Pharmacogenetics/Genomics and Personalized Medicine

http://hmg.oxfordjournals.org/cgi/content/full/14/suppl_2/R207?ref=BenimShopum.com

There have been a number of great advances in drug therapy and development in modern medicine, but a main problem that continually arises is that there are some patients who suffer severe side effects or do not respond favorably to the drug prescribed. Pharmacogenetics is the future of medicine because it allows doctors to diagnose and treat certain diseases with more accuracy and confidence. One important point that this article brings up is the more accurate drug testing will be in the future. With the creation and research of pharmocogenetics, drug testers will be able to more accurately recruit patients for testing. As a result this will lower the percentage of patients with adverse reactions to the drug and doctors will be able to get more accurate results and can make decisions based off of more accurate results. It is well known that efficiency in drugs is one of the most important and prevalent topics in medicine these days and this article further asserts this notion. One thing that I really liked about this article was how they incorporated the evidence of genotyping and targeting personal genes in a case study of Irotecan incorporated into the article. Not only does this show how important that this research is, it shows how quickly we are starting to incorporate and analyze this research. Throughout the article the author states that there are more obstacles that still need to be overcome to help advance this new development, but the article never explicitly states these problems.

Systems Biology, Proteomics, and the Future of Health Care: Toward Predictive, Preventative, and Personalized Medicine

http://pubs.acs.org/doi/full/10.1021/pr0499693?cookieSet=1

Systems Biology as defined in this article is the analysis of the relationships among the elements in a system in response to genetic or environmental perturbations with the goal of understanding the system or the emergent properties of the system.  A system can be protein molecules carrying out a simple task or it can be a complex set of proteins working together to achieve a much more complex task. Therefore these systems include molecules, cells, organs, individuals, and even entire ecosystems.  The emergence of this field brings forth new sets of challenges that we are facing today in the world of healthcare.  Understanding these systems to the fullest will help us in creating a more efficient way to diagnose and treat patients, which is exactly what pharmacogenetics is aimed at.  Medical efficiency has been one of the hottest topics of debate recently. Efficiency can be in a number of different things including the treatment of the patients, the time to diagnose, and the accuracy of diagnosis. This articles main point is that understand systems biology and proteomics is the key to making medicine more predictive and preventative. Proteomics, the large scale study of proteins, has increased significantly within the last five years according to the article. I found this interesting because the article also states that cell behavior cannot be studied simply by looking at genes and mRNAs that encode them, which is why protoeomics was established. This article was enlightening as it taught me a lot more than I knew about the current state of personalized medicine, but I would have liked to see more technical examples about how this research can pinpoint certain diseases because this article mainly focused on the abstract.

FDA Embraces Personalized Medicine

http://www.scienceprogress.org/2009/02/fda-embraces-personalized-medicine/

This Science Progress article discussed the involvement of the FDA within personalized medicine. We have learned that, with such a new topic and an area of science that is growing exponentially, there needs to be some restrictions and regulations on personalized medicine.  The FDA has taken the initiative to create a new position, the Senior Genomics Advisor, whose main focus will be to orientate the FDA to provide scientists and physicians with genetic background information to help create a medicine for patients that will bring individual patient attention and drug dosage. The article states that two main goals need to be met before the US healthcare system can incorporate personalized medicine into everyday use: use of digital medical records and a reformed reimbursement process that rewards positive clinical outcomes.  The FDA has also partnered with Medco, a pharmaceutical benefits manager that could supply the FDA with a plethora of knowledge such as de-indentified patients' tests, dosage, and clinical outcomes.

The FDA's focus on personalized medicine is expected, especially because regulation on genetic testing sites is very spotty (as claimed by The Experimental Man author, David Ewing Duncan) and results seem to vary between different genetic testing sites.  This article doesn't really focus on the regulating power of the FDA on personalized medicine procedure, but actually a push for this type of medicine to be used in the near future.  One tends to wonder if the clinical results will be useful, as there have been problems with ignoring negative clinical outcomes due to a push for pharmaceutical drugs to be placed on the market.  I hope that the information used by the Medco-FDA partnership would be used appropriately, and that precautions would be taken if there are any negatives to how individualized dosage is carried out.  

In the future, I expect more positions to be created by the FDA as personalized medicine becomes more prominent in the US.  For such a fast growing topic, there may be a need for more guidelines and supervision of how records and genetic histories are handled.

