Biobanking, part 3: returning research results to participants

So: you've agreed to participate in a genetic study for health purposes, and (with or without your consent--see post #2 on biobanking) the data you've provided has been made available to the broader research community. A sample of your DNA is stored in a biobank, and researchers who have been vetted by the biobank owners are allowed to use that DNA in future studies.

The consent form you were required to sign at the time you agreed to participate in the original study stated that you would not be contacted by the research team with information about the results of the research, or of any testing or other processes they might perform as part of their study. "Ok," you thought--having been informed that most genetic research being done today isn't informative at an individual level and wouldn't be clinically useful anyway--"fair enough. I don't need the researchers to contact me with information I can't act on anyway."

Fast forward 20 years. The promise of genetic research is beginning to deliver. As research uncovers more information about how genetics interacts with environment and behavior, the DNA sitting in biobanks around the world is telling more tales than it used to. The DNA that was formerly mere data is increasingly yielding meaningful information about the health risks of individuals. So, in our imaginary scenario, let's say that--20 years after you consented to participate in a breast cancer study--researchers working on a different project discover that you carry a genetic mutation that has been definitively linked to Serious Medical Problem X.

Here are some of the questions this (not terribly far-fetched) scenario brings up for me. Do the researchers have a professional and/or moral obligation to share this information with you? Does it matter that the original consent form, which was written for a single study that the researchers truly didn't expect to provide individually meaningful information, said they would not contact you? What if the researcher contacts you with information that you didn't want? Might the researchers' obligation to re-contact participants depend on whether or not there are good risk-reduction or treatment options for Serious Medical Problem X?

Here's some additional reading for those who want to read more on return of results from genetic studies: here's a paper from the Social Science Research Network; recommendations of a working group at the National Heart, Lung, and Blood Institute; a nice list of refs from Stanford's Center for Clinical Bioethics; and the issue of the American Journal of Bioethics that features a target article and open peer commentaries on this topic.

Wanna read the first 2 posts on this topic? Here they are: 1 2

Quote of the Day: Does the Sex of Your Surgeon Matter?

In response to an article in the NY Times online today about a report from The Journal of the National Cancer Institute that suggest that whether a woman receives radiation treatment after breast cancer surgery may be influenced by the gender of her surgeon, a reader made the following provocative comment:

“It's a generalization, I know, but of all the different kinds of doctors I have had, the females have had overwhelmingly far better bedside manner. And better bedside manner makes for better treatment--it's the difference between being treated like human being and being treated like a GalaxoSmithKlineMerckProctor&Gamble Inc. pinata.”

Full article here; all the comments here.

Do You Double Dip?

This Super Bowl Sunday, there's a very important question on everyone's mind. No, not who's going to win - that ought to be a(n unfortunate) given. Much more important than that: do you double dip, and is it okay to do so?

Well, a new study - from the same researcher who answered the perennial 5-second on the floor food rule - shows that Mom was right: doubling down on the dip means you're swapping spit... and germs... and who knows what else, with any and everyone else using the dip.

So go for the disposable plates, spoon your dip onto your plate, and double dip to heart's content, without worrying about picking up the latest nasty cold going 'round the block.

As a bonus, here's the snippet of Seinfeld that prompted the research in the first place:



Cheers, and happy game day to everyone taking this opportunity to socialize under the guise of watching football!
-Kelly

Tooting our own horn, again...

In a follow-up to our earlier post, we've also been named one of the best ethics blogs at PredictER,
a blog that part of Predictive Health Ethics Research (PredictER), a multidisciplinary research, policy, and public education program of the Indiana University Center for Bioethics.

Thank you to our colleagues at PredictER and congrats again to our bloggers!

Genetic tests and clinical utility

There was a story on NPR's Talk of the Nation earlier this week (listen here) about the array of genetic tests that are now available to you, the consumer. The news hook was a new blood test that researchers claim can define individuals' likelihood to develop Alzheimer disease. Like many other such tests, this one doesn't yield a yes/no answer: it identifies an increased propensity to develop the condition. It can't say for sure whether a person will in fact get Alzheimer disease, or, if she does, what the course of the illness is likely to be. But, for many people, the trouble is not just the certainty of the diagnosis or the accuracy of the prediction.

