Greg is well known to THCB readers as a long term commentator on the oncology scene with a keen interest in chemotherapy assay testing. Here he writes about a new type of clinical trial — Matthew Holt
The traditional meaning of Health 2.0, according to Jane Sarasohn-Kahn’s "Wisdom of Patients" has been the use of social software and light-weight tools to promote collaboration between patients, their caregivers, medical professionals and other stakeholders in health.
An example of this in cancer medicine is Individualized Online Clinical Trial Protocol Version 1.0 by the Weisenthal Cancer Group, a Phase II evaluation of individualized cancer treatment with traditional cytotoxic chemotherapy, targeted anti-kinase drugs and anti-angiogenic agents.
With most clinical trials, investigators never give out information as to how people are doing. Most trials are failures with respect to actually improving things. The world doesn’t find out what happen until after a hundred or 500 or 2,000 patients are treated and then only 24 hours before the New England Journal of Medicine publication date.
Individualized Online Clinical Trial Protocol Version 1.0 is a
totally transparent clinical trial. Every patient who decides to enter
a study should know what happened to previous patients. Patients are treated in
real time, on the Internet, with the whole world watching to see how
they do. It includes weekly progress reports, and if individual patients
want, their own blogs as to how they are doing.
Stages have been implemented for a rather innovative clinical trial
with cell culture assays, "real time" on the Internet. The purpose of
the study is to show that cell culture assay technologies for
"targeted" agents really do work. The short-term future of cancer
therapeutics is combinations of "targeted" agents.
The online edition of the Journal of Internal Medicine reports discovery of the first practical laboratory test to guide the use of new-generation drugs that kill cancer cells by cutting off their blood supply. The new test, called the Microvessel Vascular (MVV) assay, was developed by Larry Weisenthal, MD, PhD., a medical oncologist who operates a cancer testing laboratory in Huntington Beach, California. The test works by measuring drug effects upon endothelial cells which make up blood vessels. Its use could prolong lives, save money, and spare patients exposure to harmful side-effects of ineffective chemotherapy treatments.
According to Dr. Weisenthal, therapeutic levels of ethanol in the bloodstream theoretically could be achieved simply by drinking wine or another alcoholic beverages in prescribed doses concurrent with receiving angiogenesis-inhibiting drugs. The concept might please some patients and alarm others but Dr. Weisenthal finds support in actual case studies reported in the medical literature. However, he warns that further clinical studies are required.
Dr. Weisenthal says that he would like to see the test become available to patients worldwide through service agreements with larger laboratory companies or with a biotechnology company which might develop a testing kit for sale to hospitals and laboratories. He also would like to license the test to pharmaceutical companies for use in new drug development.
I can understand about patients having negative results. However, even negative results can provide useful information about the effectiveness of treatments.
Having all the information you can gather for the participants and investigators is essential to maintain good doctor-patient communication that is beneficial for cancer patients.
Supporters of such transparent clinical trials argue that conflicts of interest undermine public trust in and support for scientific research, endanger research subjects and patients, and boost medical costs by encouraging physicians and patients to use new treatments that are no better than cheaper alternatives.
The collaborations between academia and industry has clearly brought discernible influence on clinicians, bringing with it erroneous results, suppressed data, or harmful side effects from these drugs.
There is an inherent conflict of interest when organizations provide guidelines for treating disease who receive funding from corporations that benefit financially from those recommended treatments. There is no proof beyond reasonable doubt for any approach to treating cancer today. There is only the bias of clinical investigators as a group and as individuals.
And lastly, the use of clinical trials to establish prescribing guidelines for evidence-based medicine is highly criticized because such trials have little relevance for the individual patient in the real world, the individuality and uniqueness of each patient. The choice of physicians to intergrate promising insights and methods remains an essential component of quality cancer care.
This sounds like a very interesting idea. However, the patient’s knowledge of the trial events could interfere with outcomes. They could decide to withdraw if a few patients have negative results or they could develop unreal symptoms after reading about them. Too much information for the participants and investigators may not be such a good idea.
The Musella Foundation’s virtualtrials.com is doing something similar to what the Weisenthal Cancer Group is doing. Their brain tumor virtual trial keeps track of patients and displays the results “real time” on the web (virtualtrials.com/volresults).
You select a tumor type (or all tumors to see more data). Then click on a treatment name and you see all patients who took that treatment + each of the other treatments. Click on a number of patients in each group and you get details of the group. Within this group display, click on a patient id and get their details.
But this is the kicker. The Musella Foundation also works on getting insurance companies to pay for these expensive combinations. The most popular one for brain tumors now is cpt-11 and Avastin. It can cost $600,000 a year (perhaps a U.S. Senator could afford that).
The Weisenthal website states there are no one-size-fits-all treatments in this trial and no patient unknowingly receives a placebo instead of a promising new drug he/she had hoped to receive. Patient outcomes will be reported online, in real-time, so patients and cancer physicians will learn immediately if and how patients are benefitting from anti-angiogenic, anti-tyrosine kinase, and standard drug combination therapies identified for them by the new test.
It is the first clinical trial in which novel combinations of emerging drugs are tested for activity in biopsy specimens obtained from each individual patient. While many of these potentially effective drugs are highly expensive, one problem has been in determining in advance who would benefit from them, how to make the drugs more effective by using them in combination. The effectiveness of these drugs can increase exponentially when they are combined with other drugs in various ways.
It is a trial in which each patient receives treatment designed for him/her alone rather than a treatment that serves the financial or research interest of the pharmaceutical company or institution which sponsors traditional clinical trials. Until this new test, no technology existed which allowed for individualized laboratory assessment of candidate drug “combinations” prior to administering them to patients.
LOL!!! I think you amply describe the Principal Investigator of this clinical trial!
An interesting Cell culture cartoon on vadlo!
An interesting dialogue about the clinical trial and cell culture assays has been going on over at The Medical Quack blog: