Gut gemacht,vielen Dank im Namen aller Betroffenen! Wuensche den Teilnehmern gutes Gelingen und alles Liebe und Gute!
Siehe weiter unten mein Text an die EMA :
Thank you very much for sharing this information with us.
Your contribution will be forwarded to our Safety Committee (PRAC) and taken into consideration during the ongoing review of quinolone and fluoroquinolone medicines.
The public hearing will be broadcast live from our website (
www.ema.europa.eu), if you would like to follow it on the day - 13 June (from 13:00 to 18:00, UK time).
Kind regards,
Marcia
Marcia Martins
Public Engagement Department
European Medicines Agency
30 Churchill Place | Canary Wharf | London E14 5EU | United Kingdom
PublicHearings@ema.europa.eu From: Melanie Bauernfeind [mailto:melanie.suedafrika@yahoo.de]
Sent: 08 June 2018 16:33
To: Bere Nathalie; Public Hearings
Subject: My FQ story public hearing London
God afternoon Nathalie
My name is Melanie Ludwinski and my husband Gerald got floxed in Mai/June 2016 by taking Tavaloxx (Levofloxacin) 750mg and Mofloxx (Moxifloxacin) 400mg, prescribed by his GP to treat his ear drum and ear canal infection. To make matters worse, he was also treated with cortisone in the form of pills, injections, droplets and nasal spray – the standard therapy to ease swellings. It was ridiculous and reckless by the GP to prescribe reserve antibiotics to treat a ‘simple’ ear infection; that is what the FQ antibiotics were developed for, as a last option in a life threatening situation! In July 2016 the side effects started with extreme Achilles tendon pains and beginning of August 2016, my husband googled ‘Achilles Tendon and Fluoroquinolone Antibiotics’ and was able to make the connection, while he was getting weaker day by day. In October 2016 we stopped counting at 39 serious side effects, some of them were life threatening. The doctor’s quote when my husband was hospitalised in October 2016: “that was a close shave”. By then, my husband was bed-bound, could barely walk, couldn’t lift up a glass of water or press the button at the TV remote for example and had terrible pain in his whole body and muscle cramps plus burning sensations like putting boiling oil over his body, which the Doctors were not able to control or ease not even by giving him opiates (it is now clear, that his receptors are damaged so no kind of pain medication is working!).
It is terrible to watch your loved one suffer the way, my husband is affected by these FQ antibiotics, which can easily be used as a chemical weapon. On top it makes me very cross and upset, going through all these horrible experiences we had by consulting various doctors and specialists. From denying (‘impossible, that the cause were the FQ antibiotics’), to ironic comments (‘shame, that comes with age’ – my husband is born in 1963), disbelief and pretending they have experiences in treating FQ side effects and made matters even worse, we had it all. They make you feel, like you are an idiot and/or an alien. How hard can it be as a doctor, just to get at least some information and read the possible side-effect list in the medication, they prescribe on a daily basis? It is ridiculous to read the following note in a package leaflets: if you notice any side effect, please contact your doctor or pharmacist. And then what? They have absolute no clue and it feels quite ironic to read that.
The leaflets should be updated regarding the half life time. FQ binds with metals like e.g. magnesium, copper, zinc etc. which have a positive charge; the body cells have a negative charge so of course, the FQ binds to the cells. If the cell is during its life time dying, the electrical charge is fading away as the mitochondria is dying and the FQ/metal positive charge is connecting with the next active, negative charged cell. That makes the half life time to be more likely unknown or maybe it’s even a never ending story.
The leaflets should also being updated regarding the cases of being affected by any side-effects. As a patient you are getting currently the impression that it is more likely to win the lottery jackpot or struck by lightning, than being affected by side-effects from FQ – and that meets absolutely not the reality. But if the leaflet would describe all possible side effect, it would be as thick as the telephone book/yellows pages in former days from a big city.
