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Author Topic:   Hauntings, Exorcisms and the Like
pink sasquatch
Member (Idle past 6023 days)
Posts: 1567
Joined: 06-10-2004


Message 121 of 127 (164561)
12-02-2004 12:47 AM
Reply to: Message 120 by NosyNed
12-02-2004 12:07 AM


cancer research in general
However, when you spend a bit of time thinking and discussing the problems you realize that there are no easy solutions. It is daunting to try to find and safely implement really useful therapies. We may blame drug companies, the FDA or conservative doctors. All of those problems may be there but under all that the process is complex and not something that glib answers will solve.
I'm a cancer researcher in the US, have been involved in the therapy development process, and have authored a publication that led to formation of an NIH consortium to deal with certain aspects of preclinical research - so I'm not being 'glib'. I've had plenty of first-hand, and frustrating, experience with the nature of the drug approval process. I also wasn't referring to alternative medicines, but rather drug approval in general (hence the title).
There is medicine which works and that which doesn't. When something is shown to work it is used.
If only that were true. Unfortunately it is not.
It's not that MDs don't want to help their patients, or that preclinical and clinical researchers aren't coming up with viable therapies - a major hurdle lies between these two in the form of an outdated approval system.
For example, though it is now slowly evolving, the FDA definition of cancer remains by tissue site. "Breast cancer" is considered a single disease, as is "colon cancer", which is absolutely preposterous given the knowledge about the variability of cancer. In other words, "colon cancer" represents hundreds of different pathologies, which can be categorized by underlying molecular defects.
Increasingly, targeted therapies are being developed that can essentially cure a small, predictable subset of tumors. Imagine a drug that can predictably cure 5-10% of lung cancer cases, with absolutely no side effects. Such a drug currently exists, but isn't seeing use beyond clinical trials because it doesn't beat the cure rate for the standard of lung cancer treatment (with sometimes lethal side-effects) when given to a randomized population of lung tumors. However, the drug was never meant to be a standard of treatment for all lung tumors, only a specific, diagnosable subset of lung tumors - the approval system isn't equipped to deal with this situation, and so advancement of such disease profiling and customized treatment is floundering.
In slightly different vein, therapies are pulled out of trials at the slightest hint of adverse toxicity, even if the current standard of treatment is worse, and even if toxicity susceptibility of the new drug is predictable. In other words, a possible cure is banned if 0.1% of people taking the drug will die, even if a simple test could be produced to predict that 0.1%.
Appeals to the current complexity of the approval system are incorrect, because the actual problem with the approval system is that is too damn simple. It is so simple it is virtually blocking all new cancer therapies from mainstream use, because the nature of the new therapy is more complex than the system to approve it.
It is high time the bureaucracy caught up with the medical science, and there really is no excuse at this point.

This message is a reply to:
 Message 120 by NosyNed, posted 12-02-2004 12:07 AM NosyNed has replied

Replies to this message:
 Message 123 by NosyNed, posted 12-02-2004 1:05 AM pink sasquatch has not replied
 Message 124 by lfen, posted 12-02-2004 1:19 AM pink sasquatch has replied

Dynamo321
Inactive Member


Message 122 of 127 (164562)
12-02-2004 12:50 AM
Reply to: Message 120 by NosyNed
12-02-2004 12:07 AM


Re: medical research in general
well put. Here here.

This message is a reply to:
 Message 120 by NosyNed, posted 12-02-2004 12:07 AM NosyNed has not replied

NosyNed
Member
Posts: 8996
From: Canada
Joined: 04-04-2003


Message 123 of 127 (164563)
12-02-2004 1:05 AM
Reply to: Message 121 by pink sasquatch
12-02-2004 12:47 AM


Re: cancer research in general
Thanks PS, I wasn't aware of those specific problems. However, that tells us is that some of our research is moving faster than our governence processes can keep up with.
That, to me, is part of the complexity. We are immersed in a society that will come down hard on the FDA if it approves too fast or something shows up as a mistake in hindsight. At the same time we want things fast and cheap. All of the political problems only add to the already complex science.

