhook.

If you are in the Northern Hemisphere, Scorpius may not fully appear above your horizon, but if you are on a Polynesian island, you should see all of the constellation rising in the southeast, hitting its highest point in the sky when it is due south, and setting in the southwest.

Astronomers and navigators can measure latitude using the height of the stars, which Maui and Moana did in the movie using their hands as measuring tools.

The easiest way to do this is to figure out how high Polaris is above your horizon. If you can’t see it at all, you must be south of the equator, but if you see Polaris 5 degrees (the width of three fingers at arm’s length) or 10 degrees above your horizon (the width of your full fist held at arm’s length), then you are 5 degrees or 10 degrees north of the equator.

The other stars, like those in Maui’s fishhook, will appear to rise, set and hit their highest point at different locations in the sky depending on where you are on the Earth.

Polynesian navigators memorized where these stars would appear in the sky from the different islands they sailed between, and so by looking for those stars in the sky at night, they could determine which direction to sail and for how long to travel across the ocean.

Today, most people just pull out their phones and use the built-in GPS as a guide. Ever since “Moana” was in theaters, I see a completely different reaction to my planetarium talks about using the stars for navigation. By accurately showing how Polynesian navigators used the stars to sail across the ocean, Moana helps even those of us who have never sailed at night to understand the methods of celestial navigation.

The first “Moana” movie came out when my son was 3 years old, and he took an instant liking to the songs, the story and the scenery. There are many jokes about parents who dread having to watch a child’s favorite over and over again, but in my case, I fell in love with the movie too.

Since then, I have wanted to thank the storytellers who made this movie for being so careful to show the astronomy of navigation correctly. I also appreciated that they showed how Polynesian voyagers used the stars and other clues, such as ocean currents, to sail across the huge Pacific Ocean and land safely on a very small island thousands of miles from their home.The Conversation

Christopher Palma, Teaching Professor, Department of Astronomy & Astrophysics, Penn State

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Listening for the right radio signals could be an effective way to track small drones

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theconversation.com – Iain Boyd, Director of the Center for National Security Initiatives and Professor of Aerospace Engineering Sciences, University of Colorado Boulder – 2024-12-17 17:28:00

Small drones can be hard to track at night.
Kevin Carter/Getty Images

Iain Boyd, University of Colorado Boulder

The recent spate of unidentified drone sightings in the U.S., including some near sensitive locations such as airports and military installations, has caused significant public concern.

Some of this recent increase in activity may be related to a September 2023 change in U.S. Federal Aviation Administration regulations that now allow drone operators to fly at night. But most of the sightings are likely airplanes or helicopters rather than drones.

The inability of the U.S. government to definitively identify the aircraft in the recent incidents, however, has some people wondering, why can’t they?

I am an engineer who studies defense systems. I see radio frequency sensors as a promising approach to detecting, tracking and identifying drones, not least because drone detectors based on the technology are already available. But I also see challenges to using the detectors to comprehensively spot drones flying over American communities.

How drones are controlled

Operators communicate with drones from a distance using radio frequency signals. Radio frequency signals are widely used in everyday life such as in garage door openers, car key fobs and, of course, radios. Because the radio spectrum is used for so many different purposes, it is carefully regulated by the Federal Communications Commission.

Drone communications are only allowed in narrow bands around specific frequencies such as at 5 gigahertz. Each make and model of a drone uses unique communication protocols coded within the radio frequency signals to interpret instructions from an operator and to send data back to them. In this way, a drone pilot can instruct the drone to execute a flight maneuver, and the drone can inform the pilot where it is and how fast it is flying.

Identifying drones by radio signals

Radio frequency sensors can listen in to the well-known drone frequencies to detect communication protocols that are specific to each particular drone model. In a sense, these radio frequency signals represent a unique fingerprint of each type of drone.

In the best-case scenario, authorities can use the radio frequency signals to determine the drone’s location, range, speed and flight direction. These radio frequency devices are called passive sensors because they simply listen out for and receive signals without taking any active steps. The typical range limit for detecting signals is about 3 miles (4.8 kilometers) from the source.

These sensors do not represent advanced technology, and they are readily available. So, why haven’t authorities made wider use of them?

Drones were all the buzz in the Northeast at the end of 2024.

Challenges to using radio frequency sensors

While the monitoring of radio frequency signals is a promising approach to detecting and identifying drones, there are several challenges to doing so.

First, it’s only possible for a sensor to obtain detailed information on drones that the sensor knows the communication protocols for. Getting sensors that can detect a wide range of drones will require coordination between all drone manufacturers and some central registration entity.

