21. Pawelski states:
"The ASCO study showed no evidence of benefits"

Finally, he talks about evidence. Schrag GIVES YOU evidence and THEN lets you decide.

Why doesn't he talk about evidence with respect to cell culture assay as his mentor, THE researcher of cell culture assay, Wiesenthal, does? He wants you to decide on culture tests with FIRST NO evidence available.

Even Wiesenthal knows there is no evidence and studies are underway to determine if there is any benefit.

The Pawelski ASCO conspiracy theory?
"oncologists don't want to disturb income flow":
Well, the next time you visit your oncologist, you know, the one who cares not about you, but only his cash flow, as stated by Pawelski, ask him or her his opinion of this.

Take the Pawelski challenge:

"Doctor, why do you care about your income more than you care about by outcome?"

Pawelski will say you won't get an honest answer. YOU can tell if someone is telling the truth. Come back here and tell us what he or she says.

(Reader,I'm not trashing the ideas. Neither are the vast majority of oncologists and scientists who agree with me. Just show me the evidence, Reader. I agree that some FDA approved drugs have caused significant problems. Those drugs were approved because they were effective for the disease treated. EVIDENCE existed. Your comparing apples and oranges. There is NO evidence that cell culture assays benefit the patients and the developers of these tests SAY JUST THAT as I indicated above. ONLY, I repeat, ONLY the internet blogger, Pawelski says they benefit the patient. There is no evidence of this. He says that traditional methods of treatment are ineffective. Go ahead, Reader, use the cell test. It's America. Do what you want. That's fine. Call Wiesenthal, a developer of the test, and ask him if it will benefit you. He will say that he doesn't know.)

P.S.: "Sharing knowledgeable information" requires dispassionate, objective truth. One can emote in a blog entry, but the information should stand by itself.

I appreciate the blog owners allowing me the bandwidth to express a different opinion. I hope for new breakthroughs, too, as I have lost loved ones to cancer. I hope cancer patients can trust that scientists and researchers have the best interest of the cancer patients in mind. You should feel that the medical community cares about you. If a healthcare provider does not, then it's time to find one who does. They exist everywhere.

Posted at 11:28PM on Apr 22nd 2007 by hchcec

22. Pawelski states:
"The ASCO study showed no evidence of benefits"

Finally, he talks about evidence. Schrag GIVES YOU evidence and THEN lets you decide.

Why doesn't he talk about evidence with respect to cell culture assay as his mentor, THE researcher of cell culture assay, Wiesenthal, does? He wants you to decide on culture tests with FIRST NO evidence available.

Even Wiesenthal knows there is no evidence and studies are underway to determine if there is any benefit.

The Pawelski ASCO conspiracy theory?
"oncologists don't want to disturb income flow":
Well, the next time you visit your oncologist, you know, the one who cares not about you, but only his cash flow, as stated by Pawelski, ask him or her his opinion of this.

Take the Pawelski challenge:

"Doctor, why do you care about your income more than you care about by outcome?"

Pawelski will say you won't get an honest answer. YOU can tell if someone is telling the truth. Come back here and tell us what he or she says.

(Reader,I'm not trashing the ideas. Neither are the vast majority of oncologists and scientists who agree with me. Just show me the evidence, Reader. I agree that some FDA approved drugs have caused significant problems. Those drugs were approved because they were effective for the disease treated. EVIDENCE existed. Your comparing apples and oranges. There is NO evidence that cell culture assays benefit the patients and the developers of these tests SAY JUST THAT as I indicated above. ONLY, I repeat, ONLY the internet blogger, Pawelski says they benefit the patient. There is no evidence of this. He says that traditional methods of treatment are ineffective. Go ahead, Reader, use the cell test. It's America. Do what you want. That's fine. Call Wiesenthal, a developer of the test, and ask him if it will benefit you. He will say that he doesn't know.)

P.S.: "Sharing knowledgeable information" requires dispassionate, objective truth. One can emote in a blog entry, but the information should stand by itself.

