Dubbonet and gin

Previously, I posted on my love of gin. It's not really kosher low-carb/Paleo, but it's history and heaven in a bottle. The other day, I bought a bottle of Dubonnet. Not very enjoyable, but then I noted that the late Queen Mother's favorite drink was Dubonnet and gin. Aha!

I won't buy another bottle of Dubonnet, I think, but spending an afternoon drinking with gin and browsing the web wasn't a total loss.

Wolfgang Lutz, RIP

Peter of Hyperlipid points us to the fact that Dr. Wolfgang Lutz passed away. His book Life without Bread is available from Amazon. I'm not really familiar Dr. Lutz, but I'm always impressed with the pre-WWII Germans. One of the more diabolical aspects of National Socialism was discrediting the beautiful culture German intellectuals had developed. As Scott Locklin has argued, the modern age with its fetishes for technological gadgets have nothing on the scientific progress of an earlier age.

Tsunami fallout: elderly deaths & radiation panic

The fallout from the Japanese tsunami continues. My mother informed me today that health care workers had abandoned their patients in a nursing home, and 14 elderly Japanese had died. Her tone suggested that somehow I bore some responsibility for the deaths. Of course I don't. Do the Japanese even?
There's no doubt that the tsunami is causing problems for patients and elderly people. Lack of power and supplies in the middle of winter puts patients at risk of death from hypothermia, starvation, and other causes. Unfortunately, supplies are something health care workers cannot create out of thin air. In the context of possible radiation poisoning, what are hospital and nursing home workers accomplishing by staying in harm's way?

In emergency services, it is well understood that protection of the EMTs is a prerequisite for care. Failure to put on gloves will fail you in an EMT practical exam, as will failing to secure a scene and wait for police intervention when appropriate. The rationale is clear and understandable: for a HCW to put himself in harm's way potentially creates more patients while simultaneously removing the only possibility for assistance. Similar logic would guide doctors and nurses in an emergency. In winter, without power, does it make sense for HCW to risk hypothermia when they can't actually provide heat and food to the patients anyhow? No. And when there is a radiation leak, should HCW stay at the patient bedside when they can't provide care anyhow?

The story of the 128 elderly patients found and the 14 deaths seems to have originated with irresponsible Japan-based journalist Ben Doherty. His report, which was picked up by mutliple media outlets like the Sydney Morning Herald and Slate e-zine, says that Japanese military forces found abandoned patients, as though the hospital staff had slunk off in secret without telling anyone.

As actual Japanese journalists of the Mainichi Daily News report, the military was scheduled to meet the caregivers of the 128 patients but never showed up. They then left to seek shelter from the radiation. They planned to go back, but the government ordered everyone to stay inside. In the US, this would seem like an excuse, but as Doherty himself reports, Japanese have died in collapsing buildings because they were told to stay put, such is the propensity to follow orders in Japan.

In more positive news, over 100 elderly home residents were saved when a home in Yokohama sent buses to pick them up.

Arthur Caplan, a bioethicist, addresses the question of what to do about patients during an emergency by comparing the tsunami to Hurricane Katrina. Apparently, a number of patients who were found dead around New Orleans had massive amounts of morphine and Versed in their systems, raising the question of how to leave patients.

The Derb on the plume

The other major health story to come out of the tsunami so far is the radiation plume from the Fukushima nuclear plants that is traveling toward the west coast and California. Blogger Skepchick has a series on the power plant composed of interviews with her father, a nuclear engineer. I haven't actually read the story, but she has a cool retro photo of her with her father, so I'm taking the opportunity to post it:Whatever the nuclear engineer has to say, infamous political commentator John Derbyshire gives us a healthy dose of reality on this week's RadioDerb. Here's a selection from the transcript:
I guess it's not surprising that reaction to Japan's nuclear plant crisis has been hysterical. Tokyo will have to be evacuated! A great plume of radioactive dust is crossing the Pacific! Flee! Flee! Take to the hills! America's stock of iodine pills has sold out. Makers of hazmat suits are doing brisk business. Is this the end of the world? No, but a lot of people think they can see it from here.

