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Bogus advances

Max Former Hodgkins Stage 3's picture
Max Former Hodg...
Posts: 3662
Joined: May 2012

I do not have a strong opinion regarding this.  The FDA is damned if they do, damned if they don't.   People want new drugs gotten to market FAST, but then want them to be PERFECT also.    An impossible task.....    

 

https://www.foxnews.com/health/fda-to-scrutinize-unproven-cancer-drugs

po18guy's picture
po18guy
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Joined: Nov 2011

Perfection escapes us in this life. To its credit, the FDA does "fast track" many cancer drugs, as even an imperfect drug beats a cancer death. Yet, even Bayer aspirin and Tylenol come with warnings of toxicity and adverse events. Yet, we pop them like M&Ms. 

The vaccines. History is being made and essentially the entire world is in what would otherwise be a clinical trial. There are adverse events with every drug and certainly with the vaccines. The CDC claims that all vaccine-related deaths are not directly caused by the vaccine. Frankly, I think they are deceiving us as the rushed-to-market, never before seen vaccine is not and cannot be perfect. If aspirin and tylenol are associsted with adverse events (including deaths) it is only logical that the vaccine can produce those same adverse events. But, they have a panicked public and a word energency at stake, so a little fibbing here and there keeps the ball rolling.

ShadyGuy
Posts: 685
Joined: Jan 2017

...... no one is ever forced to enter a trial or take a drug. People on here, including yourself, have always promoted participation in trials.

Max Former Hodgkins Stage 3's picture
Max Former Hodg...
Posts: 3662
Joined: May 2012

Correct Shady, trials are never manditory.    But most of the drugs in the article above are regularly prescribed to patients who are NOT in trials.   I got my Pfizer vaccine recently, which is in provisional FDA approval, but did not agree to participate in any form of 'trial.'

I was assisting a friend dying of prostate cancer, who died of it eight years ago.  He was put on a (then) new drug for castration-resistant, metastatic PCa in men for whom taxotere (chemo) had failed.  The drug was Zytiga, still very popular today.   I read its entire data sheet online, and in the extremely fine print, it noted that it extended life (as used at that time) for 'a few months.'     Most of the new lung cancer drugs are similiar....  The PR agencies scream about how they are 'breakthroughs,' but do not very forwardly mention that these breakthroughs give a few additional months of life, usually, and with pretty common, potentially severe or deadly side-effects.

Zytiga is today prescribed somewhat differently, and in combination with other, older drugs, and has a much higher effeciacy now than then.   Wonderful.

As I said when I started this thread, I am neither for or against, I just feel that people need a fuller understanding of this very common trend with new cancer treatments.  I would say that for most of them, if I was at a point where I required them, I would use them, inside or outside of a trial.

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po18guy
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Joined: Nov 2011

The world's undergarments are in a bunch. Yet, by crunching the latest US numbers, Covid-19 has a 1.7% death rate. The obverse is a 98.3% survival rate. If those numbers have not been fudged - and they almost certainly have, because money and political power hang in the balance. What are we to make of the media frenzy? Political opportunists wryly state: "Never waste a crisis."

98.3% survival in the US, where the ongoing media barrage of fear-mongering leads to anxiety at record levels. Ulterior motives in play. A frightened populace will agree to almost anything.  

PBL
Posts: 315
Joined: Jul 2016

This article has little to do with the accelerated validation process for urgently-needed vaccines in the current pandemic context, which constituted both a public health and an economic crisis. In the case of CoViD-19 vaccines, the technology already existed and speeding up through the red tape once those vaccines showed sufficiently beneficial results was the only way out of the human and economic catastrophe. That being said, we may not quite be out of the woods yet...

Instead, it pertains to the FDA’s role in the protection of the public in their dual capacity as potential cancer patients and as consumers.

The public understandably wish for new treatment offers against various cancers, without being in a position generally to figure out the efficiency of those treatments. This makes it tempting for pharmaceutical companies to widen the field of application of their existing specialties, thereby saving on proper research, and further increasing « novelty » prices – as well as mechanically raising health insurance costs - in the process.