I appreciate the blog owners allowing me the bandwidth to express a different opinion. I hope for new breakthroughs, too, as I have lost loved ones to cancer. I hope cancer patients can trust that scientists and researchers have the best interest of the cancer patients in mind. You should feel that the medical community cares about you. If a healthcare provider does not, then it's time to find one who does. They exist everywhere.

Posted at 8:52AM on Apr 23rd 2007 by hchcec

23. I don't mind if people want to post comments from a friend or aquaintance of theirs, but I do mind when they attack someone elses friends or aquaintances personally, who is incapable of addressing the topic at hand and instead launches into a personal attack, usually by ascribing some neurosis that actually applies to them.

I am providing information and a point of view. I'm not making a decision for anyone. The cancer patient's oncologist still holds all the cards in "steering" the cancer patient in the direction the oncologist wishes. I am simply giving the cancer patient or their loved ones a little more information in the most difficult of situations. People who don't want this information don't go on blogs looking for it. People who do want this information have their own responsibility to be capable of dealing with the information they receive.

The Medicare carrier, National Heritage Insurance Company, recently completed a year long, comprehensive review in which they considered all the evidence, including the point of view expressed by ASCO and saw fit to reject the latter point of view in approving payment for this service for all Medicare beneficiaries, when the tests are ordered for appropriate indications.

The decision had been made that the assay is a perfectly appropriate medical service, worthy of coverage on a non-investigational basis. And it was particularly significant that they abandon the artificial distinction between "resistance" testing and "sensitivity" testing when providing coverage for the whole FDA-approved kit.

Medicare has come to realize that selecting treatments on the basis of tumor biology rather than on reimbursement to the treating oncologist is not only good science and good medicine, but good medical economics.

If I have upset the cancer establishment......Good!

I care about cancer patients and their familes no less than oncologists. I stand up for what I say by signing my own name.

Posted at 8:51AM on Apr 23rd 2007 by Gregory D. Pawelski

24. The red herring: "personal attack" is evident here.

There is none. This is a way of deflecting the discourse away from this:

I simply am asking for evidence before the internet blogger, Pawelski, "informs you" that there is evidence.

The local Medicare co. NHIC may cover it,(it's not a national Medicare decision by any means), but this in NO way means there is any benefit to cell culture assays. Medicare covers a lot of things that are ineffective. We're beating a dead horse here.

The evidence for benefit, and cancer patients should know this, lies with the scientific method.

Wiesenthal, THE cell culture assay scientist states:

"Clinical trials ARE REQUIRED to establish the degree to which the observed in vitro drug effects reported in this abstract can be used to engineer improved treatment outcomes in cancer patients."

Only the internet blogger, Pawelski, will have you believe that your oncologist "still holds ALL THE CARDS in 'steering' the cancer patient in the direction THE ONCOLGIST WISHES," the only interest is MONEY, and evidence is NOT REQUIRED for you to realize that cell culture assays ARE the ONLY effective way to achieve benefit.

Feel free to ask your oncologist for the cell culture assay test if you want to and want to pay for it. Just know that we don't know if it will help you or not. That's all. This is not that complicated.

There is only one blogger who writes to hundreds of blogs with evidence of benefit.

There's not more than one. Only one. As long as he continues to write that assays are necessary, someone has to be there to question him and ask for the evidence.

I await that evidence.

(My not signing my name is a red herring, directing the discussion away from the evidence.)

Posted at 8:51AM on Apr 23rd 2007 by hchcec

25. In life or death situations, one must make judgements based upon the preponderance of available evidence as opposed to proof beyond reasonable doubt. It seems obvious that "evidence-based medicine" proponents may fail to apply this common sense standard on a consistent basis.

ASCO established a policy recommending against the use of cell culture assay testing as an aid to drug selection in cancer chemotherapy, based on reviews which specifically excluded from consideration studies reporting the predictive accuracy of cell culture assays.

This is especially curious, since predictive accuracy is the chief criterion traditionally used to validate all laboratory tests currently in use in cancer medicine (including hormone receptors, Her2/neu, gene expression-based assays, and all immunohistochemical staining tests).

