Tuesday, April 18, 2006

Tissue Ownership Update, II: More on Catalona

I'm getting a lot of requests for continued follow up on my NYTimes Magazine article and my last two posts (here and here), so I'll write as things happen. There will be plenty, since several news organizations are starting to cover the decision.

In a news story today Lori Andrews, director of the IIT Institute for Science, Law and Technology, raises a key point: The judge ruled that Washington University owned the samples in part because the consent forms were printed on Washington University letterhead, despite the fact that those forms said the patients were giving the tissues to Catalona [or in some cases, Catalona and his colleagues]. She calls the ruling, "a big setback for patients' rights," because it means universities can use samples for research "even over patients' objections. "

Washington University suggests that if patients control their tissues, it will have "horrible implications," because donors could refuse to donate to certain recipients. This is something the judge mentioned in his ruling. He said:
"Allowing [a research participant] to choose who can have the sample, where the sample will be storied, and/or how the sample can be used is tantamount to a blood donor being able to dictate that his/her blood can only be transfused into a person of a certain ethnic background, or a donated kidney being transplanted only into a woman or man."
I find that absurd: Giving patients the right to determine what's done with their tissues and which scientist does research on them does not equal discrimination and determining who receives the benefit of that research. Preventing patients from controling their tissues doesn't change the fact that someone decides who gets the sample, how its stored and used, and who benefits from it -- it just leaves those decisions to scientists, universities and biotech companies instead of patients. And there's no evidence that they'll make better decisions about tissues use than patients who, on the whole, want to see medicine advance (in fact, there's plenty of evidence that patient involvement can help advance science, just look at Ted Slavin, or the story of Sharon Terry -- how and why she became a co-patent holder on the gene found in her childrens' tissues, and the positive impact that had on research).

But regardless, at this point people have the right, legally and ethically, to determine who gets their tissues and organs (just read The National Organ Transplant Act). I'm extremely sensitive to the issue of race and medicine (I am writing a book that deals with it). But this feels like a case of playing the discrimination card inappropriately: By this judge's logic, if I want to give my kidney to my mother, and I sign a form saying so on Washington University letter head, then Washington University owns my kidney, doesn't have to give it to my mother, and I'm wrong for trying to give it to her? That's crazy talk.

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Anonymous Matt Hutson said...

Well, I don't think the whole argument is absurd. Only his use of "tantamount" instead of "vaguely related." Theoretically, a tissue donor could say, "Don't give my tissue to Dr. X because his research will predominantly help People A, and I hate People A." The possibility is (I hope) not likely, but it's one that should be anticipated.

The letterhead issue could go either way (though not in your kidney scenario.) On the one hand, it could be circumstantial--he just happened to use the paper lying around the office, which just happened to be university letterhead. On the other hand, it portrays Catalona as a representative of the university--as a handler of the samples for the university rather than an independent recipient of them.

2:14 PM  
Blogger dcgent said...

Also, I think you are overstating the case Rebecca--the original consent forms never say, in as direct terms as you suggest, that the patients are giving their tissues to Catalona. That repeats a misimpression created in you NYT article when you cite the 2nd form he mailed to patientes. The closest some original consent forms did say was "You are invited to participate in a research study conducted by Dr William Catalona and/or colleagues". The cout decision states "Nowhere in the forms were RPs [research patients] advised they were entrusting their samples to Dr Catalona only". One can argue what the RPs believed, but WU seems to have a clear case itself.

10:37 AM  
Blogger Rebecca Skloot said...

Washington University does have a case for this, absolutely. So do the patients. This comes down to a lack of clarity when it comes to consent for tissue reseasrch. There were several different consent forms used for the Catalona collection (they changed over the years). Some said they were giving tissues to Catalona and/or colleagues, others just said they were giving it for Catalona's research (but said so on Washington University letterhead with statements about Washington University oversight committees having approved the forms).

The forms also said: "Your participation is voluntary and you may choose not to participate in this research study or withdraw your consent at any time ... to withdraw your consent, call Dr. Catalona at [phone number]” That, among many other things, lead patients to believe that (a) they could remove their sample from research any time, and (b) they were entrusting their tissues to Catalona to handle and control. Washington University disagreed with both those things.

The forms didn't say they were giving the samples to Catalona exclusively, but they didn't say they weren't either, and according to the lawyers I've talked with, in an ambiguous situation like this, contract law says the agreement should be read in the favor of the party who signed the form, not the party who wrote it.

Don't get me wrong: I'm very pro-tissue research, but I'm also pro-disclosure and clear consent. The problem is, there's ambiguity all around. People could (and will) argue endlessly about what those forms did or didn't say, what the patients did or didn't think -- current consent practices leave a lot of room for that confusion. Which is a problem. A key point of my story was this: Moving forward, we need to fix this ambiguity and make sure everyone knows (and is okay with) what they're getting into. That way we'll avoid problems like this, and make sure that important samples like these can be used to advance science instead of being tied up in litigation.

Most people involved in this debate seem to agree on that point.

1:57 PM  
Blogger Rebecca Skloot said...

And Matt, yes, naturally my point was that you can't say those two things are the same.

And I'm not saying anything about the Catalona case is clear cut -- letterhead or no letterhead, Catalona was employed by the University, and he signed a contract with the University saying they owned his intellectual property, and these tissues. That looks clear on paper and in court. The problem is, the patient say they didn't know this, or how it impacted their tissues (those I talked to saw Catalona at Barnes Jewish Hospital and say they didn't even know he was afilliated with Washington University). The way they see it, they're being held to Catalona's contract without knowing it existed.

Complicated stuff with no easy answer.

2:00 PM  

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