In a context in which investment into healthcare is deemed an individual decision and prices are essentially set by pharmaceutical companies - cynically making many treatment options inaccessible to millions based solely on financial means - the FDA is essentially moving to stop those unscrupulous pharmaceutical companies from practicing quackery for the sole benefit of their shareholders.

ShadyGuy
Posts: 685
Joined: Jan 2017

to the drug industry. Government has no chance of making breakthroughs as it become bogged down in bureaucracy. A good example would be NASA vs Spacex. NASA, with more than 50 times the budget of Spacex, is impotent. Its a bureaucracy which counts on contractors like LMCO, Boeing and a host of others to do the actual work, both design and production. NASA shuffles papers and attends seminars. I am quite certain any drug development agency would evolve into the same type of situation. I am so glad the drug industry developed the drugs which if not saved at least extended my life. Money is not of much use to dead people.

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po18guy
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Correct. No one is "forced" to enter a trial. But consider: the vaccines are developing their human history right now. The record is unfolding. Long term effects cannot be known until the long term. Some of the vaccines might be pulled. One already was for a time, as the manufacturing plant was as clean as the average taco truck. Maybe less. Emergency approval was given, which was a huge risk, both if given or if denied.

But look at the pressure. Fear is being peddled to compel folks to get vaccinated. We are literally bombarded with Covid this, Covid that, Covid everything. I'm waiting for South Park to do an episode on Covid - if they have not already. This idle talk of Covid passports is not reality but almost certainly will be. Governmental power is an end unto itself.

Oh, as to the article, it looks like it might be a labeling issue, in that certain labels will be changed so that use of those drugs for a particular cancer may proceed only in an "off-label" manner. That, of course, requires justification and many oncologists are not willing to take the risk. For a point, drugs are effective even if they slow the tumor for a limited time. In that time, new drugs appear and those new drugs can be of no effect if the patient has already died.

ShadyGuy
Posts: 685
Joined: Jan 2017

Taking the COVID  vaccination was a calculated risk on my part. I knew there were serious risks. I figured I was more likely to die from this tenacious disease I have or from the covid infection than from vaccine effects. I have absolutely encouraged the healthy members of the family to not get it. I was told when diagnosed I had one chance in three of living 5 years. That was 10 years ago. I see it all around - people living longer and longer with diagnoses which meant certain near term death not so many years ago. I thank the drug industry not government. 

PBL
Posts: 315
Joined: Jul 2016

... and so no one is seeking one. The research laboratories are absolutely irreplaceable. When they make great advances and put out a new miracle drug, the world is grateful to them, and that gratitude for their hard work means good money.

But the issue at stake in that article is keeping greed in check. Good science gets praise and plenty of money, and that is only fair. Greed, however, should not be encouraged or rewarded - I believe we can all agree on that point. There are plenty of scandals around the world involving greedy pharmaceutical companies peddling crap to thousands of victims. Think Thalidomide. Mediator. Opioids. PIP breast implants. And the list goes on...

As to the vaccine, it is probably less of a gamble than walking around unprotected and seeing how sick you might get - and I've encouraged the healthy members of my family to get their shots as soon as they could.

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po18guy
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...and knowledge of it explains vitrually everything that occurs, anywhere on earth.

Investors seek a return on their risk. And I forget the ratio of rejected to approved drugs. Something on the order of 5:1. That's a lot of billions down the drain. Private funding and development can occur much more rapidly and flexibly than public development, as government does not have billions to risk - they do have trillions to waste, however. In my case, T-Cell Lymphomas are not even on the radar. The opportunity to both do good and make a profit has benefited me quite well. Simply put, if drug development is surrendered to the government, development will slow to a snail's pace and even B-Cell Lymphomas will be on the back burner.

PBL
Posts: 315
Joined: Jul 2016

no one is dreaming of replacing scientists with bureaucrats. Only ensuring moral standards and public safety are respected. Human nature being what it is, you simply cannot trust private investors - or anyone else for that matter - to self-regulate on their own.

Come to think of it, there is a parallel to be drawn with the actual foundations of the American Democracy, with all its built-in checks and balances and co-equal branches of government... 