For some conditions, like Alzheimer's and Huntington's, treatment is limited and cures have not yet been found ... so there isn't anything that a person might do differently to reduce the risk of getting sick. The clinical utility of testing in these situations is limited: the results of the test will not change the medical management of the patient. Some people want such information to help them plan for their own futures and those of their families; others don't want to know and might see such unwanted information as burdensome.

Lots of questions here. Would you want to know? What is the value of information in this situation, and are all reasons for testing equally deserving of respect? Should such tests be available in direct-to-consumer form, without medical direction or involvement--and does it matter if the reason people pursue testing "off the books" is to prevent their insurance company from finding out that they're at increased risk? Should counseling be mandatory, or is that too much paternalism?

From the WBP Book Club…

While I certainly do not call myself an expert on the latest “must read”, here's one I highly recommend.

Written from a feminist perspective, Susan Sherwin’s “No Longer Patient: Feminist Ethics & Healthcare,” is an in-depth exploration of medical and feminist ethics, and how each impacts the other.

Sherwin critically examines controversial issues such as abortion, reproductive technologies, invitro fertilization and surrogate motherhood and others, and how these matters, considered “traditional” by mainstream medical ethics groups, become larger, highly-charged feminist-rooted issues involving inequality of power and the powerlessness of women in directing and making their own healthcare decisions.

The book presents a powerful analysis of—and comparison—between “feminine” vs. “feminist” ethics in healthcare, defining what Sherwin calls an “oppressive” healthcare environment weighted-down by systemic barriers and other restrictions that threaten the rights of women to control the direction and ultimate destiny of their healthcare.

Biological reproduction is a major focus for all women, regardless of one's own personal position taken today in this new, still to be explored, arena of feminist bioethics. Sherwin’s perspective tackles the knowledge-base deficiencies currently in existence, the direct result of a clear lack of understanding and discussion of these issues. Sherwin issues a call to action to her readers to recognize these gaps and disparities in healthcare for women, and to become involved in initiating change. I found it difficult to put down.

Removing the need for men?

From the Daily Mail, a scientific breakthrough with a technique will help lead to new treatments for infertility, but may render the male partner obsolete in reproduction: British scientists discover how to turn women's bone marrow into sperm.

The comments to the article range from humor (But without men, who would mow the lawn?) to outrage (What is it coming to, the world has gone totally mad...) But I can think of several reasons why this won't render males obsolete -- first, I'm really rather fond of the male I'm married to, and secondly, there is nothing that indicates that the 'new' way' is more fun than the 'old way'. Also, I guess I also to like think of my life partner as something far more than a mere tool for reproduction; that our union is something that has contributed to our personal and spiritual growth.

Kansas Abortion Provider Ordered to Turn Over Medical Records

What do you consider identifying personal data in your medical records? It's not a trick question, but a genuine one based on the ruling, earlier this week, that a Kansas abortion provider must turn over 2,000 patient records - the records of all women who have had late term (21 weeks or later) abortions in the past five years.

In Kansas, citizens have a right, based on an obscure 19th century law, to convene grand juries when they feel the government isn't enforcing a law. As far as I can trace back, the two citizen subpoena's are based on two separate laws that Kansas for Life feels are not being enforced, and that these records are necessary to prove it. The first law requires reporting sexual abuse in minors (and they argue that 11 and 12 year old's are receiving late term abortions without the 'abuse' being reported), while the second prohibits late term abortions unless they are medically necessary.

In other words, it's a wide dragnet to investigate abortion in Kansas.

Now, to be clear, I'm not basing this conclusion on who is behind the subpoena, or even the stated goals of the prosecuting attorneys. I'm basing it on the argument that they are looking for signs of abuse, or medical necessity - in health records that are supposedly going to be redacted of name, age, and identifying medical history.

If you take away name, age, and identifying medical history - exactly what do you have left, that allows the investigation of either of these laws that Kansas for Life says are not being enforced?

Further indications that this is a wide dragnet hidden behind other laws is the fact that they also want the records of any woman who was 22 or more weeks pregnant who came in and even consulted about an abortion, even if she didn't have one. Where's the necessary information here in enforcing laws? I can't see one - and the request is construed broadly enough that it sounds as if even mentioning abortion (even to say "well, I know it's an option because the fetus has XYZ problem, tell me more about it... mm, I don't think that's for me, but thanks") is enough to flag your record.

