SAFE and Effective

[jtaylor2010]

https://pubmed.ncbi.nlm.nih.gov/2478...he%20inventory.



This article presents an overlooked case of research misconduct and violations of basic principles of medical and business ethics. When Bayer's Cutter Laboratories realized that their blood products, Factor VIII and IX or antihemophiliac factor (AHF), were contaminated with human immunodeficiency virus (HIV), the financial investment in the product was considered too high to destroy the inventory. Cutter misrepresented the results of its own research and sold the contaminated AHF to overseas markets in Asia and Latin America without the precaution of heat treating the product recommended for eliminating the risk. As a consequence, hemophiliacs who infused the HIV-contaminated Factor VIII and IX tested positive for HIV and developed AIDS.

[kcadrenalin]

but I was told to trust big pharma...

[Retoaded]

They should be sued out of existence.

[x-trainer ben]

In the late 1970s through 1980s, **numerous companies**, including Bayer's Cutter Biologic division, produced unsafe blood products to treat hemophilia

I wonder who else was involved?

[J.L.C.]

Yikes!

That paper is from 10 years ago, but just as scary today

"In the 1980s, Cutter and other companies targeted categories of plasma donors–-IV drug users, prison inmates, skid row residents, and promiscuous, gay males-–to manufacturer AHF because the donors were readily available and willing to sell blood for cheap and demand was high for AHF. But the companies also wanted this plasma from these high-risk donors to manufacture other lucrative blood-based products (e.g., a general immune globulin, and antigen specific immune globulins, particularly hepatitis B immune globulin [HBIG]), which had to be manufactured from blood with high levels of antibodies. The blood donors Cutter targeted were at high risk for transmitting blood-borne diseases (Cutter, 1982b,c)."

[ezmac31]

I thought wincel And JLC told us this sort of thing is impossible and never happens ?

Bunch of science deniers ITT

[jtaylor2010]

Yikes!

That paper is from 10 years ago, but just as scary today

"In the 1980s, Cutter and other companies targeted categories of plasma donors–-IV drug users, prison inmates, skid row residents, and promiscuous, gay males-–to manufacturer AHF because the donors were readily available and willing to sell blood for cheap and demand was high for AHF. But the companies also wanted this plasma from these high-risk donors to manufacture other lucrative blood-based products (e.g., a general immune globulin, and antigen specific immune globulins, particularly hepatitis B immune globulin [HBIG]), which had to be manufactured from blood with high levels of antibodies. The blood donors Cutter targeted were at high risk for transmitting blood-borne diseases (Cutter, 1982b,c)."

In September last year, Merck (Whitehouse Station, NJ, USA) withdrew its anti-arthritis blockbuster drug Vioxx® (rofecoxib) after studies showed that it increases the risk of myocardial infarctions and strokes. Vioxx is, however, only the latest in a long series of high-profile drug withdrawals. Over the past few years, pharmaceutical companies voluntarily withdrew the lipid-lowering drug Lipobay® (Baycol®; cerivastatin), the anti-obesity drugs fenfluramine and dexfenfluramine, and several other medicines due to safety concerns. And that may not be the end; according to an official with the US Food and Drug Administration (FDA), there are even more drugs on the market that should be withdrawn for safety reasons. The Vioxx case has already led to a storm of criticism from members of the US Congress, medical journals and even from within the FDA, and fuelled fierce debate about how to reorganize the agency's monitoring of approved drugs so as to prevent similar cases (Harris, 2004; Frantz, 2005).

