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Nicole Saphier, MD is a physician at Memorial Sloan Kettering Cancer Center, an assistant professor at Weill Cornell Medical College and bestselling author of, 'Panic Attack.' Her opinions are her own and not reflective of her employers.Not every problem can be fixed with a pill. Not every problem should be fixed with a pill. But in an increasingly dangerous trend, America's medical industry is presenting drugs as a quick and easy solution for nearly everything that ails us – be it major, minor, or even non-existent. Now, America is running out of the prescription medications that sick people need, because...

WASHINGTON, D.C. – Today, the U.S. Senate unanimously passed Senator Rand Paul’s (R-KY) and Senator Cory Booker’s (D-NJ) bipartisan FDA Modernization Act 2.0 to end animal testing mandates. This legislation ends an outdated FDA mandate that experimental drugs must be tested on animals before they are used on humans in clinical trials. The bill doesn’t ban animal testing outright but would allow the option for drug sponsors to use alternative methods where they are suitable. The legislation is cosponsored by Senators Mike Braun (R-IN), Ben Ray Luján (D-NM), Roger Marshall (R-KS), Mike Crapo (R-ID), Susan Collins (R-ME), Angus King (D-ME),...

Two Covid-19 antibody therapies are no longer recommended by the World Health Organisation (WHO), as Omicron and the variant's latest offshoots have likely rendered them obsolete. The two therapies - which are designed to work by binding to the spike protein of SARS-CoV-2 to neutralise the virus' ability to infect cells - were some of the first medicines developed early in the pandemic. The virus has since evolved, and mounting evidence from lab tests suggests the two therapies - sotrovimab, as well as casirivimab-imdevimab - have limited clinical activity against the latest iterations of the virus.

Google employees are receiving regular notifications from management of Covid-19 infections, causing some to question the company’s return-to-office mandates. The employees, who spoke with CNBC on the condition of anonymity, said since they have been asked to return to offices, infections notifications pop up in their email inboxes regularly. Employees are reacting with frustration and memes. The company began requiring most employees to return to physical offices at least three days a week in April. Since then, staffers have pushed back on the mandate after they worked efficiently for so long at home while the company enjoyed some of its...

The calls and text messages are relentless. On the other end are doctors and scientists at the top levels of the National Institutes for Health, Food and Drug Administration and Centers for Disease Control and Prevention. They are variously frustrated, exasperated and alarmed about the direction of the agencies to which they have devoted their careers. “It’s like a horror movie I’m being forced to watch and I can’t close my eyes,” one senior FDA official lamented. “People are getting bad advice and we can’t say anything.” That particular FDA doctor was referring to two recent developments inside the agency....

The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J's vaccine. U.S. authorities for months have recommended that Americans starting their COVID-19 vaccinations use the Pfizer or Moderna shots instead. FDA officials said in a statement that they decided to restrict J&J's vaccine after taking another look at data on the risk of life-threatening blood clots within two weeks of vaccination. J&J's vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. But the single-dose option proved less effective...

FDA on Thursday announced the availability of a draft guidance that, if finalized, would state the agency’s “intent to exercise enforcement discretion” regarding the distribution and sale of products labeled as dietary supplements and containing NAC (N-acetyl-L-cysteine). The draft guidance, which is scheduled to be published April 22 in the Federal Register, was released three weeks after FDA reaffirmed its position in responses to two citizen petitions that NAC is excluded from the definition of a dietary supplement because the ingredient was first approved as a drug in 1963. FDA, however, is still considering commencing a rulemaking to permit the...

A University of Pennsylvania law student couldn't shake his paranoid suspicion that his two neighbors, Drexel University graduate students, were foreign spies sent to work on some sort of a terrorism plot, police said. His anger-laced curiosity grew after he approached the roommates, both Indian-born bio-engineering majors, during a seemingly friendly conversation yesterday morning as the three men left the apartment building at 43rd near Pine streets before class, said cops. At about 12:30 p.m, the 31-year-old Korean-American law student returned home, took out his legal Glock-9, and knocked on his neighbors' front door. The 22-year-old Drexel student, the only...

“It makes no difference if they are criminals, flesh peddlers, and smut dealers that are exploiting American and Ecuadorian people for profit. For Clinton, if you have enough money, anything goes. This is just another reason why her brand of corruption must not be allowed into the White House.”

Dr. Robert Califf was narrowly confirmed by the Senate on Tuesday to lead the Food and Drug Administration, placing him back in the role he held during the final year of the Obama administration. The Senate confirmed President Biden’s nominee 50-46, after Califf received opposition from Sen. Joe Manchin (D-WV), who argued the doctor bore “a great deal of responsibility” for massive drug overdose deaths that have happened since his last tenure in the position. Califf, a longtime cardiology professor at Duke University, served in the role for a short 11 months and was replaced by former President Donald Trump...

