I think this easy to listen to discussion is worthy of your comments. youtu.be/vZlZIXHT0yA
The illusion of Evidence based medicine - Advanced Prostate...
The illusion of Evidence based medicine
DarrylPartner
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Darryl
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40 Replies
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Wow Darryl. Very very sobering.
I keep thinking that surely the data is out there from all of the many trials of both successful and non successful treatments. I'm guessing the STAMPEDE trial is a start but it really doesn't go far enough.
I think the take home message for all of us or those with family members with Advanced Prostate Cancer is to keep researching and advocating for ourselves.
It is indeed a sad take on our universities. We need independent research. Thank you for posting.
It's a video commentary of an opinion article where the commentator agrees with the opinion. Raw data is presented to the FDA (in the case of the U.S.) to review, and both good and bad data are presented.
Is it true Pharma may hide bad data? Possible, probable and assumed and yes. Deaths have occurred when drugs are approved and we later find out some data was withheld so we know it happens.
We have also seen many many instances where a promising drug reaches a phase 3 trial only to find it fails because of adverse side effects and the company's stock tumbles. So in those cases bad data is not withheld.
When I worked for Ingenix, we did phase 2 and phase 3 trials on behalf of Pharma companies. All data was given to the company or presented to the FDA on their behalf. Certainly not made public as to expose trade secrets.
True evidence based medicine is derived from clinical outcomes, not just studies or trials. Studies and trials are only the start. It takes years and literally millions of medical claims to compile clinical outcomes.
Science, as the video indicates, is full of bad science and as they learn more about say, microbiome, they will discover that the medical treatment of today for certain illnesses (some at least) is harming the body or causing long term damage.
Not new and not news.
It's important to understand that both the opinion piece in the British Medical Journal and the youtube video is obviously British. It is not relevant in the US, where most new drugs are approved (and US approval is accepted in most of the world). I'm not sure if Darryl posted it believing it is relevant in the US or because it may be relevant to UK members.
I don't know how exactly how it works in the UK, but can speak to how it works in the US. Almost all countries rely on the FDA new drug approval process because of its transparency and integrity. (There have been exceptions, of course, but those exceptions can be counted on one hand and led to changes in the process.)
The research on Covid19 done by corporations was just the tip of the iceberg. Governments sponsored the bulk of the research. While ivermectin was not studied by Merck, it was indeed well studied and found to be useless. Results of Covid19 research were made available, arguably too soon, on non-peer-reviewed websites (bioRrxiv or medRxiv). Peer-review was accelerated.
Governments often sponsor research when pharmaceutical companies (or supplement mfrs) don't. NCI and DoD are big sponsors, so are NGOs like the Prostate Cancer Foundation. NRG Oncology or SWOG, with NCI funding, runs most of the major trials in the US. In the UK, STAMPEDE runs many RCTs with government funding.
We rely on pharmaceutical companies to finance new drug trials. They pick a lead investigator who is usually a famous doctor in the field (eg., Oliver Sartor for Pluvicto). The lead investigator can only do what the Independent Review Board (IRB) approves. The IRB assures legal compliance and integrity. The pharmaceutical company is largely out of the picture during the trial other than funding it.
NIH requires that all listed clinical trials announced on their clinicaltrials.com website publish their results when available. They have been lax in enforcing this. It's less of a problem for corporate research than for university research. Peer-reviewed publications do bias towards positive results. That may be because there is limited space in print - as we move to online-only publication, it may become less of an issue. Increasingly, there are "open access" publications. I would applaud a nationally-owned and operated NIH peer-reviewed publication. Pure Capitalists might object.
FDA does review the raw data (which is one reason it takes so long). Perhaps NHS is the UK does not - I don't know. In addition, raw (de-identified) data is made available for purchase by other researchers. Here is a good example:
prostatecancer.news/2022/01...
TA you have to watch Dopesick. The true story of how the sacker family and Purdue pharmacy got the FDA to basically endorse their OxyContin poison. It went on for years. It really made me trust the FDA much less.
Schwah
As long as it makes news, I'm not worried.
I very much appreciate the insights you share here TA, but in this case am not as reassured as you are by the efficacy of news outlets. I worked in the newspaper industry for 25+ years and watched the standards of excellence in investigative reporting steadily degrade to the point that we now have, where in many instances reporters, who now must multitask more than specialize, find themselves so beholding to their sources of accurate inside information that they are easily swayed to not dig as deeply into the dirt, as was more often done in the past. I wish the “news” was still the reliable source of counterbalance for corruption it once was, but fear it’s not so much the case anymore. Particularly evident, I think, in some of the popular news and media outlets which are really more propaganda machines than fact reporters. Some of the latter do still operate; but their #s, and with it solid and honest investigative journalism, have waned dramatically in recent decades, IMO.