Ironically, Vioxx's pivotal study was large for a phase III study, involving 8,076 patients. Nevertheless, it was not powerful enough to reliably detect rare adverse events with a prevalence of 1%–2% compared with placebo, which eventually led to Merck withdrawing the drug. And, ironically, a study with stringent inclusion and exclusion criteria had a major role in Vioxx's withdrawal. The APPROVe (Adenomatous Polyp Prevention on Vioxx) study aimed to determine if rofecoxib prevented the malignant transformation of colon polyps and excluded patients with heart disease. Over the first 18 months, APPROVe did not link Vioxx with an increased risk of cardiovascular events. However, 3.5% of patients taking rofecoxib for more than 18 months suffered either a myocardial infarction or stroke, compared with 1.9% in the placebo group—an excess risk of 16 infarcts or strokes per 1,000 people taking the drug. During the 5.5 years it was on the market, more than 80 million people were prescribed Vioxx (Topol, 2004; Frantz, 2005).



https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1299263/

[jtaylor2010]

https://pubmed.ncbi.nlm.nih.gov/1112...nd%20transient.

Various subanalyses of clinical trials with cerivastatin indicate that the greatest lipid-lowering response can be expected in women and elderly patients. Cerivastatin is generally well tolerated and adverse events have usually been mild and transient. The overall incidence and nature of adverse events reported with cerivastatin in clinical trials was similar to that of placebo.

Conclusion: Cerivastatin is a well tolerated and effective lipid-lowering agent for patients with hypercholesterolaemia. When given at dosages currently recommended by the FDA in the US, cerivastatin achieves marked reductions in serum levels of LDL-cholesterol, reaching NCEP target levels in the vast majority of patients. Thus, cerivastatin provides a useful (and potentially cost effective) alternative to other currently available HMG-CoA reductase inhibitors as a first-line agent for hypercholesterolaemia.

















https://www.ncbi.nlm.nih.gov/pmc/articles/PMC59524/


The recent withdrawal of cerivastatin (Baycol® or Lipobay®) from the world market generated substantial attention in the lay media. According to press reports, the use of cerivastatin was linked to rhabdomyolysis, which lead to kidney failure, and was responsible for 31 fatalities in the United States and a further 21 deaths worldwide. In addition, there were 385 nonfatal cases reported among the estimated 700,000 users in the United States, most of whom required hospitalization.

Simultaneously, however, the German government accused Bayer of withholding vital information from its regulatory agency [2]. Other regulatory agencies in the United States and Europe, are reviewing the safety data or considering changes to the labeling for the other five statins, and United States law firms are putting advertisements in the press for victims of rhabdomyolysis. At the time of withdrawal, Baycol® had slightly less than 4% of the statin market in the United States. The statin manufacturers are obviously concerned, since worldwide sales in 2001 are projected to be US$16 billion.

[J.L.C.]

But, misc says long term data is typically required prior to approval. How is this happening?

[JUSA]

I thought wincel And JLC told us this sort of thing is impossible and never happens ?

Bunch of science deniers ITT

No, no, no... you got it all wrong. They admit it happened. It happened Then. Right now were are in the Now. You see the difference? That was THEN. This is NOW. Two entirely different 100% opposite situations.

Then. Now. Then. Now. Then (pause) Now.

See?

I mean, come the **** on. After the did this, nobody was put in prison, no person was held accountable and they then slapped on the wrist with a paltry fine that amounts to cheeseballs compared to the massive profits they made from this clandestine situation. Slapped on the wrist! Worst case, the companies got sued into oblivion and the owners were allowed to keep almost everything and just file Chapter 11 and move on somewhere else.

Obviously, they would never risk that happening again, so that means in the Now they are moral, upright and committed to safety, honesty and only making the world full of rainbows.

Note: I haven't read **** with this specific situation -- didn't really need to, because we all know the 'punishment' and aftermath I described is spot on accurate. Almost as if this has happened dozens of times, all with the same result.

[J.L.C.]

since worldwide sales in 2001 are projected to be US$16 billion.

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

[JUSA]

But, misc says long term data is typically required prior to approval. How is this happening?

Maybe because these companies are masters at manipulation and putting out junk studies to promote lies? And that even with long-term studies, they are good enough to bypass them for years and years until sometimes it becomes too big for them to cover up and they just laugh while counting all the money they made and end up never being put in jail and keeping almost all of it?

