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Ethics & Conflicts

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Index of Articles

Updated: August 9, 2007

   
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The following are short articles on various aspects of Ethics and Conflicts in CLL Therapy and Research, presented most recent first.

Money Trail in Research

Bias in Industry Sponsored Research

Date: 8/22/03

by Chaya Venkat

Here is an abstract from the venerable and respected JAMA, the Journal of the American Medical Association, that is troubling, to say the least. Bear in mind, this is the JAMA, the official journal of the American medical establishment, not some fringe journalistic rag or paranoid anti-establishment group. It is, in fact, the establishment itself, the product of years of toil at Harvard, Hopkins and Mayo. The rude shock, of course, is that the ivory tower exists in a domain ruled by economics, even in distant Copenhagen where the authors do their work..

The findings should not be a surprise, we have all heard the phrase "He who pays the piper calls the tune". Nevertheless, the findings are shocking in their stark clarity. Clinical trials funded by for-profit companies (i.e., pharmaceutical companies, with big profits and stupendous stock prices on the line) are likely to recommend the experimental drug being investigated 51% of the time, on average. But when the study is funded by non-profit organizations (even if they are constantly fundraising and begging for your voluntary dollars) , the conclusions are very different indeed, the experimental drug is recommended three times less frequently, to the tune of only 16%. The data comes from the prestigious Cochrane library, which does not use "flaky" or ill-defined and ill-constructed studies, only those that are considered to be of solid clinical value, reported in major peer-reviewed journals. If there is this much of a bias even in these best-of-the-bunch clinical studies, what are we to believe? The abstract also says adverse events are significantly under-reported in studies funded by for-profit companies.

Let us bring this a little closer to home. Not withstanding "poster boys" amongst our members , the only reason you folks out there should be considering Rituxan therapy is the results of studies like the ones done at M. D. Anderson, Ohio State, Dana Farber, Sarah Cannon and other major cancer centers, by researchers whose very names are household words for many of us. If we go back and look at all the Rituxan studies done for NHL and CLL, majority of the pivotal studies done with large numbers of patients were funded by IDEC and/or Genentech, at least in part, companies that make billions of dollars marketing this particular drug. As patients we depend on these studies to make our therapy decisions; as do our local oncologists. They are the ones on the frontline, who have to make a call on new therapy options, based on research done by others.

I am not suggesting that the implication here is that the researchers are on the take. Not in the least. I know too many of them personally, and know them to be men of honor and integrity. More likely the phrase that fits is "beauty is in the eye of the beholder". Something to be said for patient sponsored, patient funded and patient monitored clinical trials; because, sure as the sun rises tomorrow, these clinical trials will be played out in our bodies, with our lives on the line.

"Trust and do not ask questions" is a suckers' game. It gives you the likes of our ever-popular "CLL Research Foundation". I hope none of you waste your hard earned cash on that one! Last I heard, they still ask for our money, and they still have no time to waste in explaining what they do with the money they collect. Their official website is a disgrace. Except for a glowing tribute to "Granny" Barb, the better to pluck at your heartstrings and make you open your wallet, their website has no new information of any significance in the past couple of years. One of our members can tell you stories to curl your toes on how they treat patients, especially when $hit hits the fan. Somebody who lives in Texas and has some free time should check into the finances of this outfit. Don't they need to be licensed or something, to call themselves a non-profit?

Our anecdotal commentary is but a faint shadow of the kind of hands-on monitoring role patient groups should be playing in this clinical trials game. As things stand, we have no financial clout, we are very short on manpower. We should have patient involvement in all aspects of cutting edge clinical trials: the funding, structure, recruitment, monitoring and reporting of clinical trials. If there are no patient representatives on the CRC (CLL Research Consortium), and I admit I am not familiar with their organization, it is high time that we got some representation.

Topics is a shoestring operation. It consists of me, pounding away on my laptop, and my husband P.C. is the webmaster of our website. A small group of dedicated volunteers take care of some of the administrative chores, pitch in when the subject matter is in their area of expertise, bless their hearts! That is it. And pardon the presumption, Topics is now a major chunk of CLL patient advocacy. I said advocacy, not emotional support, or information retrieval and collation, or legislative lobbying. Don't know about you guys, but I think that is pathetic!

Abstract:

Association of Funding and Conclusions in Randomized Drug Trials

Bodil Als-Nielsen, MD; Wendong Chen, MD; Christian Gluud, MD, DMSc; Lise L. Kjaergard, MD

JAMA. 2003;290:921-928.

Previous studies indicate that industry-sponsored trials tend to draw pro-industry conclusions.
Objective: To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events.

Design: Observational study of 370 randomized drug trials included in meta-analyses from Cochrane reviews selected from the Cochrane Library, May 2001. From a random sample of 167 Cochrane reviews, 25 contained eligible meta-analyses (assessed a binary outcome; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment). The primary binary outcome from each meta-analysis was considered the primary outcome for all trials included in each meta-analysis. The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect, adverse events, and additional confounding factors (methodological quality, control intervention, sample size, publication year, and place of publication).

Main Outcome Measure Conclusions in trials, classified into whether the experimental drug was recommended as the treatment of choice or not.

Results: The experimental drug was recommended as treatment of choice in 16% of trials funded by nonprofit organizations, 30% of trials not reporting funding, 35% of trials funded by both nonprofit and for-profit organizations, and 51% of trials funded by for-profit organizations (P<.001; 2 test). Logistic regression analyses indicated that funding, treatment effect, and double blinding were the only significant predictors of conclusions. Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice (odds ratio, 5.3; 95% confidence interval, 2.0-14.4) compared with trials funded by nonprofit organizations. This association did not appear to reflect treatment effect or adverse events.

Conclusions: Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data.

Author Affiliations: The Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark.
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