Pharmacogenomics: The promise of personalized medicine. http://www.aapsj.org/articles/ps0201/ps020104/ps020104.pdf

With the development of pharmacogenomics, it is being understood that many genes play a role in drug response and toxicity, which may differ in each patient. Therefore, there is a massive complexity in identifying candidate genes.
How will this affect health care professionals? There is obviuously going to be need to implement new educational tools to properly educate our health care professionals with the complexity of personalized medicine.
In the past, the cliche was: "one drug fits all". This is obviously changing with new developments nearly every day. With the one drug fits all, some patients experience symtom relief while others may not, or may experience worsening symptoms, due to the individuality of their molecular profiles. The development of pharmacogenomics will indeed affect the development of blockbuster drugs, or drugs that have made billions of dollars for treating a certain disease or condition for billions of people. But in reality, these drugs will affect everyone differently. For example, look at anti-depressant drugs and the history of suicidal symptoms associated with them. These type of dilemmas should disappear with pharmacogenomics.
The article also addresses the many different receptors and other protein markers that exist with many potential SNP's within each.
What type of privacy issues will be associated with these molecular profiles? Who will have access to them besides our health care professionals and doctors. What about sports and athletic issues? There could be major debate here as well.

http://afsft.tripod.com/sitebuildercontent/sitebuilderfiles/personalizemedicinerevolutionizingdrugdiscovery.pdf

Sometime in the future, probably in the near future, many people will have access to individual molecular profiles, which will lead to the devolpement of personalized medicine. With this and the the continued study of the molecular basis of diseases, the pharmaceutical industry will be changed dramtaically. This article also addresses the fact that trial and error medicine may be approaching the end, because with personalized medicine we will already know what's going to happen and why; we will know what molecular targets we have to target for certain therapies, based on the indivduals molecular profile. How much will it cost to have these molecular profiles? Will health insurance change dramatically? There are many questions that arise with this growing popularity of personailzed medicine.
The article also states that clinical diagnosed diseases will be replaced by genetic markers. Instead of clinical signs and symptoms to diagnose diseases, we will have these molecular profiles. We are on our way to a safer and more effective way of treating diseases. The article also states: Personalized medicine promises to offer the right treatment for the right patient at the right time.

New Law Bans Misuse of Genetic Testing

http://www.nytimes.com/2009/11/16/business/16genes.html

The article, written by Steven Greenhouse and published today in the New York Times, discusses the installment of a new law that focuses on how we view personalized medicine in the United States.  The Genetic Informational Nondiscrimination Act (GINA) will take effect next week in American workplaces.  This law prohibits discrimination based on a employee's genetic background.  This is important for an employee's job security now that a company can't fire, hire, or promote an individual based on his or her genetic history.  This new law also prohibits insurance companies from using genetic backgrounds to deny coverage, set premiums, or deductibles.  The background checks also include the employee's immediate and extended family, as most diseases tend to stay within a family's lineage.  Companies usually give benefits to those who include information on family medical histories through such means as paid time off, or lower premiums.  This will not be allowed after the GINA law takes effect.  the new law was passed last year by Congress in response to 63% Americans saying that they would not take genetic tests if their company could view the results.  The law was passed also due to the fact that some companies such as the Burlington Northern and Santa Fe Railway Company conducted genetic testing without the knowledge of its employees.

Personalized medicine seems to be taking off recently, and the GINA law shows the impact of this interesting topic.  There definitely needs to be some regulation of genetic testing that occurs presently in the world.  Genetic testing is used to help determine if an individual is at risk for a future medical problem or inherited disease.  People are using this technology more and more in order to view personal risks such as getting breast cancer, Alzheimer's disease, heart attack, and a whole lot more.  The GINA law was passed due to the pressing issue of companies responding to personalized medicine and using the new technology to determine if a person is in risk of a disease.  It is not surprising that they would be interested in their employees' testings.  Why would they want to promote an employee for a position that places them in an important position if the person is at risk for a disease which could hinder the company's future?

There are definitely going to be some confusion with the discrimination instances in the future.  As the article suggests, there could potentially be a blurry line between firing a person due to lack of effort and firing a person because he or she has a "bad" genetic marker.  Companies have to worry about the employees using their genetic histories as a discriminatory tool if they are fired for a completely different reason.  Companies still have the right to view obituaries to gain inherited disease information.