For crying out loud. The worst case scenario anyone has so far been able to come up with from Fukushima is that there will be a melt-down at one or more of the reactors, destroying the containment vessel. That, remember, is the total worst case, which can likely be averted.

What happens then? Well, a plume of radioactive steam and smoke goes up around 1500 feet into the air for the few hours, at worst days, it takes to control the fire. Is that bad? It's way bad, but only for the immediate neighborhood — max twenty miles in whichever direction the wind's blowing. You wouldn't want to be eating any lettuce grown under that 20 mile plume. Tokyo? Ah, that's 150 miles away. Los Angeles? Five and a half thousand.

Even that may be overstating things. At Chernobyl, a far worse situation, the fire burned not for hours but for months. The debris went not 1500 feet into the air, but thirty thousand feet. Even so, there is no evidence that anyone more than twenty miles away came to any harm, other than by eating contaminated food, which was a dumb thing to do.

Here's a pop quiz: What was the death toll from Chernobyl — a far worse disaster than anything we can expect at Fukushima, remember? Well, 31 died when the thing blew. A hundred and thirty-four people got injurious doses of radiation, and some of those people have died in the quarter-century since, though many from causes not related to radiation. Wikipedia lists 60 known deaths from the explosion and radiation overdoses. However, UNSCEAR — that's the United Nations Scientific Committee of the Effects of Atomic Radiation — gives the number as 57. Estimates of the number who may eventually die from cancers triggered by lower radiation doses are all over the place. UNSCEAR claimed four thousand cases of thyroid cancer up to 2002, but this number is widely disputed, and thyroid cancer is anyway preventable with iodine supplements. Even if you get thyroid cancer it's highly treatable, with 5-year survival rates 85 percent for females and 74 percent for males. And again, the peril there was from contaminated food and water, which people ought to have been prevented from ingesting.

So if you're having nightmares about Los Anglenos glowing in the dark, forget it. The last estimate I've seen for deaths from the earthquake and tsunami was nudging 15,000, and that will probably go higher. Chernobyl, a far worse disaster than Fukushima, most likely killed less than five percent of that number, perhaps less than two percent. Japan has suffered a terrible catastrophe, but Fukushima is merely a footnote. So please, calm down and stop screaming. Last year 269 people were killed in traffic accidents on the streets of New York City. It's unlikely in the extreme that Fukushima will kill that many Japanese. It's an order of magnitude more unlikely that it will cause even a single American to lose a day off work. Calm down for goodness' sake.

The smoking auscultation game

Over at In Mala Fide, there is an unhelpful article on the "benefits" of smoking. This put in mind of a game I used to play with myself when working on the Progressive Care Unit.

When meeting a new patient for the first time, I would auscultate the lungs, then guess whether the person was a smoker or non-smoker. I would then ask them if they smoked to find out whether I could guess from lung sounds about smoking status.

This game doesn't work in ICU due to ventilators, etc. However, in the year I worked on PCU, I had an almost 100% track record in being able to guess correctly when someone was a smoker. I had only one false negative (guessed a smoker was a non-smoker) and one false positive (guessed a non-smoker was a smoker) the whole year.

Smokers have what I can only describe as a "dulling" of all sounds in all lobes of the lungs. I mark this as "diminished sounds" on the physical assessment form, but it is different from the diminished sounds due to shallow breathing, positioning, or body mass.

The thing I found most interesting about this game is that I could guess who were smokers even when the patients had stopped smoking years beforehand. Except in one case, every time I guessed a patient was a smoker but they told me they weren't, I would ask, "oh, but did you used to smoke?" Invariabely, they would drop their shoulders and tell me yes, but they quit 5, 10, 30 years ago. Literally, I was on one occasion able to correctly identify a smoker 30 years after they quit!

smoking from a nurse's perspective

One thing that bothers me about both anti-smoking campaigns and "pro-smoker" activitists is the focus on lung cancer. One thing that is readily apparent to nurses is that smoking has much broader effects on the body than simply being a risk factor for lung cancer. In fact, I would suggest that, in terms of overall quality of life for large numbers of people, lung cancer is one of the lesser problems of smoking.

