Former FDA commissioner charged under RICO Law for Levaquin cover-up

Gingergrrl

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http://ahrp.org/former-fda-commissioner-charged-in-federal-racketeering-lawsuit/

A Federal Lawsuit charges Dr. Margaret Hamburg, former Commissioner of the Food and Drug Administration (FDA) with conspiracy, racketeering & colluding to conceal deadly drug dangers – under the federal Racketeer Influenced and Corrupt Organizations law (RICO) law. The amended RICO lawsuit was filed on April 11, 2016 in the U.S. District Court in Washington DC on behalf of eight plaintiffs who claim they have suffered severe harm by ingesting the drug, Levaquin whose deadly risks were concealed to protect financial interests.

The drug is one of the controversial group of antibiotics, including Levaquin, Cipro, Avelox and other fluoroquinolones. Public Citizen petitioned the FDA in 1996 and again in 2006, to issue Black Box warnings for tendon rupture and tendinitis. Had warnings been issued, the death toll from Levaquin– reputedly more than 5,000 — and the tens of thousands who were debilitated with life-threatening diseases would likely have been averted. (Read risks at RxList)

The suit, filed by Larry Klayman, a former federal prosecutor, charges Dr. Hamburg, her husband, Peter Brown, an executive in the hedge-fund Renaissance Technologies, with collusion, conspiracy and racketeering alongside the pharmaceutical giant, Johnson & Johnson to conceal those deadly risks — to protect their financial stake.
Click on link to see the rest of the article... for those that do not know, I had a severe neurotoxic to Levaquin in 2010 which nearly tore my right triceps tendon. I do not believe I would ever have gotten as ill as I am now without the initial damage to my immune system by Levaquin. I will also never regain normal arm strength in my right arm.

My husband received this article on FB from May12.org and I felt compelled to post it. Almost every month someone PM's me on PR that they or a family member were injured by a Fluoroquinolone antibiotic and asks what they should do. Sadly, I have no answers but felt a little bit of vindication after reading this article that some justice is coming to the FDA and Big Pharma even if it is too late for me and many others who have already been injured by these meds.
 

Gingergrrl

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Thanks for posting Gingergrrl. I know it's no consolation for what you've been through, but sometimes a tiny bit of justice goes a long way.
Thanks, Grey Owl, and I know you understand. I love your new quote, BTW, "Injustice is not anonymous, it has a name and address..." (or at least I think it is new?) Also like your new avatar!
 

ahmo

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Almost every month someone PM's me on PR that they or a family member were injured by a Fluoroquinolone antibiotic and asks what they should do.
I didn't realize this is what had happened to you. My husband used Cipro for about a year. During that time he fell and damaged the tendons in 1 shoulder. Fortunately, he healed. But I spent a long time looking for resources. You've probably seen some or all of these, but I'm posting here.

Magnesium Heals Cipro Damage - NaturalNews.com
http://www.naturalnews.com/032714_magnesium_cipro.html

Drug Rep Exposes Antibiotics: Risks Outweigh Benefits, You Have Alternatives » | ThePeoplesChemist.com
http://thepeopleschemist.com/drug-r...isks-outweigh-benefits-you-have-alternatives/

Links & Resources | Floxie Hope
http://floxiehope.com/fluoroquinolones-links-resources/

My Favorite Links | Surviving Cipro
http://www.survivingcipro.com/my-favorite-links/

http://www.saferpills.org/resources/

CIPRO IS POISON!
http://ciproispoison.com/

No Cipro Please | Did Cipro or another Fluoroquinolone Antibiotic change your life? It did mine…
http://nociproplease.wordpress.com/

Surviving Cipro - Three Things that Worked for Me | Surviving Cipro
http://www.survivingcipro.com/useful-information/three-things-that-worked-for-me/

Clinafloxacin
http://wn.com/clinafloxacin

A Statement of Hope, Indeed, to Fluoroquinolones’ Victims | FCT Field Control Therapy
http://www.yurkovsky.com/what-is-fct®/

Richard’s Recovery Story – Cipro Toxicity | Floxie Hope
http://floxiehope.com/richards-recovery-story-cipro-toxicity/
 

Gingergrrl

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I didn't realize this is what had happened to you. My husband used Cipro for about a year. During that time he fell and damaged the tendons in 1 shoulder. Fortunately, he healed. But I spent a long time looking for resources. You've probably seen some or all of these, but I'm posting here.
@ahmo, Your post made me want to clarify that I did not at all mean that people sending me PM's for advice re: FQ's was in any way a complaint or an inconvenience. It is more that I feel so bad that I do not have a magic answer or way to help them. I am aware of most of your links but am also very glad you posted them above and am sorry about your husband's experience with Cipro.

I usually refer people to the FQ study at UCSD by Dr. Beatrice Golumb's group (she is also studying gulf war syndrome besides the effects of FQ antibiotics) and the study is still accepting new participants. It is:

www.fqstudy.info

I also often refer them to Dr. Jay Cohen in San Diego who does phone consults and was very helpful to me back in 2010 when I was first injured. He studies adverse drug reactions, especially to FQ antibiotics, and has written phenomenal letters to congress and the FDA, etc, amongst other advocacy work.

Lastly, there is a great documentary "Certain Adverse Events" by a filmmaker, Nancy Edwards, whose career was ended after Levaquin injured both of her knees and she had to get her thyroid removed. I had the pleasure to meet her in 2010 and correspond by e-mail as much as possible. She is a remarkable person and my goal in 2010 was to have over 100 people view the film to spread this info and stop others from getting injured.

But as far as an antidote or treatment, there really isn't one b/c the FDA cover-up was so wide spread. I took Coq10 and Magnesium in 2010 but whether it helped me at that time, is really hard to say. Some have been helped by glutathione (which I did not know back at that time) but I did have some improvements on it when I nebulized it in 2015 & 2016. But there is no miracle cure as we all know.
 

Mary

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@Gingergrrl - I'm sorry you've had to pay such a high price for Hamburg's malfeasance! Hopefully this lawsuit might deter other FDA officials from participating in such collusion. The FDA is like having the fox guarding the hen house ....

FWIW, unfortunately, the black box warning in my experience has done nothing to stop doctors from prescribing fluoroquinolones and other drugs routinely when safer and equally effective ABX are available. I've been prescribed a fluroquinolone twice in the last several years (I think it was Cipro), I refused it each time, once I literally argued with the doctor who dismissed any possibility of tendon damage, and the other doctor just seemed clueless. This was for a simple UTI! (on two separate occasions)

I had another doctor prescribe Clindamycin for a parotid gland infection when one of the penicillin drugs would have worked just fine. Unfortunately, I wasn't aware of the black box warning on this drug (I'll never not check a drug again before taking it!) after being on it for several days I got very tired, and then looked it up. It's been linked to c. difficile, which can be deadly. I stopped it immediately and tried to contact the doctor, missed her by phone and finally wrote her a letter telling her how upset I was that she prescribed this. She never responded.

I don't take ABX unless I absolutely have to, but the 3 times I've had to in the last 5 or 6 years, each time the doctor prescribed one with a black box warning. I don't know if they're ignorant or just don't care - either way, the patients are at risk by their carelessness.

Anyways, I am really glad to see this lawsuit!
 

Gingergrrl

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Thanks @Mary and I knew you'd appreciate the link. Yes the FDA is one of the most corrupt agencies in the country IMO. And yes most docs ignore the black box warnings (levaquin has six of them now!) and just prescribe it like it was candy. They get their info from the pharma reps and give the free samples to patients with zero warning which is what happened to me. Had I taken this prescription to CVS and read the warnings, I never would have taken it. This remains one of the biggest regrets of my life.
 

Mary

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Thanks @Mary and I knew you'd appreciate the link. Yes the FDA is one of the most corrupt agencies in the country IMO. And yes most docs ignore the black box warnings (levaquin has six of them now!) and just prescribe it like it was candy. They get their info from the pharma reps and give the free samples to patients with zero warning which is what happened to me. Had I taken this prescription to CVS and read the warnings, I never would have taken it. This remains one of the biggest regrets of my life.
On the Clindamycin, I looked at the prescribing information handout from WalMart and there was no mention of a black box warning. I talked to the pharmacist who waffled completely and would take no responsibility for the patient not being informed. I even contacted the state of California to see if there was any agency or regulation which mandated that patients be informed about black box warnings. There is none. We are completely on our own with this issue. So don't rely on your pharmacy or even their tiny print handouts --
 
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Thanks @Mary and I knew you'd appreciate the link. Yes the FDA is one of the most corrupt agencies in the country IMO. And yes most docs ignore the black box warnings (levaquin has six of them now!) and just prescribe it like it was candy. They get their info from the pharma reps and give the free samples to patients with zero warning which is what happened to me. Had I taken this prescription to CVS and read the warnings, I never would have taken it. This remains one of the biggest regrets of my life.
Thank you so much for speaking up about this.
 
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On the Clindamycin, I looked at the prescribing information handout from WalMart and there was no mention of a black box warning. I talked to the pharmacist who waffled completely and would take no responsibility for the patient not being informed. I even contacted the state of California to see if there was any agency or regulation which mandated that patients be informed about black box warnings. There is none. We are completely on our own with this issue. So don't rely on your pharmacy or even their tiny print handouts --
I am glad you were vigilant about this. Yes, we are completely on our own. My MD told me NOT to read the warnings re the Rx that was just prescribed. This was not for Levaquin, instead for a heart medication. I read the warnings anyway and it detailed that a side effect could be Death.
 

