Category Archives: Michelle Strecker

by MStrecker | July 18, 2012 · 10:49 AM

Conflict of Interest and Practice Guidelines: A Call to Arms

ON THE LEVEL

I admit that I started out with the intention of writing a point/counter-point piece to Bob’s post on conflict of interest. As a laboratory genetic counselor and a member of the NSGC Practice Guidelines Committee, I figured if anyone should step up, it should be me. So I started doing my background research. First, I decided that perhaps Bob just couldn’t find the Conflict of Interest Policy on the NSGC website. I was determined to find it, right there, hidden in plain sight. But, no such luck. It’s not there. There is not even a mention of it on the page with our Code of Ethics link. OK, score one for Team Resta.

So what about our “sister” organizations like ACMG and ASHG? What do they do? I went to the ACMG website and after searching for several minutes, I couldn’t find anything there, either. OK, so we weren’t the only ones who did not have a conflict of interest policy posted on our website. Team Strecker, makin’ a move. How about ASHG? (At this point I was thinking, well, if ACMG didn’t have anything, I bet ASHG won’t either.) Wrong. In fact, waaaaaaay wrong. ASHG has a link to their Conflict of Interest & Disclosure Statement, prominently displayed under their Bylaws, which provides clear definitions regarding what constitutes a conflict of interest, how both real and potential conflicts of interest are handled, and to whom the policy applies. Yeah, I admit it; I was impressed.

TAKING A GOOD, HONEST LOOK AT OURSELVES

Next I decided to tackle Bob’s recommendation that we base NSGC’s conflict of interest policy for the development of practice guidelines on the Institute of Medicine’s (IOM) Committee on Conflict of Interest in Medical Research, Education and Practice recommendations. “It would not be that difficult to implement,” he tells us. All I could think was “Sure, easy for you to say.” But then I realized, that maybe, just maybe, Mr. Know-It-Almost-All Resta might just be right. Section 7 specifically addresses conflicts of interest with respect to developing practice guidelines. I’ll summarize it for you:

1) Don’t accept industry funding for the development of guidelines.

No problemo!! I can tell you that on my watch, no one has ever offered money to help us get practice guidelines written. In fact, I almost laughed when I first read this one, because I feel like any of us would have the good sense to see the wolf dressed up in granny’s clothing here (My, what big stacks of cash you have, grandma!).

But then I reminded myself that when it comes to ethics, credibility, and money, we must assume nothing.

2) Exclude individuals with conflicts of interest from guideline development panels.

I have mixed feelings about this one because I’m not sure whether we are talking about individuals with (i) true conflicts of interest (in which case, I agree and they should have the good sense to recuse themselves) or (ii) the potential-for-the-perception-of-a-possible-conflict-of-interest.

For example, I take issue with unconditionally excluding laboratory genetic counselors from co-authoring guidelines simply because their laboratory offers a test for the condition about which the practice guideline is being written. Obviously we want the reputation of the NSGC and its practice guidelines to be above reproach, but we also need to be pragmatic. The expertise of laboratory genetic counselors should not be marginalized. Let’s use our judgment with this one, and if the magnitude of the conflict of interest is deemed significant, then it is fair to provide an option for participating as an advisor, rather than an author.

3) If there is difficulty identifying authors without any conflicts of interest, involve the public in an attempt to identify experts without any conflicts of interest.

I like this one. A lot. You know why? Because the public (and by public here, I really mean the NSGC membership) is no longer involved in any aspect of the Practice Guidelines process. Topics for upcoming practice guidelines are not provided or voted on by the membership. The fact is, as a volunteer-driven organization, we are entirely reliant upon the gracious volunteer efforts of our colleagues. So with no trace of disrespect whatsoever, you know what they say about beggars and choosers. The thing is, this method of ascertainment leaves me feeling like we’re in some sort of secret society. Apart from the Practice Guideline Committee members, the NSGC Board of Directors and the authors themselves, I’m not sure that anyone else even knows what practice guidelines the NSGC is working on for 2012-2013. (And they certainly don’t know our secret handshake. Kidding!)

