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.

Bush Pushes Genetic Privacy Legislation

Here's a newsflash I never thought I'd hear: Yesterday, with Frances Collins by his side, Bush began lobbying for Congress to pass the long-stalled Genetic Privacy Bill, which could help protect patients from genetic discrimination. This bill, in one form or another, has been in the works for about a decade, but has repeatedly been pushed aside over fears that it might inhibit research and industry. I'm very interested to see the version of the bill they're working with now, how it's changed since its last incarnation, and whether/how it will protect patients against insurance and other discrimination. If it does, passing it would be a huge step forward for the world of tissue research, one patients rights advocates have been fighting for endlessly.

Study Shows Patients Have Issues With Tissue Research

In my ongoing coverage of all things human tissue related, I came across this article about a recent study examining public attitudes toward tissue banks: "Tissue banking raises cloning fears." Interestingly, there was absolutely no coverage of this study in the U.S., where tissue research is a huge issue. The study, conducted by the Centre for Values, Ethics and the Law in Medicine at the University of Sydney, shows that Australians have many concerns over how their tissues are being used.

They're worried, for one, that scientists could clone them using stored tissue samples. There are many reasons people should question how their tissues are being used in research, but at this point, fear of being cloned isn't one of them (cloning humans isn't possible yet). But the study also found that people were opposed to tissues from their diagnostic samples -- like biopsies and blood tests -- being used "as a source of stem cells or by drug companies." to develop products. That is a very current and real issue worldwide: In the US, most people have their tissues in storage at this point, and the laws surrounding their use are unsettled and confused.

According to lead researcher Bronwen Morrell, this study shows exactly what I reported in my recent New York Times Magazine article: People want some level of control over how their tissues are being used in research and whether they'll be commercialized; they also want laws laying out requirements for consent, because at the very least, they want to know what's being done with their tissues.

Morrell also found that, when it came to the sticky issue of money, patients wanted to see profits funneled back into research, not into scientists' pockets (which is not standard practice now). Many said they trust the public sector more with their tissue than private companies: "As long as research was being done in a public hospital they would feel comfortable with that," she said. "But if it was a private company doing the research, especially drug companies, they wouldn't be that happy." This is interesting, in part because it indicates that the public isn't aware of how fuzzy the division between public hospitals and private companies can be these days.

Six Degrees of Fabricated Research Findings

At this point, pretty much everyone knows the theory of Six Degrees of Separation: That everyone in the world somehow connected through a chain of six people. Well, it turns out, the results from the study that supposedly proved the theory were actually fabricated.

The phrase "Six Degrees of Separation" was coined by Stanley Milgram -- the famous and largely controversial social psychologist who conducted studies examining people's obedience to authority by testing how many would administer potentially lethal electric shocks to screaming victims. As the official Milgram website explains it, "He found, surprisingly, that 65% of his subjects, ordinary residents of New Haven, were willing to give apparently harmful electric shocks-up to 450 volts-to a pitifully protesting victim, simply because a scientific authority commanded them to, and in spite of the fact that the victim did not do anything to deserve such punishment. The victim was, in reality, a good actor who did not actually receive shocks, and this fact was revealed to the subjects at the end of the experiment. But, during the experiment itself, the experience was a powerfully real and gripping one for most participants."

For his famous Six Degrees of Separation study, Milgram asked people to give a letter to other people they knew by name, then he tracked how long it took for each letter to end up in the hands of a person the original sender didn't know in another city. He reported that the average number of people it took to get from the sender to an unknown person was six. Hence, the phrase "six degrees of separation." But apparently no one ever bothered to look into his data, until now:

Judith Kleinfeld, a professor psychology at Alaska Fairbanks University, went back to Milgram's original research notes and found something surprising. It turned out, she told us, that 95% of the letters sent out had failed to reach the target. Not only did they fail to get there in six steps, they failed to get there at all. Milgram was a giant figure in his world of research, but here was evidence that the claim he was famously associated with was not supported by his experiments.

Which means the whole Six Degrees of Separation thing is more science-fiction than actual statistics, much to the dismay of the many the films, plays and books written using Six Degrees as their driving force.

Kleinfeld wasn't exactly happy to discover this: "I was shocked. I was horrified." Apparently other studies were done after his that claimed to find similar results:

none of those matched up to the claim either. In the most recent, two years ago, only 3% of letters reached their target. "If 95 or 97 letters out of 100 never reached their target, would you say it was proof of six degrees of separation? So why do we want to believe this?" "The pleasing idea that we live in a 'small world' where people are connected by 'six degrees of separation' may be the academic equivalent of an urban myth," she says.

