Top Ten Places for Moms to Work

Our friend and fellow blogger, Chris MacDonald, has done a post on the Top Ten Places for Moms to Work -- check it out!

Thanks, Chris!

A Career In Business Isn't For Every Gender...

From my favorite satirical website, The Onion:

I've been in this field a long time. I've seen what it can do to someone who's not thick-skinned enough to bear the slings and arrows, and believe me, it's not pretty. The business world can be a cold and unforgiving place, and to make it here, you've got to be one tough cookie. It may sound harsh, but the truth is, not every gender's cut out for this line of work.

Day in and day out I watch young people with nothing more than a graduate degree and a few years of experience try to break into upper management, and almost exactly half of them find out they don't have the correct reproductive organs to hack it. They might bitch and whine and initiate litigation, but folks, them's the breaks.

Here's the long and short of it: Some people have the proper chromosomal pairing to seal the deals, and some people just plain don't.

I'm talking about survival of the fittest here, and the truth is, nobody gets a free lunch, especially when it comes to equal opportunity in hiring practices. Sure it'd be great if we were all blessed with the genitalia it takes to succeed in business, but the real world doesn't work like that. We can't fill America's boardrooms with people and genders unfit to be there just because we don't want to hurt their feelings.

What kind of society would we be living in if we gave everybody a chance, regardless of whether or not they had the right hormonal levels to get the job done? To read the rest of article, click here.

The Male Brain (of Mice and Men)

We recently wrote about how neuroscience is a burgeoning field; some say that it will displace genetics as the leading edge of scientific discoveries in the 21st century. Significant ethical issues come along with discoveries about how our brains work.

Fortunately, thanks to the vision and generosity of Paul Allen, scientific researchers will now have the tools they need to unlock the brain's mysteries. From today's Seattle Times:

The type of brain map that used to grace high-school biology texts looked like a quilt: A pink chunk labeled "vision" bumped up against a blue blob that was the seat of language and a yellow swath representing motor perception.

Those crude representations were the result of centuries' worth of painstaking dissection, coupled with case studies of people suffering from brain damage and disease.

It took only three years for a Seattle lab founded by Microsoft mogul and philanthropist Paul Allen to revolutionize the landscape of neuroscience by creating a map of the brain that goes far beyond topography to pinpoint the workings of individual cells.

Allen, who donated $100 million to the lab, said he is so pleased with the results that he will consider similar, large-scale science projects in the future.

"This was a great opportunity to do something here that made a difference, and that we could do quickly," he said. "We'll certainly look for more opportunities like this."

Experts say the Allen Brain Atlas, which will be formally unveiled today, will boost understanding of brain circuits and chemistry — and what goes wrong in conditions ranging from schizophrenia and autism to Parkinson's disease and drug addiction.

The initial mapping will be done on male mice. While we applaud their efforts, it is important not to assume discoveries based on male models (mice or men) can be directly translated to the female gender.

We found this out with heart disease. Paul: Remember the ladies!

Sex and the Single Brain

I'm not sure if this book that the Washington Post reports on is really a thoughtful discourse or just adding fuel to the gender stereotype fires -- the article in the Post suggests the latter:

According to pop psychiatrist Louann Brizendine, author of the best-selling new book "The Female Brain," men and women come equipped with completely different operating systems -- not only below the belt but between the ears.

Like bath towels, there are his-and-her brains -- that there is no such thing as 'unisex brain.'

Brizendine insists this is a scientific fact. Males and females may perform similar calculations, but they use different "circuits." Woman is Mac. Man is PC. Blame the brain.

For Brizendine, it's all about the hormones --"The female brain is so affected by hormones, they control her very perception of reality," says the doctor. "Her values, her desires, what's important to her, even whom she loves." For him, brain awash in testosterone, it's all about sex and aggression...

