Yes, they have articles on the treatment of the Falun Gong by the murderous CCP with live organ harvesting, but they have excellent articles on health, lifestyle, politics and history. They are definitely not a right wing conspiracy paper. Even if they were, it has nothing to do with the article of the pharma drug approval process where Rexulti is outed.
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REXULTI EXPOSED FOR THE FRAUD IT IS!
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Yes, they have articles on the treatment of the Falun Gong by the murderous CCP with live organ harvesting, but they have excellent articles on health, lifestyle, politics and history. They are definitely not a right wing conspiracy paper. Even if they were, it has nothing to do with the article of the pharma drug approval process where Rexulti is outed.
The Epoch Media Group's news sites and YouTube channels have promoted conspiracy theories such as QAnon, anti-vaccine misinformation[41] and false claims of fraud in the 2020 United States presidential election
The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed the promotional communications, a direct-to-consumer (DTC) television advertisement (TV ad), titled “REXULTI MDD 2023-B TV Ad - See the Signs” (11US22EBC0039) and DTC banner (banner), titled “2023 MDD Consumer Campaign Desktop Display Banners A” (11US23EBC0168) for REXULTI® (brexpiprazole) tablets, for oral use (Rexulti), submitted by Otsuka Pharmaceutical Development and Commercialization, Inc., (Otsuka) under cover of Form FDA 2253. The TV ad and banner make false or misleading claims and representations about the efficacy of Rexulti. Thus, the TV ad and banner misbrand Rexulti within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and make its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1(e)(5). This violation is especially concerning because major depressive disorder (MDD), a debilitating and chronic illness, is a significant public health concern, and the promotional communications create a misleading impression regarding the effectiveness of Rexulti, a drug with multiple serious, potentially life-threatening or irreversible risks. Background Below are the indication and summary of the most serious and most common risks associated with the use of Rexulti.1 According to the INDICATIONS AND USAGE section of the FDA-approved prescribing information (PI) (in pertinent part): Rexulti is indicated for: Adjunctive treatment of major depressive disorder (MDD) in adults . . . The PI for Rexulti contains boxed warnings regarding increased mortality in elderly patients with dementia-related psychosis and increased risk of suicidal thoughts and behaviors in patients aged 24 years and younger. Rexulti is contraindicated in patients with a known 1 This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional communication(s) cited in this letter. Reference ID: 5270026 Kateshia Brooks Page 2 Otsuka Pharmaceutical Development and Commercialization, Inc. NDA 205422 / MA 772, 791 hypersensitivity to brexpiprazole or any of its components. In addition, the PI for Rexulti includes warnings and precautions regarding cerebrovascular adverse reactions including stroke in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, pathological gambling and other compulsive behaviors, leukopenia, neutropenia, and agranulocytosis, orthostatic hypotension and syncope, falls, seizures, body temperature dysregulation, dysphagia, and potential for cognitive and motor impairment. The most common adverse reactions reported with Rexulti as an adjunctive treatment for major depressive disorder were weight increased, somnolence, and akathisia. False or Misleading Claims about Efficacy Prescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to efficacy. The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication. The TV ad includes the following claim (in pertinent part): “When added to an antidepressant, REXULTI was proven to reduce depression symptoms 62% more than the antidepressant alone.” (Voiceover, frames 8-9) The banner also includes the following claims (in pertinent part): “When added to an antidepressant, Rexulti was proven to provide a 62% greater reduction in depression symptoms” (Frame 3) “When added to an antidepressant, Rexulti was proven to provide a 62% greater reduction in depression symptoms vs. the antidepressant alone.” (Frame 4) These claims overstate the efficacy of the drug by misrepresenting the efficacy profile of Rexulti. Specifically, these claims misleadingly suggest that a patient can expect to experience a 62% reduction (i.e., an improvement) in depression symptoms when added to an antidepressant (ADT) alone. However, this 62% reduction claimed is far greater than the reduction of 11.9% calculated based on the data from Study 1 for the 2 mg dose promoted in the TV ad and banner based on the population-level summary of the treatment effect, which is the difference in the changes from baseline in depression symptoms (as measured by the Montgomery-Asberg Depression Rational Scale [MADRS2] total score) between the two groups based on the prespecified primary analysis. 