Let’s have a moment of silence for genes, as the culprits behind your doctor’s every failed prescription have been caught. Now you seem to be thinking about how genes are related to failed prescriptions and responsible. What are you supposed to do now? PRECISION MEDICINE, my friend, is the solution to all your worries.
Imagine yourself sitting in a doctor’s clinic complaining about developing an allergic reaction to the last medicine that he prescribed or medicine not responding. The medical checkup again begins with asking you various questions about your problem while he checks your vital stats.
The checkup further proceeds with the diagnosis of the disease. This time your doctor prescribes you different medication, which surprisingly cures your ailment. When we term a medicine as unsuitable for us, there are various underlying causes for why that medicine doesn’t suit us. Genetic composition plays an important role for medicine to work. As we cannot change a person’s genetic makeup, modern science has bestowed us with the gift of precision medicine.
What is precision medicine?
The ancient method of prescribing ‘common medicines’ and the following ‘one-size-fits-all’ principle is slowly fading out, creating room for new medical innovations such as precision medicine. According to the patient’s needs, precision medicine (PM) idealizes customization of treatments, practices, medical decisions, and products. The diagnosis is made by the genetic structure, environment, and lifestyle of the individual. Precision medicine employs tools like molecular imaging, analytics, and diagnostics.
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It applies the concept that if two persons are not the same, how can their diagnosis be similar? For instance, a patient who needs a blood transfusion cannot be given blood from a random donor. The donor and recipient’s blood groups are matched first, and then further transfusion is carried out. Why? Because the blood groups are not matched before the transfusion, there is a risk that the recipient’s body may reject the received blood. Similarly, every individual has his/her genetic structure, which does not match the other person’s. Thus, the treatment should also be given suitably. This is where precision medicine comes into play.
Due to its effectiveness, the precision medicine market has seen rapid growth worldwide. A recent study from Allied Markets suggests that Precision Medicine Market is estimated to reach $7,746 million by 2023, registering a CAGR of 11.9% from 2017 to 2023.
Will it be too time-consuming and expensive to customize medicines?
Yes, it will be expensive, but the researchers have found an alternative way to tackle this problem. The individuals will be classified by their genetic structure, forming groups with their share of benefits. Firstly, it reduces the cost of the treatment by reducing repetitive administration of the same medicine and alleviating the side effects related to them. Secondly, the formed groups will have their tailored treatment. Thirdly, such groups will help in studying the population health and preventing diseases shortly.
Considering that genetic factors can boost the development of drugs instead of falling in the trial and error procedure, which is probably more strenuous and time-consuming, precision medicine will help biologists understand the cause behind the repeated occurrence of disease and relatively develop medicines to eradicate them from the root.
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Recent developments in Precision Medicine Market
In 2015, Barrack Obama dedicated $215 million to the Precision Medicine Initiative – which included the idea to map the DNA of 1 million Americans, research genetic causes of cancer, and evaluated new diagnostic drugs.
Certa Therapeutics, a firm based at the University of Melbourne, has incorporated genetics analysis to anticipate the chances of the patients who are likely to develop kidney fibrosis, the precursor to end-stage kidney failure, shortly. Greg Hunt, the Federal Health Minister, has announced the Federal Government’s Biotechnology Translation Fund’s largest investment. The Government is all set to boost the pioneering Australian company by pumping in $22 million cash. This funding aims to support the clinical trials conducted by Certa Therapeutics.
Certa’s treatment, when incorporated with target medicine, has the potential of sparing patients from undergoing dialysis as the treatment will block the key receptor of the fibrosis. On average, 53 Australians die each day due to kidney-related conditions, costing the Australian government about $1 billion per year. With its drug already escalated in Phase II clinical trials, CEO, and founder of Certa Therapeutics, Professor Darren Kelly said that the drug could be in the market within the next five years, transfiguring personalized care.
“It’s an incredibly exciting time to be working in medical science. The amount of stored genetic material at our fingertips is immense. Access to this genetic data is transforming how we treat diseases. Rather than creating drugs that work for most of the population, we can now tailor our treatment based on an understanding of genetic makeup. The implications of this for the fighting disease are profound,” said Kelly.
Apart from kidney disease, clinical trials will also be conducted for different organs susceptible to fibrosis, for example, livers, eyes, or lungs. To promote the country as the global leader in the commercialization of biomedical discoveries, clinical trials play a crucial role. Australian Government created Biomedical Translation Fund (BTF) worth $500 million in 2016.
Kelly successfully sold his previous biotech start-up, Fibrotech, to Dublin founded a pharmaceutical company, Shire, to boost its kidney drugs through a mid-stage trial phase. With this contribution by the side, Certa aims to buy back some of the drugs in exchange for an 18% stake.
Dr. Chris Nave, CEO of the Medical Research Commercialization Fund, which manages the largest pool of BTF funds, said that this investment represents the raison d’etre of the BTF in many ways. It has provided sufficient capital to Australian medical science to carry on the late-stage clinical development in Australia. As per Nave’s statement, BTS is formed to be a transformative means for the local industry of Australia, which enables research discoveries to develop from concept to commercialization in Australia itself. In the long run, this concept will create jobs and more sustainable industry.
Uniseed, a project fund backed by the universities of Queensland, Melbourne, New South Wales, and Sydney and CSIRO is contributing over $3 million.
