To Whom It May Concern,
My name is John Fratti. I work for the Food and Drug Administration as an FDA Patient Representative for Drug Safety. It is a paid part-time position. I am unable to work a full-time job. I have sustained injuries from being prescribed Levaquin, a fluoroquinolone antibiotic. I have documented nerve, tendon, and central nervous system damage. To give a brief background, I was a pharmaceutical sales representative for over seven years and had a master’s degree. I was healthy and athletic until I was prescribed Levaquin in 2005. I haven’t been the same since. I have lost over $250,000 in lost wages and another $30,000 in out of pocket medical and insurance costs. The finacial loss pales in comparison to the physical suffering that I have endured for the last six years of my life. I now have to take several strong prescription pain medications for my injuries. I never took anything prior to Levaquin.
What has happened to me and a significant number of other people from Levaquin and other fluoroquinolone antibiotics is tragic. Approximately half of the fluoroquinolone antibiotics that were once on the market have now been removed from clinical practice due to their severe toxicities. Examples include Trovan, Tequin, Omniflox, and Zagam. This antibiotic toxicity affects not only the person injured/disabled, it also affects the rest of the family. www.Antibiotics.org provides a good overview on this subject.
I made a difficult trip to the FDA to present my documentation on Levaquin toxicity. The injuries and disability from Levaquin is a cost that is being passed on from the manufacturer to the general public.
The public sector has to pay, in higher taxes, for social security disability, increased medical care costs, and lost productivity from these severe adverse reactions. Buried in the fine print of the package insert it states that Levaquin can cause irreversible pain and irreversible neurological disorders. Patients should be given the right of informed consent and better disclosure concerning a drug that can cause irreversible damage. A study of adverse drug reactions in Italy, published in 2005, found that among more than 50 types of drugs, fluoroquinolones accounted for 11 percent of all adverse events and were involved in the largest number of serious problems.
Recently, PBS did a ten minute national news segment on fluoroquinolone antibiotic toxicity. The PBS link for this news segment is at the following address:
Watch Certain Antibiotics Spur Widening Reports of Severe Side Effects on PBS. See more from PBS NewsHour.
In addition, a Levaquin documentary called “Certain Adverse Events” is currently winning numerous awards at various film festivals across the country. The documentary can be seen on Youtube under the same title. The website for the documentary is www.certainadverseevents.com The film also explores the lack of drug safety at the FDA.
I bought shares of Johnson and Johnson ( JNJ ) stock which allows me the right to attend their annual shareholder meeting. Fortunately, I do not live far from their headquarters. I was able to speak on the microphone during the question and answer period directly to the CEO, Mr. William Weldon, the Board of Directors, and the shareholders. My shareholder speech was very civil and respectful even though I felt otherwise. I asked for more safety warnings on Levaquin. I received a loud round of applause from the shareholders. The JNJ shareholders were very conscientious. Unfortunately, the CEO and Board of Directors were not. It is a matter of profits over people. Corporate greed and FDA negligence is the reason so many of us have been seriously injured or disabled from Levaquin. Many people suffering are in wheelchairs or are using walkers or crutches.
A recent FDA Freedom of Information Report for Levaquin from 11/1997 to 5/2011 lists 20,243 individual safety reports filed and 1,174 death outcomes linked to Levaquin. These numbers are the tip of the iceburg since, according to the FDA, over 90% of adverse reactions to medications go unreported to the FDA Medwatch system.
In an excerpt from Levaquin Clinical Trial N93-006, the medical officer indicates that this clinical trial has “significant flaws” in both the protocol design and implementation. The term “significant flaws” is used in 4 of the 10 clinical trials for Levaquin on which its approval in 1997 was based. The other clinical trials may also have been flawed, but it was not noted. While the flaw issues do not address safety/adverse events, a vaild argument could be made that any flaws could potentially impact the accurate assessment of safety and adverse event issues.
Through a lot of hard work, I was able to get letters from nine of my elected officials in Pennsylvania to be sent to the FDA on this subject. Letters were sent from both Senators, one Congressman, and six State Representatives. The FDA has refused to take any action. Not even a minor label change. About half of the doctors on the FDA “Safe Use” panel have received drug industry money either directly or through the organization that they represent. The doctor that orginially approved Levaquin to be on the market, is on this FDA “Safe Use” committee. I feel this represents a conflict of interest that has caused many americans to suffer preventable disabilities from this class of antibiotics, especially Levaquin.
Thank you for taking the time to read this letter.