U.S. law requires that informed consent be obtained for treatments and diagnostic tests. This means that accurate and relevant information must be disclosed to patients. If current standards of disclosure and informed consent apply then the description of the fetus must include evidence about embryology including clinical and scientific uncertainty about when consciousness, thoughts, sensations, and life begin. This is more than some of the other commentators who are in favor of the law are advocating. Providing abortion without truthful disclosure and informed consent violates existing laws, threatens the doctor-patient relationship, and jeopardizes medical professionalism.  Mandating ultrasound, especially with out disclosing all the information — especially where the law protects the doctor against deliberate failure to disclose –  means ignoring the need to obtain informed consent. One wonders how such a poorly crafted law ever reached the legislature. Indeed, as a result of legal challenges to the new law an Oklahoma judge has just granted a slight reprieve by delaying implementation for 45 days. 

[Guest blogging this week is Cheryl Cox Macpherson, Ph.D., Professor and the Chair of Bioethics Center at St George's University School of Medicine (SGU) in Grenada where she enjoys teaching medical and graduate students from many nations and background.]

Just a quick browsing of the Myriad Genetics website tells you that this company embodies just about everything bioethics researchers have been warning for in connection to the commercialisation of genetic testing since the late 1980′s. The University of Utah Research Foundation that held the claimed patent together with Myriad – and that may be assumed to have been cashing in handsomely as a passive partner – should be held equally, if not more, accountable for this attempt to undercut sound business law, decent health care ethical standards, scientific progress and, not least, the health of those people belonging to families burdened by hereditary cancer, whose access to the preventive opportunities offered through genetic testing, and forthcoming advances of medical research, has been undercut. But back to the poverty of Myriad Genetics.

To take just one example of this moral morass, Myriad offers predictive genetic testing for hereditary melanoma – a disease for which the actual risk figure is never given at the Myriad website. Clicking this product, you are immediately told that “Changes in the p16 gene increase cancer risk, making a melanoma diagnosis up to 50 times more likely by age 50″, which of course tells you absolutely nothing about what risk of melanoma you actually run before the age of 50 if you have the indicated genetic mutation, but for most people convey the impression that a mutation makes your risk of contracting melanoma before 50 an even game. Clicking further on to the page supposed to give you an in-depth background to hereditary melanoma, you’re exposed to the following explanation. Take a minute or so to read it!

Having that horrible mutation must make for a helluva risk, doesn’t it? Actually: no! Even considering that the people involved in Myriad are presumably not proper clinical doctors (if they were, AMA would have revoked their licenses by now, right? – I’m being charitable to the US medical profession here), but a bunch of lab rats and business executives, this is as close to actual fraud you can get without actually committing it in the strict legal sense. Remember that nice graph you just saw? Its Y-axis measures not the actual risk of contracting melanoma, but – again! – the change in risk compared to what risk of contracting melanoma you would run were you a random member of the general population. But the impression of the picture is not that – the impression is – once again – that if you carry the mutation you run a 50/50 risk. This message is cleverly conveyed by the sinister manner in which the general population risk figure is illustrated in the graph. That green staple to the right of the tall blue one seems to reach up to the 1 of the Y-axis, right? It’s 1% – right? Or something close to 1%? Actually, no! Have a closer look at the graph:

It is <1% – i.e. "less than 1%", i.e. the risk is not given. It could be 0.99%, it could be 0.0000000000000000000001% For all we know based on the information provided, the 50% increased risk may thus equal a 0.0000000000000000000002% risk. Who knows? Obviously not Myriad Genetics – or can they really be consciously hiding highly relevant facts from potential customers??

Just to get some perspective, hereditary melanoma is what geneticists refer to as a multi-factorial disease, i.e. it occurs as a result of the interaction between several genetic mutations and the environment. The p16 test offered by Myriad targets just one among many different genes where a mutation may increase the risk for melanoma. This is actually conveyed by this admirably pedagogic (right!) explanation of what a test result mean. Scroll down and read the message about the “uncertain variant”, there you have it! But just above, Myriad boosts about the “comprehensive” (and presumably ridiculously expensive) variant of the test, described thus: “Think of a comprehensive analysis as reading an entire encyclopedia, line by line, to look for a single misspelled word” (italics added by me). Again, as close to fraud as you might dare to wander. The “entire encyclopedia” must be read the entire human genome, including all the other genes that may increase the risk of melanoma – right?? Actually, no! It’s the same p16 gene, i.e. it’s more or less the same test, just properly done so that all known melanoma predisposing mutations of this particular gene are included. So, suppose you test negative in a “comprehensive” test – this is compatible with you carrying any of the other known genetic mutations of other genes that increase the risk of melanoma – what Myriad so handsomely describe as “no increased cancer risk” when explaining what a test result means. Did anyone mention fraud or deceitful behaviour? – I certainly did not, but it would be interesting indeed to have melanoma or cancer patient organisations trying out that concept in US civil courts (in which case, the University of Utah Research Foundation must, of course, be included in the lawsuit)!

