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Dr. Paula Stefan of Georgia State University spoke on September 10, 2014, regarding economic influence on scientific research in America.  She said that economics in research was a balance of incentives versus costs, simple factors which affect the pursuit of scientific knowledge.

For instance, ninety percent of all research in animals involves mice.  But what do mice cost?  The answer is anywhere from $60 to $3500, depending upon the type of mouse and disease to be studied.  In fact, the need for certainty and for integrity in the selection of those animals is so great that a single breeder has emerged as the best source for those pursuing research.

And breeding alone is not the only expense.  The maintenance cost of mice is 10 to 18 cents a day per mouse.  Dr. Stefan estimated that $1 billion annually is spent on keeping laboratory mice in America.

A company called Cyagen breeds mice in China charging as much as $28,000 a pair for breeding.

The National Institute of Health provides 60 percent of all research funding in America.  Its budget doubled from 1998 – 2002.

There is about $60 billion spent on scientific research in America each year.  But Dr. Stephan said, this has led to American universities being so focused on getting funding that competing research – research which either does not qualify for funding, or which does not pass the scrutiny of government agencies – goes wanting.  The result is that the universities here have become like shopping malls, where students wanting to do research are limited to those projects being funded at the schools.

This has resulted in a relatively narrow focus of research and a relative glut of doctoral students who study more and more the projects they are told to research, and less and less the projects which interest them truly.

In an ironic scheduling, the University of Houston presented a seminar on September 12, 2014, on how graduate students could qualify for National Science Foundation grants during their education.  A panel of professors, some with a history of funded projects and some who have served on screening committees, told students the way to write up funding requests, and of the need to tailor a project to the extent that a screening committee would want to even consider a project, much less actually fund it.

With Dr. Stefan’s observations freshly in mind, it seems that projects need to pass through many filters before being funded.  As those filters sift through the idea, it becomes more an image of the filters, and less the idea originally seen by the student.

View the webcast of Dr. Paula Stephan’s seminar

Link to NSF Research Fellowship Seminar


One of the fields of science that is really booming in recent decades is nanotechnology. This field of science is increasingly becoming prevalent in all of studies. In medical field innovations like targeted therapeutics will help with treatment of diseases like cancer. Instead of destroying all cells in chemotherapy, only targeted bad cells can be destroyed. Some other innovations include brain replication. Human brain is a very complicated machine. To replicate it is a very challenging and risky endeavor. However there are some interesting technological advancements being made in this arena.

“On the hardware side, Gizmag reported advancements with neuromorphic chips which aim to reverse engineer the brain. This goal is trying to be reached through ‘an interdisciplinary amalgam of neuroscience, biology, computer science and a number of other fields that attempts first to understand how the brain manipulates information, and then to replicate the same processes on a computer chip.’” [1]. Since all hardware is useless without software, “researchers at IBM have created a new software program called Corelet which they say operates like the human brain when neuromorphic chips are used for processing” [1].

These innovations are extremely exciting and look like todays sci-fi movies. As a computer scientist, I can only dream of writing code for the human brain. It should be noted that these innovations are in a very early stage of development but they pose potential for great benefits and at the same time enormous misuses. Imagine a point of error and your brain is ‘hacked’ by someone else. Today if just our email address gets hacked, we run around crazy; imagine how helpless we would be if our brains were hacked. Apart from the security aspect, we need to consider ethical and moral aspect also. Our natural brains are extremely qualified and who is to say that the human-designed brains will be moral and ethical.

Scientific and technological advancement is only valuable if done for the right reasons and with right care. If nanotechnology is used to help with early diagnosis and treatment of Alzheimer’s disease or treatment of cancer cells then it is a righteous research endeavor. Today technological and scientific advancement is happening at a very fast pace. Advancements in gene manipulation, tissue engineering and so on are extremely high profile areas. Therefore now more than ever it is extremely important to conduct proper research with proper scientific methodologies. And also it is of utmost important to be transparent in the data and analysis for every research conducted.