Were proof of efficacy (particularly in prospective, randomized trials) to be the standard for evaluating laboratory tests, then clinical oncologists would abandon all the laboratory tests currently used in the management of cancer patients, as no tests would pass this standard.

You don't establish one set of criteria for one diagnostic test, while you let all the rest follow another criteria.

Clinical oncology investigators have too often descended into an exhaustive study of hypotheses which are ultimately of limited importance. Many cancer treatments are of such limited effectiveness that they do not deserve to be protected from the competition of other approaches which are well grounded in peer review science, but which have not yet met the so-called standards of "evidence based medicine" proponents.

National Heritage Insurance Company found that even back in 1999, the Medicare Advisory Panel concluded that cell culture assay tests offered "clinical utility." After listening to detailed clinical evidence, the Medicare Coverage Advisory Committee (MCAC) found that these assay systems can aid physicians in deciding which chemotherapies work best in battling an individual patient's form of cancer.

MCAC's laboratory and diagnostic services panel heard presentations from experts regarding the clinical data associated with the assay systems. The panel questioned presenters carefully on clinical performance, study findings, literature analyses, and patient impact of the tests. After considering the evidence, the panel conclued that the tests demonstrated clinical utility for directing therapy.

Posted at 11:16AM on Apr 23rd 2007 by Gregory D. Pawelski

26. The 2007 decision by a local Medicare provider in Northere California, toucted by Wiesenthal and Pawelski is merely a local decision. In fact, the decision to cover these tests contains these words:

"There has never been a national organization’s guideline that sensitivity testing is required for chemotherapy decisions, and this LCD (local coverage decision) shall in no way be construed as making any such suggestion."

Plus, the 1999 decision was no big deal as no change was made nationally and one still hasn't been made. Local providers can do whatever they want. It doesn't mean anything with regard to the benefit of the test, especially lnog term benefit.

Cell culture assay testing has not yet proven to result in survival. Wiesenthal know this. Meidcare knows this. ASCO knows this. Insurance cos. know this. Do a pubmed seach and you will find nothing on these tests and benefit.

There's only one internet blogger who claims long term benefit from assay tests.

Again, choose the test if you like. Just understand that no data, none, at this time, indciates they are of benefit, despite what you may hear form the one individual who states that your oncologist cares more for his income than he does for you

Posted at 6:19PM on Apr 24th 2007 by hchcec

27. Now I know why only one blogger (hchcec) goes ballistic when I bring up ASCO and the chemotherapy drug concession. I guess I should bring in GOG, ECOG, NSABP, CALGB, CCG and perhaps US Oncology into the equation. Perhaps hchcec should reveal herself. Then we'll know the reasons for her biases. How can somebody who hides behind a symbol have any credibility? Unless you're somebody who consistantly gives misinformation, do you need to hide behind a symbol. Evidence-based medicine is the red herring.

The literature on cell culture assays have not been understood by these organizations (many NCI investigators and by NCI-funded university investigators) because their knowledge was almost always geared towards an old assay technique that hasn't been used by any private laboratory for more than fifteen years, nor has it ever been avocated. However, it is the basis of her contention, and what most academic oncologists virtually always refers to and thinking. I can understand that because they don't really understand assays or are willing to learn about them. That's "their" problem.

NCI studies never determine if "fresh" tumor assays worked. All of the considerable literature which supports the use of these assays in patient management has been based on true "fresh" tumor (non-passaged) cell assays.

Some years ago, NCI made an attempt to study "assay-directed" therapy of lung cancer. The study was a failure because they used established permanent cell lines (instead of fresh cells) to do the work. The result was a dismal 11% response.

The NCI used "cell lines" because the major expertise of the investigators who carried out any study was in the creation of cancer cell lines, and they wanted to see if they could perform assays on these cell lines to use in patient therapy. The results showed they were able to test successfully only 22% of specimens received, including only 7% of primary lesions.

