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

retractionwatch.com

61–70 of 79 posts

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

#61
post #46

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. 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 th…

how do they get doctors to prescribe the patented versions if they aren't better?

Sometimes they pay other companies not to make the unpatented drug: https://www.ftc.gov/news-events/media-resources/mergers-comp...

More tricks here: https://hbr.org/2017/04/how-pharma-companies-game-the-system...

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

#62
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…

> The design of clinical trials still belongs to R&D and not Marketing/Sales departments.

This is FALSE. It's literally come out in court documents. https://www.motherjones.com/environment/2010/09/dan-markings...

> In 1997, when Dr. Andrew Goudie, a psychopharmacologist at the University of Liverpool, asked AstraZeneca to fund a research study he was planning, a company official replied that “R&D is no longer responsible for Seroquel research—it is now the responsibility of Sales and Marketing.” The official also noted that funding decisions would depend on whether the study was likely to show a “competitive advantage for Seroquel.”

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

#63
post #46

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. 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 th…

how do they get doctors to prescribe the patented versions if they aren't better?

If there is once choice, doctors prescribe it. If there are two or more very similar choices, doctors prescribe one or the other. Adding competition decreases price, sometimes there may slight differences in side effects. May not be worth of the research itself, but getting into market justifies it.

Example:

Great discovery: PDE5 inhibitor helps with erectile dysfunction. Product: sildenafil (Viagra). After the mechanism was invented, tadalafil (Cialis), and vardenafil (Levitra) were pushed into market and FDA approved. There are roughly different 10 PDE5 inhibitors and the market is saturated.

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

#65
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…

> The design of clinical trials still belongs to R&D and not Marketing/Sales departments. This is FALSE. It's literally come out in court documents. https://www.motherjones.com/environment/2010/09/dan-markings... > In 1997, when Dr. Andrew Goudie, a psychopharmacologist at the University of Liverpool, asked AstraZeneca to fund a research study he was planning, a company official replied that “R&D is no longer respons…

>This is FALSE.

How do you demonstrate that one case implies all cases?

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

#66

Earlier quoted context omitted.

> The design of clinical trials still belongs to R&D and not Marketing/Sales departments. This is FALSE. It's literally come out in court documents. https://www.motherjones.com/environment/2010/09/dan-markings... > In 1997, when Dr. Andrew Goudie, a psychopharmacologist at the University of Liverpool, asked AstraZeneca to fund a research study he was planning, a company official replied that “R&D is no longer respons…

>This is FALSE. How do you demonstrate that one case implies all cases?

This isn't a small company nor is it a minor drug. This is one of the largest drug companies running a trial on one of the most lucrative drugs in the world.

And secondly, why should ANY drug trial be managed by a PR department? When you ask people to risk their lives to be in a drug trial (in the link above the subject died in the trial), why should it be to improve the PR of a drug for one company. The fact that this exists at all is a major warning sign. The indifference of people to this is frankly amazing to me (its even worse than the disinformation provided by the OP).

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

#67
Dubious evidence in medical studies is a big problem.

But I'd argue that it's only the core of the issue. The second layer out — and I think the more influential layer — is the JOURNALISM surrounding these medical studies.

Even if the underlying science is sound, a lot of outlets and reporters routinely (and sometimes willfully) get the facts wrong.

I attended a talk with Retraction Watch's Ivan Oransky, where he spelled out how easy it is for well-intentioned journalists to exaggerate, over-generalize, or misunderstand what a study says. It was eye-opening. And a little frightening.

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

#68
post #46

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. 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 th…

how do they get doctors to prescribe the patented versions if they aren't better?

Drug salespeople constantly cajole doctors to prescribe one drug over the other using soft bribes like prizes, kickbacks, junkets, etc. Doctors have very limited time to do research and prescribe mostly on the basis of what sales people recommend and what patients ask for (which itself comes from drug advertisements). The "betterness" of a drug has very little to do with what doctors prescribe.

This phenomenon is quite well-documented so I won't cite sources here.

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

#69
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…

The history of associating disease with asbestos exposure dates to the ancient Greeks.

https://en.wikipedia.org/wiki/Asbestos-related_diseases#Hist...

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

#70

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.

Study 329. GSK paid a PR company to ghostwrite a misleading paper, with the intent of concealing the fact that a) paroxetine is no more effective than placebo in the treatment of adolescent depression and b) paroxetine significantly increases the risk of suicide in adolescents.

GSK knew that their drug was worse than useless, they knew that children would die as a result, but they deliberately withheld damning data and misled clinicians. For this (and many, many other acts of deceit) they were fined a total of $3bn by the Department of Justice.

The paper has never been retracted and paroxetine is still widely prescribed to adolescents.

https://en.wikipedia.org/wiki/Study_329

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