The care industry, during the 1980s, underwent a considerable change, with many big companies forced to change direction and some going under. This was the end of the idea of mass production and the Fordist approach to production. In its place, niche marketing arose, in the era of flexible production, and smaller numbers of cars were produced, with different features, aimed at offering greater consumers choice.
It would be wrong to draw exact parallels between the car industry and medicine. Nonetheless, the new field of personalized medicine is about moving away from medics having a narrow list of mass produced drugs to choose from and the assumption that each patient will react similarly when the medicinal product is administered. So rather than condition x needing drug y, medical laboratory testing would select the appropriate therapy for an individual person based on a given person’s individual genetic make-up and particular physical characteristics.
Personalized medicine is about understating the patient and their condition and delivering the most appropriate treatment. In other words, medical decisions, practices, and drug products are developed for the individual patient rather than as mass market goods and services. To achieve this effectively, ‘personalized medicines’ are required.
There is another reason why personalized medicines could be important. Not only could treatments be more effective, focused treatments could avoid the misuse of medicines or the risks associated with patients being given general treatments not necessarily intended for their particular condition. Prescription drugs are the third most common cause of death after heart disease and cancer. Aside from direct risks, genetic medicines will not work with everyone. Examples include: attention deficit hyperactivity disorder medicine only works for one of ten pre-schoolers; cancer drugs are effective for around 25 percent of patients; and anti-depression drugs work with just six of 10 patients.
To make personalized medicines a reality, advances need to take place with genomics and with understanding the influence of the microorganisms that reside within the human body (the microbiome) have on the way medicines are processed. Gathering key patient information allows for rapid computer analysis and for healthcare professionals to make more accurate treatment decisions. As an example, medics can a conduct a genome-wide association study to examine one disease, and then sequence the genome of many patients with that particular disease. This allows the medical scientist to scan for shared mutations in the genome and then to select an appropriate treatment. Furthermore, with some types of cancer, computer modelling allows for the screening of combination treatments, which could involve more than one immunotherapeutic agent or a combination of immunotherapy and chemotherapy. This is far faster and probably more effective than is possible using traditional methods.
During December 2015, The Academy of Medical Sciences made a push for greater investment and research into personalised medicines, saying medicines tailored to the individual present a “great opportunity” to protect health. Speaking with BBC Health, Professor Sir Robert Lechler, who currently presides over the Academy, make clear why this area needs support:
“I think it’s unarguable that prevention is better than cure, and if you wait until the patient presents with signs or symptoms of kidney disease, liver disease, heart disease, very often most of the damage is done and can’t actually be recovered. So if it were possible to take steps while still in health to prevent or delay the onset of disease that seems to make very good sense.”
The development of personalized medicines has also received the backing of U.S. President Obama, although the project carries the term “precision medicine.” In April; 2015, the U.S. National Institutes of Health (NIH) began to assemble a team of medicine and science experts to begin the process of building the Precision Medicine Initiative.
The initial task is to study the U.S. population to see which areas are feasible to develop personalized medicine further. The ongoing aim to collect data relating to one million U.S. citizens. Speaking earlier this year, NIH Director Francis Collins stated: “Establishing a 1 million person cohort is an audacious endeavor. But the results from studying such a large group of Americans will build the scientific evidence necessary for moving precision medicine from concept to reality. I’m confident that we’ve pulled together the best of the best in this working group to put us on the right path forward.”
As an example of the application, scientists from Washington University School of Medicine in St. Louis have developed personalized cancer medicines. The new drugs have been used on three melanoma patients in order to assess the immunologic effects. Other areas where success has been reported include narcolepsy, lung cancer and fibromyalgia (a rheumatic condition characterized by muscular or musculoskeletal pain.)
Not every treatment area will prove to be a success. For instance, one study found personalized medicine approaches for pancreatic cancer therapies based on tumor genomics would take too long to prepare to be helpful (in that many patients would have died before treatments could be manufactured.)
As well as which types of illnesses and diseases might be suitable for personalized medicines, another consideration is how the process will be regulated. Bodies like the U.S. Food and Drug Administration (FDA) can more readily inspect, sample and review processes relating to the production of millions of pills. This becomes more difficult when small numbers of items are being manufactured.
In attempt to lay down some guidance for pharmaceutical companies, the FDA has, according to Pharmaceutical Microbiology, issued a scoping document. The report describes the concept and various definitions of personalized medicine. These are divided into diagnostic devices (like laboratory tests to measure genetic factors) and therapeutic products. FDA has been given the responsibilities for “identifying opportunities for streamlining regulatory processes and advancing the science and tools that will help drive innovation.”
Personalized medicine, at present, is an emerging field. It will only be applicable for some types of disease, and used only for some patients. It nevertheless could be the future model upon which many medical decisions are made.
This article is part of Digital Journal’s Essential Science series. Other articles in the series are ” Space-food for astronauts made from bacteria“; “Health effects of antibiotic use“; and “Graphene makes improved night vision tech.“
