I found myself puzzled that in “Standard of care” medicine we are not recommending treatments associated with strong positive outcomes in the scientific literature. And I believe that the vast majority of doctors sincerely want to heal their patients, yet the system they work within was built by the big business of hospitals and pharmaceutical companies. In an ideal world, the incentive structures of those entities would reward them for positive patient outcomes. But in today’s world they tend to get compensated simply for treating patients with little accountability for achieving desirable patient outcomes and “quality of life”.
As with all savvy investors, those investing their capital are looking for large, reliable returns on their investment. This can lead to a conflict of interest when it comes to prioritizing that which is best for the patients, and can leave it to others like non-profits such as Parsemus Foundation, or independent entrepreneurial doctor-scientists such as Dr. Dale Bredesen to push things forward in their respective areas.
Thinking about this helped me understand some of the dynamics at work in a situation where critical insights from our scientists and front-line doctors can be slow to receive the significant capital investment they need to support making it through the rigorous process that would be required to become the new “standard of care” in our complex healthcare system, including but not costly clinical trials, targeted education programs for physicians, awareness campaigns for patients, regulatory compliance, etc.
Reflections about off-exclusivity, off-patent, and orphan drugs
ChatGPT’s more concise version of my rant:
Pharmaceutical companies are hesitant to develop drugs lacking exclusivity, such as off-patent or orphan drugs. Their reluctance stems from the fear that approval for these cheaper alternatives might cannibalize sales of existing on-patent drugs, potentially reducing annual revenue. Large organizations are inherently focused on revenue growth and protection, shaping decision-making processes. Managers prioritize Key Performance Indicators (KPIs) for personal and organizational recognition, fostering a narrow perspective.
Scientists within these organizations tend to hyper-focus on specific pharmacological targets, often overlooking broader implications in physiology, dietary, and environmental sciences. This narrow focus, driven by the pursuit of the ‘next big drug,’ may lead to a lack of interest in proven, off-patent medications. The relentless pursuit of innovation can create a self-delusion that older drugs are less effective.
Unfortunately, patients face barriers to accessing potentially beneficial off-patent medications. Only those fortunate enough to have a proactive doctor willing to support ‘off-label’ use may benefit from these treatments. This creates a system where effective, existing solutions supported by scientific literature remain underutilized, hindering broader access to beneficial treatments.
My raw and personal rant (which ChatGPT summarized above):
Despite positive findings found across much of scientific literature, pharmaceutical companies are hesitant to commit to serious development of a drug for which they will not have exclusivity. Were that cheap drug approved for additional indications and would cannibalize existing sale of on-patent drugs, this could significantly reduce their annual revenue.
It’s in the DNA of all large corporations to grow and protect revenue, not decrease it: this is built into all processes of the organization. Making decisions that reduce revenue is not something managers at for-profit corporations are encouraged to do. Such pharmaceutical managers are probably not trying to do evil, but are likely hyper-focused on their teams KPIs. Likewise, the scientists reporting to those managers are likely micro-focused on the intricacies of drug discovery and development and only for very particular pharmacological targets.
Such scientists aren’t likely to spend much time thinking in broad terms about the physiology of the human body and synthesizing that knowledge with the latest findings in nutritional and environmental sciences. Instead they are probably thinking something along the lines of “I have these KPIs to hit! I need that next big drug idea so I’ll get recognized and earn that promotion…then I could afford to send my kids to that exclusive private school we hope to get them into.” As for those few individuals in a position to see all of the pieces and begin to see what is going on…it would be too easy to succumb to a process of self-delusion and denial: not unlike a thought fighting to stay within our unconscious. Is it hard to believe a person with such a vested interest might stay consistent with their pre-existing incorrect beliefs and convince themself that those “old” drugs wouldn’t really be that helpful…they aren’t even focused on the right target and well…we have much better odds of helping people if we stay focused on our commitment to develop the “next generation” of drugs that will finally “cure” cancer. And thus, despite existing scientific literature supporting the idea that many can be helped by utilizing an old, off-patent medication X, a patient in desperate need may never have it as an option unless by some miracle they learn of drug X’s potential use to treat their indication and they have a cowboy doctor who is willing to work with them and support their “off-label” use of this drug.