Noteworthy News in Bioethics this past week

- National Human Genome Research Institute (NHGRI) has set aside $3.9M in funding for 2010 to create several cross-disciplinary centers to study the ethical, legal, and social implications of genomics technologies. (Might sound like a lot, but does that money go quickly!)

- Personal genomics continues to grow and commodify, but is it accurate, is it wise? The average consumer can order up tests via the Internet, but what to make of the results? Once the information is known, what about one’s insurability in this era of tricky health care coverage?

- Transfusion-free medical facilities avoid the need for blood transfusions during surgery by using technology to conserve and re-infuse the patient’s own blood. The technique eliminates all sorts of risks and expenses.

- Emergency planners seek to help home-based life-support users in major outages, etc. All the various ice storms have been taking a toll, and sometimes the outages are so long that even those individuals prepared with backup plans aren’t adequately covered.

- Meta-analysis confirms value of risk reducing salpingo-oophorectomy for women with BRCA mutations.

- Injected biomaterial allows new blood vessels to grow by creating a “smart scaffold.”

- Life as we know it nearly created in lab. Primordial stuff, but haven't we heard this before?

- InNexus primate study clears way for human trials on non-Hodgkins lymphoma tumors.

- Government relaunches site for Web-based family tree of medical history. Touts it as a way to keep the complete family history in one place, so it’s more accurate for doctors to use.

- The “Malthusian Spectre” and American Health Care (a transcript of a discussion of health care costs and what could be done).

- Democrats seek $1B to compare effectiveness of medical treatments, part of efforts to lower health care costs.

- Both sides claim victory in patent battle over new type of heart valve. Both sides? How often does *that* happen? Actually, it makes sense when read in light of patent law.

- Government investigators report that the FDA is lax on requiring—and following up on—financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects. Ah, one of those comforting stories. Not.

- FDA promises openness in approval process for drugs and food from genetically engineered animals. Scrutiny by independent advisors at public meetings (hmmm….does that include spidergoats and glow-in-the-dark pigs?)

- USDA unable to weed out unapproved modified foods . Oh good, even if we shore up our own regs on this, we can’t keep the engineered plants and animals out of our food supply anyway. Not hopeful news.

- FDA lets drugmakers advise doctors on unapproved uses of medications, per FDA’s new guidelines on the matter. (Why does the image of foxes and henhouses come to mind?)

- People who sleep less than 7 hours per night are 3 times more likely to catch a cold. So get some rest!

[Thank you to Lisa von Biela, JD candidate, 2009, UMN, Editor of the BioBlurb, from which this content is partially taken and edited. BioBlurb is a weekly electronic publication of the American Bar Association's Committee on Biotechnology, Section of Science & Technology Law. Archived issues of the BioBlurb, as well as further information about the Committee on Biotechnology, are available here.]

11th Hour Legislation Facing Legal Challenge

In a not at all surprising move, the so-called Conscience Rule passed at the last possible minute by the Bush Administration, has been legally challenged. Connecticut's attorney general, Richard Blumenthal, filed suit on behalf of his state, as well as California, Illinois, Massachusetts, New Jersey, Oregon and Rhode Island. Separate suits have already been filed by Planned Parenthood and the ACLU.

For those that missed the ruling, which went into effect in December, the Conscience Rule

stops federal funding to any health organization -- public or private -- if it doesn't allow health professionals the right to refuse to perform or take part in any health care services they consider objectionable on ethical, moral or religious grounds.

This includes things as diverse as providing abortions, filling prescriptions, to working on any research you're hired to do, yet find objectionable.

Health and Human Services has said that they will fight this lawsuit, and believe that they are in the right with the Conscience Rule.
-Kelly Hills

What long lashes you have!

Wish you had longer, fuller eyelashes? Tired of raccoon eyes from mascara that won't stay where you put it? You might be tempted to check out Latisse, a glaucoma drug that has just been granted FDA approval for lash-lengthening.

