Holy Cow - The Benefit Of Most Cancer Drugs Is Marginal and Clinical Trials Overstate Benefits

[gusgold]

No wonder most drugs have such dismal results...Give me IADT with 50 mg Casodex

Gus

cancertherapyadvisor.com/ge...

[Hidden]

Yes it seems to be true that most trials require ECOG status of 0 or 1 (you can function), but it is also true that there is pressure, not least from the drug companies, to use approved drugs earlier in the treatment cycle, when your status is better. The claim of the article seems to be that the benefits of randomized controlled trials are illusory.

I think we have seen some extensions to QOL and to survival with abi and enza as well as with radium 223. It's Provenge where the benefits seem a little opaque. And there is always Jimmy Carter's keytruda to point to, and herceptin.

Plus ALL in children is largely cured thanks to "cancer drugs", so there's that.

[gusgold in reply to Hidden]

Martin,

what do you attribute your shrinking mets to and how is the Provenge working

Gus

[Hidden in reply to gusgold]

The shrinking mets must be due to the adt or the docetaxel. i assume it's the adt. I dont associate any benefit to the docetaxel, for no logical reason. As for the Provenge, my care has involved no tests subsequently, and I have noticed no differences, nor would I expect to. Should have a PSA upcoming, so a small possibility of seeing an unusual effect.

[Hidden]

From my 12 years of studying this shameful problem, I'd say the story vastly underestimates the breadth and depth of the problem. 50 pages of highly condensed evidence based on millions of studies has convinced me and many physicians who have researched this problem that the medical trials system is criminal at every level from the institution to most of its individuals.

[AlanMeyer in reply to Hidden]

I think "criminal" is a pretty harsh term. I agree that its inefficient in some ways and there is some careerism and bureaucracy. It's very hard to eliminate that in an organization with almost 15,000 employees.

It's also been under intense pressure from Congress for many years to reduce costs, to accelerate drug approvals, and to cooperate more closely with the drug companies - who probably have the biggest congressional lobbying effort of any industry in the U.S.

However, all in all, I have no doubt whatsoever that we are much better off with the FDA than without it, and most countries in the world don't have anything like it. They just use U.S. FDA findings to set their own national policies.

I think what we need are some "targeted therapies" to fix specific problems in the FDA and preserve the baby while draining some of the bathwater.

Alan

[Hidden in reply to AlanMeyer]

I'm not referring to the FDA or the NIH, per se. I should have said "system" rather than "institution", because I was referring to the extremely high incidence -- over 75% by some investigations -- of studies in which the conclusions were not only mandated but actually ghost-written by the drugmaker ... the vast majority of studies which don't even record, let alone admit, egregious side effects that drastically degrade patients' lives ... the vast majority of medical researchers who dance around the truth like a bunch of damned lawyers whose very JOB in our adversarial judicial system is to dance around truths to persuade gullible jurors to vote their way ... the HUGE percentage of studies that never see the light of day because the outcome would embarrass even the drug merchants ... all to keep the research money flowing and to push product.

IMO ... and that's why I said "I am convinced" rather than "It is a fact" ... that individuals who do this in industry or in the labs are criminals (and, by implication, should be prosecuted). Anyone who does things like that, to the extent that it harms the public, should not be walking the streets as free men.

[AlanMeyer in reply to Hidden]

Got it.

I think we can never reform the drug companies directly. In effect, a drug company is no different from a computer company, a car company, or any other company. Their business isn't making drugs, it's making money. The managers who do that better than other managers rise to the top, just as they do in all other companies, and if some big money making practice isn't illegal, then from their point of view, it's mandatory.

It's not an easy problem to solve. I think we need some entrepreneurial spirit and we don't want to stifle the companies with laws and regulations. But we also need to channel them in such a way that their interest coincides with public interest instead of opposing it.

Personally, I've come to believe that we've got to put our best minds to work on the problem. They have to be people who know about medicine, know about science, know about drug companies, but don't have personal money making interests in the process. These people need to come up with specific regulations - probably enacted through the FDA, to fix specific problems.

Examples:

All research findings from all research fully or partially funded by the government (that's most research these days), must be published online. Raw data must also be online in easily downloaded formats (e.g., spreadsheets), not just conclusions. This must be done under time deadlines and must be done for negative as well as positive results.

See: opentrials.net/faq/

This is a solvable problem. Here in the U.S. I think we need to unite Republicans and Democrats, liberals and conservatives, behind this. We all get sick and we all have a shared interest in getting this done.