The first thing that becomes apparent to health care workers about smokers is skin quality. Although I think everyone who knows smokers recognizes that smokers get craggley, grey skin as they age, most people think of this as only an aesthetic problem. But when your livelihood involves working with people's skin as nurses do, you start to understand that craggley grey skin means sick skin. Remember, the skin is not just the outside of the body, it is a living organ with biological functions, and when it gets tough or discolored, this means it is not healthy.

Another thing noticeable to health care workers is the poor quality of smokers' veins. You have to remember that the inside of arteries and veins are a layer of cells, just as skin is a layer of cells. If the outside looks craggley and grey, the inside is equally diseased. Most people can't see the inside of their veins, but nurses can see them indirectly by virtue of putting in IV lines. As any nurse will tell you, a long-time smoker will have small and brittle veins.

The third thing is overall energy levels and activity. Sometimes active older patients will come into the hospital with cardiac arrhythmias, etc. But I have never met an active older smoker. It could be coincidence in the sense that active smokers are less likely to be admitted, but my experience tells me that smokers become much less active as they age than do non-smokers.

Although my experience of working in a PCU/cardiac care did nothing to change my mind about the correctness of Atkins/low carb/paleo eating, I did have to concede that the health nazis are pretty much correct about smoking. I say that as an intermittent cigar and pipe smoker, too.

Fashion, uniforms, and sexy nurses

Fashion label Louis Vuitton had a show not too long in the past that showcased a new line of leather handbags. The image of the white-clad nurse was used to set off the cases. Since there hasn't been a revival of anything fashionwise related to the nursing uniform, I can only imagine that the point was to draw attention to the bags' similarity to old-fashioned medical bags and, in drawing attention itself, to dispell any criticism of the bags as boringly derivative of the old medical bags. No doubt fashion insiders would have different explanations.As I mentioned on a previous post of The Sexy Nurse Report series, the white-clad nursing uniform that is ubiquitous in Sexy Nurse imagery remains so because it has social and aesthetic cache. While it's true that presenting nurse imagery of this uniform promotes misguided thinking about the nursing profession, it has remained for reasons other than a desire on the part of the public to think of nurses as "handmaidens" to doctors, etc. It is a powerful visual image in its own right.

Why it should be a powerful image, I am not entirely certain. How did any fashion arise in any time? Fashion is in conversation with its own history at all times but must also give a nod to the aesthetics of the human body as well as functionality and other considerations. As can be seen from the following fashion photo, the white nursing uniform in broad outline is a modern white dress that is still favored today.
history of the (white) nursing uniform

I don't want to write a lot about the history of the nursing uniform. This is information that is pretty much available to anyone with access to an academic library or the Internet. If you are looking for a good starting point for research, try the dyk2 site and its mirror. These both have lots of photos.

For my purpose, we only need to recognize that in the history of nursing, the white nursing uniform is not a standard. Herewith, a few historical images to make my point. First some period medieval and rennaisance imagery of nurses.

In the WWI era, uniforms tended to be long, cover a lot, and trend toward greys and subdued colors.
Common in this era was the very unsexy and unfashionable apron.
And with this apron, I think we have the origin of the modern image of the white nurse uniform. It is not, as you might imagine, that the white apron turned into a white uniform. Quite the opposite. It is the unfashionableness and lack of visual power in this apron that led to the downfall of this style of uniform. The connection is that WWI saw the nurse used in a national mobilization campaign to support the war effort. Take a look at advertisements from this period.

As you can see, advertising images from this period had very little to do with the reality of nursing uniforms like the ones shown in the photos above. The idealized, all-white uniform is simply a powerful visual image created, or at least enlarged and perfected, by advertisements and propaganda of this era.