ShadyGuy
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Joined: Jan 2017

Whose moral standards? "Moral Standards" range from none at all to arbitrary and orthodox. I prefer legal standards. Only dictators can legislate morality and even then it usually doesn't last.

lindary's picture
lindary
Posts: 709
Joined: Mar 2015

To me the role of the FDA is like that of a traffic cop. Making sure the manufacturers are following "the rules" when developing a new product. I agree with all that has been said. It also made me think back to the chemo drugs given to me and how they were tested. In some ways they are still being tested. I am sure that with each paitient doctors monitor for reactions or side-effects that are outside of the expected reactions. I am guessing that is how it was discovered that Rituxan helps with conditons beyond cancer. In a sense chemo drugs are still be "tested" on people. 

I've been cleaning out a lot of old stuff and finding some gems. One was a Science magazine from 1967 talking about research into RNA. Additional reasearch online I found that the research started around 1961. That means there is already 60 years of various reasearch. I still want to dig more into the history of RNA research. I am guessing that by 2019 they had already been developing what they found into a way to attack known viruses. The roll-out to people may seem to be fast to us but if other vaccines had been developed using RNA to fight simila viruses that could explain why the FDA was willing to okay it's use so quick. 

Personl opinion: Considering that testing a new drug on people can take years I don't think we could afford to wait that long for full standard testing process to be done. Based on what has been done over the last 5 - 6 months with administrating the drugs, I trust pfizer & moderna but no so much the other 2. My husband & I plus 2 of our 3 kids have gotten the vaccine. The third kid is waiting for herd immunity. (grrr) 

When I get more time I want to dig more into the development of using RNA.

 

 

 

po18guy's picture
po18guy
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Like in Nazi Germany? Soviet Russia? The Khmer Rouge? I see epic fail there. Each is an example of moral and political relativism.

There have to be absolute standards, as in the laws of physics. Otherwise, there is no foundation for human thought, interaction and governmance.

ShadyGuy
Posts: 685
Joined: Jan 2017

Its all human invention whether you call it law or religion. You must admit that there are a plethora of religious beliefs and they sometimes clash dramatically. Watch the news or read the paper and see what I mean. In the end people in any given situation must decide how to get along in spite of their religious leanings. That agreement is what i call "law". Good luck. I truly wish you well. 

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po18guy
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The laws of physics. What if they were subject to external influences? Would life make any sense? Would it even be possible?

The universe is expanding. Entropy reigns - yet the laws remain the same. How can that be?

ShadyGuy
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everything is relative - except death and taxes and water beds will always be on sale! LOL. Have a great day!

po18guy's picture
po18guy
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Joined: Nov 2011

Interesting viewpoint. I read this as absolutes which are not your preferred absolutes are not absolutes. "There is no truth" contradicts itself by asserting that it is true!

Absolutes are far easier to defend. Absolutes based on the highest standards of human interaction even more so. 

ShadyGuy
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Joined: Jan 2017

I tried (A little). Have a great weekend and good luck fighting your medical problems. You are a real fighter!

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po18guy
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Joined: Nov 2011

Buncha Qs: What if the laws of physics were relative? First, mathematics would become incomprehensible. Science would become an abstract art. Research impossible. Gravity itself might "evaporate" or become exponentially more powerful. Ultimately life, which needs consistency, would cease to exist in an environment of utter chaos. Who or what established the laws of physics? Who or what ensures that they remain constant, even in an expanding universe? Entropy is observable and measurable in all of the universe. Yet, the entropic process does apply to the laws of physics. Those laws came from somewhere, and if they are random, how come they stopped right where they are?

ShadyGuy
Posts: 685
Joined: Jan 2017

hopeless I would say. Why try? Have a great Memorial Day.

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po18guy
Posts: 1192
Joined: Nov 2011

Without it one is...

From time to time I am asked to believe in less than I do. After what I have learned; after what I have experienced, I cannot believe less. Can one "unexperience" something? Can one abandon that which satisfies the universal need of humanity? Rather, by striving (often failing) to provide an example of hope, I desire to be a small part of restoring hope in others.

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