The folks at Allergan, the manufacturer of Latisse, are (not coincidentally) the same people who brought you Botox (which also started its life as a drug for medical, rather than cosmetic, use). They'll charge slightly more for Latisse than for Lumigan (the version of the drug it sells for glaucoma).

Like all drugs, Latisse/Lumigan carries the risk of side effects. In clinical trials, 15 to 45% of patients experienced red eyes (conjunctival hyperemia) and/or itchiness. Other side effects include changes in eye or eyelid color, vision disturbances, foreign-body sensation, and systemic effects (mainly upper respiratory infections). Latisse is applied with an applicator, and just to the eyelid, and the dose is less--but still, these side effects aren't uncommon, and some of them are contrary to the goal of having more attractive eyes. Then again, compared with the risks associated with cosmetic surgery and other procedures (including Botox and other kinds of cosmetic injections), they're not so substantial.

For my part, I'm not all that interested in the ethical implications involved in women's decisions to use Latisse; I mean, in our current autonomy-centered age, how could it possibly be anyone's business if a woman wants to pay money to slop this stuff on her eyelids? Sure, there needs to be disclosure of the side effects, but they're not exactly life-threatening.

The re-release of Latisse raises other questions, though, about the commercial nature of drug development and the regulatory environment. In the current economic downturn, pharmaceutical companies--like everybody else--are needing to make hard cuts. What does it say about that industry when effort is devoted to cosmetic "treatments" rather than medical ones? And what does it say about us ("the market") if this really is the smarter investment for those businesses? Additionally, when there are consumer groups (rightly) up in arms about the tortoise pace of FDA review, why are we prioritizing Latisse over drugs that actually treat medical problems?

One more proof, as if we needed it, of how broken the US healthcare system really is.

"Cancer-free" baby born in UK: what's wrong with this picture?

So: today's news reports that the first "cancer-free" baby has been born.

"What's this?" you ask. "Isn't it awfully rare for babies to have cancer?" Yep. Especially breast cancer, which is more common in older women. But the genetic test to identify known breast-cancer-causing mutations has been around for some time. Now, for the first time, it has been used as a prenatal test--technically, in this case, through preimplantation genetic diagnosis (PGD), which is testing embryos conceived through IVF prior to their being implanted in the uterus.

Certain rare BRCA mutations greatly increase a woman's risk of breast cancer and ovarian cancer--so much so that some women with these mutations decide on prophylactic surgery to remove their breasts and ovaries. However, because these really bad mutations are rare, experts recommend that only women with a strong family history of breast cancer pursue testing. The news story doesn't say whether the couple had such concerns, though presumably this is the case.

Stories like this one don't help the general public understand what genetic testing can and can't do. Even BRCA results are probabilistic: not everyone who has a positive result will go on to develop breast cancer. And there are prophylactic and curative treatments available for breast cancer (though they are, obviously, pretty awful). And who knows what the state of medicine and oncology will be by the time the BRCA mutation carrier born today is old enough to worry about breast cancer?

The opposite set of concerns plays in here too; the fact that this fetus happens not to have any of the mutations that have been shown to increase breast cancer risk does not guarantee that she won't get breast cancer anyway -- presumably there are causal factors we don't know anything about yet, since the vast majority of breast cancer is not due to one of these familial syndromes -- or any of the other zillions of cancers that afflict humankind. "Cancer-free" may be a misnomer in this case.

And finally, isn't there a morally relevant difference between choosing to terminate a pregnancy because of a positive diagnostic result (eg, Tay-Sachs, Down syndrome) and choosing to do so based on a measure of susceptibility? And no hate mail please: I don't mean to imply that the former sort of case is necessarily the right thing to do...only that some such choices might be more easily justified than others.

Art Caplan: And now for the dumbest divorce claim of 2009

Sounds like the start of a corny joke: your money or your wife? When I was a trial attorney (in a previous life), I had my fair share of rancorous divorce cases, but this one takes the cake:

According to a Newsday article,when Dr. Richard Batista's wife needed a kidney, he gave her one of his (how lucky they were a match!) -- and now that Mrs. Batista has filed for divorce, he says he it wants it back -- either that or $1.5 million -- the supposedly value of the kidney transplant.