Researchers from North Carolina State University have recently developed a wireless biological remote sensing interface that would let you control the movement of your very own cockroach, or let’s say “Robo-roach”! Dr. Alper Bozkurt, an Assistant Professor in the Department of Electrical and Computer Engineering, and his project team came up with a device which put the cockroaches into autopilot mode after mounting a small computer chip on the roach’s back and implanting electrodes to its antennae. Using a remote control, Bozkurt and his colleagues can direct the Madagascar hissing cockroaches where to crawl. 2

roach
According to Dr Bozkurt the aim of the project is to create a wireless robust biological interface with cockroach which can ultimately infiltrate small and difficult remote places. These roaches could carry tiny sensors, cameras and microphones which will help to collect and transmit information in challenging situation, e.g. for finding survivors in building destroyed in an earthquake. Building small scale robot at this level for such uncertain dynamic situation is very challenging and expensive, whereas biobot cockroaches could easily be a better alternative keeping in mind that they are experts to perform in such hostile environments, they already have a natural power process, they live long (almost for two years) and slow movement of Madagascar cockroach is very flexible for a steady control.

The project definitely intends a noble and brilliant idea but at the same time it creates some controversies. First of all like any other animal model used in scientific medical research, especially which involves surgical intervention, it also highlights the old debate of how ethical it is to inflict pain in animals for the benefit of scientific research. The cockroaches are properly anesthetized during the chip implantation and the electric impulses sent through their antennae to stimulate body movement are very tiny and not more than enough to drive the neural circuitry just like its very own natural body impulses. So there is no fear of electrocuting the insect and forcing it to respond to signals because of pain, claims Dr Coby Schal, a professor of entomology at NCSU who works in collaboration with Dr Bozkurt in the project and looks after the ethical side of this biological research. Bozkurt hopes his work will one day mark a time when insects can be used as large mammals were in earlier stages of human civilization. “Information is the new payload,” he said. “In the past, people lived and worked with large mammals like horses and oxen to build entire civilizations. Now, with the technology that we have, insects can carry information that can advance civilization.”3

Michelle Rafacz, assistant professor of biology in the Columbia Science and Math Department, also supports this research and believes creating biobots has important social implications. “Socially, this is extremely practical,” she said. “People do not respect insects in terms of their complexity. They have an incredible sense of smell and sensory capabilities that can play a huge role when it comes to helping people.” 3

Recently based on this research Backyard Brains of Ann Arbor, Michigan, has developed a robotic “backpack” called RoboRoach, selling for $99, which can be attached to a cockroach and with a handy iPhone app you can steer your own cyborg cockroach left or right. They hope the app will inspire a new generation of youngsters, prompting them to become curious about the wonders of neuroscience, and hopefully lead them to someday cure neurological ailments like Alzheimer’s or Parkinson’s disease. The kit comes with guidelines of how to do the “surgery” and handle the roaches with proper hygiene. The application of the kit looks promising for demonstration in laboratories to kids under expert supervision. But the whole idea of selling this kit in a relatively cheap price over Amazon creates fear of heavy misuse and makes it appear as a marketing strategy to make benefit selling fancy new “toys” to kids. Bioethicist Gregory Kaebnick from the Hastings Center in New York told Science magazine that the Roboroach “gives you a way of playing with living things” and finds the product “unpleasant.”4 Many claims that performing amateur surgery on insects is cruel and exactly the opposite of progressive science. The company also admits it has received emails saying the Roboroach teaches “kids to be psychopaths.”4 While some pointed towards the fact that almost all of us would scream for pest control as soon as we see roaches in our house or probably would love to flush them out in toilet, few argued saying that, “Killing a cockroach is one thing. Torturing it like this FOR FUN is another thing altogether.”4 And we should not also forget that with such easy access to cheap personal biobot, it would not be difficult to use this technology for severe misconduct like spying, robbery or even in terrorist attack. So how much good fortune will this Roboroach bring to our society is still a matter of hot debate.

Video link : http://media.brisbanetimes.com.au/technology/tech-talk/iphone-controls-cyborg-cockroach-4822085.html

The cyborg cockroaches reveal a larger issue of the bioethics of animal and cyborgs. In an interview with the NewsHour, Emily Anthes, the author of “Frankenstein’s Cat,” saw developments like the cyborg cockroach as inevitable. She said “I think this meshing of the biotic and the abiotic of living and machine is really the future of biotechnology. And we’re going to see a lot more animals and, frankly, humans that have electronic components integrated with their bodies.”3 So looks like the Roboroachs are here to stay and going to bring a lot more new controversies with them in future.

