Jeanne Lenzer, associate editor of The BMJ (British Medical Journal) takes a close look at just how industry influences medicine and with the help of the FDA, supports the agenda of the very industries it is supposed to regulate.
In this published expose, a little known foundation, The Reagan-Udall Foundation, a public charity, was established a decade ago to fill the gaps left by a seriously underfunded U.S. Food and Drug Administration (FDA).
The foundation's mission was to analyze dangers emerging from new products the FDA oversees. The FDA does little to forecast dangers and proactively prevent them. Reactively, it allows the industries it regulates to quietly recall dangerous drugs and devices. (There have been exceptions, ie; dangerous dog food Instead it allow industry to conduct its own voluntary recalls of problematic products.)
Instead of doubling funding of the FDA so it could do a better job protecting Americans, something the Institute of Medicine (IOM) had already recommended, the FDA budget rose just 19% from 2006 to 2016.
Congress also demanded the FDA contribute somewhere from $500,000 to $1.2 million to the newly formed foundation, which was already the recipient of funding from drug and medical device manufacturers.
Between 2009 and 2013 the Reagan-Udall Foundation reported about 22% of its revenue came from the FDA, 39% from industry and 38% from not-for-profit entities such as trade associations for the pharmaceutical industry.
Some felt the foundation was essentially a front for industry. The mission was already co-mingled with the FDA. With little oversight, industry could dictate how funds, some taxpayer funds, would be used.
The Reagan-Udall Foundation responded that it would follow conflict of industry rules.
However, Lenzer reports:
Of 14 board members, only four could come from FDA regulated industries. As it stands now, of the 13 board members, nine have or had financial ties to industry, writes Lenzer. They include a director at Johnson & Johnson (Mark McClellan), and a chief executive of the medical device lobbying group, AdvaMed (Pamela Bailey), among others.
FDA Commissioner Robert Califf announced a foundation project to analyze big data to identify safety issues – Innovation in Medical Evidence Development and Surveillance (IMEDS) was born.
New FDA Commissioner Scott Gottlieb, a recipient of drug and medical device industry fees, has promised to slash regulations for industry so it is not burdened with lengthy clinical trials. Most readers already understand that the 510(k) clearance process involves a few thousand dollars and paperwork, which hardly could be considered a burden. Class II medical devices, such as mesh, are cleared through the 510(k) clearance to sell process.
Big data analysis includes insurance claims, electronic health records, registries, the FDA’s Sentinel system, and social media. It is less likely to yield usable adverse events data than large randomized controlled trials, and more likely to yield biased results, reports Lenzer.
Big data analysis is promoted by the industry-backed foundation and by industry-backed 21st Century Cures Act. http://www.cmaj.ca/content/174/5/635
Lenzer tells MND “Big Data are bad for providing evidence of efficacy and bad for harms detection.
“Regarding “Harms,” - Contrary to expectations, Big Data have proved to be very poor at detecting harms, according to studies that have examined the question.
RCTs (randomized controlled trials) are poor at detecting harms, but Big Data have proved even worse – far worse.
Regarding “Efficacy - Big Data are, by definition, observational data – something that can only detect associations, not causation and even many of the associations will be false due to the sheer number of data points that can be examined.”
The foundation can avoid an inquiry through a Freedom of Information Act request, that the FDA is required by law to respond to.
Big data’s big bias: bringing noise and conflicts to US drug regulation, BMJ 2017; 358:j3275, July 18, 2017