Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, January 21, 2025

JnJ sells nasal ketamine for depression

What is the worst source of info on drugs? - Big Pharma press releases on their own product.
.
SPRAVATO® (esketamine) approved in the US as the first and only monotherapy for adults with treatment-resistant depression
Special K (ketamine) is called a psychedelic.
[Matthew "Chandler" Perry would love it, wouldn't he?] Following U.S. FDA Priority Review, approval is based on data demonstrating SPRAVATO® alone met its primary endpoint at 4 weeks and led to rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours [1].

SPRAVATO® alone showed a rapid and superior improvement vs. placebo in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, with numerical improvements across all 10 MADRS items seen at day 28 in a post-hoc analysis [2].
Monotherapy data adds to well-established clinical efficacy and real-world safety profile

TITUSVILLE, New Jersey, Jan. 21, 2025 – Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.

MDD is one of the most common psychiatric disorders, with an estimated 21 million adults in the U.S. living with the disease. About one-third of adults will not respond to oral antidepressants alone, which has a significant negative impact on the quality of life of those affected. MDD has a high economic burden, with nearly half of it attributable to treatment-resistant depression (TRD) [3,4,5]. More

Sunday, July 28, 2024

Physical immortality now: DNA longevity


I edited my DNA on a secret island (to be able to live forever)
(Bryan Johnson) June 14, 2024: I flew to Prospera, Honduras, for gene therapy that might change the future of humanity by making me live longer than 120 years. Thanks to our friends at Minicircle for their groundbreaking work: minicircle.clinic.


Who is this would-be immortal?

Does Bryan Johnson’s $2 million biohacking routine work? We test it | Hard Reset
Plant based vegan gives life so gets more life
(Freethink) Premiered Dec. 7, 2023: Who has ever heard about the $2 million yearly price tag Mormon and Blueprint CEO Bryan Johnson pays to reduce his biological age? His effort to wind back the clock to age 18 again includes fasting [cleansing], a plethora of supplements, and strict adherence to his workout regime and plant-based diet. But how attainable is this routine for someone who doesn’t have millions to spend? Follow along as we try to biohack our way to Bryan Johnson level fitness over the span of 30 days.

About the episode: 18-hour fast, 100 supplements, bizarre tech -- we tried Bryan Johnson’s age-reversal routine for 1 month.

Subscribe to Freethink on YouTube ► freeth.ink/youtube-subscribe. Watch on Freethink ► freethink.com/series/hard... About sponsor: To order a free set of 100 Henson blades, visit hensonshaving.com/hardreset and use the code: reset

What is Blueprint?
I’ve invested millions of dollars building the world’s leading anti-aging protocol, becoming the most measured human in history [after all the work I did on my penis, like shocking it]. Blueprint is an algorithm, built by science, that takes better care of me than I can myself. And it’s available to you for free. Check out the Blueprint website for recipes, exercise, and other protocols. Become the next evolution of human: protocol.bryanjohnson.co

Friday, July 19, 2024

MAPS: FDA votes on psychedelic therapy

(Science Friday) Last month, the first psychedelic therapy treatment came before the FDA (Food and Drug Administration) for a vote. It entailed using MDMA, also known as ecstasy, E, or molly, to treat PTSD (post-traumatic stress disorder).

MDMA therapy has looked promising as a treatment for PTSD and other mental health conditions in some studies.
  • [It was thought by many in MAPS or the Multidisciplinary Association for Psychedelic Studies) to be a slam dunk for the first approval before moving on to passing magic mushrooms, DMT, and other scientifically-validated entheogens.]
But the FDA scientific advisory panel that evaluated this treatment voted overwhelmingly against approving it.
  • [For one thing, how would Big Pharma make so much money on endless "treatments" if someone comes up with an actual "cure" for a serious ailment?]
Many of the arguments against approval had less to do with MDMA itself than with the methodology of the clinical trials done by Lykos Therapeutics, formerly the Multidisciplinary Association for Psychedelic Studies (MAPS).

The FDA panel was presented with allegations of misconduct and incongruous data, including a letter by trial participant Sarah McNamee.

McNamee, who joined the trial for treatment of PTSD, is also a licensed psychotherapist and researcher of trauma and psychotherapy at McGill University in Montreal.

She joins Science Friday guest host Rachel Feltman alongside Dr. Eiko Fried, a methodologist and psychologist at Leiden University in the Netherlands, to discuss the decision.