Global supplies of pharmaceutical drugs are getting tighter and tighter, and this has very serious implications for 2022 and beyond. If you depend upon a certain pharmaceutical drug in order to stay alive, I would recommend doing whatever you can to make sure that you have as much of that drug stockpiled as possible, because a day may come when you are unable to get any more for an extended period of time. Much of our drug production has been outsourced to China, and our relations with China are not going so well right now. In fact, the moment that...

The pandemic has saved the reputation of some pharmaceutical giants whose track records should not be whitewashedast week, a commission set up by Stanford University and the Lancet found that the devastating opioid crisis in North America could happen again, and not just there. The unethical practices that Patrick Radden Keefe documented in his prize-winning 2021 book, Empire of Pain, were not restricted to one company, Purdue Pharma, and the part of the Sackler family that owned it. They were and remain normal behaviour in the pharmaceutical industry and in the agencies that are supposed to regulate it. The Covid...

Drugmaker Johnson & Johnson has halted production of its single-dose COVID-19 vaccine, according to a New York Times report. The pharmaceutical company last year quietly shut down production at a plant in Leiden, Netherlands, which was the only facility where usable doses of the vaccine were manufactured, catching some of its customers off guard, the report states. Johnson & Johnson has instead been using the plant to work on an experimental and potentially more profitable drug that could protect against an unrelated respiratory virus, according to the report.

In one five-year period, teens and preteens in the US may have lost about 200,000 years of life to unintentional drug overdoses, according to a new study. The study, published Monday in JAMA Pediatrics, may be one of the first to calculate lives lost to unintentional drug overdoses among young people. Researchers looked at overdose data from the US Centers for Disease Control and Prevention between 2015 and 2019 to calculate the total number of years of life lost for 10- to 19-year-olds who died during that time. If the data is expanded to include people up to 24 years...

— Proposal would cover aducanumab (Aduhelm) in patients on qualifying clinical trialsMonoclonal antibodies targeting amyloid beta in Alzheimer's disease, including the newly approved drug aducanumab (Aduhelm), would be covered for people with Medicare only if they are enrolled in qualifying clinical trials, according to CMS plans announced Tuesday. The proposed CMS National Coverage Determination would cover FDA-approved monoclonal antibodies targeting amyloid in Alzheimer's disease through coverage with evidence development (CED). To date, the only such approved treatment is aducanumab. "Throughout this National Coverage Determination process, CMS has been and remains committed to providing the American public with a clear, trusted,...

If you want to understand the way prescription drugs are marketed today, have a look at the 1928 book, "Propaganda," by Edward Bernays, the father of public relations in America. SNIP Just as Bernays sold pianos by selling the music room, pharmaceutical marketers now sell drugs by selling the diseases that they treat. The buzzword is "disease branding." To brand a disease is to shape its public perception in order to make it more palatable to potential patients. Panic disorder, reflux disease, erectile dysfunction, restless legs syndrome, bipolar disorder, overactive bladder, ADHD, premenstrual dysphoric disorder, even clinical depression: All these...

According to the FDA, a “drug is removed from the market when its risks outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug that cannot be corrected, such as when it is discovered that the drug can cause serious side effects that were not known at the time of approval.” The FDA also takes into account the number of people taking a drug being considered for removal so as to not harm those patients. The drugs below have been removed from the market by the FDA for various reasons, but the...

Future pandemics could be even more lethal than COVID-19 so the lessons learned from the outbreak must not be squandered and the world should ensure it is prepared for the next viral onslaught, one of the creators of the Oxford-AstraZeneca vaccine said. The coronavirus has killed 5.26 million people across the world, according to Johns Hopkins University, wiped out trillions of dollars in economic output and turned life upside down for billions of people. "The truth is, the next one could be worse. It could be more contagious, or more lethal, or both," Sarah Gilbert said in the Richard Dimbleby...

Could this supply-chain disruption affect pharmaceuticals? Concretely, I mean is there a chance that pharmacies will not be able to fill some prescriptions for a dangerous length of time (i.e., neither could a drug store fill a prescription nor send the patient to another drug store)? I do NOT wish to start rumors. But I'd appreciate any informed insights. Thanks for any info!

A pair of new companies are being launched to tackle high drug costs, the latest sign of employer frustration with the middlemen, known as PBMs, whose job it is to keep down the spending. The Mark Cuban Cost Plus Drug Company PBC and the Purchaser Business Group on Health, a nonprofit coalition of nearly 40 large public and private employers, said they are each starting new pharmacy-benefit management companies. PBMs work on behalf of employers, labor unions and governments to decide which drugs are available to patients, negotiate rebates on the prices paid for those drugs and process payments to...