This contrasts with a 75% overall success rate reported by earlier investigators who used the same assay system in "fresh" tumor and a routinely obtained >95% success rate using improved (cell death) methods available today.

When you look over the literature of evidence-based medicine, there is not a single drug or combination that is uniformly curative of any solid tumor. NONE. Available drugs provide responses in a minority of solid tumor patients (around 40% overall with single digit CR rates).

1.5 million articles have been published in the field. $200 billion has been spent on research and therapy. The clinical trial process is not working with only one in seven trials being positive (i.e. successful). High dose therapies have proven ineffective. It is hard to imagine anything could be much worse than what has been accomplished.

It is increasingly evident for those genuinely familiar with the scientific literature that the genomic revolution is merely scratching the surface of human biological complexity. There appears to be an inverse correlation between one's degree of scientific sophistication and one's belief in the genomic revolution.

Over 1600 peer reviewed results with "cell-death" assays in the literature establish the merit of cell cultures as highly correlated with clinical time including response, time to progression and survival. This is what National Heritage Insurance Company spent a year reviewing to approve Medicare coverage for the tests.

They made the courageous decision to reverse trend and noted that ASCO and others had failed to consider any of the many studies which support the predictive accuracy of cell death-based assay testing. Again, their decision had been made that the assay is a perfectly appropriate medical service, worthy of coverage on a non-investigational basis, and abandon the artificial distinction between "resistance" testing and "sensitivity" testing and are providing coverage for the whole FDA-approved kit.

And note: Medicare coverage is available for Chemosensitivity (Resistance) Testing for a tumor specimen from a Medicare patient obtained anywhere within the United States, but submitted for testing by one of the approved laboratories located within California.

Posted at 6:17PM on Apr 24th 2007 by Gregory D. Pawelski

28. "Over 1600 peer reviewed results with "cell-death" assays in the literature establish the merit of cell cultures as highly correlated with clinical time including response, time to progression and survival. "

As an example of how the above is misleading, one need only refer to a letter written by a researcher who was misquoted that assays have survival advantages.

http://jco.ascopubs.org/cgi/content/full/23/29/7363

Notice that Pawelski doesn't inlcude links to the 1600 studies.

Pawelski:

"It is hard to imagine anything could be much worse than what has been accomplished."

Well, then perhaps cancer patients should give Essiac tea and homeopathy a try since highly educated scientists have accomplihsed nothing.

For Pawelski, who has stated ON THIS BLOG, that you are "doomed" if you don't try an unproven assay, evidence just isn't good enough.

Posted at 5:42PM on Apr 24th 2007 by hchcec

29. Evidence-based medicine is a "trial and error" process of a clinical trials to see what might "appear" to be improving cancer survival. It is the mindset of rewarding academic achievement and publication over all else. There is this aurora that organizations, government agencies, scientists, researcher and even practitioners work together, sharing information for the benefit of patients.

Each group has its own priorities and its own agenda. Moreover, the image of cooperation between these different groups only gives the illusion that reform isn't needed. The present system exists to serve academic achievement and publication, but not to serve the best interests of cancer patients.

The demise of the "discoverer" type with its not so well organized risk-taking, in favor of the "investigator" culture, well organized, exhaustive analysis of trivial hypotheses, is a perfect example of thirty years of the "trial and error" mind-set that has occupied cancer research. A dysfunctional culture that pushes tens of thousands of physicians and scientists toward the goal of finding the tiniest improvements in treatment rather than genuine breakthroughs, that rewards academic achievement and publication even though their proven activity has little to do with "curing" cancer.

While new regimens "appear" to be improving survival, when these same regimens are tested on a wider range of cancer patients, the results have been very disappointing. In other words, oncologists at a single institution may obtain a 40% to 50% response rate (not cure) in a tightly controlled study, when these same regimens are tested in a real-world setting, the response rates may be 17% to 27%.

Also, whatever clinical response that has resulted to the average number of patients in a randomized trial, is no indication of what will happen to an individual at any particular time. They are trying to identify the "best guess" treatment for the average patient. You cannot mate notoriously heterogeneous diseases into "one-size-fits-all" treatments.