So the question then becomes - can you truly redact medical records that will remove personal and identifying information, and still leave meaningful data that will tell them what they want to know about abortions in Kansas? Your medical history is a map across your body, building a record that's unique to each individual. Every scar I have leads the way to a story, every surgery, every break and set of bone, every time my lungs decide to stop working. Every medication taken is a marker along the path, all of which will build to create a single individual.

Yes, in theory Tiller, the abortion provider, will be passing these files to another doctor and attorney to independently review and redact. But I remove identifying data from papers all the time, and I know how easy it is to miss just a single word that clearly flags who the person is. Attempting to redact 2,000 medical records in 68 days? The magnitude of error possible is staggering.

As of yesterday, Tiller's attorneys have filed an appeal to the Kansas Supreme Court, and refused to hand over any files until after the Supreme Court makes their ruling.

-Kelly

Friday, Feb 1st - Paint the Town Red!

Heart disease is the number one killer of women - a fact that is often overlooked. Because of that, February goes red for women's heart health, and the month starts off with National Go Red For Women day. So on Friday, put on your favourite bits of red, and support the cause and raise awareness for women's heart health!

All month long, you'll be able to buy products that have gone red, from a variety of sources that pledge to donate a percentage of the sale to women's heart health. While this is a great concept, make sure you check it out before you commit to buying a red product. As with any other product/donation campaign, different companies donate different amounts and have different rules for how they donate - and some are surprising. This isn't to discourage people from buying red - only to encourage smart shopping!

And as for tomorrow, I'll definitely be one of the ladies in red. (I don't know what it is with the musical references today, so sorry!)
-Kelly

Tainted Drugs*

A state-owned Chinese pharmaceutical company is at the heart of an international drug scandal after it's been revealed that over 200 patients were paralyzed or otherwise hurt by tainted leukemia drugs last summer. But in what we sometimes cynical Westerner's might consider a surprise, given recent cover-up history (especially regarding lead in toys), China's Food and Drug Administration has been at the heart of chasing down the pharma company managers, and responsible for closing the plant when the tainted drugs were discovered.

This would be alarming news to receive about any major pharma company, regardless of their involvement in the import/export industry, but the fact that Shanghai Hualian is the sole supplier of mifepristone (RU-486) for the United States raises even bigger concerns.

So far, the contaminated medications have been isolated to a factory about an hour away from the one that makes RU-486, but obviously when a company has one manufactoring problem, concern spreads to the entire system.

The United States Food and Drug Administration declined to answer questions about Shanghai Hualian, because of security concerns stemming from the sometimes violent opposition to abortion. But in a statement, the agency said the RU-486 plant had passed an F.D.A. inspection in May. “F.D.A. is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone,” the statement said.

When told of Shanghai Hualian’s troubles, Dr. Sidney M. Wolfe, a leading consumer advocate and frequent F.D.A. critic, said American regulators ought to be concerned because of accusations that serious health risks had been covered up there. “Every one of these plants should be immediately inspected,” he said.

The director of the Chinese F.D.A.’s drug safety control unit in Shanghai, Zhou Qun, said her agency had inspected the factory that produced mifepristone three times in recent months and found it in compliance. “It is natural to worry,” Ms. Zhou said, “but these two plants are in two different places and have different quality-assurance people.”

And while I do see this point, and agree with it to a degree, but given recent concerns both about the FDA and it's process, as well as China covering up manufacturing and health issues... I would certainly feel a lot better if the FDA released something more concrete than a no comment. That the FDA won't reveal what other medications are made/imported by the company also is worrisome. Again, on the one hand, I can understand not wanting to run consumers off by fear - but on the other hand, a lot of pets died because of contaminated food. Do we want to see the same health risks in our medications?

-Kelly

(*And as an aside, apologies to anyone else who now has Soft Cell's Tainted Love spinning 'right round in their head.)
-Kelly

Policy briefing: requiring individual health insurance

The health care problem is not only an ethical issue (many people, myself included, believe that Americans should not go without needed health care because they're poor) but also, increasingly, a major factor in the overall economic picture. (This isn't a new problem--check out the news on GM, for example--but one that is becoming ever more pressing for a variety of reasons.)