Somehow in your world, even when they've openly done this and there is no debate, with long term years-long studies, in your eyes they could never do it for Warp Speeded bullchit studies for junk vaccines.

[jtaylor2010]

But, misc says long term data is typically required prior to approval. How is this happening?

But shills say products are proven as safe and effective before allowed to hit the market. Yet we average over 1,000 recalls per year. How is this happening?

[J.L.C.]

Maybe because these companies are masters at manipulation and putting out junk studies to promote lies? And that even with long-term studies, they are good enough to bypass them for years and years until sometimes it becomes too big for them to cover up and they just laugh while counting all the money they made and end up never being put in jail and keeping almost all of it?

Somehow in your world, even when they've openly done this and there is no debate, with long term years-long studies, in your eyes they could never do it for Warp Speeded bullchit studies for junk vaccines.

Could be.

I imagine that's why some folks are concerned with, and avoid, and/or are opposed to all pharmaceutical products (including vaccines).

It makes sense

[J.L.C.]

But shills say products are proven as safe and effective before allowed to hit the market. Yet we average over 1,000 recalls per year. How is this happening?

Which products have/had post-phase 3 long term data prior to approval?

Are folks okay with those products?

Everything in this thread is from post-market study.

[jtaylor2010]

No, no, no... you got it all wrong. They admit it happened. It happened Then. Right now were are in the Now. You see the difference? That was THEN. This is NOW. Two entirely different 100% opposite situations.

Then. Now. Then. Now. Then (pause) Now.

See?

I mean, come the **** on. After the did this, nobody was put in prison, no person was held accountable and they then slapped on the wrist with a paltry fine that amounts to cheeseballs compared to the massive profits they made from this clandestine situation. Slapped on the wrist! Worst case, the companies got sued into oblivion and the owners were allowed to keep almost everything and just file Chapter 11 and move on somewhere else.

Obviously, they would never risk that happening again, so that means in the Now they are moral, upright and committed to safety, honesty and only making the world full of rainbows.

Note: I haven't read **** with this specific situation -- didn't really need to, because we all know the 'punishment' and aftermath I described is spot on accurate. Almost as if this has happened dozens of times, all with the same result.

And Shirley they wouldn’t do this in an area where they have used their influence to legislate complete immunity from harm.


https://www.ncbi.nlm.nih.gov/books/N...side%20effects.

“ manufacturer is not liable for harm caused by a nondefective product due to its inherent or unavoidable dangerousness. Thus, if a properly manufactured vaccine will cause harmful side effects in some portion of the recipient population, the manufacturer of the vaccine is not liable for those side effects.”



BRB - “you can’t hold us accountable because these products can be inherently dangerous”



BRB - “we need to push these on as many people as possible because they’re ’safe and effective’ “

[J.L.C.]

And Shirley they wouldn’t do this in an area where they have used their influence to legislate complete immunity from harm.


https://www.ncbi.nlm.nih.gov/books/N...side%20effects.

“ manufacturer is not liable for harm caused by a nondefective product due to its inherent or unavoidable dangerousness. Thus, if a properly manufactured vaccine will cause harmful side effects in some portion of the recipient population, the manufacturer of the vaccine is not liable for those side effects.”



BRB - “you can’t hold us accountable because these products can be inherently dangerous”



BRB - “we need to push these on as many people as possible because they’re ’safe and effective’ “

These are legitimate reasons to avoid all pharmaceutical products, imo.

[JUSA]

These are legitimate reasons to avoid all pharmaceutical products, imo.

So there is no legal difference between rushed vaccines where the manufacturers demanded full immunity from liability and other products that (at least) go through the long term trials?

That is a very interesting opinion you have there.

[J.L.C.]

So there is no legal difference between rushed vaccines where the manufacturers demanded full immunity from liability and other products that (at least) go through the long term trials?