It is a common tactic for quackwatch people who unload a deluge of meaningless references when they cannot cobble together a cohesive and persuasive original argument based upon logic and the issues at hand. This is indeed the fundamentalism that is guiding their principles. Dr. Michael Castro aptly describes the position of ASCO and those wedded to their position as "fundamentalist."

http://jco.ascopubs.org/cgi/content/full/23/15/3645

Posted at 8:18PM on Apr 24th 2007 by Gregory D. Pawelski

30. A terrific rebuttal to all aspects of the prolific internet blogger, Pawelski's position, is given as a follow-up response to the link he supplies above. It says it all and is must reading for anyone who wants to finally put this issue to bed.

(Most interesting is the position of the author of the link Pawelski himself provides. I'm quoting:

"IVCT (in vitro chemosensitivity testing) still waits for validation in prospective randomized trials."

"pivotal randomized trials of IVCT have yet to be undertaken."

For blogger Pawelski, benefit ALREADY exists for IVCT and the treatment YOU are getting today is worthless. All the research has been worthless and has even harmed you.

Pawelski:
"If we'd never done a single prospective, randomized trial in ovarian cancer, for example, I am certain that we'd be no worse off than we are today and WE'D PROBABLY BE A LOT BETTER OFF."

He's certain.

No one who actually works in the field of IVCT is certain of its benefit. Only one, who blogs prolifically will have you believe that your doctor cares more about his income than your outcome because he or she refuses to use IVCT. (I guess if IVCT should be paid for by the taxpapyer without evidence of benefit, then we should also pay for shark cartilage, laetrile, reflexology, auric healing, etc.)

Remember, it's Pawelski who said:

"A lot of cancer patients who succumb to their disease get the wrong information on their death certificates. And a lot of oncologists get away with camouflaging their negliegent (sp) mistakes."

‘If a Man will begin with certainties, he will end in doubts; but if he will be content to begin with doubts he will end in certainties.’

Posted at 9:13AM on Apr 25th 2007 by hchcec

31. Approximately 80% of academic oncologist and 35% of private practice oncologists are ordering the $3,600 test (Oncotype DX) at a time when it had only been shown to be accurate (and not efficacious) and only in a retrospective study in which all assays were done not under real world situations but by a single lab team in the space of two weeks. The only studies planned were studies to confirm the predictive accuracy prospectively.

Lung cancer oncologists are performing gene mutation tests to determine whether or not patients should be treated with Tarceva, in the absence of any studies in American patients showing survival correlations and with the absence of any studies showing that using the test makes a difference in treatment outcomes.

Name me a single laboratory test which has ever been shown to improve treatment outcomes? Why is it appropriate to specifically exclude test accuracy as a factor to evaluate cell culture assay testing when test accuracy is the only factor used to evaluate every single other type of medical test?

The Her2/neu has only been shown to correlate with and predict for activity. It's never been shown to improve the results of therapy. Same thing for every other laboratory test used in medicine. No one is proposing clinical trials to show that Oncotype Dx or any other test improves the results of therapy (except ASCO would like to have only the cell culture assay tests do that).

The NCI "state of the art" website says that in treatment of metastatic breast cancer (the type of cancer which probably has the most clinical trials), they list 25 equally acceptable therapies. They state that it hasn't been proven that any one is any better than any other. They state that it hasn't even been proven that combinations are better than single agents. However, recent literature proves that oncologists select drugs for metastatic breast cancer based on how much money the treatments make the doctors.

The cell culture assays are used essentially as a tie breaker, selecting from among otherwise "equal" treatments. Therefore, all you have to show is that the tests can distinguish between drugs with a higher than average chance of working on one hand and a lower than average chance of working on the other hand. This has been confirmed in scores of studies involving thousands of patients, with a great many of these studies having been published in excellent peer review journals. Yet all of these studies were excluded from reviews cited by Aetna, ASCO, and BC/BS. That's crap!

