Tag Archives: FDA

Kakistocracy

Kakistocracy is defined as government by the least competent or suitable. To which I would add: most corrupt. And that corruption goes well beyond the White House, where Trump’s incompetence is on constant display.

Examples abound. The Guardian recently reported accusations that the FDA has “direct links” to the opioid crisis.

The Food and Drug Administration is sacrificing American lives by continuing to approve new high-strength opioidpainkillers, and manipulating the process in favor of big pharma, according to the chair of the agency’s own opioid advisory committee.

Dr Raeford Brown told the Guardian there is “a war” within the FDA as officials in charge of opioid policy have “failed to learn the lessons” of the epidemic that has killed hundreds of thousands of people over the past 20 years and continues to claim about 150 lives a day.

Brown accused the agency of putting the interests of narcotics manufacturers ahead of public health, most recently by approving a “terrible drug”, Dsuvia, in a process he alleged was manipulated.

Brown’s accusations come at a time when the FDA’s credibility is low; it has been damaged by  the opioid crisis and by accusations that the agency has behaved less as a regulator and overseer of the pharmaceutical industry and more like a business partner of drug manufacturers.

The FDA was also embarrassed by revelations that officials responsible for opioid approvals were taking part in “pay to play” schemes in which manufacturers paid to attend meetings to draw up the criteria for approving prescription narcotics.

Things are no better at the EPA.

The EPA is in charge of ensuring companies and utilities follow national environmental laws. Its enforcement has actually been on the decline for the past decade and reached 10-year lows in the fiscal year 2017, according to the agency’s own data. But the numbers really plummeted between the fiscal years 2017 and 2018, according to the Environmental Data and Governance Initiative, an advocacy group formed by university researchers to counter what they see as the Trump administration’s rejection of science.

The decline in enforcement is intentional, according to environmental groups and former EPA personnel.

“The administration has strongly sent a message, to the folks who do enforcement, that they should cut back on their role,” says Marianne Sullivan, a public-health professor at William Paterson University in New Jersey and an EDGI volunteer who conducted the interviews. “There are declining resources. There’s much more deference to industry.”

Less enforcement, of course, means–among other things– that more Americans may be exposed to lead, smoke, and other pollutants that the EPA regulates.

Here in Indiana, we have  two recent examples of the consequences of EPA non-performance. In Franklin, Indiana, residents attribute a cluster of childhood cancers to a toxic site identified years ago by the EPA–after which nothing was done.

And in the small town of Wheatfield, Indiana, toxic coal ash is leaching into the groundwater.

In Indiana, coal ash ponds are leaking at 15 out of 15 power plant sites tested. But the problem isn’t limited to the Hoosier State, which currently has the most coal ash dumps in the country. Based on the industry’s own data, 92 percent of all coal ash ponds and landfills tested under the new rule have contaminated groundwaterwith harmful levels of toxic chemicals like arsenic and boron. Oklahoma reported in June that 4 out of 4 sites tested had contaminated groundwater, while Illinois revealed in November that 22 out of 24 coal ash sites tested positive for groundwater contamination. In total, the U.S. is home to more than 1,400 of these sites, many of them filled with millions of gallons of toxic ash.

As news about the contamination leaks out, coal companies and electric utilities are desperate to water down the 2015 regulations, including weakening the reporting, closure, siting, and cleanup requirements in the new rule.

Last March, Trump’s EPA heeded their wishes, proposing to gut coal ash regulationsjust as the nation began discovering that many coal ash ponds and landfills are leakingtoxic pollutants into groundwater. The 2015 rule opened a door to a hidden disaster; weak regulators now want to slam it shut. And they’re just getting started.

To characterize the current administration as “just” a Kakistocracy is to be kind. If it isn’t also a criminal enterprise, it’s close.