Now if you can get past the Sturm und Drang, there are a few ideas and insights to consider.
I am not suggesting anything nefarious but think about this quote, "It is difficult to get a man to understand something, when his salary depends on his not understanding it."--Upton Sinclair
This is more than a business decision. It is a point of worry and concern. If we continue to turn a blind eye to bias and thinly veiled marketing disguised as evidence-based medicine--shame on us.
You might be surprised by the list of the key-tools of non-evidence-based medicine in 2016 (splendlidly serving vested interests) as described by John Ioannidis, MD.
•Practice guidelines based on seemingly rigorous processes
•Systematic reviews and meta-analyses
•Observational studies and risk factor epidemiology
•X-omics, predictive medicine, precision medicine, personalized medicine, individualized medicine
- > 10,000 drugs in U.S. market
- More than half of all promotional expenditures focus on 50 top-selling drugs (yes it is an older study but does anyone think it has improved?)
- Physicians and other prescribers are more familiar with the most-promoted drugs
"Drugs can save lives and improve health when used appropriately but Promotion interferes with appropriate use of drugs" -- Adriane Fugh-Berman, MD
This is a list of fines levied against a leading pharmaceutical company. They all have similar pay-outs so I am not going to single-out only this company--but you get the idea.
XXX’s Legal Settlements: 2011 -2015
$2.5 million for inflating drug prices charged NY
$264.9 million for class-action suit
$14.5 million for illegal marketing of drug x
$60 million for bribing foreign physicians
$43 million for deceptive marketing of drug A, drug B
$55 million for deceptive marketing of drug C
$18 million for defrauding Medicaid
$190 million for violating anti-trust laws via drug d marketing $325 million for marketing drug D for unapproved uses
$400 million for deceiving investors about marketing of drug D
- The AMA Physician Masterfile contains demographic data sold to industry since 1940s
- Marketing of a drug starts long before drug approval
- Marketing messages often focus on how a condition is underdiagnosed, widespread, and affects quality of life; and how current treatments are absent, inadequate or problematic
Kendra Lawrence, RN, BSN,MHLP student presented at Lown Conference in Chicago. Here are a few findings from her presentation, Accessing Unpublished Clinical Trials: How to Obtain the Hidden Data and What if Reveals.
•Outcome reporting assessed in nearly 10,000 trials that contributed to nearly 300 systematic reviews:
•Primary harm outcome inadequately reported in 76% of trials (705/931) that comprise 92 systematic reviews
•Primary harm outcome not reported in 47% (4159/8837) trials that comprise 230 systematic reviews
•Reporting of data on harms likely less complete than reporting on efficacy
“Increasing proof of the unreliability of published trials and a move to liberalise access to regulatory reports has led to calls for the use of regulatory data for clinical decision-making.”--
I do collaborate with a handful of clients aligned with the need to avoid marketing influence and data distortion--here are a few best practices in my toolbox.
The European Medicines Agency now releases full clinical study reports upon request. If you want access to complete trial information it is helpful to also use other data sharing platforms, such as YODA or CSDR (see below).
So what is a [insert your role] to do? Where is the evidence?
(CAPRIE trial for clopidogrel was originally 8805 pages--journal article?--11 pages)