References:
1. http://ibionics.ece.ncsu.edu/assets/EMBC_12.pdf
2. http://www.ece.ncsu.edu/news/21621
3. http://columbiachronicle.com/cyborg-insects-may-be-tomorrow%E2%80%99s-heroes/
4. http://www.dailymail.co.uk/sciencetech/article-2449562/The-app-lets-control-COCKROACH.html
5. http://www.pbs.org/newshour/rundown/2013/10/cyborg-cockroaches-theyre-alive.html


“Publish or Perish” has become a norm in the academia these days. Not only that, to enter the academia itself, one needs to show a list of publications before he is even considered for a post. Whether a person with higher quantity or quality gets an academic post all relies on the mindset of the committee who decides on who gets the job. After getting an academic post say an assistant professorship, that person has to prove himself again to get in the higher ladders of the academia. For all of this, from the very beginning of getting to a job, to reaching and surviving at one peak level like a tenureship requires ‘publications’.

In order to get as many publications as one wants most people in academia would like to be in big labs with lots of research going on. There will be many graduate students, post-doctoral researchers (post-docs), research professors etc in that lab. With many experiments being conducted by various persons in that lab comes the ethical dilemma of who gets to be an author and who doesn’t in the research papers to be published from that lab. As an example, we can actually take the “Boss” or the professor who owns the lab. There are instances where the generation of ideas, doing the required experiment, writing and reviewing of the paper is mostly done by the graduate students and the post-docs. The so called “Boss” or the Principal Investigator (PI) just attracts funding for the lab or does some editing at the end when the manuscript is ready. So, does that give him the privilege of gaining an authorship? Some may argue that without his money nothing could have been done. It might be true in one sense, but if there are no regular meetings, no regular inputs from that professor (the PI) and it’s the funding that is the only deciding factor, then I think it would be better to put him as a contributor rather than an author of a manuscript.

In medical science, the International Committee of Medical Journal Editors (ICMJE) is a respected group whose recommendations are followed by many of the world leading medical journals. It gives recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals. It defines an “author” as a person who fulfills all of the following 4 criteria:

• Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work;
• Drafting the work or revising it critically for important intellectual content;
• Final approval of the version to be published;
• Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Now comes the problem of whether all the authors in a manuscript have fulfilled all these criteria or not. There might be scientists who just looked at certain aspects of the experiment like the statistics. Or, someone else might just have conducted the experiment only like a lab technician or a graduate student. So, comes the question: Will it be ethical to give authorship to all the personnel involved from those who just did some technical work and did not provide any scientific input to some who have worked in all aspects from start to the end of the experiment and writing the paper. There is no clear definition of what we can actually call “substantial contributions” as mentioned in the ICMJE criteria and none of the papers are going to be published without the name of the professor who owns the lab. Whether he always provides that substantial contribution is a big question. Similarly, to get volunteers to participate in a study a lab might take help from other clinicians, who might also want to get an authorship because of the help he did. There might be a person who just edited the paper and did not contribute much to the experiments or other part of the work, but who is an influential name in that area of research. Some researchers may want to put his name in the manuscript so that it gets published. So, there are various forms of unethical practices like this one; which are termed as Gift authorship (authorship given out of favor); Honorary authorship (out of respect); Prestige authorship (to rub off prestige) and the worst one, ghost authorship (where author does not know anything about the research but has a name on it showing he did the work when it was all done by somebody else.) The last one “ghost authorship” is most prevalent in pharmaceutical companies so that the companies can prove that some big shot doctor has found their drug to be very good when in fact that person has done nothing and it is all done by the employees of the pharmaceutical company. These are some of the unethical practices that medical literature is plagued of.

So how can this are stopped? When pride, money and the desire to succeed by any means fills the mind of a scientist there are many instances where he can be unethical. Some of the journals these days have started asking authors to be divided according to the amount or part of contribution they had in the manuscript. Some might have worked in the designing of experiments, others conducting the experiments and yet others analyzing the results etc. Dividing in such a way at least helps the readers to know which author has worked for which part. Although, not fully error free, this might be one step ahead in lessening the unethical practices in authorship.

Finding out how much an author has contributed to a manuscript would be a big research in itself for the editors of journals. With the volume of articles being submitted it is virtually impossible to do that. Thus, it finally boils down to the part of scientist himself whether to be an ethical or unethical author. The culture of “Publish and Perish” has created a big question on ethics of authorship. More methods that can effectively check and balance unethical authorship need to be researched and implemented.


The brain is the most complex organ in our bodies. It consists of millions of inter connected neurons that work together to give us our personalities, motivations, memories, etc. The brain is capable of things beyond our imagination; we have just started to see what it might be capable of doing. However, the complexity of the brain also makes it a very difficult organ to study because we are still unaware of all of its functions. As scientists, we have to be extremely careful about how we deal with the brain and what advances we make public because any wrong decision could become detrimental and costly for the human race.