Aside from the fact that you probably can get a kidney transplant for a lot less, thanks to medical tourism (not that I am advocating it) in China or India, medical ethicists, Art Caplan and Robert Veatch are saying it's just not argument that is going anywhere.

It is just such a shame that the show Boston Legal was canceled ~ they would have had so much fun with this case. (E.g. -- Episode 1 of Season 3 "Can't we all just get a lung?", starring Michael Fox)

No Monkeys Allowed?: Limitations on Service Animals

Those of you familiar with my writings know that interconnectedness of us and all other creatures with which we share the planet is one of my major themes. So, I was delighted to read Rebecca Skloot's story, Creature Comforts, in the NY Times about all types of service animals and how they help people with disabilities. And you can imagine how dismayed I was to read on Rebecca's blog, Culture Dish, that the Department of Justice is trying to limit the types of animals that can be used for service animals, so I am partially reposting her entry in the hopes of bringing attention to this matter and stimulating action:

"NEWSFLASH: In this weekend's New York Times Magazine, I reported that the Department of Justice had proposed a ban on guide miniature horses, service monkeys, and other non-canine assistance animals (brief overview of the story and legal issues here, several follow up posts here). In my story, I mentioned that no one knew whether the DOJ had removed the species ban from their proposal after the public hearings this summer.

Well, I just got an email from a source who's seen a leaked version of the latest DOJ regulations, and the agency has in fact made the species ban more restrictive. Its initial proposal would have allowed cats and other commonly domesticated animals (perhaps including parrots). But the current version (which the DOJ approved on 12/3 and is now pending final approval by the OMB), limits service animals to only dogs.

The outpouring of response I've gotten from this article has been predominantly opposed to the idea of banning non-canine animals. Folks have asked who they should contact to speak out in favor of these animals, since the final proposal is still awaiting approval. For those interested, you can contact the Department of Justice here, and the OMB here. You can also contact your government representatives and state senators to let them know about the issue. (Update for those who've asked: The relevant way to reference this issue is as, The DOJ's proposed ADA regulations that would ban the use of any species other than dogs as service animals. The exact regulation in question is 'Title III Regulation 28 CFR Part 36: Nondiscrimination on the Basis of Disability by Public Accommodations and in Commercial Facilities.' "

The rest of Rebecca's post and comments can be found here, and her update here.

Is there really a rational basis to limiting ADA service animals to dogs? What am I missing here?

This Looks Familiar...

Perhaps, sometimes, at the long end of a night spent counting sheep in a futile effort to get to sleep, your mind wanders from sheep to Dolly to cloning, and you find yourself wondering whatever happened to the people behind Genetic Savings and Clone. Well, thanks to an end of 2008 article by the New York Times, you'll no longer have that distraction as you count your Dolly's. It seems that Lou Hawthorne, the man behind the Missyplicity project as well as Genetics Savings and Clone, is back again with a new company. This one is named BioArts, and it started off with five public auctions for dog cloning services. And if I'm reading the NYTimes article correctly, while the company is located in the California Bay Area, actual cloning services are being provided by Hwang Woo Suk's South Korean laboratory, also answering the "what is he up to now" question regarding the disgraced doctor, who appears to be the chief geneticist for Hawthorne's latest venture.

The article itself is full of the usual over-the-top promise of cloning-as-identical-pet/personality, but also has interesting comments from Hawthorne's mother, who doesn't think the clones are anything like her beloved original, Missy. Unfortunately, the final quote of the article, from Ed Otto (who paid $155,000 to have his dog Lancelot cloned) likely still accurately expresses the average person's perceptions of what cloning means: “Cloning means you could have the opportunity to have the same dog with you for your entire life."

It would seem that the "that's not quite what cloning is" side needs to step up their educational efforts. Perhaps someone should make a shiny website?
-Kelly Hills