Often in medicine, a situation may occur in which two patients have identical medical history and receive the same prognosis and treatment plan, however one of the patients does not respond to treatment. Traditional medicine works like this with protocols to follow for every patient. This has been extremely successful in the past decades, however researchers have discovered a new approach to improve the success of medicine. Since genetic variation is extremely common and often affects how one’s body responds to medication and therapy, researchers are working on incorporating each patient’s individual genetic profile into their treatment plan. This is called personalized medicine, which is a method in which diagnosis and treatment of a medical condition is catered toward the particular patient’s genetic profile to compensate for metabolic differences, seemingly silent mutations, and inactive viruses. Thanks to recent scientific advances in genomics (specifically the Human Genome Project), personalized medicine has the potential to provide patients with more advanced diagnostic testing methods. The sequencing of the human genome has made it possible for researchers to link many diseases and treatments to certain genes. These scientific advances make it easier to map molecular pathways, treat disorders, and understand how medication interacts with the body, thereby improving treatment protocols.
Figure 1: Although the government provides some barriers for personalized medicine, the Department of Defense has allocated increasing amounts of funds ($ in millions) towards The Human Genome Project. However, the majority of funding for the Human Genome Project research came from from NIH grants.
The majority of physicians prefer to stick to traditional trial-and-error medicine. Perhaps this is because of the great risk involved in trying new therapies when existing protocols are usually successful. Physicians who practice personalized medicine must create a unique treatment plan that takes into account the patient’s exceptional physiology, metabolism, and genome. Personalized medicine faces several boundaries, for example traditional physician practice, the pharmaceutical industry, the medical payment system and regulatory procedures. After personalized medicine can overcome these obstacles, much benefit prevails with this methodology such as saving more lives, reducing treatment costs, and improving patient recovery time through the accuracy, efficiency, safety, and speed that personalized medicine has to offer.
Obstacles of Personalized Medicine
Since personalized medicine is a new diagnostic approach that requires a good amount of training and studying to prevail in, there are many obstacles blocking its path to success. The most prominent barrier present is traditional trial-and-error medicine because it is extremely difficult to replace something that has been used for hundreds of years. Trial-and-error medicine has become a standard treatment process for doctors all over the world. It works in the sense that a patient presents typical symptoms, the physician provides a typical diagnosis, and then follows up with a typical treatment plan. When the treatment plan does not provide relief for the patient, the physician will go through this loop again and again until a diagnosis and treatment bring the patient back to being healthy. The problem with this type of protocol is that several treatments cost the patient more money and occupy an increasing amount of the patient’s time. The down-fall of this methodology is that the wrong treatment (although not occurring the majority of the time) can also lead to the patient becoming sicker, or even dying. One big reason for why physicians are not switching to personalized medicine is because many medical schools do not cover genomics and genetics completely in their curriculum, therefore graduating doctors may not understand the relevance and promise of incorporating their patient’s genome into their diagnosis. Personalized Medicine is very complicated and incorporates many specialties (figure 2) in order to serve the patient well, without a thorough education, physicians cannot be expected to take up this new protocol right away.
Figure 2: Personalized Medicine is a complicated health care practice which utilizes many fields and specialties.
Another barrier in the way of personalized medicine is the pharmaceutical industry. This is a helpful industry that has lead medicine along its way throughout history, however the pharmaceutical field has created a habit often referred to as the “blockbuster drug†model. A “blockbuster drug†is a product that is capable of achieving sales over $1 billion annually. In order to achieve these results, the product must be in wide enough use to earn this much revenue (i.e. a large number of patients should be using the product). Many patients, although they are the minority, suffer from adverse effects of largely prescribed medication and this can often lead to death. If the number of dying patients is statistically insignificant when compared to the amount of patients with no complaints, the pharmaceutical industry considers the drug of product economically favorable and continues production and distribution. This explains the fact that pharmaceutical companies are most profitable when they treat large populations of people with a given disease because the most profits come to industry when there are more consumers. Personalized medicine clashes with the “blockbuster drug†model because it incorporates each and every patient’s needs into a particular treatment plan, hence a small group of patients with similar treatment needs may not be supported by the pharmaceutical industry. As for drugs that are linked to diagnostics, pharmaceutical companies run in the other direction in fright that this may complicate the market to physicians and slow the identification and treatment of patients.