According to hchcec's logic, it's perfectly okay to give unproven empiric therapy, but it's not okay to use unproven tests to select between unproven empiric therapies. That logic is total crap! But again, any ideologue who has to hide behind a symbol doesn't have any credibility in the first place. She knows that.

Posted at 6:37PM on Apr 25th 2007 by Gregory D. Pawelski

32. Notice, AGAIN, the prolific internet blogger, Pawelski, offers you no links to any of his purported evidence of benefit for chemotherapy cell culture assay testing.

He cites Oncotype DX as a model for his cell culture assay for chemotherapy choice. Apples and oranges here.

Oncotype DX informs the patient whether chemotherapy will be of ANY benefit.
It's a fine test for early and late stage breast cancer, but not yet intermediate.

The test Pawelski is pushing, to determine WHICH chemotherapy protocol to use, is unproven to be of any benefit at this time.

The other questions he asks are beautifully answered here:

http://jco.ascopubs.org/cgi/content/full/23/15/3646

He has it wrong when he states that Oncotype Dx shows no benefit. In fact, it does. It informs a patient whether she will benefit or not benefit from chemotherapy. His chemotherapy assay cell cultures do not show whether you will benefit or not from chemotherapy. It attempts to show benefit of one regimen over another. At this point in time, there is no evidence of this and there are many major problems with these tests and the study limitations abound. (He provides no links to these excellent tests he says exist.)

Oncotype DX manufacturer with the assistance of scientifically sound NCI guidelines and tissue banks have performed rigorous research and it's obvious that DX is effective.

http://investor.genomichealth.com/news/20041210-172512.pdf

He calls your current therapy "unproven." Discuss this with the heads of Hopkins, Sloan Kettering, and Dana Farber, individuals he calls "EVIL ACADEMICIANS."

What else does he have to say about the scientific community:

"It's death by clinical trial, the academician's weapon of choice, which they wield expertly. These guys know very well what they are doing."
from this blog 9/06.

(For those of you in clinical trial, remember,this is only ONE blogger's opinion.)

Posted at 12:27PM on Apr 25th 2007 by hchcec

33. With relapsed, platinum-resistant ovarian cancer, every clinical trial in history has just shown a 10-12 month median survival in this setting. However, background data (680 fresh surgical specimens) for the design of a clinical trial to determine the efficacy of assay-directed therapy of platinum-resistant ovarian cancer, submitted to the Society of Gynecologic Oncology, had a 27 month median survival and a fair number of long-term survivors. All specimens were tested with two separate Medicare-approved assays (DISC and MTT) having cell-death endpoints (2004-AB-171-SGO). However, if you're not a "member" of this fraternal organization, you're on the "outside" when it comes to grant reviews. Really makes for good, practical, "evidence-based" science.

PubMed lists a paper that reports an increase from 35% to 65% response rate for recurrent ovarian cancer patients when cell culture assay tests were used to select the chemotherapy drugs. The P values (P=.005, etc.) given are measures of the statistical significance of the findings. The smaller the number, the higher the statistical significance. “P” refers to the probability that the finding is due to random chance. So, high P values are bad. P values of 5% or less are deemed to be statistically significant. All of the P values reported in this study indicate that the results are, indeeed, statistically significant. (Am J Obstet Gynecol. 2003 Nov;189(5):1301-7)

According to a study by Dr. Holly Gallion, published in the International Journal of Gynecological Cancer (IJGC) researchers using the Chemo FX Assay by Precision Therapeutics, identified which chemo agent would be most lethal to an individual patient's cancer. In the study of 256 women with recurrent ovarian cancer, the time women went before a worsening of their disease was two to three times longer if they were treated with an assay-sensitive drug compared to an assay-resistant drug. The bottom line is the assay is able to predict the patient's response to treatment. The Chemo FX is a (cell-death) assay test. Their study adds to the already large body of evidence of the accuracy of cell culture assays in ovarian cancer.

