OZEMPIC: why does it matter if a drug is “Off label use” v “FDA approved”

ARTICLE:“Off-label use: Oft not evidence based,Physicians lack knowledge of off-label drug use, FDA approval status”
(SOURCE: https://www.uchicagomedicine.org/forefront/news/off-label-use-oft-not-evidence-based)


“In a recent national survey, a substantial minority of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration. This mistaken belief could encourage them to prescribe these drugs, despite the lack of scientific evidence supporting such use.”


It was discovered a number of physicians don’t know which drugs are FDA approved and which are considered off-label use…
“Off-label prescribing is common, but researchers have not always known why. Our research shows that some off-label prescribing might be driven by mistaken beliefs about FDA approval and the level of evidence supporting off-label drug use,” said G. Caleb Alexander, MD, MS, Assistant Professor of Medicine at the University of Chicago Medical Center and corresponding author of the research, which will be published under an embargo in Pharmacoepidemiology and Drug Safety on August 21, 2009.“


“The results indicate an urgent need for more effective methods of informing physicians about the level of evidence supporting off-label drug use–especially for common off-label uses that are ineffective or carry unacceptable risks of harm.”


DOCTORS don’t always know if a drug is ”FDA APPROVED“ and when it is considered ”OFF-LABEL USE“. So, why do doctors assume their patients know when a drug is FDA APPROVED or being prescribed as ”OFF LABEL USE“? Drugs are not approved by the FDA when the risks outweigh the reward. If the risks of Ozempic outweigh the reward of weight loss, why are doctors prescribing it for weight loss? Our healthcare system is corrupt & chooses profits over patients everyday.


“In many cases, the proportion of physicians who erroneously believed a particular drug was FDA approved for a specific indication was higher among physicians who had prescribed the drug for that indication.”


So, no, the general public does not know what off-use label is because doctors don’t tell them. Why don’t doctors tell them? Because doctors often don’t know themselves. How could they possibly be properly informing their patients?  And…If they don’t fully know the risks, why are they prescribing it?


“For example, 26 percent of all physician respondents erroneously believed that lorazepam was FDA approved for chronic anxiety. That figure rose to 33 percent for physicians who had prescribed lorazepam for chronic anxiety.”


The doctors that didn’t know its proper usage were more likely to prescribe it. Thats not good.


“We hope our research will increase awareness of off-label prescribing and highlight the pressing need for more evidence-based use of prescription drugs,” Alexander said. “Although some off-label uses are well-supported, many are not. New ways are needed to help physicians tap the scientific evidence supporting various prescription drug uses.”

(SOURCE: https://www.justice.gov/opa/pr/pharmaceutical-giant-astrazeneca-pay-520-million-label-drug-marketing)


More good information =less sick people

“Many consumers aren’t aware that doctors are free to prescribe as they wish in accordance with good medical practice, they’re not constrained to using products only for FDA-approved indications,” Dr. Caleb Alexander, professor of epidemiology and medicine at Johns Hopkins Bloomberg School of Public Health, told MedTruth. “And that will come as a surprise.”


“Not only are doctors not required to disclose off-label use, doctors themselves often don’t know the status of a drug, according to a 2009 national survey of about 1,200 primary care physicians and psychiatrists co-authored by Alexander.


Nearly half the time, surveyed physicians incorrectly identified the FDA status of drugs paired with particular conditions.”


Doctors are NOT required to tell you when a drug is “off label use”. Doctors are not required to educate their patients on the prescription they are prescribing. Why not? Because our healthcare system is corrupt.


(SOURCE:https://medtruth.com/articles/health-features/off-label-prescriptions/)


Heres another example how prescribing something that is “off label use” is dangerous:


“The United States alleges that AstraZeneca illegally marketed Seroquel for uses never approved by the FDA.”


“The United States alleges that AstraZeneca illegally marketed Seroquel for uses never approved by the FDA. Specifically, between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness).“


”These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.“


”According to the settlement agreement, AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.“


Big pharma found doctors that were not properly informed on psychiatric medication and incentivized them to sell more.  They did the same thing with epidurals & opioids.


”In March 2006, AstraZeneca brought certain conduct to the attention of the government and then cooperated in the investigation of the allegations being settled today.“


”The United States contends that AstraZeneca promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programs. The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel. In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.“


Big pharma recruited doctors to put their name on studies that they did not conduct.:


“Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets,” said Attorney General Eric Holder. “This Administration is committed to recovering taxpayer money lost to health care fraud, whether it’s by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation’s biggest companies.”

(SOURCE: https://www.justice.gov/opa/pr/pharmaceutical-giant-astrazeneca-pay-520-million-label-drug-marketing)

BIG PHARMAS FALSE CLAIMS PUT PUBLIC HEALTH AT RISK.


“Many consumers aren’t aware that doctors are free to prescribe as they wish in accordance with good medical practice, they’re not constrained to using products only for FDA-approved indications,” Dr. Caleb Alexander, professor of epidemiology and medicine at Johns Hopkins Bloomberg School of Public Health, told MedTruth. “And that will come as a surprise.”


If doctors arent properly educated  on pharmaceuticals, why would someone assume that the general public is properly educated on off label use?  They aren’t.


“Not only are doctors not required to disclose off-label use, doctors themselves often don’t know the status of a drug, according to a 2009 national survey of about 1,200 primary care physicians and psychiatrists co-authored by Alexander.


Nearly half the time, surveyed physicians incorrectly identified the FDA status of drugs paired with particular conditions.”
(SOURCE:https://medtruth.com/articles/health-features/off-label-prescriptions/)


“The FDA does, however, prohibit drug companies from promoting off-label uses. However, that doesn’t mean drug companies always comply.”


“…off-label drug use can also pose serious, even life-threatening, risks”
(SOURCE:https://www.justice.gov/opa/pr/pharmaceutical-giant-astrazeneca-pay-520-million-label-drug-marketing)


“Many consumers aren’t aware that doctors are free to prescribe as they wish in accordance with good medical practice, they’re not constrained to using products only for FDA-approved indications,” Dr. Caleb Alexander, professor of epidemiology and medicine at Johns Hopkins Bloomberg School of Public Health, told MedTruth. “And that will come as a surprise.”


“Not only are doctors NOT REQUIRED to disclose off-label use, doctors themselves often don’t know the status of a drug, according to a 2009 national survey of about 1,200 primary care physicians and psychiatrists co-authored by Alexander.
Nearly half the time, surveyed physicians incorrectly identified the FDA status of drugs paired with particular conditions.”


“The FDA does, however, prohibit drug companies from promoting off-label uses. However, that doesn’t mean drug companies always comply.”


Because”…off-label drug use can also pose serious, even life-threatening, risks.”


OZEMPIC for weight loss is NOT APPROVED which means the risks outweigh the reward. Doctors are not properly informing their patients because they are not properly informed themselves. Why are doctors allowed to prescribe risky drugs that they don’t know enough about? Big pharma has found another way to make us sick & keep us sick.

#OPTOUT
#NOZEMPIC

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