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Saturday, September 17, 2016

Toxic Levaquin, FDA failure, Guns and the 2016 Election

Campaign 2016: Toxic side effects

by Dan Walter
Forget about guns… according to a long-time nemesis and drug safety activists, chances are that the Secret Service should be protecting Hillary Clinton from her doctor.
Among those who panicked at the recent sight of Hillary Clinton being physically helped toward the finish line in this election, supporters in the patient safety community suffered an extra jolt with the news that Clinton is being administered the antibiotic Levaquin to treat her pneumonia. The widely prescribed drug, along with other drugs like Cipro in the class known as fluoroquinolones, has been associated with an outsized risk of particularly nasty side effects — and should Hillary find herself among the minority of those who are injured by the drug, one of her main antagonists says the Democratic nominee for president may have herself partly to blame.
The Food and Drug Administration sent out an advisory in May of this year telling physicians what a lot of people already know about the class of drugs called fluoroquinolones: They can they be very dangerous. The problem seems to be that many doctors may not have gotten the memo.
“In my experience,” says patient safety advocate Linda Radach, “it is not uncommon for physicians to not know what the FDA has said or done. The chances are very high that Clinton’s physician has no idea that the FDA has posted black box warnings for the broad spectrum antibiotic. In general, unless there is someone within the provider network assigned to keep watch for FDA urgent postings, most physicians remain clueless of these warnings.”
“No matter how important a doctor is or how trusted, they are never fully informed about everything,” says Kathy Day, a retired nurse and safety advocate from Maine.
That has been my experience as well. I consider my current doctor to be the best primary care physician I have ever been to, but when it came time to treat bronchitis, he prescribed a fluoroquinolone. When I told him about the many people injured by the drug, the survivor support groups, the lawsuitsand the FDA advisories, he was genuinely surprised. He has been prescribing the drugs with great efficacy and no serious side effects for many years. In light of current knowledge about how these drugs can have crippling side effects in a small percentage of patients, one can assume that the doctor and his patients have simply been fortunate, although another possibility is that any injuries were latent and were not perceived to have been the result of the antibiotic.
But the fact that this very skilled and otherwise knowledgeable physician was unaware of the risks illustrates the information overload problem confronting doctors.
Rachel Brummert was prescribed fluoroquinolone for a sinus infection in 2006, and today she endures the suffering from the many bad reactions which began shortly after she took it, including nine tendon ruptures, peripheral neuropathy, arrhythmia, tremors, vertigo, tinnitus, persistent gastric problems and more.
She is now Executive Director of the Quinolone Vigilance Foundation and works to raise awareness of Fluoroquinolone Toxicity — among doctors.
“Whether Hillary Clinton should be prescribed Levaquin is obviously a matter for her to discuss with her doctor,” Brummert says. “One would assume that it is entirely appropriate. But for me, the point is that not all doctors have the information they should be getting from the FDA.”
Brummert says that the FDA should have been sending out “Dear Doctor” letters to increase the chances of informing physicians that these very powerful and effective antibiotics should be wielded with care. She sees current news coverage as an opportunity. “This highlights a bigger problem that needs to be addressed,” she says. “And we are hopeful that Clinton’s being put on Levaquin will spark a national conversation about medication safety and the balance between risk vs benefit.
Brummert has been pushing for the FDA to send out “Dear Doctor” letters for many months. “While I know that not all doctors will read them and their time is valuable, it’s better than whatever system is not working right now,” she says.
In the face of the FDA’s inaction, Brummert has taken the task upon herself through her foundation and expects to begin sending letters out by the end of the month.
***
Meanwhile, professional Clinton nemesis Larry Klayman probably could not believe his astonishing good luck when he heard the news that Hillary was being treated with Levaquin. Klayman’s the man who keeps the Clinton email controversy fully stoked through Judicial Watch, his “non-partisan educational foundation,” and with the antibiotic story, he has hit the triple jackpot in his Javert-like quest to take Hillary down a peg or two, having recently filed an $800 million lawsuit on behalf of five Levaquin victims.
In conjunction with the suit against Johnson & Johnson, the purveyors of Levaquin, Klayman initiated a RICO lawsuit charging former FDA commissioner Margaret Hamburg and her husband, hedge fund executive Peter Brown, with “collusion, conspiracy and racketeering alongside the pharmaceutical giant, Johnson & Johnson to conceal those deadly risks — to protect their financial stake.”
And here’s the kicker: Klayman says Hamburg got her job at the FDA because she and her husband contributed heavily to Hillary’s campaign, and to the Clinton Foundation, and that they “gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.” In short, the suit alleges, “Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton’s recommendation.”
The icing on the cake for Klayman is that one of the side effects of Levaquin plays right into Trumpian conspiracy theories regarding the health of the Democratic nominee. He plays the magnificent cards he’s been dealt expertly, as demonstrated by the headline for a recent press releaseproclaiming that “Hillary Clinton’s medical condition may be result of her taking dangerous drug Levaquin.”
Thus, Hillary’s everyday “medical condition” is transformed from pneumonia into one with far more profound political implications in Klayman’s release:
Under the heading “Central Nervous System Effects” on the Levaquin label, it states: “Fluoroquinolones, including Levaquin, have been associated with an increased risk of central nervous system (CNS) effects, including convulsions, toxic psychoses, increased intracranial pressure…. Fluoroquinolones may also cause… tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose….”
And now Fluoroquinolone toxicity has been added to the already poisonous brew of the 2016 presidential election.

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