Bogus advances

po18guy said:

The vaccines

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.

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

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.

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.

... 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.

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... 

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.

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. 

Max Former Hodgkins Stage 3 said:

Trials

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.

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.  

ShadyGuy said:

There are no absolutes …

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

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 said:

Oh Well …,

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

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?