In recent years, there has been a huge advancement in the field of neuroscience and this advancement has led to areas of research of the brain that may be ethically questionable. Neuroscience has now gone beyond the clinical applications to a variety of new areas that are well beyond our imagination. From the measurement of mental processes using functional imaging to the manipulation of the brain using selective drugs, the new capabilities of neuroscience raises many ethical and social issues and requires us to question how far we will go before putting individuals’ lives in danger. Technological advances in neuroscience have led to innovations in medicine that have therapeutic, as well as non-therapeutic implications that extend beyond areas explored by scientists. We are coming to a point in history where technology that we have invented can go beyond helping just the medical community. The question that scientists need to ask now is what ethical issues arise because of these innovations and what ethical standards should be applied to brain research?

Research done on the brain thus far has greatly improved our ability to understand and treat people with neurological disorders. We now understand many neurological disorders and have came up with various treatments to treat these disorders. There are various drugs on the market that are currently used to improve the mood, cognition, or behavior of people with problems in these areas. However these drugs are now starting to gain the interest of the general public. People are now starting to experiment with these drugs in order to see how they can help them with their normal brain functions. From a science perspective, this growing interest is very dangerous and can lead to many problems in the future. These drugs, which are meant for people with mental disorders, can enhance normal people’s brain activities and therefore have the capability to intervene with normal brain functions. Using these drugs, normal people have the capability to focus more clearly anywhere, be cheerful all the time and even have enhanced memory. What might happen if the industry decided to sell these drugs that are supposed to help individuals with neurological problems to ordinary people? Will society come to the point where we will be medicalizing normal behavior?

Drugs like Ritalin and Adderall are currently used to improve the attention of people with ADHD, but they are also known to enhance attention in healthy individuals. Surveys have shown that many Americans are now buying these drugs from people that they know or from dealers in order to help them enhance brain functions in their daily lives. Everyone from college students to office employees are using these drugs to have some kind of advantage and to help them get ahead of their peers. So far only a few people know about the effects of these drugs and can purchase them. However, it will not be long before these drugs will be provided to the public for brain enhancement. Even though the effects of these drugs sound great, and we would all love to use them in our daily lives, there are many ethical issues that scientist need to think about and address before making these drugs commercially available to the general public. These drugs seem to help people with neurological disorders but we have little research on the long term effects of these drugs even for these people. We are far away from knowing how these drugs will affect ordinary people and therefore cannot allow people to have access to such drugs in order to have brain enhancement.

As we have seen with other scientific advancements in the past, it takes a very long time for the scientific community to be fully aware of the negative connotations associated with the advancement. With the case of tobacco, for instance, thousands of lives were lost due to lung cancer before it became well known that tobacco causes cancer. Tobacco was made available to the public before its effects were fully understood by the scientific community and this lack of knowledge led to many people dying unknowingly. With brain enhancement drugs, are we ready to take that same risk again? These drugs work on the organ that is the seat of our knowledge, the organ that controls our every move. Can we really afford to make the same mistakes again? Side-effects and unintended consequences are always a concern with any type of drug, but neuroscience based enhancement involves intervening in a far more complex system and therefore we face an even greater risk when we intervene with brain functions. With the little knowledge that we have about the long-term side effects of these drugs, it is unsafe for us to make such drugs publically. If we have learned anything as scientists from our past, we know that those who profit from these drugs will always claim that these drugs are safe and will find ways to prove themselves right. We, as scientists, cannot put the lives of millions of people at risk until we have enough proof that these drugs will not cause any harm and will only help those who are taking them.

Neuroscience has also made great advancements in the area of brain imaging. Even though we are not at a point where we can read minds using imaging, the advances that are taking place ensure us that we are not far away from reaching this goal. The neuroimaging techniques are becoming so advanced that it is now possible to infer not only people’s mental states but also their unconscious attitudes and predispositions. Recent FMRI studies show that measurements can now be obtained for complex human processes such as decision making, moral and non-moral social judgments, and even personality.

Scientists are now working towards providing us with a society where everyone will be transparent and no one will be able to hide any bad intentions or cause harm to society. However, these advancements raise many critical ethical issues that need to be addressed. Brain processes and thinking are a very private matter and these advances could jeopardize personal identities and privacy of people in the future. Imagine a legal system where you are forced to have your brain scanned in order to see if you are lying or telling the truth. Imagine your employer routinely performing brain scans to view your intelligence level, mood, and even criminal intentions. Is the public ready to live in a world where everything they think about can be easily accessed by those who have the authority to do so? Should they even be provided with the power and means of authorities to carry out such actions? As scientists, it is our job to look at the long term consequences and implications of such advancements. We have to realize that these advancements in neuroscience can have many negative consequences that could put the public in harm’s way and take away their privacy.

