Does big pharma already “own” the new FDA Commissioner?

It seems conflicts of interest and even corruption are key parts of the FDA Commissioner’s job description. In fact, last spring, Senator Bernie Sanders of Vermont came off the campaign trail to protest the Obama administration’s latest nominee to serve as FDA Commissioner, Robert Califf.

What was Sanders’ big beef with Califf?

According to a 2014 financial disclosure, large drug companies — including Eli Lilly and Merck — underwrote Califf’s salary while he was at Duke University. Big pharma also helped fund research studies he oversaw.

Of course, Califf won the appointment despite these glaring conflicts of interest and Sanders’ principled protest. (As a side note, when I was nominated to head the FDA back in 1996, Bernie also interviewed me — without protest. I eventually withdrew since I just had gotten out of Washington, D.C., and did not want to go back.) Sadly, compared to former FDA Commissioner Dr. Margaret Hamburg, Califf almost looks like a boy scout.

More scandals than you can count

A new lawsuit claims Hamburg conspired to conceal the deadly dangers of a prescription antibiotic called Levaquin. The suit is being filed under the federal Racketeer Influenced and Corrupt Organizations (RICO) law.

Ironically, the racketeering law makes it sound as if we’re talking about a mob family like Corleone or Soprano. But we’re actually talking about the former FDA Commissioner, whose role and responsibility is to protect the public.

The scandal also reminds me of the lyrics of the late, great Warren Zevon, “send lawyers, guns, and money… get me out of this…,” which aptly applies to this former public servant. For the poor public, however, Zevon continues, “I am the innocent bystander, but somehow I got stuck, between a rock and hard place, and I’m down on my luck…”

The eight plaintiffs who claim they suffered severe damages while taking Levaquin filed the lawsuit in April 2016 in U.S. District Court in Washington, D.C. They claim Hamburg concealed Levaquin’s deadly risks in order to protect her financial interests.

Larry Klayman, who is a former federal prosecutor, filed the lawsuit. It charges Hamburg and her husband, Peter Brown (a hedge-fund operator), with collusion, conspiracy, and racketeering along with Johnson & Johnson to conceal deadly risks and protect profits. The suit claims that Brown’s income increased from $10 million to $215 million over two years due in whole, or in part, to Hamburg’s “racketeering conspiracy” at the FDA to withhold information about the deadly health effects of Levaquin.

Too much quid pro quo in Washington

The Obama administration nominated Hamburg in 2009, after President Obama won re-election. According to the lawsuit, Hamburg and her husband had made large donations to Hillary Clinton’s campaigns and to the Clinton Foundation. And they also made political contributions to the Obama campaign to induce him to nominate her to the FDA. Plus, during the Senate confirmation process, Hamburg failed to disclose her clear-cut conflicts of interest with big pharma.

Then, once confirmed, Hamburg used her influence to suppress information about the dangers of Levaquin.

Levaquin belongs to a controversial group of fluoroquinolone antibiotics that also includes Cipro and Avelox. For 20 years, the watch-dog group Public Citizen has petitioned the FDA to issue their ominous “black box” warnings about the risks of tendonitis and even ruptured tendons from these drugs. But the FDA never issued the warnings, and the death toll from Levaquin reportedly totals more than 5,000 people, with tens of thousands more debilitated with life-threatening, chronic complications.

Hamburg has also come under fire for pushing a highly addictive pain drug called Zohydro ER through approval. The FDA’s own expert panel voted 11 to 2 against approval of this drug. In addition, 28 law enforcement agencies voiced concerns about its overdose potential. Furthermore, 15 anti-addiction organizations wrote letters of complaint to the Secretary of Health and Human Services protesting the approval.

The lawsuit alleges that Hamburg approved the drug because she and her husband held stock in the company that makes another drug used to treat Zohydro’s dangerous complications!

The list of allegations goes on and on 

Hamburg’s entanglements actually date back to 1993 when Bill Clinton created the federal office of “AIDS coordinator” for her during his first term as President. Clinton then promoted her to Assistant Secretary in the alphabet soup of Department of Health and Human Services in 1997.

Then, she and her husband gave contributions to Hillary in 2005, 2006, 2007, and 2008 until she finally got appointed to the FDA in 2009. Even when acting as FDA Commissioner, Hamburg made her allegiances clear, speaking at a meeting on behalf of the Clinton Foundation in 2014.

In the world of Clinton cash and corruption, part of public service includes sending “lawyers, guns and money…” and it comes with apparent immunity from lawsuits.

In China, they would simply have executed a government commissioner for this kind of corruption and breach of public trust, as they did several years ago over tainted products.

Here in the U.S., we have RICO, which legislators intended to fight organized crime. When it comes to politically appointed “public servants” and their conspiracy with big pharma, again, in the immortal lyrics of Warren Zevon, RICO may be “looking for the next, best thing…”


“Former FDA Commissioner Charged in RICO Lawsuit,” Alliance for Human Research Protection (www. 4/23/2016