Hopefully, the ruling against patenting actual genes or naturally occurring genetic mutations will undercut the sour-tasting business of Myriad Genetics and other similar companies. For one thing, as a legal precedent, it has the potential of putting a stop to attempts of making ethically well-motivated and responsibly handled predictive genetic testing offered by national health services – for instance for colon-, breast- and ovarian cancer – unnecessary expensive and thus accessible for more people at risk. From a moral point of view, it is thus most welcome. From a legal point of view as well, since what judge Robert Sweet argues in the ruling, “…the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter” has been obvious to anyone from the outset interested in applying actual patent law, rather than laying the foundation for a new branch of business. If Myriad has a unique procedure to detect DNA, they may patent that, of course, but do they? It remains to be seen, but my guess is that they use the same state of the art science and technology as does any molecular genetic research lab, and that they knew very well that their only chance to make a buck was attempting the patenting of DNA trick.

The only defense offered by Myriad’s and the UURF’s lawyer was that patenting genes promotes “innovation” and therefore promotes health. False. In fact, the patent claims on BRCA-1 and BRCA-2 has made medical research based on these genes that may lead to deeper understanding of the mechanisms of these forms of cancer, and thus to newer and better treatments, slower and/or more expensive. Patents have the potential of furthering innovation only when all of the basic scientific work has been done (until then, the scientific principle of openness, free sharing, access and use of information is far superior), and in the case of human genetics, identifying genes connected to disease-groups is just the first letter of the first name of that long process. When Myriad says “innovation” they mean business and so does – shame on them – the UURF.

[Cross-posted from Christian Munthe's Philosophical Comment blog.  Christian and research fellow Daniela Cutas have agreed to guest blog in the coming months]

He mentions that breasts today do not bear any resemblance to what actual breasts look like. He is right, they try to look natural, but the key word is “try”. Several points that his statement make me think of is, if they are unnatural looking why do we want them to look natural? As a woman who has a genetic predisposition on the higher end of the size curve, I do not understand. The unnatural version of natural looks nothing like my own natural ones, even if we are the same cup size. I have friends who fall in to the same category that I do and talked to them about it and they agree. There is a level of insecurity, but it is not insecurity about size, but about gravity. The posthuman breasts go against the body’s natural inclination to succumb to gravitational pull, if you will. My friends and I however cannot pay to fight gravity; we are left to lesser forms of posthuman enhancements such as the push-up bra. This leads to my second point about Tom’s statement: actual breasts. Is the desirable path one where breasts do not bear any resemblance to natural breasts? Form over function. Breasts work, but do we still need them to work in the same way?

We have formula now, that while it can in no way match breast milk, it does work and many women use it. It is an alternative. Before you send me any hate comments, I breastfed all three of my children, not for a year, but I did. I did eventually switch over to formula. Regardless, if we want surreally attractive breasts, does the functionality need to remain the same or will sex and sexual appeal transition to be the exclusive function.

As adults, we can talk and think about these types of questions and issues, but what about the young girls. Tom Ford makes another point in the video that girls are seeing the adults with their unnatural breasts and think that they need to get their breasts done. He goes on to mention that we have lost touch with what a real breast actually looks like. Again, as adults that is one thing, as a young girl it’s another. In the adoption of the posthuman form are we taking critical examination of what images and ideas we are passing on to the next generation. Further examination though should include the messages conveyed and the impact of these messages on young girls. When thinking about the posthuman woman, the girls of today, how will their lives change by the choices made today. They could very possibly choose to go against the grain of the constructions of beautiful breasts and choose the au natural route. Insecurity about breast size is a facet of growing up that girls deal with. Plastic surgery enables them to address these insecurities, but what do they gain and what does it solve? Large unnatural breasts are not something a mother can pass on to her daughters naturally, it will require, at this point in time, a monetary investment of perpetuation within culture.