Techniques for manipulating the brain and its functions are advancing at a very fast pace and few people are looking into the consequences associated with these advancements. We do not know how the different systems of the brain interact with each other or the consequences of intervening with normal brain functions. We are not aware of how these interventions effect human beliefs, desires, intentions, emotions, memory, and etc. Should we even be allowed to make such interventions in the brain? Evolution has made us who we are today and maybe there is a reason why we cannot read each other’s minds. Maybe there is a reason why we do not have super memory or the capability to always be happy. The knowledge that we have gained so far is very powerful but we have to remember that there is a lot more to learn before we take huge leaps to advance our society. What little we do know about our brain and its functions may be enough to lead to great advances, but we have to think about how these advances can affect our future. The knowledge that we have gained so far is very powerful, but with this knowledge comes the responsibility to prevent its misuse and abuse.


What causes stuttering? Is it because of the genetics or is it a learned behavior? Dr. Wendell Johnson, a strong proponent of general semantics and a professor at University of Iowa in 1930s was one of the most influential speech pathologists in his area. He was a very popular professor in his university, he himself used to stutter and he strongly believed that it is a learned behavior influenced by the environment, for example parent’s criticism of their child’s slightest of stammering. He himself tried hard to overcome his stuttering while he was young using contemporary speech therapy and chiropractic available at that time, but failed. He was very passionate and hardworking and wanted to better understand why it is so and how it works? Along with his graduate student, Mary Tudor, he designed what came to be known as the “Monster” study. In the study they recruited 12 normal orphan children who were originally non-stutterers. They were divided into two groups of six each, one experimental and one control. The first group was told they stutter and was belittle for every speech imperfection and other group were told that they do not stutter and were in fact praised for their fluency. The negative speech therapy on the first group left an indelible mark on the psyche of the six children who were constantly belittle for speech imperfections. Although it did not make them all stutterers, they all became more reserved and were embarrassed to speak even to their peers. This affected their performance throughout their lives. This group of individuals sued the university and were awarded nearly a million dollar of compensation in 2007 for the lifelong psychological and emotional scar that they suffered during the study.

Even though ethical standards were different during that time the study was unethical on many fronts and was purely driven by the greed and curiosity of researchers. First of all, researchers used institutionalized children as they were easily available. It is unfortunate that vulnerable people, like the black men of Macon county in the Tuskegee study, are used a lab rats through deception. Orphan children were never briefed about the study and were deceived to take part in the study without any consent. After the study was over, although Ms. Tudor did visit the group few times to check on them and report back to Dr. Johnson as how they are doing, they were not provided any positive speech therapy. The most disheartening aspect of the study was that it failed to prove Johnson’s hypothesis that stuttering is a learned behavior. Of the six fluent orphans, only for two did the fluency actually fell after the six months intervention. For two others fluency actually increased marginally. Results were not only insignificant but also in the opposite direction as the researchers expected and thus were not published in any scientific journal. Dr. Johnson did not even mention this study in his seminal work, Onset of Stuttering published in 1959. Along with being a professor, Dr. Johnson was also an actor and a famous psychologist. It is obvious to believe that all his graduate students respected him a lot and were followers of this theory and thus Ms. Tudor also did not confront him about publishing the results as she was afraid of his authority and the study could have tarnished his image.

This is highly unfortunate and unethical thing as the researchers did not publish their negative results. One would wonder as what would have happened had the results were published? Could it have changed the landscape of treatment of stuttering children? We have no objective way of measuring the loss due to non-publication of the results. Even now there are no stringent laws which necessitate researchers to publish whatever results they get. Unfortunately, we have conditioned ourselves to accept only positive results. Many times researchers try to protect their doctrine even if the results say otherwise for the fear of losing future grants. A recent article in Guardian (http://www.theguardian.com/science/2013/oct/29/scientists-fears-over-unpublished-drug-trials) points out that one out of three large clinical trials in the United States remain unpublished. This is a violation of ethical obligation towards people who take part in the study and we need stronger legislations to publish results of all trials and provide a complete picture to the general public about how effective a new drug really is and what are its side-effects?