But some of her critics say that what Brizendine did was overstate the science. In part, it may be the style that Brizendine adopts when she speaks and writes. When science looks for differences, it finds them in the average male and average female -- meaning that if six in 10 women show an advantage in one area, so do four in 10 men. But this gets lost
in the prose.

n a 2001 National Academy of Sciences report, the authors write: "Sex matters. Sex, that is, being male or female, is an important basic human variable that should be considered when designing and analyzing studies in all areas and at all levels of biomedical and health-related research."

I'd like to get Martha Farah's or Judy Illes's take on this supposed scientific research, two women who have been among the founders of The Neuroethics Society, a brand new interdisciplinary group of scholars, scientists and clinicians who share an interest in the social, legal, ethical and policy implications of advances in neuroscience.

Pet Cloning

Should we worry about pet cloning? I was asked that question the other day by a woman who had just heard about CC the cloned cat and the Genetic Savings and Clone company. And while it might seem like a trivial, sideshow kind of issue, a quick internet search revealed that they follow a set of internally developed bioethical code of conduct. I was impressed - wish all biotech companies had such transparent guidelines.

Whether you support pet cloning or not, I think her question reveals the core anxiety we all feel about emerging technologies: Could we? Would we? Should we? And why it is so important to always ask the bigger question of "what kind of a world do we want to live in."

Stem Cell Wars

I just read a newly released book called “Stem Cell Wars: Inside Stories from the Frontlines” by Eve Herold. I don’t like the use of war metaphors, especially in the time of real war, even for politically contentious issues. But Palgrave Macmillan knows more about selling books than I do, so I won’t hold it against the book.

More a chronicle of events than hard hitting analysis, Herold methodically provides the reader a primer on stem cell research and cloning, the politics of science during the Bush administration, and the inside story of the South Korean scientific fraud. For those of us who have watched this issue closely, Herold’s account doesn’t provide any new information but her eyewitness reporting style will have appeal to those who have been watching from the sidelines (and wondering what the heck is happening.)

I think the book could have benefited from a more rigorous examination of the ethical issues surrounding stem cell research beyond the “moral status of the embryo.” Perhaps a forward by bioethicists Laurie Zoloth or R. Alta Charo rather than Harvard physician George Q. Daley would have better served the reader. While Herold does touch on it briefly, she seems genuinely confused why some on the political right continue to equate stem cell research with abortion, because, as she correctly points out, stem cell research could continue unabated even if all abortions were outlawed. Or perhaps her editors decided it wasn’t appropriate to further explore how the stem cell war is also about the abortion war, contraception and IVF war, assisted suicide war, Terri Schiavo war and the broader bioethics agenda of the political right.

The most delightful surprise was learning the story of Bernard Siegel, Founder and Executive Director of the Genetics Policy Institute. It is a fascinating story of how one man, compelled by his concern for the welfare of a supposedly “cloned” child, exposed the Raelian media hoax. All in all, the book is an easy read, puts a human face to the issues, and is an important call to stop the politicizing of scientific research in the US.

More Than A Choice

Often, the "pro-choice" versus "pro-life" debate fails to acknowledge the reality of women's lives and is reduced to meaningless sound bites that make good fundraising copy but lousy public policy. Jessica Arons, Director of Women's Health and Rights at the Center for American Progress has just published a compelling new whitepaper: "More Than A Choice - A Progressive Vision for Reproductive Health and Rights." Arons, who is known for her ability to bring together diverse voices and craft a vision for the future, has produced a progressive blueprint for reproductive health and rights.

From the report:
"The core values that ground a progressive understanding of reproductive health and rights in the United States are easily stated but necessarily complex. At the Center for American Progress, we embrace equally the rights to have or not have children, with a partner of one’s choosing, in a time and manner that honors one’s conscience and life circumstances. So many factors shape such weighty decisions that it may be difficult to tackle them all simultaneously, but, at a minimum, it is critical that the reproductive health and rights policies supported by progressives address the reality of people’s lives and the context in which such decisions are made.