In fact, most of the time, members don’t even know a practice guideline is in the works until it is made available for Membership Review. Oh wait, we don’t even have that anymore. This March, the Practice Guidelines Committee received feedback from the NSGC Board that guidelines were taking too long to complete, and in order to help “streamline the process” the NSGC Board determined that practice guidelines would no longer undergo Membership Review. This was none too popular with the Committee, but we were informed that the Board’s decision was final. So, this IOM recommendation got me to thinking that perhaps we could institute an open call to the NSGC membership once a practice guideline proposal has been accepted in order to allow interested individuals with relevant expertise the opportunity to volunteer as co-authors. This would allow us to identify as many conflict-of-interest-free potential co-authors and expert reviewers as possible, and although it wouldn’t be the same as re-instituting member review, it would be a step in the right direction.

4) If exclusion of authors with conflicts of interests is not feasible, the number of authors with potential conflicts of interest must comprise a minority of the author group.

Whew. Done and done. We are good here – our policy already states this.

5) The chair of the guideline committee should have no conflicts of interest.

I am with Bob here – we need to revise our current Conflict of Interest Policy to reflect this. At present, our policy for practice guidelines authors states that “a conflict of interest does not exclude an individual from being appointed lead author if doing so is anticipated to improve the overall quality of the guideline.” It is a very well-intentioned statement, but in order to garner respect for our profession, our society and our practice guidelines, we have to toe the line on this one and make it clear that lead authors cannot have any relevant conflicts of interest.

6) Individuals with a potential conflict of interest should not be included in voting for the acceptance of a practice guideline.

Woohoo! Got that one! Oh wait, maybe not. Dang it! The reality is that the Practice Guideline Committee members with potential conflicts of interest have always recused themselves from voting on practice guideline proposals and final drafts of guidelines, but after re-reading our Conflict of Interest Policy, I realized that we don’t actually say that we do this in the document, and we need to.

DIVULGING OUR FINANACIAL AFFILIATIONS

So we have clearly established that Bob might, in fact be right about that whole IOM thing not being all that difficult to implement. But what about his challenge to make our corporate income sources publically available? I don’t have a problem with Bob’s suggestion to make a list of our corporate sponsors available, but rather than providing them with free advertising on our site, perhaps it could be made available on request. In addition, I would like to once again direct your attention to our colleagues at ASHG and their “Guidelines for Corporate Sponsorship” in which they delineate the steps that are taken to prevent concerns about undue financial influence on the society by outside sponsors. I think a similar policy would be a great addition to the NSGC website. Being upfront about our sources of income helps demonstrate that it is important to us to be free from undue external pressure and lends credibility to our professional society.

BRING IT!

I’ll close with the quote that appears on the title page of the IOM’s recommendations regarding conflict of interest:

“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe

You see, Pom-Poms Resta, you sit comfortably on the sidelines, telling us that it is not your intention to actually DO anything about the issues you bring up; all the while, taunting the rest of us to “Buh-ring it!”. OK. You know what have to say about that? In the immortal words of Priscilla in “Not Another Teen Movie” (Columbia, 2001) let me just say– “Oh it’s already been buh-roughten!”. (Insert sassy Z snap here for emphasis.)

I have contacted the NSGC Practice Guidelines Committee’s Board liaison to propose a volunteer taskforce dedicated to strengthening our Conflict of Interest Policy and fortifying our efforts toward transparency in our corporate sponsorship ties.

So, the only question remaining is “Who is willing to get all Goethe on this issue with me?”

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Filed under Michelle Strecker

Tagged as conflict of interest, ethics, Michelle Strecker, practice guidelines

by Robert Resta | February 16, 2012 · 11:15 PM

Why We Love Genetics: A Group Post by The Staff of The DNA Exchange

We suspect that many genetic counselors out there got hooked on genetics by an intriguing bit of information, something that grabbed your attention and made you say “Hey, that’s pretty cool. I want to learn more about this field.” Sure we all want to help people and be good counselors, but the intellectual stimulation of the complex field of genetics also plays a critical role in keeping the spark in your career relationship.