[gusgold]

Nal,

I was taking Avodart, Metformin, Arimidex, Dostinex and like you a ton of the usual supplements. My PSA has been slowing going up - .1 --.2--.3--.4---.5 these readings are at 3 month intervals....I started reading about Casodex monotherapy in Europe...I got my Doc to give me a prescription for Casodex 50 mg...zero side effects and within 30 days my PSA dropped to .1....then I read the study below and said Holy Shit....I plan on adding Casodex 50 mg to the drugs above and staying on Casodex for 9 months then going to IADT...with Casodex on at PSA 1 and off at PSA .1

Gus

[gusgold in reply to gusgold]

Nal.

here is the study of the guy on IADT Casodex for 18 years and he is still fishing...maybe we can make it to 100...so you can go fishing

[gusgold in reply to gusgold]

hindawi.com/journals/criu/2...

[gusgold]

Nal,

the problem with Lupron is the side effects and that Lupron can and usually does lead to CRPC. I have not found any studies where Casodex monotherapy leads to CRPC...what can happen is AR mutation where Casodex no longer lowers PSA. So I would say try Casodex IADT and if it does not control PSA then add Lupron

[AlanMeyer]

I'm going to divide your posting into two parts - a discussion of the article and a discussion of Casodex as a monotherapy.

1. The article.

The article says that many new drugs that are approved only benefit relatively younger and healthier patients, and only by small amounts, averaging 2.1 months. One possible change suggested is, if the initial trials only show small benefit like this, delay full approval and put them on an "accelerated" schedule for more trials before full approval.

I see that, but I think it's not at all what patients want. Imagine you have become castration resistant. You try chemo but it only works for a short time. A new drug has just passed trials and shown to be safe and with an median life extension of 2.1 months for men your age, or maybe younger than you - though a few lucky guys got a year or two years, or more. You ask for the drug. The doc says, sorry, it's only available in trials. You say, yes, but it passed a big trial. He says, I understand, but the FDA hasn't approved it for general use. It will take another few years. You'll have to just go home and die.

Most of the complaints about the FDA are that they take too long to approve drugs that can help people. Patients rage about that all the time. Do we really want to postpone use of drugs that are known to provide at least some benefit for at least some people?

2. Casodex as monotherapy.

I seem to remember that Casodex was once common as a monotherapy at doses of 150 mg per day. Lupron came along and seemed to have fewer permanent side effects (e.g., gynecomastia and heart problems) and it became the more common treatment. Again, if I remember correctly, 50 mg didn't have as many problems but it wasn't enough treatment for most patients.

So, if you, Gus, are getting a complete response from 50 mg a day, you've won the ADT lottery! I think your plan is an excellent one and I predict a long and happy future for you

Best of luck.

Alan

[gusgold in reply to AlanMeyer]

Alan, I don't think my PSA control is from Casodex 50 mg alone but from my combo of Casodex, Avodart, Metformin, Arimidex, and Cabergoline

[gusgold]

Nal,

how long is your on cycle and your off cycle..do you use a set time period or on/off based on PSA

Gus

[dmt1121]

I believe that we can only go on what information is available. If we await "real world" results to be compared to clinical trials, we might not live to make a more informed decision. Even now, our information may be 10 to 20 years out from clinical trials while newer trials will be ongoing. In my case, my choice was to look at the completed clinical trail results, read articles and books, talk with people who have gone through what I was about to embark upon and then let my logic and intuition consider all the information and for me to move ahead from there.

For me, the clinical trials were never a place that I felt gave extremely reliable answers because I found many conflicts in the interpretations between "experts". We look for the "silver bullet" but we find a fuzzy ball of yarn. Once we unravel at least part of it, we have an idea of what might work for me. We just have to deal with imperfect data and supplement it with more information, human experience and our own ability to put together a treatment plan that we feel good about.

[Doseydoe]

I have recently stopped taking Casodex and intend to re-evaluate that decision following my next PSA test (currently 0.03). I have a 3 monthly Eligard shot, I competed 9 shots of Docetaxel and currently in the middle of 20 VMAT sessions. Advice from the MO and RO is that in the ADT scheme of things, Eligard does the heavy lifting (98%) and Casodex does (2%). So I thought I'd stop Casodex for a couple of months and see what happens, thoughts anyone? 😎 DD.