You've likely heard about plans -- some in place (as in Massachusetts), some proposed (like the one just rejected this week in California) -- to require that individuals purchase health insurance. It being an election year, we're likely to start hearing more, soon, about the candidates' plans for fixing the health care "system." Such individual-mandate approaches may be part of that picture.

Just in time, here's a chance to learn more: you can tune in to a live webcast today at 1:30 ET, sponsored by the Henry J. Kaiser Family Foundation. It should be an informative session, featuring a panel of well-known experts in health policy and finance.

If you can't tune in today (sorry for the short notice!), the archived webcast will be available online afterward.

Why Sex Matters for Neuroethics...

There is a provocative article in the American Journal of Bioethics Neuroscience today which asks: "Why should we pay special attention to the neuroscience of sex differences? " Authors lay out a plethora of directions in which such research could go, posing such as questions as "How ought we disseminate this information into a sensitive social environment that has a history of bias and discrimination against women? What are the implications of this work for our understandings of what makes us women and men? How should this research be applied in educational, medical, and legal contexts, if at all?... In considering the neuroscience of sex differences, we confront a fundamental issue: how do science and society understand female-male differences, or rather, women and men?"

A little different approach than the previous post we had on Gender: Love it or Kill it?.

The full article can be accessed here, subscription required.

Tooting our own horn . . .

Our friends at RH* Reality Check just posted that they've named this blog--along with several others--"Excellent."

Thanks to RH Reality Check, and congratulations to WBP and to the blog contributors!

....*that's for Reproductive Health

When is a Painkiller Not a Painkiller? A Patient's Right To Choose

Most patients trust their doctors. If prescribed a treatment, therapy or drug, many would not question the necessity, or authenticity of the physician's advice or prescribing strategy.

Indeed. In a study published this month in the Journal of General Internal Medicine, of 466 physicians surveyed at medical schools in the Chicago-area, 45% admitted to prescribing placebos to patients without the patient's knowledge, a practice striking at the very heart of Western medical ethics: informed consent.

Even more startling, one in five doctors admitted to actually lying to patients, claiming the placebos were medication, in clear violation of American Medical Association (AMA) guidelines, which directs its members to use placebos only if the patient is aware of and agrees to it.

Perhaps some might argue that the issue is not that significant--since placebos are viewed as harmless--but just how important is it? Particularly in terms of the doctor-patient relationship? Others might argue it raises major trust issues, and even a violation of patient rights.

See the full Time.com article here.

Religion of the Father?

AP reports that the Oregon Supreme Court has ruled that a 12 year old boy's preferences on whether or not to be circumcized should guide the decision in the dispute between his parents.

Excerpt:

The father, James Boldt, converted to Judaism in 2004 and wants the boy to be circumcised as part of the faith. The mother, Lia Boldt, appealed to the high court, saying the operation could harm her son physically and psychologically.

The state Supreme Court ruled that earlier court decisions failed to determine whether the boy wanted the circumcision, as his father contended, or opposed it, as his mother alleged.

The Supreme Court sent the case back to the trial court to answer that question.

If the trial court finds the child agrees to be circumcised, the Supreme Court said, it should deny the mother's requests. But if the trial court finds the child opposes the circumcision, the court has to determine if it will affect the father's ability to care for the child.

The custody dispute began when the child was 4 and the circumcision issue began three years ago when he was 9.

We have several interesting issues impacting this case. First: informed consent of the patient. Is a 12 year old mature and competent enough to make a decision about this permanent operation? There is a precedent in our society that denies non-medically indicated permanent procedures. For reference, most physicians deny elective sterilization operations to women even if they are of legal, consenting age (depending on the state, 25 is often used as a "no questions approval" cutoff).

Second, what is the nature of the circumcision procedure? Ought it be considered a ritual fully protected by free exercise of religion, or an elective permanent surgical procedure for non-health related reasons, thus violating the non-maleficence clause of the Hippocratic Oath? Note the sliding scale of the perceived magnitude of circumcision - from something akin to a piercing to mutilation of one's body and bodily function.

