Ex-FDAAdvisoryCommittee.com Head Accused of Conspiring to Suppress Information About Harmful Effects of Johnson & Johnson Antibiotic

Ex-FDA Head Accused of Conspiring to Suppress Information About Harmful Effects of Johnson & Johnson Antibiotic
February 9, 2016
By Alex Keown, BioSpace.com Breaking News Staff

WASHINGTON -- Margaret Hamburg, the former commissioner of the U.S. Food and Drug Administration, conspired to conceal harmful side effects of Johnson & Johnson ’s antibiotic drug Levaquin, according to a lawsuit filed by six patients, Qmed reported this morning.

The lawsuit alleges that Hamburg suppressed information about the drug’s side effects so her husband, Peter Brown, co-chief executive officer of Renaissance Technologies, a hedge fund, could profit from Johnson & Johnson stock. Attorney Larry Klayman, who filed the lawsuit on behalf of the plaintiffs, speculated Brown earned approximately $500 million in Johnson & Johnson stock due to his wife’s suppression of information, according to a statement on his website. In addition to Hamburg, her husband and Johnson & Johnson are listed as defendants.

“This is a major scandal, one that seriously affects the health of not just plaintiffs, but thousands of others. Defendants are alleged to have callously reaped large financial gains and profits at the expense of my clients. The entire sad episode is an example of how some in private industry are alleged to conspire and act with Washington D.C. public officials to greedily line their own pockets, leaving everyone else to be damned,” Klayman’s statement said.

According to the lawsuit, the defendants conspired to “conceal the risks of serious adverse events, including mitochondrial toxicity, certain neuropsychiatric adverse events, increased risk of acquiring potentially fatal Carbapenem-Resistant Enterobacteriaceae, Fluoroquinolone-Associated Disability (FQAD), and other chronic, degenerative illnesses directly associated with Levaquin.”

Attorneys for Hamburg told Richmond, Va.’s ABC8 news that the allegations are “patently false, reckless and offensive.” Johnson & Johnson also told the ABC affiliate that it stands behind its antibiotic drug.

Levaquin is typically prescribed to combat infections, including sinus or urinary tract infections. However, patients claim the drug is only effective in pain relief, rather than combating infections. In November, an FDA advisory committee overwhelmingly supported changing label information on antibiotics such as Levaquin and Cipro. Both antibiotics are fluoroquinolones, which can help patients with bronchitis, sinusitis and urinary tract infections, the panel said, according to an ABC report. A drugwatch.com report shows a number of studies links Levaquin and Cipro to a number of dangerous side effects, including aortic dissection and aortic aneurysm.

This is not the first time Levaquin has been at the center of a lawsuit. In 2012, Johnson & Johnson settled lawsuits with about 845 plaintiffs who claimed the drugmaker didn’t properly warn of the risks of tendon damage from its antibiotic Levaquin.

Klayman is the founder of Judicial Watch, a conservative organization, which, according to its website, “advocates high standards of ethics and morality in our nation’s public life and seeks to ensure that political and judicial officials do not abuse the powers entrusted to them by the American people.”

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