Not saying this particular video holds great credence, but more think it suggests there may be as much, if not more, collusion amidst federal agencies and the medical and insurance industries than existed in the past. And with the decline in good investigative journalism we might want to not be so trusting in that realm for offering protection against profit driven predatory practices.
That is exactly the conclusion (tip of the iceberg) that conspiracy theories thrive on. Sorry, I don't buy into secrets being kept when large numbers of people are aware of them. More suspect is that the authors of the articles are plugging a book on the subject and their list of references are almost entirely from more than 20 years ago. No actual primary source journalism went into the article or the youtube video.
Quite true. And yet the question in my mind still remains: “Why did it take the FDA so long to recognize the effectiveness of an important treatment option which has been used overseas for quite some time?” The “Priority Study” authorization could have come along much earlier than late last year, IMO.
LU177PSMA617 had never been studied in a randomized clinical trial until the VISION trial. Until then, you and I may have suspected that Pluvicto was more beneficial than standard of care, but there was never any evidence of it.
Germany gave it to any PCa patient because of their Compassionate Use Law. The FDA must comply with US law which demands it assure safety and efficacy first. You may remember that thalidomide was approved in Europe, but not in the US, and was found to cause birth defects. The US probably has the highest bar for new drug approval, which is why most other countries accept FDA approval. Incidentally, Pluvicto will now probably be approved in Europe because of FDA approval.
The FDA gave it priority review status as soon as the VISION data was submitted to them. It takes a long time even with priority review because they have to review all of the raw data. The importance of the review of all the raw data is the main point made in the BJM opinion piece. - you can't have it both ways: either they quickly accept and decide upon the summarized data, OR they go over each case, one by one, in a process that takes many months.
Thanks, TA
The video is by a UK guy, but the authors are drawing from their experience from US data, mainly about psychiatric drugs. And not the first book on this topic.
Yet, that's not how it works with the FDA. The FDA examines raw data.
The authors focus on company marketing practices: hiring ghost writers, paying for "thought leaders" to give talks, and so on.
I have no problem with marketing as long as it’s not deceptive.
Well, the whole point of this is that it is deceptive, according to the authors. They have access to thousands of pages of internal documents from the manufacturer due to lawsuits. Are they right? I have no interest in reading everything to find out.
Deceptive drug advertising is bad and the FDA has an office just for stopping it:
fda.gov/about-fda/center-dr...
Unscrupulous companies may try to subvert the law. Hopefully, they are usually caught and penalized. I am more worried about erroneous claims made by the multibillion dollar supplements industry. It is much harder to control and laws are inadequate.
in reply to Tall_Allen
There you go again with the supplements industry. You complain about conspiracies yet you seem to subscribe to one -- that supplements are bad and can't be trusted.
Tall_Allen in reply to
While pharmaceuticals are gov't controlled, the multibillion dollar supplement industry isn't.
in reply to Tall_Allen
I'll re-iterate my FDA approved prescription medicine vs supplement experience. FDA approved Xiaflex injection for Peyronies put me in the ER with retention and didn't cure the Peyronies which I continued to suffer with for a year.
Took 12.5 mg Iodoral (iodine) supplement for several weeks. Peyronies cured.
FDA approved Xiaflex 0, Iodoral 1, for those of you scoring at home. Has there ever been a clinical trial for Iodoral treatment of Peyronies? Nope. Who would pay for it?
Tall_Allen in reply to
I took Xiaflex for Peyronie's too after trying your suggestion for Iodoral. It worked. Iodoral didn't do anything. Xiaflex 1 Iodoral 0. So what does our n=2 experiment prove? Nothing. Your pseudoscientific approach is useless.
in reply to Tall_Allen
As usual you "know it all" and remain quite abrasive as usual.
MrG68 in reply to
To me there’s two different issues there. There’s the fact that supplements aren’t regulated, and that’s true they’re not. I believe that a lot of supplements are useless actually. Some companies and their products are better than others.
But there’s also the train of thought that supplements are ineffective. That I don’t subscribe to.
I think the issue is people see some study about some positive benefit of a supplement like melatonin, D3, selenium for example and think great I’ll give that a shot and probably even be in the mindset that more is good.
They’ll probably not see any benefit and give up on it. They could even be on about 4/5 different supplements. It will cost a lot of money as well.