The decision to have a child, for instance, is connected to plans for education and career, as well as family. A healthy pregnancy requires quality medical care, a safe environment and emotional well-being. Parents must be able to provide love, attention and stability to their children, facilitated and supported by decent housing, schools, employment, child care, health care, and other societal structures that strengthen family life. In order to prevent or plan for parenthood, people need reliable education about sexuality and access to safe and affordable contraception and abortion care.

Simply put, reproductive rights are about more than just abortion.

Check out the entire report.

Functional MRI Raises Questions

As I write this the scientists at the Medical Research Council Cognition and Brain Sciences Unit (MRC) in Cambridge, England are conducting a test. They are using a new technique, called the functional M.R.I., to peer inside the human brain (Benedict NY Times). This new equipment is allowing them to map the regions of the brain that are stimulated when a patient is put to different tests. By comparing the reaction of a healthy, uninjured brain to that of someone who has been in an accident the scientists can tell what type of damage has occurred.
This brings a whole new level of diagnosing ability when it comes to brain damaged patients. For years physicians have had only the educated guess to rely on as a tool to determine whether a patient was cognizant of what was happening, could feel pain, or had any understanding of them self whatsoever. Through the use of this new software many of these questions can know be answered. The diagnosing physician can have real-time evidence as to the extent of a patient’s injury, and will therefore be better able to perform treatment.
If this new scanning technique can offer as much information as Dr. Adrian Owen, the MRC’s lead brain researcher says it will, then its going to force much of the medical community to rethink some major issues (Benedict NY Times). Specifically, the issue of physician assisted euthanasia, and many of the concerns regarding patient autonomy and the role of decision maker. If patients that previously were thought to be in a “vegetative” state can be shown to have a significant amount of brain function, should that change how they are cared for? Would a situation similar to that of the “Terri Schiavo Case” be handled differently if there could have been evidence of pronounced brain function?
Members of the medical community have differing opinions as to what the impact of the functional M.R.I. will be. It is undecided as to what extent this new technology should be used, and whether it can be fully trusted as a diagnosing tool. Anatomically speaking there is more going on in the brain then just electrical currents passing from neuron to neuron. Dr. Owen admits that this new software doesn’t solve the entire puzzle, but provides a significant piece (Benedict NY Times). Patients who suffer severe brain damage due to oxygen deprivation may show brain activity on the scan, but will never regain consciousness or function as normal, healthy human beings.
Regardless, this new technology gives the medical community a stronger scientific basis to make their case against what often times becomes a discussion of moral and ethical behavior. Euthanasia, the treatment of patients in a “vegetative” state, and even the level at which autonomy of the patient should be deciphered all have to be re-examined due to these recent breakthroughs. Dr. Joseph Fins, chief of the medical ethics division at NY Presbyterian Hospital, said it best, “For now I think what this study does is to create another shade of gray in the understanding of gray matter.”

-Peter A. Beaulieu

Mental Activity Seen in a Brain Gravely Injured, Benedict Carey, September 8, 2006: NY Times (http://www.nytimes.com/2006/09/08/science/08brain.html)

Genetics in Chicago

Quick heads-up for any of our readers who are in or near Chicago: the Illinois Humanities Council is hosting a Town Hall meeting on the topic, "Future Perfect: Conversations on the Meaning of the Genetics Revolution" on September 26, 6:00-8:00 pm, at the Museum of Contemporary Art Theater. The event is free and open to the public--and it kicks off a year-long program on genetics and society.

More info available here.

[Hat tip: Mark Sheldon at Northwestern]

The 'Moral Chaos' of the Twilight Zone, continued

Earlier, we had posted about how new neurotechnologies might change the way we look at MCS or PVS patients -- just a few days ago, Rob Stein of the Washington Post reported about a young woman was deep in a "vegetative state" -- completely unresponsive and unaware of her surroundings after a traumatic brain injury a little more than a year ago. But then a team of scientists in the UK decided to do an unprecedented experiment, employing functional MRI technology to try to peer behind the veil of her brain injury for any signs of conscious awareness.