This message is a reply to:
 Message 121 by pink sasquatch, posted 12-02-2004 12:47 AM pink sasquatch has not replied

Replies to this message:
 Message 125 by Dynamo321, posted 12-02-2004 1:20 AM NosyNed has not replied

lfen
Member (Idle past 4678 days)
Posts: 2189
From: Oregon
Joined: 06-24-2004


Message 124 of 127 (164564)
12-02-2004 1:19 AM
Reply to: Message 121 by pink sasquatch
12-02-2004 12:47 AM


Re: cancer research in general
Sas,
Thank you, for a truly informative post. I'd like to ask if this is purely an agency problem with the FDA, or are there executive or legislative problems? That is can congress make changes? The President? or is up to the head of the FDA?
I'm just wondering if and how the system could be changed?
lfen

This message is a reply to:
 Message 121 by pink sasquatch, posted 12-02-2004 12:47 AM pink sasquatch has replied

Replies to this message:
 Message 126 by pink sasquatch, posted 12-02-2004 2:41 AM lfen has not replied

Dynamo321
Inactive Member


Message 125 of 127 (164565)
12-02-2004 1:20 AM
Reply to: Message 123 by NosyNed
12-02-2004 1:05 AM


Re: cancer research in general
Never thought of it that way. True.

This message is a reply to:
 Message 123 by NosyNed, posted 12-02-2004 1:05 AM NosyNed has not replied

pink sasquatch
Member (Idle past 6023 days)
Posts: 1567
Joined: 06-10-2004


Message 126 of 127 (164572)
12-02-2004 2:41 AM
Reply to: Message 124 by lfen
12-02-2004 1:19 AM


more ramblings...
I don't think of it as an executive problem so much as a need for policy change. The problem seems to be systemic, including to some extent the medical community, and I think evolution of the process will come with turnover of the next "intellectual generation", so to speak.
As in many situations it is in part a matter of the revered and respected running the show; but unfortunately that seems to mean a conservative stance, reluctant to embrace the inevitable next step in medicine - customized therapy. However, as more career 'middle-aged' scientists are rising in reputation and power, their pressure seems to be acting as a catalyst for some change.
Another big push is coming from drug companies because the new classes of drugs they've spent millions developing are set up to fail approval. There are companies that have developed fantastic drugs for customized therapy, and they are in some cases suffering severe financial problems due to approval problems. There is also some concern that drug companies are beginning a slow transition away from developing cures for life-threatening diseases, and towards producing 'lifestyle drugs' that are easier to get approved and often more profitable - think sexual dysfunction, anxiety, heartburn, etc... I hope this ends up not being the case, because drug companies do contribute a large amount of monetary power to disease research, and gobs of money brings the kind of influence that could change the system.
I suppose if the right person got in the right position an extensive overhaul of the approval system could be enacted, unfortunately these positions of power aren't usually filled with the type to shake things up. Or perhaps a President or the Congress could demand an overhaul - but I wouldn't hold my breath given the low priority health matters seem to be assigned at the federal level.
Ideally, I think there should be an integrated group that constantly updates the bureaucracy to keep pace with the science. This stems from the appearance that change seems to follow those involved with the process rising in reputation - however, by the time they have influence their big ideas may be ten years or more outdated. So change occurs, but much later than necessary.
One thing I haven't done is extensive research into how other countries approve drugs. It seems that some European countries do approve therapies relatively quickly, cheaply, and safely.
Hopefully my ramblings provide some insight - currently change will come slowly, brought about by the usual suspects of time, money, and power...

This message is a reply to:
 Message 124 by lfen, posted 12-02-2004 1:19 AM lfen has not replied

Adminnemooseus
Administrator
Posts: 3974
Joined: 09-26-2002


Message 127 of 127 (164584)
12-02-2004 3:46 AM


Terminal topic drift
Haven't followed this one, but the recent stuff sure doesn't seem to have anything to do with the topic theme.
It is interesting though - To good to be buried in and off-topic place. New topic time, with links back to this one?
Closing this one down.
Adminnemooseus

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