However, as life imitates art, the images created by artists and advertisements for WWI became the reality of nursing uniforms by WWII.
Perhaps it was the widespread use of black-and-white photography and an increased consumption of magazines and media during the post-war era. Whatever the case, from this famous kiss to today, the white dress, stockings, and white cap have been considered the quintessential nursing uniform. The white uniform became "what a nurse wears" in the public imagination. This despite the fact that, as the following photo from the 1960s shows, real nurses continued to dress in a variety of ways.
white uniforms in the sexual revolution

As I mentioned in a previous post, the sexual revolution that started in the 1960s resulted in part in a breakdown of the censorship of sex in literature and, eventually, in pop culture, resulting in the free Internet pr0n available to all today. I documented some of the changes brought about by these new standards in my post Sinners in White.

But the changes in censorship did not apply to only books and the printed page. There was a rash of low quality films from this period that highlighted previously forbidden violence and sex. The term "grindhouse films" describes some of this phenomenon, as do the terms "sexploitation" and "blaxploitation," referencing films made on a low budget and meant to attract viewers purely by exploiting prurient interests or the desire of African-American viewers to see their own race and racial themes presented on screen.As any man will tell you, the male sexual psyche is an abundance of creative energy. Women in all sorts of roles became sexual characters as well as nurses. (This is in complete conformity with Rule 34, which is a truism of modern media and the male mind.)

As we have seen, the white nursing uniform we identify as a Sexy Nurse Uniform was thought of by the public at this time simply as "how nurses dress." So, it should come as no surprise if sexploitation and the public's perception of nursing resulted in the presentation on film of nurses in sexual situations wearing the stereotyped white uniform. And this is just what we got. For example, the 1970s film The Sensuous Nurse.
Midnight Blue was a sexploitation TV show that started in the 1970s and ran til 2002.

There was even a series of films with Charlie's Angels style Sexy Nurses that ran in the 1970s, starting with Night Call Nurses.



To be fair, films did recognize in a limited degree that nures wore other uniforms. As you can see from this foreign pr0n film, Sexy Nurses can dress in blue as well:Of course, sexploitation is only one step away from pornography. And we did start to get that as well. Note that in these ealier pornography films, as in Nurses Report above, the plots stay closer to a hospital-based script. This indicates to me that the Sexy Nurse, at this early point in time, was still essentially a fantasy that existed only in men's heads and in the seamy outlets like the occasional adult theatre where these fantasies could be played out. The Sexy Nurse as a nationally recognizable trope or image had not yet entered the general culture.


Later in the development of pr0n, the Sexy Nurse became less a fantasy tied to the real world and more a stock character. The plots, likewise, began to stray more from a recognizable hospital script:
In the present day, the Sexy Nurse is a full stock character, but at the same time, real nurses uniforms have less connection to the Sexy Nurse image. As a result, current pr0n films have taken to modifying the uniform with large medical crosses and red trim indicating the Red Cross color scheme so many identify with health care. These new Sexy Nurse portrayals can be downloaded all over the Internet.
And as others have pointed out or document regularly, pornography is now a part of our general culture. So, as you would expect, the current image of the Sexy Nurse in white (with red trim) uniform has become ubiquitous. As with the WWI artists creating the image of the nurse uniform that became a reality in following decades, life again imitates art, and imagery like that above can be seen in public. Celebrities are into it.
And if you want to dress up for Halloween, the Sexy Nurse is one of your best options, even at the last minute. In fact, if you do a Google search for nurse Halloween costumes, just see what you get.
conclusion

So here's a summary of my story about the white nurses uniform and the imagery of the Sexy Nurse.
  1. Before WWI, nurses wore aprons and other unsexy wear.
  2. During WWI, artists and advertisers got the war campaign bandwagon and started promoting images of the nurse all in white, a powerful visual image that worked well on posters and in advertisements.
  3. During WWII, the white nurses uniform previously promoted on posters became more of a widespread reality.
  4. With famous images like the V-J Day photograph of the sailor and nurse kissing, the white nurses uniform entered the public mind as the reality of "what a nurse looked like."
  5. The sexual revolution ended most censorship in the US and Europe. The result was the portrayal of nurses as sexual characters.
  6. Based on #4 and #5 above, it was only natural that sexualized images of nurses would portray them in the white uniform.
  7. As time has progressed, the Sexy Nurse in the white nursing uniform has become a stock character of pornography, while the real world of health care has moved away from the white nursing uniform, resulting in a severing of Sexy Nurse imagery from hospital- and health-care-based scripts.
  8. Pornography is now an accepted part of our culture and available generally. As a result, the image of the Sexy Nurse portrayed in pr0n has become the standard in the public mind, most visible in lame Halloween costumes.