The reimbursment system that exists today is also working against personalized medicine. Medicare, Medicaid, and health insurance companies cover the majority of medical costs. These reimbursement institutions provide financial support for each procedure conducted. Therefore, rather than spending time to correctly diagnose a patient, physicians are often pressed for time to squeeze as many procedures into their schedule as possible for the most economic gain. If companies develop new and improved diagnostic testing methods to help physicians more accurately diagnose their patients, perhaps physicians would be more likely to provide their patients with the proper treatment plan.
The most popularly despised barrier of personalized medicine is the world of regulatory affairs, referred to as the FDA (Food and Drug Administration) in the United States. The current regulatory system is not economically feasible with the way that personalized medicine works, however the FDA is not in opposition to personalized medicine. Since clinical trials of drug-development costs are high, it takes much time to pass the safety and efficiency of new drugs. If a certain drug pertains to a small percentage of patients (as in personalized medicine), a clinical trial may not be cost effective enough to put that drug through the FDA process. In the FDA’s support of personalized medicine, Dr. Andrew Von Eschenbach, Director of the FDA, gave a briefing to the Personalized Medicine Coalition at the National Press Club. He announced that the FDA is working on ways to bring new testing and treatment methods to the molecularly-based market. On the other side of regulatory affairs lies the U.S. government. Despite what many citizens may think, the government is quite involved with this scientific advancement. Since very few genomics-based tests and treatments are available to consumers, government officials have been taking a stand to support personalized medicine. For example, Senator Barak Obama introduced the Genomics and Personalized Medicine Act to overcome scientific barriers by promoting medical advancements to regulatory obstacles. Mike Leavitt, United States Secretary of Health and Human Services, has created a committee called the Secretary’s Advisory Committee on Genetics Health and Society. A specific committee dedicated to updating government officials on genetic health and advancements is a big step in the direction of personalized medicine. Although regulatory obstacles do exist, there are also steps being taken to help medical advancement towards personalized medicine.
Advantages of Personalized Medicine
Patients with acute or fairly progressed diseases do not have the comfort of time that it takes for traditional trial-and-error medicine. If the first diagnosis and treatment plan doesn’t work, it may be too late to save the patient. As you can see in figure 3 below, symptoms progress and diseases worsen quickly and many patients don’t have the luxury of time that it takes for traditional medicine to treat them. By utilizing the patient’s unique genome and identifying which treatments are sure not to work, personalized medicine can save this patient much sooner than traditional medicine. If the patient is treated sooner, their bed and room in the hospital may open up in time to save another patient’s life. Saving time is crucial to the patient, the hospital, and physicians alike.
Figure 3: Shows the relationship and correlation between time, disease management of traditional trial-and-error medicine, and disease progression.
With that said, less treatment therapies used means less money spent. Personalized medicine has the potential to save each patient thousands of dollars. The FDA estimates that if diagnostic tests based on genomics were used on just the patients needing warfarin, the United States health care system could save as much as $1.1 billion dollars every year. These types of tests are currently available and can be used hand-in-hand with personalized medicine to refine each patient’s treatment plan; unfortunately these tests are underused. If each physician were to routinely utilize these diagnostic methods, they could save billions of dollars by just avoiding adverse patient reaction to the inaccurate treatment.
Researchers are currently trying to trace metabolic pathways, genetic variants, and treatment resistance in the human genome. Once each of the three are linked together, they will develop diagnostic tools for each situation. The advantages of personalized medicine are enormous, however there are many difficult road blocks to overcome before personalized medicine can hit the mainstream. The people fighting for personalized medicine, like the Personalized Medicine Coalition (PMC), need to work harder and faster to get it over the hurdles, but most of all they need more support. Personalized medicine is for YOU and you only, so do a little work for it.
For further information on Personalized Medicine: FUSE, Realizing the Promise of Personalized Medicine, MayoClinic, and Pharmacogenomics.