So, in a slightly belated Valentine’s Day posting, we wonks and nerds here at the DNA Exchange (well, there is no “here” here, just 5 of us who email back and forth on an irregular basis) decided to provide some Genetic Factoids that caught our fancy. They include the profound, the moving, the questionable, the near sensationalist, and some gee whiz stuff. Be stimulated by them, have fun with them, and in the Comments section, share your fave facts about genetics with our readers.

♥ During the course of mammalian evolution, the RNA of retro- and other viruses have become integrated into host genomes, thanks to that clever devil of an enzyme, reverse transcriptase. Currently about 8% of the human genome is derived from these viruses. And these are not just inconsequential inert bits of DNA. Some viruses play a critical role in mammalian biology. For example, the HERV-W retrovirus plays an important role in placental physiology, and, by one estimate, 0.4% of human genetic diseases are the result of insertions of Alu elements of retroviral origin. On top of that, about 90% of the cells in the human body are not actually human, as we are inhabited by a large populations of bacteria and other microbes (biology makes for strange bedfellows). Among other things, this calls into question just how much we are defined by “our” DNA, as well as how we delineate the borders between species. It also makes me smile about our growing obsession with germophobic practices. (Horie M, et al. Endogenous non-retroviral RNA virus elements in mammalian genomes. Nature , 2010, 463:84-7; Ryan F. Human endogenous retroviruses in health and disease: a symbiotic perspective. J R Soc Med, 2010, 97:560-5.; Katzourakis A, Gifford RJ. Endogenous viral elements in animal genomes. PLoS Genetics, 2010, 6(11):e1001191)

♥ The largest mammalian gene family has nothing to do with placentas, fur, intelligence, or behavior. Instead, the award for body system with the most DNA devoted to it goes to the olfactory system. Three percent of the human genome codes for olfactory receptors, more than the combined total of genes devoted to immunoglobulin and T-cell receptors. The smell of love is in the air, we have the genes to help us detect it, and Chanel takes advantage of that. (Shepherd GM Neurogastronomy: How the brain creates flavor and why it matters. 2011. Columbia Univ. Press)

♥ During the early 1990s, two out of three of deaths among men with hemophilia were the result of AIDS related complications, the majority of which were young men who had acquired the virus during transfusion treatments. In 2009, about half of all people diagnosed with hemophilia in the United States were infected with the Hepatitis C virus. One disease’s cure is another disease’s cause (vide infra, PKU) (Committee Reports, 111th Congress (2009-2010), House Report 111-220, Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriation Bill, 2010.; Soucie JM et al. Mortality among males with hemophilia: relations with source of medical care. Blood. 2011. 96:437-42.)

♥ In the United States in 2009, there were as many babies exposed to maternal PKU as there were babies born with PKU. Given the inadequate funding for follow-up of patients who have genetic diseases detected by newborn screening and the potentially harmful effects of maternal PKU, the benefits of PKU newborn screening in preventing developmental disabilities hang in a delicate balance. It also makes one wonder what surprises the law of unintended consequences holds for expanded newborn screening (vide supra, hemophilia). (Resta R (2012) Generation n + 1: Projected Numbers of Babies Born to Women with PKU Compared to Babies with PKU in the United States in 2009. Am J Med Genet (in press).)

♥ A study of 194 DNA exonerations of criminal convictions found that witness/victim misidentification was a factor in 75% of wrongful convictions. False confessions were obtained in 30% of the cases, and jailhouse/government informants played a role in 22% of false convictions. Invalid forensic science testimony played a significant role in wrongful convictions, including serology (38% of cases, mostly blood, saliva, semen, and vaginal fluids), hair comparisons (22%), fingerprinting (2%), and bite mark analysis (3%) (And CSI make it look so easy and objective). Of exonerees, 58% were African American, and 43% of crimes were classified as cross-race (i.e., a perpetrator of one race committing a crime against a victim of a different race). DNA plays a critical role in the legal system. Still, I am shocked by proposed state laws that require collecting DNA at the time of arrest (not at the time of conviction). (Hampikian G, et al. The genetics of innocence: Analysis of 194 US DNA exonerations. Ann Rev Genomics Hum Genet. 2011. 12:97-120.)