So, to bring it back around to Louis Vuitton now, I think it is most likely that, although Vuitton's mankiller bags were modeled in nursing uniforms more similar to the real uniforms of the 1940s-1970s than to the fantasy uniforms of current pr0n, it is pornography that is responsible for the continuation of the public association of nursing with the white uniform.

Japan, 'kongo', and the earthquake

Author Robert Twigger has an article in The Independant about why Japan will recover:
In all areas of life the Japanese extol, in a light-hearted but determined way, konjo, or "guts". To possess it is seen as the norm rather than the exception. When I was earning my living in Tokyo as a teacher, I once phoned in to say that I had a temperature of 40C. I was told to go in anyway. (The Japanese sound like nurses! - ed.)
. . .
The tragedy now unfolding in Japan must dwarf any trite evaluation of that country's ability to recover, yet, as anyone who has experience of Japan and its history will opine: the Japanese are different.

The missing, then present, then missing pulse

From the "mistakes were made" file:

Post-op patient comes with multiple bypass procedures on one leg. The surgical leg had no pulses before surgery, even by doppler. The non-surgical leg had pulses that could be detected by doppler. Coming to me after surgery, the pedal and post-tibial pulses on the surgical leg are easily dopplered, though. The surgeon came with the patient and dopplered a popliteal pulse, pointed it out, and said that was the one he was concerned with.

Later in the evening, the patient's non-surgical leg pedal pulse disappears. The foot is warm, and the post-tibial is present. Probably not a good time to call. Then the non-surgical pedal pulse returns and the surgical pedal pulse disappears... erh?!

After some mucking around, it appears that turning the patient side-to-side causes the pedal pulse on one side to disappear and on the other side to re-appear. What gives? I don't know. Nobody else knows.

Judging either foot, the situation does not warrant a call to MD. However, the patient also has a swelling that appears to be a supremely enlarged mons pubis. It feels hard underneath. I'm thinking, hematoma?

Looking at the whole context, does the positional nature of the pedal pulses tell us anything about a possible hematoma in the pelvis?

Apparently, the answer is no. If you want to feel like an idiot, explain this theory to the surgeon at about, say... 4:00 AM.

Open letter to ANA on genetic testing

In reporting on the recent March 8-9 meeting of the MCG Panel of the FDA's advisory committee, I find it problematic that I have no recording or minutes of the meeting. Of the five W's of reporting, I am missing the vital Who and hoW components. So, I was taken by surprise yesterday as I was working on my call to nursing organizations to submit comments to federal docket FDA-2011-N-006 in support of patients' rights to view their own genetic information. It turns out the American Nurses' Association has already weighed in on this matter by sending Ann Maradiegue of George Mason University to testify before the panel on March 8th. The ANA has endorsed her testimony, which is available in PDF format from NursingWorld.org.

In reading Dr. Maradiegue's testimony, I was struck by how much she seems to stay "on message." It leads one to speculate that, as Dan Vorhaus and Daniel MacArthur have suggested, the outcome of the MCGP meeting was pretty much a forgone conclusion. For a fact-finding meeting, Dr. Maradiegue presents little transparency of the assumptions and reasoning underlying her testimony, while the research she presents tells us only that the industry is currently unregulated, which everyone knows. She presents no evidence in support of her implied preference for a "routed through a clinician" standard of regulation. The meeting, indeed, appears to have been an exercise in consensus-building rather than fact-finding.

Speaking as a nurse, I cannot endorse or agree with Dr. Maradiegue's testimony. She and the ANA claim to speak for all nurses on this matter. She told the MCGP that, in her testimony, she would inform them "what the nursing profession’s perspective is on the regulation of genetic tests, including Direct to Consumer genetic testing." However, she did not. If she had, her talk would have included statistics on professional opinion research conducted by the ANA. Instead, she has simply reiterated the opinions of select members of the ANA leadership. As the ANA does not license nurses or count them all as members, this is not the "nursing profession's perspective".