2 The MADRS is a 10-item clinician-related scale used to assess the degree of depressive symptomatology, with 0 representing no symptoms and 60 representing worst symptoms. Reference ID: 5270026 Kateshia Brooks Page 3 Otsuka Pharmaceutical Development and Commercialization, Inc. NDA 205422 / MA 772, 791 According to the CLINICAL STUDIES, Adjunctive Treatment of Major Depressive Disorder section of the PI, the primary endpoint evaluated in the two studies supporting Rexulti’s use in the treatment of MDD was change from baseline to Week 6 in the MADRS. We note that the mean MADRS total score was 27 at randomization. According to Table 12, in Study 1, the least-squares mean change from baseline for the primary endpoint was -8.4 for the Rexulti (2 mg/day) + ADT treatment group compared to -5.2 for placebo + ADT, with a placebo-subtracted difference of -3.2 (95% unadjusted confidence interval [CI]: -4.9, -1.5). Therefore, upon comparison with mean baseline, the placebo-subtracted difference of -3.2 equates to a reduction in depression symptoms of 11.9% from the mean baseline of 27 (3.2 divided by 27), far less than the 62% reduction claimed in the TV ad and banner. Furthermore, although the TV ad and banner promote the 2 mg tablet, we applied the above analysis from Study 1 to Study 2 to more fully consider the claims made. According to the PI, Study 2 evaluated a 1 mg/day and 3 mg/day dose of Rexulti + ADT versus placebo + ADT for the adjunctive treatment of MDD. Like Study 1, patients in Study 2 did not reach the 62% reduction claimed. According to Table 12, in Study 2, the least-squares mean change from baseline for the primary endpoint was -7.6 for the Rexulti (1 mg/day) + ADT treatment group compared to -6.3 for placebo + ADT, with a placebo-subtracted difference of -1.3 (95% CI: - 2.7, 0.1). The placebo-subtracted difference of -1.3 equates to a change of 4.8% from the mean baseline of 27 (1.3 divided by 27). The least-squares mean change from baseline for the primary endpoint was -8.3 for the Rexulti (3 mg/day) + ADT treatment group compared to -6.3 for placebo + ADT, with a placebo-subtracted difference of -2.0 (95% CI: -3.4, -0.5). The placebo-subtracted difference of -2.0 equates to a change of 7.4% from the mean baseline of 27 (2.0 divided by 27). Therefore, as with Study 1, data from Study 2 also demonstrated a significantly lower reduction in depression symptoms from the mean baseline (4.8% and 7.4%, respectively, as measured by MADRS) than the 62% reduction claimed in the TV ad and banner. OPDP acknowledges that the TV ad and banner include the SUPER “Individual results may vary” (in pertinent part; TV ad, frame 9; banner, frame 4). However, this does not mitigate the misleading impression created by the promotional communications of the magnitude of benefit that patients can expect when taking Rexulti and an ADT. Conclusion and Requested Action For the reasons discussed above, the TV ad and banner misbrand Rexulti within the meaning of the FD&C Act and make its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1(e)(5). This letter notifies you of our concerns and provides you with an opportunity to address them. OPDP requests that Otsuka cease any violations of the FD&C Act. Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all promotional communications (with the 2253 submission date) for Rexulti that contain representations like those described above, and Reference ID: 5270026 Kateshia Brooks Page 4 Otsuka Pharmaceutical Development and Commercialization, Inc. NDA 205422 / MA 772, 791 explaining any plan for discontinuing use of such communications, or for ceasing distribution of Rexulti. If you believe that your product is not in violation of the FD&C Act - Questions related to the submission of your response letter should be emailed to the OPDP RPM at CDER-OPDP-RPM@fda.hhs.gov.
