The human genome project has opened a new vista in therapeutics. Clinical genomics (or medical genomics) and bioinformatics has the promise of ushering a new era in healthcare. The advent of personalized medicine based on genetic profiling will not be a fast forward science, its commercialization is expected to be slow, yet sure. There are a number of ethical issues that need to be continually resolved to take personalized medicine forwards. Yet the start of an era of personalized medicine, an offshoot of the human genome project is round the corner.
One can say that it was the discovery of the gene and further characterization of the nucleic acids that gave genesis to genomics (thus knowing the susceptibility of an individual to gene-related diseases) and therapeutic approaches based on the genetic profile (personalized medicine).
Puzzling to pharma marketers
Although it is apparent that genomics is leading to an era of personalized medicine, one wonders how it will affect pharma product promotion, healthcare marketing and healthcare practice? To get an insight in to the emerging opportunity of pharma marketing in an era of personalized medicine, let us read the following futuristic hypothetical example of a MR – to – doctor product promotional experience:
Medical Representative: “Greetings to you doctor. As you agree, genetic history evaluation has revolutionized the modern approach to healthcare. Today, genetic history evaluation can recognize the susceptibility of individuals to chronic ailments like Alzheimer’s disease – senile dementia, restless legs syndrome, diabetes mellitus Type 2 and autoimmune diseases like lupus and rheumatoid arthritis.
Doctor, we are happy to announce the results of a first of its kind large double blind randomized crossover clinical trial – the gold standard – for the efficacy and safety of Brahmi (like Brahmi Himalaya) in the preventive management of senile dementia. In this multicentric multi-racial clinical trial conducted at different centers – Manila, Singapore, Bangalore, Chennai, Dubai, Lisbon, Ankarra, Baghdad, London, Chicago, and New York, on 25,000 healthy volunteers with a genetic susceptibility to senile dementia ,were involved. Of these 13,500 were given Brahmi, one capsule a day at bedtime. The preventive dose of Brahmi was selected based on authoritative classical Ayurvedic references including Bhavaprakasha Nighantu. The standardized extract in the capsule is made by a proprietary technology. The remaining of the patients were on placebo.
It is interesting to note that all the volunteers were given a special wristwatch with a GPS system, sms and alarm reminder technologies. This means the volunteer could be tracked and at the same time daily reminders through sms and alarm ensured that each volunteer took Brahmi or placebo as applicable at the right time everyday.
Further, a dedicated call center ensured that phone follow-ups were done regularly to ensure compliance to therapy and collecting feedbacks of the effects. Every week the volunteers had to report for a regular check up on various clinical and biochemical parameters.
Obviously being a Ayurvedic herb, safety and efficacy was guaranteed. It is amazing to note that till date in this ongoing Phase 4 clinical trial not a single major side effect or drug toxicity has been noted.
Sophisticated computer enabled electronic dispensers have been used so that at no point would volunteers on placebo consume Brahmi and vice versa would also not be possible. Thus, the system was foolproof.
The clinical trial was handled by an ecosystem of CROs (clinical research organizations) like Lotus Labs, Bangalore and Quintilles. The statistical processing has been done by Accenture.
Doctor, this is a large timeframe 30 year Phase 4 ongoing clinical trial. The first 10-year milestone report is just out now. The results (pointing to the bar graph in the visual aid) clearly points out that Brahmi is superior to placebo at P (chance proportion) less than 0.01. This means that Brahmi would have acted by chance only once if we had repeated the clinical trial 100 times, the results are statistically highly significant. We have assessed for beta amyloid, tau and other protein markers and related amino acids. These show a positive picture in patients on Brahmi. Comprehensive scoring techniques using mental evaluation techniques like Mini-Mental State Examination score were used to assess the impact of Brahmi/placebo on mental abilities.
So clearly Brahmi retards the onset and progression of dementia in genetically susceptible individuals.
In fact, doctor, we have ongoing trials for assessing Ashvagandha as a preventive herb in patients genetically susceptible to hypertension. Ashvagandha reduces anxiety, promotes adaptation to stress, and thereby retards onset and progress of hypertension in genetically susceptible patients. Another herb Karela is similarly useful to retard onset and progression of prediabetes and diabetes in genetically susceptible patients. However, that is another story for another day.
Doctor, now, can I go with your assurance that you will encourage taking genetic history along with family history, and in genetically susceptible individuals you will prescribe Brahmi for retarding onset and progression of dementia?"
Doctor: "I am impressed with your presentation and of course with your company – the way it is constantly reinventing itself. I will definitely prescribe Brahmi in patients with family history and genetic history to retard the onset and progression of dementia."
The above hypothetical doctor-to-MR transaction describes the potential for wellness market of pharmaceutical and healthcare products. In fact, the concept of personalized medicine while revolutionizing the approach to healthcare, will create clinical trials that explore the preventive aspects of pharma products, companies will come out with wellness products and products with wellness positioning, and health insurance companies will use probability science to work out premiums based on genetic mapping. It is inevitable that it will be routine to draw cord blood to store stem cells and look in to the genomic profile to develop a disease prevention and management approach. Of course there will be debates on ethical matters but the field of clinical genomics is all set to evolve faster and the healthcare paradigm will change to keep pace.
This post is done at the neighbourhood cyber cafe at 1.20 pm IST on Saturday, 21.7.2007. THNKS FOR GOING THROUGH PLEASE GO THROUGH ALL OTHER POSTS - they are worth it.