Therefore, I feel obliged to send Dr. Maradiegue and the ANA the following open letter critiqueing their statements and asking them to revise their position.


Ann Maradiegue, PhD
School of Nursing
George Mason University
Fairfax, Virginia
amaradie@gmu.edu


Dear Dr. Maradiegue:

As a nurse, I would like you to know how strongly I disagree with your March 8 testimony for the FDA on direct-to-consumer genetic testing and encourage you and the ANA to submit new comments on federal docket FDA-2011-N-0066.

In the coming era of cheap gene sequencing, access to and control of personal genomic data will--and should be--seen as a human right. Your testimony implied that health care professionals should be a protected category of Americans with an exclusive right to order and receive the results of genetic tests. As you must be aware, when whole genome sequencing becomes affordable in the near future, this standard of regulation must result in a denial of access to fundamental information about Americans' personal histories and relationships to our species and its development.

Moreover, your implicit suggestion that health care providers' interpretive abilities keep patients safe is disingenuous in multiple ways. First, as Bloss, Schork, and Topol (2011) demonstrated, the available evidence shows no harm to consumers in DTC genetic testing. Second, as you well know, neither APNs nor MDs receive education that specially qualifies them to interpret genetic data. Third, your comments presuppose genetic testing in the context of acutely or chronically ill patients when the FDA is considering regulation of all genetic testing. Fourth, your comments present a false dichotomy between an unregulated industry and clinician control of access to genetic data when a range of regulatory rules are possible that would not restrict Americans' access to their own personal genomes.

That genetic testing interpretation is complex and uncertain is due to the fact that genomewide profiling of the type offered in DTC testing is not diagnostic but reflective of risk, risk that is also found in lifestyle choices about exercise, substance use, and nutrition. In these other areas, knowledge of risk (and even advice about risk reduction) is openly available to patients without clinician intervention. Nurses should support a regulatory scheme that would promote testing accuracy but make information about genetic risks as available to Americans as information about lifestyle risks.

Your testimony puts you and the ANA, in the words of former President Clinton, "on the wrong side of history." Rather than leading change and advancing health, your testimony promotes social and technological stagnation that will send innovative industries overseas. Rather than promoting patient rights, your testimony acts as a handmaiden to the American Medical Association's docket comments and their misguided guild mentality toward the future of medicine. This guild mentality is reflected in your call for federal funds to educate nurses about genetics when you could have easily called for federal funds to improve science education and increase public knowledge of genetics.

I call on you to revise your position on DTC genetic testing. Your testimony's implicit support for the AMA's recommendation of a "routed through a clinician" regulatory standard can be undone by an explicit statement that this standard should be rejected. The FDA has re-opened its comment period for federal docket FDA-2011-N-0066. I encourage you and the ANA to submit comments in support of DTC regulation that would ensure the accuracy of consumer genetic tests while maintaining free and open access to their own genomes for all Americans.

Thank you for your attention.

[Updated March 15, 2011: Dr. Maradiegue responded to my e-mail by asking for my full name and "background information." While this is reasonable in polite society, it is also what someone would do if they intended to silence you by exerting professional pressure. No accusations here, but we must say "c'est la vie" and leave it at that...]

ResearchBlogging.org
Bloss, C., Schork, N., & Topol, E. (2011). Effect of Direct-to-Consumer Genomewide Profiling to Assess Disease Risk New England Journal of Medicine, 364 (6), 524-534 DOI: 10.1056/NEJMoa1011893

Sinners in white: romance and sleaze of the sexy nurse

This summary is not available. Please click here to view the post.

Nursing organizations should comment on DTC genetic testing

On the issue of Direct-to-Consumer genetic testing, nursing organizations like NYSNA and the American Nurses Association can make official statements. Since the FDA re-opened its docket comments on the recent March 8-9 meeting of the Molecular and Clinical Genetics Panel, there is a forum for the FDA to hear official statements from nursing organizations.

