The Unjust Treatment of Whistle-blowers by Pharmaceutical Companies and the FDA

March 14th, 2019

Discovering something that could be potentially harmful to ourselves and to others creates (in most) an ingrained reaction to want to bring awareness to that danger. Makes sense, right? Well that is essentially what healthcare whistle-blowers are doing, and not all of them are being treated with the consideration and respect that they deserve… to say the least.

           Some of the biggest corporate outings of the past twenty years were heralded by whistleblowers: Sherron Watkins raised the red flag internally at Enron, Cynthia Cooper let management know of major accounting problems at WorldCom, and Matthew Lee brought problems to his management team at Lehman Brothers. The whistleblowers weren’t able to halt their companies’ declines and—in some cases—faced punishment for calling attention to internal misdeeds. Looking at these examples, it would be easy to say that whistle-blowers have little impact on how companies both conduct themselves and weather corporate storms. But that’s not the case.

According to Bloomberg BNA reporter James Swann:

“Whistleblowers were responsible for $3.7 billion in health-care recoveries in fiscal year 2017, and that number will likely increase, attorneys said at a recent Federal Bar Association conference…”

             This is only one example of the effective power that simply speaking up can have in a world where misdeeds being continuously swept under the rug is just business as usual. The health industry and it’s lobbyists, the FDA, USDA and Big Pharma create a putrid sewer of corruption and inhumane activities.

             One case in particular is that of Judy Mikovits. Judy is a PhD, Molecular Biologist, Biochemist and has worked as a researcher at the National Cancer Institute in Frederick Maryland as well as research director at the Whittemore Peterson Institute (WPI), a chronic fatigue syndrome research organization in Reno, Nevada, from 2006-2011. Judy’s story is rather grim and unsettling but needs to be discussed more often publicly due to the implications it presents as well as the fact that her case is anything but an isolated incident.

              In 2009, Judy was working on autism research and related neurological diseases. She found that many of the study subjects had cancer, motor-neuron disorders and chronic fatigue Syndrome (CFS). She believed a virus may have been responsible for these symptoms, and through her research, she isolated the viruses that turned out to come from mice. She soon realized that these protein and viral contaminants were being introduced into the human population via contaminated vaccines, creating a rather lucrative situation for the Pharmaceutical industry.

In response to this discovery, she was fired from her job, indicted, prosecuted, jailed and ordered to retract her research and publicly claim she “made it all up.” She refused to cover up the scientific evidence and was targeted and punished. She was actually thrown in prison.

“Just dragged out of my house in shackles… I refused to denounce the data… we have the data… they basically said tell everybody you made it all up and you can go home. If you don’t, we’ll destroy you. And they did.”

Similar situations pop up all the time, The pharmaceutical industry often operates like the rules don’t apply to it. Over the years, prescription drug manufacturers have been slapped with billions in fines after they are caught overstepping regulatory limits meant to protect patients and taxpayers. The most significant cases were initiated by whistleblowers, and thanks to them, greater transparency has been forced on the industry.

           In a more recent situation (2017), a Ninth Circuit Court of Appeals decision has revived a whistleblower lawsuit against Gilead Sciences.  A federal district court had dismissed the case in 2015, saying the complaint had failed to state a claim that violated the False Claims Act.

       U.S. ex rel. Campie v. Gilead Sciences Inc., brought by two former Gilead employees, alleges that Gilead violated the False Claims Act by misleading the Food and Drug Administration as to the source and quality of active ingredients used in Gilead’s HIV drugs Emtriva, Truvada and Atripla. Those drugs are among the world’s most widely prescribed HIV medications.

        The FDA’s approval of these drugs was based in part on Gilead’s statement that the active ingredient would be sourced from specific manufacturing facilities in Canada, Germany, South Korea and the US. The whistleblowers alleged that Gilead falsely stated that the active ingredient came from an approved source when it was really from an unapproved Chinese source.

        Gilead continued to use the Chinese-sourced ingredient “for at least two years” before it finally received FDA approval in 2010. To get that approval, Gilead allegedly falsified or concealed data, such as information about batches it received from the Chinese plant that had failed testing because of contamination.

If Pharmaceutical companies, their lobbyists and the FDA are complicit in upholding these falsifications then what else are they lying about? Where do they draw the line when it comes to morality vs business and does this line even actually exist?