I actually do take take supplements. I choose ones that target inflammation. Inflammations is strongly associated with cancer. I integrate them into a lifestyle and diet that I believe is beneficial to improve my immune system. I believe that your best cancer fighting mechanism is your body. It’s designed to do it. EVERYONE has cancer cells - right now. Your body targets them discriminately and kills them.
However, supplements are not a panacea. You need good exercise, sleep, stress managements, and a diet that suits your body type.
Drugs sooner or later will become ineffective and you’ll end up on other drugs.
To me, the side effects are horrific. To others, not so much.
It’s worth pointing out that some people have managed their cancer effectively for years which has included meds. But it’s also true that people have done it without them.
It’s everyone’s choice though.
I like how you think MrG. And how you write.
hub.jhu.edu/2021/06/21/fda-...
Despite the FDA advisory committee's nearly unanimous decision against approving aducanumab—they said there was not enough evidence that the drug provided clinical benefit—the FDA gave its OK to the drug.
Glaring override of the FDA advisory committee by the FDA....I'd guess to say the raw data didn't factor into their decision, so why did they approve if the approval is data driven?
The approval is also based on a surrogate marker, not on a clinical outcome.
Meaning, an outcome that appears to be positive, but doesn't necessarily show a clinical improvement for the patients. So generally TA is correct, but the FDA DOES NOT ALWAYS follow the rules.
I think they approved it based on nothing else being available for Alzheimer's. Remember, it made news because it is so rare that the FDA doesn't rubber stamp committee approval. Were they right to approve it? IDK, but I don't have a close relative with Alzheimer's.
Good points. We have NICE (or not very nice as some like to say) in the UK, who have to approve treatments. It will be interesting to see how far behind the FDA we are with LU177 approval.
My understanding is that NICE does a cost-benefit analysis. That only occurs in the US with insurance drug plans. So far Medicare has approved everything that is FDA approved, but drug plans may decide to opt out. I think in Canada, provincial drug plans can decide what to cover.
In the US the FDA gives restricted approvals very narrowly limited to trial populations. Since these are done most commonly in most advanced disease, mCRPC and often after one or more now failed treatments. This creates subject populations much closer to death so OS data can “mature” without having to wait so many years. Understandable. However these restrictions say nothing about limiting effectiveness in less advanced disease. And often case may be more effective if deployed earlier. Pluvicto is a case in point with its approval restrictions of mCRPC with prior taxane and one AAR drug, for which there is no evidence that it would not work better in HSPC, low volume, LN only cases, etc. Data from Australia and Germany strongly indicate or suggest this. Pluvicto depends upon PSMA activity, distribution and concordance, etc. Not on CR vs HS stages of progression.Another example is Provenge being limited to mCRPC. Same considerations. The default should be that treatments proven effective in advanced disease should be presumed to be effective in earlier disease unless evidence or mechanisms suggest otherwise. Just my opinion around the raggedy edges of SOC.
Well said, MB!
In the U.K. it’s the MHRA. The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
Since Brexit, the U.K. no longer necessarily follow the EU medicines agency or indeed the FDA.
In Ireland we await the EU view, then develop our own which has a nasty habit of rejecting expensive medicines!
Covid19 aside, practically it’s usually FDA approval first before EU or / and U.K. except for compassionate use situations.
Hugh
Thanks Darryl. How True
Quite apart from the arguable merits of EBM, I find it interesting that both Campbell (and Malone) have been prominently criticized for promoting disinformation about covid; disinformation that has been soundly disputed by that evidence-based literature.
I love how everyone on the site defends “the pill for every Ill” situation we are in. But truth is, there is not as much money in studying nutrition. Common sense rules.
Unfortunately it’s a LOT of work and expensive!! We know! My husbands protocols take 5-8 hours a day and cost us a fortune! A magic pill would be awesome. BUT his cancer is very aggressive so we HAVE to include all options! And constantly balance the benefits vs risks.
Not everyone 😀
Great commentary on the state of universities and medicine. The corporations have taken over the impartiality of universities just as stated in the Powell Memorandum.
He favorably mentions magnesium and iodine supplements which I both take and recommend, further stating that there's no money in subjecting these to anything resembling clinical trials. I like this guy.
This trend is clearly evident after the whole COVID fiasco and how medicine became politics. It is amazing how many on this forum think the US is different. Research money controls the universities here. And govt controls the research money. NIH. We have revolving doors to industry and government. FDA. Just look at drug companies' attempt to hide trial data for 75 YEARS!! No, approval here in the US is all tainted. Has been for a long time but now more are seeing it. Anyone who thinks otherwise is either a fool or . . . a fool blinded by self-interest (read-politics).
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