Corruption at the FDA: Former Chief Sued

• Dr. Margaret Hamburg accused of covering up facts about drugs she knew could be deadly.

By Ronald L. Ray —

Homicide, conspiracy, racketeering, bribery.

These are the stock-in-trade of organized crime and drug dealers. But should they be the practices of a government agency charged with keeping safe what we eat and what we use to treat illness? Sadly, in today’s America, where corporate kleptocrats control the political prostitutes who rule over us, the distinction between the United States republic and a crime syndicate is largely fictitious. So it is that former Commissioner of the Food and Drug Administration (FDA) Dr. Margaret Ann Hamburg is being sued in federal court for alleged involvement in all of the nefarious activities just cited.

Should we really be surprised? America has suffered repeatedly from the decades-long-merry-go-round of profiteers moving from industry to government “service” and back. Our political system does nothing so much as favor the ruthless and amoral, who exploit the naïveté of the masses and purchase protection for their misdeeds, essentially by bribing government bureaucrats.

However, the case of Dr. Hamburg, who was FDA commissioner from 2009 to 2015, is a particularly clear example of why government should be protecting us from Big Business—in this case, Big Pharma—and not the reverse.

Dr. Hamburg has worked in a number of government and think-tank posts. Her husband is Peter Fitzhugh Brown, “an artificial intelligence researcher and co-CEO and co-president of Renaissance Technologies LLC, a hedge fund sponsor that was one of the world’s first to employ quantitative trading,” according to The Wall Street Journal. He and Dr. Hamburg are co-defendants in Terry Aston, et al., v. Johnson & Johnson, et al., which was filed in U.S. District Court on January 19, 2016.

According to the complaint filed on behalf of the five plaintiffs, Dr. Hamburg was nominated to head the FDA “as a result of huge political and other gratuities” given to Hillary Clinton—who recommended her to Barack Hussein Obama—to the Clinton Family Foundation, and to Obama himself. It’s “the Chicago way.”

Once in office, Dr. Hamburg is alleged to have acted “illegally and outside the scope of her authority” to suppress information about serious adverse reactions to two pharmaceuticals, Levaquin and Zohydro. Consequently, the plaintiffs claim Dr. Hamburg, Brown, and Renaissance Technologies profited by millions of dollars from existing and subsequent investments in the manufacturers. They likewise failed to disclose Dr. Hamburg’s and Brown’s continuing conflict of interest due to ongoing Renaissance Technologies profit sharing in which Brown participated.

The plaintiffs further claim the manufacturers of Levaquin and Zohydro, Johnson & Johnson (J&J) and Alkermes respectively, profited from higher sales and were functionally protected against loss arising from the two drugs’ adverse side effects during Dr. Hamburg’s tenure. Dr. Hamburg apparently also appointed a number of J&J employees to key FDA boards.

Zohydro is essentially a concentrated, timed-release form of hydrocodone, a highly addictive opiate used for pain management, containing five to ten times more of the drug than Vicodin. Eleven of 13 members of the FDA’s advisory board opposed its public use, due to serious concerns about abuse and possible overdose, but Dr. Hamburg pushed through Zohydro’s approval nonetheless.

Levaquin is a powerful antibiotic of the fluoroquinolone class, similar to Cipro and Norfloxacin. It is known for significant and even severe side effects, especially for the elderly. A common problem is chronic inflammation and degeneration of the tendons, including sudden detachment of the Achilles tendon. At least 500 persons have died from Levaquin.

According to the lawsuit, “On November 5, 2015, after Defendant Hamburg had resigned, an FDA employee, Debra Boxwell, finally exposed . . . that Defendant Hamburg and the FDA had been aware that Levaquin may result in multi-system disability since 2013, but that it . . . instead conspired with the other Defendants to fraudulently withhold [the information].” Following Dr. Hamburg’s departure, the FDA finally added further drug warnings.

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It seems this sort of corruption is standard fare at the FDA, where pharmaceutical and agricultural executives and toadies are appointed to police their former employers. Monsanto is one egregious example. Another is the new FDA commissioner, Robert Califf, who has longstanding, lucrative major ties to numerous pharmaceutical giants, including J&J.

The problems at the FDA are systemic and require radical change. The U.S. Supreme Court, however, has become its unindicted co-conspirator. In a key recent case, five of nine justices voted to protect 80% of the pharmaceutical industry from lawsuits like Aston. Those lugubrious “illogicians” claimed that only original drug manufacturers can be held liable for medication side effects, not generic or other subsequent producers. The court claimed that, if the FDA says a drug is safe, then it is “safe”—whether or not it is true.

Big Pharma rejoiced at this new protection of their corruption. But ordinary Americans were left helpless before exploitation by the pill pushers and political prostitutes. Let us hope that Aston v. Johnson & Johnson will be a wake-up call for fundamental reform at the FDA.

Ronald L. Ray is a freelance author and an assistant editor of THE BARNES REVIEW. He is a descendant of several patriots of the American War for Independence.