Skip to main content

Home/ TOK Friends/ Group items tagged FDA

Rss Feed Group items tagged

ilanaprincilus06

The FDA Has Approved An Obesity Drug That Helped Some People Drop Weight By 15% : NPR - 0 views

  • Regulators on Friday said a new version of a popular diabetes medicine could be sold as a weight-loss drug in the U.S.
  • In company-funded studies, participants taking Wegovy had average weight loss of 15%, about 34 pounds (15.3 kilograms). Participants lost weight steadily for 16 months before plateauing.
  • "With existing drugs, you're going to get maybe 5% to 10% weight reduction, sometimes not even that,"
  • ...5 more annotations...
  • In the U.S., more than 100 million adults — about 1 in 3 — are obese.
  • Dropping even 5% of one's weight can bring health benefits, such as improved energy, blood pressure, blood sugar and cholesterol levels, but that amount often doesn't satisfy patients who are focused on weight loss
  • The drug carries a potential risk for a type of thyroid tumor, so it shouldn't be taken by people with a personal or family history of certain thyroid and endocrine tumors. Wegovy also has a risk of depression and pancreas inflammation.
  • Like other weight-loss drugs, it's to be used along with exercise, a healthy diet and other steps like keeping a food diary.
  • Wegovy builds on a trend in which makers of relatively new diabetes drugs test them to treat other conditions common in diabetics.
jmfinizio

Opinion: UK decision to delay second Covid-19 vaccine dose is dubious - CNN - 0 views

  • The second dose of both vaccines can now be given up to 12 weeks after the first dose
  • Similar proposals about delaying the second dose have been discussed in the US,
  • the FDA does not support changing the vaccine administration protocol initially set forth
  • ...7 more annotations...
  • how can the public trust the right decisions were made
  • how can the public trust the right decisions were made
  • How can knowledgeable independent healthcare professionals endorse those decisions when they are not privy to the process?
  • Pfizer vaccine to have a 90% short term efficacy, and a single dose of the Oxford vaccine to have a 70% short term efficacy.
  • Would confidence in the vaccine be reduced by multiple reports of vaccine failures among at-risk individuals
  • Perhaps the UK could consider instead other ways to conserve vaccine supplies that may be safer than the delayed second dose option.
  • Also, for people who have recovered from Covid-19 a single vaccine dose may indeed be sufficient to boost their antibodies to high levels
haubertbr

FDA cracks down on 'illegal' cancer treatments - 1 views

  •  
    On Tuesday, the agency responsible for policing the American food and drug market issued warning letters to 14 companies that it says are "illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer." "There's a couple of issues here," Jason Humbert, a regulatory operations officer in the FDA's Office of Regulatory Affairs, told CNN.
Javier E

Underselling the Vaccine - The New York Times - 0 views

  • Of the 32,000 people who received the Moderna or Pfizer vaccine in a research trial, do you want to guess how many contracted a severe Covid case? One.
  • If anything, the 95 percent number understates the effectiveness, because it counts anyone who came down with a mild case of Covid-19 as a failure. But turning Covid into a typical flu — as the vaccines evidently did for most of the remaining 5 percent — is actually a success.
  • Although no rigorous study has yet analyzed whether vaccinated people can spread the virus, it would be surprising if they did. “If there is an example of a vaccine in widespread clinical use that has this selective effect — prevents disease but not infection — I can’t think of one!” Dr. Paul Sax of Harvard has written
  • ...10 more annotations...
  • “Please be assured that YOU ARE SAFE after vaccine from what matters — disease and spreading.”
  • The risks for vaccinated people are still not zero, because almost nothing in the real world is zero risk. A tiny percentage of people may have allergic reactions
  • the evidence so far suggests that the vaccines are akin to a cure.
  • The Moderna and Pfizer vaccines — the only two approved in the U.S. — are among the best vaccines ever created, with effectiveness rates of about 95 percent after two doses.
  • That’s on par with the vaccines for chickenpox and measles.
  • The Moderna and Pfizer vaccines are “essentially 100 percent effective against serious disease,” Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said. “It’s ridiculously encouraging.”
  • “It’s going to save your life — that’s where the emphasis has to be right now,”
  • “We’re underselling the vaccine,”
  • Right now, public discussion of the vaccines is full of warnings about their limitations: They’re not 100 percent effective. Even vaccinated people may be able to spread the virus. And people shouldn’t change their behavior once they get their shots.
  • These warnings have a basis in truth, just as it’s true that masks are imperfect.
grayton downing

F.D.A. Seeks Tighter Control on Prescriptions for Class of Painkillers - NYTimes.com - 0 views

  • The Food and Drug Administration on Thursday recommended tighter controls on how doctors prescribe the most commonly used narcotic painkillers.
  • The drugs at issue contain a combination of hydrocodone and an over-the-counter painkiller like acetaminophen or aspirin and are sold either as generics or under brand names like Vicodin or Lortab. Doctors use the medications to treat pain from injuries, arthritis, dental extractions and other problems.
  • Medical Association and pharmacy organizations, have continued to fight the measure, citing the impact on patients.
  • ...4 more annotations...
  • “These are very difficult tradeoffs that our society has to make,” said Dr. Woodcock. “The reason we approve these drugs is for people in pain. But we can’t ignore the epidemic on the other side.”
  • In 2011, about 131 million prescriptions for hydrocodone-containing medications were written for some 47 million patients, according to government estimates. That volume of prescriptions amounts to about five billion pills.
  • Schedule II drugs are those drugs with the highest potential for abuse that can be legally prescribed.
  • Along with changing how doctors prescribe these drugs, the classification change will also impose added storage and recordkeeping requirements on druggists. In some states, nurse practitioners and other health care professionals who can currently prescribe hydrocodone-containing drugs may no longer be able to do so.
sissij