Another unethical issue with the study was that the sample was not a good representation of the general population to study the effect of conditioning on stuttering on fluent young kids. The age of the six children in the experimental group was 5, 9, 11, 12, 12 and 15. Five of these six were beyond the age at which stuttering usual begins and that itself could have confounded the results as many of those children had already lived a fluent life for many years.


Advances in science and technology are typically met with excitement by public. Scientific advancements making genetic testing more affordable and mainstream have proven to be no different. Genetic testing will ultimately be integrated into the medical field as the promise of personalized medicine comes to fruition, and I for one, believe this is a great advancement! However, as with any great scientific advancement we, the scientific community, have the ethical duty to inform the public of the realistic short comings and the unknowns of such advancements.

Today anyone who desires genetic testing can obtain it without visiting a medical professional. Companies like 23andMe1 and ConnectMyDNA2 are only two of a growing number of commercially available resources that allow the general public with the money to do so, to “discover the whole view of you2” through genetic testing. 23andMe markets through a number of different media outlets to get its message across to the public. All you need is $99 dollars and to spit into a container that was sent through the mail1! Sounds great doesn’t it! Not only is this much less expensive than many other types of DNA testing, but according to the 23andme website you can find out if your genes place you at an increased risk for diabetes, arthritis, coronary heart disease, breast cancer, and if your lactose intolerant, and the list goes on.

So what is the potential harm in this? Genetic testing is serious business. It requires more interaction with a genetic counselor or doctor that just about any other lab test. Before a genetic test is performed in a clinical setting, a trained individual, many times a genetic counselor, informs the patient of the likelihood of a positive test and what a negative test result means. Unlike a blood test for diabetes that state the patients’ blood sugar is normal or abnormal; a negative genetic test result does not prove that the patient does not suffer from the genetic disease in question. This is because the worth of a negative genetic test result is completely depended on the knowledge of the scientific community at the time the genetic testing is performed. A patient’s chance of obtaining a useful test result depends on the patient’s ethnicity, family history, and clinical manifestations of the disease in question. In direct to consumer testing (DTC), the patient is not made aware of the scientific likelihood that to test will provide useful results, and what the implications of those results, be it true or not, could mean to the patient’s life.

The patient is also not made aware of likelihood of a false positive, or a test result that states the patient has a misspelling in a gene when in fact their true DNA does not have the misspelling. These false positives are typically due to the short comings of the specific type of genetic test performed by the DTC companies. The term “genetic testing” covers a wide array of different testing modalities spanning from sequencing, or spelling out, the entirety of one gene8 (the gold standard), to generalized assessment of chromosomal markers for studies on inheritance7. The specific genetic test performed by many of the commercial companies, including 23andMe (SNP chip arrays5), increases the likelihood of a false positive test result.

Basically, DTC genetic testing websites that claim to identity medical attributes from patient DNA are providing a medical test without first educating patients about how these tests are performed. When giving a DNA sample to 23andme, the patient is unaware of exactly what information their DNA might provide and the likelihood that these test results are false. The inability of the patient to make an informed decision is a huge ethical dilemma! The high error rate found in DTC genetic testing is so concerning that recently the FDA sent a warning letter6 to 23andme demanding that they discontinue genetic testing until the company could provide “analytically or clinically validated” measurements of their testing. In this letter, the FDA stated a specific example of the type of harm under taking such testing can induce:

“…For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist….. These risks are typically mitigated by ….. management under a physician’s care.”

In essence, the DTC DNA testing companies that provide medical information in their reports are doing so without properly informing the patient about the risk involved in the testing. Genetic testing is just at the beginning stages of becoming clinically, but anyone who has been involved in the field of genetics realizes the far reaching ethical dilemmas that such testing affords. Of which, adiquent patient education is just one concern. Worth noting is that not all DTC companies provide medical information, some only provide ancestry information. For more information on direct to consumer genetic testing please clink on the following link. I have also placed webpages with additional information below.

https://ghr.nlm.nih.gov/handbook/testing/directtoconsumer

References
1. https://www.23andme.com/howitworks/
2. http://www.connectmydna.com/
3. http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/
4. http://res.illumina.com/documents/products/datasheets/datasheet_human_omni_express.pdf
5. http://learn.genetics.utah.edu/content/health/pharma/snips/
6. http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm
7. http://genome.wellcome.ac.uk/doc_WTD020778.html
8. http://www.bio.davidson.edu/Courses/Bio111/seq.html

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