If anyone is struggling with PTSD or other mental health conditions, call 988 for the suicide and crisis lifeline.
Further research

Saturday, June 29, 2024

Science: C-19 vaxx kills 74% of sudden deaths


Vaxxed, Plandemic (bitchute.com)
The Lancet,
 one of the world's more respected peer-reviewed medical science journals is censored, with popular article pulled from a rigorous study and review of many other cases. They show that 74 per cent of sudden deaths can be attributed to the Covid-19 vaccine, a killer experiment foisted on all of us, rushed by an "emergency authorization act" that means no one is allowed to sue the Big Pharma corporations who made, sold, and profited from these pharmacological (pharmakos = allopathic sorcery) poisons. We were lied to by Dr. Anthony Fauci and many others in the pharmaceutical industry and in government, NPR and other boosters and promoters supporting government lies and propaganda.

Thursday, January 5, 2023

Cancer CURE found then suppressed (doc)


Suppressing a CURE for more than 40 years: Burzynski: The Cancer Cure Cover-up (full doc)
(FilmIsNow Movies & Trailers, Jan. 1, 2023) Burzynski: The Cancer Cure Cover-up is the story of a pioneering biochemist who discovered a unique and proprietary method of successfully treating most cancers. Director: Eric Merola

🔴 Subscribe to be notified when new videos are posted. SUBSCRIBE to the channel and click the bell icon: SubFIN. This documentary takes the audience on a near 50-year journey both Dr. Burzynski and his patients have been enduring in order to obtain FDA-approved clinical trials of Antineoplastons.

Defying the face of skepticism, legal attacks from state and federal agencies, and a powerful propaganda campaign to stop Burzynski – this doctor and his patients are still going strong (sidewaysfilm.com).

This film is under a non-exclusive license from Sideways Films #FilmIsNow #FreeDocumentary #burzynskicancercurecoverup

NOTICE: All of the films uploaded to FilmIsNow are legally licensed, and we have YouTube rights for specific territories. For any copyright issues, please reach out to us first before filing a claim with YouTube. Send us an email at copyrightfilmisnow@gmail.com detailing concerns and we'll make sure the matter is resolved immediately Contact us for any partnership inquiries, content submissions, or other requests at filmisnowpromo@gmail.com

#FilmIsNow is the best channel to catch the latest official movie trailers and movie clips and spots, featurettes, behind the scenes, interviews, and other great original content.

The FilmIsNow team is dedicated to providing all the best new videos because just like others, we are big movie fans.

Friday, May 13, 2016

The cure for all diseases? (video)

Dr. Al Sears, M.D. (JBSYAu); Pat Macpherson, CC Liu, Seth Auberon, Wisdom Quarterly


What are telomeres? (MPW)
Dr. Al Sears, M.D. exposes the FDA and the for-profit pharmaceutical industry's plot to censor, ban, and blacklist the Nobel Prize winning "cure for all diseases" in order to advance a trillion dollar chemical drug industry.

Big Pharma with its co-opted regulatory arm are actively suppressing telomere technology and telomerase activation, which can cure disease and help reverse oxidative stress and degenerative aging.

Dr. Sears shows natural ways to use this outlawed cure for all disease for ourselves and our loved ones. More
  • Since the birth of the American Medical Association (AMA) over 100 years ago, their goal has become more and more focused on the profitable management of disease. They have become, sadly, a special-interest group advocating the business interests of doctors. There’s not much profit in the prevention or cure of disease. This monumental medical breakthrough wasn’t made by medical doctors. A handful of molecular biologists won the Nobel Prize in Medicine for their groundbreaking discovery. The cure never saw the light of day.
Numerous healing discoveries
Wisdom Quarterly (COMMENTARY)
There are in fact many cures for typical (not normal but common) degeneration, particularly due to parasites and disease-causing microbes. They only have an opportunity to produce illness when our natural immunity is first weakened.

Look into Rife technology, which has the capacity to destroy any and all inimical germs and viruses with resonant frequencies. But perhaps the best demonstrated cures are found in the books of Hulda R. Clark.  

Cancer (which is not one but literally hundreds of different diseases) can be cured rather than merely "treated" at great expense that enriches oncologists. There are easier, more natural remedies as well, such as essiac tea, and supplementing nutritional deficiencies with the 90 essential nutrients for life and vibrant health at Critical Health News and Dr. Joel Wallach.

