Showing posts with label consent. Show all posts
Showing posts with label consent. Show all posts

Thursday, July 4, 2013

The Ethics of Publishing Genomes: Can Today’s Family Members Give Consent For The Next Generation?

In 1951, a black tobacco farmer and mother of five named Henrietta Lacks died of cervical cancer at the age of 31. But before she died, the doctors treating her at Johns Hopkins took samples of her cervical tumor — and without her knowledge or consent those samples went on to become the most prolific human cells in medical research.

The cells, commonly referred to as HeLa cells, have helped research treatments for everything from HIV to cancer. But they have also become a cautionary tale about the importance of ethical standards in research: Lacks’ own family didn’t even know about her research legacy for over 20 years. When European researchers published the full genome transcript of HeLa cells without the knowledge or consent of her family earlier this month, they started a new chapter in that tale about the complex relationship between researchers and the privacy of genetic information.

It’s a complicated chapter, as Dr. William Pewen, Assistant Professor of Public Health and Family Medicine at Marshall University, and a former top health care adviser to the now retired Sen. Olympia Snowe (R-ME), noted to ThinkProgress:

“The release of Henrietta Lack’s genome illustrates the fact that genetic information isn’t an individual matter — it impacts family members as well. This underscores the need to ensure the rights of individuals and preserve the confidentiality of research data. Once patient privacy is lost, problems are simply compounded. Just how can today’s family members give consent for the next generation?

It’s easy to argue that HeLa cells have saved lives, that their net result was good — but to say so without acknowledging that they are also the result of a highly suspect act that demonstrated disregard for the privacy and consent of a patient ignores the ethical standards that should define scientific research. Similarly, with genetic information, many concerns are raised: It’s very difficult, if not impossible, to guarantee the long-term confidentiality of genetic information and it can reveal much more about an individual and their relatives than basic medical records.

And while the public may generally agree that there are great benefits to be gained through genetic research, it’s important that the concept of medical progress is not put ahead of the informed consent of patients — especially, as Pewen also notes because “[i]n an age of technology advances and ‘Big Data’ analytics, it’s clear that medical data can be used in countless detrimental ways. That will simply be fostered if we allow ethics and human rights to be undermined by expediency.”

The researchers who posted the HeLa genome sequence have already retracted their paper due to complaints from the Lacks family, but as other have noted Lacks’ genome sequence can still be gleamed from other databases.

Genetic information is health information protected by Health Insurance Portability and Accountability (HIPAA) Act disclosure rules and there have been legislative attempts to resolve some of the issues raised by advances in genetic testing, such as the Genetic Information Nondiscrimation Act (GINA) of 2008, which also prohibited employers and health insurance companies from discriminating based on genes — but those regulations won’t help Henrietta Lacks’ descendants: The final rule modifying HIPAA to implement GINA and Health Information Technology for Economic and Clinical Health Act (HITECH) protections effective yesterday does “not protect the individually identifiable health information of persons who have been deceased for more than 50 years,” conveniently excluding HeLa cell information.


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Thursday, May 30, 2013

‘Girls’ Adam, ‘How I Met Your Mother’s Barney Stinson, Stopping Rape, And Eroticizing Consent

The most recent episode of Girls aired while I was at South By Southwest, and in a way I’m glad I’ve had some time to watch the episode slowly, and to think about it before writing about it, given the flood of reaction and debate to the half-hour of television.

The storyline that’s provoked the most commentary has been a sequence towards the end of the episode in which Adam, after running into Hannah while on a date with his current girlfriend Natalia, falls off the wagon, takes Natalia back to his apartment, and when she expresses some dismay at the state of it, orders her on all fours and has her crawl to her bedroom. What commences there clearly makes Natalia uncomfortable from the outset. When Adam pulls off her panties and begins trying to get her aroused, she notes she hasn’t showered that day, which Adam interprets only as an expression of concern for him, rather than as a tactful attempt to ask him to stop. They have short-lived penetrative sex, at which point Adam pulls out and prepares to ejaculate on Natalia. Though she only tells him not to come on her dress, an injunction he complies with, she is obviously deeply distressed after the event, telling Adam “I, like, really didn’t like that.”

Much of the analysis of the episode has centered on the question of whether Adam committed a sexual assault against Natalia. “‘No means no,’” wrote my friend Amanda Hess at Slate, “is not the only measure of consent.” “This episode asks us why we’re so, so careful not to call things rape, or why we think there’s an acceptable level of reluctance, coercion, or intimidation that can be part of a sexual encounter,” Margaret Lyons writes at Vulture. Adam is clearly a man with boundary issues, someone I’ve found creepy enough to justify the cops showing up and creating some distance between him and Hannah. And while I think that the fact that this episode has been so upsetting, confusing, and sparked such a powerful debate about the space between an outright no and a clear yes that’s so often interpreted as consent to sex or sexual acts, I actually found myself focusing on something else: the fact that Adam was also portrayed as miserable and upset at the end of the encounter, too.

This is not to say that Adam’s feelings about his encounter with Natalia are more important than her feelings. But in his question to Natalia after she made clear how upset she was, “Is this it? Are you done with me?” there are some interesting issues, and potential answers to the question of how to train men, not just women, to prevent sexual assault.