The assay determines which agents are most potent against a specific tumor and what concentration works best. No more hit or miss in the patient. Armed with that information, the treating physician and patient can proceed with a chemo regimen likely to work right out of the gate and subjecting the patient to less toxicity. If the assay finds that the tumor responds to none of the currently avialable treatments, a patient could then be referred to a clinical trial before a history of less useful treatments rules her out as a clinical trial candidate.

Posted at 6:34PM on Apr 25th 2007 by Gregory D. Pawelski

34. On that pubmed study:
A devastating reply to the author of the study->

Fruehauf and Alberts state that "the Gynecologic Oncology Group has approved the concept of performing a trial to assess assay directed therapy for patients with platinum resistant epithelial ovarian cancer" and that this decision is "partially on the basis of the recent article by Loizzi et al, demonstrating a significant survival advantage for ovarian cancer patients who were treated with assay assisted therapy."4 As the individual who conceived the trial design to be employed in the Gynecologic Oncology Group study, I must clearly state that the genesis of this concept was ABSOLUTELY NOT a claimed survival advantage in this, or ANY other, retrospective analysis of any chemotherapy sensitivity or resistance assay system. IN FACT, it is precisely BECAUSE of the UNSUBSTANTIATED claims, comparing any assay-directed therapy to a historical control population (described in detail in the excellent ASCO review), that it is critically important for carefully considered, well-designed, prospective trials to be conducted to determine the clinical utility of this technology.

When he supplies the links to the other studies, I will reply. As of now, as indicated above here, benefit from cell culture assay testing is on very shaky, unproven ground.

AND,what does Loizzi state at the very end of the study Pawelski offers as PROOF?

"Randomized, prospective, controlled trials are needed."

Why does researcher Loizzi know this, but NOT internet blogger Pawelski? Because the researcher knows that bias is frequently incurred during detection and selection of cases.
-------

"The enthusiasm for chemosensitivity assays, in general, has diminished over the years, due to the poor positive predictive values."

http://www.regence.com/trgmedpol/lab/lab06.html

Posted at 1:59PM on Apr 25th 2007 by hchcec

35. On that pubmed study:
A devastating reply to the author of the study->

Fruehauf and Alberts state that "the Gynecologic Oncology Group has approved the concept of performing a trial to assess assay directed therapy for patients with platinum resistant epithelial ovarian cancer" and that this decision is "partially on the basis of the recent article by Loizzi et al, demonstrating a significant survival advantage for ovarian cancer patients who were treated with assay assisted therapy."4 As the individual who conceived the trial design to be employed in the Gynecologic Oncology Group study, I must clearly state that the genesis of this concept was ABSOLUTELY NOT a claimed survival advantage in this, or ANY other, retrospective analysis of any chemotherapy sensitivity or resistance assay system. IN FACT, it is precisely BECAUSE of the UNSUBSTANTIATED claims, comparing any assay-directed therapy to a historical control population (described in detail in the excellent ASCO review), that it is critically important for carefully considered, well-designed, prospective trials to be conducted to determine the clinical utility of this technology.

When he supplies the links to the other studies, I will reply. As of now, as indicated above here, benefit from cell culture assay testing is on very shaky, unproven ground.

AND,what does Loizzi state at the very end of the study Pawelski offers as PROOF?

"Randomized, prospective, controlled trials are needed."

Why does researcher Loizzi know this, but NOT internet blogger Pawelski? Because the researcher knows that bias is frequently incurred during detection and selection of cases.
-------

"The enthusiasm for chemosensitivity assays, in general, has diminished over the years, due to the poor positive predictive values."

http://www.regence.com/trgmedpol/lab/lab06.html

Posted at 6:34PM on Apr 25th 2007 by hchcec

36. There are limitations involved with randomized clinical trials. Perhaps the greatest limitation is that it is predictive of population trends, and is not definitive. Clinical trials provide few black and white answers. The problem with the empirical approach is it yields information about how large populations are likely to respond to a treatment. Doctors don't treat populations, they treat individual patients.

