Tuesday, August 4, 2009

Trials on trial

Gina Kolata published a typically strong story, Lack of Study Volunteers Hobbles Cancer Fight, in yesterday's Times about the difficulty of accruing cancer patients for studies, particularly when those patients have other options. Here's a key part of the piece:

There are more than 6,500 cancer clinical trials seeking adult patients, according to clinicaltrials.gov, a trials registry. But many will be abandoned along the way. More than one trial in five sponsored by the National Cancer Institute failed to enroll a single subject, and only half reached the minimum needed for a meaningful result, Dr. Ramsey and his colleague John Scoggins reported in a recent review in The Oncologist.

Even worse, many that do get under way are pretty much useless, even as they suck up the few patients willing to participate. These trials tend to be small ones, at single medical centers. They may be aimed at polishing a doctor’s résumé or making a center seem at the vanguard of cancer care. But they are designed only to be “exploratory,” meaning that there are too few patients to draw conclusions or that their design is less than rigorous.

“Unfortunately, many patients who are well intentioned are in trials that really don’t advance the field very much,” said Dr. Richard Schilsky, an oncologist at the University of Chicago and immediate past president of the American Society of Clinical Oncology.
At one point in the article, Kolata or someone else alludes to the possibility of "even" paying study participants.

My reaction was, How about just covering the damn expenses? Or defraying them a little? Three years of disease, and by far my largest out-of-pocket expense has been the brivanib trial. The drug is free, but the every three week nursing or doctor's visits aren't. And the scans: Those cost my insurance company $7,000 every six weeks and require pre-approval every time. Then I have to travel nearly 300 miles to one of the most expensive cities in the world every three weeks for services that sometimes only last a few minutes (except for the waiting). These trips can cost close to $1,000 ($250, train for two; $400 and change, hotel and tax, two nights; $250 or so, cabs and meals). When I sometimes travelled alone for the shorter nursing visits in more spartan style, I could get off "easy" at $325 ($75 for a shorter train ride plus gas for a longer drive, $200 and change for one night at a hotel, maybe $50 for meals and cabs). Either way, it adds up. And as much fun as we've had in NYC -- our focus has been on pleasure and togetherness, not economizing -- this has been hard on our budget.

If a stipend is impossible, maybe the drug company could spend the cash differently and let me, for example, have the nurses at my local hospital look me over, do a symptoms chart, and draw the blood into the special tubes and Fedex them to the Bristol-Myers Squibb lab.
At any rate, I'm in the midst of my second trial, gratefully discharging my duty to science and moaning with complaints only occasionally. I know I'm lucky to have access to this medicine; so many people are less healthy or less fortunate. But my personal gratitude can't mask all the problems with clinical trials.

After all, I'm a really sick guy with a couple of bucks and a belief in the process of science. Of course I'll sign up. Attracting more (or less) fortunate patients is going to require reform. There's no question that the process is an expensive, intrusive pain in the rear, even at a big academic medical center with a standing institutional review board. Unless clinical trials are reformed into something patient friendly, it's going to be hard to ever push that three percent participation number up. The costs are too clear, the rewards too vague.


Kathy said...

As one of those less fortunates, I agree that the cost is dire and has caused me a bit of a financial hardship. But, the healthcare reform I would like to see does not include the single payer system or any government plan whatsoever. I'm a Libertarian and that kind of government intrusion in my life allows the government to take my choices away from me. As a resident of Chicago, I know better than to put my hopes into any government official to fix anything. IL is bankrupt, corrupt, and a sorry mess. The only reform I am hoping for is a way to lower costs without assigning a dollar value to human life and the ability to shop for and procure a plan despite pre-existing conditions. I think we as Americans, can figure out how to do this without resorting to a government takeover. Your life is best left in your hands. Though you may trust this administration (I don't), there may be an administration further down the line you would not want doling out your care. Hoping that you are on the mend. You are in my thoughts and prayers.

SG said...

Thanks for your thoughts, Kathy. I don't know. I'm not the best person to argue health care reform. I'd personally like to see something done about the nearly 50 million uninsured and the skyrocketing costs. The pre-existing condition issue is huge, too, and probably requires a government mandate -- otherwise, the first insurer that leapt into THAT pool would be bankrupt. Whatever plan emerges will reserve a huge amount of power and influence to the private sector, though I wonder if HMO bureaucrats are really all that much better than government ones. Have you read about "rescissions," where people actually get sick and then lose their insurance for irrelevant "previous conditions" they had no idea they had? On the other hand, I don't know if the plans being discussed can lower costs enough to get wide adoption/be affordable for the government. It's a huge a problem, which is why it has been brewing for 15 years at least... i'm grateful to have a decent plan, even if "optional" things like trials are expensive. take care of yourself...