What they found was surprising:

The researchers put the woman in a scanner that detects brain activity and told her that in a few minutes they would say the word "tennis," signaling her to imagine she was serving, volleying and chasing down balls. When they did, the neurologists were shocked to see her brain "light up" exactly as an uninjured person's would. It happened again and again. And the doctors got the same result when they repeatedly cued her to picture herself wandering, room to room, through her own home.

To read on, click here.

Chile: Birth Control Free for Women Over 14

Thanks to Chris MacDonald of the Business Ethics Blog for bringing this to our attention:

SANTIAGO, Sep 4 (IPS) - The Chilean government decreed that all public health centres must provide birth control, including emergency contraception, to adolescents and women over the age of 14 -- a measure that immediately drew the ire of the Catholic Church and the right-wing opposition parties.

"We applaud the decision of the Chilean Health Ministry, because we believe it safeguards the rights of women and gives us a chance to interrupt the cycle of poverty," Ximena Rojas, assistant director of the non-governmental Centre for the Development of Women (DOMOS), remarked to IPS.

After President Michelle Bachelet, a pediatrician, took office in March, Domos asked the Health Ministry to expand the distribution of emergency contraception.

The measure, announced Saturday by Health Minister Soledad Barría during the fifth Chilean Congress of Pediatric and Adolescent Obstetrics and Gynecology, forms part of the new "national norms on fertility regulation" that will begin to be applied this month in all public hospitals and clinics around the country.

Any teenage girl over the age of 14 will now be able to directly ask her doctor for a prescription for birth control, without authorisation from her parents, and the contraceptives must be provided free of charge by the public health system.

The new decree complies with the sexual and reproductive rights approved at the 1994 United Nations International Conference on Population and Development in Cairo.

The most controversial aspect of the Health Ministry decree is that it not only covers traditional birth control methods, but also emergency contraception, which up to now was only available free of charge in cases of rape, although it was available by prescription in the country’s pharmacies.

Although it is popularly known as "the morning after pill", emergency contraception can be taken up to five days (120 hours) after unprotected intercourse. The pill works by providing high levels of synthetic hormones, which interfere with ovulation and change the lining of the uterus, significantly reducing the likelihood of pregnancy.

The World Health Organisation (WHO) clarifies that emergency contraception is "not effective once the process of implantation has begun, and will not cause abortion."

But archbishop of Santiago Francisco Javier Errázuriz said the decision by the centre-left government was a blow to marriage, the birth rate, and the Chilean family.

"I was hoping for good news for Chile at the beginning of the month of the fatherland," said Errázuriz, referring to the fact that on Sep. 18 and 19, Chile will celebrate 196 years of independence, and will pay homage to the army. "But it is not good news for a country to be obsessed with contraception."

Several mayors from right-wing opposition parties also rejected the government decree, and threatened not to respect it. (Municipal governments are in charge of administering the public health clinics.)

To read on, click here.

Entering the Twilight Zone

Although the article in Wired this month about altering PVS (persistent vegetative state) patients consciouness' from persistent to minimal or more is entitled "Back from the Dead", I think a more appropriate title might be "Entering the Twilight Zone". Writer Gary Greenberg attempts to tackle the "moral chaos" that might arise if, in fact, we might be able to restore varying degrees of consciousness to PVS patients with a 'brain shock":

A small but passionate group of doctors say that electricity applied deep in the brain can jolt patients out of irreversible comas. That's when the real problems begin.

By Gary Greenberg

For someone left for dead 12 years ago, Candice Ivey seems to be doing pretty well. She's still got her homecoming queen looks and A-student smarts. She has earned a college degree and holds a job as a recreational therapist in a retirement community. She has, however, lost her ballerina grace and now walks a bit like her feet are asleep. She slurs her words a little, too, which sometimes leads to trouble. "One time I got pulled over," she says in her North Carolina twang. "The cop looked at me and said, 'What have you been drinking?' I said, 'Nothing.' He said, 'Get out here and walk the line.' I was staggering all over the place. He said, 'All right, blow into this.' Of course I blew a zero, and he had to let me go." (To read the rest of the article, click here.)

Designing Children: For Health or More?