Companies like F. Hoffmann-La Roche Ltd. (Roche), Illumina, AstraZeneca are some of the players that offer precision medicine in various fields like oncology, auto-immune disease, and central nervous system (CNS) as well.
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Involvement of AI
Artificial intelligence (AI) involvement cannot be denied as it provides an exemplary shift towards precision medicine. AI techniques are currently used in target cardiovascular medicine better to understand the genotype and phenotype of existing diseases, enhance patient care quality, and decrease mortality rates and readmission.
Machine learning algorithms are used to analyze and determine inferences from the enormous amount of patient data that healthcare institutions record every moment. It is also utilized for genomic sequence. AI can be implemented to analyze patterns in the data and provide insights to medical professionals regarding the condition of an individual. Genome sequencing can be expedited using AI as well. AI can also be used for clustering and segregate the population into groups that can aid in the production of customized medicine.
Although precision medicine has immense benefits, there is a fair share of drawbacks associated with its implementation. The major issue arises while handling the humongous amount of the population’s genetic structure data.
Blockchain technology can be applied here to ensure that no data is mishandled and it is used ethically. It can also ensure that genetic information is shared securely across different platforms.
Benefits of Precision Medicine Market
As discussed before, President Obama had announced a $215 million proposed genetic plan under the name of Precision Medicine Initiative. As proposed by the plan, NIH is supposed to receive $130 million for mapping the DNA of 1 million people. The received amount was divided as follows:
- The National Cancer Institute received $70 million
- The FDA received $10 million
- Tech infrastructure to analyze and safely store data received $5 million.
As usual, this announcement had sparked a series of online controversies. According to internet gurus, this plan is a trap for you. It could prevent you from getting married, finding a job, or acquiring health insurance because we all are about to become a part of elephantine genetic experimentation that aims to alter human beings. It will also lead us in knee-deep debt, and big pharma companies will reap the benefits. The hilarious theories include Obama’s plotting of the genetic apocalypse.
Despite all this hogwash news, I have some concerns as well as some optimistic news.
- New Diagnosis:
Finally, we will be able to pinpoint the genetic source of diseases that were unknown.
- Effective prevention of the disease and early diagnosis:
Comprehending diseases at an early and detectible stage will help us to effectively prevent the disease before it strikes rather than reacting after its onset.
- Studying shielding genes:
Every individual has a certain gene set that immunes them against their own ‘bad genes’ or diseases. Analyzing these variations can help us understand how to watch over those diseases.
- Drug advancement:
Instead of using the traditional trial-and-error method, therapies can be developed sooner and more efficiently by targeting the actual culprit.
- Customized treatment:
Treatments can be molded according to the patient’s genomic structure, preventing the risk of allergic reactions and death due to allergic reactions.
- World health:
An easy way to study the causes of ailments, cultivate new treatments, and prevent diseases of the entire globe.
- Low healthcare cost
If the focus changes from treatment to prevention, there are chances to cut medical aid costs.
Potential Downsides:
- Data storing:
We all are aware of the fact that gene sequencing will create a massive amount of data.
Gene sequencing of million people is going to generate a mindboggling amount of data. The matter of concern is how and where we will store such an amount of data to create sensible analysis?
- Security:
The biggest concern of the era. With all these incidents of data leaks, how are we supposed to be assured that our genetic information will be safe?
- Data applicability:
As per Obama’s statement, 1 million volunteers will be selected for data sourcing. That is a particular cross-section of people, which may not represent the entire population of the US. On this basis, how is it possible to make health recommendations for the entire population? Only certain types of people will sign up for the data collection while the others won’t. In this scenario, we will certainly miss some disorders.
- Cultural problem:
Since our genetic information will be out in the open, there is no means to prevent the below issues:
Will we find potential partners?
Will we find jobs that do not discriminate on a genetic basis?
Will we be eligible for health insurance?
A whole new type of racism will be born, genetic racism. Brace yourselves! We are on the path of a real-life version of Gattaca.
- Proprietorship:
The ownership of these genetic data should be given to the source of these genes rather than the government claiming ownership. On the contrary, a genetic sequencing company named 23 & Me had a bad experience giving ownership to individuals. The FDA has barred the company from handing over individuals their generic information.
- Medical Aid Cost:
Yes, I agree there are chances that healthcare costs may go down, but the chances of going sky-rocketing high are also equivalent. Genetically mapping the population, analyzing the information, ensuring its safe storage, and developing treatments and recommendations is not easy.
- Agreement between private and public sector:
For the private sector, genetic research and development is a very productive and promising sector. The chances of involvement of government in this project have a 50-50 chance. If the government gets involved in this project, will the government agencies work cooperatively or competitively with them?
- Infrastructural needs:
For target therapy to work effectively, its infrastructural base has to be strong enough. Massive infrastructure and time will be needed for the appliance. These are the essential changes that have to be made for precision medicine to work smoothly. The fund provided by the federation may not cover the necessity required for data collection, sharing, and storage. Who will have to pay the rest of the fund remains unclear.
Despite the challenges in its execution, I am excited about the positive effects of this initiative prime one being its impact on population health. At the same time, the other part of me is anxious about the government’s invasion of private space, which could decelerate the development of these life-saving therapies.
Srushti Helwande