There Is No Such Thing As Soy Milk | Big Think - 0 views

  • But are they all milk? No. There is no such thing as soy milk.
  • The same goes for almond, coconut, hemp, rice, cashew, hazelnut, and oat. Milk comes from mammals and there are no lactating almonds.
  • since the Chinese company Vitasoy entered the US market in 1979, the Food and Drug Administration still has a very specific, cow-centric, definition: "Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows."
  •  
    I found that the definition of milk is gradually changing as people have new inventions and ideas. It shows that language is not dead and unchanging. Language is closely associated with the development of the society. I think another reason why we call it soy milk is partly because of the translation problem. Soy milk is originally from China and I think western country has never seen it before. The Chinese use soy milk as the name of their product is because they want to give a connotation to their product therefore the western customers would be less afraid about it. People tends to accept things that has some familiarities to them. --Sissi (4/29/2017)
ilanaprincilus06

A Medication-Assisted Treatment For Meth Addiction Shows Promise : Shots - Health News ... - 0 views

  • For the first time, a medication regime has been found effective for some patients with meth addiction in a large, placebo-controlled trial.
  • Unlike opioid addiction, for which medication-assisted treatment is the standard of care, no medication has been approved by the Food and Drug Administration for use with meth.
  • patients in clinics around the U.S. suffering from methamphetamine use disorder were treated for 12 weeks with a combination of medications — naltrexone and bupropion — or placebo.
  • ...10 more annotations...
  • The treatment helped 13.4% of patients with their addiction, compared with 2.5% of the placebo group.
  • This medication therapy provides another tool for doctors to try with patients.
  • "As we understand the complexity of the human brain, it becomes very much of a magical thinking that one pill will solve the problem of addiction,"
  • The treatment regimen in the trial combined two medications that have been studied separately for treating methamphetamine addiction with limited success.
  • This clinical trial was successful enough that the National Institute on Drug Addiction's Volkow says she expects to move forward toward securing FDA approval.
  • lack of medical treatments for those addicted to meth has complicated efforts to curb demand for the drug.
  • The human cost has been catastrophic. Researchers say overdose deaths linked to meth increased fourfold over the last decade.
  • Even users who don't overdose often experience damage to the heart and other tissues, and can see their lives spiral out of control.
  • "For heroin users, there's methadone, there's suboxone. I just wonder why we haven't researched [treatments for] this drug yet,"
  • "It's about evidence-based care, it's about empathy and it's about survivability,"
krystalxu

Consumer Updates > Coping With Memory Loss - 0 views

  • Frequent memory lapses are likely to be noticeable because they tend to interfere with daily living.
  • What’s being forgotten?
  • may cause individuals to get lost in a familiar place or put something in an inappropriate place because they can’t remember where it goes (think car keys in the refrigerator).
  • ...15 more annotations...
  • —the process of thinking, learning, and remembering—can affect memory.
  • Anything that affects cognition
  • Depression, which is common with aging, causes a lack of attention and focus that can affect memory.
  • Brain imaging – either using computerized axial tomography (CAT) scans or magnetic resonance imaging (MRI) – can help to identify strokes and tumors, which can sometimes cause memory loss.
  • Heavy alcohol use can cause deficiencies in vitamin B1 (
  • Stress, particularly because of emotional trauma, can cause memory loss. I
  • Doctors evaluate memory loss by taking a medical history, asking questions to test mental ability
  • repeated head trauma, as in boxers and footballers can result in progressive loss of memory and other effects.
  • Research has shown that the combination of shifting estrogen and progestin levels increased the risk of dementia in women older than 65. There is no evidence that the herb ginkgo biloba prevents memory loss.
  • vascular diseases (heart disease and stroke) that result from elevated cholesterol and blood pressure may contribute to the development of Alzheimer’s disease,
  • Don’t smoke or abuse alcohol.
  • Get regular exercise.
  • Maintain healthy eating habits.
  • Maintain social interactions,
  • Keep your brain active
Javier E

Opinion | For the F.D.A., Cold Medicine That Doesn't Work Is Just the Tip of the Iceber... - 0 views

  • Congress needs to develop a way of better funding the F.D.A. review process. Perhaps a small excise tax could be levied on over-the-counter sales or fees assessed to makers of over-the-counter drugs to fund the F.D.A. review process or to fund studies into drugs that went on the market before 1962. Leaders need to suggest more options. There should also be a way to prioritize which drugs to look at first. The agency should review old drugs for which there are already many complaints about lack of effectiveness in the manner it did recently for phenylephrine.
  • Right now, Americans spend billions on drugs that contain ingredients that will not help them. That’s not just a waste of money — it could mean they are delaying appropriate treatment, which can lead to more severe illnesses. This is risky not only for health but also for trust. The American public deserves medicines that do what they are advertised to do.
1 - 9 of 9
Showing 20 items per page