More on Fake Blood and Research Ethics

A few days ago, I posted about some sketchy ethical practices in a clinical trial that's been testing fake blood without people's consent in 18 states. Well, it looks like things may get more interesting with that soon: Senator Charles Grassley has called on the FDA to tell the public (a) what's happening with this study and (b) how potential benefits of this blood substitute could outweigh the risks ... He called the trial unethical and said it never should have been approved. Grassley is accusing the FDA of disregarding their responsibility to "protect the public health," and saying the burden of opting-out shouldn't be on the public. "Equally outrageous," he said, "is the FDA's apparent failure to ensure that communities are fully aware of the risks, benefits, and nature of this experiment." I'm eager to hear their response.

For more information on all of this, see two publications from the ever-impressive American Journal of Bioethics -- their recent open letter to IRBs and their piece about race and Polyheme launched the media coverage of this issue and finally brought these questions to the public's attention. Bravo to them.

Fake Blood and Research Ethics

For some time now, I've been following the debate over clinical trials of a blood substitute called Polyheme, which was designed by a company called Northfield to use in trauma cases instead of human blood. To get this product out to market, it has to be tested on humans to see if it's safe and effective. The problem is, getting informed consent for that is impossible: When a person shows up hemorrhaging in an emergency room, they're in no condition to understand and consent to the potential risks of a study like this. But since the mid-90s, the FDA has allowed clinical trials of various things (including antidotes to potential biological warfare) without informed consent, if informed consent is "unfeasable" to get.

So, for the last two years -- without consent -- patients in emergency rooms around the country (including Chicago, Denver, San Diego) have been getting this blood substitute instead of real blood to test the product's effectiveness. Technically, patients can say they don't want this research done on them, but to do so they have to get and wear an opt-out bracelet, which tells people in emergency rooms that they want real blood instead. The problem is, if you want one of these bracelets, you have to know the study is happening before you go to the emergency room. Today, a Chicago Tribune article lays out some of the ethical concerns well:

"Medical ethicists and community leaders in some areas of the country where Northfield has been testing its product for the last year have said the process does not allow for enough community input. In some cases, ethicists have complained those running the trials have placed tiny legal ads in newspapers that resulted in town meetings attended by only a few people ... some critics of Northfield's trial have gone so far as to say the research protocol is racist because the testing is done in and around inner-city hospitals, and potential test subjects would have little way of knowing they could become part of a clinical trial. The San Diego Reader, a weekly newspaper, in July reported that Polyheme was being tested only on trauma patients too ill to consent in downtown San Diego and three minority neighborhoods.

In a January letter to Illinois congressional leaders, a Chicago-area surgeon involved in clinical trials, Dr. Raymond Pollak, compared Northfield's trial to the Tuskegee syphilis experiment--a 40-year clinical study in which African-American men with syphilis went untreated by government doctors. "The Tuskegee experiment ... is a painful reminder of the potential for the harm that can come from the unethical conduct of human experimental clinical trials," said Pollak, a former University of Illinois professor and current head of clinical trials at Edward Hospital in Naperville. "I believe that similar concerns have now emerged in regard to an ongoing clinical trial being conducted by Northfield Laboratories, with the tacit approval of the FDA.

The makers of Polyheme were, not surprisingly, unhappy about the recent bad press (They make a point in their press release to say that Polyheme is a promising treatment for people with sickle cell anemia, which African Americans suffer from disproportionatly -- surely an oblique (and inadequate) response to the accusations of racism and comparisons to Tuskegee?).

This case is disturbing on many levels. Of course, it's very important for science to advance, and for new therapeutics like this to be developed -- Polyheme could solve blood shortage problems and eliminate the need for blood-type-matching -- but we have endless historical examples illustrating precisely why this should only happen with full consent and disclosure to the public. There are ways to inform the communities surrounding the hospital so they (a) know this trial is happening, and (b) can exercise their legal right to opt-out if they don't want to participate (federal law mandates that all people be given that right). At this point, this doesn't seem to be happening. [It's also not clear that it will be enough if it does happen] This is precisely how we end up with Tuskegee-like problems in the first place. Which is why the researchers involved in this trial (and the FDA) should take the issue of consent very seriously and devise ways to move forward without violating people's right to not be used as research subjects.

[A side note: I've been off line lately because every waking moment (and most sleeping moments) have been consumed by a big story I just finished for the New York Times Magazine (it will be on the cover of the magazine in a few weeks -- I'll post more about it then). In the meantime, I have a huge backlog of things to post about ...]