This is a hugely important read for anyone who’s affected by medical science (i.e. you).
It’s scary to realize the level of unethical behavior in an area as important as medical research… But, hopefully the more people who know, the more likely those involved will clean up their acts! (By the way, this is likely how statin drugs got so high up on their undeserving pedestal.)
Here are some bullet pointed highlights of this article from ChrisKresser.com for your skimming pleasure:
POINT #1: Research misconduct and fraud is often not reported
- One of the FDA’s roles in the drug approval process is to inspect clinical trial sites to determine whether these sites are complying with FDA regulations.
- Siefe and his assistants used the Freedom of Information Act to request information from the FDA, and supplemented that data with Google searches of the FDA database. They found 57 clinical trials that were directly linked to an OAI inspection. (OAI = Official action indicated; the most severe violation)
- 96 percent of these articles failed to mention the violations identified by the FDA inspection—despite the fact that in the majority of cases the inspection was completed at least 6 months before the article was published.
- Ex. Researcher falsified lab test results to hide a patient’s impaired kidney and liver function in a trial comparing two chemotherapy regimens. The first dose of the regimen proved to be fatal to this patient, and the researcher was sentenced to 71 months in prison. Despite this episode being described in both FDA and court documents, not one of the studies in the peer-reviewed literature associated with the chemotherapy trial have any mention of the falsification, fraud, or homicide.
- Ex. Large trial of apixaban (anti-clotting drug) in China: FDA determined patient records were altered and data falsified in order to prove that this drug saved lives. None of this discussion appears in the scientific literature. Studies since 2011 have consistently relied on the full data set (including the fraudulent data from the China trial site), and this was even true for an article published nearly 18 months after the fraud was discovered.
- How is this possible? FDA does not notify journals when a site participating in a clinical trial receives an OAI inspection, nor does it typically make any announcement which would alert the media and general public to the issues it identified. They do this to protect the identity of the drug company involved in the trial( = “confidential commercial information”).
POINT #2: Conflicts of interest in academic research are rarely disclosed
- It is well established that two-thirds of medical research is sponsored by drug companies, and industry-sponsored trials are more likely to report favorable results for drugs because of biased reporting, biased interpretation, or both.
- A couple quotes to keep in mind: “It’s difficult to get a man to understand something, when his salary is dependent upon him not understanding it.” (Upton Sinclair), and “Don’t bite the hand that feeds you.”
- Very few universities make required reports to the government about the financial conflicts of interest of their researchers—and even when they are reported, the universities rarely require those researchers to eliminate or reduce these conflicts.
- 90 percent of universities relied solely on the researchers themselves to decide whether to report their potential conflicts of interest, and half of universities don’t even ask their faculty to disclose the amount of money or stock they make from drug or device makers.
- 8 out of the 9 doctors on the panel that creates the official blood cholesterol target values for the U.S. had direct ties to statin drug manufacturers (there’s a link to the specific names in the article). (Sales of statin drugs reach $30 billion a year.)
- 64% of experts who served on advisory panels in 2007 to evaluate vaccines for flu and cervical cancer had potential conflicts of interest that were never identified or resolved. The report also revealed that the CDC failed nearly every time to ensure that experts adequately disclosed that they were being paid by vaccine manufacturers. (Sales of vaccines reach $20 billion a year.)
- Another related problem is the “revolving door” between public agencies like the CDC and FDA or institutions like the U.S. Congress, and pharmaceutical companies. Ex. director of the CDC became president of Merck Vaccines AND over half of the lobbyists employed by the pharmaceutical industry in 2008 had worked in Congress or another branch of the federal government, and 35 had been former members of Congress.
- There are certainly some honest, unbiased, objective people out there, but financial interests of researchers are positively associated with outcomes favorable to the sponsor in medical studies, and research institutions can be influenced by industry sponsorships such as grants, endowed chairs, and other gifts.
- “…science is a human endeavor, and like all human endeavors, it is subject to the vagaries of human ethics and behavior.”