Part of the reason I was so struck by this episode of Girls is because I’ve been rewatching How I Met Your Mother for a piece on what that show says about contemporary relationships. And I’ve been struck by the extent to which that show both fetishizes Barney Stinson’s (Neil Patrick Harris) conquests, and how much his technique has to do with impairment and manipulation of consent. On New Year’s in the first season he picks up Natalya, whose most important trait seems to be that she hails from “The former Soviet republic of Drunk-Off-Her-Ass-Istan,” as Barney puts it. Lily asks Barney at one point “they’re blonde and drunk, isn’t that your type?” But I can’t think of a moment when the show ever discusses the impact of sobriety on consent—it’s just a running joke that Barney likes to, and is very good, at taking advantage of women who are heavily intoxicated. He’s also a liar, changing his presentation of himself so women will be more likely to consent to sex with him. ” I’ve told some outrageous lies. I have told women that I was famous, a war hero, that sex with me would cure their nearsightedness,” he explains in season seven. And at one point, these deceptions do seem to cross over into a clear, and what ought to be ugly, taking of sexual advantage, when Barney explains that he likes to meet women new to New York “with no idea what a casting director could legally ask her to do, hold, or lick during an audition.”

Women get emotionally hurt by Barney, including Nora, on whom he cheats with Robin, Quinn, who he realizes he doesn’t really trust, and the ten women (to date) who have named him in paternity suits. And Barney is occasionally hurt by his own womanizing, as is the case when he loses Nora, who can’t forgive him for cheating, or when he realizes he needs to reform for Robin to be able to truly love and ultimately marry him. But How I Met Your Mother is decidedly vague on the question of whether Barney’s seduction techniques or the kinds of sex he’s had with someone have ever hurt someone, in part because that would require the show to reckon more carefully with the consequences of the very thing that made Barney a breakout character: his riff on the pick-up artist playbook. Admitting that Barney Stinson might have had sex with someone without appropriately gaining her consent would make the character decidedly unlegendary—as would the idea that Barney was miserable after one of his conquests precisely because he realized that he hadn’t obtained consent, and felt guilt, shame, and remorse. So even as Barney moves into marriage, his legacy of banging drunk chicks or manipulating women into having sex with him because they need work will remain largely unexamined, and largely valorized.

Girls may not have a clear name to offer up for what Adam did to Natalia, and outside commenters may argue about what it is that happened to her. But the show’s done something valuable in stripping away a Barney Stinsonized-patina of valor from the idea that consent is a hurdle, rather than a gateway to better sex. If Barney Stinson is an advocate for a world where you have as much sex, and as many kinds of sex, with as many women as possible, Adam is an illustration of what happens somewhere along the way, when you assume that lack of a total no means a yes. Because for some woman, somewhere, that’s precisely what it will mean.

And I think that’s a conversation worth having. As Irin Carmon has pointed out in Salon, trying to educate men not to rape women may not much to deter predators for whom lack of consent and the power involved in sexual assault is precisely the point. And it’s worth acknowledging that what Carmon describes as a potentially wishful stereotype of “a basically ‘decent’ young man who, were it not for too much alcohol and too little communication, would never do such a thing,” is precisely that. But for men who live in the space where Adam appears to live, that area between no and yes, maybe one way to change the dynamic is to eroticize a clear yes. “I like how clear you are with me,” Adam tells Natalia earlier in the episode. But he’s not actually clear with her about what he wants and enjoys sexually in the way he was with Hannah—at least not before ordering Natalia to her knees. Because he’s not capable of being honest with her and running the risk that if he asks her to do the things he did, that she’ll say no, Adam ends up at minimum humiliating Natalia and putting himself in a position where he feels ashamed and upset, a position I can’t imagine is preferable to having been turned down. Adam may have convinced himself that he had Natalia’s consent. But after he was done, I don’t think he could have possibly convinced himself that he actually had excellent sex.

That’s the crux of an idea television should be better at communicating, that consent isn’t just permission, it’s a way for sex to be better, and that it’s something that happens at every step along the way. It’s one thing to teach people that “no means no,” though apparently some people are impervious to accepting that dictum. It’s another entirely to teach people that it takes a clear and affirmative yes to get to a real yes.


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Tuesday, March 5, 2013

Boehringer Ingelheim Ohio subsidiary enters consent decree

Jan 31 (Reuters) - Ben Venue Laboratories Inc., a unit of German drug company Boehringer Ingelheim, may not freely make or distribute drugs from its facility in Bedford, Ohio, until U.S. regulators have determined it is in compliance with good manufacturing standards.

The U.S. Food and Drug Administration said a federal judge approved a consent decree on Thursday under which the company must bring its facility into compliance with regulatory requirements or face fines and other penalties.

Ben Venue has repeatedly violated good manufacturing practices, the FDA said in a statement. Recent FDA inspections found that poorly maintained equipment deteriorated to the point that it shed particles into injectable drugs.

"The company's failure to promptly address these problems put patients at risk of receiving poor quality drugs and compromises the availability of medically necessary products," said Melinda Plaisier, acting associate commissioner for regulatory affairs.

Ben Venue's chief executive officer, its vice president of operations and its vice president of quality operations were named defendants in the consent decree which was signed by Judge Lesley Wells of the U.S. District Court for the Northern District of Ohio.

A spokesperson for Boehringer Ingelheim was not immediately available for comment. The company this month said in a statement it had voluntarily entered a consent decree and would be permitted to continue manufacturing more than 100 drugs. The agreement was subject to approval by the judge.

Ben Venue manufactures products including sterile injectable drugs. It also makes drugs for other companies. FDA said it is working with Ben Venue to prioritize and ensure the availability of the company's medically necessary drugs to respond to and prevent potential drug shortages.

(Reporting by Toni Clarke; Editing by James Dalgleish)


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