Monday, May 9, 2016

Notorious FDA? Feds turn to hip-hop

Shots - Health News (NPR.org); CC Liu, Wisdom Quarterly
An ad from the Food and Drug Administration's Fresh Empire campaign.
Notorious FDA? Feds turn to Hip-Hop to tamp down teen smoking
For its latest anti-tobacco campaign, the Food and Drug Administration wants to harness hip-hop swagger to reach minority teens -- who disproportionately suffer the consequences of smoking. Disaster ensues. More

    Friday, June 5, 2015

    Pink female SEX pill approved by FDA

    Rob Stein (npr.org); Ashley Wells, CC Liu, Amber Larson, Wisdom Quarterly; New York Times
    Now you're all wet, baby! - Shut up, you sexist jerk with your for-profit science.
    Oh-my-bodhisattva, what have I done under placebo?
    For 15 years, Carla Price and her husband's sex life was great. But then things began to change.
     
    "Before, I would want to have sex," says Price, who is 50 and lives in central Missouri. "But over the years my sexual desire has just dwindled to nothing."
     
    Price has no idea why. She's healthy. She's not really stressed out about anything. And she's still totally crazy about her husband.
     
    A screen shot from the documentary "Orgasm Inc."
    Poison all problems.
    "It's not that our relationship got boring," Price says. "Because it's actually the opposite -- we became closer as we got older together."

    "We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women." 
    - Terry O'Neill, president, National Organization for Women 

    Junior Anti-Sex League (1984)
    But her lack of interest in sex almost wrecked their marriage.
     
    "It did get to the point where my husband thought that perhaps we just needed to divorce," she says.
     
    Women like Price, who see their decreasing sex drive as a problem, are at the center of an intense, emotional debate that's been raging for years over whether the Food and Drug Administration should approve the first drug that claims to boost a woman's libido [sexual desire].
     
    NPR reached Price through Sprout Pharmaceuticals Inc., the company that makes the drug.
     
    Mountains of "little blue pills" and their chemical kin have transformed the way many people think about sex and aging.
    A sea of chemicals
    "Men have a number of treatment options for sexual dysfunction, says Cindy Whitehead, Sprout's CEO. "We haven't yet gotten to one for women's most common dysfunction."
     
    "Up until now," she says, "the treatment paradigm for women with sexual dysfunction has essentially been: Let's take a drug that works in men and let's see if it works in women."

    "The misrepresentation that 'everybody should be having it... has a problem if they don't have it,' is to change what sexuality is into more of a medical thing." 
    - Leonore Tiefer, psychologist, New York University 
    If you struggle you'll fail (LiH).
    None of them did. But Sprout's drug, flibanserin, takes a totally different approach than, say, Viagra. Instead of increasing blood flow to the genitals, flibanserin affects a different part of the body: the brain.
     
    Flibanserin shifts the balance of three key brain chemicals, Whitehead says. The drug, she says, increases "excitatory factors for sex" -- dopamine and norepinephrine -- and decreases serotonin, which can dampen the sex drive.
     
    But there's a lot of skepticism about flibanserin. The FDA has rejected it twice, saying there wasn't much evidence it works. The agency also questioned the drug's safety, especially with long-term, daily use.
     
    Sprouts' Whitehead (Allen G. Breed/AP)
    "The combination of...not very robust effectiveness, and the fact that the safety profile had not been really characterized very well at all made us reach that conclusion, that it really wasn't ready for approval," says Sandra Kweder, deputy director of the FDA's Office of New Drugs.
     
    The company acknowledges flibanserin can have side effects, including sleepiness, nausea, and dizziness. And there are no results yet, Sprout says, on whether the drug might interfere with the [presumably] helpful action of Zoloft, Prozac, or other SSRI antidepressants, which are thought to work primarily by boosting levels of serotonin in the brain.
     
    "Women...want drugs that work.
    And this doesn't seem to be one of them." 
    - Cindy Pearson, executive director, National Women's Health Network
     
    But Whitehead argues that flibanserin is safe and says the company's studies show it can help many women.
     
    Katherine Streeter for NPR
    Testosterone power!
    "We increase their desire by 53 percent," she says of study participants. "We decrease their distress by 29 percent, and then they doubled their number of satisfying sexual events."
     
