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Comment by vannevar | Hacker News Reader

Somewhere out there, a business model is waiting to be found.

I hope so, because the current one isn't working for consumers. Even with the billions spent on R&D, it turns out that many of the drugs Big Pharma turns out are no better than placebos. It's not hard to see why: a big company spends X amount on each failure and needs a 10X hit to offset the costs. If one doesn't materialize, it's not hard to rig the statistics to show some marginal benefit for a chosen winner, and a big marketing budget and the placebo effect takes care of the rest. Thanks to this model, we've finally conquered the scourges of restless leg syndrome, overactive bladder, and general anxiety disorder.

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Actually it's almost impossible to rig the statistics. And every drug on the market has shown efficacy compared to placebo in large tests calle phase 3 clinical trials.

Actually it's almost impossible to rig the statistics.

I would argue that it's actually impossible to economically conduct sufficient studies to reliably predict the efficacy and long term safety of drugs in the general population. And you're right, every drug on the market has passed Phase 3 trials because they're cherrypicked. A big drug company knows how many drugs it needs in production to ensure that some percentage of them are statistically likely to get through Phase 3 trials. To believe otherwise is to believe a drug company would bet a multi-billion-dollar enterprise purely on a research gamble. Is it possible for them to lose? Sure, 'statistically likely' isn't a guarantee. But it's much better odds than depending on stumbling into an actual cure.

Do you have any evidence for that? I don't have any background in pharma, but my background in stats tells me that the odds of passing a controlled study with a placebo would be so low as to be economically infeasible.

If I run a big clinical trial pitting a placebo against a useless drug, the odds of getting the same results from both are low: one is going to appear more effective than another. If I run a hundred of these kinds of trials, I'm virtually guaranteed to see a few cases where one appears much more effective than another. And if I test my worthless drug against an existing treatment that was approved through the same process, I may as well be testing against another placebo.

I'm not suggesting all drugs are worthless; only that drug companies do not need to produce effective drugs to stay in business.

That's not true. Drug companies can't just cherry pick trials to report to the FDA. The FDA is involved from very early on in the process. Furthermore, if the drug company is doing suspicious things like shutting down trials, the FDA will be even more strict in their requirements for approval.

The drug companies don't need to shut down trials, they just need to spread their bets sufficiently to ensure there are some winners. Sort of a VC model, except they have a clearer victory condition in FDA approval. Once a drug is approved, the pharmaceutical equivalent of retail shelf space is assured and the marketing machine can kick in to guarantee profitability. And the FDA has little incentive to prevent marginally effective drugs from reaching the market as long as no better alternative treatment exists. Which it won't, if big drug companies can keep churning out pharmaceutical 'hits' without much regard for efficacy. The system is a self-sustaining money machine for them.

If what you claim is true, and drug companies only get things approved by brute force, then we'd expect just 5% (for p-value of 0.05, as is commonly used) of trials to succeed at every level. But that's not the case.

"Actually it's almost impossible to rig the statistics."

Pretty sure the opposite has been proven, e.g. GSK's shenanigans with paroxetine.

Do you not believe these are actually problems for people?

They're a problem for a lot of people. So many in fact that they fall into the range of normal human physiology and behavior. My point is that for most people, the cures that are being vigorously marketed by drug companies are no better than placebos for many of these 'disorders'. These drugs are an artifact of the pharmaceutical industry business model, which the parent comment acknowledges is broken albeit for a different reason.

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