It is a sad reality that some of the regulatory agencies have been captured by the industry groups. This is especially concerning in healthcare and pharma industry. Take for example Vioxx and Opioid issues: Merck Manipulated the Science about the Drug Vioxx - https://www.ucsusa.org/manipulating-science-about-drug-vioxx Purdue infiltrated WHO, manipulated opioid policies to boost sales, report finds - https://arstechn…
“Evidence-based medicine has been hijacked”: John Ioannidis (2016)
51–60 of 79 posts
Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)
#52Evidence-based medicine has been hijacked: a report to David Sackett (2016)
Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)
#53There wasn’t a lot of substance in this article, would have to read Dr. Ioannidis’ referenced papers to actually understand his point.
The crux of the problem is this: we as a society value science, and the epitome of this in healthcare has been the goal of evidence based medicine (EBM) or evidence based practice (EBP). The idea seems simple enough, that healthcare decisions and procedures should be based on scientific evidence.
This clashes, however, with the reality that much of research in the biomedical sciences is unreplicable or completely invalid for other reasons. The reasons for this are complex but you have things like p-hacking, selective reporting of results, confounds, and so forth and so on. Think "how to lie with science" instead of "how to lie with statistics."
As a result, EBM gets hijacked by those who are trying to manipulate; appeals to science becomes a form of fallacious argument, sort of a version of appeal to authority error, where one appeals to a scientific finding because it's peer reviewed etc. without invoking the underlying integrity of the research per se. Then you have the unscrupulous making money off of bad science, and authority figures (in medical care and administration) cudgeling people for not using EBM/EBP when what is really happening is people are recognizing it as bad science. Sometimes no science is better than bad science--or sometimes, science means rejecting peer-reviewed research, even with all the right surface features.
The paper is part of a slightly personal exchange between Ioannidis and someone he looks up to but is also close to, so it has a kind of poignant conversational style. It's not so much a scientific paper as it is a personal discussion.
Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)
#54> 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…
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.
What Ioannidis is saying is that profit motivates pharma research. This is in a sense a tautology. Even then, Pharma do fund trials initiated by investigators not affiliated with the company.
Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)
#55Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)
#56> 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 th…
Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)
#57Earlier quoted context omitted.
Off the top of my head: He does meta studies -- aka studies of studies -- and finds that most studies are flawed, so most of the evidence we think we have isn't really there. It doesn't exactly make him popular because he calls into question a lot of existing supposedly "proven" medical science. He talks a lot about the biased assumptions that are the foundation of a lot of the framing of studies. If your baseline fr…
Stupid question - what makes us think the meta studies are themselves valid? Also wouldn't junk itself have many subclassifications as how it is junk? Say poor study data quality, wrong assumptions of wider applicability, wrong analysis or conclusions, etc.
Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)
#58Earlier 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?
https://www.vice.com/en_us/article/pg7ez9/pharma-reps-are-ba...
Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)
#59> 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…
Until recently, Big Pharma CEOs were either medical doctors of pharmacists. Marketing and finance were important, but not a driving force. Nowadays all of Big Pharma is headed by bean counters, marketing drones and finance guys, and are only interested in EBITDA. This is the main problem in all industries were science and engineering once prevailed.
Novartis - former head of R&D.
Pfizer - PhD in Veterinary Medicine (he joined their AH division in 93)
Astra Zeneca - Veterinary too
Merck / MSD - Lawyer
Roche - Economics & Law
Gilead - Biology
abbvie - never went to college, 30 years at company
Amgen - Biology
Re: “Evidence-based medicine has been hijacked”: John Ioannidis (2016)
#60Earlier 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?