Clinical Trials - Who Pays and what are the costs?

[Guest guest]

> Jeff wrote the following: " They're actually billing me

for CAT scans required for the clinical trial, blood work,

etc, in addition to the infusions of Ofatumumab. They're

deducting what my insurance company covers, and telling me

I'm responsible for the rest. "

Is it no wonder that the participation in Clinical Trials is

so low in the US? I just got off the phone with a fellow

participant in a PCI Trial who asked if I had been billed

for CT scans required by the Clinical Trial? I had not as

yet but I have been a Lab-Rat for only just under three

months.

When entering a Clinical Trial you will be asked to read and

sign a contract of sorts in which you are acknowledging the

terms and conditions of your participation to include what

is expected of you regarding your financial responsibilities

that are defined as part of your " standard of care " . I will

copy the following part of my agreement for my PCI Trial to

try and make the case that patients with lymphadenopathy

(SLL part of CLL) going into a Clinical Trial under my

agreement should not be financially obligated by CT scan

costs. Here is what my agreement states under the title

" COSTS "

" The study drug, PCI-32765, will be provided by the sponsor,

Pharmacyclics, Inc. The tests that are exclusively done for

the research will not be billed to you or your insurance

company. These include research blood draws which will be

testing to see how much of the study drug is in your blood

and how your body is reacting to the study drug. The ECG's

and the urine tests, T/B/NK Cell Count, Serum Ig, and PET/CT

scans for SLL subjects done during the study are considered

research and will be paid for by the sponsor with no

additional cost to you or your insurance company. " Pretty

clear to me.

Here is where things get tricky to interpret and I believe

are misleading at worst and in need of clarification at a

minimum.

" Under normal circumstances you would have physician

appointments and undergo similar lab and scan procedures on

the same schedule. " OH yeah... says who? CT scans every

three months? Dr. Byrd has never suggested I get CT scanned

in spite of massive node involvement going back to 2008.

That does not mean that some oncologists somewhere might

want frequent scanning.

" This is known as standard of care, and therefore you and/or

your insurance company will be billed for the study doctor

visits and tests. " Frequent CT scanning would never be a

part of this boy's " standard of care " . Even if PCI may play

a part in my current heart problems for instance, I believe

it reasonable that my heart health care costs be mine or my

insurance company's responsibility because I had prior

evidence of heart issues before taking PCI.

There are gray areas in the arena of causation and need

regarding problems and testing but clearly the frequency of

CT scanning is for the benefit of the pharma company in its

effort to get drug approval. Yes, it is expensive to get a

drug from conception to being approved (estimated 800

million) but what we are not told is that half that amount

is drug promotion. (info from LRF Brooklyn Conference 2009)

Costs should not only be judged by dollar amounts alone, for

there are human health costs to the unfortunate Trial

participants who may be crippled or die from unanticipated

side effects. Additional financial pressures, forced often

unexpectedly, on Trial participants are unacceptable.

What do you think?

WWW - Lab-Rat in training