Tissue Ownership Update: William Catalona v. Washington University, the ruling

This just in: Judge Rules People Don't Own Their Tissues (again). In my last post, I described my story in this week's New York Times Magazine about tissue ownership and promised an update, so here it is: [Please note: Before reading further, you should read my article, otherwise this post won't make much sense, because it follows up on the story's final section and assumes readers of this post have read the entire story.]

In the story, among other things, I wrote about the potentially landmark court case between Washington University and Dr. William Catalona, which questioned whether patients can control the use of their tissues in research, and whether they retain any property rights in their excised body parts. (The case where Washington University claimed ownership of 6,000 tissue samples from patients who asked that their samples be removed from the university's prostate cancer bank, which is worth millions of dollars). After more than a year of deliberating, the judge finally ruled on Friday (4/14/06), which was interesting timing for me, since my article had already gone to press for publication the next day. It was too late to include his ruling in my story, where I would have covered it in detail and given experts the chance to comment on it. Since I couldn't do that, please pardon the long post while I'll give some details here as a follow-up:

Judge Stephen Limbaugh ruled in favor of Washington University on all counts saying, "Washington University owns all biological materials, including but not limited to blood, tissue, and DNA samples, in the GU Repository." (The GU Repository stands for Genito-Urinary Repository, otherwise known as the prostate collection.) "Neither Dr. William Catalona nor any research participant," he wrote, "... has any ownership or proprietary interest in the biological samples."

In the end, when it came to property rights, the judge didn't do anything new: He simply went along with the Moore and Greenberg rulings (explained in my story), which said, "the property right in blood and tissue samples ... evaporates once the sample is voluntarily given to a third party," regardless of whether you've been informed about what your tissue will be used for. So nothing changes there: You don't own or control your tissues once they're removed from your body, unless you (like Ted Slavin) negotiate terms on the front end.

At points, the Catalona ruling is a bit circular: The judge said that having possession of something can establish ownership, and since Washington University had possession of these tissues samples (though patients asked for them to be transferred elsewhere and W.U. refused), they were acting as owners, and therefore they own it. Which is what the patients were disputing in the first place. The patients argued several other points, including that they didn't want their tissues and DNA distributed to scientists for research they didn't consent to. But the judge discounted all patient testimony saying, "these gentlemen all had a deep personal connection to Dr. Catalona, and believed that they owed their lives to him. " Because of this, he called their testimony "suspect."

The judge pointed to several ambiguities in the case: The consent forms didn't say whether patients gave their tissues to Catalona exclusively. They did said patients could withdraw from the research at any time, but didn't say what that meant regarding tissues. The judge wrote, "There is nothing stated in the governing federal regulations which equates a right to discontinue participation with a right to control the disposition and use of the excised biological materials." Contract law says that in the case of ambiguities in written agreements (like consent forms), the ambiguity goes against the writer of the contract -- if you don't specify it in the form, you don't get it. But that's not how this judge ruled. Instead, he said, "The Court finds that the right to discontinue participation in a research project means nothing more than that the [research participant] has chosen not to provide any more biological materials ... Nothing more can or should be read into this right." In other words, you can't ask scientists to stop doing research on your tissue. This ruling could have a far-reaching impact, since it's the first to define the federal right to withdraw in terms of tissue research. (See story for details).

In the end, the judge surprisingly discounted all arguments regarding the consent forms, calling these tissues a "gift," and saying -- in a disturbing statement -- that "the existence of the informed consent forms is inconsequential." He didn't mention one important thing: The law says if there is consent in writing, you must honor it, which means those forms aren't "inconsequential" at all.

In a statement that parrots the Moore ruling, this judge said, "Medical research can only advance if access to these materials to the scientific community is not thwarted by private agendas. If left unregulated and to the whims of a [research participant], these highly-prized biological materials would become nothing more than chattel going to the highest bidder. It would no longer be a question of the importance of the research protocol to public health, but rather who can pay the most." This is ironic, given that many experts argue (and several studies have supported this) that access to these materials is already being "thwarted by private agendas" in an area of science where materials are no longer shared freely because of a focus on proprietary information and profits instead of public health. People have been arguing for years that profits and competition in science have created precisely the situation this judge says he hopes to prevent. The one thing he's done is cut patients off from having a say in this -- these patients weren't after profits of any kind. They wanted their tissues used for the research they intended it for -- the university was the party raising the issue of profits.

I'm very interested to see what happens from here -- many interesting debates will follow, and an appeal. This case isn't over, so the saga continues ...

I'll be live on the air discussing my story and the Catalona ruling tomorrow on NPR affiliate KPCC in Los Angeles from 11:00 to 11:40 (west coast time). So tune in.

Catalona Appeal Ruling: Patients Don't Control Their Tissues

Some time ago, I wrote this story for the New York Times Magazine titled, "Taking the Least of You: Those blood and tissue samples you routinely give - where are they? Who owns them? What are they being used for? And how come you don't know?" Since that story ran, I've been publishing updates here on the Washington University vs. William Catalona trial that I covered -- it was a potentially landmark court case that questioned whether patients can control the use of their tissues in research, and whether they retain any property rights in their excised body parts (in this case, Washington University claimed ownership of 6,000 tissue samples from patients who asked that their samples be removed from the university's prostate cancer bank, which is worth millions of dollars).

Well, here's another update: Initially, the court ruled in favor of Washington University, saying individuals don't own their tissues. Catalona and his patients appealed. This morning, the 8th District Court finally ruled on that appeal: Their decision states, "We affirm the well-reasoned opinion and judgment of the district court." In other words, they ruled against Catalona and his patients, saying that they don't own their prostate cancer tissues, Washington University does. You can read the full decision here.

This ruling is a serious blow to the patients' rights advocates who've spent decades fighting for people to have control how researchers use their their bodily tissues (and the DNA inside them). This ruling reaffirms the precadent set by the famous John Moore case. But the Catalona case isn't over yet, I'm sure. More on this decision, and the case, soon.

Update on the Catalona Case

A quick update on the tissue ownership case of William Catalona v. Washington University, which I wrote about in detail for the New York Times Magazine, and in several posts on my blog:

Catalona and the patients, who lost the original suit, just filed their appeal. I got the documents late last night -- the patients' brief (68 pages), makes a very strong argument for overturning the ruling. I'll be posting on that in more detail -- and on Washington University's response when it comes -- very soon.

As I said in my Times article, regardless of the first ruling, this case is far from over ... I look forward to seeing what happens next.

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.

Another Tissue Ownership Update: The Catalona Ruling Documents

A few people have emailed asking where they can find the judge's ruling in the Catalona trial, so I thought I'd post links: You can find the Judge's opinion here, and the Judge's order here.

Since no one has put the patients' briefs online, I'm going to get an electronic version to post (my copy is the print version), so folks can read both sides of the case.

Tissue Ownership Update III: AP on Catalona

The AP just ran a story on the ruling. It cites the usual info, and includes a statement from William Catalona, who plans to appeal: "he regrets that Limbaugh made it 'a fairly narrow case of property law,' when a higher issue, 'patient autonomy' and the need to respect the wishes of research subjects, is at stake."

The story cites David Korn, senior vice president of the Association of American Medical Colleges, making an analogy I wanted to include in my story, but it was cut for space: He sees tissue collections as research libraries. "If, at any time, book donors or their heirs could walk into the library and take out volumes, it would be awfully hard to maintain a library of any scholarship value." Korn always does an excellent job of showing why this issue is complex from both sides.

It is possible to maintain a top-of-the-line tissue library while getting consent -- the National Cancer Institute is on their way to becoming the model for doing so.