The Hacker News discussion revolves around several key themes concerning the pharmaceutical industry, regulatory bodies, political influence, and the concept of technocracy.
Erosion of Trust and Norms in Western Politics
A prominent concern is the perceived decline in the integrity of western political systems, leading to a potential increase in systemic corruption and a disregard for facts. This sentiment is linked to a broader loss of faith in institutions and a weakening of societal norms.
- "The political uncertainties of western countries where 'there is no truth' and 'facts don't matter' could easily bring this level of systemic corruption to them as well," notes_kurthr._ He continues, "People love to rage bait and say how bad it is now, but that seems to have largely led to groups giving up on enforcing norms, and bodes poorly for the future."
The FDA's Role and Perceived Political Interference
The discussion touches upon the FDA's reputation and the extent to which it has been influenced by political appointments and priorities. While some argue for the FDA's general competence, others point to instances where political pressures or the qualifications of appointees have compromised its effectiveness. The specific case of approving generics from factories with past quality issues is highlighted as a symptom of this.
- "In both cases, the FDA was generally run and staffed by non-political people who were at least vaguely competent. I have plenty of issues with how the FDA operated, but it didn’t matter much who was president,"_amluto_observes, contrasting past administrations with the present.
- He further elaborates, "Today, most of the Cabinet positions are held by people who love to talk, who are generally extremely wealthy and/or well connected, and who are generally unqualified for their jobs. And, even more relevantly, they have been very heavily interfering in the operation of their respective departments."
- _thfuran_criticizes the FDA's practices, stating, "The FDA has been approving generics from factories known to have repeatedly failed prior audits or had products recalled for quality issues without re-inspecting the factories or inspecting the drugs on import. And they're doing it via a special process that bypasses the ordinary review process and over the objections of many of the inspectors."
Technocracy vs. Politicization of Decision-Making
The concept of technocracy, where decisions are made based purely on evidence and rational methods, is explored as a potential alternative to politically influenced governance. However, the discussion also acknowledges the risks associated with such a system, including groupthink and the potential for "optimizing out" variables that are important to human welfare.
- _ggm_introduces the idea of Leo Szilard's concept of a "bund" to fix politics through evidence-based methods, noting, "It wouldn't work, but when I see appeals to authority (FDA) enter the room, it's usually to feel superior because its a logical fallacy in argument but the place it actually fits (which btw, is here, in this thread) is that compliance to standards and policing them, is not 'argument' it's the 'you only had one job' part of the gig."
- He illustrates the ideal of a technocratic approach with a hypothetical scenario: "'yes Mr Kennedy, these friends of yours are very nice at parties, but unfortunately they are neither qualified, nor actually capable of fulfilling their role and so no, you won't be appointing them' is what the Bund would do."
- _ggm_also points out a critique of politicization: "Being able to take a compliance body oversight function and leverage it to remove adjuvents because of one paper, despite overwhelming evidence to the contrary, is precisely whats wrong in the current politicised situation."
- Countering the uncritical embrace of technocracy, _elcritch_warns, "Ah yes because technocrats are never prone to groupthink or missing the forest because of the trees, et cetera."
- _elcritch_cites China's leadership, predominantly with engineering degrees, leading to policies like the one-child act, and its negative consequences, stating, "Be careful what you wish for, as you’re possibly a variable which could optimized out."
- He further cautions about the limitations of specialized expertise divorced from broader welfare considerations: "Alternatively consider the long term ramifications of leaving pandemic responses purely in the hands of unelected epidemiologists whose primary focus is a virus and not the overall welfare of a population."
- _elcritch_concludes by advocating for diverse viewpoints: "IMHO, alternative means of thinking are needed in a governmental system for the best overall outcomes."
Pharmaceutical Manufacturing Standards and Generic Drugs
A significant portion of the discussion delves into the practices of pharmaceutical manufacturing, particularly concerning the quality control of drug batches and the implications for generic drugs. The analogy of "binning" products, similar to microchip manufacturing, is used to describe a system where batches with minor deviations might be sold. The effectiveness and variability of generic drugs are also debated.
- _hinkley_shares an anecdote about a pharmaceutical company tracking manufacturing tolerance mistakes to find markets for different batches: "You'd like to think that companies have factories with quality control laws and there are local people trying to ensure that all of their product are up to the local standards. What you don't expect is that they are binning them like Intel CPUs, where they just make a batch and hope for the best, take cream off the top until the priority orders are done and then everyone else gets whatever is left."
- _xdfgh1112_queries the implications: "Does that mean that generics really are worse than the brand pharmaceuticals. Or are they binned the same way?"
- The general understanding among discussants is that generics are produced by different companies, and their effectiveness is largely tied to the regulatory oversight of each country.
- _nick__m_provides a nuanced perspective on generics in Canada, stating, "here in Canada the active ingredient must be identical in identical quantity but the binding agents, excipient, and propellant are proprietary. The generics have to have the same bioavailability +-20%.In some drugs it doesn't matter, in others there is a world of difference." He shares personal experiences where generic versions caused adverse effects, necessitating the use of brand-name medications.
- _speff_questions the absolute nature of "perfectly made" products, arguing, "Is this system not preferable over just trashing anything not perfectly made? Sure it would be nice if everyone can have perfectly manufactured medicine, but that's not reality. I would think something that's still likely good is still better than nothing."
- _colechristensen_distinguishes between minor efficacy differences and drugs becoming "no longer effective at all to a reasonable level or toxic."
- _energy123_draws a parallel to food processing, where lower-quality items are sold under different brands or reprocessed, suggesting that the alternative to this practice is waste. He states, "I'm not going to cast stones at this practice because as always the alternative isn't some magical world where all produce is perfect, the real alternative is that it gets thrown in the trash and wasted, and everyone is worse off despite feeling better about themselves."