‘So are you really saying there was anti-vax info out there that was not true???? You can’t possibly be serious! The whole vax program was based on lies by Fauci et al!!!! Then you mentioned the “fraud” concerning the 2020 election implying there was none! Good God, have you ever done any research of your own on this issue?? The DOJ squashed any meaningful deep investigation into voter fraud! Of course there was fraud! No, you are trying to imply that because the article was critical of the drug approval process and they used the approval of Rexulti the Me-too as their example that it must be another of your fabricated “conspiracies” by the Epoch Times.
Whatever you think about the other topics is meaningless. What they said about Rexulti the Me-too is spot on!
EXACTLY! And if you think Rexulti is a joke, wait till you hear about NUEDEXTA, 30 ml of generic cough syrup ($1 at best) with 10 mg of generic quinidine (10 cents) sold for over 600 Dollars to treat symptoms of TBI's (Traumatic Brain Injuries) by Otsuka. This goes back about 7-8 years. Otsuka entered into an agreement with Avanir to market this garbage, which only treated involuntary crying and involuntary laughter at inappropriate times due to TBIs.
All of a sudden Otsuka announced - without reason - it would halt promotion. Someone at the home office got wind of the fact "60 Minutes" was going to run a segment on NUEDEXTA, and the company didn't want its name dragged through the mud. Interesting that nobody of the salesforce objected to this BS, but the same people have problems with me milking Otsuka because I use their SUV for doing my Uber/Lyft runs...
All of a sudden Otsuka announced - without reason - it would halt promotion. Someone at the home office got wind of the fact "60 Minutes" was going to run a segment on NUEDEXTA, and the company didn't want its name dragged through the mud. Interesting that nobody of the salesforce objected to this BS, but the same people have problems with me milking Otsuka because I use their SUV for doing my Uber/Lyft runs...
Ah, the level of sophistication of an Otsuka bagel boy at display!
NUEDEXTA WAS THE BIGGEST SHAM THAT ANY PHARMACEUTICAL COMPANY HAS EVER PULLED ON THE FDA AND THE AMERICAN PUBLIC! THE DRUG WAS TOTAL BULLSHIT YET WE PROMOTED IT JUST LIKE WE DO REXULTI, THE ULTIMATE ME TOO! IF YOU SELL REXULTI OR ANY DRUG LIKE IT, YOU HAVE ABSOLUTELY NO SELF ESTEEM OR ETHICS. WE DON’T GIVE 2 SHITS ABOUT PATIENTS AND NEVER HAVE OR EVER WILL! JUST SEND ME MY FUCKING CHECK EVERY 2 WEEKS!
So because I wrote INDESPUTABLE FACTS, you copy and paste my response to you. Is that the best you can do, or is there more coming? Probably not, you have disappointed in the past with lack of creativity and skills, so why would now be any different?
Totally agree. We had speakers participate in this nonsense. I remember one guy doing 3 talks in one day, getting chauffeured around by an Uber driver with the most expensive option. A black, oversized SUV. But hey, Otsuka just NEEDED to be in on this scam...Even in those days I only talked about it when my DM worked with me. It was simply too embarrassing asking providers if they had patients with uncontrollable emotional outbursts... If 60 minutes had not put on a segment about this BS, we would still be talking about it today. Wondering if the Home Office Bloke had his hands in this charade as well. Notice how he did not take me up on my offer to work with me...a real chump!!! I bet he is servicing his supervisor under the desk...
No one wants to work with a moronic thief. You’re obnoxious, immature, and have low cognitive dissonance. Adding to your qualities of being abhorrent, a sanctimonious idiot, and impudent. I don’t associate with peons. You have proven that you lack concision and are imprudent. Working with you would be like taking career advice from an Uber driver.
