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» SAFE and Effective
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post 1696338643 01-13-2024, 05:03 PM
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#151
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Originally Posted By Paul
Federal Judge Orders CDC to Make Public 7.8 Million V-safe Free-Text Entries Within 12 Months

I am pleased to share that United States District Judge Matthew J. Kacsmaryk has issued a decision and order requiring CDC to release the 7.8 million free-text entries from CDC’s COVID-19 V-Safe program to the public.

These are entries sent to CDC from roughly 10 million V-safe users, typically detailing injuries following receipt of a COVID-19 vaccine.


https://aaronsiri.substack.com/p/v-s...l-judge-orders
Will be interested to see what types of things were reported and what kinds of trends emerge from the reports.
post 1696358443 01-14-2024, 07:08 AM
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#152
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https://www.drugwatch.com/avandia/la...ent-penalties/

GlaxoSmithKline paid billions of dollars to the U.S. government to settle allegations the company hid the risks of its Type 2 diabetes drug Avandia and marketed it improperly. The drugmaker has continued toinsist the drug is ,

butadmitted it failed to report clinical data.


State and federal prosecutors, as well as U.S. Senate investigators,accused GlaxoSmithKline of actively concealing the serious heart risks associated with Avandia and misleadingly promoting the diabetes drug as safer than alternatives.

GSK in 2012 pleaded guilty to federal charges that it failed to report clinical data on Avandia.



The Senate investigation also revealed that GSK’s own 2006 meta-analysis of dozens of Avandia studies established that the drug increased the risk of serious heart problems by nearly a third.

The Senate report concluded GSK knew of the cardiovascular dangers associated with Avandia and “took [steps] to create doubt regarding negative findings about the drug.”


A few months later GSK came in for more censure when company documents uncovered by The New York Times revealed that in 1999, GSK set out to determine if Avandia was safer for the heart than Actos, a similar medication made by Takeda. Not only was Avandia found to be no better than Actos, it was actually riskier. But instead of publishing the study’s outcomes, the company covered them up,according to The Times.
post 1696359093 01-14-2024, 07:45 AM
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#153
  1. J.L.C.
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Originally Posted By jtaylor2010
https://www.drugwatch.com/avandia/la...ent-penalties/

GlaxoSmithKline paid billions of dollars to the U.S. government to settle allegations the company hid the risks of its Type 2 diabetes drug Avandia and marketed it improperly. The drugmaker has continued toinsist the drug is ,

butadmitted it failed to report clinical data.


State and federal prosecutors, as well as U.S. Senate investigators,accused GlaxoSmithKline of actively concealing the serious heart risks associated with Avandia and misleadingly promoting the diabetes drug as safer than alternatives.

GSK in 2012 pleaded guilty to federal charges that it failed to report clinical data on Avandia.



The Senate investigation also revealed that GSK’s own 2006 meta-analysis of dozens of Avandia studies established that the drug increased the risk of serious heart problems by nearly a third.

The Senate report concluded GSK knew of the cardiovascular dangers associated with Avandia and “took [steps] to create doubt regarding negative findings about the drug.”


A few months later GSK came in for more censure when company documents uncovered by The New York Times revealed that in 1999, GSK set out to determine if Avandia was safer for the heart than Actos, a similar medication made by Takeda. Not only was Avandia found to be no better than Actos, it was actually riskier. But instead of publishing the study’s outcomes, the company covered them up,according to The Times.
Originally Posted By J.L.C.
Does this mean their MMR, DTaP, hapatitis, meningitis, and polio vaccines are all bad?
Probably
post 1696359303 01-14-2024, 07:52 AM
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#154
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Originally Posted By J.L.C.
The thread seems to suggestwe should be highly skeptical of, and perhaps reject, products made by pharmaceutical companies.

I agree.

Glad we agree on this!
post 1696359483 01-14-2024, 07:58 AM
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#155
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Originally Posted By jtaylor2010
Glad we agree on this!
A rarity!
post 1696359553 01-14-2024, 08:00 AM
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#156
  1. jtaylor2010
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Originally Posted By J.L.C.
A rarity!
Probably more common than we think, it’s just that you are are purposefully argumentative and obtuse. For example I posted a thread about how the prevailing view on testosterone and prostate cancer was incredibly flawed and mostly based on a single, garbage study. Even though you agreed with me, you for some reason decided to try and argue and divert the conversation anyway. It’s just what you do, either due to some strange personality trait or because your main goal here is to troll.