Since DTC genetic testing is a patient- and consumer-advocacy issue, I hope that nursing organizations will take the opportunity to let the FDA know that they oppose a "routed through a clinician" level of regulation that would take away Americans' rights to have access to information about their own genes.

The American Medical Association has already let the FDA know its position. The AMA believes all genetic testing should require a doctor's prescription and the results of genetic tests should only be available under a doctor's supervision, for patient safety. However, as various bloggers have pointed out, direct-to-consumer genetic testing has been a reality for several years, and the only studies of the issue have shown no harm to patients. An evidence-based approach to regulation contradicts the AMA's position.

As I have argued in another post, the health risk information provided by genetic testing is non-diagnostic and similar to the health risk information provided by nutritional information. Therefore, a standard of regulation similar to nutrition facts and health claims on food labeling is more appropriate to genetic testing companies than requiring doctor supervision for genetic testing. I hope nursing organizations would take a similar view.

about FDA docket comments

The Food and Drug Administration maintains an independent committee of expert science advisors. This committee's Molecular and Clinical Genetics Panel (MCGP) recently met over a 2-day period to hear presentations about and to discuss DTC genetic testing before making its recommendation to the FDA on regulating DTC testing.

Government agencies solicit official statements, called comments, from interested parties as part of fact-finding missions before making regulatory decisions. These comments are solicited through the federal government's official journal, the Federal Register. The Federal Register publishes an indentification number, called a docket number, and organizations wishing to submit comments use this docket number to tell federal agencies which regulatory decisions they are commenting on. Comments are submitted online and can be read by the public at www.regulations.gov. This website is searchable by docket number.

Comments for the MCGP meeting were solicited under federal docket number "FDA-2011-N-0066," which can be seen at the following web address:
http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0066
The Federal Register call for comments on the MCGP meeting can be read here (click on the PDF there for a scan of the Federal Register page).

Comments are meant to be made by organizations and institutions with a vested interest in the outcome of the federal regulatory decisions, not by individual citizens. Nursing organizations, which have a vested interest in any regulations affecting patient rights, should submit official comments soon. Individual nurses and health care professionals can send letters to the FDA and to Congress.

read more about DTC genetic testing

Here are some resources for reading more about Direct-to-Consumer genetic testing:
  • This 23andMe webpage, explains what direct-to-consumer genetic testing is, and how it works.
  • The International Society of Nurses in Genetics has released a statement on DTC genetic testing: as noted above, their main concern over DTC testing, the safety of patients, has been shown through evidence not to be a problem!
  • Ann Maradiegue testified on behalf of the ANA at the MCGP meeting March 8-9. Although she implied that she supports a "routed through a clinician" standard of regulation as against a lower standard of regulation, she did not state this explicitly. The ANA and other nursing organizations should take this opportunity to undo the damage done by Dr. Maradiegue's testimony and state explicitly their support for regulation without a "routed through a clinician" standard.
  • You can read all my posts about DTC testing, in which I lay out the position that consumers need assurances about genetic testing that would parallel the FDA's system of food regulation, not regulations appropriate for potentially dangerous drugs and equipment.
  • Genetics lawyer Jennifer Wagner has written an open letter to Congress about FDA over-reach in this area.
  • Lawyer Dan Vorhaus provides excellent, if very detailed, coverage of the MCGP meeting and the whole issue of DTC genetic testing
  • Geneticist Dan Macarthur comments on the AMA's position
Thanks for your attention.

The author of this blog is a registered nurse who works in an ICU in the northeastern United States. You can connect on LinkedIn.

[revised March 13 @5PM]

DTC genetic testing: the issue isn't dead!

According to legal expert Dan Vorhaus, the FDA is going to re-open its site for public comments on Direct-to-Consumer genetic testing as well as hold town hall-style meetings around the country.

This means the issue of DTC testing isn't dead, yet. So get in those e-mails, faxes, letters, and phone calls to the FDA... and to your representatives in Congress!

Find mailing addresses and more information in all my posts on DTC genetic testing. Remember, if you are a health care professional, this a patient and consumer advocacy issue.