“Evidence-based medicine has been hijacked”: John Ioannidis (2016) • Hacker News Board

Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)

#41

Post by tomp » Fri, Jul 05, 2019, 10:03 AM UTC

ekianjo wrote: post #28

hannob wrote: post #25

Earlier quoted context omitted.

> Hasn't this been fixed with the requirement to pre-register trials? If it was that simple... Preregistration is a step in the right direction, but there are still plenty of ways to game the system, particularly as it's not properly enforced: http://compare-trials.org/

But it is the necessary step to highlight the problem so that actions can be taken. Also, you can safely assume that the large majority of outcomes that were not published were:\ - negative - worse than negative (i.e. safety issues?) - not properly designed So if you compare the number of trials disclosed/not disclosed for each drug/each company that gives you a pretty good picture of who is doing what already. With…

My assumption is that most unpublished trials were "no effect".

Be a drug company. Develop a "drug" that is really a placebo (has no effect). Do 10 trials. 8 are "no effect", 1 is positive (by chance), 1 is negative (by cance). Publish the positive drug. Market the drug as having positive effect. Sell the drug, make billions. It would take decades for enough other research (mostly "no effect") to accumulate before it becomes obvious that your drug actually has no effect.

Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)

#42

Post by dredmorbius » Fri, Jul 05, 2019, 10:07 AM UTC

fit2rule wrote: post #38

ben_w wrote: post #19

Earlier quoted context omitted.

Did Donald Rumsfeld also convince the European Union, who have their own interests and a similar sized economy, that it was safe? https://www.efsa.europa.eu/en/press/news/131210 or the “more than 90 countries worldwide” [1] that the Canadian government refers to on their own website? https://www.canada.ca/en/health-canada/services/food-nutriti... There are certainly cases where I don’t trust USA regulations. This jus…

There is a big difference between what law-makers/legislators think is safe in the context of their desire to promote the economies of their commercial partners, and what scientists consider safe in the context of human health and safety. The two cannot be conflated. Scientists can call for something to be re-considered, safety-wise, long after legislators have put their deals to bed. There are countless examples of…

asbestos was once 'scientifically and legally proven to be safe'

Source?

Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)

#43

Post by marcus_holmes » Fri, Jul 05, 2019, 10:13 AM UTC

wallace_f wrote: post #13

Alex3917 wrote: post #3

Earlier quoted context omitted.

> This does not follow well logically. Instead of trying to reason from first principles about whether or not what he's saying is true, maybe instead go on Amazon and buy one of the dozens of books on the subject.

I don't know if what he is saying is true, but I do know from having worked in another industry that the idea of sales/marketing dictating product development is not necessarily illogical, even if at face value it is.

in a lot of industries, Sales/Marketing dictating product development is the default.

Sales and Marketing folks get used to that kind of power... and then they transfer to a new industry.

Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)

#44

Post by marcus_holmes » Fri, Jul 05, 2019, 10:15 AM UTC

ekianjo wrote: post #30

RobertRoberts wrote: post #4

Earlier quoted context omitted.

> If it were meaningless, FDAs and other regulatory bodies would not even accept it during the clinical trial design review phase. Go look up how many corporate stooges are in the place in the FDA over the years. A good starting point is the history of Aspartame, I'd link some articles, but I suspect the sources would be shot down and evidence ignored. The people at the FDA were complicit in its approval, despite sci…

Assuming the FDA is corrupted is one thing, assuming regulatory bodies ACROSS the world are all corrupted at the very same time is just very close to being a ridiculous claim.

it's known as "regulatory capture" and it's extremely common.

Most planning authorities worldwide are captured by property developers.

The more money involved in an industry, the more likely it is that the industry regulator is captured.

Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)

#45

Post by hef19898 » Fri, Jul 05, 2019, 10:21 AM UTC

dalbasal wrote: post #34

PeterStuer wrote: post #16

Earlier quoted context omitted.

Sales and Marketing do control which outcomes are allowed to be published though. If you allow me selective disclosure of trials I can show you that my roulette strategy is infallible.

As a sales and marketing person... I'll admit to a lot of blame for a lot of bad things... definitely playing with words to they point where they mean very little. Selective publishing and "p-hacking" though, these are research/academia pathologies not marketing ones.

I understand why you are getting downvoted. Yet I think you make a valid and important point. Sure marketing and sales are putting a lot of pressure on, in that case RandD. But then RandD is, at some point, deciding to publish or find what is wanted. And, at least in my experience, good marketing people would rather not have falsified results and even if it is just for PR reasons.

Just blaming someone else, like marketing and sales, is quite often juat a lazy excuse to not have to look at oneself. Goes zhe other way round, so. Marketing saying "we didn't force them to find value X" might be literally true as marketing almost certainly didn't use these words. But pressure cam be applied in more than one way, it doesn't have to be explicit.

One good example is the series Chernobyl. Pressure from above to deliver certain things, ignoring truth until it's too late and then looking for someone to blame. Plant management did it with the reactor control crew and the political higher ups indirectly with plant management. So yes, all of them have to blamed. Not simply a communist problem as this thread about pharma R and D shows, right?

Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)

#46

Post by nabla9 » Fri, Jul 05, 2019, 10:47 AM UTC

ekianjo wrote: post #2

> The sales and marketing departments in most companies are more powerful than their R&D departments. Yes, this is correct. > Hence, the design, conduct, reporting, and dissemination of this clinical evidence becomes an advertisement tool. This does not follow well logically. The design of clinical trials still belongs to R&D and not Marketing/Sales departments. Even if Marketing/Sales want to target for a specific o…

> If it were meaningless, FDAs and other regulatory bodies would not even accept it during the clinical trial design review phase.

Billions in R&D goes to getting molecular entities approved by FDA that are clinically meaningless. The medical R&D is done just to get a product that provides already existing functionality or already existing treatment with a slightly modified molecule that can be patented.

It's like the joke about man who goes to patent office and says that he invented gunpowder. Patent clerk says that unfortunately gunpowder has already been invented. The man says: "But I invented more of it." Approval process is not looking if the new drug is meaningful improvement over existing drugs. "Inventing more of the same" is approved if it can be tweaked a little to be unique.

Alternative is also true. There are potentially clinical treatments and medicines that receive no approvals because there is no profit motive to push them trough the expensive process of approval.

Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)

#47

Post by andrewla » Fri, Jul 05, 2019, 10:56 AM UTC

tomp wrote: post #41

ekianjo wrote: post #28

Earlier quoted context omitted.

But it is the necessary step to highlight the problem so that actions can be taken. Also, you can safely assume that the large majority of outcomes that were not published were:\ - negative - worse than negative (i.e. safety issues?) - not properly designed So if you compare the number of trials disclosed/not disclosed for each drug/each company that gives you a pretty good picture of who is doing what already. With…

My assumption is that most unpublished trials were "no effect". Be a drug company. Develop a "drug" that is really a placebo (has no effect). Do 10 trials. 8 are "no effect", 1 is positive (by chance), 1 is negative (by cance). Publish the positive drug. Market the drug as having positive effect. Sell the drug, make billions. It would take decades for enough other research (mostly "no effect") to accumulate before it…

That’s the whole point of preregistration. The nine unpublished trials can be assumed to be negative, or at least neutral, and were aware that they were done because of preregistration. Therefore regulators have the ability to reject the notion of the effectiveness because so few of the studies reported positive outcomes. In addition, any cancelled studies now taint the authors and sponsors with a (small) amount of suspicion that they are refusing to publish non-positive effects which, cumulatively, will cause their results to be further discounted. That will hopefully provide a strong incentive to publish neutral and negative results.

Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)

#48

Post by andrewla » Fri, Jul 05, 2019, 10:58 AM UTC

hannob wrote: post #25

viraptor wrote: post #24

Earlier quoted context omitted.

Hasn't this been fixed with the requirement to pre-register trials? https://chrisblattman.com/2016/03/01/13719/ I'm not sure if every org requires it now or not, but if not then it seems like a question of time only.

> Hasn't this been fixed with the requirement to pre-register trials? If it was that simple... Preregistration is a step in the right direction, but there are still plenty of ways to game the system, particularly as it's not properly enforced: http://compare-trials.org/

From the results there it is clear that they failed to game the system since the gaming was detected. Getting to the point where regulators can actively use the preregistration information is the next step, but the foundation is there.

Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)

#49

Post by andrewla » Fri, Jul 05, 2019, 11:02 AM UTC

marcus_holmes wrote: post #44

ekianjo wrote: post #30

Earlier quoted context omitted.

Assuming the FDA is corrupted is one thing, assuming regulatory bodies ACROSS the world are all corrupted at the very same time is just very close to being a ridiculous claim.

it's known as "regulatory capture" and it's extremely common. Most planning authorities worldwide are captured by property developers. The more money involved in an industry, the more likely it is that the industry regulator is captured.

Regulatory capture will mean that outsiders - small companies without big pharma connections - will find it difficult to get effective drugs approved.

Similarly, innovative ways of proving drug effectiveness, even if they are more efficient and accurate, will be difficult to bring into practice.

Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)

#50

Post by ben_w » Fri, Jul 05, 2019, 11:35 AM UTC

donatzsky wrote: post #32

ben_w wrote: post #31

Earlier quoted context omitted.

Authorities are called such for a reason. It is only a fallacy to invoke an authority who is unrelated to the subject, or if your opponent is also an authority. > As far as artificial sweeteners go, you'd have to be an idiot to knowingly consume an unnatural, laboratory made chemical. On the subject of fallacies, this one is called the “appeal to nature”.

If said authorities were infallible, I'd agree with you. Unfortunately that is rarely the case.

Authorities don’t have to be infallible to have a better track record than anyone else. If they did, we wouldn’t have senior software engineers, we would have the pointy head boss writing all the code; we wouldn’t have doctors, as everybody’s home remedy would be just as good; we wouldn’t have CEOs, as communism would be correct and the workers would be more effective at running their businesses than the owners ever were (hello ironic counterpoint); etc.

Of course, everybody including authorities is capable of making mistakes. It is generally a bigger mistake to think you know better than they do. Not always, but generally.