    Whitehead argues the FDA is holding flibanserin to a higher standard than it uses to evaluate drugs for men. And some women's rights advocates worry that might be true.
    Choose sex over hypocrisy (Stivers)
    "We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women," says Terry O'Neill, president of the National Organization for Women. "And I fear that it's that cultural attitude that men's sexual health is extremely important, but women's sexual health is not so important. That's the cultural attitude that I want to be sure the FDA has not, maybe unconsciously, imported into its deliberative process." More
    Patriarchy: When sex goes wrong
    Patriarchs Dick Cheney and fellow Christian Republican Dennis Hastert, D.C. (AP)

    .
    Oops, wrong party. - Not so fast, Jeff.
    What could go wrong as we medicate every perceived problem and inconvenience in America? The medical system has money it needs to make, and we have problems we need solved, so what if our livers suffer in the process of chasing easy cures? Why look into the deeper causes -- institutional sexism, bias, childhood sexual trauma, emotional and physical harm, oppression, and shaming... Then there are the hypocrites and molesters -- Catholic Christian priests, conservative Republican lawmakers, military comrades, and so on.

    The gay Church fathers made me do it!
    Closet homosexual child molester former Republican House Speaker Hastert: But years before [her brother's] death, his sister said, he told her that his first homosexual contact was with [former Republican House Speaker, former high school teacher and coach, nominal Christian, and hypocrite] Hastert and that it lasted throughout his high school years.

    Let's keep this quiet, says hypocrite Hastert
    [Her brother] Stephen Reinboldt attended Yorkville High School, where Hastert was a history teacher and coach from 1965 to 1981. In an interview aired Friday on ABC's "Good Morning America," Burdge said Hastert had been a [homosexual] father figure to her [molested] brother but also caused him irreparable harm [through rape and ongoing sexual abuse]. More
     
    Yum, yum, that's terrible! I mean, really, guys, quit it! (Rick Perry)

    Thursday, April 4, 2013

    Curing Methamphetamine addiction

    Seth Auberon, Ashley Wells, Wisdom Quarterly; Kathleen Miles (Huff Po)


    LOS ANGELES - The Food and Drug Administration [FDA] has fast-tracked human tests of what may be the first cure for methamphetamine addiction. The drug also may be the first non-opiate drug treatment for heroin and opiate addiction.
     
    Metallica: meth dealer forms band (AFP)
    In a recent trial, UCLA researchers administered the drug Ibudilast, or MN-166, to 11 non-treatment-seeking meth addicts. The trial, the first of three phases of Ibudilast human testing required for FDA approval, was meant to test the safety of the drug taken in combination with meth. Researchers said the treatment appears to have passed the safety test and eased the addiction.

    "Very preliminary results would indicate that Ibudilast may dampen craving and improve cognitive functioning," said Dr. Aimee Swanson, co-investigator on the trial and research director at the UCLA Center for Behavioral and Addiction Medicine.

    Pound of methamphetamine (wiki)
    Researchers have been trying to develop medication to treat meth addiction for more than 20 years.
     
    There were about 439,000 meth abusers [not counting all the consumers at raves who take it in the form of Ecstasy] in the U.S. in 2011, according to the Substance Abuse and Mental Health Services Administration's national survey. Meth addiction cost the country an estimated $23.4 billion in 2005 alone, according to a RAND Corp. study.

    The only options right now for meth addicts seeking recovery are counseling, an in-patient rehab center or Narcotics or Crystal Meth Anonymous. These treatments don't work for many people, Swanson said. The FDA fast tracks treatments for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. The designation may lead to expedited regulatory review. More

    Tibetan thangka (religious tapestry) depiction of the miserable realms of interminable torment (naraka-loka) and depraved craving (preta-loka)
     
    Hungry Ghosts in Los Angeles
    In the Realm of Hungry Ghosts
    Against the Stream Buddhist Meditation Society seems to be based on addiction recovery as much as meditation. The Buddha's Dharma (teaching, doctrine, realization) goes "against the stream." The "stream" is the flood (ogha) of samsara, the endless cycling through the realms of miserable existence -- heavens (devas), hells (narakas), the realm of hungry ghosts (of addicts), animal worlds, plane of impatient titans, and this human world. Yes, the heavens for all their splendor are ultimately miserable (dukkha, unsatisfactory or disappointment). The human world can go either way, and within it are expressions or manifestations of all of the other planes. The ghosts are here. We can become "hungry ghosts" as we slip into dependence, avoidance patterns using substances to help us stay willfully-ignorant of all we wish to avoid, and depraved examples of gross neediness. "Drugs are not addictive," as substance abuse specialist Dr. Gabor Mate explains in In the Realm of Hungry Ghosts: Close Encounters with Addiction
     
    Japanese depiction of a hungry ghost (preta)
    Drugs in combination with a history of childhood trauma from physical, emotional, and/or sexual abuse -- leaving us susceptible to the draw of pleasant substances/activities -- that's addiction. If drugs themselves were "addictive" all who used them would remain hopelessly addicted. We can break free not only of chemical substances, synthetic or natural, but of habits and behavioral crutches as well. But how will we if we fail to recognize our predicament? People are addicts, but as people we are addicted to things that in and of themselves do not have a universal ability to addict people. Two might go astray, ignoring the Five Precepts, and drink alcohol. Why does one become an alcoholic and the other not? Dr. Mate explains why, and he is not the only one. Even Dr. Drew Pinsky agrees that it may be possible to drink in rehab. Some people can. The danger is that the first to apply to such "rehab" programs are those who can't. The addict is adept at fooling him/herself as well or better than fooling others.