Same with this thread. Even though we agree with the overall theme, you are insistent upon building countless strawmen.
post 1696359693 01-14-2024, 08:03 AM
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#157
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Originally Posted By jtaylor2010
Probably more common than we think, it’s just that you are are purposefully argumentative and obtuse. For example I posted a thread about how the prevailing view on testosterone and prostate cancer was incredibly flawed and mostly based on a single, garbage study. Even though you agreed with me, you for some reason decided to try and argue and divert the conversation anyway. It’s just what you do, either due to some strange personality trait or because your main goal here is to troll.
Well no.

Spinning my words and ignoring background info is a popular strategy tho.

Like how some vaccines are bad because they're made by Pharma companies. But others aren't, for reasons
post 1696359903 01-14-2024, 08:07 AM
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#158
  1. jtaylor2010
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Originally Posted By J.L.C.
Well no.

Spinning my words and ignoring background info is a popular strategy tho.

Like how some vaccines are bad because they're made by Pharma companies. But others aren't, for reasons
What did you mean by this?
Originally Posted By J.L.C.
So what happened to their sales, 13 years ago?

This is why all pharma products are bad, right?

Lol @ not anti-vaccine, only anti-covid vaccine
Who said all pharmaceutical products are bad??


Why is it funny to come to the conclusion that you don’t need a Covid vaccine, but that there are lots of other useful vaccines??


Or are you just trolling and building strawmen as usual??
post 1696360233 01-14-2024, 08:19 AM
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#159
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Originally Posted By jtaylor2010
What did you mean by this?






Who said all pharmaceutical products are bad??


Why is it funny to come to the conclusion that you don’t need a Covid vaccine, but that there are lots of other useful vaccines??


Or are you just trolling and building strawmen as usual??
What makes a vaccine "useful". What's the benchmark?
post 1696360343 01-14-2024, 08:24 AM
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#160
  1. jtaylor2010
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https://www.drugwatch.com/featured/c...d-hidden-data/


Before the U.S. Food and Drug Administration (FDA) approves a prescription drug, it must first go through a series of clinical trials. Data obtained from these trials should ensure the safety and effectiveness of drugs before they make it into the hands of patients.

To this end, Big Pharma may influence clinical trials in a number of ways, including funding the trials, designing the trials and handpicking trial results. These practices could skew trial results in favor of drug companies and put patients at risk.

For example, the New England Journal of Medicine — one of the most prestigious medical journals in the world — published 73 studies of new drugs. Of those studies, a pharmaceutical company funded 60, 50 had drug-company employees among the authors and 37 lead researchers had accepted money from a drug company, according to a review conducted by the Washington Post.

This means drug companies greatly influence the majority of medical information provided to the public.

Unreliable clinical trials resulting from the possibility for bias due to Big Pharma influence is an ongoing issue because “clinical trials for pharmaceuticals are conducted and funded by the industry,” Dr. Michael A. Carome, director of the Health Research Group of Public Citizens in Washington, D.C., told Drugwatch.


Studies funded by the NIH, academic medical centers or voluntary specialty groups (charities) are classified as independent studies because these groups are not driven by money to achieve a successful outcome. These types of trials are the gold standard for data and more likely to be in the best interest of the patient.


But data shows each year there are fewer independent studies.

For instance,a report from John Hopkins University showed that the number of clinical trials funded by the pharmaceutical industry has increased each year since 2006, while those funded by the NIH decreased. In 2014, Big Pharma paid for 6,550 trials, while NIH funded 1,048, according to a study by Stephan Ehrhardt and colleagues published in JAMA.

“That’s important for the general public, I think, because if we only get industry funded trials off the ground and given that the industry has a vested interest in the outcome of those trials then we don’t get good data to inform health of the public,”
Ehrhardt told Reuters Health about the study results.

But drug companies’ primary motivation is “big profits.” So, they design studies and report the results “in a manner that is biased toward showing a favorable risk-benefit profile,” Carome told Drugwatch.

It is not unusual for clinical trials to be run, designed and analyzed by researchers on the drug company’s payroll. For example, it’s common practice for drug companies to hire private physicians or third-party companies called contract research organizations (CROs) to run trials for them.

The problem is many of these doctors and CROs are more focused on profit than research.


In a 2012 study published in PLoS Medicine, bioethicist Jill A. Fisher of Vanderbilt University and doctoral student Corey A. Kalbaugh of University of North Carolina Chapel Hill interviewed and observed physicians and research staff at 25 private-sector research organizations in the U.S.