So far, worldwide there is no known treatment to heal the side effects of FQ and the wide spectrum and complexity of serious side effects, the damage on each cell and destructive action on subcellular level, the DNA-, RNA- and Mitochondria damage, disturbances on hormones, nervous systems etc. makes it impossible, to find that ONE solution. Even the US Army (where money and highly trained scientists are available) until today is unable to help the victims of FQ side effects when hundreds of thousands of young and fit soldiers were given Ciprofloxacin in the Gulf War I and II beginning of the 1990 and 2000 as a prevention medication for possible anthrax attacks. So, the wide spread side effects are known for a very long time but it seems, there is a big failure in the communication and handling these reserve antibiotics and from my point of view it is a scandal. I also wonder, why the EMA is only having a public hearing in June 2018 while the FDA is having more than enough proof to restrict and black box labelled FQ antibiotics for years as an ongoing process. Even Bayer sent a warning letter in August 2016 to the FDA (the letter is available on the Floxiehope web page in case you don’t have it), that the use of Fluoroquinolone should be limited because of disabling and possible irreversible serious and life threatening side effects – so I really wonder, what else do you need and what are you waiting for to take action to inform and protect the European patients? From my point of view it is unacceptable that as a patient you have to find first the cause why you are suffering (when you are already weak and sick and especially vulnerable) before a doctor confirms the FQ side-effects, than you have to help and treat yourself because there is no know treatment yet, you have to pay for your treatment out of your own pockets and with your very limited energy while being severely sick to mobilise via social media, self-help forum of FQ victims etc. that at least the EMA public hearing is taking place in London? Doesn’t it mean, that the EMA failed his mandate to inform and protect the patients?
FQ antibiotics should be extremely restricted and should only be given patients while they are hospitalised by especially trained and informed medical doctors, pharmacologists and nurses. There should also be (after informing the patient verbally about the severe side-effects) a form that every patient needs to sign, that she/he understood the risks before taking any FQ antibiotics. The warning is supposed also to include the important information, that cortisone, antihistamine, PPI’s and any anti-inflammatory medications increase the risk of severe side-effects. To give the patients at least a minimum of protection, they should also be given (with the FQ Antibiotics) Probiotics (to protect the gut flora) plus R Form Alpha Lipoic Acid (to protect the cells).
It would also be great, if there is in the near future a kind of a disease code so that all involved medical health related stuff as well as health insurance companies are in the picture, what they have to deal with. I wonder, why there is not a big outcry from the health insurances because they have to cover the costs for countless specialised doctors, radiology, lab testing, physiotherapy and so much more, while the Pharmaceutical Industry is getting the benefit from the sales of FQ? And the question should also be raised, who is paying for all the expenses from FQ side-effected victims, which are not covered by a health insurance company? Who is compensating the losses of income? And last but not least: what about a fund (provided by the Pharma Industry) for getting various scientists together (maybe at the Cochrane Institute because they are a non-profit/non-government organization) so that they’ll have a deeper look into the matter and starting finding solutions? The world seems to be a funny place. For example: VW never injured or killed anybody (regarding the Diesel scandal) they just lied and they had to pay so far over 20 Billion Euros for compensation and in fines. The FQ manufacturers killed many thousands of people, disabled and crippled them and destroyed many lives and they are getting away Scot free. According to the law, if you harm a person, you are liable and you must pay and regarding the leaflet information, they were withholding crucial information.
Now in June 2018 my husband is still in terrible pain constantly. For nearly 2 years there is absolute no social life for us at all. That means, he is not able to join a birthday party, a dinner with friends, no holiday trip because he is unable to sit with his legs down for longer than +/- 30 minutes so travelling is a mission impossible. I am sick and tired to explain, why my husband is not able to join a function because people’s life is going on like usual while ours is far from normal.
Anyway, Gerald as a chemist and biochemist (MSC Chemistry and Biochemistry) is treating himself (in order to support the regeneration of the peripheral nervous system as well as the cell proliferation and production of healthy mitochondria in the best possible way) with large amounts of specific bioidentical and organic vitamins, minerals, micronutrients, trace elements, amino acids, enzymes and bacteria. But of course, that is extreme expensive – we are talking about spending between 800 and 1.000 Euro a month since August 2016! Because of Gerald’s before mentioned condition, he as a self-employed consultant is only able to work maximum half days so on top of being every day in extreme pain, having a non-existing social life comes on top to the financial difficulties but who cares except myself and my husband?! It makes my heart very sore, to see my husband suffer day after day after day. What the future will bring, luckily nobody knows. But the long-term outlook for FQ side-effected patients is not glory at all.
Please also note, that I am glad, that FQ antibiotics were developed as a last option to save lives in cases of multiple, life threatening infections/situations. But please make sure, that these reserve antibiotics are not prescribed for simple and uncomplicated ear, bladder and sinus etc. infections.
I Melanie Ludwinski and my husband Gerald are German Citizen
Kind regards
Melanie Ludwinski