Tom points out that we are becoming our own art by manipulating our bodies and creating them the way we want them to look. He also says that it desexualizes, comparing these beautiful bodies to cars. Since they are so glossy, polished and an idealized form of perfection, they are too scary and not human. I would love to hear the answers to the questions he poses about after these surgeries of breast enhancement does it help ones sex life? Or is it intimidating? A body in its artistic form is admirable at a distance without touching. Not like a ball of clay where you want to get your hands dirty and really play with it intensely

Last night, as I was thinking about what I was going to say in the piece I turned on VH1, yes, I think it is a valuable source for pop culture insight. It did not fail me. The show that I turned on was “VH1News Presents: Plastic Surgery Obsession”. It fit in perfectly with what I was thinking and wanted to say, without the reference to post-humanism. The show is about the rise in popularity of plastic surgery, in and now out of Hollywood. The show supports both the new ideals of women’s bodies and that the younger generation is picking up these ideals. The fact that VH1 aired the show, despite a voyeuristic appeal that shows like this have, says something about what we want to see on TV. Finally, at the end of the episode the show touched on males and cosmetic surgery. Tom Ford did not talk about the men being posthuman in his interview, or at least the clip I heard, but VH1 talked about how tricky it was for men to undergo plastic surgery and come out of it looking “natural”. Does this mean that with women getting around 98% of the plastic surgeries they are more willing to transition to a posthuman form or is it just easier for them? What does this mean and how does this reflect on men? Are men going to, can they follow the same path as women? These are interesting questions to think about in addition to the critical examinations of the decisions of women. I look forward to hearing and thoughts.

Elizabeth Reis is the author of Bodies in Doubt: An American History of Intersex (Johns Hopkins University Press, 2009). She is associate professor of women’s and gender studies and history at the University of Oregon in Eugene.

[On January 29, 1951, David Lacks sat behind the wheel of his old Buick, watching the rain fall. He was parked under a towering oak tree outside Johns Hopkins Hospital with three of his children—two still in diapers—waiting for their mother, Henrietta. A few minutes earlier she'd jumped out of the car, pulled her jacket over her head, and scurried into the hospital, past the "colored" bathroom, the only one she was allowed to use. In the next building, under an elegant domed copper roof, a ten-and-a-half-foot marble statue of Jesus stood, arms spread wide, holding court over what was once the main entrance of Hopkins. No one in Henrietta's family ever saw a Hopkins doctor without visiting the Jesus statue, laying flowers at his feet, saying a prayer, and rubbing his big toe for good luck. But that day Henrietta didn't stop.

She went straight to the waiting room of the gynecology clinic, a wide-open space, empty but for rows of long, straight-backed benches that looked like church pews.

"I got a knot on my womb," she told the receptionist. "The doctor need to have a look."

For more than a year Henrietta had been telling her closest girlfriends that something didn't feel right. One night after dinner, she sat on her bed with her cousins Margaret and Sadie and told them, "I got a knot inside me."

"A what?" Sadie asked.

"A knot," she said. "It hurt somethin' awful—when that man want to get with me, Sweet Jesus aren't them but some pains."

When sex first started hurting, she thought it had something to do with baby Deborah, who she'd just given birth to a few weeks earlier, or the bad blood David sometimes brought home after nights with other women—the kind doctors treated with shots of penicillin and heavy metals.

About a week after telling her cousins she thought something was wrong, at the age of 29, Henrietta turned up pregnant with Joe, her fifth child. Sadie and Margaret told Henrietta that the pain probably had something to do with a baby after all. But Henrietta still said no.

"It was there before the baby," she told them. "It's somethin' else."

They all stopped talking about the knot, and no one told Henrietta's husband anything about it. Then, four and a half months after baby Joseph was born, Henrietta went to the bathroom and found blood spotting her underwear when it wasn't her time of the month.

She filled her bathtub, lowered herself into the warm water, and slowly spread her legs. With the door closed to her children, husband, and cousins, Henrietta slid a finger inside herself and rubbed it across her cervix until she found what she somehow knew she'd find: a hard lump, deep inside, as though someone had lodged a marble the size of her pinkie tip just to the left of the opening to her womb.

Henrietta climbed out of the bathtub, dried herself off, and dressed. Then she told her husband, "You better take me to the doctor. I'm bleeding and it ain't my time."

Her local doctor took one look inside her, saw the lump, and figured it was a sore from syphilis. But the lump tested negative for syphilis, so he told Henrietta she'd better go to the Johns Hopkins gynecology clinic.

The public wards at Hopkins were filled with patients, most of them black and unable to pay their medical bills. David drove Henrietta nearly 20 miles to get there, not because they preferred it, but because it was the only major hospital for miles that treated black patients. This was the era of Jim Crow—when black people showed up at white-only hospitals, the staff was likely to send them away, even if it meant they might die in the parking lot.