The well-educated are significantly more open to the idea of "designing" babies than the poorly educated, according to a new study by psychologists at the University of East Anglia in the United Kingdom; the study had some interesting results including:

* The better educated prospective parents are, the further they are prepared to go to improve their children's IQ.
* Women interpret certain interventions in child rearing as "design acts" more readily than men.
* People over 50 interpret certain interventions as "design acts" more readily than people under 25.
* Because of "parental uncertainty" - the idea than women know for certain if a child is their's whereas men do not -- men show a significantly greater preference than female parents for their children to inherit their own characteristics.
* Parents see different physical, social and intellectual characteristics as desirable depending on the sex of the child.
* Older women and childless women are significantly more willing to "improve" the physical, social and intellectual characteristics of prospective children? (This can be explained by women seeking to increase their genetic heredity, particularly when their time to reproduce begins to decrease.)
* Both men and women see genetic engineering as acceptable primarily for medical applications.

A Carnival of Feminists: Women and Healthcare theme

I had not heard of a 'blog carnival' until blogger No-More-Nice-Girls-Nikki Giovanni (aka Lingual Tremors) sent us an invite to submit to the 23rd edition of the Carnival of Feminists to posted on September 20, 2006. The theme this year is Women and Healthcare, our favorite topic!

You can use the Blog Carnival submission form or email lingualx (at) yahoo. com. Submissions are due by 18 September 2006 at midnight.

Monsters and Motherly Mad (and Bad) Scientists

In mad science films, maternity is both danger and salvation, according to an article in the Scientist by J. Kasi Jackson, an assistant professor in the Center for Women's Studies at West Virginia University:

In my work on female scientists in B-movies, I explore the way that such films deal with our inclination to view science as masculine and nature as feminine. When men are doing the science, this isn't a contradiction; in these films, masculine, rational science dominates and controls irrational, feminine nature. Sometimes, the pattern is obvious, such as when a wild-haired, wild-eyed Frederick Frankenstein (Gene Wilder) from Young Frankenstein (1974) shouts that he will use science to "penetrate into the very womb of impervious nature herself."

But what happens when the mad scientist is a woman?

Instead of being portrayed as madly evil in the Young Frankenstein, messy-haired sense, B-movie female scientists are capable and feminine -- but with a bizarre twist: an emotional, intuitive and maternal drive channeled toward nature. Or as Stacy Alaimo puts it, she is "unfaithful" to those who trained her, "allying herself with the nature she is supposed to control."

A great example is Carnosaur (1993), in which Jane Tiptree (Dianne Ladd), fed up with humans messing up the environment, decides to wipe them off the face of the planet by genetically engineering a virus that causes women to give birth to dinosaur eggs. Although Tiptree is decidedly mad, she is also very feminine -- she alone sports manicured nails, plucked brows, and makeup. She is a maternal (not sexy) female figure, a vengeful Mother Nature who will destroy humanity to save the world. The dinosaurs are her children, literally -- she willingly sacrifices herself to her own virus and dies when a Carnosaur digs its way through her abdomen.

A theme I have noticed in B-movies is that, to escape madness such as Tiptree's, the female scientist must redirect maternal impulses she has about nature towards human children or a romantic partner. In Kingdom of the Spiders (1977), she does both. Scientist Dianne Ashley (Tiffany Bolling) and veterinarian Robert 'Rack' Hansen (played by a typically macho William Shatner) fight human-eating tarantulas. Ashley starts the film on nature's side -- she argues that the spiders kill large animals because pesticides have destroyed their prey, and her preferred solution is to let nature attain a new balance.

In one strikingly classy scene, Ashley, clad in a towel, finds a spider in her dresser drawer. As we wait in delicious suspense for the inevitable shrieks of fear, she instead picks it up and croons: "Well, hello there." But Ashley eventually abandons her inhuman alliance with nature and, along with it, her scientific role; she spends the last part of the film protecting and consoling Hansen's young niece -- and forgetting her initial objection to hooking up with Hansen.