Gingergrrl

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Thank you so much for speaking up about this.
Of course, am happy to and wish I could do more! When I was first injured by levaquin I vowed that I would do advocacy, and actually did a lot for many years, but then when I got mono and all the subsequent triggers leading to my current illness, I wasn't able to do it anymore.

But this one was too egregious not to share and hoping it leads to some real changes within the FDA (although that is probably pure fantasy on my part...)
 

Gingergrrl

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I am glad you were vigilant about this. Yes, we are completely on our own. My MD told me NOT to read the warnings re the Rx that was just prescribed. This was not for Levaquin, instead for a heart medication. I read the warnings anyway and it detailed that a side effect could be Death.
I've been told similar things yet reading the labels is how I've learned of potentially fatal drug interactions and if they contain any food dyes or inactive ingredients that I am allergic to!
 

Gingergrrl

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On YouTube it's split into 5-6 parts but you can also buy the DVD to watch it in it's entirety from:

www.certainadverseevents.com

* I am not affiliated with this in any way and make no profit from the DVD. Even the filmmaker doesn't profit and it was a labor of love for her.

Back in 2010, I bought copies of the DVD for all of my doctors offices and wish I could still do this now.
 

Paralee

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@Gingergrrl, I hope your doctors watched the dvd's. I often wonder how many articles, etc. we take to them that just get thrown in file 13.
I got Cipro'd back in the spring of 2015. I knew it was bad for some people, but I didn't know it was cumulative. The doctor even told me it had a black box warning and smiled. I said "well, I've taken it before so I guess it's all right". Stupid me.
There have been many law suits but only on the brand names, the generic are exempt. And the time period that you can take legal action is pretty short, so probably a lot of sick people don't know what hit them in time.
Sorry you got floxxed. It's not fun.
 
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http://www.wsj.com/articles/fda-requires-stronger-warnings-for-antibiotics-side-effects-1463088485

WASHINGTON—The Food and Drug Administration said Thursday it will require heightened warnings about serious and sometimes disabling side effects from the commonly used class of antibiotics called fluoroquinolones.

That class of medications is mostly sold now as generic drugs. But well-known brand names include Bayer AG’s Cipro, generically called ciprofloxacin; and Johnson & Johnson’s Levaquin, or levofloxacin. The class of antibiotics has been marketed for about three decades.

The federal agency is calling for an updated boxed warning, informing patients that the serious side effects of the medicines generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections, if patients have other treatment options.

The side effects can involve damage to tendons, muscles, joints, nerves and the central nervous system. The agency’s action follows a study of the issue by the FDA’s Office of Surveillance and Epidemiology, which concluded as early as 2013: “We continue to find an association between fluoroquinolone antibiotic use and disabling peripheral neuropathy.”

The cases evaluated by that office included weakness, numbness, pain, discomfort, burning and tingling. This research also disclosed the case of a man who suffered a hypersensitivity reaction while taking levofloxacin and died.

Another FDA review reported a risk of cardiovascular disease and of tendon rupture.

The FDA in August 2013 issued a public warning. But it subsequently concluded that a range of seemingly unconnected problems can occur with people taking the drugs. So the agency convened a safety panel that met last November, which strongly advised the FDA to issue the more stringent warnings.

Johnson & Johnson said it is studying the FDA’s statement and noted that Levaquin has been used for more than 20 years. Bayer said it is aware of the FDA statement and will work closely with the FDA on the topic.

Fluoroquinolones are very commonly prescribed. IMS Health, the drug-research firm, said there were a total of more than 36 million prescriptions written in 2014, but wasn’t able immediately to provide a more recent figure.
 
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Little Bluestem

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A Federal Lawsuit charges Dr. Margaret Hamburg, former Commissioner of the Food and Drug Administration (FDA) with conspiracy, racketeering & colluding to conceal deadly drug dangers – under the federal Racketeer Influenced and Corrupt Organizations law (RICO) law.
I suppose I am being sexist, but I really hate it when I see that a woman has been involved in something like this. :grumpy:
 

Valentijn

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It sounds like this is a lawsuit by a group of citizens, not something which involves criminal charges. The title of the original article is pretty sloppy. The former commissioner is being accused, not charged.
 
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The FDA admits to knowing about the dangers of fluoroquinolones since July 2008. Then another FDA warning came about in August 2013. And in November 2015 the FDA discussed it again. Then the link below is a FDA Safety announcement dated 5-12-2016.


The FDA still has not banned fluoroquinolones.

What is the role of the FDA?

"FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation."​

http://www.fda.gov/AboutFDA/WhatWeDo/

I think we need to rename the FDA from "Food and Drug Administration" to "Failed Drug Adminstration"