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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID -- Ignore unavailable to you. Want to Upgrade?


To: Richard Belanger who wrote (1713)5/26/2000 3:56:00 PM
From: Maurice Winn1 Recommendation  Read Replies (1) | Respond to of 1762
 
Thanks so much for the explanation Rich.

<rant on>I think ignorance is one of the worst aspects of the bad part of life; if we understand the 'due process' it probably doesn't look as bad as it does when waiting for some treatment, which has already been developed, to trundle through the process.

Patience is NOT a virtue for patients who will be dead in a month or a year if they don't get treatment. If a product causes a bit of neutropenia, dammit, or a faint fever and facial flushing in a few people [who can't be determined beforehand], it seems a good risk balance compared with the alternative. Better Red than Dead say I.

Rituxan adverse effects seem trivial and many of the people being treated must be quite old and susceptible to any burden from treatment. But even in them, the risks seem low and painless. So the slow uptake is puzzling.

The value of human life, unfortunately, does not amount to the cost of Rituxan treatment for most of the people in the world who get treatable lymphoma. That is apparently the case in New Zealand and will certainly be the case in much of Asia and Africa. With India's GNP per capita of a few hundred dollars, they won't be able to afford $$thousands for Rituxan or Zevalin. I suppose the issue doesn't arise as much as you'd think with 1bn people because life expectancy is still low, so I suppose the proportions with lymphoma are much lower than in the longer-lived countries. In Africa, hordes die from AIDS and other diseases before lymphoma gets a chance [being predominatly an older-age problem].

Well, on that unpleasant note, I'll go read some WWeb stuff.

I suppose 'due process' is just an annoying fact of life to some extent, but we should never let a bit of shroud-waving conceal what might really be bureaucracy at it's worst. "Safety you know!", is the fashionable catchcry of people who are really just interested in exerting authority and doing things their slow, comfortable and profitable way. It's an easy out for them. We are all expected to agree, "Oh yes, Safety. I forgot. Yes, we can't compromise safety." Then not take a closer look.

We don't want ambulances running over children at 200kph on the way to rescue somebody who has got a broken arm or even a life-destroying oxygen loss. Yes, due process has it's place. But it's interesting that tow-trucks, which operate on getting to the accident first to get the tow and make the money, invariably beat the ambulance to the scene. That seems to me to mean that due process is not working right! Ambulances should be able to be there first - a minute matters. Actually, when holding one's breath or short of oxygen, 10 seconds matters! Maybe they need some competition. </rant off>

Since lymphoma isn't a single variable disease in even one person, with a wide array of cell-types, it seems obvious that unless something like telomers can be targeted, a multi-treatment makes sense [and would cost a lot more - what's a person-month worth?...depends on the person].

Maurice



To: Richard Belanger who wrote (1713)12/4/2004 5:08:59 PM
From: Maurice Winn1 Recommendation  Read Replies (1) | Respond to of 1762
 
Hi Rich. Long time no hear. I hope things are well with you. Things are good here, Tarken is well, hasn't had a revisit of NHL [first occurrence Sept 1997] and is now living in Japan. As you can see he's having a lot of fun: blog.livedoor.jp

Today I thought I'd check up on what's going on with Rituxan and intermediate-grade diffuse large B-cell non-Hodgkins lymphoma.

</rabid rant on... As I [a complete layman] figured out way back in 1997, after not many weeks of reading and thinking, the medical guilds are criminally negligent and incompetently stupid*. At least they try to be ethical, provided their ethics don't conflict too badly with their cash flow. Okay, maybe there are exceptions and hey, some of my best friends are medical people, so I'm not prejudiced against them. It's also fair to say that we are all prone to mistakes and all of us have vast tracts of ignorance in our brains. But it's quite annoying when they assume power, reject what's obvious when it's pointed out to them and explained, and they won't allow the person the choice themselves. "NO, you may not have Rituxan! It's no use and harmful." A few years later [when many of the patients who would have benefited have died]. "We have established that you should have Rituxan. Please give us lots of money and we'll let you have it."

In 2002, years, and swarms of dead people later, they figured out the obvious which was that it's a good idea to use Rituxan and CHOP in combined treatment at first diagnosis.

Here's the conclusion. bcbs.com

Finding the doctor with the brains to recognize an opportunity when it's put in front of them is important to staying alive. They also have to be in a political system which allows people access to medical treatments; New Zealand for example won't allow medical treatments until many government people and medical guild people have clipped the ticket and bagged their cash. ...rabid rant off/>

From your post of 4.5 years ago:

<Me: Rituxan has been available for 2 and a half years. Zevalin is grinding ever so slowly through the linear regression analyses and FDA hoop-jumping procedures excruciatingly slowly. All grist to the highly-paid guild members of course. Yet oncologists seem still to be 'discovering' Rituxan with the % of patients being treated continuing to increase.

You: There is still some reluctance to use Rituxan as front-line therapy and I can understand that. What I can't understand is why Rituxan isn't eventually used in ALL NHL patients who are relapsed or refractor to other therapies. It can prolong life with quality. There is nothing to lose! Aren't these oncologolists keeping up with their continuing education requirements? If Greg Rasp is listening, maybe he can comment on this from the onc. viewpoint.

Me: Meanwhile, Zevalin seems a much better idea than Rituxan, so it's a puzzle that oncologists are happy to keep messing about with Rituxan when Zevalin seems a real method of dealing with lymphoma cells.

You: It seems like the real hope is in combinatorial therapies. Zev treatment also involves Rituxan, and I would imagine there are many combinations of antibodies and radioconjugates that will eventually prove better than anything currently available. For example, each isotope performs optimally against tumors of a given size, and many NHL patients have multiple tumors with different sizes. So theoretically at least it would make sense to use a combo of isotopes. It's all very complicated, trying to determine optimal doses and treatment regimens. I guess that's why there's 150 Rituxan trials going on.
>

I wonder if Zevalin is now standard treatment for newly-diagnosed. I don't have a pressing need to know now, so I'll save that for a rainy day.

</rabid rant on... One consolation is that doctors and FDA members also get NHL, so with luck, some of the people who hold things up and permit things in exchange for cash, [admittedly only their salaries, but it's still cash for permission], have suffered the consequences instead of some innocent victims. .../rabid rant off>

Actually, it's a rainy day today. Cold too, despite it allegedly being summer.

Thank you to the IDEC people. Keep up the good work.

Mqurice

* - this wasn't the first evidence I've come across in half a century.