Susan Drake (Ann Turkel) from Humanoids from the Deep (1980) is not so fortunate. Drake genetically engineers fast-growing salmon to replenish a depleted fishery. However, native coelacanths eat the salmon and mutate into half-man/half-fish monsters which are driven to mate with human women and kill all the men. As the voiceover in the trailer aptly summarizes, it's "a battle over the survival of the fittest -- where man is the endangered species and woman the ultimate prize." Drake helps the local people defeat the humanoids, but afterwards she helps the last remaining impregnated woman give birth to one of the mutant monsters, which kills the mother in the process and leaves sequels open to further madness.

In mad science films, maternity is both danger and salvation. If her maternal feelings are linked with nature, the female scientist will create monstrosities that will destroy mankind. The woman scientist who redirects her instincts to people, however, saves people from nature's wild ways, but she must sacrifice practicing science to achieve this. Either way, the choice to mother, and if so, what to mother, will define her.

The Vatican's Intelligent Designs?

My heart sank when I heard that the Pope was preparing to embrace theory of intelligent design ~ according to the Guardian, the Pope expressed concern when he raised the issue in the inaugural sermon of his pontificate, saying: "We are not the accidental product, without meaning, of evolution." ~ but I didn't think that Darwinian evolution necessarily "unseats humanity as master of a divine creation."

I just hope that the Vatican doesn't renege on its apology to Galileo.

To Clone or Not to Clone: Is that the question?

To Clone or Not to Clone: Is That the Question?

A Moderated Panel Discussion

The Women's Bioethics Project will present a moderated panel discussion titled “To Clone or Not to Clone: Is That the Question?” A compelling and broad look at cloning and related issues.

The event will be held in the ACT Theater's Bullit Room on Tuesday, August 29 from 6:00–8:00PM followed by a cheese and wine reception.* This is a free event and space is limited so please RSVP.

The rapid advance of emerging new technologies leave many people bewildered and concerned. This accessible and interactive event is for anyone who is curious about what science, ethics and the arts have to say about cloning and related issues. It will shed further light on the ethical issues raised by stem cell research and cloning.

Panelists:

Paul Abrams, MD/JD, former President and CEO of CEPTYR, who will talk about the science behind adult and embryonic stem cells, therapeutic and reproductive cloning. He will address the following questions: How does adult stem cell s compare to embryonic stems cells? How is stem cell research connected to cloning technologies? What is the difference between therapeutic and reproductive cloning? What is the reality of those technologies today?

Emilie Clemmens, Ph.D., Research Fellow, Women's Bioethics Project, who will discuss the ethical implications of these emerging technologies. She brings her perspectives as a woman, mother, scientist, and ethicist to these critically important questions.

Kurt Beattie, Artistic Director, ACT Theater, who will speak about what the arts have to say about emerging technologies including ACT's upcoming production of "A Number." He will discuss how theatre can shed light on these difficult and complex questions.

Moderators:
Kathryn Hinsch, Founder, Women's Bioethics Project

Petra Franklin Lahaie, Board Member of both Women’s Bioethics Project and ACT Theater

Quote from Kathryn Hinsch, Founder, Women's Bioethics Project: “A key part of the Women’s Bioethics Project’s mission is to help people understand the implications of merging technologies.” said Kathryn M. Hinsch, founder of the Women’s Bioethics Project. “To some, cloning might seem like science fiction. But, in fact, last year, more than 500 bills were introduced at the state level that related to cloning or stem cell research. Since there is currently no federal law banning human cloning, we expect it will be a hot topic in 2006. Just this past year, California, Connecticut, and Massachusetts each passed legislation banning human cloning, but permitting the technique for research purposes. It is something voters need to know about now”

For more, check out the WBP home page.

New technique for developing embryonic stem cells: Does it make a moral difference?

Big news on the stem cell front this week: researchers at Advanced Cell Technology this week reported that they've developed a method for culturing embryonic stem cells from a single cell removed at the 8-cell stage. Removing the cell doesn't harm the embryo or hamper further development; in fact, this is the process currently used for preimplantation genetic diagnosis.

