Medicine
fromwww.theguardian.com
1 day agoMedicines watchdog to investigate UK peptide clinics over health claims
UK clinics may be illegally promoting unregulated peptide therapies with unverified health claims.
A report last year found unnecessary surgeries were carried out, cancers were missed and poor standards of care were delivered at the University Hospital of North Durham and Darlington Memorial Hospital. CDDTF said it wanted to support the patients it had let down, including by offering access to psychological support, and to ensure they knew how to make a claim or raise concerns with police.
RBC Capital analyst Luca Issi upgraded the stock to Outperform from Sector Perform with a price target of $35, up from $11. Wells Fargo also upgraded uniQure to Overweight from Equal Weight with a $60 price target. The catalyst: the departure of Vinay Prasad from the FDA. RBC views this as a positive for uniQure, noting it is "not inconceivable" that the FDA reverts to its prior stance, and believes Prasad's departure is likely to open up a more balanced discussion on risk/reward for Huntington's disease.
According to the patent, a specific crystalline form of the drug known as polymorph C may be more effective than other versions because it is absorbed more efficiently by the body. The patent also notes that laboratory studies showed the drug reduced tumor growth and helped mice with brain tumors live longer, prompting early clinical trials to test whether the treatment is safe and effective in humans.
Federal regulators have issued warnings that unapproved exosomes could leave customers with severe skin infections. As procedures like exosome therapy become more popular, they draw attention to the potential threat to consumer health posed in some Florida med spas. In their rush to obtain the newest, buzziest treatments, customers may be injected with unapproved, mislabeled or even outright toxic substances.
Emma Dyer remembers the moment she clicked "buy now" on a set of weightloss jabs she found online. She had no medical consultation, no ID checks, and no questions about her history of anorexia and bulimia. "It was just so easy - too easy," she says. "They never asked for my medical history or what medication I was taking. It was like buying groceries."
Prasad's tenure was generally marked by controversy, but he is departing amid a cluster of self-destructive decisions. Those include a shocking rejection of an mRNA vaccine (which was over the objections of agency scientists and quickly reversed); a demand for an additional clinical trial on a gene therapy for Huntington's disease, which was widely seen as moving the goalpost for the therapy; his startling choice to publicly attack the maker of that gene therapy, UniQure; and alleged abuse of FDA staff, who say he created a toxic work environment.
The U.S. Food and Drug Administration is reportedly mulling whether more prescription drugs should be sold over the counter (OTC) at pharmacies. In an interview on Wednesday, FDA commissioner Martin Makary told CNBC that everything should be over the counter except drugs that are deemed unsafe or addictive or that require clinical monitoring. Makary said the agency is reviewing how it decides which drugs can be sold with or without a prescription from a health care practitioner.
A blood pressure medication has been recalled after a mix-up that may have led to some bottles containing the wrong drug. According to Health Canada, Marcan Pharmaceuticals Inc. has recalled two lots of MAR-Amlodipine 5 milligram tablets, which are used to treat high blood pressure and chest pain. That's because some bottles may instead contain 2.5 milligram tablets of midodrine, a medication used to treat low blood pressure.
Well, would you look at that? Not only is water wet, the ocean vast, and the Beckham feud enduring, but the abortion pill mifepristone is safe-and the FDA studies between 2011 and 2023 that declared it so were based on nothing other than fact and real science. If only we knew how good we had it when we had it.
The news is the latest sign of the FDA's heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation's top health official. Moderna received what's called a "refusal-to-file" letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today.
Now, researchers have created an artificial-intelligence system that vastly simplifies and accelerates the process of chemical synthesis. The system, which is called MOSAIC and is described in a study published in Nature on 19 January, recommended conditions that researchers were able to use to generate 35 compounds with the potential to become products like pharmaceuticals, agrochemicals or cosmetics without needing to do any further trawling or tweaking.
Yes, there has been a shocking lack of progress in developing transformative psychiatric medicine (We need new drugs for mental ill-health, 5 February), but this may be because in mental health, drugs are not always the answer (see, for example, Richard P Bentall's Doctoring the Mind). Huge progress has been made in the effectiveness of talking therapies for example, free effective treatment for post-traumatic stress disorder (PTSD) is available to all UK army veterans through the charity PTSD Resolution.
When generic drug manufacturers have issues like contamination, it is difficult for those who take the medications to know if they are affected. There is no standardized way to look up the data for where the pills in your bottle came from. ProPublica made an app that makes the lookup more straightforward. Even though generic drugs make up 90% of prescriptions dispensed in the U.S., the FDA only provides piecemeal information about them.
In 2021, amid the COVID‑19 pandemic, Kristin Wall became pregnant with her second child. Her physician told her that little was known about the COVID-19 vaccine's safety and effectiveness in pregnant people. Observational data - collected from those vaccinated before they knew that they were pregnant - suggested that the vaccine was safe, so she could have it. Still, she'd have to weigh up the risks and benefits herself.
Before treatment began, participants underwent neuroimaging. Instead of relying on a single modality, the researchers fused structural connectivity (how regions are physically wired) with functional connectivity (how regions co-activate at rest). The goal was not to throw every possible feature at a black box, but to learn a constrained pattern-what the authors call structure-function "covariation"-that carries the most predictive signal for outcome. In other words, the model tries to find the smallest set of connections that meaningfully forecasts symptom change.
Public health consultant Dr Ross Keat said supporting people earlier to make small preventative changes would make "a big difference later on". Some 3,500 people in the north of the island within that age bracket are eligible for the checks. The checks will be carried out by two pre-existing nurses that support GP staff and would not replace GP appointments, Keat explained, adding that the cost would be minimal and absorbed by Ramsey Group Practice.
While the move came as a surprise to the high-profile vaccine maker, it is just the latest hostility toward vaccines-and mRNA vaccines in particular-from an agency overseen by the fervent anti-vaccine activist Robert F. Kennedy Jr. In his first year in office, Kennedy has already dramatically slashed childhood vaccine recommendations and canceled $500 million in research funding for mRNA vaccines against potential pandemic threats.