♥ About 8-9% of dizygotic twins are the result of more than one coition and 1/400 dizygotic twins born to married white women in the US are bipaternal. Some people are very romantic. ( James WH. The incidence of superfecundation and of double paternity in the general population. Acta Genet Med Gemellol (Roma).1993. 42(3-4):257-62.)

♥ Elizabeth Taylor’s thick eyelashes were the result of a mutation in FOXC2, which can cause lymphedema-distichiasis syndrome (though she did not appear to have “photo”-phobia). (Elizabeth by J. Randy Taraborrelli, Grand Central Publishing, 2006).

♥ Because of a mutation and in-breeding, the town of Sao Pedro, Brazil has a 10% rate of twinning. Most of the twins have blue eyes and blond hair, which had raised suspicions that the unusual number of twins was the legacy of some peculiar science experiment by German ex-pat in hiding Josef Mengele (Nazi ‘Angel of Death’ Not Responsible for Town of Twins, New Scientist, January 27, 2009).

♥ Levels of gene expression for genes involved in fighting infection are lower in people who are lonely, according to researcher Stephen Cole (Ah, yes, but the lonely suffer less from heartache).(Cole S. et al., Social regulation of gene expression in human leukocytes. Genome Biology, 2007, 8:R189).

♥ In a study by Muscarella and Cunningham, males and females viewed 6 male models with different levels of facial hair (beard and mustache or none) and cranial hair (full head of hair, receding and bald). Participants rated each combination on 32 adjectives related to social perceptions. Males with facial hair and those with bald or receding hair were rated as being older than those who were clean-shaven or had a full head of hair. Beards and a full head of hair were seen as being more aggressive and less socially mature, and baldness was associated with more social maturity.Of course, social maturity is very difficult to measure in men. (From: http://en.wikipedia.org/wiki/Baldness; Muscarella, F. & Cunningham, MR. The evolutionary significance and social perception of male pattern baldness and facial hair. Ethology and Sociobiology, 1996, 17 (2): 99–117. doi:10.1016/0162-3095(95)00130-1).

♥ If you were to recite the ATCG sequence in your own DNA (which is 3 billion bases pairs long) and uttered 100 ATCG sequences per minute without taking a break for sleeping, eating, or drinking, you would speak for 57 long years. Not so helpful for maintaining close relationships.

♥ 1000 cell nuclei could be squeezed into a period mark at the end of a sentence. (http://www.geneplanet.com/the_abcs_of_genetic_analysis/interesting_genetic_facts)

♥ A report in Scientific American in late 2011 looked at the websites that were most commonly linked to by science-lovers on Twitter. There are several flaws inherent in the “study design,” but regardless it is interesting to note that Genetics and Astronomy were very closely linked: meaning people who linked to Astronomy articles & content were more likely to also link to Genetics content and visa versa (Hey there Genetic Counselor, you with the stars in your eyes). Other interesting correlations included Physics and Fashion as well as the fact that Chemistry appeared to be an outlier, not being linked to any other science.

♥ In terms of heritability versus shared environmental effects, genetic factors account for 50-64% of an individual’s right-wing authoritarian attitudes with 0-16% due to shared environmental effects, while genetic factors account for approximately 54% of an individual’s extraversion, 49% of their conscientiousness and 57% of their openness with no appreciable shared environmental effects. (Bouchard TJ. Genetic Influence on Human Psychological Traits. Curr Dir Psychol Sci. 2004;13(4):148-51.)

♥ And, of course, let us never forget The Jumping Frenchmen of Maine.