Because of this, doctors give treatments knowing full well that only a certain percentage of patients will receive a benefit from any given medicine. They subject patients to one combination chemotherapy after another, just going from one journal paper to another journal paper. They need information about the characteristics that predict which patients are more likely to respond well. The empirical approach doesn't tell doctors how to personalize their care to individual patients.

ASCO tires to point out that as outlined by the Institute of Medicine, any kind of tests are useful only if the information they produce leads to patient management changes that improve outcomes, such as longer survival, better quality of life, or fewer adverse events. Until the controlled, randomized clinical trial approach has delivered curative results with a high success rate, the choice of physicians to intergrate promising insights and methods remains an essential component quality cancer care.

Posted at 6:34PM on Apr 25th 2007 by Gregory D. Pawelski

37. Sounds like a little contrition here.

"the choice of physicians to intergrate PROMISING INSIGHTS AND METHODS..."

I could actually agree with this. :-) Not factual benefit at this time, but promising method.

I am not at all against adding to the treatment regimen. Just know that current knowledge "cannot tell us whether it is of benefit."

Those few words, delivered in an objective and kind manner to a patient will go a long way toward enhancing healthcare relationships.

We actually agree on some things:
-underfunding of research,
-our awful administration,
-our concern for the health and well-being of cancer patients.

We disagree on others:

-study interpretation
-scientist, researcher, oncologist priorities
-radical honesty

The discourse is lively. The passion evident.

It's the best of the Greek tradition.

Posted at 6:33PM on Apr 25th 2007 by hchcec

38. Despite the anticipated flow of arguments, denials, narrow-minded responses and/or personal attacks from hchcec, I'll provide some final thoughts or information:

There is a lot more to say about the subject of cell culture assays, but at this point it is like beating a dead horse. The horse (hchcec) will not think logically anymore. It's the same broken record. She defends an old and dying paradigm of cancer treatment.

Just remember, hchcec is hiding behind a symbol (which she changes from time to time on different web sites) to disguise the reasons for her misinformation about cell culture assays. Hiding behind a symbol does not lend any credibility.

Posted at 6:33PM on Apr 25th 2007 by Gregory D. Pawelski

39. Internet blogger Pawelski:

Just remember, hchcec is hiding behind a symbol (which she changes from time to time on different web sites) to disguise the reasons for her misinformation about cell culture assays. Hiding behind a symbol does not lend any credibility.

The misinformation is that there is PROVEN BENEFIT in culture assay testing. It is now clear there is no proven benefit based on current research. There has been none presented here by the blogger, the researchers who do the studies know this and are doing more, and THIS internet blogger who does not work in field and yet who continually says that you are doomed with the "old paradigm" (he has actually said on THIS BLOG that you will pay an early visit to the "mortuary") because you refuse unproven methods...well, it must be said: this is intellectual dishonesty.

P.S. Still waiting for those links to your proof.

The obsession with cell culture assays, the warnings to cancer patients of their impending doom, the posts to hundreds of blogs, makes me a bit, shall I say nervous. No wonder I use a pseudonym? Eh?

Posted at 11:25PM on Apr 25th 2007 by hchcec

40. Internet blogger Pawelski:

Just remember, hchcec is hiding behind a symbol (which she changes from time to time on different web sites) to disguise the reasons for her misinformation about cell culture assays. Hiding behind a symbol does not lend any credibility.

The misinformation is that there is PROVEN BENEFIT in culture assay testing. It is now clear there is no proven benefit based on current research. There has been none presented here by the blogger, the researchers who do the studies know this and are doing more, and THIS internet blogger who does not work in field and yet who continually says that you are doomed with the "old paradigm" (he has actually said on THIS BLOG that you will pay an early visit to the "mortuary") because you refuse unproven methods...well, it must be said: this is intellectual dishonesty.

P.S. Still waiting for those links to your proof.

The obsession with cell culture assays, the warnings to cancer patients of their impending doom, the posts to hundreds of blogs, makes me a bit, shall I say nervous. No wonder I use a pseudonym? Eh?

Posted at 9:08AM on Apr 26th 2007 by hchcec