Stakeholder alignment plays an important role in reaching strategic objectives for health care. The idea is that if we change either the incentives or the governing norms of an industry, it would be possible for all stakeholders to pursue a common goal without facing any obstacles – a true win-win situation. The recent change in guidelines governing the diagnosis of Alzheimer’s disease takes us in a new direction – whether it will help us achieve our common goal remains to be seen.
New guidelines are motivating pharma companies to explore proactive treatments
A recent NY-Times article walks us through the real-life scenario of a person signed up for a clinical trial sponsored by Bristol Myers Squib (BMS), which will test a drug that is expected to treat Alzheimer’s at its very early stages. The drug is BMS-708163 that is targeted towards patients with Prodromal (early-onset) Alzheimer’s Disease. The study is still recruiting patients.
Scientists have realized over the past few years that mid- to late-stage Alzheimer’s disease is probably not the best time for either understanding the underlying the mechanisms of the disease or to try to find cures for the disease. By this time, degeneration of the patients’ brain cells have advanced to irreversible stages and any improvements would probably be masked by the disease progression. They have realized that to find a cure for the disease we need to start very early – with people who are susceptible to the disease rather than those who have started seeing its effects (a time when the disease has reached its irreversible levels).
Pharma companies would have realized this logic, however it was only after the thresholds describing the disease were changed that they began specific initiatives with patients very early in its progression. The BMS study will be a new type of clinical trial that will recruit patients who probably have a much better chance to enhance their lives by delaying the onset of Alzheimer’s.
Now, this initiative is made challenging by new FDA regulations that require pharma companies to prove more than just the reduction of amyloid plagues in the brain (something that these drugs target) with the new treatments. They want to see proof that these drugs can actually improve memory and the ability to think and reason better than people who do not take this medication. This of course worsens the dilemma about anti-amyloids, currently the governing theory behind Alzheimer’s drugs.
A risky bet with early onset Alzheimer’s but worthwhile nevertheless
Alzheimer’s disease currently affects about 5.3 million people in the US alone and 30 million people worldwide. There is a dire need for the industry and for the patients to come up with a solution that can save lives and maintain good quality of lives for those affected. It is encouraging to see that all stakeholders are aggressively pursuing viable strategies in this matter, given the challenges involved