Proponents of the new technology say that it eliminates the major objection of those opposed to embryonic stem cell research: it doesn't destroy embryos. Some disagree, however, arguing that the single cell that is removed also has a right to life. The Vatican, which has long opposed all IVF technologies, says that the new method is unacceptable.

Still others doubt that technological changes can answer the inescapable ethical/moral question of whether embryonic research should be permissible. As Art Caplan told the New York Times (see the third link below), "This isn't a technique that's going anywhere. This isn't an alternative to anything."

Read more all over the place: here, here, and here, for starters.

FDA Approves Plan B's Over-the-Counter Sale

From the Washington Post this morning:

By the end of the year, American women will be able to walk into any pharmacy and buy emergency contraceptive pills without a prescription as a result of a Food and Drug Administration decision announced yesterday.

The decision means women will not have to go to a doctor first as long as they can prove they are 18 or older to a pharmacist, who will keep the drugs behind a counter. Younger teenagers will still need a prescription, and the pills will not be sold at gas stations, convenience stores or other outlets that do not have pharmacists.

The approval marks the first time a hormonal contraceptive will be broadly available in the United States without a prescription. The pills, which will be sold as Plan B, will probably cost about $25 to $40 per dose, and men will also be able to buy them.

The announcement was aimed at resolving one of the longest and highest-profile health controversies of the Bush administration, but opponents said they are considering plans to block the decision, either in court or in Congress.

To read on, click here.

Is meat-packing better regulated than the tissue transplant industry?.

We've all heard a bit in the news lately about the need to better regulate the tissue transplant industry. Inadequate screening transplant tissues for disease and decomposition has led to several fatal events for transplant receivers, and new stories of illegal tissue harvesting have scared the beejezus both of potential receivers and kin of the deceased.

As organ and tissue transplantation has become more viable and more commonly practiced, the demand for donor tissues and organs has increased. An industry of companies that harvest and provide tissues for transplant has surfaced to meet this demand. Almost any kind of tissue may be handled by this industry, including organs, skin, and bone. So how exactly is it that companies who provided this service were not required to register with the FDA until 2004?

It seems that prior to 2004 regulation of transplant tissues paled in comparison to that of the meat-packing industry. How is it possible that tissues that we eat and pass through our bodies are better screened than those that are placed permanently in our bodies? While my knowledge of the immune system is far from up to par, it seems to make biological sense that its easier for my immune system to fight off a population of bacteria originating from a food that passes through the digestive system, as there it will at least be partly processed and degraded, unlike a bacterially infected tissue that takes permanent home with other bodily organs and tissue.

New developments have surfaced since first beginning this writing in July 2006. Just this month, the FDA ordered the human tissue recovery firm Donor Referral Services (DRS) to shut down its operations, finding “serious deficiencies in its manufacturing practices, including those governing donor screening and record keeping.” I find this astounding. It seems that at every suspect outbreak of mad-cow disease, there is a barrage of public health warnings and media hype, quickly followed by indications that the disease path as been tracked and the origination determined and quickly shut down. Amazingly, records and manufacturing processes for tissue recovery and donation seem much looser. Case in point is the instigation of the shut down of DRS: “FDA's inspection identified serious violations of the regulations, including the failure to establish and maintain procedures for manufacturing steps...FDA also found several instances where records provided by DRS to another HCT/P establishment were at variance with the official death certificates FDA had obtained from the state where the death occurred.”

The FDA's new regulations for tissue recovery and transplant services took effect in May 2005. “Among other mandates, the regulations require firms to properly screen and test donors and, when needed, they enable FDA to take swift action in the interest of public health.” Better late than never I suppose; but I can't help but suspect that both the industry and the FDA is saving face for not implementing preemptive regulation long ago.

New regulations for donor eligibility and screening can be viewed here: http://www.fda.gov/bbs/topics/news/2004/NEW01070.html

Press release on DRS shutdown: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01433.html