They foundmoney was the primary reason these doctors became contract researchers — some said they earned around $300,000 a year as principal investigators (PI). PIs are important because they are supposed to be highly qualified doctors who supervise the trials and analyze the final results.

But PIs interviewed by Fisher and Kalbaugh said they viewed themselves more as businessmen and not researchers. As a result, their ethics were more aligned with industry goals.
Many PIs hired other staff to do their work for them and very few actually participated in writing the final study.

“Several study coordinators in our sample joked about how clinical research helped physicians improve their golf games,” Fisher and Kalbaugh wrote in their study. “Our observations confirm that at the majority of the 25 sites at which we conducted our research, the PIs were frequently absent from the clinic.”

In the case of Essure Permanent Birth Control, a number of trial participants came forward stating that Conceptus falsified questionnaire answers and omitted side effects in its report to the FDA. As a result, the FDA is investigating these claims.

Because it is in the drug company’s best interest to publish positive results about their drugs, researchers rarely publish studies with negative results. This practice is also referred to as publication bias.

Carome used an example from a 2008 study of antidepressant drug trials submitted to the FDA, noting that thepharmaceutical companies that developed these drugs published 97 percent of the trials that yielded positive results. Only 39 percent of the studies that were found to have “negative” or “questionable” results as determined by the FDA were published.

Cochrane uncovered more than 70 clinical trials and more than 100,000 pages of unpublished data — many of them were negative or inconclusive trial results. It found the drug had little to no benefit in preventing the flu or shortening the duration of flu symptoms. It also had a chance of life-threatening side effects, including suicide linked to the drug.

If Big Pharma influences trial results, it makes data on drugs unreliable. The biggest problem with unreliable data is that doctors don’t have the proper information to make good decisions for their patients, and patients may be forced to question the safety of their medications.

A drug that starts out as a miracle cure may later turn out to be dangerous and life-threatening. There are several examples of drugs with manipulated data or poorly designed clinical trials that later ended up hurting people.
post 1696360423 01-14-2024, 08:25 AM
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#161
  1. J.L.C.
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Originally Posted By jtaylor2010
https://www.drugwatch.com/featured/c...d-hidden-data/


Before the U.S. Food and Drug Administration (FDA) approves a prescription drug, it must first go through a series of clinical trials. Data obtained from these trials should ensure the safety and effectiveness of drugs before they make it into the hands of patients.

To this end, Big Pharma may influence clinical trials in a number of ways, including funding the trials, designing the trials and handpicking trial results. These practices could skew trial results in favor of drug companies and put patients at risk.

For example, the New England Journal of Medicine — one of the most prestigious medical journals in the world — published 73 studies of new drugs. Of those studies, a pharmaceutical company funded 60, 50 had drug-company employees among the authors and 37 lead researchers had accepted money from a drug company, according to a review conducted by the Washington Post.

This means drug companies greatly influence the majority of medical information provided to the public.

Unreliable clinical trials resulting from the possibility for bias due to Big Pharma influence is an ongoing issue because “clinical trials for pharmaceuticals are conducted and funded by the industry,” Dr. Michael A. Carome, director of the Health Research Group of Public Citizens in Washington, D.C., told Drugwatch.


Studies funded by the NIH, academic medical centers or voluntary specialty groups (charities) are classified as independent studies because these groups are not driven by money to achieve a successful outcome. These types of trials are the gold standard for data and more likely to be in the best interest of the patient.


But data shows each year there are fewer independent studies.

For instance,a report from John Hopkins University showed that the number of clinical trials funded by the pharmaceutical industry has increased each year since 2006, while those funded by the NIH decreased. In 2014, Big Pharma paid for 6,550 trials, while NIH funded 1,048, according to a study by Stephan Ehrhardt and colleagues published in JAMA.

“That’s important for the general public, I think, because if we only get industry funded trials off the ground and given that the industry has a vested interest in the outcome of those trials then we don’t get good data to inform health of the public,”
Ehrhardt told Reuters Health about the study results.

But drug companies’ primary motivation is “big profits.” So, they design studies and report the results “in a manner that is biased toward showing a favorable risk-benefit profile,” Carome told Drugwatch.

It is not unusual for clinical trials to be run, designed and analyzed by researchers on the drug company’s payroll. For example, it’s common practice for drug companies to hire private physicians or third-party companies called contract research organizations (CROs) to run trials for them.

The problem is many of these doctors and CROs are more focused on profit than research.


