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« Should I Share My Joy? | Main | Researching Clinicial Trials »

September 07, 2010

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Susan Zaret

Hi,
I was the 1st patient on a Phase 2 clinical trial for Mantle Cell Lymphoma that is on going at the Sylvester Cancer Center in Miami. I am in the maintenance stage of the treatment and doing great. I feel blessed that this treatment was available to me. It was only by the grace of God that I was recommended to Dr. Lossos at SCCC and he actually started the trial a few weeks earlier than he anticipated once he met me. I strongly believe that Clinical Trials need more media attention and more Dr's & patients to get informed and involved. It would be a privilege to help out in any way I can with your efforts. Please contact me and let me know what I can do to help.
Thank you,
Susan Zaret

Richard Frank, MD

Dear Dr. Harpham,

As a community oncologist and director of a community cancer center research program I would like to make a few observations on this issue.

There are two sides to the problem of low clinical trial accrual. One is the professional side, the other is the patient side.

On the professional side, it is correct that not enough centers offer clinical trials. This is directly due to lack of adequate funding (clinical trials receive five cents of every dollar that goes to basic science research) and incredibly onerous regulatory burdens imposed by industry and government. Many offices simply can't afford the time to invest in supporting a robust trial program.

On the patient side, many patients turn down trials because the consent forms often contain pages and pages of scary side effects (which they must for legal reasons) but none of the possible benefits, so even the most routine trial would appear very risky. Also, in phase III trials, patients are randomized between the new treatment (often the standard plus a new medicine) and the current standard treatment (plus a "placebo" or no experimental medicine). Fewer patients agree to be randomized to these trials in the US because most, naturally, want to gain the possible advantage of the new drug being studied. They should realize however, that often times the new drug is either no better or may only cause added toxicity without benefit, so "new" does not always mean better.

Researchers involved in the clinical trial structure are trying to address the above problems with new types of trial design. Still, trials will always require patients to take a "leap of faith" and join trials, at least in part, for the betterment of society although we know the major reason to join a trial will always be for the individual participant to live longer and better.

Julie A. Meynard

Some patients don't participate in clinical trials because their insurance companies don't cover "standard of care" checkups, tests, scans, etc. I went through two weeks of arduous prescreening and qualified for a trial last year at MD Anderson, only to stand in the business office on the phone with my insurance company telling me "no, they don't cover experimental treatment." I know that will change with the new healthcare reform laws, but not until 2014, and I do not believe if have that much time. Would I be getting the checkups, tests and scans whether I'm taking a trial drug or not? Yes. Oh wait, if the drug works, I will eventually cost them more money, needing more future checkups if I get better. Insurance companies' rationale behind business decisions is beyond my comprehension.

Wendy S. Harpham, M.D.

Dear Dr. Frank,
Thank you for your clarifying comments. Maybe in a future post I should talk about the "leap of faith" I took in 1993 when I entered the Phase I trial of what is now the most commonly prescribed drug for my type of lymphoma. With hope, Wendy

Wendy S. Harpham, M.D.

Dear Susan,
Posting your comment on this blog is a start, because personal vignettes affect listeners in ways raw data don't.

The main reason I share my success story in clinical trials is to encourage people to talk with their physicians about trials, and to make a wise decision about whether or not a trial is the right choice for them.

[Note: I never, ever say trials are the best option for someone else unless I've been intimately involved in the decision-making as a support person with all the needed information to make that judgment. Trials are not for everyone, by any means.]

Feel free to contact me via email off-blog, if you would like to discuss further. I'm happy to help someone who is trying to help someone else.

With hope, Wendy

Wendy S. Harpham, M.D.

Dear Julie,
In addition to the resources listed in today's post (Researching Clinical Trials), you can contact other national advocacy organizations geared toward guiding patients to get optimum reimbursement possible from insurance companies.

Over the years, I've seen patients make multiple attempts at reimbursement before finally obtaining success.This is one situation where the squeaky wheel gets the grease.

Does it upset me that patients are fighting insurance battles and worried not only about if a treatment works but also if they can even get a treatment? Yes!

Keep us posted. With hope, Wendy

Finn

I think there are other misperceptions that keep people out of clinical trials. One is the notion that they're only for last-ditch efforts after standard treatments have failed. Another is the mistaken idea that clinical trials always compare experimental treatment to a placebo so partipants run the risk of receiving no treatment at all. A third is the idea that people will be used as "guinea pigs" without their full knowledge or consent--a particular problem in the black community, which has indeed been used this way not only in the past but right into the 1970s.

And yet, pediatric cancer treatment made great strides by enrolling very large percentages of patients in clinical trials. What can we learn from this experience that we can apply more broadly?

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