In the absence of information that makes it possible to decode the radio frequency signals, all that can be inferred about a drone is a rough idea of its location and direction. This situation can be improved by deploying multiple sensors and coordinating their information.

Second, the detection approach works best in “quiet” radio frequency environments where there are no buildings, machinery or people. It’s not easy to confidently attribute the unique source of a radio frequency signal in urban settings and other cluttered environments. Radio frequency signals bounce off all solid surfaces, making it difficult to be sure where the original signal came from. Again, the use of multiple sensors around a particular location, and careful placement of those sensors, can help to alleviate this issue.

Third, a major part of the concern over the inability to detect and identify drones is that they may be operated by criminals or terrorists. If drone operators with malicious intent know that an area targeted for a drone operation is being monitored by radio frequency sensors, they may develop effective countermeasures. For example, they may use signal frequencies that lie outside the FCC-regulated parameters, and communication protocols that have not been registered. An even more effective countermeasure is to preprogram the flight path of a drone to completely avoid the use of any radio frequency communications between the operator and the drone.

Finally, widespread deployment of radio frequency sensors for tracking drones would be logistically complicated and financially expensive. There are likely thousands of locations in the U.S. alone that might require protection from hostile drone attacks. The cost of deploying a fully effective drone detection system would be significant.

There are other means of detecting drones, including radar systems and networks of acoustic sensors, which listen for the unique sounds drones generate. But radar systems are relatively expensive, and acoustic drone detection is a new technology.

The way forward

It was almost guaranteed that at some point the problem of unidentified drones would arise. People are operating drones more and more in regions of the airspace that have previously been very sparsely populated.

Perhaps the recent concerns over drone sightings are a wake-up call. The airspace is only going to become much more congested in the coming years as more consumers buy drones, drones are used for more commercial purposes, and air-taxis come into use. There’s only so much that drone detection technologies can do, and it might become necessary for the FAA to tighten regulation of the nation’s airspace by, for example, requiring drone operators to submit detailed flight plans.

In the meantime, don’t be too quick to assume those blinking lights you see in the night sky are drones.The Conversation

Iain Boyd, Director of the Center for National Security Initiatives and Professor of Aerospace Engineering Sciences, University of Colorado Boulder

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Vaccine misinformation distorts science – a biochemist explains how RFK Jr. and his lawyer’s claims threaten public health

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theconversation.com – Mark R. O’Brian, Professor and Chair of Biochemistry, University at Buffalo – 2024-12-17 07:01:00

Many fatal childhood illnesses can be prevented with vaccination.
Westend61/Getty Images

Mark R. O’Brian, University at Buffalo

Vaccinations provide significant protection for the public against infectious diseases and substantially reduce health care costs. Therefore, it is noteworthy that President-elect Donald Trump wants Robert F. Kennedy Jr., a leading critic of childhood vaccination, to be secretary of Health and Human Services.

Doctors, scientists and public health researchers have expressed concerns that Kennedy would turn his views into policies that could undermine public health. As a case in point, news reports have highlighted how Kennedy’s lawyer, Aaron Siri, has in recent years petitioned the Food and Drug Administration to withdraw or suspend approval of numerous vaccines over alleged safety concerns.

I am a biochemist and molecular biologist studying the roles microbes play in health and disease. I also teach medical students and am interested in how the public understands science.

Here are some facts about vaccines that Kennedy and Siri get wrong:

Vaccines are effective and safe

Public health data from 1974 to the present conclude that vaccines have saved at least 154 million lives worldwide over the past 50 years. Vaccines are also continually monitored for safety in the U.S.

Nevertheless, the false claim that vaccines cause autism persists despite study after study of large populations throughout the world showing no causal link between them.

Claims about the dangers of vaccines often come from misrepresenting scientific research papers. In an interview with podcaster Joe Rogan, Kennedy incorrectly cited studies allegedly showing vaccines cause massive brain inflammation in laboratory monkeys, and that the hepatitis B vaccine increases autism rates in children by over 1,000-fold compared with unvaccinated kids. Those studies make no such claims.

In the same interview, Kennedy also made the unusual claim that a 2002 vaccine study included a control group of children 6 months of age and younger who were fed mercury-contaminated tuna sandwiches. No sandwiches are mentioned in that study.