    Wednesday, September 3, 2008

    Cloned meat already in food supply: FDA

    Editing by Christian Wiessner; Eds., Wisdom Quarterly

    Gloria, the first calf born to a cloned cow, Vitoria (L), is seen on a government farm outside Brasilia in this 10-4-04 file photo (Jamil Bittar/Files/Reuters).

    In ancient India, three Dharmas ("spiritual traditions") -- Buddhism, Hinduism, Jainism -- sensibly advocated a compassionate diet. They were concerned with nirvana and liberating all beings from suffering. However, it's an individual choice. Now that choice may be becoming easier. Meat eaters beware. Protests over meat imports in Korea seem to have been well founded. Genetically modified cloned meat and dairy products used to be banned, but their offspring were not. While vegans may be safe from FrankenMeat cloning and tainted milk in the US food supply, the FDA is reporting something else to turn US consumers' stomachs.

    Clones' offspring may already by in food supply: FDA
    Christopher Doering

    WASHINGTON (Reuters, 9-2-08) -- Food and milk from the offspring of cloned animals may already have entered the U.S. food supply, the Food and Drug Administration said on Tuesday, but it would be impossible to know because there is no difference between cloned and conventional products.
    • [International reports in January 2008 exposed the finding that the US seems to have already approved the sale of meat and milk from cloned and genetically modified livestock (ABC News Australia/AFP at abc.net.au).]
    The FDA said in January that meat and milk from cloned cattle, swine, and goats, and their offspring were as safe to eat as products obtained from traditional animals. Before then, farmers and ranchers had followed a voluntary moratorium that prevented the sale of clones and their offspring.

    "It is theoretically possible" offspring from clones are in the food supply, said Siobhan DeLancey, an FDA spokeswoman.

    (villagevoice.com)

    Proponents, including the Biotechnology Industry Organization, say cloned animals are safe and a way to create animals that produce more milk and better meat and are more disease-resistant. There are currently an estimated 600 cloned animals in the United States.

    The small cloning industry and the FDA have maintained cloned animals and their offspring are as safe as their regular counterparts. Cloning animals involves taking the nuclei of cells from adults and fusing them into egg cells that are implanted into a surrogate mother.

    FDA and the U.S. Agriculture Department have said it is impossible to differentiate between cloned animals, their offspring, and conventionally-bred animals, making it difficult to know if offspring are in the food supply.

    "But they would be a very limited number because of the very few number of clones that are out there and relatively few of those clones are at an age where they would be parenting," said Bruce Knight, USDA's undersecretary for marketing and regulatory programs.

    Even as the FDA unveiled its final rule, the USDA asked in January for the cloning industry to prolong the ban on selling products from cloned animals during a "transition" period expected to last at least several months. That ban did not extend to meat and milk from the clone's offspring.


    Critics still contend not enough is known about the technology to ensure it is safe, and they also say the FDA needs to address concerns over animal cruelty and ethical issues.

    "It worries me that this technology is out of control in so many ways," said Charles Margulis, a spokesman with the Center for Environmental Health. The possibility of offspring being in the food supply "is just another element of that," he said.

    Despite the backing from FDA, major food companies including Tyson Foods Inc., the largest U.S. meat company, and Smithfield Foods Inc. have said they would avoid using cloned animals because of safety concerns.

    The list grew on Tuesday after the Center for Food Safety and Friends of the Earth said 20 food producers and retailers vowed not to use ingredients from cloned animals in their products.

    The list, provided by the two groups, included Kraft Foods Inc., General Mills Inc., Campbell Soup Co., Nestle SA, California Pizza Kitchen Inc. and Supervalu Inc.

    In a letter to the Center for Food Safety, Susan Davison, director of corporate affairs with Kraft, said product safety was "not the only factor" the company considers.

    "We must also carefully consider additional factors such as consumer benefits and acceptance... and research in the U.S. indicates that consumers are currently not receptive to ingredients from cloned animals," she said.