FCR for CLL - conflict of interest?

[Guest guest]

Helen wrote: I thought that you would find this article of interest. I am not

sure if it would be helpful to those on the list with or caring for a loved one

with CLL but you can post it if you think useful.

Doctors criticise leukaemia drug study http://bit.ly/fJvCKb

“Australian oncologists say cancer treatment research published in one of the

world's most prestigious medical journals may have been compromised by a drug

company that funded the study.â€

===

Thank you, Helen. This is indeed an important topic for discussion – and not

just for CLL.

As always a comprehensive look at the raw data and study methods are required to

have an informed opinion about any clinical report. (Study size, patient

selection, risk factors, eligibility, toxicities, etc.)

We hope that the peer-review clinical trial system provides confidence in the

interpretation of published trials, but that so many clinical trials are

industry-dependent speaks to the need for rigorous assessment of methods and

interpretations by *independent* experts, ideally in a public forum.

(Even the perception of bias from having a financial conflict can be harmful to

public confidence.)

· Noting that experts who are independent of industry payments for

speaking, consulting, etc. are increasingly difficult to find – and does not

lead necessarily or intentionally to bias.

· and that industry money (which is a good thing) also influences what

is studied (not a perfect thing) – given the expense of conducting clinical

trials, and the competitive nature of for-profit business entities (to dominate

rivals)

Regarding FCR vs FC for CLL:

Here’s one report about the study methods and findings

http://cancerology.blogspot.com/2010/10/fcr-better-than-fc-for-cll.html

… showing a survival benefit for FCR:

“At 3 years after randomization, progression-free survival was 65% in the

rituximab group and 45% in the chemotherapy group (hazard ratio, 0.56; P <

..0001). Overall survival was 87% with rituximab and 83% with chemotherapy alone.

Almost half of the patients in the rituximab group achieved complete remission

after 3 years, compared with less than a quarter in the chemotherapy group.â€

This and other data was submitted also to FDA and became the basis for marketing

approval, which substantially increases my confidence (in the question of FC vs.

FCR), because FDA has strict legal standards regarding financial conflicts and

evidence-based review.

Rituximab combination approved [by FDA] to treat adult CLL

http://www.hemonctoday.com/article.aspx?rid=61136

See also for discussion of safeguards against financial conflicts of interest in

medical decision making: http://www.lymphomation.org/conflict-of-interest.htm

“While most people think conflicts of interest are a problem of overt

corruption, that is, that professionals consciously and intentionally

misrepresent the advice they give so as to secure personal gain, considerable

research suggests that bias is more frequently the result of motivational

processes that are unintentional and unconscious. "

Source: The Dirt on Coming Clean:

The Perverse Effects of Disclosing Conflict of Interest

Hope this helps. : )

~ Karl