Similarly, Siri filed a petition in 2022 to withdraw approval of a polio vaccine based on alleged safety concerns. The vaccine in question is made from an inactivated form of the polio virus, which is safer than the previously used live attenuated vaccine. The inactivated vaccine is made from polio virus cultured in the Vero cell line, a type of cell that researchers have been safely using for various medical applications since 1962. While the petition uses provocative language comparing this cell line to cancer cells, it does not claim that it causes cancer.

Gloved hands of clinician placing band-aid on child's arm, a syringe and vaccine vial beside them
Vaccines are continuously monitored for safety before and long after they’re made available to the general public.
Elena Zaretskaya/Moment via Getty Images

Vaccines undergo the same approval process as other drugs

Clinical trials for vaccines and other drugs are blinded, randomized and placebo-controlled studies. For a vaccine trial, this means that participants are randomly divided into one group that receives the vaccine and a second group that receives a placebo saline solution. The researchers carrying out the study, and sometimes the participants themselves, do not know who has received the vaccine or the placebo until the study has finished. This eliminates bias.

Results are published in the public domain. For example, vaccine trial data for COVID-19, human papilloma virus, rotavirus and hepatitis B are available for anyone to access.

Aluminum adjuvants help boost immunity

Kennedy is co-counsel with a law firm that is suing the pharmaceutical company Merck based in part on the unfounded assertion that the aluminum in one of its vaccines causes neurological disease. Aluminum is added to many vaccines as an adjuvant to strengthen the body’s immune response to the vaccine, thereby enhancing the body’s defense against the targeted microbe.

The law firm’s claim is based on a 2020 report showing that brain tissue from some patients with Alzheimer’s disease, autism and multiple sclerosis have elevated levels of aluminum. The authors of that study do not assert that vaccines are the source of the aluminum, and vaccines are unlikely to be the culprit.

Notably, the brain samples analyzed in that study were from 47- to 105-year-old patients. Most people are exposed to aluminum primarily through their diets, and aluminum is eliminated from the body within days. Therefore, aluminum exposure from childhood vaccines is not expected to persist in those patients.

Ironically, Kennedy’s lawyer, Siri, wants the FDA to withdraw some vaccines for containing less aluminum than stated by the manufacturer.

Vaccine manufacturers are liable for injury or death

Kennedy’s lawsuit against Merck contradicts his insistence that vaccine manufacturers are fully immune from litigation.

His claim is based on an incorrect interpretation of the National Vaccine Injury Compensation Program, or VICP. The VICP is a no-fault federal program created to reduce frivolous lawsuits against vaccine manufacturers, which threaten to cause vaccine shortages and a resurgence of vaccine-preventable disease.

A person claiming injury from a vaccine can petition the U.S. Court of Federal Claims through the VICP for monetary compensation. If the VICP petition is denied, the claimant can then sue the vaccine manufacturer.

Gloved hand picking up vaccine vial among a tray of vaccine vials
Drug manufacturers are liable for any vaccine-related death or injury.
Andreas Ren Photography Germany/Image Source via Getty Images

The majority of cases resolved under the VICP end in a negotiated settlement between parties without establishing that a vaccine was the cause of the claimed injury. Kennedy and his law firm have incorrectly used the payouts under the VICP to assert that vaccines are unsafe.

The VICP gets the vaccine manufacturer off the hook only if it has complied with all requirements of the Federal Food, Drug and Cosmetic Act and exercised due care. It does not protect the vaccine maker from claims of fraud or withholding information regarding the safety or efficacy of the vaccine during its development or after approval.

Good nutrition and sanitation are not substitutes for vaccination

Kennedy asserts that populations with adequate nutrition do not need vaccines to avoid infectious diseases. While it is clear that improvements in nutrition, sanitation, water treatment, food safety and public health measures have played important roles in reducing deaths and severe complications from infectious diseases, these factors do not eliminate the need for vaccines.

After World War II, the U.S. was a wealthy nation with substantial health-related infrastructure. Yet, Americans reported an average of 1 million cases per year of now-preventable infectious diseases.

Vaccines introduced or expanded in the 1950s and 1960s against diseases like diphtheria, pertussis, tetanus, measles, polio, mumps, rubella and Haemophilus influenza B have resulted in the near or complete eradication of those diseases.

It’s easy to forget why many infectious diseases are rarely encountered today: The success of vaccines does not always tell its own story. RFK Jr.’s potential ascent to the role of secretary of Health and Human Services will offer up ample opportunities to retell this story and counter misinformation.

This is an updated version of an article originally published on July 26, 2024.The Conversation

Mark R. O’Brian, Professor and Chair of Biochemistry, University at Buffalo

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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