Looks like I ruffled your feather, schtuppster. And what do you know about "low cognitive dissonance"? For your 250,000 a year you do remarkably little. You like to create the impression you work "hard" but in reality, you have a cushy job. You don't get your hands dirty, your back does not hurt, you have no blisters on your hand, but you probably have a rug between your lips and nose. After all, you need to impress your peers. Fact is, bro, I am not the least bit impressed by you. A know-it all, Otsuka has way too many of your type. And you didn't take my challenge, because you KNOW you would fail. If Drs don't want to talk to reps, what are YOU gonna do? Show your credentials from Berkeley? Impress Drs with your vocabulary? You will get laughed out of the office my friend. But you can't admit that. Instead you have to insult me and put me down so you can feel "above" me...it's the typical behavior of people with low self esteem. But hey, no surprise coming from someone like you. See, I put you in your place without using a single insult. I am VERY secure in my position and in my personality. You, on the other hand, try to impress people with acronyms and putting others down. Trust me bro, you are NOTHING SPECIAL. Now, go back to your spreadsheet and drink your milk, son.
What are you doing here? Why do you feel the need to post on a board for reps? Would a lesbian post on gay board? No, but you seem to feel the need to post here, or are you just trying to improve your typing skills and mouth off because it is your "right" to do so? Nobody respects you or your antics anyways, no matter how desperately you try to look superior. You are not. Trust me. You enable the scumbags at the home office and feel no shame.
HERE! HERE! Well said my good man and all true! Since the article brought to light just exactly what a POS drug Rexulti is, and just how corrupt the FDA approval policy is, management is in a lather because they know they don’t have a response because the article is all true!
Look at you. You have another title, Captain Uber of the Internet Patrol. This is not a board only for reps. This is how CafePharma describes their site, “the original site for employees in pharma, medical, and diagnostic sales and related industries.”
I am superior. You’re dumb and capricious. Look at how many replies you typed to attempt your latest idiotic retort. Do not get upset because you try to dish it out but can’t take the rebuttal.
Thank you, but I am not so sure management knows about the article. They don't comment here. I can only hope one of the babysitters (DMs) forwarded the article all the way to the top. It's in Otsuka's best interest NOT to comment, because whatever they would say can't contradict the story, it would be seen as a lame excuse and strengthen the argumentation the Epoch times used. Bottom line? A total shit show nobody wants to admit! In the meantime the home office bloke is trying to impress us with his self - proclaimed (un)importance.
Why do you spend your time insulting others, if you don’t like when it’s done to you? I have friends who are physicians. That’s how it works on this side. Smart people are around other smart people because we don’t spend our off-time doing gig work. Plus, the conversation does not consist of “bagel boy” and “drink your milk.” That’s cute, doctors laughing me out of the office. That’s the difference between us. Why would a doctor listen to a fake finance expert who became a gig worker and pharmaceutical rep? Once, again, do you think before you post? You walk into their offices with no advanced science degrees or training and tell them how to treat their patients. The difference is I have degrees and specialties that a physician does not have. A couple of bachelor’s in math and finance plus two advanced degrees are impressive. My job consists of understanding the science of numerous disease states, the finance of a deal, plus the early pipeline and peri-launch strategy. That is why you are impressed with me. This was you “notice how he did not take me up on my offer to work with me.” Why would you make such a statement if you are not impressed? It hurt your feelings that you were methodically dismissed. There was no chance that would have had a propitious result. Just keep being proletariat.
This is like playing chess with a toddler. You get excited when you move your pawn forward two spaces. Again, it’s not an insult if no one knows what you are talking about. Are you yawning yet, or is this not a challenge for you? Those are your next two buffoonish attempts at being clever. Read the WSJ some more. Maybe it will give you better material, because the nonsense you spew may work when catching peanuts at the bar, but it’s flaccid with an intelligent adult. Next, practice that material and sharpen your skills during your next Portillo’s delivery or drop off at Midway.
You need to get off your high horse. You accuse me of being a "moronic thief", but have no qualms looking the other way while Otsuka is ripping off the healthcare system and patients. You are at best a hypocrite. And so proud of your dubious "contributions" you make to the company. I suggest you STFU...!!!
You need to get off your high horse. You accuse me of being a "moronic thief", but have no qualms looking the other way while Otsuka is ripping off the healthcare system and patients. You are at best a hypocrite. And so proud of your dubious "contributions" you make to the company. I suggest you STFU...!!!