When the nurse called Henrietta from the waiting room, she led her through a single door to a colored-only exam room—one in a long row of rooms divided by clear glass walls that let nurses see from one to the next. Henrietta undressed, wrapped herself in a starched white hospital gown, and lay down on a wooden exam table, waiting for Howard Jones, the gynecologist on duty. When Jones walked into the room, Henrietta told him about the lump. Before examining her, he flipped through her chart:

Breathing difficult since childhood due to recurrent throat infections and deviated septum in patient's nose. Physician recommended surgical repair. Patient declined. Patient had one toothache for nearly five years. Only anxiety is oldest daughter who is epileptic and can't talk. Happy household. Well nourished, cooperative. Unexplained vaginal bleeding and blood in urine during last two pregnancies; physician recommended sickle cell test. Patient declined. Been with husband since age 14 and has no liking for sexual intercourse. Patient has asymptomatic neurosyphilis but canceled syphilis treatments, said she felt fine. Two months prior to current visit, after delivery of fifth child, patient had significant blood in urine. Tests showed areas of increased cellular activity in the cervix. Physician recommended diagnostics and referred to specialist for ruling out infection or cancer. Patient canceled appointment.]

To read more excerpt, click here.  You can also hear Terry Gross interview Rebecca about her book here on NPR.

 
From issues in medical paternalism to the dark history of experimentation on African Americans and legal and ethical battles over whether or not we control the stuff we are made of (as in the Moore vs California Bd of Regents case, which is a thorn in the side of most bioethicists I know), this book rocks! 
I’m recommending it for the WBP Summer Book Club!

(Roughly translated from Latin as Sex God in the machine) We all know that technology can improve our lives (sometimes….well, at least when it’s working properly), but who’d have thunk that nanotechnology could improve your sex life?

In yet one more ‘tool’ in the arsenal against dreaded erectile dysfunction, nanotechnology to the rescue! Scientists at Albert Einstein College of Medicine of Yeshiva University have developed a foam with nanoparticles encapsulating nitric oxide for the topical treatment of erectile dysfunction (ED). Why is topical better? Because ED medications such as sildenafil , vardenafil, and tadalafil have limitations — they can cause systemic side effects such as headache, facial flushing, nasal congestion, upset stomach, and abnormal vision. Might this have implications for Female Arousal Disorder for which there remains little, if any, treatment? One can only hope….perhaps the announcement of the new ‘female viagra‘ for pre-menopausal women can benefit from this new delivery system.

On balance, though, Blue Cross Biomedical has developed a new foam condom for use by women, that looks like a vaginal inhaler. The Blue Cross Foam Condom uses a “formulated condom concentrate” comprised of nano silver particles as well as ‘surfactant octyl phenoxy -RH4,tween-20, sapn-60,polyethylene glycol 400, deionized water’. Perhaps a male contraceptive can be advanced utilizing a nano-delivery system?

My humble request to scientists and researchers: Equal time for both sexes, please!

So: in light of recent discussions about the Suleman case (specifically the question of whether there should be an enforceable maximum number of embroys that can be transferred into a woman’s uterus), how much additional risk is too much? At what point ought the state step in?

Women and girls are the new face of HIV/AIDS. Globally, there are twelve HIV-positive women for every ten HIV-positive men. In the hardest hit countries of sub-Saharan Africa, young women are three times more likely than their male peers to become infected.

The disproportionate impact of HIV on women is due to a variety of biological and socioeconomic factors, factors that also make current HIV prevention tools – including condoms and mutual monogamy – inaccessible to those most at risk. For example, many women do not have the social or economic power necessary to insist on condom use and fidelity, or to abandon partnerships that put them at risk.

Thus, there is a desperate need to develop new user-controlled tools to enable women to protect themselves, such as vaginal microbicides. Over the past two years, a series of flat findings and trial closures have shaken public confidence in research to develop safe and effective microbicides. But now there’s a glimmer of hope.

Yesterday, at the 16^th Conference on Retroviruses and Opportunistic Infections in Montreal, a team of researchers funded the US National Institutes of Health announced the results of HPTN 035, a clinical trial of PRO2000 and BufferGel, two candidate vaginal microbicides.

This study enrolled over 3000 at-risk women in Malawi, South Africa, United States, Zambia and Zimbabwe. In addition to showing that these products were safe to use, the study found that women used PRO2000 (as a topically-applied gel) plus condoms had 30% fewer HIV infections than those who used only condoms or condoms plus a placebo gel.

Although the decrease in HIV infections among women using PRO2000 did not quite achieve statistical significance, this is first large-scale clinical trial showing that a candidate microbicide might actually work in women. A second trial of PRO2000, enrolling more than 9000 at-risk women in Southern Africa, is currently underway. The results of that study – known as MDP201 – will be available in November. If the data from the MDP201 trial also show that PRO2000 is safe and effective, it is expected that this gel will be submitted for regulatory review and approval, hopefully giving women worldwide access to a new and sorely needed HIV prevention tool.