Third, the dispute between the parents should be considered carefully, and both parties' motives must be separated from what is in the best interest of the teenager. However, the "father's ability to care for the child" should not be used as a factor, as it should be categorically seen as a sign of unfit parenting to abuse or neglect one's child for not conforming to religious practice.

In my opinion, a case would be made for supporting such a procedure on someone not legally competent only if 1) there were a medical indication or 2) there were a time-sensitive factor to the procedure in terms of reducing side effects or discomfort. Thus, there is potential for supporting circumcision of infants over children or teenagers because some believe less pain is felt at that time (I do not endorse this position, I simply present it for argument) than would be felt later on. And there are rare cases where a circumcision is medically indicated in a child or a teenager due to developmental or other impairments.

However, this situation does not fulfill either criterion - a 12 year old does not have time-sensitive reasons for seeking a circumcision, there is no medical indication, and even the religious argument falls short due to the father's recent conversion. I do not see a reduction in suffering that would result from the operation occuring now or occuring six years from now, but the difference legally, cognitively, and ethically would be significant. Therefore, while I applaud the court's intent to look to the teenager's wishes, I do not feel that he is able to ethically consent to such a procedure at this time, and there should not be a circumcision until he comes of legal age of consent.

Addendum: Upon further reflection, I suspect that this is an attempt by the court to foist responsibility for the act (or non-act) onto the teenager so they do not have to risk appearing to be anti-religion. If so, that is an irresponsible course of action.

The Enhanced Ethicist

Professor Julian Savulescu, director of the centre of practical ethics at Oxford University: "To fail to do beneficial research is as harmful as doing harmful research," he says. The whole article is available here.

And oh, yeah -- and James Hughes of the IEET quips: "When I get enhanced I want to look like Julian. Oh, and be tenured at Oxford also."

Fiction or...?

As I'm sure most of the regular blog readers have realized, I'm a fan of pop culture. I'm endlessly fascinated with the media and how it spreads knowledge - or misinformation.

The new ABC show Eli Stone, which I have quite been looking forward to - the premiere has George Michael as prophet singing Faith - is by the same producer who's given us Brothers & Sisters and Dirty Sexy Money. So I was thinking "how in the world could this go wrong, it'll be fabulous!"

Well, apparently the world likes to make a point sometimes. The American Academy of Pediatrics wants the first show either pulled or substantially re-edited, because the opening scene involves a woman suing a pharmaceutical company over the supposed autism/vaccine link, saying that it's the reason her child is autistic. The link we know doesn't exist. Where the lead researcher involved was charged with misconduct in an effort to put the link/controversy to rest. The lawyers settle, after the woman makes your typical heartwarming by a wronged mother speech.

Given the description, you would think that the pharma companies would be going after ABC, but instead it's the pediatricians. They're worried that the heavy promotion ABC has been giving Eli Stone (a new show in a sea of repeats due to the writer's strike), and the likelihood of high viewership, will result in frightening more parents away from vaccinating.

The sad thing is, it's clear from the entire set-up that the scenario is supposed to make us dislike Eli, the main character, so that at his redemption we feel something for him. But it would have been completely possible to make him an utter bastard of a lawyer - and not propagate medical misinformation in the process.

ABC's response, to run a website for the CDC at the end of the show, isn't going to alleviate fears - it's not even going to address them. It's the difference between using scare tactics to get a message across versus a mass mailed flyer. And ultimately, they're counting on popular misconception and fear to tell their story for them, which is plain lazy writing.

But don't take my word for it, make your own decision. You can see for yourself. The first seven minutes of the show are available at ABC. Just select Eli Stone from the left side menu, and then select the sneak peak episode.
-Kelly

Reducing the use of animals in research

It's cool when science turns its methods back on itself to improve its own methods. In some ways you could argue that this is what science is about, anyway; but sometimes, there's a more obvious ethical impact to such self-improving activities.

Today's example is researchers who are working to find ways of reducing the use of animals in research (AP story). Contrary to what some critics seem to believe, it's simply not true that researchers who work with animals don't care about the animals' welfare. You can listen to a pretty powerful story that illustrates what I mean here--the link you want is the first one, "Don't Fall in Love with Your Monkey."

