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Ozempic in Teens Is a Mess
Somehow, America’s desire for Ozempic is only growing. The drug’s active ingredient, semaglutide, is sold as an obesity medication under the brand name Wegovy — and it has become so popular that its manufacturer, Novo Nordisk, recently limited shipments to the U.S. and paused advertising to prevent shortages. Its promise has enticed would-be patients and set off a pharmaceutical arms race to create more potent drugs.
Part of the interest stems from Ozempic’s potential in teens: In December, the FDA approved Wegovy as a treatment for teenagers with obesity, which affects 22% of 12-to-19-year-olds in the United States. The drug’s ability to spur weight loss in adolescents has been described as “mind-blowing.” In January, in its new childhood-obesity-treatment guidelines, the American Academy of Pediatrics (AAP) recommended that doctors consider adding weight-loss drugs such as semaglutide as a treatment for some patients.
But although many doctors and obesity experts have embraced semaglutide as a treatment for adults, some are concerned that taking it at such a young age — and at such a precarious stage of life — could pose serious risks, especially because the long-term physical and mental health effects of the medication are still unknown.
Others, however, believe that not using this medication in adolescents is riskier, because obesity makes teens vulnerable to serious health conditions and premature death. In part because of the apprehension among doctors, prescriptions for semaglutide in teens are not taking off like they are for adults. At this point, whether these drugs will ever catch on as a treatment for teens remains deeply uncertain.
Elon Musk’s Neuralink Says It Has FDA Approval for Study of Brain Implants in Humans
Elon Musk‘s brain-implant company Neuralink on Thursday said the U.S. Food and Drug Administration (FDA) had given the green light to its first-in-human clinical trial, a critical milestone after earlier struggles to gain approval.
Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling web browsing and telepathy. He made headlines late last year when he said he was so confident in the devices’ safety that he would be willing to implant them in his children.
On at least four occasions since 2019, Musk predicted Neuralink would begin human trials. But the company only sought FDA approval in early 2022 and the agency rejected the application, seven current and former employees told Reuters in March.
The FDA had pointed out several concerns to Neuralink that needed to be addressed before sanctioning human trials, according to the employees. Major issues involved the lithium battery of the device, the possibility of the implant’s wires migrating within the brain and the challenge of safely extracting the device without damaging brain tissue.
Amazon.com Faces Lawsuit Over Artificial Tears Eye Drops Bacterial Contamination
A Michigan woman has filed a lawsuit against Amazon.com and the manufacturers of recalled Artificial Tears eye drops, indicating she suffered an infection from bacterial contamination which left her blind in her right eye.
The case joins a growing number of EzriCare Artificial Tears lawsuits now being pursued by consumers nationwide, who have experienced Pseudomonas aeruginosa infections that have caused a wide range of health problems, including vision problems, bloodstream infections and death.
A number of eyedrops class action lawsuits have also been filed against the manufacturers, seeking damages on behalf of all consumers who purchased the Artificial Tears products that were recalled in February 2023.
According to a recent report by the U.S. Centers for Disease Control and Prevention (CDC), the recalled Artificial Tears eye drops have been linked to 81 cases of bacterial contamination, including multiple reports of vision loss, four reports of consumers requiring removal of an eyeball, and four reports of deaths.
EU and Pfizer Renegotiate Controversial Vaccine Contract
The European Commission and U.S. pharmaceutical giant Pfizer have renegotiated a massive contract for COVID-19 vaccine doses that the EU entered into at the height of the pandemic.
The Commission announced that the two parties had agreed Pfizer would spread out deliveries over the course of the next four years, into 2027, and to reduce the total amount of doses down from the 450 million that were due to be delivered this year. However, the Commission didn’t disclose the new total in its announcement. When asked by POLITICO about the revised delivery figure, Commission Health Spokesperson Stefan de Keersmaecker referred POLITICO to EU member countries for a response.
The financial terms of the deal are also not public, but the Commission said that the bloc retained the possibility to buy the remainder of the original 450 million doses and that it was paying extra for the option — something that ministers have previously criticized as a “cancellation fee.” In practice, this increases the price per dose, though the overall price tag would be lower.
The long-standing negotiations raise the question of why such a large contract was entered into with deliveries so far in the future — in 2022 and 2023 — when the pandemic conditions might have changed, without a clause to negotiate down doses.
Doctor’s Tip: Big Pharma’s Inappropriate Influence on the Practice of Medicine
Over the past several decades the pharmaceutical industry has developed drugs that prolong life and improve quality of life. However, there’s a dark side.
The April issue of the American Family Physician Journal has an article about new national guidelines for drug treatment of asthma. You would expect that these guidelines would be unbiased and free from Big Pharma’s influence, but that’s not the case. In the same issue, there is an editorial that speaks to this titled “Recent Changes in International Asthma Guidelines May Be Influenced by Pharmaceutical Industry Conflicts of Interest.”
There were two boards that came up with the recommendations in the new guidelines, and according to the editorial, almost all the studies that led to the new recommendations were done by scientists working for pharmaceutical companies that would benefit financially from them. Furthermore, the large majority of both boards were made up of industry scientists — hardly unbiased. The medication recommended in the new guidelines is Symbicort (generic name budesonide/formoterol), which is made by AstraZeneca, and “reported more than $2.5 billion in sales worldwide in 2021.”
We are the only developed country in the world that allows pharmaceutical companies to market drugs directly to our citizens. Bottom line: Big Pharma has more influence than it should on physicians and the way they practice.
Moderna Looks for Opportunities in China After Registering Legal Entity
Vaccine maker Moderna Inc (MRNA.O) said on Friday it was looking for opportunities in China after confirming that it had registered a legal entity in the world’s second-largest economy.
The U.S. biotech firm registered a unit called Moderna (China) Biotech Ltd in Shanghai on May. 24 with capital of $100 million, according to Chinese data providers including company database Qichacha.
“We are exploring opportunities to engage in the market and bring the power of Moderna’s mRNA platform to the people of China,” a company spokesperson said in response to a query from Reuters.
Moderna has said that it was keen to sell its mRNA vaccine to China but the company and its foreign peers have so far been kept out as Beijing has insisted on using only Chinese-made COVID-19 vaccines for its population.
Dozens of Democrats Join GOP in Passing Bill on Fentanyl-Related Drug Penalties
Legislation to permanently classify fentanyl-like substances into a category reserved for the most dangerous drugs passed the House on Thursday.
The GOP-sponsored HALT Fentanyl Act passed 289-133 with support from 74 Democrats, who wanted to be on record as supporting legislation intended to crack down on the synthetic opioid crisis.
Fentanyl itself is approved by the Food and Drug Administration for medical use, so it is a Schedule 2 drug. The bill would crack down on illicit fentanyl copycats.
Johnson & Johnson Cites Rebates and Discounts for Drug Price Increases
Why do companies jack up their drug prices each year in the U.S.? In recent years, some drugmakers have tried to answer this question with annual statements dressed up as “transparency” reports.
Now, pharma giant Johnson & Johnson has presented its 2022 document, arguing that its rising prices are necessary to cover the growing costs it pays in the form of rebates, discounts and other fees to insurance companies, government programs, distributors and other players in the healthcare system.
J&J’s rebates, discounts and fees added up to $39 billion last year, according to the report, with $11.2 billion going to commercial payers and pharmacy benefit managers, while $8.9 billion went to Medicare and Medicaid programs.