That is a very interesting opinion you have there.

Which products went through long-term trials prior to approval?

Apprehension and fear of pharmaceuticals is legitimate, imo.

[frankdtank20]

I suspect we're going to hear more about mysterious "turbo cancer" later this decade.

[JUSA]

Which products went through long-term trials prior to approval?

Apprehension and fear of pharmaceuticals is legitimate, imo.

Dunno. Maybe ask Curtis Wright IV?

[Dave22reborn]

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

Ummmmm, explain why present day, why anyone should get the jab, if they haven't already.

[J.L.C.]

Dunno. Maybe ask Curtis Wright IV?

So you're okay with some products that meet a specific criterion, but aren't aware of which products meet that criterion?

That is a very interesting opinion you have there

[J.L.C.]

Ummmmm, explain why present day, why anyone should get the jab, if they haven't already.

Any jab?

All vaccines are manufactured by pharmaceutical companies. Agreed?

[Dave22reborn]

Any jab?

All vaccines are manufactured by pharmaceutical companies. Agreed?

Why should anyone get the COVID jab, present day, if they haven't already.

[J.L.C.]

Why should anyone get the COVID jab, present day, if they haven't already.

This thread doesn't seem to be about covid vaccines. You introduced them to the discussion.

Given the concerns presented in this thread about pharmaceutical products, in general, why should any of them be taken, by anyone?

What differentiates "acceptable" pharmaceutical products from "unacceptable" pharmaceutical products?

[x-trainer ben]

This thread doesn't seem to be about covid vaccines. You introduced them to the discussion.

Given the concerns presented in this thread about pharmaceutical products, in general, why should any of them be taken, by anyone?

What differentiates "acceptable" pharmaceutical products from "unacceptable" pharmaceutical products?

After reading each and every post in here i asked myself the same question?

You, your family, your friends, ***no one should take anything*** given the risks and no repeatable studies by neutral parties.

"Given the concerns presented in this thread about pharmaceutical products, in general, why should any of them be taken, by anyone?
What differentiates "acceptable" pharmaceutical products from "unacceptable" pharmaceutical products?"

[jtaylor2010]

After reading each and every post in here i asked myself the same question?

You, your family, your friends, ***no one should take anything*** given the risks and no repeatable studies by neutral parties.

"Given the concerns presented in this thread about pharmaceutical products, in general, why should any of them be taken, by anyone?
What differentiates "acceptable" pharmaceutical products from "unacceptable" pharmaceutical products?"

This thread is not an attempt to conclude no medications should be taken. This thread will probably just be used to highlight very extensive problems with the system in place, cases of corruption, examples of constantly prioritizing profits over health, etc. These corporations have long track records of bad behavior. Approaching their claims with skepticism could be considered a good approach in many cases. This is particularly true for new products.


People should do their own research(though I know many have demonized that lately), and many are unaware of a lot of the things these corporations have done in the past. Nothing wrong with healthy skepticism imho.

[Dave22reborn]

This thread doesn't seem to be about covid vaccines. You introduced them to the discussion.

Given the concerns presented in this thread about pharmaceutical products, in general, why should any of them be taken, by anyone?

What differentiates "acceptable" pharmaceutical products from "unacceptable" pharmaceutical products?

No idea why a preteen should be on puberty blockers, except for profits.

[J.L.C.]

This thread is not an attempt to conclude no medications should be taken. This thread will probably just be used to highlight very extensive problems with the system in place, cases of corruption, examples of constantly prioritizing profits over health, etc. These corporations have long track records of bad behavior. Approaching their claims with skepticism could be considered a good approach in many cases. This is particularly true for new products.


People should do their own research(though I know many have demonized that lately), and many are unaware of a lot of the things these corporations have done in the past. Nothing wrong with healthy skepticism imho.

Agreed.

My longstanding opinion is that the skepticism should be applied broadly and equally