Research that aims at reducing the number of animals used in research by finding technological substitutes, research that tries to find ways of reducing the pain and distress animal subjects experience when they are used in research--these are not super-high priorities for federal funding. (You can learn more about protections and guidelines that govern the use of animals in research here.)

It's worth noting that the push for the research referenced in the news tag above is partly a response to help corporations deal with the upcoming EU ban on animal testing. There's a lesson here: when financial incentives exist to build a better mousetrap (sorry for the unfortunate metaphor), science will focus on the problem...whether the funds come from the feds, from corporations, or from abroad.

Women Targeted: The Pornographic Gaze

Today’s New York Times Business Day section discusses a NYC Time’s Square billboard which depicts a woman “splayed across” a red and white target, the retailer’s logo, her crotch forming the center of the bull’s-eye. http://www.nytimes.com/2008/01/28/business/media/28target.html?_r=1&ref=business&oref=slogin

According to the Times, Shaping Youth http://www.shapingyouth.org founder and bloggger contacted the retailer to complain that ad was demeaning and was reported told that the retailer does not respond to “nontraditional media;” the Times concludes by saying that the retailer “does not plan to change it’s ads.”

The crotch shot is indeed repugnant, but hiding behind the source of the criticism rather than taking it on raises the ante on this one. The traditional media are of course the ones who are tone deaf to this sort of issue. If you have not been reading the inside back cover of MS. Magazine, check out their “No Comment” feature, a roundup of “traditional” advertising that is depicts women in sexual and/or degrading ways in order to sell ordinary sort products and services completely unrelated to sex. http://www.msmagazine.com/spring2005/nocomment.asp

It is noteworthy that the male version of the ad mentioned here depicts him skating across the logo. The focus on the woman’s crotch distracts from less obvious problems with this and other ads: women are depicted as immobilized, passive, pinned while men are active, dominant, in control. For me, this is the more disturbing element since it flies under the radar and is less accessible to criticism yet arguably has a greater role in maintaining the conceptual underpinnings of women’s subordination. I have benefited in thinking about these issues by Jane Caputi’s powerful work on “The Pornography of Everyday Life” from her book _Goddesses and Monsters: Women, Myth, Power and Popular Culture_. [Full Disclosure: Caputi is my colleague and friend.]

Now, what shall we do about this retailer and others who do not take the dignity of women seriously?

do you sing the body electric?

A case going before the Ohio Supreme Court this week has the potential to change autopsies in the state - but also, potentially, surgeries and other procedures. At the heart of the matter is whether or not the state has the right to classify removed portions of the body as medical waste, and dispose of them in a timely fashion, or if those items of the body must eventually be returned to the family/loved ones. The specific plaintiff in this case is the family of a man who was buried without his brain.

The reason for this isn't as gruesome, nor as forensic show plot-y as it sounds. It's actually rather simple; when preparing a brain, during an autopsy, it typically takes longer to prepare the brain for viewing than it does to release the rest of the body for burial/cremation. Once the examination of the brain is done, and final cause of death has been determined, the brain is disposed of like most other medical waste - incineration.

But it raises a host of ethical, legal and social issues. Many people, backed by many different religions, believe that the body must be returned to the ground whole, for various reasons involving religious tenants and the afterlife/Resurrection. Others, perhaps fueled by media reports of wrongdoing on the part of funeral directors and the like, simply fear what is happening to those body parts - are they being used for research without permission? Unauthorized grafts or transplants? They want accountability for the whole of their loved one's body, and feel that it is well within our cultural history to demand it.

The defendants argue that this will severely harm their practice, of forensics and crime scenes, of autopsies, and perhaps more. After all, they point out, when a body dies, fluids - blood and more - are lost at the scene, and this is not collected for return. Likewise, there are times when the entire body simply cannot be returned, due to the natural of the death itself. Or most simply, as attorney Mark Landes has pointed out, it is a definitional impossibility to both do an autopsy and return the entire body.

Unfortunately, this is a situation of cultural and social beliefs hitting up against practical considerations and laws - we need to know how people died, particularly when it is a suspicious death, but we want to respect the religious and cultural beliefs of the people involved. And there are times when the two simply cannot be reconciled - and in those cases, what do you do?

I know what my decision would be - what's yours?
-Kelly