In a 2012 study published in PLoS Medicine, bioethicist Jill A. Fisher of Vanderbilt University and doctoral student Corey A. Kalbaugh of University of North Carolina Chapel Hill interviewed and observed physicians and research staff at 25 private-sector research organizations in the U.S.

They foundmoney was the primary reason these doctors became contract researchers — some said they earned around $300,000 a year as principal investigators (PI). PIs are important because they are supposed to be highly qualified doctors who supervise the trials and analyze the final results.

But PIs interviewed by Fisher and Kalbaugh said they viewed themselves more as businessmen and not researchers. As a result, their ethics were more aligned with industry goals.
Many PIs hired other staff to do their work for them and very few actually participated in writing the final study.

“Several study coordinators in our sample joked about how clinical research helped physicians improve their golf games,” Fisher and Kalbaugh wrote in their study. “Our observations confirm that at the majority of the 25 sites at which we conducted our research, the PIs were frequently absent from the clinic.”

In the case of Essure Permanent Birth Control, a number of trial participants came forward stating that Conceptus falsified questionnaire answers and omitted side effects in its report to the FDA. As a result, the FDA is investigating these claims.

Because it is in the drug company’s best interest to publish positive results about their drugs, researchers rarely publish studies with negative results. This practice is also referred to as publication bias.

Carome used an example from a 2008 study of antidepressant drug trials submitted to the FDA, noting that thepharmaceutical companies that developed these drugs published 97 percent of the trials that yielded positive results. Only 39 percent of the studies that were found to have “negative” or “questionable” results as determined by the FDA were published.

Cochrane uncovered more than 70 clinical trials and more than 100,000 pages of unpublished data — many of them were negative or inconclusive trial results. It found the drug had little to no benefit in preventing the flu or shortening the duration of flu symptoms. It also had a chance of life-threatening side effects, including suicide linked to the drug.

If Big Pharma influences trial results, it makes data on drugs unreliable. The biggest problem with unreliable data is that doctors don’t have the proper information to make good decisions for their patients, and patients may be forced to question the safety of their medications.

A drug that starts out as a miracle cure may later turn out to be dangerous and life-threatening. There are several examples of drugs with manipulated data or poorly designed clinical trials that later ended up hurting people.
So vaccines that go through phase 1 to 3 clinical trials are okay as long as CRO's don't conduct the trials? If not a CRO, who should do it? The manufacturer themselves? Which vaccines do these criteria leave as "useful"?
post 1696360783 01-14-2024, 08:43 AM
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#162
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Originally Posted By J.L.C.
So vaccines that go through phase 1 to 3 clinical trials are okay as long as CRO's don't conduct the trials? If not a CRO, who should do it? The manufacturer themselves? Which vaccines do these criteria leave as "useful"?
Why are you so adamant about discussing vaccines in this thread?
post 1696360843 01-14-2024, 08:46 AM
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#163
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Originally Posted By jtaylor2010
Why are you so adamant about discussing vaccines in this thread?
Because of the title.
post 1696360953 01-14-2024, 08:50 AM
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#164
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Originally Posted By J.L.C.
Because of the title.
The title was chosen to illustrate an extensive history of pharmaceutical companies manipulating data to lie about both the safety and effectiveness of their products. Not sure why that would make you insist on discussing vaccines.
post 1696361353 01-14-2024, 09:01 AM
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#165
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Originally Posted By jtaylor2010
The title was chosen to illustrate an extensive history of pharmaceutical companies manipulating data to lie about both the safety and effectiveness of their products. Not sure why that would make you insist on discussing vaccines.
Fair enough.

Back to decades old stuff
post 1696369013 01-14-2024, 12:05 PM
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#166
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Originally Posted By J.L.C.
Fair enough.

Back to decades old stuff
Originally Posted By J.L.C.
The thread seems to suggestwe should be highly skeptical of, and perhaps reject, products made by pharmaceutical companies.

I agree.

Glad we agree on this!
post 1696409273 01-15-2024, 06:05 AM
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#167
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Originally Posted By Paul
You no like that study, okay..I can post all day..


IgG4 Antibodies Induced by Repeated Vaccination May Generate Immune Tolerance to the SARS-CoV-2 Spike Protein

https://www.mdpi.com/2076-393X/11/5/991

"This supports the notion that an increase in IgG4 subclasses could lead to extended viral persistence in case of infection"
It’s almost like the guy who helped lead the way in developing this technology was correct in some of the things he warned about….


But based on the links in this thread I’m sure the pharmaceutical companies wouldn’t lie so there’s probably nothing to worry about.
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